Patent Application 17761019 - ROPINIROLE-CONTAINING PATCH AND METHOD FOR - Rejection
Patent Application 17761019 - ROPINIROLE-CONTAINING PATCH AND METHOD FOR
Title: ROPINIROLE-CONTAINING PATCH AND METHOD FOR IMPROVNG SKIN PERMEABILITY OF ROPINIROLE
Application Information
- Invention Title: ROPINIROLE-CONTAINING PATCH AND METHOD FOR IMPROVNG SKIN PERMEABILITY OF ROPINIROLE
- Application Number: 17761019
- Submission Date: 2025-04-08T00:00:00.000Z
- Effective Filing Date: 2022-03-16T00:00:00.000Z
- Filing Date: 2022-03-16T00:00:00.000Z
- National Class: 424
- National Sub-Class: 449000
- Examiner Employee Number: 98172
- Art Unit: 1615
- Tech Center: 1600
Rejection Summary
- 102 Rejections: 0
- 103 Rejections: 1
Cited Patents
No patents were cited in this rejection.
Office Action Text
DETAILED ACTION
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 .
Summary
Claims 1-2 and 4-8 are pending in this office action. Claim 3 is cancelled. All pending claims are under examination in this application.
Priority
The current application filed on March 16, 2022 is a 371 of PCT/JP2020/034464 filed September 11, 2020. The current application also claims foreign priority to JP2019-168963 filed on September 18, 2019.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 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 non-obviousness.
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 1-2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ohashi et al. (WO2018/155390A1, published August 2018) in view of Uchida et al. (US2018/0055783A1, published March 2018).
[The Examiner is going to introduce each reference and then reject the instant claims by combining the citations.]
1. Ohashi et al.
Ohashi et al. is considered to be the prior art closest to the present application and teaches an adhesive skin patch and packaged product thereof (see title). Additionally, Ohashi et al. disclose a patch comprising:
a backing layer; and
an adhesive layer, wherein
the adhesive layer contains a mixture of a pharmaceutically acceptable acid addition salt of ropinirole and potassium hydrogen carbonate, and the mixture contains at least one selected from the group consisting of ropinirole and pharmaceutically acceptable acid addition salts thereof and potassium hydrogen carbonate (see abstract).
2. Uchida et al.
Uchida et al. teach a transdermal patch containing ropinirole (see title). In addition, Uchida et al. disclose that the present invention provides a patch comprising a backing and an adhesive agent layer laminated on the backing, wherein the adhesive agent layer comprises ropinirole or a pharmaceutically acceptable salt thereof, an organic amine or an acid addition salt thereof, and an adhesive agent (see abstract).
Combination of Ohashi et al. and Uchida et al.
Regarding instant claim 1, Ohashi et al. and Uchida et al. teach a ropinirole-containing patch comprising a backing layer and an adhesive agent layer. The necessary citations within Ohashi et al. and Uchida et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Ohashi et al. and Uchida et al. Citations
A ropinirole-containing patch comprising a backing layer and an adhesive agent layer,
Ohashi et al. disclose a patch comprising a support layer and an adhesive layer (see claim 1 within Ohashi et al.).
wherein the adhesive agent layer containing: at least one selected from the group consisting of ropinirole and a pharmaceutically acceptable salt thereof;
Ohashi et al. disclose wherein the adhesive layer contains a mixture of a pharmaceutically acceptable acid addition salt of ropinirole and potassium bicarbonate, the mixture containing at least one selected from the group consisting of ropinirole and its pharmaceutically acceptable acid addition salts, and potassium bicarbonate (see claim 1 within Ohashi et al.).
a fatty acid metal salt having 7 or more carbon atoms which is a metal salt of at least one salt selected from the group consisting of oleic acid, capric acid, and lauric acid; and an adhesive agent.
Ohashi et al. disclose that in the present invention, examples of acids for the pharmaceutically acceptable acid addition
salts of ropinirole include hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, phosphorous acid, hydrobromic acid, maleic acid, malic acid, ascorbic acid, tartaric acid,
lauric acid, stearic acid, palmitic acid, oleic acid, myristic acid, lauryl sulfuric acid, linoleic acid, and fumaric acid (see paragraph [0020] within Ohashi et al.; fatty acids in bold). Additionally, Ohashi et al. disclose the use of a potassium bicarbonate-derived component (see claim 2 within Ohashi et al.) of fatty acids including potassium oleate and potassium laurate (see paragraphs [0022-0023] for the potassium metal salts of oleic acid and lauric acid, respectively, within Ohashi et al.).
