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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/24/2025 has been entered.
Applicants Declaration filed under 37 CFR 1.132 by Elka Touitou has been entered and considered.
Claims 87, 90, 92, 93, 95-111 are pending. Claims 97-110 are withdrawn. Claims 87, 90, 92, 93, 95, 96, 111 have been considered on the merits. All arguments and amendments have been considered.
The previous rejection of Claim(s) 87, 90, 92-96, 112, 113 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by CN101137370 (IDS) is withdrawn in light of applicants showing in the Touitou Declaration.
The previous rejection of Claim(s) 87, 90, 92, 93, 95, 111-113 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO2011/089604 (IDS) is withdrawn in light of applicants claim amendments.
Claim Objections
Claim 87 is objected to because of the following informalities: in the 3rd to last line of the claim the word “pembrolizumab” is followed by a “)”, see pembrolizumab). The ) should be deleted.
Claim Interpretation
Claim 87 is drawn to a liquid formulation comprising an alcohol, wherein the alcohol is one or more C2-C4 alcohols, and wherein the total concentration of the alcohol is from 60% - 98% w/w; one or more acrylate polymers wherein the acrylate polymer is poly(methacrylate), poly(ethylacrylate), a copolymer thereof, or polycarbophil, poly(methyl methacrylate), poly(ethyl methacrylate), poly(N,N-dimethylaminoethyl methacrylate), poly(butyl methacrylate), poly(ethylacrylate), Eudragit® , Eudragit100® or Eudragit L100®, wherein the one or more acrylate polymers is soluble in the alcohol and practically insoluble in water or an aqueous solution at a pH < 6 and wherein a total concentration of the one or more polymers is in a range from 1% to 20% w/w; water at a concentration of less than 20% w/w, and one or more active ingredients. Thus, a reference which teaches the formulation ingredients is taken to anticipate applicants’ invention and is a formulation which upon instillation through a catheter into the urinary tract, bladder, or kidney forms a mass and releases the active agent over time according to claim 87. Thus, any formulation containing these ingredients is interpreted to inherently possess applicants claimed characteristics.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 87 and 95 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 87 and 95 contain the trademark/trade name Eudagrit®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polymer and, accordingly, the identification/description is indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 87, 90, 92, 93, 96 , 111 is/are rejected under 35 U.S.C. 102(a)(1)and (a)(2) as being anticipated by Touitou et al. (US20120114574 A1).
Touitou teaches a liquid formulation for therapeutic delivery comprising at least one drug/active agent, a solvent in an amount ranging from 50-90%, and at least one film-forming ingredient in an amount ranging from 0.2-15% (0053-0062, for example). The reference teaches an alcohol, specifically ethanol or propylene glycol as the solvent present in amounts ranging from 50-90% (specifically 61-95%) total weight according to claims 87, 90 (0057, 0067, 0070, 0080, 0081, 0093, 0097, 1018, 0109), an active/therapeutic agent including oxybutynin and lidocaine according to claims 87 and 111 (0048, 0050, 107, 108), optionally water and present in amounts of less than 20% (ex. 2, 3, for example and 0034, 0035, 0041, 0058) and a polymer including the acrylate polymers, i.e., Eudagrit® present in amounts ranging from 0.2-15% total weight according to claims 87, 90, 92, 93 (0055, 0076) and additional additives including excipients not limited to pH-buffering agents, plasticizers, emollients, antioxidants, stabilizers, according to claims 87, 92 (0062, 0071-0072).
Regarding claim 96, the reference teaches the composition may be applied as a spray or metered spray and thus the composition would be in a container (0117). meRegarding claim 111, the active ingredient includes lidocaine and oxybutynin (0050, 0107).
Thus, the reference anticipates the claimed subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Touitou et al. (US20120114574 A1) as applied to claims 87, 90, 92, 93, 96, 111 above, and further in view of CN107569690.
The teachings of Touitou are found above. While the reference teaches using Eudragit as the acrylate polymer, they do not specifically teach Eudragit S100 or L100 of amended claim 95.
CN690 teaches an extended-release drug formulation (for treating disorders of the bladder) comprising active ingredients including naproxen (p. 4, last 5 parag.-p. 5, whole page) and oxybutynin (p. 5, 4th, 7th -9th para., for example), propylene glycol (p. 12, 4th parag.), and a pH-dependent/sensitive polymer which facilitates release of the active agent (p. 7, last parag.). The polymers include the methacrylate polymers Eudragit S100, L100 (p. 10, last 2 parag’s), surfactants, pH adjusters, plasticizers (p. 11, 2nd and 3rd full parag., p. 12, 3rd, 4th parag.). The formulation is designed to release the active ingredient for an extended time for prolonged release of the ingredient including for 1 hour to up to about 10 hours (p. 8, 1st and 2nd parag.).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to use Eudragit S100 or L100 in the formulation for extended release because the art teaches that these water-insoluble, pH-dependent polymers are specifically designed for extended release of active agents. Thus, one of ordinary skill has a good reason to pursue known options within his or her technical grasp with a reasonable expectation of successfully providing a formulation designed for extended release of drugs/active agents.
Response to Arguments
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive.
Regarding US574, applicant argues that none of the active ingredients, now part of claim 87 are disclosed in the reference and that although lidocaine is mentioned, the combination of lidocaine with oxybutynin is not disclosed.
It is the Examiners position that the reference lists both lidocaine and oxybutynin as active agents to be used in the formulation, i.e. at least one active/therapeutic agent including oxybutynin and lidocaine according to claims 87 and 111 (0048, 0050). Additionally, claim 87 is not limited to an active ingredient of only oxybutynin in combination with lidocaine.
Applicants argue the intended use of applying to the nail or skin, and that the formulation of the prior art requires rapid evaporation of solvents and requires a phospholipid, which applicants have removed such limitation from the current claims.
It should be noted that applicants formulation is one which “comprises” and thus does not exclude the use of additional components.
Further, While the claimed invention is for use in the bladder, urinary tract, or kidney; the claimed invention is drawn to a composition and the intended use and function of the claimed substrate does not patentably distinguish the composition, per se, since such undisclosed use and function is inherent in the reference composition. In order to be limiting, the intended use and function must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use and function fails to create a structural difference, thus, it is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Moreover, the claimed function must be inherent to the reference composition. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new. Thus, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. (MPEP 2112).
The reference teaches a liquid formulation for therapeutic delivery comprising an alcohol, specifically ethanol or propylene glycol as a solvent present in amounts ranging from 50-90% (specifically 61-95%) total weight according to claims 87, 90 (0057, 0067, 0070, 0080, 0081, 0093, 0097, 1018, 0109), an active/therapeutic agent including oxybutynin and lidocaine according to claims 87 and 111 (0048, 0050, 107, 108), optionally water and present in amounts of less than 20% (ex. 2, 3, for example and 0034, 0035, 0041, 0058) and a polymer including the acrylate polymers, i.e., Eudagrit® present in amounts ranging from 0.2-15% total weight according to claims 87, 90, 92, 93 (0055, 0076) and additional additives including excipients not limited to pH-buffering agents, plasticizers, emollients, antioxidants, stabilizers, according to claims 87, 92 (0062, 0071-0072). The formulation allows for the formation of a “mass” which exhibits sustained release and improved delivery of an active agent (0013 and 0014).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651