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. Election/Restrictions Applicant's election with traverse of: Group I, claims 1- 4, 6, 8, 9, 16-23 and species of composition , in the reply filed on 12 / 22 /202 5 , is acknowledged. Group I c laims 1- 4, 6, 8, 9, 16-23, read on the elected species . Applicant’s traversal regarding unity of invention is on the ground(s) that Yoon et al., does not include water, which is an essential component of the composition of the present invention. Examiner references prior art Yu, Ha Na et al., ( WO-2014104784-A4 ), which disclose s all technical features of the composition of the present invention . Therefore , in citing this reference, the claimed composition does not share any special technical feature. Applicant’s election of species of injectable composition a) Sorbitan: sorbitan monooleate/ 9 to 90 wt %; b) Phospholipid: phosphatidylcholine/ 9 to 90 wt % ; c) Liquid crystal hardener: tocopherol acetate/ 0.1 to 50 wt %; d) water: 0.5 to 50 wt %; and e) GNRH analog: leuprolide/ 0.01 to 50 wt %, is acknowledged. The requirement is still deemed proper and is therefore made FINAL. Claim Status The claim listing filed 12/22/2025 is pending. Claims 1- 4, 6, 8, 9, 16-23 , 27 are hereby examined on the merits. Claims 24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Priority The instant application filed 12/14/2022 , is a National Stage entry of PCT/KR2021/008187, i nternational f iling d ate: 06/29/2021 and claims foreign priority to 10-2020-0080621, filed 06/30/2020 . The certified copy has been filed in the parent application but no translation has been provided. Information Disclosure Statement The information disclosure statement (IDS) submitted 02/23/2023, 04/17/2024, 05/08/2024, 11/15/2024 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner . Claim Rejections - 35 USC § 102 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-4, 6, 8, 9, 16-18 are rejected under 35 U.S.C. 102(a)( 1 ) and 102(a)(2) as being anticipated by Yu, Ha Na et al., hereinafter Yu (WO2014/104784A4; published 3 July 2014 ; reference provided in the IDS ) as evidenced by Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376. The applied reference has a common Assignee and joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Regarding claims 1-4 and 6 and 9 1 Yu teaches a sustained-release lipid pre-concentrate comprising: a) at least one crystal former; b) at least one neutral phospholipid; c) at least one liquid crystal hardener; and d) at least one anionic anchoring agent (see page 4; [18]). For use as a liquid crystal former, Yu teaches sorbitan unsaturated fatty acid ester , preferably with two or more - OH( hydroxyl) groups in the polar head (see page 5; [24]) and is preferably , sorbitan monooleate (see page 6; [32]) , i.e. component ‘a’ i n claims 1-3 ) . Yu teaches that phospholipids are preferably neutral and selected more than one from among phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, sphingomyelin, and a combination thereof (see page 7; [45] ) , i.e. component ‘ b ’ in claims 1 and 4 . Liquid crystal hardener as taught in Yu , is tocopherol acetate (see page 8; [47]) , i.e. component ‘c’ in claims 1 and 6 , and anionic anchoring agent encompasses all agents that allow for sustained release of pharmacologically active substance (see page 8; [50]). Cationic pharmacologically active substance in the lipid pre-concentrate , includes leuprolide (see page 9; [61]) , i.e. GnRH analog; meeting the limitation of component ‘e’ in claim 1 and 9 . Yu teaches that the sustained-release lipid pre-concentrate can be applied to the body using a method selected from among injection. Particularly, when the route of injection is taken, the pre-concentrate may be administered using subcutaneous or intramuscular routes (see page 12; [71]). Yu specifically teaches that in the lipid pre-concentrate, in comparative E xample 21, 3.75 mg of leuprolide (meeting the limitation of component ‘e’ in claim 1 and 9 ) is added with 1 ml of physiological saline (i.e. water, component d) , followed by homogenization at room temperature (see page 18; [109]). In Fig 3 , Yu teaches the subcutaneous injection of the pharmaceutical composition of Example 21 , at a leuprolide acetate dose of 12.5 mg/kg into the back of 6 SD rats with an average body weight of 300 g. Yu teaches that the composition of Example 21 allows excellent sustained