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 .
Priority
This application is a national stage entry of PCT/CN2022/103787 filed on 07/05/2022.
Response to Amendment
Applicant’s amendment filed on March 24, 2026 amending claim 1 and canceling claim 2 has been entered. Claims 1 and 3-24 are currently pending.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1 and 3-19) drawn to an injectable composition comprising cytolytic compound in gel, gel-forming solution or gel-forming suspension for reduction of fat, comprising: a cytolytic compound as a first component; and a pharmaceutically acceptable excipient in the reply filed on March 24, 2026 is acknowledged. Applicant's election with traverse of deoxycholic acid (DCA) or a salt thereof as a cytolytic compound; L-lysine as a species of a basic amino acid; aspirin as a species of an anti-inflammatory drug; and lidocaine as a species of a local anesthetic in the reply filed on March 24, 2026 is also acknowledged.
The traversal is on the ground(s) that Sun et al. does not teach the technical feature of the claims as currently amended since Sun et al. does not teach a concentration of deoxycholate ion equivalent to that in 7-51 mg/ml of sodium deoxycholate and Sun et al. does not teach a composition for reduction of fat. These arguments are not found persuasive because claim 1 is now currently amended and said limitations were not previously present. Thus the technical feature determined in the claims as previously presented was a composition of claim 1 which did not require any specific amounts of deoxycholate ions. Moreover, “for reduction of fat” is an intended use of the composition and not afforded patentable weight because if the composition of the prior art is the same as claimed, the composition of the prior art is necessarily capable of performing the claimed intended use. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Furthermore, even if the amendments as currently claimed were previously presented, other prior art references would have been applied to teach the technical feature and thus demonstrate that the technical feature is not a special technical feature (see rejections below). Applicant’s arguments with respect to the species elections are found not persuasive since these species elections are required for search purposes only and if Applicant’s elected species are not found in the prior art, the search will be expanded to include the additional non-elected claimed species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-12 are being examined as they read on the elected species.
Drawings
The drawings filed on November 30, 2023 are objected to because the text is too small and illegible, and the details of the figures cannot be ascertained. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The claims are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Vidal WO 2021/041891 A1 (Provided on IDS).
Claim 1 of the instant application claims an injectable composition comprising cytolytic compound in gel, gel-forming solution or gel-forming suspension for reduction of fat, comprising: a cytolytic compound as a first component; and a pharmaceutically acceptable excipient; wherein the cytolytic compound is DCA or its pharmaceutically acceptable salt, the concentration of deoxycholate ion is equivalent to that in 7-51 mg/mL of sodium deoxycholate. The claims are being interpreted as the composition comprises 7-51 mg/mL of sodium deoxycholate or 0.7% to 5.1% of sodium deoxycholate.
Vidal teaches uses of deoxycholic acid, salts, or derivatives thereof in managing bacterial infections and compositions related thereto (page 1 lines 25-26). Vidal teaches an effective amount is a liquid, paste, or gel composition comprising deoxycholic acid, salts, or derivatives thereof at a concentration between 10.0 mg/mL to 0.1 mg/mL (page 1 lines 1-3).
Vidal teaches in certain embodiments, pharmaceutical compositions comprising a deoxycholic acid, salt, or derivative thereof and optionally a second antibiotic and optionally a glucocorticoid (page 2 lines 25-27). Vidal teaches in certain embodiments, the deoxycholic acid, salt, or derivative thereof is at a concentration of less than 10.0 and greater than 0.1 mg/mL and the glucocorticoid is selected from cortisol (hydrocortisone), cortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, fludrocortisone acetate, and deoxycorticosterone acetate (page 2 line 27- page 3 line 3).
Vidal teaches in some embodiments, the composition further comprises an additional therapeutic agent, including an additional antimicrobial agent, an anti-inflammatory agent, a corticosteroid, or combinations thereof (page 10 lines 7-14, page 15 lines 5-8).
Vidal teaches in certain embodiments the composition comprises a pharmaceutically acceptable gel formulation providing immediate release of deoxycholic acid, salts, or derivatives thereof, and additional embodiments of the formulation may also include an agent that enhances the viscosity of the formulations (page 12 lines 1-4).
