Prosecution Insights
Last updated: October 04, 2026
Application No. 17/348,515

Adeno-Associated Virus Vector Delivery for Muscular Dystrophies

Final Rejection §DP
Filed
Jun 15, 2021
Priority
Jun 15, 2020 — provisional 63/039,252 +3 more
Examiner
GONZALES, JOSEPHINE MARIA
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Sarepta Therapeutics Inc.
OA Round
6 (Final)
27%
Grant Probability
At Risk
7-8
OA Rounds
0m
Est. Remaining
65%
With Interview

Examiner Intelligence

Grants only 27% of cases
27%
Career Allowance Rate
17 granted / 64 resolved
-33.4% vs TC avg
Strong +38% interview lift
Without
With
+38.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
40 currently pending
Career history
117
Total Applications
across all art units

Statute-Specific Performance

§101
5.5%
-34.5% vs TC avg
§103
42.5%
+2.5% vs TC avg
§102
16.6%
-23.4% vs TC avg
§112
23.2%
-16.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 64 resolved cases

Office Action

§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 . Priority The instant application, U.S. Application Number 17/348,515, filed June 15, 2021, claims priority from the earliest provisional application 63/039,252, filed June 15, 2020. Claim Status In the response filed July 7, 2026, Applicant has amended claim 47 and canceled claims 1-46, 48-50, 52, 55-57, 58-62, 64-72, 74-75, 81, and 93-94. Currently, claims 47, 51, 53-54, 63, 73, 76-80, 82-92, and 95-99 are under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 07/07/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Withdrawn Objections & Rejections Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. 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 47, 51, 53-54, 63, 73, 76-80, 82-92, and 95-99 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-2, 5-6, and 13-14 of Patent No. US12491265 B2 (Application Number 17/253,956, hereinafter as “’265 patent”), in view of Chicoine, Louis G., et al. (Molecular Therapy 22.2: 338-347; published 2014, hereinafter as “Chicoine”, previously presented), “Study: Researchers Identify Way to Increase Gene Therapy Success.” (Nationwide Children’s Hospital, Nationwide Children’s Hospital, 30 Oct. 2013, hereinafter as “Nationwide Children’s Hospital,” previously presented), Tagawa, et al., (Journal of the neurological sciences 157.1: 90-95, published 1998, previously presented), Tse, Longping V., et al.,(Expert opinion on biological therapy 15.6: 845-855, published 2015, previously presented), and Pham, Huy P., et al., (Transfusion and Apheresis Science 58.3: 237-246, published 2019, previously presented). This rejection is a new rejection due to Applicants claim amendments. However, since it is substantially similar to a rejection set forth in the final Official action mailed on July 7, 2026, therefore any aspect of applicant's response considered relevant to the rejection as newly set forth is responded to following the statement of rejection. Although the conflicting claims are not identical, they are not patentably distinct from each other because the competing claims are drawn to a disclosed species of the instant claims. Regarding claim 47, 63, 73, 80, and 98-99, the ‘265 patent claims 1-2, 5-6, and 13-14 discloses a method of expressing a recombinant adeno-associated virus (rAAV) serotype rh.74 comprising the nucleotide sequences of SEQ ID NO: 9, and the systemic route of administration is an intravenous route and the rAAV administered was about 2x1014 vg/kg. Further, the dose of the rAAV is determined by utilizing a super-coiled DNA standard. These disclosures expressly disclose the limitations of instant claim 47, 63, 73, 80, and 98-99. The difference between cited application method and instant method is that instant method requires a first dose of the rAAV, followed by TPE, followed by a second dose of the rAAV, and wherein the subject has a total antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800 after administration of the first dose of rAAV but prior to administering the TPE. However, Chicoine teaches Duchenne muscular dystrophy (DMD) is a monogenic disease potentially treatable by gene replacement (abstract) corresponding to the limitation of a method for treating a muscular dystrophy as claimed. Chicoine teaches the use of recombinant adeno-associated virus (AAV) will ultimately require a vascular approach to broadly transduce muscle cells (abstract) corresponding to the limitation of administering a first dose of recombinant adeno-virus associated. Regarding claims 47, 51, 53-54, 57, 63, 73, 76-80, and 95-99 Chicoine teaches administrating two rounds of plasmapheresis corresponding to the limitation administering a second dose of therapeutic plasma exchange (TPE)(see e.g. pages 341-342, 345-347). Chicoine teaches the subject's plasmas is subject to at least two TPE prior to administration of the 2nd dose or rAAV (see e.g. page 341, col. 2). Further, Chicoine