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 on 09/26/2023, is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2022/057708, filed on 03/23/2022, which claims priority to European Application No. 21165271.4 filed on 03/26/2021. However, an English translation of certified copy of the foreign priority application has not been filed. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 09/26/2023, 11/18/2025 and 04/20/2026, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The premilitary amendment filed on 04/23/2024, that amended claims 3-12, 14-15 and 17-19, is acknowledged. Claims 1-19 are pending.
Election/Restriction
Applicant’s response filed on 04/20/2026 to Restriction/Election Requirement filed on 02/20/2026, is acknowledged. Pursuant to the Election of Species Requirement, Applicant respectively elected with traverse MPC inhibitor and pioglitazone as species thereof for preventing or treating a primary, congenital cardiomyopathy. Claims 1-6, 8, 12-14 and 17-18 read on the elected species. Claims 7, 9-11, 15-16 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Thus, claims 1-19 are pending with claims 7, 9-11, 15-16 and 19 are withdrawn, and claims 1-6, 8, 12-14, and 17-18 are currently under consideration.
Response to Arguments:
Applicant argues:
Applicant notes that the instant claims specifically recite "primary, congenital, cardiomyopathy". Applicant submits that claim 1 is specifically restricted to that rather rare "primary form" of cardiomyopathy. The instant specification states that "primary, congenital cardiomyopathies do not arise as a secondary condition in the context of other diseases and are hence independent medical conditions that distinguish themselves from secondary myocardial hypertrophies." ([0002] of the specification as filed) Further, the context of the "Birnbaum" citations makes it clear ("reducing the risk of developing dilated cardiomyopathy ") that the generic term "dilated cardiomyopathy" is not directed to the (rare) primary form, but to the acquired secondary form, which is typically the consequence of other (cardiac) diseases like a myocardial infarction, ischemia etc. (that is why it is designated as "secondary") (see also para. 0004 of the present application).
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. The instant specification describes myocardial hypertrophy (HCM) and dilated cardiomyopathy (DCM) as primary, congenital cardiomyopathies: “HCM is the by far most common primary, congenital cardiomyopathy.”, see instant specification page 2, line 11-13. “Primary, congenital cardiomyopathies that can be preventively or therapeutically treated, in particular, are hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), restrictive HCM, etc.” page 5, line 19-21. HCM and DCM also described as primary cardiomyopathy by Sanble (A. Sanbe, Biol. Pharm. Bull. 2013; 36(1):18-22) and Brieler et al. (J. Brieler et al. American Family Physician, 2017, Volume 96, Number 10, pp 641-647).
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpretation for “preventing”
Claim 1 recites “PPARγ agonist and/or MPC inhibitor for use in a method for preventing or treating a primary, congenital cardiomyopathy.
The term preventing does not define by the claim or the instant specification. As provided in MPEP 211.01 III, [T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005) (en banc); Sunrace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1302, 67 USPQ2d 1438, 1441 (Fed. Cir. 2003); Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298, 67 USPQ2d 1132, 1136 (Fed. Cir. 2003) ("In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art."). Where neither the claims, nor the specification, nor the prosecution history offer sufficient clarity on claim scope, extrinsic evidence may become a necessary part of claim interpretation. Moreover, MPEP 2111.01 stated that it is improper to “read limitations into a claim from the preferred embodiment described in the specification, even if it is the only embodiment described, absent clear disclaimer in the specification." In view of the lacking of definition, the term “preventing” is given its plain meaning as described by National Library of Medicine (National Academies Press (US); 2009. 3, Defining the Scope of Prevention. Available from: https://www.ncbi.nlm.nih.gov/books/NBK32789/). The National Library of Medicine define the scope of the term “preventing” including “prevention is a complementary approach in which services are offered to the general population or to people who are identified as being at risk for a disorder, and they receive services with the expectation that the likelihood of a future disorder will be reduced.” Thus, “preventing” is interpreted as described by National Library of Medicine.
Claim interpretation for primary, congenital cardiomyopathy
Claim 1 is directed to PPARγ agonist and/or MPC inhibitor for use in a method for preventing or treating a primary, congenital cardiomyopathy.
