DETAILED ACTION
Notice of AIA Status
The present application is subject to the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ). The application contains or contained at any time at least one claim to a claimed invention having an effective filing date on or after 16 March 2013. Accordingly, the application is being examined under the first inventor to file provisions of the AIA (see MPEP § 2159.02 and § 2159.03).
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) and a qualifying submission, was filed after final rejection. Since this application is eligible for continued examination under 37 CFR § 1.114, and the required fee has been timely paid, the finality of the previous Office Correspondence has been withdrawn pursuant to 37 CFR § 1.114. The applicant's submission filed on 30 June 2026, has been entered (see MPEP § 706.07(h) and 35 U.S.C. § 132(b)).
Information Disclosure Statement
The Information Disclosure Statement, filed 20 May 2026, is acknowledged and has been considered.
Status of the Claims
Amendments to the Specification, Amendments to the Claims and Arguments/Remarks filed 30 June 2026, in response to the Office Correspondence dated 21 April 2026, are acknowledged.
The claim listing filed 30 June 2026 has been examined. Claims 1, 3, 5-13, 15-17, 22-25 are pending. Claims 1, 8, and 9 are currently amended and claim 25 is newly added. Claims 2, 4, 14, 21 are canceled and claims 18- 20 are withdrawn from consideration.
Response to Amendment
The Request for Continued Examination and accompanying amendment and remarks have been entered and considered. The amendment to the Specification correcting the identified typographical error has likewise been considered.
The applicant argues that the prior § 112(b) rejection directed to the absence of a reference basis for the “25% by mass or more and 95% by mass or less” limitation has been cured by amending claim 1 to specify that the percentage is based on the total weight of the composition. That argument is persuasive as to the specific defect identified in the in the prior rejection. Accordingly, the prior § 112(b) rejection based upon the absence of an identified reference basis for component (D)’s mass percentage is withdrawn.
Claim 1 has been amended to require, inter alia, that component (C), the non-volatile base, comprises an ester oil and an alkanolamine, that component (D) is a lower alcohol present in an amount of 25% by mass or more and 95% by mass or less based on the total weight of the composition, that the mass ratio [(E)/(D)] is 0.005 or more and 2.0 or less, and that the composition has a viscosity at 25°C of 1.0 mPa·s or more and 10,000 mPa·s or less. Claims 8 and 9 have been amended in view of the amendment to claim 1.
New claim 25 has been added and depends from claim 1. The recited alkanolamines of claim 25 find support in the originally filed disclosure, which identifies triethanolamine, triisopropanolamine, diisopropanolamine, monoisopropanolamine, and 2-amino-2-methylpropanol among the exemplary alkanolamines useful as component (C). Accordingly, the addition of claim 25 is not considered to introduce new matter.
The amendment does not, however, place the application in condition for allowance. The arguments directed to the outstanding rejection under 35 U.S.C. § 103 and the provisional nonstatutory double-patenting rejection have been fully considered but are not persuasive for the reasons stated below in the Response to Arguments.
The prior rejection of claims 1-3, 5-13, 15-17, and 22-24 under 35 U.S.C. § 103 over Bhalani et al. (US10080763B2; “Bhalani”) in view of Tojo and Fukuda (US11351402B2; “Tojo”) and in further view of Suzuki (EP3685823A1) is withdrawn and replaced by the rejections set forth below. The applicant’s amendments change the scope of independent claim 1 by requiring, in combination, that component (C) comprise both an ester oil and an alkanolamine, that the volatile lower alcohol constitute 25-95% by mass of the composition, that the water-to-volatile-solvent mass ratio [(E)/(D)] be 0.005-2.0, and that viscosity at 25 °C be 1.0-10,000 mPa·s, claims 8 and 9 were correspondingly amended, and new claim 25 expressly limits the alkanolamine species.
The previously applied Bhalani examples and the Bhalani, Tojo, and Suzuki combination did not provide as direct of a teaching of these newly required limitations together in a medicinal composition. Accordingly, additional search and reconsideration of the closest prior art were necessitated by the claim amendments. Salin-Drouin (US20080038220A1), is now applied as the principal reference because its worked hydroalcoholic medicinal gel places a drug, Carbopol® 980 980, isopropyl myristate, triethanolamine, 67 wt% ethanol, and water in the same formulation. Pimplaskar (US8785426B1), supplies directly analogous 25 °C viscosity data, and Dow et al. (US6387383B1), establishes the known water-insoluble character of highly crosslinked Carbopol® 980 980.
Bhalani and Suzuki have not been disregarded and remain of record, wherein they are retained below where their teachings remain particularly probative of specific dependent-claim limitations. Tojo and Meyer likewise remain pertinent cumulative evidence concerning conventional viscosity adjustment and skin-applied film-forming compositions conventionally possessed 25 °C viscosities within the presently claimed range but are no longer necessary to the principal claim 1 rejection. However, Pimplaskar is more directly analogous because it expressly measures viscosity at 25 °C in testosterone/carbomer/ethanol/water medicinal gels substantially similar to Salin-Drouin’s vehicle.
Suzuki remains pertinent to instant claim 7, as outlined below, because it teaches a water-insoluble diacetoneacrylamide-containing acrylic copolymer in a high-ethanol skin-film spray, wherein Salin-Drouin’s expressly listed ethylcellulose together with Bhalani and Arnaud’s pharmaceutical/cosmetic ethylcellulose teachings. Bhalani remains highly pertinent to the dependent claims directed to specifically recited medicinal actives, therapeutic classes, film-forming polymers, ester/nonvolatile components, topical dosage forms, and spray administration. Bhalani has therefore been retained selectively, but is no longer used as the principal claim 1 reference because Salin-Drouin more directly teaches the newly amended conjunction of ester oil, alkanolamine, ≥25% lower alcohol, and an E/D ratio within the claimed interval in a single medicinal formulation.
A new rejection of the claims under 35 U.S.C. § 112(b), regarding the term lower alcohols, is detailed below and the prior provisional nonstatutory double-patenting rejection is maintained, as modified below, and now includes new claim 25.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 103 is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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. 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. The 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.
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 underlying obviousness under 35 U.S.C. § 103 are those set forth in Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966), and 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.
Claims 1, 6, 8-13, 15, 16, 23, and 25 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”).
Evidentiary reference Tamura et al. (US20110177143A1, published 21 July 2011; hereinafter “Tamura”) is additionally cited as evidence of the conventional characterization of isopropyl myristate as an ester oil and is not relied upon to introduce a different component into the combination. For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin is directed to pharmaceutical hydroalcoholic gels for transdermal delivery of testosterone (Abstract) and therefore concerns the same general field and formulation problem as the presently claimed medicinal composition. More specifically, Salin-Drouin Example 2 identifies the materials used to prepare its formulations as including Carbopol® 980, testosterone, isopropyl myristate, triethanolamine, propylene glycol, and absolute ethanol (Example 2, Material). Formulation 5 per 100 g final formulation contains 1% testosterone, 0.5% Carbopol® 980, 67% absolute ethanol, 0.50% triethanolamine (TEA), and 0.5% isopropyl myristate (Example 2, Formulations Table, Formulation 5).
Salin-Drouin further specifies that 1 g of Formulation 5 is prepared from 685 mg of a solution containing testosterone and 0.5 g isopropyl myristate in 67 g absolute ethanol, 305 mg of base gel obtained by swelling 0.5 g Carbopol® 980 in 30 g water, and 10 mg of TEA half-diluted in water (Example 2, Formulation 5). Thus, Salin-Drouin places the instant claimed drug, polymer, ester, alkanolamine, lower alcohol, and water together in a single worked medicinal gel.
Salin-Drouin’s testosterone is a medicinal ingredient (instant claimed Component (A)) administered transdermally for therapeutic purposes (claim 7). Salin-Drouin uses Carbopol® 980, a highly crosslinked polyacrylic-acid polymer (instant claimed Component (B), water-insoluble polymer; ¶[0013]). Dow independently identifies Carbopol® 980 as a polyacrylic-acid polymer having a high level of crosslinking that produce gels (col. 4, ll. 36-39) with high viscosity from 40,000 to 60,000 cP for a 0.5% solution of CARBOPOL® 980 (Brookfield viscometer at 20 rpm; reference: B.F. Goodrich Product Guide, Bulletin 2 [Product Guide. Carbopol: The Proven Polymers in Pharmaceuticals, Bulletin 2, pp. 1-2, Copyright 1994 The B.F. Goodrich Co.]; col. 4, ll. 44-45), explaining “Highly crosslinked polymers of this type do not dissolve in water, rather they form gels by forming homogeneous dispersions.” (col. 5, ll. 16-18).
