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 .
DETAILED ACTION
Status of the Claims
Claims 28-30 have been withdrawn. Claims 1-15, 17 and 19-20 have been canceled. Claim 16 has been amended. Claims included in the prosecution are claims 16, 18 and 21-27.
Withdrawn Objections/Rejections
The objections to claim 16 are withdrawn.
In light of the new amendments and/or upon further consideration, the rejection of claim 16 under 35 U.S.C. § 112(b) as being indefinite is withdrawn.
New Rejections
Applicant’s amendments have necessitated the following grounds of rejection:
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 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 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 21, 22 and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over Kugelmann et al. (WO 2007101660 A1). Citations from Kugelmann are taken from the machine translated documents.
The disclosure of Kugelmann et al. is directed to a transdermal therapeutic system (TTS) plaster patch (abstract). Kugelmann et al. teach and suggest an active ingredient-containing plaster comprises in addition to a carrier layer, at least one adhesive layer. (page 11, paragraph 3). The adhesive layer of the active ingredient-containing patches is preferably based on a pressure-sensitive adhesive. The pressure-sensitive adhesive preferably comprises at least one polymer (page 11, paragraph 4). The active substance can be contained in the adhesive-capable layer (drug-in-adhesive) and/or another layer, for example in a matrix isolated from the adhesive layer (drug-in-matrix) (page 12, paragraph 5).
Kugelmann et al. teach that the active ingredient is at least partially contained in the adhesive layer; at least partially embedded in a matrix, wherein the matrix in turn may be part of the adhesive layer or form an independent layer; wherein it is a matrix patch (page 12, paragraph 6). The matrix patch comprises a carrier layer, of which a surface adjoins the matrix containing the active substance (active substance-containing layer), and a stickable layer (page 12, paragraph 6). Here the prior art is teaching the distinction between the two layers to meet the outer perimeter of the active-substance carrier layer limitation.
Kugelmann et al. further teach that the adhesive layer preferably covers the entire surface of the carrier layer (page 12, paragraph 6) to read on the coated with PSA and bonded to the carrier layer in lines 22-23 of instant claim 16. The intervening matrix preferably covers only a part of the surface of the carrier layer, so that an outer edge of the carrier layer remains, which is indeed covered with the adhesive layer but not with the matrix (page 12, paragraph 6). In the event that the active substance-containing patch does not have a full-surface adhesive layer, it may also be designed so that the pressure-sensitive adhesive is present only in the edge zones of the active substance-containing layer, wherein these edge zones preferably contain no active ingredient (page 13, paragraph 2).
Kugelmann et al. disclose a layer thickness of the adhesive layer of the active substance-containing plaster that is 3 to 100 μm (page 14, paragraph 4). In the case of the active substance-containing plaster, the adhesive-capable layer preferably directly adjoins a carrier layer (page 14, paragraph 6). The carrier layer preferably has a thickness such that the active substance-containing patch has sufficient mechanical stability (page 14, paragraph 7). The carrier layer has a layer thickness in the range of 5.0 to 125 μm, the carrier layer forms one of the two surface layers of the active substance-containing plaster, i.e., starting from the preferably directly to the carrier layer adjacent adhesive layer contains the active ingredient-containing patch beyond the carrier layer preferably no further layer (bridging pages 14-15). Here the prior art is teaching the spacial arrangement of the layers, i.e., adjacent, directly adjoining, and their relationship to the pressure-sensitive adhesive (coating).
Kugelmann et al. teach wherein the plaster (2) containing active substance and the adhesive layer (3) is subdivided into an active substance release area (3a) and an active substance-free area (3b) (claim 13); characterized in that the drug-free region (3b) surrounds the active substance-containing region (3a) at the outer edge of the adhesive layer (3) (claim 14). Here Kugelmann et al. by highlighting the active-substance carrier layer being surrounded at the outer edge by the substance-free carrier layer meets the circumferential edge zone limitation.
Regarding the zone being folded downward, as Kugelmann et al. describes a reduction in thickness one of ordinary skill would envision the folding downward of such a zone.
It would have been prima facie obvious to one of ordinary skill in the art to have utilized the transdermal device taught by Kugelmann et al. with expected results. One would be motivated to do so because the plaster in the packaging according is preferably active ingredient. In the therapy, active ingredient-containing patches have been proven, as they allow a painless, convenient and easy administration of an active ingredient to the patient over a longer period (page 10, paragraph 3).
