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 .
1. The Amendment filed June 29, 2026 in response to the Office Action of January 28, 2026, is acknowledged and has been entered. Claims 1, 3-12 are pending. Claims 2 and 13-32 are canceled. Claims 1, 9, and 10 are amended. Claims 3, 4, 6-8, and 11 remain withdrawn. Claims 1, 5, 9, 10, and 12 are currently being examined as drawn to the elected species of:
A. (i) anti-CD3 antibody NOT further linked to anti-CD19 or CD20 antibody (withdraw claims 3 and 11);
B. (ii) therapeutic molecule comprising ONE autoantigen (withdraw claim 4); and
C. auto-antigen Dsg3 (claim 5).
New Rejections
(necessitated by amendments)
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, 9, 10, and 12 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.
Claim 1 recites that said one or more auto-antigen(s) is “an antibody binding fragment thereof”. No previous auto-antigen antibody was recited, therefore, it is unclear what the antibody binding fragment is derived from (“thereof”). The metes and bounds of the claimed auto-antigen antibody binding fragment cannot be determined. Dependent claims 5 and 12 are rejected for encompassing this rejected limitation of claim 1.
Claims 9 and 10 recite the limitation "the multi-target molecule of claim 2". Claim 2 is canceled, therefore there is insufficient antecedent basis for this limitation in the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
3. Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depends from claim 1. Claim 1 is limited to an auto-antigen that is “an antibody binding fragment thereof”. Claim 5 recites that the auto-antigen is Dsg3, which is outside the scope of “an antibody binding fragment thereof”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
NOTE: The scope of “auto-antigen(s)” that are “an antibody binding fragment thereof” as recited in claim 1 is unclear for the reasons stated above in the 35 USC 112(b) rejection. The instant specification does not provide a definition for what is encompassed by an auto-antigen that is “an antibody binding fragment thereof”. For the sake of compact prosecution, claim 1 is interpreted to encompass “auto-antigens” that are any antibody binding fragments.
4. Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nafsika Forte; (2018) New Strategies for Cysteine Bioconjugation and Protein Cross-Linking. Doctoral thesis (Ph.D), UCL (University College London).
Forte teaches a multi-target therapeutic bispecific antibody comprising a T-cell binding anti-CD3 antibody chemically linked to an anti-HER2 antibody fragment, wherein the chemical linker is a non-peptide moiety (Figure 11, section 1.2.5 Bispecific antibodies). Figure 11:
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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.
5. Claim(s) 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nafsika Forte; (2018) New Strategies for Cysteine Bioconjugation and Protein Cross-Linking. Doctoral thesis (Ph.D), UCL (University College London).
Forte teaches the multi-target therapeutic bispecific antibody comprising a T-cell binding anti-CD3 antibody chemically linked to an anti-HER2 antibody fragment, wherein the chemical linker is a non-peptide moiety, as set forth above.
Forte does not teach the multi-target therapeutic bispecific antibody is comprised in a pharmaceutical composition in a therapeutically effective amount.
However, Forte teaches the anti-HER2/ anti-CD3 multi-target therapeutic bispecific antibody is a BiTE (Bispecific T-cell Engager), and BiTE constructs are used for therapeutic application to bind a tumor-associated antigen and to bind to, and recruit/activate, T cells expressing CD3 in close proximity to the cancer cells in order to result in a highly efficacious killing process (p. 37-38).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filed to make a pharmaceutical composition comprising a therapeutically effective amount of BiTE taught by Forte. One would have been motivated to, and have a reasonable expectation of success to, because Forte teaches the function of the BiTE is to therapeutically treat cancer. Given the BiTE is a known therapeutic agent for the treatment of cancer, it is well within the level of the ordinary skilled artisan to formulate the BiTE in a pharmaceutical composition and in a therapeutically effective amount for its therapeutic application to treat cancer.
6. All other objections and rejections recited in the Office Action mailed January 28, 2026 are hereby withdrawn in view of amendments. The prior art rejections under 35 USC 102 have been withdrawn in view of the amendment to claim 1 excluding auto-antigen Dsg and requiring a chemical, non-peptide linker.
7. Conclusion: No claim is allowed.
Conclusion
8. 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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