DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 19 September 2025 has been entered.
Status of the Claims
Claims 1-13 and 15-18 are pending in the present application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 September 2025 was filed with the RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The rejection of claims 1-11 and 15-18 under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Loubert et al. (US 8,124,689); the rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Loubert et al. (US 8,124,689) as applied to claims 1-11 and 15-18 above, further in view of Hahn et al. (US 3,983,298); and the rejection of claim 13 under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Loubert et al. (US 8,124,689) as applied to claims 1-11 and 15-18 above, further in view of Aliyar et al. (US 2015/0196515 A1) are overcome in view of the amendment to delete buprenorphine and limit the instant claims to the active agent being rivastigmine. As noted by Applicant, Colas et al., Loubert et al., Hahn et al., and Aliyar et al. are silent on rivastigmine as an active ingredient.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating or delaying of progression of Alzheimer’s disease, dementia associated with Parkinson’s disease, and/or symptoms of traumatic brain injury, does not reasonably provide enablement for treating any disease in a human patient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the nature of the invention
2) the state of the prior art
3) the relative skill of those in the art
4) the predictability of the art
5) the breadth of the claims
6) the amount of direction or guidance provided
7) the presence or absence of working examples
8) the quantity of experimentation necessary
The instant specification fails to provide guidance that would allow the skilled artisan to practice the instant invention without resorting to undue experimentation, as discussed in the subsections set forth herein below.
The nature of the invention
The claimed invention relates to a method of treating a disease in a human patient, the method comprising applying a TTS according to claim 1 to the skin of the patient in need thereof for at least 24 hours, wherein the active agent is rivastigmine.
The state of the prior art
Rivastigmine is known for the treatment of Alzheimer’s disease, dementia associated with Parkinson’s disease, and symptoms of traumatic brain injury. See instant specification, para. [0240], [0242], etc.
The relative skill of those in the art
A person of ordinary skill in the art would know that rivastigmine is suitable for the treatment of dementia associated with Alzheimer’s disease and Parkinson’s disease, and symptoms of traumatic brain injury.
The predictability of the art
A person of ordinary skill in the art would not be able to predict the efficacy of a TTS comprising rivastigmine as the active agent for the treatment of diseases other than those noted above.
The breadth of the claims
The claims are broadly drawn to treating any disease in a human patient, which broadly includes diseases that are not known to be treatable with rivastigmine.
The amount of direction or guidance provided
The instant specification teaches that the TTS comprising rivastigmine is suitable for treating or delaying of progression of Alzheimer’s disease, dementia associated with Parkinson’s disease, and/or symptoms of traumatic brain injury.
The presence or absence of working examples
The instant specification provides examples of TTS comprising rivastigmine as the active ingredient and skin permeation studies, but does not provide examples of treatment of diseases in human patients.
The quantity of experimentation necessary
It would require undue experimentation to determine which diseases other than those discussed above that can be effectively treated with the TTS according to claim 1 comprising rivastigmine as active agent.
Therefore, for the aforementioned reasons, the Applicant is enabled for treating or delaying of progression of Alzheimer’s disease, dementia associated with Parkinson’s disease, and/or symptoms of traumatic brain injury, but is not reasonably enabled for treating any disease in a human patient.
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.
Claims 1-2, 4-11 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Frank et al. (US 2014/0134230 A1).
Regarding instant claim 1, Colas et al. teach a construction (i.e., transdermal therapeutic system) comprising an external film layer (i.e., backing layer), a pressure sensitive adhesive (PSA) that has been blended with a therapeutic concentration of a pharmaceutical active ingredient, and a silicone gel adhesive (SGA) (Abstract; [0008]-[0009]; Examples 1-20; Claim 1). The SGA is a skin contacting adhesive ([0002], [0004], [0047]), and the PSA comprises silicone PSAs ([0015]-[0023]). Colas et al. teach that the useful active agents include drugs having an action on the central nervous system and drugs for Parkinson’s disease ([0052]).
Colas et al. do not explicitly disclose the active agent rivastigmine.
Frank et al. teach transdermal therapeutic systems comprising a silicone adhesive layer and rivastigmine for the treatment of patients with mild to moderately severe dementia of the Alzheimer type (also known as Alzheimer's Disease), dementia associated with Parkinson's disease and symptoms of traumatic brain injury ([0038], [0053], [0067]-[0070], etc.; Claims 1-12).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare transdermal systems according to Colas et al. wherein the active agent included within the PSA is a drug having an action on the central nervous system or drugs for Parkinson’s disease, such as rivastigmine. Such would have been obvious because Colas et al. and Frank et al. both teach a TTS for delivery of active agents, wherein the active agents include drugs having an action on the central nervous system and drugs for Parkinson’s disease.
