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 .
Response to Amendment
Applicant's response, filed 03 August 2026, has been received and entered. Claims 1-124 have been canceled and claims 125-126 have been newly added. Claims 125-126 are currently pending.
The current claim set does not comply with 37 CFR 1.121 (c) which requires:
In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The claim set which was submitted only indicated that claims 107-124 were canceled and did not indicate the status of claims 1-106. While these claims were previously canceled (amendment filed 04 April 2024), the claim listing must indicate the status of every claim. Applicant should correct the claim listing in response to this Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant's response and withdrawn.
Applicant's arguments filed 03 August 2026 have been fully considered but are not found to be persuasive.
Drawings
The drawings were received on 03 August 2026. These drawings are not acceptable because Figure 2A contains amino acid/nucleic acid sequences. Sequence should not be repeated in the figures. Pursuant to 37 CFR 1.83(a), sequence that are included in the "Sequence Listing XML" should not be duplicated in the drawings. MPEP 2422.02 makes clear that sequences that are included in the sequence listing should not be duplicated in the drawings. If the material being presented rises to the level of a significant sequence characteristic which may only be demonstrated by a figure, such as “sticky ends” and the like, such features may be included in the form of a drawing. The feature which is being demonstrated in Figure 2A is a single amino acid difference between two sequences which does not require reproduction of the sequence in a figure. Therefore, the drawings remain objected to.
Response to Arguments
Applicant argues at page 4 of the response that Figure 2A includes boxes highlighting differences between mutant and wild-type residues and that the sequence listing cannot include such highlighting to show the precise location of a mutation. Applicant’s argument has been fully considered, but is not found persuasive. A drawing is not necessary to convey the difference between mutant and wild-type proteins – the proteins are numbered and reference to the position number and an identification of the substitution in the mutant compared to the wild-type protein conveys the same information without a repeating the amino acid sequences in the Figure. The difference between the wild-type and the mutant is clearly communicated by the name of the mutant protein (CANINE igGB_65_Fc_N434H) compared to the wild-type (CANINE igGB_65_Fc_WT).
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.
Claim(s) 125-126 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michels et al. (Vet. Dermatol. 2016; 27: 478-e129) in view of WO2020082048 (filed 18 October 2019; Zhan et al.) (cited by Applicant).
Michels et al. teach a caninized monoclonal antibody that binds and neutralizes canine IL31 (lokivetmab). The antibody of Michels has the same variable light and variable heavy chains as that of the instant claim 125 as evidenced by U.S. Pat. Pub. 2020/0023076 A1 (lokivetmab has a variable light and heavy chain comprising the amino acid sequences of SEQ ID NO:68 and 70 except for position 434, which has an asparagine instead of a histidine). Michels et al. teach the administration of this antibody to dogs for the treatment of atopic dermatitis (see page 681). Dogs were treated with 0.125, 0.5 or 2.0 mg/kg lokivetmab administered subcutaneously (see page 682 under “Study design” and “Duration of effect study”). The dogs were then challenged with IL-31 to induce pruritus before lokivetmab administration and again on days 1, 7, 14, 28, 42 and 56 post-lokivetmab administration to evaluate the duration of antipruritic effect of the antibody. This would be considered a therapeutic effect which would indicate the presence of a therapeutic level of anti-IL31 antibody. Michels et al. teach that a dose of 0.125 mg/kg lokivetmab achieved a significant reduction in pruritus up to day 14 and up to day 28 for a dose of 0.5 mg/kg and up to day 42 for a dose of 2.0 mg/kg (see page 683, column 1, top of page). Therefore, Michels et al. teaches a method of maintaining a therapeutic level of an anti-IL31 antibody in a dog over a period of time, wherein the period of time falls within the range of 2-7 months. Michels et al. does not disclose the amino acid sequences of the heavy/light chains of the antibody (lokivetmab), however, the structure of lokivetmab was known in the prior art. ‘076 teaches the amino acid sequences of the heavy and light chains of the antibody lokivetmab, which is the caninized anti-IL31 antibody (see Table 4) of Michels et al. The amino acid sequence of the heavy chain of this antibody (SEQ ID NO:535) differs from the amino acid sequence of SEQ ID NO:70 of the instant claim at position 434. The amino acid sequence of the light chain of this antibody (SEQ ID NO:536) is identical to that of SEQ ID NO:68 of the instant claims. Michels et al. do not teach a method of maintaining the therapeutic level of an anti-IL31 antibody in a dog wherein the anti-IL31 antibody which has a substitution at position 434 (N434H).
