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
Status of the Claims
Claims 1-15, 19, and 23 are pending. Claims 2-7, 9, and 10 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 8, 11-15, 19, and 23 are examined on their merits.
35 U.S.C. § 102(a)(2) Rejections Maintained
Applicant’s amendments in the response filed on February 25th 2026 are acknowledged. Applicant has amended the claims to be directed towards a patient population that “does not have cachexia or muscle wasting.” Applicant states that Tweardy is directed towards “methods of treating, preventing or reducing severity of muscle wasting or chachexia,” and thus does not anticipate the claimed methods.
It is noted that the “prevention” of a condition in a patient necessitates that the patient does not have said condition. Thus, a method of “preventing muscle wasting in a patient with diabetes via administration of a compound,” is equivalent to administering the compound to a patient with diabetes and without muscle wasting. Thus, Tweardy is still anticipatory of applicant’s method.
Furthermore, Tweardy’s claimed method is not only directed towards the treatment of cachexia and muscle wasting in the described patient population, but also the treatment of muscle weakness. Thus, Tweardy teaches the treatment of a patient population with muscle weakness (exclusive of cachexia/muscle wasting) and diabetes (Tweardy, claims 3, 5), and Tweardy remains anticipatory of applicant’s claims.
35 U.S.C. § 102(a)(2) Rejections Reiterated
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 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)(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.
The rejection of claims 1, 8, 11-15, 19, and 23 under 35 U.S.C. 102(a)(2) as being anticipated by Tweardy (U.S. Patent No. 11,161,831 issued on November 2nd 2021, effectively filed on July 18th 2013).
Claims 1 and 8 are directed towards the treatment of diseases such as diabetes and chronic kidney disease with the compound,
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(N-(1’,2-dihydroxy-1,2’-binaphthalen-4′-yl)-4-methoxybenzenesulfonamide).
Tweardy teaches the administration of the same compound to individuals with diabetes or chronic kidney disease (Tweardy, col. 346, claim 5), anticipating claims 1 and 8.
Claims 11-15 are directed towards the treatment of metabolic syndrome1 in humans, wherein the metabolic syndrome comprises risk factors associated with diabetes and cardiovascular disease, including high blood pressure, belly fat, high blood sugar, high blood triglycerides, and low high-density lipoprotein cholesterol.
Tweardy teaches patient populations with these risk factors:
High blood pressure—see Tweardy, col. 313—hypertension
Belly fat—see Tweardy, col. 313—BMI 27.4
High blood sugar—see Tweardy, col. 313—diabetes
Low HDL cholesterol—see Tweardy, col. 313—atherosclerosis
Elevated triglycerides—see Tweardy, col. 313—atherosclerosis
As Tweardy teaches administration of the compound to human patients with each of the described risk factors, Tweardy anticipates claims 11-15.
Claim 19 requires that the compound used in the method of claim 1 is N-(1’,2-dihydroxy-1,2’-binaphthalen-4′-yl)-4-methoxybenzenesulfonamide, and is anticipated by Tweardy for the same reasons as claim 1.
Claim 23 requires that, in the method of claim 1, an additional therapy is administered. Tweardy teaches administration of an additional therapy (Tweardy, claim 7), and Tweardy thereby anticipates claim 23.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Nonstatutory Double Patenting Rejections Maintained
The nonstatutory double patenting rejections are maintained for the same reasons as the above 102 rejections.
Nonstatutory Double Patenting Rejections Reiterated
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.
Claims 1, 8, 11-15, 19, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,161,831. Although the claims at issue are not identical, they are not patentably distinct for the reasons stated in the above 102 rejection over U.S. Patent No. 11,161,831.
Claims 1, 8, 11-15, 19, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,676,455. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches administration of the same compound to patients with chronic kidney disease and diabetes with the same compound (reference patent, claim 1), enabled by explicit treatment of patients with the described risk factors (reference patent, col. 311),
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Note that metabolic syndrome is typically defined as the presence of a collection of cardiovascular and diabetes related risk factors, including those described in the aforementioned claims.
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