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 .
Status of Application
Receipt of the Applicants’ remarks and amended claims filed on June 20, 2026, is acknowledged.
Claims 1-9 and 11-21 are pending in this application.
Claims 1, 4, 5, 7-8, 11-12, 14-15, and 21 have been amended.
Claim 10 has been cancelled.
Claims 17-19 are withdrawn from consideration per the restriction requirement dated July 24, 2025.
Claims 1-9, 11-16 and 20-21 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on March 3, 2026, is acknowledged. A signed copy is attached to this office action.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 4-5, 7-8, 14-15, and 21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because:
claims 4-5, 7-8, 14-15, and 21, the claims recite “at least one additional, initially active ingredient free pressure sensitive adhesive layer (3)”, however, it is unclear what the recitation of “initially active ingredient free” is intended to convey has been withdrawn in view of the amendment to claim 4 to recite “said system further comprises at least one additionally layer disposed between… wherein the at least one additional layer is free from active ingredients”;
claims 8 and 14-15, the recitation of “if present, the at least one additional, initially active ingredient-free, pressure sensitive adhesive layer (3)”, the initially active ingredient-free, pressure sensitive adhesive layer (3), is not included until claim 4 since the rejected claims depend from claim 1 has been withdrawn in view of the amendment to the claim dependency, however, Applicant is directed to the new 112(d) rejection below;
additionally in claim 14, the claim recites the broad recitation “one or more non-amine-resistant, pressure sensitive silicone adhesives of the matrix layer, and the claim also recites preferably one or more of the non-amine-resistant, pressure adhesive sensitive silicone adhesive have a medium tack and one or more of the non-amine-resistant, pressure sensitive silicone adhesives have a high tack” which is the narrower statement of the range/limitation has been withdrawn in view of the amendment to the claim to delete the “preferably” language from the claim.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 6, 8-16, and 20-21 under 35 U.S.C. 103 as being unpatentable over Breitenbach et al. (WO 2014198423) in view of Kanios et al. (US 6,337,086) has been withdrawn in view of the arguments regarding Breitenbach’s distinct layer system between the adhesive layer and the active drug layer and the lack of a teaching of amine and non-amine resistant silicone polymers employed transdermal system. Applicants’ arguments regarding unexpected properties is also noted.
The rejection of claims 4-5 and 7 under 35 U.S.C. 103 as being unpatentable over Breitenbach et al. (WO 2014198423) in view of Kanios et al. (US 6,337,086) as applied to claim 1-3, 6, and 8-16, and further in view of Banerjee et al. (Aspect of adhesive in transdermal drug delivery systems, Internation Journal of Adhesion & Adhesives 50 (2014) 70-84) has been withdrawn in view of the arguments regarding Breitenbach’s distinct layer system between the adhesive layer and the active drug layer and the lack of a teaching of amine and non-amine resistant silicone polymers employed transdermal system. Applicants’ arguments regarding unexpected properties is also noted.
Newly Applied Objection/Rejections
Claim Objections
Claims 14 are objected to because of the following informalities: the claim recites “at least one of said layers has a medium tack and at least one another of said layers has a high tack.”, however this does not read well. It is suggested the claim be amended to recite “at least one of said layers has a medium tack and the other of said layers has a high tack.” . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8, 14, and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim has been amended to depend from claim 4. Claim 4 requires the additional layer, however, claims 8 and 14-15 state “and if present, the at least one additional layer”, thereby indicating the additional layer is optional. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
The claims are free of the prior art. The closest prior art is that of Breitenbach et al. (WO 2014198423) which discloses a three-layer transdermal therapy system comprising rotigotine. The system comprises a backing layer and a protective layer. The middle layer comprises the active substance (rotigotine). The rotigotine is mixed with a hygroscopic polymer such as polyvinylpyrrolidone. As noted in the Applicant remarks dated June 30, 2026, Breitenbach does not disclose a matrix layer comprises a silicone adhesive or paraffin. Additionally, Breitenbach does not provide any distinction between amine containing and non-amine containing silicone adhesives. The instant specification, as noted by Applicant in the remarks filed on June 30, 2026, provides unexpected properties with the addition of paraffin regarding improved adhesion, suppression of rotigotine recrystallization, and enhanced permeation efficacy.
Conclusion
Applicants’ 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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