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 .
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.
Election/Restrictions
Examiner have withdrawn 112, 102 and 103 rejection on record.
New 102 and 103 rejections are made due to applicant’s amendments to the claims.
Examiner found prior art on Markush search extended species,
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where G1 is,
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monocyclic heterocyclic group, L is COO, G2 is
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bicyclic aromatic heterocyclyl group wherein the compound is not
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. Therefore Markush search was not extended to other species.
The species read on claims 1-7, and 14-16.
Claims 8-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/29/2025.
Claims 1-7 and 14-16 are examined on merits.
Current Status of 17/995,914
This office action is in response to the amended claims on 03/24/2026.
Claims 1,4, 7 currently amended; claim 2-3,6 and 16 are original; claims 14-15 are previously presented; and claims 5 and 8-13 are withdrawn.
Claims 8-13 are withdrawn
Claims 1-7 and 14-16 are examined on merits.
Priority
The effective filing date is 04/10/2020 since the instant claims find support in provisional application no. 63/008,289.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10/30/2020 and 03/27/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks 03/24/2026. Examiner have reviewed these remarks and amendments.
Regarding 112 rejections, applicant amended claim 4 to depend on claim 2 thus overcoming 112 rejections. Thus 112 rejection is withdrawn.
Regarding 102 rejections applicant amended claim 1 to recite the limitation
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, thus overcoming 102 rejections. Therefore 102 rejection is withdrawn.
Regarding 103 rejection, applicant amended claim 1 to recite the limitation
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, thus overcoming 103 rejections. Therefore 103 rejection is withdrawn.
Response to Amendments.
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.
Claims 1-7 and are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eltis et.al. (Bioorganic & Medicinal Chemistry 16 (2008) 5761–577).
Eltis et al discloses compound
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where (corresponding to compound of formula I, formula II and formula III of claims 1-3) G1 is,
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monocyclic heterocyclic group, L is COO, G2 is
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bicyclic aromatic heterocyclyl group wherein the compound is not
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., wherein, X1 = N; X2 =CH; X3 is NH; and X5 is O thus anticipating claims 1-7(Table 1, compound 66).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Claims 1-7 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over
Eltis et.al. (Bioorganic & Medicinal Chemistry 16 (2008) 5761–577)
In view of
Chen et.al. (Journal of Pharmaceutical Analysis 10 (March 26, 2020, 313-319)
1. Determining the scope and contents of the prior art.
Eltis et al discloses compound
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where G1 is,
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monocyclic heterocyclic group, L is COO, G2 is
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bicyclic aromatic heterocyclyl group wherein the compound is not
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., wherein, X1 = N; X2 =CH; X3 is NH; and X5 is O thus anticipating claims 1-7 (page 5762, Table 1, compound 66). Eltis futher teaches
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(page 5763, Table 1, compound 66) inhibits SARS 3CLpro (a coronoviral proteinase) (Elitis , page 5762, column 1), partially teaching claims 15-16.
Chen et. al. teaches 3CLpro enzyme is a proven drug discovery target in the case of severe acute respirator syndrome coronavirus (SARS-CoV). (Chen et.al. abstract). Chen et.al. further teaches 3CLPro enzyme in SARS-CoV is preserved severe acute respiratory syndrome corornavirus disease (SAR-CoV-2)(covid-19) (conclusion section page, 318-319) (partially teaching claims 15-16).
2. Ascertaining the differences between the prior art and the claims at issue.
Although Eltis et.al teaches compound
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which inhibits SARS 3CLpro (a coronoviral proteinase) (Eltis, page 5762, column 1 and page 5763, Table 1, compound 66), Eltis does not teach pharmaceutically acceptable salt or method of treating severe acute respiratory syndrome.
Chen et. al does not teaches the compound of formula I or formula II and its pharmaceutically acceptable salt or method of treating severe acute respiratory syndrome.
3. Resolving the level of ordinary skill in the pertinent art.
A level of ordinary skill in the art is an artisan who have sufficient background in developing pharmaceutical acceptable salts for treatment of severe acute respiratory syndrome such as covid 19.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to develop a method of treating severe respiratory syndrome with pharmaceutical acceptable salt of compound
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, an inhibitor of SARS 3CLpro (a coronaviral proteinase) (Eltis , page 5762, column 1) because, 3CLpro enzyme is a proven drug discovery target for severe acute respirator syndrome in coronavirus (SAR-CoV), and is preserved in SARS-CoV-2) covid-19 (Chen et.al. abstract & conclusion section page, 318-319). A person skilled in the art would be expected to develop a method of treating SARs with pharmaceutical acceptable salt of compound
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(Eltis, page 5762, column 1 and page 5763, Table 1, compound 66) because 3CLpro enzyme is a proven drug discovery target for SAR-CoV(Chen et.al. abstract). Furthermore, since 3CLpro enzyme in SAR-CoV is preserved in SAR-CoV-2 (covid-19) (Chen et.al.conclusion section page, 318-319), a person skilled in the art is expected to use compound
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to treat covid-19 by targeting CLpro enzyme. Thus, teaching claims 1-7 and 14-16. Therefore, it would be prima facia obvious for a person skilled in the art to combine teaching of Eltis et.al. with the teaching of Chen et.al to develop pharmaceutical composition for treating severe acute respiratory syndrome.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Conclusion
No claims are allowable as written.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625