The instant specification describes myocardial hypertrophy (HCM) and dilated cardiomyopathy (DCM) as primary, congenital cardiomyopathies:
“HCM is the by far most common primary, congenital cardiomyopathy.”, see instant specification page 2, line 11-13. “Primary, congenital cardiomyopathies that can be preventively or therapeutically treated, in particular, are hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), restrictive HCM, as well as cardiomyopathy, etc.” page 5, line 19-21.
Thus, primary, congenital cardiomyopathy is interpreted consistent with instant specification, and myocardial hypertrophy (HCM) and dilated cardiomyopathy (DCM) are primary, congenital cardiomyopathy.
Abstract
The Abstract of the disclosure is objected to because the Abstract recites “the present invention relates to …”. Applicant is reminded of the proper language and format for an abstract of the disclosure. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Rejections 35 U.S.C. 112(b)
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.
Claims 2-3, 8, 13-14 and 17-18 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.
Claims 2-3, 8, 13-14 and 17 recite a broad limitation and narrow limitation in the same claim. “A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2 and 3 recite the broad recitation “primary, congenital cardiomyopathy”, and the claim also recites “in particular, diseases from the Noonan syndrome spectrum” which is the narrower statement of the range/limitation. Claim 8 recites the broad recitation “a glitazone”, and the claim also recites “in particular, selected from the group consisting of ciglitazone, balaglitazone, etc.” which is the narrower statement of the range/limitation. Claims 13-14 and 17 also recite broad limitation together with “in particular” limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 8 and 18 are indefinite for reciting preferences. Claim 8 recites in line 5 “preferably …”, and claim 18 recites I line 3 “preferably”. As provided in MEMP 2173.05(d), “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. Note that the recitation of preferences is repeated in the non-elected claims (claims 9-11, and 15-16).
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.
35 USC § 102 Rejection over Birnbaum
Claims 1-5, 8, 12-14, and 17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Y. Birnbaum (US PG-PUB 2011/0092456A1, 04.21/2011, “Birnbaum” cited in the PTO-892).
Birnbaum teaches a method of reducing ischemia-reperfusion injury in an individual in need of such treatment consisting of administering a ligand for the peroxisome proliferator-activated receptor gamma, PPARg in an amount effective in increasing intracellular levels of cyclic adenosine monophosphate, thereby reducing ischemia-reperfusion injury in said individual, particularly, the peroxisome proliferator-activated receptor gamma is a thiazolidinediones, pioglitazone or rosiglitazone, wherein the individual is at risk of developing stroke, myocardial infarction, chronic coronary ischemia, arteriosclerosis, congestive heart failure, dilated cardiomyopathy, restenosis, coronary artery disease, heart failure, arrhythmia, angina, atherosclerosis, hypertension, renal failure, or myocardial hypertrophy. [0049].
Birnbaum discloses in some embodiment, a method of augmenting the cardioprotective effects in an individual comprising of co-administering pharmacologically effective amounts of a HMG CoA reductase inhibitor with a compound effective in increasing intracellular levels of cyclic adenosine monophosphate, where the co-administration augments the cardio-protection in the individual, wherein the compound is thiazolidinedione, pioglitazone, or rosiglitazone, wherein the individual at risk of developing stroke, myocardial infarction, chronic coronary ischemia, arteriosclerosis, congestive heart failure, dilated cardiomyopathy, restenosis, coronary artery disease, heart failure, arrhythmia, angina, atherosclerosis, hypertension, renal failure, or myocardial hypertrophy. [0053]
Birnbaum discloses that pioglitazone reduces cardiovascular complications in diabetic patients, protects the heart against ischemia-reperfusion injury and reduces infarct size in the rat. [0009]. Birnbaum discloses reported that intraperitoneal rosiglitazone, administered 45 min before ischemia, attenuates myocardial stunning following ischemia-reperfusion. [0009]. Birnbaum discloses that pioglitazone stable metabolite of prostacyclin, have anti-inflammatory, anti-atherosclerotic and myocardial protective effects. [0010]. Birnbaum discloses that the of pioglitazone and rosiglitazone have myocardial protective effect, as pioglitazone and rosiglitazone reduced infarct size. [0012]
Birnbaum discloses that pioglitazone is administered in vivo for treating myocardial and provide cardio protective effect, wherein pioglitazone decrease the area of risk, decrease infarct size, augmented PKA activity, augmented cPLA2 activity, significantly increased COX2 activity has stronger protective effect against H-89, etc. see [0073]-[0087]. Birnbaum discloses that pioglitazone is suspended in water and administered orally. [0073].
