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 .
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.
Claim Interpretation
Claim 4 recites an acrylic copolymer based on vinyl acetate, 2-ethylhexyl acrylate, 2-hydroxyethyl acrylate, and optionally glycidyl methacrylate. The examiner understands this to require that the copolymer be a polymer made from polymerization of the monomers of vinyl acetate, 2-ethylhexyl acrylate, and 2-hydroxyethyl acrylate, and optionally crosslinked with glycidyl methacrylate.
The examiner also understands that the material known by the trade names of “Duro-tak 87-4287”, “Duro-tak 287-2287” “Duro-tak 87-2287”, “Duro-tak 387-2516” and “Duro-tak 87-2516” as well as other trade names disclosed on pages 13-14, paragraph 0087 of the instant specification as filed to meet this claim limitation.
The examiner will proceed with examination with the understanding that prior art drawn to the product with the trade name “Dow Corning Bio-PSA 7-4202”, which is taught to be a polysiloxane adhesive on page 21 of the instant specification, meets the requirements of the polysiloxane of instant claim 8.
Multiple Numerical Ranges in Claims
The examiner notes that various claims have multiple numerical ranges in the same claim. As an example of this, the examiner cites claim 6, which recites at least one polar polymer in a range of about 10% to about 50% or about 10% to about 25%. These ranges are recited in the alternative.
The reciting of multiple numerical ranges of varying scope in the alternative would not appear to render the claim indefinite. In support of this position, the examiner notes that the Markush group, "selected from the group consisting of amino, halogen, nitro, chloro and alkyl" should be acceptable even though "halogen" is generic to "chloro." See MPEP 2173.05(h)(I), last paragraph. In a similar vein, the reciting of the broader range of about 10% to about 50% together with a narrower range of about 10% to about 25% is acceptable.
The examiner notes that description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(c) and 2173.05(d). However, in the preliminary amendment on 23 October 2024, applicant amended the claims so that they are not drawn to examples or preferences by cancelling the term “preferably” from the claims. As such, because the term “preferably” is no longer recited by the claims, the instant claims are not rejected as indefinite under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103 – Obviousness
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 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.
Claim(s) 1-3, 5-7, 10-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miwa et al. (US 2021/0030724 A1) in view of Shahid et al. (Drug Development and Industrial Pharmacy, Vol. 44 No. 12, 2018, pages 2061-2070).
Miwa et al. (hereafter referred to as Miwa) is drawn to transdermal patch comprising tizanidine, as of Miwa, title, abstract, and figure on front page, which is reproduced below.
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In one embodiment, Miwa teaches that the drug adhesive matrix layer comprises the following ingredients, as of Miwa, page 10, paragraph 0116, reproduced below.
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As to claim 1, part (A), the claim requires a backing layer. This is taught by the above-reproduced figure from the front page of Miwa.
As to claim 1, part (B)(i), Miwa teaches tizanidine, as of Miwa, title, abstract, and above-reproduced table. Miwa is not anticipatory because in the above-reproduced table, Miwa teaches tizanidine hydrochloride rather than tizanidine free base. Nevertheless, in the abstract, Miwa teaches “tizanidine or a pharmaceutically acceptable salt thereof.” The examiner understands this to provide motivation for the skilled artisan to have substituted tizanidine free base in place of tizanidine hydrochloride. The simple substitution of one known element (e.g. tizandine free base) in place of another (tizanidine hydrochloride) in order to achieve predictable results (the therapeutic effects of tizanidine) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 1, part (B)(iii), Miwa teaches terpene resin and styrene-isoprene-styrene block copolymer, as of the above-reproduced table. These are non-polar polymers.
As to claim 1, part (B)(iv), Miwa teaches oleic acid, as of the above-reproduced table.
Miwa differs from the claimed invention because in the composition of Miwa, there does not appear to be a polar polymer in the tizanidine-containing layer. While Miwa teaches a polar polymer such as that known by the trade name “DURO-TAK 387-2287”, it is present in a separate layer as compared to the tizanidine containing layer, rendering the composition of Miwa different from the claimed composition.
