The patent application process is complicated, with many technical and procedural requirements that many businesses, entrepreneurs, and inventors are unaware of. The path from concept to patent grant takes considerable work, expertise, and time. Each stage of the process carries distinct legal and procedural requirements under U.S. patent law. This article details the steps involved in obtaining a utility patent through the United States Patent and Trademark Office (USPTO) and the typical timeline.
There are three main types of patents: utility patents, design patents, and plant patents. This article focuses on the utility patent application process. The patent application process in the United States is governed by federal statutes and regulations implemented by the USPTO. A patent grants the inventor exclusive rights to exclude others from making, using, selling, or importing the claimed invention for a limited term, typically 20 years from the original filing date of the utility patent application.
Typically, the patent application process takes anywhere from about one year from the time of the filing date to two or more years, depending on the complexity of the invention and the particular art unit that handles the application. Some art units are more impacted than others, leading to longer wait times. For example, art units that handle business methods, software-based inventions, and financial technologies (such as those within Technology Center 3600) often experience significantly longer average pendencies, ranging from three to five years or more before a final disposition. This is due to both high application volumes and more intensive scrutiny under 35 U.S.C. § 101, which deals with whether the application covers proper subject matter that is eligible for patent protection.
In contrast, applications assigned to less burdened art units, such as those handling mechanical inventions or certain chemical technologies (e.g., Technology Centers 1700 and 3700), often proceed more quickly, with some applications being examined and allowed within 12 to 18 months from the filing date.
Applicants can take specific actions to avoid unnecessary delays during the examination process, which are discussed below.
Before beginning the filing process, a thorough patent search is strongly recommended. This search helps determine whether the invention is novel and non obvious in light of prior art, which includes previously granted patents, published patent applications, and other publicly disclosed information.
A prior art search can identify references that may be cited during the examination process. The prior art search and analysis will indicate how smooth the examination process will be. If there is closely related prior art, then the examination process is going to be difficult and prolonged. Your patent attorney will likely need to submit multiple rounds of claim amendments and legal arguments to convince the patent examiner that your invention is patentable. The prior art search can also help the patent attorney craft the scope of the claimed invention to put the patent application in a better form for examination, allowing them to focus on the aspects of the invention that are distinct from the related search results.
There may be good reasons for filing a provisional patent application instead of a non provisional patent application. The decision affects the application process, patent rights, and timeline. A provisional patent application can be an attractive option for several practical reasons.
First, it can be a cost-effective way to secure an early filing date without the formalities and expense of a full utility non-provisional patent application, while still allowing the applicant to legally use the term "patent pending" in connection with the invention. This can be especially useful for startups, individual inventors, or early-stage companies that are seeking funding, evaluating market interest, or refining their invention before committing to the full costs of prosecution.
Second, a provisional application can serve as a strategic placeholder. It gives the applicant up to 12 months to further develop the invention, conduct market research, or seek partnerships while preserving the filing date as a priority date for any subsequent utility non-provisional application claiming benefit of the provisional.
Filing a provisional application does not initiate substantive examination by the USPTO and does not result in a patent grant unless a utility non-provisional patent application is filed within 12 months. This means that while the provisional filing preserves rights, it effectively delays the start of the examination process. As a result, the overall timeline to get a patent may be extended by up to one year. Nonetheless, this delay can be beneficial, as it provides time to improve the invention and prepare a stronger, more complete utility application.
In sum, the choice to file a provisional patent application can provide flexibility, cost savings, and strategic advantages, particularly when an invention is still being finalized or when immediate protection is needed while preparing for a full utility application.
A provisional application establishes a provisional filing date. It does not require claims, an oath or declaration, or formal drawings, but it must fully describe the invention to satisfy the written description requirement under 35 U.S.C. § 112. A provisional application gives the applicant 12 months to file a corresponding non-provisional application that claims the benefit of the provisional filing date.
The utility non-provisional patent application is the formal document examined by a patent examiner. It must include at least one claim, an abstract, a specification with sufficient detail, and drawings where applicable. This is the application that initiates the full examination process, leading either to a patent grant or final rejection.
Applications may be filed electronically through the USPTO’s Patent Center. To complete the filing process, applicants must submit several key documents, including a specification that describes the invention in detail, at least one claim that defines the scope of legal protection sought, and any necessary drawings that support the disclosure. An oath or declaration must also be included, affirming the inventorship and compliance with relevant legal standards. Additionally, applicants must pay several required fees, which include filing fees, a publication fee, and an issue fee.
Beyond these initial fees, applicants are also responsible for paying a search fee and examination fee as part of the review process. Once a patent is granted, ongoing responsibilities include the payment of maintenance fees at regular intervals to keep the patent in force. These fees are due at 3.5, 7.5, and 11.5 years after the date of patent grant and are critical to maintaining patent rights for the full term.
After submission, the utility patent application enters the examination process. A patent examiner at the patent office (USPTO) reviews the application for compliance with legal requirements such as novelty, non-obviousness, and adequate disclosure.
The examiner begins by performing a prior art search and comparing the claimed invention to existing references. This stage may take between 12 and 18 months after the filing of a nonprovisional application, depending on the assigned art unit and examiner workload. Following this search, most applications receive a first office action, which typically contains one or more grounds of rejection. This first office action is part of standard patent prosecution and does not terminate the application.
Applicants are given an extendable deadline of three months to respond to an office action in order to avoid incurring extension fees, though the deadline may be extended by up to three additional months with payment of appropriate fees. The typical back-and-forth with the examiner adds anywhere from 3 to 6 months to the overall timeline.
If the examiner maintains the rejections after a response, a second office action is often issued, and in many cases this will be a final rejection. Upon receiving a final rejection, applicants may file a Request for Continued Examination (RCE) to continue prosecution before the same examiner, which typically adds another 4 to 6 months to the pendency. Alternatively, applicants may choose to appeal the rejection to the Patent Trial and Appeal Board (PTAB), a process that may extend the application timeline by 1 to 2 years or more depending on the complexity of the issues on appeal.
Because of this iterative process, the total pendency of a utility application from filing to final disposition (either allowance or abandonment) can vary significantly, often ranging between 12 and 48 months. This timeframe depends not only on the responsiveness of the applicant but also on the nature of the invention and the efficiency of the assigned art unit.
Once the patent examiner reviews and allows the application, the applicant must pay the issue fee. After that, the patent grant is issued, conferring enforceable patent rights. Patent owners must continue to pay maintenance fees at 3.5, 7.5, and 11.5 years to keep the patent active.
Applicants can take specific actions to avoid unnecessary delays during the examination process.
Submitting a complete and compliant application with well-drafted claims, a thorough specification, and high-quality drawings can help prevent early rejections. Promptly responding to office actions, avoiding unnecessary claim amendments that introduce new issues, and engaging in proactive interviews with the examiner can also facilitate more efficient prosecution.
Additionally, programs such as the Track One prioritized examination can reduce pendency to under 12 months for an additional fee and may be a worthwhile option for applicants seeking an expedited patent grant. Track One is available for utility and plant patent applications and allows for final disposition within about 12 months from the grant of prioritized status. To qualify, the applicant must submit a complete application with no more than four independent claims and thirty total claims, and pay an additional prioritized examination fee and processing fee.
Other acceleration programs also exist. Applicants who are 65 years or older, or whose health or other circumstances justify expedited handling, may file a petition to make special based on age or health. Also, first-time filers that also qualify as micro-entities can accelerate their applications with the submission of a form. These petitions are typically granted without requiring additional fees.
Participation in these programs can be especially valuable when the applicant is seeking early market entry, investment, or licensing opportunities. However, they require careful preparation to ensure eligibility and maximize the likelihood of success.
Patent attorneys play a critical role in crafting strong claims, responding to office actions, and ensuring procedural compliance. A patent attorney can also advise you as to the accelerated prosecution options that may be available to you. Consulting a qualified patent attorney is especially important for complex technologies or strategic filings.
A frequently asked question is, how long does it take to get a patent? The answer depends on several factors, including the technology area, filing completeness, examiner workload, and responsiveness to USPTO communications. As described in earlier sections, the type of application filed also plays a role. Filing a provisional patent application delays substantive examination by up to 12 months, as no action is taken by the USPTO unless a nonprovisional is filed within that time.
Following submission of a utility nonprovisional patent application, examination typically begins between 12 and 24 months later, depending on the assigned art unit. The initial office action generally issues within that time frame, and each round of examination and response can add 6 to 12 months. In the case of a final rejection, further actions such as an RCE (4-6 months) or appeal to the PTAB (1 to 2 years) can add significant time. As a result, the average timeframe for a final disposition, either a patent grant or abandonment, is a broad range of 12 to 48 months.
U.S. applicants may also pursue foreign patents through national or regional patent applications, such as those filed with the European Patent Office. Under the Patent Cooperation Treaty (PCT), a foreign application can be filed based on a U.S. utility application within 12 months to preserve priority.
During the national phase, applicants must comply with the legal and procedural requirements of each designated jurisdiction. Differences in examination, language, and formality rules can affect timing and outcomes.
Compared to the European Patent Office, where examination timelines also span several years, the U.S. pendency is an average timeframe compared to international patent offices. For applicants seeking a quicker path to issuance, several accelerated examination programs are available. The Track One prioritized examination program, for example, allows qualifying utility applications to reach a final disposition within 12 months from prioritized status for an additional fee. Other options, such as the Accelerated Examination Program or petitions to make special based on age or health, also provide pathways to expedited review. These programs can be especially beneficial for applicants pursuing time-sensitive commercialization or funding strategies.
The U.S. patent application process is complicated and requires a high degree of skill to handle successfully. Each phase requires careful attention and timely action.
There is no exact answer to the question "how long does it take to get a patent?". The answer depends heavily on how well the process is managed. We find that the average length of the process is in 18-24 month range, but it is highly variable. By engaging experienced professionals, inventors can maximize their chances of securing their intellectual property rights in a timely manner.
If you are considering pursuing a patent application, contact our office for a free consultation.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Businesses and entrepreneurs often face a critical problem: they fail to recognize patentable subject matter in their innovative products or services and inadvertently forfeit valuable patent rights by entering the marketplace without first filing a patent application. Whether developing cutting-edge digital technologies, advanced electronics, chemical innovations, novel consumer products, or new machinery, innovators must understand how to protect their creations from the outset.
In the United States, there is a limited grace period (12 months for utility patents and 6 months for design patents) after public disclosure, sale, or offer for sale of an invention during which a patent application can still be filed. If the application filed is not submitted within this grace period, the invention becomes part of the public domain, and the patent applicant permanently forfeits the right to obtain a patent grant for that invention.
First-time patent applicants, tech startups, and other innovators must understand when to initiate the patent process to avoid losing protection. Understanding patentable subject matter and recognizing potentially patentable innovations enables inventors to investigate patent protection and maximize the commercial value of their developments.
This article provides an overview of the types of inventions that may be protected under U.S. patent law pursuant to 35 U.S.C. §101. We also discuss important aspects of design patents, plant patents, and developments under European patent law to give innovators a comprehensive guide to safeguarding their innovations.
Under 35 U.S.C. §101, a patentable invention must be a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." This definition encompasses substantially every invention that falls within the "useful arts," but it is not without limits.
The most common type of patent is a utility patent, which protects functional inventions and innovations. Four categories define utility patent eligibility under U.S. patent law, each requiring that the claimed invention be new, useful, and directed to eligible subject matter.
To be eligible, the invention claimed must meet the utility requirement, meaning it must serve an intended purpose and provide some identifiable benefit. While the threshold for utility is low, courts and the patent office have occasionally rejected inventions for lacking practical utility, such as perpetual motion machines or other devices that violate the laws of physics.
Despite the breadth of §101, courts have carved out certain judicial exceptions to what is considered patentable subject matter. Subject matter that falls into these judicially created categories are non-patentable:
A claimed invention that falls into one of these judicial exception categories is not patentable unless it includes additional elements that amount to "significantly more" than the judicial exception itself—a standard articulated in landmark cases such as Alice Corp. v. CLS Bank, 573 U.S. 208 (2014) (regarding abstract ideas implemented on a generic computer) and Mayo Collaborative Services v. Prometheus Labs, 566 U.S. 66 (2012) (regarding laws of nature in medical treatment methods). In practice, this means the invention must incorporate an inventive concept sufficient to transform the judicial exception into a patent-eligible application.
To be eligible for a patent grant, an invention must satisfy three primary patentability requirements: (1) it must be within the statutory subject matter defined by §101, (2) it must be novel under §102, and (3) it must be non obvious under §103. This article focuses on the first prong—patentable subject matter.
The novelty requirement ensures that a claimed invention is new and has not been disclosed in the prior art before the filing date of the patent application. Under 35 U.S.C. §102, an invention is anticipated, and therefore not novel, if a single prior art reference discloses each and every element of the claimed invention, either expressly or inherently. Anticipation requires that the prior art enable a person of ordinary skill to make and use the invention without undue experimentation. If an invention is anticipated, it cannot receive a patent grant because it does not add anything new to the public domain. Click for a more in-depth explanation of novelty.
The non-obviousness requirement, set forth in 35 U.S.C. §103, mandates that a claimed invention must not be an obvious variation of the prior art to a person having ordinary skill in the relevant field. Even if an invention is novel, it is not patentable if the differences between the invention and prior art would have been obvious at the time the patent application was filed. Courts assess non-obviousness by considering factors such as the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of skill in the pertinent art. Click for a more in-depth explanation of obviousness.
A critical step in determining whether your invention is patentable is conducting a thorough patent search and prior art search. The United States Patent and Trademark Office (USPTO) evaluates whether the claimed invention is novel and non obvious in view of the prior art, which includes any printed publication, earlier patent applications filed, or known uses. As each patent application must be tailored to the unique attributes of an invention, a thorough prior art search is essential to achieving a patent grant.
In the U.S., an application filed can take the form of a provisional application or a non provisional application. A provisional application is a placeholder that establishes an early filing date but is not examined. A non provisional application is the full patent application examined by the USPTO.
A design patent protects the ornamental appearance of an article of manufacture, rather than its utilitarian features. Unlike a utility patent, which protects how an invention works, a design patent protects how an article looks. This includes the shape, surface ornamentation, or a combination of both applied to an article of manufacture.
