DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 23, 2026 has been entered.
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 .
Application Priority
This application filed 08/02/2022 is a 371 of PCT/JP2021/004740 filed on 02/09/2021, which claims priority to JAPAN 2020-021277 filed on 02/12/2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 1/23/26 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103(a) rejection of claims 14-25 and 27 over Hatanaka et al. (US9308187B2) in view of CN103933481A is not persuasive. The rejection is herewith modified in view of amendments made to the claims. The rejections are addressed below.
Applicant’s arguments over the 35 U.S.C. 103(a) rejection of claims 27 over Hatanaka et al. (US9308187B2) in view of CN103933481A, as applied to claims 14-25 and 27 further in view of Tomomi et al. (WO 2009096315 A1) is not persuasive. The rejection is herewith modified in view of amendments made to the claims.
Applicant argues " Newly-inserted claim 28 now limits the at least one patch to only a backing layer and an adhesive layer through the use of the closed transition "consists of" Moreover, independent claim 28 further limits the active ingredient to only being in the adhesive.” Furthermore, the Examiner reminds Applicant the primary reference is drawn to a diclofenac sodium adhesive patch, not containing additional actives argued.
The arguments CN103933481A are moot in view of withdrawal of the reference.
In response, the Examiner points out that the method of the claims does not exclude additional actives. The method comprises “applying at least one patch to skin of the patient once a day, wherein the at least one patch consists.” The “comprising” language of the claims does not exclude additional components including steps or steps including additional actives.
The nonstatutory double patenting of Patent No. U.S. Patent No. 9308187B2 in view of CN103933481A is not persuasive. The rejection is herewith modified in view of amendments made to the claims. Applicant’s argument over nonstatutory double patenting rejections depends on the validity of the previous arguments which were not found persuasive.
The following rejections are made:
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 28-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US9308187B2) in view of Pan et al. ((2016) Repurposing Drugs in Oncology (ReDO)—diclofenac as an anti-cancer agent ecancer 10 610).
Hatanaka et al. teaches a patch comprising a support layer and an adhesive layer, wherein the adhesive layer comprises diclofenac sodium, dimethyl sulfoxide, and citric acid. The adhesive layer further comprises oleic acid. The adhesive layer further comprises at least one compound selected from the group consisting of liquid paraffin and a liquid rubber. The adhesive layer is a styrene-isoprene-styrene block copolymers and/or polyisobutyrene. The tackifier include rosin esters, hydrogenated rosin esters, maleated rosins, alicyclic saturated hydrocarbon resins, and terpene resins. The patch of Example 2 (area: 140 cm2) were attached to the skin. The prior art teaches two to three sheets of the patch were attached to the skin (reads on daily) (i.e. Fig 6).
While the reference teaches mass part of the diclofenac sodium, the reference does not specify the dose of the diclofenac sodium of 150 mg to 225 mg per application or application once a day.
Pan et al. teaches “Diclofenac (DCF) is a commonly used non-steroidal anti-inflammatory drug (NSAID) used in the treatment of pain in rheumatoid arthritis and other musculoskeletal conditions, migraine, fever, acute gout and post-operative pain…DCF is also commonly available as a gel for topical application for localized pain or for the treatment of actinic keratosis.” (Introduction) Pan et al. points out that “topical application at a dose of 6 mg/kg retarded and then stopped tumor growth compared to controls.” “DCF, which is available as a sodium or potassium salt, is used in tablet, gel/emulsion, injection and suppository forms. Dosages vary by format and indication.”
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the teaching of Pan et al. to treat cancer pain at the dosage claimed. The motivation to treat cancer pain comes from the teaching Pan et al. that DCF is also commonly available as a gel for topical application for localized pain and dosages vary by format and indication. A skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US9308187B2) in view of Pan et al. ((2016) Repurposing Drugs in Oncology (ReDO)—diclofenac as an anti-cancer agent ecancer 10 610), as applied to claims 28-38 and 40 further in view of Tomomi et al. (WO 2009096315 A1).
