Prosecution Insights
Last updated: April 19, 2026
Application No. 18/253,916

SMALL MOLECULE INHIBITOR FOR CATHEPSIN C AND MEDICINAL USE THEREOF

Non-Final OA §112
Filed
May 22, 2023
Examiner
HABTE, KAHSAY
Art Unit
1624
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Reistone Biopharma Company Limited
OA Round
1 (Non-Final)
85%
Grant Probability
Favorable
1-2
OA Rounds
1y 11m
To Grant
93%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allow Rate
1348 granted / 1589 resolved
+24.8% vs TC avg
Moderate +8% lift
Without
With
+8.1%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 11m
Avg Prosecution
45 currently pending
Career history
1634
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
6.9%
-33.1% vs TC avg
§102
18.9%
-21.1% vs TC avg
§112
47.0%
+7.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1589 resolved cases

Office Action

§112
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 . Claims 1-2, 4-6, 8-11, 13-14, 17, 23-24, 28-33 and 36-37 are pending in this application. Election/Restrictions Applicant’s election without traverse of Group I and a species b. (i.e. X1 = -C- or -C-C-and X2 = -O-; or X1 = O and X2 = -C- or -C-C-) in the reply filed on 01/05/2026 is acknowledged. The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action. Note that compounds VI-c, VI-d and VI-I in claim 2 for example are non-elected species. 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 1-2, 4-6, 8-11, 13-14, 17, 23-24 and 28-31 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: a. Claims 1, 10 and claims dependent thereon are rejected because variable X2 is missing or chopped from the compound formula VI. PNG media_image1.png 239 953 media_image1.png Greyscale PNG media_image2.png 240 429 media_image2.png Greyscale Where is variable X2 in the formula V or VI? Do applicants intend the variable next to variable X1? It appears the chemical structure was cut and paste into the claims. Applicants have to redraw the chemical structures and show variable X2 clearly in the chemical formula V and VI. b. In claims 1 and 23, the definition of R3b is not clear. Applicants inserted a chemical structure in the definition of R3b, but the chemical structure is defective (see below). PNG media_image3.png 105 149 media_image3.png Greyscale The upper bonds from the oxo are overlapping with S. Note that the specification at page 3 show a correct chemical structure. It is recommended that applicants check the chemical structures recited in claims 28-29 and fix the problem for the overlapped chemical structures. c. In claims 9 and 28, the species recited contain defective chemical structures. The ring oxygen atom in the seven membered ring overlaps with the bond (see below). PNG media_image4.png 189 270 media_image4.png Greyscale Applicants have to fix the problem in claims 9 and 28 as it was done in claim 8 (see below). PNG media_image5.png 187 298 media_image5.png Greyscale It is recommended that applicants check the chemical structures recited in claims 28-29 and fix the problem for the overlapped chemical structures. d. Regarding claim 10, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d). e. In claim 30, the phrase “isotope substitute of the compound” is not clear. What is the isotope substitute of the compound? What is covered and what is not? How can one tell if a compound is isotope substitute? To overcome this rejection, the examiner recommends that applicants delete said claim. Claim Objections Claims 28-29 are objected to because of the following informalities: Claims 28-29 are objected to because some chemical structures are faded and not consistent with the other. In claim 28 as shown below for example, the top one is drawn properly with bold bonds but the bottom one is faded. It is recommended that applicants review the chemical structures. PNG media_image6.png 236 307 media_image6.png Greyscale Appropriate correction is required. Information Disclosure Statement Applicant’s Information Disclosure Statement, filed on 05/22/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith. To expedite prosecution, the examiner recommends that applicants delete non-elected species, delete claims 36-37 that are drawn to non-elected invention of Group II, and also applicants delete “preventing” from the method of use claims and recite specific diseases in claim 32 as it was done in claim 33. Conclusion 8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 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, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Kahsay Habte/ Primary Examiner, Art Unit 1624
Read full office action

Prosecution Timeline

May 22, 2023
Application Filed
Jan 29, 2026
Non-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

1-2
Expected OA Rounds
85%
Grant Probability
93%
With Interview (+8.1%)
1y 11m
Median Time to Grant
Low
PTA Risk
Based on 1589 resolved cases by this examiner. Grant probability derived from career allow rate.

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