Prosecution Insights
Last updated: April 19, 2026
Application No. 18/237,189

SMALL MOLECULAR INHIBITOR AGAINST BTK AND/OR BTK C481S AND USE THEREOF

Non-Final OA §102§112
Filed
Aug 23, 2023
Examiner
RODRIGUEZ-GARCIA, VALERIE
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Arromax Pharmatech Co. Ltd.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
2y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
558 granted / 811 resolved
+8.8% vs TC avg
Strong +32% interview lift
Without
With
+31.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
35 currently pending
Career history
846
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
22.3%
-17.7% vs TC avg
§102
24.5%
-15.5% vs TC avg
§112
36.2%
-3.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 811 resolved cases

Office Action

§102 §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 1-10 are currently pending. Claim 1 is independent. Priority The instant application claims priority as follows: PNG media_image1.png 34 474 media_image1.png Greyscale PNG media_image2.png 54 404 media_image2.png Greyscale Response to Election/Restriction Applicant's election, without traverse, of Group I, claims 1-4, drawn to a compound of PNG media_image3.png 198 214 media_image3.png Greyscale and elected species PNG media_image4.png 150 210 media_image4.png Greyscale found in claim 2, in the reply filed on November 24, 2025 is acknowledged. Claims 1-4 read on the elected species. Claims 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 24, 2025. Examination Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. The elected species was searched and no applicable prior art was identified. The Examiner expanded the search and examination to the compounds of formula (I) PNG media_image3.png 198 214 media_image3.png Greyscale wherein W1, W2 and W3 are each CH, X is NH, R is cyclohexyl substituted by -NHalkyl or CH2-OH, Y is PNG media_image5.png 52 56 media_image5.png Greyscale and G is the group PNG media_image6.png 150 105 media_image6.png Greyscale . The expanded search encompasses the elected species and reads in part on claims 1-4. The need to limit examination is warranted based on the extensive permutations permitted on all the available variables, which require separate electronic searches and which structures are classified in different classes. Subject matter outside of the examined scope and claims 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim. Specification Objection - Abstract Applicant is reminded of the proper content of an abstract of the disclosure. With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B. The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b). The examiner requests Applicant to illustrate compound species representative of what is currently claimed. A depiction of formula (I) will not obviate this objection. Depicting compounds of claim 2 may obviate this objection. 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 1, 3-4 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. The following issues are found in claim 1: At the definition for R, “an amine in which the alkyl group is unsubstituted or substituted”. There is lack of antecedent basis in the phrase “in which the alkyl group”. Amines do not inherently have alkyl groups. At the definition for R, “carbocyclic ring having a heteroatom including, but not limited to….” In chemistry, carbocyclic rings are composed only of carbon. Thus, a carbocyclic ring having a heteroatom is unclear. However, heterocycles may be composed of heteroatoms. In addition, the phrase “including, but not limited to” is ambiguous. It renders the claim indefinite because it is drawn to a variable definition that is open-ended and as such, the scope of the claim is unclear. It is also unclear whether the limitation(s) following the phrase (N, S, and O) are required. See MPEP § 2173.05(d). G is defined as a five membered aryl group and this is unclear. This can only refer to a cyclopentadiene anion, which is not possible to be present in this compound. G is defined as a “saturated carbocyclic ring or unsaturated carbocyclic ring containing a heteroatom.” In chemistry, carbocyclic rings are composed only of carbon. Thus, a carbocyclic ring having a heteroatom is unclear. However, heterocycles may be composed of heteroatoms. The definition for Y recites that Y “is not limited to” PNG media_image7.png 57 263 media_image7.png Greyscale . This makes the claim unclear because the claim does not point out the full scope of Y, what is Y. After the definition for Y the claim recites: PNG media_image8.png 30 186 media_image8.png Greyscale . This lacks antecedent basis because the definition for Y does not recite that Y may be absent. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim depends of claim 1 but it contains compounds that are outside of the scope of claim 1. Note compound I-60. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al. (WO 2020/239124). The prior art teaches the compound of formula PNG media_image9.png 100 208 media_image9.png Greyscale in at least page 68, or a salt thereof, to be used in pharmaceutical compositions with a pharmaceutically acceptable carrier (page 16), and alone or in combination with a second therapeutic agent. It reads on compound I-30 of claim 2. Conclusion Claims 1-4 are rejected. No claim is in condition for allowance. The elected species appears allowable. Note to Applicants Not every piece of prior art found in the search has been applied against the instant claims. See MPEP 904.03. Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm. 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, Clinton Brooks can be reached at 571-270-7682. 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. /VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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Prosecution Timeline

Aug 23, 2023
Application Filed
Feb 07, 2026
Non-Final Rejection — §102, §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
69%
Grant Probability
99%
With Interview (+31.6%)
2y 6m
Median Time to Grant
Low
PTA Risk
Based on 811 resolved cases by this examiner. Grant probability derived from career allow rate.

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