The applicant defines a “water-insoluble polymer” by whether more than 0.5 g of an initial 1 g polymer sample remains undissolved after exposure to 10 g water for 24 hours at 23 °C. A polymer characterized in the prior art as highly crosslinked and as not dissolving in water meets the broader criterion that more than one-half of the sample remain undissolved. Dow is relied upon to establish an intrinsic physical property of Salin-Drouin’s expressly disclosed Carbopol® 980 rather than to substitute a different polymer into Salin-Drouin.
Salin-Drouin Formulation 5 contains both 0.5% isopropyl myristate and 0.05% of the alkanolamine triethanolamine (Example 2, Formulation 5; instant claimed ester oil and alkanolamine Component (C)). The evidentiary reference Tamura provides evidence that isopropyl myristate was conventionally classified as an ester oil, which expressly identifies isopropyl myristate as an example of an “ester oil which is liquid at 25 °C” and as a branched saturated fatty-acid ester (¶[0026]-[0027]). Thus, Salin-Drouin teaches the amended instant claim requirement that component (C) comprise both an ester oil and an alkanolamine.
Salin-Drouin Formulation 5 contains 67 wt% absolute ethanol [monohydric two-carbon lower alcohol] (Example 2, Formulation 5; instant claimed lower alcohol at 25-95 mass% Component (D)). Salin-Drouin additionally teaches generally that its compositions may contain 40-75 wt%, preferably 50-70 wt% of a C2-C6 alcohol (¶[0024]) and identifies ethanol as the preferred alcohol (¶[0025]).
Regarding the component (E) [water] and the [(E)/(D)] ratio, the quantitative preparation of Salin-Drouin Formulation 5 gives approximately 67 wt% ethanol and approximately 30.5 wt% water. The water amount follows from the 305 mg Carbopol® 980 base gel derived from 0.5 g Carbopol® 980 in 30 g water and the TEA-water portion of the 1 g final formulation (Example 2, Formulation 5). Accordingly, (E)/(D) = 30.5/67, or the value 0.455, which falls squarely within the instant claimed interval of 0.005-2.0.
Regarding the viscosity at 25 °C, Salin-Drouin recognizes formulation viscosity as a result affected by alcohol concentration and polymer concentration, wherein Salin-Drouin investigates the effect of ethanol on hydroalcoholic Carbopol® 980 gels and reports that increasing ethanol from 50 to 65 wt% decreases viscosity from 15.0 to 0.800 Pa·s. Salin-Drouin separately varies Carbopol® 980 980 from 0.3 to 0.7% and reports viscosities ranging from 0.125 to 12 Pa·s (Viscosity study, Tables 4 and 5). Thus, Salin-Drouin identifies the polymer/alcohol balance as a variable affecting viscosity. However, Salin-Drouin does not expressly report the viscosity of Formulation 5 at precisely 25 °C.
Although, Pimplaskar concerns directly analogous topical testosterone hydroalcoholic gels (Abstract), wherein Pimplaskar Example 1, Table 1 discloses formulations containing 1% testosterone, Carbomer® 980, ethanol and water, including Examples 1-7 to 1-10 having 67.0-67.5% ethanol and 0.9% Carbomer® 980 with viscosities at 25 °C of 275, 494, 1,102 and 766 cP for Examples 1-7 to 1-10, respectively (Example 1, Table 1). Because 1 cP = 1 mPa·s, each value lies within instant claim 1’s broad 1-10,000 mPa·s range. Pimplaskar additionally discloses a worked testosterone gel containing 78.35% ethanol, 1.50% Carbomer® 980, 5% water, polyols, and ester-containing cosolvents, demonstrating the operability of high-alcohol Carbomer® medicinal gels (Example 3, Table 3).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to adjust Salin-Drouin’s Carbopol® 980, ethanol, and water formulation, if necessary, so that its viscosity at 25 °C lies within the conventional range demonstrated by Pimplaskar. Salin-Drouin and Pimplaskar are not unrelated references joined only through hindsight. Both concern topical testosterone delivery from Carbopol® 980 and Carbomer® hydroalcoholic gels, and both employ closely corresponding ethanol and polymer levels. Pimplaskar supplies direct evidence of the expected 25 °C rheological behavior of the same type of medicinal formulation.
Moreover, Salin-Drouin itself expressly establishes that ethanol amount and Carbopol® 980 amount affect viscosity. Therefore, those variables were known result-effective variables, and the selection of an operable value within the extremely broad claimed interval would have constituted ordinary formulation optimization (see In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Applied Materials, Inc., 692 F.3d 1289, 1295-97 (Fed. Cir. 2012); MPEP § 2144.05). A reasonable expectation of success is supplied by Pimplaskar’s actual preparation and measurement of closely analogous formulations, therefore instant claim 1 would have been obvious.
Instant claim 6 further requires component (B) to be a water-insoluble acrylic, cellulosic, or vinyl polymer. Salin-Drouin teaches the use of Carbopol® 980, an acrylic-acid-based polymer and identifies Carbopol® 980 polymers as acrylic-acid-based polymers crosslinked with allyl sucrose or allylpentaerythritol (¶[0018]). Dow establishes that highly crosslinked Carbopol® 980 does not dissolve in water, as described above. Thus, the composition resulting from the instant claim 1 combination contains a water-insoluble acrylic polymer, satisfying instant claim 6.
Instant claim 8 requires component (C) to further comprise a nonpolar oil and/or polyol. Salin-Drouin teaches propylene glycol, a polyol, as a penetration enhancer for its hydroalcoholic testosterone gels (¶[0013]). More importantly, Salin-Drouin expressly teaches compositions containing both propylene glycol and isopropyl myristate, including embodiments comprising 0.1-5.0% propylene glycol, 0.1-4.0% isopropyl myristate, 40-75% C2-C6 alcohol, a gelling agent, testosterone, and optionally water (¶[0087]). Salin-Drouin further states that the addition of isopropyl myristate provides markedly improved results when used in conjunction with propylene glycol (¶[0086]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to incorporate Salin-Drouin’s expressly recommended propylene glycol into the Formulation 5 type vehicle because Salin-Drouin itself identifies the combination and reports improved penetration results, supplying both motivation and reasonable expectation of success in doing so. Accordingly, claim 8 would have been obvious.
Instant claim 9 recites, inter alia, isopropyl myristate, propylene glycol, and triethanolamine. Salin-Drouin Formulation 5 contains isopropyl myristate and triethanolamine and also teaches propylene glycol in combination with isopropyl myristate, as described above, thus instant claim 9 adds no patentable distinction.
Salin-Drouin’s 67 wt% ethanol is a monohydric lower alcohol containing two carbon atoms and therefore satisfies instant claim 10’s requirement of four or fewer carbon atoms (Example 2, Formulation 5). Salin-Drouin Formulation 5 contains 1 wt% testosterone, which lies within instant claim 11’s 0.001-30 mass% medicinal-ingredient range. Salin-Drouin Formulation 5 contains 0.5 wt% Carbopol® 980, within instant claim 12’s 0.01- 30 mass% polymer range. Salin-Drouin Formulation 5 contains at least 0.5% isopropyl myristate and 0.5 % triethanolamine for at least 1.0 mass% instant claimed component (C) attributable to the expressly required ester oil and alkanolamine. The amount lies within instant claim 13’s 0.001-30 mass% range. Salin-Drouin Formulation 5 contains approximately 30.5 mass% water, falling within instant claim 15’s range of 0.1-70 mass% (Example 2, Formulation 5).
Instant claim 16 is written in the alternative and requires a lotion, gel, ointment, cream, or foam formulation. Salin-Drouin identifies and prepares its composition as a gel for topical/transdermal administration (¶[0013]). Example 2 repeatedly refers to the formulations as radio-labelled gels and to the Carbopol® 980 base gel. Disclosure of the claimed gel species satisfies the alternative limitation of instant claim 16.
Salin-Drouin Formulation 5 includes 1.0% testosterone (instant claimed component (A)), 0.5% Carbopol® 980 (instant claimed component (B)), and 0.5% isopropyl myristate and 0.5% triethanolamine (total 1.0% instant claimed component (C)) (Example 2, Formulation 5). Thus, (A)/[(B)+(C)] = 1.0/(0.5+1.0) = 0.667. The calculated ratio 0.667 lies within instant claim 23’s interval of 0.001-2.00.
Instant claim 25 requires the alkanolamine to comprise one or more of triethanolamine, triisopropanolamine, diisopropanolamine, monoisopropanolamine, or 2-amino-2-methylpropanol. Salin-Drouin Formulation 5 expressly uses triethanolamine (Example 2, Formulation 5). Salin-Drouin further teaches that the base is preferably selected from, inter alia, triethanolamine and aminomethylpropanol, and states that triethanolamine permits optimum swelling and viscosity (¶[0085]). Thus, instant claim 25 adds no patentable distinction.