To qualify for design patent protection, the design must meet several specific requirements:
The scope of protection for a design patent is limited to the visual features shown in the submitted drawings, making the preparation of accurate and comprehensive drawings critical to the patent process. Term protection for U.S. design patents is 15 years from the date of patent grant, with no maintenance fees required during that period. Click for a more in-depth explanation of design patents.
Under 35 U.S.C. §161, a plant patent may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant. The plant must be asexually reproduced (not grown from seed), not found in an uncultivated state, and distinct from known varieties. Examples include new rose or apple tree cultivars. Like utility patents, plant patents last for 20 years from the filing date. Click for a more in-depth explanation of plant patents.
Under European patent law, the criteria are slightly different but similar in concept. The European Patent Convention (EPC) recognizes patentable inventions if they have industrial applicability, are novel, and involve an inventive step. Under EPC Article 56, the "inventive step" requirement is akin to obviousness; what matters is whether the claimed invention would have been obvious to the person skilled in the art, considering the state of the art as a whole.
Software inventions, for example, are treated more restrictively in Europe and must provide a "further technical effect" beyond a basic computer implementation. European practice also places emphasis on technical processes and disallows claims that are purely business, aesthetic, or mental in nature.
A valid patent gives the patent owner the exclusive right to exclude others from making, using, or selling the patented invention for a limited time. For utility patents in the U.S., that term is generally 20 years from the earliest effective filing date, subject to the payment of maintenance fees.
Ownership initially resides with the named inventors unless assigned. Patents can enter the public domain if maintenance fees are not paid, or if the patent expires.
It is important to distinguish patents from other forms of intellectual property, as different types of legal protection cover different aspects of creative and commercial endeavors.
Understanding these distinctions is essential for securing comprehensive intellectual property rights. Innovators often seek overlapping protection—for example, by obtaining patent protection for functional features, copyright protection for related written materials or designs, and trademark protection for product names and logos—to create robust legal safeguards for their creations and business assets.
Entrepreneurs that innovate and development novel products and services should understand how to identify patentable innovations. Whether your innovation is a composition of matter, a technical process, a novel design, or a new plant variety, being able to recognize whether it includes patentable subject matter can mean the difference between acquiring intellectual property rights or forfeiting them.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
The written description requirement under 35 U.S.C. §112(a) plays a foundational role in U.S. patent law. This requirement mandates that a patent specification contain a "written description of the invention" in a full and clear manner. Over decades, this statutory provision has evolved through jurisprudence to function as a gatekeeping doctrine that ensures an inventor was in "possession of the claimed invention" as of the filing date. This article surveys the written description requirement, including its statutory foundation, major case law, how it is applied by the courts and United States Patent and Trademark Office, and practical tips for satisfying the requirement.
The written description requirement is codified in the first paragraph of 35 U.S.C. § 112(a), which provides that the application must contain a written description of the invention, including the process of making and using it, in a full, clear, and concise manner as to enable any person skilled in the art to determine that the applicant was in possession of the claimed invention as of the filing date.
This language has been consistently interpreted by the courts to impose two distinct but related requirements: (1) a written description of the invention, and (2) enablement. The first clause—“a written description of the invention”—is not merely a preamble to the enablement requirement, but an independent obligation. The Federal Circuit reaffirmed this principle in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir. 2010), where the court held: “Section 112, para. 1, contains a written description requirement separate from the enablement requirement.”
In Ariad, the court emphasized that the statutory phrase “written description of the invention” refers to a disclosure that clearly allows a person of ordinary skill in the art to conclude that the inventor was in possession of the claimed invention as of the filing date. This requirement ensures that the claims define what the applicant actually invented, and are not speculative or based on an after-the-fact realization.
The statute is thus interpreted to require that the specification “conveys with reasonable clarity to those skilled in the art that, as of the filing date, the inventor was in possession of the invention,” as later claimed. The inquiry is factual in nature, assessed on a case-by-case basis, and varies depending on the complexity and predictability of the field of invention.
The written description requirement and the enablement requirement are distinct yet related obligations under 35 U.S.C. § 112(a). While both serve to ensure that the inventor has sufficiently disclosed their invention, they address different questions.
The written description requirement asks: Did the inventor actually invent the claimed subject matter as of the filing date? It focuses on demonstrating that the inventor had possession of the claimed invention and conveyed it with sufficient detail in the specification. In contrast, the enablement requirement asks: Can a person of ordinary skill in the art (POSITA) make and use the claimed invention without undue experimentation based on the disclosure?
For example, in Ariad v. Eli Lilly, the claims were directed to methods of reducing NF-κB activity. Although the specification described the desired biological effect and hypothesized mechanisms, it failed to describe any actual molecules or working examples that achieved the disclosed function. The court found a lack of written description because the inventors had not yet conceived how to perform the invention.
In contrast, a claim might satisfy the written description requirement but fail enablement if the invention is clearly possessed but the disclosure does not teach a POSITA how to practice the invention without "undue experimentation" (extensive research). For instance, where the applicant describes a complex genetic construct with no guidance on how to synthesize or deliver they may show possession but not enablement.
Thus, written description ensures the inventor had the idea, while enablement ensures the public can practice it. Both are required for valid claims.
At the core of the written description requirement is a fundamental and fact-intensive inquiry: Did the inventor possess the claimed subject matter as of the filing date? This inquiry is rooted in the statutory mandate of 35 U.S.C. §112(a), which requires that the specification contain a “written description of the invention.” The Federal Circuit has repeatedly emphasized that the purpose of this requirement is to ensure that the inventor had fully conceptualized and was in possession of the claimed invention when the application was filed—not merely an unformed idea or a research plan with a hoped-for result.
This possession standard is not satisfied merely by describing an end goal or a broad concept. Rather, the specification must convey with reasonable clarity to a person of ordinary skill in the art (POSITA) that the inventor had actually invented what is being claimed. This is evaluated from the perspective of the POSITA, taking into account the nature and predictability of the technology, and the level of detail required to reflect possession will vary accordingly.
The question of whether there is adequate written description is a fundamental factual inquiry that takes into consideration the entirety of the application, including the specification, drawings, and claims to determine whether there is sufficient evidence that the invention was captured in the original filing on the filing date sought. Possession may be demonstrated in a variety of ways, depending on the context and subject matter. The Federal Circuit has identified several illustrative examples of how written description may be satisfied:
In chemical and biotech cases, where claims are directed to compounds or molecules, the inclusion of precise structural chemical formulas may provide conclusive evidence of possession. For instance, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200 (Fed. Cir. 1991), the Federal Circuit stated that a claim to a specific DNA sequence lacked written description where the specification failed to disclose the sequence itself or any means to predict it.
The Federal Circuit considered whether certain claims in Amgen’s ‘008 patent, covering DNA sequences encoding erythropoietin (EPO), were valid under the written description requirement of 35 U.S.C. § 112. The dispute centered on whether the description in the application relied on by Amgen to demonstrate possession of the full scope of DNA claims, particularly those generically claiming any sequence encoding a polypeptide “sufficiently duplicative” of EPO to exhibit its biological activity, sufficiently supported the claims.
The Federal Circuit invalidated claims 7, 8, 23–27, and 29 for lack of written description. These claims drawn to generic DNA sequences were not sufficiently supported by the disclosure, which described only a limited number of EPO analogs. Although the specification asserted that numerous analogs could be created, the court found that Amgen had provided insufficient examples and technical guidance for producing DNA sequences other than the few disclosed. The court emphasized that the claims require a broad genus of DNA sequences, yet the specification only described and enabled a small subset.
Moreover, the court rejected the notion that the original claim language alone could support the expansive scope of these claims. The court reiterated that a claim's breadth must reasonably correlate with the scope of the enabling and descriptive disclosure. Because Amgen's application did not provide support for the full genus of claimed DNA sequences, the claims were found invalid under § 112(a).
Possession may also be shown by describing features or properties that allow a POSITA to recognize the claimed invention. This is especially relevant where an invention involves biological materials or genera of compounds. In Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed. Cir. 2002), the court acknowledged that a deposit of biological material, or a description of identifying characteristics, may suffice if it allows one to distinguish the claimed invention from others.
In Enzo Biochem, Inc. v. Gen-Probe Inc., the Federal Circuit addressed whether the disclosure in Enzo’s patent satisfied the written description requirement of 35 U.S.C. § 112 for nucleic acid probes specific for Neisseria gonorrhoeae. The case focused on whether descriptions in the specification, including references to deposited DNA sequences and their hybridization properties, adequately described the full scope of the claims.
The district court had granted summary judgment invalidating the claims, reasoning that they defined compositions based only on function, preferential hybridization to N. gonorrhoeae over N. meningitidis, and failed to describe the actual nucleotide sequences. However, the Federal Circuit reversed, holding that referencing a deposit in a public depository may be sufficient to satisfy the written description requirement when structural disclosure is otherwise unavailable. The court emphasized that deposits made the biological material accessible to the public and thus potentially descriptive.
To determine sufficiency, the court adopted the USPTO’s written description guidelines, which allow compliance through disclosure of sufficient details of the invention, such as structure, function when correlated to structure, or deposit. Although the exact terms of the sequences were not recited in the specification, the accessibility of the deposited material could establish disclosure.
The court held that if an applicant shows through deposit, function, and expert testimony that one skilled in the art could recognize the claimed sequences, the written description requirement may be met. Because factual questions remained, such as whether the described functional characteristics and deposited sequences were representative, the court remanded for further proceedings, acknowledging that presenting evidence on these issues could prove dispositive.
A description of how the invention was actually made and tested, including experimental results, can strongly support a finding of possession. This type of disclosure shows that the inventor did not merely theorize about the invention but actually implemented it in a working embodiment.
While functional claiming is permissible, merely reciting the function of an invention is not enough. The specification must include sufficient detail, such as representative species, examples, or structural information, to demonstrate that the inventor invented the means of achieving the function. In Juno Therapeutics v. Kite Pharma, 10 F.4th 1330 (Fed. Cir. 2021), the court invalidated claims to a genus of antibodies defined only by function, holding that the absence of representative examples rendered the disclosure inadequate.
The Federal Circuit reversed a jury verdict upholding the validity of claims in U.S. Patent No. 7,446,190, finding that the patent failed to provide an adequate written description of the claimed invention. The asserted claims were directed to a chimeric antigen receptor (CAR) comprising a CD3-zeta signaling domain, a CD28 costimulatory domain, and a single-chain variable fragment (scFv) binding element capable of targeting selected antigens, including CD19.
The Federal Circuit found that the claimed invention encompassed a functionally defined genus of scFvs, those that bind to a "selected target". However, the specification disclosed only two scFv examples, one binding to CD19 and one to PSMA, without amino acid sequences or other structural or functional details that would enable a person skilled in the art to identify which scFv perform the claimed function. The court emphasized that in cases involving genus claims defined by function, the specification must include either a representative number of species or structural features common to the genus members. Here, the patent specification did neither.
Testimony that scFvs were generally known in the art was insufficient to establish possession of the entire genus. The court concluded that the written description failed to demonstrate that the inventors possessed the full scope of the functional genus they claimed, particularly in light of the vast number of possible scFvs and the unpredictability of binding functionality. Accordingly, the claims were held invalid for lack of an adequate written description of the claimed invention.
Under both 35 U.S.C. § 112(a) and 35 U.S.C. § 132(a), an amended claim or a new or amended claim introduced during prosecution must be adequately supported by the originally filed specification. These provisions collectively prohibit the introduction of new matter, that is, subject matter not disclosed in the application as originally filed. If an applicant attempts to amend a claim to recite limitations not supported by the original disclosure, the U.S. Patent and Trademark Office (USPTO) may reject the claim for failing to comply with the written description requirement of § 112.
In In re Rasmussen, 650 F.2d 1212 (CCPA 1981), the Court of Customs and Patent Appeals addressed this very issue. There, the examiner rejected an amended claim under § 132 for improperly introducing new matter. However, the court held that the correct basis for such a rejection is § 112, not § 132. Section 132 prohibits the introduction of new matter procedurally, but the substantive inquiry into whether a claim is supported by the disclosure must be made under § 112. The court emphasized that a claim amendment must be grounded in the original specification and that failing to do so renders the claim unpatentable for lack of written description support.
Amendments to patent claims can become necessary to advance a patent application to a patent. For example, there may be prior art that renders the originally claimed invention obvious. When an applicant amends claims, especially to overcome prior art, the key question becomes whether the claim language finds support in the originally filed specification. If not, the amendment may fail for lack of adequate disclosure, even if the newly introduced subject matter would otherwise be patentable.
When an applicant claims a genus defined by functional language, the Federal Circuit has consistently held that the written description requirement under 35 U.S.C. § 112(a) imposes a heightened obligation to demonstrate possession of the full scope of the claimed subject matter. Specifically, the applicant must either (1) disclose a representative number of species falling within the genus, or (2) identify common structural features shared by members of the genus such that a person of ordinary skill in the art (POSITA) can visualize or recognize the scope of the claimed genus.
This principle reflects the concern that functional language, while potentially useful for claiming a broad invention, may overreach the actual contribution disclosed in the specification. Without sufficient structural guidance or exemplification, such claims may cover more than what the inventor actually invented and disclosed as of the filing date, violating the core tenet that patent protection is available only for that which the inventor possessed at the time of filing.
This doctrine was central in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which involved claims to a genus of monoclonal antibodies that bind to a specific epitope of the PCSK9 protein. The court found that although the patent described a few specific antibodies, the broad functional genus claim encompassed potentially millions of other antibodies. Because the patent failed to disclose a representative number of species or structural features sufficient to define the full scope of the genus, the claims lacked adequate written description support.
A similar result occurred in Juno Therapeutics, Inc. v. Kite Pharma, where the patentee claimed a chimeric antigen receptor (CAR) incorporating a single-chain variable fragment (scFv) that binds to CD19. The claims were defined functionally—by binding capability—but the patent did not disclose any actual CD19-specific scFv sequences or sufficient structural detail to represent the genus. The Federal Circuit concluded that the patent did not demonstrate that the inventors possessed the claimed genus and invalidated the claims for lack of written description.
These cases highlight the danger of overbroad functional claiming in unpredictable fields like biotechnology. To satisfy the written description requirement, an applicant must show more than a desired function or result. They must either exemplify a meaningful number of species within the genus or articulate structural characteristics common to the genus members. Absent such disclosure, the claims may be rejected or invalidated as lacking sufficient written description.
