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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 02/26/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 1-3, 5, 7-9 are pending and under examination.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Scasso et al. (US20190117585) in view of Inoo et al. (US20170231959) and Venkateshwaran et al. (US5783208).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Scasso et al. teaches A device for the transdermal administration of Buprenorphine, which comprises an adhesive matrix, a backing layer and release liner, where such adhesive matrix supports a non-crosslinked adhesive acrylic polymer without carboxylic functionality, Buprenorphine Base, Levulinic Acid and Isopropyl Myristate (abstract). Therefore, it is an aim of the present invention, a device for the transdermal administration of Buprenorphine, which comprises an adhesive matrix, a backing layer and a release liner, in which that adhesive matrix comprises a non-crosslinked adhesive acrylic polymer, without carboxylic functionality, Buprenorphine Base, Levulinic acid and Isopropyl Myristate, preferably where the Buprenorphine Base is found in a concentration less than or equal to 8% by weight of the total dry weight of said adhesive matrix, where the Levulinic acid is found in a concentration from about 5% to about 10% by weight of the total dry weight of said adhesive matrix and where the Isopropyl Myristate is found in a concentration from about 5% to about 10% regarding the total dry weight of the adhesive matrix ([0032]). In a particular embodiment of the invention, a device for the transdermal administration of Buprenorphine of the above mentioned characteristics, where such adhesive matrix includes a non-crosslinked adhesive acrylic polymer without carboxylic functionality, which, preferably, is a polymer with hydroxyl functionality. In other particular embodiment, such non-crosslinked adhesive acrylic polymer, without carboxylic functionality, is a non-functional polymer. In a specially preferred embodiment, such non-crosslinked adhesive acrylic polymer, without carboxylic functionality is selected from the adhesives Duro-Tak 87-900A, 87-901A, 87-9301, 87-4098, 87-9088, 87-2510, 87-208A, 87-2287 and 87-4287 ([0033]). In working example, the concentration of Buprenorphine Base is from 4% to 10% by weight and DT 87-4287 is ued ([0068]).
Inoo et al. teaches transdermal patch with adhesive layer (abstract). The adhesive solution was spread over a release-treated film, and the solvent was removed by drying to form an adhesive layer having a thickness of 60 to 70 μm. Then a support was placed on the adhesive layer to press-bond and transferred the adhesive layer, whereby a patch was obtained ([0081]). Adhesive polymer includes Duro-tak 87-4287 (2-ethylhexyl acrylate/vinyl acetate/2-hydroxyethyl acrylate copolymer) and Ethylhexyl acrylate/vinylpyrrolidone copolymer ([0084]).
Venkateshwaran et al. teaches A matrix type transdermal patch for coadministering estradiol and another steroid wherein the matrix is composed of a N-vinyl-2-pyrrolidone-containing acrylic copolymer pressure sensitive adhesive, estradiol, the other steroid, and optionally a permeation enhancer, and the respective fluxes of estradiol and the other steroid from the matrix are independent of the respective concentrations of the other steroid and estradiol in the matrix (abstract). The pressure sensitive adhesive copolymer component of the matrix is a NVP (N-vinyl-2-pyrrollidone)-containing acrylic copolymer. The NVP constitutes 5 to 50 mol % with other acrylic monomers comprising 40 to 95 mol%. Other monomers typically used in acrylic copolymer adhesives are described in the Back ground section, EPA 893.10350.7 for example discloses a copolymer of NVP and EHA (2-ethylhexylacrylate). The EHA constitutes 45 to 80 mol%. preferably 55 to 70 mol% of the copolymer whereas NVP constitutes 20 to 55 mol %, preferably 30 to 45 mol % of the copolymer (column 1, line 25-42; column 3, line 46-57).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Scasso et al. is that Scasso et al. do not expressly teach Ethylhexyl acrylate/vinylpyrrolidone copolymer. This deficiency in Ethylhexyl acrylate/vinylpyrrolidone copolymer is cured by the teachings of Inoo et al. and Venkateshwaran et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Scasso et al., as suggested by Inoo et al. and Venkateshwaran et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to replace Ethylhexyl acrylate/vinylpyrrolidone copolymer for Duro-tak 87-4287 (2-ethylhexyl acrylate/vinyl acetate/2-hydroxyethyl acrylate copolymer) because this is simple substitution of one known adhesive polymer for another to obtain predictable results. MPEP 2143, it is prima facie obviousness for simple substitution of one known element for another rto obtain predictable results. Under guidance from Inoo et al. teaching both Ethylhexyl acrylate/vinylpyrrolidone copolymer and Duro-tak 87-4287 (2-ethylhexyl acrylate/vinyl acetate/2-hydroxyethyl acrylate copolymer) as adhesive polymer for patch, Venkateshwaran et al. teaching N-vinyl-2-pyrrolidone-and 2-ethylhexyl acrylate copolymer as acrylate adhesive for patch; it is obvious for one of ordinary skill in the art to replace N-vinyl-2-pyrrolidone and 2-ethylhexyl acrylate copolymer for Duro-tak 87-4287 ( 2-ethylhexyl acrylate/vinyl acetate/2-hydroxyethyl acrylate copolymer) and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3, 5, 7-9, prior art teaches transdermal device comprising a back layer and an adhesive matrix comprising 4%-10% of Buprenorphine, about 5% to about 8% of levulinic acid and acrylic adhesive N-vinyl-2-pyrrolidone-and 2-ethylhexyl acrylate copolymer. Vinylpyrrolidone has solubility parameter 9.7 (cal/cm3)1/2, ethylhexyl acrylate has solubility parameter less than 7.8 (cal/cm3)1/2 according to applicant’ specification ([0046, 0057]). As a transdermal device, adhesive matrix (layer) is coated (integrally laminated) on the backing layer of the transdermal device. Furthermore, Inoo et al. teaches adhesive layer is bonded to support (backing layer).
