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 amendment to the claims, filed 30 July 2026, has been received and entered. Claims 104 and 114 have been amended and claims 1-96 have been canceled. Claims 97-114 are currently pending in the instant application.
Election/Restrictions
Applicant's election with traverse of Group III, claim 114, in the reply filed on 30 July 2026 is acknowledged. The traversal is on the ground(s) that each of the identified groups relates to a common inventive concept and the claims are therefore properly examinable together. This is not found persuasive because “common inventive concept” is not sufficient for establishing unity of invention. As was pointed out in the Lack of Unity mailed on 02 June 2026, the common technical feature of caninized anti-IL31 antibody with a substitution of N434H did not make a contribution over the prior art of U.S. Pat. Pub. 2020/0023076 and WO2018/073185 for the reasons of record.
The requirement is still deemed proper and is therefore made FINAL.
Claims 97-113 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 July 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 23 July 2026 have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Replacement drawings were received on 30 July 2026 (Figures 2A and 2B). These drawings are not acceptable (see objection below).
The drawings are objected to because:
Figures 2A, 2C contain amino acid/nucleic acid sequences. Sequences 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. Figure 2A does not contain any structural features which can only be shown effectively by reference to a drawing figure as the only structural difference which is shown is a single point mutation (N434H) which can be effectively described with words (see MPEP 2422.02). Therefore, the Figure is not deemed necessary and it fails to comply with 37 CFR 1.83(a). Figure 2C contains no structural information which would warrant a duplication of the nucleic acid sequence in the drawings, which clearly fails to comply with 37 CFR 1.83(a).
Figure 2B is found on multiple pages, all of which are now labeled as “FIG.2B” which is not compliant with 37 CFR 1.84(u)(1). The various pages are meant to appear in a particular order, therefore, each progressive page should have a different letter designation. For example, the 6 pages which are all labeled as “FIG.2B” should be labeled as FIG.2B-2G in order to maintain the proper order/orientation for the sequences to make sense.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it does not include “that which is new in the art to which the invention pertains”. The elected invention of claim 114 is directed a method of manufacturing an antibody with a specific structure (an anti-IL31 antibody with a canine constant domain with an N434H mutation); none of this is conveyed in the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The disclosure is objected to because of the following informalities:
The Description at [000227] does not comply with 37 CFR 1.52(a)(1)(iv-v). The text of this paragraph is not in permanent dark ink or its equivalent as the letters do not have solid black lines and therefore, there is insufficient clarity and contrast between the paper and the writing. See screenshot below:
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Appropriate correction is required.
The use of the terms BIACORE and SAPIDYNE, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The terms are found at [000134], for example, and while they are capitalized, they do not include a proper symbol indicating use in commerce and the generic terminology is not provided. The specification should be reviewed for any other instances of their use or other trademarked products which are not properly identified.
Additional terms, which are also trade names, are found at [000211] (TWEEN and PLURONICS) and [000234] (Gyrolab xP™, Watson™, Excel™). Again, the terms are lacking a proper symbol indicating use in commerce and generic terminology.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 114 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 114 is directed to a method for recombinantly manufacturing the antibody of claim 104. The claim depends from a non-elected claim and therefore, is indefinite because the claim is incomplete.
Claim 114 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: any and all steps to recombinantly manufacture the recited antibody. The claim contains no steps and the recitation of recombinant manufacturing do not convey any specific step or set of steps to achieve the claimed method. Therefore, the claim is indefinite for being incomplete.
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) 114 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 104 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 recombinant production of the caninized 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). Zhn 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). Zhan et al. also teach recombinant 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. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art, absent evidence to the contrary.
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
