Prosecution Insights
Last updated: April 19, 2026
Application No. 19/342,217

CAPSID POLYPEPTIDES AND METHODS OF USE THEREOF

Non-Final OA §102§112§DP
Filed
Sep 26, 2025
Examiner
MARVICH, MARIA
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dyno Therapeutics Inc.
OA Round
1 (Non-Final)
55%
Grant Probability
Moderate
1-2
OA Rounds
4y 2m
To Grant
82%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allow Rate
529 granted / 967 resolved
-5.3% vs TC avg
Strong +27% interview lift
Without
With
+26.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
53 currently pending
Career history
1020
Total Applications
across all art units

Statute-Specific Performance

§101
2.9%
-37.1% vs TC avg
§103
26.7%
-13.3% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
34.9%
-5.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 967 resolved cases

Office Action

§102 §112 §DP
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This office action is in response to an amendment filed 1/13/2026. Claims 50-79 are pending. This application is a continuation of International Application No. PCT/US2025/014959, filed February 7, 2025, which claims the priority benefit of U.S. provisional application 63/551,418, filed February 8, 2024, and U.S. provisional application 63/707 ,055, filed October 14, 2024. Election/Restrictions Applicant’s election of Group I Claims 50-60 and 62-69, drawn to a capsid polypeptide with at least 95% identity to SEQ ID NO:1 with 7 substitutions at Q579, Q592, T593, W595, V596, N598 and I601 as well as virus comprising in the reply filed on 1/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 61 and 70-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (VEGF-C), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/13/2026. Information Disclosure Statement Information disclosure statements filed 1/13/2026 and 9/26/2025 have been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. Specification The use of the term RNAlater (see e.g. ¶1628), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claims 50-56 are objected to because of the following informalities: when referencing sequences by SEQ ID NO: it is proper to refer to –capsid polypeptide comprising the amino acid sequence of SEQ ID NO:-- . The SEQ ID NO: is simply a placeholder and not a sequence. . Appropriate correction is required. Claim Rejections - 35 USC § 112, first paragraph 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. Claims 50-56, 58-60 and 62-69 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicants claim an amino acid sequence with 95% sequence identity to SEQ ID NO:1. This amount of changes between SEQ ID NO:1 and 95% is 37 amino acids. The specification discloses only 1-7 amino acid changes and these changes are integral to altering function. Given that the 7 changes are critical to new function, alteration of any other amino acids would be changes above and beyond what have been described. The mutations that are claimed only amount to 7 modifications which is a relationship of 99% identity to SEQ ID NO:1. Comparing SEQ ID NO:12 and SEQ ID NO:1, the edit distance is 7. PNG media_image1.png 834 1315 media_image1.png Greyscale Hence, the disclosure does not teach capsid peptides or virus comprising thereof with less than 99% identity or more than 7 edit distance units. PNG media_image2.png 196 661 media_image2.png Greyscale The structure of a capsid which in this case is an AAV capsid and the virus comprising thereof which is an AAV is intimately tied to its function. Modifications can alter structural integrity and therefore function. The disclosure defines this thus, 0029] Functional: As used herein in reference to a polypeptide component of a dependoparvovirus capsid (e.g., Cap (e.g., VP1, VP2, and/or VP3) or Rep), the term "functional" refers to a polypeptide which provides at least 50, 60, 70, 80, 90, or 100% of the activity of a naturally occurring version of that polypeptide component (e.g., when present in a host cell). For example, a functional VP1 polypeptide can stably fold and assemble into a dependoparvovirus capsid (e.g., that is competent for packaging and/or secretion). As used herein in reference to a dependoparvovirus capsid or particle, "functional" refers to a capsid or particle comprising one or more of the following production characteristics: comprises a desired payload, is fully folded and/or assembled, is competent to infect a target cell, or remains stable (e.g., folded/assembled and/or competent to infect a target cell) for at least a threshold time. To that end, many mutations were made. However, only a few mutations were functional. 