The Federal Circuit has played a central role in shaping and enforcing the modern contours of the written description requirement, particularly through a series of landmark decisions that have elevated the doctrine into a significant and sometimes controversial gatekeeper of patent validity. Prior to the Federal Circuit’s decisive intervention, the boundary between written description and enablement was often blurred, with courts and practitioners treating them as interrelated inquiries under a single statutory clause. However, this began to change with cases like Regents of the University of California v. Eli Lilly & Co., and culminated with the Federal Circuit’s en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly.
In Ariad, the Federal Circuit squarely addressed whether § 112(a) includes a written description requirement independent from the enablement requirement. The court answered unequivocally in the affirmative, holding that “[t]he specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” This doctrinal clarification marked a pivotal shift in patent law. Post-Ariad, the Federal Circuit has consistently enforced written description as a distinct statutory requirement, often applying it stringently, particularly in biotechnology, pharmaceuticals, and other unpredictable arts.
However, this aggressive application has not been without criticism. In his article, “The Federal Circuit’s En Banc Written Description Requirement: Time for the Supreme Court to Reverse Again,” Allen Yu contends that the written description requirement has become an ad hoc safety valve used by courts to invalidate claims they view as too broad or speculative, particularly in cases involving functional claiming or insufficient exemplification. Yu argues that rather than reflecting a coherent or principled doctrinal framework, the written description requirement has evolved into a policy tool that allows courts to avoid the more complex inquiries posed by enablement, such as the undue experimentation analysis.
Critics like Yu caution that this approach undermines the predictability and integrity of the patent system, allowing courts to impose unarticulated standards that may chill innovation, particularly in rapidly developing fields. Nonetheless, the Federal Circuit continues to treat written description as a distinct and essential safeguard that ensures the claims are commensurate with what the inventor actually disclosed and possessed as of the filing date.
The United States Patent and Trademark Office (USPTO) provides guidance to patent examiners on the application of the written description requirement under 35 U.S.C. § 112(a) through the Manual of Patent Examining Procedure (MPEP) § 2163. These guidelines reflect the USPTO’s interpretation of governing case law, particularly Federal Circuit precedent, and instruct examiners on how to analyze whether a patent application complies with the statutory requirement that the specification “contain a written description of the invention.”
The primary inquiry under MPEP § 2163 is whether the specification as originally filed reasonably conveys to a person of ordinary skill in the art (POSITA) that the inventor had possession of the claimed invention as of the filing date. To make this determination, the examiner must conduct a fact-specific analysis, grounded in the disclosure, the claim language, and the level of skill in the art.
The examiner is directed to assess whether the applicant has described the invention with sufficient detail to enable a POSITA to recognize that the inventor had conceived of the full scope of the claimed subject matter. This includes an evaluation of whether each claim limitation is explicitly or implicitly supported in the originally filed specification. Importantly, support does not require a verbatim match; instead, the specification must include adequate disclosure, through words, drawings, figures, or formulas, that reasonably conveys the inventor’s possession of the claimed features.
Where claims have been amended during prosecution, or where the applicant introduces new or amended claims, examiners must also determine whether these claims are reasonably supported by the originally filed disclosure. If not, the claim may constitute new matter, which is impermissible under § 132, and more substantively, the claim may fail the written description requirement under § 112(a). As clarified in In re Rasmussen, the appropriate ground for rejecting such a claim is § 112, not § 132, because the issue is one of insufficient support, not mere procedural defect.
The guidelines list several factors examiners should consider when determining compliance with the written description requirement. These include the predictability of the art, the breadth and nature of the claims, the level of detail provided in the disclosure, and whether the specification includes representative examples or structural features for any claimed genus. For example, in unpredictable fields like biotechnology, mere functional descriptions may be insufficient unless accompanied by representative species or clearly defined structural characteristics.
A written description rejection is appropriate when the examiner finds that a claim recites subject matter that is not adequately supported by the original disclosure. Examiners must articulate a clear rationale for the rejection, identifying the specific claim limitations that lack support and explaining why a POSITA would not have understood the inventor to have possession of those aspects of the invention.
Applicants can overcome such rejections by amending the claims to conform to the disclosure, submitting arguments demonstrating adequate support, or providing evidence, such as affidavits or experimental data, that clarifies what was conveyed in the original specification. Ultimately, the written description requirement ensures that patent rights are granted only for what was actually disclosed and possessed by the inventor at the time of filing.
The written description requirement under 35 U.S.C. § 112(a) has significant consequences for both the drafting of patent applications and their subsequent prosecution before the USPTO. Failure to satisfy this requirement can result in rejection of claims or invalidation during litigation. As such, applicants and practitioners must proactively draft specifications and claims that clearly demonstrate the inventor's possession of the full scope of the claimed invention as of the filing date. Below are practical guidelines and strategies to help meet this standard.
To minimize the risk of written description rejections, patent drafters should adopt several best practices:
When a patent examiner issues a written description rejection under 35 U.S.C. § 112(a), the applicant must demonstrate that the specification, as originally filed, sufficiently conveys to a person of ordinary skill in the art (POSITA) that the inventor was in possession of the claimed invention at the time of filing. To rebut such a rejection, applicants can rely on a variety of forms of objective evidence, so long as the evidence is consistent with and supported by the disclosure in the application as originally filed. Below are common and effective strategies for overcoming written description rejections during prosecution.
Illustrative drawings can be powerful tools in demonstrating possession, particularly in mechanical, electrical, or design-related inventions. The Federal Circuit and USPTO have acknowledged that visual depictions of a claimed structure, when detailed and precise, can serve as adequate written description support. For example, if a claim recites a particular configuration or physical relationship between components, a properly annotated figure showing these features may establish that the inventor was in possession of the claimed subject matter.
To be persuasive, the figures must convey the same limitations recited in the claims. Mere high-level illustrations, such as conceptual block diagrams, may be insufficient unless coupled with written explanation in the specification.
Experimental results and empirical data, even if not expressly included in the original application, may help show possession when they are consistent with the disclosure and aid in understanding the invention’s operation. For instance, in the chemical and biotech arts, data demonstrating binding affinity, therapeutic efficacy, or functional behavior can support broad functional claims—provided the claims do not exceed the scope of what the data substantiate.
Although post-filing data cannot substitute for original disclosure, the USPTO and courts permit the use of such data to corroborate that the original disclosure supported a claimed function or structure.
Where applicable, applicants may bolster written description by showing that the invention was actually reduced to practice before the filing date. If the inventor had physically constructed and tested the invention, and this is described in the specification or demonstrated through internal documentation consistent with the original disclosure, it can serve as compelling evidence of possession.
Reduction to practice must be clearly described or supported by corroborating documentation, such as lab notebooks, photos, or signed reports, especially in contested proceedings such as interferences or derivation proceedings.
If an examiner issues a written description rejection, the first step is to closely analyze the originally filed specification and claim language to determine whether there is a reasonable basis to infer possession. It may be possible to argue that the disclosure, even if not express, would convey the claimed invention to a person skilled in the art.
If not, consider narrowing the claim to match disclosed embodiments or amending the language to better align with the written description. Alternatively, where the current application cannot support the full scope of the claim, applicants may file a continuation-in-part (CIP) or rely on a parent application to establish priority and supplement the disclosure.
By understanding and anticipating written description issues, applicants can draft robust applications and implement effective prosecution strategies that minimize delays and strengthen claim validity.
The written description requirement remains a critical filter in the U.S. patent system, ensuring that claims define only that which was truly invented. The requirement serves not just to prevent overclaiming, but to reinforce the patent law quid pro quo—exclusive rights in exchange for public disclosure. Whether through the lens of functional language, structural chemical formulas, or descriptive means, compliance with the written description requirement must be evaluated on a case by case basis using an objective standard grounded in what a person skilled in the art would understand.
Ultimately, as courts continue determining compliance, inventors must appreciate that the written description is not merely a formality but a substantive mandate of reasonable clarity, grounded in the reality of skilled artisans and the public interest.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Business owners and entrepreneurs need to have a basic understanding of intellectual property law. Whether launching a startup, developing a product, or building a brand, you need to know how intellectual property rights can protect and affect your business. It is not uncommon for lay people to be unfamiliar with all the distinctions between trademarks and patents. This guide aims to demystify the differences between trademarks and patents, including how they are obtained, the protections they offer, and their distinct business values.
Intellectual property (IP) refers to creations of the mind, innovations, brand identities, artistic works, and more, that can be legally protected. IP protects these intangible assets from unauthorized use by granting exclusive rights to the creators or owners. The prominent forms of intellectual property protection include trademark protection, patent protection, and copyright protection.
Each type of IP protects different kinds of assets. Trademarks protect brand identifiers like logos and slogans, patents protect inventions, and copyrights protect creative works fixed in a tangible medium like books or motion pictures.
A trademark is a word, phrase, symbol, and/or design that serves to identify to consumers the source of the goods or services. When used for services rather than goods, the term service mark is sometimes applied, although "trademark" often refers to both.
Trademarks can include:
The purpose of a trademark is to create a connection between a product or service and the business that offers it. Trademarks help build a brand's reputation, ensuring consumers know what to expect when purchasing goods or services under that mark.
A registered trademark provides exclusive rights to use the mark in connection with specific goods or services. This can prevent other businesses from using the same name or confusingly similar marks.
A patent is a legal right granted to inventors that gives them exclusive rights to use, make, and sell their invention for a limited time, typically 20 years from the patent application filing date. A patent protects inventions, not brand names.
There are different types of patents:
The public is most familiar with utility patents, which is the focus of the discussion in this article. To learn more about design patents and plant patents, click the links. Patents are issued by the United States Patent and Trademark Office (USPTO) through a rigorous patent application process.
Intellectual property (IP) is a powerful asset that can significantly enhance a company’s competitive position and market value. Patents protect innovative products and processes by allowing patent owners to exclude competitors and generate revenue through licensing or exclusivity. Trademarks safeguard brand identity by securing exclusive rights to names, logos, and slogans, helping build consumer trust and recognition. Together, patents and trademarks provide the legal tools for protecting innovation and brand equity, often serving as key drivers of business growth, investment, and strategic partnerships.
A strong trademark helps consumers recognize and trust your brand. This builds brand loyalty, increases market share, and provides legal leverage against counterfeiters or imitators. Trademark protection also adds to your business’s valuation and can be a key asset during mergers or acquisitions.
A patented invention gives you a competitive edge by preventing other parties from copying your innovation. For companies that develop products or technologies, patents can create new revenue streams through licensing or sales. This is particularly critical in fields like machinery, chemical technologies, biotechnologies, medical devices, pharmaceutical drugs, and many others.
Trademark protection allows you to enforce your trademark rights against infringers, e.g., through trademark litigation in state or federal court to recover monetary damages and injunctions to prevent unauthorized use of your brand. Registration with the USPTO adds benefits like nationwide protection and constructive notice to the public.
Patents allow the owner to prevent others from making, using, or selling the patented invention, even if they developed it independently. This is critical for many types of business, and particularly in high capital investments fields such as digital technology, biotech, and energy technology where patent exclusivity is essential.
No. A trademark cannot protect a product or service's functionality. Conversely, a patent protects things like the structure of a new device, the function of a new device, chemical and material compositions (e.g., a novel drug, fertilizer, etc.), new methods of applying technologies (e.g., a new method of applying fertilizers to crops), new methods of making things (e.g., a new method of producing aluminum), and other useful innovations. A critical concept is that utility patents protect functional improvements in production, form, and use. However, it should be understood that a product might be protected by multiple forms of IP. For example, a smartphone’s function may be protected by a utility patent, its exterior design might be protected by a design patent, its branding by a trademark, and its software by copyright protection.
Copyright protection covers original creative works such as books, music, visual arts, and motion pictures. A copyright owner gets rights to reproduce, distribute, and display the work for the author's life plus 70 years. Also, copyrights are registered through the Copyright Office, not the USPTO.
Both patents and trademarks can be registered with the United States Patent and Trademark Office, which is the executive federal agency tasked with overseeing patent and trademark registrations.
The trademark registration process begins with conducting a comprehensive search of the USPTO database to confirm that your desired trademark is not already in use or registered by someone else. This search helps avoid conflicts and potential legal disputes down the road. Once you have cleared your mark, the next step is to file a trademark application with the USPTO. This application requires detailed information, including the owner’s identity, a clear representation of the mark, and a description of the goods or services with which the mark will be used. After submission, your application will be assigned to an examining attorney who will review it for compliance with federal trademark laws. If the examining attorney identifies any issues with the application, they will issue an office action to which the applicant must respond within the given timeframe.
If the application is approved by the examiner, it is published for opposition in the USPTO's Official Gazette. There is a 30-day opposition period during which third parties may oppose the registration of your trademark for various legitimate reasons (e.g., they were using the same or similar mark before you). If your application successfully overcomes any objections or oppositions, the mark will proceed to registration. To maintain the registration, you must file periodic renewals and declarations confirming ongoing use.
A patent application should be filed only if your invention meets the basic requirements for patentability: it must be novel, non-obvious, and useful. This typically involves conducting a prior art search to determine whether similar inventions already exist and evaluating whether your invention represents a meaningful advancement over what is already known. Once you have established that your invention is potentially patentable, the next step is to prepare a comprehensive patent application. This document must include a full written description of the invention, drawings, and one or more claims that define the scope of the legal protection being sought. Preparing the application requires precision and technical accuracy, as vague or overly narrow claims can significantly impact the value and enforceability of the resulting patent. After the application is filed with the USPTO, a patent examiner will review it and may issue rejections or objections in office actions. Responding to these rejections involves amending claims and/or presenting legal arguments to distinguish the claimed invention from the "prior art" (technology that existed before the application). If the application is allowed (approved by the examiner), a patent will be granted. Once granted, the patent owner has enforceable rights and intellectual property that can be licensed and commercialized.
Understanding the difference between trademarks and patents is important for any business looking to secure a competitive advantage. While trademarks focus on protecting your brand and its reputation in commerce, patents protect your innovation and ideas. Both are crucial forms of intellectual property protection that offer legal benefits and long-term value.
Additionally, business owners and entrepreneurs should not overlook the importance of registering their intellectual property. Protecting your IP safeguards your investment in branding and innovation, enhances your market position, and provides a basis for licensing the intellectual property.
