DETAILED ACTION
Status of the Claims
Claims 1-20 are pending in the instant application. Claims 16 have been withdrawn based upon Restriction/Election as discussed below. Claims 1-15 and 17-20 are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Restriction/Election
Applicant's election without traverse of Group I drawn to compositions of matter, currently claims 1-15 and 17-20, in the reply filed on 05/29/2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Claim 16 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/29/2026.
Priority
The instant Application is a US entry (371) of PCT/JP2022/043366 filed 11/24/2022 and claims priority to JP2021-196430 filed 12/02/2021 and JP2022-179851 filed 11/09/2021.
The U.S. effective filing date has been determined to be 11/24/2022, the filing date of the PCT/JP2022/043366. Certified copies of both JP2021-196430 and JP2022-179851 have been received, however, the copies are not in English such that the examiner can verify written description (112(a)).
Information Disclosure Statement
The information disclosure statement(s) submitted on 05/14/2024 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
The abstract of the disclosure is objected to because the abstract is too short (31-words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Appropriate correction of the Title and Abstract is required.
Claim Amendments
Applicant has amended claim 1 to recite “wherein the adhesive layer does not include a polyol fatty acid monoester.” in lines 5-6. Applicant has pointed to the Examples as not including a polyol fatty acid monoester for support. However, the support is not in the Examples but on page 28 item (g2) Polyhydric alcohol fatty acid monoester (polyol being synonymous with polyhydric alcohol). MPEP §2173.05(i) discusses negative limitations, and the proviso “wherein the adhesive layer does not include a polyol fatty acid monoester.” finds support in the original disclosure on page 28 item (g2) Polyhydric alcohol fatty acid monoester.
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 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 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 1-10, 12-15 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over TANAKA (US 2018/0235902 A1; published August 2018) in view of Bhutkar et al. (“Evaluation of dimethylsulfoxide and Aloe vera as penetration enhancers for cutaneous application of lidocaine,” 2019, Ars Pharmaceutica, Vol. 60, No. 2, pp. 85-92) and VENKATESHWARAN (US 5,985,317; published November, 1999).
Applicants Claims
Applicant claims a patch comprising: a support; and an adhesive layer on the support, the adhesive layer including a local anesthetic , a thermoplastic elastomer, a higher fatty acid ester, and dimethyl sulfoxide, wherein the adhesive layer does not include a polyol fatty acid monoester (instant claim 1). Applicant claims thermoplastic elastomer is a styrene-based block copolymer (instant claim 5), including a mixture of styrene-isoprene-styrene block copolymer and styrene-isoprene block copolymer (claim 6), wherein the amount of the styrene-isoprene block copolymer in the mixture is 50% by mass or greater (instant claim 7). Applicant claims the local anesthetic is a mixture of lidocaine and prilocaine or a mixture of lidocaine and tetracaine (instant claims 14-15). Applicant claims the higher fatty acid ester is selected from the group consisting of octyldodecyl myristate, isostearyl isosterate, cetyl-2-ethylhexanoate, and hexyldecyl isostearate (instant claim 17). Applicant further claims the adhesive layer includes medium-chain triglyceride (instant claim 11) a filler that is light anhydrous silicic acid (instant claims 12 & 19), a surfactant that is polyoxyethylene sorbitan monolaurate (instant claims 13 & 20), and sesame oil (instant claim 18).
Determination of the scope
and content of the prior art (MPEP 2141.01)
TANAKA teaches “a patch having practical adhesive force and cohesive force as a pharmaceutical product, and also exhibiting a fast-acting anesthetic action. The present invention provides a patch formed from an adhesive layer comprising 5% by weight or more and less than 20% by weight of a mixture of lidocaine and another local anesthetic, wherein the adhesive layer comprises at least a rubber-based pressure-sensitive adhesive and liquid paraffin and a content of a tackifier in the adhesive layer is 10% by weight or less.” (title, abstract, see whole document).
TANAKA teaches that: “The mixture of lidocaine and another local anesthetic
is preferably a mixture of lidocaine and prilocaine, a mixture of lidocaine and tetracaine, or a mixture of lidocaine and benzocaine, and is more preferably a mixture of lidocaine and prilocaine or a mixture of lidocaine and tetracaine.” ([0021])(instant claims 1, 14-15).
