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 .
Election/Restrictions
Applicant’s election without traverse of Group II, encompassed by claims 2 and new claims 127-143, drawn to a method of treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM), in the reply filed on March 10, 2026 is acknowledged.
Examiner also required an election of species of a beta-blocker, calcium channel blocker, non-dihydropyridine calcium channel blocker, and disopyramide. However, because claims 4, 70, 91, 93, 95, and 97 have been cancelled, the species election is moot.
Applicant has not pointed to any errors in the Examiner' s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Application and Claims Status
Claims 1-6, 70-71, 91-99, 106, 108, and 126 were pending. In the amendment as filed on March 10, 2026, applicants have amended no claim; cancelled claims 1, 3-6, 70-71, 91-99, 106, 108, and 126; and added new claims 127-143. Therefore, claims 2, and 127-143 are currently pending.
Priority
The instant application is a nonprovisional application and claims priority to U.S. Provisional Application No. 63/370,435, filed August 4, 2022; U.S. Provisional Application No. 63/405,310, filed September 9, 2022; U.S. Provisional Application No. 63/377,279, filed September 27, 2022; U.S. Provisional Application No. 63/427,067, filed November 21, 2022; U.S. Provisional Application No. 63/483,882, filed February 8, 2023; U.S. Provisional Application No. 63/485,215, filed February 15, 2023; and U.S. Provisional Application No. 63/524,559, filed June 30, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 11/21/2023 and 03/10/2026 are in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Forms 1449 are included with this Office Action.
The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992).
Claim Objections
Claims 127-130 are objected to because of the following informality: the term “aficamten” should be replaced with “the therapeutically effective amount of aficamten”. Appropriate correction is required.
Claim 131 is objected for its use of non-standard Markush claim language. Markush claims are commonly formatted as “wherein R is independently selected from the group consisting of A, B, and C” or “wherein R is A, B, C, or D”. In claim 131, as an example, applicant recites “…wherein the method results in an improvement in one of more of: exercise capacity…heart rate response; and health status and health-related quality of life…”(emphasis added). Proper Markush claim language could optionally recite “…wherein the method results in an improvement selected from the group consisting of: exercise capacity…heart rate response; and health status and health-related quality of life…” or “wherein the method results in an improvement in one of more of: exercise capacity…heart rate response; or health status and health-related quality of life…”. Relevant guidance can be found in the MPEP § 2173.05(h), titled “Alternative Limitations,” which deals with claims that list alternatives.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 2, and 127-143 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, because the specification, while being enabling for treatment, does not reasonably provide enablement for prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly discussed: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The term “treatment” and related terms are defined on page 25, paragraph 0133 of the specification and said definition also embraces prevention. Applicant recites, “the term covers both complete and partial reduction or prevention of the condition or disorder…” and “thus, compounds described and/or disclosed herein may prevent an existing disease or disorder from worsening…” (emphasis added).
It is presumed “prevention” of the claimed condition would require a method of identifying those individuals who will develop the claimed condition before they exhibit symptoms.
The factors to be considered in making an enablement rejection were summarized above. 1) Preventing diseases requires identifying those patients who will acquire the condition before the symptoms occur. This would require extensive and potentially open-ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical pharmacology and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will develop oHCM before the fact. 6) The artisan using Applicants invention would be a Board Certified physician. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of oHCM. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable for any agent to be able to prevent oHCM. 7) It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed conditions.
As claims 127-143 depend upon claim 2, they are also rejected.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 127-129, and 131-143 are rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al. (US 2019/0256504, published 8/22/2019, cited on IDS filed on 11/21/2023)(hereinafter, ‘Chaung’) and Olivotto et al. (“Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial”, published 9/12/2020, cited on IDS filed on 11/21/2023)(hereinafter, ‘Olivotto’).