Contact our office for a free consultation regarding your intellectual property and how it can protect and enhance your business.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Works for hire or “Works made for hire” is a statutorily defined category of works for which copyright ownership is transferred from artists and other creators to the party who commissioned their creative work (e.g., an employer or contracting enterprise). The work made for hire statute vests copyright ownership in the employer or commissioning party rather than the individual who actually created the work. However, the doctrine doesn't apply in every situation. There is some nuance in determining what constitutes a work made for hire. If you are in the content creation business or work with artists and creators, it important to be able to identify who holds the copyrights in commissioned works. The default presumption under copyright law is that the creator retains ownership, unless the work is made by an employee in the scope of their employment, or the work falls within a narrow set of statutory categories and is expressly designated as a work made for hire in a signed contract. Thus, clear, written agreements in the context of commissioned works are an important tool for avoiding later copyright disputes and loss of rights.
There are several persistent misconceptions surrounding the “work made for hire” doctrine that can lead to costly legal disputes. One of the most common misunderstandings is the belief that employers automatically own all works created by their employees, regardless of when or how the work was produced. In reality, for a work to qualify as a work made for hire under 17 U.S.C. § 101(1), it must be created within the scope of employment. If an employee creates a work entirely on personal time, using personal resources, and outside the duties of their job, the employer may not have any ownership rights.
Another common error is assuming that any work created by an independent contractor can be designated as a work made for hire with a simple clause in a contract. In fact, under 17 U.S.C. § 101(2), such a designation is only valid if the work falls into one of nine specific statutory categories and there is a written agreement stating the work is made for hire. Misconceptions also arise when parties attempt to retroactively assign work-for-hire status after the work is completed, which courts have consistently rejected. Finally, some mistakenly believe that payment alone—without a written agreement or qualifying employment relationship—confers copyright ownership. It does not.
Errors in contractual arrangements with graphic designers, authors, videographers, and other commonly commissioned content creators can lead to disputes about what you are lawfully able to do with things like logos, ad copy, audiovisual work like commercials, and other creative content for which you have paid.
Under the Copyright Act, a work is considered a “work made for hire” in one of two scenarios: (1) the work is prepared by an employee within the scope of their employment, or (2) the work is specially ordered or commissioned for use in one of nine enumerated categories, and there is a written agreement signed by both parties stating that the work is a work made for hire.
When a work qualifies under this doctrine, the employer or commissioning party, not the individual creator, is deemed the legal author and owner of the copyright from the outset. This can have significant implications for rights of reproduction, distribution, licensing, and enforcement. For employees, ownership generally rests with the employer if the work is created as part of their job duties. For independent contractors, however, the criteria are more stringent, and without a properly executed written agreement and qualification under the statutory categories, copyright remains with the creator.
Given the potential for disputes, parties involved in creative work should carefully consider copyright ownership and memorialize their intentions in writing at the outset of the engagement.
Works created by employees during their employment typically belong to the employer unless stated otherwise in a contract. This principle is rooted in the understanding that an employee’s contributions within the scope of their employment are made for the benefit of the employer. Under US copyright law, a work made for hire includes works prepared by an employee within the boundaries of their job responsibilities, including the work’s creation.
Typically, ownership rights of works created by employees are assigned to the employer, emphasizing that the creator does not retain the copyrights. However, the absence of a written agreement can lead to disputes over ownership, as the presumption of a work being for hire may only be overridden by evidence to the contrary. The status of a worker as an employee or independent contractor cannot be gamed. The status of the individual as an employee or independent contractor is defined by agency law and is determined by the nature of the relationship with the party commissioning the work, such as the level of control by commissioning party, the creator's tax treatment, and eligibility for employee benefits. Thus, attempts to control the ownership of copyrights in a commissioned work by characterizing an independent contractor as an employee are ill-advised and will not work.
Understanding whether a creator is an employee or an independent contractor is essential before commissioning any creative work, as this classification directly impacts copyright ownership. In Community for Creative Non-Violence v. Reid, 490 U.S. 730 (1989), the U.S. Supreme Court emphasized that the definition of “employee” under the Copyright Act must be drawn from common law agency principles. The case involved a nonprofit organization (CCNV) that commissioned a sculptor, James Reid, to create a statue. Although CCNV provided direction and funding, but Reid worked independently, using his own tools and studio, and retained full discretion over the creative process. The Court determined that Reid was an independent contractor, not an employee, and therefore the statue could not be classified as a work made for hire under § 101(1). This case highlights the importance of correctly identifying the creator’s status before work begins and, where the creator is an independent contractor, executing a clear and thorough written agreement in advance.
Clear, written agreements are crucial to delineate ownership rights and avoid potential conflicts. Both employers and employees need to understand the extent of their rights and responsibilities regarding the works created during employment, especially when the parties expressly agree on specific terms.
Independent contractors and commissioned work is treated differently under the work for hire doctrine. For a work to be classified as made for hire, the work must be (1) specially commissioned for specific uses like motion pictures, translations, compilations, tests, and atlases and (2) created under a signed agreement identifying the commissioned work as a work for hire. Works created by independent contractors must meet these criteria in order for the ownership of the work to be transferred from the independent contractor to the commissioning party.
For a work to be ‘specially commissioned’ under copyright law, it must be ordered by the hiring or commissioning party, agreed in writing as a work made for hire, and fit one of nine specific categories defined by the Copyright Act. The hiring party provides the specifications for the commissioned work, but doesn’t need exert full artistic control over the final product.
As discussed above, the “work made for hire” doctrine applies to two distinct scenarios: (1) works created by employees within the scope of their employment, and (2) certain commissioned works, but only if they fall within one of nine specific categories enumerated in Section 101 of the U.S. Copyright Act and if there is a written agreement stating that the work is to be considered a work made for hire. These categories are narrowly defined and apply only in limited circumstances. Below is a summary of each category:
To classify a commissioned work as a “work made for hire” under U.S. copyright law, there must be a written agreement executed before the work is created. This agreement must be signed by both parties and must explicitly state that the work is a “work made for hire.” Courts have consistently emphasized that without such a written agreement, the default rule applies: the creator retains copyright ownership, regardless of the commissioner’s expectations or financial investment in the project.
In Gladwell, the plaintiff, a government services contractor, alleged copyright infringement based on the unauthorized use of retention schedules it developed. Crucially, some of the materials in dispute had been created before the parties entered into a contract. The court held that these “Pre-Existing Materials” could not be retroactively designated as works made for hire because there was no written agreement executed before creation expressly stating that the works would be treated as such. The agreement's generic ownership clause did not suffice to transfer copyright ownership under 17 U.S.C. § 204(a). As a result, the plaintiff retained ownership and had standing to sue for infringement. The court emphasized that any assignment or work-for-hire designation must be made through a signed writing executed before the work is created.
Warren v. Fox Family Worldwide dealt with statutory categories of works eligible for commissioned work-for-hire treatment. Composer Richard Warren claimed ownership in over 1,900 musical compositions he created for the television series Remington Steele. Although Warren worked as an independent contractor, the court found that the compositions were works made for hire under 17 U.S.C. § 101(2) because the contracts fell within the statutory category of “a part of a motion picture or other audiovisual work.” The written agreements explicitly stated that the compositions were created as works made for hire and that the producer would own all rights. The court held that such musical works created specifically for use in a television series fell squarely within the statutory categories, and Warren, not being the legal or beneficial owner, lacked standing to bring a copyright infringement claim.
In contrast, in the Community for Creative Non-Violence v. Reid case discussed above, the work was a sculpture and did not qualify under 17 U.S.C. § 101(2) because it did not fall into one of the nine statutory categories of commissioned works eligible for work-for-hire treatment.
These cases underscore the importance of precise and timely agreements and proper subject matter. Even where there is a working relationship or financial exchange, courts will not infer work-for-hire status without an express, pre-creation agreement. To avoid disputes, parties commissioning creative work should consult a copyright attorney before the work begins to ensure proper contractual language is included. Attempting to retroactively assign work-for-hire status after a work is completed is legally ineffective and will not shift ownership away from the original creator.
When a work qualifies as a “work made for hire” under the Copyright Act, the employer or commissioning party is considered the legal author and automatic owner of the copyright from the moment of creation. This has important legal and commercial implications, as it eliminates the creator’s rights to control or reclaim the work in the future. The copyright never vests in the creator at all, thereby avoiding the need for any subsequent transfer, assignment, or license. The employer or commissioning party of a work for hire can directly apply for copyright registration of the commissioned work as legal author, rather than an assignee.
Commissioned works that qualify as works for hire are considered the work of the commissioning party and thus are not subject to some of the disadvantages of other forms of copyright transfers. To illustrate, when a copyright is initially owned by the creator and later transferred by assignment or is licensed, the transfer is subject to certain statutory limitations. Most notably, under 17 U.S.C. § 203, authors have a right to terminate a copyright assignment or license 35 years after its execution, even if the agreement states otherwise. This termination right does not apply to works made for hire. As a result, the commissioning party in a work-for-hire scenario benefits from long-term certainty of ownership and control without the risk of future reclamation by the creator or their heirs.
The employer or commissioning party of a work for hire can also directly apply for copyright registration of the commissioned work as legal author, rather than an assignee.
The duration of protection for works made for hire is different from that of individually authored works. Instead of lasting for the life of the author plus 70 years, a work made for hire is protected for 95 years from publication or 120 years from creation, whichever expires first. This term provides a more predictable term, eliminating mortality risks, and facilitates long-term planning for licensing, enforcement, and commercialization of creative assets.
In situations where the work made for hire doctrine does not apply, such as when a work is created by an independent contractor outside the statutory categories or without a qualifying written agreement, copyright ownership remains with the creator. In these cases, a properly executed copyright assignment is essential to transfer rights from the creator to the hiring party. A copyright assignment is a written agreement in which the original author expressly transfers some or all ownership rights to another party.
This assignment mechanism provides a legally enforceable means of acquiring copyright, even when work-for-hire status cannot be established. Assignments must comply with 17 U.S.C. § 204, which requires the agreement to be in writing and signed by the copyright holder or an authorized agent thereof. Hiring parties should seek assignment agreements before work begins or at the time of engagement to avoid disputes over ownership. Unlike work-for-hire, however, assignments remain subject to statutory termination rights after 35 years.
The “Works Made For Hire” doctrine is a central feature of the law regarding copyright ownership and rights. Employers, entrepreneurs, and creators should be aware of it. Those who remain ignorant of the work for hire doctrine do so at their peril. Consulting a copyright attorney prior to a transaction for a commissioned work is a prudent practice. You want to ensure all legal protections are in place before entering into any agreement. If you need assistance with a contract for a commissioned creative work or other copyright matters, please contact our office for a free consultation.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Trademarks serve as source identifiers, enabling consumers to distinguish the goods or services of one party from those of others. This function allows consumers to rely on trademarks as indicators of consistent quality, fostering valuable goodwill associated with the mark. Trademark owners often leverage this established reputation and value by extending their brand reach through licensing agreements with third parties. These arrangements can be mutually beneficial, generating revenue for the trademark owner and allowing licensees to operate under a recognized brand. However, this practice carries inherent risks if not managed carefully, as uncontrolled licensing can lead to the erosion and eventual loss of trademark rights.
The core principle underlying the naked licensing doctrine is that trademark owners need to maintain adequate control over the quality of goods or services produced or offered by licensees. The failure to do so can undermine the very purpose of a trademark, leading to consumer deception and the potential abandonment of the mark.
Naked licensing is raised as an affirmative defense in trademark infringement litigation to challenge the validity of the plaintiff’s trademark rights. The defense asserts that the trademark owner failed to exercise adequate quality control over a licensee’s use of the trademark, effectively abandoning the mark. If successful, this defense can be fatal to the infringement claim, as abandonment means the mark no longer functions as a source identifier and is unenforceable under the Lanham Act. Courts will evaluate whether the plaintiff maintained specific quality control measures, conducted meaningful supervision, or relied on a close working relationship that justified limited oversight. If the plaintiff cannot demonstrate actual control during the license period, the court may deem the mark abandoned—eliminating the basis for asserting trademark infringement. Thus, naked licensing not only rebuts liability but may extinguish the plaintiff’s valuable trademark rights altogether.
A finding of naked licensing can lead to a particular trademark being deemed abandoned. Rooted in the essential function of trademarks to signify consistent quality to consumers, this doctrine imposes a duty on trademark owners to maintain adequate quality control when they engage in trademark licensing. Naked licensing arises when a trademark owner licenses the use of the trademark but fails to exercise control over the quality standards of the goods or services offered by the licensee. In such cases, courts may hold that the mark has lost its distinctive character, rendering it no longer a reliable indicator of source and deem it abandoned.
Written trademark license agreements are essential in properly controlling licensed use of a trademark. In the context of enforcing a trademark in litigation, courts evaluate both whether the license agreement includes specific quality control measures and whether the licensor exercises meaningful supervision over the licensee's operations. A license agreement that includes contractual rights to inspect or approve products, conduct site visits, or review marketing materials helps support a finding of actual control. However, even with an express contractual framework, the trademark owner must actually exercise control.
A well-drafted written license agreement is the cornerstone of an effective trademark licensing relationship. It not only evidences the parties' intentions but also establishes a legal structure that supports the licensor's ability to exercise control over the licensee's use of the trademark. Without a written agreement containing enforceable quality control terms, the trademark owner's rights are exposed to attack by third parties asserting naked licensing and trademark abandonment.
To avoid these risks, trademark owners should ensure that any trademark license agreement contains comprehensive quality control provisions tailored to the particular goods or services being licensed. These provisions should explicitly state the quality standards that the licensee must adhere to and specify the licensor's right to monitor and enforce those standards. This may include submitting product samples for approval, allow site visits, or comply with detailed branding and marketing guidelines to ensure consistent quality.
Further, the agreement should grant the licensor an express contractual right to terminate the license in the event of quality control failures. Courts often view such termination clauses as evidence that the trademark owner retains ultimate authority over the use of the mark. The inclusion of periodic reporting requirements, submission of advertising materials for review, and performance benchmarks can also strengthen the licensor's position.
Importantly, the written agreement should also define the permitted use of the trademark, specifying the geographic scope, channels of trade, and nature of the products or services sold under the licensed mark. Limiting the scope of the license and requiring prior approval for any expansions helps prevent unauthorized or inconsistent uses that could diminish the distinctive character of the mark.
