DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Status of Claims
The amendment, filed on 10 August 2026, is acknowledged.
Claims 1, 16, and 19-25 have been amended.
Claims 17-18 have been cancelled.
Claims 1, 16, and 19-25 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the specific one or more cellulose derivatives are hydroxyethyl cellulose;
the specific one or more permeation enhancers are diethylene glycol monoethyl ether;
the specific water-insoluble polymer is zein;
the specific one or more non-ionic surfactants are polysorbate; and
the specific one or more other topically acceptable agents are preservatives.
Objections Withdrawn
Objections to Specification
Applicant’s amendment to the specification, submitted on 10 August 2026, has overcome the objection to the Specification set forth in the Office Action mailed on 15 May 2026. Accordingly, the relevant objection is withdrawn.
Objections to Claims
Applicant’s amendment to claims 16 and 19-25 have overcome the objections to the claims set forth in the Office Action mailed on 15 May 2026. Accordingly, the relevant objections are withdrawn. The Applicant’s cancellation of claims 17-18 have rendered the relevant objections moot.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 103
The rejection of claims 1, 16, and 19-25 under 35 U.S.C. § 103 is withdrawn in view of Applicant’s amendments to the claims and in favor of the new grounds of rejection below. The rejection of claims 17-18 under 35 U.S.C. § 103 is rendered moot in view of Applicant’s cancellation of the claims.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 16, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Venema et al. (WIPO International Patent Publication No. WO 2021/074314 A1, published on 22 April 2021, provided by Applicant in the IDS filed on 9 February 2024, hereafter referred to as Venema) in view of Shukla et al. (Ind. Crops Prod. 2001, 13 (3), 171., hereafter referred to as Shukla), Farjami et al. (Trends Food Sci. Technol. 2019, 86, 85., hereafter referred to as Farjami), and Osborne et al. (AAPS PharmSciTech. 2018, 19 (8), 3512., hereafter referred to as Osborne).
Venema teaches aqueous formulations comprising tiotropium bromide for the treatment of skin (Abstract). Typical deodorants and antiperspirants are taught to comprise salts of aluminum and/or zirconium which block sweat ducts and “are not effective at treating the symptoms of hyperhidrosis” (pg. 1, final para.) Venema states that they have unexpectedly found that their aqueous formulations comprising 0.0001-1.5% w/w tiotropium equivalent and 70-99.9% w/w aqueous phase successfully treat hyperhidrosis symptoms (pg. 2, lines 15-28). Tiotropium equivalent is defined by Venema to include salts of tiotropium and preferably be anhydrous or monohydrate tiotropium bromide (pg. 3, lines 32-37). The aqueous phase is defined as a phase which comprises water, ethanol, propylene glycol, and/or glycerol (pg. 4, lines 1-3). The formulations may be in the form of emulsions and aqueous gels (pg. 4, lines 18-20).
The formulations are also taught to comprise a gelling agent, which in some embodiments is a cellulose derivative such as hydroxyethyl cellulose (claim 4). Venema additionally teaches that their formulations may comprise dermatologically acceptable excipients, in some embodiments these excipients being humectants, sequestering agents, emollients, and surfactants (pg. 6, lines 25-28). In one embodiment, the surfactant is a non-ionic surfactant (pg. 7, lines 1-3). Finally, Venema teaches that their composition should be applied to affected skin three or more times per day to provide tiotropium in a specified dosage (pg. 8, line 29 - pg. 9, line 9).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the concentration range of tiotropium bromide taught by Venema, which significantly overlaps with the range recited in instant claim 22.
Venema does not teach their composition to comprise diethylene glycol monoethyl ether in the range of 0.3 to 5.0% w/w, zein, and polysorbate nor formulating their composition as an oil-in water emulsion gel. These deficiencies are offset by the teachings of Osborne, Shukla, and Farjami.
Osborne teaches a review of diethylene glycol monoethyl ether (DEGEE), commercially known as Transcutol®, and its uses in enhancing drug solubilization, percutaneous absorption rate, and/or drug retention in the skin of subjects (Abstract). Penetration of the skin barrier is described as a difficult task for delivery of drugs and has resulted in the use of “enhancers” which “reduc[e] skin’s barrier properties and/or enhanc[e] the quantity/rate of the drug transfer across the stratum corneum” (pg. 3512, Introduction, para. 1-3). DEGEE is described as a hydroalcoholic solvent, a category also containing water, ethanol, and propylene glycol, which provides many advantages as an enhancer, including non-volatility, low odor, maintenance of skin structure integrity, “superior stabilization power”, and a well-established safety profile (pg. 3513, left col., para. 2 and Tables I and II). Transcutol® is taught to be readily able to “penetrate the stratum corneum and strongly interact with the water of the intercellular path to modify the skin permeation of the active pharmaceutical ingredient” (pg. 3513, left col., para. 3). As of the time of writing, the U.S. Food and Drug Administration (FDA) listed DEGEE safe for use in transdermal delivery up to concentrations of 5% w/w (pg. 3513, Identity, Purity, Safety, and Regulatory Aspects, para. 2.)