Claims 1 and 3 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”), as applied to claim 1 above, and in further view of Miranda and Sablotsky (US5958446A, published 28 September 1999; hereinafter “Miranda”), and Abbott (An integrated approach to optimizing skin delivery of cosmetic and pharmaceutical actives. Int J Cosmet Sci. 2012 Jun;34(3):217-22).
For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin, in view of Pimplaskar and Dow, teaches the limitations of instant claim 1, as described above, from which instant claim 3 depends, however do not explicitly teach the specific limitations of instant claim 3.
Salin-Drouin does not expressly calculate the applicant’s presently claimed ΔSP value for Example 2, Formulation 5. However, Miranda and Abbott establish that before the effective filing date the relationship between the SP of a medicinal active and the SP of the surrounding polymer/formulation system was a known result-effective formulation variable deliberately adjusted in dermal drug-delivery development.
Miranda is directed to solubility parameter based transdermal drug-delivery systems (Abstract). Miranda teaches that the transdermal permeation rate is controlled by varying the polymer components of a multiple polymer adhesive system so as to alter the difference in solubility parameter of the polymer system relative to the drug (col. 7, l. 61-col. 8, l. 30). Miranda additionally teaches varying the relative proportions of the polymers to alter the system’s net SP and provides numerical SP values for drugs and polymers (Examples 2-6, 28-29). Thus, Miranda explicitly identifies drug versus polymer system SP difference as a variable affecting drug saturation and transdermal permeation.
Abbott concerns optimization of skin delivery of cosmetic and pharmaceutical actives using the three Hansen solubility parameters δD, δP, and δH (p. 218, Solubility and partition section). Abbott teaches characterizing both an active and formulation ingredients by their HSP values, calculating the HSP relationship between an active and individual ingredients, and calculating the “gap” between an active and the complete formulation. Abbott further teaches that the quantities of formulation ingredients can be entered and the formulation optimized to provide a smaller active-formulation gap (p. 220, The basics section).
Abbott explains that larger gaps correspond to poorer solubility, while gaps below approximately 4 are generally desirable for reasonable compatibility (p. 221, Figure 4 legend) and demonstrates that mixtures of ingredients may be selected to obtain an HSP match to an active (p. 221. ¶1 and example Figure 4). Although Abbott’s three-dimensional Hansen “gap” is not mathematically identical to the applicant’s scalar absolute difference of total SP values, Abbott is relied upon for the prior art recognition that the SP relationship between active and formulation mixture should be calculated and optimized.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, in preparing Salin-Drouin’s medicinal polymer, ester, alkanolamine vehicle to determine and adjust the solubility-parameter relationship between the medicinal ingredient and the surrounding instant claimed B+C mixture because Miranda teaches that drug/polymer-system SP difference affects transdermal drug saturation and permeation, and Abbott teaches optimizing a skin-delivery formulation by adjusting ingredient identity and quantity to control the active and formulation Hansen relationship. The instant claimed SP relationship was therefore not an unrecognized parameter discovered only by the applicant. Rather, the prior art expressly directed the formulator to investigate and optimize that physicochemical relationship.
It would have been obvious to select the identities and relative proportions of Salin-Drouin’s polymer and nonvolatile formulation constituents to obtain a compatible drug to matrix SP relationship, including a difference within the broad claimed interval of 0.10-10.00, because it was established as a result effective variable (see In re Applied Materials, Inc., 692 F.3d 1289, 1295-97 (Fed. Cir. 2012)). Thus, the present rejection relies on the affirmative prior art teaching that the drug to formulation solubility parameter relationship was a known result-effective variable subject to routine formulation optimization.
A reasonable expectation of success existed because Abbott teaches using component HSP values and formulation quantities as practical formulation design variables, while the Miranda demonstrates that changing the composition of the polymer system predictably changes its SP relationship to the drug and resulting drug delivery behavior. Accordingly, instant claim 3 would have been obvious.
Claims 1, 5, and 24 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”), as applied to claim 1 above, and in further view of Bhalani et al. (US10080763B2, published 25 September 2018; hereinafter “Bhalani”).
For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin, in view of Pimplaskar and Dow, teaches the limitations of instant claim 1, as described above, from which instant claims 5 and 24 depend, however do not explicitly teach the specific limitations of instant claims 5 and 24.
Instant claim 5 alternatively requires the medicinal ingredient to comprise, inter alia, diclofenac, ketoprofen, felbinac, indomethacin, piroxicam, flurbiprofen, and other listed actives. Bhalani is directed to a topical medicinal film delivery system (Abstract) and identifies numerous nonsteroidal anti-inflammatory agents suitable as active agents, including piroxicam, diclofenac, indomethacin, ketoprofen, felbinac, flurbiprofen (col. 28, ll. 42-62).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to substitute one of Bhalani’s expressly taught topical NSAIDs (e.g., felbinac or ketoprofen) for the medicinal ingredient of the otherwise obvious hydroalcoholic topical vehicle of Salin-Drouin because Bhalani teaches those agents specifically for topical pharmaceutical administration and Salin-Drouin teaches the vehicle as a general transdermal medicinal gel architecture.
The references are analogous topical pharmaceutical art, and the substitution would amount to selecting a known topical medicinal active for the same known therapeutic delivery function. There is no requirement that one active be universally interchangeable with all others, wherein Bhalani specifically identifies the claimed NSAIDs as suitable topical actives. A reasonable expectation of success follows from their explicit prior art topical use (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416-18 (2007). Thus, instant claim 5 would have been obvious.
Instant claim 24 alternatively requires an anti-inflammatory analgesic, local irritation component, blood circulation promoting component, antihistamine, antipruritic, local anesthetic, bactericidal, antibacterial, or other listed therapeutic class. Bhalani identifies the active agents of its topical pharmaceutical films as including nonsteroidal anti-inflammatory agents, including felbinac, diclofenac, indomethacin, piroxicam, flurbiprofen, and ketoprofen (col. 28, ll. 42-62). Because an anti-inflammatory analgesic is one of the alternatives of instant claim 24, Bhalani’s topical NSAIDs meet the additional therapeutic class limitation.
Thus, for the reasons stated for instant claim 5, use of such an explicitly taught topical anti-inflammatory active in the otherwise obvious hydroalcoholic medicinal composition would have been predictable and reasonably expected to succeed, rendering instant claim 24 therefore would have been obvious.
Claims 1 and 7 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”), as applied to claim 1 above, and in further view of Bhalani et al. (US10080763B2, published 25 September 2018; hereinafter “Bhalani”), Arnaud and Thau (US5908631A, published 01 June 1999; hereinafter “Arnaud”), and Suzuki (EP3685823A1, published 29 July 2020).
For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin, in view of Pimplaskar and Dow, teaches the limitations of instant claim 1, as described above, from which instant claim 7 depends, however do not explicitly teach the specific limitations of instant claim 7.
Salin-Drouin expressly identifies ethylcellulose among the cellulose derivatives/gelling agents usable in its pharmaceutical compositions and teaches that the gelling agent may be selected based upon the pH and desired viscosity (¶[0018]). Bhalani independently identifies ethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, and hydroxypropylcellulose among suitable film-forming agents for topical pharmaceutical films (claim 27).
Arnaud characterizes ethylcellulose as a hydrophobic film-forming agent and water-insoluble polymer component of cosmetic and pharmaceutical compositions and explains that it increases adhesion, durability, viscosity, and hydrophobicity (col. 1, ll. 45-54), wherein ethylcellulose is an expressly recited species of instant claim 7.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use ethylcellulose as the polymer because both Salin-Drouin and Bhalani identify ethylcellulose as a suitable polymer for topical pharmaceutical compositions, and Arnaud establishes that ethylcellulose performs the known film-forming/viscosity function while being water-insoluble. This constitutes selection of a clearly identified alternative polymer for its known function and predictable properties (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-18 (2007); MPEP § 2143). A person of ordinary skill would reasonably have expected success in doing so because Salin-Drouin itself lists ethylcellulose as suitable in the same pharmaceutical formulation architecture and Bhalani and Arnaud independently confirm its topical pharmaceutical utility.
Futher, Suzuki remains additionally pertinent to another species within instant claim 7. Suzuki’s worked skin-film sprays expressly employ the water-insoluble resin Plascize L-53, identified as an alkyl-acrylate/alkyl-methacrylate/diacetone-acrylamide/methacrylic-acid copolymer, in conjunction with approximately 55- 60 parts 95% ethanol (Table 1 Examples). This teaching further confirms that diacetoneacrylamide-containing acrylic copolymers encompassed by the broadly recited “(acrylates/diacetoneacrylamide) copolymer” species were known water-insoluble skin-film formers in alcoholic formulations.
Claims 1 and 17 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”), as applied to claim 1 above, and in further view of Zhang et al. (US20070189977A1, published 16 August 2007; hereinafter “Zhang”).
