Prosecution Insights
Last updated: April 19, 2026
Application No. 17/779,425

ANTI-PD-1-ANTI-VEGFA BISPECIFIC ANTIBODY, PHARMACEUTICAL COMPOSITION AND USE THEREOF

Non-Final OA §102§103§DP
Filed
May 24, 2022
Examiner
HOPKINS, SAMANTHA LAKE
Art Unit
1641
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Akeso Biopharma, Inc.
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
4y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
21 granted / 34 resolved
+1.8% vs TC avg
Strong +56% interview lift
Without
With
+56.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
30 currently pending
Career history
64
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
24.9%
-15.1% vs TC avg
§102
16.5%
-23.5% vs TC avg
§112
36.1%
-3.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 34 resolved cases

Office Action

§102 §103 §DP
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/Restriction Applicant’s election without traverse of Invention I, in the reply filed on 05AUG2025 is acknowledged. Claims 15-17, 23, 26, 28, 31-34, and 36-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species. Election was made without traverse in the reply filed on 05AUG2025. Claim Status Claims 21 and 36 have been amended. Claims 1-13, 20, 22, and 24-25 are cancelled. Claims 14-19, 21, 23, and 26-44 are pending in the instant application. Claims 14, 18-19, 21, 27, 29-30, and 35 are examined on the merits. Priority The present application is a 371 National Stage of PCT International Application No. PCT/CN2020/131447, filed 25NOV2020, which claims foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of CN 201911164156.2 filed on 25NOV2019 has been received and is acknowledged. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 24AUG2022, 26SEP2024, 10SEP2025 (2x), 03OCT2025 is/are acknowledged and the references cited therein have been considered. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825. The sequence disclosures are located p 35, line 4 (i.e., “repeating GGGGS”) of the 24MAY2025 specification. Required response – Applicant must provide: A "Sequence Listing" part of the disclosure, as described above in item 1); as well as An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2); A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4). If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter; If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide: A replacement CRF in accordance with 1.825(b)(6); and Statement according to item 2) a) or b) above. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See for example p 35, (GGGGS)4 should be identified as SEQ ID NO: 18. Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter. Claim Objections Claim 14 is objected to because of the following informalities: Claim 14, lines 5-6 are unclear and should be updated to “…there are two first protein functional regions and there is a single second protein functional region…” or an equivalent thereof for the purpose of clarity. Appropriate correction is required. 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. Claims 14, 27, and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/167320 (CUREVAC AG, et. al, 20SEP2018), herein referred to as “’320” as evidenced by Ivonescimab, Drug Detail, CKB, herein referred to as “CKB” and KEGG, Ivonescimab, herein referred to as “KEGG”. ‘320 teaches compositions comprising anti-PD1 inhibitors, wherein preferred antibodies include nivolumab,…AK-112 (Akeso Biopharma, bispecific), etc. (p 61, lines 20-43). In this instance the bispecific AK-112 from Akeso Biopharma is also known as ivonescimab or SMT-112, as evidenced by CKB. Furthermore, as evidenced by KEGG, the AK-112 HC sequence is a 100% query match to a fusion of SEQ ID NOs: 24-18-9-18-17 of the instant application, wherein the C-terminus of the HC of the immunoglobulin is linked to the N-terminus of the scFv, wherein the HC of the VEGFA immunoglobulin is set forth in SEQ ID NOs: 24, the linkers are set forth in SEQ ID NOs: 18 and the VH and VL of PD-1 scFv are set forth in SEQ ID NOs: 9 and 17, respectively (OA.APPENDIX). As further evidenced by KEGG, the AK-112 LC sequence is 100% query match to SEQ ID NO: 26 of the instant application (OA.APPENDIX). ‘320 further teaches that the antibodies are able to specifically bind to their target epitopes determined by various ligand binding assays such as radioactive ligand binding assays, ELISA, FRET (e.g., fluorescent donor labeled antibody and fluorescent acceptor labeled antigen), etc. (p 59, lines 34-41). Therefore, the prior art anticipates the invention as presently claimed. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 18-19, 21, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/167320 (CUREVAC AG, et. al, 20SEP2018), herein referred to as “’320” as evidenced by Ivonescimab, Drug Detail, CKB, herein referred to as “CKB” and KEGG, Ivonescimab, herein referred to as “KEGG” and in further view of CA 3052670 A1 (Genentech, Inc., et al., 07SEP2018), herein referred to as “’670.” The teachings of ‘320 as evidenced by CKB and KEGG are summarized above. However, they do not teach: a conjugate comprising the bispecific antibody of claim 14 and conjugated money, a kit comprising the bispecific antibody of claim 14 and a second antibody capable of specifically recognizing the bispecific antibody of claim 14, a pharmaceutical composition comprising the bispecific antibody of claim 14 or claim 29. Nevertheless, ‘670 teaches anti-VEGFA x anti-PD1 bispecific antibodies, which are used for IHC, wherein the antibodies are either directly labeled with a detection label (i.e., fluorescent tag or an enzyme-label) or indirectly detected utilizing a secondary antibody that is labeled which detects the bispecific antibody for detecting the presence and/or expression level of a protein to determine if, for example the patient is eligible for angiogenesis therapy (i.e., VEGFA) or as a biomarker (i.e., PD1) (see entire document, specifically see abstract and p 102). ‘670 further teaches pharmaceutical formulations of the bispecific antibodies including pharmaceutically acceptable carriers, excipients, or stabilizers for administration to a subject (p 162, section E). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the light chain and heavy chain VEGF immunoglobulin, wherein each HC of the immunoglobulin comprises a PD-1 scFv antibody disclosed by ‘320 by utilizing the bispecific antibody in a kit for primary or secondary detection or in a pharmaceutical formulation for administration as disclosed by ‘670 because being able to directly detect or indirectly detect the bispecific antibody provides information about therapy eligibility and/or biomarker levels and the pharmaceutical formulation provides a stable composition for the bispecific antibody for administration. One would have been motivated to do so, given the teachings of ‘320 that the bispecific antibody could be fluorescently labelled and/or could be used in an ELISA assay. There would have been a reasonable expectation of success, given the knowledge that utilizing the bispecific antibodies for direct or indirect detection of biomarkers or in a pharmaceutical formulation lead to a bispecific antibody which could detect biomarkers and determine therapy eligibility or use as a therapeutic, as taught by ‘670 Thus, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time of filing. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 14, 21, 27, 29-30, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,195,527 B2, herein referred to as “’527.” Although the claims at issue are not identical, they are not patentably distinct from each other because the product of the ‘527 patent anticipates the product of the instant application. Specifically, the both products are drawn to a bispecific antibody comprising an anti-VEGFA IgG antibody having the same VH and VL and two anti-PD1 single chain antibodies comprising the same VH and VL and the same linkers for the VH/VL of the single chain antibodies and the to link the single chain antibodies to the HC of the Ig antibody and pharmaceutical compositions thereof. The issued claims of the ‘527 patent recite: A bispecific antibody comprising a VEGF IgG1 immunoglobulin comprising the VH/VL pair of SEQ ID NOs: 5 and 7 and a human Ig constant region and two PD1 single chain antibodies comprising VH/VL of SEQ ID NOs: 9 and 11 and a linker between the PD1 VH and VL as well as between the HC of the IgG and VH of the single chain antibody comprising SEQ ID NO: 13 (i.e., claim 1). A pharmaceutical formulation comprising the bispecific antibody of claim 1 and a pharmaceutically acceptable excipient (i.e., claim 6). In this instance, because the VH and VL of the anti-VEGFA IgG1 are the same as the instant application, the VH and VL comprise constant regions of an IgG antibody, the VH and VL of the anti-PD1 scAb are the same as the instant application, the linkers are the same as the instant application, and the pharmaceutical compositions comprise the bispecific antibody and a pharmaceutically acceptable excipient there is no clear difference in the scope between the products of the instant application and the ’527 patent (see OA.APPENDIX). Claims 14, 21, 27, 29, 30, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 18/024471; herein referred to as the “reference application.” Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-PD1 x anti-VEGF bispecific antibody in the composition of the reference application anticipates the anti-PD1 x anti-VEGF bispecific antibody of the instant application. Specifically, the anti-PD1 x anti-VEGF bispecific antibodies of the reference and instant application are the same. The co-pending claims of the reference application recite: A pharmaceutical composition, preferably for treating a tumor, comprising a component A and a component B, wherein the component A is an antibody that specifically binds to CD47 or an antigen-binding fragment thereof; the component B is selected from one or more of the following: a component B1, a component B2 and a component B3, wherein the component B 1 is a bispecific antibody or an antigen- binding fragment thereof, the component B2 is an anti-tumor chemotherapeutic, and the component B3 is an anti-PD-1 monoclonal antibody or an antigen-binding fragment thereof (i.e., claim 1). The pharmaceutical composition according claim 1, wherein the antibody that specifically binds to CD47 comprises or consists of…; the anti-PD-1/anti-CTLA4 antibody comprises or consists of…; the anti-PD-1/anti-VEGFA antibody comprises or consists of a heavy chain and a light chain selected from the group consisting of the following: a heavy chain set forth in SEQ ID NO: 141 (preferably encoded by a nucleotide sequence set forth in SEQ ID NO: 142) and a light chain set forth in SEQ ID NO: 143 (preferably encoded by a nucleotide sequence set forth in SEQ ID NO: 144); the anti-PD-1 monoclonal antibody comprises or consists of… (i.e., claim 6). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises a pharmaceutically acceptable carrier and/or excipient (i.e., claim 12). In this instance, because the anti-PD1 x anti-VEGFA bispecific antibody of the composition of the reference application is the same as the anti-PD1 x anti-VEGF bispecific antibody of the instant application (see OA.APPENDIX), there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 14, 27, 29, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-31 of co-pending Application No. 18/264242; herein referred to as the “reference application.” Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-PD1 x anti-VEGF bispecific antibody in the composition of the reference application anticipates the anti-PD1 x anti-VEGF bispecific antibody of the instant application. Specifically, the anti-PD1 x anti-VEGF bispecific antibodies of the reference and instant application are the same. The co-pending claims of the reference application recite: A composition, comprising: an anti-CD73 antibody or an antigen-binding fragment thereof comprising HCDR1,HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 15, 16, 17, 18, 19, and 20, respectively; and an anti-PD x anti-VEGFA bispecific antibody or an antigen-binding fragment thereof, the anti-PD-1 region comprising HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 41, 42, 43, 44, 45, and 46, respectively, and the anti- VEGFA region comprising HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 31, 32, 33, 34, 35, and 36, respectively (i.e., claim 10). The composition of claim 10, wherein the anti-PD 1/anti-VEGFA bispecific antibody is in an anti-PD 1 single chain antibody/ anti-VEGFA immunoglobulin configuration (i.e., claim 12). The composition of claim 10, wherein the anti-PD-1-anti-VEGFA bispecific antibody or antigen binding fragment thereof comprises a heavy chain amino acid sequence comprising at least 85% identity with SEQ ID NO: 23, and a light chain amino acid sequence comprising at least 85% identity with SEQ ID NO: 25 (i.e., claim 26). In this instance, because the anti-PD1 x anti-VEGFA bispecific antibody of the composition of the reference application is the same as the anti-PD1 x anti-VEGF bispecific antibody of the instant application (see OA.APPENDIX), there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 14, 27, 29, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-37 of co-pending Application No. 18/264138; herein referred to as the “reference application.” Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-PD1 x anti-VEGF bispecific antibody in the composition of the reference application anticipates the anti-PD1 x anti-VEGF bispecific antibody of the instant application. Specifically, the anti-PD1 x anti-VEGF bispecific antibodies of the reference and instant application are the same. The co-pending claims of the reference application recite: A composition, comprising: an anti-TIGIT antibody or an antigen binding fragment thereof comprising HCD 1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 3-5 and SEQ ID NOs: 8-10, respectively; and an anti-PD1/anti-VEGFA bispecific antibody or an antigen-binding fragment thereof, wherein the anti-PD 1 region of the anti-PD 1/anti-VEGFA bispecific antibody or the antigen- binding fragment thereof comprises HCD1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 45-47 and SEQ ID NOs: 48-50, respectively, and wherein the anti-VEGFA region of the anti-PD1/anti-VEGFA bispecific antibody or the antigen- binding fragment thereof comprises HCD1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 comprising the sequences of SEQ ID NOs: 35-37 and SEQ ID NOs: 38-40, respectively (i.e., claim 9). The composition of claim 9, further comprising a linker connecting the anti-PD 1 region and the anti-VEGFA region, the linker comprising (GGGGS)n, wherein n is a positive integer from 1 to 6 (i.e., claim 22). The composition of claim 22, wherein the heavy chain of the anti-PD 1/anti-VEGFA bispecific antibody comprises SEQ ID NO: 27, and wherein a light chain of the anti-PD1/anti- VEGFA bispecific antibody comprises SEQ ID NO: 29 (i.e., claim 25). In this instance, because the anti-PD1 x anti-VEGFA bispecific antibody of the composition of the reference application is the same as the anti-PD1 x anti-VEGF bispecific antibody of the instant application (see OA.APPENDIX), there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST. 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. 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. /SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641 /MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
Read full office action

Prosecution Timeline

May 24, 2022
Application Filed
Nov 19, 2025
Non-Final Rejection — §102, §103, §DP
Jan 28, 2026
Interview Requested
Feb 18, 2026
Applicant Interview (Telephonic)
Feb 18, 2026
Examiner Interview Summary
Apr 13, 2026
Applicant Interview (Telephonic)
Apr 13, 2026
Examiner Interview Summary

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Prosecution Projections

1-2
Expected OA Rounds
62%
Grant Probability
99%
With Interview (+56.5%)
4y 0m
Median Time to Grant
Low
PTA Risk
Based on 34 resolved cases by this examiner. Grant probability derived from career allow rate.

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