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 .
DETAILED ACTION
Formal Matters
Claims 1-7 are cancelled. Claims 8-24 are pending and under examination.
Priority
The instant application is a continuation of 17/244,552 filed on 4/29/2021, which is a continuation of 16/474,213 filed on 6/27/2019, which is a national stage application of PCT/JP2017/046697 filed on 12/26/2017, which claims priority from JP2016-256702 filed on 12/28/2016.
Information Disclosure Statements
The information disclosure statements filed on 11/8/2024, 12/5/2024, 2/20/2025, 4/1/2025, 9/30/2025 and 12/12/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 112
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 the applicant regards as his invention.
Claims 11, 12 and 14 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "at least one adhesive" in the claim where the prior recitation in claim 8 is “an adhesive”. Thus, it is unclear if “at least one adhesive” is referring to “an adhesive” or if this is an additional adhesive that is being added. There is insufficient antecedent basis for this limitation in the claim. Applicant may consider amending the claim to recite “…. wherein the adhesive comprises at least one adhesive selected…..”
Claim 12 indicates the adhesive layer comprises a styrene-isoprene-styrene block copolymer, but it is unclear if this is a further item to those items already in the adhesive layer of claim 8 (drug, DMSO, adhesive) or if applicant is defining a new adhesive layer for the patch which may only have styrene-isoprene-styrene copolymer. If applicant means this to be “an adhesive” as introduced in claim 8, then applicant might consider saying “wherein the adhesive comprises a styrene….”
Claim 14 indicates the adhesive layer comprises an organic acid, but it is unclear if this is a further item to those items already in the adhesive layer of claim 8 (drug, DMSO, adhesive) or if applicant is defining a new adhesive layer for the patch which may have an organic acid. If applicant means this to be a further limitation of the adhesive layer, then applicant should consider saying “further comprises an organic acid.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 8-11, 14, 16 and 19-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marra EP2370067B1 (2013, Google English translation).
Marra teaches a patch comprising a skin self-adhesive layer, a backing layer and a release liner, the adhesive layer comprising an antiviral agent selected from the group consisting of acyclovir penciclovir, famciclovir, idoxuridine, edoxudine dissolved in dimethylsulfoxide and a polymeric adhesive soluble in highly volatile solvents (claim 1 of Marra). Marra teaches the backing layer is polyurethane ether or ester film, polyethylene, ethylene vinyl acetate or polyolephine film with a MVTR (moisture vapor transmission rate) from 50 to 3500 g/m2/day and a thickness from 20 to 150 µm (claim 9 of Marra). Marra teaches antiviral agent (drug) and DMSO in the dried adhesive matrix (claims 2 and 3 of Marra). Marra teaches example 1 with backing layer and composition having DMSO, PVP adhesive, citric acid, acyclovir (drug) and plastoid solid (adhesive polymer blend). Marra teaches example 2 with the composition having DMSO, PVP adhesive polymer, penciclovir (drug) and polyvinyl alcohol polymer (adhesive). Marra allows for acrylic adhesives such as polymethacrylic acid and acrylic ester copolymer (paragraph 29). Marra teaches “adhesive a blend of PVP (Kollidon® K 90 P) and a water solution of acrylates/dimethylamino methacrylates copolymer, known as Plastoid” (paragraph 47, example 1). Since an acrylic adhesive is present in Marra, it will be presumed to have such probe tack values based on this copolymer.
Marra teaches an overlapping range for MVTR with the applicant’s claim and allows up to 3500 g/m2/day.
One of ordinary skill in the art before the time of filing would have worked within MVTR ranges presented by Marra to provide patches with backing layers with such MVTR values as Marra provides an overlapping range (MPEP 2144.05 – obviousness of overlapping range of the prior art). Therefore, there was a reasonable expectation of success in utilizing the teachings of Marra to provide a patch of applicant’s claims that would successfully contain and deliver a drug to a subject.
Claims 8-14, 16-22 and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ah WO2005123046.