Regarding instant claim 2, Colas et al. do not explicitly disclose an example comprising a silicone PSA comprising a silicone acrylic hybrid, a polymer blend of a silicone-based polymer and an acrylic polymer, a polymer blend of a silicone acrylic hybrid polymer and a silicone-based polymer, or a polymer blend of a silicone acrylic hybrid polymer and an acrylic polymer, as instantly claimed.
However, Colas et al. teach that the silicone PSAs generally comprise the product of (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. A type of silicone PSA comprises a PSA produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin and a silicon-containing capping agent wherein the silicon-containing capping agent includes acrylates. Another type of silicone PSA is a reaction product of a silicon-containing PSA, an ethylenically unsaturated monomer and an initiator. Typically, the silicon-containing PSA is produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. The ethylenically unsaturated monomer can be acrylates and methacrylates ([0015]-[0023]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Colas et al. comprising a silicone PSA that is a silicone acrylic hybrid polymer. Such would have been obvious because Colas et al. teach that a type of silicone PSA comprises a PSA produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin and a silicon-containing capping agent wherein the silicon-containing capping agent includes acrylates; and another type of silicone PSA is a reaction product of a silicon-containing PSA, an ethylenically unsaturated monomer and an initiator. Typically, the silicon-containing PSA is produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. The ethylenically unsaturated monomer can be acrylates and methacrylates ([0015]-[0023]).
Regarding instant claim 4, Colas et al. teach that the silanol-terminated polydiorganosiloxane and silanol-containing silicone resin are typically mixed together. The silanol groups of the polydiorganosiloxane generally undergo some condensation with the silanol groups of the silicone resin such that the polydiorganosiloxane is crosslinked with the resin ([0018], [0064]-[0069]).
Regarding instant claims 5-9, Colas et al. teach that the silicone PSAs generally comprise the product of (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. A type of silicone PSA comprises a PSA produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin and a silicon-containing capping agent wherein the silicon-containing capping agent includes acrylates. Another type of silicone PSA is a reaction product of a silicon-containing PSA, an ethylenically unsaturated monomer and an initiator. Typically, the silicon-containing PSA is produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. Typically the ethylenically unsaturated monomer can be aliphatic acrylates, aliphatic methacrylates, cycloaliphatic acrylates, cycloaliphatic methacrylates, and combinations thereof ([0015]-[0023]).
Regarding the number of carbon atoms in the alkyl radical, a person of ordinary skill in the art would have been able to determine through routine experimentation the appropriate alkyl group size for the aliphatic (meth)acrylates and cycloaliphatic (meth)acrylates according to Colas et al. that would be suitable for producing the PSA with effective adherence to the substrate.
Regarding instant claim 10, Colas et al. do not explicitly disclose a continuous external phase and a discontinuous internal phase.
However, Colas et al. teach silicone acrylic hybrid polymers, wherein the PSA is a reaction product of a silicon containing PSA, an ethylenically unsaturated monomer and an initiator ([0023]). As evidenced by the instant specification, silicone acrylic hybrid polymers necessarily comprise a continuous external phase and a discontinuous internal phase, wherein the solvent helps control which phase is the continuous phase and which phase is the discontinuous phase. Therefore, the silicon PSA according to Colas et al. will necessarily also possess either a silicone continuous phase and an acrylic discontinuous phase, or an acrylic continuous phase and a silicone discontinuous phase.
Regarding instant claim 11, Colas et al. teach compositions comprising silicone gel adhesives prepared by reacting vinyl-terminated polydimethylsiloxane with hydrogen-functional dimethylsiloxane in the presence of a platinum catalyst ([0070]-[0071]; Examples 1-20).
Regarding instant claim 15, Colas et al. teach a release liner on the SGA to cover and protect the SGA ([0049]). Colas et al. teach examples of release liners applied to the SGA (Examples 1-20).
Regarding instant claim 16, Colas et al. teach that the active agents useful in their construction are suitable for treating various diseases ([0052]).
Regarding instant claim 17, Colas et al. do not explicitly disclose an example comprising applying a release liner to the SGA opposite the low density film, followed by removing the low density film prior to adhering to the active agent-containing PSA.