Thus, Birnbaum anticipates claims 1 and 2 because Birnbaum discloses a method of using PPARg pioglitazone for preventing primary, congenital cardiomyopathy, dilated cardiomyopathy, and myocardial hypertrophy. [0049]. See claim interpretation above.
Claims 3 and 4 are met because Birnbaum discloses myocardial hypertrophy. Myocardial hypertrophy is hypertrophic cardiomyopathy (HCM), see instant specification page 25, line 15.
Claims 5 and 8 are met because Birnbaum discloses that the PPARg agonist is a thiazolidinediones, pioglitazone, or rosiglitazone.
Claims 12, 13, 14, and 17 are met because Birnbaum discloses that pioglitazone is suspended in water and administered orally. [0073].
35 USC § 102 Rejection over Birnbaum as evidenced by National Library of Medicine
Claim 6 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Y. Birnbaum (US PG-PUB 2011/0092456A1, 04.21/2011, “Birnbaum” cited in the PTO-892), as applied above to claims 1-5, 8, 12, 13, 14, and 17, as evidenced by National Library of Medicine, 2016, https://pubchem.ncbi.nlm.nih.gov/compound/Pioglitazone, cited in the PTO-892).
Birnbaum discloses a method of using PPARg pioglitazone for preventing or treating primary congenital cardiomyopathy, dilated cardiomyopathy, and myocardial hypertrophy. [0049]. Pioglitazone has the structure below as evidenced by National Library of Medicine:
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266
194
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The pioglitazone structure above meets the limitations of claim 6 because the thiazolidine-2,4-dione is substituted at the C5 ring atom.
35 USC § 102 Rejection over Birnbaum as evidenced by National Library of Medicine
Claim 18 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Y. Birnbaum (US PG-PUB 2011/0092456A1, 04.21/2011, “Birnbaum” cited in the PTO-892), as applied above to claims 1-5, 8, 12, 13, 14 and 17, as evidenced by Reagan-Shaw et al. The FASEB Journal, 2007, Vol. 22, 659-661, “Reagan-Shaw” cited in the PTO-892).
Birnbaum discloses MPC inhibitor for use in a method for preventing or treating a primary, congenital cardiomyopathy, wherein HPC inhibitor is pioglitazone. Birnbaum discloses Example 14, wherein mice receive 5mg/kg/d pioglitazone. [0071].
Reagan-Shaw teaches dose translation from animal to human. [Title]. Reagan-Shaw teaches a method for the translation of drug doses from animal studies to human studies. Reagan-Shaw teaches that converting the dose used in a mouse to a dose based on surface area for humans includes multiply mouse dose in mg/kg by the Km factor (3) for a mouse and then divide by the Km factor (37) for a human (Table 1), this calculation results in a human equivalent dose. [page 660, col. 1, 2nd para., Figure 1, and Table 1].
Therefore, Birnbaum’s pioglitazone dose of 5 mg/kg/d in mice calculates to 24.3 mg in human (adult), and 8/11 mg child. 5 mg/kg/d (mice dose) x 3/37 = 0.405 mg/kg (human dose). To convert human dose to mg: 0.405 mg/kg x 60 kg (human weight) = 24.3 mg. The human dose of 0.405 mg/kg calculates to 8.11 mg for a child.
Therefore, Birnbaum as evidenced by Reagan-Shaw meets the limitation of claims 18.
Conclusion
Claims 1-6, 8, 12-14 and 17-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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