Prosecution Insights
Last updated: April 18, 2026
Application No. 18/263,453

GALLIUM 68 LABELED AFFIBODY PROTEIN PET IMAGING AGENT AND USE THEREOF

Non-Final OA §101§103§112
Filed
Jul 28, 2023
Examiner
CABRAL, ROBERT S
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
West China Hospital Of Sichuan University
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
95%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
531 granted / 852 resolved
+2.3% vs TC avg
Strong +32% interview lift
Without
With
+32.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
24 currently pending
Career history
876
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
39.8%
-0.2% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 852 resolved cases

Office Action

§101 §103 §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 . Applicant’s preliminary amendment filed 7/28/2023, is acknowledged. Claims 1-5 are pending. 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. Claim 3-5 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. Claims 4 and 5 are directed to a use of a compound as an imaging agent. To that end, the claims merely recite an intended use of the claimed compound without reciting any active steps for what may be perceived as a process for using the claimed compound. See MPEP § 2173.05(q). Consequently, the metes and bound of the claims are unclear. Claim Rejections - 35 U.S.C. § 101 35 U.S.C. § 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 4 and 5 are rejected pursuant to 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. As claimed (i.e., recited as a “use” only), the invention does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. § 101 (process, machine, manufacture, or composition of matter). The claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., it results in a claim which is not a proper process claim pursuant to this statutory section. See, for example, Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967), and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Velikyan et al., Nuclear Medicine and Biology 88-89 (2020) 73-85, in view of Lindborg et al., J. Mol. Biol. (2011) 407, 298-315, and Wirz et al., Matrix Biol. 2011 January; 30(1); 9-15. The differences between claim 1 and Velikyan et al. in that claim 1 defines the specific sequence of Z-tri, thereby obtaining a more stable trimeric PDGFRβ targeting affibody. However, Lindborg et al. discloses an engineered high-affinity affibody targeting PDGFRβ. Wirz et al. discloses a human collagen XV trimeric affibody protein which has a very stable structure and can be used for protein trimerization engineering modification, and (G4S) 3 is also a common linker. Therefore, on the basis of Velikyan et al. combined with Lindborg et al. and Wirz et al. and conventional techniques in the art, it would have been obvious to arrive at the technical solution of claim 1. Claim 1 does not involve an inventive step. On this basis, claims 2 and 3 would also have been obvious, and do not involve an inventive step. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm. 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, Ali Soroush can be reached at 571-272-9925. 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. /ROBERT S CABRAL/Primary Examiner, Art Unit 1614
Read full office action

Prosecution Timeline

Jul 28, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §101, §103, §112 (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
62%
Grant Probability
95%
With Interview (+32.5%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 852 resolved cases by this examiner. Grant probability derived from career allow rate.

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