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 .
Claims 2-19, 23-27, 29-32, 34-36, 40-68, and 73-75 have been cancelled.
Applicant's arguments filed 4/27/2026 have been fully considered but they are not fully persuasive.
Election/Restrictions
Claims 37-39 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025. This claims are not subject to rejoinder for reasons of record.
Information Disclosure Statement
The information disclosure statement filed 4/27/2026 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The IDS size fee written assertion under 37 CFR 1.98 indicated that no fee was due. This is incorrect. Applicant has cited over 100 references (cumulatively) in the IDSs filed 8/27/2025 and 4/27/2026.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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 69-71 are rejected under 35 U.S.C. 103 as being obvious over Li et al. (U.S. Patent No. 10,093,731, of record) in view of Zhan et al. (WO 2020/191289, published 24 September 202, filed 20 March 2020).
As set forth in the prior Office action, Zhan et al. has an inventor in common with the instant application. However, this document is by other than the instant inventive entity. Page 7, paragraph 5, of applicant’s 4/27/2026 included a conspicuous statement according the MPEP 717.02(c) to invoke an exception under 102(b)(2)(C). As such, Zhan et al. is not available as prior art under 35 USC 102(a)(2).
However, Zhan et al. was published on 24 September 2020. The instant application is not entitled to priority to provisional applications 63/0144,033 (filed 4/22/2020) and 63/014,549 (filed 4/23/2020) for claims 69-71. Basis is not seen in these documents for a sequence that is “at least 95% identical to SEQ ID NO: 95.” As such, the effective filing date for claims 69-71 of the instant application is 4/22/2021 and Zhan et al. remains valid prior art under 35 USC 102(a)(1).
Li et al. (U.S. Patent No. 10,093,731) discloses canonized IgG-B antibodies against canine IL-31.
The VL of SEQ ID NO: 24 of Li et al. corresponds to instant SEQ ID NO: 24. It contains the CDRs of instant SEQ ID NOS: 8, 9, and 10.
The light chain of SEQ ID NO: 21 of Li et al. corresponds to instant SEQ ID NO: 21 and contains instant SEQ ID NO: 24.
The VH of SEQ ID NO: 25 of Li et al. corresponds to instant SEQ ID NO: 25. It contains the CDRs of instant SEQ ID NOS: 1, 2, and 3.
SEQ ID NO: 18 corresponds to the heavy chain of the canonized antibody against canine IL-31. SEQ ID NO: 18 corresponds to instant SEQ ID NO: 126 except for a leucine (L) instead of a serine (S) at amino acid position 113 and a leucine (L) instead of a tyrosine (Y) at amino acid position 256. Instant SEQ ID NO: 90 corresponds to amino acids 234-453 of SEQ ID NO: 18 except for a leucine (L) instead of a tyrosine (Y) at amino acid position 23 of SEQ ID NO: 90 (i.e. amino acid position 256 of SEQ ID NO: 18). SEQ ID NO: 18 contains the CDRs of instant SEQ ID NOS: 1, 2, and 3. See at least Example 3 and Table 1. Li et al. discloses that the antibodies could include any canine class, including modifications. See at least column 16, line 58, through column 17, line 25.
Zhan et al. (WO 2020/191289, published 24 September 202, filed 20 March 2020) discloses SEQ ID NO: 198 which is a caninized IgG-B sequence having the mutation L23Y corresponding to the sequence of instant SEQ ID NO: 95 (i.e. instant SEQ ID NO: 90 having the L23Y mutation as in instant claim 1.). See at least Table 1 and Embodiments 47-49.
It would have been obvious to use the caninized IgG-B Fc sequence having the mutation L23Y (i.e. SEQ ID NO: 198 of Zhan et al.) in the anti-canine IL-31 antibody disclosed by Li et al. Li et al. discloses that any appropriate IgG sequence could be used and Zhan et al. discloses a suitable IgG-B sequence. One would have been motivated to do so to created additional caninized antibodies. The antibody suggested by the combination of Li et al. and Zhan et al. meet the structural limitations of claims 69-71.
The claimed antibodies would have been obvious.
Claims 1, 20-22, 28, 33, 72, and 76-78 are allowable.
Conclusion
THIS ACTION IS MADE FINAL. 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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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