Prosecution Insights
Last updated: April 19, 2026
Application No. 18/525,721

COMPOUNDS FOR IMPROVED VIRAL TRANSDUCTION

Non-Final OA §DP
Filed
Nov 30, 2023
Examiner
MONTANARI, DAVID A
Art Unit
1632
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Genetix Biotherapeutics Inc.
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
3y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allow Rate
491 granted / 754 resolved
+5.1% vs TC avg
Strong +49% interview lift
Without
With
+49.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
42 currently pending
Career history
796
Total Applications
across all art units

Statute-Specific Performance

§101
4.7%
-35.3% vs TC avg
§103
33.1%
-6.9% vs TC avg
§102
15.9%
-24.1% vs TC avg
§112
31.7%
-8.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 754 resolved cases

Office Action

§DP
Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. DETAILED ACTION 1. The instant application is a CON of 17/125,930, now U.S. Patent No. 11,834,668 which is a CON of 16/665,892, now U.S. Patent No. 10,907,177 which is a CON of 15/997,643, now U.S. Patent No. 10,501,759, which is a CON of 14/348,572, now U.S. Patent No. 9,988,644. 2. Claims 29-48 are examined in the instant application. Claim Objections Claim 35 is objected to because of the following informalities: claim 35 is not grammatically correct. At step (e) the capital letter “A” should be replaced with a lower case “a”. Appropriate correction is required. Claim 41 is objected to because of the following informalities: claim 41 is not grammatically correct. At step (e) the capital letter “A” should be replaced with a lower case “a”. Appropriate correction is required. Claim 47 is objected to because of the following informalities: claim 47 is not grammatically correct. At step (e) the capital letter “A” should be replaced with a lower case “a”. Appropriate correction is required. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp . (A) Claims 29-48 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-28 of U.S. Patent No. 11,834,668. Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant method s (claims 29, 37 and 43) of increasing lentiviral transduction efficiency of CD34+ hematopoietic stem or progenitors cells does not recite a species for the CD34+ hematopoietic stem or progenitors cells the instant method would be obvious over the human CD34+ hematopoietic stem or progenitors cells of ‘668 since the instant CD34+ hematopoietic stem or progenitors cells encompass any species including human. Further the instant dependent clams, 30-36, 38-42 and 44-48 , are either identical to or encompass the same scope as dependent claims 2-12, 14-20 and 22-28 of ‘668. The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289 . (B) Claims 29- 48 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-28 of U.S. Patent No. 10,907,177. Although the claims at issue are not identical, they are not patentably distinct from each other because while the method of increasing lentiviral transduction efficiency of CD34+ hematopoietic stem or progenitors cells in ‘177 does not recite a length of time regarding contacting for the CD34+ hematopoietic stem or progenitors cells the instantly recited human CD34+ hematopoietic stem or progenitors cells would be obvious over the method of ‘177 since the method encompass contacting for at least twenty-four hours (claims 9, 17 and 25 of ‘177) . Further the instant dependent clams, 30-36, 38-42 and 44-48, are either identical to or encompass the same scope as dependent claims 2-12, 14-20 and 22-28 of ‘668. The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289 . (C) Claims 29-48 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-29 of U.S. Patent No. 10,501,759. Although the claims at issue are not identical, they are not patentably distinct from each other because while the method of increasing lentiviral transduction efficiency of CD34+ hematopoietic stem or progenitors cells in ‘759 was claimed as an in vitro method, the instantly claimed methods are identical except for the practice of the methods in vitro . However, the instant claimed method encompasses practicing the method in vitro since the contacting in step (a) is done with a culture medium and thus would be obvious over the methods of ‘759. Further the instant dependent clams, 30-36, 38-42 and 44-48, are either identical to or encompass the same scope as dependent claims 2-1 3 , 1 5-21 and 2 3-29 of ‘ 759 . The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289 . (D) Claims 29-48 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-56 of U.S. Patent No. 9,998,644. Although the claims at issue are not identical, they are not patentably distinct from each other because while the method of increasing lentiviral transduction efficiency of CD34+ hematopoietic stem or progenitors cells in ‘644 does not recite a length of time regarding contacting for the CD34+ hematopoietic stem or progenitors cells the instantly recited human CD34+ hematopoietic stem or progenitors cells would be obvious over the method of ‘644 since the method encompass contacting for at least twenty-four hours (claims 11, 29-31 and 48-50 of ‘644). Further the instant dependent clams, 30-36, 38-42 and 44-48, are either identical to or encompass the same scope as dependent claims 2 -18, 20-37 and 39-56 of ‘ 644 . The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289 . Conclusion No claims are allowed. The claims are free of the prior art. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DAVID A MONTANARI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-3108 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Tr 8-6 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Peter Paras can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4517 . 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. /DAVID A MONTANARI/ Examiner, Art Unit 1632
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Prosecution Timeline

Nov 30, 2023
Application Filed
Mar 07, 2026
Non-Final Rejection — §DP (current)

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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
65%
Grant Probability
99%
With Interview (+49.1%)
3y 10m
Median Time to Grant
Low
PTA Risk
Based on 754 resolved cases by this examiner. Grant probability derived from career allow rate.

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