Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s remarks and amendments to the claims received 10/27/2025 have been acknowledged. Claims 71 and 72 have been canceled. The cancellation of claims 71 and 72 renders moot the rejections made under 35 USC 112(a) written description and enablement previously set forth in the Final Rejection of 08/25/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement
Claims 62-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification demonstrated that IgG2, IgG4, or IgG1 (LALA) isotypes of the anti-PD-1 antibody 3.7C6 lacked agonist activity (Example 5).
Claims 62-65 (which depend on claims 48, 51, or 54) recite a method for inhibiting an immune response in a mammal or treating an inflammatory/autoimmune disorder in mammal comprising administering a recited anti-PD-1 binding agent, wherein the anti-PD-1 binding agent comprises an Fc region of IgG1 or other Fc region that binds to FcyR as stated in claims 48, 51, 54.
All four IgG subclasses (IgG1, IgG2, IgG3, and IgG4) can bind to FcγRs although their binding strengths and the specific FcγRs they interact with differ. IgG4 binds to the high affinity Fc gamma receptor FcγRIa with a two-fold lower affinity compared to IgG1 and IgG3. While IgG2 does not bind FcγRIa, it still binds to other FcyRs including FcγRIIa and FcγRIIIa (se de Taeye et al, see 3rd paragraph of Section 3.1: Fc-Receptors). Thus, the method claims encompass inhibiting an immune response or treating an inflammatory/autoimmune disease in a subject using an anti-PD-1 binding agent having an Fc region of IgG2 or IgG4 isotypes. Since the IgG2 and IgG4 isotypes of the claimed anti-PD-1 antibodies were shown to lack agonist activity, artisans would not reasonably expect the claimed anti-PD-1 antibodies having an Fc region of the IgG2 or IgG4 isotypes to be able to effectively inhibit an immune response or treat an inflammatory/autoimmune disease in a subject commensurate in scope of the claims.
Therefore, the specification is not enabled over the full scope of the claims.
Applicant may overcome rejection by amending claims 48, 51, and 54 to recite “The PD-1 binding agent of claim 1 (or claim 42), wherein the PD-1 binding agent comprises an Fc region of IgG1”.
Conclusion
Claims 1 and 39-61 are allowable. Claims 62-70 are not allowable.
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/LIA E TAYLOR/Examiner, Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641