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 filed on 07/30/2024 is a CON of 17/703,543 filed on 03/24/2022 which is a CON of PCT/US2021/031144 filed on 05/06/2021 and has a PRO 63/021,400 filed on 05/07/2020.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed August 28, 2026 to the restriction requirement made on July 1, 2026. Applicant's election without traverse of Inflammatory dermatosis-atopic dermatitis (claims 1-20 & 23); High Krafft temperature surfactant-ceteth-8 phosphate (claims 1-24); and Moisturizer-petrolatum (claims 1-24). in the reply filed on August 28, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
The claims corresponding to the elected subject matter are 1-20 and 23 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/30/24 (7), 10/7/24 (2), 2/14/25, 2/27/25, 3/3/25, 3/27/25, 8/6/25, 7/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The following rejections are made:
Claim Rejections - 35 USC § 102
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 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 1, 3-10, 13-20 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osborne (9,895,359).
Osborne teaches roflumilast are useful for treating psoriasis and atopic dermatitis. A formulation comprising
Roflumilast
0.5% w/w
White Petrolatum
10.0% w/w
Isopropyl Palmitate
5.0% w/w
Crodafos ™ CES (Cetearyl Alcohol, Dicetyl
10.0% w/w
Phosphate, and Ceteth-10 Phosphate)
Hexylene glycol
2.0% w/w
Diethylene glycol monoethyl ether
25.0% w/w
(Transcutol P)
Methylparaben
0.2% w/w
Propylparaben
0.05% w/w
Purified Water
q.s. ad 100 (47.25%)
is taught. The roflumilast composition further comprises at least one additional component selected from the group consisting of a solvent, moisturizer, surfactant or emulsifier, polymer or thickener, antifoaming agent, preservative, antioxidant, sequestering agent, stabilizer, buffer, pH adjusting solution.
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.
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) 1-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (US20130018104A1 – presented in IDS) in view of Giordano (US20090111780A1).
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
While Lathrop et al. teaches the use of an active, the reference does not teach roflumilast.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate roflumilast in Lathrop et al. The motivation to incorporate roflumilast is because Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37). Hence, a skilled artisan would have reasonable expectation of successfully achieving topical anti-inflammatory and anti-bacterial effects.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 11-12 are rejected under 35 U.S.C. 103 as being anticipated by Osborne (9,895,359), as applied to claims 1, 3-10, 13-20 and 23 above.
While Osborne teaches the pH adjusting agent, the reference does not teach pH of 3.5-9.
However, Osborne teaches the pH of the formulation may be critical, because dissolved ionized active ingredients typically do not permeate the skin as effectively as active ingredients that do not carry a charge.
It would have been obvious to one of ordinary skill in the art to adjust the pH in Lathrop et al. The motivation to adjust the pH is because Osborne teaches the pH of the formulation may be critical, because dissolved ionized active ingredients typically do not permeate the skin as effectively as active ingredients that do not carry a charge. Hence, a skilled artisan would have reasonable expectation of successfully achieving dissolved topical formulation.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. Osborne et al. (US Applic. No. 18745005) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a pharmaceutical composition for topical administration comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1% (w/w); (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; (iii) a solvent; and (iv) water; wherein said surfactant is in an amount sufficient to produce a stable emulsion, and wherein said roflumilast composition has a roflumilast absorption profile that produces in a patient following administration a plasma concentration time curve with a peak to trough ratio less than 2 at steady state.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa).” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. Osborne et al. (US Applic. No. 18745002) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a topical pharmaceutical composition comprising: (i) roflumilast in an amount of 0.005—2% (w/w); (ii) hexylene glycol in an amount sufficient to inhibit roflumilast crystal growth in the composition; (iii) = water; (iv) asurfactant; and (v) a solvent, wherein the composition is in the form of a cream or foam.With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Example 1 formulation is essentially identical to the formulation in Example 1 of the specification. Absent evidence to the contrary, the similar emulsifier blend taught is expected to result in a similar roflumilast skin penetration lag time a claim.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. Osborne et al. (US Applic. No. 18744999) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a topical pharmaceutical composition comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1% (w/w); (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; (iii) a solvent; and (iv) water; wherein said surfactant is in an amount sufficient to produce a stable emulsion, and wherein said roflumilast composition has a roflumilast absorption profile that produces in a patient following administration a plasma concentration time curve with a peak to trough ratio less than 2 at steady state..
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. Osborne et al. (US Applic. No. 18670960) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a topical pharmaceutical composition comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1% (w/w); (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; and (iv) water; wherein said pharmaceutical composition is in the form of a foam, and wherein the Cmax of roflumilast from the topical composition is reduced relative to an oral roflumilast formulation marketed under the trademark DALIRESP®.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. Osborne et al. (US Applic. No. 18653662) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a method of treating inflammatory dermatoses comprising topically administering a pharmaceutical composition comprising: (i) roflumilast in an amount of 0.05-1.0% w/w; (ii) diethylene glycol monoethyl ether; and (iii) an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; and (iv) water, wherein the composition is administered once daily.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. Osborne et al. (US Applic. No. 18627861).
