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 .
Election/Restrictions
Applicant elects, without traverse, the invention of Group I (e.g. Claim(s) 1-10 and 44) drawn to a composition of sprayable liquid comprising oxybutynin, a penetration enhancer, an aliphatic solvent, and a film-forming excipient in the reply filed on April 21, 2026.
Status of Priority
Examiner acknowledges the claimed priority of the Instant disclosure for the U.S. Provisional Patent Application 63/422,804, filed on November 4, 2022.
Claim Status
Claim(s) 1-10 and 44 are examined on the merits herein.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim(s) 1, citing reference to a “penetration enhancer”, is interpreted analogously to other terms which describe agents found within topical compositions that assist with skin permeabilization (e.g. permeation enhancer).
Claim 9, citing reference to a “washability” enhancer, is interpreted inasmuch as it refers to a washability enhancer such as polyethylene glycol 400 and/or tromethamine, as defined in the specification [0012].
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends (Claim 1), or for failing to include all the limitations of the claim upon which it depends. Claim 1 recites 'a film forming excipient' followed by “the film forming excipient” (which, based on the specification [0033], limits the claim to exactly one particular excipient from a possible multiple). Claim 6 depends from Claim 1, yet recites a definition of excipient that encompasses 'one or more' (i.e. … and ethyl cellulose).
Therefore, Claim 6 is rejected under 35 USC § 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-10 and 44 are rejected under 35 U.S.C. 102(a)(2) as being unpatentable over Lulla et al (Published: 28 October 2004; US 2004/0213744 A1; henceforth Lulla), in view of Dandiker et al (Priority Filing: 10 January 2019; US 2020/0330397 A1; henceforth Dandiker) and Gee et al (Published: 13 January 2014; Gee CM et al., The Effect of Formulation Excipients on the Penetration and Lateral Diffusion of Ibuprofen on and within the Stratum Corneum Following Topical Application to Humans, Journal of Pharmaceutical Sciences, 103(3), pg. 909-919; henceforth Gee) as evidenced by Drugs.com via the WayBack machine (URLs: https://web.archive.org/web/20220626174855/https://www.drugs.com/inactive/methacrylic-acid-methyl-methacrylate-copolymer-1-2-467.html; Published: 13 September 2021 AND https://web.archive.org/web/20220626174855/https://www.drugs.com/inactive/methacrylic-acid-methyl-methacrylate-copolymer-1-1-466.html; Published: 24 February 2022 ; pdf(s) attached).
Lulla teaches a topical, medicinal spray composition comprising a drug or combination of drugs in a carrier which, when sprayed on a surface, forms a film, and in doing so, addresses several requirements of the Instant invention.
In regards to Claim(s) 1-8, the Instant disclosure describes several limitations of the composition, namely:
1. comprisal of oxybutynin from about 1-20 % w/v
2. comprisal of a penetration enhancer
3. comprisal of an aliphatic solvent at, at least, 65 % w/v
4. comprisal of a film-forming excipient with solubility in water at pH 1-10
5. the form of a sprayable liquid solution that forms a washable film when sprayed on skin
Lulla meets all of these mentioned limitations, first teaching their spray composition to comprise up to about 30 %, but most preferably up to about 5 %, of a medicament [0023], with preferred medicaments being agents being drugs used to treat incontinence [0028] such as vasopressin and oxybutynin [0029], specifically claiming the use of oxybutynin in their composition [Cl. 18]. Lulla also teaches the use of permeation enhancers, defined as components used to enhance the penetration rate of drugs through the skin [0020], which include lipophilic solvents, surfactants, menthol, fatty acid esters and polyhydric alcohols [0020], specifically claiming the use of permeation enhancers in their composition [Cl. 1]. In teaching the permeation enhancers to include surfactants, Lulla also lists several exemplary surfactants to include oleic acid and diethylene glycol monoethylether EP (transcutol), or combinations thereof [0034] and claims them in their invention [Cl. 20]. Lulla also teaches the use of aliphatic solvents as non-aqueous vehicles, with preferred non-aqueous vehicles to include acetone, isopropyl alcohol, methylene chloride, methyl-ethyl-ketone, absolute alcohol, ethyl acetate and trichloromonofluoromethane (Pll), methylene dimethyl ether, or combinations thereof [0035], specifically claiming, at least, acetone in their invention [Cl. 23]. Additionally, in a specific embodiment, Lulla teaches the use of a combination aliphatic solvent (ethanol/acetone/methylene chloride) 27 % / q.s. / 27 % [[0060]; Example 7], nearly overlapping with the Instant use range of, at least, 65 % when acetone is added at 9 % and similar non-aqueous solvent mixtures tolerate up to 27 % acetone [[0064]; Example 10]. Lulla also teaches the use of film-formers [0030], referring to compounds, preferably polymers, that form stable films on a surface [0016] when applied up to 10 % w/w [0023], specifically claiming polymers that are water-soluble at a pH range of 1-10, such as acrylic polymers or copolymers (i.e. methacrylic acid copolymer types A, B), polyvinyl acetate, cellulose acetate, polyvinyl alcohol, povidone, copolypovidone povidone vinyl acetate, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, methyl cellulose and ethyl cellulose in their invention [Cls. 31-32] and teaching the use of these film-forming polymers (i.e. povidone, povidone VA-64) from 4 % to 6 % in a specific embodiment, thereby meeting the limitations required by the mentioned claims. While methacrylic acid copolymer type(s) A and B are not explicitly claimed, they are evidenced by Drugs.com to be acceptable names for methacrylic acid and methyl methacrylate copolymer (1:1) and methacrylic acid and methyl methacrylate copolymer (1:2), respectively, before the effective priority date of the Instant application.
Instant Claim(s) 9-10 describe the further addition of a “washability enhancer” that is claimed to be polyethylene glycol 400 (PEG 400). In a specific embodiment, Lulla teaches the addition of PEG 400 into a similar spray composition as that which was described above [[0052]; Example 2], thereby meeting the limitations of the mentioned claims.
However, Lulla makes no specific mention of octisalate and its use as a penetration enhancer, as required by Claim(s) 8 and 44.
Dandiker teches a formulation that includes testosterone, octisalate for use as a penetration enhancer [pg. 3; [0047]], a film-forming ingredient, solvents, and washability enhancers such as polyethylene glycol, for the topical administration of testosterone. In doing so, Dandiker meets several limitations of the mentioned claim by teaching Composition 7 [pg. 7; Table 3], a formulation comprising octisalate, methacrylic acid and methyl methacrylate copolymer 1:2, and polyethylene glycol 400.
A prima facie case of obviousness can be raised for one of ordinary skill in the art to take the teachings of Lulla to produce a topical film composition for the delivery of oxybutynin, and combine them with the teachings of Dandiker to include octisalate as a specific penetration enhancer, to reproduce the Instant invention before the filing date of this application. One of ordinary skill in the art would be motivated to do so, not only owed to its abundant usage by Dandiker across their analogous embodiments of topical drug delivery films, but also to its physicochemical mechanism of lipid bilayer fluidization to create effective diffusion pathways across the epidermal layer, as taught by Gee [Introduction; par. 3]. In doing so, one of ordinary skill in the art can be met with a high expectation of success in producing a topical drug delivery film formulation matching the Instant invention.
Therefore, Claim(s) 1-10 and 44 are found unpatentable over Lulla, in view of Dandiker, and are rejected under 35 USC § 103.
Conclusion
No claims are allowed in this action
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STANLEY BRAM whose telephone number is (571)272-8779. The examiner can normally be reached 7:30 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee R Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights