DETAILED ACTION
The claims were filed on April 5, 2024 are herein acknowledged.
Claims 1-36 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 03/24/2022 is a CON of 17/703,543 filed on 03/24/2022, which is a CON of PCT/US2021/031144 filed on 05/07/2021 which has a PRO 63/021,400 filed on 05/07/2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 4/5/24 (7), 7/11/24, 10/7/24 (2), 2/27/25, 3/3/25, 3/27/25, 8/6/25, 12/31/2025 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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kearns (US 20040234628 A1).
Kearns et al. teaches a topical composition for the treatment of skin disorders comprising Rosa Rubignosa Oil 0.300, Lavender Oil 0.200, Evening Primrose Oil 0.150, Bergamot Oil 0.050, Geranium Bourbon Oil 0.100, Immortelle Oil 0.100, Vitamin E Oil (Tocopherol) 0.250, Jojoba Oil 45.000, Germaben II-E 1.000, Polysorbate Tween 80 1.000, Natural Beeswax 4.500, Calendula Extract (Glycerin Base) 9.000, Incroquat Behenyl TMS--Behentrimonium Methosulfate (and) Ceteayl Alcohol 2.700, Crodafos Ces-Ceteayl Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate 2.700, Deionized Water 32.950, Total 100.00. (Table 1). Skin disorders discussed in Kearns includes eczema. The composition can be prepared in a variety of topical compositions including creams, ointment, sprays, and lotions, each of which may be prepared in a conventional manner.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
Claims 1-14, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chollet et al. (FR 3008890 A1).
Chollet et al. teaches creams with the following Ingredients in Phase A: H20 Water Qsp100, Ultrez10 in 0.25%, Phase B: Glycerin 4.00%, Phenoxyethanol qs, Phase C: Brij S2 SS (Steareth-2) 0.40%, Brij S10 SO (Steareth-10) 1.20%, Crodafos CES 4.00, Crodacol CS 90 (Cetearyl Alcohol) 1.50%, Laurocapram 2.50%, BRB CM 56 (Cyclopentasiloxane (and) Cyclohexasiloxane) 2.00%, Crodamol OSU (Diethylhexyl succinate) 7.00%, Phase D: Potassium Sorbate 0.10%, Phase E: Water 3.00, NaOH 30% 0.40%, Phase F: Oak Fruit Extract 3.00%. The reference teaches in external use, preparations of oak bark (baths, gargles and compresses) act on the affections of the skin and the mucous membranes. Antiperspirant, they soothe the forms of eczema, treat burns and the reduction, amelioration, progression, alleviation, and / or elimination of dermatological effects. The pH is 5.0-5.5.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
Claims 1-14, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lathrop et al. (WO2005016296A1)
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
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) 1-36, are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (WO2005016296A1) in view of Garrett et al. (WO 2009061298 A1) and CN 1294920 A.
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
While the reference teaches 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, the reference does not specifically specify a patient suffering from dermatoses.
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claim(s) 1-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (WO2005016296A1) in view of Garrett et al. (WO 2009061298 A1) and Moore et al. (US 20190175675 A1).
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
While the reference teaches 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, the reference does not specifically specify a patient suffering from contact dermatitis.
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to treat contact dermatitis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat contact dermatitis. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claim(s) 1-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (WO2005016296A1) in view of Garrett et al. (WO 2009061298 A1) and Santo (WO 03086432 A1).
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
While the reference teaches 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, the reference does not specifically specify a patient suffering from atopic dermatitis.
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to treat atopic dermatitis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat atopic dermatitis. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (WO2005016296A1) in view of Garrett et al. (WO 2009061298 A1) and GB 1805764 A.
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
While the reference teaches 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, the reference does not specifically specify a patient suffering from seborrheic dermatitis.
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to treat seborrheic dermatitis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat seborrheic dermatitis. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claim(s) 1-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lathrop et al. (WO2005016296A1) in view of Garrett et al. (WO 2009061298 A1) and Hu (EP 0904774 A1
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.
