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 .
Status of the Claims
Amendments to the Specification, Amendments to the Claims, and Arguments/Remarks and 37 CFR § 1.132 Declaration filed 20 March 2026, in response to the Office Correspondence dated 31 December 2025, are acknowledged.
The listing of Claims filed 20 March 2026, have been examined. Claims 1-3, 5-13, 15-17, and 22-24 are pending. Claims 1 and 10 are amended and are supported by the originally-filed disclosure. Claims 4, 14, and 21 are canceled, claims 18-20 remain withdrawn, and no new claims have been added.
Response to Amendment
Claim 1 has been amended to include the limitation wherein the volatile solvent is a lower alcohol from 25-95% by mass or less, and wherein the mass ratio component (E)/ component (D) is 0.005-2.0. Claim 10 has been amended to include the limitation that the lower alcohol is a monohydric alcohol having 4 or less carbon atoms.
The specification title objection for being vague and non-descriptive is withdrawn as the amended title, “Topical Composition with Medicinal Ingredient, Water-Insoluble Polymer, and Defined Viscosity”, is deemed acceptable under 37 CFR 1.72(a).
The rejection of claims 1-3, 5-13, 15-17, and 22-24 under 35 USC § 103 as unpatentable over Bhalani in view of Tojo and Suzuki are maintained, as the applicant’s arguments are not persuasive (see Response to Arguments below). The provisional nonstatutory double patenting rejections of claims 1-3, 5-13, 15-17, and 22-24 over the claims of co-pending Application No. US 18/998,371 is maintained. A new ground of rejection has been made under 35 USC § 112(b) necessitated by amendment to claim 1, as set forth below.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 31 December 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-3, 5-13, 15-17, and 22-24 are rejected under 35 U.S.C. § 103 as being unpatentable over Bhalani et al. (US10080763B2; 23 February 2017, hereinafter referred to as “Bhalani”) in view of Tojo and Fukuda (US11351402B2; published 30 April 2020, hereinafter referred to as “Tojo”) and in further view of Suzuki (EP3685823A1; published 29 July 2020).
Bhalani teaches a topical film delivery system comprising the active agent nonsteroidal anti-inflammatory drug, felbinac (column 28, line 42-50; calculated Hansen Solubility Parameter of approximately 22.0 MPa¹ᐟ², within the instant claim 22 range), used to relieve pain and inflammation, thus it would have been obvious to select an active agent from these known, taught categories, meeting the limitations of instant claims 5 and 24, wherein the active agent is present at a concentration ranging from 1% to 60% w/w (column 40, lines 33-49), overlapping with the instant claim 11 range of 0.001-30% by mass.
In addition, Bhalani teaches the composition containing water-insoluble film forming polymer cellulose derivatives (cellulosic polymer) and methacrylate-based polymers (acrylic polymer) selected from the group consisting of methyacrylic acid-ethyl acrylate copolymers, methacrylic acid, methacrylate-based polymers, methylmethacrylate copolymers and a combination thereof, thus meeting the limitation of instant claims 6, wherein the film forming agent is present at a concentration from 1% to 80% w/w of the composition (claim 1), which overlaps with the instant claim 12 range of 0.01-30% by mass.
A person of ordinary skill in the art of pharmaceutical and cosmetic formulation would know that selecting a specific, commercially available film-forming methacrylate copolymers (e.g., standard Eudragit® types) would inevitably mean selecting a polymer with a solubility parameter of 17-27. Wherein the selected polymer is a acrylates/diacetoneacrylamide copolymer, the calculated Hansen Solubility Parameter is approximately 19-22.0 MPa¹ᐟ². Consequently, a vast majority of commercial acrylic, methacrylate and acrylates/diacetoneacrylamide polymers used in films would be expected to have SP values comfortably within the instant claim 2 range of 17.00-27.00 range. The upper bound of 27.00 is very high and encompasses even highly polar polymers. Therefore, specifying a solubility parameter of 17-27 for the polymer component does not impart an unexpected or non-obvious characteristic to the composition, it simply defines a property that the polymers taught by the prior art already possess.