For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin, in view of Pimplaskar and Dow, teaches the limitations of instant claim 1, as described above, from which instant claim 17 depends, however do not explicitly teach the specific limitations of instant claim 17 which requires an aerosol formulation or pump-spray-type formulation.
Zhang is directed specifically to spray-on formulations for dermal delivery of drugs. Zhang teaches a drug-containing formulation having an initial viscosity suitable to be expelled from a pressurized container or manual pump container and applied to the skin as a layer (Abstract). Zhang further teaches embodiments comprising a drug, nonvolatile solvent system, solidifying agent, and optional volatile solvent (claims 1 and 62). Zhang claim 59 places the formulation in a pressurized container, claim 60 places it in a manual pump container, claim 65 specifies spraying from a pressurized container, and claim 66 specifies spraying using a manual pump. Zhang also provides medicinal spray embodiments, including formulations containing testosterone (¶[0093]) or ketoprofen (¶[0081]) and volatile water and ethanol systems (¶[0035]; claim 10).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to provide the Salin-Drouin-type hydroalcoholic medicinal composition in a pump-spray or pressurized/aerosol delivery system because Zhang addresses the same dermal drug delivery objective and expressly teaches spray administration of drug/polymer/nonvolatile-solvent/volatile-solvent compositions.
The reason to make this modification is supplied by Zhang as a convenient application of the medicinal formulation to skin as a controlled layer. Zhang additionally teaches adjusting viscosity so that the formulation can be expelled through the manual or pressurized spray device, providing a reasonable expectation of success. Accordingly, instant claim 17 would have been obvious.
Claims 1 and 22 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Salin-Drouin (US20080038220A1, published 14 February 2008), in view of Pimplaskar (US8785426B1, published 22 July 2014), and Dow et al. (US6387383B1, published 14 May 2002; hereinafter “Dow”), as applied to claim 1 above, and in further view Valencia et al. (US20060067958A1, published 30 March 2006; hereinafter “Valencia”), and Dufresne et al. (US20080146480A1, published 19 June 2008; hereinafter “Dufresne”).
For purposes of the following rejections, 29 January 2021, is treated as the effective filing date relevant to the presently claimed subject matter. The cited reference qualifies as prior art because it is published prior to the instant effective filing date, and therefore predates the instant claimed invention.
Salin-Drouin, in view of Pimplaskar and Dow, teaches the limitations of instant claim 1, as described above, from which instant claim 22 depends, however do not explicitly teach the specific limitations of instant claim 22, requiring an SP value for component (A) of 15.00-27.00.
Valencia concerns pharmaceutical topical alcoholic gels (Abstract) and identifies methyl salicylate, menthol, camphor, diphenhydramine, ketoprofen, and diclofenac among suitable pharmaceutical active ingredients (¶[0014]). Valencia details methyl salicylate as an analgesic (¶[0026]). Thus, Valencia provides a distinct reason to select methyl salicylate, the medicinal ingredient recited in instant claim 5, for a high-alcohol topical medicinal formulation. Further, Valencia Example 2 prepares topical alcoholic gels containing 10% methyl salicylate, 7% menthol, polymer, 4% water, optional 25% propylene glycol, and ethanol q.s. Valencia claim 19 separately recites a topical gel containing 10-20% methyl salicylate, 40-80% ethanol, 10-30% diol/triol, polymer, and 0-15% water.
Dufresne tabulates methyl salicylate as having a total Hansen solubility parameter of 21.7 MPa1/2 (¶[0024]). The value 21.7 lies squarely within instant claim 22’s range of 15.00-27.00. Dufresne is relied upon for an intrinsic physicochemical property of the methyl salicylate that Valencia provides a reason to use.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use methyl salicylate, taught by Valencia, as component (A) of the otherwise obvious topical hydroalcoholic composition because Valencia demonstrates that drug in a closely analogous pharmaceutical dosage form. Once methyl salicylate is selected, its SP value of approximately 21.7 necessarily accompanies the material and therefore instant claim 22 would have been obvious (see In re Best, 562 F.2d 1252, 1255 (CCPA 1977); MPEP § 2112).
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy, including prevention of an unjustified or improper timewise extension of the right to exclude conferred by a patent and prevention of potential harassment by multiple assignees of patents directed to patentably indistinct subject matter (see In re Berg, 140 F.3d 1428, 1431-35, 46 USPQ2d 1226, 1228-32 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052-53, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 892-93, 225 USPQ 645, 648-49 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 943-48, 214 USPQ 761, 766-70 (CCPA 1982); In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970); MPEP § 804, II.B).
Where the conflicting claims are not identical, a nonstatutory double patenting rejection is appropriate when an examined application claim is not patentably distinct from the reference claim because the examined claim is anticipated by, or constitutes an obvious variation of, the invention defined by the reference claim. The analysis proceeds by construing the examined and reference claims and identifying their differences, and determining whether those differences render the examined claim patentably distinct (see Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008); AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 1377-80, 112 USPQ2d 1001, 1008-10 (Fed. Cir. 2014)).
An obviousness-type double-patenting analysis is analogous to, but not necessarily identical to, an analysis under 35 U.S.C. § 103 (see In re Braat, 937 F.2d 589, 592-93, 19 USPQ2d 1289, 1292 (Fed. Cir. 1991); In re Longi, 759 F.2d 892, 225 USPQ 645, 648-49 (Fed. Cir. 1985)). The pertinent considerations include the scope of the conflicting claims, the differences between them, the level of ordinary skill in the art, and any relevant objective indicia as to why the subject matter of the examined claim would have been an obvious variation of the invention defined by the reference claim (see MPEP § 804, II.B.3). Portions of the reference specification that support and describe embodiments falling within the scope of the reference claims may properly be considered in construing the reference claims and determining whether the examined claims are obvious variations of the invention actually claimed (see In re Vogel, 422 F.2d at 441-42, 164 USPQ at 622; MPEP § 804, II.B.1).
When an examined claim covers a species encompassed within or overlapping with a genus of a reference claim, the species is not patentably distinct if a person of ordinary skill in the art, considering the claimed genus and properly construed relevant portions of the specification, would have directly envisaged the species or otherwise regarded its selection as an obvious variation (see AbbVie Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F.3d 1377-80, 112 USPQ2d 1001, 1008-10 (Fed. Cir. 2014)).
Claims 1, 3, 5-13, 15-17, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-10, and 15-19 of co-pending U.S. Application No. 18/998,371 (“reference application”). Although the claims at issue are not identical, they are not patentably distinct from each other because they define overlapping or obvious species and variations of the composition invention claimed in the reference application.
This rejection is provisional because the patentably indistinct claims of the reference application have not yet matured into an issued patent (see MPEP § 804). The instant application and reference application are commonly assigned to Kao Corporation and have at least one inventor in common. For purposes of the present patentable-distinctness analysis, the one-way inquiry is whether the instant claimed invention would have been anticipated by or would have been an obvious variation of the invention defined by the reference claims, as described below.
Reference claim 1 claims a composition comprising a (A) medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, and (D) a volatile solvent, wherein component (B) comprises both a cellulosic polymer (B1) and an acrylic polymer (B2), the B2/B1 mass ratio is 0.05-30, and the composition has a viscosity at 25°C of 1.0-10,000 mPa·s. Reference claim 6 claims the composition of claim 1 further comprising 1-70 mass% water. Reference claim 7 claims medicinal ingredient categories substantially overlapping those now recited in instant claim 24. Reference claim 8 claims component (C) selected from, inter alia, nonpolar oils, polyols, and alkanolamines. Reference claim 9 specifies an alcohol having four or fewer carbon atoms as component (D), and reference claim 10 specifies the same 0.001-30 mass% range for component (A) recited by instant claim 11.
Reference claim 15 claims numerous medicinal ingredients also recited by instant claim 5, including glycol salicylate, methyl salicylate, diclofenac sodium, loxoprofen sodium hydrate, ketoprofen, felbinac, indometacin, flurbiprofen, glycyrrhetinic acid, l-menthol, dl-camphor, nonylic acid vanillylamide, tocopherol acetate, diphenhydramine, chlorpheniramine maleate, and capsicum. Reference claims 16 and 17 claim the same cellulosic and acrylic polymers recited by instant claim 7, including hypromellose phthalate and acrylates/diacetoneacrylamide copolymer. Reference claim 18 claims, among others, isopropyl myristate, 1,3-butylene glycol, dipropylene glycol, polyethylene glycol, triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol. Reference claim 19 claims methanol, ethanol, propanol, isopropanol, and the several butanols as component (D).