Regarding claim 21, Kugelmann et al. teach the pressure-sensitive adhesive preferably comprises at least one polymer, preferably selected from the group consisting of polyacrylates, polyvinyl ethers, polyvinyl alcohols, polyisobutylenes, acrylate copolymers, ethylene-vinyl acetate copolymers, polyurethanes, styrene-isoprene copolymers, styrene butadiene copolymers, cellulose derivatives, silicones, rubbers, resins and optionally hydrogenated esters of rosin (page 11, paragraph 4). And also, as examples of suitable materials of the carrier layer may be polybutylenes; polystyrenes; copolymers, acrylonitrile-butadiene-styrene terpolymers (page 14, paragraph 8).
Regarding claim 22, Kugelmann et al. teach (Sex) hormones (page 4, paragraph 4).
Regarding claim 27, Kugelmann et al. describe how unintentional fixing must be actively released (page 2, paragraph 2) and teach an adhesive layer covering protective film (release liner) which is an integrated protective film thereby reducing the use of materials (page 2, paragraph 4).
Claims 18 and 23-26 are rejected under 35 U.S.C. § 103 as being unpatentable over Kugelmann et al. (WO 2007101660 A1) further in view of Johannison (US 20140142490 A1). Citations from Kugelmann are taken from the machine translated documents.
The teachings of Kugelmann above are incorporated herein.
Claim 18 is a product-by-process claim. MPEP 2113(III) states that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable.
Kugelmann et al. disclose that the preparation of the active substance-containing patch can be carried out by known production methods and include conventional method steps, such as lamination, coextrusion, stamping, delamination, unwinding, cutting, rewinding, mounting or dosing (page 15, paragraph 3).
Johannison et al. teach a cutting/punching tool.
Johannison et al. disclose a self-adhesive wound care product, including a backing layer having a self-adhesive coating, the backing layer of the product comprising a first area in which the adhesive coating has a first thickness, and a second area along at least a portion of the edges of the product. The second area has an adhesive coating having a thickness, which is less than the first thickness and which gradually decreases in a direction towards the edge of the product, from a thickness which is substantially equal to said first thickness to a thickness of 0-0.05 mm; or the second area is substantially free from adhesive coating (abstract, [0005], [0022], [0034], claim 8). Punching (cutting) adhesive material ([0031]) is taught and figures of the tool that does this are provided (see Figs. 3A, 4, and 4A-4E). The cutting tool includes a cutting edge defining the circumference of the wound care product to be cut ([0022]).
Johannison et al. disclose a wound care product (Fig. 1 shown below with labels provided for convenience) that comprises a backing layer 1 having a self-adhesive silicone-gel adhesive coating 2 ([0034]). In the first area A1, the backing layer 1 has a self-adhesive silicone gel adhesive coating having a thickness t1([0034]). In this example the second area A2 has a silicone-gel adhesive coating has a thickness that gradually decreases in the direction towards the edge 3 of the product, from a thickness t2 which is substantially equal to adhesive coating thickness t1 of the first area, to a thickness t3 of substantially 0-0.05 mm ([0034]).
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It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply circumferential cutting (i.e., punching) as taught by Johannison et al. to Kugelmann et al. with expected results. One would be motivated to do so with a reasonable expectation of success because Johannison et al. teach an adhesive taught provides an improved stay on ability, so that they do not roll up in the edge ([0004]), provide coatings that give good adherence to skin, while being thin enough to provide excellent flexibility ([0021]), stay-on properties in all directions ([0022]), and an improved ability to remain attached to the skin at the outermost edges; this characteristic is even more pronounced when there is an outermost non-adhesive area substantially free from adhesive ([0043]).
Regarding claim 23, Johannison et al. teach that the area of t3 is smaller than t2 and that the area of t2 is smaller than t1. Where the thickness of the adhesive in the outermost area gradually decreases to approximately 0 mm, and that the area which is substantially free from adhesive coating is present at the outermost edges of the products ([0040]). The coating may be reduced and in an amount that goes from (0.05-0.3 mm) ([0021]) to (0.0-0.05 mm) ([0033]) to read on the claimed percentage (not more than 20% of 0.05 is 0.01; 20% of 0.3 is 0.06).
Regarding claim 24, Johannison et al. teach a thickness of 0.05 mm ([0033]).
Regarding claim 25, Johannison et al. teach a circle ([0033]).
Regarding claim 26, Johannison et al. teach 0.02 mm (20 µm) ([0033]).
Response to Arguments
Applicants’ arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Conclusion
All claims under consideration remain rejected; no claims are allowed. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 0830-1630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen A Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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