Zhan et al. teach Fc variants with altered binding to neonatoal Fc receptor for veterinary use (see title). Zhan et al. teach improving the binding affinity of IgG to FcRn at an acid pH by mutagenesis of the Fc region of the IgG responsible for binding to FcRn (see [0004]). Increasing the binding to FcRn increases the half-life of the antibody which is a well-known concept in the prior art. Zhan et al. teach that the IgG Fc polypeptide is from a canine (see page 2). Zhan et al. teach multiple embodiments which comprise the N434H mutation (see SEQ ID NO: 46, 36, 41, 31, 99 and 98) as well as teaching methods of producing IgG Fc Variants (see disclosure beginning at page 96).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the antibody of Michels et al. with the mutation of Zhan et al. in order to increase the affinity of the antibody to FcRn in order to increase the half-life of the antibody for therapeutic purposes. Michels et al. already teach that the antibody has therapeutic benefit in treating atopic dermatitis in dogs and increasing the therapeutic half-life of the antibody would result in less frequent administrations of the antibody. It would have been obvious to make the antibody with the mutation of Zhan et al. by the recombinant methods taught in Zhan et al. with a reasonable expectation of success because Zhan et al. teach production of mutant antibodies with success. While the prior art does not provide a concrete number for how long the therapeutic level would be maintained, the mutation of Zhan et al. would predictably increase the half-life, therefore, one of ordinary skill in the art would expect the therapeutic level to be maintained for an extended time beyond that which was demonstrated by Michels et al. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art, absent evidence to the contrary.
Response to Arguments
Applicant argues at pages 7-8 that WO 2018/073185 and US PGPub 2020/0023076 did not teach the N434H mutation. Applicant’s arguments were persuasive. In view of such, new grounds of rejection are provided above wherein Zhan et al. teach introducing an N434H mutation in the Fc region of an antibody to increase circulating half-life.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 125-126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-103 of copending Application No. 19/570,699 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to overlapping subject matter. The difference between the pending claims and the claims in ‘699 is that the instant claims recite maintaining a therapeutic level of anti-IL-31 antibody over a period ranging from 2 months to 7 months while the claims of ‘699 recite maintaining a therapeutic level of anti-IL-31 antibody over a period ranging from 7 days to 210 days. The instant claims also recite that the method is for treating atopic dermatitis however, the prior art was well aware of inhibition of IL-31 for this purpose and therefore, treating atopic dermatitis would have been obvious over the claims of ‘699. Additionally, the antibody being administered in the methods of instant claims and those of ‘699 is identical, therefore, the half-life of the antibody would be the same in both methods. The fact that the instant claims recite a different range for maintaining the therapeutic level of the antibody does not distinguish from the claims of ‘699 as such a level would be expected in the method of ‘699 as the method steps and antibody being administered are the same. Therefore, the instant claims are not patentably distinct from those of ‘699.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant requests at page 6 of the response that the rejection be held in abeyance until an indication of allowance is made in this application. Applicant’s request is improper as there are no provisions for holding a rejection in abeyance. Futhermore, Applicant should either address the merits of the rejection, amend the claims to avoid the rejection or file an appropriate terminal disclaimer. Failure to appropriately address any and all rejections may be considered as a non-responsive reply.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
