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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 10th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1-20 are pending in this application. Claims 21-28 have been cancelled by applicant.
Allowable Subject Matter
Claims 14-15 contain allowable subject matter.
Claims 14-15 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.
Claim Interpretation
Claim 1 mentions R2 can be oxopyrrolidinyl. The specification (para. bridging pages 10-11) mentions R2 can be selected from the group consisting of oxopyrrolidinyls below:
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Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites the limitation "subscript n is 4 or 3" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not mention a “subscript n.”
For the purposes of applying art, it will be assumed that claim 6 refers to claim 5, which is the only preceding claim with a subscript n.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 8-11, and 19-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hoffman et al. (WO 2005/113,580 A1 – From IDS).
Regarding claim 1 and 4, Hoffman discloses the compound of Formula I below (bottom of page 1-3 and claim 1 of Hoffman), which anticipates the instantly claimed compounds of Formulae I and Ia when: X (corresponding to instant R1) is -OR6, wherein R6 can be C6-10 aryl, independently substituted with 1-3 R7, wherein R7 (corresponding to instant R1a) can be halogen; R2 (corresponding to instant -CH2R2) can be
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,
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, or
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, wherein R3 can be H or C1-3 alkyl; Y (corresponding to instant R5) can be H, -Me, or -Et; Z (corresponding to instant -CH(R4)-) can be
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, wherein R1 (corresponding to instant R4) can be C1-7 alkyl, independently substituted with 1-3 R7 (corresponding to instant R4a here), wherein R7 can be C1-4 alkyl; m can be 0; and A (corresponding to instant R6) can be a 4-10 member heterocycle, or C6-10 -aryl, optionally substituted with 1-3 R7 (corresponding to instant R6a here), wherein R7 can be -O-C-1-3-alkyl, C1-4 alkyl, -OH, C3-6 cycloalkyl.
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Regarding claim 2, Hoffman discloses their compound of Formula I wherein R2 can be
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, wherein R3 can be H (2-oxopyrrolidin-3-yl).
Regarding claim 8, Hoffman discloses their compound of Formula I wherein the group corresponding to instant R3 is always H.
Regarding claims 9-10, Hoffman discloses their compound of Formula I wherein R1 (corresponding to instant R4) can be C1-7 alkyl, independently substituted with 1-3 R7 (corresponding to instant R4a here), wherein R7 can be C1-4 alkyl, or C3-6 cycloalkyl.
Regarding claim 11, Hoffman discloses their compound of Formula I wherein Y (corresponding to instant R5) can be H or -Me.
Regarding claims 19-20, Hoffman speaks to a method of treating a coronavirus infection, wherein the coronavirus is SARS coronavirus (SARS-CoV), comprising administration of a pharmaceutically effective amount of their compounds (claim 18 of Hoffman).
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 3, 5-7, 12-13, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (WO 2005/113,580 A1 – From IDS), as applied to claim 1.
The teachings of Hoffman et al. are disclosed in the 102 section above and incorporated herein.
Regarding claims 3 and 5, Hoffman discloses the compounds of Formula I, wherein X (corresponding to instant R1) is -OR6, wherein R6 can be C6-10 aryl (reading on phenyl) independently substituted with 1-3 R7, wherein R7 (corresponding to instant R1a) can be halogen.
Regarding claim 6, Hoffman discloses their compound of Formula I, wherein X (corresponding to instant R1) is -OR6, wherein R6 can be C6-10 aryl (reading on phenyl) independently substituted with 1-3 R7, wherein R7 (corresponding to instant R1a) can be halogen, reading on instant n being up to 3 halogens on the phenyl.
Regarding claim 7, Hoffman discloses their compound of Formula I, wherein R7 (corresponding to instant R1a) can be halogen, reading on fluorine.
Regarding claim 12, Hoffman discloses their compound of Formula I, wherein A (corresponding to instant R6) can be 4-10-member heterocycle. Hoffman states that “4-10-member heterocycle” includes aromatic and non-aromatic heterocycles, specifically mentioning indolyl and benzofuranyl derivatives as being encompassed by this limitation (page 6, para. 2, lines 1-3 and 18).
Regarding claim 13, Hoffman discloses their compound of Formula I, wherein the group corresponding to instant R6 can be substituted with 1-3 R7 (corresponding to instant R6a here), wherein R7 can be alkoxy, -OH, etc.
Regarding claims 16-17, Applicant is advised that one having ordinary skill in the art would have found the claimed compounds prima facie obvious, particularly the exemplary cases shown below, since they are generically embraced by the disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See also In re Malagari, 499 F.2 1297, 182 USPQ 549 (CCPA 1974); In re Lemin, 332 F.2d 839, 141 USPQ 814 (CCPA 1964); In re Rosicky, 276 F.2d 656, 125 USPQ 341 (CCPA 1960). The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Hoffman et al. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
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MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel's mere arguments cannot take the place of evidence in the record.
Regarding claim 18, Hoffman discloses pharmaceutical compositions of their compounds may contain suitable excipients (page 15, line 4).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the teachings of the prior art references is fairly suggestive of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Robert T. Crow/Supervisory Patent Examiner Trainer, Art Unit 4100