The Patent Novelty Requirement

The novelty requirement is a foundational aspect of US patent law. An invention must be something new in order to be considered patentable. Patents are only granted for inventions that are truly new. Anticipation is not the only requirement for patentability. Novelty is one of several statutory requirements, including patent-eligible subject matter, novelty, obviousness, written description, enablement, and definiteness. We provide separate articles for each of these requirements. This article explains the novelty requirement, including key concepts like anticipation and inherency.

Statutory Basis for Novelty

The novelty requirement is primarily codified in 35 U.S.C. § 102. This section sets forth the conditions under which an invention is considered novel. The statute has undergone significant changes, most notably with the passage of the America Invents Act (AIA) in 2011, which transitioned the U.S. from a "first-to-invent" system to a "first-to-file" system. Under the pre-AIA law, the focus was on whether the invention was known or used by others in the U.S. before the applicant's date of invention or whether it was patented or described in a printed publication anywhere in the world before the invention date. Post-AIA, the critical date shifted to the filing date of the application, and the relevant prior art includes disclosures anywhere in the world before the effective filing date.

Anticipation under US Patent Law

35 U.S.C. § 102 outlines the conditions for patentability with respect to novelty. The claimed invention in a patent application must be new relative to the relevant prior art. Thus, in order to understand the novelty requirement, you must understand what qualifies as prior art with respect to a particular patent application.

What is Prior Art?

A claimed invention is not novel if it was patented, disclosed in a printed publication, publicly used, offered for sale, or otherwise available to the public before the priority date of the patent application. Additionally, if the claimed invention was described in a patent or in a patent application published or deemed published under 35 U.S.C. § 122(b), and the patent or application has different inventorship and was effectively filed before the effective filing date of the claimed invention, it is considered prior art. For determining whether a patent or application is prior art under 35 U.S.C. § 102(a)(2), the patent or patent application reference is considered to have been effectively filed as of the actual filing date, or the earlier filing date of a prior filed application if it claims priority to the prior-filed application.

Excluding a Prior Art Reference

The statute also provides exceptions under 35 U.S.C. § 102(b). Disclosures made one year or less before the effective filing date of the claimed invention are not considered prior art if the disclosure was made by an inventor, joint inventor, or someone who obtained the subject matter disclosed directly or indirectly from one of the inventors. Moreover, prior art does not include subject matter publicly disclosed by the inventor or a joint inventor before the effective filing date of the patent application.

Another critical aspect is the consideration of joint research agreements under 35 U.S.C. § 102(c). Subject matter disclosed and the claimed invention are deemed to have been owned by the same person or entity if they were developed under a joint research agreement in effect on or before the effective filing date of the patent application. The patent application must disclose the names of the parties to the joint research agreement.

Admissions as Prior Art

An applicant’s identification of another's work as "prior art" in the specification or during prosecution is an admission usable for anticipation determinations, even if it would not otherwise qualify under 35 U.S.C. § 102. However, the inventor's own work is not prior art unless statutorily qualified. Examiners must verify if the admitted prior art is the inventor’s or another’s work, treating it as another’s in the absence of evidence.

Anticipation - All Elements of the Claimed Invention are Disclosed

A single prior art reference must disclose all the elements of the claimed invention in order to anticipate the patent claim. This means that the prior art must explicitly or inherently disclose every aspect of the claimed invention. The novelty requirement prevents the patenting of inventions that are already known and encourages innovation by ensuring that only new and unique inventions are granted patent protection. The prior art reference must be enabling to one or ordinary skill in the art in order to be a proper prior art reference. This means that the reference must provide sufficient information for a person of ordinary skill in the art to practice the claimed invention without undue experimentation. The prior art reference must include a level of detail that allows a skilled person to understand and practice the claimed invention. This includes descriptions of the invention's components, methods, and any necessary conditions or parameters. This concept applies both to patent applications and prior art references used to challenge the novelty of a patent claim.