Shahid et al. (hereafter referred to as Shahid) is drawn to a drug delivery system for transdermal delivery of tizanidine hydrochloride, as of Shahid, page 2061, title and abstract. The composition of Shahid appears to be a matrix-type composition having the following components, as of Shahid, page 2062, Tables 1 and 2, reproduced below.
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CAP is cellulose acetate phthalate, PVP is polyvinyl pyrrolidone, and EL100 is Eudragit L100, which is an acrylate containing polymer; see Shahid, page 2062, left column, section entitled “Materials.” The examiner understands these to be polar polymers.
Shahid differs from the claimed invention at least because does not appear to teach a fatty acid.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the polymers of Shahid with the matrix drug-containing layer of the composition of Miwa. Miwa is drawn to a tizanidine containing transdermal patch, and teaches a tizanidine-containing matrix layer. While the matrix layer of Miwa does not include polar polymers, it is nevertheless the case that Shahid teaches polar polymers in a tizanidine matrix layer of a transdermal patch. As such, the skilled artisan would have been motivated to have included the polar polymers of the matrix layer of Shahid in the matrix layer of Miwa for predictable delivery of tizanidine transdermally with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. polyvinylpyrrolidone, Eudragit, and/or cellulose acetate phthalate, as of Shahid) for incorporation into a composition (e.g. the matrix layer in the composition of Miwa), based on its recognized suitability for its intended use (transdermal delivery of tizanidine). See MPEP 2144.07.
As to claim 2, Miwa teaches 1.72% tizanidine in the drug adhesive matrix layer, as of page 10, paragraph 0116. Miwa also teaches a range of from 0.5% to 10% as of paragraph 0043.
As to claim 3, Shahid teaches both polyvinylpyrrolidone as well as Eudragit L100, which is an acrylic polymer, as of Shahid, page 2062, left column, “Materials” section.
As to claim 5, Shahid teaches polyvinylpyrrolidone, as of Shahid, page 2062, left column, “Materials” section.
As to claim 6, Shahid teaches 400 mg of Eudragit L100 per (200 mg cellulose acetate phthalate, + 400 mg Eudragit L100 +10 mg drug + 240 mg propylene glycol) in the first line of Table 2 on page 2062 (i.e. T1-PE01). This appears to be about 47% Eudragit L100 in that embodiment. Shahid teaches lower percentages of Eudragit L100, as of the second line of Table 1 (i.e. T2-PE02). As such, the amounts of the polymer taught by Shahid appear to overlap with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 7, Miwa teaches polyisobutylene in paragraph 0055. As best understood by the examiner, Miwa teaches polyisobutylene in the overlaying adhesive layer, which is separate from the drug adhesive matrix layer. Nevertheless, this difference is insufficient to overcome the applied rejection. This is because placing the polyisobutylene integral to the drug layer would still appear to result in a prima facie case of obviousness in the absence of unexpected results; see MPEP 2144.04(V)(B).
As to claim 10, Miwa teaches 16% styrene-isoprene-styrene block copolymer and 28% terpene resin. The amount of terpene resin appears to be within the claimed range. Also, when the terpene resin in combination with styrene-isoprene-styrene is taken together, this amount appears to be about 44% and is also within the claimed range.
As to claim 11, Miwa teaches oleic acid, as of the table in paragraph 0116. This has 18 carbons and reads on the requirement of claim 11.
As to claim 12, the amount of aliphatic acid taught by Miwa appears to be lower than what is claimed. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence on the record that the concentration of oleic acid is critical. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a tizanidine transdermal patch comprising oleic acid have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of this component via routine experimentation.
As to claim 13, Miwa teaches methyl laurate in paragraph 0047. Miwa appears to be silent regarding the amount of methyl laurate. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there is no evidence on the record that the concentration of methyl laurate is critical. Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a tizanidine transdermal patch comprising methyl laurate have been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of methyl laurate via routine experimentation.