The touchstone case Kentucky Fried Chicken Corp. v. Diversified Packaging Corp., 549 F.2d 368 (5th Cir. 1977) involved a license granted by KFC to Diversified Packaging for the production of food packaging materials bearing KFC's trademarks. Although the license agreement did not set forth extensive quality control procedures, the court found that KFC's oversight—through approval of packaging designs and maintenance of product standards—was sufficient to avoid a finding of naked licensing. The court held that KFC's ability to review and approve the packaging materials ensured that consumers would continue to associate the mark with a consistent level of quality. The key takeaway from the case is that the level of control need not be onerous or frequent; rather, it must be reasonable under the circumstances to protect the source-identifying function of the mark.
In contrast, the Seventh Circuit in Eva's Bridal Ltd. v. Halanick Enterprises, Inc. reached the opposite result based on the complete lack of quality control. In that case, the original Eva's Bridal store had licensed the name to a family member operating an independent bridal salon. Despite the familial relationship, there was no written agreement, no oversight, and no supervision of the licensee's operations. The licensor neither inspected the store nor monitored the services provided. The court found this to be a textbook case of naked licensing, holding that "a mark is abandoned when the licensor fails to exercise adequate quality control over the licensee."
The policy rationale in Eva's Bridal rests on the consumer protection function of trademark law: trademarks serve as a signal of consistent quality and commercial source. Allowing licensing without oversight would erode consumer confidence and diminish the mark's significance. The Seventh Circuit made clear that personal trust, even within a family, is not a substitute for actual control.
Together, these cases demonstrate the balancing act courts perform: while KFC reflects a pragmatic tolerance for minimal but effective control, Eva's Bridal illustrates the risks of informality and assumptions of trust.
In FreecycleSunnyvale v. The Freecycle Network, the Ninth Circuit affirmed a finding that The Freecycle Network (TFN) had abandoned its trademark through naked licensing. TFN, a nonprofit organization promoting reuse through local community groups, allowed affiliated groups to use the Freecycle mark without formal license agreements or specific quality control measures. The court emphasized that TFN failed to exercise actual control over its licensees’ activities, did not conduct site visits, or enforce quality standards. While TFN argued that its members shared a common mission and that oversight was unnecessary, the court rejected this, reiterating that even informal networks must maintain adequate quality control to preserve trademark rights. The decision illustrates that nonprofit status or alignment in purpose does not excuse the obligation to monitor trademark use.
The case of Blue Mountain Holdings Ltd. v. Bliss Nutraceuticals LLC involved a dispute over the "VIVAZEN" trademark, used for kratom-based products. Lighthouse Enterprises, a Barbados-based holding company, owned the trademark and entered into a "Brand Sale Agreement" with Blue Mountain Holdings. Despite being labeled a sale, the Eleventh Circuit Court of Appeals agreed with the district court's assessment that the agreement constituted a license because Lighthouse retained certain interests in the mark. Subsequently, Blue Mountain and Lighthouse jointly sued Bliss Nutraceuticals for trademark infringement. In defense, Bliss argued that Lighthouse had abandoned its trademark rights by engaging in naked licensing, specifically by failing to exercise adequate control over Blue Mountain's use of the mark.
The Eleventh Circuit upheld the district court's finding of naked licensing. The appellate court's determination rested on the fact that Lighthouse, despite retaining some control over the trademark, engaged in no meaningful supervision or inspection of the products bearing the VIVAZEN mark that were being sold by Blue Mountain. The court emphasized that the substance of the agreement and the actual conduct of the parties were paramount, noting that the labeling of the transaction as a "sale" was not dispositive. Testimony from officials of both Lighthouse and Blue Mountain confirmed unequivocally that Lighthouse had never supervised Blue Mountain's production, marketing, or sale of the products. This lack of oversight led the court to conclude that Lighthouse had abandoned quality control, resulting in the abandonment of the trademark itself. This case underscores the critical importance of actual quality control in licensing arrangements, even when the agreement purports to be a sale or assignment.
Lawn Managers, Inc. v. Progressive Lawn Managers, Inc., 959 F.3d 903 (8th Cir. 2020)
The case of Lawn Managers, Inc. v. Progressive Lawn Managers, Inc. involved a trademark infringement suit brought by Lawn Managers against Progressive Lawn Managers. Progressive, in turn, counterclaimed for cancellation of Lawn Managers' trademark, alleging naked licensing, and also raised the defense of unclean hands. The dispute arose from the dissolution of a business partnership between Zweifel and Smith, where Smith continued to operate a similar lawn care business under a licensing agreement with Zweifel, using the "Lawn Managers" mark. The licensing agreement did not contain explicit contractual provisions for quality control, and there was no evidence of actual control exercised by Lawn Managers over Progressive's operations. The district court ruled in favor of Lawn Managers, awarding damages and attorney's fees, which Progressive appealed.
The Eighth Circuit Court of Appeals affirmed the district court's judgment, specifically agreeing with the finding that naked licensing had not occurred. The appellate court reasoned that Zweifel, as the licensor, could reasonably rely on Smith's quality control efforts due to their long-term business relationship and the structure of the licensing agreement. The court noted that the agreement allowed Smith to operate a similar business using the same name and equipment, which implied a continuity in the quality of services provided. Furthermore, the court observed that there was no evidence presented of any deviations in quality at Progressive during the period of the license. The adversarial nature of the post-divorce relationship between the parties was not deemed sufficient to negate the trust in Smith's ability to maintain service quality. The provided snippets do not mention any dissenting or concurring opinions in this case. However, legal commentary suggests that this decision has been subject to criticism for potentially overlooking the consumer protection aspect of trademark law by prioritizing the licensor's reliance on the licensee without more stringent quality control measures. This case illustrates a scenario where a pre-existing close working relationship can, in certain circumstances, mitigate the need for formal quality control in a licensing agreement.
Failure to follow these guidelines invites arguments of trademark abandonment, which may lead to an avoidable loss of intellectual property that can undermine a company’s entire brand equity.
Courts consistently hold that without actual control—whether through site visits, review of marketing materials, or specific quality control measures—a trademark owner risks trademark abandonment and loss of valuable trademark rights. While courts may tolerate some flexibility depending on context, the overarching rule is clear: trademark owners must proactively manage the use of the trademark to ensure consistent quality in the goods or services offered by licensees.
The risks of failing to comply are high, but they are avoidable through well-drafted license agreements and diligent oversight. Trademark counsel plays a vital role in structuring and maintaining licensing frameworks that protect the mark's distinctive character and integrity in the marketplace.
For assistance with trademark licensing or other trademark-related matters, please contact us to discuss how we can help protect and strengthen your intellectual property portfolio.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
The rise of generative artificial intelligence (AI) has introduced dramatic shifts in creative industries. As generative AI tools become widely used in generating images, music, literature, and more, critical legal and policy issues surrounding authorship, originality, ownership, and copyrightability have emerged. There is an urgent need for an adaptation of existing legal frameworks, particularly copyright law, to address these new issues. Central to these issues is how written, audio, and visual works created by generative AI systems are treated under existing law and current Copyright Office registration practices. We discuss here the current treatment of generative AI by the Copyright Office in the context of copyright registration.
The U.S. Copyright Office (USCO) has taken a leading role in evaluating copyright and artificial intelligence through its ongoing AI initiative. In 2023, the Copyright Office issued registration guidance clarifying its position on works incorporating AI-generated content. The Copyright Office emphasized that while copyright law is technologically neutral, human authorship remains a fundamental prerequisite for protection.
According to the Copyright Office, works generated solely by AI systems, with no human contribution, are not eligible for copyright. However, works in which a human makes creative arrangements, selects or modifies AI output, or embeds AI-generated material within a larger human-generated work may qualify for registration if the human contributions are determined sufficient expressive elements to support authorship.
Under the Copyright Act and established doctrine, copyright protects "original works of authorship fixed in a tangible medium." The requirement of a human author has been emphatically affirmed in cases such as Thaler v. Perlmutter, 687 F. Supp. 3d 140, 149-50 (D.D.C. 2023). In that case, Dr. Stephen Thaler attempted to register a visual artwork titled "A Recent Entrance to Paradise," which was autonomously created by an AI system he developed called the "Creativity Machine." Thaler did not claim any human contribution to the work’s creation; rather, he listed the AI as the sole author and himself as the claimant by virtue of his ownership of the machine.
The USCO denied registration, citing the lack of human authorship. Thaler requested reconsideration twice, asserting that AI-generated works should be eligible for copyright and that ownership should vest in the machine’s owner. The USCO maintained its position that human creativity is a prerequisite to copyright, ultimately rejecting the claim. Thaler then filed suit under the Administrative Procedure Act (APA), arguing that the USCO’s decision was arbitrary and capricious.
The Court upheld the USCO’s determination. The court held that U.S. copyright law, both by its statutory language and by longstanding judicial interpretation, requires human authorship. In rejecting Thaler’s claims, the court emphasized that the Copyright Act protects "original works of authorship," and that the term "author" has always been understood to mean a human being. The court further rejected Thaler’s arguments based on ownership doctrines like work-for-hire or property law principles, concluding that these theories could not apply where no copyright existed to begin with.
The court rooted its decision in historical and constitutional policy rationales. It noted that the Framers of the Constitution granted Congress authority over copyright to promote the progress of science and the useful arts by incentivizing human creativity. The incentive structure underpinning copyright—granting exclusive rights to spur human expression—has no application to machines or non-human actors. Because AI systems do not require incentive to create and cannot be deterred or encouraged by rights and remedies, the fundamental purpose of copyright protection is not served by extending authorship to AI.
The Thaler decision affirms a bedrock principle of U.S. copyright law: the protection of works under copyright depends upon human creativity. This requirement acts as a gatekeeper against efforts to extend intellectual property rights to machine-generated content in the absence of meaningful human input. While the court acknowledged the potential complexities that may arise as AI becomes more deeply integrated into creative processes, it held that those questions were not at issue in the case before it—where no human had contributed at all.
The Copyright Office’s registration guidance aligns with this precedent by requiring applicants to disclose and disclaim AI-generated portions of works and to focus registration claims solely on the human-authored components. Prompts alone, no matter how complex or refined, are insufficient to establish authorship, as they lack the degree of expressive control required by law. The ruling in Thaler reinforces the Office’s position and provides a judicial foundation for its ongoing application of the human authorship requirement.
The Copyright Office’s Copyright and Artificial Intelligence, Part 2: Copyrightability report outlines specific criteria used to evaluate whether AI-generated content is part of a protectable work. It examines whether a human made meaningful creative decisions reflected in the final product. This includes scenarios where a human arranges AI-generated content, modifies outputs creatively, or combines them with original expressive elements.
In assessing authorship, the Copyright Office conducts a fact-specific inquiry that centers on whether the human claimant exercised control over the expressive elements of the work. The mere triggering of an AI system to generate content—by providing prompts or instructions—is generally insufficient. Instead, the Office seeks evidence that the claimant contributed original expression by selecting, coordinating, or arranging AI-generated content in a creative way or by meaningfully modifying the outputs to shape the final expression.
The Copyright Office has reiterated that generative AI tools, like other technological aids, can support but not supplant human authorship. The difference lies in whether the human uses the AI as a tool to express original ideas, or whether the AI system independently determines the expressive elements. The use of AI in assistive or augmentative capacities does not preclude copyrightability, but AI-generated outputs must be embedded in a larger human-generated work or reflect a human author’s creative control.
The Office’s inquiries into whether there is sufficient human authorship may include questions such as:
For example, if a designer uses an AI program to generate dozens of visual motifs and then selects a handful, modifying their color, composition, and integration into a human-designed layout or publication, the resulting work may contain protectable human-authored elements. By contrast, if a user generates a single AI image using a descriptive prompt and submits it without further creative refinement, the output would not meet the threshold of human authorship.
Another illustrative scenario involves a comic book creator who uses AI to generate background art, which is then incorporated into a graphic novel that features original characters, plot, and dialogue written by the author. If the AI backgrounds are creatively chosen, altered, and integrated into the panel layout, and if the overall selection and coordination reflect human authorship, the work may be registrable with a disclaimer as to the AI-generated elements.
Copyright holders must clearly identify and disclaim any AI-generated portions that do not reflect human authorship in their registration applications. Applicants are expected to describe the human contributions in detail—for instance, by identifying which parts of a visual work were modified by the claimant and how. The Copyright Office may register the human-created parts of a work while excluding purely AI-generated material, and failure to disclose the use of generative AI may result in cancellation of a registration.
This fact-driven, case-by-case analysis ensures that copyright protection remains grounded in the core principle of human creativity, while providing a flexible framework for creators who use generative AI tools in an assistive capacity.
In copyright registration practice, the Copyright Office requires applicants to disclose the use of generative AI systems and clearly differentiate between human and machine-generated content. This identification and disclaimer requirement stems from the Office’s March 2023 policy guidance and reflects the fundamental principle that copyright protects only human authorship.
When a work submitted for registration contains AI-generated material, the applicant must identify such content in the application and disclaim authorship of those specific portions. This is typically done by providing a statement in the “Author Created” and “Limitation of Claim” sections of the application, explaining what was created by the human author and what, if any, was generated by an AI system. The Office provides examples, such as: “AI-generated text excluded; human-authored text claimed” or “Image generated by Midjourney AI excluded; layout and captions claimed.”
Failure to properly identify and disclaim AI-generated content may result in cancellation of the registration or refusal to register the claim. The Office treats nondisclosure of AI-generated elements as a material misrepresentation, which can jeopardize the validity of the registration and undermine the applicant’s ability to enforce rights in court.
The degree of human authorship is critical. If a work consists primarily or entirely of AI-generated content without sufficient human involvement, the Office will reject the application altogether. However, where the human author contributes creatively—for example, by arranging AI-generated elements, modifying them meaningfully, or incorporating them into a larger original work—registration may be granted for the human-authored portions.
The Copyright Office has further clarified these procedures through updates to the Compendium of U.S. Copyright Office Practices and has held public webinars to assist applicants in navigating the registration process. These efforts form part of the Office’s broader copyright office’s AI initiative and reflect a commitment to clarity and transparency as creators adapt to new tools.
In sum, the registration framework requires a candid accounting of AI involvement. This approach both preserves the integrity of copyright’s human authorship requirement and facilitates the responsible integration of generative AI into creative practice. As generative AI technology evolves, applicants must remain attentive to changes in the law and USCO's guidance to ensure their works are compliant with the requirements of copyright law and USCO practice.