Illustrative Example of an Anticipated Claim

Claim: A pharmaceutical composition comprising:

1. A therapeutically effective amount of Compound X;
2. Citric acid in a concentration of about 0.1 micromolar to about 1.0 micromolar; and
3. A pharmaceutically acceptable carrier.

Prior Art Reference: A scientific journal article published two years before the effective filing date of the patent application describes a pharmaceutical composition that includes Compound X in a therapeutically effective amount and citric acid in a concentration of 0.5 micromolar in a pharmaceutically acceptable carrier.

Analysis: In this case, the prior art discloses all the elements of the claimed invention. The composition described in the journal article includes Compound X, citric acid in the claimed range, and a pharmaceutically acceptable carrier. Therefore, the reference anticipated the claimed invention because all of the elements were disclosed.

Counter-Example of a Claim That Is Not Anticipated

The same claim would not be anticipated by a scientific journal article published two years before the effective filing date of the patent application describes a pharmaceutical composition that includes Compound X in a therapeutically effective amount and citric acid at a concentration of 2.0 micromolar in a pharmaceutically acceptable carrier. Additionally, a different prior art reference from a different journal describes Compound X and citric acid in the claimed range, but does not combine it with a pharmaceutically acceptable carrier.

Analysis: In this scenario, no single prior art reference discloses all the elements of the claimed invention. The first journal article describes a composition with Compound X and a carrier, but the citric acid is not in the claimed concentration range. The second reference disclosed compound X and citric acid in the claimed range, but does not disclose the pharmaceutically acceptable carrier claim limitation. Because there is no single reference that discloses all of the claimed elements, the claim is not anticipated.

There are some further nuances to the application of an anticipation rejection, which are discussed below.

Inherent Characteristic in a Prior Art Reference

Inherent disclosures of a prior art reference can be used to reject claims as anticipated under 35 U.S.C. 102. Inherency refers to implicit features within prior art that are not explicitly stated in the written description, but are necessarily present. A discovery of a new property of a prior art composition does not make it patentable. For example, the identification of a previously unrecognized DNA sequence does not render the sequence novel if it was inherently present in prior art. The inherent feature does not need to be recognized at the time of the prior art's publication. Even if the characteristic was unknown, it can still anticipate the claim if it is a necessary feature of the prior art. Anticipation rejections are appropriate when a prior art product appears identical to the claimed subject matter, except that the prior art is silent about an inherent characteristic. The US patent office must identify and provide evidence that the missing limitation is inherent in the prior art technology. The patent examiner must demonstrate that the asserted inherent characteristic is actually inherent in the subject matter disclosed by the prior art reference. This principle applies to product, apparatus, and process claims described in terms of function, property, or characteristic. Hence, inherent features in prior art references play a critical role in patent examinations and litigation.

Anticipation of Ranges

Anticipation of ranges in patent claims is determined by whether a prior art reference disclosing a specific example falls within the claimed range. In the example of above, the prior art disclosed a pharmaceutical composition that includes Compound X in a therapeutically effective amount and citric acid in a concentration of 0.5 micromolar in a pharmaceutically acceptable carrier, where the claim recited citric acid in a range of 0.1 micromolar to 1.0 micromolar. Thus, the prior art reference anticipates the claim because 0.5 micromolar falls in the claimed range. A prior art reference disclosing a value or range close to but not overlapping or touching the claimed range does not anticipate the claim.

Anticipation in Genus-Species Situations

Anticipation in genus-species situations involves whether a prior art reference disclosing a species can anticipate a claim to a broader genus. If a prior art reference discloses a specific species within a claimed genus, it anticipates the genus claim. For example, if a reference names a specific chemical species within a Markush claim of a genus of compounds, the species can anticipate the entire genus. A Markush claim is a type of patent claim used to define a genus by specifying a list of alternative species or elements within a single claim, as follows: "A composition comprising a member selected from the group consisting of A, B, C, and D." If a reference disclosed a composition comprising A, it would support an anticipation rejection.