Regarding claim 2: Chuang teaches a method of treating obstructive hypertrophic cardiomyopathy (oHCM) comprising administering to a patient in need thereof a composition comprising a compound of formula (I) (See [0043]-[0044], [0170], [0174], see also claims 1 and 41-43), and more specifically, Chuang teaches compound #184 (see Table 1 on page 52, see Table A on page 226, right column and see claim 56), shown below:
Formula (I) Compound #184
PNG
media_image1.png
94
156
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Greyscale
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88
245
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Greyscale
Compound #184 is identical to instantly claimed compound (Aficamten, CK-3773274 or CK-274).
Furthermore, Chuang teaches that the compounds of the invention are myosin inhibitors (See [0007]-[0008] and [0170]).
Olivotto teaches a randomized, Phase 3 clinical trial using a first-in-class cardiac myosin inhibitor, mavacamten, for the treatment of symptomatic oHCM—the same indication of the instant invention.
Claim 2 recites, “wherein the patient is treatment naïve for oHCM”. The specification defines “treatment naïve” on page 23 as “patients who have received no previous standard-of-care therapy for oHCM” (emphasis added). Regarding the term “treatment naïve”, the specification consistently uses the broad language of embodiments where “the patient is treatment naïve for oHCM, or the patient has previously received standard of care medical therapy for oHCM”. Therefore, the embodiments cover both patients who are treatment naïve and those who are not treatment naïve.
Furthermore, the specification, specifically Examples 1-5 on pages 80-147, does not provide any rationale as to why a subject who is treatment naïve would be treated any differently than a subject who is not treatment naïve. Therefore, any subject may be treated the same, regardless of past treatments, unless there is evidence to the contrary. As such, this limitation in the instantly claimed method has not been given any weight.
Regarding claim 127: Claim 127 recites, “wherein the patient has been diagnosed with oHCM within 12 months prior to administering aficamten, or a pharmaceutically acceptable salt thereof”. Again, as with the previous reasoning, the specification does not provide any rationale as to why a subject who has been diagnosed with oCHM within 12 months prior to administering aficamten would be treated any differently than a subject who has not been diagnosed with with oHCM within 12 months prior to administering aficamten. Therefore, any subject may be treated the same, regardless of oHCM diagnosis status, unless there is evidence to the contrary. As such, this limitation in the instantly claimed method has not been given any weight.
Regarding claim 128: Olivotto teaches, on page 768, use of mavacamten as a “monotherapy in a small number of patients”. Specifically, on page 765, Olivotto teaches “most patients not using β blockers were prescribed non-dihydropyridine calcium channel blockers, with very few patients in each treatment group taking neither (four of 123 in the mavacamten group and 16 of 128 in the placebo group were not on any background hypertrophic cardiomyopathy therapy)”.
Regarding claim 129: Olivotto teaches, in Figure 3B, on page 766, that mavacamten was administered to 66 patients who had an LVEF at baseline <75% and mavacamten was administered to 51 patients who had an LVEF at baseline ≥ 75%. This covers the entire universe of ranges of what the LVEF at baseline could possibly be.
Regarding claims 131-143: With respect to claim 134, Olivotto teaches, “At week 30 compared with baseline, the reduction in NT-proBNP after mavacamten treatment was 80% greater than for placebo (proportion of geometric mean ratio between the two groups 0.202, 95% CI 0.169 to 0.241)” on page 765. With respect to claim 135, Olivotto teaches, “all secondary endpoints, including change in LVOT gradient (figure 3B), showed consistent benefit for mavacamten across prespecified subgroups, irrespective of β blocker use” on page 765-766. With respect to claim 136 and 140, Olivotto teaches, “patients on mavacamten showed a greater mean increase in pVO2 by 1.4 mL/kg per min than those on placebo (95% CI 0.6 to 2.1; p=0.0006). Also, 80 (65%) of 123 patients given mavacamten had at least one NYHA class improvement versus 40 (31%) of 128 on placebo (difference 33.8%, 95% CI 22.2 to 45.4; p<0.0001)”, on page 764. Furthermore, measuring pVO2 by cardiopulmonary exercise testing (CPET) is routine and standard. With respect to claim 138, Olivotto teaches, “the proportion of participants improving at least one NYHA class was 34% greater and the proportion meeting both primary endpoint components (at least 3.0 mL/kg per min pVO2 increase and at least one NYHA class improvement) was 13% greater than placebo” on page 767. With respect to claim 142, Olivotto teaches, “Both KCCQ-CCS (positive change better) and HCMSQ-SoB (negative change better) scores improved more with mavacamten than with placebo (KCCQ-CCS +9.1, 95% CI 5.5 to 12.7; HCMSQ-SoB −1.8, −2.4 to −1.2; p<0.0001 for both)”, on page 765.