As to claim 14, Miwa teaches the following on page 10, Table 13, reproduced below.
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As to claim 15, Miwa teaches the following, as of paragraph 0042, relevant text reproduced below.
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Miwa suggests applying the patch for 72 hours, as of paragraph 0079. As such, the skilled artisan would have expected that the composition of Miwa would have provided the required amount of tizanidine in the required time period.
As to claim 16, Miwa teaches treating a human patient as of at least paragraph 0072.
As to claim 17, Miwa teaches 1.72% tizanidine in the drug adhesive matrix layer, as of page 10, paragraph 0116. Miwa also teaches a range of from 0.5% to 10% as of paragraph 0043.
As to claim 19, Miwa teaches oleic acid, as of the table in paragraph 0116. This has 18 carbons and reads on the requirement of claim 11.
Note Regarding Filing Date: The examiner notes that the instant application appears to have an earliest effective filing date of 15 October 2021, based upon a foreign priority claim. Miwa was published on 4 February 2021, which is less than a year earlier than the earliest effective filing date of the instant application. As such, Miwa is prior art under AIA 35 U.S.C. 102(a)(1). In addition, the examiner notes Miwa et al. (WO 2019/151423 A1). This is a Japanese-language WIPO publication that appears to have the same text as Miwa et al. (US 2021/0030724 A1), but was published over a year earlier than the earliest effective filing date of the instant application.
Claim(s) 4 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miwa et al. (US 2021/0030724 A1) in view of Shahid et al. (Drug Development and Industrial Pharmacy, Vol. 44 No. 12, 2018, pages 2061-2070), the combination further in view of Friedrich et al. (US 2015/0148759 A1).
Miwa is drawn to a transdermal tizanidine drug delivery form. Shahid is also drawn to a transdermal tizanidine drug delivery form. See the rejection above over Miwa in view of Shahid. Both Miwa and Shahid teach the inclusion of an adhesive; see at least Miwa, paragraph 0041 and Shahid, page 2066, right column, first paragraph below figure 2.
Neither Miwa nor Shahid teach an acrylic copolymer based on vinyl acetate, 2-ethylhexyl acrylate, and 2-hydroxyethyle acrylate.
Friedrich et al. (hereafter referred to as Friedrich) is drawn to a transdermal patch for the administration of tapentadol, as of Friedrich, title and abstract. Friedrich teaches various pressure sensitive adhesives, as of Friedrich, abstract. These pressure sensitive adhesives may include the adhesive known by the trade name “Durotak 87-4287” as of paragraph 0314. The adhesives may also include polyisobutylene, as of paragraph 0131, and silanol endblocked polydimethylsiloxane (PDMS) with a silicate resin, as of paragraph 0141.
Friedrich differs from the claimed invention at least because the drug delivered by Friedrich different from tizanidine.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the adhesives of Friedrich with the composition of Miwa in view of Shahid. The combination of Miwa in view of Shahid is drawn to a transdermal patch for the delivery of tizanidine which comprises an adhesive. The Durotak 87-4287, polyisobutylene, and silanol endblocked PDMS of Friedrich are adhesives useful for transdermal patches for drug delivery. As such, the skilled artisan would have been motivated to have combined the Durotak 87-4287, polyisobutylene, and silanol endblocked PDMS of Friedrich with the composition of Miwa in view of Shahid for predictable adhesion with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. Durotak 87-4287, polyisobutylene, and silanol endblocked PDMS, as of Friedrich) for incorporation into a composition (e.g. the transdermal patch of Miwa in view of Shahid), based on its recognized suitability for its intended use (to obtain adhesion, which is necessary for the formation of a transdermal patch for transdermal delivery of an active agent). See MPEP 2144.07.
As to claim 4, the Durotak 87-4287 of Friedrich, paragraph 0314, is understood to read on the requirements of this claim. See the section above entitled “Claim Interpretation” in which this issue is explained in greater detail.
