Prosecution Insights
Last updated: July 17, 2026
Application No. 19/248,341

PHARMACEUTICAL COMPOSITIONS COMPRISING NOVEL CYCLIC PEPTIDES

Non-Final OA §112§DP
Filed
Jun 24, 2025
Priority
Mar 08, 2019 — provisional 62/815,917 +10 more
Examiner
COFFA, SERGIO
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Lisata Therapeutics Inc.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
1y 10m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
449 granted / 734 resolved
+1.2% vs TC avg
Strong +33% interview lift
Without
With
+33.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
69 currently pending
Career history
789
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
47.4%
+7.4% vs TC avg
§102
12.3%
-27.7% vs TC avg
§112
9.5%
-30.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 734 resolved cases

Office Action

§112 §DP
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 . DETAILED ACTION Status of the Claims Claims 1-20 are pending in this application. Claims 1-20 are presently under consideration as being drawn to the elected species/invention. Claim Objections Claims 1-20 are objected to because of the following informalities: With respect to claim 1, the acronym “THF” should be spelled out. Claim 2 should be amended to recite “The method of claim 1, wherein the resin is Rink Amide AM Resin With respect to claims 7 and 19, the acronyms “DMF” and “DIPEA” should be spelled out. With respect to claim 8, the acronyms “DIC”, “TCTU” and “HOBt” should be spelled out. With respect to claim 9, the acronym “IPA” should be spelled out. With respect to claim 10, the acronyms “TFA”, “TIS” and “EDT” should be spelled out. Furthermore, the phrase “….in the presence of suitable scavengers: H2O….” should be amended to recite“….in the presence of a suitable scavenger selected from H2O….”. With respect to claim 12, the acronyms “HPLC” and “ACN” should be spelled out. With respect to claims 15 and 17, the acronym “MBHA” should be spelled out. Claims 3-6, 11, 13-14, 16, 18 and 20 are also objected as they depend from claim 1. 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 3-10 are 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. With respect to claim 3, the phrase “until the resin carries the complete the required amino acid sequence” is unclear. One of ordinary skill in the art would not understand what is being claimed. Claims 4-9, which depend from claim 3, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 3. Claim 7 recites “Coupling of protected building blocks (protected amino acid derivatives)….”. It is unclear whether the “protected amino acid derivatives” in parenthesis are the only protected building blocks encompassed by the claim. In other words, there are more protected building blocks than protected amino acid derivatives, thus it is unclear whether the claim is limited to the protected amino acid derivatives in parenthesis. See MPEP § 2173.05(d). Furthermore, with respect to the phrases “in a solvent of DMF”, it is noted that DMF is a solvent. Thus, one of ordinary skill would not know what is encompassed by said solvent of the solvent DMF. Claims 8-9, which depend from claim 7, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 7. Claim 10 recites the limitation "the peptide resin" in line 3. There is insufficient antecedent basis for this limitation in the claim. 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12351653. ‘653 teaches the same peptide instantly claimed (claim 1), which is prepared by following the same steps instantly claimed (columns 13 and 22-23). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970). Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-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, MELISSA FISHER can be reached at 571-270-7430. 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. /SERGIO COFFA Ph.D./ Primary Examiner Art Unit 1658 /SERGIO COFFA/Primary Examiner, Art Unit 1658
Read full office action

Prosecution Timeline

Jun 24, 2025
Application Filed
Jun 10, 2026
Non-Final Rejection mailed — §112, §DP (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

1-2
Expected OA Rounds
61%
Grant Probability
94%
With Interview (+33.1%)
2y 11m (~1y 10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 734 resolved cases by this examiner. Grant probability derived from career allowance rate.

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