DETAILED ACTION
The Office Action is in response to the Applicant's reply filed March 11, 2026 to the non-final rejection made on December 11, 2025.
Claims 1, 3-4, 6-16 are currently pending and are examined on the merits herein.
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 .
Priority
This Application filed on 11/18/2022 is a 371 of PCT/JP2021/018793 filed on 05/18/2021 which claims foreign priority to JAPAN 2020-087793 filed on 05/20/2020.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claim 5 is persuasive in view of cancellation of the claim. The rejection is herewith withdrawn.
Applicant’s arguments over the 35 U.S.C. 103 rejection over Tatsumi et al. (USPN 10,045,948 B2) in view of Durif et al. (USPN 5,939,094 A) of claims 1-15 is not persuasive. The rejection is herewith maintained. Applicant argues “an unexpected superior solubility of apomorphine in the claimed formulation. Specifically, Apparent from Table 1 of the present specification, for example, apomorphine solves just 0.25 weight% in propylene carbonate (CP) alone. Whereas, the claimed combinations of propylene carbonate and polyhydric alcohol result in the unexpectedly superior solubility of apomorphine. See Table 1 of the present specification. Such a dramatic improvement in solubility cannot be predicted from reading the cited references by those skilled in the art based on the properties of the individual solvent ingredients. Moreover, as MPEP § 2144.05 states, "Applicants can rebut a prima facie case of obviousness based on overlapping ranges by showing the criticality of the claimed range." With respect to dependent claim 16, Applicant submits that there is an unexpectedly superior increase of transdermal absorption from 10 weight% of apomorphine as shown in Figures 1 and 2 of the present specification. Accordingly, Applicants submit that the cited references do not render the presently claimed invention obvious.”
In response, the Examiner points out Applicant points to comparative data with specific amounts, while the claims broadly encompass any amounts of actives, with the proviso that the ratio of PEG and PPC are in a ratio range of 1:1-10:1. For example, FIG 1 and 2 rely on an apomorphine formulation in 10 weight% while claims are broad to any amounts or greater than 10%. Furthermore, the argument regarding the need for an ionic liquid for solubility, is not persuasive as the comprising language of the claims do not exclude addition agents.
The following rejections are made:
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.
Claims 1, 3-4, 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsumi et al. (USPN 10,045,948 B2) in view of Durif et al. (USPN 5,939,094 A).
Tatsumi et al. teaches a transdermal patch (tape) of pramipexole or pharmaceutically acceptable salt thereof a C14-C18 fatty acid-based ionic liquid, a divalent alcohol, a fatty acid ester, and a plastering material comprising an elastomer and/or tackifier, wherein the content of the C14-C18 fatty acid-based ionic liquid is at least 0.2 parts by weight based on a value of 1 for the amount of the plastering material used in the treatment of Parkinson's disease. The “C14-C18 fatty acid-based ionic liquid” refers to an equimolar salt of each of the fatty acids of myristic acid (C14), palmitic acid (C16), oleic acid (C18), isostearic acid (C18) and stearic acid (C18) and each of the alkanolamines of diethanolamine, diisopropanolamine, triethanolamine and triisopropanolamine; Tatsumi et al. teaches a mixture of two types of fatty acids consisting of isostearic acid and oleic acid (Reads on the organic acid of claim 9-10). The divalent alcohol is one or more divalent alcohols selected from propylene glycol, polyethylene glycol and 1,3-butanediol (reads on the polyhydric alcohol of claim 6). The fatty acid ester is one or more fatty acid esters selected from diethyl sebacate, isopropyl myristate, propylene carbonate and diisopropyl adipate. Examples of antioxidants include organic antioxidants such as BHT, propyl gallate or sodium ascorbate, and inorganic antioxidants such as sodium thiosulfate, sodium bisulfite, sodium sulfite or sodium pyrosulfite (reads on the antioxidant of claim 7-8). The content of the fatty acid-based ionic liquid of the invention of the present application based on a value of 1 for the amount used of the active ingredient in the form of pramipexole is preferably 1.0 times or more from the viewpoint of pramipexole solubility and percutaneous absorption, and preferably 20 times or less in consideration of usage limitations, preparation formulation and the like in the Japanese Pharmaceutical Excipients Directory. The amount of the fatty acid-based ionic liquid used is more preferably 4 times to 16 times based on a value of 1 for the amount used of the active ingredient in the form of pramipexole.
The reference does not specify the active apomorphine as claimed.
Durif et al. teaches a water-soluble gel compositions that contain apomorphine, optionally together with a permeation enhancer, or transdermal patches (abstract). The reference teaches transdermal patches are typically held in contact with the skin by means of a pressure-sensitive adhesive layer and are left in place for a period of 24 hours or longer for the continuous controlled transdermal administration of drugs.
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange pramipexole with apomorphine. The motivation to interchange pramipexole with apomorphine is because Durif et al teaches apomorphine are used in transdermal patches are typically held in contact with the skin by means of a pressure-sensitive adhesive layer and are left in place for a period of 24 hours or longer for the continuous controlled transdermal administration of drugs as a dosage form that are easy to use and are well suited to the abilities of a patient with Parkinson's disease . Therefore, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. With respect to the amount of claim 16, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(1)) Moreover, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(Il)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 14-15 recite the intended use of the transdermal patch for Parkinson’s disease. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003)
Conclusion
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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