DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 6, 2025 and June 1, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1, 2, 6 – 13 and 15 – 24 are examined here-in.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 recites “wherein the component (A) comprises one or more medical ingredients…” The term “medical” should be “medicinal” for consistency with independent claim 1 and other claims.
“Ibuprofen” is the only drug capitalized in claim 15. For consistency, ibuprofen should not be capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 7 – 13, and 15 – 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawamura (WO 2006/013963 A1, citations to English translation by EspaceNet).
Kawamura teaches an external preparation for nails (paragraph 0001).
In example 2, Kawamura teaches a composition with 5% butenafine hydrochloride, 2% 1,3-butylene glycol, 75.5% ethanol, 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), anticipating instant claim 1.
Kawamura’s teaching of butenafine hydrochloride (paragraph 0018) reads on component (A) a medicinal ingredient recited in instant claim 1.
Kawamura’s teaching for 0.5% hydroxypropyl cellulose and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018) reads on component (B) a water-insoluble polymer selected from the group of (B1) a cellulosic polymer and (B2) an acrylic polymer with a mass ratio of (B2) to (B1) of 0.05 to 30 as recited in claim 1. The mass ratio of (B2) to (B1) is 30:1. Specific examples in the prior art that fall within the claimed range are anticipatory according to MPEP 2131.03(ii).
Kawamura’s teaching for 1,3-butylene glycol (paragraph 0018) reads on component (C) a non-volatile base recited in claim 1.
Kawamura’s teaching for ethanol (paragraph 0018) reads on component (D) a volatile solvent recited in claim 1.
Kawamura’s example 2 (paragraph 0018) does not report the viscosity of the composition, however, this functional limitation appears to be the result of a combination of claimed components (A) – (D), as in example 2 of Kawamura since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations. For instance, examples 40 – 42, 56, 61, 62, 70, 80, 96, and 98 of the instant disclosure each contain components (A) – (D) as recited in claim 1, with component (C) being 1,3 butylene glycol and (D) being ethanol, reporting viscosities within the claimed range. Since Kawamura’s example 2 (paragraph 0018) also contains the claimed components (A) – (D), with component (C) being 1,3 butylene glycol and (D) being ethanol, the viscosity would also be expected to be within the claimed range. According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since Kawamura’s example 2 (paragraph 0018) also contains the claimed components (A) – (D), and appears to overlap with the claimed composition, the skilled artisan would have expected that the composition of Kawamura would have had the same viscosity properties as that which is instantly claimed. Something which is old (e.g., the composition of Kawamura) does not become patentable upon the discovery of a new property (e.g., viscosity within the range of 1.0 mPa*s and to 10,000 mPa*s at 25 °C ), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Kawamura’s prior art teachings recite a composition containing components (A) – (D), the functional limitation of claim 1 is anticipated.
In example 2, Kawamura teaches a composition has 2% 1,3-butylene glycol, 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reading on components (C) and (B) of the instant claims. 2% 1,3 butylene glycol to 15.5% polymer is a ratio of 0.13 component (C) to component (B), which falls within the claimed range of 0.01 to 50 recited in claim 2. Specific examples in the prior art that fall within the claimed range are anticipatory according to MPEP 2131.03(ii).
Butenafine hydrochloride (paragraph 0018) is an anti-fungal, anticipating instant claims 7 and 15.
1,3-butylene glycol (paragraph 0018) is a polyol, anticipating instant claims 8 and 18.
Ethanol (paragraph 0018) is an alcohol having 4 or less carbon atoms, anticipating instant claims 9 and 19.
Kawamura’s example 2 has 5% butenafine hydrochloride (paragraph 0018), which falls within the claimed range of 0.001 to 30% by mass recited in instant claim 10. Specific examples in the prior art that fall within the claimed range are anticipatory according to MPEP 2131.03(ii).
