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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed July 10, 2025, is a reissue of U.S. Patent 10,245,235 (hereinafter the ‘235 patent), which issued from U.S. application Serial No. 15/842,580 (the ‘580 application) with claims 1-2 on April 2, 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on June 11, 2026 has been entered.
Double Patenting
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-12 of copending Application No. 19/377,792 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claim 1, the method in claim 5 of the reference application treats a muscular dystrophy known as α-dystroglycanopathy with the claimed compound. α-Dystroglycanopathy is a congenital muscular dystrophy. According to the reference application specification, α-dystroglycanopathy is linked to mutations in FKRP (see p. 1, lines 10-28). Thus, claim 5 of the reference application anticipates instant claim 1.
With respect to instant claim 2, the treatment of α-dystroglycanopathy as per claim 5 of the reference application renders obvious treating or reducing the development of muscle weakness, particularly in view of the fact that the method in claim 5 of the reference application, via its dependency back to claim 2 of the reference application, requires that the method increases, restores, or enhances functional glycosylation of α-dystroglycan in the subject.
With respect to instant claims 3 and 4, oral administration is a conventional form of administration of a pharmaceutical compound, and thus, would have been obvious to one of ordinary skill in the art when administering the compound to a subject having α-dystroglycanopathy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19/685,584 (reference application).
With respect to instant claims 1-4, claims 1 and 7-11 of the reference application teach a method of delaying the development of muscle weakness or improving muscle function in a subject in need thereof having the instantly claimed disease, the method comprising administering to the subject a therapeutically effective amount of the instantly claimed compound, wherein the subject has a loss of function mutation in a FKRP gene. Claims 12 and 13 of the reference application depend from claims 10 and 11 and set forth oral administration of the compound.
Accordingly, instant claims 1-4 are anticipated by the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/685,602 (reference application).
Instant claim 1 is anticipated by the reference application’s claim 2, which sets forth a method of treating limb girdle muscular dystrophy 21 (LGMD-21) in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising a therapeutic amount of the instantly claimed compound, wherein the subject has a loss of function mutation in a FKRP gene.
Instant claim 2 is anticipated or rendered obvious by the reference’s application’s claim 2, because treatment of a subject having the same disease here claimed with the same compound here claimed would be expected to provide the same or similar effect, i.e., the treatment or reduction of muscle weakness.
Claim 21 of the reference application depends from claim 2 of the reference application and administers the compound orally to the subject. Thus, claim 21 of the reference application anticipates instant claim 3 (which depends from instant claim 1), and anticipates or renders obvious instant claim 4 (which depends from instant claim 2).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,245,235 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
Prosecution Insights