DETAILED ACTION 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. Claim of Priority Applicant’s claim of foreign priority and certified copy of foreign priority documents are acknowledged. Election/Restrictions Applicant’s election without traverse of Group I, corresponding to claims 1-11 and 13-16, in the reply filed on November 25, 2025, is acknowledged. Applicant elected Tween 80 and P407 as species. Claims 17-21 are withdrawn. Status of the Claims Claims 1-11 and 13-21 are pending. Claims 17-21 are preliminarily withdrawn. Claims 1-11 and 13-16 are examined. Specification The use of the terms poloxamer, Tetronic®, Tween, Cremophor, Kolliphor, and others, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Rejections - 35 USC § 112 Claims 1-11 and 13-16 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. The use of poloxamer is a tradename. According to M.P.E.P. 2173.05(u) : “If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020). With regard to claim 4 , the phrase “ cannabi diol rich ” is not defined in the Specification. It is not clear what the metes and bounds of this phrase is. 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. Claim s 1-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Du et al. , (CN110433133A) (cited in ISR) , in view of Ferrari et al. , (US20210154300) (filed December 12, 2021) . Du teaches a temperature sensitive gel for nasal administration of cannabidiol for targeting the brain to treat conditions such as PTSD and anxiety, among others. See Abstract. The temperature sensitive gel comprises poloxamer 407 and poloxamer 188. See Example 1. Further, glyceryl monooleate is used a non-ionic surfactant. The gel includes 15 to 35 parts water and 0.1 to 10 parts poloxamer 188 and 1 to 10 parts poloxamer 407. Cannabidiol can be present in an amount of 0.5 to 5 parts. A dosage can be 20 mg/ml (i.e., 2%) or 20 μl of unilateral nostril per day. A preparation includes a cannabidiol aqueous solution. Cannabinoids are known to have been isolated from plants and they include CBD, CBN, and CBG, among others. Ferrari teaches a thermo-responsive gel in liquid formulation to deliver an active substance. See Abstract. The polymer can include those such as poloxamer 124, poloxamer, 188, poloxamer, 237, and poloxamer 338. See par. 10. The liquid composition can be suitable to be made to obtain a sol-gel transition composition. See par. 72. The transition can be at body temperature. See par. 74. The composition can comprise a non-ionic surfactant including: polyoxyethylene sorbitan fatty acid esters , such as polysorbate 20, polysorbate 60, polysorbate 80 and the like; polyoxyethylene alkyl ethers, such as PEG-20 cetostearyl ether, polyoxyl 25 cetostearyl, cetomacrogol 1000 and the like; sorbitan fatty acid esters surfactants, such as sorbitan monolaurate, sorbitan monopalmitate, sorbitan monooleate, sorbitan monostearate and the like. The composition can be a micellar dispersion and this can be a water based solution. Polymeric micelles are contemplated. See par.’s 49, 53, 7,3, 109, and prior art claim 11. Administration be through most routes of administration, including nasal and intranasal. See par. 10. Ferrari further teaches that the transition from a liquid to a gel enhance the bio-adhesiveness and enhancement to tissue adhesion of the mucosa or submucosa. See par. 76. The poloxamers used can be P188, P407 or a mixture, e.g. See par.’s 82-84. The polymer can be included in a concentration of 0.1 to 30%. See par. 86. Polysorbate 80 I s a preferred non-ionic surfactant. See par. 92. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and 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). In this case, the claimed parameters are properties secondary to the components and percentages of those components used. Moreover, the claimed parameters are desired for administration of a sol-gel composition to gel and adhere to the nasal mucosa for a purpose of remaining at that location for a time to deliver an active agent. Not only is this taught, but the prior art provides a roadmap for the tunability and optimization of these parameters by modifying the concentrations of components- each of which are taught for use in a composition as described. It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Du and Ferrari to arrive at the claimed methods. One would be motivated to do so because the prior art teaches a thermoreversible sol-gel comprising cannabidiol as an active agent delivered with a known thermoreversible poloxamer, including P407, P188, and each of those claimed. Moreover, the composition can include a plurality of micelles. Additionally, the claimed non-ionic surfactant