Vidal teaches in certain embodiments, the compositions comprise the agents disclosed therein impregnated into gels and pastes disclosed therein optionally comprising biodegradable polymers (page 15 line 14-page 17 line 11). In certain embodiments, this disclosure relates to compositions comprising agents disclosed therein and at least one gelling agent (page 15 line 4-page 17 line 11).
Vidal teaches that bile salts produced in the human liver and secreted into the gut, include sodium deoxycholate (page 19 lines 26-27). Vidal teaches that sodium deoxycholate at a concentration of 10 mg/mL is an injectable treatment to reduce fat under the chin (page 19 lines 27-28).
Vidal specifically teaches the preparation of a formulation comprising Sodium deoxycholate (page 20 lines 13-17). Vidal also further specifically teaches the preparation of a sterile Sodium deoxycholate gel pH to 8.3 (page 20 lines 19-23). Vidal further teaches the preparation of a sterile Sodium deoxycholate gel comprising dexamethasone pH to 8.3 (page 20 lines 25-30).
Thus Vidal specifically teaches a composition comprising a cytolytic compound in gel, gel-forming solution or gel-forming suspension comprising: a cytolytic compound as a first component; and a pharmaceutically acceptable excipient; wherein the cytolytic compound is DCA or its pharmaceutically acceptable salt, which is sodium deoxycholate.
Vidal does not teach the specific concentration range of 7-51 mg/mL of sodium deoxycholate.
However, Vidal teaches a gel composition comprising deoxycholic acid, salts, or derivatives thereof at a concentration between 10.0 mg/mL to 0.1 mg/mL which overlaps with the claimed range of 7-51 mg/ml.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
With respect to the limitation of an injectable composition, it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). Moreover, with respect to the claimed intended use of for reduction of fat, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Furthermore, Vidal specifically teaches that sodium deoxycholate at a concentration of 10 mg/mL is an injectable treatment to reduce fat under the chin, and thus it is known in the art that formulations such as those taught in Vidal which contain sodium deoxycholate can be injected (page 19 lines 27-28). Moreover, since Vidal teaches a sterile gel formulation comprising sodium deoxycholate in amounts that overlap with the claimed amounts, the composition of Vidal is necessarily capable of being an injectable composition for reduction of fat as claimed in the instant claims. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Thus claim 1 of the instant application is rendered obvious over Vidal.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vidal WO 2021/041891 A1 (Provided on IDS) as applied to claim 1 above and further in view of He et al. (Luminescence 2012; 27: 4–10).
Claims 3-8 of the instant application further claim the composition further comprises a second component which is elected as the basic amino acid, L-lysine, and a third component which is an anti-inflammatory agent.
Vidal is as set forth above.
Vidal does not teach further including a basic amino acid such as L-lysine.
He et al. investigates the influence of three alkaline amino acids, L-lysine, L-arginine, and L-histidine on aggregation behavior of sodium deoxycholate (NaDC) (abstract). He et al. teaches that the added amino acids can effectively make it is easier for NaDC to aggregate in a compact manner (abstract). He et al. teaches that the presence of amino acids result in the aggregation numbers of NaDC to increase, indicating that more NaDC molecules connect together to form stable aggregates (abstract). He et al. studies concentrations of L-Lysine between 10 mmol/L and 100 mmol/L which is equal to about 1.5 mg/ml to about 15 mg/ml (molecular weight of L-lysine 146.19 g/mole) (figure 2 page 5).
He et al. teaches that the performance of L‐Arg is similar to that of L‐His, and both of these amino acids produce a smaller effect on the three parameters than does L‐Lys, wherein the three parameters, including electrostatic effect, hydrophobic interaction and hydrogen bonding, which provide an important impetus during the interaction between amino acids and NaDC for the growth of aggregates (page 9). He et al. teaches that in consideration of the pKa values and hydrophobic index of the three amino acids, it is L‐Lys that exerts strongest effect on the aggregation behavior of NaDC (page 9).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Vidal which teaches a composition comprising sodium deoxycholate, with the teachings of He et al. which teaches that the addition of amino acids including L-lysine, L-arginine, and L-histidine improves aggregation behavior of sodium deoxycholate (NaDC), effectively making it is easier for NaDC to aggregate resulting in the aggregation numbers of NaDC to increase, indicating that more NaDC molecules connect together to form stable aggregates. Thus He et al. teaches that the addition of L-lysine and other amino acids improves the properties of sodium deoxycholate formulations. Therefore, an ordinary skilled artisan would have been motivated to add L-lysine to the sodium deoxycholate formulation of Vidal with a reasonable expectation of improving the properties of the formulation by increasing stability of the sodium deoxycholate in the formulation.