Ah teaches a novel transdermal preparation with a hydrophobic polymeric sensitive adhesive matrix layer with droplets of active ingredient uniformly dispersed therein (abstract). Ah teaches various active ingredients including ketoprofen, diclofenac and indomethacin (claims 1 and 7 of Ah). Ah teaches “21.4g (6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 1.2g of dimethylsulfoxide, 1.2g of dimethylisosorbide, 0.6g of diethanolamine and 0.5g of ketoprofen were mixed and stirred until the mixture became transparent (4.8% DMSO 1.2 g DMSO/24.9 g total). Ah teaches backing layers that can include fabric or non-woven of polyolefin, polyester, nylons and cottons and water-permeable or water-impermeable films of polyolefins and polyesters (claim 14 of Ah). After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 60 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation” (example 30). Ah teaches “23.6g (6.6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 5.6g of dimethylsulfoxide, 1.4g of diethanolamine, 0.5g of meloxicam and lg of propyleneglycolmonocaprylate were mixed and stirred until the mixture became transparent. After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 60 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation” (example 31, also see example 32, also see tables 2 and 3). Example 25 teaches “21.4g (6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 1.4g of dimethylsulfoxide, 1.4g of dimethylisosorbide, 0.7g of diethanolamine and 0.5g of ketoprofen were mixed and stirred until the mixture became transparent. After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 30 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation.” Ah teaches “at least one adhesive selected from the group consisting of acrylic pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives and silicone pressure-sensitive adhesives.” (claim 4 of Ah). Ah teaches styrene copolymers and polyisoprenes (claim 5 of Ah). Ah teaches that the matrix layer would have an absorption enhancer that may be a fatty acid (claims 8-10 of Ah). Fatty acids like oleic acid or stearic acid are a type of organic acid. Ah teaches 6-55% by weight of polar aprotic solvent (pages 11 and 12 of Ah) (DMSO is a polar aprotic solvent). Ah teaches the backing layer is water permeable or water impermeable film (claim 14 of Ah and page 10). Water permeable films would be considered to have higher water vapor transmission rate than a film that is water impermeable. Ah does not limit water vapor transmission rates.
The teachings of Ah provide for materials such as cotton (cellulose), nylon (a polyamide) and polyolefins for the backing layer (claim 14 of Ah). These are also materials for backing layers of applicant’s claims, but applicant does not provide information regarding their WVTR values as they do for the polyester PET or the polyurethane materials. Thus, as the cotton/cellulose, nylon and polyolefins are the same materials of the claim, they will be likely to have such WVTR values in a backing layer (see MPEP 2112 – a composition (in this case, backing layer) and its properties are inseparable).
The teachings of Ah provide rubber based pressure-sensitive adhesives (claims 4 and 5 of Ah). Ah also teaches “The rubber-based pressure-sensitive adhesive is preferably at least one adhesive selected from the group consisting of natural rubbers, styrene copolymers, polyisoprenes and polyisobutylenes” (Disclosure and claim 19 of Ah). Thus, there are adhesive materials found in teachings of Ah that will have such probe tack values for an adhesive as the applicant also uses a rubber adhesive (MPEP 2112).
One of ordinary skill in the art at the time of filing of the examined claims would have been capable of utilizing cotton/cellulose, nylon and polyolefin materials carrying their respective WVTR values in a backing layer as well as rubber adhesives taught by Ah. As such a patch with such backing would be reasonably made by teachings of the prior art and it also contains adhesive, drug and DMSO, it will release DMSO at similar rates and offer values of DMSO after 24 hours of wear and versus the initial DMSO concentration after 24 hours wear. In making such a patch in teachings of Ah, one of ordinary skill in the art would be capable of achieving the patch with the materials taught by Ah for backing and adhesive layers where the materials will provide their respective properties to the layered patch. Thus, there was a reasonable expectation of making the claimed patch with a reasonable expectation of success and having the patch have the properties of water vapor transmission rate and probe tack based on those backing (cotton (a cellulose), nylon (a polyamide), polyolefin) and adhesive materials (rubber based) as they are similar materials to what applicant is using in making their patches.
