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 .
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.
Response to Amendment
The amendment filed March 16, 2026 has been entered. Claims 1, 3-4, 6-8, 10-12, 18-19 have been amended, claims 5 have been cancelled, and claims 20-22 have been added. Applicant’s amendments to the claims have overcome 112(b) and 102 rejections previously set forth in the Non-Final Office Action mailed September 16, 2025. Applicants cancellation of claim 5 have rendered the corresponding rejections/objections moot. As such, these rejections are hereby withdrawn. This application claims benefit of provisional application 63/342,284 filed May 16, 2022.
Applicant’s arguments filed March 16, 2026 were fully considered but they were not persuasive. Modified/New rejections necessitated by Applicant’s amendment and response to arguments as they currently apply are addressed below.
Claims 1-4 and 6-22 are pending in this application.
Modified/New 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.
Claims 1-4, 6-10, and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kalayoglu (WO 2014/138426, cited in previous action) in view of Ling (US 2020/0197324, cited in previous action).
Regarding claims 1-4, 6-10, and 13-21: Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009. Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). According to the instant specification, a lipoma is a benign tumor (pg. 4, para. 0015). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Kalayoglu teaches the compositions are directed towards suitable administration to humans (pg. 17, para. 0077, pg. 36, para. 00165).
Kalayoglu does not specifically teach alleviating a condition, such as a lipoma, familial multiple lipomatosis, or Dercum’s disease, caused by abnormal subcutaneous deposit of adipose tissue or fat in a subject.
However, wherein Kalayoglu is drawn to a reduction in reduce body fat comprising administration of resveratrol or curcumin compositions with a carrier, and suggests that diseases characterized by lipomas such as familial multiple lipomatosis, adiposis dolorosis (Dercum’s disease), and pelvic lipomatosis may be may be amenable to methods that reduce body fat, it would have been prima facie obvious to a person of ordinary skill in the art to apply the method of Kalayoglu to the alleviation of these conditions. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as Kalayoglu teaches lipomas, a collection of fat cells, are characteristic of these diseases and the method drawn to reducing body fat would effectively reduce these lipomas.
Kalayoglu does not teach wherein the carrier comprises a pharmaceutically acceptable non-ionic surfactant that has an HLB value greater than 10, such as a polyoxyethylene castor oil derivative, and wherein the active agent forms a plurality of micelles with the surfactant. Kalayoglu does not teach wherein the weight ratio of the active agent to surfactant is 1:2-1:500. Kalayoglu does not teach wherein the micelles have a diameter of 1nm to 200 nm.
However, Ling teaches pharmaceutical composition for reducing localized fat, comprising drug-containing micelles made of surfactants, and curcumin encapsulated in said drug-containing micelles (abstract). Ling teaches the formulation has the advantage of high stability, high fat tissue bioavailability, few side effects, and sustained release (pg. 1, para. 0006). Ling teaches the compositions can include resveratrol (pgs. 1-2, para. 0016). This pharmaceutical composition for reducing localized fat can reduce the fat at the administration site, and has the advantages of high stability, high bioavailability for fat tissue, few side effects, and sustained release (abstract). The drug-containing micelles are a microstructure formed by a pharmaceutically acceptable polyoxyethylene castor oil derivative, and the hydrophilic-lipophilic balance value (HLB value) of the polyoxyethylene castor oil derivative is greater than 10 (pg. 2, para. 0027). The preferred weight ratio of curcuminoid to polyoxyethene is 1:5-1:500 (pg. 2, para. 0034). The preferred diameter of the drug-containing micelles is 3-50 nm (pg. 2, para. 0041). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (See MPEP 2144.05 (I)). The formulations can be for injection and injected into the subcutaneous fat layer of rats (pg. 2, para. 0019, pg. 10, para. 0224, pg. 14, para. 0279). The formulations can be administered to a human (pg. 16, paras. 0315-0316).
Taken together, it would have been prima facie obvious to modify the method of Kalayoglu such that the formulations of Ling are utilized for the purpose of treating the diseases characterized by localized fat. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the formulation is known in the art for reducing localized fat and has the added benefit of high stability, high fat tissue bioavailability, few side effects, and sustained release.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kalayoglu (WO 2014/138426, cited in previous action) and Ling (US 2020/0197324, cited in previous action) as applied to claims 1-4, 6-10, and 13-21 above in view of Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action).
