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, 34-35, and 40-68 have been cancelled. Claims 69-78 have been newly added.
Election/Restrictions
Applicant’s election of Group I and the species as reflected in the amended claims in the reply filed on 12/31/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant requested rejoinder of Group II presenting arguments based on burden of search. However, burden of search is not a consideration in lack of unity requirements. The written restriction set forth the reasons for lack of unity with request to the claims.
Applicant presented no arguments with respect to the claims of Groups III-V. It is noted that these claims are now cancelled.
Applicant traversed the species requirement but presented no argument. It is noted that the claims have been amended to reflect to particular species elected.
Claims 37-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claims 1, 20-22, 28, 33, 36, and 69-77 are under consideration.
Specification
The sequence listing submitted 10/19/2022 was in XML format. The replacement sequence listing submitted 6/9/2023 was in XML format. The replacement sequence listing submitted 6/20/2023 was in TXT format.
When an application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of 37 CFR 1.824(a)(2) -(6) and (b), and applicant has not filed a sequence listing in a PDF file, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e). Note that the specification must contain a statement in a separate paragraph that incorporates by reference the material in the ASCII text file identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes. See MPEP 2422.03(I). The sequence listing submitted 9/20/2018 by EFS-Web was not accompanied by an amendment to the specification that incorporates by reference the material in the ASCII text file.
The specification amendment to page 1 submitted on 10/19/2022 does not reference the current sequence listing information. Correction is required.
Claim Objections
Applicant is advised that should claim 28 be found allowable, claims 73-75 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 28 depends upon claim 1 and requires 100% sequence identity to SEQ ID NO: 95.
Claims 73-75 are each dependent upon claim 1 and require 100% sequence identity to SEQ ID NO: 95. That, claim 73-75 require identical structures to each other and to claim 28. They are all directed to the same product. The functional limitations in claims 73-75 would be inherent characteristics of the product of claim 28. Claims 73-75 are substantial duplicates of claim 28.
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 1, 20-22, 28, 36, and 69-78 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).
The applied Zhan et al. reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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. The inventors are Zhan, Nguyen, Chin, Qian, Li, and Chu. The inventors of the instant application are Li, Nguyen, Chu, Chin, and Zhan. This document is by other and valid prior art under 102(a)(2).
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 1, 20-22, 22, 28, 69-72, and 76-78 and the functional limitation of claim 36. With respect to the functional limitations of claims 73-75, the antibody suggested by the prior art has the structural limitations required by the claims and would have the characteristics recited in these claims as disclosed in the instant specification. A product and its properties cannot be separated.
The claimed antibodies would have been obvious.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to remove the limitation binding to canine IL-31. However, it is clear from the specification disclosure that all antibodies encompassed by claim 1 would have this binding. Claim 36 depends upon claim 1 and recites that the antibody binds to IL-31. This is confusing as this is already a characteristic of all antibodies encompassed by claim 1. Claim 36 doesn’t clearly further limit the subject matter of claim 1. It is suggested that claim 1 be amended to recite the binding to canine IL-31 and that claim 36 be cancelled.
Claim 33 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 33 requires a light chain amino acid sequence of instant SEQ ID NO: 21. The is taught by Li et al. Claim 33 also requires a heavy chain amino acid sequence of instant SEQ ID NO: 126. Li et al. discloses the heavy chain of SEQ ID NO: 18 and Zhan et al. suggests the L23Y mutation of claim 1 that is present in instant SEQ ID NO: 126. However, SEQ ID NO: 18 contains a second difference with respect to SEQ ID NO: 126 as set forth above. SEQ ID NO: 18 has leucine (L) instead of serine (S) at amino acid position 113. The change to serine at this position as in instant SEQ ID NO: 126 is not suggested by the prior art.
Conclusion
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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/Marianne P Allen/Primary Examiner, Art Unit 1647
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