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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 6, 7, 8, 19-21, 26 and 27) in the reply filed on 07/10/2026 is acknowledged. Upon further consideration, the restriction requirement as set forth in the Office action mailed on 01/12/2026 (pages 2-4) is hereby withdrawn and claims 22-25, directed to the process of treatment comprising the composition set forth in Group I will be fully examined for patentability under 37 CFR 1.104.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1, 6-8 and 19-27 are under examination.
Effective Filing Date
The provisional application serial no. 63/302,514 does not disclose the sequences recited in the claims, therefore the effective filing date of claims 1, 6-8 and 19-27 of the instant application is 01/24/2023.
Information Disclosure Statement
The information disclosure statement (IDS) filed 05/03/2024 has been considered. Reference no. 142 (Gaillard et al.) has been lined through because neither the copy of the reference nor the IDS contain the full citation with date. The date of the reference could not be determined with the information provided. Please indicate the date of reference no. 142.
Specification
The disclosure is objected to because of the following informalities. Any new application (including continuations and divisionals) with an actual filing date (application filed under 111(a)) or an international filing date (application filed under 371) on or after July 1, 2022, must submit sequence listings under ST.26. See MPEP 2412. While sequence listings previously submitted under ST.25 (filed before July 1, 2022) permitted sequences having less than 10 nucleotides or less than 4 amino acids, such sequences are prohibited under ST.26. In the instant case, the original application discloses SEQ ID NOs: 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 127, 142, 147 and 152 at Table 1 (paragraph [00087]) under the heading “Amino Acid Sequences of Antigen Binding Domains”. Applicant must amend all disclosures of skipped sequences in the instant specification with either the three- or one-letter codes for peptides. For instance, SEQ ID NO: 45 would appear as Glu-Ala-Ser or EAS.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 6-8 and 19-27 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.
Any new application (including continuations and divisionals) with an actual filing date (application filed under 111(a)) or an international filing date (application filed under 371) on or after July 1, 2022, must submit sequence listings under ST.26. See MPEP 2412. While sequence listings previously submitted under ST.25 (filed before July 1, 2022) permitted sequences having less than 10 nucleotides or less than 4 amino acids, such sequences are prohibited under ST.26. Independent claim 1 recites SEQ ID NOs: 45, 85 and 147, each of which are peptides comprising 3 amino acid residues and are thus skipped sequences. The original application discloses at Table 1 (paragraph [00087]) under the heading “Amino Acid Sequences of Antigen Binding Domains” that SEQ ID NO: 45 has the sequence EAS; SEQ ID NO: 85 has the sequence ATS and SEQ ID NO: 147 has the sequence DAS. Furthermore, in addition to SEQ ID NOs: 45, 85 and 147, the instant specification at Table 1 discloses skipped sequences SEQ ID NOs: 40, 50, 55, 60, 65, 70, 75, 80, 90, 95, 100, 105, 110, 115, 127, 142 and 152. Applicant must amend all disclosures of skipped sequences in the instant specification and claims with either the three- or one-letter codes for peptides. For instance, SEQ ID NO: 45 would appear as Glu-Ala-Ser or EAS.
The dependent claims are hereby included in this rejection for depending upon the indefinite claim 1 without resolving the indefiniteness.
Status of the Art
Fischer et al. (WO2023139293—on IDS filed 05/03/2024) shares the same filing date, inventive entity and Applicant as the instant specification. The Written Opinion of the International Search Authority (WOISA, mailed 2023) of the Fischer et al. case cited two prior art references, WO2020/106708 (on IDS filed 05/03/2024) and Harris et al. (Scientific Reports, 2021, 11 (1): 10592—on IDS filed 05/03/2024), however, neither of these documents disclose the specific sequences recited in the claims. The fused sequences of SEQ ID NO: 1 – SEQ ID NO: 2 – SEQ ID NO: 3 are disclosed in the prior art, for example, see the alignment between the fused sequences and the heavy chain disclosed in Winter et al. (WO2004058822 – see Figure 10):
Query Match 80.4%; Score 104.5; Length 116;
Best Local Similarity 31.2%;
Matches 25; Conservative 0; Mismatches 0; Indels 55; Gaps 2;
Qy 1 GFTFSSY-----------------AISGSGGST--------------------------- 16
||||||| |||||||||
Db 26 GFTFSSYAMSWVRQAPGKGLEWVSAISGSGGSTYYADSVKGRFTISRDNSKNTLYLQMNS 85
Qy 17 -----------AKSYGAFDY 25
|||||||||
Db 86 LRAEDTAVYYCAKSYGAFDY 105
Nevertheless, the prior art does not teach or suggest the full composition recited in claim 1.
The post-filing date art by Montorfani et al. (Journal for ImmunoTherapy of Cancer 2025; 13: e010650. doi:10.1136/jitc-2024-010650) teach “IL-2R/IL-15R signaling can be selectively activated within the tumor, thereby minimizing associated systemic toxicities, by using a bispecific antibody (bsAb) pair consisting of CD122×TAA and CD132×TAA bsAbs” (see p. 1, right column panel). See also Figure 3, which shows that treatment with the composition “induces MSLN-dependent expansion and activation of intratumoral CD8+ T cells and NK cells” (Figure Legend, p. 7).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
Prosecution Insights