1625] A library of variants was created utilizing multiple sets of strategies of design and selection. The main objectives were to develop capsids capable of packaging into AAV particles efficiently, transducing central nervous system tissues effectively after intravenous administration, and detargeting the liver and other tissue types. [1661] Capsid polypeptide Variant 1 (“V1”), having a VP1 polypeptide sequence as set forth in SEQ ID NO:12, resulted in viral particles with an improved CNS, cardiac, and skeletal muscle delivery profile, as well as improved liver detargeting, as compared to viral particles with wild type AAV9 capsid sequences having a VP1 capsid polypeptide as set forth in SEQ ID NO:1. [1677] The V1 AAV capsid (having a VP1 polypeptide sequence as set forth in SEQ ID NO:12) demonstrated efficient transduction and biodistribution of cardiac and skeletal muscles as measured by payload expression (FIG. 5A) and viral genome quantification (FIG. 5B). Biodistribution to DRG and off-target peripheral organ samples was low (FIG. 5B). The particular sequence of SEQ ID NO:1 encodes an AAV9 capsid. The disclosure states that single modifications were analyzed but no results were provided. Hence, the disclosure teaches a single specific structure and no other to embody the genus of molecules claimed. By claiming peptides with 95% identity, peptides with at most 37 mutations are claimed. Even considering those with 98% identity, almost 15 mutations are claimed. However, the disclosure only teaches a capsid peptide with at least 99% sequence identity to SEQ ID NO:1 which is SEQ ID NO:12 or VP2 or VP3 comprising. This characterization is not generic but specific with functional properties that can not be assured especially in light of the results provided. Given the large size and diversity of the recited sequences, and the single embodiment: undue experimentation would be required to practice the claimed methods with reasonable expectation of success, absent a specific and detailed description in the specification. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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 50-56, 58-60 and 62-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (WO 2023060264). Chen et al teach a sequence with 99% wherein an alanine at a position corresponding to W595 of the VP1 capsid polypeptide of instant SEQ ID NO:1;(e) a leucine at a position corresponding to V596 of the VP1 capsid polypeptide of instant SEQ ID NO:1, (f) a serine at a position corresponding to N598 and (g) an alanine at a position corresponding to I601 of the VP1 capsid polypeptide (see claim 5) and sequence below showing one such mutation. The modifications are made in a sequence called SEQ ID NO:1 which is the same as SEQ ID NO:1 of the instant claims. 3983 99.9 736 PCT-US22-77804-64 2022-10-07 8 CAPSID VARIANTS AND METHODS OF USING THE SAME (en) ALIGNMENT: Query Match 99.9%; Score 3983; Length 736; Best Local Similarity 99.9%; Matches 735; Conservative 1; Mismatches 0; Indels 0; Gaps 0; Qy 1 MAADGYLPDWLEDNLSEGIREWWALKPGAPQPKANQQHQDNARGLVLPGYKYLGPGNGLD 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MAADGYLPDWLEDNLSEGIREWWALKPGAPQPKANQQHQDNARGLVLPGYKYLGPGNGLD 60 Qy 61 KGEPVNAADAAALEHDKAYDQQLKAGDNPYLKYNHADAEFQERLKEDTSFGGNLGRAVFQ 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 KGEPVNAADAAALEHDKAYDQQLKAGDNPYLKYNHADAEFQERLKEDTSFGGNLGRAVFQ 120 Qy 121 AKKRLLEPLGLVEEAAKTAPGKKRPVEQSPQEPDSSAGIGKSGAQPAKKRLNFGQTGDTE 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 AKKRLLEPLGLVEEAAKTAPGKKRPVEQSPQEPDSSAGIGKSGAQPAKKRLNFGQTGDTE 180 Qy 181 SVPDPQPIGEPPAAPSGVGSLTMASGGGAPVADNNEGADGVGSSSGNWHCDSQWLGDRVI 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 SVPDPQPIGEPPAAPSGVGSLTMASGGGAPVADNNEGADGVGSSSGNWHCDSQWLGDRVI 240 Qy 241 TTSTRTWALPTYNNHLYKQISNSTSGGSSNDNAYFGYSTPWGYFDFNRFHCHFSPRDWQR 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 TTSTRTWALPTYNNHLYKQISNSTSGGSSNDNAYFGYSTPWGYFDFNRFHCHFSPRDWQR 300 Qy 301 LINNNWGFRPKRLNFKLFNIQVKEVTDNNGVKTIANNLTSTVQVFTDSDYQLPYVLGSAH 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 LINNNWGFRPKRLNFKLFNIQVKEVTDNNGVKTIANNLTSTVQVFTDSDYQLPYVLGSAH 360 Qy 361 EGCLPPFPADVFMIPQYGYLTLNDGSQAVGRSSFYCLEYFPSQMLRTGNNFQFSYEFENV 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 EGCLPPFPADVFMIPQYGYLTLNDGSQAVGRSSFYCLEYFPSQMLRTGNNFQFSYEFENV 420 Qy 421 