Prosecution Insights
Last updated: April 19, 2026
Application No. 18/346,745

BIFUNCTIONAL DEGRADERS OF HEMATOPOIETIC PROGENITOR KINASE AND THERAPEUTIC USES THEREOF

Non-Final OA §112§DP
Filed
Jul 03, 2023
Examiner
FETTEROLF, BRANDON J
Art Unit
1626
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Gilead Sciences Inc.
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
4y 1m
To Grant
60%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
84 granted / 177 resolved
-12.5% vs TC avg
Moderate +13% lift
Without
With
+13.0%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
80 currently pending
Career history
257
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
28.5%
-11.5% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
28.4%
-11.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 177 resolved cases

Office Action

§112 §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 . Application Status The preliminary amendment filed on 9/25/2023 is acknowledged. Claims 3, 6, 9-13, 15, 18, 34 and 37-45 are currently pending and under consideration. Information Disclosure Statement The information disclosure statement filed on 10/29/2024 has been considered except where lined though. The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a). 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, 6, 9-13, 15, 18, 34 and 37-45 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. Independent claim 3 recites a compound having a structure of Formula (Ib): PNG media_image1.png 253 186 media_image1.png Greyscale and defines some, but not all, the variables. For example, LHM, L, X, R12 and R11 are not defined, as well as n and m. Accordingly, the claims are indefinite. Claim 10, which depends from claim 9, recites a L having the structure PNG media_image2.png 70 193 media_image2.png Greyscale . However, L in claim 9 has the structure PNG media_image3.png 83 249 media_image3.png Greyscale , wherein L1 is a direct bond, -C(O)NH- or C(O)- and L2 is -C(O)NH-, -O-, or -NH-. As such, there is insufficient antecedent basis for this limitation in the claim since a NH is not an option for L1 and -C(O)- is not an option for L2. Please note: The Examiner is assuming that the structures recited in claim 10 are read (L to R) in a similar fashion as in Claim 9. Claim 12, which depends from claim 11 has similar issues as claim 10 (above). Specifically, there are compounds within claim 12 which do not contain a -C(O)- as the first substituent (reading L to R). 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 3, 6, 11-13, 15, 18, 34 and 37-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 11739101B2 to Shunatona et al. (2023-08-29). Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patent and instantly application overlap in scope with the bifunctional degraders of hematopoietic progenitor kinase and therapeutic uses thereof. Claims 3, 6, 11-13, 15, 18, 34 and 37-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/797,148 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the application overlap in scope with the bifunctional degraders of hematopoietic progenitor kinase and therapeutic uses thereof. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US11925631B2 to Balan et al. 2024-03-12 discloses a compound having the structure PNG media_image4.png 297 683 media_image4.png Greyscale . Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. 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, Joseph McKane can be reached at 571-272-0699. 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. /BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Read full office action

Prosecution Timeline

Jul 03, 2023
Application Filed
Nov 17, 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
48%
Grant Probability
60%
With Interview (+13.0%)
4y 1m
Median Time to Grant
Low
PTA Risk
Based on 177 resolved cases by this examiner. Grant probability derived from career allow rate.

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