teaches a method of treating muscular dystrophy in a human subject in need thereof comprising the steps of a) subjecting the subject's plasma to at least one therapeutic plasma exchange (TPE) prior to administering recombinant adeno-virus associated (rAAV)(see e.g. page 341-342). Additionally, Chicoine discloses wherein the subject's plasma is subjected to TPE for at least 2 days prior to administration of the rAAV (see e.g. pages 345-347). Moreover, Chicoine teaches wherein the subject is administered an anti-inflammatory steroid about 24 hours prior to administration of the rAAV, which would have been obvious to control inflammation (see e.g. page 346). Further, Chicoine discloses a range of end point titers: 1:400 to 1:3,200 for AAVrh.74 sero-positive (see e.g. page 339, Supplementary Figure S2)), corresponding to the claim limitation of antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800. Although Chicoine does not explicitly disclose wherein the subject has a total antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800 after administration of the first dose of rAAV but prior to administering the TPE. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." Regarding the issue of inherency, see Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020). (see MPEP 2112 (IV)). Accordingly, it would have been obvious to claim the invention of cited application and combine the method steps of a first dose of the rAAV, followed by TPE, followed by a second dose of the rAAV as taught by Chicoine wherein the subject has a total antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800 after administration of the first dose of rAAV but prior to administering the TPE because Chicoine suggests that an intervening plasmapheresis is able to eliminates the negative impact of AAV antibodies generated from a first dose that would normally inhibit the second dose (see e.g. Abstract). Further, Chicoine discloses the groups of sero-negative (i.e. naïve or no pre-existing antibodies) and sero-positive (naturally infected) animals receiving the gene transfer with AAVrh.74. and that the post plasmapheresis titer of the sero-positive animals was not different from that of sero-negative animals (see e.g. page 341-342, Figure 5), and that the levels of AAVrh.74 binding antibodies in the post-vector period had no effect on transgene expression in the sero-positive pheresed groups. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success. Additionally, the prior art of Nationwide Children’s Hospital discloses that levels of micro-dystrophin gene expression increased in animals that did not at first receive plasmapheresis (see e.g. page 2). Further, the prior art of Jeune discloses that combining high vector doses and plasmapheresis would allow for treatment of up to 90% of potential patients who had previously undetectable levels of neutralizing factors (see e.g. page 64). Thus, a person of ordinary skill in the art of gene therapy would have been able to use the invention of cited application with the combined method steps of a first dose of the rAAV, followed by TPE, followed by a second dose of the rAAV as taught by Chicoine with a reasonable expectation of success. Although Chicoine teaches performing two rounds of plasmapheresis (i.e. two rounds of three plasma volume exchanges over 2 consecutive days)(i.e. total of six TPE exchanges)(see page 342), Chicoine is silent regarding seven, eight, nine or ten therapeutic plasma exchange (TPE). However, the prior art of Tagawa discloses a range of three to ten therapeutic plasma exchange (TPE) (i.e. plasmaphereses) in patients (see page 91, col. 1). Further, the prior art of Tse discloses that after six plasma volumes of plasmapheresis (i.e. TPE) over a 2-day period, sero-positive animals had similar transduction efficiencies as sero-negative animals (see e.g. page 849). Further, the following is noted from the MPEP: MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” MPEP 2144.05(I) teaches “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” In regards to overlapping ranges, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”, continuing in regards to ranges are close, “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”. Accordingly, it would have been obvious for a person of ordinary skill in the art to modify the methods of the cited application and Chicoine with seven or more therapeutic plasma exchange (TPE) (i.e. plasmaphereses) as taught by Tagawa and Tse because Tse discloses that a clinical study found that multiple sessions of plasmapheresis are required to reduce naturalizing antibodies (NAbs) for effective gene therapy. Additionally, the prior art of Nationwide Children’s Hospital discloses that as gene therapy becomes more prevalent that patient may need to receive more than one treatment and plasmapheresis would allow them to be treated again (see