PFHSSYAHSQSLDRLMNPLIDQYLYYLSKTINGSGQNQQTLKFSVAGPSNMAVQGRNYIP 480 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 421 PFHSSYAHSQSLDRLMNPLIDQYLYYLSKTINGSGQNQQTLKFSVAGPSNMAVQGRNYIP 480 Qy 481 GPSYRQQRVSTTVTQNNNSEFAWPGASSWALNGRNSLMNPGPAMASHKEGEDRFFPLSGS 540 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 481 GPSYRQQRVSTTVTQNNNSEFAWPGASSWALNGRNSLMNPGPAMASHKEGEDRFFPLSGS 540 Qy 541 LIFGKQGTGRDNVDADKVMITNEEEIKTTNPVATESYGQVATNHQSAQAQAQTGWVQNQG 600 |||||||||||||||||||||||||||||||||||||||||||||||||||||||:|||| Db 541 LIFGKQGTGRDNVDADKVMITNEEEIKTTNPVATESYGQVATNHQSAQAQAQTGWLQNQG 600 Qy 601 ILPGMVWQDRDVYLQGPIWAKIPHTDGNFHPSPLMGGFGMKHPPPQILIKNTPVPADPPT 660 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 601 ILPGMVWQDRDVYLQGPIWAKIPHTDGNFHPSPLMGGFGMKHPPPQILIKNTPVPADPPT 660 Qy 661 AFNKDKLNSFITQYSTGQVSVEIEWELQKENSKRWNPEIQYTSNYYKSNNVEFAVNTEGV 720 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 661 AFNKDKLNSFITQYSTGQVSVEIEWELQKENSKRWNPEIQYTSNYYKSNNVEFAVNTEGV 720 Qy 721 YSEPRPIGTRYLTRNL 736 |||||||||||||||| Db 721 YSEPRPIGTRYLTRNL 736 Thus this meets claims 50-56 requiring 95%, 96%, 97%, 98%, 99%, edit distance of 12, 11, 10 (claims 50-56). Chen teaches VP1 and virus particles comprising the sequences (see abstract) thus meeting the limitations of claims 58-60 and 62-69. In fact, the provided for sequences is almost perfectly matched with SEQ ID NO: 12 RESULT 2 PCT-US22-77804-2 (NOTE: this sequence has 12 duplicates in the database searched. See complete list at the end of this report) Sequence 2, PC/TUS2277804 GENERAL INFORMATION APPLICANT: Dyno Therapeutics, Inc. (en) TITLE OF INVENTION: CAPSID VARIANTS AND METHODS OF USING THE SAME (en) FILE REFERENCE: 257394.001302 CURRENT APPLICATION NUMBER: PCT/US22,77804 CURRENT FILING DATE: 2022-10-07 NUMBER OF SEQ ID NOS: 268 SEQ ID NO 2 LENGTH: 736 TYPE: PRT FEATURE: NAME/KEY: source LOCATION: 1..736 QUALIFIERS: mol_type = protein organism = synthetic construct Query Match 99.7%; Score 3965; Length 736; Best Local Similarity 99.6%; Matches 733; Conservative 1; Mismatches 2; Indels 0; Gaps 0; Qy 1 MAADGYLPDWLEDNLSEGIREWWALKPGAPQPKANQQHQDNARGLVLPGYKYLGPGNGLD 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 MAADGYLPDWLEDNLSEGIREWWALKPGAPQPKANQQHQDNARGLVLPGYKYLGPGNGLD 60 Qy 61 KGEPVNAADAAALEHDKAYDQQLKAGDNPYLKYNHADAEFQERLKEDTSFGGNLGRAVFQ 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 KGEPVNAADAAALEHDKAYDQQLKAGDNPYLKYNHADAEFQERLKEDTSFGGNLGRAVFQ 120 Qy 121 AKKRLLEPLGLVEEAAKTAPGKKRPVEQSPQEPDSSAGIGKSGAQPAKKRLNFGQTGDTE 180 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 121 AKKRLLEPLGLVEEAAKTAPGKKRPVEQSPQEPDSSAGIGKSGAQPAKKRLNFGQTGDTE 180 Qy 181 SVPDPQPIGEPPAAPSGVGSLTMASGGGAPVADNNEGADGVGSSSGNWHCDSQWLGDRVI 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 181 SVPDPQPIGEPPAAPSGVGSLTMASGGGAPVADNNEGADGVGSSSGNWHCDSQWLGDRVI 240 Qy 241 TTSTRTWALPTYNNHLYKQISNSTSGGSSNDNAYFGYSTPWGYFDFNRFHCHFSPRDWQR 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 241 TTSTRTWALPTYNNHLYKQISNSTSGGSSNDNAYFGYSTPWGYFDFNRFHCHFSPRDWQR 300 Qy 301 LINNNWGFRPKRLNFKLFNIQVKEVTDNNGVKTIANNLTSTVQVFTDSDYQLPYVLGSAH 360 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 301 LINNNWGFRPKRLNFKLFNIQVKEVTDNNGVKTIANNLTSTVQVFTDSDYQLPYVLGSAH 360 Qy 361 EGCLPPFPADVFMIPQYGYLTLNDGSQAVGRSSFYCLEYFPSQMLRTGNNFQFSYEFENV 420 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 361 EGCLPPFPADVFMIPQYGYLTLNDGSQAVGRSSFYCLEYFPSQMLRTGNNFQFSYEFENV 420 Qy 421 PFHSSYAHSQSLDRLMNPLIDQYLYYLSKTINGSGQNQQTLKFSVAGPSNMAVQGRNYIP 480 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 421 PFHSSYAHSQSLDRLMNPLIDQYLYYLSKTINGSGQNQQTLKFSVAGPSNMAVQGRNYIP 480 Qy 481 GPSYRQQRVSTTVTQNNNSEFAWPGASSWALNGRNSLMNPGPAMASHKEGEDRFFPLSGS 540 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 481 GPSYRQQRVSTTVTQNNNSEFAWPGASSWALNGRNSLMNPGPAMASHKEGEDRFFPLSGS 540 Qy 541 LIFGKQGTGRDNVDADKVMITNEEEIKTTNPVATESYGTVATNHQSAQAQAVAGALQSQG 600 |||||||||||||||||||||||||||||||||||||| ||||||||||||: ||||||| Db 541 LIFGKQGTGRDNVDADKVMITNEEEIKTTNPVATESYGVVATNHQSAQAQAIVGALQSQG 600 Qy 601 ALPGMVWQDRDVYLQGPIWAKIPHTDGNFHPSPLMGGFGMKHPPPQILIKNTPVPADPPT 660 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 601 ALPGMVWQDRDVYLQGPIWAKIPHTDGNFHPSPLMGGFGMKHPPPQILIKNTPVPADPPT 660 Qy 661 AFNKDKLNSFITQYSTGQVSVEIEWELQKENSKRWNPEIQYTSNYYKSNNVEFAVNTEGV 720 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 661 AFNKDKLNSFITQYSTGQVSVEIEWELQKENSKRWNPEIQYTSNYYKSNNVEFAVNTEGV 720 Qy 721 YSEPRPIGTRYLTRNL 736 |||||||||||||||| Db 721 YSEPRPIGTRYLTRNL 736 Double Patenting A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). 