Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 04/05/2026.
Claims 1-44 are pending.
Claims 1,2,7,22,24,26,28,30,32,34-35, and 38-44 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/05/2026.
Claims 3-6,8-21,23,25,27,29,31, and 36-37 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
skin disease: psoriasis
statin: simvastatin 1-5% w/w
penetration enhancer/surfactant: Transcutol, urea
solvent: propylene glycol 5-50%
gelling agent: polyacrylamide
solvent: BHT
method: prepared as a non-aqueous topical composition.
Upon further search and examination the species election over solvent is broadened to include water, polyethylene glycol, oleic acid, and 2-(2-ethoxyethoxy) ethanol.
Information Disclosure Statement
The information disclosure statement filed 12/16/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 21 is objected to because of the following informalities: missing comma after water. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-6,8-21,23 are rejected under 35 U.S.C. 103 as being unpatentable over Mustoe (US 20190030045 A1; as submitted on IDS of 12/16/2023) and Kurban et al (US 20200345678 A1) in view of Wasan (US 20080026049 A1) as evidenced by TONGE (US 20170367973 A1).
Mustoe discloses compositions, systems, and methods for treating wounds with the combination of statins and cholesterol to help prevent and reduce scar formation (see entire document, for instance, abstract). Mustoe teaches the composition comprises a pharmaceutically acceptable carrier ([0010]). Mustoe discloses the cholesterol derivative is a cholesterol ester ([0010]). The cholesterol ester is selected from the group consisting of: cholesteryl capronate, cholesteryl pelargonate, cholesteryl caprinate, cholesteryl laurate, cholesteryl tridecilate, cholesteryl miristinate, cholesteryl palmitate, and cholesteryl stearate (see entire document, for instance, [0010]). Mustoe teaches the cholesterol, cholesterol derivative, or cholesterol analog is present at 2-10% in the composition ([0010]). Mustoe discloses the statin is selected from the group consisting of: simvastatin, rosuvastatin, lovastatin, cerivastatin, fluvastatin, mevastatin, pitavastatin, and pravastatin. In some embodiments, the statin has molecular weight less than 500 Daltons (e.g., 499-400 Daltons, or 300-399 Daltons) (see entire document, for instance, [0011]). Mustoe teaches the statin is present at: i) a concentration of 45 to 150 μM or a percentage of 2-5% of the composition, or ii) a concentration of 225-400 μM (e.g., 235 . . . 255 μM) or a percentage of 8-20% (e.g., 9-11%) of the composition (see entire document, for instance, [0011]). Mustoe teaches the composition comprises an emulsion ([0012]). Mustoe discloses the emulsion comprises an microemulsion, and wherein the microemulsion comprises an oil phase, a first surfactant (e.g., a non-ionic surfactant), a second surfactant, and an oil phase ([0012]). Mustoe teaches the emulsion comprises an oil-in-water emulsion as well as the emulsion comprises a water-in-oil emulsion ([0012]). Mustoe discloses the emulsion comprises a surfactant (e.g., non-ionic surfactant) and a solvent ([0012]). Mustoe teaches the surfactant comprises monoacylglycerols ([0012]). Mustoe discloses the solvent is selected from the group consisting of: water polyethylene glycol, oleic acid, and 2-(2-ethoxyethoxy) ethanol ([0012]). Mustoe teaches the pharmaceutical formulation in the form powder, a spray, an ointment, a paste, a cream, a lotion, and a gel (see entire document, for instance, [0013]).
However, it a does not expressly disclose pH, and biphasic liposomal-PEG carrier. Kurban et al, Wasan et al remedy this deficiency.
