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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2020/054221, filed 10/05/2020, which claims the priority benefit of PRO Application No. 62/910,931, filed 10/04/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/01/2022, 05/27/2022, 08/09/2023, 04/11/2024, 11/26/2024, and 07/11/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of claims
Claims 1, 3, 6-15 and 24 are pending in this application and are currently under examination. Claims 2, 4-5, and 16-23 have been cancelled.
Applicant’s arguments, filed 12/29/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. They constitute the complete set presently being applied to the instant application.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (Specification pg. 13, lines 17-18). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 6 is 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 6 recites “wherein the eosinophilic disorder is refractory to treatment with imatinib, sunitinib, and/or regorafenib”. It is unclear whether the disorder must be refractory to all of imatinib, sunitinib, and regorafenib as indicated by “and” or whether the refractory disorder is required to be refractory to only one of imatinib, sunitinib, or regorafenib based on the recitation “or”. See MPEP 2173.05(c). Examiner suggests deleting “and/” and optioning inserting a claim dependent from claim 6 which recites “wherein the eosinophilic disorder is refractory to treatment with imatinib, sunitinib, and regorafenib”.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The methods of instant claims 1, and 6-15 make a contribution over the prior art of record. The closest prior art found is the teaching of Lübke (Inhibitory effects of midostaurin and avapritinib on myeloid progenitors derived from patients with KIT D816V positive advanced systemic mastocytosis). Lübke teaches the effects of the KIT-inhibitor avapritinib on single-cell-derived myeloid progenitor cells using granulocyte-macrophage colony-forming-units of patients with KIT D816V positive advanced systemic mastocytosis (advSM) (Abstract). Lübke also discloses a subject with myeloproliferative neoplasm (MPN) and eosinophilia in table 2 but does not explicitly teach a method of treating an eosinophilic disorder. The main difference between the prior art of record and the instant claims is that though Lübke teaches applicants compound I (avapritinib) as a KIT-inhibitor and the role of KIT D816V mutation in advSM, Lübke does not fairly teach an embodiment or provide one of ordinary skill in the art with sufficient motivation to predictably conclude avapritinib would be an effective treatment for an eosinophilic disorder. Accordingly, the instant claims are not taught or suggested by the prior art.
Conclusion
Claims 1 and 6-15 are allowable, claims 3 and 24 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F 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, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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