CTNF 18/560,003 CTNF 87702 DETAILED ACTION Status of the Claims Claims 1-2, 5-6, 8, 10, 12, 16-18, and 24-26 are currently pending and are the subject of this Office Action. 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections Claims 8, 10, and 17 are objected to as being dependent upon a rejected base claim, but would be free from the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Appropriate correction is required. Claim Rejections – 35 U.S.C. 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Renner et al. and Boder et al. 07-21-aia AIA Claim s 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Renner et al. (WO 2010/106431 A2, cited in the IDS of 03/25/2025) in view of Boder et al. ( Nature Biotechnology , 1997, vol. 15, pp. 553-557) . Regarding claims 1 (in part), 2, and 5-6 , Renner discloses a method of designing an antigen binding region (ABR) that specifically binds to an MHC-peptide complex of interest (e.g., as per the Abstract and throughout) comprising: (a) identifying by structural analysis the peptide binding contact residues in an initial ABR (e.g., Renner determines crystal structures of the 3M4E5 Fab/NY-ESO-1 157-165 /HLA-A*0201 complex at 1.9Å resolution and identifies direct peptide contact residues in the Fab CDR loops, as per Tables 3A-3B and Fig. 5); (b) generating a diverse ABR library of polynucleotide coding sequences by randomizing one or more codons encoding peptide binding contact residues in the initial ABR (e.g., as per para. [000166]-[000168], which discloses randomization of codons at the identified peptide contact positions of the 3M4E5 Fab light and heavy chains using random NNB codon mutations to generate a library of 10 8 independent clones); and (d) selecting for proteins that bind to the MHC-peptide complex of interest (e.g., as per para. [000168]-[000169], which discloses multiple rounds of selection against the biotinylated variant, as per para [000176], of HLA-A*0201/NY-ESO-1 157-165 complex yielding clones with specific, high-affinity binding). However, Renner is silent as to step (c) (expressing the library where the library ABR proteins are present on the cell surface), as Renner employs a phage-displayed phagemid library wherein antigen binding fragments are presented on the surface of phage particles rather than cells (e.g., as per para. [000179]). Bader discloses a yeast surface display system wherein scFv antibody fragments are expressed as fusions to the Aga2p receptor of Saccharomyces cerevisiae, presenting the scFv on the yeast cell surface, and wherein displayed clones are selected by FACS against a target antigen (e.g., as per Boder, p. 553-56). Bader further explicitly states that yeast cell surface display " is well suited/or engineering mammalian cell-surface and secreted proteins (e.g., antibodies, receptors, cytokines) that require endoplasmic reticulum-specific post-translational processing for efficient folding and activity" and that "[a] eukaryotic host should alleviate expression biases present in bacterially propagated combinatorial libraries" (e.g., as per Bader, p. 553). It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to substitute the yeast cell surface display system of Bader for the phage display system of Renner in step (c). One of ordinary skill in the art would have been motivated to do so since Boder explicitly teaches that yeast cell surface display is advantageous over bacterially propagated phage systems for antibody fragments such as scFvs, identifying the eukaryotic folding environment and elimination of bacterial expression bias as direct motivating benefits, and further teaches FACS-based selection as a more discriminating alternative to phage panning. One of ordinary skill in the art would have had a reasonable expectation of success as of the effective filing date in modifying the references to arrive at the claimed invention since yeast surface display of scFv and related antibody fragments was a well-established and routine technique in the antibody engineering field, having been demonstrated and validated by Boder more than a decade prior to the filing date of Renner . Conclusion 12-151-07 AIA 07-97 12-51-07 Claim s 12, 16, 18, and 24-26 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684 Application/Control Number: 18/560,003 Page 2 Art Unit: 1684 Application/Control Number: 18/560,003 Page 3 Art Unit: 1684 Application/Control Number: 18/560,003 Page 4 Art Unit: 1684 Application/Control Number: 18/560,003 Page 5 Art Unit: 1684 Application/Control Number: 18/560,003 Page 6 Art Unit: 1684
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