is also taught for inclusion in the claimed composition. Not only are each of the claimed components taught, but a purpose for arriving at a claimed formulation is for the liquid to turn into a gel when administered to the nasal cavity to adhere to the nasal mucosa and remain there for a sufficient period of time to delivery an active agent. Thus, the claimed components are each known result effective variables that can be optimized through nothing more than routine experimentation to arrive at a composition with the claimed properties. Claim s 1-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Du et al. , (CN110433133A) , in view of Ferrari et al. , (US20210154300) (filed Decembe r 12, 2021) , and in further view of Altuntas et al. , “Formulation and Evaluation of Thermoreversible In Situ Nasal Gels Containing Mometasone Furoate for Allergic Rhinitis,” AAPS PharmSciTech, Vol. 18, No. 7, October 2017 , and in view of Bodratti et al. , “Formulation of Poloxamers for Drug Delivery,” J. Funct. Biomater. 2018, 9, 11. Du teaches a temperature sensitive gel for nasal administration of cannabidiol for targeting the brain to treat conditions such as PTSD and anxiety, among others. See Abstract. The temperature sensitive gel comprises poloxamer 407 and poloxamer 188. See Example 1. Further, glyceryl monooleate is used a non-ionic surfactant. The gel includes 15 to 35 parts water and 0.1 to 10 parts poloxamer 188 and 1 to 10 parts poloxamer 407. Cannabidiol can be present in an amount of 0.5 to 5 parts. A dosage can be 20 mg/ml (i.e., 2%) or 20 μl of unilateral nostril per day. A preparation includes a cannabidiol aqueous solution. Cannabinoids are known to have been isolated from plants and they include CBD, CBN, and CBG, among others. Ferra r i teaches a thermo-responsive gel in liquid formulation to deliver an active substance. See Abstract. The polymer can include those such as poloxamer 124, poloxamer, 188, poloxamer, 237, and poloxamer 338. See par. 10. The liquid composition can be suitable to be made to obtain a sol-gel transition composition. See par. 72. The transition can be at body temperature. See par. 74. The composition can comprise a non-ionic surfactant including : polyoxyethylene sorbitan fatty acid esters , such as polysorbate 20, polysorbate 60, polysorbate 80 and the like; polyoxyethylene alkyl ethers, such as PEG-20 cetostearyl ether, polyoxyl 25 cetostearyl, cetomacrogol 1000 and the like; sorbitan fatty acid esters surfactants, such as sorbitan monolaurate, sorbitan monopalmitate, sorbitan monooleate, sorbitan monostearate and the like. The composition can be a micellar dispersion and this can be a water based solution. Polymeric micelles are contemplated. See par.’s 49, 53, 7,3, 109, and prior art claim 11. Administration be through most routes of administration, including nasal and intranasal. See par. 10. Ferrari further teaches that the transition from a liquid to a gel enhance the bio-adhesiveness and enhancement to tissue adhesion of the mucosa or submucosa. See par. 76. The poloxamers used can be P188, P407 or a mixture, e.g. See par.’s 82-84. The polymer can be included in a concentration of 0.1 to 30%. See par. 86. Polysorbate 80 I s a preferred non-ionic surfactant. See par. 92. Alt untas teaches developing a sol-gel mucoadhesive thermoreversible nasal gel that has a temperature tailored to prevent drainage of the formulation. Further, poloxamer 407 and a mucoadhesive polymer were used to gel below 34 degrees C in the nasal cavity. A favourable gelling temperature was approximately 30.1 degrees C and a mucoadhesion strength of about 2.9 was also developed. Concentration of P407 was optimizable as 18% PL407 was used and the gelation temperature correlation was determined. The amount used provided an optimum sol-gel temperature of 29.5 degrees C for nasal administration. See p2676. Gelation temperate and concentration of mucoadhesive polymer is shown in Figure 1. As concentration of mucoadhesive polymer increases, Tsol-gel decreased significantly from 50 degrees C to about 30 degrees C. Viscosity studies showed that the mucoadhesive polymer increased viscosity in a concentration-dependent manner. See p2677, 1 st par. Mucoadhesive strength increased significantly as the mucoadhesive polymer increase from 0.15% to 0.35%. Formulations showed a mucoadhesive strength of 0.020 to 0.448 mJ. “ Tsol-gel determination is a preliminary step in the formulation of thermoreversible gel (27). Zaki et al. (9) indicated the optimum Tsol-gel for nasal drug delivery as 25– 32°C. ” See p2679, 4 th full par. The hardness of the compositions ranged from about 4 to about 37 g; the adhesiveness ranged