TAKANA teaches that: “a content of the styrene-isoprene-styrene block copolymer in the mixture of a styrene-isoprene-styrene block copolymer and a styrene-isoprene copolymer is preferably 10% by weight or more and 90% by weight or less, more preferably 15% by weight or more and 60% by weight or less, and most preferably 20% by weight or more and 50% by weight or less.” ([0036])(instant claims 1, 5 – “thermoplastic elastomer”; instant claims 6-7). TAKANA does not teach or disclose the viscosity of the thermoplastic elastomer, however, the commercial products – “In addition, such a mixture of a styrene-isoprene-styrene block copolymer and a styrene isoprene block copolymer is commercially available, and examples of the commercially available product include "KRATON D1161," "KRATON D1163," "KRATON D1113" and "KRATON D1119,"which are manufactured by KRATON POLYMERS, "JSR 5229," "JSR 5403" and "JSR 5505," which are manufactured by JSR, and "Quintac 3620" "Quintac 3421" and "Quintac 3520," which are manufactured by Zeon Corporation.” [emphasis added]([0040]). – which are disclosed by the instant Specification as satisfying the viscosity requirement (instant Specification, p. 16, lines 8-24)(instant claim 9). And further that: “In one example of the present invention, in the above-described ranges, a content of the rubber-based pressure- sensitive adhesive is preferably 30% by weight or more and 55% by weight or less, and more preferably 35% by weight or more and 50% by weight or less.”
TAKANA teaches inclusion of esters (e2) including octydodecyl myristate ([0061]) alone or in combination of two or more types ([0062]), “a content of the esters is preferably 55% by weight or less, more preferably 45% by weight or less, further preferably 35% by weight or less, particularly preferably 25% by weight or less, and most preferably 15% by weight or less, based on the total amount of pressure-sensitive adhesive components.” ([0063])(instant claims 1-4, and 17).
TAKANA teaches the inclusion of a surfactant (e1)(instant claim 13).
TAKANA teaches the inclusion of a filler (e5) including silicic acid ([0071]-[0073])(instant claims 12 & 19).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of TAKANA is that TAKANA does not expressly teach the inclusion of dimethyl sulfoxide.
Bhutkar et al. teaches that dimethyl sulfoxide as a permeation enhancer for topical delivery of lidocaine (title, abstract, see whole document). Bhutkar et al. teaches that: “Dimethyl sulfoxide (DMSO) is a molecule with a long history in pharmaceutics. It is now well established as a penetration enhancer in topical pharmaceutical formulations.” (p. 86, col. 1, 6th paragraph). Bhutkar et al. teaches topical formulations including 1% to 3% dimethyl sulfoxide relative to 2% lidocaine (p. 87, Table 1)(instant claims 19 & 10). Bhutkar et al. does not teach lidocaine and dimethyl sulfoxide in an adhesive topical patch, however this is taught by VENKATESHWARAN.
VENKATESHWARAN teaches pressure sensitive adhesive matrix patches for transdermal delivery of pharmaceutical agents (title, abstract, see whole document). VENKATESHWARAN teaches that: “Preferred water-based adhesives include acrylic and polyisobutylene adhesives, and preferred drugs include ketorolac tromethamine, diclofenac sodium, buspirone HCl, lidocaine HCl, and clonidine HCl. Preferred permeation enhancers include cell envelope disordering compounds, solvents, and mixtures thereof.” (col. 3, lines 22-27).
VENKATESHWARAN teaches that: “As used herein, "permeation enhancer," "penetration-enhancer," "chemical enhancer," or similar terms refer to compounds and mixtures of compounds that enhance the flux of a drug across the skin. Flux can be increased by changing either the resistance (the diffusion coefficient) or the driving force (the gradient for diffusion).” And that: “Chemical enhancers are comprised of two primary categories of components, i.e., cell-envelope disordering compounds and solvents or binary systems containing both
cell-envelope disordering compounds and solvents.” (col. 5, lines 13-22). And further that: “Suitable solvents include […] DMSO […].” (col. 5, lines 45-47).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a drug-in-adhesive type patch including a styrene-isoprene-based thermoplastic elastomer, a higher fatty acid ester such as octyldodecyl myristate, a filler and a surfactant, the drug being a combination of lidocaine/prilocaine or lidocaine/tetracaine, as taught by TAKANA, and further to include dimethyl sulfoxide (DMSO) as a penetration enhancer as suggested by Bhutkar et al. for the enhanced penetration of topical lidocaine, and VENKATESHWARAN in an adhesive topical patch, for enhanced dermal penetration of the drug(s)(lidocaine/prilocaine or lidocaine/tetracaine).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because each of the claimed constituents are taught as useful for topical drug-in-adhesive type patch. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over TANAKA in view of Bhutkar et al. and VENKATESHWARAN as applied to claims 1-10, 12-15 17 and 19 above, and further in view of FITA (US 2006/0140986 A1; published June, 2006).