The scope of reference claim 1 is further illustrated by Examples 29-31, which satisfy the structural limitations of reference claim 1, wherein they contain 1 mass% hypromellose phthalate (B1) and 2 mass% acrylates/diacetoneacrylamide copolymer (B2), giving B2/B1 = 2, and have viscosities of 42.9–43.6 mPa·s. Because these embodiments fall within reference claim 1, they may properly be considered for the limited purpose of construing the claimed invention and identifying its immediately apparent and obvious variations. Significantly, those same reference Examples 29-31 contain isopropyl myristate, expressly identified as an ester oil, at 1 mass%; 2-amino-2-methylpropanol, expressly identified as an alkanolamine, at 0.3 mass%; polyethylene glycol 4000, identified as a polyol, at 1-2 mass%; ethanol at 57 mass%; purified water at 29.60-30.60 mass%; a water/ethanol mass ratio of 0.52-0.54; component (A) at 4.13 mass%; component (B) at 3 mass%; component (C) at 2.27-3.27 mass%; A/(B+C) ratios of 0.66-0.78; and viscosities of 42.9-43.6 mPa·s at 25°C.
Thus, rather than merely presenting a broad list from which the limitations of amended claim 1 must be reconstructed with hindsight, the reference specification identifies actual embodiments within the scope of reference claim 1 that simultaneously employ an ester oil and an alkanolamine, a lower alcohol at a concentration falling within the instant range, water at a water/lower-alcohol ratio falling within the instant range, and the required viscosity.
Instant claim 1 differs from reference claim 1 principally by affirmatively requiring (i) water; (ii) that component (C) comprise both an ester oil and an alkanolamine; (iii) that component (D) be a lower alcohol at 25-95 mass%; and (iv) an E/D water-to-volatile-solvent mass ratio of 0.005-2.0. Conversely, reference claim 1 is narrower with respect to component (B), because it requires both a cellulosic and an acrylic polymer at B2/B1 = 0.05-30, whereas instant claim 1 merely requires a water-insoluble polymer. Those differences do not render instant claim 1 patentably distinct.
First, the additional polymer limitation of reference claim 1 does not distinguish instant claim 1. A composition satisfying the reference requirement for both B1 and B2 necessarily satisfies instant claim 1’s broader requirement for a water-insoluble polymer. The reference’s polymer blend therefore represents a species encompassed by the instant polymer limitation, rather than a limitation that must be removed to arrive at the instant claimed subject matter. Second, water is expressly claimed as an additional component in reference claim 6 at 1-70 mass%. The pertinent reference embodiments contain approximately 30 mass% water.
Third, although reference claim 8 generically permits a nonvolatile base selected from several classes rather than expressly requiring an ester oil and an alkanolamine simultaneously, the reference claim 1 embodiments of Examples 29-31 expressly employ both isopropyl myristate as an ester oil and 2-amino-2-methylpropanol as an alkanolamine. These embodiments therefore establish that simultaneous use of the two classes is not an extraneous disclosure unrelated to the claimed invention but is an embodiment squarely within reference claim 1. Fourth, reference claim 9 limits component (D) to an alcohol having four or fewer carbon atoms, while reference claim 19 expressly identifies ethanol and the other C1-C4 monohydric alcohols. Examples 29-31 use 57 mass% ethanol. That amount falls squarely within instant claim 1’s 25-95 mass% range.
Fifth, Examples 29-31 report water/ethanol mass ratios of 0.52, 0.53, and 0.54, all well within instant claim 1’s E/D range of 0.005-2.0. Finally, reference claim 1 and instant claim 1 recite the identical viscosity range of 1.0-10,000 mPa·s at 25°C, and the claimed reference embodiments have measured viscosities of approximately 43 mPa·s. Accordingly, one of ordinary skill in the art, construing the invention of reference claim 1 in light of embodiments that indisputably fall within that claim, would have immediately recognized and had reason to employ the ester-oil/alkanolamine/ethanol/water combination now required by instant claim 1.
Examples 29-31 demonstrate that the precise combination was an operative implementation of the reference claimed invention, with the pertinent solvent concentration, water/solvent ratio, polymer ratio, and viscosity all within the instant ranges. Thus, this is not a case in which the rejection depends merely upon the proposition that a skilled artisan could have optimized numerous unrelated variables. The skilled artisan also would have had a reasonable expectation of success because the reference itself reports successful embodiments containing the relevant combination and evaluates those compositions for coating-film crystallization, stickiness, durability, and moisture resistance. Instant claim 1 therefore defines, at most, an obvious overlapping species of the composition invention claimed in reference claim 1 and is not patentably distinct therefrom.
Regarding the Hansen solubility-parameter difference of dependent instant claim 3, the reference claims do not expressly recite an SP limitation, and the rejection therefore does not rely on the proposition that the reference application independently teaches optimization of Hansen solubility parameters. Rather, the SP value is a calculated physical property of the selected components and their proportions. The instant specification itself explains that SP values are calculated from Hansen dispersion, polarity, and hydrogen-bonding components and that the SP of a mixture is determined from its component values and volume fractions.
The reference claims expressly encompass felbinac (claim 15), hypromellose phthalate (claim 16), acrylates/diacetoneacrylamide copolymer (claim 17), isopropyl myristate, diisopropanolamine and 2-amino-2-methylpropanol (claim 18), ethanol (claim 19), and water (claim 6); and the reference’s own claim 1 embodiments establish the practical combination of the corresponding polymer, ester-oil, alkanolamine, ethanol, and water classes. The instant specification, in turn, reports a representative composition employing felbinac, hypromellose phthalate plus acrylates/diacetoneacrylamide copolymer, isopropyl myristate, diisopropanolamine, 2-amino-2-methylpropanol, ethanol and water as having a calculated Δ(SPA−SPB+C) of 1.54, within instant claim 3.
The applicant’s data are relied upon here only as evidence of the intrinsic calculated property resulting from the otherwise obvious ingredient selection, not as prior art supplying a missing teaching. Accordingly, the recitation of the calculated SP difference does not patentably distinguish instant claim 3 where an otherwise obvious composition necessarily possesses the recited calculated property.
Regarding the instant claim 5’s medicinal ingredient species, reference claim 15 expressly claims numerous species recited in instant claim 5, including glycol salicylate, methyl salicylate, diclofenac sodium, ketoprofen, felbinac, indometacin, flurbiprofen, glycyrrhetinic acid, l-menthol, dl-camphor, nonylic acid vanillylamide, tocopherol acetate, diphenhydramine, chlorpheniramine maleate, and capsicum. Selecting one or more of those expressly claimed alternatives for component (A) does not confer patentable distinctness.
Regarding the polymer classes of instant claim 6, reference claim 1 requires both a cellulosic polymer and an acrylic polymer. Those polymers fall expressly within instant claim 6’s generic recitation of one or more polymers selected from acrylic, cellulosic, and vinyl polymers. Claim 6 is thus broader as to the polymer classes and does not distinguish the claimed subject matter.
Regarding the polymer species of instant claim 7, reference claims 16 and 17 identify numerous polymers also recited in instant claim 7, including hypromellose phthalate and acrylates/diacetoneacrylamide copolymer. Examples 29-31 employ those two particular polymers together. Selection of the claimed species therefore constitutes, an obvious species within the overlapping claimed polymer genus.
Regarding the additional nonpolar oil or polyol of instant claim 8, reference claim 8 expressly includes both nonpolar oils and polyols as component (C) alternatives. Moreover, Examples 29-31 include polyethylene glycol 4000, identified as a polyol, in addition to isopropyl myristate and 2-amino-2-methylpropanol. Thus, the limitation added by instant claim 8 is expressly instantiated in an embodiment within reference claim 1 and does not render the claim patentably distinct.
Regarding the specific nonvolatile bases of instant claim 9, reference claim 18 expressly claims isopropyl myristate, 1,3-butylene glycol, dipropylene glycol, polyethylene glycol, triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, each of which is recited by instant claim 9. Examples 29-31 specifically use isopropyl myristate, 2-amino-2-methylpropanol and polyethylene glycol. Claim 9 therefore does not define a patentably distinct selection.
Regarding the C1-C4 monohydric alcohol of instant claim 10, reference claim 9 recites an alcohol having four or fewer carbon atoms, and reference claim 19 expressly claims methanol, ethanol, propanols and butanols. This is coextensive with or narrower than the pertinent limitation of instant claim 10.
Regarding the component (A) 0.001-30 mass% of instant claim 11, reference claim 10 recites the identical 0.001–30 mass% range. Examples 29-31 contain 4.13 mass% component (A). Instant claim 11 therefore does not patentably distinguish the composition.
Regarding the component (B) 0.01-30 mass% of instant claim 12, even without relying upon any reference claim outside the presently identified claims 1-2, 6-10 and 15-19, the limitation does not provide patentable distinction. Reference claim 1 encompasses Examples 29-31, in which component (B) is 3 mass%, squarely within instant claim 12.
Regarding component (C) 0.001-30 mass% of instant claim 13, reference Examples 29-31, which fall within reference claim 1, contain 2.27-3.27 mass% component (C), squarely within instant claim 13. Thus, claim 13 encompasses the expressly demonstrated claimed-reference embodiments.