Kurban discloses topical medications for the treatment of skin diseases (see entire document, for instance, abstract). Kurban teaches it is known in the art that topical treatment includes hydrating creams, urea, salicylic acid, glycolic acid and propylene glycol ([0034] - [0035]). Kurban discloses a combination of cholesterol at about 2% by weight and lovastatin at about 2% by weight in a cream base (see entire document, for instance, [0042], claim 1). Kurban discloses lovastatin is the inhibitor of cholesterol synthesis which inhibits the HMG-CoA reductase, and may be substituted with other inhibitors of HMG-CoA reductase such as simvastatin ([0039]). Kurban teaches the combined cholesterol and statin will block the cholesterol synthesis pathway that has several toxic metabolites and at the same time will replace the cholesterol for the normal skin differentiation ([0062]). The glycolic acid creams will help in desquamating the external keratotic part of the skin that allows the internal penetration of the cholesterol/statin combination ([0062]). Kurban discloses application in dry skin, eczema, different forms of dermatitis, and psoriasis ([0063]). Kurban teaches suitable preparations include, lotion, gel, cream, ointments, and aerosols, and other formulations known in the art for their respective routes of administration ([0067], [0074]). Kurban discloses creams are semi-solid emulsions, which are mixtures of oil and water in which APIs (Active Pharmaceutical Ingredients) are incorporated ([0074]). They are divided into two types: oil-in-water (OAV) creams which compose of small droplets of oil dispersed in a continuous water phase, and water-in-oil (W/O) creams which compose of small droplets of water dispersed in a continuous oily phase ([0074]). Oil-in-water creams are user-friendly and hence cosmetically acceptable as they are less greasy and more easily washed with water ([0074]). An ointment is a viscous semisolid preparation containing APIs, which are used topically on a variety of body surfaces ([0074]). The vehicle of an ointment is known as ointment base ([0074]). It is essential that the active drug penetrates the skin for the optimum bio-dermal efficacy ([0074]). The particle size of the active drug plays an important role here ([0074]). It is necessary that the active drug is available in colloidal or molecular dispersed state for the product being highly efficacious form ([0074]). Also this is to be achieved in the safe pH compatible environment of skin (4.0 to 6.0) ([0074]). To achieve all these, it is essential to choose proper vehicles or co-solvents for the dissolution or dispersion of the drug ([0074]). The product is highly efficacious due to the pronounced antifungal/anti-inflammatory & wound healing activity of the active ingredients, which are available in ultra micro-size, colloidal form, which enhances skin penetration ([0074]).
Wasan discloses liposome delivery vehicle (see entire document, for instance [0002]). Wasan teaches statin therapy has been examined in a number of chronic immune mediated inflammatory diseases ([0008]). Wasan discloses simvastatin ([0008]). Wasan discloses micelle may combine with the lipid bilayer of the liposome such that the micelle components, including the agent is incorporated into the outer leaflet or both inner and outer leaflets of the lipid bilayer of the liposome; the micelle-forming compound may include a hydrophilic or amphipathic moiety such as a PEG-lipid conjugate (e.g., DSPE-PEG.sub.2000) ([0011]). Wasan teaches the agent may be dissolved in a solvent, such as ethanol ([0012]). Wasan discloses preparing a first liposome composition by combining a vesicle-forming lipid with the agent under conditions suitable for forming a liposome such that the agent is loaded into the liposome ([0019]). Wasan teaches the presence of "vesicle-forming lipids" which are defined as amphipathic lipids capable of either forming or being incorporated into a bilayer structure ([0036]). Wasan discloses any suitable vesicle-forming lipid may be utilized in the practice of this invention as judged by one of skill in the art ([0038]). This includes cholesterol, ceramides ([0038]). Wasan discloses ammonia ([0060]).
TONGE discloses poor water solubility presents a fundamental problem in delivering oil-soluble active materials to sites within or topically upon the body ([0002] ).TONGE discloses compositions of use in the solubilisation of hydrophobic substances, particularly in the solubilisation of hydrophobic active agents which are of use in the field of cosmetics or pharmaceuticals, and in the solubilisation of peptides and proteins for the investigation of their structure and their interactions with other substances ([0001]). TONGE teaches PEG lipids are used to sterically stabilise liposomes, although high concentrations result in their solubilisation ([0041]). Tonge discloses the presence of PEG (2000)-DSPE stabilises the intermediate structures, while cholesterol is required for the preference of discoidal intermediates over threadlike intermediates. Tonge discloses it is known in the art the optimisation of a mixture of DSPC, cholesterol and PEG (5000)-DSPE can provide stable dispersions of flat bilayer discs which may be of use in the study of protein structure and delivery of protein/peptide and hydrophilic drugs ([0042]). TONGE discloses advantages such as be more stable and/or have controlled stability ([0051]); result in less irritation when used in pharmaceutical/cosmetic applications ([0052]); allow a higher loading of active agent (either by dry weight or absolute weight) ([0053]); facilitate enhanced penetration through the skin ([0055]). TONGE discloses ceramides ([0164]). TONGE teaches the suitability of a particular pure lipid or lipid mixture for use in the present invention may be determined by those skilled in the art by routine experimentation based on the guidance provided herein ([0180]).