Bhalani discloses the use of a permeation enhancer selected from the group of esters in natural oils including isopropyl myristate, isopropyl palmitate, isopropyl stearate, octyl stearate, tridecyl neopentanoate, linoleic acid, alpha-linolenic, oleic acid, cod liver-oil, menthol derivatives, and a combination thereof (claim 1), thus meeting the limitation of instant claims 8 and 9. Isopropyl myristate is used in the exemplified formulations (Examples 1-4 and 6, Tables 1-4 and 6, respectively). Although Bhalani does not explicitly disclose a concentration range for the permeation enhancer, exemplified embodiments of the invention use isopropyl myristate at a 2% w/w concentration based on the total weight of the composition (Examples 1-4 and 6, Tables 1-4 and 6, respectively), which is within the 0.001-30% by mass range of instant claim 13.
Bhalani also teaches the use of the volatile lower alcohol ethanol as plasticizer present at a concentration from 1% to 20% w/w of the composition (claim 1), thus meeting the limitation of instant claim 10, and the use of water or a hydroalcoholic solvent (e.g., ethanol and water) as a solvent (see the use of the volatile absolute alcohol solvent Examples 1-4 and Example 1 using 16.5% w/w absolute alcohol ethanol, a volatile solvent and 47% w/w purified water; Table 1) at a concentration ranging from 10% to 90% w/w (column 44, lines 31-44), which overlaps with the instant claim 14 range of 10-95% by mass for the volatile alcohol solvent and the instant claim 15 range of 0.1-70% by mass water in the composition.
Bhalani exemplifies the use of 8% polymer and isopropyl myristate at a 2% w/w concentration based on the total weight of the composition (4:1 weight ratio; Examples 1-4 and 6 and Tables 1-4 and 6, respectively), thus given an approximate 22.0 MPa¹ᐟ² SPA (felbinac), approximate 21.5 MPa¹ᐟ² SPB (copolymer) and approximate 8.5 MPa¹ᐟ² SPC (isopropyl myristate), the SPB+C would be approximately 18.9 MPa¹ᐟ² and therefore, the [Δ(SPA−SPB+C)] is approximately 3.1 MPa¹ᐟ², falling squarely within the instant claimed range of 0.10-10.00. Thus, the concentrations of constituents A, B and C exemplified in functional embodiments of the invention taught by Bhalani have the specific solubility parameter compatibility that prevent drug crystallization or phase separation, ensure proper drug solubility within the polymer matrix for predictable diffusion and promotes uniform and flexible film formation that characteristically falls within the instant claim 3 solubility parameter range.
The examples also teach an active ingredient use from 1-20% w/w, 8% w/w co-polymer and 2% w/w isopropyl myristate (Examples 1-4 and 6 and Tables 1-4 and 6, respectively), resulting in a mass ratio of [(A)/{(B) + (C)}] from 0.10-2.00, which is within the instant claim 23 range of 0.001-2.00.
Bhalani teaches, “Formulations for topical application can take the compositional form of a liquid, a semisolid dosage form (e.g., a paste, a cream, a lotion, a powder, an ointment or a gel) or a patch.” (column 7, lines 56-59), wherein, “The term “topical” refers to administration of a pharmaceutical composition at, or immediately beneath, the point of application. The composition may be applied by pouring, dropping, or spraying, if a liquid; rubbing on, if an ointment, lotion, cream, gel, or the like; dusting, if a powder; spraying, if a liquid or aerosol composition; or by any other appropriate means.” (column 25, lines 19-29), thus it would have been obvious to formulate the composition of Bhalani into the specifically disclosed topical dosage forms and delivery systems of the limitations of instant claims 16 and 17.
