DETAILED ACTION
Claims 1-17 and 19-32 are pending.
Status of Claims
Claims 1-17 and 19-32 are pending. Claims 1, 3, and 8-9 have been amended. Claim 18 has been cancelled. Claims 19-32 have been withdrawn. Claims 6-9 have been withdrawn as they are drawn to a nonelected species (see response to restriction filed on 05/16/2025 and the non-final office action mailed on 08/22/2025).
Claims 1-5 and 10-17 are under examination.
Withdrawn Claim Objections and/or Rejections
The rejection of claims 1-3, 10-13, 15-16, and 18 under 35 USC 102 as being anticipated by Fu et al., as set forth on pp. 3-6 of the previous office action (mailed on 08/22/2025) has been withdrawn in view of the amended claims (filed on 11/18/2025).
The rejection of claims 4-5 under 35 USC 103 as being unpatentable over Fu and Merriman et al., as set forth on pp. 6-8 of the previous office action (mailed on 08/22/2025) has been withdrawn in view of the amended claims (filed on 11/18/2025).
The rejection of claims 14 and 17 under 35 USC 103 as being unpatentable over Fu and Lenardo et al., as set forth on pp. 8-9 of the previous office action (mailed on 08/22/2025) has been withdrawn in view of the amended claims (filed on 11/18/2025).
The rejection of claims 1, 3-5, and 18 for nonstatutory double patenting over claims 7-13, 17-20, and 24-25 of U.S. Patent No. 12366570 as set forth on pp. 9-12 of the previous office action (mailed on 08/22/2025) has been withdrawn in view of the amended claims (filed on 11/18/2025).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1.Claims 1-5 and 10-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
MPEP 2163 provides a procedure for evaluating the adequacy of written description to
support the claim elements: a) determining what the claim covers as a whole, b) reviewing the
entire application to understand how applicant provides support for the claimed invention
including each element and/or step, and 3) determining whether there is sufficient written
description to inform a skilled artisan that inventor was in possession of the claimed invention as
a whole at the time the application was filed. The proscription against the introduction of new
matter in a patent application serves to prevent an applicant from adding information that goes
beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211
USPQ 3232, 326 (CCPA 1981).
Claim 1 has been amended to recite “wherein the ZnT8-antibdoy complex comprises ZnT8 and at least one anti-ZnT8 antibody or antigen-binding fragment thereof that specifically binds to the cytoplasmic-domain of ZnT8 and is present in a molar excess relative to ZnT8 sufficient to fully occupy cytoplasmic-domain epitopes prior to the contact, and wherein the ZnT8-antibody complex is pre-formed and pre-assembled before the biological sample is added”.
A search of the specification shows no disclosure of the ZnT8-antibdoy complex comprising ZnT8 and at least one anti-ZnT8 antibody or antigen-binding fragment thereof that specifically binds to the cytoplasmic-domain of ZnT8 and is present in a molar excess relative to ZnT8 sufficient to fully occupy cytoplasmic-domain epitopes prior to the contact, and wherein the ZnT8-antibody complex is pre-formed and pre-assembled before the biological sample is added. The specification teaches that the anti-ZnT8 antibody or antigen-binding fragment thereof that specifically binds the cytoplasmic domain of ZnT8 blocks the binding of any autoantibodies to the cytoplasmic domain of ZnT8 (see page 17 lines 1-5). The specification teaches the complex peaks remained monodisperse in diluted solution with 2x molar excess of free Fabs to maintain a full Fab binding occupancy for multiple days and the solvent accessible surface of CTD is completely shielded from additional CTDA access in a Fab20-ZnT8-Fab39 ternary complex (see pages 38-39). The specification does not provide support for the newly amended claim limitations. While the specification teaches that CTD can be completely shielded, it does not teach the anti-ZnT8 antibody being sufficient to fully occupy cytoplasmic-domain epitopes prior to the contact, and wherein the ZnT8-antibody complex is pre-formed and pre-assembled before the biological sample is added.
Accordingly, the amendments to claim 1 constitute new matter. Claims 2-5 and 10-17 are included in this rejection as they depend on claim 1.
Applicant is reminded that when pointing out support, the support needs to be in reference to the originally filed specification.
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.
2. Claims 1-5 and 10-17 are 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.
The term “sufficient” in claim 1 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the claim refers to anti-ZnT8 antibody or antigen binding fragment thereof being sufficient to fully occupy cytoplasmic-domain epitopes, it does not provide a requisite degree for what is considered “sufficient”. Claims 2-5 and 10-17 are also rejected under 35 USC 112(b) as they depend on rejected claim 1.
The term “excess” in claim 1 is a relative term which renders the claim indefinite. The term “excess” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the claim refers to anti-ZnT8 antibody or antigen binding fragment thereof being present in molar excess, it does not provide a requisite degree for what is to be considered “excess”. Claims 2-5 and 10-17 are also rejected under 35 USC 112(b) as they depend on rejected claim 1.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fu et al., (WO2019014044A1) (IDS filed on 12/06/2021).
Fu teaches a method comprising the steps of: (a) contacting in a first mixture a biological sample obtained from a patient with a zinc transporter 8 (ZnT8) -antibody complex, wherein the ZnT8-antibody complex comprises ZnT8 and at least one detectably labeled anti-ZnT8 antibody or antigen-binding fragment thereof that specifically binds to the cytoplasmic domain of ZnT8;
wherein the ZnT8-antibody complex is pre-formed and pre-assembled before the biological sample is added;
(b) contacting in a second mixture the first mixture of step (a) with an immunoglobulin G (IgG) labeled with a tag molecule; and
(d) detecting a signal emitted from the detectably labeled anti-ZnT8 antibody or antigen-binding fragment thereof.
Fu does not teach the ZnT8-antibody complex that is present in a molar excess relative to ZnT8 sufficient to fully occupy cytoplasmic-domain epitopes prior to the contacting.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678