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 .
Status of the Claims
This Non-Final Office Action is in response to the February 6, 2026 Preliminary Amendment (i.e., filed due to missing chemical structures, error messages in text.
Claims 23-42 are pending and new and claims 1-22 are cancelled, in the above-identified application.
Priority
U.S. Pat. Appln. No.18/278,715, Filed: August 24, 2023 is a 371 Nat.’ l Stage Entry of WO 2022/179611 A1 (i.e., PCT/CN2022/077962, Inter.’ l Filing Date: February 25, 2022), which claims foreign priority to CN 202210153298.4, Filed: February 18, 2022, CN 202210103134.0, Filed: January 27, 2022, and CN 202110214692.X, Filed: February 25, 2021.
Information Disclosure Statement
Five (5) Information Disclosure Statements (IDS) submitted on October 22, 2025, July 1, 2025, December 13, 2024, October 21, 2024 and December 22, 2023 is in compliance with the provisions of 37 CFR 1.97.
Accordingly, Information Disclosure Statements have been considered by the Examiner.
Non-Statutory Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. 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).
[A] The Present Invention
In particular, present invention are directed to a pyridine-2,4-dione derivative compound of formula (I) or pharmaceutically acceptable salt thereof or corresponding pharmaceutical compositions thereof; where:
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.
[B] Provisional Nonstatutory Double Patenting Rejection
Although the conflicting claims are not identical, they are not patentably distinct from
each other because:
compounds of formula (I), attached variables attached to core scaffold and corresponding functional group moieties thereof of the instant claimed invention as set forth under section [A] supra overlap with the claimed subject matter identified in the following U.S. Patent document(s) set forth below:
[1] Claims 23 and 29-42, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-6, 8-10,12-13,15, 51,54-59 and 61 of co-pending U.S. Appln. Ser. No. 17/833,127 (i.e., corresponds to U.S. Pat. Pub.: , 371 Filing Date: July 25, 2024, PCT Filing Date: January 16, 2023; “U.S. ‘127 Appln.")
The U.S. ‘108 Appln. discloses:
[1] a 7-azaspiro [4,5] decane-6,10-dione compound of formula (I)
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or a pharmaceutically acceptable salt thereof; i.e.:
which reads on, encompassed by and/or has overlapping compound claim scope with that of the claimed invention; i.e.,
when R1 and R2
together with the carbon atom to which they are attached form a C4-6 cycloalkyl ring (i.e., as defined in claim 23); OR
with the carbon atom to which they are attached form
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(i.e., as defined in claims 29-31)
where C4-6 cycloalkyl or cyclopentyl ring optionally substituted by 1, 2, 3, or 4 Rb (i.e., here zero (0) optional substituents);
R3 = R5 = H;
R4 = C1-4 alkyl,
where C1-4 alkyl optionally substituted by 1, 2, 3, or 4 Rc (i.e., here zero (0) optional substituents);
R6 = F; and
n = 2; and
[2] corresponding:
pharmaceutical compositions as defined as shown (as in claim 38); and
treatment methods for diseases related to cardiac myosin inhibitor, heart failure, hypertropic cardiomyopathy administering above identified compounds of formula (I) or pharmaceutically acceptable salt thereof as defined in [1] (i.e., as defined in claims 39-42).
Applicants are requested to carefully review and amend the claims to remove overlapping subject matter from the claims accordingly.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a non-statutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
The ordinary artisan would recognize as obvious that determination of whether “said compounds were present in the prior art,” is implicit in the patented claim in view of Sun Pharmaceutical Industries, LTD. v. Eli Lilly and Company which states the following: “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No. SUN PHARMACEUTICAL v. ELI LILLY 85,563,165 (“’165 patent”), at [57], col.1 11.11-14, col.3 11.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 1.49- col. 108 1.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
However, one skilled in the art would recognize that the issued patent specifically contains the compounds of Formula (I) seen in claim 1 in the instant application.
A non-statutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Obviousness-type double patenting requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent, or a non-commonly owned patent but subject to a joint research agreement as set forth in 35 U.S.C. 103 (c)(2) and (3), when the issuance of a second patent would provide unjustified extension of the term of the right to exclude granted by a patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 58 USPQ2d 1869 (Fed. Cir. 2001); Ex parte Davis, 56 USPQ2d 1434, 1435-36 (Bd. Pat. App. & Inter. 2000).
One having ordinary skill in the art at the time of the invention would have noted that subject matter exists in both the instant invention and the co-pending applications that is not patentably distinct from each other. It has also been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
Appropriate action is required accordingly
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 23-42 contain allowable subject matter over the prior art.
These claims would be in condition for allowance upon filing a terminal disclaimer to overcome the identified outstanding provisional non-statutory rejection supra.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to GRACE C HSU whose telephone number is (571) 270-1689. The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Kortney L. Klinkel can be reached on 571-270-5239.
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/G.C.H./
Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627