Regarding the 0.1-70 mass% water of instant claim 15, reference claim 6 expressly requires 1-70 mass% water, a range wholly within instant claim 15’s 0.1-70 mass% range. Examples 29-31 contain approximately 30 mass% water. Instant claim 15 therefore does not confer patentable distinctness.
Regarding the lotion, gel, ointment, cream, or foam formulation of instant claim 16, the reference specification, in describing dosage forms of the composition claimed in reference claim 1, identifies lotion, gel, ointment, cream, and foam formulations. Because these are disclosed dosage-form embodiments of the claimed composition, this disclosure is appropriately considered construing the claimed invention. Merely placing the otherwise patentably indistinct claimed composition into one of its expressly contemplated dosage forms is an obvious variation and does not impart patentable distinction (see Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008); Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386-89, 95 USPQ2d 1797, 1801-03 (Fed. Cir. 2010)).
Regarding the aerosol or pump-spray formulation of instant claim 17, the reference likewise identifies aerosol and pump-spray formulations using the composition for external preparation, it states that the composition may serve as the aerosol stock solution and that a pump-spray formulation is formed by filling the composition into a pump-spray container. Those are distinctly contemplated embodiments and uses of the composition defined by the reference claim. Providing the otherwise patentably indistinct composition in those expressly identified delivery formats would therefore have been an obvious variation of the reference claimed invention.
Regarding the 15.00-27.00 SP value of component (A) of instant claim 22, reference claim 15 expressly claims medicinal ingredients including felbinac and l-menthol. The instant specification reports the Hansen SP values of felbinac and l-menthol as 21.77 and 18.50, respectively, both are within instant claim 22’s range and glycol salicylate is reported as 26.55 and loxoprofen sodium as 20.18. The SP limitation therefore describes an intrinsic property of medicinal ingredients expressly encompassed by the reference claims rather than a structurally distinguishing component.
Regarding the A/(B+C) = 0.001-2.00 of instant claim 23, reference Examples 29-31, which fall within reference claim 1, expressly report A/(B+C) ratios of 0.78, 0.72, and 0.66. Each is within instant claim 23’s range. Instant claim 23 therefore reads directly on the quantitative relationship present in claimed-reference embodiments and does not provide patentable distinction.
Regarding the medicinal-ingredient functional classes of instant claim 24, reference claim 7 expressly recites anti-inflammatory analgesic, local irritation, blood-circulation-promoting, antihistaminic, crude-drug, antipruritic, local-anesthetic, keratin-softening, bactericidal, and antibacterial/antifungal components. These substantially coincide with the categories of instant claim 24. Selecting one or more of those expressly claimed medicinal categories therefore fails to distinguish instant claim 24.
Regarding the specified alkanolamines of instant claim 25, reference claim 18 expressly claims triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, three of the five alternatives recited by instant claim 25. Because instant claim 25 requires one or more members of its Markush group, compositions using any of those three common species fall within instant claim 25. Further, Examples 29-31 use 2-amino-2-methylpropanol as the alkanolamine together with isopropyl myristate as the ester oil. Instant claim 25 therefore encompasses an expressly demonstrated embodiment of the reference claimed invention and is not patentably distinct.
In summary, considered as a whole, the instant claims do not define a distinct inventive concept from that of the composition invention claimed in U.S. Application No. 18/998,371. The reference claims define the same medicinal-ingredient/water-insoluble-polymer/nonvolatile-base/volatile-solvent film-forming composition, with the same viscosity regime, and expressly claim the overlapping medicinal ingredients, polymer species, nonvolatile-base species, lower alcohols, water, and component concentration ranges discussed above.
Most importantly for amended claim 1, the specification embodiments properly considered in construing reference claim 1 do not merely suggest the possibility of the newly recited combination. Examples 29-31 actually embody the relevant combination of a cellulosic/acrylic water-insoluble-polymer system, an ester oil, an alkanolamine, a polyol, 57 mass% ethanol, approximately 30 mass% water, a water/ethanol ratio of approximately 0.52–0.54, and a viscosity of approximately 43 mPa·s. Those embodiments fall within the scope of reference claim 1 and simultaneously fall within the pertinent limitations of amended instant claim 1.
The remaining dependent limitations either select expressly claimed species or categories, encompass quantitative values actually present in those claimed-reference embodiments, recite intrinsic calculated properties of otherwise overlapping compositions, or specify dosage forms expressly identified for the claimed composition. A person of ordinary skill in external pharmaceutical formulation therefore would have regarded the claimed subject matter as an obvious overlapping species or predictable variation of the invention defined by the reference claims, with a reasonable expectation that the composition would possess the intended film-forming properties because the reference application demonstrates successful embodiments of substantially the same composition. Accordingly, claims 1, 3, 5-13, 15-17, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-2, 6-10, and 15-19 of co-pending U.S. Application No. 18/998,371.
The applicant may traverse the rejection by demonstrating that the presently rejected claims are patentably distinct from the claims of the reference application, by amending the claims to be patentably distinct, or by canceling the claims. Alternatively, where the applicable common-ownership requirements are satisfied, a compliant terminal disclaimer under 37 C.F.R. § 1.321(c) may ordinarily be submitted with a reply requesting reconsideration of the rejection. The filing of a terminal disclaimer alone does not constitute a complete reply (see MPEP § 804).
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 30 June 2026, have been fully considered. The applicant argues deficiencies in the particular factual mapping underlying the former Bhalani, Tojo, and Suzuki prior art rejection. However, upon consideration of the amended claims and further prior-art search, a new ground of rejection under 35 U.S.C. § 103 is made, including the rejection of claim 1 over Salin-Drouin et al. (US20080038220 A1) in view of Pimplaskar (US8785426 B1) and Dow et al. (US6387383B1), with the additional references applied to the respective dependent claims as set forth in the rejection above (consistent with MPEP § 707.07(f)). Thus, presently, the relevant question is therefore whether the amended claims are patentable over the newly applied art, rather than whether the former Bhalani-based rationale should be preserved.
The applicant argues that amended claim 1 now requires component (C) to comprise both an ester oil and an alkanolamine, that Bhalani teaches ester oils such as isopropyl myristate but does not teach an alkanolamine, and that Bhalani, Tojo, and Suzuki collectively fail to teach or suggest employing an alkanolamine as component (C). The applicant additionally asserts that, in the claimed invention, the alkanolamine is employed not merely as a pH adjuster but as one of the non-volatile bases for film formation. The arguments have been considered but do not establish patentability.
Regarding the alkanolamine limitation, Bhalani, standing alone, does not expressly require a separately added alkanolamine as the non-volatile-base component in the embodiments principally relied upon in the prior rejection. The rejection is therefore not maintained on a finding that Bhalani expressly discloses every aspect of the newly amended ester oil and an alkanolamine limitation.
The applicant’s broader assertion that there is no teaching or suggestion from Bhalani, Tojo, and Suzuki on using an alkanolamine as a component, however, is not persuasive. Suzuki expressly describes an acrylic-resin alkanolamine in an alcoholic, skin-applied film-forming spray and exemplifies the acrylic-resin alkanolamine together with film-forming acrylic resin and ethanol. Thus, alkanolamine-containing or alkanolamine-associated acrylic film-forming chemistry was not foreign to the pertinent topical-film art.
Suzuki’s acrylic resin alkanolamine terminology is not relied upon as necessarily establishing, by itself, the presence of a separately added free alkanolamine satisfying every aspect of amended component (C). Rather, the point is that applicant’s assertion that the cited art contains no pertinent alkanolamine teaching is not supported by the record. The complete treatment of the newly amended requirement that component (C) comprise both an ester oil and an alkanolamine is set forth in the 35 U.S.C. § 103 rejection above.
The applicant’s additional characterization that its alkanolamine is not merely a pH adjuster but instead functions as a non-volatile base for film formation also does not establish a distinction beyond the language actually recited in claim 1. Claim 1 requires the composition to contain an alkanolamine as part of non-volatile component (C), and it does not recite a particular chemical mechanism by which the alkanolamine must participate in film formation, nor does it exclude an alkanolamine that also functions as a pH-adjusting agent. Patentability is determined from the limitations of the claim, and an asserted intended purpose or functional characterization does not distinguish otherwise corresponding subject matter unless it imposes a structural or other operative limitation on the claimed product (see In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997); In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004); MPEP § 2111). Accordingly, the newly asserted functional explanation for the alkanolamine has been considered, but the argument is not commensurate with an additional limitation of claim 1.