The reference teaches a formulation comprising the identical high Krafft temperature surfactant, moisturizer and water, no hexylene glycol, therefore, reducing formation of surfactant micelles after application of a topical pharmaceutical formulation to a patient is inherent.
While the reference teaches 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, the reference does not specifically specify a patient suffering from psoriasis.
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to treat psoriasis . The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat psoriasis . Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
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 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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 as claimed (and compared to the composition of claim 27).
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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..
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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®.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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) in view of Lathrop et al. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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) in view of Lathrop et al. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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®.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Garrett et al. (WO 2009061298 A1), Giordano (US20090111780A1), and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis. GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol. Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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) in view of Lathrop et al. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 11-12, 14, 23, 25-30 of U.S. Patent No. Osborne et al. (US Applic. No. 18/345,760 ) in view of Lathrop et al. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
Osborne et al. teaches a topical pharmaceutical composition comprising roflumilast, diethylene glycol monoethyl ether in an amount of 10-30% w/w, and an emulsifier blend, wherein the emulsifier blend comprises cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, wherein said roflumilast is in an amount sufficient to treat inflammatory skin conditions, and wherein said composition has a pH between 4.0 and 6.5, and wherein the skin penetration lag time of roflumilast is less than 1 hour
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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%).
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Giordano (US20090111780A1), Garrett et al. (WO 2009061298 A1) and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 1-36 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. (WO2005016296A1), Garrett et al. (WO 2009061298 A1), Giordano (US20090111780A1), and CN 1294920 A/ Moore et al. US 20190175675 A1/ Santo WO 03086432 A1 / GB 1805764 A / Hu (EP 0904774 A1).
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.
Osborne et al. does not exemplify a formulation.
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).
Garrett et al. teaches a topical dapsone formulation is used to treat G6PD-deficient patients suffering from impetigo, erythrasma, erysipelas, rosacea (perioral dermatitis, rhinophyma), furuncles, carbuncles, alopecia, panniculitis, psoriasis, dermatitis, cysts, bullous diseases (pemphigus vulgaris, bullous pemphigoid, and herpes gestationis), collagen vascular diseases (dermatomyositis, systemic lupus erythematosus, eosinophilic fasciitis, relapsing polychondritis, and vasculitis), sarcoidosis, Sweet's disease, lichen planus, hirsutism, toxic epidermal necrolysis, dermatitis herpetiformis, eczema, atopic dermatitis, seborrhoeic dermatitis (dandruff, cradle cap), diaper rash, urushiol-induced contact dermatitis, inflammatory acne, non-inflammatory acne and rosacea, etc.
CN 1294920 teaches an external medicine for treating dermatosis is compounded with both Chinese and Western medicines including Chinese pyrola herb phenol, menthol, camphor, resorcinol, salicylic acid and Resina Draconis.
Moore et al. teach a topical formulation treat dermatology disease eczema psoriasis contact dermatitis comprise extract cannabis menthol resorcinol phenol.
Santo teach keratinizes by salicylic acid and / or resorcinol It has a very good promoting effect and the best therapeutic effect for atopic dermatitis.
GB 1805764 teaches treatment of skin maladies, e.g. acne and seborrheic dermatitis, with fibrous boehmite, sodium thiosulphate, resorcinol.
Hu teaches resorcinol derivatives of formula I are also useful for the treatment of inflammatory disorders such as psoriasis and acne.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange resorcinol or dapsone in the formulation of Lathrop et al. to dermatosis/ contact dermatitis/ atopic dermatitis/ seborrheic dermatitis/ psoriasis. The motivation to interchange dapsone and resorcinol comes from the teaching of the secondary reference that both treat eczema, contact dermatitis, atopic dermatitis, seborrheic dermatitis, and eczema. Hence, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Conclusion
No claims allowed.
.Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM PST.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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