COMPOSITION FOR LOCALIZED FAT REDUCTION WITHOUT PAIN, EDEMA AND SIDE EFFECTS AND METHOD OF ADMINISTRATION THEREOF

§103 §DP

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 Instant application 18/896,502 filed on 09/25/2024 claims benefit as follows: CONTINUING DATA: PNG media_image1.png 16 322 media_image1.png Greyscale Status of the Application Claims 1-9 are pending. Information Disclosure Statement The information disclosure statement (IDS) submitted on 09/09/2025 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-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. 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. Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over US-2019/0201328-A1. US-2019/0201328-A1 teaches and claims: PNG media_image2.png 181 432 media_image2.png Greyscale Further, US-2019/0201328-A1 teaches and claims a method for removing localized fat comprising administering the said composition by injection: PNG media_image3.png 235 550 media_image3.png Greyscale PNG media_image4.png 77 543 media_image4.png Greyscale Regarding instant claim 3, US-2019/0201328-A1 teaches the composition may be administered multiply to the target side, including 2 to 10 times: PNG media_image5.png 181 549 media_image5.png Greyscale Regarding instant claim 4, US-2019/0201328-A1 teaches the target site may be set in a range of 1 to 50 (see para [0212]). Further, US-2019/0201328-A1 teaches the target site may be, for example, 0.1cmx0.1 cm to about 5 cmx5 cm. [0264]. Regarding instant claim 5, US-2019/0201328-A1 teaches: PNG media_image6.png 99 541 media_image6.png Greyscale The 0.1 - 1 ml range per target site disclosed by US-2019/0201328-A1 overlaps with the range recited in instant claims (0.1 to 0.5 ml per target site). Regarding instant claim 6, US-2019/0201328-A1 teaches the recited target areas: PNG media_image7.png 223 546 media_image7.png Greyscale Regarding instant claim 8, US-2019/0201328-A1 teaches the method is intended for treatments of adipose tissue or hyperproliferative disorder (see para [0146]). (It should be noted that hyperproliferative disorder is characterized by overproliferation.) Regarding instant claim 9, US-2019/0201328-A1 teaches the method is intended for treatments a subject that is obese or has a lower eyelid prolapse, lipoma, Dercum's disease, Madelung's neck, lipedema, piezogenic nodules, xanthelasma, lipodystrophy or fat accumulation associated with cellulite: PNG media_image8.png 268 550 media_image8.png Greyscale US-2019/0201328-A1 does not teach in one single embodiment a method wherein the composition is administered in 2-week intervals at a concentration of 25 mg/ml. US-2019/0201328-A1 teaches clinical evaluation at intervals of 4 weeks (see Example 6): PNG media_image9.png 380 570 media_image9.png Greyscale However, a person of ordinary skill before the effective filing date of the instant application would have been capable of adjusting concentrations and administration schedule by routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Further, US-2019/0201328-A1 teaches the composition may be administered once or multiply to the target side over 2 weeks (see para. [0214]). PNG media_image10.png 75 545 media_image10.png Greyscale Furthermore, US-2019/0201328-A1 teaches composition comprising 25 mg/ml of PPC: PNG media_image11.png 105 554 media_image11.png Greyscale PNG media_image12.png 146 551 media_image12.png Greyscale Therefore, it would be obvious to select the concertation and administration intervals suggested by US-2019/0201328-A1. 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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of U.S. Patent No. 11,298314-B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 11,298314-B2 recite a method comprising administering an effective amount of a composition consisting essentially of phosphatidylcholine; and at least one solubilizing agent of phosphatidylcholine selected from the group consisting of glycocholic acid, taurocholic acid and salt thereof: PNG media_image13.png 302 515 media_image13.png Greyscale It should be noted that the specification of 11,298314-B2 teaches that 25.0 mg/ml of PPC is equivalent to 2.5%, Therefore the concentration recited in instant claims is encompassed by the range between 0.3125 to 10% recited in claim 1 of 11,298314-B2 (see column 56, first line). Further, the claims of U.S. Patent No. 11,298314-B2 recite the administration comprises a subcutaneous injection (see claim 4). The claims of U.S. Patent No. 11,298314-B2 does not recite a method wherein the composition is administered in 2 week intervals at a concentration of 25 mg/ml in one single embodiment. The claims of 11,298314-B2 are also silent about administration areas. However, a person of ordinary skill before the effective filing date of the instant application would have been capable of adjusting concentrations and administration schedule and administration areas by routine experimentation. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm. 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, Clinton A Brooks can be reached at (571)270-7682. 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. /I.S./Examiner, Art Unit 1621 /GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621