Regarding the limitation of 5-10% of N-vinyl-2-pyrrolidone and 90-95% of 2-ethylhexyl acrylate, Venkateshwaran et al. teaches 2-ethylhexyl acrylate (other acrylic monomer) constitutes 40 to 95 mol % of the copolymer and the N-vinyl-2-pyrrolidone constitutes 5-50 mol % of the copolymer, when N-vinyl-2-pyrrolidone is 10% mol and 2-ethylhexyl acrylate is 90% mol, the amount of N-vinyl-2-pyrrolidone (MW 111.14) is 111.14 x0.1 g= 11.11g and the amount of 2-ethylhexyl acrylate (MW184.28) is 184.28x0.9g=165.85g for 1 mol of copolymer. Thus, the percentage by mass of N-vinyl-2-pyrrolidone is 11.11/(11.11+165.85)=6.3%, the percentage by mass of 2-ethylhexyl acrylate is 147.42 /(147.42+22.23)=93.7%, inside claimed range.
Regarding the mass ratio of levulinic acid to Buprenorphine; Levulinic acid at about 5% to about 10%; and Buprenorphine 8% or less preferably and 4% to 10% in general. The term “about 5% to about 8%” can be broadly interpreted as to encompassing 4% and 4.5%, because use of the word 'about' in a prior art is appropriate where the prior ar contains a range of components with no absolute boundaries, and is only limited to the extent that prior art exists which would limit broad interpretation. See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1217-1218, 18 USPQ2d 1016 (Fed. Cir. 1991). In the instant case, there is no prior art teaching that would limit the range recited solely to between 5% and 8%. Accordingly, the range recited by prior art is interpreted broadly. Thus, “about 5% to about 8%” reasonably encompasses 4% and 4.5%. When Levulinic acid is at 4.5% and Buprenorphine is 8%, the mass ratio of Levulinic acid and Buprenorphine is 4.5% / 8% = 0.56, inside claimed range.
Regarding claim 2, Buprenorphine has amine structure
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to argument:
Applicants argue about unexpected results for examples 6-10.
In response to this argument: this is not persuasive. Applicant’s data are not sufficient to overcome the 103 rejection at least for the following reasons. Firstly, applicants od not have sufficient data in or out of claimed range to prove criticality. For example, there is no data about 12:88 and 4:96 to prove criticality of 5-15% :90-95%. MPEP 716.02(d) II, To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Secondly, example 6-7 have different arylate (n-Octyl arylate + ethyl acrylate) from acrylate (ethyl hexyl acrylate or acrylic acid) in examples 8-10, and it is unclear whether those difference also contribute to the performance instead of percentage of N-vinyl-pyrrolidone. Thus, no unexpected results has been demonstrated, and the 103 rejection is still proper.
Applicants argue about criticality of ratio of 0.2 to 0.6 from example 2.
In response to this argument: this is not persuasive. Applicant’s data are not sufficient to overcome the 103 rejection at least for the following reasons. Firstly, applicants od not have sufficient data in or out of claimed range to prove criticality. For example, there is no data about 0.15 and 0.65 to prove criticality of 0.2 to 0.6. MPEP 716.02(d) II, To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Thus, no unexpected results has been demonstarted, and the 103 rejection is still proper.
Applicants argue that no teaching of ratio of 0.2 to 0.6 and working example; no teaching of 5-10% of N-vinyl-2-pyrrolidone and 90-95% of 2-ethylhexyl acrylate.
In response to this argument: this is not persuasive. The modified 103 rejection has already addressed the limitation of ratio of 0.2 to 0.6 and 5-10% of N-vinyl-2-pyrrolidone and 90-95% of 2-ethylhexyl acrylate. It is well settled, however, that the teachings of a reference are not limited to the working examples. See in re Miiis and Pairner, 470 F.2d 649 (CCPA 1972) ("[A] reference is not limited to the disclosure of specific working examples."), In re Chapman and Cosby, 357 F.2d 418, (CCPA 1966) ("A reference can be used for all it realistically teaches, and is not limited to the disclosures in its specific illustrative examples."), and In re Widmer, Batzer and Nikles, 353 F2d 752 (CCPA 1965) ("Examples in a reference are merely that, exemplary of the broader disclosure, all of which is available for what it clearly teaches."). Thus, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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