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 .
Status of the Claims and Response to Restriction Requirement
Claims 1-16, 18-19 and 28-29 are pending as of the response filed 06/22/2026. Claims 17 and 20-27 are cancelled. Applicant’s election of group I claims without traverse, is acknowledged. The examiner notes that Applicant has amended the group II claim, claim 29, to read on the elected group.
Applicant’s election of a species of compound E18 shown below without traverse, is acknowledged.
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Claims 1-13 and 29 encompass the elected species. Claims 14-16, 18-19 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-13 and 29 are examined to the extent to which they are readable on the above identified elected species.
The elected species was examined and found to be free of prior art. Therefore, the examiner has extended the search to include the entire genus of compounds of formula as in instant claim 1. The following prior art that anticipates the formula of claim 1 was found, as discussed below.
Priority
This application is a 371 of PCT/US2022/077707 filed 10/06/2022,
PCT/US2022/077707 has PRO 63/253,026 filed 10/06/2021.
The subject matter of the instant claims are supported by the provisional application, PRO 63/253,026. Accordingly, the effective filing date of instant claims 1-13 and 29 is 10/06/2021.
Information Disclosure Statement
The information disclosure statement submitted 04/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Para. [0013] of the specification should read “Fig. 3 shows a [[second]]third general scheme for the preparation of compounds provided herein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xing et al. (WO 2021/078022 A1, 29 March 2021, hereinafter Xing, in the IDS) (citations are made to the attached Google English translation).
Regarding instant claim 1, Xing teaches a small molecule compound and pharmaceutically acceptable salt thereof (Abstract). Xing teaches an intermediate in the synthesis of a compound TDM-180636, the compound of Example 36g and Example 36h (Pg. 8, last paragraph).
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The intermediate compounds of Example 36g and Example 36h of Xing falls within the scope of the formula of instant claim 1, wherein
R1 is CH;
R2 is NH;
R3 is C2-10 heteroaryl (pyrazolyl);
R4 is C1-4 alkyl (methyl);
R5 is H;
R6 is H;
R7 is H;
J is 0;
R9 is C and Z is 1;
R8 is N(Boc) (example 36g), NH (example 36h);
X is 1;
M is 1;
R10 is H.
Further, the intermediate compounds of Example 46g and Example 46h of Xing falls within the scope of the formula of instant claim 1 (Pg. 13, last paragraph), with variables similar to above, except R1 is N.
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Further, the intermediate compounds of Example 126cand Example 126e of Xing falls within the scope of the formula of instant claim 1 (Pg. 25, first paragraph), with variables similar to above, except R1 is N; R10 is CH2CN;
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or a salt thereof as in Example 126d (Pg. 25, first paragraph).
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The above compounds further anticipate the limitations of instant claims 2-11 and 13.
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.
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 12 is rejected under 35 U.S.C. 103 as being unpatentable Xing et al. (WO 2021/078022 A1, 29 March 2021, hereinafter Xing, in the IDS) (citations are made to the attached Google English translation) as applied to claims 1-11 and 13 above, in view of Wermuth (Molecular variations based in isosteric replacements, 1996).
The teachings of Xing are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 12, Xing teaches the intermediate compounds of Example 36 g and Example 36 h.
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The intermediate compounds of Example 36 g and Example 36 h of Xing overlaps the scope of the formula of instant claim 12, wherein
R2 is NH;
R11 is
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(example 36 g),
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(example 36h);
R13 is
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.
[AltContent: arrow]The intermediate compounds of Example 36 g and Example 36 differ in the R12 being
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versus the instantly claimed
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, i.e., presence of a fluorine in the instant compound, as highlighted above.
Wermuth teaches bioisosteric replacement of hydrogen with fluorine and states that organic fluorine is often compared to hydrogen because of its chemically inert nature and small size (Pg. 226, fourth paragraph). Wermuth further teaches H
↔
F isosterism will often serve to give analogues that are more resistant to metabolic degradation (Pg. 227, second paragraph).
According to MPEP 2144.09 (III), “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979). See also In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating depression would have been expected to have similar activity because the structural difference between the compounds involved a known bioisosteric replacement)”.
Therefore, in view of the teachings of Wermuth, the compounds of Example 36 g and Example 36 h of Xing, would be expected to have very similar or identical utilities and functional properties to the instant compound having
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for R12 as noted above, rendering it prima facie obvious. A person of ordinary skill in the art at the time the application was effectively filed would have been motivated to produce the closely-structurally-related species of compounds of Example 36 g and Example 36 h, for use in as inhibitors of JAK kinase. The motivation being to provide additional candidates for further pharmacological and/or commercial development.
Allowable Subject Matter
Claim 29 is 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.
Conclusion
Claims 1-13 are rejected.
Claim 29 is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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