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 .
Claim Status
Claims 46-87 are pending. Claims 48, 51-54, 56-64, 67, 69-75, 77-78 and 80-87 are withdrawn. Claims 46-47, 49-50, 68, 76 and 79 are rejected. Claims 55 and 65-66 are objected to.
Election/Restrictions
Applicant’s election without traverse of compound
PNG
media_image1.png
230
152
media_image1.png
Greyscale
and McArdle disease in the reply filed on January 26th, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected combination appears free of the art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 55 and 65-66 as well as the scope of claims 46-47, 49-50, 68, 76 and 79 where the disease is a cardiomyopathy and the compound is as follows:
PNG
media_image2.png
85
282
media_image2.png
Greyscale
; or
the disease is a congenital muscular dystrophy and the compound is
PNG
media_image3.png
244
186
media_image3.png
Greyscale
or
PNG
media_image4.png
214
166
media_image4.png
Greyscale
.
These combinations are not allowable under 35 USC 103. Any subject matter discussed outside this scope was discovered incidental to the expanded search and is presented in the interest of compact prosecution.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention are held withdrawn from further consideration. Examination has been limited to claims embracing the elected species which are claims 46-47, 49-50, 55, 65-66, 68, 76 and 79. Claims 46-47, 49-50, 55, 65-66, 68, 76 and 79 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected combination. Since the nonelected combination has not been found allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration. Any subject matter discussed beyond this scope is presented in the interest of compact prosecution.
Claims 48, 51-54, 56-64, 67, 69-75, 77-78 and 80-87 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claim(s) 46 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/178355 A1 by Wagner et al. which claims priority to U.S. Provisional 62/984,010 filed March 2nd, 2020.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “new inhibitors for the KEAP1-NRF2 protein-protein interaction” and discloses the following compound on page 37 (page 87 of ‘010):
PNG
media_image2.png
85
282
media_image2.png
Greyscale
.
The prior art compound is embraced by instant formula III’ where each Y is C(R3) where R3 is hydrogen, A is absent, R1 is hydrogen, R7 and R8 are absent (n and p are 0), R25 is hydrogen, and R2 is C6 carbocycle substituted by OR10 where R10 is C6 carbocycle substituted by NO2.
Regarding instant claims 46 and 49-50, the prior art discloses that the compound above may administered in a method of treating a metabolic disease wherein the disease is diabetic cardiomyopathy (paragraph [0063]; page 64 of ‘010).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses a method of treating a metabolic myopathy such as diabetic cardiomyopathy but does not disclose that the prior art compound was administered to a subject.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person of ordinary skill seeking to treat a subject having a metabolic myopathy such as diabetic cardiomyopathy would have been motivated to administer the prior art compound as taught by Wagner et al. in order to improve therapeutic outcomes.
Claim(s) 68 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/178355 A1 by Wagner et al. which claims priority to U.S. Provisional 62/984,010 filed March 2nd, 2020. as applied to claims 46 and 49-50 above, and further in view of Borghetti et al. (2018). Diabetic Cardiomyopathy: Current and Future Therapies. Beyond Glycemic Control. Frontiers in physiology, 9, 1514.
Wagner et al. disclose a method of treating a metabolic myopathy such as diabetic cardiomyopathy by administering a compound embraced by instant Formula III’ but do not suggest administration of an additional active agent as required by instant claim 68.
Borghetti et al. discuss (title) “Diabetic Cardiomyopathy: Current and Future Therapies. Beyond Glycemic Control.” and report (abstract):
…several drugs currently in use can improve cardiac health beyond their ability to control glycemia. GLP-1 receptor agonists and sodium-glucose co-transporter 2 inhibitors have been shown to have a beneficial effect on the cardiovascular system through a direct effect on myocardium, beyond their ability to lower blood glucose levels. In recent years, great improvements have been made toward the possibility of modulating the expression of specific cardiac genes or non-coding RNAs in vivo for therapeutic purpose, opening up the possibility to regulate the expression of key players in the development/progression of diabetic cardiomyopathy.
MPEP 2144.06 states:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Accordingly, a person of ordinary skill seeking to treat a subject with diabetic cardiomyopathy would have been motivated to modify the method of Wagner et al. to administer an additional therapeutic agent such as a GLP-1 receptor antagonist taught by Borghetti et al. in order to improve treatment.
Claims 46-47, 50, 68, 76 and 79 are rejected under 35 U.S.C. 103 as being obvious over WO 2020/097265 A1 by Hunt et al. (cited in the IDS filed 08/03/2023) which claims priority to U.S. Provisional 62/756,539 filed November 6th, 2018 in view of National Organization for Rare Disorders. Myotonic Dystrophy. Published 2017. Accessed February 18th, 2026 at https://rarediseases.org/rare-diseases/dystrophy-myotonic/
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art discloses pyridazinone compounds such as compound I-59 shown below (page 108; page 85 of ‘539):
PNG
media_image4.png
214
166
media_image4.png
Greyscale
.
The prior art compound is embraced by instant formula I’ where each Y is N, A is NR4 where R4 is hydrogen, R1 is C6 carbocycle substituted by halogen, R7 and R8 are absent (n and p are 0), R25 is hydrogen, and R2 is C2 alkyl.