However, the presently relevant inquiry regards Salin-Drouin. Salin-Drouin describes topical testosterone formulations containing the claimed classes of components. Most significantly, Example 2, Formulation 5 contains, per 100 g final formulation testosterone, 1 g, Carbopol® 980® 980, 0.5 g, absolute ethanol, 67 g, triethanolamine (TEA), 0.50 g, and isopropyl myristate, 0.5 g. Salin-Drouin’s detailed preparation of Formulation 5 likewise states that the formulation contains isopropyl myristate in the 67-g absolute-ethanol phase, Carbopol® 980® 980 swollen in water, and TEA. Thus, unlike the previous Bhalani-based rejection, the present rejection does not require piecing together an ester oil from one embodiment and an alkanolamine from other disclosures. Salin-Drouin places isopropyl myristate and triethanolamine together in the same expressly prepared topical formulation.
Salin-Drouin additionally characterizes triethanolamine as a pharmaceutically acceptable base. It teaches that, with an acrylic-acid-based gelling polymer, the base contributes to neutralization, permits optimum swelling of the polymer chains and formation of polymer salts, and permits optimum viscosity to be obtained. Salin-Drouin specifically identifies triethanolamine as a preferred base for this purpose. Accordingly, the applicant’s factual premise that an alkanolamine is absent from the relevant prior-art composition is no longer applicable to the rejection now of record.
In addition, Salin-Drouin does not merely identify TEA as an arbitrary pH-adjusting additive, it teaches that the base/neutralizer affects the swelling of the acrylic polymer chains, formation of polymer salts, and viscosity of the resulting topical gel. Those teachings directly associate the alkanolamine with formation and physical properties of the polymeric composition. Moreover, where the same chemical component is present in an otherwise substantially corresponding composition, merely assigning an additional property or function to that known component does not ordinarily render the composition patentably distinct (see In re Spada, 911 F.2d 705, 708-09, 15 USPQ2d 1655, 1657-58 (Fed. Cir. 1990); In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP § 2112.01). Thus, the applicant’s asserted functional characterization of the alkanolamine therefore does not overcome the present rejection.
Regarding the applicant’s argument concerning the amount and role of volatile solvent and water, the applicant argues that statement that Bhalani discloses a total solvent content of 10-90 wt%, including ethanol-water mixtures used as primary solvents, does not establish the claimed requirement that component (D), specifically a lower alcohol, be present at 25-95% by mass. The applicant’s criticism is acknowledged to the extent that the prior Office Correspondence could be read as equating Bhalani’s entire 10-90 wt% solvent range with a 10-90 wt% ethanol or lower-alcohol concentration. Bhalani’s disclosure of a solvent or hydroalcoholic solvent system should not, without more, be treated as an express disclosure that the lower-alcohol component itself occupies that entire 10-90 wt% range. Accordingly, the present rejection above does not rely upon that proposition as such.
Salin-Drouin directly discloses an amount of lower alcohol falling well within the presently claimed range. Example 2, Formulation 5 contains 67 mass% absolute ethanol. Ethanol is a lower alcohol and 67 mass% falls squarely within claim 1’s requirement of 25-95 mass% component (D), based on the total weight of the composition. The same formulation contains approximately 30.5 mass% water. Accordingly, (E/D)/67, falls well within the claimed range of 0.005-2.0.
Thus, unlike the former rejection, the present ground does not depend upon equating total solvent with lower alcohol, nor does it depend upon modifying a 20 mass% ethanol embodiment upward merely to reach the applicant’s 25 mass% lower boundary. Salin-Drouin supplies an actual topical formulation containing 67 mass% ethanol and approximately 30.5 mass% water, producing an E/D ratio near 0.455, directly within both claimed quantitative limitations. Salin-Drouin additionally discloses embodiments containing 50-70 or 50-75 wt% C2-C6 alcohol together with gelling agent, penetration enhancer, isopropyl myristate, and optional water, further confirming that the high-alcohol regime exemplified in Formulation 5 is not an isolated or accidental disclosure. Consequently, the applicant’s traversal of Bhalani’s total-solvent disclosure does not identify a deficiency in the presently applied ground.
The cited art expressly recognizes the underlying film-formation mechanism on which the applicant relies. Tojo teaches spraying a liquid composition onto skin and forming a coating by volatilization of the volatile component, alcohols, including ethanol, are among the volatile substances contemplated by Tojo, and water may additionally be present in the liquid composition. Thus, the general concept that a volatile alcoholic phase evaporates from an applied composition to leave a polymer-containing film was known in the pertinent art and is not unique to the present disclosure.
In addition, Suzuki provides a particularly pertinent disclosure of alcoholic film-forming spray compositions for skin, including examples employing approximately 55-60 parts of 95° ethanol together with acrylic film-forming materials. Thus, Suzuki supplies a materially stronger teaching of relatively high lower-alcohol content in a skin-applied film-forming system than the characterization of Bhalani disputed by the applicant.
The applicant’s reliance on ¶[0013] of the instant Specification, that components (D) and (E) volatilize after application so that components (A)-(C) remain as a coating film, does not by itself impart patentability to a composition whose structural and quantitative limitations would otherwise have been obvious. The obviousness inquiry asks whether the claimed subject matter as a whole, including the claimed quantitative limitations, would have been obvious to a person of ordinary skill, not whether the prior art expressed the applicant’s theory or purpose in precisely the same terminology (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19, 419, 421 (2007); MPEP § 2143).
That argument likewise does not overcome the present rejection. Claim 1 does not recite the asserted post-application sequence as a process limitation. It claims a composition defined by its ingredients, quantitative relationships, and viscosity. The prior art need not solve the identical problem in the identical manner where it otherwise provides reason to make the claimed composition. Salin-Drouin already places the pertinent medicinal ingredient, acrylic polymer, ester oil, alkanolamine, ethanol, and water together in a topical composition in the claimed quantitative regime. The present rejection therefore does not rest on hindsight reconstruction merely because the applicant subsequently articulated a particular film-formation rationale.
Salin-Drouin’s Formulation 5 employs Carbopol® 980® 980, an acrylic-acid polymer crosslinked with polyfunctional material. Dow explains the pertinent physical behavior of this class of crosslinked Carbopol® 980 polymers, wherein highly crosslinked polymers of this type do not dissolve in water but instead swell and form homogeneous dispersions, and Dow specifically identifies Carbopol® 980® 980 as a highly crosslinked Carbopol® 980 polymer. This evidence supports treating the Carbopol® 980® 980 used by Salin-Drouin as a water-insoluble acrylic polymer within the broadest reasonable interpretation of component (B).
With respect to viscosity, Salin-Drouin expressly investigates viscosity as a function of ethanol concentration and Carbopol® 980 concentration. For example, it reports that changing ethanol content from 50 to 65 wt% markedly changes hydroalcoholic Carbopol® 980-gel viscosity and reports a viscosity of 3.50 Pa·s for a 0.5% Carbopol® 980® 980 hydroalcoholic gel under the stated conditions. Salin-Drouin therefore identifies polymer concentration and alcohol concentration as result-effective variables governing gel viscosity. Pimplaskar further supplies direct 25°C empirical evidence from closely related topical testosterone gels: Table 1 reports viscosities including 275, 494, 732, 763, 766, 978, 1,017, 1,102, 1,383, 1,436, and 1,531 cP at 25°C, all falling within claim 1’s broad range of 1-10,000 mPa·s.
Accordingly, the present rejection is supported not by speculation that a topical gel is likely to satisfy the claimed viscosity, but by experimental teachings that closely analogous hydroalcoholic topical gels employing Carbopol® 980-type polymers possess viscosities within the recited range and that viscosity is predictably adjustable by known formulation variables. The combination furthermore provides a reasonable expectation of success because Salin-Drouin itself successfully prepares the pertinent hydroalcoholic Carbopol® 980/TEA/IPM topical formulation, expressly teaches how alcohol, polymer, and base affect viscosity, and Pimplaskar supplies measured 25°C viscosities for closely related topical testosterone gels.
To the extent the claimed alcohol concentration, water/alcohol ratio, viscosity, or related formulation parameters represent quantitative selections from conditions recognized in the art as affecting evaporation, sprayability, film formation, viscosity, or skin feel, the pertinent obviousness principles include In re Aller, 220 F.2d 454, 456 (CCPA 1955), and In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003). Those decisions recognize that optimization of workable or overlapping ranges of known result-affecting variables ordinarily supports a prima facie case of obviousness, subject to consideration of evidence of criticality or unexpected results (see MPEP § 2144.05). A variable need not previously have been optimized for exactly the same numerical endpoint; it is sufficient that the art recognizes that changing the variable affects the pertinent result (see In re Applied Materials, 692 F.3d 1289, 1295-1298 (Fed. Cir. 2012)). The application of these principles to the newly amended limitations is provided in the rejection above.
