DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/15/2025 has been entered.
Response to Amendments
Applicant's amendments filed 10/15/2025 to claim 60 has been entered. Claims 1-59, 61-75, 78-113, and 116-118 are canceled. Claims 60, 76, 77, 114, 115, and 119-121 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
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.
Claims 60, 76, 77, 114, 115, and 119-121 are rejected under 35 U.S.C. 103 as unpatentable over Choi et al. 2012 (Appl. Microbiol Biotechnol (2012), 95:671-682; provided in the IDS dated 4/30/2024) as evidenced by Medzihradsky (Methods Mol Biol (2008), 446, 293-316) and Jiang et al. (Protein Expression and Purification (2011), 76, 7-14).
Choi teaches a composition comprising an anti-Her2 antibody produced in Pichia pastoris expressing Leishmania major oligosaccharyltransferase STT3D (Abstract; methods on p672-675, particularly the paragraph spanning p672-673 for anti-Her2), reading on 60, the embodiment of a single homogenous protein produced for claims 76 and 119, claims 77, 114, 115, 120, and the embodiment of a full length antibody for claim 121. Choi teaches that the inclusion of Leishmania major oligosaccharyltransferase STT3D improves N-glycan occupancy to greater than 99% and summing to 100% for the recombinant anti-Her2 antibody produced in Pichia pastoris (Table 2; see the ± values for the anti-Her2 antibody in Table 4), reading on claim 60, 76, 77, and 119. Choi teaches anti-Her2 antibody comprises GlcNAc2Man3-type glycosylation and summing to about 82.8-87.5% (Table 4, G0, G1, and G2, the cited range being ± the SD measurements of Choi), reading in-part on claim 60.
Regarding claim 60, Medzihradsky teaches that the N-glycosylation consensus sequence is AsnXxxSer/Thr/Cys, where Xxx can be any amino acid except proline and that N-glycosylated species are modified at Asn residues. (See the Summary on p293). Therefore, Choi as evidenced by Medzihradsky inherently reads on the Asn consensus sequence of claim 60.
Regarding claim 120, Choi is silent if the anti-Her2 antibody is or is not fucosylated. However, Jiang teaches that glycosylated proteins produced in Pichia pastoris are not fucosylated (p8, left column, paragraph starting “A humanized anti-HER2/neu receptor IgG1 mAb…”; Fig. 4B). Therefore and absent any showing to the contrary, the teachings of Choi as evidenced by Jiang reads on claim 120.
Claim 60 and dependent claims 76, 77, 114, 115, and 119-121 are product-by-process claims. See M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure of the claimed composition that is implied by the steps. Furthermore, alternate grounds of rejection under both 102 and 103 is permissible given the lack of physical description of product-by-process claims and the inability of the USPTO to manufacture and compare products. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any non-obvious structural characteristics to the claimed product as compared to the composition taught by Choi. Choi teaches a substantially similar glycosylated antibody composition produced in different host but with over an expressed Leishmania oligosaccharyl/glycosyl-transferase. Applicant must clearly set forth why any structural difference between the claimed composition and the composition of Cho is non-obvious.
Regarding claim 60, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See M.P.E.P. § 2144.05(I). In this case, the difference in the at least 90% % GlcNAc2Man3-type glycosylated antibody composition of the claim and the 82.8-87.5% GlcNAc2Man3-type glycosylated antibody of Choi are so close that a person of ordinary skill in the art would have expected them to have same properties, absent any persuasive showing to the contrary.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 4-6 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
In response to applicant's argument on pages 4-6 of the reply that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., 90-100% glycans consisting of Man3GLcNAc2) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Choi clearly and unambiguously teaches that G0, G1, and G2 type N-glycans comprises the “Man3GLcNAc2” structure in Table as cited, and summing these three categories together to partially meet claim 60 meets the broadest reasonable interpretation of the scope of the claim. See M.P.E.P. § 2111.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653