DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and species election of Q_CH2.94_E; N_CH2.97_Y; S_CH3.45_D; M_CH3.105_Y; and Q_CH3.118_Y in the reply filed on 9/12/2025 are acknowledged. After further consideration the species election is hereby withdrawn and claims 7 and 8 will be rejoined.
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/12/2025.
Claims 1-12 are pending and will be examined on the merits
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 and 12 are drawn to a product, however the claim recites “for use in”. This renders the claim indefinite. It is unclear whether the claim is drawn to a product or a method. The preamble of the claims is drawn to a product and depend from Claim 1, which is drawn to a product. Appropriate correction is requested.
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.
Claims 7-8 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 7-8 are drawn to an IgA2 antibody comprising an Fc variant, wherein the antibody has increased FcαR affinity, or increased ADCC, relative to an IgA2 antibody comprising a parent Fc polypeptide, and wherein the antibody comprises an amino acid modification at a positions recited in Claim 7. The claims are broadly drawn to any amino acid substitution at the listed positions. The instant specification provides specific amino acid substitutions at the recited positions to result in the desired function of increased affinity and ADCC, relative to the parent Fc. Applicant’s do not show possession of the broad range of possible IgA2 Fc variants encompassed by the instant claim.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010).
The prior art shows that specific amino acid substitutions within the Fc region can have varied altered effector functions. For example, Su et al. (Antibodies, 2018, 7, 20) teach IgA Fc mutations at positions C253Y/H304R in the CH3 region of IgA2 could effect antigen binding. The instant specification teaches specific amino acid mutations with defined substitutions in the Fc IgA2 region, however the broad genus of possible Fc variants encompassed by instant Claim 7 is not adequately described.
Conclusion
Claims 7-8 and 11-12 are rejected.
Claims 1-6, 9 and 10 are allowable.
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/Meera Natarajan/Primary Examiner, Art Unit 1643