Kawamura’s example 2 has 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), which falls within the claimed range of 0.02 to 30% by mass as recited in instant claim 11.
Kawamura’s example 2 has 2% butylene glycol (paragraph 0018), which falls within the claimed range of 0.001 to 40% by mass recited in claim 12.
Kawamura’s example 2 has 75.5% ethanol (paragraph 0018), which falls within the claimed range of 10 to 95% by mass recited in claim 13.
Kawamura’s example 2 includes hydroxypropyl cellulose (paragraph 0018), anticipating instant claim 16.
Kawamura’s example 2 includes methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reads on claim 17’s recitation for an alkyl acrylate copolymer, anticipating instant claim 17.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1, 2, 7 – 13, and 15 – 19 are also rejected under 35 U.S.C. 103 below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 2, 6 – 13, 15 – 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Kawamura does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 2, 7 – 13, and 15 - 19 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Kawamura thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Kawamura teaches an external preparation for nails containing a hydrophobic film-forming agent, an alcohol-soluble and water-soluble polymer, and an antifungal (paragraphs 0001, 0007).
Kawamura teaches the hydrophobic film-forming agent is selected from methacrylic acid methyl methacrylate copolymer, alkyl methacrylate-aminoethyl copolymer, and ethyl cellulose and is suitable for inclusion in the composition in an amount of 10 to 30% by mass (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17).
Kawamura teaches the alcohol-soluble and water-soluble polymer is selected from hydroxypropyl cellulose, polyvinyl pyrrolidone, and hydroxyethyl cellulose and is suitable for inclusion in the composition in an amount of 0.1 to 1% by mass (paragraph 0007, page 4 lines 9 – 11, line 18).
Kawamura teaches a lower alcohol such as ethanol or isopropyl alcohol as a solvent suitable for inclusion in the composition in an amount of 60 to 85% by mass (paragraphs 0007, 0014, page 4 lines 13 – 14).
Kawamura teaches the antifungal agent is butenafine hydrochloride, terbinafine hydrochloride, neticonazole hydrochloride, or ketoconazole suitable for inclusion in the amount of 0.5 to 10% by mass (paragraph 0013).
Kawamura teaches the inclusion of an oily base such as isopropyl myristate or 1,3 butylene glycol, among others (paragraph 0015).
Kawamura teaches the composition includes less than 5% by mass water (paragraph 0016).
In Example 2, Kawamura teaches a composition with 5% butenafine hydrochloride, 2% 1,3-butylene glycol, 75.5% ethanol, 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018).
Kawamura teaches the preparation is applied to the nails and the active ingredient is released (paragraph 0008). Kawamura teaches the composition can be removed by bathing (paragraph 0008).
As discussed above, for the purposes of this rejection and purely arguendo, the examiner will take the position that Kawamura does not teach a specific embodiment having each of the claimed elements, however, claims 1, 2, 6 – 13, 15 – 21, and 23 are rendered prima facie obvious over the teachings of Kawamura, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., medicinal ingredient, water-insoluble polymer, non-volatile base, volatile solvent) were known in the prior art (e.g., compositions for application to the skin) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a composition that forms a film when applied to the skin to deliver an active ingredient) to one of ordinary skill in the art.
Kawamura’s teaching for an external preparation containing a hydrophobic film-forming agent, an alcohol-soluble and water-soluble polymer, an antifungal, an oily base, and a lower alcohol solvent (paragraphs 0001, 0007, 0015 - 0016) reads on instant claim 1. Kawamura’s example 2, teaching a composition with 5% butenafine hydrochloride, 2% 1,3-butylene glycol, 75.5% ethanol, 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reads on instant claim 1.
Kawamura’s teaching for an antifungal agent, in example 2 butenafine hydrochloride (paragraphs 0013, 0018) reads on component (A) a medicinal ingredient recited in instant claim 1.
