DETAILED ACTION
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 .
Status of the Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application. Applicant's submission of the RCE filed on 07/10/2026 has been entered for further consideration of the claims.
The Examiner acknowledges the following:
Claims 41-51 are under current examination.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 07/10/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Rejections - 35 USC § 112-indefinite
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 41-51 are 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 41 recites the phrase in the last paragraph “under conditions permitting production of the antibody or antigen binding fragment”. However, said conditions are not defined by the claim which is directed to a method of making, and the specification does not provide any guidance as to which conditions are necessary in permitting production of the antibody or antigen binding fragment of claim 41. The phrase conditions permitting is vague and indefinite absent a clear indication of which conditions are required by the claim to produce said antibody or antigen binding fragment.
Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention as to which conditions are required by the claims such that there is production of the antibody or antigen biding fragment.
Claims 42-51 do not rectify this deficiency to claim 41.
Claim Rejections - 35 USC § 112(a)-written description
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 41-51 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.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Instant claim 41 in the last paragraph recites the culturing of a host cell comprising one or more polynucleotides encoding the HCVR and LCVR of the antibody or antigen binding fragment under conditions permitting production of the antibody or antibody binding fragment.
Actual Reduction to Practice/sufficient relevant characteristics: In the instant case, the specification at paragraph [0052] recites the culturing of host cells under conditions permitting production of the antibodies or antibody fragments. However, the specification does not disclose which conditions are required for culturing of the host cells such that production of said antibodies or antibody fragments are permitted. Notably, claim 41 does not limit the host cell to CHO cells which may require a particular set of conditions that differ from other host cells. The breadth of the claims encompasses “conditions” that permit production of antibodies or antibody fragments, however there is no mention as to what conditions must necessarily be required to culture a genus of host cells and permit production of said antibodies or antigen-fragment. Accordingly, claims 41-52 lack written description for “conditions permitting production” for culturing a host cell.
Conclusion
Claims 41-51 are rejected.
Conclusion
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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