Section 101 Examples
Example 16 (8): Antibodies

This is an example provided by the U.S. Patent and Trademark Office for analyzing Section 101 patent subject matter eligibility issues. The example is one of the "Nature Based Product Examples" provided by the USPTO on December 16, 2014, and this example should be viewed in light of the introduction that was provided with it. The original PDF document is found here. The numbering of these examples is taken from Appendix 2 of the July 2015 Update on Subject Matter Eligibility.

The index for all of the examples provided by the Patent and Trademark Office is found on BitLaw's Section 101 Index.

Example 16 (8): Antibodies

This example illustrates that products created by human manipulation of natural processes (claims 2 and 3), as well as products that are changed in structure as compared to a product’s natural counterpart (claims 4 and 5), can have markedly different characteristics.

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:

1. An antibody to Protein S.
2. The antibody of claim 1, wherein the antibody is a human antibody.
3. 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.
4. The antibody of claim 1, wherein the antibody is a chimeric or humanized antibody.
5. 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.