Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 55-61 are pending and are under consideration in the instant office action.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 10/06/2025 are acknowledged. Claims 55-57 and 61 are cancelled. Claim 58 is amended and new claims 62-63 are added. Claims under consideration in the instant office action are claims 58-60 and 62-63.
Applicants' arguments, filed 10/06/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
.
Double Patenting
New grounds of rejection necessitated by the amendment dated 10/06/2025
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 58-60 and 62-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over each of the following U.S. Patents; claims 1-12 of 11,833,159 (‘159), Claims 1-16 of 11,690,853 (‘853) and claims 1-11 of 8,334,279 (‘279)
Instant claims 58-60 and 62-63 are drawn to A method of treating muscular dystrophy or reducing symptoms of muscular dystrophy by modulating NF-κB comprising administering to a patient in need thereof a pharmaceutical composition comprising an amount of a compound having a structural formula
PNG
media_image1.png
245
417
media_image1.png
Greyscale
in a tablet or a capsule form, wherein the pharmaceutical composition further comprises at least one excipient chosen from binders, inert diluents, lubricating agents, surface active agents, and dispersing agents and wherein the compound is present in an amount effective to modulate NF-κB.
Claims 1-12 of ‘159 are drawn to A pharmaceutical composition comprising between 10 to 200 mg of a compound having the structural formula
PNG
media_image2.png
130
176
media_image2.png
Greyscale
or a salt thereof, wherein the pharmaceutical composition is formulated for oral administration and wherein the compound is present in an amount effective to treat or reduce the symptoms of muscular dystrophy.
Claims 1-13 or ‘853 are drawn to a method of treating or reducing the symptoms of muscular dystrophy by increasing percentage of ejection fraction and increasing percentage of fraction shortening in a patient, the method comprising the administration, to the patient in need thereof, of a therapeutically effective amount of a compound for treating the muscular dystrophy, the compound having the structural formula
PNG
media_image2.png
130
176
media_image2.png
Greyscale
or a salt thereof, wherein the therapeutically effective amount is greater than or equal to 2 mg/kg/day.
Claims 1-11 of ‘279 is drawn to a method of treating or reducing the symptoms of muscular dystrophy, comprising the administration, to a patient in need thereof, of a therapeutically effective amount of a compound having the structural formula
PNG
media_image2.png
130
176
media_image2.png
Greyscale
Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claims the method treat the same condition which is Muscular dystrophy by administering a composition comprising the same compound as recited by the copending patents. With regards to the composition formulated as tablets or a capsule form, wherein the pharmaceutical composition further comprises at least one excipient chosen from binders, inert diluents, lubricating agents, surface active agents, and dispersing agents, these are prima facia obvious to a person of ordinary skil in the art and are part of routine optimization of a formulation of drug formulation.
It is noted that the copending patent claims does not specify that the compound modulate NF- κB or the amount of the compound is effective to modulate NF-κB or that it inhibits TNF-α induced NF-kb activation or NF-kb nuclear translocation. However, modulating NF-kB by inhibiting TNF-α is a functional limitation of the compound and absence of evidence to the contrary, the composition of the same compound taught in the copending patents useful to treat the same subject population will inherently posses the property of inhibiting TNF-α and modulating NF-kB. In practicing the claims of the copending applications, the functional limitations set forth in the instant application will be achieved. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.. In addition,. It is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the adapalene to modulate expression of IL-1ra would be present in the adapalene taught by Graeber et al. and would therefore elicit these effects whenever it is administered .
Therefore subject matter disclosed in claims instant claims 58-60 and 62-63 of the instant application are prima facia obvious over claims of ‘159 ‘853 and ‘279 as they are drawn to the same compound and its use in the same condition as instant claims.
Conclusion
Claims 58-60 and 62-63 are rejected. No claims are allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7.00 am to 4.00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000/
/SAVITHA M RAO/ Primary Examiner, Art Unit 1691