However, Colas et al. teach forming the active agent-containing PSA on a release liner and drying, followed by laminating the active agent-containing PSA with a backing material and removing the release liner. In a separate operation the SGA is formed on a film. The active agent-containing PSA layer is then laminated onto the SGA layer using a hydraulic press, and the film is removed from the surface of the SGA to expose a skin facing surface (Examples 1-20). Colas et al. further teach that the process for manufacturing the construction comprises forming the SGA on a release liner or applying a liner over the SGA after it is formed ([0056]-[0059]).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to form the SGA on a foil/film, apply a release liner to the SGA, remove the foil/film, and then contact the SGA to the active agent-containing PSA. Such would have been obvious because Colas et al. teach prepare the active agent-containing PSA and applying it to a backing layer, and separately forming the SGA on a film or the release liner, followed by contacting the SGA with the active agent-containing PSA.
Response to Arguments
Applicant's arguments filed 19 September 2025 have been fully considered. Applicant argued that Colas et al. is silent on rivastigmine as an active ingredient.
The examiner respectfully argues that Frank et al. teach a TTS comprising rivastigmine for the treatment of patients with mild to moderately severe dementia of the Alzheimer type (also known as Alzheimer's Disease), dementia associated with Parkinson's disease and symptoms of traumatic brain injury ([0038], [0053], [0067]-[0070], etc.; Claims 1-12). It would have been prima facie obvious for a person of ordinary skill in the art to prepare a TTS according to Colas et al. wherein the active agent is rivastigmine. Frank et al. teach that TTS comprising rivastigmine increase efficacy and tolerability, and improves compliance ([0008]-[0010], [0075]-[0081], [0089]-[0090]). Therefore, a person of ordinary skill in the art would have been motivated to prepare the TTS according to Colas et al. wherein the active agent is rivastigmine.
Applicant further argues that their TTS exhibits unexpected technical effect. Applicant asserts that similar or even higher cumulative permeation of rivastigmine was observed from the presently claimed rivastigmine TTS (Examples 1-4) when compared to a commercial rivastigmine patch, Exelon® (Comparative Example 1; Fig. 1-2).
The examiner respectfully argues that Frank et al. teach that a TTS comprising a silicone gel adhesive does not change the release profile of the active ingredient ([0007]). Frank et al. teach that tests with active ingredients for the treatment of Alzheimer's disease have surprisingly shown that a line of silicone adhesive can be applied to a poorly adhesive reservoir matrix, thus significantly increasing the adhesive properties of the preparation without affecting the thermodynamic properties of the TTS, i.e. without reducing the release of active ingredient from the matrix and its permeation through the skin ([0017], [0020]). Therefore, a person of ordinary skill in the art would reasonably expect the silicone gel adhesive to provide adequate adhesive properties without affecting the release of rivastigmine.
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Frank et al. (US 2014/0134230 A1) as applied to claims 1-2, 4-11 and 15-17 above, further in view of Loubert et al. (US 8,124,689).
Regarding instant claim 3, Colas et al. teach that another type of silicon PSA that can be used are those described in U.S. patent application Ser. No. 12/303,362. In particular this PSA is a reaction product of a silicon containing PSA, an ethylenically unsaturated monomer and an initiator. Typically, the silicon containing PSA is PSA produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin. The ethylenically unsaturated monomer can be any monomer having at least one carbon-carbon double bond. Typically, the ethylenically unsaturated monomer is a compound selected from the group of aliphatic acrylates, aliphatic methacrylates, cycloaliphatic acrylates, cycloaliphatic methacrylates, and combinations thereof ([0023]).
Colas et al. do not explicitly disclose that the ethylenically unsaturated monomer comprises one or more monomers selected from the group consisting of acrylic acid, butylacrylate, 2-ethylhexylacrylate, glycidylmethacrylate, 2-hydroxyethylacrylate, methylacrylate, methylmethacrylate, butylmethacrylate, t-octylacrylamide, and vinylacetate.
However, Colas et al. teach that in particular this silicone PSA contains 85 parts to 99.9 parts by weight of a PSA produced from (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin as described above and 0.1 parts to 15 parts by weight of a silicon-containing capping agent wherein the silicon-containing capping agent is selected from the group of acrylate functional silanes, acrylate functional silazanes, acrylate functional disilazanes, acrylate functional disiloxanes, methacrylate functional silanes, methacrylate functional silazanes, methacrylate functional disilazanes, methacrylate functional disiloxanes and combinations thereof ([0022]). Another type of silicon PSA that can be used is a reaction product of a silicon containing PSA, an ethylenically unsaturated monomer and an initiator. The ethylenically unsaturated monomer can be any monomer having at least one carbon-carbon double bond. Typically, the ethylenically unsaturated monomer is a compound selected from the group of aliphatic acrylates, aliphatic methacrylates, cycloaliphatic acrylates, cycloaliphatic methacrylates, and combinations thereof ([0023]). Colas et al. teach adhesives 7-4301, 7-4102, 7-4501, 7-4202, 7-4302 and 7-4502 ([0064]-[0069]). The instant specification teaches that suitable silicon-based PSA include BIO-PSA series (7-4100, 7-4200, 4300 and 7-4500) ([0180]-[0183]).