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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b). Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 50-56, 58-60 and 62-69 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 6-8, 16, 21-23, 26 and 28 of U.S. Patent 12,116,385. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 6-8, 16, 21-23, 26 and 28 of U.S. Patent 12,116,385. That is, the cited claims of U.S. Patent 12,116,385 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, application U.S. Patent 12,116,385 is drawn to overlapping mutants as above and include an alanine at a position corresponding to W595 of the VP1 capsid polypeptide of instant SEQ ID NO:1;(e) a leucine at a position corresponding to V596 of the VP1 capsid polypeptide of instant SEQ ID NO:1, (f) a serine at a position corresponding to N598. Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,116,385, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,116,385, and thus improperly there would be possible harassment by multiple assignees. Relationship of SEQ ID NO:2 above to SEQ ID NO:1 3965 99.7 736 US-18-323-135-2 Claims 50-56, 58-60 and 62-69 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8, 16 and 19-23 of U.S. Patent 12,331,082. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 6-8, 16, 19-23 of Patent 12,331,082. That is, the cited claims of U.S. Patent 12,116,385 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, application U.S. Patent 12,331,082 is drawn to overlapping mutants as above and include an alanine at a position corresponding to W595 of the VP1 capsid polypeptide of instant SEQ ID NO:1;(e) a leucine at a position corresponding to V596 of the VP1 capsid polypeptide of instant SEQ ID NO:1, (f) a serine at a position corresponding to N598 and an alanine at I601. Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,331,082, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,331,082, and thus improperly there would be possible harassment by multiple assignees. Relationship of SEQ ID NO:2 above to SEQ ID NO:1 1 3965 99.7 US-18-790-657-2 2024-07-31 Claims 50-56, 58-60 and 62-69 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7, 16, 22-27 and 30 of U.S. Patent 12,331,081. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 6-8, 16, 19-23 of Patent 12,331,081. That is, the cited claims of U.S. Patent 12,116,385 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, application U.S. Patent 12,331,081 is drawn to overlapping mutants as above and include an alanine at a position corresponding to W595 of the VP1 capsid polypeptide of instant SEQ ID NO:1;(e) a leucine at a position corresponding to V596 of the VP1 capsid polypeptide of instant SEQ ID NO:1, (f) a serine at a position corresponding to N598 and an alanine at I601. Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,331,081, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,331,081, and thus improperly there would be possible harassment by multiple assignees. Relationship of SEQ ID NO:2 above to SEQ ID NO:1 1 3965 99.7 US-18-788-938-2 2024-07-30 Claims 50-56, 58-60 and 62-69 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-7, 16, 22-27 and 30 of U.S. Patent 12,528,841. An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 6-8, 16, 19-23 of Patent 12,331,081. That is, the cited claims of U.S. Patent 12,116,385 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, application U.S. Patent 12,331,081 is drawn to overlapping mutants as above and include an alanine at a position corresponding to W595 of the VP1 capsid polypeptide of instant SEQ ID NO:1;(e) a leucine at a position corresponding to V596 of the VP1 capsid polypeptide of instant SEQ ID NO:1, (f) a serine at a position corresponding to N598 and an alanine at I601. Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,331,081, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,331,081, and thus improperly there would be possible harassment by multiple assignees. Relationship of SEQ ID NO:2 above to SEQ ID NO:1 1 3965 99.7 US-19-209-113-2 2025-05-15 Conclusion Claim 57 is free of the art and is objected to as dependent on a rejected claim bit would otherwise be considered allowable if redrafted in independent form. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm. 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, Maria Leavitt can be reached at 571-272-1085. 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. /MARIA MARVICH/Primary Examiner, Art Unit 1634
Read full office action

