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
This is a response to Applicant’s communication filed on July 16, 2026. Application No. 19/542,047, filed February 17, 2026, is a Continuation of PCT/US25/22429, filed April 1, 2025, and claims the benefit of U.S. Provisional application No. 63/573,253, filed April 2, 2024. In an amendment filed July 16, 2026, Applicant cancelled claims 15 and 17-24. Claims 1-14, 16, and 25 are pending.
Rejection Withdrawn
Rejection of claim 6 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because of the phrase “e.g., daily” is withdrawn in view of Applicant’s July 16, 2026, Amendment & Remarks.
Rejections Maintained
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.
The rejection of claims 14 and 16 under 35 U.S.C. 102(a)(1) as being anticipated by Deokar et al., US2014/0100225 A1, is maintained for reasons made of record. Applicant argues that Deokar does not disclose the dosages of 300 mg. or 500 mg as claimed by the present invention. Applicant’s argument has been fully considered and is not persuasive.
Deokar discloses a range of dosages from 0.1mg/kg to 100 mg/kg of body weight. The average human body weight is about ~62 kg. Accordingly, Deokar discloses a range of dosages from 6.2 mg to 6200 mg. See Deokar et al., ‘225 publc’n, p. 12, para. [0303]; see Id., para. [0060]-[0062], for pharmaceutical salts; see Id., p. 45, claim 27, for administrative dosages; and see Id., p. 22, para. [0349], for routes of administration including oral.
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.
The rejection of claims 1-14, 16, and 25 under 35 U.S.C. 103 as being unpatentable over Deokar et al., US2014/0100225 A1, in view of Sitapara et al., WO2024/035884 (publ’d, February 15, 2024) (citing the U.S. equivalent, Sitapara et al., US2026/0042816 A1), is maintained for reasons made of record. Applicant argues that Deokar and Sitapara do not provide a motivation to treat PAH with a compound of Formula (I) or nor a reasonable expectation of success. Applicant’s argument(s) has been fully considered and is not persuasive.
Applicant argues that there is no motivation in the prior art to use the compound of formula (I), (hereafter the imatinib prodrug or prodrug of imatinib), to treat Pulmonary Arterial Hypertension. Applicant cites previous conducted clinical trials attempting to treat PAH with imatinib resulting in adverse advents (GI issues) which lead to the discontinuation of the trials. Nonetheless, the claims of the present invention are merely drawn to a method of treating PAH with the imatinib prodrug of formula (I).
For purposes of patentability, whether the ordinary artisan would have been motivated to treat PAH with the imatinib prodrug is supported by the referenced clinical trials contrary to Applicant’s assertion. It would have been obvious to treat PAH as done in the previous clinical trials in an alternative prodrug form such as that of formula (I) to avoid the adverse events noted by the Applicant..
With respect to the unexpected results, more data is required. Claim 25 of the present invention is drawn to the numerous other imatinib prodrugs as Applicant points out that are also disclosed in Deokar. Applicant argues that the unexpected results are in the improved tolerability (lack of adverse events relating to GI issues) of at least the compound of formula (I). Notably, the unexpected results are not an unexpected improvement in treating PAH. This unexpected improvement in tolerability reenforces the motivation to try the improved prodrug form of imatinib in treating PAH with a reasonable expectation of avoiding the adverse events which resulted in the discontinuation of the prior clinical trials.
As stated in the April 24, 2026, Non-Final Office action, Deokar discloses the imatinib derivative of the present invention for treating cancer as well as bacterial and viral infections. See Deokar et al., ‘225 publc’n, p. 12, para. [0303]. The difference between the prior art and present invention is the disclosed use of the imatinib tyrosine inhibitor derivative of formula (I) (as well as formula (II) of claim 25) to treat pulmonary arterial hypertension.
Deokar teaches that imatinib derivative(s) it discloses have improved/maintain desirable safety and toxicity profile relative to imatinib mesylate. See Deokar et al., p. 23, para. [0363]. Sitapara teaches treating pulmonary arterial hypertension using known tyrosine inhibitors, specifically imatinib mesylate. See Sitapara et al., ‘816 publc’n, p. 9, claims 1-84; see Id, specifically claim 3, for the use of imatinib to treat pulmonary arterial hypertension. Accordingly, all the elements of the present invention were known in the art at time of the invention.
It would have been obvious to the ordinary artisan to use the imatinib derivative of Formula (I) (as taught by Deokar) in treating pulmonary arterial hypertension as taught by Sitapara with a reasonable expectation of success. In this case, the claimed invention combines prior art elements accordingly to known methods to yield predictable results.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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