Frank et al. teach that the polymer in the reservoir layer includes polydimethylsiloxanes and polyacrylates ([0039]).
Loubert et al. teach a silicone acrylate hybrid composition that is the reaction product of a silicon-containing pressure sensitive adhesive composition comprising acrylate or methacrylate functionality, an ethylenically unsaturated monomer, and an initiator (col. 1, ln. 7-16; col. 4, ln. 8-40; Claims; etc.). Loubert et al. teach that the aliphatic acrylates that may be selected as one of the ethylenically unsaturated monomers are selected from the group consisting of methyl acrylate, ethyl acrylate, propyl acrylate, n-butyl acrylate, iso-butyl acrylate, tert-butyl acrylate, hexyl acrylate, 2-ethylhexyl acrylate, iso-octyl acrylate, iso-nonyl acrylate, iso-pentyl acrylate, tridecyl acrylate, stearyl acrylate, lauryl acrylate, and mixtures thereof. The aliphatic methacrylates that may be selected as one of the ethylenically unsaturated monomers are selected from the group consisting of methyl methacrylate, ethyl methacrylate, propyl methacrylate, n-butyl methacrylate, iso-butyl meth acrylate, tert-butyl methacrylate, hexyl methacrylate, 2-ethylhexyl methacrylate, iso-octyl methacrylate, iso-nonyl methacrylate, iso-pentyl methacrylate, tridecyl methacrylate, stearyl methacrylate, lauryl methacrylate, and mixtures thereof. The cycloaliphatic acrylate that may be selected as one of the ethylenically unsaturated monomers is cyclohexyl acrylate, and the cycloaliphatic methacrylate that may be selected as one of the ethylenically unsaturated monomers is cyclohexyl methacrylate. Certain other monomers, described herein as polar monomers, include, but are not limited to, acrylic acid, vinyl acetic acid and hydroxy ethyl acrylate (col. 12, ln. 35 to col. 13, ln. 12; col. 22, ln. 42-60; Examples).
Therefore, it would have been prima facie obvious to prepare a PSA according to Colas et al. wherein the PSA comprises a silicone containing PSA and an ethylenically unsaturated monomer, wherein the ethylenically unsaturated monomer is at least one including aliphatic acrylates, aliphatic methacrylates, cycloaliphatic acrylates, cycloaliphatic methacrylates, and combinations thereof, including the acrylates taught by Loubert et al.
Regarding instant claim 18, Colas et al. teach that the PSA is a reaction product of a silicon containing PSA, an ethylenically unsaturated monomer and an initiator, wherein the ethylenically unsaturated monomer includes aliphatic acrylates, aliphatic methacrylates, cycloaliphatic acrylates, cycloaliphatic methacrylates, and combinations thereof ([0023]).
Colas et al. do not explicitly disclose that the ethylenically unsaturated monomer is a combination of 2-ethylhexyl acrylate and methyl acrylate in a ratio of from 40:60 to 70:30.
Loubert et al. teach that the aliphatic acrylates include 2-ethylhexyl acrylate and methyl acrylate (col. 12, ln. 35 to col. 13, ln. 12; col. 22, ln. 42-60). Loubert et al. also teach examples comprising a combination of 2-ethylhexyl acrylate and methyl acrylate in a ratio of ~3:1, ~2.3:1, or ~1:1 (Example 12-28).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare PSA according to Colas et al. and Loubert et al. wherein the ethylenically unsaturated monomer is a combination of 2-ethylhexyl acrylate and methyl acrylate in a ratio of ~3:1, ~2.3:1, or ~1:1.
Response to Arguments
Applicant's arguments are the same as above. Therefore, the examiner’s response is repeated here as well.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Frank et al. (US 2014/0134230 A1) as applied to claims 1-2, 4-11 and 15-17 above, further in view of Hahn et al. (US 3,983,298).
