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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 120-133, 136, 139, 145-146, 149 and 152 drawn to a pharmaceutical composition comprising a drug conjugate having a drug moiety covalently attached to the rest of the drug conjugate, the drug conjugate having formula [D-(X)b-(AA)w-(T)g-(L)-]n-Ab in the reply filed on 01/07/2026 is acknowledged.
Claims 134-135, 137-138, 140-144, 147-148, 150-151 and 153-154 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/07/2026.
Applicant has added claims 149-154. No new matter was added. The new claims that are elected or withdrawn from further consideration is reflected in the above statements. Claims 120-133, 136, 139, 145-146, 149 and 152 are is pending. Claims 120-133, 136, 139, 145-146, 149 and 152 is now evaluated on its merits.
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.
Claims 120-126, 129-130, 132-133, 136, 139, 145-146, 149 and 152 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.
Regarding claim 120 in which all the preceding claims depend from, recites the limitations of X and T are extending groups that may be the same or different and Ab is a moiety comprising at least one antigen binding site. The structural limitations according to the claim of X, T and Ab are relatively broad. The claim is open to administrating any extending group, in which extending group is not defined by the specification, and any moiety having an antigen binding site. Thus, one of ordinary skill in the art would not be able to ascertain which structures of X, T and Ab moiety would read to the claimed inventions as per MPEP 2163 (I): To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claims 121-126, 129-130, 132-133, 136, 139, 145-146, 149 and 152 which depends from claim 120, lacks written description as failing to structurally limit X, T and moiety Ab.
Allowable Subject Matter
Claims 127-128 and 131 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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