Regarding claim 11: As discussed above, Ling and Kalayoglu render obvious the methods of 1-10 and 12-19. Kalayoglu establishes adiposis dolorosis (Dercum’s disease), a disease characterized by multiple lipomas, may be amenable to methods used to reduce body fat. Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198).
They do not teach wherein the lipoma is a diffuse or nodular lipoma.
However, Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form – a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form – a form with pain in and around multiple lipomas IV. Juxtaarticular form – a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of Ling and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kalayoglu (WO 2014/138426, cited in previous action) and Ling (US 2020/0197324, cited in previous action) as applied to claims 1-4, 6-10, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action).
Regarding claims 12 and 22: As discussed above Kalayoglu and Ling render obvious the method of claim 9. Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111). Ling teaches quercetin can be a drug included in the formulation (pg. 3, para. 0050). It is prima facie obvious to substitute equivalents for the same purpose (See MPEP 2144.06 (I)).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over Kalayoglu and Ling utilizing quercetin to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
Modified/New 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, 6-8 and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/466,003 (US 2024/0165050, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1-4, 6-8 and 14-18: The copending claims teach a method for treating edematous fibrosclerotic panniculopathy in a subject in need thereof comprising administering an effective amount of a pharmaceutical composition to the subject, wherein the pharmaceutical composition comprises a plurality of amphiphilic nanoparticles having one or active ingredients encapsulated therein, each of the amphiphilic nanoparticles is formed by of a non-ionic surfactant, a polymeric carrier, or a lipid carrier, and a hydrophilic-lipophilic balance (HLB) value of the non-ionic surfactant is greater than 9, wherein the pharmaceutical composition is administered via a parenteral route by an injection, a microneedle, or an implant, or via topical administration or transdermal administration (copending claim 1). The amphiphilic nanoparticles are a plurality of micelles formed by the non-ionic surfactant, and the active ingredients are one or more lipophilic components and/or hydrophilic components (copending claim 7). The non-ionic surfactant comprises at least one member selected from polysorbate 80, polyoxyl 15 hydroxystearate, polyoxyethylene derivatives, and polyoxyethylene castor oil derivatives (copending claim 8). The method of claim 1, wherein the active ingredients comprise one or more lipophilic components, and the lipophilic components comprise at least one member selected from curcumin, quercetin, oxyresveratrol, resveratrol, and derivatives, metabolites, or isomers thereof (copending claim 9). The method of claim 1, wherein a weight ratio of the active ingredients to the non-ionic surfactant, the polymeric carrier, or the lipid carrier falls within a range of 1:2 to 1:500 (copending claim 10). The a diameter of each of the amphiphilic nanoparticles is less than 200 nm, and a polydispersity index (PDI) of the amphiphilic nanoparticles is less than 0.4 (copending claim 13). According to the copending specification, edematous fibrosclerotic panniculopathy (EFP), also known as cellulite, gynoid lipodystrophy, or local lipodystrophy, is a topographic alteration of the skin and subcutaneous adipose commonly observed on the buttocks, lower limbs, and abdomen (pg. 1, para. 0002). Thus EPP is a condition caused by abnormal subcutaneous deposit of adipose tissue or fat in a subject. The copending claims are encompassed by instant claims 1-4, 6-8 and 14-18.
Claims 9-11, 13, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/466,003 (US 2024/0165050, cited in previous action) as applied to claims 1-4, 6-8 and 14-18 above in view of Kalayoglu (WO 2014/138426, cited in previous action), Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 9-11, 13, 19-21: As discussed above the copending claims teach the methods of claims 1-4, 6-8 and 14-18.
They do not teach wherein the condition to be treated are lipoma related conditions as recited by instant claims 9-11 and 13 via administration to the lipoma as recited by instant claim 19.