Bhalani does not explicitly disclose wherein the viscosity of the composition is 1.0-10,000 mPa.s at 25°C, as required by the limitation of instant claim 1. However, wherein the composition maybe applied as an ointment, lotion, cream, gel or the like (column 25, line 27), one of skill in the art would recognize that thinner lotions and medium viscosity gels typically fall within the wide viscosity range of claim 1 and that the viscosity of the formulation can be adjusted to the optimum viscosity desired for beneficial film formation on the skin and a particular spray package by adapting the weight ratio of copolymer to lower alcohol (e.g., increasing the amount of lower alcohol decreases the viscosity of the formulation or increasing the amount of copolymer increases the viscosity of the formulation (see evidentiary reference Meyer and Lang, US20140100285A1, ¶[0006]). Furthermore, the exemplified embodiments of the invention taught in Examples 1-5 all use film-forming gel formulations (Tables 1-5) that are likely to fall within the instant claimed viscosity range. In addition, Bhalani teaches the use of viscosity modifiers (claim 1), to modify the composition to achieve the desired/optimal consistency for the formulation. A person of ordinary skill in the art, seeking to formulate such a pre-film gel or liquid for topical application would have been motivated to adjust the viscosity using routine experimentation to achieve a sprayable, spreadable, stable formulation.
Tojo teaches a method for electrostatically spraying a liquid composition directly on the surface of skin to produce a film (Abstract), wherein the liquid composition preferably has a viscosity at 25° C of 5-3,000 mPa·s (column 8, lines 54-59), all Examples 1-8 having a viscosity within the range of 1.0-10,000 mPa.s at 25°C (i.e., 14.1-760 mPa.s) having sprayability, good adhesion to the skin and film forming capacity (Table 1, columns 31 and 32). The viscosity range taught by Tojo overlaps with the instant claim 1 range.
Bhalani does not explicitly disclose the use of the specific acrylic polymer as acrylates/diacetoneacrylamide copolymer, as per the limitation of instant claim 7.
Suzuki teaches a protective film forming spray for skin surface that can contain an antibacterial agent and/or a surface-active agent (claim 2) to protect the skin from abrasion and dirt, wherein the exemplary embodiments of the invention include the use of the copolymer Plascize L-53 [AMP-acrylates/diacetoneacrylamide copolymer in alcoholic solutions] (¶[0045]; Examples 1-6, Table 1). Thus, it would have been obvious to select a specific, known acrylate copolymer like (acrylates/diacetoneacrylamide) copolymer for its film-forming properties in the invention of Bhalani for the methacrylate-based polymers (acrylic polymers) as film formers.
Thus, it would have been It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to choose to optimize the viscosity of the formulation taught by Bhalani to that of the range taught by Tojo for sprayable film-forming compositions, given that viscosity range results in adequate sprayabitlity, good formulation adherence to the skin and film formation and to specifically use a more specific acrylic polymer such as acrylates/diacetoneacrylamide copolymer, as taught to be used by Suzuki for formulation of a topical film-forming composition.
While Bhalani does not explicitly disclose solubility parameter values or the specific numerical solubility parameter value ranges nor the specific mass ratio of the instant claims, the selection of specific, conventional medicinal ingredients, polymers, and bases with solubility parameters falling within these ranges, and the formulation of them in component effective concentration ranges and ratios that achieve a stable, film-forming composition, would have been a matter of routine optimization for one of ordinary skill in the art based on the desire to achieve proper solubility, miscibility, and film formation as taught by Bhalani. The specific, broad ranges claimed encompass concentrations that are conventional and obvious to try. The claimed ranges and ratio are not shown to produce any unexpected results over the compositions of Bhalani and there is a reasonable expectation of success in making the change. The combination of references and the application of routine skill do not inventively distinguish the claimed subject matter.
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Claims 1-3, 5-13, 15-17, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-10, 15-19 of co-pending Application No. US 18/998,371 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to overlapping and obvious variations of the same inventive concept, as outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Both the co-pending application and reference application claims are directed to a film-forming composition for external application, comprising the same five essential components: (A) a medicinal ingredient, (B) a water-insoluble polymer, (C) a non-volatile base, (D) a volatile solvent, and (E) water. The reference application explicitly recites water in claim 6 as an optional component with a content of 1-70% by mass. The reference teaches that water is a preferred, non-essential component to improve properties (reference application ¶[0151]). Therefore, the reference discloses compositions both with and without water, the latter reading directly on the instant claims.