To the extent the applicant continues to rely upon the previously submitted Additional Comparative Example A concerning the E/D ratio, that evidence has again been considered but does not overcome the new rejection. The prior showing compares an application example at E/D = 1.69 against a comparative composition at E/D = 2.26. The newly cited Salin-Drouin Formulation 5, however, provides a prior-art composition having an E/D ratio of approximately 0.455 (i.e., well inside the claimed range rather than merely adjacent to its upper boundary).
Evidence offered to establish unexpected results must be evaluated relative to the closest prior art, and the showing must be reasonably commensurate in scope with the claims. The prior declaration does not compare the claimed subject matter with Salin-Drouin Formulation 5 or otherwise establish that compositions across the breadth of claim 1 exhibit an unexpected property relative to that substantially closer formulation. The showing therefore does not outweigh the evidence of obviousness presented by the presently applied references.
The rejection must be evaluated on the teachings of the references as a whole. Nonobviousness cannot be established merely by attacking individual references where the rejection rests upon a combination (see In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). In the presently presented rejection above, Salin-Drouin provides the principal compositional architecture and an especially pertinent Formulation 5, Dow supplies corroborating technical evidence concerning the water-insolubility of highly crosslinked Carbopol® 980 polymers, and Pimplaskar supplies direct 25°C viscosity data and closely related topical-gel formulation evidence. These teachings are complementary rather than contradictory, and their combination does not require reconstruction of the invention from unrelated technologies.
The applicant’s arguments against the former Bhalani, Tojo, and Suzuki rejection do not overcome the new rejection under 35 U.S.C. § 103. The applicant’s remarks do not separately identify a substantive deficiency in the additional prior-art teachings applied to the respective limitations of dependent claims 3, 5-13, 15-17, and 22–25. Those claims are rejected for the specific reasons and under the respective reference combinations set forth in the new grounds of rejection, as applied above.
In addition, the applicant argues that amended claim 1 is now patentably distinguished from claims 1-2, 6-10, and 15-19 of co-pending Application No. 18/998,371. The applicant further argues that the present application has the earlier patent-term filing date and relies upon MPEP § 804(I)(B)(1)(b)(i) as requiring withdrawal of the provisional rejection. The arguments have been considered but are not persuasive at this stage of prosecution.
MPEP § 804 states that if a provisional nonstatutory double-patenting rejection is the only rejection remaining in the application having the earlier patent-term filing date, the examiner should withdraw that provisional rejection and permit the earlier-term application to issue, thereby converting the provisional rejection in the later-term application into an actual nonstatutory double-patenting rejection upon issuance. Because substantive rejections under 35 U.S.C. § 103 and § 112(b) remain outstanding, that procedural condition has not presently been satisfied. The provisional nonstatutory double-patenting rejection is not the only rejection remaining in this application. Consequently, the procedural circumstance identified in MPEP § 804 for withdrawal of the provisional double-patenting rejection in the application having the earlier patent-term filing date has not yet arisen.
The fact that an application has the earlier patent-term filing date also does not, standing alone, establish that a provisional nonstatutory double-patenting rejection is legally improper (see In re Hubbell, 709 F.3d 1140, 1150 (Fed. Cir. 2013), and In re Kaplan, 789 F.2d 1574, 1577-78 (Fed. Cir. 1986)). Even where the application under examination has the earlier patent-term filing date, a one-way determination of patentable distinctness ordinarily remains appropriate absent the mainly circumstances involving U.S. Patent and Trademark Office’s responsibility for delay and the applicant’s inability to have presented the conflicting claims in a single application (see MPEP § 804). Here, the applicant has not established such circumstances. Accordingly, the applicant’s reliance on MPEP § 804 does not presently require withdrawal of the provisional rejection.
Nonstatutory double patenting focuses upon the claims of the respective applications. Where the claims are not identical, the proper inquiry is whether an examined claim is anticipated by, or would have been an obvious variation of, the invention defined by the reference claim or claims (see In re Berg, 140 F.3d 1428, 1432-35 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052-53 (Fed. Cir. 1993); In re Vogel, 422 F.2d 438, 441-42 (CCPA 1970); MPEP § 804). The amended requirement that component (C) comprise both an ester oil and an alkanolamine does not, on this record, establish the asserted patentable distinction.
The reference claims of co-pending Application No. 18/998,371 are directed to the same general film-forming composition containing medicinal ingredient (A), water-insoluble polymer (B), non-volatile base (C), and volatile solvent (D), with the same broad viscosity range. Reference claim 6 expressly adds water. Reference claims 8 and 18 expressly encompass alkanolamines as component (C), and reference claim 18 recites “one or more” materials selected from a list that includes isopropyl myristate, an ester oil, as well as triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, each of which falls within the alkanolamine terminology now recited in instant claims 1 and/or 25. Reference claims 9 and 19 encompass lower alcohols, and reference claim 13 recites a component (D) content of 10-95% by mass.
Particularly, the “one or more selected from” language of reference claim 18 does not restrict component (C) to exactly one member of its recited group. Its scope encompasses selection of more than one listed member, including an ester oil such as isopropyl myristate together with one or more of the expressly claimed alkanolamines. Thus, merely changing instant claim 1 from generic component (C) language to require an ester oil plus an alkanolamine does not remove the instant claim from the subject matter encompassed or rendered obvious by the reference claims.
Likewise, instant claim 25 does not establish patentable distinction merely because its Markush group additionally names triisopropanolamine and monoisopropanolamine. Instant claim 25 remains broad enough to encompass triethanolamine, diisopropanolamine, and 2-amino-2-methylpropanol, which are expressly recited by reference claim 18. The relevant inquiry is patentable distinction of the claim as a whole, not whether every alternative species appearing in the instant Markush group is repeated verbatim in the reference claim.
The reference application’s narrower requirement concerning the particular water-insoluble-polymer combination also does not confer patentability upon the broader instant claims. MPEP § 804 and more specifically § 806.04(i) recognizes this generic/species situation, wherein the conflicting reference claim defines a species or subgenus falling within the examined generic claim, the broader examined claim may be nonstatutorily double patented because permitting a later-issued broader claim can extend the right to exclude associated with the narrower claimed invention (see In re Goodman, 11 F.3d 1046, 1052-53 (Fed. Cir. 1993); In re Berg, 140 F.3d, 1432-35, 46 USPQ2d 1226 (Fed. Cir. 1998)).
The reference application’s specification is not being treated as prior art for purposes of this provisional double-patenting rejection. A reference specification may be consulted insofar as necessary to construe the scope and subject matter of the reference claims, but unclaimed disclosure cannot simply be substituted for the reference claims as though it were prior art under 35 U.S.C. § 103 (see In re Vogel, 422 F.2d at 441-42; In re Basell Poliolefine Italia S.p.A., 547 F.3d 1371, 1378-79 (Fed. Cir. 2008); MPEP § 804.03). The amendments therefore do not, without more, establish that instant claims 1, 3, 5-13, 15-17, and 22-25 are patentably distinct from the pertinent reference claims. The provisional nonstatutory double-patenting rejection is maintained for the reasons set forth in the rejection and as clarified herein.
Should prosecution subsequently reach the point at which a provisional nonstatutory double-patenting rejection is the only rejection remaining in this application, and the present application is confirmed to have the earlier patent-term filing date under the criteria of MPEP § 804, the procedure prescribed therein will be applied at that time. The applicant may otherwise overcome the provisional rejection by establishing that the respective claims are patentably distinct or filing a compliant terminal disclaimer in accordance with 37 C.F.R. § 1.321. MPEP § 804 expressly recognizes those mechanisms for overcoming a provisional nonstatutory double-patenting rejection.
In summary, the applicant’s amendments and arguments have been fully considered. The applicant’s criticism of the prior characterization of Bhalani’s 10-90 wt% solvent disclosure is acknowledged to the limited extent discussed above, and is not currently rely on that disclosure as though it were an express disclosure of 10-90 wt% lower alcohol. The applicant’s argument concerning the newly recited alkanolamine does not establish patentability because the asserted particular role of the alkanolamine is not an additional limitation of claim 1, the cited art is not wholly devoid of pertinent alkanolamine teachings, and the complete treatment of the amended structural limitation is provided in the rejection elsewhere in this action.
However, the former § 103 rejection over Bhalani in view of Tojo and Suzuki is not maintained in its prior form. Salin-Drouin Example 2, Formulation 5, directly addresses the principal distinctions asserted by the applicant and, together with the additional teachings of Pimplaskar, Dow, and the claim-specific secondary references identified in the rejection, establishes the presently stated prima facie case of obviousness.
The applicant’s request to withdraw the provisional nonstatutory double-patenting rejection based on the earlier patent-term filing date is also denied at this time because that rejection is not the only rejection remaining, as expressly required by the applicable MPEP § 804 procedure, and the applicant has not demonstrated patentable distinction from the pertinent reference claims. Accordingly, the applicant’s request for withdrawal of the outstanding rejections and for issuance of a Notice of Allowance is denied.
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights