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 Election filed November 3, 2025 in response to the Office Action of October 31, 2025 is acknowledged. Applicant elected with traverse the 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).
2. Applicants argue there is no search burden to search each genus.
3. The arguments have been considered but are not found persuasive because search burden does not constitute grounds for restriction when considering lack of unity for applications filed as a National Stage entry under 35 U.S.C. 371. As stated in the restriction, the species listed in A-C do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The technical feature linking the species appears to be an anti-CD3 or T-cell binding antibody linked to an autoantigen.
However, said technical feature does not constitute a special technical feature in view of WO 2003/068822, Zocher et al. Zocher et al teach an anti-CD3 antibody linked to an autoantigen (autoreactive antigen) such as MOG, dsg1, or dsg3 (p. 9-10; 30; claims 1-14; Figure 2).
Therefore, the technical feature linking the species does not constitute a special technical feature as defined by PCT Rule 13.2 as it does not define a contribution over the prior art. Accordingly, the species are not so linked by the same or a corresponding special technical feature as to form a single general inventive concept and restriction for examination purposes as indicated is proper. Thus, “special technical feature” does not define a contribution over the prior art. For these reasons, the restriction requirement is deemed to be proper and is therefore made FINAL.
4. Claims 1-12 are pending. Claims 3, 4, 6-8, 11 are withdrawn as being drawn to non-elected species. Claims 1, 2, 5, 9, 10, and 12 are currently under prosecution as drawn to the elected species.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, for example on page 19. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. Amendment to delete http:// to deactivate the live link is sufficient. See MPEP § 608.01. Appropriate correction is required.
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.
6. Claims 9 and 10 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. Claims 9 and 10 recite the limitation "the antigen binding fragment of an anti-CD3 antibody" (claim 9), and “the anti-CD3 antigen binding fragment of an anti-CD3 antibody” (claim 10). There is insufficient antecedent basis for these limitations in the claims because claim 1 does not mention an anti-CD3 antibody or antigen binding fragment thereof.
It appears claims 9 and 10 should have depended from claim 2. For the sake of compact prosecution, Examiner will examine as such for the prior art rejections below.
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.
(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.
7. Claim(s) 1, 2, 5, 9, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2003/068822, Zocher et al.
Zocher teaches a polypeptide construct comprising a T-cell binding anti-CD3 antibody linked with a linker to an autoantigen (autoreactive antigen), wherein the autoantigen is dsg3 (p. 9-10; p. 30; p. 32-33; claims 1-14; Figure 2); wherein the antibody is an scFv fragment or fragment of IgG molecule (p. 32 and 47; Figure 2). Zocher teaches a pharmaceutical composition comprising a therapeutically effective amount of the polypeptide construct (abstract; p. 40-45).
8. Claim(s) 1, 2, 5, 9, 10, and 12 are rejected under 35 U.S.C. 102(a)(2) as anticipated by US Patent Application Publication 2025/0129136, Rashidian et al, claiming priority to December 14, 2021.
Rashidian teaches a fusion polypeptide comprising an anti-CD3 scFv antibody fragment fused through a linker to autoreactive antigen Dsg3 ([44-45]; [96-99]; [118-126]; [178-179]; [336]; Figures 3, 8, 11, and 15B; claims 57-60). Rashidian teaches utilizing scFv antibody fragments or IgG fragments in the fusion polypeptide ([59-63]; Figure 8). Rashidian teaches pharmaceutical compositions comprising a therapeutically effective amount of the fusion polypeptide ([54]; [130-151]).
Figure 8 shows production of Dsg3 autoreactive antigen fused by click chemistry linker to an anti-CD3 scFv antibody:
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9. Conclusion: No claim is allowed.
10. 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