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
Nonfinal Rejection
Claim Status
Claims 1-7, 9, and 17-19 are pending examination.
Priority Status
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86
360
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed. It is noted, however, that applicant has not filed a certified copy of the UK 2107924.9 application as required by 37 CFR 1.55.
Information Disclosure Statement
All references have been considered in the one (1) IDS(s) filed 07/08/2024 unless marked with a strikethrough.
Drawings
The one (1) drawing submission filed on 12/04/2023 has been accepted by the Examiner
Response to Restriction/Election of Species
In Response to the Restriction and Species Election Requirement dated 08/01/2025:
Applicant elected Group I, Claims 1-7, 9, and 17-19.
Claims 8, 10-15 and 20-21 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Election was made without traverse.
Claim Objections
Claims 5 and 6 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7, 9, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/120390 A1(Boyle; hereinafter “Pub’390”).
With respect to Claims 1-4, 7, 9, and 17-19, Pub’390 teaches the Applicant’s Instant Claim compound (Table 1, Example 50, pg. 79. Identical compound) and containing a compound (Claims 4 & 18; pg. 50, lns. 17-23, which reads on the claimed range), wherein at least 55% of the compound is present as a single optical isomer (e.g. enantiomer or diastereoisomer). In one general embodiment, 99% or more (Claims 4 & 18; pg. 50, lns. 17-23, which reads on the claimed range) of the total amount of the compound. This would affect the salt ratio of the pharmaceutical acceptable salt. Since the compound (Example 50 of the prior art, identical compound of Applicant’s Instant Compound) is already known, its physical properties at a natural stoichiometric balance is characteristic. The underlying molecular structure doesn’t change by changing the salt ratio; Pub’360 is modifying the physical state, which makes it structurally similar to the prior art Example 50.
Pub’390 also discloses that the same compound as the Instant Claim inhibits or modulates the activity of Chk-1 kinase, and pharmaceutical compositions containing the compounds and the therapeutic uses of the compounds (abstract). Finally, Pub’360 discloses the compounds can be a type of crystalline solvate in which the ratio of the host molecule (or crystal lattice) to the solvent molecule is exactly as defined by the stoichiometric coefficients in the balanced chemical equation for the formation process (stoichiometric or non-stoichiometric solvates).
Pub’360 fails to teach the claimed the maleate, tosylate, besylate and malonates salts species of the 5-[[5-[4-(4-fluoro-1- methyl-4-piperidyl)-2-methoxy-phenyl]-1H-pyrazo 1-3-yl] amino]pyrazine-2- carbonitrile’s form.
Berge teaches the list of FDA approved commercially marketed salts in Table 1 and teaches that the above salt forms are one of the finite number of FDA approved commercially marketed salt forms to formulate an active pharmaceutical ingredient, and the most preferred. Berge additionally states that several benefits are gained by formulating different active pharmaceutical ingredients into salt form, including chemical, biological, physical and economical properties of the active pharmaceutical agent (pg. 1, col. 1, para. 1; pg. 2, able 1).
Accordingly, one of ordinary skill in the art at the time of the invention would have found it obvious to formulate the compound 5-[[5-[4-(4-fluoro-1- methyl-4-piperidyl)-2-methoxy-phenyl]-1H-pyrazo 1-3-yl] amino]pyrazine-2- carbonitrile, in the maleate, tosylate, besylate and malonates salt form in view of the teachings of Pub’390 and Berg in order to arrive at the instantly claimed species.
One of ordinary skill in the art at the time of the invention would have found it obvious to employ the pharmaceutically acceptable salts above (pg. 7, lns. 7-13) to elicit the advantages disclosed by Pub’390 and Berg with a reasonable expectation of success because (1) Pub’390 teaches that the claimed compound can be formulated as a pharmaceutically acceptable salt coupled with the knowledge that (2) the differing salt form claimed are preferred salt species for formulating medicinal compounds due to the corresponding physiological benefits and ease of synthesis as taught by Pub’390 and Berg.
Conclusions
Claims 1-4, 7, 9, and 17-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 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, Clinton A. 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.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights