DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 31-53 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 12/17/24 (5); 9/4/25; 12/31/25 and 6/4/26. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 17 of U.S. Patent Application No. 11707454 in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant refers to 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, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; – The patented claims recites a method of treating a fungal infection in a subject in need thereof, comprising administering to the subject a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof. Although the instant claims differ in that the claims are to a composition, nonetheless Osborne teaches that their formulation can be used for allergic dermatoses, eczema etc (see col. 9, lines 30+) and the specification of the instant teaches their composition for treating local skin disorders such as psoriasis (see instant specification pg 12, lines 5+). Therefore, it would have been obvious to one of ordinary skill in the art to have used the instant claims or the patented claims in practicing the instant invention because claims 11 recites the use of 0.3% w/w, phosphate ester surfactant blend and diethylene glycol mono ether.
Additionally, when the specification of the patent is used as a dictionary it teaches that the topical composition can be in the form of a cream or a foam (see col. 4, lines 55+) as claimed by the instant claims.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 2 of U.S. Patent Application No. 11534493 in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant refers to 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, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; – The patented claims recites a pharmaceutical composition comprising pharmaceutical composition consisting of roflumilast, white petrolatum, isopropyl palmitate, an emulsifier blend of cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, hexylene glycol, N-methyl pyrrolidone, diethyl glycol monoethyl ether, methylparaben, propylparaben and water in the following proportions: Roflumilast 0.5% w/w White Petrolatum 10.0% w/w Isopropyl Palmitate 5.0% w/w Emulsifier blend 10.0% w/w Hexylene glycol 8.0% w/w N-methyl pyrrolidone 12.0% w/w Diethylene glycol monoethyl ether 25.0% w/w Methylparaben 0.2% w/w Propylparaben 0.05% w/w Purified Water q.s. ad 100. Although the instant claims differ in that the patented claims recites other agents included in the compositions, such as Methylparaben, hexylene glycol etc is taught in the instant specification. Therefore one of ordinary skill in the art would have been motivated to use the instant claims in practicing the claimed invention.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 14 of U.S. Patent Application No. US 11,129,818) in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant refers to 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, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; – The patented claims recites a method of treating a fungal infection in a subject in need thereof, comprising administering to the subject a composition comprising an antifungal effective amount of roflumilast or a pharmaceutically acceptable salt thereof. Although the instant claims differ in that the claims are to a composition, nonetheless Osborne teaches that their formulation can be used for allergic dermatoses, eczema etc (see col. 9, lines 30+) and the specification of the instant teaches their composition for treating local skin disorders such as psoriasis (see instant specification pg 12, lines 5+). Therefore, it would have been obvious to one of ordinary skill in the art to have used the instant claims or the patented claims in practicing the instant invention because claims 11 recites the use of 0.3% w/w, phosphate ester surfactant blend and diethylene glycol mono ether.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 13 of U.S. Patent Application No. 11793796 in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant refers to 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, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; – The patented claims recites a pharmaceutical composition comprising pharmaceutical composition consisting of roflumilast, white petrolatum, isopropyl palmitate, an emulsifier blend of cetearyl alcohol, dicetyl phosphate and ceteth-10 phosphate, hexylene glycol, N-methyl pyrrolidone, diethyl glycol monoethyl ether, methylparaben, propylparaben and water in the following proportions: Roflumilast 0.5% w/w White Petrolatum 10.0% w/w Isopropyl Palmitate 5.0% w/w Emulsifier blend 10.0% w/w Hexylene glycol 8.0% w/w N-methyl pyrrolidone 12.0% w/w Diethylene glycol monoethyl ether 25.0% w/w Methylparaben 0.2% w/w Propylparaben 0.05% w/w Purified Water q.s. ad 100. Although the instant claims differ in that the patented claims recites other agents included in the compositions, such as Methylparaben, hexylene glycol etc is taught in the instant specification. Therefore one of ordinary skill in the art would have been motivated to use the instant claims in practicing the claimed invention.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent Application No. 9884050 in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The formulation of the patented claim 10 recites a pharmaceutical composition comping roflumilast, a phosphate ester surfactant blend comprising cetostearyl alcohol, dicetyl phosphate wherein claim 1 of the patent recites a pharmaceutical composition comprising pharmaceutical composition consisting of roflumilast and hexylene glycol. It would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the patented claims with a reasonable expectation of success.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 12 of U.S. Patent Application No. 12011437 US 12,005,052 (claims 1-9); US 12,042487 (claims 1-30) in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the instant refers to topical roflumilast pharmaceutical composition comprising:(i) roflumilast in an amount of 0.05-1.0%(w/w); (ii) water; (iii) a solvent comprising diethylene glycol monoethyl ether; and (iv) a surfactant; wherein said topical 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 and the patented claims are to 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 flattened plasma concentration time curve at steady state relative to oral administration of 500 mcg roflumilast.
It would have been obvious to one of ordinary skill in the art would have used the patented claims in practicing the instant claims with a reasonable expectation of success because they are drawn to the same composition with the same amounts and therefore would result when 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.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 12 of U.S. Patent Application No. 12016848. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
It would have been obvious to one of ordinary skill in the art would have used the patented claims in practicing the instant claims with a reasonable expectation of success because they are drawn to the same composition with the same amounts and therefore would result in 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.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 – 20 of U.S. Patent Application No. 12144802. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
It would have been obvious to one of ordinary skill in the art would have used the patented claims in practicing the instant claims with a reasonable expectation of success because they are drawn to the same composition with the same amounts and therefore would result in wherein said topical roflumilast 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.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent Application No’s. 11,129,818, 10940142 (claims 1-14), 10,171,841 (claims 1-19), 10,105354 (claims 1-14) 9895359 (claims 1-16) and 9,907,788 (claims 1-17) in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other.
The patented claims refer to a method and pharmaceutical composition of improving treatment adherence by improving delivery and extending the plasma half-life of a roflumilast composition, comprising (a) adding hexylene glycol, diethylene glycol monoethyl ether, dicetyl phosphate and ceteth-10 phosphate to a composition comprising roflumilast, (b) topically administering said composition to a patient in need of treatment with roflumilast, on a dosing regimen, and (c) continuing said dosing regimen after multiple administrations when said patient misses at least one dose, wherein the plasma half-life of said roflumilast remains at a therapeutically effective dose level topically administered.
It would have been obvious to extend the half-life of roflumilast using the instant claimed invention (see patented claim 13 for the composition in view of Osborne above), thus one of ordinary skill in the art would have used the instant claimed invention to practice the method of extending the plasma life would have been an inherent property of the instant claimed invention with a reasonable expectation of success.
Claims 31-53 are ejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 29 of U.S. Patent Application No. US 11992480) in view of Osborne above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant refers to 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, wherein the phosphate ester surfactant blend is in an amount of 1.0-25% w/w; and (iii) water; and the patented claims drawn to 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.
It would have been obvious to one of ordinary skill in the art to have used the pharmaceutical composition of the instant claims for the treatment in the method claims of the patent with a reasonable expectation of success.
Therefore, in view of the foregoing, the patented claims and the current application claims are obvious variations.
In summary, it is noted that applicant has numerous issued patent and pending applications encompassing the same or similar subject matter of the instant application. Applicant should review all subject matter considered the same or similar and submit the appropriate Terminal Disclaimer(s) for each and every one considered to be the same or similar subject matter.
In summary, it is noted that applicant has numerous issued patent and pending applications encompassing the same or similar subject matter of the instant application. Applicant should review all subject matter considered the same or similar and submit the appropriate Terminal Disclaimer(s) for each and every one considered to be the same or similar subject matter.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 10/6/2026
