DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 04/30/2026, is acknowledged. Amendments to the specification have been entered.
Claims 1-12, 20 are pending in this action. Claims 15-19 have been cancelled. Claims 13, 14 have been cancelled previously. Claims 1, 3-4, 7, 9, 12 have been amended. New claim 20 has been added. No new matter was added. Claims 1-12, 20 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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.
Claim Objections
Claims 1, 6-7, 9 are objected to because of the following informalities:
Claim 1 comprises the typographic error “viscosity of 5 mm2/s to” that needs to be corrected to ”viscosity of from 5 mm2/s to”. Similar is applied to claims 7, 9.
Claim 6 comprises the typographic error “the number of hydroxyl groups” that needs to be corrected to “a number of hydroxyl groups”.
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, 20 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.
Newly amended claim 1 recites the limitation “weight average molecular weight of 20,000 or greater and 500,000” that is unclear and indefinite. In the present case, the recited numerical limitation is not clearly delineated (e.g., Da, KDa, g/mol, etc.), and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to other numerical limitations recited in claim 1 as well to claims 7, 9. 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 newly amended independent claim 1 discloses the use of “a drug selected from the group consisting of tetracaine, lidocaine, prilocaine, and pharmaceutically acceptable salts thereof“. Therefore, it is unclear how claim 2 narrows the scope of the claim upon which it dependents. Similar is applied to claim 6 (dependent on claim 1), to claim 10 (dependent on claim 9), and claim 20 (dependent on claim 7). Clarification is required.
Claim 3 (dependent on claim 1) discloses the use of the thermoplastic elastomer that is “selected from the group consisting of a styrene-butadiene block copolymer, a styrene-butadiene-styrene block copolymer, a styrene-isoprene block copolymer, a styrene- isoprene-styrene block copolymer, a styrene-ethylene/butylene block copolymer, a styrene- ethylene/butylene-styrene block copolymer, a styrene-ethylene/propylene block copolymer, a styrene-ethylene/propylene-styrene block copolymer, a styrene-isobutylene block copolymer, and a styrene-isobutylene-styrene block copolymer”. To this point, it is noted that newly amended independent claim 1 discloses the use of the thermoplastic elastomer that is a mixture of a styrene-isoprene-styrene block copolymer and a styrene-isoprene block copolymer. Therefore, it is unclear how claim 3 narrows the scope of the claim upon which it depends. Clarification is required.
Claim 4 (dependent on claim 3, 1) recites the limitation “the styrene-based block copolymer is a mixture of the styrene-isoprene-styrene block copolymer and the styrene-isoprene block copolymer”. As stated above, the newly amended claim 1 discloses the use of the thermoplastic elastomer that is a mixture of a styrene-isoprene-styrene block copolymer and a styrene-isoprene block copolymer. Therefore, it is unclear how claim 4 narrows the scope of the claims upon which it depends. Clarification is required.
As stated previously, claim 6 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). Further, it is noted that newly amended claim 1 disclose a kinematic viscosity of 5-50 mm2/s. Therefore, it is unclear how claim 6 narrows the scope of the claims upon which it depends. Therefore, the metes and bounds of the claim are not reasonably clear. Similar is applied to claim 12 (dependent on claim 9). 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, 20 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).
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 teaches the use of such mixtures of a styrene-isoprene-styrene block copolymer and a styrene-isoprene block copolymer as Kraton D119, Quintac3520, JSR SIS5505 (Examples as applied to claims 1, 7, 9) identified in the instant specification as the commercial products of the mixtures to be used, wherein said copolymers have a weight average molecular weight of 10,000-500,000 (see instant specification Para. 0044-0047).
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 1, 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 teaches the use of non-volatile hydrocarbon oil having a kinetic viscosity of 5-50 mm2/s 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).
Response to Arguments
Applicant's arguments, filed 04/30/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to the applicant’s argument that Ogino teaches aways from using liquid paraffin having viscosity of less than 60 mm2/s, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In the present case, the cited prior art teaches transdermal absorption preparations, in which a drug-containing adhesive layer comprises a thermoplastic elastomer (e.g., styrene-based block copolymer), and a non-volatile hydrocarbon oil (e.g., liquid paraffin), and wherein said transdermal absorption preparations have sufficient drug solubility, transdermal permeability, adhesiveness to the skin and showing low skin irritation. To this point, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions/preparations) depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/preparation. In the present case, Hamada teaches that said adhesive layer compositions may include liquid paraffin having a kinematic viscosity of 0.1-10,000 cSt (i.e., mm2/s) at 40 °C to adjust adhesiveness or improve coating property of layer compositions comprising additional compounds. Therefore, the examiner maintains the positions that the claimed 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, because every element of the invention has been collectively taught by the combined teachings of the references cited. Applicant is advised to clarify the claim language and scope, 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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