Hatanaka and Pan et al. are discussed above.
Hatanaka and Pan et al. fail to teach the polyethylene terephthalate.
Tomomi et al. teaches an adhesive patch which comprises a substrate having stretchability and a pressure-sensitive adhesive layer superposed on at least one side of the substrate. The stretch substrate comprises a both-side-knitted woven fabric including two or more rows of a crimped polyethylene terephthalate multifilament yarn. Specifically, the method uses a melted material to spread on the release coating, and further covered with double-sided knitted polyethylene terephthalate. After the melted material is pressure-transferred, the melt is squared to 7 × 10 cm. Cut to prepare a patch.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate a knitted polyethylene terephthalate in a patch. The motivation to incorporate a knitted polyethylene terephthalate in a patch comes from the teaching double-sided knitted woven fabric having two or more multifilament yarns of polyethylene terephthalate subjected to crimping provides a stretchable support . A skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
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 14-15, 17-25, 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US9308187B2 in view of Pan et al. ((2016) Repurposing Drugs in Oncology (ReDO)—diclofenac as an anti-cancer agent ecancer 10 610).
Hatanaka et al. teaches a patch comprising a support layer and an adhesive layer, wherein the adhesive layer comprises diclofenac sodium, dimethyl sulfoxide, and citric acid. The adhesive layer further comprises oleic acid. The adhesive layer further comprises at least one compound selected from the group consisting of liquid paraffin and a liquid rubber. The adhesive layer is a styrene-isoprene-styrene block copolymers and/or polyisobutyrene. The tackifier include rosin esters, hydrogenated rosin esters, maleated rosins, alicyclic saturated hydrocarbon resins, and terpene resins. The patch of Example 2 (area: 140 cm2) were attached to the skin
While the reference teaches mass part of the diclofenac sodium, the reference does not specify the dose of the diclofenac sodium of 150 mg to 225 mg per application or application once a day.
Pan et al. teaches “Diclofenac (DCF) is a commonly used non-steroidal anti-inflammatory drug (NSAID) used in the treatment of pain in rheumatoid arthritis and other musculoskeletal conditions, migraine, fever, acute gout and post-operative pain…DCF is also commonly available as a gel for topical application for localized pain or for the treatment of actinic keratosis.” (Introduction) Pan et al. points out that “topical application at a dose of 6 mg/kg retarded and then stopped tumor growth compared to controls.” “DCF, which is available as a sodium or potassium salt, is used in tablet, gel/emulsion, injection and suppository forms. Dosages vary by format and indication.”
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the teaching of Pan et al. to treat cancer pain at the dosage claimed. The motivation to treat cancer pain comes from the teaching Pan et al. that DCF is also commonly available as a gel for topical application for localized pain and dosages vary by format and indication. A skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results.
Claims 14-15, 17-25, 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8 of U.S. Patent Applic. number 17433289 (IDS filed on . Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a transdermal patch comprising: an adhesive layer on a backing[[,]]:wherein the adhesive layer contains a drug, DMSO, and an adhesive base[[, and]];wherein the adhesive base contains a styrene-based thermoplastic elastomer and the styrene-based thermoplastic elastomer has a triblock content of 35% to 65%[[.]]wherein a mass concentration of the DMSO based on a total mass of the adhesive layer is2 mass% to 10 mass%, wherein the drug comprises diclofenac sodium, a mass ratio of the DMSO to the diclofenac sodium being between 1:0.1 and 1:5, and wherein the transdermal patch is configured for application to skin that can extend and contract during motion while the claims herein are drawn to a method for relieving cancer pain in a patient, the method
comprising administering at least one patch to a patient in need thereof, wherein at least
one patch comprises a backing layer and an adhesive layer laminated on the backing layer, the adhesive layer comprises an adhesive base and an active ingredient, wherein the active ingredient consists of diclofenac sodium, and wherein the at least one patch is applied once a day to the patient, thereby administering to the patient a dose of the diclofenac sodium of 150 mg to 225 mg per application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
Prosecution Insights