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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 20, 2026 has been entered.
The amendment filed August 20, 2026 has been entered. Claims 1, 9, 11, 13, 18-20 have been amended, claims 5 and 14 have been cancelled, and claims 23-25 have been added.
Applicant’s arguments filed August 20, 2026 were fully considered but they were not persuasive. Rejections and response to arguments as they currently apply are addressed below.
Claims 1-4, 6-13 and 15-25 are pending in this application.
Claim Objections
Claims 11 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 contains the trademark/trade names Tween® and Solutol® (See USPTO Trademark Registry). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalayoglu (WO 2014/138426, cited in previous action).
Regarding claims 23 and 25: 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).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Kalayoglu (WO 2014/138426, cited in previous action) as applied to claims 23 and 25 above, further in view of Kalaoglu (WO 2014/138426, cited in previous action).
Regarding claim 24: As discussed above Kalaoglu teaches the method of claim 24.
Kalaoglu does not explicitly teach treatment of Dercum’s disease.
However, Kalaoglu Some tumors, for example lipomas, are characterized by local collections of fat cells that may be amenable to methods used to reduce body fat. 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).
Taken together it would have been prima facie obvious to apply the method of Kalaoglu to the treatment of Dercum’s disease as suggested by Kalaoglu. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as the method of Kalaoglu teaches a method of treatment to reduce body fat, and directly suggests Dercum’s disease as one such disease to be treated by the method.
Claims 1-4, 6-11, 13, 15-25 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) and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action).
Regarding claims 1-4, 6-11, 13, 15-25: 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. Additionally,
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.
They do not teach wherein the treatment alleviates pain in the subject.
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), Ling (US 2020/0197324, cited in previous action), and Hansson (Orphanet Journal of Rare Diseases, 2012, cited in previous action) as applied to claims 1-4, 6-11, 13, and 15-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892).
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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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, Ling, and Hansson to alleviate painful liposarcomas as suggested by Huang and Enzinger. 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 and the subject population is known and in need of treatment.
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, 8-11, 13-21, and 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/718,186 (unpublished, cited on PTO-892) 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, 8-11, 13-21, and 23-25: The copending claims teach a method for reducing local fat comprising administering a pharmaceutical composition of claim 38 to a subject (copending claim 49). The copending claims teach wherein the local site has an abnormal subcutaneous deposit of adipose tissues or fat (copending claim 50). The composition is administered by subcutaneous injection (copending claim 51). The abnormal deposit of adipose tissues or fat comprises fat tissue of a tumor (copending claim 52). The tumor is a lipoma, sarcoma, liposarcoma, or lipedema (copending claim 53). The subject is a human subject that has dercum’s disease (copending claim 54). The composition has active agent comprising a curcumin compound, a resveratrol compound, or a combination thereof, an excipient comprises a polyoxyethylene solvent, the weight ratio of active agent to excipient is 1:3 to 1:000 (copending claim 38). The composition comprises polyoxyl 35 castor oil (ELP) (copending claim 40). 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.
Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/718,186 (unpublished, cited on PTO-892), 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, 13-21, and 23-25 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, 13-21, and 23-25.
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 copending Application No. 19/718,186 (unpublished, cited on PTO-892), 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, 13-21, and 23-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892). 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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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 painful liposarcomas as suggested by Huang and Enzinger. 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 and the subject population is known and in need of treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-11, 13-21, and 23-25 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, 13-21, and 23-25: 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.
Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
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, 13-21, and 23-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892). 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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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 painful liposarcomas as suggested by Huang and Enzinger. 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 and the subject population is known and in need of treatment.
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, 13-21, 23-25 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, 13-21, and 13-25: 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.
Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
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, 13-21, and 23-25 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, 13-21, and 23-25.
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, 6-11, 13-21, and 23-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892). 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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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 painful liposarcomas as suggested by Huang and Enzinger. 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 and the subject population is known and in need of treatment.
Claims 1-4, 6-11, 13-21, and 23-25 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, 13-21, and 23-25: 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.
Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
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, 13-21, and 23-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892). 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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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 painful liposarcomas as suggested by Huang and Enzinger. 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 this subject population is known in the art and is need in treatment. A person of ordinary skill in the art would recognize the applicability of the method towards treating this condition.
Claims 1-4, 6-11, 13-21, and 23-25 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, 13-21, and 23-25: 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.
Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
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, 13-21, and 23-25 above in view of Huang (Life Sciences, 2006, cited in previous action) and Enzinger (Virchows Arch. Path. Anat., 1962, cited on PTO-892). 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 painful liposarcoma or soft tissue sarcoma.
However, Huang teaches quercetin prevents atypical lipomatous tumors/well-differentiated liposarcomas from mature adipocytic proliferation (abstract). Enzinger teaches lipocarsomas can cause pain in select subjects (pg. 369, para. 4, table 3).
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 painful liposarcomas as suggested by Huang and Enzinger. 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 this subject population is known in the art and is need in treatment. 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 August 20, 2026 with respect to the claims have been fully considered but they are not persuasive.
On page 8 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. 7). 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. 7). On pages 8-10 of Applicant’s response, Applicant argues none of the applied references provide any insight with respect to whether the compositions 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 art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
On page 9 of Applicant’s response, Applicant argues that lipoma does not always cause pain, as evidenced by Cleveland Clinic.
However, according to the Cleveland Clinic reference provided by Applicant, Dercum’s disease causes painful lipomas to grow (pg. 2, what causes a lipoma?). Thus wherein the art establishes reduction of lipomas with the claimed compositions and suggests Dercums disease is amenable by such compositions, it would have been prima facie obvious to treat Dercums disease. This would reduce the painful lipomas that occur, thereby reducing/alleviating pain in the subject, absent evidence to the contrary.
On page 9 of Applicant’s response, Applicant argues Hansson discloses classification of Dercum’s disease, Hannson does not touch on the active agent used in the claimed method (last para.).
However, wherein these classifications of Dercums disease are in need of treatment, possess painful lipomas, it would have been obvious to apply the treatment of reducing lipomas in a subject with a reasonable expectation of success, given the arts recognition of the compositions reducing lipomas generally.
On page 10 of Applicant’s response, Applicant argues there is no suggestion that quercetin has the effect of alleviating pain caused by liposcarcomas (para. 3).
However, see response to arguments above wherein pain is resolved by treating the underlying condition. Also see modified 103 rejections above using Enzinger as a reference, establishing that liposarcoma patients have pain as their symptoms. Wherein the patient subpopulation is known in the art and is in need in treatment, a person of ordinary skill in the art would be motivated to target this subpopulation specifically.
On pages 10-13 of Applicant’s response, Applicant argues that the double patenting rejections do not touch on the ability of the active agents to alleviate pain caused by abnormal subcutaneous deposit of adipose tissue or fat.
However, see response to arguments above wherein pain is resolved by treating the underlying condition. Also see modified double patenting rejections above using Enzinger as a reference, establishing that liposarcoma patients have pain as their symptoms. Wherein the patient subpopulation is known in the art and is in need in treatment, a person of ordinary skill in the art would be motivated to target this subpopulation specifically.
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.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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