However, as discussed above with the 103 rejections, Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009). Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form - a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form - a form with pain in and around multiple lipomas IV. Juxtaarticular form - a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of the copending claims and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/466,003 (US 2024/0165050, cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6-11, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 12 and 22: As discussed above the copending claims, Kalayoglu and Hansson render obvious the method of claim 9. The copending claims teach the composition can comprise quercetin (claim 14). Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over the copending claims, Kalayoglu and Hansson to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition and the art establishes resveratrol, quercetin are equivalents suitable for the same purpose. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-11, and 13-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/169,585 (US 2023/0190674, cited in previous action) in view of Kalayoglu (WO 2014/138426, cited in previous action) and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1-4, 6-11, and 13-21: The copending claims teach a method for reducing subcutaneous fat comprising administering subcutaneously a pharmaceutical composition to a subject at a local site where reduction of local subcutaneous fat is needed wherein the pharmaceutical composition administered comprises a plurality of micelles comprising resveratrol and a non-ionic surfactant wherein the non-ionic surfactant has an HLB value greater than 10 (copending claim 1). The non-ionic surfactant comprises a polyoxyethylene castor oil derivative (copending claim 2). The weight ratio of resveratrol to the surfactant is 1:4 to 1:500 (copending claim 4). The subject is human (copending claim 21). The diameter of the microstructure (i.e. micelle) ranges from 5-50 nm (copending claim 24).
They do not teach a method of alleviating a condition caused by abnormal subcutaneous fat in a subject or wherein the condition to be treated are lipoma related conditions as recited by instant claims 9-11 and 13 via administration to the lipoma as recited by instant claim 19.
However, as discussed above with the 103 rejections, Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009). Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form - a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form - a form with pain in and around multiple lipomas IV. Juxtaarticular form - a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of the copending claims and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/169,585 (US 2023/0190674, cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6-11, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 12 and 22: As discussed above the copending claims, Kalayoglu and Hansson render obvious the method of claim 9. The copending claims teach the composition can comprise quercetin (claim 11). Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over the copending claims, Kalayoglu and Hansson to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition and the art establishes resveratrol, quercetin are equivalents suitable for the same purpose. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 8-11, and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,716,824 (cited in previous action) in view of Kalayoglu (WO 2014/138426, cited in previous action) and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action).
Regarding claims 1-4, 6, 8-11, and 13-21: The patented claims teach a method for reducing subcutaneous fat comprising administering subcutaneously a pharmaceutical composition to a subject at a local site where reduction of local subcutaneous fat is needed wherein the pharmaceutical composition administered are encompassed by the instantly claimed compositions. Specifically patented claims 1-2 teach:
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The patented claims teach the composition can further comprise resveratrol (claim 19).
They do not teach a method of alleviating a condition caused by abnormal subcutaneous fat in a subject or wherein the condition to be treated are lipoma related conditions as recited by instant claims 9-11 and 13 via administration to the lipoma as recited by instant claim 19.
However, as discussed above with the 103 rejections, Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009). Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form - a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form - a form with pain in and around multiple lipomas IV. Juxtaarticular form - a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of the copending claims and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,716,824 (cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6, 8-11, and 13-21 above in view of Ling (US 2020/0197324, cited in previous action).
Regarding claim 7: As discussed above, the patented claims and prior art render obvious the method of claims 1-4, 6, 8-11, and 13-21.
They do not teach wherein the micelles have a diameter ranging from about 1 nm to about 200 nm.
However Ling teaches pharmaceutical composition for reducing localized fat, comprising drug-containing micelles made of surfactants, and curcumin encapsulated in said drug-containing micelles (abstract). This pharmaceutical composition for reducing localized fat can reduce the fat at the administration site, and has the advantages of high stability, high bioavailability for fat tissue, few side effects, and sustained release (abstract). The drug-containing micelles are a microstructure formed by a pharmaceutically acceptable polyoxyethylene castor oil derivative, and the hydrophilic-lipophilic balance value (HLB value) of the polyoxyethylene castor oil derivative is greater than 10 (pg. 2, para. 0027). The preferred weight ratio of curcuminoid to polyoxyethene is 1:5-1:500 (pg. 2, para. 0034). The preferred diameter of the drug-containing micelles is 3-50 nm (pg. 2, para. 0041). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (See MPEP 2144.05 (I)). The formulations can be for injection and injected into the subcutaneous fat layer of rats (pg. 2, para. 0019, pg. 10, para. 0224, pg. 14, para. 0279). The formulations can be administered to a human (pg. 16, paras. 0315-0316).
Taken together, it would have been prima facie obvious to person of ordinary skill in the art to modify the method such that the micelles have a diameter ranging from about 1 nm to about 200 nm as taught by Ling. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success given that this formulation has been shown in the art to effectively reduce body fat, thereby ameliorating the condition.