Both claim sets require the composition to have a viscosity at 25° C. of 1.0 mPa·s to 10,000 mPa·s. Reference application claim 15 lists felbinac specifically as a medicinal ingredient that are encompassed by instant claim 5 and new claim 24, which lists the same functional categories as reference application claim 7. The instant application and the reference application use overlapping polymers. The water-insoluble polymer (B) in the reference application must comprise two or more selected from specific classes (B1: cellulosic, B2: acrylic, B3: vinyl) with a required mass ratio between them. Instant claims 6 and 7 define the polymer (B) as comprising one or more from these same classes. The reference application’s narrower requirement of a blend of two specific polymer types represents a particular embodiment within the broader, generic "one or more" scope of the instant claims. The reference application uses the specific polymer blend acrylates/diacetoneacrylamide copolymer and hypromellose phthalate (reference application Example 1; ¶[0221]), in which a selection of one or more components including acrylates/diacetoneacrylamide copolymer and hypromellose phthalate are explicitly listed in instant claim 7.
The instant application and the reference application use overlapping non-volatile bases and volatile solvents. Reference application claims 8, 9, and 18 list specific non-volatile bases (e.g., ester oils like isopropyl myristate, polyols, alkanolamines) that are encompassed by instant claims 8 and 9. Reference application claims 9 and 19 define component (D) as a lower alcohol (C1-C4), which is encompassed by instant claim 10. The instant application and the reference application also use overlapping composition component content ranges. The reference application claims specify content ranges for components (A)-(D) and water that substantially overlap with or fall within the broader ranges of specified in instant claims 11-15.
The primary differences between the instant claims and the reference application claims are that the reference application claims require that polymer (B) comprises two or more specific polymer types and that a mass ratio [(B2)/(B1)] from 0.05 to 30 is maintained. The specific mass ratios of 0.05 to 30 would be a result of routine optimization to achieve the desired balance of properties, as demonstrated in the reference examples, thus then obvious as a matter of routine formulation optimization.
The reference specification teaches that using only one kind of water-insoluble polymer, or only the same kind of polymers even when two or more kinds are used, high durability and moisture resistance difficult to realize (reference application ¶[0036]). This teaching provides a motivation to combine different polymer types to solve the identified problem. Thus, it would have been obvious to a person of ordinary skill in the art to modify a composition containing a single water-insoluble polymer, as in instant claim 1 to include a second, different polymer type from the known classes (e.g., cellulosic, acrylic, vinyl) taught in the instant specification to be suitable for use as a water-insoluble polymer component (B) for the invention (¶[0053]) and in the reference application to improve film properties (reference application ¶[0036]).
Instant dependent claims 2, 3, 22, and 23 add limitations regarding solubility parameters values and mass ratios. The reference application teaches the importance of component compatibility for film formation (reference application ¶[0033]-[0037]). Determining and optimizing solubility parameters and component ratios to ensure compatibility and performance is a routine practice in polymer and formulation science. Adding these parameters to further define or optimize the claimed composition would have been obvious.
Thus, the claims in the instant application are not patentably distinct from those of the reference application. The instant application claims merely present a broader, generic version of the invention claimed in the reference claims. The reference claims provide the enabling disclosure and motivation to arrive at the subject matter of the instant application claims through routine modification and optimization.
To overcome this provisional rejection, the applicant may amend the instant claims to patentably distinguish them from the reference application claims or file a terminal disclaimer.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 31 December 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which Applicant regards as his invention.
Claims 1-3, 5-13, 15-17, and 22-24 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 has been amended to recite “…the content of the component (D) in the composition is 25% by mass or more and 95% by mass or less…”, however fails to recite what the weight percentage is relative to, leading to ambiguity in the scope of the claims. The claims do not clarify whether the weight percentage of the component (D) is relative to the total weight of the composition, the weight of component (E), or another undefined reference. Without an explicit reference, the percentage weight could be interpreted in multiple ways, rendering the claim scope unclear. Claims must be "definite" to inform the public of the invention's boundaries with reasonable certainty (Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)) and provide clear meaning to a skilled artisan (MPEP 2173.02).
To overcome this rejection, the applicant may amend the claim to specify the reference basis for the weight percent (e.g., “…the content of the component (D) in the composition is 25% by mass or more and 95% by mass or less, based on the total weight of the composition, …”) or provide a definition in the specification clarifying the basis for percentage weight where not explicitly stated in the claims. Dependent claims 2, 3, 5-13, 15-17, and 22-24 are included in this rejection because they do not cure the defect noted above.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 20 March 2026, have been fully considered, but are not persuasive for the reasons outlined below.