Claim 23 in addition to Claims 8-14, 16-22 and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ah WO2005123046 and Tsuru WO2016136556A1 (published 9-1-2016, English translation based on related US20180036255A1).
Ah teaches the claims as discussed above.
Ah does not teach the limitation of claim 23.
Tsuru teaches an adhesive skin poultice with a base cloth and plaster layer (abstract). Tsuru teaches the knitted fabric preferably has a 50% modulus (load at 50% elongation) of 2 to 12 N / 5 cm in the course direction, a 50% modulus in the wale direction of 2 to 12 N / 5 cm, and 2 to 8 N / 5 cm in the course direction and is important for following the stretching of the skin (paragraphs 29-30, English translation by way of its related application US20180036255A1). Tsuru teaches backing fabric including polyethylene, polypropylene, cotton and/or rayon as well as non-woven or knitted fabric (paragraphs 22-24 and 26). Tsuru teaches its active substance can have percutaneous absorbability (paragraph 33). Tsuru teaches patches (paragraphs 63 and 86).
One of ordinary skill in the art before the time of filing would have been capable of including backing fabrics that have desired 50% modulus values as taught by Tsuru and used them in drug containing patches taught by Ah in order to have acceptable stretch for applying to skin. Thus, there was a reasonable expectation of success in providing patch backing layers of similar material types by teachings of Tsuru to patches of Ah in order to achieve proper stretching of the patch for application to skin.
Obviousness-type 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).
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 nonstatutory 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11020356 in view of Ah WO2005123046 and Tsuru WO2016136556A1 (published 9-1-2016, English translation based on related US20180036255A1). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for patches with backing layer and adhesive layer comprising DMSO, drug and adhesive of similar materials laminated on the backing layer. As ‘356 provides for the adhesive of styrene-isoprene-styrene block copolymer and polyisobutylene, it will have the claimed probe tack values.
‘356 does not teach the type of backing materials or the 50% modulus value of the claims.
Ah teaches a novel transdermal preparation with a hydrophobic polymeric sensitive adhesive matrix layer with droplets of active ingredient uniformly dispersed therein (abstract). Ah teaches various active ingredients including ketoprofen, diclofenac and indomethacin (claims 1 and 7 of Ah). Ah teaches “21.4g (6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 1.2g of dimethylsulfoxide, 1.2g of dimethylisosorbide, 0.6g of diethanolamine and 0.5g of ketoprofen were mixed and stirred until the mixture became transparent (4.8% DMSO 1.2 g DMSO/24.9 g total). Ah teaches backing layers that can include fabric or non-woven of polyolefin, polyester, nylons and cottons and water-permeable or water-impermeable films of polyolefins and polyesters (claim 14 of Ah). After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 60 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation” (example 30). Ah teaches “23.6g (6.6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 5.6g of dimethylsulfoxide, 1.4g of diethanolamine, 0.5g of meloxicam and lg of propyleneglycolmonocaprylate were mixed and stirred until the mixture became transparent. After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 60 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation” (example 31, also see example 32, also see tables 2 and 3). Example 25 teaches “21.4g (6g on a dry weight basis) of an acrylic pressure-sensitive adhesive (87- 2074), 1.4g of dimethylsulfoxide, 1.4g of dimethylisosorbide, 0.7g of diethanolamine and 0.5g of ketoprofen were mixed and stirred until the mixture became transparent. After the solution was allowed to stand at room temperature for 24 hours, visual examination was conducted to observe crystallization of the active ingredient. The solution was coated on a release paper so as to have a thickness of 30 μm after drying, and dried at 80°C for 20 minutes. An optical microscope was used to observe whether droplets were formed or not. A polyurethane non-woven fabric as a backing layer was laminated to the dried coating layer to produce a transdermal preparation.” Ah teaches “at least one adhesive selected from the group consisting of acrylic pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives and silicone pressure-sensitive adhesives.” (claim 4 of Ah). Ah teaches styrene copolymers and polyisoprenes (claim 5 of Ah). Ah teaches that the matrix layer would have an absorption enhancer that may be a fatty acid (claims 8-10 of Ah). Fatty acids like oleic acid or stearic acid are a type of organic acid. Ah teaches 6-55% by weight of polar aprotic solvent (pages 11 and 12 of Ah) (DMSO is a polar aprotic solvent). Ah teaches the backing layer is water permeable or water impermeable film (claim 14 of Ah and page 10). Water permeable films would be considered to have higher water vapor transmission rate than a film that is water impermeable. Ah does not limit water vapor transmission rates.
