The USPTO has provided 49 examples* to help understand the application of Section 101 (35 U.S.C. 101), subject matter eligibility, in particular situations. These examples were issued at different times between 2014 and 2024 (most recent group of examples published in July 2024) and are split between different documents. Thus, it can be hard to identify all of these examples quickly. We have compiled the examples that involve life sciences subject matter to help in this regard.
Figure 1 provides a list of the life sciences-related USPTO 101 Examples. Although Section 101 patentable subject matter issues most frequently arise in medical diagnostics, as you can see, the USPTO examples cover a wide range of life-sciences related technologies.
Figure 1. Bio Examples Issue Spotting:
For more information on Section 101/patent subject matter eligibility, and to see relevant cases, guidelines, and data, check out our other recent post on the topic. As we discuss in that post, it is noteworthy that the 2019 Patent Eligibility Guidelines (PEG) clarified that a claim meets the requirements of Section 101 if it recites an additional element(s) that integrates the judicial exception into a practical application. Some of the USPTO Section 101 Examples were published before this time, and thus their analysis does not discuss this practical application analysis.
If you have not recently checked out any of these hypothetical examples, they provide hypothetical background facts and claims, followed by an analysis section. We provide the full USPTO analysis for Example 16, which focuses on claims to antibodies, in the Appendix below. It is interesting that although Section 101 issues come up most frequently in life sciences in medical diagnostics inventions, and recent case law involving antibody patents focus on 35 U.S.C. 112, some 35 U.S.C. 101 issues can arise for virtually any life sciences inventions (e.g., new antibodies) as well. Plus, the USPTO examples provide issues and analysis for each example that is applicable to many different categories of life sciences inventions.
The bottom of Figure 2 and the text below set out the hypothetical claims provided by the USPTO for this example that focuses on antibody claims. For each of these claims, the figure shows the flow of the analysis leading to the final USPTO determination (i.e. the eligibility path). The analysis focuses on whether the claimed antibodies and antibodies found in nature is a marked difference based on structural and functional analysis. In this example, the USPTO determined that hypothetical claim 1 is ineligible, while claims 3-5 are eligible.
Figure 2. Example 16 Antibodies Eligibility:
The key points of the analysis of these claims are as follows:
Claims/Conclusion: Key point:
An antibody to Protein S.
Invalid: Some antibodies within scope are exactly as found in nature.
The antibody of claim 1, wherein the antibody is a human antibody.
Valid: From facts provided, no human antibodies to Protein S exist in nature.
The antibody of claim 1, wherein the antibody is a murine antibody comprising complementarity determining region (CDR) sequences set forth as SEQ ID NOs: 7-12.
Valid: From facts provided, no murine antibodies with CDRs 7-12 have been found in nature, and the fact that there may be undetected antibodies with CDRs 7-12 in nature does NOT change the conclusion of validity unless such antibodies are actually found.
The antibody of claim 1, wherein the antibody is a chimeric or humanized antibody.
Valid: The claimed antibodies do not occur in nature, and they likely have improved properties from natural antibodies.
The antibody of claim 1, wherein the antibody comprises a variant Fc domain.
Valid: The claimed antibodies do not occur in nature, and they likely have improved properties from natural antibodies.
10/25/24
DV and EV
This post is not legal advice and does not necessarily express the views of DHL or DHL's clients.
APPENDIX
USPTO analysis from example 16, Antibodies:
Background:
Newly discovered Staphylococcus texana bacteria have an antigen called Protein S on their outer surface. The specification describes the discovery of naturally occurring antibodies to Protein S in mice and wild coyotes living in Texas. No human antibodies to Protein S are naturally occurring. Antibodies have two types of domains: (1) constant domains such as the Fc domain, which are unvarying in antibodies of a particular class (e.g., IgA) within a species; and (2) variable domains comprising complementarity determining regions (CDRs) that bind to an antigen and that vary from antibody to antibody.
The specification describes multiple types of antibodies to Protein S, including:
murine antibodies, that were created by injecting laboratory mice with Protein S;
human antibodies, that were created by injecting transgenic mice with Protein S;
chimeric antibodies (defined as antibodies that have murine variable domains and human constant domains);
humanized antibodies (defined as antibodies having murine CDRs but are otherwise human); and
antibodies with variant Fc domains (defined as antibodies having an Fc domain that is engineered to comprise at least one amino acid modification relative to a wild-type Fc domain).
