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 .
Status of Claims
Claims 1-4, 6, 10-11, 16, 18-19, 21, 24-26, and 31-36 are pending as of the response and amendments filed on 4/22/26. Claims 5, 7-9, 12-15, 17, 20, 22-23, and 27-30 have been canceled. Claims 16, 18-19, 21, 24-26 and 31 are currently withdrawn from examination as being directed to a non-elected invention. Claims 32-36 have been newly added. Claims 1-4, 6, 10-11, and 32-36 are currently under examination.
The objection to the specification is withdrawn in consideration of the amendments filed on 4/22/26.
The rejection of claims 3-4, 6, and 10-11 under 35 USC 112(b) is withdrawn in consideration of the amendments.
The rejections under 35 USC 102(a)(1) and 103 over Jablonski are withdrawn in consideration of the amendments.
A new rejection under 35 USC 112(b) is made based on the amended claims, discussed below.
Regarding the previous provisional nonstatutory double patenting rejection over the claims of 18273700, Applicants have requested in the response filed on 4/22/26 that this rejection be held in abeyance. This rejection is maintained for reasons of record, and modified to account for the amended claims.
Claims 1-4, 6, 10-11, and 32-36 were examined and are rejected.
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.
Claims 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 as amended recites “the preservative” and “the pH modifier” however there is no antecedent basis for these limitations in the claim. There is no previous reference to a preservative or pH modifier in the claim, and claim 1, from which claim 6 depends from, doesn’t recite a preservative or pH modifier. The metes and bounds of the claim aren’t clear.
Claim Rejections-Nonstatutory 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, 6, 10-11, and 32-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 11-12 of copending Application No. 18273700 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to pharmaceutical compositions comprising pregabalin and a phospholipid, wherein pregabalin and the phospholipid are dispersed in the composition. Both sets of claims further recite the composition to include a rheology modifier (see instant claim 2 and copending claim 3); and wherein the concentration of pregabalin is more than 2.5% by weight, and the concentration of phospholipid is from 0.1-5% by weight (see copending claim 7 and instant claim 1). Additionally, both sets of claims recite the phospholipid in the composition and solvent are homogenized by a HPH (instant claim 1 and copending claims 1-2); while instant claim 1 as recites “such that the phospholipid undergoes a structural change”, and this limitation is not explicitly recited by the copending claims, it would have been reasonably expected that homogenization by a HPH as recited by the copending claims would have also resulted in a structural change in the phospholipid. New instant claims 32-36 recite the topical composition to have a higher reduction in paw withdrawal threshold; a longer lasting reduction in paw withdrawal threshold in a chronic constriction injury model; a pain alleviating effect of more than 3 hours; a pain alleviating effect of more than 5 hours; and to be stable at room temperature for more than 1 year. While these limitations are not explicitly recited in the copending claims, it would have been expected that the topical pregabalin-phospholipid composition of the copending claims would have had these characteristics as well, being composed of the same ingredients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
Prosecution Insights