Regarding instant claim 12, Colas et al. do not explicitly disclose an SGA comprising reacting a copolymer of vinylmethylsiloxane and dimethylsiloxane with methylhydrogen polysiloxane with trimethylsilyl end groups in the presence of a platinum catalyst.
However, Colas et al. teach SGA obtained by reacting a gel producing composition comprising (A) at least one alkenyl-substituted polydiorganosiloxane, (B) at least one organosiloxane containing silicon-bonded hydrogen atoms, and (C) at least one catalyst. Colas et al. teach that the alkenyl group comprise vinyl, and the remaining silicon-bonded organic groups in the alkenyl-substituted polydiorganosiloxane include methyl, wherein at least 50 percent of the organic groups in the alkenyl-substituted polydiorganosiloxane are methyl ([0027]-[0028]). Colas et al. teach that alkenyl-substituted polydiorganosiloxanes (A) and the organosiloxane containing silicon-bonded hydrogen atoms (B) are known in U.S. Pat. No. 3,983,298).
Hahn et al. teach polyorganosiloxane compositions that are curable to produce pressure sensitive adhesives, wherein the compositions comprise a vinyl endblocked polydiorganicsiloxane, an organopolysiloxane having silicon bonded hydrogen atoms, and a platinum catalyst (col. 2, ln. 1-19). Hahn et al. specifically teach examples comprising vinyl endblocked polydimethylsiloxane and an organopolysiloxane fluid comprising trimethylsiloxane units, dimethylsiloxane units and methylhydrogensiloxane units (Example 2; Claim 5).
Therefore, it would have been prima facie obvious to prepare SGA according to Colas et al. comprising reacting a gel producing composition comprising a copolymer of vinylmethylsiloxane and dimethylsiloxane with methylhydrogen polysiloxane with trimethylsilyl endgroups in the presence of a platinum catalysts, as reasonably suggested by Colas et al. and Hahn et al.
Response to Arguments
Applicant's arguments are the same as above. Therefore, the examiner’s response is repeated here as well.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Colas et al. (US 2012/0135225 A1) in view of Frank et al. (US 2014/0134230 A1) as applied to claims 1-2, 4-11 and 15-17 above, further in view of Aliyar et al. (US 2015/0196515 A1).
Regarding instant claim 13, Colas et al. do not explicitly disclose a silicate resin-reinforced SGA that contains from about 2 to about 45% by weight of at least one hydroxyl substituted silicate resin.
However, Aliyar et al. teach a multi-layer transdermal delivery system comprising a backing layer, a drug-loaded layer, a permeable or semi-permeable support substrate, a non-drug loaded silicone gel adhesive layer, and a release liner ([0010]-[0014]; Claim 1). The drug-loaded layer may be a non-curing silicone pressure sensitive adhesive, such as a silicone acrylic hybrid ([0035]-[0048]). The non-drug loaded silicone gel adhesive layer may include a silicone resin-reinforced SGA that includes between about 2 to about 45 percent by weight of at least one hydroxyl substituted siloxane resin ([0060]; Claim 10).
Aliyar et al. teach examples of compositions comprising a backing layer (i.e., SCOTCHPAK® 1022 and SCOTCHPAK® 8038), a drug-loaded silicone containing layer (ibuprofen or estradiol and PSA-1 or PSA-2), a support substrate, a non-drug loaded silicone gel adhesive layer (SGA-1 or SGA-2), and a release liner (Examples 3-22). Aliyar et al. teach that silicone PSAs useful hereby generally comprise the product of (I) a silanol-terminated polydiorganosiloxane crosslinked with (II) a silanol-containing silicone resin ([0038]).
Aliyar et al. also teach that SGA-1 is a two part curing adhesive including a part A produced by blending 99.72 wt.% vinyl-terminated polydimethylsiloxane with 0.280 wt.% platinum complex and a part B produced by blending 98.78 wt.% vinyl-terminated polydimethylsiloxane, 1.19 wt.% hydrogen-functional polydimethylsiloxane and 0.030 wt.% inhibitor. SGA-2 is a two-part high adhesion elastomeric silicone adhesive ([0114]-[0115]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare compositions according to Colas et al. wherein the SGA comprises from about 2 to about 45% by weight of at least one hydroxyl substituted silicate resin, as reasonably suggested by Aliyar et al. Such would have been obvious because a person of ordinary skill in the art would have been motivated to use a known silicone gel adhesive according to Aliyar et al. having sufficient properties for use in a transdermal patch.
Response to Arguments
Applicant's arguments are the same as above. Therefore, the examiner’s response is repeated here as well.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616