Regarding instant claims 46-47, 49-50, 76 and 79 the prior art discloses that the compound above may administered in a method of treating a neuromuscular condition such as myotonic dystrophy 1 (paragraph [0010]; paragraph [0095] of ‘539).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art discloses a method of treating myotonic dystrophy 1 by administering the compound above but does teach that the condition is a congenital dystrophy as required by the instant claims.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
The National Organization for Rare Disorders (NORD) provides a disease overview for Myotonic dystrophy and reports (page 2):
Myotonic dystrophy refers to two rare genetic disorders of muscle that actually affect multiple systems of the body. The disorder is abbreviated DM, which is for dystrophia myotonia. This is the Latin name for the disorder. There are two main types DM. DM type 1 (DM1) can be further classified as mild DM1, classic DM1 and congenital DM1.
Accordingly, a person of ordinary skill performing the method of treating myotonic dystrophy 1 by administering the compound above could be expected to encounter subjects with congenital myotonic dystrophy and would have been motivated to treat them in the method of Hunt et al.
Regarding instant claim 68, NORD discuss standard therapies for the disease including pain medications such as “anti-inflammatories (NSAIDs), gabapentin, tricyclic antidepressants, mexiletine, and low-doses of glucocorticoids such as prednisone” (page 14). MPEP 2144.06 states:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Therefore, a person of ordinary skill seeking to optimize therapeutic outcomes would have been motivated to administer a secondary agent for the treatment of symptoms such as pain as taught by NORD.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 46-47, 50, 68, 76 and 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11236065 in view of National Organization for Rare Disorders. Myotonic Dystrophy. Published 2017. Accessed February 18th, 2026 at https://rarediseases.org/rare-diseases/dystrophy-myotonic/
Claim 25 of the patent discloses the following compound (Col. 311):
PNG
media_image3.png
244
186
media_image3.png
Greyscale
.
The compound is embraced by instant formula I’ where each Y is N, A is NR4 where R4 is hydrogen, R1 is C5 carbocycle, R7 and R8 are absent (n and p are 0), R25 is hydrogen, and R2 is C2 alkyl.
Regarding instant claims 46-47, 49-50, 76 and 79, claim 30 of the patent discloses that the compound above may be administered in a method of treating a neuromuscular condition such as myotonic dystrophy 1 (Col. 312); however the patent does not specify that the condition is a congenital dystrophy as required by the instant claims.
The National Organization for Rare Disorders (NORD) provides a disease overview for Myotonic dystrophy and reports (page 2):
Myotonic dystrophy refers to two rare genetic disorders of muscle that actually affect multiple systems of the body. The disorder is abbreviated DM, which is for dystrophia myotonia. This is the Latin name for the disorder. There are two main types DM. DM type 1 (DM1) can be further classified as mild DM1, classic DM1 and congenital DM1.
Accordingly, a person of ordinary skill performing the method of treating myotonic dystrophy 1 by administering the compound above could be expected to encounter subjects with congenital myotonic dystrophy and would have been motivated to treat them in the method of the patent.
Regarding instant claim 68, NORD discuss standard therapies for the disease including pain medications such as “anti-inflammatories (NSAIDs), gabapentin, tricyclic antidepressants, mexiletine, and low-doses of glucocorticoids such as prednisone” (page 14). MPEP 2144.06 states:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
Accordingly, a person of ordinary skill seeking to optimize therapeutic outcomes would have been motivated to administer a secondary agent for the treatment of symptoms such as pain as taught by NORD.
Claims 46-47, 50, 68, 76 and 79 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12415794 in view of National Organization for Rare Disorders. Myotonic Dystrophy. Published 2017. Accessed February 18th, 2026 at https://rarediseases.org/rare-diseases/dystrophy-myotonic/
Claim 26 of the patent discloses the following compound (Col. 264):
PNG
media_image3.png
244
186
media_image3.png
Greyscale
.
The compound is embraced by instant formula I’ where each Y is N, A is NR4 where R4 is hydrogen, R1 is C5 carbocycle, R7 and R8 are absent (n and p are 0), R25 is hydrogen, and R2 is C2 alkyl.
Regarding instant claims 46-47, 49-50, 76 and 79, claim 6 of the patent discloses that the compound above may administered in a method of treating a neuromuscular condition such as myotonic dystrophy 1 (Col. 261); however the patent does not specify that the condition is a congenital dystrophy as required by the instant claims.
The National Organization for Rare Disorders (NORD) provides a disease overview for Myotonic dystrophy and reports (page 2):
Myotonic dystrophy refers to two rare genetic disorders of muscle that actually affect multiple systems of the body. The disorder is abbreviated DM, which is for dystrophia myotonia. This is the Latin name for the disorder. There are two main types DM. DM type 1 (DM1) can be further classified as mild DM1, classic DM1 and congenital DM1.
Accordingly, a person of ordinary skill performing the method of treating myotonic dystrophy 1 by administering the compound above could be expected to encounter subjects with congenital myotonic dystrophy and would have been motivated to treat them in the method of the patent.
Regarding instant claim 68, patent claim 12 of discloses the method further comprising administering an additional active agent (Col. 262).
Allowable Subject Matter
Claims 55 and 65-66 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626