Osborne et al. teaches a method for reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient, comprising topically administering to said patient, a formulation comprising a high Krafft temperature surfactant, a moisturizer and water, wherein said formulation does not include hexylene glycol, and wherein said high Krafft temperature surfactant reduces the formation of surfactant micelles as compared to a formulation containing nonionic surfactants, resulting in a reduction in the extraction of epidermal lipids.With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Example 1 formulation is essentially identical to the formulation in Example 1 of the specification. Absent evidence to the contrary, the similar emulsifier blend taught is expected to result in a similar roflumilast skin penetration lag time as claimed.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. Osborne et al. (PAT no. 12011437) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches topical roflumilast pharmaceutical composition comprising: (i) roflumilast in an amount of 0.05-1.0% w/w; (ii) water; (iii) a hydrophobic component; (iv) a solvent comprising diethylene glycol monoethyl ether; and (v) a surfactant; wherein said topical roflumilast composition is an emulsion, and wherein said topical roflumilast composition has a roflumilast absorption profile that produces in a patient following administration, a flattened plasma concentration time curve at steady state relative to oral administration of 500 mcg roflumilast.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. Osborne et al. (US Applic. No. 18465446) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a topical pharmaceutical composition comprising roflumilast in an amount of 0.05%-1% w/w, hexylene glycol, and water, wherein the hexylene glycol is in an amount sufficient to inhibit crystal growth of roflumilast in the composition for at least six weeks of storage at 15°C-26°C, wherein the composition is in the form of a cream or foam.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. Osborne et al. (US. No. 12016848) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a topical roflumilast pharmaceutical composition comprising: (i) roflumilast in an amount of 0.05-1.0% w/w; (ii) water; (iii) a hydrophobic component; (iv) a solvent comprising diethylene glycol monoethyl ether; and (v) a surfactant; wherein said topical roflumilast composition is an emulsion, and wherein said topical roflumilast composition has a roflumilast absorption profile that produces in a patient following administration, a plasma concentration time curve having a delayed Tmax relative to oral administration of roflumilast.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. Osborne et al. (US Applic. No. 18439564) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a method for inhibiting roflumilast crystal growth or changes in particle size in a composition, comprising including hexylene glycol in a composition comprising roflumilast.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. Osborne et al. (US. No. 12042487).
Osborne et al. teaches pharmaceutical composition for topical administration comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1% w/w; (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; wherein the Cmax of roflumilast from the topical composition is reduced relative to an oral roflumilast formulation marketed under the trademark DALIRESP®.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Example 1 formulation is essentially identical to the formulation in Example 1 of the specification. Absent evidence to the contrary, the similar emulsifier blend taught is expected to result in a similar roflumilast skin penetration lag time as claimed.
It is well within the purview of a skilled artisan to select any order of mixing ingredients. Hence, claim 1 is rendered obvious by the teachings of the prior art. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Claims 1-20 and 23 , are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. Osborne et al. (US. No. 12005052) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches pharmaceutical composition for topical administration comprising: (i) roflumilast, wherein the roflumilast is in an amount of 0.05-1.0% w/w; (ii) water; (iii) diethylene glycol monoethyl ether; and (iv) an emulsifier blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate; wherein the plasma half-life of the roflumilast is between 3 and 5 days after topical administration of the composition
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-65 of U.S. Patent No. Osborne et al. (US Applic. No. 18335315) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches method of treating a fungal infection or overgrowth in a subject in need thereof, comprising topically administering to the subject, a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof, wherein the subject is suffering from seborrheic dermatitis, and wherein the fungal infection or overgrowth is caused by Malassezia species; and wherein said composition comprises 0.3% w/w roflumilast; and wherein said phosphate ester surfactant comprises a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate; and wherein said diethylene glycol monoethyl ether is in an amount between 10% to 30% w/w.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. Osborne et al. (US Applic. No. 17887798).
Osborne et al. teaches a topical pharmaceutical composition comprising: a pharmaceutically effective amount of an active ingredient; diethylene glycol monoethyl ether; and water, and wherein the topical pharmaceutical composition has a pH that is less than or equal to 6.3, wherein the pharmaceutical composition satisfies European Pharmacopeia Efficacy of Antimicrobial Preservation Criteria A, and wherein the pharmaceutical composition does not comprise an antimicrobial preservative.With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Example 1 formulation is essentially identical to the formulation in Example 1 of the specification. Absent evidence to the contrary, the similar emulsifier blend taught is expected to result in a similar roflumilast skin penetration lag time as claimed.
It is well within the purview of a skilled artisan to select any order of mixing ingredients. Hence, claim 1 is rendered obvious by the teachings of the prior art. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-34, 36-46, 48-49, 53-61, 64 of U.S. Patent No. Osborne et al. (US Applic. No. 17703543).
