Prosecution Insights
Last updated: August 14, 2026
Application No. 18/853,933

EGFR INHIBITORS

Non-Final OA §112
Filed
Oct 03, 2024
Priority
Apr 05, 2022 — provisional 63/327,631 +1 more
Examiner
SHIM, DAVID M.
Art Unit
Tech Center
Assignee
Blueprint Medicines Corporation
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
1y 0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
52 granted / 90 resolved
-2.2% vs TC avg
Strong +56% interview lift
Without
With
+55.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
68 currently pending
Career history
128
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
37.4%
-2.6% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
35.8%
-4.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 90 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 . DETAILED ACTION Claims 1, 2, 6, 7, 10, 13, 16, 17, 21, 24, 27, 29, 33, 35, 38, 39, 43 and 47-49 are pending in the application. Claims 10, 29 and 39 are rejected. Claims 1, 7, 13, 24, 29, 38, 39, 47 and 48 are objected to. Claims 2, 6, 16, 17, 21, 27, 33, 35, 43 and 49 are allowable. Priority This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2023/017384, filed on April 4, 2023, which claims benefit of Provisional Application No. 63/327,631, filed on April 5, 2022. Information Disclosure Statement The Information Disclosure Statement(s) (IDS) filed on September 8, 2025 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached. Claim Objections Claims 1, 7, 13, 24, 29, 38, 39, 47 and 48 are objected to because of the following informalities: Claim 1 should be amended to replace the recited generic structure of Formula (A) with a larger structure for sake of clarity. Claim 7 should be amended to ensure “(II-7)” and “(II-8)” are located together with their respective structural formulas (i.e., on same page) for sake of clarity. Claim 13 should be amended to cancel the duplicate recitation of variable “OH” (indicated below) for sake of clarity. See page 13. PNG media_image1.png 227 772 media_image1.png Greyscale Claim 24 should be amended to cancel the expression “optionally wherein” for sake of clarity and consistency. Claim 29 should be amended to recite “R2 and R3 are each independently C1-C4 alkyl; [[and]] R4 is halo[[,]]; and Claim 38 should be amended to recite, “the [[a]] compound of claim 1” for sake of clarity and consistency. Claim 39 should be amended to recite, “comprising administering to a subject in need thereof an effective amount of the [[a]] compound of claim 1” for sake of clarity and consistency. Claim 47 should be amended to recite, “comprising administering to the subject” for sake of clarity. Claim 48 should be amended to recite, “the [[a]] compound of claim 1” for sake of clarity and consistency. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 10 and 39 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 10 recites the limitation “...wherein the...thiadiazolyl” in the definition for variable “R1” and is rejected as indefinite. See 16th line of claim 10. There is insufficient antecedent basis for this limitation in the claim as Applicant has further limited variable “R1” to alternatives of which “thiadiazolyl” is not included. Claim 39 recites the limitation “brain cancers (glioma)” and is rejected as indefinite. Firstly, it is unclear how “a cancer” (i.e., singular entity) can properly be described as being “brain cancers” (i.e., plural entity). In addition, it is unclear whether Applicant intended the parenthetical expression “(glioma)” to be considered further limiting of “brain cancer[].” See MPEP 2173.05(d). It is suggested Applicant amend claim 39 to recite, “brain cancer[[s]] Claim 39 recites the expression “the cancer in the subject in need thereof has metastasized” and is further rejected as indefinite. It is unclear whether Applicant intended claim 39 to be drawn towards a) any and all metastasized cancers or b) metastasis of the cancers recited in (i) and/or (ii). The instant specification appears to support interpretation b) as seen, for instance, on page 99 which discloses the following: PNG media_image2.png 634 901 media_image2.png Greyscale . It is, therefore, suggested that Applicant amend claim 39 to limit the “cancer” as recited in the expression “the cancer in the subject in need thereof has metastasized” to those cancers recited in (i) and/or (ii) of the claim to overcome the issue of indefiniteness and to avoid potential lack of enablement issues. Claim Rejections - 35 USC § 112(d) 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. Claims 10 and 29 are 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. Claim 10 recites the following alternatives for variable “R1”: PNG media_image3.png 29 199 media_image3.png Greyscale PNG media_image4.png 28 136 media_image4.png Greyscale PNG media_image5.png 28 458 media_image5.png Greyscale . See bottom of page 9. Each of the aforementioned alternatives do not derive support from parent claim 1 which does not provide for “C1-C4alkyl” (i.e., with respect to variable “R1”) to be substituted with variable “R11.” Therefore, claim 10 fails to include all the limitations of parent claim 1. Claim 29 recites PNG media_image6.png 72 88 media_image6.png Greyscale as an alternative for variable “R1.” However, neither parent claims 1 nor 27 provides for an instance wherein variable “R1” is defined as an alkyl group substituted with “R11.” Therefore, claim 29 fails to include all the limitations of parent claims 1 and 27. 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. Allowable Subject Matter Claims 2, 6, 16, 17, 21, 27, 33, 35, 43 and 49 are allowable. Claims 1, 2, 6, 7, 10, 13, 16, 17, 21, 24, 27, 29, 33, 35, 38, 39, 43 and 47-49 are free of the prior art. With the exception of the claim objections (i.e., claims 1, 7, 13, 24, 29, 38, 39, 47 and 48) and claim rejections (i.e., claims 10, 29 and 39), the instant claims are otherwise allowable. Conclusion Claims 10, 29 and 39 are rejected. Claims 1, 7, 13, 24, 29, 38, 39, 47 and 48 are objected to. Claims 2, 6, 16, 17, 21, 27, 33, 35, 43 and 49 are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST. 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, RENEE CLAYTOR can be reached at (571)272-8394. 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. /D.M.S./Examiner, Art Unit 1626 /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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Prosecution Timeline

Oct 03, 2024
Application Filed
Aug 05, 2026
Non-Final Rejection mailed — §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+55.9%)
2y 11m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 90 resolved cases by this examiner. Grant probability derived from career allowance rate.

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