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 .
Response to Amendments
Applicant's amendments filed 6/18/2026 to claim 60 have been entered. Claims 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 No claims are withdrawn from consideration at this time.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.
The instant amendments to claim 60 have overcome the 35 U.S.C. § 103 rejections of record over Choi, which are withdrawn. New grounds of rejection are set forth below
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 102 and 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schuster et al. (US 9,051,577; Reference A).
Schuster teaches a glycosylated antibody wherein the glycan structure is GlcNAc2Man3 and lacks fucose (claim 8, depending from claim 1), anticipating or reading on the embodiment of 100% glycosylation for claims 60, 114, 115, 120, and the embodiment of full-length antibody for claim 121. Schuster further teaches a monoclonal antibody lacking fucose (Column 6, lines 10-21), reading on the embodiment of 100% homogenous antibody for claim 76 and 119, and alternatively anticipating or reading on claim 120. Schuster further teaches at least 50% occupancy of glycosylation sites on the antibodies (claim 11, depending from claim 1), reading on claim 77. Schuster further teaches Fab, F(ab’)2, and scFV antibody fragments (Column 6, lines 41-51), reading on those embodiments of claim 121.
Claim 60 is a product-by-process claim. Claims 76, 77, 114, 115, and 119-121 depend from claim 60. See M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure 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 novel and/or non-obvious structural characteristics to the claimed product as compared to the substantially identical glycosylated antibody composition wherein the glycan structure is GlcNAc2Man3 and lacks fucose as taught by Schuster. Particularly, if the product-by process limitations of claim 60 impart no structural difference then claims 60, 77, 114, 115, 120, and 121 are anticipated. If the product-by process limitations of claim 60 impart a structural difference, then Applicant must persuasively set forth why any structural difference between the claimed composition and the composition of Schuster is otherwise non-obvious.
Regarding claims 76, 77, and 119 and the other alternative embodiments of claim 121, in so much that Schuster expressly considers these alternative limitations a person of ordinary skill in the art would have had a reasonable expectation of success and been motivated to modify Schuster accordingly and so must be held prima facie obvious absent any showing to the contrary. See M.P.E.P. § 2143(I)(A) and (I)(B).
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 4-7 of the reply have been fully considered, but not found persuasive of error over the new grounds of rejection over Schuster set forth above and necessitated by the instant claim amendments.
Conclusion
No claims are allowed. No claims are free of the art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
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, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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