With respect to claim 6 which claims the concentration of L-lysine is 11-145 mg/mL, He et al. teaches concentrations of L-Lysine between 10 mmol/L and 100 mmol/L which is equal to about 1.5 mg/ml to about 15 mg/ml (molecular weight of L-lysine 146.19 g/mole). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
With respect to claim 7, Vidal teaches the preparation of a sterile sodium deoxycholate gel having a pH of 8.3 which is close to the pH of 6.45-7.75 as claimed (page 20 lines 19-23). In addition, Vidal teaches the pH of the formulations is about 8.1 to about 8.5 or about 7.5 to about 8.5 which overlaps with the claimed range of 6.45-7.75 (page 13 lines 1-7). With regard to the limitation in claim 7 wherein the pH of L-lysine before mixing is <8.0, said limitation is interpreted as a product by process limitation. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. Thus in the absence of a demonstration of criticality of adjusting the pH of L-lysine to <8.0 before mixing, claim 7 of the instant application is rendered obvious.
Claim 8 of the instant application is rendered obvious since Vidal teaches in some embodiments, the composition further comprises an additional therapeutic agent, including an additional antimicrobial agent, an anti-inflammatory agent, a corticosteroid, or combinations thereof (page 10 lines 7-14, page 15 lines 5-8). Moreover, Vidal specifically teaches the preparation of a sterile Sodium deoxycholate gel comprising the anti-inflammatory agent dexamethasone (page 20 lines 25-30).
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vidal WO 2021/041891 A1 (Provided on IDS) in view of He et al. (Luminescence 2012; 27: 4–10) as applied to claims 1 and 3-8 above and further in view of Kolodney et al. WO 2006/086038.
Claims 9 and 10 of the instant application claim the injectable composition further comprises an anti-inflammatory drug as a third component, wherein the anti-inflammatory drug is aspirin and the concentration of aspirin is 14-100 mg/mL or 1.4%-10%.
Vidal in view of He et al. is as set forth above.
Vidal in view of He et al. do not teach the addition of aspirin.
However, Vidal teaches in certain embodiments the composition can further comprise a second therapeutic agent selected from the group consisting of: anti-microbial agents, vasoconstrictors, anti-thrombotic agents, anti-coagulation agents, anti-depressants, anti-inflammatory agents, analgesics, dispersion agents, anti-dispersion agents, penetration enhancers, steroids, tranquilizers, muscle relaxants, and anti-diarrhea agents (page 15 lines 5-9).
The teachings of Kolodney et al. are related to the teachings of Vidal in that they pertain to formulations containing pharmacologically active detergents or bile acid(s) and/or bile salt(s), or deoxycholic acid or a salt thereof, or sodium deoxycholate (abstract and [0007]). Kolodney et al. teaches that the formulations can further comprise a second therapeutic agent selected from the group consisting of: anti-microbial agents, vasoconstrictors, anti-thrombotic agents, anti-coagulation agents, suds-depressants, anti-inflammatory agents, analgesics, dispersion agents, anti-dispersion agents, penetration enhancers, steroids, tranquilizers, muscle relaxants, and anti-diarrhea agents [0008]. Thus Kolodney et al. teaches suitable agents for formulations containing deoxycholic acid or salts thereof. Kolodney et al. teaches that examples of anti-thrombotic agents that can be used with the compositions include the anti-platelet aggregation agent aspirin [00116]. Kolodney et al. teaches that examples of anti-coagulation agents that can be used with the compositions include aspirin [00117]. Kolodney et al. teaches that suitable non-steroidal anti-inflammatory agents include aspirin [00122]. Thus, Kolodney et al. teaches that aspirin serves multiple purposes including anti-coagulation, anti-thrombotic and anti-inflammatory.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Vidal which teaches in certain embodiments the composition can further comprise a second therapeutic agent selected from the group consisting of: anti-microbial agents, vasoconstrictors, anti-thrombotic agents, anti-coagulation agents, anti-depressants, anti-inflammatory agents, analgesics, dispersion agents, anti-dispersion agents, penetration enhancers, steroids, tranquilizers, muscle relaxants, and anti-diarrhea agents, with the teachings of Kolodney et al. which teaches that aspirin serves as an anti-thrombotic agent, an anti-coagulation agent, and an anti-inflammatory agent. Thus, an ordinary skilled artisan would have been motivated to include aspirin in the composition of Vidal as a second therapeutic agent with a reasonable expectation of providing anti-thrombotic, anti-coagulation, and anti-inflammatory properties.