Therefore, it would be within the purview of the skilled artisan to utilize components which are used in topical compositions and are well known to those skilled in the art by routine experimentation, with a reasonable expectation of success. It would have been obvious to utilize a biphasic liposomal-PEG carrier as taught in Wasan evidenced by TONGE in the composition of Mustoe and Kurban. One would have been motivated to do so Wasan evidenced by TONGE teaches that liposomal-PEG carrier is particularly useful for imparting such as be more stable and/or have controlled stability; result in less irritation when used in pharmaceutical/cosmetic applications; allow a higher loading of active agent (either by dry weight or absolute weight); facilitate enhanced penetration through the skin in the safe pH compatible environment of skin. There would be a reasonable expectation of success since Mustoe, Kurban and Wasan are drawn to statin compositions.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to optimize the amounts of the components present within the taught ranges, and thereby arriving at the instantly claimed ranges and ratios. One would have been motivated to do so since the prior art expressly teaches ranges that overlap the instantly claimed ranges. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." It is further noted that MPEP 2144.05 states: "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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Claim(s) 3-6,8-21, 23,25,27 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Mustoe (US 20190030045 A1) and Kurban et al (US 20200345678 A1) in view of Wasan (US 20080026049 A1) as evidenced by TONGE (US 20170367973 A1) as applied to claims 3-6,8-21, 23 and 36 above, and further in view of McGraw et al (US 20100080768 A1).
The teachings of Mustoe, Kurban and Wasan et al have been set forth above. They disclose cholesterol. However, it is silent to ceramides, hyaluronic acid, cholesterol, and free fatty acids. McGraw et al remedies this deficiency.
McGraw discloses compositions in the treatment of inflammatory conditions of the skin including psoriasis (see entire document, for instance, [0002]). McGraw teaches petrolatum, tocopherols, dimethicone, vitamins E, caprylic/capric triglyceride, cholesterol, ceramide np, glycerin, ceramides eop, phytosphingosine, and sodium hyaluronate (see entire document, for instance, [0018], [0032], [0049]- [0051], claim 9). McGraw teaches hyaluronic acid in an amount ranging from about 0.01 to 15% ([0049]). McGraw discloses the composition provides benefits to the function of the skin barrier, which is important in treating dermatological conditions ([0053]). McGraw teaches a dysfunctional epidermal barrier is treated or prevented by topical application of a formulation comprised of certain major epidermal lipids ([0053]). These combinations are effective both as moisturizing agents and as agents for the restoration of barrier function ([0053]). It is generally accepted that the intercellular lamellar bilayer of the stratum corneum lipids are the key constituents in skin barrier functionality ([0053]). The epidermal lipids consist of a mixture of polar and non-polar species which include, but are not limited to: ceramides, cholesterol, and fatty free acids ([0053]). McGraw discloses weight of each of these species of lipids is ceramides (40%), cholesterol (20-25%), and fatty free acids (10-15%). Disorders of the skin (such as atopic dermatitis) that result from a dysfunctional epidermal barrier are treated or prevented by topical application of a formulation comprised of the three major epidermal lipids just discussed (ceramides, cholesterol, and fatty acids) ([0053]). McGraw teaches as generally recognized by the art, combinations of these epidermal lipids in a molar concentration of 32:37:16:15 (cholesterol: ceramides: free fatty acids and minor fractions) are effective as moisturizers and as agents for restoration of barrier function ([0053]).
Therefore, it would be within the purview of the skilled artisan to utilize components which are used in topical compositions and are well known to those skilled in the art by routine experimentation, with a reasonable expectation of success. It would have been obvious to utilize ceramides, hyaluronic acid, cholesterol, and free fatty acid as taught in McGraw in the composition of Mustoe, Kurban and Wasan et al. One would have been motivated to do so McGraw teaches that ceramides, hyaluronic acid, cholesterol, and free fatty acid are particularly useful to replenish and repair the barrier function of the skin and provide multiple skin benefits, such as skin protection, itching relief, and irritation prevention.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to optimize the amounts of the components present within the taught ranges, and thereby arriving at the instantly claimed ranges and ratios. One would have been motivated to do so since the prior art expressly teaches ranges that overlap the instantly claimed ranges. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." It is further noted that MPEP 2144.05 states: "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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Claim(s) 3-6,8-21,23,29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Mustoe (US 20190030045 A1) and Kurban et al (US 20200345678 A1) in view of Wasan (US 20080026049 A1) as evidenced by TONGE (US 20170367973 A1) as applied to claims 3-6,8-21,23 above, and further in view of Perricone (US 20110245183 A1).