As to claim 7, the polyisobutylene of Friedrich, paragraph 0131, is understood to read on this requirement.
As to claim 8, Friedrich teaches BIO-PSA 7-4202 in paragraph 0139. This is understood to read on the claimed requirement. See the section above entitled “Claim Interpretation.”
Claim(s) 7-9 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miwa et al. (US 2021/0030724 A1) in view Shahid et al. (Drug Development and Industrial Pharmacy, Vol. 44 No. 12, 2018, pages 2061-2070), the combination further in view of Mohr et al. (US 2020/0085759 A1).
Claim(s) 7-9 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miwa et al. (US 2021/0030724 A1) in view of Shahid et al. (Drug Development and Industrial Pharmacy, Vol. 44 No. 12, 2018, pages 2061-2070) and Friedrich et al. (US 2015/0148759 A1), the combination further in view of Mohr et al. (US 2020/0085759 A1).
Miwa is drawn to a transdermal tizanidine drug delivery form. Shahid is also drawn to a transdermal tizanidine drug delivery form. See the rejection above over Miwa in view of Shahid. Both Miwa and Shahid teach the inclusion of an adhesive; see at least Miwa, paragraph 0041 and Shahid, page 2066, right column, first paragraph below figure 2. Friedrich teaches additional pressure-sensitive adhesives; see the rejection above over the combination of Miwa in view of Shahid and Friedrich.
For the purposes of this rejection, the examiner understands that neither Miwa, Shahid, nor Friedrich teach the polysiloxane required by claim 8 nor the polyisobutylene mixture required by claim 9 in the required layer.
Mohr et al. (hereafter referred to as Mohr) is drawn to a transdermal therapeutic drug delivery system comprising a self-adhesive layer, as of Mohr, title and abstract. Mohr teaches the presence of polsiloxanes and polyisobutylenes in the same layer as the active agent, as of Mohr, item “B” in abstract, reproduced below.
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As such, Mohr teaches polysiloxanes and polyisobutylenes in the same layer as the drug in a transdermal therapeutic composition. The polysiloxanes and polyisobutylenes appear to be useful as pressure-sensitive adhesives, as of Mohr, paragraph 0147.
Mohr differs from the claimed invention because the therapeutic agent in Mohr differs from the claimed therapeutic agent.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the polysiloxanes and polyisobutylenes of Mohr into the transdermal therapeutic system of Miwa in view of Shahid, optionally in view of Friedrich. Miwa teaches adhesives, as of Miwa, at least paragraph 0041. The polysiloxane and polyisobutylenes of Mohr are pressure sensitive adhesives. As such, the skilled artisan would have been motivated to have combined the polysiloxanes and polyisobutylenes of Mohr with the system of Miwa in view of Shahid and optionally Friedrich in order to have predictably caused the transdermal system of Miwa in view of Shahid to have adhesive properties with a reasonable expectation of success. Generally, it is prima facie obvious to select a known material (e.g. the polysiloxanes and polyisobutylenes of Mohr) for incorporation into a composition (that of Miwa in view of Shahid), based on its recognized suitability for its intended use (as adhesives, which are desired by Miwa). See MPEP 2144.07.
As to claim 7, the polyisobutylene of the abstract of Mohr reads on the additional requirement of this claim.
As to claim 8, the material known as “BIO-PSA 7-4202” as taught by Mohr, paragraph 0283, is understood to meet the additional requirements of claim 8. See the section above entitled “Claim Interpretation” for a further description of issues related to this trade name.
As to claim 9, Mohr teaches the following as of paragraph 0288, which is reproduced in part below.
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The entirety of the teachings of paragraph 0288 of Mohr are understood to meet the requirements of instant claim 9.
As to claim 17, this claim is rejected for the same reason that claim 2 is rejected.
As to claim 18, this claim is rejected for the same reason that claim 9 is rejected.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights