Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 170-190 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fossel (US PG pub. 2009/0221536) in view of Colombo (US PG pub. 2008/0292684).
Fossel teaches the transdermal delivery of pharmaceutical agents through the stratum corneum of the skin, which can be used for improved sexual function (see abstract). Fossel teaches that the delivery system can comprise a nitric oxide donor such as L-arginine hydrochloride and a pharmaceutical agent, such as sildenafil, in the form of a transdermal patch (see abstract; paragraphs 0023, 0032, 0048). Fossel teaches that the composition can provide an environment of high ionic strength, such as one greater than 1 M, and a high pH environment of between about 7 and about 11 (paragraph 0027). Fossel teaches that the composition can further include propylene glycol in an amount of 1%, polysorbate 20 in an amount of 1%, magnesium chloride, and sodium chloride (paragraphs 0049-0051; Table 3, pg. 9). Fossel teaches a nitric oxide donor such as L-arginine in an amount of 0.5% (paragraph 0039). Fossel teaches sodium chloride present in an amount of 5% (paragraph 0050). Fossel teaches the composition further comprising a penetrating agent such as citric acid (paragraphs 0030-0031). Fossel teaches the pharmaceutical agent present in an amount of between about 0.1% and about 25% (paragraph 0069, see full document, specifically areas cited). Fossel teaches use of penetration enhancer oleic acid, glyceryl stearate, squalene, polysorbate 60, see [0049]. Non-limiting examples of packaging which would be carried into tissue includes liposomes or emulsions of collagen, collagen peptides or other components of skin or basement membrane, [0027].
Fossel does not teach a transdermal patch further comprising a stabilization polymer comprising xanthan gum. Fossel does not teach the composition wherein the xanthan gum is present at least about 0.5.
Colombo is drawn towards a device for the delivery of active principles transdermal application in the form of a two-layered patch (see abstract). Colombo teaches xanthan gum as the adhesive in the transdermal patch (paragraph 0024; claim 1). Colombo teaches such an adhesive polymer in an amount between 1 and 50% (claim 13).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have formulated a composition wherein the xanthan gum is present at an amount of the taught range of 1 and 50% (which is within the claimed range of at least 0.5%), as suggested by Colombo, and produce the instant invention. One of ordinary skill in the art would have been motivated to do so since it is prima facie obvious to incorporate a known adhesive, such as xanthan gum, to a transdermal patch for its known purpose such as sustained contact of the patch to the skin surface, with a reasonable expectation of success absent evidence of criticality of the particular formulation. Given the general amounts of various ingredients taught for transdermal application of nitric oxide donor, it would be within skill of an artisan to optimize the amounts by performing experimental manipulation.
Nonstatutory double patenting rejection
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 170-190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of (USP 9,492,458) in view of Fossel (WO 2005/102282, also published as (US-2009/0221536 or USP 9,050,365).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
Fossel teaches the transdermal delivery of pharmaceutical agents through the stratum corneum of the skin, which can be used for improved sexual function (see abstract). Fossel teaches that the delivery system can comprise a nitric oxide donor such as L-arginine hydrochloride and a pharmaceutical agent, such as sildenafil, yohimbie, and vardenaifl in the form of a transdermal patch (see abstract; paragraphs 0023, 0032, and 0048). It would have been obvious to one of ordinary skill to have utilized the patented cream topically and come to the claimed invention for treating sexual dysfunction because Fossel teaches use of sildenafil yohimbe, tadalafil for treating sexual dysfunction and the patent teaches mixing of the ingredients.