from approximately 0.09 to 1.6 mJ; and the cohesiveness ranged from approximately 0.2 to 1.2 mJ. Each of these parameters are optimizable through routine experimentation. Even further, Bodratti teaches poloxamers exhibit an amphiphilic character in aqueous solution. “The association in aqueous solution of poloxamer unimers into micelles is well understood.” The micellization process commences when the PEO-PPO block copolymer concentration in solution reaches a certain critical micellization concentration (cmc) at a fixed temperature. Conversely, increasing the temperature to the critical micellization temperature (cmt) at a fixed block copolymer concentration also induces micellization. The temperature dependence of micellization can be interpreted and predicted by the use of a two-state model, which considers both polar and apolar interactions in the PEO and PPO segments [49]. The result of the reduced solubility is a microphase separation of the PPO blocks out of the aqueous environment and into the micelle core. Thus, the ability to form micelles as described by Ferrari is known and optimizable/achievable to a POSA. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and 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). In this case, the claimed parameters are properties secondary to the components and percentages of those components used. Moreover, the claimed parameters are desired for administration of a sol-gel composition to gel and adhere to the nasal mucosa for a purpose of remaining at that location for a time to deliver an active agent. Not only is this taught, but the prior art provides a roadmap for the tunability and optimization of these parameters by modifying the concentrations of components - each of which are taught for use in a composition as described. It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Du, Ferrari, Altuntas and Bodratti to arrive at the claimed methods. One would be motivated to do so because the prior art teaches a thermoreversible sol-gel comprising cannabidiol as an active agent delivered with a known thermoreversible poloxamer, including P407, P188, and each of those claimed. Moreover, the composition can include a plurality of micelles. Additionally, the claimed non-ionic surfactant is also taught for inclusion in the claimed composition. Not only are each of the claimed components taught, but a purpose for arriving at a claimed formulation is for the liquid to turn into a gel when administered to the nasal cavity to adhere to the nasal mucosa and remain there for a sufficient period of time to delivery an active agent. Thus, the claimed components are each known result effective variables that can be optimized through nothing more than routine experimentation to arrive at a composition with the claimed properties. Even further, Altuntas teaches developing a sol-gel mucoadhesive thermoreversible nasal gel that has a temperature tailored to prevent drainage of the formulation. It uses P407 and describes advantages for arriving a compositions with the claimed properties. Altuntas also provides data on the hardness of the compositions ranged from about 4 to about 37 g; adhesiveness ranged from approximately 0.09 to 1.6 mJ; and cohesiveness ranged from approximately 0.2 to 1.2 mJ. Bodratti explains the ability and advantages of micelle formation with poloxamers through their self-assembly process in aqueous solution. Each of these processes/ parameters are optimizable through routine experimentation with a reasonable and predictable expectation of success. 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 s 1-11 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 27-45 of copending Application No. 18/253,573 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the 573’ application are directed to a product and a method that requires the product. The product claimed in ‘573 application also includes a thermoresponsive poloxamer, such as P407, and a surfactant, such as POE sorbitan monooleate, a cannabinoid, and a sol-gel formulation. Micelles are also claimed and CBD is the API. A gelation temperature and viscosity of composition are claimed to be the same and/or overlapping as well. Further, the described micellar compositions result poloxamers being in water. As evidenced by This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. As such, no claim is allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2795 . The examiner can normally be reached on FILLIN "Work schedule?" \* MERGEFORMAT 9-5 M-F . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571-272- 1310 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/ Primary Examiner, Art Unit 1628