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
Applicant’s election in the reply filed on 08/29/2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant provided complaint species of formula I and the corresponding formula II:
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Examiner did not find prior art on applicant elected species. Therefore, Markush search was extended to the 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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.
The species read on claims 1-4, 6-7, and 14-16.
Claims 5, and 8-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1-4, 6-7 and 14-16 are examined on merits.
Current Status of 17/995,914
This office action is in response to the amended claims on 08/29/2025.
Claims 1-13, and 16 are original; and claims 14-15 are previously amended.
Claims 1-4, 6-7, 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 10/10/2022, 11/13/2024 and 05/27/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 4 are 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation " X4 is N ". There is insufficient antecedent basis for this limitation in claim 1. Claim 1 does not contain the limitation “X4”. As drafted, “X4 is N” in claim 4 renders the metes and bounds of claim 4 undefined. Hence renders claim 4 indefinite, since artisan does not know where “X4” is in claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 4, which contains “X4 is N” fails to properly further limit base claim 1, since claim 1 has no limitations drawn to X4. Thus, claim 4 is rejected under 35 USC 112(d).
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 1-4, 6-7 and 14 and are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghosh et al. (Bioorg. Med. Chem. Lett. 18 (2008) 5684-5688).
Ghosh et.al. discloses
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(page 5685, table 1 compound 5) corresponding to compound of formula II and III, where G1 is,
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, a monocyclic heterocyclic group wherein X4 is N and R1 is Cl; L is COO wherein X5 is O; and G2 is
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, bicyclic aromatic heterocyclyl group, wherein X1 =X2 =CH and X3 is N thus anticipating claims 1-4, 6-7 and 14.
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 1-4, 6-7 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over
Ghosh et al. (Bioorg. Med. Chem. Lett. 18 (2008) 5684–5688)
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.
Ghosh et.al teaches compound
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(claims 1-4 and 6-7, see 102 rejection) and Ghosh further teaches compound
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inhibits SARS-CoV-3CLpro enzymes (page 5685, table 1).
Chen et. al. teaches 3CLpro enzyme is a proven drug discovery target in the case of severe acute respirator syndrome coronavirus (examiner interpret this to include covid-19 (abstract) part.
2. Ascertaining the differences between the prior art and the claims at issue.
Although Ghosh teaches
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, Gosh does not teach pharmaceutically acceptable salt or method of treating severe acute respiratory syndrome or covid 19.
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 or covid 19.
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 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 pharmaceutical acceptable salt of compound
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to treat severe acute respiratory syndrome, such as covid-19 because compound
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inhibits SARS-CoV-3CLpro enzymes(Ghosh, page 5685, table 1) since 3CLpro enzyme is a proven drug discovery target for severe acute respirator syndrome coronavirus (examiner interpret this to include covid-19 (Chen et.al. abstract). Therefore, it is expected compound
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and its pharmaceutical acceptable salt will also be able to treat severe acute respiratory syndrome coronavirus, such as covid-19 because compound
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inhibits SARS-CoV-3CLpro enzymes(Ghosh, page 5685, table 1). Thus, teaching claims 1-4, 6-7 and 14-16.
Conclusion
No claims are allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625