e.g. page 3). Thus, a person of ordinary skill in the art would have optimized the number of TPE for the patient with predictable results and a reasonable expectation of success. Regarding claims 47, 51, 53-54, 57, 63, 73, 76-80, and 95-99, Chicoine does not explicitly state the plasma volume of about 1 to 1.5 plasma volume. Further, the prior art of Pham discloses that TPE exchanges that about 1 to 1.5 plasma volumes per treatment provide the most benefit (see page 238). Accordingly, it would have been obvious for a person of ordinary skill in the art to modify the methods of the cited application and Chicoine with TPE exchanges that are about 1 to 1.5 plasma volumes per treatment as taught by Monteilhet and Pham because Pham discloses that treating volumes in excess of a 1.5-plasma volume exchange confers little benefit due to the diminishing return effect, while placing the patient at higher risk for procedural complications (see page 238). Further, Monteilhet discloses that the standard plasma exchange procedure consisted of removal of one and half plasma volume during each session (page 2089). Therefore, a person of ordinary skill in the art would have a reasonable expectation of success to optimize each TPE exchanges to be about 1 to 1.5 plasma volumes. Response to Traversal: Applicant respectfully disagrees with the characterization of Chicoine and asserts that Chicoine is directed to the presence of pre-existing antibody immunity with AAVrh.74 (Remarks, page 9). Applicant argues that Chicoine does not teach or suggest using plasmapheresis in a subject population with an antibody titer of anti-AA Vrh.74 antibodies following a first dose of rAAV, much less with the antibody titer of anti-AAVrh.74 antibodies of at least 1: 12,800 (Remarks, page 9). Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. In response to Applicants argument, it is noted that Chicoine is directed to the presence of preexisting immunity to AAV (see abstract). However, Chicoine does disclose the comparison of “sero-negative (i.e. naïve) and sero-positive (naturally infected) animals to gene transfer with AAVrh.74., where there was a rapid and robust increase in antibody levels in the two immune-positive groups, whereas the sero-negative group had a modest antibody response following vector delivery” (See page 342). Furthermore, it is noted that the MPEP at 2113 states “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. As discussed above, if a person of ordinary skill in the art performed the first and second dose with SEQ ID: 9 or SEQ ID NO: 3 with the TPE exchanges of about 1 to 1.5 plasma volumes than the subject’s total range of end point titers: 1:400 to 1:3,200 for AAVrh.74 sero-positive, as taught by Chicoine (see e.g. page 339, Supplementary Figure S2)), corresponding to the claim limitation of antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800. Further, the prior art of Tse discloses that “clinical interventions such as plasmapheresis and pharmacological modulation of the immune system offer promising, alternative solutions to address pre-existing immunity and/or vector re-administration (page 851). Therefore, a person of ordinary skill in the art would understand that the pre-existing immunity (as taught by Chicoine) would apply to patients that need re-administration. In response to Applicants argument that Chicoine also provides absolutely no expectation of success in using TPE to reduce the high AAV antibody titer levels (Remarks, page 11). Contrary to Applicants assertion, Chicoine teaches different antibody titers for sero-negative (i.e. naïve) and sero-positive (naturally infected) animals to gene transfer with AAVrh.74.. Thus, a person of ordinary skill in the art would already know that optimization to account for the difference in antibody titers would be different. Further, It is noted that the features upon which applicant relies (i.e. AAV antibody titers) are not recited in the rejected claims. In response to applicant's argument that using TPE to reduce the high AAV antibody titer levels, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant argues that the disclosures of NCI, Tagawa, Tse, Jeune, and Pham, do not teach or suggest a subject population having a total antibody titer of anti-AAVrh.74 antibodies of at least I: 12,800 after administration of the first dose of rAAV but prior to administering the TPE (Remarks, page 10). Applicant asserts that Tse itself expressly states that "[p]lasmapheresis has proven useful in autoimmune disease to remove pathogenic antibodies from patients and might be beneficial in cases of low Nab [neutralizing antibody] titer." Tse, page 11, paragraph 1 (emphasis added). Similarly, Jeune states that "plasmapheresis will likely only be valuable in patients that have relatively low neutralizing titers." Jeune, page 64, col. II, paragraph 3” (Remarks, page 10). Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive. In response to Applicants’ argument regarding of NCI, Tagawa, Tse, Jeune, and Pham, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). In the instant case, Tagawa is cited for teaching the number of plasmaphereses sessions to a given patient and is not cited for teaching AAV-based therapy. As discussed above, the prior art of Tse discloses that after six plasma volumes of plasmapheresis (i.e. TPE) over a 2-day period, sero-positive animals had similar transduction efficiencies as sero-negative animals (see e.g. page 849). As discussed above, Chicoine is cited for disclosing the range of end point titers: 1:400 to 1:3,200 for AAVrh.74 sero-positive (see e.g. page 339, Supplementary Figure S2)), corresponding to the claim limitation of antibody titer of anti-AA Vrh.74 antibodies of at least 1: 12,800. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Closest Prior Art Art made of record but not relied upon for art rejection: Art cannot be applied to the claims as written without reading limitations into the claims. Nonetheless, the following prior art reference teaches many of the elements/steps inferred by the disclosure as filed. The closest prior art of record is Rodino-Klapac et al (WO2019078916A1, U.S. App. No. 16/757,207, Applicant Research Institute at National Children’s Hospital, filed 3/16/2018) (See file .rni, Result #1, Score Alignment Below). Rodino-Klapac et al. teaches SEQ ID NO: 3, which recombinant AAV vector expressing micro-dystrophin PNG media_image1.png 98 829 media_image1.png Greyscale (see claim 34, see also Spec Figure 1 below). However, the prior art of Rodino-Klapac does not teach nor reasonably suggest a recombinant adeno associated virus (rAAV) vector, wherein the MHCK7 promoter comprises a substitution, the intron sequence or the micro-dystrophin sequence comprises nucleotides 55-5021 of SEQ ID NO: 3 or SEQ ID NO: 9 of instant Application. See alignment below of SEQ ID NO:3 of Rodino-Klapac (bottom strand) with nucleotides 55-5021 of SEQ ID NO: 3 of instant Application (see SCORE search 12/06/2023, .rni file, result #1). PNG media_image2.png 796 586 media_image2.png Greyscale PNG media_image3.png 717 587 media_image3.png Greyscale PNG media_image4.png 775 587 media_image4.png Greyscale PNG media_image5.png 779 586 media_image5.png Greyscale PNG media_image6.png 716 582 media_image6.png Greyscale PNG media_image7.png 779 588 media_image7.png Greyscale PNG media_image8.png 779 583 media_image8.png Greyscale Accordingly, the closest prior art of Rodino-Klapac et al does not teach the instant nucleotide sequence that is 100% identical to nucleotides 55-5021 of SEQ ID NO: 3. Furthermore, see alignment below of SEQ ID NO:3 of Rodino-Klapac (bottom strand) with nucleotides of SEQ ID NO: 9 of instant Application (see SCORE search 12/06/2023, .rni file, result #1). PNG media_image9.png 874 598 media_image9.png Greyscale PNG media_image10.png 886 542 media_image10.png Greyscale PNG media_image11.png 801 541 media_image11.png Greyscale PNG media_image12.png 806 566 media_image12.png Greyscale PNG media_image13.png 905 583 media_image13.png Greyscale PNG media_image14.png 819 564 media_image14.png Greyscale PNG media_image15.png 894 567 media_image15.png Greyscale PNG media_image16.png 899 555 media_image16.png Greyscale Accordingly, the closest prior art of Rodino-Klapac et al does not teach the instant nucleotide sequence that is 100% identical to SEQ ID NO: 9. Conclusion SEQ ID Nos: 27-31, 41-43 and 10-19 are free of the prior art (see Search results 10/10/2024, 10/11/2024, and 09/11/2026). No claim is allowed. Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPHINE GONZALES whose telephone number is (571)272-1794. The examiner can normally be reached M-Th: 10AM - 5:00PM (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, Tracy Vivlemore can be reached at 571-272-2914. 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. Josephine Gonzales PhD Examiner Art Unit 1638 /JOSEPHINE GONZALES/ Examiner, Art Unit 1638 /Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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Prosecution Timeline

Show 13 earlier events
Sep 12, 2025
Response after Non-Final Action
Oct 22, 2025
Applicant Interview (Telephonic)
Oct 22, 2025
Examiner Interview Summary
Nov 04, 2025
Request for Continued Examination
Nov 05, 2025
Response after Non-Final Action
Mar 10, 2026
Non-Final Rejection mailed — §DP
Jul 07, 2026
Response Filed
Sep 17, 2026
Final Rejection mailed — §DP (current)

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Prosecution Projections

7-8
Expected OA Rounds
27%
Grant Probability
65%
With Interview (+38.4%)
4y 1m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 64 resolved cases by this examiner. Grant probability derived from career allowance rate.

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