DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I in the reply filed on 1/15/2026 is acknowledged.
Claims 7-9 and 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/15/2026.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 6/23/2023 and 12/10/2025 are acknowledged.
Claim Rejections - 35 USC § 103
3. 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.
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.
Claims 1-5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. KR 102112702 in view of Thibonnier (WO 2020010059).
Jeong et al. KR 102112702 (hereinafter Jeong et al.) disclose nanoparticles comprising a calcium carbonate crystal and a biocompatible polymer, wherein the calcium carbonate crystal is incorporated in the biocompatible polymer (para 0038 and claim 1). An adipocyte targeting peptide is located on the surface of the nanoparticles (para 0038 and claim 1). The biocompatible polymer includes those such as PLGA (claim 6). The diameter of the nanoparticles may be 100 nm to 250 nm.
A fatty acid located on the surface is not disclosed.
Thibonnier (WO 2020010059) (hereinafter Thibonnier) discloses adipocyte targeting compositions for treating an obese patient, and disclose a lipid, which is dodecanoic acid, palmitic acid, steric acid, oleic acid or hexadecenoic acid as a targeting element for promoting delivery of the therapeutic agent to a targeted adipocyte (claims 1, 7, 8, 23 and 24). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to apply the lipids as taught by Thibonnier, which is an adipocyte targeting element and substitute for the adipocyte targeting peptide of Jeong et al. Substitution of one adipocyte targeting element for another would yield predicable results as both are known to target adipocytes.
4. Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. KR 102112702 in view of Thibonnier (WO 2020010059), as applied to claims 1-5 and 10 above, and further in view of (JP 2018500327).
The modified Jeong et al. has been discussed supra and does not disclose the weight ratio of fatty acid and biocompatible polymer.
(JP 2018500327) disclose that the ratio of the HDL component to polymer is adjusted to achieve the desired result, such as maintaining lipid homeostasis and these include ratios of 1:9 to 9:1. The HDL component is cholesterol and the core polymer is PLGA. The molecules or moieties attached to the core (e.g., HDL components) can be present in the core, can be present on the outer surface of the nanoparticle, or between the core and outer surface of the nanoparticle. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to optimize the ratio of the lipid (e.g., HDL component) to the polymer component. One would have been motivated to do so to maintain the desired lipid homeostasis.
DOUBLE PATENTING
5. 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 1-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17787274 in view of Jeong et al. KR 102112702 in view of Thibonnier (WO 2020010059).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to biocompatible nanoparticles encapsulating calcium carbonate crystals that are surface modified. The differences being that the ‘274 application does not disclose fatty acid surface modified nanoparticles.
Thibonnier discloses adipocyte targeting compositions for treating an obese patient, and disclose a lipid, which is dodecanoic acid, palmitic acid, steric acid, oleic acid or hexadecenoic acid as a targeting element for promoting delivery of the therapeutic agent to a targeted adipocyte (claims 1, 7, 8, 23 and 24). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to apply the lipids as taught by Thibonnier, which is an adipocyte targeting element and substitute for the adipocyte targeting peptide of Jeong et al. Substitution of one adipocyte targeting element for another would yield predicable results as both are known to target adipocytes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CORRESPONDENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615
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