It is well-known in the art that murine antibodies have different constant domains than human and coyote antibodies, and that murine antibodies may cause allergic reactions and anaphylactic shock when administered to humans or coyotes. The specification discloses a particular murine antibody created by applicants, comprising SEQ ID NOs: 7-12 as its six CDR sequences. There is no naturally occurring antibody that has this particular combination of CDR sequences. It is well-known in the art that chimeric and humanized antibodies are less immunogenic to humans than murine antibodies. It is also well-known that antibodies with variant Fc domains may exhibit different characteristics (e.g., increased cytotoxicity and/or serum half-life) than antibodies with wild-type Fc domains.
Claims:
An antibody to Protein S
The antibody of claim 1, wherein the antibody is a human antibody.
The antibody of claim 1, wherein the antibody is a murine antibody comprising complementarity determining region (CDR) sequences set forth as SEQ ID NOs: 7-12.
The antibody of claim 1, wherein the antibody is a chimeric or humanized antibody.
The antibody of claim 1, wherein the antibody comprises a variant Fc domain.
Analysis of Claims:
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Because all of the claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and are nature-based products (an antibody), the markedly different characteristics analysis is used to determine if the nature-based products are exceptions.
Claim 1: Ineligible.
As described in the specification, some antibodies to Protein S are naturally occurring in mice and wild coyotes living in Texas, while other antibodies to Protein S (such as chimeric antibodies) have non-natural forms and may contain domains from multiple species. The claim thus encompasses antibodies that are structurally identical to naturally occurring antibodies, and antibodies that are structurally changed. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed and naturally occurring antibodies for at least some of the embodiments encompassed by the claim, the claimed antibodies do not have markedly different characteristics, and thus are a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES ). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2: Eligible.
The claim is limited to human antibodies to Protein S. No human antibodies to Protein S are naturally occurring. The claimed antibodies have different complementarity determining regions (CDRs) than what exists in nature, and therefore have different structural (e.g., different amino acid sequences and three-dimensional structures) and functional (e.g., bind to different antigens) characteristics. These differences rise to the level of a marked difference, and so the claimed antibodies are not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 3: Eligible.
The claim is limited to murine antibodies comprising complementarity determining region (CDR) sequences set forth as SEQ ID NOs: 7-12. Some murine antibodies to Protein S occur in nature, and it is possible that nature might randomly create a murine antibody having the CDR sequences of SEQ ID NOs: 7-12. But unless the examiner can show that this particular murine antibody exists in nature, this mere possibility does not bar the eligibility of this claim. See, e.g., Myriad, 133 S. Ct. at 2119 n.8 (“The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable” (emphasis in original)). Because the claimed antibodies have different CDRs than what exists in nature, they have different structural (e.g., different amino acid sequences and three-dimensional structures) and functional (e.g., bind to different antigens) characteristics. These differences rise to the level of a marked difference, and so the claimed antibodies are not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 4: Eligible.
The claim is limited to chimeric and humanized antibodies, which are defined as fusion proteins formed by physically fusing together part of a murine antibody (CDRs or variable domains) and part of a human antibody (constant domains). The claimed antibodies have different structural characteristics than natural antibodies, because the combination of murine and human antibody fragments into a single antibody molecule does not exist in nature. There may also be differences in functional characteristics, e.g., chimeric antibodies are typically less immunogenic to humans than murine antibodies. These differences rise to the level of a marked difference, and so the claimed antibodies are not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Claim 5: Eligible.
The claim is limited to antibodies comprising a variant Fc domain, which is defined as an Fc domain that is engineered to comprise at least one amino acid modification relative to a wild-type Fc domain. The claimed antibodies have different structural characteristics (e.g., different amino acid sequences and three-dimensional structures) than natural antibodies, and may also have different functional characteristics (e.g., different cytotoxicity and/or serum half-life). These differences in characteristics rise to the level of a marked difference, and so the claimed antibodies are not “product of nature” exceptions. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
The full list of examples including those above:
Examples 1-10 and 21-36 (issued between December 16, 2014 through December 15, 2016):
Examples 1-27 (July 2015 Update Appendix 2: Index of Eligibility Examples):
2019 PEG Examples 37 through 42 (issued January 7, 2019):
October 2019 Examples 43-46 (issued October 17, 2019):
2024 AI Examples 47 through 49 (effective July 17, 2024):
Full index of examples 1-49:
Notes:
*As of current article publication (10/25/24)
Footnotes:
[1] - Examples are provided by the USPTO under their subject matter eligibility examples documents. https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility
[2] - Example 16 comes from the USPTO examples 1-36 (issued between December 16, 2014 through December 15, 2016). https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.pdf
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