Claims 170-190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-23 of (USP 9,737,543).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a method, comprising: applying a composition comprising a cream, gel, or lotion to the genital region of a subject, the composition comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight, an ionic salt at a concentration of at least about 0.25 M; xanthan gum at no more than about 1 wt %; propylene glycol at at least about 6% by weight; Polysorbate 20 at no more than about 3 wt %; and sildenafil and/or a salt thereof, wherein the subject is female. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-21 of (USP 9,675,619).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a method, comprising: applying a composition comprising a cream, gel, or lotion to the genital region of a subject, the composition comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight, an ionic salt at a concentration of at least about 0.25 M; xanthan gum at no more than about 1 wt %; propylene glycol at at least about 6% by weight; Polysorbate 20 at no more than about 3 wt %; and a pharmaceutical agent and/or salt thereof for treating sexual dysfunction, comprising one or more of yohimbe, alprostadil, tadalafil, apomorphine, and vardenaifl, at a concentration of at least about 0.1% by weight of the composition. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of USP (10,1728,65).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a method, comprising: applying a composition comprising a cream, gel, or lotion to the genital region of a subject, the composition comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight, an ionic salt at a concentration of at least about 0.25 M; xanthan gum at no more than about 1 wt %; propylene glycol at at least about 6% by weight; Polysorbate 20 at no more than about 3 wt %; and a pharmaceutical agent and/or salt thereof for treating sexual dysfunction, comprising one or more of yohimbe, alprostadil, tadalafil, apomorphine, and vardenaifl, at a concentration of at least about 0.1% by weight of the composition. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of (USP 9,463,158).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a composition for topical delivery to the skin of a subject, the composition being a cream and comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight; an ionic salt at a concentration of at least about 0.25 M; xanthan gum at no more than about 1 wt%; propylene glycol at at least about 6% by weight; a polysorbate surfactant comprising Polysorbate 20 at no more than about 3 wt%; and sildenafil and/or a salt thereof, at a concentration of at least about 0.1% by weight of the composition, wherein the composition is stable when exposed to a temperature of 40.degree. C. for at least about 4 weeks. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 170-191 of (USP 10,682,357). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a composition for topical delivery to the skin of a subject, the composition comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight; xanthan gum at no more than about 1 wt%; propylene glycol at at least about 6% by weight; a polysorbate surfactant comprising Polysorbate 20 at no more than about 3 wt%; and sildenafil and/or a salt thereof, wherein the composition has an ionic strength of at least 1 M, and wherein the composition is a cream, gel, or lotion. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 170-191 of (USP 10,898,489). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a composition for topical delivery to the skin of a subject, the composition comprising: a nitric oxide donor comprising a pharmaceutically acceptable salt of L-arginine at a concentration of about 2.5% to about 15% by weight; xanthan gum at no more than about 1 wt %; propylene glycol at at least about 6% by weight; a polysorbate surfactant comprising Polysorbate 20 at no more than about 3 wt %; and sildenafil and/or a salt thereof, wherein the composition has an ionic strength of at least 1 M, and wherein the composition is a cream, gel, or lotion. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of (USP 12,138,268). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a composition for topical delivery to the skin of a subject, comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride at a concentration of about 2.5% to about 15% by weight; xanthan gum at about 0.5% to about 1% by weight; propylene glycol at about 1% to about 10% by weight; a polysorbate surfactant at about 1% to about 4% by weight; sildenafil and/or a salt thereof; and an ionic salt, wherein the composition has an ionic strength of about 0.25 M to about 15 M. The patented claims read on the instant claims as the components are mixed.
Claims 170-190 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of (USP 11,684,624). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a method for preparing a transdermal composition, the method comprising: (a) mixing a nitric oxide donor, an ionic salt, water, and sildenafil or pharmaceutically acceptable salt thereof to form an aqueous mixture; (b) mixing xanthan gum, propylene glycol, and Polysorbate 20 to form a non-aqueous mixture; (c) combining the aqueous mixture and the non-aqueous mixture to form the transdermal composition.
The patented claims recite a composition for delivery to the skin of a subject, the composition being a cream, a gel, or a lotion, the composition comprising: a nitric oxide donor comprising L-arginine and/or L-arginine hydrochloride, wherein the nitric oxide donor is at a concentration of at least 2.5 wt %; xanthan gum; propylene glycol; a polysorbate surfactant; and sildenafil and/or a salt thereof, wherein the composition has an ionic strength of at least 0.25 M. The patented claims read on the instant claims as the components are mixed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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