DETAILED ACTION
Claim 24, submitted on May 17, 2024, is pending in the application and is rejected for the reasons set forth below. No claim is allowed.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first-to-invent provisions of the Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. In the event the determination of the status of the application as subject to pre-AIA 35 U.S.C. 102 and 103 (or as subject to 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.
Claim Rejections – 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 24 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/ 0165796 A1 by Kshirsagar et al.
Kshirsagar (cited in applicant’s IDS1) discloses an extended-release pharmaceutical composition of levetiracetam with once-a-day dosing (see abstract). Example dosage amounts of these extended-release dosage forms include 500 mg (see, e.g., Examples 1-6 at para. 0033-43) and 750 mg (Examples 8-13 at para. 0046-67). On the other hand, the reference (para. 0005) acknowledges that an immediate-release dosage form of 250 mg of levetiracetam, referred to as KEPPRA, was known in the prior art. One therefore would have understood that 250 mg is a suitable dosage amount of levetiracetam. Even though the reference discloses 500 mg and 750 mg as example dosage amounts of extended-release dosage forms, it would nevertheless have been apparent that 250 mg extended-release dosage forms would also have been useful. One would therefore have been motivated to make a 250 mg extended-release dosage form of levetiracetam because it was known, by analogy to KEPPRA, that this dosage amount has pharmaceutically utility. One would have had a reasonable expectation of success because changing the amounts of ingredients in the compositions of Kshirsagar would have been a matter of routine experimentation that is “known to one of ordinary skill in the art” (see, e.g., para. 0026, 0028, and 0030).
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.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 8,604,075 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘075 Patent is directed to a method for treating age-related cognitive impairment in a human subject in need thereof, the method comprising the step of administering to said human subject levetiracetam or a pharmaceutically acceptable salt thereof at a daily dose of 125-250 mg. The accompanying specification explains that the levetiracetam may be in the form of an extended-release dosage form (col. 7, ll. 38-43).
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,159,648 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘648 Patent is directed to an oral, one-dosage-unit, once-a-day pharmaceutical composition, wherein the composition comprises levetiracetam or a pharmaceutically acceptable salt, hydrate, solvate or polymorph thereof, wherein the levetiracetam or the pharmaceutically acceptable salt, hydrate, solvate or polymorph thereof in the composition is formulated in a single dosage unit for extended release, and wherein the composition comprises 220 mg of levetiracetam.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,925,834 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘834 Patent is directed to an extended-release pharmaceutical composition comprising levetiracetam. The accompanying specification explains that 220 mg is an example dosage amount of levetiracetam (col. 2, ll. 20-25).
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104, 124, and 180-183 of copending Application No. 18/107,336 (reference application). The ‘336 Application claims a method of using an extended-release dosage form (claim 124) of 0.1 mg to 350 mg of levetiracetam (claim 104). The range claimed in the ‘336 Application (0.1 to 350 mg) overlaps with the range claimed in the instant application (125 to 250 mg), so a prima facie case of obviousness exists. See MPEP 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 66 of copending Application No. 18/411,753 (reference application). Claim 66 of the ‘753 Application is directed to an extended-release pharmaceutical composition of levetiracetam, and the accompanying specification (p. 6) explains that a suitable dosage amount is 125-250 mg. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/852,724 (reference application). Claim 1 of the ‘724 Application is directed a pharmaceutical composition comprising 0.7 to 350 mg of levetiracetam, which overlaps with the dosage amount referred to in the instant claim. Claim 7 of the ‘724 Application further requires that the dosage amount is an extended-release form for one-a-day administration. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Conclusion
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
December 18, 2025
1 See the information disclosure statement (IDS) submitted on May 17, 2024.