Claims 12 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,716,824 (cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6, 8-11, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 12 and 22: As discussed above the patented claims, Kalayoglu and Hansson render obvious the method of claim 9.. Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over the patented claims, Kalayoglu and Hansson to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition and the art establishes resveratrol, curcumin, and quercetin are equivalents suitable for the same purpose. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
Claims 1-4, 6-11, and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,433,034 (cited in previous action) in view of Kalayoglu (WO 2014/138426, cited in previous action) and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action).
Regarding claims 1-4, 6-11, and 13-21: The patented claims teach a method for reducing subcutaneous fat comprising administering subcutaneously a pharmaceutical composition to a subject at a local site where reduction of local subcutaneous fat is needed wherein the pharmaceutical composition administered are encompassed by the instantly claimed compositions. Specifically patented claims 1-5 teach:
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The phrase curcumonoid includes curcumin. The patented claims include quercetin (claim 11).
They do not teach a method of alleviating a condition caused by abnormal subcutaneous fat in a subject or wherein the condition to be treated are lipoma related conditions as recited by instant claims 9-11 and 13 via administration to the lipoma as recited by instant claim 19.
However, as discussed above with the 103 rejections, Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009). Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form - a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form - a form with pain in and around multiple lipomas IV. Juxtaarticular form - a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of the copending claims and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
Claims 12 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,433,034 (cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6-11, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 12 and 22: As discussed above the patented claims, Kalayoglu and Hansson render obvious the method of claim 9. The patented claims include quercetin (claim 11). Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over the patented claims, Kalayoglu and Hansson utilizing quercetin to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
Claims 1-4, 6-11, and 13-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,357,588 (cited in previous action) in view of Kalayoglu (WO 2014/138426, cited in previous action) and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action).
Regarding claims 1-4, 6-11, and 13-21: The patented claims teach a method for reducing subcutaneous fat comprising administering subcutaneously a pharmaceutical composition to a subject at a local site where reduction of local subcutaneous fat is needed wherein the pharmaceutical composition administered are encompassed by the instantly claimed compositions. Specifically patented claim 1 teaches:
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. Patented claim 5 teaches:
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. Patented claims 14-16 teach:
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The phrase curcumonoid includes curcumin. The patented claims include quercetin in the composition (patented claim 3).
They do not teach a method of alleviating a condition caused by abnormal subcutaneous fat in a subject or wherein the condition to be treated are lipoma related conditions as recited by instant claims 9-11 and 13 via administration to the lipoma as recited by instant claim 19.
However, as discussed above with the 103 rejections, Kalayoglu teaches a method comprising local administration of certain AMPK activators to the skin or subcutaneous fat of a subject causes local reduction of body fat and adipocytes in the subject (pg. 4, para. 0021). Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Kalayoglu teaches some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat (pg. 2, para. 0009). Lipomatosis is any condition characterized by the formation of multiple lipomas on the body, e.g., familial multiple lipomatosis, adiposis dolorosis (Dercum's disease), pelvic lipomatosis, etc (pg. 2, para. 0009). Kalayoglu teaches in certain embodiments the compound to be administered is resveratrol (formula (V), pg. 6, para. 0029) or curcumin (formula (XXII), pg. 11, para. 0046). Kalayoglu specifically teaches formulations comprising curcumin and lipoderm® (i.e. carrier, pgs. 44-45, para. 00208, table III, group 7). Kalayoglu teaches administration locally can comprise administering to the skin, subcutaneously, by injection (e.g. to a visceral fat deposit), and administering intralesionally (e.g., within a lipoma) (pg. 14, para. 0063). Kalayoglu teaches the compounds can be used in a pharmaceutical composition and a carrier (pg. 30, para. 00137-00138, pg. 35, para. 00160). Kalayoglu teaches compositions can be formulated for parenteral administration (pg. 34, para. 00156). Hansson teaches Dercum’s disease is classified into: I. Generalized diffuse form A form with diffusely widespread painful adipose tissue without clear lipomas, II. Generalized nodular form - a form with general pain in adipose tissue and intense pain in and around multiple lipomas, and III. Localized nodular form - a form with pain in and around multiple lipomas IV. Juxtaarticular form - a form with solitary deposits of excess fat for example at the medial aspect of the knee (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method to the treatment of class I-III Dercum’s diseases as suggested by Hansson. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the method of the copending claims and Kalayoglu are capable of reducing body fat in adipose tissue/lipoma thereby ameliorating Dercum’s disease, and these classes of Dercum’s disease are known in the art, are in need of treatment, and are characterized by nodular/diffuse adipose tissue/lipomas as taught by Hansson.