The teachings of Mustoe, Kurban and Wasan et al have been set forth above. They disclose it is essential that the active drug penetrates the skin for the optimum bio-dermal efficacy. It is necessary that the active drug is available in colloidal or molecular dispersed state for the product being highly efficacious form. Also, this is to be achieved in the safe pH compatible environment of skin (4.0 to 6.0). To achieve all these, it is essential to choose proper vehicles or co-solvents for the dissolution or dispersion of the drug. However, it is silent to buffered glycolic acid and ammonia. Perricone remedies this deficiency.
Perricone discloses to topical compositions to prevent and to treat skin aging and to improve the appearance skin ([0002]). Perricone teaches ammonia ([0020]). Perricone discloses lotion, cream, ointment ([0035]). Perricone teaches ingredients commonly found in skin care compositions and cosmetics, such as, propylene glycol, butylated hydroxy toluene (BHT), cetyl alcohol ([0039]). Perricone discloses buffering agents are employed in many compositions ([0040]). Typical buffering agents are chemically and physically stable agents commonly found in cosmetics, and can include compounds that are also adjunct ingredients such as citric acid, malic acid, and glycolic acid buffers ([0040]).
Therefore, it would be within the purview of the skilled artisan to utilize components which are used in topical compositions and are well known to those skilled in the art by routine experimentation, with a reasonable expectation of success. It would have been obvious to one of ordinary skill in the art to utilize the buffered glycolic acid and ammonia of Perricone in the composition of Mustoe, Kurban and Wasan et al because Perricone teaches , the amount of buffering agent is one that results in compositions having a certain pH and Perricone teaches buffering agents are chemically and physically stable agents commonly found in cosmetics, therefore motivating one of ordinary skill in the art to use the buffered glycolic acid and ammonia of Perricone in the composition of Mustoe, Kurban and Wasan et al .There would be a reasonable expectation of success since Perricone discloses buffering agents are employed in many topical compositions.
Claim(s) 3-6,8-21,23 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Mustoe (US 20190030045 A1) and Kurban et al (US 20200345678 A1) in view of Wasan (US 20080026049 A1) as evidenced by TONGE (US 20170367973 A1) as applied to claims 3-6,8-21,23 above, and further in view of CHENG (US 20190307693 A1).
The teachings of Mustoe, Kurban and Wasan et al have been set forth above. They disclose cholesterol. However, it is silent to amount of liposome-PEG. CHENG et al remedies this deficiency.
CHENG discloses liposomal statin formulation ([0002]). CHENG teaches various efforts have been made to improve solubility of the statins ([0005]). CHENG discloses formulation, which contains skin penetrating enhancing surfactants (e.g., Span 20 or Span 60), surface charge imparting agents (e.g., stearylamine or dicetyl phosphate), cholesterol and simvastatin ([0005]). CHENG discloses vitamin E ([0008]). One method involves liposomal statin formulations for a liposome simvastatin formulation mainly composed of distearoylphosphatidylcholine (DSPC), polyethylene glycol 2000-distearoylphosphatidylethanolamine (PEG-2000-DSPE),, cholesterol, and simvastatin ([0006] ).CHENG teaches a topical formulation of liposomal statins comprising phosphatidylcholine present in the range of 15 to 40 wt. %, cholesterol present in the range of 1 to 5 wt. %, statins present in the range of 0.1 wt. % to 10 wt. %, ([0008]). CHENG teaches 2-(2-ethoxyethoxy) ethanol (e.g. TRANSCUTOL) ([0047]).
Therefore, it would be within the purview of the skilled artisan to utilize components which are used in topical compositions and are well known to those skilled in the art by routine experimentation, with a reasonable expectation of success. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to optimize the amounts of the components present within the taught ranges, and thereby arriving at the instantly claimed ranges and ratios. One would have been motivated to do so since the prior art expressly teaches ranges that overlap the instantly claimed ranges. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." It is further noted that MPEP 2144.05 states: "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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611
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