Furthermore, Uchida et al. disclose both the use of fatty acids as percutaneous absorption promoting agents (see paragraph [0037] within Uchida et al.) or plasticizers giving flexibility to the adhesive agent layer (see paragraph [0035] within Uchida et al.).
Therefore, it would be routine modification for a skilled artisan (POSITA; person having ordinary skill in the art) to remove the potassium bicarbonate used within Ohashi et al. and make the corresponding metal salt of the desired fatty acid. Finally, Ohashi et al. disclose the use of an adhesive agent (see claim 5 and paragraph [0027] within Ohashi et al.).
Regarding instant claim 2, Ohashi et al. and Uchida et al. teach wherein the fatty acid metal salt is a fatty acid alkali metal salt. Ohashi et al. disclose the use of a potassium bicarbonate-derived component (see claim 2 within Ohashi et al.) of fatty acids (see paragraphs [0022-0023] within Ohashi et al.). Potassium is an alkali metal salt. Examples of fatty acid potassium salts include potassium laurate, potassium
stearate, potassium palmitate, potassium oleate, and potassium myristate (see paragraph [0023] within Ohashi et al.).
Regarding instant claim 4, Ohashi et al. and Uchida et al. teach wherein the adhesive agent is at least one selected from the group consisting of a rubber-based adhesive agent, an acrylic-based adhesive agent having no carboxy group, and a silicone-based adhesive agent. Ohashi et al. disclose examples of the adhesive include rubber-based adhesives, acrylic-based adhesives, and silicone-based adhesives, and any one of these may be used alone or two or more of them may be used in combination (see paragraph [0027] within Ohashi et al.).
Regarding instant claim 5, Ohashi et al. and Uchida et al. teach wherein a content of the fatty acid metal salt is 0.1 to 45% by mass relative to a total mass of the adhesive agent layer. Ohashi et al. disclose that furthermore, in the adhesive layer according to the present invention, the content of the potassium bicarbonate and/or the component derived from the potassium bicarbonate relative to the total mass of the adhesive layer preferably satisfies the condition of the molar ratio to the content of ropinirole and/or a pharmaceutically acceptable acid addition salt thereof, calculated as ropinirole free form, and although this cannot be generally stated as it depends on the content, it is preferably 1.5 to 21.0 mass%, more preferably 1.5 to 16.0 mass%, even more preferably 3.0 to 16.0 mass%, and even more preferably 3.5 to 15.0 mass%, calculated as potassium bicarbonate (see paragraph [0026] within Ohashi et al.).
Regarding instant claim 6, Ohashi et al. and Uchida et al. teach wherein in the adhesive agent layer, a content of the fatty acid metal salt is 0.1 to 5.0 mol relative to 1.0 mol of the at least one selected from the group consisting of ropinirole and a pharmaceutically acceptable salt thereof in content in terms of free ropinirole. Ohashi et al. disclose wherein the content of the potassium bicarbonate and/or the component derived from the potassium bicarbonate, calculated as potassium bicarbonate, is 0.5 to 3.0 mol per 1.0 mol of the content of the ropinirole and/or its pharmaceutically acceptable acid addition salt, calculated as ropinirole free form (see claim 3 within Ohashi et al.).
Regarding instant claim 7, Ohashi et al. and Uchida et al. teach wherein a content of the at least one selected from the group consisting of ropinirole and a pharmaceutically acceptable salt thereof in terms of free ropinirole is 5 to 30% by mass relative to a total mass of the adhesive agent layer. Ohashi et al. disclose wherein the content of the ropinirole and/or the pharmaceutically acceptable acid addition salt thereof, calculated as ropinirole free form, is 7.7 to 20.0% by mass relative to the total mass of the adhesive layer (see claim 4 within Ohashi et al.).
Regarding instant claim 8, Ohashi et al. and Uchida et al. teach a method for improving skin permeability of at least one selected from the group consisting of ropinirole and a pharmaceutically acceptable salt thereof in a ropinirole-containing patch comprising a backing layer and an adhesive agent layer, wherein the adhesive agent layer containing: at least one selected from the group consisting of ropinirole and a pharmaceutically acceptable salt thereof and an adhesive agent, the method comprising: a step of causing the adhesive agent layer to further contain a fatty acid metal salt having 7 or more carbon atoms which is a metal salt of at least one salt selected from the group consisting of oleic acid, capric acid, and lauric acid. Please see the discussion and citations within instant claim 1 (see Table I) for the relevant references.