Additionally, the wherein clause of claim 131 does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: a method of treating symptomatic oHCM in a subject, comprising administrating a composition comprising aficamten. MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case, the entirety of the wherein clause of claim 131 appears to be the result of the process made obvious by the prior art: a method of treating symptomatic oHCM in a subject, comprising administrating a composition comprising mavacamten, e. g. the intended result of a process step positively recited. Moreover, the specification does not discriminate between a population of naïve and non-naïve in treating oHCM. As such, both populations are considered alternatively useable and equivalent.
Similarly, the statement, “wherein the result is improved as compared to treatment with metoprolol” of claims 132, 137, 139, 141, and 143 does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art. As such, this limitation in the instantly claimed method has not been given any weight.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time before the effective filing date of the claimed the invention, to practice the disclosed utility of Olivotto with the claimed compounds and pharmaceutical composition: treating oHCM. A person of ordinary skill in the art would have been motivated to use the myosin inhibitor of Chuang for treating oHCM because the compound is particularly known as a myosin inhibitor. Further, Olivotto teaches that myosin inhibitors treat oHCM. Thus, treatment of the underlying etiology (overactive myosin) would have a reasonable expectation of ameliorating the symptom (oHCM).
Claim 130 is rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al. (US 2019/0256504, published 8/22/2019, cited on IDS filed on 11/21/2023)(hereinafter, ‘Chaung’) and Olivotto in view of Tom et al. (WO 2021/011807 A1, published 1/21/2021, cited on IDS filed on 11/21/2023)(hereinafter, ‘Tom’).
The combined teachings of Chuang and Olivotto have been previously discussed. Further, Tom teaches polymorphic Forms I-VI of aficamten. Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time before the effective filing date of the claimed the invention, to practice the disclosed utility of Olivotto with the claimed compounds, pharmaceutical compositions, and polymorphic forms of Chuang and Tom: treating oHCM. A person of ordinary skill in the art would have been motivated to use the myosin inhibitor and polymorphic forms of Chuang and Tom, respectively, for treating oHCM because the compound is particularly known as a myosin inhibitor. Further, Olivotto teaches that myosin inhibitors treat oHCM. Thus, as before, treatment of the underlying etiology (overactive myosin) would have a reasonable expectation of ameliorating the symptom (oHCM).
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 8 of copending Application No. 18/916,215 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 2 is directed to a method of treating oHCM in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of aficamten, or a pharmaceutically acceptable salt thereof, wherein the patient is treatment naïve for oHCM. The limitation “wherein the patient is treatment naïve for oHCM” has been addressed in the 103 rejection above and the same reasons are equally applicable here.
Reference claim 8 of ‘215 is embraced by the instant claim 2, and further recites:
wherein said patient is eligible for septal reduction therapy (SRT),
wherein the therapeutically effective amount of Compound 1, or the pharmaceutically acceptable salt thereof, is selected by titrating a daily dose of Compound 1, or a pharmaceutically acceptable salt thereof,
wherein the titrating comprises administering to the patient a first daily dose of Compound 1, or a pharmaceutically acceptable salt thereof, for a first time period, wherein the first daily dose is about 5 mg; and
based on one or more components of a first echocardiogram for the patient acquired after the first time period, administering to the patient a second daily dose of Compound 1, or a pharmaceutically acceptable salt thereof, for a second time period, wherein the one or more components of the first echocardiogram comprises a biplane LVEF and a post-Valsalva LVOT-G, and
wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is about 10 mg when the biplane LVEF of the first echocardiogram is at or above 55% and the post-Valsalva L VOT-G of the first echocardiogram is at or above 30 mmHg, or wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is the same as the first daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, when either of the following conditions are met on the first echocardiogram: (1) the biplane LVEF is at or above 50% and below 55%; or (2) the biplane L VEF is at or above 55% and the post-Valsalva LVOT-G is below 30 mmHg.
