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 .
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive. Applicant argues the amendment of claim 42 to cancel compounds I-301 and I-308, and addition of claim 73 incorporated into claim 64 render the rejections moot over Smithgall et al. (US 20150291534 A1). It is noted Smithgall teaches at the X4 position hydroxyl (claim 73) and at the X3 position (CH2)nR6 wherein R6 is selected from a group that includes heteroaliphatic. For the reasons above the rejections of claims 42, 64 and 68 is maintained.
Applicant has canceled claim 73. Claims 1, 15-31, 33-42, 45-72 and 74-75 is now evaluated on its merits.
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.
Claims 42, 64, 68 and are rejected under 35 U.S.C. 103 as being unpatentable over Smithgall et al. (US 20150291534 A1).
Regarding claims 42, 64 and 68, Smithgall teaches compounds and a method of inhibiting and treating a biological function of Nef; HIV replication (para. 0020) by administering a compound of Formula 2
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and a pharmaceutically acceptable excipient (para. 0009) post-exposure prophylactically to a subject having HIV (para. 0031). Of Formula 2, X and Y are nitrogen (para. 0013), R1 is a heteroaryl (para. 0009), R2 is hydroxyl (para. 0010), R3 in particular disclosed embodiment is (CH2)nR6 wherein n is 0-2 and R6 is selected from a list which includes a heteroaliphatic (para. 0011). Smithgall teaches R4 in particular disclosed embodiments as a phenyl substituted with one or more substituents selected from a list which includes trifluoromethyl and a halogen (para. 0012) as shown in compounds
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and
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(para. 0118).
Smithgall additionally teaches R1 typically is selected from hydrogen, phenyl, pyridyl, amide, ester, carboxyl, guanidino (or derivatives thereof), thioamide (or derivatives thereof), imidazoline, or combinations thereof. Thus, a combination of a phenyl and imidazoline is of structure
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, (relevant to claim 68) which reads to claimed invention of X1 as benzimidazolyl. R4 as taught by Smithgall may also include a heteroaliphatic (para. 0012), which includes N-heterocycloalkyl by the definitions of aliphatic (para. 0074) and heteroaliphatic (para.0086).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have constructed compounds that reads to the limitations of claim 64 and compound
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. One would have been motived to do so from the teachings of Smithgall of
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and
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in which R1 is a combination phenyl and imidazoline structure
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and R3 is a (CH2)heteroaliphatic structure
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to form structure
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. There is a reasonable expectation of developing compound
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from the teachings of Smithgall.
Allowable Subject Matter
Claims 1, 15-31, 33-41, 45-63, 70-72 and 74-75 are allowed. Closest prior art is of Smithgall et al. (US 20150291534 A1) which differs from claimed invention claims on the embodiments of X1-X3.
Claims 65-67 and 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627