Prosecution Insights
Last updated: April 19, 2026
Application No. 19/195,843

DECELLULARIZED BIOMATERIAL FROM NON-MAMMALIAN TISSUE

Final Rejection §112
Filed
May 01, 2025
Examiner
DAVIS, RUTH A
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nextgen Biologics Inc.
OA Round
4 (Final)
61%
Grant Probability
Moderate
5-6
OA Rounds
3y 4m
To Grant
92%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
540 granted / 889 resolved
+0.7% vs TC avg
Strong +31% interview lift
Without
With
+30.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
45 currently pending
Career history
934
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
33.3%
-6.7% vs TC avg
§102
18.8%
-21.2% vs TC avg
§112
30.3%
-9.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 889 resolved cases

Office Action

§112
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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 10, 2026 has been entered. Claims 1 – 19 are pending and have been considered on the merits. All arguments have been fully considered. Claim Objections Claim 14 remains objected to because of the following informalities: The claim is grammatically inaccurate and includes an inappropriate underscore in line 6. The claim ends with two periods. Appropriate correction is required. 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 14 – 19 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 14, 17, 18, 19 and dependents are drawn to methods of using a material for various “uses” however the methods remain indefinite for failing to set forth any active, positive steps delineating how the uses are actually practiced. Rather, claim 14 only recites steps for producing a biomaterial. Clarification is required. See MPEP 2173.05(q). In claim 14, line 6, the recitation of “and grafting the as a biomaterial as a tissue graft” is confusing and fails to clearly delineate the claimed invention. The phrase “in need of said tissue graft” renders the claim indefinite because it is unclear what is in need and what the need is. Applicant argues that the claims have been amended to include a “grafting” step. However, this argument and the amendments fail to overcome the rejection as no active steps are recited to carry out any process and amount to nothing more than a “use” claim without claims to any process. Allowable Subject Matter Claims 1 – 13 are allowed. Conclusion All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm). 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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. /RUTH A DAVIS/Primary Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

May 01, 2025
Application Filed
Sep 20, 2025
Non-Final Rejection — §112
Sep 30, 2025
Response Filed
Oct 30, 2025
Final Rejection — §112
Dec 30, 2025
Request for Continued Examination
Jan 07, 2026
Response after Non-Final Action
Jan 08, 2026
Final Rejection — §112
Mar 10, 2026
Request for Continued Examination
Mar 16, 2026
Response after Non-Final Action
Mar 20, 2026
Final Rejection — §112 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
61%
Grant Probability
92%
With Interview (+30.9%)
3y 4m
Median Time to Grant
High
PTA Risk
Based on 889 resolved cases by this examiner. Grant probability derived from career allow rate.

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