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. Priority This application, filed 07/21/2023 is a National Stage entry of PCT/HU2022/050004, International Filing Date: 01/24/2022. PCT/HU2022/050004 claims foreign priority to P2100019, filed 01/22/2021. A certified copy of the foreign priority application is of record. Status of Claims Claims 1-4, 6, 10-11, 16, 18-19, 21, 24-26, and 31 are pending as of the response filed on 11/13/25. Claims 5, 7-9, 12-15, 17, 20, 22-23, and 27-30 have been canceled. Applicant's election with traverse of invention I, claims 1-4, 6, and 10-11 in the reply filed on 11/13/25 is acknowledged. The traversal is on the ground(s) that the Office has not established it would pose an undue burden to search the full scope of the claims. This is not found persuasive because the instant application is a national stage entry of an international application, and restriction is not based in such instances on establishment of undue search burden, but rather that the claimed inventions lack unity of invention. As discussed in the restriction mailed on 11/3/25, although inventions I, II, and III share the technical feature of a topical composition comprising pregabalin and a phospholipid dispersed in the composition, this shared technical feature is not a special technical feature since it would have been prima facie obvious in view of Trimble, US 20170319534 (of record). Since a special technical feature is not present, unity of invention among the different inventions is lacking, and restriction is proper. In the event that the claims drawn to the elected product are found allowable, rejoinder of the withdrawn process claims will be considered, provided that they incorporate all of the limitations of allowed product claims. The requirement is still deemed proper and is therefore made FINAL. Claims 16, 18-19, 21, 24-26, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/13/25. Claims 1-4, 6, and 10-11 were examined and are rejected. Objection to Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See specification, p. 11. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. 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 appl icant regards as his invention. Claim s 3-4, 6, and 10-11 are 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. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim s are replete with terms “preferably”, “more preferably”, and/or “most preferably” . The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language, e.g., “preferably”, “more preferably”, and/or “most preferably” is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim Rejections-35 USC § 102 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-4 and 10-11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Jablonski et. al., WO 2019126172 A1, publ. 6/27/2019 . Jablonski discloses microemulsion compositions comprising a discontinuous internal phase comprising an aqueous solution encompassed within an internal emulsifier; a continuous oil phase encompassing the internal phase; and an external emulsifier encompassing the oil phase , wherein the compositions are suitable for ocular delivery (title & abstract; p. 1, lines 30-35). Jablonski discloses the aqueous solution to contain a water-soluble drug; pregabalin is exemplified (p. 3, line 20-p. 4, line 5). Jablonski further discloses the composition as a hydrogel, wherein the aqueous solution comprises a mucoadhesive polymer (p. 4, lines 6-18). Jablonski discloses the following microemulsion hydrogel composition (p. 27, Table 2 , lines 2-13 ): . Notably, the composition above comprises pregabalin in a concentration of 0.6% w/w, lecithin in a concentration of 6.5% w/w, deionized water, and the rheology modifier, CARBOPOL 981 (polyacrylic acid derivative) ; lecithin is a mixture of phospholipids (p. 10, lines 3-7). Furthermore, Jablonski discloses the composition as a dispersion (p. 5, lines 18-20) , and as a topical formulation (p. 41, claim 20) . Jablonski therefore discloses a topical pharmaceutical composition comprising pregabalin and phospholipid, wherein pregabalin and the phospholipid are dispersed in the composition. Regarding claim 1, “in which a mixture comprising the phospholipid and solvent is homogenized with a high pressure homogenizer”, from this language the claim is interpreted as being drawn to a product-by-process. See MPEP 2113: "[E] ven though product-by-process claims are limited by and defined by the process , determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process ." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). While Jablonski doesn’t explicitly disclose homogenizing phospholipid and a solvent with a high pressure homogenizer, the composition disclosed by Jablonski appears to have the identical structural composition to the product of the instant claims. Therefore, the claim is anticipated by Jablonski in the absence of evidence showing the product by Jablonski differs from the composition as claimed. Regarding instant claim 3, “in which the mixture of phospholipid and a solvent, or a mixture of solvents and optionally other ingredients are homogenized with an HPH homogenizer”, this recitation, along with the steps a), a.1.), a.2), b.), b.1.), …e.2.) all introduce process steps, when the claim is drawn to a product. Although Jablonski doesn’t explicitly disclose these steps, the product disclosed by Jablonski appears to be structurally identical to the claimed composition, and therefore the process steps don’t distinguish the claimed composition from Jablonski. See MPEP 2113. Regarding instant claims 4 and 10-11, the recitation from “composition obtainable the process according to claim 1….”, introduces process steps. However, as discussed above, the product disclosed by Jablonski appears to be structurally identical to the claimed composition, and therefore the process steps don’t distinguish the claimed composition from Jablonski. Claim Rejections-35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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 . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim (s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski et. al., WO 2019126172 A1, publ. 6/27/2019, as applied to claims 1-4 and 10-11 . The disclosure of Jablonski as discussed previously is incorporated herein. Additionally, Jablonski teaches the concentration of water-soluble drug, i.e., pregabalin is at least 1.2% w/w (p. 45, claim 49; p. 46, claim 51 ). Moreover, Jablonski teaches an embodiment wherein the concentration of lecithin in the microemulsion composition ranges between about 1% to about 13% w/w (p. 21, lines 21-32). Although Jablonski doesn’t explicitly teach the more than 2.5% by weight concentration of pregabalin recited in claim 6, Jablonski does suggest a concentration of pregabalin of more than 1.2% w/w as acceptable in the formulation. It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have adjusted the concentration of pregabalin in the composition taught by Jablonski by routine experimentation, and have arrived at a concentration of more than 2.5% by weight, such as 2.6% by weight, in the a bsence of evidence indicating the criticality of this concentration . See MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, one of ordinary skill in the art would have arrived at the concentration of 0.1-5% by weight phospholipid, e.g., lecithin, as recited by instant claim 6, as Jablonski exemplifies a concentration of lecithin that overlaps with this range. Furthermore, “pharmaceutical composition obtainable by the process according to claim 1”, and “high pressure homogenized” phospholipid are interpreted as process steps, however, the claim is drawn to a product. As patentability of product claims is not determined by the manner in which the product was processed, and as the claimed composition has the same structural components as the composition taught by Jablonski, the process steps do not distinguish the composition from Jablonski. See MPEP 2113. The language “and further can comprise as further excipients….” has been interpreted to mean that the excipients following this recitation as optional and not required. 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, and 10-11 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 6) . It is noted that both sets of claims recite process steps; however, the patentability of a claimed product is not determined by the manner in which the product is produced. See MPEP 2113: "[E] ven though product-by-process claims are limited by and defined by the process , determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process ." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The instant and copending claims aren’t patentably distinct, being drawn to compositions comprising the same components, pregabalin and a phospholipid, in dispersed form. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Information Disclosure Statement The IDS filed on 7/21/23 has been considered. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH PIHONAK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7710 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 9:00-5:30 EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5239 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT SARAH . PIHONAK Primary Examiner Art Unit 1627 /SARAH PIHONAK/ Primary Examiner, Art Unit 1627