The applicant argues that the prior art fails to teach or suggest the claimed (E)/(D) ratio (0.005 to 2.0) and that the ratio is “critical” to quick-drying property, reduced stickiness, and storage stability and yields unexpected results. The applicant relies on Additional Comparative Example A (Table A) and the accompanying Declaration to show that when (E)/(D) = 2.26, performance is inferior to Example 34 where (E)/(D) = 1.69. This argument is not persuasive.
The claimed range is broad and overlaps with the prior art. The lower limit of 0.005 is de minimis (essentially trace water). The upper limit of 2.0 is not a sharp cutoff but rather a routine optimization choice. Bhalani’s Example 2 has an (E)/(D) ratio of 2.34 (only 17% above the applicant’s upper limit). The minor numerical difference between 2.0 and 2.34 in the prior art does not demonstrate unexpected results, it demonstrates routine optimization. Optimization of solvent balance (water vs. alcohol) is a well-known formulation parameter affecting drying time, tackiness, and film integrity. A person of ordinary skill in the art would have been motivated to adjust this ratio to optimize these known properties.
Comparative Example A is not commensurate with the scope of the claims. The Declaration tests only one composition at one ratio slightly outside the claimed range. This single data point does not establish that the entire claimed range (0.005 to 2.0) is critical or that the prior art would not have worked within that range. The applicant has not shown that compositions with (E)/(D) ratios between 0.005 and 2.0 uniformly outperform those just outside that range, nor has the applicant provided evidence that Bhalani’s compositions would fail within the claimed range. Further, the applicant’s own specification undermines the alleged criticality. The specification discloses numerous working examples with (E)/(D) ratios ranging from 0.00 (Comp. Ex. 4) to 1.69 (Ex. 34). The applicant has not identified any unexpected result across this range that would not have been predictable from the prior art.
The alleged “criticality” is an expected result of adjusting solvent ratios. A person of ordinary skill in the art formulating a hydroalcoholic topical composition would understand that increasing the proportion of water relative to alcohol generally slows drying time and increases residual stickiness. This is a fundamental principle of formulation science, not an unexpected discovery.
Bhalani teaches hydroalcoholic systems with varying water/alcohol ratios, and optimizing the ratio for desired drying time and feel is routine. The ratio of water to alcohol in topical formulations is a classic result-effective variable, routinely optimized depending on evaporation rate, solubility, and skin feel. Evidentiary reference by Meyer and Lang (US20140100285A1; published 10 April 2016), teaches that adjusting the weight ratio of copolymer to lower alcohol directly controls viscosity (¶[0006]), providing explicit motivation and methodology for a person of ordinary skill in the art to modify Bhalani’s compositions to achieve the viscosity range taught by Tojo. This further supports the obviousness of claim 1’s viscosity limitation. Thus, arriving at a ratio within 0.005-2.0 would have been obvious through routine experimentation optimization.
The applicant argues that Bhalani only teaches 1-20 wt% ethanol and does not teach or suggest a lower alcohol content of 25-95% by mass. This argument is not persuasive. While Bhalani explicitly discloses ethanol at 1-20 wt% (which is only one arbitrary selection of one monohydric alcohol having 2 carbon atoms from other known options, wherein claim 10 requires that the lower alcohol comprises such an alcohol but is open-ended), Bhalani also broadly teaches hydroalcoholic systems with total solvent content of 10-90 wt%, including ethanol-water mixtures used as primary solvents (column 44, lines 31-44). The 25-95 wt% range substantially overlaps with Bhalani’s 10-90 wt% range. Increasing the ethanol content from 20 wt% to 25 wt% is a trivial, predictable modification of a well-established optimization parameter to improve drying rate, film formation, and sprayability. The distinction between “plasticizer” and “solvent” is not limiting in the context of formulation composition; ethanol functions interchangeably as a volatile solvent and plasticizer depending on formulation balance.
In addition, Tojo explicitly teaches compositions optimized for spray application with viscosities overlapping the claimed range and implicitly requiring sufficiently high volatile solvent content to achieve atomization and rapid drying. Tojo’s compositions contain volatile solvents (including ethanol) in amounts that would fall within the applicant’s range when adjusted for sprayability. The motivation to increase volatile solvent content to reduce viscosity for spraying is explicitly taught by the combination of Bhalani (which teaches topical films) and Tojo (which teaches viscosity ranges for sprayability).
Thus, adjusting ethanol concentration upward into the claimed range constitutes routine optimization of a result-effective variable, particularly where drying rate and viscosity are known to be dependent on solvent content. The upper limit of 95 wt% is not critical. At 95 wt% volatile solvent, the composition is predominantly solvent with minimal solids. Such compositions are conventional spray-on films or tinctures. No criticality for the specific lower bound of 25% has been established.
The Declaration under 37 C.F.R. § 1.132 has been considered but is not sufficient to overcome the obviousness rejection. The comparison is limited to a single data point (Example 34 vs. Comparative A). The Declaration does not compare the claimed invention to the closest prior art. Comparative Example A is compared only to Example 34 of the application. It is not compared to any composition actually taught by Bhalani, Tojo, or Suzuki. To establish unexpected results, the applicant must show that the claimed composition surprisingly outperforms compositions that are within the prior art’s express teachings. The applicant has not done so. The comparative example (E/D = 2.26) is extremely close to the claimed boundary (2.0), suggesting a gradual optimization effect, not a critical threshold.
The Declaration tests only one polymer (acrylates/diacetoneacrylamide copolymer), one medicinal ingredient (felbinac), and one base (isopropyl myristate/diisopropanolamine/2-amino-2-methylpropanol). The claims are far broader, encompassing many polymers, medicinal ingredients, and bases. The Declaration does not support unexpected results across the full scope of the claims, across the full claimed range (0.005-2.0).
The differences shown in Table A are incremental, not unexpected. A reduction in quick-drying property from 4.1 to 2.9 (on a 5-point scale) and sticky feeling from 4.9 to 3.9 upon increasing the (E)/(D) ratio from 1.69 to 2.26 is exactly what a person of ordinary skill in the art would expect as a result of adjusting solvent ratios (more water slows drying and increases stickiness). This is a predictable, dose-dependent effect, not an unexpected result. Accordingly, the evidence does not establish unexpected results commensurate in scope with the claims.
The applicant does not substantively argue against the viscosity range being obvious. As previously atates, Tojo explicitly teaches viscosities of 5-3,000 mPa·s at 25°C (column 8, lines 54-59) for sprayable film-forming compositions, which falls squarely within the applicant’s range of 1.0-10,000 mPa·s. The overlap is substantial and adjusting viscosity via solvent/polymer balance is a routine formulation practice. A person of ordinary skill in the art seeking a sprayable film-forming composition would look to Tojo and would have a reasonable expectation of success in formulating Bhalani’s compositions to have viscosities within that range by adjusting solvent/polymer ratios.
The applicant does not argue that the prior art fails to teach solubility parameter and ratio limitations of claims 2, 3, 22, and 23. As previously established, the specific polymers, medicinal ingredients, and bases taught by Bhalani inherently possess solubility parameters and mass ratios within the claimed ranges. Compatibility optimization using solubility parameter values is standard practice. These limitations do not impart patentable distinction.
The dependent claims (5-13, 5-17, 23 and 24) recite known actives (e.g., felbinac), known polymers, known bases and solvents, and known concentration ranges. All remain taught or suggested by the combination of Bhalani, Tojo, and Suzuki, or represent routine optimization.
The provisional nonstatutory double patenting rejection over co-pending Application No. US 18/998,371 is maintained. The applicant argues that the rejection should be withdrawn due to earlier filing date. This argument is not persuasive. MPEP § 804(I)(B)(1)(b)(i) applies only where double patenting is the sole rejection remaining. In the present case, substantive § 103 rejections remain outstanding. Therefore, withdrawal is not appropriate. Additionally, the claims remain not patentably distinct for the reasons previously articulated. The amendment to alcohol concentration and ratio does not sufficiently distinguish over the reference claims. A terminal disclaimer remains an appropriate remedy.
Conclusion
No claims are allowed.
The 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 (87 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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