DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without travers of Group I (drawn to a polypeptide) and the species of SEQ ID NO:10 in the Response filed on July 15, 2026 is acknowledged.
Claims 1-18
are pending.
Claims 8-18 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected inventions.
Claims 1-7 are currently under consideration as they read on the elected invention.
3. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Applicant is required to identify the written support for claims 1-7, particularly the claimed limitation of “wherein the substitution is Q311A, Q311C, Q311D, Q311E, Q311F, Q311G, Q311H, Q3111, Q311K, Q311L, Q311M, Q311N, Q311P, Q311R, Q311S, Q311T, Q311V, Q311W, or Q311Y, and wherein the amino acid position is based on EU numbering” in independent claim 1 and wherein the polypeptide has increased binding affinity to canine FcRn in claim 2.
While the specification discloses an amino acid other than the wild type amino acid occurring at amino acid position 311 (e.g. see [0113] of the specification as-filed) and examples of Q311V and Q311A (e.g. see Table 1 and alanine scanning mutagenesis in Example 1), nowhere in the specification discloses Q311C, Q311D, Q311E, Q311F, Q311G, Q311H, Q3111, Q311K, Q311L, Q311M, Q311N, Q311P, Q311R, Q311S, Q311T, Q311W, or Q311Y and the correlation of increased binding affinity to canine FcRn.
Therefore, this application repeats a substantial portion of prior USSNs 18/061,755 (filed on December 5, 2022), 16/861,077 (filed on April 28, 2020), 16/733,105 (filed on January 2, 2020), and provisional application 62/788,035 (filed on January 3, 2019) and adds and claims additional disclosure described above that is not presented in the prior applications, as indicated above. Since this application names an inventor or inventors named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to obtain the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120 and 37 CFR 1.78.
Further, given that the limitations described above in independent claims 1 and dependent claim 2 are not supported by the instant specification and by the domestic priority documents, claims 1-7 have not been accorded the priority of these priority applications. Rather, claims 1-7 are deemed to have the earliest priority date of the filing of the instant application on January 30, 2024.
4. 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.
5. Claim 6 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 6 contains the trademark/trade name “nanobody". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a binding domain and, accordingly, the identification/description is indefinite.
6. 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.
7. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campos et al. (WO 2022/165067).
Given that the instant application is deemed to have the priority date of the instant filing date on January 30, 2024 (see discussion above), Campos et al. is qualified as a prior art under 35 U.S.C. 102(a)(1).
Campos et al. teach a canine IgG antibody comprising mutations in the constant region. Specifically, Campos et al. teach a canine IgG comprising a mutated Fc region comprising at least one amino acid substitution relative to a wild-type canine IgG Fc region in position 311 including Q311W (EU numbering), wherein the mutated IgG has the function of increasing serum half-life (e.g. see( [00014]-[00015]). Campos et al. teach that substitution in position Q311 including Q311H, Q311R, Q311Y, Q311W in the Fc region of a canine IgG can enhance the Fc’s binding affinity to FcRn (e.g. see [000105]).
In working Example 1, Campos et al. discloses using canine IgGB comprising VH and VL to construct canine IgG Fc mutants (e.g. see [000157]). Campos et al. further teach determination of the canine IgGB mutant binding to dog FcRn at pH6 and pH7.4 and show that mutants comprising Q311 substitutions such as Q311G binds FcRn better at pH6 than pH7.4 (e.g. see pages 51-54). Campos et al. teach a pharmaceutical composition comprising the IgG comprising the Fc mutant for veterinary applications (e.g. see [000141]). Given that the prior art teaches the same wild type canine IgGB, the prior art wildtype IgGB Fc would have the same amino acid sequence as the instantly recited amino acid sequence in claim 4.
Therefore, the reference teachings anticipate the instant invention.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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