Tsuru teaches an adhesive skin poultice with a base cloth and plaster layer (abstract). Tsuru teaches the knitted fabric preferably has a 50% modulus (load at 50% elongation) of 2 to 12 N / 5 cm in the course direction, a 50% modulus in the wale direction of 2 to 12 N / 5 cm, and 2 to 8 N / 5 cm in the course direction and is important for following the stretching of the skin (paragraphs 29-30, English translation by way of its related application US20180036255A1). Tsuru teaches backing fabric including polyethylene, polypropylene, cotton and/or rayon as well as non-woven or knitted fabric (paragraphs 22-24 and 26). Tsuru teaches its active substance can have percutaneous absorbability (paragraph 33). Tsuru teaches patches (paragraphs 63 and 86).
One of ordinary skill in the art before the time of filing would have utilized backing layer materials with properties available in the prior art by teachings of Ah and Tsuru for backing layers of the patch of claims in ‘356 with a reasonable expectation of success of obtaining a patch with these types of backing layers for drug containing adhesive patches.
Claims 8-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12178922 in view of Tsuru WO2016136556A1 (published 9-1-2016, English translation based on related US20180036255A1). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for patches with backing layer and adhesive layer comprising DMSO, drug and adhesive of similar materials laminated on the backing layer.
‘922 does not teach the limitation of claim 23 in its claims.
Tsuru teaches an adhesive skin poultice with a base cloth and plaster layer (abstract). Tsuru teaches the knitted fabric preferably has a 50% modulus (load at 50% elongation) of 2 to 12 N / 5 cm in the course direction, a 50% modulus in the wale direction of 2 to 12 N / 5 cm, and 2 to 8 N / 5 cm in the course direction and is important for following the stretching of the skin (paragraphs 29-30, English translation by way of its related application US20180036255A1). Tsuru teaches backing fabric including polyethylene, polypropylene, cotton and/or rayon as well as non-woven or knitted fabric (paragraphs 22-24 and 26). Tsuru teaches its active substance can have percutaneous absorbability (paragraph 33). Tsuru teaches patches (paragraphs 63 and 86).
One of ordinary skill in the art before the time of filing would have utilized backing layer materials with properties available in the prior art by teachings of Tsuru for backing layers of the patch of claims in ‘922 with a reasonable expectation of success of obtaining a patch with these types of backing layers for drug containing adhesive patches.
Advisory Notice to Applicant
In regards to claim 15, applicant has data toward using a polyester such as found in claim 15’s group with MVTR values of the instant claim (see examples of specification). The prior art also does not teach or motivate these compounds in claim 15 for the backing layer where the adhesive layer would also have DMSO. If applicant imported the limitation of claim 15 into claim 8 so that the backing layer is made up of materials in claim 15, then applicant will have a claim free of the prior art. Applicant would also need to correct 112 issues and address double patenting rejections as appropriate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US20120089104A1 -example 4 -antiviral drug, dimethylsulfoxide, lauric acid, polyisoprene (adhesive polymer) in a mixture coated on polyurethane backing. Would constitute a similar combination as with the prior art cited above.
US20040033254A1 – The enhancers which would include DMSO in ‘254 are contained in a separate layer from the adhesive.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/
Examiner, Art Unit 1613
Prosecution Insights