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the concentration range of DEGEE taught by Osborne, which encompasses the range recited in instant claim 1.
Shukla teaches an overview of zein, an industrial protein from corn, and its applications in fields including coatings and cosmetics (Abstract). Zein is taught to belong to the protein class of prolamines, to be alcohol soluble, and to be derived from the endosperm of corn, making it abundantly available (pg. 172, right col., para. 1 - pg. 173, left col., para. 1). While historic uses of zein were primarily in coating pharmaceutical tablets, Shukla teaches that new applications have been discovered (pg. 185, 5. Industrial and consumer applications of zein, para. 1). Due to its poor water solubility, the protein has been used to encapsulate drugs for controlled release applications (pg. 185-186, 5.1. Controlled release applications). In addition, zein has found applications in the cosmetic field as a coating to “prevent direct contact between the epidermis and the inorganic chemicals” that may be present (pg. 186, 5.2. Coatings).
Farjami teaches an overview of emulsion gels, factors that influence their properties and functionality, and their use in pharmaceutics, cosmetics, and food (Abstract). Emulsions are taught to be widely used in cosmetics and pharmaceuticals, but due to thermodynamic instability will eventually separate back into water and oil phases, limiting more widespread application (pg. 85, left col., para. 1). In particular, emulsions are limited for use in some pharmaceutical compositions due to “unpredictable drug release profiles and possible toxicity that arise from emulsion instability” (pg. 85, left col., para. 1). Farjami teaches that the stability of emulsions may be “greatly improved” by confining the oil droplets of the oil-in-water emulsion in three-dimensional networks, otherwise known as hydrogels (pg. 85, right col., para. 1). Hydrogels are taught to be capable of delivering compounds due to their protective abilities and responsiveness to environmental stimuli, but are limited by their inability to deliver hydrophobic compounds (pg. 85, right col., para. 1). A composition system known as an emulsion gel or “emulgel” combines the advantages of both emulsions and hydrogels, delivering both hydrophobic and hydrophilic components while maintaining stability and possessing rheological properties than can be modified (pg. 85, right col., para. 1 - pg. 86, left col., para. 2). Farjami additionally teaches that emulsion gels “have advantages over conventional emulsions and hydrogels for certain applications, such as improved physical or chemical stability, texture modification, encapsulation of both lipophilic and hydrophilic components, and controlled release” (pg. 93, 4. Conclusions).
The concentration, type, and identity of the emulsifier used in emulsion gels is taught to impact its properties (pg. 87, left col., para. 3-4). When a protein is also present in the emulsion gel, Farjami teaches that the ratio of the surfactant to the protein can be used to modify the storage modulus (pg. 88, left col., final para.). In one particular example, it is taught that the non-ionic water-soluble surfactant Tween™ 20 was effective at displacing proteins from oil-water interfaces, which led to the emulsion gel decreasing its storage capacity of encapsulated molecules (pg. 88, right col., para. 2). As evidenced by pg. 5, lines 23-25 of the instant specification, Tween™ 20 is a polysorbate non-ionic surfactant.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Osborne, Shukla, and Farjami with the invention of Venema because the combination of prior art elements to impart known benefits produces predictable results. Venema teaches a dermatologically acceptable composition comprising tiotropium bromide, hydroxyethyl cellulose, one or more non-ionic surfactants, water, ethanol, glycerol, and propylene glycol for the treatment of hyperhidrosis. In view of the teachings of Osborne, one of ordinary skill would be motivated to include DEGEE in the invention above because Osborne teaches the compound to improve the penetration of active ingredients into the skin of users while maintaining stability, skin integrity, and safety. The ordinary artisan would find it obvious to include a penetration enhancer to improve the efficacy of the active ingredient tiotropium bromide. Further, the ordinary artisan would be motivated to optimize in the range of 0-5% w/w DEGEE as a result of the FDA guidelines taught by Osborne, which significantly overlaps with the range recited in instant claim 1.
In view of the teachings of Shukla, one of ordinary skill would be motivated to use the protein zein to encapsulate the active ingredient tiotropium bromide because Venema teaches that their composition should be applied multiple times throughout the day and can contain a sequestering agent and Shukla teaches that zein can be utilized in cosmetics and pharmaceuticals for controlled release. The person of ordinary skill would recognize the utility of using zein as the sequestering agent to achieve sustained release of tiotropium bromide for the treatment of hyperhidrosis.
