Prosecution Insights
Last updated: October 04, 2026
Application No. 19/293,815

NEURAL REGENERATING CELLS WITH ALTERATIONS IN DNA METHYLATION

Non-Final OA §101§112§251
Filed
Aug 07, 2025
Priority
Apr 30, 2008 — provisional 61/125,978 +3 more
Examiner
DRISCOLL, LORA E BARNHART
Art Unit
3991
Tech Center
3900
Assignee
Sanbio Inc.
OA Round
1 (Non-Final)
32%
Grant Probability
At Risk
1-2
OA Rounds
3y 8m
Est. Remaining
52%
With Interview

Examiner Intelligence

Grants only 32% of cases
32%
Career Allowance Rate
128 granted / 400 resolved
-28.0% vs TC avg
Strong +20% interview lift
Without
With
+20.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 10m
Avg Prosecution
34 currently pending
Career history
427
Total Applications
across all art units

Statute-Specific Performance

§101
4.6%
-35.4% vs TC avg
§103
21.6%
-18.4% vs TC avg
§102
29.4%
-10.6% vs TC avg
§112
29.3%
-10.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 400 resolved cases

Office Action

§101 §112 §251
Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. Status of Application and Claims US Patent 10,316,288 issued on 6/11/19 from application 12/736,665 with claims 1-6. Application 17/339,167 was filed on 6/4/21 as a reissue of the ’288 patent. The ’167 application issued on 10/14/25 with claims 1-3, 5, and 6 as RE50,635. This application was filed on 8/7/25 with claims 1-3 and 5-30. Claims 1-3, 5, and 6 in this application are identical to those in the RE’635 patent. Claims 7-30 are new. Claim Objections Claim 4 is canceled but is presented with text. This is improper under 37 CFR 1.173(b)(2). A replacement claim listing is required. Multiple Reissue Applications This reissue application is the continuation of application 17/339,167. 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). Accordingly, the first sentence of each reissue specification must provide notice stating that more than one reissue application has been filed, and it must identify each of the reissue applications and their relationship within the family of reissue applications, and to the original patent. An example of the suggested language to be inserted is as follows: Notice: More than one reissue application has been filed for the reissue of Patent No. 99,999,999. The reissue applications are application number 99/999,994 (the present application); and application number 99/999,995, which is a continuation reissue of Patent No. 99,999,999. See MPEP 1451. Election by Original Presentation 37 CFR 1.176(b) permits the examiner to require restriction in a reissue application between claims newly added in a reissue application and the original patent claims where the added claims are directed to an invention that is separate and distinct from the invention(s) defined by the original patent claims. See MPEP 1450. Further, in the reissue application, if a restriction requirement is made by the examiner, the original patent claims will be held to be constructively elected. Where a restriction requirement is made by the examiner, the original patent claims will be held to be constructively elected, except where disclaimer applies. Applicant may file divisional reissue applications directed to the constructively non-elected inventions. See MPEP 1450. Claims 1-3, 5, and 6 correspond to the invention defined by the original patent claims. Claims 7-22 are independent of and distinct from that invention because they recite a method that modifies different genes within the MASCs, plus claims to the products of those methods. The method of claims 7-14 has a materially different design, mode of operation, function, and effect relative to the original patent claims. They are also mutually exclusive of each other and not obvious variants of each other. See MPEP 806.05(j). Claims 23-30 are independent of and distinct from the invention of the ’288 patent because they are methods of using the cells of claims 15-22 to treat a neural disorder. The cells of claims 15-22 can be used in a materially different process, specifically in studies of neural differentiation in vitro that do not require the administration step of claims 23-30. See MPEP 806.05(h). Claims 7-30 are withdrawn from consideration as being drawn to constructively non-elected inventions. Claims 1-3, 5, and 6 are under examination. Reissue Oath/Declaration The reissue declaration filed with this application is defective because it fails to identify at least one error which is relied upon to support the reissue application. See 37 CFR 1.175 and MPEP § 1414. The reissue declaration is limited to a discussion of claims 17-21, none of which are under examination. The declaration fails to identify any error in the ’288 patent that is corrected by amendment to claims 1-3, 5, and 6 and was not already corrected in the RE’635 patent. Claim Rejections—35 U.S.C. 251 Claims 1-3, 5, and 6 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175. The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action. Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 251 because the reissue is not correcting an error in the original patent. Claims RE50,635 of US Patent 10,316,288 have been superseded by the previous reissue US RE50,635. Once a claim in the patent has been reissued, it does not exist in the original patent; thus, it cannot be reissued from the original patent in another reissue application. Applicant should cancel claims 1-3, 5, and 6. See MPEP 1451. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-3, 5, and 6 are indefinite because the invention is not particularly pointed out and distinctly claimed. Claims 1-3, 5, and 6 present the same coverage in previous reissue US RE50,635 and in this reissue application. This is inconsistent. Once a claim in the patent has been reissued, it does not exist in the original patent; thus, it cannot be reissued from the original patent in another reissue application. See MPEP 1451(I). Claim Rejections—35 U.S.C. 101 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 Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3, 5, and 6 of prior U.S. Patent No. RE50,635. This is a statutory double patenting rejection. Conclusion Claims 1-3, 5, and 6 are rejected. Maintenance Fees Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01. Duty to Disclose Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,316288 or Patent No. RE50,635 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORA E BARNHART DRISCOLL, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET. 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, Patricia Engle, can be reached at 571-272-6660. 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. /Lora E Barnhart Driscoll/Patent Reexamination Specialist, Art Unit 3991 Conferees: /KSO/ Patent Reexamination Specialist, Art Unit 3991 /Patricia L Engle/SPRS, Art Unit 3991
Read full office action

Prosecution Timeline

Aug 07, 2025
Application Filed
Aug 07, 2025
Response after Non-Final Action
Sep 10, 2026
Non-Final Rejection mailed — §101, §112, §251 (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
32%
Grant Probability
52%
With Interview (+20.0%)
4y 10m (~3y 8m remaining)
Median Time to Grant
Low
PTA Risk
Based on 400 resolved cases by this examiner. Grant probability derived from career allowance rate.

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