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 .
Priority
This application, filed 29 November, 2021, is a national stage application of PCT/US2020/0634609, filed 27 May, 2020, which claims the benefit of U.S. Provisional Application N° 62/855,372, filed 31 May, 2019.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 December, 2025 has been entered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 5 December, 2025, in the matter of Application No. 17/614,826. Said documents have been entered on the record.
Claims 1 and 22 are amended. No new matter was introduced.
Thus, Claims 1 and 21-22 represent all claims currently under consideration.
Response to Arguments
Applicant’s amendments are sufficient to overcome the previous rejections of Claim 1 under 35 USC 112(a) and 112(b).
Applicant's arguments and amendments, filed 5 December, 2025, have been fully considered but they are not persuasive. Applicant has amended Claim 1 to amend a subject “at risk of developing cardiac fibrosis” to “post myocardial injury.”
Applicant’s argument focuses on the intended result of the method – namely, achieving inhibition of cardiac fibrosis – rather than on the actual operative step that defines the claimed method, which is simply administering a known compound to a specific patient population. The closest prior art of record, including Tassoni and Levin, already discloses the identical compound now claimed, administered in the same therapeutic context of cardiac injury and heart failure, and operating through the same metabolic mechanism described in the present application. Applicant’s amendment to recite a subject “post myocardial injury” does not distinguish the claimed method from the cited references because Tassoni and Levin both administer the same compound in patient populations that are recognized in the art as experiencing myocardial injury, ischemic damage, or heart-failure-associated remodeling, and thus fall within the scope of a post-injury condition. A newly discovered result or property of a known compound does not render that compound patentable. See MPEP § 2141.02(III). Because the cited references teach administration of the same compound under conditions in which the claimed biological effect would necessarily occur, Applicant’s emphasis on the asserted therapeutic outcome does not provide a basis for distinguishing over the prior art. Applicant’s comparative data against other CPT1 inhibitors are not probative because they do not address whether the compound recited in the claims performs differently from the same compound disclosed in Tassoni and Levin which remains the appropriate comparator when evaluating nonobviousness.
Accordingly, for reasons discussed above, the previously made rejections under 35 U.S.C. § 103 are maintained. The amendments to the claims do not overcome the prior art of record and, in fact, introduce additional issues under 35 U.S.C. § 112 as detailed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a subject post myocardial injury”, which introduces uncertainty because the claim does not define the nature, type, severity, or temporal stage of myocardial injury encompassed by this term. As drafted, it is unclear whether “post myocardial injury” refers to the immediate acute phase following infarction, the subacute healing period, chronic remodeling, ischemic injury short of infarction, microinfarcts, cardiomyopathic injury, or other forms of myocardial stress. In the absence of objective boundaries or criteria establishing which clinical states fall within the scope of the claim, a person of ordinary skill in the art cannot determine with reasonable certainty whether a given subject satisfies the “post myocardial injury” limitation.
Claim 21 further requires that the myocardial injury be “associated with a disease, disorder, or condition,” but the claim does not set forth the degree, type, or temporal relationship of the required association, nor whether the listed disease must cause the injury or may merely coexist. Without such objective boundaries, a person of ordinary skill in the art cannot determine the scope of the claim with reasonable certainty.
Claim 22, which depends on Claim 21, recites an extensive list of disease, disorders, and conditions – such as diabetes, congenital heart disease, hypertension, heart failure, and high cholesterol – without defining the specific clinical states or severities encompassed by each condition or clarifying whether each must directly contribute to, precede, or merely accompany the myocardial injury. Because the listed conditions differ widely in etiology and effect on the myocardium, and because the claim provides no guidance as to which of these conditions satisfy the limitation of claim 21, the scope of claim 22 cannot be determined with reasonable certainty.
Claim Rejections - 35 USC § 103 (MAINTAINED)
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tassoni et al. (WO 2007/096251, previously cited, and in IDS), hereinafter Tassoni.
Regarding Claim 1, Tassoni teaches 1-(2-hydroxyethyl)-4-(2,3,4-trimethoxybenzyl)piperazine (‘251, Pg. 12, Line 10), and other CPT-1 inhibitors in the treatment of heart disorders such as congestive heart failure (CHF) (‘251, Abstract and Pg. 10, Lines 16-17.) Tassoni further discloses the action of these compounds seems to take place, at least in part, by promoting a shift in the cellular metabolism in the myocardium which leads to the preferential use of glucose reducing the oxidation of the fatty acids by inhibiting the activity of CPT1 (‘251, Pg. 2, Lines 6-9.)
