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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 PCT/CN2022/081361 03/17/2022, which claims benefit of the provisional application: 63265004 12/06/2021, and 63162125 03/17/2021.
2. Claims 1-20 are pending in the application.
3. 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 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.
Claim Rejections - 35 USC § 102
4. 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.
Claim 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Oslob et al. US 2014/0378464 A1, Oslob et al. US 2014/0378491 A1, Kay et al. CAS: 98: 34604, 1983, and Hu et al. CN 110698415 (i.e., also see English-translated version) respectively.
Applicants claim a compound of formula (I),
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, or a tautomer, cis- or trans-isomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein Ring A represents
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or
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, R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4, see claim 1.
Oslob et al. ‘464 discloses 11 compounds in claim 18, see columns 63-64. They clearly anticipate the instant compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4.
Oslob et al. ‘491 discloses 4 compounds in claim 20, see column 22. They clearly anticipate the instant compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4.
Kay et al. ‘604 discloses 2 compounds in claim 20, see RN: 68098-44-2 and 68098-46-4. They clearly anticipate the instant compounds of formula (I), wherein ring A represents
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, R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4.
Hu et al. ‘415 discloses 30 compounds from I-1 to I-30 on pages 12-15 or see pages 21-24 of Hu et al. ‘415 English-translated version. They clearly anticipate the instant compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, naphthyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 4-6, 9 and 15-20 are rejected under 35 U.S.C. 103(a) as being
obvious over Oslob et al. US 2014/0378464 A1, Oslob et al. US 2014/0378491 A1,
and Hu et al. CN 110698415 (i.e., also see English-translated version) respectively.
Applicants claim a compound/composition of formula (I),
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, or a tautomer, cis- or trans-isomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein Ring A represents
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or
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, R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4, see claim 1. Dependent claims 4-6, 9 and 15-20 further limit the scope of compound, i.e., specific variables R1 and R3 are hydrogen, alkyl, cycloakyl or heteroaryl, n is 0, 1 or 2, methods of use for treating hypertrophic cardiomyopathy or heart failure.
Determination of the scope and content of the prior art (MPEP §2141.01)
Oslob et al. ‘464 discloses a compound/composition of the formula:
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, R1-R3 are alkyl, cycloalkyl, phenyl, heteroaryl or heterocycle, R4 is H, X is H or F. Oslob et al. ‘464 compounds/compositions read on the instant compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4. Oslob et al. ‘464 compounds/compositions are used for treating heart disease including hypertrophic cardiomyopathy, see columns 62-64.
Oslob et al. ‘491 discloses a compound/composition of the formula:
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, R1-R3 are alkyl, cycloalkyl, phenyl, heteroaryl or heterocycle, R4 is H, X is H or F. Oslob et al. ‘464 compounds/compositions read on the instant
compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4. Oslob et al. ‘491 compounds/compositions are used for treating heart disease including hypertrophic cardiomyopathy, see columns 21-23.
Hu et al. ‘415 discloses compounds/compositions of formula (I),
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, wherein R1-R2 are alkyl, phenyl, heteroaryl or heterocycle, and X is H or F, Cl, Br or I, Hu et al. ‘415 compounds/compositions read on the instant compounds of formula (I), wherein ring A represents
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R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, naphthyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4.
Hu et al. ‘4i5 compounds/compositions are used for treating heart disease including hypertrophic cardiomyopathy, see pages 2-5.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Oslob et al. ‘464 and ‘491, and Hu et al. ‘415 is that the instant compounds of formula (I) are embraced within the scope of
Oslob et al. ‘464 and ‘491, and Hu et al. ‘415. It is noted that the instant ring A of formula (I) represents
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or
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, while Oslob et al. ‘464 and ‘491, and Hu et al. ‘415 represent
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at the same position. Oslob et al. ‘464 and ‘491, and Hu et al. ‘415 read on the instant compounds/composition and methods of use in claims 1, 4-6, 9 and 15-20.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1, 4-6, 9 and 15-20 prima facie obvious because one would be motivated to employ the compound/ composition and methods of use of Oslob et al. ‘464 and ‘491, and Hu et al. ‘415 to obtain instant invention.
The motivation to make the claimed comounds/compositions and methods of use derived from the known compound/composition and methods of use of Oslob et al. ‘464 and ‘491, and Hu et al. ‘415 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Zhang et al. co-pending application No. 18/253,704.
Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a compound/composition of formula (I),
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, or a tautomer, cis- or trans-isomer, mesomer, racemate, enantiomer, diastereomer, or mixture thereof, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein Ring A represents
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or
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, R is –(CR1R2)nR3, R1 and R2 is hydrogen, alkyl, cycloalkyl, aryl or heteroaryl, R3 is hydrogen, alkyl, cycloalkyl, heterocyclyl, phenyl, or heteroaryl, R’ is alkyl, alkoxy, cycloalkyl, heterocyclyl, aryl or heteroaryl, and n is 0-4, see claim 1.
Zhang et al. ‘704 claims a compound of formula (I),
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, wherein ring A is cycloalkyl, heterocycle, aryl or heteroaryl, R1, R2, R3a, and R3b are hydrogen, alkyl, halogen, and R0 is alkyl or
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L1 is a covalent bond and ring B is cycloalkyl, heterocycle, aryl or heteroaryl, see claim 1.
The difference between instant claims and Zhang et al. ‘704 is that the instant
claims are embraced within the scope of Zhang et al. ‘704. It is noted that the instant ring A of formula (I) represents
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or
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, while Zhang et al. ‘704 represent
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at the same position.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the compound of Zhang et al. ‘704 to obtain instant invention.
The motivation to make the claimed compounds derived from the known compounds of Zhang et al. ‘704 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
7. Claims 14 is neither anticipated nor rendered obvious over the record, and therefore are allowable.
Claim Objections
Claims 2-3, 7-8 and 10-13 are objected to as being dependent on rejected claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 30, 2025