Reference claim 8 is embraced completely by the instant invention, encompassed by the open-ended term “comprising” of instant claim 2, and further disclosed all of the above features on page 12 ([00360) and in Example 3B, on pages 118-119 ([0371]-[0372], Table 21) and pages 123-124 ([0382-0383], Table 24B) of instant specification.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 88 of copending Application No. 19/257,352 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 88 recites a method that is more specific than the method of instant claim 2. Instant claim 2 is directed to a method of treating oHCM in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of aficamten, or a pharmaceutically acceptable salt thereof, wherein the patient is treatment naïve for oHCM. The limitation “wherein the patient is treatment naïve for oHCM” has been addressed in the 103 rejection above and the same reasons are equally applicable here.
Reference claim 88 of ‘352 is embraced by the instant claim 2, and further recites:
wherein the first daily dose is about 5 mg; and
based on one or more components of a first echocardiogram for the patient acquired after
the first time period, administering to the patient a second daily dose of Compound 1, or a
pharmaceutically acceptable salt thereof, for a second time period, wherein the one or more
components of the first echocardiogram comprises a LVEF and a post-Valsalva LVOT-G, and
wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is about 10 mg when the LVEF of the first echocardiogram is at or above 55% and the post-Valsalva L VOT-G of the first echocardiogram is at or above 30 mmHg, or wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is the same as the first daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, when either of the following conditions are met on the first echocardiogram: (1) the LVEF is at or above 50% and below 55%; or (2) the LVEF is at or above 55% and the post-Valsalva LVOT-G is below 30 mmHg.
Reference claim 88 is embraced completely by the instant invention, encompassed by the open-ended term “comprising” of instant claim 2, and further disclosed all of the above features on page 12 ([00360) and in Example 3B, on pages 118-119 ([0371]-[0372], Table 21) of instant specification.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim at least claim 1 of U.S. Patent No. 12,370, 179. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 recites a method that is more specific than the method of instant claim 2. Instant claim 2 is directed to a method of treating oHCM in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of aficamten, or a pharmaceutically acceptable salt thereof, wherein the patient is treatment naïve for oHCM. The limitation “wherein the patient is treatment naïve for oHCM” has been addressed in the 103 rejection above and the same reasons are equally applicable here.
Reference claim 1 of ‘179 is embraced by the instant claim 2, and further recites:
wherein the first daily dose is about 5 mg and the first time period is about 2 weeks; and
based on one or more components of a first echocardiogram for the patient acquired after the first time period, administering to the patient a second daily dose of Compound 1, or a pharmaceutically acceptable salt thereof, for a second time period, wherein the second time period is about 2 weeks, wherein the one or more components of the first echocardiogram comprises a LVEF and a post-Valsalva LVOT-G, and
wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is about 10 mg when the LVEF of the first echocardiogram is at or above 55% and the post-Valsalva LVOT-G of the first echocardiogram is at or above 30 mmHg, or wherein the second daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, is the same as the first daily dose of Compound 1, or the pharmaceutically acceptable salt thereof, when either of the following conditions are met on the first echocardiogram: (1) the LVEF is at or above 50% and below 55%; or (2) the LVEF is at or above 55% and the post-Valsalva LVOT-G is below 30 mmHg.
Reference claim 1 is embraced completely by the instant invention, encompassed by the open-ended term “comprising” of instant claim 2, and further disclosed all of the above features on page 12 ([00360) and in Example 3B, on pages 118-119 ([0371]-[0372], Table 21) of instant specification.
Conclusion
No claims are allowed.
All claims are rejected.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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