Claims 12 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,357,588 (cited in previous action), Kalayoglu (WO 2014/138426, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6-11, and 13-21 above in view of Huang (Life Sciences, 2006, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 12 and 22: As discussed above the patented claims, Kalayoglu and Hansson render obvious the method of claim 9. The patented claims include quercetin in the composition (patented claim 3). Kalayoglu teaches quercetin can be used as an alternative active compound (pg. 24, para. 00111).
They do not teach wherein the tumor is a malignant tumor that is liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to apply the method rendered obvious over the patented claims, Kalayoglu and Hansson utilizing quercetin to alleviate liposarcomas as suggested by Huang. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as quercetin is recognized in the art as having therapeutic efficacy against this condition. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
Response to Arguments
Applicant’s arguments filed March 16, 2026 with respect to the claims have been fully considered but they are not persuasive.
On page 9 of Applicant’s response, Applicant argues the instant method overcomes the obviousness rejections described above, because the claimed method achieves unexpected therapeutic effects (last para.). On page 10 of Applicant’s response, Applicant argues the instant application demonstrates a working example of treating lipoma and Dercum’s disease in human patients using a curcumin-containing example (para. 1). Applicant specifically points to Example 2. Applicant argues the curcumin composition is effective in alleviating pain in human patients with lipoma and Dercum’s disease (para. 1). Applicant argues that a skilled person would not have expected reducing fat could result in pain relief, in which pain management in Dercum’s disease is a known challenge in the art (paras. 2-3). Applicant states that, “
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(para. 2) Applicant argues neither Ling nor Kalayoglu provide any insight with respect to whether the curcumin-containing composition of Ling would be effective in alleviating pain in patients with lipoma and Dercum’s disease.
However, according to the instant specification Dercum’s disease is characterized by chronic pain due to multiple lipomas in the adipose tissue and has symptoms comprising characteristic painful episodes (pg. 1, paras. 0002-0003). As discussed above, Kalayoglu establishes adiposis dolorosis (Dercum’s disease), a disease characterized by multiple lipomas, may be amenable to methods used to reduce body fat. Kalayoglu teaches that treatment of an adipocyte-related disease can be accomplished by adipocytes that is microscopic rather than macroscopic, or diffuse rather than focal (pg. 42, para. 00198). Thus, wherein the prior art suggests treatment of Dercum’s disease, a person of ordinary skill in the art would expect pain to decrease in patients via treatment of the underlying condition. Even if the argument of unexpected results were found to be persuasive, Example 2 of the instant specification demonstrates the use of a single composition comprising curcumin (pg. 34, para. 00149). Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support (See MPEP 716.02(d)). The instant claims are not limited to treating Dercums disease with the composition utilized in example 2).
On page 11 of Applicant’s response, Applicant argues that Hansson does not negate the argument of unexpected results as argued above (paras. 3-5).
See response to arguments above.
On pages 12-13 of Applicant’s response, Applicant argues that the double patenting rejections over copending application 18169585 are improper because they do not establish the superior pain-relieving effects achieved by the instant claims (section II).
See response to arguments above.
On pages 13 of Applicant’s response, Applicant argues that the double patenting rejections over US patent 10716824 are improper because they do not establish the superior pain-relieving effects achieved by the instant claims (section III).
See response to arguments above.
On pages 13-14 of Applicant’s response, Applicant argues that the double patenting rejections over US patent 11433034 are improper because they do not establish the superior pain-relieving effects achieved by the instant claims (section IV).
See response to arguments above.
On page 14 of Applicant’s response, Applicant argues that the double patenting rejections over US patent 11433034 are improper because they do not establish the superior pain-relieving effects achieved by the instant claims (section V).
See response to arguments above.
On page 14 of Applicant’s response, Applicant argues that the newly added claims are novel and non-obvious over the cited references and are patentably distinct compared to the conflicting US patents and copending application (last para.).
See response to arguments above.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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