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 .
Applicant’s response filed 4/26/2026 has been received and entered into the case.
Claims 87, 90, 92, 93, 96-110 are pending. Claims 97-110 are withdrawn. Claims 87, 90, 92, 93, 96 have been considered on the merits. All arguments and amendments have been considered.
The following rejections are withdrawn in light of applicants claim amendments; the rejection of claim(s) 87, 90, 92, 93, 96 , 111 under 35 U.S.C. 102(a)(1)and (a)(2) as being anticipated by Touitou et al. (US20120114574 A1) and the rejection of claims 87 and 95 under 35 U.S.C. 112(b).
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), 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 § 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) 87, 90, 92, 93, 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Touitou et al. (US20120114574 A1) in view of CN107569690, Gupta et al. (US20140051702) and Lee et al (US8801694).
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 and combinations thereof according to claim 87 (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).
While the reference teaches that combinations of the active agents may be used which includes oxybutynin and lidocaine, they do not specifically teach these two together; however, compositions having an intended use for instillation into the bladder, or urinary tract including a combination of oxybutynin and lidocaine were known in the prior art before the effective filing date.
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.).
Gupta (US20140051702) teaches a composition for instillation into the bladder (claim 28) comprising active agents selected from lidocaine and oxybutynin or combinations thereof (0175) which may be administered via extended release (0154). Additionally, the reference teaches additional agents which are used for treating issues of the bladder which include bupivacaine (0166), naproxen (0175).
Lee et al (US8801694) teaches a formulation for instillation into the bladder to treat bladder conditions comprising a combination of lidocaine and oxybutynin (col. 3, lines 53-60, col. 11, lines 28-32, 40-60). Depending on the conditions to be treated, additional agents are disclosed for treating bladder issues including naproxen, fentanyl (col. 12, lines 1,2), cisplatin, doxorubicin, thiotepa, mitomycin, methotrexate, for example (col. 12, lines 20-40).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to use a combination of oxybutynin and lidocaine (when instilling into the bladder or urinary tract) because these active agents and combinations thereof are known for treating bladder issues in a formulation for extended release. 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 having an intended use of being instilled into the bladder.
Response to Arguments
Applicant's arguments filed 4/26/2026 have been fully considered but they are not persuasive.
Applicants argue that the claims have now been amended to include the combination of oxybutynin with lidocaine and that the references do not teach this combination.
It is the Examiners position that the Touitou 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 or combinations thereof according to claims 87 (0048, 0050).
However secondary references have been applied herein to provide motivation to use the combination when the formulation is intended to be instilled into the urinary tract, bladder or kidney.
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 (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).
Therefore, the composition would be expected to provide the same function of forming a mass which releases the one or more active agents. One of ordinary skill in the art would have a reasonable expectation of successfully releasing any of the claimed active agents when using the formulation of Touitou.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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
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