Venema teaches that their composition may be formulated as an emulsion or gel, but does not teach the form of an emulsion gel. In view of the teachings of Farjami, a person of ordinary skill would be motivated to formulate the composition of Venema as an emulsion gel because Farjami teaches the form to combine the benefits of each form without the instability that may be present in emulsions or the issues with hydrophobicity present in hydrogels. In addition, Farjami teaches that oil-in-water emulsion gels have improved properties over conventional oil-in-water emulsions and hydrogels and are suitable for controlled release, which the ordinary artisan would recognize as beneficial for the delivery of tiotropium bromide over time. Finally, one of ordinary skill would be motivated to use the polysorbate Tween™ 20 as the non-ionic surfactant in the invention of Venema because Farjami teaches the species to be useful in oil-in-water emulsion gels for releasing encapsulated molecules. The ordinary artisan would recognize the utility of this property to release encapsulated tiotropium bromide and would use the polysorbate to optimize delivery of the active ingredient to users. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1, 16, and 19-23 in view of the teachings of Venema, Osborne, Shukla, and Farjami.
Claims 1 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Guskey et al. (U.S. Patent No. 6,123,932 A, published on 26 September 2000, hereafter referred to as Guskey) in view of Venema (WIPO International Patent Publication No. WO 2021/074314 A1, published on 22 April 2021, provided by Applicant in the IDS filed on 9 February 2024), Osborne (AAPS PharmSciTech. 2018, 19 (8), 3512.), and Farjami (Trends Food Sci. Technol. 2019, 86, 85.).
Guskey teaches deodorant compositions comprising a cyclodextrin odor controlling agent which are “especially effective at preventing or eliminating malodors resulting from perspiration” and methods of using and making the compositions (Abstract). The compositions are taught to address malodors via application to the underarm skin (claims 20-21). In addition to the odor controlling cyclodextrin, Guskey teaches their composition to comprise a gellant, which is interpreted as producing a gel formulation, and a liquid carrier “suitable for topical application to the human skin” in an amount from 10-90% w/w (claim 1 and col. 9, lines 15-28). Examples of suitable liquid carriers include propylene glycol, ethanol, and glycerin, which is considered equivalent to the recited glycerol (col. 90, lines 51-54). Finally, Guskey teaches that their composition comprises water, in the aqueous formulation in the amount of 10-75% w/w and in the anhydrous formulation in amounts ≤10% w/w (claim 1 and col. 11, lines 60-67).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). These guidelines apply to the range of quantities of water, ethanol, glycerin, and propylene glycol taught by Guskey, which significantly overlap with or encompass the ranges recited in instant claims 24-25.
Guskey does not teach their composition to comprise tiotropium bromide, diethylene glycol monoethyl ether in the range of 0.3 to 5.0% w/w, nor formulating their composition as an oil-in-water emulsion gel. These deficiencies are offset by the teachings of Venema, Osborne, and Farjami.
Venema, Osborne, and Farjami have been described above.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Osborne, Venema, and Farjami with the invention of Guskey because the combination of prior art elements to impart known benefits produces predictable results. Guskey teaches a dermatologically acceptable gel composition for eliminating or preventing malodors associated with perspiration comprising water, ethanol, glycerin, and propylene glycol in quantities that overlap with or encompass the amounts recited in instant claims 24-25.
In view of the teachings of Venema, one of ordinary skill would be motivated to incorporate tiotropium bromide in amounts of 0.0001-1.5% w/w in the invention of Guskey for the treatment of hyperhidrosis because Venema teaches the active ingredient to be unexpectedly effective at treating hyperhidrosis. Guskey teaches that malodors are associated with perspiration and the ordinary artisan would be motivated to include a component in a composition that is already being applied to underarm skin to treat excessive perspiration. In view of the teachings of Osborne, one of ordinary skill would be motivated to include DEGEE in the invention above because Osborne teaches the compound to improve the penetration of active ingredients into the skin of users while maintaining stability, skin integrity, and safety. The ordinary artisan would find it obvious to include a penetration enhancer to improve the efficacy of the active ingredient tiotropium bromide. Further, the ordinary artisan would be motivated to optimize in the range of 0-5% w/w DEGEE as a result of the FDA guidelines taught by Osborne, which significantly overlaps with the range recited in instant claim 1.
Finally, in view of the teachings of Farjami, a person of ordinary skill would be motivated to formulate the composition of Guskey as an oil-in-water emulsion gel because Farjami teaches the form to combine the benefits of an oil-in-water emulsion and gel forms without the instability that may be present in oil-in-water emulsions or the issues with hydrophobicity present in hydrogels. In addition, Farjami teaches that oil-in-water emulsion gels have improved properties over conventional oil-in-water emulsions and hydrogels and are suitable for controlled release, which the ordinary artisan would recognize as beneficial for the delivery of tiotropium bromide over time. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1 and 22-25 in view of the teachings of Guskey, Venema, Osborne, and Farjami.