Kawamura’s teaching for hydrophobic film-forming agent selected from methacrylic acid methyl methacrylate copolymer, alkyl methacrylate-aminoethyl copolymer, and ethyl cellulose (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17) as well as alcohol-soluble and water-soluble polymer selected from hydroxypropyl cellulose, polyvinyl pyrrolidone, and hydroxyethyl cellulose (paragraph 0007, page 4 lines 9 – 11, line 18); which in example 2 is 0.5% hydroxypropyl cellulose and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reads on component (B) a water-insoluble polymer selected from the group of (B1) a cellulosic polymer and (B2) an acrylic polymer with a mass ratio of (B2) to (B1) of 0.05 to 30 as recited in claim 1. The mass ratio of (B2) to (B1) for the amounts taught in example 2 is 30:1. Generally, Kawamura teaches alcohol-soluble and water-soluble polymer in an amount of 0.1 to 1% by mass (paragraph 0007, page 4 lines 9 – 11, 18) and hydrophobic film forming agent in an amount of 10 to 30% by mass (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17), which is a B2 to B1 ratio of 10 to 30% to 0.1 to 1% by mass, or a ratio of (B2 = 10 to 30%) : (B1 = 0.1 to 1%). A ratio of (B2 = 10 to 30%) : (B1 = 0.1 to 1%) overlaps on the claimed ratio of B2 as 0.05 to 30 to B1 as 1 as recited in instant claim 1. Claimed ranges that overlap with the prior art are prima facie obvious according to MPEP 2144.05(i).
Kawamura’s teaching for an oily base such as isopropyl myristate, or in the case of example 2, 1,3-butylene glycol (paragraphs 0015, 0018) reads on component (C) a non-volatile base recited in claim 1.
Kawamura’s teaching for a lower alcohol such as ethanol or isopropyl alcohol as a solvent, in the case of example 2, ethanol (paragraphs 0007, 0014, 0018), reads on component (D) a volatile solvent recited in claim 1.
Kawamura’s example 2 (paragraph 0018) does not report the viscosity of the composition, however, this functional limitation appears to be the result of a combination of claimed components (A) – (D), as in example 2 of Kawamura since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations. For instance, examples 40 – 42, 56, 61, 62, 70, 80, 96, and 98 of the instant disclosure each contain components (A) – (D) as recited in claim 1, with component (C) being 1,3 butylene glycol and (D) being ethanol, reporting viscosities within the claimed range. Since Kawamura’s example 2 (paragraph 0018) also contains the claimed components (A) – (D), with component (C) being 1,3 butylene glycol and (D) being ethanol, the viscosity would also be expected to be within the claimed range. According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a).
Since Kawamura’s example 2 (paragraph 0018) also contains the claimed components (A) – (D), and appears to overlap with the claimed composition, the skilled artisan would have expected that the composition of Kawamura would have had the same viscosity properties as that which is instantly claimed. Something which is old (e.g., the composition of Kawamura) does not become patentable upon the discovery of a new property (e.g., viscosity within the range of 1.0 mPa*s and to 10,000 mPa*s at 25 °C ), and this feature need not have been recognized at the time of the invention. See MPEP 2112(I) and 2112(II). Put another way, "When the claimed compositions are not novel they are not rendered patentable by recitation of properties, whether or not these properties are shown or suggested in the prior art." In re Spada, 911 F .2d 705, 709, (Fed. Cir. 1990). Therefore, since Kawamura’s prior art teachings recite a composition containing components (A) – (D), the functional limitation of claim 1 is obvious.
In example 2, Kawamura teaches a composition has 2% 1,3-butylene glycol, 0.5% hydroxypropyl cellulose, and 15% methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reading on components (C) and (B) of the instant claims. 2% 1,3 butylene glycol to 15.5% polymer is a ratio of 0.13 component (C) to component (B), which falls within the claimed range of 0.01 to 50 recited in claim 2.
