The NON-Final rejection mailed on May 8, 2025 has been WITHDRAWN, and replaced with the NON-final rejection herein.
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 14, 2025 has been entered.
The rejection is in response to the Pre Appeal decision made on 9/3/2025.
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 .
Response to Arguments
The rejection of claims 1, 6-7, and 11-12, 14, 23, 25-30 under 35 U.S.C. 103(a) as being unpatentable over Lathrop et al. (US20130018104A1 – presented in IDS) in view of Giordano (US20090111780A1) is persuasive in part. The rejection is herewith modified. Applicant argues roflumilast is the only API of the formulation but Lathrop contains dapsone. In response, the modified rejections below addresses the newly added limitations.
The (US Applic. No. 18745005) (US Applic. No. 18745002) (US Applic. No. 18744999) (US Applic. No. 18670960) (US Applic. No. 18653662) (US Applic. No. 18627861) (US Applic. No. 18465446) (US Applic. No. 18439564) (US Applic. No. 18335315,) (US Applic. No. 18335315) (US Applic. No. 17887798) and (US Applic. No. 17703543) rejections are withdrawn in view of the T.D. and approval filed on 11/12/24 and 4/26/24.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 3/14/25, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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, 6-7, and 11-12, 14, 23, 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (US20130018104A1 – presented in IDS) in view of Bolle et al. (WO2003099334) and evidenced by Kouchak M, Handali S. Effects of various penetration enhancers on penetration of aminophylline through shed snake skin. Jundishapur J Nat Pharm Prod. 2014 Feb;9(1):24-9. doi: 10.17795/jjnpp-12904. Epub 2014 Feb 20. PMID: 24644435; PMCID: PMC3957139.
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.
Bolle et al. is used for the teaching that a topical formulation comprising roflumilast is used for treatment of disorders of the skin such as dermatoses (especially of a proliferative, inflammatory and allergic nature) such as, for example, psoriasis (vulgaris), toxic and allergic contact eczema, atopic eczema, seborrhoeic eczema, lichen simplex. Furthermore, the Bolle et al. reference is used for its teaching that dosage forms for topical application may prove to be extremely difficult or is impossible if the intention is to administer an active ingredient which has a very low solubility. Further, specifically emphasizing, “the solubility in water found for the PDE 4 inhibitor N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-di- fluoromethoxybenzamide (INN: roflumilast) is only 0.53 mg/l at 21°C.”
Kouchak et al. is used to show that lag time values vary based on carriers.
It would have been obvious to one of ordinary skill in the art to interchange dapsone for roflumilast in the topical formulation of Lathrope. The motivation to interchange dapsone for roflumilast is because both teach a topical formulation for treatment of dermatosis, acne, and skin conditions, and Lathrope’s base of exogeneous oils, emollients and the like in such an emulsion will not cause separation or precipitation of the dapsone, due to dapsone’s solubility issues. [0005]-[0007] The Bolle reference teaches “provision of dosage forms for topical application may prove to be extremely difficult or is impossible if the intention is to administer an active ingredient which has a very low solubility.” Furthermore, “the solubility in water found for the PDE 4 inhibitor N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-di- fluoromethoxybenzamide (INN: roflumilast) is only 0.53 mg/l at 21°C.” Hence, a skilled artisan would have reasonable expectation of successfully interchanging the low soluble actives achieving similar solubility efficacy and results. Furthermore, calculation of the penetration lag time is obvious from the teaching of Kouchak et al. Specifically, the motivation to calculate the lag time of the emulsifier blend carrier comes from the teaching that the lag time varies based on the penetration enhancers. Hence, a skilled artisan would have had reasonable expectation of achieving a lag time with the emulsifier blend taught in Lathrop et al.
The recitation ”sufficient to treat inflammatory skin conditions” is an intended use of a method of manufacturing.
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, 6-7, and 11-12, 14, 23, 25-30 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).
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, 6-7, and 11-12, 14, 23, 25-30 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, 6-7, and 11-12, 14, 23, 25-30 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) in view of Bolle et al. (WO2003099334).
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.
While Lathrop et al. teaches the use of an active, the reference does not teach roflumilast.
Bolle et al. is solely used for the teaching that a topical formulation comprising roflumilast is used for treatment of disorders of the skin such as dermatoses (especially of a proliferative, inflammatory and allergic nature) such as, for example, psoriasis (vulgaris), toxic and allergic contact eczema, atopic eczema, seborrhoeic eczema, lichen simplex.
It would have been obvious to one of ordinary skill in the art to interchange dapsone for roflumilast in the topical formulation of. The motivation to interchange dapsone for roflumilast is because both teach a topical formulation for treatment of dermatosis, acne, and skin conditions, and Lathrope’s base of exogeneous oils, emollients and the like in such an emulsion will not cause separation or precipitation. [0007] Hence, a skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
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 Bolle 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, 6-7, and 11-12, 14, 23, 25-30 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) in view of Bolle et al. (WO2003099334).
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.
Bolle et al. is solely used for the teaching that a topical formulation comprising roflumilast is used for treatment of disorders of the skin such as dermatoses (especially of a proliferative, inflammatory and allergic nature) such as, for example, psoriasis (vulgaris), toxic and allergic contact eczema, atopic eczema, seborrhoeic eczema, lichen simplex.
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 Bolle 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, 6-7, and 11-12, 14, 23, 25-30 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) in view of Bolle et al. (WO2003099334).
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.
Bolle et al. is solely used for the teaching that a topical formulation comprising roflumilast is used for treatment of disorders of the skin such as dermatoses (especially of a proliferative, inflammatory and allergic nature) such as, for example, psoriasis (vulgaris), toxic and allergic contact eczema, atopic eczema, seborrhoeic eczema, lichen simplex.
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 Bolle 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, 6-7, and 11-12, 14, 23, 25-30 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) in view of Bolle et al. (WO2003099334).
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.
Bolle et al. is solely used for the teaching that a topical formulation comprising roflumilast is used for treatment of disorders of the skin such as dermatoses (especially of a proliferative, inflammatory and allergic nature) such as, for example, psoriasis (vulgaris), toxic and allergic contact eczema, atopic eczema, seborrhoeic eczema, lichen simplex.
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 Bolle 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 1627