Applicants Claims
Applicant claims a patch comprising: a support; and an adhesive layer on the support, the adhesive layer including a local anesthetic , a thermoplastic elastomer, a higher fatty acid ester, and dimethyl sulfoxide, wherein the adhesive layer does not include a polyol fatty acid monoester (instant claim 1). Applicant claims thermoplastic elastomer is a styrene-based block copolymer (instant claim 5), including a mixture of styrene-isoprene-styrene block copolymer and styrene-isoprene block copolymer (claim 6), wherein the amount of the styrene-isoprene block copolymer in the mixture is 50% by mass or greater (instant claim 7). Applicant claims the local anesthetic is a mixture of lidocaine and prilocaine or a mixture of lidocaine and tetracaine (instant claims 14-15). Applicant claims the higher fatty acid ester is selected from the group consisting of octyldodecyl myristate, isostearyl isosterate, cetyl-2-ethylhexanoate, and hexyldecyl isostearate (instant claim 17). Applicant further claims the adhesive layer includes medium-chain triglyceride (instant claim 11) a filler that is light anhydrous silicic acid (instant claims 12 & 19), a surfactant that is polyoxyethylene sorbitan monolaurate (instant claims 13 & 20), and sesame oil (instant claim 18).
Determination of the scope
and content of the prior art (MPEP 2141.01)
TANAKA teaches an adhesive patch for topical delivery of a local anesthetic such as lidocaine, as discussed above and incorporated herein by reference.
Bhutkar et al. teaches that dimethyl sulfoxide as a permeation enhancer for topical delivery of lidocaine, as discussed above and incorporated herein by reference.
VENKATESHWARAN teaches pressure sensitive adhesive matrix patches for transdermal delivery of pharmaceutical agents, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of TAKANA et al. is that TAKANA et al. do not expressly teach the inclusion of the surfactant polyoxyethylene sorbitan monolaurate (syn. polysorbate 20 or 21, TWEEN 20 or 21)(instant claim 2).
FITA teaches anesthetic composition for topical administration (title) including lidocaine (abstract, see whole document). FITA teaches the inclusion of dimethyl sulfoxide as a penetration enhancer ([0019]), and teaches that: “In a preferable embodiment the surfactant is a non-ionic surfactant and in a more particular embodiment, polysorbates are used (e.g. polysorbate 20 and 80).” ([0022])(instant claim 20). FITA teaches that: “It has now been surprisingly found that a topical anesthetic composition comprising a mixture of lidocaine, prilocaine and tetracaine, exhibit a significantly more rapid onset of the anesthetic effect than comparable transdermal anesthetics […].” ([0014]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a drug-in-adhesive type patch including a styrene-isoprene-based thermoplastic elastomer, a higher fatty acid ester such as octyldodecyl myristate, a filler and a surfactant, the drug being a combination of lidocaine/prilocaine or lidocaine/tetracaine, as taught by TAKANA, and further to include dimethyl sulfoxide (DMSO) as a penetration enhancer as suggested by Bhutkar et al. for the enhanced penetration of topical lidocaine, and VENKATESHWARAN in an adhesive topical patch, for enhanced dermal penetration of the drug(s)(lidocaine/prilocaine or lidocaine/tetracaine), and further to include the nonionic surfactant polysorbate 20 (polyethylene sorbitan monolaurate), as suggested by FITA,
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because each of the claimed constituents are taught as useful for topical drug-in-adhesive type patch. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claims 11, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over TANAKA in view of Bhutkar et al. and VENKATESHWARAN as applied to claims 1-10, 12-15 17 and 19 above, and further in view of FRIEDMAN (WO 93/18752 A1; published September, 1993).
Applicants Claims
Applicant claims a patch comprising: a support; and an adhesive layer on the support, the adhesive layer including a local anesthetic , a thermoplastic elastomer, a higher fatty acid ester, and dimethyl sulfoxide, wherein the adhesive layer does not include a polyol fatty acid monoester (instant claim 1). Applicant claims thermoplastic elastomer is a styrene-based block copolymer (instant claim 5), including a mixture of styrene-isoprene-styrene block copolymer and styrene-isoprene block copolymer (claim 6), wherein the amount of the styrene-isoprene block copolymer in the mixture is 50% by mass or greater (instant claim 7). Applicant claims the local anesthetic is a mixture of lidocaine and prilocaine or a mixture of lidocaine and tetracaine (instant claims 14-15). Applicant claims the higher fatty acid ester is selected from the group consisting of octyldodecyl myristate, isostearyl isosterate, cetyl-2-ethylhexanoate, and hexyldecyl isostearate (instant claim 17). Applicant further claims the adhesive layer includes medium-chain triglyceride (instant claim 11) a filler that is light anhydrous silicic acid (instant claims 12 & 19), a surfactant that is polyoxyethylene sorbitan monolaurate (instant claims 13 & 20), and sesame oil (instant claim 18).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of TAKANA et al. is that TAKANA et al. do not expressly teach the inclusion of the surfactant polyoxyethylene sorbitan monolaurate (syn. polysorbate 20 or 21, TWEEN 20 or 21), medium chain triglycerides or sesame oil (instant claims 11, 18, 20).