release as demonstrated by the stable PK profile guaranteeing an efficient pharmaceutical effect (see page 20; [134] ; Fig 3 ). Yu teaches that sustained-release lipid pre-concentrate exists as a lipid liquid phase in the absence of aqueous fluid before injection, but forms liquid crystal after exposure to aqueous fluid (see page 21; [149]). Yu discloses that ‘aqueous fluid’ includes water, body fluid, etc. and the pharmaceutical composition pre-concentrate is liquid before application to the human body (i.e. subject in claim 1) and shifts into a liquid crystalline phase sustained release behavior within the body (see page 11; [66]) , meeting the limitation of claim 1 . The teachings of Yu clearly anticipate claims 1-4 and 6. Regarding claim 8, Yu teaches that in comparative Example 21, 3.75 mg of leuprolide is added with 1 ml of physiological saline, followed by homogenization at room temperature (see page 18; [109]). Physiological saline is 0.9% NaCl in distilled water (Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376). As noted in Table 2, Example 21, Yu teaches that the composition comprises 3.75 mg Leuprolide, 1 mg Phosphatidic acid, 35 mg sorbitan monooleate, 45 mg phosphatidyl choline, 15 mg tocopherol acetate and 5 mg ethanol , meeting the limitation of water in the claim . Regarding claims 16-18 , Yu teaches in Example 21 (see Table 2) weights , corresponding to ratios of component a) and component b) (1:1.2); a)+ b) and component c) (5.3:1); a)+b)+c) and component d) (1:10), meeting the limitations of the weight ratios of components in the claims. Therefore, the disclosure as taught in Yu , anticipate claims 1-4, 6, 8, 9 and 16-18 . 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 . Claim(s) 1-4, 6, 8, 9, 16 -1 9 - -23 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Yu, Ha Na et al., hereinafter Yu (WO2014/104784A4; published 3 July 2014) as evidenced by Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376 . Claims 19-23 and 27 to drawn to the species of composition elected by the applicant comprising a) Sorbitan: sorbitan monooleate/ 9 to 90 wt %; b) Phospholipid: phosphatidylcholine/ 9 to 90 wt %; c) Liquid crystal hardener: tocopherol acetate/ 0.1 to 50 wt %; d) water: 0.5 to 50 wt %; and e) GNRH analog: leuprolide/ 0.01 to 50 wt %. The teachings of Yu have been set forth above. Additionally, Yu teaches injectable sustained-release lipid pre-concentrate composition in Example 21 containing water. Here, Yu discloses that 3.75 mg leuprolide is added with 1 ml of physiological saline ( see page 18; [109]; Table 2 ; Fig 3 ). Physiological saline is 0.9% NaCl in distilled water (Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376) which corresponds to 90 wt % water in the composition in Example 21 . As disclosed in Yu, p reparation of composition in comparative example 15 , does not indicate water (see page 18; Table 4) . In Fig 3, Yu specifically teaches in vivo test for sustained release of leuprolide comparing the pharmaceutical compositions of Examples 21 and 15 by subcutaneous injection into the back of 6 SD male rats with an average body weight of 300 g. Yu teaches that the composition in Example 15 was about 2-fold higher in the initial burst concentration compared to the composition in Example 21. In Example 21 , the initial burst concentration is 5-fold higher. Notably, Yu teaches that the composition of Example 21 , allows for excellent sustained release as demonstrated by stable PK profile (pharmacokinetic profile) sufficient to guarantee an efficient pharmaceutical effect (see page 21; [134]). Yu does not teach water in the lipid pre-concentrate composition is 0.5 to 50 wt %. 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%) (MPEP § 2144.04 (II. A)) . Consequently, in the instant case, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the weight percent of water in the composition to the claimed composition in the instant application. One motivated to do so would have a reasonable expectation of success as the claimed weight percent of water falls within the range disclosed by Yu (MPEP § 2144.04 (I)). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.". See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) ( (MPEP § 2144.04 (II. A)). Thus , one would have recognized that applying the teaching of Yu, and testing by routine procedures to verify expected properties would have yielded predictable results in achieving the composition as claimed (MPEP § 2143 (I) E). 