DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 02/14/2024, are acknowledged. Claims 1-12, 15-19 are pending in this action. Claims 13, 14 have been cancelled. Claims 1, 3, 5-7, 11-12 have been amended. New claims 15-19 have been added. No new matter was added. Claims 1-12, 15-19 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a 371 of PCT/JP2022/030654, filed August 10, 2022, which claims benefit of foreign priority to JP 2021-133024, filed August 17, 2021, and to JP 2021-133025, filed August 17, 2021. No English translations of the certified copies of PCT/JP2022/030654 and/or JP 2021-133025 have been received.
Inventorship
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.
Specification
The lengthy specification (108 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The use of the trademarks/trade names and/or product names has been noted in this application (e.g., Para. 0046-0047, 0053, 0112-0113, 0119, 0125, 0146-0148, 0150-0151, 0154-0156, 0158-0162, 0165-0167, 0169-0170, 0173-0182). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
Citation list (Para. 0004) should be removed from the specification. MPEP 608.01. If applicant wants these references be printed in the patent, the applicant should submit them in the form of information disclosure statement to be considered by examiner. MPEP § 609.04(a) states "the list may not be incorporated into the specification but must be submitted in a separate paper." Further, it is noted that the publications recited in the instant application should be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., “weight average molecular weight of block copolymers 10,000” (Para. 0110). Appropriate correction is required.
Further, it is noted that amendments to the specification, filed 02/14/2024, have not been entered, because newly introduced Table 2 does not correspond to Table 2 as originally filed. Clarification is required.
Information Disclosure Statement
The information disclosure statement, filed 02/14/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Objections
Claims 1, 6, 7, 9, 12, 15-19 are objected to because of the following informalities:
Claim 1 comprises the typographic error “the number of hydroxyl groups” that needs to be corrected to “a number of hydroxyl groups”. Similar is applied to claims 6, 7, 9, 12.
Claim 15 comprises the typographic error “the tetracaine, the lidocaine, and the prilocaine” that needs to be corrected to “tetracaine, lidocaine, and prilocaine”. Similar is applied to claims 16-19.
Appropriate correction is required.
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 the applicant regards as his invention.
Claims 1-12, 15-19 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “a kinematic viscosity of 60 mm2/s or less” that is not reasonably, because the recited range is not clearly delineated (see instant specification Para. 0051). Therefore, the metes and bounds of the claim are not reasonably clear. Similar is applied to other numerical limitations recited in claim 1 as well as to claims 6, 7, 9, 12. Clarification is required.
Claim 2 (dependent on claim 1) recites the limitation “wherein the (a) drug includes (i) an amino group that may have a substituent”. To this point, it is noted that independent claim 1 discloses that “the (a) drug includes (i) an amino group that may have a substituent”. Therefore, it is unclear how claim 2 narrows the scope of the claim upon which it dependents. Similar is applied to claims 7, 9, 10. Clarification is required.
Claim 3 recites the limitation “thermoplastic elastomer includes a styrene-based block copolymer” that is not reasonably clear. First, it is unclear what is disclosed as thermoplastic elastomer – a mixture of compounds (i.e., includes), or a specific compound/copolymer. Second, it is unclear what is defined by the term “styrene-based block copolymer”, e.g., how many styrene monomers should be present in said block copolymer. Similar is applied to claim 4 regarding the limitation “the styrene-based block copolymer includes a mixture of a styrene-isoprene-styrene block copolymer and a styrene-isoprene block copolymer. Clarification is required.
Claims 5, 8, 11 are rejected as being dependent on rejected independent claims 1, 7, 9 and failing to cure the defect.
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.
Claims 1-12, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ogino et al., US 2016/0206568A1 (cited in IDS; hereinafter referred to as Ogino), in view of Hamada et al., US 2019/0000774A1 (hereinafter referred to as Hamada).
Ogino teaches adhesive sheet for application to the skin that causes low skin irritation, and wherein said adhesive sheet comprises a support/patch and an adhesive layer formed on the support/patch (Title; Abstract; Para. 0028, 0038). Ogino teaches that said adhesive layer may include:
(i) a thermoplastic elastomer that is a styrene-based block copolymer, e.g., a mixture of a styrene-isoprene-styrene block copolymer and a styrene-isoprene block copolymer (Claims 1, 3-4; Abstract; Para 0018-0019, 0034 as applied to claims 1, 3-4, 6, 7, 9, 12);
(ii) a non-volatile hydrocarbon oil, e.g., liquid paraffin, squalene, and having kinematic viscosity of 60 mm2/s at 40 oC (Para. 0041, 0042 as applied to claims 1, 6, 7):
(iii) a drug, e.g., lidocaine hydrochloride, tetracaine hydrochloride (Para. 0051 as applied to claims 1, 6-7, 9, 12, 15-19).
Ogino teaches that the non-volatile hydrocarbon oil is present in an amount of 50-800 parts by weight per 100 parts by weight of the thermoplastic elastomer (Para. 0029 as applied to claims 1, 6, 7).
Ogino also teaches that styrene-based block copolymer is present in an amount of not less than 20 wt% (Claim 5; Para. 0029 as applied to claims 9, 12).
Ogino teaches that said adhesive sheet/layer can be prepared by mixing a drug, a thermoplastic elastomer and a non-volatile hydrocarbon (Para. 0091; Examples as applied to claim 6).
Ogino does not specifically teaches the use of non-volatile hydrocarbon oil having a kinetic viscosity of 60 mm2/s or less at 40 oC (claims 1, 6, 7, 9, 12).
Hamada teaches transdermal absorption preparations, in which a drug-containing adhesive layer (e.g., comprising donepezil or a salt thereof, lidocaine hydrochloride, tetracaine hydrochloride) is formed on a support/patch, and wherein said adhesive layer contains a thermoplastic elastomer (e.g., styrene-based block copolymer), and wherein said transdermal absorption preparations have sufficient drug solubility, transdermal permeability, and sufficient adhesiveness to the skin and showing low skin irritation (Abstract; Para. 0001, 0024, 0025, 0068). To this point, Hamada teaches that said layer compositions include liquid paraffin having a kinematic viscosity of 0.1-10,000 cSt (i.e., mm2/s) at 40 °C as measured according to ASTM D-445 to adjust adhesiveness or improve coating property of layer compositions comprising additional compounds, e.g., fatty acid esters (Para. 0058, 0079, 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to controlled viscosity of non-violent hydrocarbon oil, e.g., liquid paraffin as taught by Hamada, preparing compositions as taught by Ogino. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used for controlling/improving adhesiveness and/or coating property of layer compositions comprising a drug, a thermoplastic elastomer/styrene-based block copolymer and additional compounds that can be present even in large amounts (i.e., comprising/including).
Regarding the “anti-delamination” properties (claim 7, 8), it is noted that the cited prior art teaches compositions/layers that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claimed language, the structure of compounds to be included into the claimed compositions/layers and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615