The proliferation of generative AI models, such as Stable Diffusion, DALL-E, and GPT-based systems, has led to a wave of copyright litigation and regulatory scrutiny. AI developers now face legal challenges involving claims of unauthorized use of copyrighted content as AI training data and in AI generative output. These legal issues cut to the core of what constitutes copyright infringement in the age of machine learning and content synthesis.
At the heart of these disputes is the training process itself. Generative AI systems are typically trained on massive datasets that often include copyrighted material scraped from the internet, including news articles, books, artwork, and photographs. Plaintiffs have asserted that using these materials without authorization constitutes unlawful reproduction and distribution under the Copyright Act giving rise to infringement claims. Defendants, in contrast, argue that the ingestion of content into training models is transformative and constitutes fair use, especially when the AI does not retain or replicate specific copyrighted elements in a recognizable form.
In one of the most closely watched cases, The New York Times filed suit against OpenAI and Microsoft, alleging that millions of its articles were used without permission to train large language models, including ChatGPT. The Times contends that this practice not only infringes its copyrights but also threatens its business model, as the AI system can generate summaries or reproductions of paywalled content that compete directly with the original. The lawsuit underscores questions about whether AI output that mimics or paraphrases source material constitutes derivative works under copyright law.
Similarly, Getty Images has filed litigation against Stability AI in both the United States and the United Kingdom, alleging that Stability used Getty’s licensed images without consent to train the Stable Diffusion image generation model. Getty asserts that Stable Diffusion outputs images that are substantially similar to or directly derived from Getty’s copyrighted content, and in some cases even replicate its watermark. Getty’s claims focus not only on infringement through training but also on the risk of output-based infringement and reputational harm due to association with unlicensed or low-quality derivatives.
These lawsuits raise complex and unresolved legal questions. Among them: Is training on copyrighted works without permission a violation of the reproduction right? Do AI-generated outputs constitute derivative works? What role does the fair use doctrine play in this context? And what obligations do AI companies have in disclosing or licensing their training data?
While the Copyright Office has not yet adopted a formal position on the legality of training AI models using copyrighted material, it has acknowledged in its reports that this issue presents serious licensing considerations. The Office has also noted that fair use may serve as a potential defense, though its application is highly fact-specific and uncertain in this novel context. Some advocates argue that AI training for scientific research or non-commercial uses may be defensible under fair use, while others contend that commercial AI development based on unlicensed AI training data erodes the rights of content creators.
As these cases progress through the courts, they are likely to shape the contours of liability for AI developers and clarify how existing law applies to training AI, generating outputs, and distributing derivative works. In the meantime, they highlight the growing tension between innovation in generative AI technology and the foundational rights of copyright holders.
Congress, the Copyright Office, and various stakeholders continue to debate broader legislative responses to the rise of generative AI systems. Legislative proposals such as the No FAKES Act and the Generative AI Copyright Disclosure Act reflect an increasing willingness to regulate AI-generated content. These measures focus on key concerns such as unauthorized digital replicas, the protection of personal likeness and voice, and transparency through mandatory disclosure of AI-generated content.
The Copyright Office’s public listening sessions and its Notice of Inquiry have revealed widespread concern among creators, copyright holders, and AI developers. Participants have voiced apprehension about copyright infringement, the erosion of licensing markets, and the displacement of human authorship in sectors such as journalism, illustration, and music. Many emphasize the need to further the constitutional goals of promoting the progress of science and the useful arts, while also ensuring that legal frameworks are adaptable to technological evolution.
Internationally, the approach to AI-generated content varies significantly, underscoring the growing need for global harmonization. The United States maintains a strict human authorship requirement, and the Copyright Office has consistently stated that AI-generated material lacking sufficient human creative input is not eligible for protection under the Copyright Act. However, other major jurisdictions have adopted different policies.
For example, the United Kingdom recognizes copyright in computer-generated works under Section 9(3) of its Copyright, Designs and Patents Act 1988, which provides that for works generated by a computer in circumstances such that there is no human author, the author is deemed to be the person “by whom the arrangements necessary for the creation of the work are undertaken.” This approach effectively provides copyright protection for some AI-generated works, although the scope and enforceability of these rights remain debated.
In contrast, the European Union has taken a more cautious and structured approach. The EU AI Act and other pending legislation do not currently extend copyright protection to AI-generated content, but the European Parliament has considered proposals for sui generis rights or other regulatory mechanisms to manage AI-generated outputs. Additionally, the EU Copyright Directive gives authors and publishers the right to opt out of having their works used for text and data mining, which impacts the permissibility of using copyrighted materials as AI training data.
These divergent approaches demonstrate the difficulty of these issues and the need for action in determining solutions through national copyright laws and innovation policies. As AI-generated content becomes more prevalent in cross-border creative markets, inconsistencies in protection and enforcement could create friction. This makes international dialogue and technology law review essential to harmonize standards, clarify authorship, and balance the interests of innovation and intellectual property protection.
Generative AI presents a rapidly evolving challenge to traditional copyright doctrines. The legal implications of AI-generated material require ongoing adaptation of copyright law and policy. While current registration guidance confirms that works generated solely by AI systems are not protected, works incorporating AI-generated content may qualify if a human being contributes sufficient expressive elements.
As AI developers, creators, and policymakers grapple with the legal implications of artificial intelligence, the importance of maintaining a clear boundary between human authorship and AI output is critical. The copyright office continues to refine its policies, monitor developments, and participate in ongoing public inquiry seeking input on the treatment of AI-generated works. Through this process, the law will hopefully find an equitable balance between creative expression, technological development, and the rights of copyright holders.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Double patenting is a doctrine in patent law aimed at preventing the improper extension of patent rights through multiple patents covering the same invention or an obvious variations of an earlier invention by the same party. The difference between a double patenting rejection and a standard anticipation rejection or obviousness rejection is that the double patenting rejection is not a prior art rejection; it is a prohibition on extending the patent grant beyond its intended term. It is made based on the claims of the earlier patent, not "prior art". It is also worth noting that the inventive entity is the same. In other words, you are not being rejected based on someone else's prior work, you are being rejected based on your own prior patent claims. This doctrine ensures that a patent applicant cannot unjustly extend the exclusivity of their patent protection beyond the statutory patent term.
We sometimes run across the misconception that a patentee can reapply for the same invention claimed in an earlier patent. However, this misconstrues the fundamental quid pro quo of the patent system: in exchange for your valuable innovation, the US government will grant you a limited term of exclusivity to take economic advantage of your innovation. Double patenting is a violation of this fundamental bargain.
There are two primary forms of double patenting rejection: statutory double patenting and nonstatutory double patenting. Each of these versions is explained below.
The statutory double patenting doctrine arises under 35 U.S.C. §101, which states that an inventor may obtain "a patent" for an invention claimed, thereby prohibiting the issuance of two or more patents for the same invention. This rejection is often referred to as a statutory double patenting rejection.
A statutory double patenting rejection is applied when the patent examiners determine that the claimed invention in a second patent is identical to the invention claimed in an earlier patent. Unlike nonstatutory double patenting, which relies on an obviousness analysis, statutory double patenting is strictly focused on whether the claimed subject matter in the second patent is the same as that in the earlier patent.
For a statutory double patenting rejection to be properly established, the United States Patent and Trademark Office (USPTO) must show:
A statutory double patenting rejection differs from an anticipation rejection in several key ways. Under 35 U.S.C. §102, a prior art reference, which may include the applicant’s own prior patent, anticipates the claimed subject matter if every element is disclosed in the reference. Rather than assessing whether a prior patent discloses every element of the claimed invention, statutory double patenting focuses on whether the earlier patent and second patent claim include the same limitations with no meaningful variation.
Additionally, ownership considerations play a crucial role in differentiating these doctrines. A 102 rejection applies regardless of ownership, meaning that even a third party’s prior disclosure can bar a patent application under this statute. Conversely, a statutory double patenting rejection arises only when the earlier patent and the second patent are commonly owned or share at least one inventor. Another major distinction lies in the use of terminal disclaimers. While both statutory double patenting and 102 rejections serve to prevent improper awards of patent rights in the same invention that has already been patented, their legal bases are different.
The application of statutory double patenting is very straight forward, as the claims have to include the same elements. The rule prevents a second patent from issuing on the same subject matter. No patent can be issued in the case of statutory double patenting, without exception. However, Section 101 does not address situations where there are slight modifications to the subject matter of the claim that do not add any patentable feature. The federal courts have developed the doctrine of obviousness-type double patenting to address these slight variations in subject matter between patent filings.
The nonstatutory double patenting rejection, also known as obviousness type double patenting, is a judicially created doctrine aimed at preventing a patent applicant from obtaining a second patent that merely claims an obvious variation of an earlier patent. The doctrine is grounded in an equitable principle that prevents an unjustified extension of the patent term.
Several key decisions by the federal appellate courts have shaped the doctrine of double patenting:
In Miller v. Eagle Manufacturing Co., the Supreme Court set an early precedent by holding that an inventor cannot obtain a second patent on an identical claimed invention simply to extend patent rights. In this case, the patentee sought to secure an additional patent on a spring mechanism for improving plows or cultivators that had already been disclosed and claimed in an earlier patent. The court explained that allowing such a practice would unjustly prolong the inventor’s exclusive rights and contradict the purpose of the patent term limitation. This case remains a cornerstone in statutory double patenting jurisprudence, reaffirming that a patent must not grant more than one period of exclusivity for the same invention.
In In re Vogel, the court expressed a basic two step approach for analyzing double patenting issues: (1) if it is the same invention, Section 101 forbids a second patent, and (2) if a new claim of the application is no more than an obvious variation of the applicant's earlier patent, then the new claim is not patentable. The court was careful to point out that specification of the prior patent cannot be used as prior art. The double patenting rejection is not a prior art rejection, it is made based on the claims of the earlier patent, and cannot be based on the broader disclosure of the specification. The court found that Vogel was not claiming the same subject matter, but was merely extending the sausage making method of issued patent from pork to beef with a few obvious changes.
In re Schneller involved an application for a wire lathing clip used in construction. The applicant, Schneller, had already received a patent on a similar clip system and sought to claim a version that included a slightly modified lip structure. Schneller argued that his new claims were directed to a distinct and independent invention that was different from his earlier patent. Specifically, he contended that the addition of the lip structure created a patentably distinct improvement. The court explained that while Schneller’s new claims did add an additional structural feature, the claimed invention was still fundamentally covered by his prior patent. The court emphasized that the public interest in preventing the unjustified extension of the patent term outweighed any arguments that minor modifications justified a second patent. Importantly, the court noted that Schneller’s original patent claims were drafted broadly enough to encompass the improvements, meaning that granting a second patent would effectively extend the exclusive rights beyond the allowable term.
In Gilead Sciences, Inc. v. Natco Pharma Ltd., the federal circuit reinforced the core of the double-patenting concept. An earlier-expiring patent was found to be a basis for an obviousness type double patenting rejection against a later-expiring patent, even though the later-expiring patent issued first. Gilead had obtained two patents—U.S. Patent Nos. 5,763,483 and 5,952,375—relating to antiviral compounds. The '483 patent issued before the '375 patent, but expired after it. Gilead sued Natco for infringing the '483 patent, and Natco defended by asserting that the '483 patent was invalid due to obviousness type double patenting over the earlier-expiring '375 patent.
Gilead argued that the '375 patent could not be used as a reference against the '483 patent because it was issued later. The Federal Circuit found that it could, emphasizing that the key policy concern of the judicially created doctrine grounded in double patenting is to prevent the unjustified extension of a monopoly beyond the expiration date of a patent.
The court explained that the proper inquiry should be based on the patent term, not the issuance date, particularly under the current America Invents Act patent system where expiration dates are determined by filing date rather than issue date. Allowing a later-expiring patent to claim an obvious variation of an earlier expiring patent would improperly extend exclusivity on claimed subject matter that should have entered the public domain.
A common method to overcome a nonstatutory double patenting rejection—that is, an obviousness type double patenting rejection—is the filing of a terminal disclaimer under 37 C.F.R. § 1.321. A terminal disclaimer is a statement filed by the patent applicant voluntarily disclaiming any portion of the patent term that extends beyond the expiration date of an earlier patent. In addition, it must include a provision requiring that both the earlier and later patent remain commonly owned for their entire enforceable lives. The terminal disclaimer is intended to ensure that the patentee does not enjoy unjustified extended protection for obvious variations of the same inventive concept. When accepted, it effectively neutralizes the double patenting rejection by aligning the expiration dates of the patents in question and tying their enforceability to common ownership.
The use of terminal disclaimers is primarily intended as an equitable measure that prevents patent term extensions for related inventions that are not patentably distinct. However, it does not apply to statutory double patenting rejections, which are based on claims to the same invention. In such cases, a terminal disclaimer is ineffective because the law prohibits issuance of two or more patents for one invention regardless of term alignment.
A significant statutory safeguard against double patenting rejections—particularly nonstatutory double patenting—is provided under 35 U.S.C. § 121, which applies to divisional applications filed in response to a restriction requirement imposed by the U.S. Patent and Trademark Office. A restriction requirement occurs when the examiner determines that a single patent application contains claims directed to two or more inventions that are independent and distinct. In such cases, the examiner may require the applicant to elect one invention for continued prosecution in the original application. The applicant may then file a divisional application to pursue the non-elected claims.
Under § 121, if a divisional application arises from an examiner-imposed restriction and the claims in the divisional are consonant with the restriction groupings, then the divisional application is protected from a nonstatutory double patenting rejection based on the parent application or any sibling divisional. This statutory protection acknowledges that the filing of multiple applications was not the result of applicant manipulation, but rather a procedural necessity imposed by the patent office. Importantly, the protection only applies where the claimed subject matter in the divisional maintains consonance with the restriction—i.e., it does not cross over or recombine elements from different groups that were originally required to be restricted.
However, this safe harbor does not apply to statutory double patenting rejections, which are predicated on the existence of identical claims. Moreover, if the applicant files what is effectively a voluntary divisional—one not based on a restriction requirement—or if the claims in the divisional diverge materially from the originally restricted invention, the safe harbor will not apply, and the applicant may face a obviousness type double patenting rejection.