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 1-4, 6, 8, 9, 16-19--23 and 27 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-17 of U.S. Patent No. US 9,526,787 B2 in view of Yu, Ha Na et al., hereinafter Yu (WO2014/104784A4; published 3 July 2014) as evidenced by Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376. Regarding claim 1-4, 6, 8, 9, 16-19--23 and 27 , reference patent teaches a pharmaceutical composition comprising sustained release lipid pre-concentrate comprising sorbitan unsaturated fatty acid ester, phospholipid, liquid crystal hardener and pharmacologically active ingredient selected from among a protein. Reference patent teaches administering the composition to a mammal, whereby the composition transforms from a liquid state into a liquid crystal gel state (see claims 1-17). Reference patent does not teach water in the composition . As noted previously , Yu teaches a composition comprising 3.75 mg Leuprolide (i.e. pharmacologically active ingredient protein, as recited in claim 8 of reference patent), 1 mg Phosphatidic acid, 35 mg sorbitan monooleate, 45 mg phosphatidyl choline, 15 mg tocopherol acetate and 5 mg ethanol. L euprolide is added with 1 ml of physiological saline (see page 18; [109]; Table 2; Fig 3) , that is 0.9% NaCl in distilled water (Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376) which corresponds to 90 wt % water in the composition in Example 21. 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) . Consequently, in the instant case, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include leuprolide i.e., pharmacologically active ingredient in physiological saline, with the water in a specific weight percent in the composition, to generate the composition as claimed . One motivated to do so would have a reasonable expectation of success as the reference patent specifically teaches the composition comprising pharmacologically active ingredient selected from among a protein. See MPEP § 2144.04 (I). Claims 1-4, 6, 8, 9, 16-19--23 and 27 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 24 of U.S. Patent No. US 10, 722,585 B2 in view of Yu, Ha Na et al., hereinafter Yu (WO2014/104784A4; published 3 July 2014) as evidenced by Wang et al., J Orthop Surg Res . 2022 Aug 6; 17(1):376. Regarding claim 1-4, 6, 8, 9, 16-19--23 and 27 , reference patent teaches a pharmaceutical composition comprising sorbitan unsaturated fatty acid, phospholipid, liquid crystal hardener, GnRH analog wherein the composition exists as a liquid phase in the absence of aqueous fluid and forms into liquid crystal in the presence of aqueous fluid (see claims 1-24). Reference patent does not teach water. Yu specifically teaches water in the composition in Example 21, Fig 3. In vivo test for sustained release of leuprolide comparing the pharmaceutical compositions of Examples 21 (leuprolide in 1 ml of physiological saline) and Example 15 (no physiological saline) by subcutaneous injection demonstrates an initial burst concentration 5-fold higher in Example 21. Notably, Yu teaches that the composition of Example 21, allows for excellent sustained release as demonstrated by stable PK profile (pharmacokinetic profile) sufficient to guarantee an efficient pharmaceutical effect (see page 21; [134]). Consequently, in the instant case, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include leuprolide in water in a specific weight percent in the composition, to produce the claimed composition in the instant application. One motivated to do so would have a reasonable expectation of success as the reference patent specifically teaches the composition comprising leuprolide and the method of Yu discloses excellent sustained release of the composition comprising water to guarantee an efficient pharmaceutical effect. See MPEP § 2144.04 (I). Conclusion No claim is allowed. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ARCHANA VARADARAJ whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2366 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 10:00am-5:00pm . 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 Melissa Fisher can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712707430 . 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. /ARCHANA VARADARAJ/ Examiner, Art Unit 1658 /Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658