FRIEDMAN teaches that: “The present invention relates to the field of drug
delivery and, particularly, to the administration of various pharmaceutical or cosmetic agents to a patient through the skin or mucous membranes by the application of innovative, non-irritating topical compositions of these agents in the form of submicron oil spheres.” (p. 1, lines 5-10, see whole document). FRIEDMAN teaches that: “The first component is typically present in an amount of about 5 to 20%, and includes oily liquids such as a medium chain triglyceride oil having a chain length of about 8 to 12 carbons, a vegetable oil, a mineral oil, an oil of animal source, a synthetic derivative thereof, or mixtures thereof.” (p. 3, lines 25-30). FRIEDMAN teaches that: “Examples of such MCT oils include TCR ([…] a mixture of triglycerides wherein about 95% of the fatty acid chains have 8 or 10 carbons) and MIGLYOL 810 or 812 ([…] a mixed triester of glycerine and of caprylic and capric acids). Examples of vegetable oils include soybean oil, cotton seed oil, olive oil, sesame oil and castor oil. The mineral oils may be natural hydrocarbons or their synthetic analogs.” (p. 8, lines 18-27)(instant claims 11 & 18). FRIEDMAN teaches the inclusion of surfactants “preferably be non-ionic to minimize irritation” including Polysorbate 20 (p. 9, lines 17-20 & 28)(instant claims 13 & 20). FRIEDMAN teaches the active ingredient includes lidocaine and tetracaine, among others (p. 12, line 15; claims 23-24).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a drug-in-adhesive type patch including a styrene-isoprene-based thermoplastic elastomer, a higher fatty acid ester such as octyldodecyl myristate, a filler and a surfactant, the drug being a combination of lidocaine/prilocaine or lidocaine/tetracaine, as taught by TAKANA, and further to include dimethyl sulfoxide (DMSO) as a penetration enhancer as suggested by Bhutkar et al. for the enhanced penetration of topical lidocaine, and VENKATESHWARAN in an adhesive topical patch, for enhanced dermal penetration of the drug(s)(lidocaine/prilocaine or lidocaine/tetracaine), and to include the nonionic surfactant polysorbate 20, the oil species medium-chain-triglycerides (MTC) and/or sesame oil, as suggested by FRIEDMAN as suitable for topical deliver of lidocaine and tetracaine.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because each of the claimed constituents are taught as useful for topical drug-in-adhesive type patch. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 1-15 and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 20 of copending Application No. 18/683,624 (hereafter ‘624) in view of TANAKA; Bhutkar et al.; VENKATESHWARAN; FITA; and FRIEDMAN
Instant claims are discussed above.
Copending ‘624 claim 1 recites a patch comprising an adhesive layer including (a) a drug selected from the group consisting of tetracaine, lidocaine, prilocaine, […]; (b) a thermoplastic elastomer; and (c) non-volatile hydrocarbon oil this is liquid paraffin or squalane […].
The difference between the instantly rejected claims and the claims of copending ‘624 is that the claim of copending ‘624 do not expressly claim a higher fatty acid ester, DMSO, a filler, a surfactant, MCT, or sesame oil.
TANAKA teaches an adhesive patch for topical delivery of a local anesthetic such as lidocaine, as discussed above and incorporated herein by reference.
Bhutkar et al. teaches that dimethyl sulfoxide as a permeation enhancer for topical delivery of lidocaine, as discussed above and incorporated herein by reference.
VENKATESHWARAN teaches pressure sensitive adhesive matrix patches for transdermal delivery of pharmaceutical agents, as discussed above and incorporated herein by reference.
FITA teaches anesthetic composition for topical administration (title) including lidocaine, as discussed above and incorporated herein by reference.
FRIEDMAN teaches drug delivery and, particularly, to the administration of various pharmaceutical or cosmetic agents to a patient through the skin or mucous membranes by the application of innovative, non-irritating topical compositions of these agents, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of copending ‘624 because the claims are directed to topical thermoplastic elastomer adhesive patch for delivery of the same local anesthetic agents. The skilled artisan would have been motivated to modify the claims of copending ‘624 and produce the instantly rejected claim because it would have been prima facie obvious to include ingredients known for incorporation into a patch. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill to combine the claimed constituents to produce a patch for delivery of lidocaine, among other local anesthetic(s).
This is a provisional obviousness-type double patenting rejection.
Conclusion
Claims 1-15 and 17-20 are pending and have been examined on the merits.
Claims 1-15 and 17-20 are rejected under 35 U.S.C. 103; and claims are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/683,624. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
Prosecution Insights