Osborne et al. teaches a method for reducing formation of surfactant micelles after application of a topical pharmaceutical formulation, comprising topically administering to said patient, a formulation comprising a high Krafft temperature surfactant, a moisturizer and water, wherein said formulation does not include hexylene glycol, and wherein said high Krafft temperature surfactant reduces the formation of surfactant micelles as compared to a formulation containing nonionic surfactants, resulting in a reduction in the extraction of epidermal
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Example 1 formulation is essentially identical to the formulation in Example 1 of the specification. Absent evidence to the contrary, the similar emulsifier blend taught is expected to result in a similar roflumilast skin penetration lag time as claimed.
It is well within the purview of a skilled artisan to select any order of mixing ingredients. Hence, claim 1 is rendered obvious by the teachings of the prior art. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. Osborne et al. (US. No. 11707454) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a composition consists of: roflumilast 0.3% w/w white petrolatum 10.0% w/w isopropyl palmitate 5.0% w/w cetearyl alcohol, 10.0% w/w dicetyl phosphate and ceteth-10 phosphate blend hexylene glycol 2.0% w/w diethylene glycol 25.0% w/w monoethyl ether methylparaben 0.2% w/w propylparaben 0.05% w/w, and purified water q.s. ad 100 (47.45%).
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. Osborne et al. (US. No. 11992480) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a method for reducing gastrointestinal side effects of roflumilast relative to an oral roflumilast formulation marketed under the trademark DALIRESP®, comprising topically administering to said patient, a composition comprising (i) roflumilast in an amount of 0.05%-1% w/w and (ii) a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in an amount of 1.0-25% w/w.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. Osborne et al. (US10105354) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches a method for inhibiting phosphodiesterase 4 in a patient, comprising administering a composition comprising at least two active agents in combination with hexylene glycol to a patient in need thereof, wherein one of said active agents is roflumilast, wherein one of said active agents is dissolved in the composition and wherein one of said active agents is a microparticulate pharmaceutical dispersed in said composition.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Claims 1-20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. Osborne et al. (US Applic. No. 18335315,) in view of Lathrop et al. (US20130018104A1 – presented in IDS) and Giordano (US20090111780A1).
Osborne et al. teaches topical pharmaceutical composition comprising roflumilast and an emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said composition has a pH less than 7.5.
While Osborne et al. teaches the emulsifier blend, the reference does not teach a method of manufacturing claimed.
Lathrop et al. teaches in Example 1: dapsone 5.0 w/w%, White petrolatum 10.0 w/w%, Isopropyl palmitate 5.0 w/w%, Crodafos® CES1 10.0 w/w%, Purified water qs 100, Ethoxydiglycol (also known as: diethylene glycol monoethyl ether) 25.0 w/w%, Methylparaben 0.2 w/w%, Propylparaben 0.05 w/w%. 'Crodafos® CES is manufactured by Croda, Inc. It is a blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10. The topical emulsive composition has stability and provides solubility. (see abstract). Dapsone is known to be used for skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome. (page 1 lines 25-29). The emulsive composition provides therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization.(page 5 line 13-18) The emulsive composition wherein acidic and or basic components are neutralized or buffered to a pH of from about 4 to 8, preferably 5 to 8, especially preferably 5 to 7. (see claim 23) The reference teaches cream formulations.
Giordano teaches a topical formulation comprising an anti-inflammatory selected from roflumilast (see claim 4), anti-bacterial selected from dapsone (see claim 3) and skin penetration enhancers (see claim 37).
It would have been obvious to one of ordinary skill in the art to incorporate diethylene glycol monoethyl ether and emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate in the amounts claimed with the roflumilast of Giordano et al. The motivation to incorporate the diethylene glycol monoethyl ether and emulsifier blend comprising cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate is because Lathrop teaches the emulsive composition provide therapeutic benefits such as, but not limited to, anti-inflammatory activity, antibacterial activity, anti- itch activity and emollient properties so that it is useful in the treatment of such dermatological disorders as psoriasis, dermatitis and the itch associated with healing or gealed burn wounds while maintaining skin and/or mucosal integrity, flexibility, stretch and moisturization. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
With respect to the recitation regarding a skin penetration lag time of less than 1 hour, Lathrop et al.’s Example 1 formulation is essentially identical to the formulation in Example 1 of the specification, sans the active, roflumilast. Additionally, Lathrop et al. teaches the emulsive composition enables the use of a wide variety of oil phase components as vehicles for the topical (skin or mucosa) delivery of dapsone or a derivative thereof. The emulsive composition of the invention also provides for the use of polar phase components for the augmented delivery and enhancement of dapsone or a derivative thereof on the skin or mucosa.” Absent evidence to the contrary, the similar emulsifier blend taught in Lathrop et al. and Giordano et al. is expected to result in a similar roflumilast skin penetration lag time as claimed.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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