While Tassoni fails to specify inhibition of cardiac fibrosis, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the claimed compound to a subject at risk of developing cardiac fibrosis, as Tassoni teaches administering the instant compound to heart failure patients, a population well recognized in the art as post myocardial injury. A person of ordinary skill in the art would have been motivated to treat such patients to improve cardiac outcomes, including reducing or preventing fibrotic remodeling associated with heart failure. There would have been a reasonable expectation of success that administering the compound as taught in the art would inherently inhibit or reduce cardiac fibrosis; the “thereby inhibiting cardiac fibrosis” clause is an intended result that does not alter the method steps.
Regarding Claim 21, the additional limitation that “the myocardial injury is associated with a disease, disorder, or condition” does not patentably distinguish over Tassoni, which teaches administration to heart failure, a condition well known to be associated with myocardial injury. Thus, Claim 21 is obvious for the reasons set forth above.
Regarding Claim 22, the further limitation selecting heart failure from the recited group likewise does not patentably distinguish, because Tassoni expressly teaches administration of the instant compound to heart failure patients. Accordingly, Claim 22 is also obvious for the reasons set forth above.
Claims 1 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tassoni (WO 2007/096251), as applied to Claims 1 and 21-22 above, and further in view of Karwi et al. (Frontiers in Cardiovascular Medicine, Vol. 5, Article 68, June 6, 2018, previously cited, and in IDS), hereinafter Karwi.
The teachings of Tassoni (2007) are set forth in the above 35 U.S.C. 103 Rejections and are incorporated herein. Tassoni teaches the instant compound (Formula IX) and other CPT-1 inhibitors in the treatment of heart disorders such as congestive heart failure (CHF) and discloses the action of these compounds takes place, at least in part, by promoting a shift in the cellular metabolism in the myocardium which leads to the preferential use of glucose reducing the oxidation of the fatty acids by inhibiting the activity of CPT1.
Regarding Claims 1 and 21-22, Karwi teaches two molecules, namely etomoxir and perhexiline, are shown to inhibit CPT1 (Figure 3) and limit fatty acid oxidation with parallel increase in glucose oxidation in mouse and rat models of heart failure (Karwi, Pg. 10, § Inhibiting Fatty Acid Oxidation.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to substitute the CPT-1 inhibitor of Karwi for the alternative CPT-1 inhibitor of Tassoni, as both references disclose CPT-1 inhibition as a therapeutic strategy for treating patients with heart failure by shifting cardiac energy metabolism away from fatty oxidation and toward glucose oxidation.
One of ordinary skill would have been motivated to make such a substitution because the art establishes CPT-1 inhibition as a recognized mechanism of action for improving cardiac function in heart failure, and the skill artisan would have reasonably expected structurally different CPT-1 inhibitors to be interchangeable for this purpose.
There would have been a reasonable expectation of success that the compound taught by Tassoni, when used in the method of Karwi, would provide the same therapeutic benefit in heart failure patients, and therefore those post myocardial injury, since both references target the same enzyme and metabolic pathway to achieve the same clinical effect.
Claims 1 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Levin (US 2018/0360975, cited in IDS.)
Reference shares an inventor with the instant application.
Regarding Claims 1 and 21-22, Levin teaches the same Formula IX compound (‘975, Pg. 2, Para 0020), which shifts cardiac metabolism from fatty acid oxidation to glucose oxidation (‘975, Pg. 3, Para 0028 and 0029), in methods of treating conditions by providing compositions of the invention, wherein the condition may be heart disease, such as heart failure (‘975, Pg. 11, Para 0177, and Pg. 33, Claims 54-58.)
While Levin fails to specify inhibition of cardiac fibrosis, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer the claimed compound to a subject post myocardial injury, as Levin teaches administering the instant compound to heart failure patients, a population well recognized in the art as post myocardial injury. A person of ordinary skill in the art would have been motivated to treat such patients to improve cardiac outcomes, including reducing or preventing fibrotic remodeling associated with heart failure. There would have been a reasonable expectation of success that administering the compound as taught in the art would inherently inhibit or reduce cardiac fibrosis; the “thereby inhibiting cardiac fibrosis” clause is an intended result that does not alter the method steps.
Regarding Claim 21, the additional limitation that “the myocardial injury is associated with a disease, disorder, or condition” does not patentably distinguish over Levin, which teaches administration to heart failure, a condition well known to be associated with myocardial injury. Thus, Claim 21 is obvious for the reasons set forth above.
Regarding Claim 22, the further limitation selecting heart failure from the recited group likewise does not patentably distinguish, because Levin expressly teaches administration of the instant compound to heart failure patients. Accordingly, Claim 22 is also obvious for the reasons set forth above.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627