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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-16 and 20-21) in the reply filed on September 24, 2025 is acknowledged. The traversal is on the ground(s) that a search burden does not exist since the methods of Groups II and III require all the limitations of Group I. This is not found persuasive because searching the additional inventions would require different search terms and consideration of the prior art under 35 U.S.C. 112.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim.
Status of Application
Receipt of the Preliminary Amendment dated July 22, 2022 is acknowledged.
Claims 1-21 are pending in this application.
Claims 1-19 have been amended.
Claims 20-21 are new.
Claims 17-19 are withdrawn from consideration based on the restriction requirement discussed above.
It is noted the preliminary amendment claims filed on July 22, 2025 is under examination. The claims filed on March 29, 2023 were submitted to as supplemental response to the notification of missing requirements.
Claims 1-16 and 20-21 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on July 22, 2024, August 29, 2024; October 8, 2024; December 6, 2024; April 29, 2025; and September 24, 2025 is acknowledged. Signed copies are attached to this office action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5, 7-8, 14-15, and 21 are rejected 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.
Regarding 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. The specification does not describe how the layer is “initially” active ingredient free and is a pressure sensitive adhesive layer only. Clarification is requested.
Further regarding 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. Therefore, there is not antecedent basis for “the at least one additional…” limitation.
Further regarding claim 14, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, 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. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 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 1-3, 6, 8-16, and 20-21 are rejected 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).
Breitenbach 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. The middle layer also comprises paraffin oil and a silicone adhesive, such as BIO-PSA 7-4101, BIO-PSA 7-4102, BIO-PSA 7-4201, BIO-PSA 7-4202, BIO-PSA 7-4301 and BIO-PSA 7-4302, which are amine-resistant.
Regarding claim 2, the oil (paraffin) can be present in the concentration in the silicone adhesive in the range of 0.01 to 10% by weight.
Regarding claim 3, the TTS has a total weight per unit at most 60 g / m2.
Regarding claim 10, as noted above, the active agent is disclosed to be rotigotine and can be amorphous or crystalline and can be mixed with polyvinylpyrrolidone.
Regarding claims 11-12, the at least one hygroscopic polymer is polyvinylpyrrolidone and the at least one hygroscopic polymer, preferably at least 25% by weight after saturation more preferably at least wt.% -35% based on its own weight. The instant claims differ from the references only in the specific percentage selected for the compositions. However, it would have been deemed prima Facie obvious to one having ordinary skill in the art at the time of the invention to optimize the hygroscopic polymer and active agent to prepare a device composition containing rotigotine having the optimum therapeutic effect is well within the level of one having ordinary skill in the art, and the artisan would be motivated to determine optimum amounts to get the maximum effect of the active compounds. Therefore, the invention as Whole has been prima face obvious to one of ordinary skill in the art at the time the invention was made.
Regarding claim 13, the TTS contains less than 9% of the active agent.
Regarding claim 16, antioxidants can be added to at least one of the layers, including the matrix layer.
Breitenbach does not disclose non-amine resistant adhesives.
Kanios discloses a transdermal drug delivery device for the controlled transdermal delivery of an active pharmaceutical agent. The device comprises a drug delivery device comprising an active pharmaceutical agent and a means for its controlled delivery through the skin; and (B) a silicone pressure sensitive adhesive for maintaining contact between the device and the skin of a wearer (abstract).
Kanios discloses pressure sensitive adhesive (PSA) compositions must contain a certain concentration of silicon bonded hydroxyl groups (silanol) to be useful for certain applications. Specifically, when silicone PSAs are used in transdermal drug delivery devices, the silanol content of the PSA must be adjusted based on the active pharmaceutical agent to ensure that the adhesive strength remains acceptable over time. When the silanol content of the adhesive is too high, the drug can cause the silanols to condense, resulting in increased shear of the adhesive and, thus, decreased adhesive strength. When the silanol content of the adhesive is too low, on the other hand, there is little crosslinking of the adhesive network and the materials is plasticized (softened) to too high a degree, thus resulting in unwanted flow (cold flow) (column 2, lines 35-50).
The silicone PSAs can be combined or blended with other adhesives including, for example, other silicone adhesives or other organic adhesives. These blends could be, for example, in weight ratios of silicone PSAs to other adhesives of 10:90 to 90:10 (column 15, lines 32-41).
Regarding claim 6, as noted above, weight ratios of silicone PSAs to other adhesives of 10:90 to 90:10, which is 10-90%.
Regarding claims 8 and 14-15, as noted above, the silicone PSAs can be combined or blended with other adhesives including, for example, other silicone adhesives or other organic adhesives. Since the silicone PSA CAN be combined, does not require the combination and could be a single species.
Regarding claim 9, silicone PSAs with well-defined silanol concentrations are often desired for certain drugs. The silanol concentration in these PSAs can be adjusted by chemically treating the resin copolymer, the polydiorganosiloxane, or the mixture of these materials. Likewise, the desired silanol concentration can be achieved by blending a PSA having a substantial silanol concentration with a PSA having a reduced silanol concentration as disclosed below (column 4, lines 30-38).
Regarding claims 20-21, as noted above, the paraffin can be present in the concentration in the silicone adhesive in the range of 0.01-10% by weight; the weight per unit area is dependent upon the thickness of the pressure adhesive layer thickness; weight ratios of silicone PSAs to other adhesives of 10:90 to 90:10, which is 10-90%.; the TTS contains less than 9% of the active agent (rotigotine).
Therefore, it would have been obvious to substitute the amine-resistant silicones for non-amine resistant silicones as taught by Kanios in order to achieve the desired properties, such as when silicone PSAs are used in transdermal drug delivery devices, the silanol content of the PSA must be adjusted based on the active pharmaceutical agent to ensure that the adhesive strength remains acceptable over time. When the silanol content of the adhesive is too high, the drug can cause the silanols to condense, resulting in increased shear of the adhesive and, thus, decreased adhesive strength. When the silanol content of the adhesive is too low, on the other hand, there is little crosslinking of the adhesive network and the materials is plasticized (softened) to too high a degree, thus resulting in unwanted flow (cold flow).
Claims 4-5 and 7 are rejected 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).
The teachings of Breitenbach and Kanios are discussed above.
The combination does not disclose an additional active ingredient free pressure sensitive adhesive layer.
Banerjee discloses transdermal drug delivery systems (TDDS) designed to deliver a therapeutically effective amount of a drug across the skin (abstract).
One example of the TDDS is a matrix system which is depicted as:
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Regarding claim 4, The matrix system comprises a drug layer of a semisolid matrix containing a drug solution or suspension in the adhesive (matrix systems). The adhesive properties of TDDS systems are fundamental to transdermal or dermal treatment. The entire delivery surface of the patch has to maintain complete skin contact for the required period to ensure an efficient drug delivery. For this reason, pressure sensitive adhesives (PSAs) will adhere to a substrate. Silicone based adhesives are used in the design of transdermal patches. (Section 7 PSA’s).
Regarding claim 5, the weight per unit area is dependent upon the thickness of the pressure sensitive adhesive layer. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. 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 In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Regarding claim 7, as noted above in Kanios, weight ratios of silicone PSAs to other adhesives of 10:90 to 90:10, which is 10-90%.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have added an adhesive layer as taught by Banerjee into the formulation configuration of Breitenbach since it is discloses TDDS/skin contact over the whole application period allows a consistent delivery and absorption of the drug. In other words, the quality of contact between patch and skin is directly reflected in the consistency of drug delivery.
Conclusion
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