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/CN2021/131642 (11/19/2021)
and claims foreign priority to CHINA 202011310827.4 (11/20/2020)
CHINA 202110021509.4 (01/08/2021)
CHINA 202110244090.9 (03/05/2021)
CHINA 202110464375.3 (04/28/2021).
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-10, 12, 15-19, in the reply filed on 12/5/25 is acknowledged.
Applicant also elected the following species:
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Compound 16, corresponding to claim 1 formula (I) where:
A is phenyl; R1 is methyl; R2 is fluoro; m is 1; R3a is methyl; R3b is H;
R0 is tetrahydropyran-4-yl;
stated to read on claims 1-10, 12, 15-19 of the elected group. Claim 19 was determined not to read on the elected species. New claims 21-23, and 25 were also determined to read on the elected species. Thus, claims 1-10, 12, 15-18, 21-23, and 25 read on the elected species.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Accordingly, claims 19, 24, and 26 are also withdrawn.
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
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 1-10, 12, 15-18, 21-23, and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhu et al. (US20240262804, EFD 2021-03-17).
Zhu teaches compounds, including the following compound which anticipates the claims:
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For example instant claim 1, formula (I)
where:
A is phenyl; R1 is methyl; R2 is fluoro; m is 1; R3a is methyl; R3b is H;
R0 is tetrahydropyran-4-yl.
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 1-9, 12, 15-18, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Oslob et al. (US20140378464) in view of Kai et al. (US20110319414), Flores et al (US20110319400), and Wermuth (“The Practice of Medicinal Chemistry”, 4th ed. (2015), Ch. 8, pages 181-241 provided).
Oslob teaches compounds useful as pharmaceuticals in the treatment of hypertrophic cardiomyopathy (HCM) including Example 9 (p. 18):
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Oslob teaches the compound possess myosin inhibitor activity (p. 60, Table 2; [0520]-[0521] inhibition assay measuring ATP conversion showing “+++” IC50 < 1 mM) and is useful in treating HCM (claim 19).
Oslob differs by a 1,3-diazinane-2,4-dione core heterocycle vs. the instant claims having a 1,3,5-triazine-2,4-dione – i.e., differing by a CH vs. a N at the 5-position (annotated above).
Kai teaches pharmaceutical compounds that act as an inhibitor to modulate ATP activity ([0454]-[0455], Table, [0002]-[0004]) having a 1,3,5-triazine-2,4-dione such as (p. 27, claim 5):
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Kai also teaches species including I-223 experimentally demonstrated as active (Table 122):
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Flores teaches pharmaceutical compounds including that of formula (I) (claim 1):
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wherein “W” can be CH and N (Table 1) and useful in treating pain (Abstract, claim 1) with species including compound 97 (p. 32):
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.
Wermuth teaches the well-known technique of bioisosterism in pharmaceutical development which is routinely used in the art to change heterocyclic rings such as diazine with triazine (p. 196)
.
One of ordinary skill in the art following the teaching of Oslob would have considered applying the well-known technique of bioisosterism to replace the 5-position CH with a N, particularly in view of the success demonstrated by Kai and Flores in the structurally-related compounds having related utilities taught therein. Particularly, Flores teaches the genus where the same position “W” can be interchanged among CH and N and maintain utility. One of ordinary skill in the art would have had a reasonable expectation of success in view of each Oslob, Kai, and Flores teaching the corresponding compounds as having pharmaceutical activity and performing such as modification is routinely done in the art as taught by Wermuth. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626