In response to a nonstatutory double patenting rejection, a patent applicant may seek to overcome the rejection by demonstrating that the claimed invention in the later application is patentably distinct from the claims of the earlier patent. This is typically done through a detailed obviousness analysis, analogous to the approach taken under 35 U.S.C. § 103. The applicant must argue that the subject matter of the rejected claims would not have been obvious to a person of ordinary skill in the art at the time of the invention, in light of the claims of the reference patent, potentially in combination with secondary references or prior art.
These arguments may focus on structural, functional, or methodological differences that confer unexpected results, enhanced properties, or additional features not taught or suggested by the earlier claims. For example, if the later claims include elements not found in the earlier claims and those elements are shown to produce a synergistic effect or solve a problem unaddressed by the prior disclosure, the applicant may assert that the two inventions do not share the same inventive concept. In support, applicants can submit affidavits, technical declarations, or literature references demonstrating the non-obvious nature of the later claims. If successful, such arguments can preserve the full scope and term of the later-filed application without the need for a terminal disclaimer.
Addressing a non-statutory double patenting rejection can have drawbacks. Arguing against the scope of the claims in the patent used as the basis for a nonstatutory double patenting rejection can require the assertion that the earlier claims are narrow or limited. This may unintentionally weaken the enforceability or value of that earlier patent. Making negative statements about the scope or breadth of the first patent's claims could be used by third parties, including patent infringers, to undermine or avoid liability under the earlier patent. Such arguments may also be viewed as inconsistent or contradictory, potentially affecting credibility during prosecution or future litigation.
An obviousness rejection under 35 U.S.C. § 103 and an obviousness-type double patenting rejection both concern whether a claimed invention would have been obvious to a person having ordinary skill in the art, but they differ in statutory basis, reference sources, and available responses. A § 103 rejection is based on prior art—typically published patents and patent applications having an earlier priority date, or printed publications—existing before the effective filing date of the claimed invention. In contrast, an obviousness-type double patenting rejection is a judicially created doctrine designed to prevent the unjustified extension of exclusivity for obvious variations of a previously claimed invention and is based on the claims of the applicant’s own earlier patent or commonly owned application, not on prior art per se.
To overcome a § 103 rejection, the applicant may argue that the references do not teach or suggest the claimed combination, or that the differences would not have been obvious due to secondary considerations (e.g., commercial success, unexpected results). In contrast, to overcome an obviousness-type double patenting rejection, the applicant may either amend the claims to make them patentably distinct from the earlier claims or file a terminal disclaimer aligning the expiration date of the later patent with the earlier one and ensuring common ownership throughout their terms.
The federal circuit has consistently held that a patent term adjustment (PTA) cannot be used to extend the expiration date of a patent when a terminal disclaimer has been filed in the application. Filing a terminal disclaimer results in the disclaimed patent expiring on the same day as the earlier patent to which it is terminally disclaimed, regardless of any PTA that might otherwise be available under 35 U.S.C. § 154(b). This rule reinforces the principle that a patentee should not receive an extended period of exclusivity for obvious variations of an existing invention simply due to administrative delays by the trademark office. Once a terminal disclaimer is on record, the disclaimed patent term is fixed and cannot be modified by later PTA calculations.
This strict limitation stands in contrast to the Novartis AG v. Ezra Ventures LLC decision, where the court upheld the enforceability of a proper patent term extension (PTE) under 35 U.S.C. § 156.
The Novartis AG v. Ezra Ventures LLC, the Federal Circuit upheld the validity of a patent term extension (PTE) under 35 U.S.C. § 156, ruling that the doctrine of obviousness-type double patenting does not invalidate a properly extended patent. Novartis held two patents—the ’229 patent, which received a five-year PTE, and the later-filed but earlier-expiring ’565 patent. Ezra argued that the extended term of the ’229 patent unlawfully extended exclusivity over subject matter covered by the ’565 patent. The court rejected this, finding that § 156 authorizes a single patent extension per product, and the ’229 patent alone received the extension. The court reaffirmed that statutory PTEs cannot be invalidated by judicially created doctrines. Since only the ’229 patent was extended and the requirements of § 156 were met, the extension was valid, even if both patents were not patentably distinct.
Under the America Invents Act (AIA), 35 U.S.C. § 102(c) replaced the pre-AIA statute 35 U.S.C. § 103(c) and provides that disclosures made by one party to a joint research agreement (JRA) will not be considered prior art against another party to the agreement under certain conditions. Specifically, if an invention is made by or on behalf of parties to a written JRA that was in effect before the effective filing date of the claimed invention, and the invention arose out of activities within the scope of the agreement, then the disclosure is not considered prior art under §§ 102(a)(1) or 102(a)(2).
Although § 102(c) directly addresses prior art rejections, its underlying policy rationale also informs treatment of obviousness type double patenting in collaborative research contexts. The USPTO has generally required common ownership to overcome a nonstatutory double patenting rejection, but where parties are subject to a qualifying JRA, they may achieve compliance through a terminal disclaimer that ensures both patents remain commonly owned or enforceable only during joint ownership.
In this context, applicants must ensure that the existence of a valid JRA is disclosed and that the claimed subject matter falls within the scope of the collaborative activities defined in the agreement. This approach enables related patents from different but collaborating entities to coexist without triggering an obviousness type double patenting rejection based solely on obviousness, provided they satisfy the procedural safeguards of the AIA and terminal disclaimer requirements. Accordingly, § 102(c) promotes innovation across institutional boundaries while preserving the core judicially created doctrine aimed at preventing unjust extensions of patent term through multiple patents on obvious variations of the same inventive concept.
Double patenting issues can also arise during reexamination proceedings, particularly where amended or newly presented claims are not patentably distinct from claims in a separate, earlier patent held by the same owner or commonly owned entity. Although reexamination is intended to reevaluate the validity of claims in view of prior art, the scope of the examination is not strictly limited to novelty and obviousness under §§ 102 and 103. The patent examiners may also consider double patenting rejections, especially where the reexamined claims appear to duplicate or represent obvious variations of those in another patent held by the same applicant or assignee.
In such instances, the Office may issue a nonstatutory double patenting rejection, requiring the applicant to demonstrate that the reexamined claims are patentably distinct from the reference claims in the earlier patent. The applicant may overcome the rejection either by amending the claims to introduce meaningful distinctions or by filing a terminal disclaimer to align the expiration date of the reexamined claims with that of the related patent.
The risk of double patenting rejection in reexamination highlights the need for applicants to carefully coordinate claim strategy across a portfolio of related patents, particularly when pursuing parallel or serial protection on the same inventive concept. Where patents are subject to continuation, divisional, or improvement filings, or are being reexamined concurrently with prosecution of related applications, the potential for conflicting claims and double patenting scrutiny increases. Clear claim differentiation and careful portfolio management should be employed to maintain enforceability and avoid obviousness type double patenting rejections.
Double patenting rules protect against the unlawful extension of the patent grant beyond the twenty years allowed by US patent law. Patent owners should be aware of this restriction and understand that the patent grant has a limited life span. Claiming small changes to a patented technology are unlikely to extend the patent protection beyond the twenty year term. It is equally important to understand that your important products and technologies can be covered by claims of different scope in order to provide protection against as many potential design arounds that a third party might conceive. While these different claims expire together, they provide more comprehensive patent protection, even those that may be subject to a nonstatutory double patenting rejection.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
A common misconception in patent law is that a granted patent remains enforceable until its expiration date. However, patents are not invincible; they can be challenged and invalidated at any time if they fail to meet statutory requirements. A patent's enforceability is contingent on its validity, and numerous legal mechanisms exist to scrutinize and potentially invalidate a patent before it reaches the end of its term.
A patent can be invalidated on various grounds, including the existence of prior art, lack of patent-eligible subject matter, and failure to meet statutory requirements. Patent invalidation proceedings can take place in courts, before the Patent Trial and Appeal Board (PTAB), or through post-grant review mechanisms such as inter partes review (IPR). This article provides an in-depth overview of patent invalidity, relevant legal standards, and strategies for conducting an effective patent invalidity search.
Under 35 U.S.C. § 282, a United States patent is presumed valid. The burden of proving invalidity falls on the party challenging the patent, requiring "clear and convincing evidence". Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91 (2011). However, if relevant prior art was not considered by the patent examiner, the burden may be easier to meet.
Patent validity can be challenged on several grounds, including:
Under 35 U.S.C. § 102, a claimed invention is invalid if it was disclosed in prior art before the patent priority date, it lacks novelty and is invalid. Anticipation occurs when a single prior art reference (e.g., a previously existing patent or publication) discloses each and every element of a claimed invention, either explicitly or inherently, before the patent’s effective filing date. If a claimed invention is anticipated, it lacks novelty and is therefore invalid. To establish anticipation, a challenger must show that the prior art reference predates the patent, discloses every element of the claimed invention, and is enabling.
A prior art reference predates the patent if it was publicly available—such as through publication, an issued patent, public use, or sale—before the patent’s effective filing date. Under the America Invents Act (AIA), which applies to patents with an effective filing date on or after March 16, 2013, any disclosure before the filing date qualifies as prior art unless an exception applies. In addition to being prior in time, the reference must disclose every element of the claimed invention, arranged as in the claim. If even a single element is missing, anticipation is not established, though the reference may still serve as evidence of obviousness under § 103.
A well-known case involving public disclosure and anticipation is In re Hall, 781 F.2d 897 (Fed. Cir. 1986), which addressed whether a single prior art reference was publicly accessible before the patent’s priority date. In this case, the patent applicant sought to patent an invention, but the United States Patent and Trademark Office (USPTO) rejected the claims based on an earlier doctoral dissertation that was housed in a university library in Germany. The applicant contested the rejection, arguing that the dissertation was not publicly available in a manner that would qualify it as prior art under § 102. The Federal Circuit ruled that a dissertation cataloged in a university library constituted prior art because it was sufficiently accessible to the public. The court explained that even if a reference is not widely disseminated, it can still be considered publicly available if it is accessible to those skilled in the relevant field who are likely to seek it out.
It should also be noted that the disclosure in the prior art may be explicit or inherent. While explicit disclosure is straightforward, a reference can also anticipate if an element is inherently present—meaning it necessarily exists in the prior art, even if not expressly stated. The test for inherency is whether a person of ordinary skill in the art (POSITA) would recognize the missing element as necessarily present. Finally, the prior art must be enabling, meaning a POSITA could practice the invention based on the disclosure without undue experimentation. If the reference is merely conceptual and lacks sufficient detail, it may not be considered anticipatory.
Under 35 U.S.C. § 103, a patent claim is invalid for obviousness if the differences between the claimed invention and the prior art are such that the invention would have been obvious to a POSITA at the time the invention was made. Unlike anticipation, where a single prior art reference must disclose every element of the claimed invention, obviousness can be established by combining multiple references and/or modifying an existing reference in a way that would have been predictable to a POSITA.
To determine obviousness, courts apply the framework set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), which involves four key factors:
A finding of obviousness does not require an exact blueprint of the claimed invention in the prior art but rather an analysis of whether a POSITA would have been motivated to modify or combine prior art references to arrive at the claimed invention with a reasonable expectation of success. The KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) decision reinforced this principle by rejecting rigid application of obviousness tests and emphasizing a more flexible, common-sense approach that considers whether a combination of known techniques was merely an obvious step forward.
Under 35 U.S.C. § 101, an invention must fall within the categories of patent-eligible subject matter—namely, a process, machine, manufacture, or composition of matter—to be patentable. U.S. patent law has long held that certain categories of subject matter, including laws of nature, natural phenomena, and abstract ideas, are not eligible for patent protection because they are fundamental principles that belong to all and cannot be monopolized. This doctrine prevents the patent system from unduly restricting the use of basic scientific and mathematical concepts that are essential for innovation.
To determine whether a claimed invention falls within patent-eligible subject matter, courts apply the two-step test established in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014):
In applying this framework, courts assess whether an invention is merely a generic implementation of an abstract idea (e.g., on a computer) or whether it introduces a specific technological advance that improves the functioning of a computer or another technical field. For example, a business method that simply automates conventional practices using a general-purpose computer is typically found ineligible, whereas an innovation that improves data processing efficiency or enhances cybersecurity may be eligible.
Under 35 U.S.C. § 112, a patent specification must provide a clear, complete, and precise disclosure of the invention to justify the grant of exclusive rights. This section imposes several distinct requirements: the written description requirement, the enablement requirement, and the definiteness requirement. Failure to satisfy any of these requirements can render a patent invalid or unenforceable.
The written description requirement under § 112(a) ensures that the inventor had possession of the claimed invention at the time of filing. To meet this requirement, the patent must describe the invention in enough detail that a POSITA would recognize that the inventor was in possession of the claimed subject matter.
A lack of sufficient written description can arise when claims are broader than what is disclosed, meaning the inventor is attempting to claim more than what was actually described in the application. This issue frequently occurs in biotechnology and chemical patents, where an applicant may claim a broad genus of compounds without describing enough representative species to show possession of the full scope. Courts analyze whether the specification reasonably conveys to those skilled in the art that the inventor actually invented what is claimed.
The enablement requirement, also under § 112(a), requires the patent to disclose enough information to enable a POSITA to make and use the claimed invention without undue experimentation. This ensures that the public receives the full benefit of the invention in exchange for the patent grant.
A patent fails enablement if the disclosure lacks sufficient guidance, requiring excessive trial and error for a skilled artisan to practice the invention. Courts assess factors such as the predictability of the field, the breadth of the claims, and the amount of experimentation required to determine whether a patent is enabled. The enablement requirement is especially scrutinized in cases involving broad functional claims (e.g., "any compound that treats disease X") when the patent fails to provide adequate working examples or detailed instructions.
Under § 112(b), the definiteness requirement mandates that claims be written in clear and precise terms, ensuring that the boundaries of the patent’s scope are properly defined. This allows competitors to understand what is and is not covered by the patent. Claims that are ambiguous, vague, or subjective (e.g., terms like "efficient," "aesthetically pleasing," or "substantially pure") may be invalidated for indefiniteness.
The Supreme Court in Nautilus Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) set the standard that a patent claim is indefinite if it fails to inform a POSITA, with reasonable certainty, about the scope of the invention. In Nautilus v. Biosig, the Supreme Court ruled that a patent claim using the term "spaced relationship" between two electrodes was indefinite because it did not provide clear objective boundaries. The Court held that claims must provide reasonable certainty and that ambiguous language can lead to invalidity. Courts consider whether a POSITA would have to guess at the meaning of a claim term or whether reasonable interpretations could differ significantly.
