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, filed 07/31/2023 is a National Stage entry of PCT/US2022/016073, International Filing Date: 02/11/2022. PCT/US2022/016073 Claims Priority from Provisional Application 63148201, filed 02/11/2021.
Status of Claims
Claims 1, 6, 11, 13, 18-19, 25-27, 30-31, 34, 40-41, 50, 52, 54, and 60-62 are pending as of the most recent claim set filed on 4/11/24. Claims 2-5, 7-10, 12, 14-17, 20-24, 28-29, 32-33, 35-39, 42-49, 51, 53, 55-59, and 63 have been canceled.
Claims 1, 6, 11, 13, 18-19, 25-27, 30-31, 34, 40-41, 50, 52, 54, and 60-62 were examined and are rejected.
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(s) 1, 6, 11, 13, 18-19, 25-27, 30-31, 34, 40-41, 50, 52, 54, and 60-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowery et. al., WO 2020142729 A1, publ. 7/9/2020, international filing date 1/3/2020.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Lowery teaches compounds as inhibitors of Cgas activity and pharmaceutical compositions comprising these compounds, for treating or preventing inappropriate activation of a type I interferon response in a subject (title & abstract; para [0002], [0005-0006]):
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. Lowery further teaches the pharmaceutical compositions to further comprise an appropriate carrier, solvent, adjuvant, or diluent; and a method for treating or preventing inappropriate activation of a type I interferon comprising administering a compound as described above to a subject in an effective amount (para [0007-0008]). Lowery further teaches disorders to be treated to include autoimmune disorders (para [0010-0011]). Lowery further exemplifies the following compound (p. 38, compound 52):
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. Although this compound is excluded in the proviso of instant claim 1, the instant claims do recite the following compound:
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. This compound is included within formula (I), having m=1; n=0; R2=methyl; ring A=pyrrolidine; R3=COOR5; R5=H; R4=-C(O)NR6R7; R6=H; R7=phenyl substituted with R9; and R9=CF3, and is structurally very similar to compound 52 as exemplified by Lowery. The only difference is the phenyl ring of the instantly claimed compound has a trifluoromethyl substituent attached at the para ring position, while compound 52 of Lowery has the phenyl ring unsubstituted. However, Lowery teaches the aryl ring positions for R1C (of the R4 group of Lowery) are optionally substituted with one or more R1B, wherein R1B includes C1-6 haloalkyl, e.g., CF3 (para [0006]). Therefore, one of ordinary skill in the art would have arrived at the instantly claimed compound of formula (I), (2S,4R)-1-(2-methylbenzofuro[3,2-d]pyrimidin-4-yl)-4-(2-oxo-2-((4-((trifluoromethyl)phenyl)amino)ethyl)pyrrolidine-2-carboxylic acid, based on the teachings of Lowery, and have had a reasonable expectation of success, as Lowery exemplifies the highly structurally similar compound 52. Furthermore, one of ordinary skill in the art would have been motivated to have treated or prevented inappropriate activation of a type I interferon, and treated an autoimmune disorder comprising administering to a subject in need thereof (2S,4R)-1-(2-methylbenzofuro[3,2-d]pyrimidin-4-yl)-4-(2-oxo-2-((4-((trifluoromethyl)phenyl)amino)ethyl)pyrrolidine-2-carboxylic acid, based on the disclosure of Lowery of the activity of the compounds for treating or preventing inappropriate activation of a type I interferon.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627