Kawamura’s teaching that the composition includes less than 5% by mass water (paragraph 0016) reads on instant claim 6. Kawamura’s range of less than 5% by mass overlaps on the instantly claimed range of 1 to 70% by mass. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Kawamura’s teaching to include an antifungal agent such as butenafine hydrochloride, terbinafine hydrochloride, neticonazole hydrochloride, or ketoconazole (paragraphs 0013, 0018) reads on instant claims 7 and 15.
Kawamura’s teaching for an oily base such as isopropyl myristate or 1,3 butylene glycol, among others (paragraph 0015, 0018) reads on instant claims 8 and 18.
Kawamura’s teaching for a lower alcohol such as ethanol or isopropyl alcohol as a solvent (paragraphs 0007, 0014, 0018), reads on instant claims 9 and 19.
Kawamura’s teaching for antifungal agent in an amount of 0.5 to 10% by mass (paragraph 0013) overlaps on the claimed range of 0.001 to 30% by mass recited in instant claim 10. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Kawamura’s teaching for hydrophobic film-forming agent in an amount of 10 to 30% by mass (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17) and alcohol-soluble and water-soluble polymer in an amount of 0.1 to 1% by mass (paragraph 0007, page 4 lines 9 – 11, line 18) is a total amount of component B in the range of 10.1 to 31% by mass, which overlaps on the claimed range of 0.02 to 30% by mass as recited in instant claim 11. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Kawamura’s example 2 has 2% butylene glycol (paragraph 0018), which falls within the claimed range of 0.001 to 40% by mass recited in claim 12.
Kawamura’s teaching for a lower alcohol solvent in an amount of 60 to 85% by mass (paragraphs 0007, 0014, page 4 lines 13 – 14) overlaps on the claimed range of 10 to 95% by mass recited in claim 13.
Kawamura’s teaching for an alcohol-soluble and water-soluble polymer selected from hydroxypropyl cellulose, polyvinyl pyrrolidone, and hydroxyethyl cellulose (paragraph 0007, page 4 lines 9 – 11, line 18) reads on instant claim 16. Example 2’s specific teaching of hydroxypropyl cellulose (paragraph 0018) reads on instant claim 16.
Kawamura’s teaching for hydrophobic film-forming agent selected from methacrylic acid methyl methacrylate copolymer, alkyl methacrylate-aminoethyl copolymer, and ethyl cellulose (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17) reads on instant claim 17. Example 2’s specific teaching for methacrylic acid / methyl methacrylate copolymer (paragraph 0018), reads on claim 17.
Kawamura’s teaching for an alcohol-soluble and water-soluble polymer such as polyvinyl pyrrolidone (paragraph 0007, page 4 lines 9 – 11, line 18) reads on component (B3) of instant claim 20. Generally, Kawamura teaches alcohol-soluble and water-soluble polymer (in this case, polyvinyl pyrrolidone (B3)) in an amount of 0.1 to 1% by mass (paragraph 0007, page 4 lines 9 – 11, 18) and hydrophobic film forming agent in an amount of 10 to 30% by mass (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17), which is a B2 to B3 ratio of 10 to 30% to 0.1 to 1% by mass, or a ratio of (B2 = 10 to 30%) : (B3 = 0.1 to 1%). A ratio of (B2 = 10 to 30%) : (B3 = 0.1 to 1%) overlaps on the claimed ratio of B2 as 0.05 to 30 to B3 as 1 as recited in instant claim 20. Claimed ranges that overlap with the prior art are prima facie obvious according to MPEP 2144.05(i).