Prosecution Timeline

Sep 26, 2025
Application Filed
Feb 07, 2026
Non-Final Rejection — §102, §112, §DP
Mar 06, 2026
Interview Requested
Mar 17, 2026
Applicant Interview (Telephonic)
Mar 17, 2026
Examiner Interview Summary

Precedent Cases

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NUCLEIC ACID MOLECULES CONTAINING SPACERS AND METHODS OF USE THEREOF
2y 5m to grant Granted Apr 14, 2026
Patent 12590321
METHODS AND COMPOSITIONS FOR GENETICALLY MODIFYING AND EXPANDING LYMPHOCYTES AND REGULATING THE ACTIVITY THEREOF
2y 5m to grant Granted Mar 31, 2026
Patent 12589151
T Cell Modification
2y 5m to grant Granted Mar 31, 2026
Patent 12589128
ONCOLYTIC ADENOVIRUS COMPOSITIONS
2y 5m to grant Granted Mar 31, 2026
Patent 12571002
GENE THERAPIES FOR LYSOSOMAL DISORDERS
2y 5m to grant Granted Mar 10, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
55%
Grant Probability
82%
With Interview (+26.9%)
4y 2m
Median Time to Grant
Low
PTA Risk
Based on 967 resolved cases by this examiner. Grant probability derived from career allow rate.

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