With regard to the amount as claimed in claim 10 of the instant application, it is within the skill of an ordinary skilled artisan to include an amount effective for the intended purpose which is for providing anti-thrombotic, anti-coagulation, and anti-inflammatory properties. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Thus claims 9 and 10 are rendered obvious in view of the cited prior art teachings.
Claims 1, 3-8, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Modi U.S. Publication No. 2016/0339042 A1 (Provided on IDS).
Claims 1, 3-8, 11 and 12 of the instant application claim an injectable composition comprising a cytolytic compound in gel, gel-forming solution or gel-forming suspension for reduction of fat, comprising: a cytolytic compound as a first component; and a pharmaceutically acceptable excipient; wherein the cytolytic compound is DCA or its pharmaceutically acceptable salt, the concentration of deoxycholate ion is equivalent to that in 7-51 mg/mL of sodium deoxycholate. The claims are being interpreted as the composition comprises 7-51 mg/mL of sodium deoxycholate or 0.7% to 5.1% of sodium deoxycholate. The composition further comprises a basic amino acid which is L-lysine, an anti-inflammatory drug and a local anesthetic which is lidocaine.
Modi teaches compositions clinically proven to reduce unwanted adipose tissue at or proximate to the administration area [0028]. It provides lipo-dissolving agents in a formulation for topical application such as a cream, lotion, emulsion, paste, ointment, etc. [0028]. Modi teaches without being limited to a specific theory, a possible mechanism of action is the detergent action of deoxycholate non-specifically inducing fat cell destruction [0029]. Modi teaches that human fat injected with a compounded phosphatidylcholine formulations (PC/DC) results in acutely adipocyte vacuolization and in acute and chronic inflammation within the septae and lobules of the subcutaneous fat, wherein recruited inflammatory cells directly disrupt or indirectly destroy the adipocyte cell membranes via cytokine or lytic enzyme release, resulting in eventual fat necrosis [0029].
Modi et al. teaches the invention provides methods and formulations for demonstrated reductions in subcutaneous fat deposits non-invasively, i.e., topically, wherein the topical formulation is applied to the skin surface at a desired site or sites [0032]. Modi teaches that the formulation may be a solution, suspension, emulsion, cream, lotion, gel, foam, salve, ointment, powder, paste, vapor, tincture, solid (e.g., akin to a deodorant stick) etc. [0032].
Modi teaches that the composition may contain a variety of pharmacologically active detergents and in one embodiment a bile salt is used as the active detergent in the unit dose, preferably sodium deoxycholate [0035]. Modi further teaches administration of at least a second therapeutic agent wherein in one embodiment an analgesic, preferably lidocaine, is used as the second therapeutic agent [0035].
Modi et al. teaches in a preferred embodiment, the composition includes sodium deoxycholate [0063]. Modi et al. teaches that the detergent can be used in any suitable amount or concentration in the composition such as from about 0.5% by weight to about 30% by weight, and in one embodiment, the composition includes from about 1% by weight to about 15% by weight of the detergent [0063].
Modi further teaches the composition can be administered subcutaneously in contact with a lipomas to dissolve the lipoma [0068].