As discussed above with regards to instant claim 1, the functional limitation “wherein the composition has a viscosity at 25°C of from 1.0 mPa-s to 10,000 mPa-s” recited in claims 20 and 23 appears to be the result of a combination of claimed components (A) – (D), as taught by Kawamura since it does not appear from the instant disclosure that additional elements are required to cause the functional limitations. Since Kawamura’s teachings (paragraphs 0007 - 0015) also contains the claimed components (A) – (D), the viscosity would also be expected to be within the claimed range. According to MPEP 2112(III) and 2163.07(a), an inherent feature of a composition or method does not need to be explicitly recognized in the prior art for the prior art to be applied. Said differently, “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it” MPEP 2163.07(a). Therefore, since Kawamura’s prior art teachings recite a composition containing components (A) – (D), the functional limitations of claims 20 and 23 are obvious.
Kawamura’s teaching for hydrophobic film-forming agent selected from methacrylic acid methyl methacrylate copolymer, alkyl methacrylate-aminoethyl copolymer, and ethyl cellulose (paragraph 0007, page 4 lines 4 – 7, lines 16 – 17) reads on instant claim 21.
Kawamura’s teaching that the preparation is applied to the nails and once dried the active ingredient is released, after which the composition can be removed by bathing (paragraph 0008) reads on instant claim 23.
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kawamura (as cited above) in view of Kottayil (US 2017/0296485 A1).
Kawamura’s teachings are addressed above.
Kawamura does not teach the component (B3) is selected from polyvinyl alcohol, polyvinyl acetate, and polyvinyl butyral, or that the composition is applied to the skin.
Kottayil teaches the missing elements of Kawamura.
Kottayil teaches a polymer bioadhesive film-forming topical spray formulation for the release of active agents on human skin (abstract, paragraph 0002).
Kottayil teaches polyvinyl alcohol and polyvinyl acetate are suitable hydrophilic polymers for use in the composition (paragraph 0072). Kottayil teaches the inclusion of such hydrophilic polymers enables the desired release of the active agent (paragraph 0072).
Kottayil teaches the polymeric film-forming spray formulation is applied to the skin (paragraph 0009).
The combination of Kawamura and Kottayil’s teachings renders claims 22 and 24 prima facie obvious according to MPEP 2143(i)(a) combining prior art elements according to known methods to yield predictable results. A person of ordinary skill in the art would have been motivated to modify the composition of Kawamura to include the polyvinyl alcohol or polyvinyl acetate polymers of Kottayil because Kottayil teaches polyvinyl alcohol and polyvinyl acetate are hydrophilic polymers suitable for inclusion in the composition to enable the release of active ingredient (paragraph 0072). Further, a person of ordinary skill in the art would be motivated to apply such a composition to the skin as taught by Kottayil because application to the skin facilitates transdermal drug delivery, thus more possibilities than Kawamura’s application to nails. The combination of Kawamura and Kottayil’s teachings is prima facie obvious as combining prior art elements (components A – D, polyvinyl alcohol and/or polyvinyl acetate polymers) according to known methods (drug delivery compositions) to yield predictable results (a composition which enables drug delivery to the skin).
Kawamura’s teaching for an external preparation containing a hydrophobic film-forming agent, an alcohol-soluble and water-soluble polymer, an antifungal, an oily base, and a lower alcohol solvent (paragraphs 0001, 0007, 0015 - 0016) in combination with Kottayil’s teaching for polyvinyl alcohol or polyvinyl acetate as hydrophilic polymers suitable for drug delivery compositions (paragraph 0072) reads on instant claims 20 and 22. A person of ordinary skill in the art would be motivated to include polyvinyl alcohol or polyvinyl acetate as taught by Kottayil (paragraph 0072) as a general alcohol-soluble and water-soluble polymer in the formulation of Kawamura because Kottayil teaches polyvinyl alcohol and polyvinyl acetate are hydrophilic polymers suitable for inclusion in the composition to enable the release of active ingredient (paragraph 0072).
The combination of Kawamura and Kottayil’s teachings that the combination of a medical agent, polymers, a non-volatile base, and volatile solvent forms a drug delivery composition that is suitable for application to the skin (Kottayil paragraph 0009) reads on instant claim 24. A person of ordinary skill in the art would be motivated to apply the composition to the skin (as taught by Kottayil) rather than just the nails (as taught by Kawamura) to widen the possibility of drugs delivered and conditions treated.