In the context of instant method claim 8, the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to claims 1-7 and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Analogous Art
The Ohashi et al. and Uchida et al. disclosures are all relevant for the rejection of instant claims 1-8 due to their direct application to the present invention.
Obviousness
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 modify the ropinirole patch disclosed by Ohashi et al., using the teachings Uchida et al. to incorporate the fatty acid salt within the transdermal layer containing ropinirole. Starting with Ohashi et al., the skilled person only had to try the fatty acid salts within the transdermal layer containing ropinirole disclosed by Uchida et al. The combination of Ohashi et al. and Uchida et al. would allow one to arrive at the present application without employing inventive skill. This combination of the ropinirole patch taught by Ohashi et al. along with the use the necessary fatty acid salts within the transdermal layer containing ropinirole taught by Uchida et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the ropinirole patch disclosed by Ohashi et al. with the use of the necessary fatty acid salts within the transdermal layer containing ropinirole taught by both Uchida et al. This combined modification would have led to an enhanced ropinirole patch that would be beneficial for patients and consumers.
Response to Arguments
Applicant's arguments filed January 17, 2025 have been fully considered but they are not persuasive.
The instant claim amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that unexpectedly superior results are obtained by selection of the metal salts of the fatty acids, oleic and lauric acid.
Examinerâs Rebuttal: Ohashi et al. disclose the use of the potassium salt of both oleic and lauric acid (see paragraph [0023] within Ohashi et al.). Additionally, Ohashi et al. disclose the use of the metal fatty acid salts within the composition (see claim 2 within Ohashi et al.). Therefore, the same âunexpected superior resultsâ would be obtained using the teachings of Ohashi et al.
Applicant Argument: The Applicant argues Ohashi et al. describes a patch comprising an adhesive layer which comprises a mixture of a pharmaceutically acceptable acid addition salt of ropinirole and potassium bicarbonate. Ohashi et al. lists oleic acid and lauric acid as examples of acids of the acid addition salt of ropinirole (see, paragraph [0020] within Ohashi et al.). And Ohashi et al. lists potassium oleate and potassium laurate as examples of the potassium bicarbonate-derived components (see, paragraph [0023] within Ohashi et al.). However, Applicant submits that Ohashi et al. is silent about specific selection of oleic acid and lauric acid as the acid of the acid addition salt of ropinirole. In fact, Ohashi et al. only shows examples using a hydrochloric acid as the acid. Further, Ohashi et al. also lists stearic acid as the acid. Applicant submits that even if the potassium stearate can be obtained in the adhesive layer from the mixture of ropinirole stearate and potassium bicarbonate, excellent skin permeability and availability cannot be achieved (see, Example 4 of the present Application).
Examinerâs Rebuttal: The Examiner respectfully disagrees. Ohashi et al. does disclose within claim 2 wherein the mixture further comprises a potassium bicarbonate-derived component (see claim 2 within Ohashi et al.). Ohashi et al. lists oleic acid and lauric acid as examples of acids of the acid addition salt of ropinirole (see paragraph [0020] within Ohashi et al.). Furthermore, Ohashi et al. lists potassium oleate and potassium laurate as examples of the potassium bicarbonate-derived components (see paragraph [0023] within Ohashi et al.). The Examiner does concede the fact that within the Examples section, only the hydrochloric acid salt of ropinirole is disclosed. However, regardless of the fact that the hydrochloric acid salt of ropinirole is exemplified within Ohashi et al., paragraphs [0020] and [0023] do support the use of both the oleic acid and lauric acid addition salt of ropinirole, and the potassium bicarbonate-derived components of the same acids (potassium laurate and potassium oleate), respectively. Both acids and their potassium metal salts can be used within the composition. As a result, the same excellent skin permeability and availability data would be obtained a skilled artisan (POSITA).
Applicant Argument: The Applicant argues that the fatty acid metal salt is not taught by Ohashi et al.
Examinerâs Rebuttal: The Examiner respectfully disagrees. As stated above, the potassium metal salt of oleic acid and lauric acid can be used within the composition (see citations and discussion directly above).
Thus, the 35 U.S.C. 103 rejection is maintained for instant claims 1-2 and 4-8.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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 examinerâs supervisor, Robert A Wax can be reached on 571-272-0623. 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.
/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