Modi further teaches that the inventive compositions further comprise at least one micelle-forming compound selected from the group containing lysine, wherein the micelle-forming compound is present in the composition in a concentration between about 1 wt./wt.% and 20 wt./wt. % of the total composition [0070]. In one embodiment, the micelle-forming compound is present in the composition in a concentration of between about 1 wt./wt.% and 5 wt./wt. % of the total composition [0070].
Modi teaches the composition pH should typically be in the range of pH 5 to pH 8, more preferably in the range of pH 6 to pH 7 [0079].
Claims 26-46 of Modi pertain to the use of a composition for reducing localized adipose tissue as well as a composition comprising at least one biologically compatible pharmacologically active detergent such as a bile acid or salt thereof in a concentration ranging from about 0.5% to about 30% by wt. of the composition and at least one phospholipid, wherein the bile acid is deoxycholic acid, and additionally comprising at least one micelle-forming compound, such as lysine, wherein the micelle-forming compound is present in the composition in a concentration between about 1 wt./wt. % and 20 wt./wt. % of the total composition, and additionally comprising one or more of agent such an anti-inflammatory agent.
Thus Modi teaches a composition comprising a bile salt used as the active detergent, preferably sodium deoxycholate further comprising a second therapeutic agent such as an analgesic, preferably lidocaine, and further comprising an anti-inflammatory agent. Modi et al. teaches that the detergent can be used in an amount from about 0.5% by weight to about 30% by weight, such as from about 1% by weight to about 15% by weight of the detergent which overlaps with the claimed range of 0.7% to 5.1%.
Modi does not specifically exemplify a gel form. Modi does not exemplify lysine as the micelle-forming compound.
Although Modi does not specifically exemplify a gel form, Modi specifically teaches that suitable forms for the formulation include a gel [0032].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious and within the skill of a person of ordinary skill in the art to prepare a gel form for the formulation of Modi with a reasonable expectation of similar results as the other preferred forms disclosed therein. Therefore, selecting a gel form is seen as an obvious alternative which will yield predictable results. Thus preparing a gel form is rendered obvious in view of the cited prior art teachings.
Although Modi does not exemplify lysine as the micelle-forming compound, Modi specifically teaches that the inventive compositions further comprise at least one micelle-forming compound which may be selected as lysine, wherein the micelle-forming compound is present in the composition in a concentration between about 1 wt./wt.% and 20 wt./wt. % of the total composition, which overlaps with the range as claimed in claim 6 of 1.1% to 14.5% (11-145 mg/ml) [0070].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious and within the skill of a person of ordinary skill in the art to select lysine as a micelle-forming compound for the formulation of Modi with a reasonable expectation of similar results as the other micelle-forming compound disclosed therein. Thus lysine is seen as an obvious alternative which yields predictable results. Thus the use of lysine as a micelle-forming compound is rendered obvious in view of the cited prior art teachings.
With respect to claim 7, Modi teaches the composition pH should typically be in the range of pH 5 to pH 8, more preferably in the range of pH 6 to pH 7, which overlaps with the claimed pH of 6.45-7.75 [0079]. With regard to the limitation in claim 7 wherein the pH of L-lysine before mixing is <8.0, said limitation is interpreted as a product by process limitation. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. Thus in the absence of a demonstration of criticality of adjusting the pH of L-lysine to <8.0 before mixing, claim 7 of the instant application is rendered obvious.
Claim 8 of the instant application is rendered obvious since Modi teaches in some embodiments, the composition further comprises an additional therapeutic agent, including an anti-inflammatory agent (see claim 46).
With respect to the limitation of an injectable composition, it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). Moreover, with respect to the claimed intended use of for reduction of fat, it is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963).
Furthermore, Modi specifically teaches that the composition can be administered subcutaneously in contact with a lipomas to dissolve the lipoma, and that the composition is for reducing localized adipose tissue in a patient ([0068] and claim 26). In addition, since Modi renders obvious a gel formulation comprising sodium deoxycholate in amounts that overlap with the claimed amounts, the composition of Modi is necessarily capable of being an injectable composition for reduction of fat as claimed in the instant claims. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
With regard to the overlapping amounts and ranges as detailed above, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1 and 3-12 are rejected. Claims 13-24 are withdrawn. Claim 2 is canceled. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights