Prosecution Insights
Last updated: April 19, 2026
Application No. 17/781,543

NEW CONJUGATES OF PEPTIDES AND POLYSACCHARIDE

Non-Final OA §112§DP
Filed
Jun 01, 2022
Examiner
COFFA, SERGIO
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Enlitisa (Shanghai) Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
94%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
436 granted / 719 resolved
+0.6% vs TC avg
Strong +34% interview lift
Without
With
+33.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
780
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
32.1%
-7.9% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
27.0%
-13.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 719 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 Election/Restrictions Applicant’s election without traverse of Group I and SEQ ID NO: 153 in the reply filed on 10/3/2025 is acknowledged. Claims 12-13, 16, 19-26, 28-47, 56, 61-68 and 70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/3/2025. Status of the Claims Claims 1-5, 7-14, 16-47, 50-53, 56, 61-68 and 70 are pending in this application. Claims 12-13, 16, 19-26, 28-47, 56, 61-68 and 70 are withdrawn from consideration as being drawn to a non-elected species/invention. Claims 1-5, 7-11, 14, 17-18, 27 and 50-53 are presently under consideration as being drawn to the elected species/invention. 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 1-5, 7-11, 14, 17-18, 27 and 50-53 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. Claim 1 recites “….Q represents a structural fragment of formula II……..Q1, Q2 and Q3 independently represent structural fragments of formula III”. The specification does not define the claimed “structural fragments”. It is unclear which fragments of formula II or formula III are encompassed by the claims. For instance, would NH or O be considered a structural fragment of formula II (or of formula III)? Claims 2-5, 7-11, 14, 17-18, 27 and 50-53, which depend from claim 1, 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 1. Because it is impossible to determine what is being claimed in instant claims 1-5, 7-11, 14, 17-18, 27 and 50-53, the claims have not been examined beyond pointing out issues with 112 second paragraph. 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 1-5, 7-11, 14, 17-18, 27 and 50-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, 18, 20-24, 26, 28, 31-36, 41-47 and 49 of copending Application No. 17/781438 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same compound. ‘438 teaches the same compound instantly claimed (see claims). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-5, 7-11, 14, 17-18, 27 and 50-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-40, 43-44, 47, 50 and 53 of copending Application No. 18/282362 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same compound. ‘362 teaches the same compound instantly claimed (see claims). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 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 01, 2022
Application Filed
Jun 01, 2022
Response after Non-Final Action
Dec 01, 2025
Non-Final Rejection — §112, §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
61%
Grant Probability
94%
With Interview (+33.6%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 719 resolved cases by this examiner. Grant probability derived from career allow rate.

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