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 .
DETAILED ACTION
Priority
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, is acknowledged.
Status of Claims
Claims 1-2, 4-16, 19, 22-23, 25, and 26 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on 10/08/2025 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 12/06/2023, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement Applicants have elected Group II [which includes claims 2 , 19, 22, and 23], drawn to a method for treating Arrhythmogenic Cardiomyopathy (ACM) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a compound of Formula I
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, without traverse, acknowledged.
Claims 1, 4-16, 25, and 26 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter. Therefore, the requirement for restriction is still deemed proper and made it final.
Applicants preserve their right to file a divisional on the non-elected subject matter.
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.
Claims 2, 19, 22, and 23 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Chiamvimonvat et al (WO 2018/231702 A1, IDS). Applicant claims a method of treating Arrhythmogenic Cardiomyopathy (ACM) in a subject in need thereof, comprising administering to the subject an effective amount of a dual cyclooxygenase-2 (COX-2) / inhibitor of soluble epoxide hydrolase (sEH) having Formula I. Chiamvimonvat et al (WO 2018/231702 A1, paragraph 0005-7, pages 1-3) also disclose an identical method of treating Arrhythmogenic Cardiomyopathy (ACM) in a subject in need treatment thereof, the method comprising administering to the subject an effective amount of a dual cyclooxygenase-2 (COX-2) / inhibitor of soluble epoxide hydrolase (sEH) (page 5, line 18-19, “in some embodiments, a dual inhibitor of sEH and COX-2 is administered as the sole active agent”) having Formula I thereof, wherein R1 is NR1aR1b, R1a and R1b are each independently H, R2 is aryl, R3 is cycloalkyl, n is integer 3
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, [Table 2, page 39, 4th compound], which anticipates the instantly claimed inventions.
Claim Rejections - 35 USC § 112
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.
Claims 2, 19, 22, and 23 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The expressions a method of “preventing -------- Arrhythmogenic Cardiomyopathy (ACM)” (claim 2, lines 2-3, page 2, and all other occurrences, if any), which broaden the enabling disclosure because it is unclear what kind of “Cardiomyopathy”, the applicant is intending to encompass with this broad expression and/or how this ACM disease is treated and therefore, the specification fails to provide sufficient support to treat all the wide range of Cardiomyopathy by administering to a subject in need thereof a therapeutically effective amount of a compound of Formula I. The type or mode of action and functionality of preventable or treatable Cardiomyopathy is not defined in the claims or anywhere in the specification so as to ascertain the metes and bounds of the claimed subject matter.
The recitations a method of “preventing -------- Arrhythmogenic Cardiomyopathy (ACM)”, which are not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. § 112 first paragraph because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. As stated in the MPEP 2164.01 (a), there are many factors [1) The nature of the invention, 2) The state of the prior art, 3) The level of ordinary skill in the art, 4) The level of predictability in the art, 5) The amount of direction and guidance provided by the inventor, 6) The existence of working examples, 7) The breadth of the claims, and 8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (In re Wands, 8 USPQ 2d 1400, 1404 (CAFC, 1988)] to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” Therefore, it is not likely that a single compound would be predicted to be able to prevent, delay or treat the progression of diverse “Cardiomyopathy”, as claimed in the instant application. Based on the unpredictable nature of the invention and state of the prior art and the extreme breadth of the claims, one skilled in the art could not perform the claimed methods of use without undue experimentation, see In re Armbruster 185 USPQ 152 CCPA 1975. Thus, the specification fails to provide sufficient support of the broad use of the method claims 2, 19, 22, and 23 to treat all kinds of “Cardiomyopathy” in a subject in need thereof, the method comprising administering to the subject an effective amount of a composition comprising a compound of Formula I. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “preventing” and limiting with “treating -------- Arrhythmogenic Cardiomyopathy (ACM)” only with compound of Formula I in order to overcome the rejection.
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.
Claim 22 is 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 pre-AIA the applicant regards as the invention. The recitation of selected from the group in “Table 4” [claim 22, line 2 and page 5 and all other occurrences, if any] renders the claim indefinite because it is unclear from the claim what the Applicant is intending to encompass with this type of broad expression ‘Table 4’ reference without disclosing the actual chemical names and/or chemical formula of compounds [confusion over the intended scope of a claim, see MPEP 2173.05(d)] and therefore, it is not possible to ascertain the metes and bounds of the claimed subject matter. The claim is indefinite because the claim does not itself define the invention but rely on external material and modern claim practice requires that the claims stand alone to define the invention. Ex parte Fressola, 27 USPQ2d 1608. Therefore, it is suggested to delete the expression “Table 4” “ and/or amend the claim within the context and scope of the claim (e.g., disclosing the names or structures of the specific chemical formula of compounds that actually contemplated on pages 31-34 of the specification) in order to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621