Under 35 U.S.C. § 115, a patent application must correctly identify the true inventors of the claimed invention. An inventor is defined as someone who contributes to the conception of at least one claim in the patent. If improper inventorship occurs—either by omitting a true inventor or including someone who did not actually invent—the patent may be challenged for invalidity. However, 35 U.S.C. § 256 provides a mechanism to correct inventorship errors, which can prevent invalidation if the mistake was unintentional and properly remedied. Thus, patent inventorship is a critical issue that should be addressed at the beginning of the patenting process.
A patent invalidity search is performed to identify prior art that can be used to invalidate claims in an issued patent. This search is essential in patent litigation, inter partes review, post-grant review, and patent disputes generally.
Conducting a thorough patent invalidity search requires careful examination of various aspects of the patent. The independent and dependent claims of the patent must be analyzed for their scope based on the plain language of the claims. Independent claims define the broadest scope of the invention and serve as the foundation for dependent claims, which add limitations or modifications. Analyzing these claims is crucial because any invalidity argument must directly challenge the patent’s claimed invention as recited in the claims.
The next step is to review the patent's file wrapper, which contains the complete history of the patent’s prosecution before the USPTO. This record includes the patent examiner's communications, initial claim rejections, amendments made during the application process, and applicant arguments. Examining the file wrapper can provide more clarity on the meaning of the claim terms based on the representations made to the patent examiner by the patentee about the meaning of the claims and how they are distinguishable from previous technologies. It may also uncover weaknesses in the patent, such as concessions made by the patent owner, prior rejections, or inconsistencies in claim language. If the patent examiner overlooked relevant prior art or improperly allowed certain claims, these issues can serve as valuable evidence in an invalidity challenge.
Once the claims have been examined, the effective priority date of the patent claims must be determined. The filing date and the priority chain establish which prior art references can be considered relevant. If a patent claims priority from an earlier patent application, it is essential to assess whether that priority claim is valid and whether it impacts the prior art available for invalidation. The earliest filing date dictates the timeline of prior art searches, ensuring that only documents published before that date are used in the invalidity analysis.
Subsequently, a prior art search is conducted to find public information that predates the patent’s priority date. This involves searching patent databases for granted patents, patent applications, and cited patents, as well as reviewing non-patent literature such as research papers, technical documents, product manuals, and industry publications. The goal is to identify references that disclose the same invention or render it obvious. Various search techniques are used to locate such prior art, including keyword searches, classification searches, and citation analysis.
The uncovered prior art references must be thoroughly analyzed to determine their relevance to the patent's claims. This process involves comparing the prior art with each element of the claims to assess whether it anticipates one or more claims or supports a case of obviousness against the claims. Identifying the closest prior art and establishing how it relates to the claimed invention strengthens an invalidity argument.
The America Invents Act (AIA) introduced Inter Partes Review (IPR) and Post-Grant Review (PGR) as administrative procedures before the Patent Trial and Appeal Board (PTAB) within the USPTO. These reviews, conducted by administrative patent judges, provide a mechanism for challenging the validity of granted patents.
Post-Grant Review (PGR) is an administrative procedure that allows a third party to challenge the validity of a patent before the PTAB that must be filed within nine months of a patent’s issuance and permits challenges based on any ground of invalidity, including patent-eligible subject matter (§ 101), novelty (§ 102), obviousness (§ 103), and written description or enablement deficiencies (§ 112). To initiate PGR, the petitioner must show that it is more likely than not that at least one claim is unpatentable. PGR provides a cost-effective alternative to litigation, though PTAB decisions may be appealed to the Federal Circuit Court of Appeals.
IPR is an administrative procedure that allows a third party to challenge the validity of a patent before the PTAB after nine months from a patent’s issuance or after the Post-Grant Review (PGR) window closes. Unlike PGR, IPR is limited to challenges based on prior patents and printed publications, specifically addressing lack of novelty and obviousness. In contrast, PGR allows for a broader range of invalidity challenges, including those based on patent-eligible subject matter and written description deficiencies. Both proceedings have strict timelines and require a petitioner to demonstrate that the prior art or legal deficiencies more likely than not render the patent claims invalid.
In federal litigation, accused infringers can challenge a patent’s validity as a defense in a patent infringement lawsuit. Invalidity challenges are generally the same as those available in a PGR proceeding. However, litigation allows broader challenges and includes live witness testimony, which is restricted in PTAB proceedings. A court’s final decision on validity takes precedence over administrative rulings. If a patent is found invalid, it cannot be enforced. Appeals go to the Federal Circuit Court of Appeals, which reviews legal and factual determinations.
The Patent Trial and Appeal Board (PTAB) and federal courts may reach differing conclusions, leading to legal uncertainties. The biggest distinction between procedure in PTAB proceedings and federal lawsuits is that invalidity can be shown by a preponderance of the evidence in PTAB proceedings, which is a lower standard than the clear and convincing evidence standard in federal court. Courts generally defer to the PTO's decisions, but final court rulings take precedence.
Patent invalidity plays a central role in intellectual property disputes. Whether challenging or defending a patented invention, understanding prior art, the patent process, and grounds for invalidation is essential. Proper preparation and strategic use of invalidity arguments can determine the outcome of a patent infringement lawsuit, ensuring a fair balance between innovation and competition in the market.
© 2025 Sierra IP Law, PC. The information provided herein does not constitute legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
Business owners are often confused about the differences between trade names and trademarks. It is often assumed that establishing a trade name through a corporate registration or business license automatically grants trademark rights, but this is incorrect. While both terms relate to a business’s identity, they serve distinct legal and commercial purposes. A trade name is simply the official name under which a business operates, often registered with the state through the formation of a corporation, limited liability company, or other entity. However, it does not provide exclusive trademark rights. In contrast, a trademark offers legal protection for brand names, logos, and other identifiers associated with goods or services, preventing others from using confusingly similar marks. Understanding these differences is crucial for business owners looking to protect their brand and build a strong market presence. In this article, we’ll break down the key distinctions between trade names and trademarks and explain why properly registering both can enhance brand identity and legal security.
The Lanham Act (15 U.S.C. § 1127) provides statutory definitions of trade names and trademarks. A trade name or commercial name is any name used to identify a business or vocation, while a trademark is any word, name, symbol, or device, or any combination thereof used to identify goods or services provided or sold.
A trade name, also known as a ‘fictitious name’ or ‘assumed name,’ is the official name under which a company conducts business. This name is used to distinguish the business from others and serves as a form of branding. For instance, when you see a company operating under a unique name, that’s its trade name in action. However, while trade names aid in brand recognition, but they do not automatically confer exclusive rights or trademark protection. They must be used in commerce as a source identifier for goods or services to establish trademark rights.
It is the name a business uses in commerce, on signage, marketing materials, and other public-facing communications. However, unlike trademarks, a trade name filing, such as a business license does not grant exclusive rights or legal protection against others using a similar name. Trade names are typically registered at the state or local level as a requirement of doing business under local law. However, business licenses, corporate registrations, or registrations of business organizations alone do not prevent competitors from using the same or a similar name in another location or industry.
Many companies operate under trade names that differ from their formal legal entity names. Some well-known examples include:
A trade name creates a distinct company identity in the marketplace. Trademark rights can be established under a trade name when it is used as a source identifier on goods or services offered by the company. Trade names like Coca-Cola obviously carry trademark rights, as the name Coca-Cola is prominently featured on its beverages and is recognized the world over as the source of its beverages. In the case of Coca-Cola, the trade name carries widespread trademark rights.
Trade names are registered at the state or local level, often involving the completion of a ‘doing business as’ (DBA) form for a business entity to conduct business. This process typically includes a form submission, a fee, and sometimes a legal newspaper notice. Checking if the name is already in use can help avoid legal conflicts.
Filing a business license for a trade name is necessary, but does not grant exclusive rights or legal protection against others using it like a trademark registration.
A trademark is a name, logo, symbol, or slogan that offers legal protection for a company’s brand and aids in establishing brand recognition in the marketplace. Unlike trade names, trademarks are specifically identified with the goods or services provided by a company. For example, Nike’s swoosh symbol is a trademark that not only identifies the company but also is present on every pair of shoes that it sells. It has become symbol of the quality of the goods that is associated with the Nike company. The swoosh is a trademark. The trade name Nike also functions as a trademark because it is also on every pair of shoes Nike sells and indicates the quality and source of the shoes. The Nike name and the swoosh logo have also been registered as trademarks with the United States Patent and Trademark Office, establishing nationwide trademark rights.
Trade names can often be trademarked if they also serve as identifiers for the company’s goods or services. This dual functionality can enhance brand recognition and provide an extra layer of legal protection. Trade name registration can further solidify these benefits.
Trademarks provide legal protection by ensuring that only the trademark owner has the right to use the mark in commerce. This protection helps prevent others from using similar marks that could cause confusion among consumers. The process of establishing trademark rights involves trademark registration, which can be done at the state, federal, or international level. Registering a trademark with the United States Patent and Trademark Office (USPTO) provides the right to exclusive use of the mark and provides protection against infringement.
It is should be noted that a proper trademark search should be performed before adopting a trademark to ensure that it is not already in use. This step is essential to avoid potential legal disputes and to secure your brand’s identity in the marketplace. Thus, if you trade name will also serve as a trademark for your business, a trademark search should be performed before you adopt a business name and open your doors.
There are differences between trade names and trademarks. While both serve to establish a brand’s presence, they do so in different ways. Trade names are used for business operations but do not necessarily serve a branding function unless used as trademarks. In contrast, trademarks are used to identify the goods or services that the business offers in a manner that communicates the quality of the goods or services, informing the consumer on a general level of what they can expect from the goods or services..
One of the most significant differences lies in the rights carried by each. A trade name does not confer exclusive rights, meaning that multiple businesses can theoretically operate under the same trade name without necessarily infringing on each other’s rights. On the other hand, provide legal protection by granting exclusive rights to use the mark in commerce and preventing others from using confusingly similar marks for related goods or services. This distinction is crucial for businesses that want to protect their brand identity and avoid legal conflicts.
However, as noted earlier, a trade name can function as a trademark if it used as a trademark. Maintaining consistency between a trade name and a trademark can strengthen brand identity and recognition. When a business’s trade name and trademark align, it creates a cohesive brand image that is easily recognizable by consumers. This consistency not only enhances brand recognition but also builds consumer trust.
Tiffany & Co. v. Costco Wholesale Corp., 994 F. Supp. 2d 474 (S.D.N.Y. 2014) illustrates how a trade name can be used as a trademark. The court examined Costco’s unauthorized use of the name “Tiffany” to describe engagement rings that were not manufactured by Tiffany & Co. The case underscores the dual nature of Tiffany as both a trade name (identifying the company itself) and a trademark (protecting its exclusive brand identity in the jewelry market). Tiffany & Co.'s use of Tiffany both as a trade name and a trademark extended its brand protection beyond just company identification—it also grants exclusive rights in commerce. The misuse of “Tiffany” by Costco could mislead customers into believing they were purchasing authentic Tiffany-brand rings, thereby harming the brand’s reputation and leading to potential consumer confusion.
Both trade names and trademarks play essential roles in establishing a brand’s presence and ensuring legal protection.
Registering a trade name typically involves completing a Statement of Trade Name form at the state or local government level. In many states, a ‘doing business as’ (DBA) registration (e.g., a local business license) is necessary when a business operates under a name that is not its legal name. The DBA registration process usually requires a form submission, a fee, and sometimes a legal newspaper notice.
Before registering a trade name, businesses should check for potential conflicts to avoid legal disputes. However, state trade name registration does not guarantee exclusivity, as multiple businesses may register similar names in different industries or locations. A trade name must be unique from other registered names in the same jurisdiction; otherwise, registration will not be permitted. This step is crucial to ensure that your business operates under a distinct name, preventing any potential legal issues down the road.
The legal implications of using trade names versus trademarks are significant. Trade names do not offer legal protection on their own, meaning that a business cannot assume that it has exclusive rights simply based on the fact that it uses a trade name. Where the trade name is used in a trademark manner, such as prominently in association with its goods (e.g., on packaging), trademarks rights may be built in the trade name. The use of a trade name as a trademark can build common law trademark rights, providing the right to exclude others from use of a similar mark in the area where the trade name is in use. However, these trademark rights do not prevent third parties from registering similar marks. If a business uses its trade name as a trademark, it should consider registering the trade name as a trademark to establish registered trademark rights and enhance its legal protection, especially if the name identifies their products or services.
Choosing a trade name is a critical step in establishing your business’s identity. A thoughtfully selected name can be a valuable asset, contributing to your success in the marketplace. Conducting a trademark search to vet your proposed trade name and ensure it is not already in use is a prudent step. This due diligence can prevent future legal disputes and help you avoid weak brand and potential forced rebranding.
Once you have selected a trade name and trademark, you should proceed with registration both with the local or state government and with the USPTO. Conducting a thorough trademark search and promptly registering your trade name with the appropriate authorities, provides legal protection and exclusive rights before potential competitors or infringers have a chance to adopt the same or similar trade name.
Selection and vetting of a trade name can be challenging of the layperson. Consulting a trademark lawyer can ensure you are adopting a protectable and unique trade name. The lawyer can help you conduct thorough investigations to verify that your chosen trademark has not been previously registered.
A trademark lawyer can also guide you through the registration process, helping you understand the legal protections available for your trade name and educating you on proper use of your trade name. A trademark attorney can also clarify the distinctions between a legal business name, a trade name, and a trademark in your particular situation. Working with professionals helps avoid potential legal issues and secure your business’s brand identity.
In summary, understanding the differences between trade names and trademarks is crucial for protecting your business’s identity. While trade names help establish your business’s presence, trademarks provide legal protection for your brand. Both play essential roles in building a successful business.
By choosing a unique trade name, conducting proper clearance searches, using the trade name as a trademark, and registering your trade name as a trademark, you can secure a strong brand identity. Consulting with legal professionals can provide valuable insights and ensure compliance with all requirements. Protecting your brand is an investment in your business’s future success.
© 2025 Sierra IP Law. The information provided herein is not intended to be legal advice, but merely conveys general information that may be beneficial to the public, and should not be viewed as a substitute for legal consultation in a particular case.
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