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
The instant application is a CON of Abandoned Application No. 18/185,844 371 filed March 17, 2023 which claims benefit to domestic provisional Application No. 63/321,032 filed March 17, 2022.
Status of Claims
Acknowledgement is made of cancelled (1-59) and new (60-78) claims filed on January 28, 2026. Claims 60-78 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on February 10, 2026 has been considered except where lined through.
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.
Claims 60-67, 70, 77-78 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et. al.1
Regarding claim 60-67, 70 and compounds of Formula IV, Tran teaches ralineprag tert-butyl ester derivatives of core Compound 8, such as CAS# 2088955-33-1 (see Tran at p. 915 Scheme 1 and Table 1).
Tran Compound 8
wherein R1 is 4-Cl
CAS# 2088955-33-1
Instant Formula IV
Instant Claim 70
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226
594
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124
316
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110
288
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CAS# 2088955-33-1 corresponds with instant Formula I.
Regarding claims 77-78 and a composition and method of treating PAH, Tran discusses ralinepag for treating pulmonary arterial hypertension orally and a composition comprising MCT (i.e. a carrier) (see Tran at Title and Abstract).
The prior art differs from the instant claims as follows: While CAS# 2088955-33-1 shares the core of Formula IV, i) Formula IV limits R8 to C5-C24 alkyl instead of C4 alkyl and ii) Tran does not specify a composition or method of treating PAH.
However,
Substituting one C4 alkyl for any other alkyl, straight-chain or branched, would have been an obvious change. “Alkyl” is widely regarded in the art as a class of substituents (even acknowledged by Applicant in “C5-24alkyl”), and an artisan would appreciate exchanging one alkyl group such as tert-butyl for another such as tert-pentyl or pentyl (both C5 alkyl groups) would be a suitable exchange with the expectation of similar properties. Per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. Here, the prior art teaches a highly similar structural compound compared to the instantly claimed invention, which shares a core with a known PAH treatment (ralinepag, as taught by Tran). An artisan would readily appreciate that compounds sharing the ralinepag core would have PAH activity, including compounds such as CAS# 2088955-33-1 (as taught by Tran), and alkyl analogs of CAS# 2088955-33-1. An artisan would thus be motivated to formulate such compounds into a composition in order to administer to a subject to treat PAH in a subject.
Allowable Subject Matter
Claims 68-69 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.
Claims 71-76 appear to be free of the prior art.
The closest prior art is Tran, which does not teach morpholine or piperdinyl rings at the R4/R5 position of Formula II. No reasonable motivation or suggestion was found to modify a compound of Tran to contain a morpholine or piperdinyl ring.
Conclusion
Claims 68-69 are objected to.
Claims 60-67, 70, 77-78 are rejected.
Claims 71-76 are allowed.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1Cite No. 056 in the IDS filed 2/10/26. Tran et. al. "Discovery of 2-(((1r,4r)-4-(((4-Chlorophenyl)(phenyl)carbamoyl)oxy)methyl)cyclohexyl)methoxy)acetate (Ralinepag): An Orally Active Prostacyclin Receptor Agonist for the Treatment of Pulmonary Arterial Hypertension" J. Med. Chem. 2017, 60, 3, 913–927 DOI: 10.1021/acs.jmedchem.6b00871 Hereinafter Tran.
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