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 .
Continued Examination Under 37 CFR 1.114
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 after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2026 has been entered.
Withdrawn Rejections
The rejection of claims 2, 5, 9, 12, 17-18, 21-22, 33, 37-39 and 40-41 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kisielow et al. (WO2016/097334; published June 23, 2016; cited by applicant) has been withdrawn in view of applicant’s amendments to the claims.
The rejection of claims 7, 34-36 and 40 under 35 U.S.C. 103 as being unpatentable over Kisielow et al. (WO2016/097334; published June 23, 2016; cited by applicant) has been withdrawn in view of applicant’s amendments to the claims.
The rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Kisielow et al. (WO2016/097334; published June 23, 2016; cited by applicant) and Lybarger et al. (Journal of Biological Chemistry, July 2003, 278(29):27105-27111) has been withdrawn in view of applicant’s amendments to the claims.
The rejection of claim 2 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11939572 has been withdrawn in view of applicant’s amendments to claim 2.
The rejection of claim 2 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10865408 has been withdrawn in view of applicant’s amendments to claim 2.
Claim Objections
Claim 39 is objected to because of the following informalities: Claim 39 does not end with a period. Appropriate correction is required.
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 2, 5, 7-10, 12, 17-18, 21-22, 33-35, and 37-41 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 legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
The claims are directed to a method for identifying candidate peptides presented by major histocompatibility complexes (MHCs), the method comprising:
generating a library of nucleic acids each encoding a candidate peptide cloned upstream of, and in-frame with, a nucleotide sequence encoding beta and/or alpha chains of a recombinant MHC;
transducing the library into a reporter cell line;
determining the levels of cell surface expression of one or more MHCs and enriching reporter cells based thereon;
isolating DNA from the reporter cells enriched in step (iii); and
determining the sequence of the candidate peptides encoded by the DNA isolated in step (iv).
Step (iii) states “determining the levels of cell surface expression of one or more MHCs and enriching reporter cells based thereon”. However, it is not clear what level of cell surface expression of one or more MHCs is required to then enrich reporter cells. The specification teaches that reporter cells that “efficiently” express MHC on their surface are enriched by FACS or MACS cell sorting. It is noted that the specification does not define “efficiently expressed” such that one of ordinary skill in the art would know what level of MHC expression triggers an enrichment step.
Enriching reporter cells depends on (or is based on) the level of cell surface expression of one or more MHCs, but there is no teaching of (or correlation between) a particular level of cell surface expression of one or more MHCs that leads to enrichment of a particular reporter cell.
Given the breadth of the claims, the lack of guidance in the specification, and the lack of predictability of the art, it would require undue experimentation for one skilled in the art to use the claimed composition and method.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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