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 is a 371 of PCT/CN2022/117124 (09/05/2022) and claims foreign priority to
CHINA 202111057236.5 (09/09/2021)
CHINA 202111296533.5 (11/03/2021)
CHINA 202210138841.3 (02/15/2022)
CHINA 202210793838.5 (07/05/2022)
CHINA 202210982186.X (08/16/2022).
Applicant has filed a certified copy of the foreign priority document – however the Examiner requires a certified English translation as per 37 C.F.R. 1.55 to perfect the priority claim. See MPEP 706.02.
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 1-8, 14-16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lin et al. (WO2021226546, Published 2021-11-11, EFD 2020-05-08).
Lin teaches the following compound (claim 23):
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which corresponds to instant claim 1, formula (IV):
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(IV)
when R2 is methyl; R3 is t-butyl; B is dimethyl-cyclopropyl. Lin teaches a method of treating a coronavirus infection, SARS-CoV-2 (claim 65-70) including use of ritonavir (Fig. 23).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (WO2021226546, Published 2021-11-11, EFD 2020-05-08).
Lin teaches the following protease inhibitor compound (claim 23, Fig. 12 “ML1004m”):
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which corresponds to instant claim 1, formula (IV):
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(IV)
when R2 is methyl; R3 is t-butyl; B is dimethyl-cyclopropyl. Lin teaches a method of treating a coronavirus infection, SARS-CoV-2 (claim 65-70) including use of ritonavir (Fig. 23).
Lin also teaches protease inhibitor compounds teaches examples of the formula (Fig 10):
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where R1 is trifluoromethyl, R2 is 1,1-dimethylethyl (t-butyl), R3 is gamma-lactamyl, R4 is a alpha-ketoamide “warhead” group
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. Lin teaches (claim 12):
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which encompasses the claims including where R1 is alkyl (trifluoromethyl), R2 is cycloalkyl (cyclohexyl), R3 is gamma-lactamyl, R4 is R4 is a alpha-ketoamide (C(O)C(O)NH-cyclopentyl).
Lin’s Fig 10 compound and claim 12 differs from the instant claims in the particular selection of R2 as t-butyl vs. cyclohexyl and R4’s terminal group as cyclobutyl vs. cyclopentyl.
One of ordinary skill in the art following the teaching of Lin would have readily considered the alkyl homologs within the scope of Lin’s claim 12, particularly in view of the alternative compounds shown in Lin’s Fig 10. One of ordinary skill in the art would have had an expectation that the compounds would share the same utility because they are within the scope of Lin’s claim 12 and because of the small differences in structure among the examples, for example differing by only a CH2 and considered a homolog as per MPEP 2144.09 and considered prima facie obvious in view of the structurally similar compounds.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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