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 entry of PCT/US2022/036569 filed on 07/08/2022, which claims priority to U.S. Provisional Application No. 63/257,896 filed on 10/20/2021 and U.S. Provisional Application No. 63/220,404 filed on 07/09/2021.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-64 and 66) drawn to compounds of formula I and compositions thereof; and compound 127
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as a species of a compound of formula I in the reply filed on March 26, 2026 is acknowledged. The traversal is on the ground(s) that Applicant has amended claims 1, 16, and 65 and in view of the amendments, Group I and Group II are now related as genus (Group I) and species (Group II). Applicant argues that restriction between genus and species is not proper. This is not found persuasive because even with the amendments to claim 65, claim 65 is still drawn to compounds that are not within the genus of Group I. For example there is a compound on page 29 of the claims that has a different core structure than the compounds of Group I since it contains a pyrimidine ring and not a phenyl ring as does the compounds of Group I. Thus since not all of the compounds in claim 65 are species of Group I as argued by Applicant, Applicant’s arguments are found not persuasive
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-15, 19, 36-38, 45-46, 52-65 and 67-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-7, 16-18, 20-35, 39-44, 47-51 and 66 are being examined as they read on the elected species.
Claim Objections
Claims 20, 21, 24-25, 33, 35, 44 and 66 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). Accordingly, for the sake of compact prosecution, the claims are being interpreted as being dependent upon claim 1 and have been further treated on the merits.
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.
Claims 1-7, 16-18, 20-35, 39-44, 47-51 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. WO 2022/007461 A1 (Provided on IDS) filed on April 15, 2021 (effective filing date of July 4, 2020) (equivalent to U.S. Publication No. 2023/0159465 A1 used as English Translation).
The cited claims of the instant application are drawn to a compound of Formula (II) having the following structure:
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such as
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, wherein A is pyrazole substituted with isopropyl; B is -CH(RA)(RB) and both RA and RB are cyclopropyl; n is 2; R5 is cyclopropyl and F; R1 and R2 are hydrogen and methyl; R3 and R4 are hydrogen and CH2CF3.
Li et al. teaches compounds of formula (V) having the following structure:
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wherein R1 is -C(O)R11, R11 is
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substituted with R1a which may be selected as -C1-6alkyl; R2 and R3 are hydrogen; ring A and B are
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; C ring is
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; RC1 is -C0-4alkylene-C(O)NRC2RC3; RC2 and RC3 are selected from hydrogen and C1-6alkyl substituted with halogen ([0107]-[0115] and claims 15 pages 81-82). Li et al. teaches in one embodiment of formula (V) ring C as
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is
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([0116] and claim 16 page 82). Li et al. further teaches R1 may be selected as
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(page 72 claim 2). Li et al. further teaches that the C ring may be substituted with 1-4 RC1 which include in addition to -C0-4alkylene-C(O)NRC2RC3, halogen, and 3-10 membered cycloalkyl, wherein the alkyl and alkylene are substituted with C1-6 alkyl (page 71).
With respect to Applicant’s elected species, the prior art does not appear to provide sufficient specificity, i.e., involves too much "picking and choosing" to give rise to anticipation. See Coming Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect ....the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the various combinations of features claimed from within the prior art disclosure to arrive at the instantly claimed subject matter, specifically compounds of formula (V) having the following structure:
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wherein R1 is
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; R2 and R3 are hydrogen; ring A and B are
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; C ring is phenyl substituted with 1-4 RC1 wherein RC1 is -C0-4alkylene-C(O)NRC2RC3, halogen, and 3-10 membered cycloalkyl, wherein the alkylene is substituted with C1-6 alkyl, and RC2 and RC3 are selected from hydrogen and C1-6alkyl substituted with halogen to arrive at
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wherein the pheny ring is substituted with halogen, and 3-10 membered cycloalkyl. In view of the foregoing teachings, Applicant’s elected species is rendered obvious.
In addition, Li et al. specifically teaches the following structure:
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(pages 34 and 100). This structure renders obvious a compound as claimed of formula (II) when A is pyrazole substituted with methyl; B is -CH(RA)(RB) and both RA and RB are cyclopropyl; n is 0; R1 and R2 are methyl; R3 and R4 are hydrogen and C2-6 alkyl substituted with C3-10 carbocycle.
Although in this compound of Li et al., one of the substituents corresponding to R1 or R2 of the instant compounds is not hydrogen, or there is no substituent corresponding to R5 as claimed wherein n is at least 1, Li et al. further teaches that the C ring (phenyl) may be substituted with 1-4 RC1 which include in addition to -C0-4alkylene-C(O)NRC2RC3, halogen, and 3-10 membered cycloalkyl (page 71).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the compounds of Li et al. according to the guidance provided therein. Thus including additional substituents on the C ring (phenyl) of the compound of Li et al. such as halogen, 3-10 membered cycloalkyl, etc. to arrive at a compound as claimed in the instant application is rendered obvious.
Claim 66 is rendered obvious since Li et al. teaches a pharmaceutical composition, comprising the compounds disclosed therein or a deuterated compound, a stereoisomer, or a pharmaceutically acceptable salt thereof and a pharmaceutically-acceptable adjuvant ([0128], [0161] and claim 22).
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 8-15, 19, 36-38, 45-46, 52-65 and 67-69 are withdrawn. Claims 1-7, 16-18, 20-35, 39-44, 47-51 and 66 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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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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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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