Double Patenting
The non-statutory 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 non-statutory 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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double Patenting over U.S. Application No. 18/262,942
Claims 1, 2, 6 – 13 and 15 – 24 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 3, 5 – 13, 15 – 17, and 22 25 of copending Application No. 18/262,942.
Although the claims at issue are not identical, they are not patentably distinct from each other because: instant claim 1 is drawn to a composition comprising: (A) medicinal ingredient; (B) a water-insoluble polymer consisting of two or more selected from (B1) a cellulosic polymer and (B2) an acrylic polymer, wherein a mass ratio of (B2)/(B2) is from 0.05 to 30; (C) a non-volatile base; and (D) a volatile solvent, wherein the composition has a viscosity at 25°C of from 1.0 mPa*s and to 10,000 mPa*s.
Conflicting claim 1 is drawn to a composition comprising: (A) medicinal ingredient; (B) a water-insoluble polymer; (C) a non-volatile base comprising an ester oil and an alkanolamine; (D) a volatile solvent that is a lower alcohol in the amount of 25 to 95% by mass of the composition; and (E) water, wherein the mass ratio of (E)/(D) is 0.005 to 2.0 and wherein the composition has a viscosity at 25°C of from 1.0 mPa*s and to 10,000 mPa*s.
The instant and conflicting claims differ because conflicting claim 1 recites the inclusion of component (E) water, wherein a mass ratio of (E)/(D) is 0.005 to 2.0. Instant claim 6 recites the inclusion of water in an amount of 1 to 70% by mass of the composition. Instant claim 13 recites the component (D) is in the amount of 10 to 95% by mass of the composition. Together the amounts recited in instant claims 6 and 13 overlap on the mass ratio recited in conflicting claim 1.
The instant and conflicting claims differ because conflicting claim 1 recites the inclusion of (B) water-insoluble polymer however does not specify that (B1) a cellulosic polymer and (B2) an acrylic polymer, wherein a mass ratio of (B2)/(B2) is from 0.05 to 30 as recited in instant claim 1. Conflicting claim 6 recites component (B) is one or more water-insoluble polymers selected from the group consisting of an acrylic polymer, a cellulosic polymer, and a vinyl polymer.
Conflicting claims 5 and 24 recite several options for component (A), overlapping with instant claims 7 and 15.
Conflicting claim 7 recites component B is selected from various acrylate, cellulose, and vinyl polymers, reading on instant claims 16, 17, 21, and 22.
Conflicting claim 8 recites component (C)further comprises one or more of a nonpolar oil and a polyol, reading on instant claim 8.
Conflicting claim 9 recites several specific options for component (C) reading on instant claim 18.
Conflicting claim 10 recites the alcohol is a monohydric alcohol having 4 carbons or less, reading on instant claims 9 and 19.
Conflicting claim 11 recites component (A) is in a range of 0.001 to 30% by mass, overlapping on the claimed range of 0.001 to 30% by mass recited in instant claim 10.
Conflicting claim 12 recites component (B) is in a range of 0.01 to 30% by mass, overlapping on the claimed amount of 0.01 to 30% by mass recited in instant claim 11.
Conflicting claim 13 recites component (C) is in a range of 0.001 to 30% by mass, overlapping on the claimed range of 0.001 to 40% by mass recited in instant claim 12.
Conflicting claim 15 recites water in in a range of 0.1 to 70% by mass, overlapping on the instantly range of 1 to 70% by mass recited in instant claim 6.
Conflicting claim 25 recites the alkanolamine (of component (C)) is one of several options, reading on instant claim 18.
Each of the conflicting dependent claims not explicitly addressed (3, 16, 17, 22, and 23) above are also rejected due to their dependence on a rejected independent claim.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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