However, a genus does not always anticipate a claim to a species within that genus unless the species is clearly named in the reference. For example, if a reference lists multiple compounds, the mere inclusion of a claimed species among them anticipates the species claim.

A generic disclosure will anticipate a claimed species when the species can be "at once envisaged" from the disclosure. This means that the prior art must provide sufficient detail that a person skilled in the art can immediately recognize the specific species within the broader genus. For example, in Kennametal, Inc. v. Ingersoll Cutting Tool Co., a prior art reference was found to anticipate a claim because it provided sufficient evidence that a person skilled in the art would immediately envisage the specific combination of elements. In contrast, if a generic formula encompasses an infinite number of compounds, a specific compound within that formula is not anticipated unless the reference provides a more limited and detailed disclosure. This was highlighted in In re Meyer, where a specific compound was not anticipated because the prior art limited the generic composition disclosure.

In summary, anticipation in genus-species situations depends on the specificity and detail provided in the prior art reference. A specific species can anticipate a genus, and a generic disclosure can anticipate a species if it allows the species to be readily envisaged.

Use of Multiple References in Anticipation Rejections

While normally a single reference is used for rejections under 35 U.S.C. § 102, multiple references can be employed under specific circumstances: to prove the primary reference contains an "enabled disclosure," to explain the meaning of a term in the primary reference, or to show an inherent characteristic not explicitly disclosed.

1. Primary reference contains an "enabled disclosure": The primary reference disclosed the claimed compound structure, and additional references showed methods of making such compounds, proving the primary reference enabled one of ordinary skill in the art to create the claimed compound structure.
2. Extrinsic evidence or a secondary reference may clarify the meaning of terms in the primary reference. For example, extrinsic evidence providing a more detailed technical explanation can demonstrate that the term "MOSFET" in the primary reference means a metal oxide semiconductor field effect transistor (MOSFET).
3. Extrinsic evidence or a secondary reference can be used by the patent office to demonstrate an inherent characteristic in the primary reference. For example, later medical research demonstrating the anti-coagulation effects of aspirin may be used to show that a patent disclosing the ingestion of aspirin for treating pain anticipates method for treating angina with ingestion of aspirin.

These scenarios highlight the flexibility in applying multiple references to ensure a comprehensive assessment of the primary reference's disclosure, enabling a proper anticipation rejection under 35 U.S.C. 102.

Examination under 35 U.S.C. § 102 by the Patent Office

During patent examination, the examiner searches for prior art, such as printed publications or patents, that are published and that were filed prior to the priority date of the examined patent application. This involves comparing the effective filing date of the patent application and the date of the reference. The examiner must also ascertain the issue or publication date of the reference to make a proper comparison. If the reference predates the effective filing date of the claimed invention, it may be used to in an anticipation rejection. The examiner may also look to evidence of public use, sale, or knowledge of the invention by others. This includes admissions by the applicant or examiner’s knowledge of the invention’s public disclosure.

Examiners can request additional information from applicants to resolve issues related to public use or sale, ensuring that the information sought is reasonably necessary for the patentability decision. Failure to respond to these requests within the specified timeframe can result in the application being considered abandoned.

Applicants can overcome a 35 U.S.C. § 102 rejection by arguing that the reference fails to disclose each and every element in the claim language, the reference is not enabled, and/or by amending the claims.

Understand Novelty Before Filing a Patent Application

Understanding the nuances of prior art disclosure, including the timing of disclosures is crucial for inventors and patent practitioners. The statutory provisions under 35 U.S.C. § 102 provide a comprehensive framework to assess the novelty of a claimed invention, ensuring that patent claims are genuinely new and not anticipated by prior art references. The novelty requirement protects the public from the unjustified patenting of existing knowledge, thereby encouraging new innovation.