Response to Arguments
Applicant's arguments filed on 10 August 2026 have been fully considered but they are not persuasive.
Applicant argues from the final para. of pg. 6 to the final para. of pg. 7 that they have found unexpected results. Guidelines on determining whether results are expected or unexpected are provided in MPEP § 716.02. To demonstrate that results are unexpected and significant, the Applicant has the responsibility of presenting evidence that establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d)-716.02(e).
In para. 2-3 of pg. 6, Applicant explains that diethylene glycol monoethyl ether (described as Transcutol® HP) may alter “evaporation dynamics, polymer (zein) precipitation kinetics, or interfacial structure” as compared to “classical behavior” of solubility with respect to systemic permeation. In para. 4, Applicant directs the reader to Table 22 in the instant spec. and argues that formulation F12 demonstrates the unexpected result of more tiotropium reaching sweat glands, as a result of the presence of Transcutol® HP. Applicant argues this result is unexpected because Transcutol® HP “would ordinarily be expected to increase system flux proportionally; instead, F12 yields a dermally-focused depot effect consistent with altered nanoparticle self-assembly and solvent-polymer interactions”.
Table 22 compares the distribution of tiotropium following application of formulations F12 and F15, both in the presence of and absence of zein. Table 21 of the instant spec. discloses that formulation F12 comprises 2.58% or 2.76% w/w Transcutol® HP, that formulation F15 comprises no Transcutol® HP, and that formulation F15 comprises ~5 times the concentration of tiotropium. This comparison is not a persuasive demonstration of unexpected and surprising results. The only comparisons allowed by Table 22 are the presence and absence of Transcutol® HP and zein. It is not clear from the data presented in Table 22 if the increased retention of tiotropium in the dermis is a result of the presence of Transcutol® HP or the greater concentration of tiotropium in the formulation. Further confounding the data is the marked increase of retention of tiotropium in the dermis when zein is present, presenting the possibility that Transcutol® HP has no effect, the reduced retention observed for formulation F15 is a result of the greater concentration of tiotropium, and the observed retention increases in the presence of zein is an effect of the polymer.
The Applicant has not demonstrated unexpected results commensurate in scope with the claimed invention. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP § 716.02(d). Only one example inside the claimed range has been provided (formulation F12) and the absence of Transcutol® HP in formulation F15 is not a persuasive test outside the claimed range. Therefore, the data presented in Table 22 does not demonstrate the criticality of the claimed range.
The Applicant also has not compared their invention with the closest prior art. See MPEP § 716.02(e). The comparison provided in Table 22 is between two formulations produced by the Applicant, with only one containing Transcutol® HP. Venema et al. (WIPO International Patent Publication No. WO 2021/074314 A1), which was provided by Applicant in the IDS filed on 9 February 2024 and used in a rejection under 35 U.S.C. § 103 in the previous Office Action, teach dermatologically acceptable composition comprising tiotropium bromide, hydroxyethyl cellulose, one or more non-ionic surfactants, water, ethanol, glycerol, and propylene glycol for the treatment of hyperhidrosis. Therefore, a comparison with the closest subject matter in the prior art should include a comparison to Venema et al.
Finally, Applicant argued that the inclusion of Transcutol® HP “would ordinarily be expected to increase system flux proportionally” rather than a “dermally-focused depot effect”. This effect is not present in the claims; rather, the instant claims are limited to a composition comprising the permeation enhancer, which has been rendered obvious above. In addition, the claimed effect is a result of the components present in the composition (as evidenced by the instant spec.), which has been rendered obvious, and would inherently be present in the claimed composition. As a result, Applicant’s allegation of unexpected results is found to be unpersuasive.
In the final three lines of the penultimate para. of pg. 7, Applicant argues that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Oil-in-water emulsions comprising tiotropium bromide were known in the art prior to the submission of the instant application (see Venema above). Diethylene glycol monoethyl ether was known in the prior art to enhance drug solubilization, percutaneous absorption rate, and/or drug retention in the skin of subjects, to have many advantages as an enhancer, including non-volatility, low odor, maintenance of skin structure integrity, “superior stabilization power”, and a well-established safety profile, and to be readily able to “penetrate the stratum corneum and strongly interact with the water of the intercellular path to modify the skin permeation of the active pharmaceutical ingredient” (see Osborne above). It would have been prima facie obvious to a person of ordinary skill in the art to combine the tiotropium-containing compositions with DEGEE prior to the filing of the instant application without the need for hindsight reasoning and the argument is found to be unpersuasive.
Conclusion
No claims are allowed.
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.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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