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 . Claims included in the prosecution are claims 1-15.
Applicants' arguments, filed 12/22/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1. Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (WO 2014/060625 A1, Apr. 24, 2014) in view of Wright IV (US 8,784,880, Jul. 22, 2014).
Fernandez discloses an eye dressing designed to allow the application of medicaments without requiring the complete removal of the dressing, thereby avoiding unnecessary discomfort for the patient. The dressing comprises a base layer (2) (i.e., claimed first cushion layer) having a lower surface (i.e., claimed inner surface) comprising adhesive edges (2a) and a central opening (2b); a closing layer (3) (i.e., claimed second outer layer) suitable for covering said central opening (2b); and attachment means (4) (i.e., claimed selectively releasable adhesive material) suitable for repeatedly sticking the closing layer (3) (i.e., claimed second outer layer) to the base layer (4) (i.e., claimed first cushion layer) and unsticking it from same (abstract).
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The attachment means (4) (i.e., claimed selectively releasable adhesive material) may be arranged on the periphery of the central opening (2b) of the upper surface (i.e., claimed outer surface) of the base layer (2) (i.e., claimed first cushion layer), on the periphery of the lower surface (i.e., claimed inner surface) of the closing layer (3) (i.e., claimed second outer layer), or both (claim 6).
Fernandez differs from the instant claims insofar as not disclosing a third intermediate layer impermeable to an active agent and configured to be disposed on the outer surface of the first cushion layer and span the opening of the base layer (2), the third intermediate layer affixed to the lower surface of the closing layer (3) such that a periphery of the third intermediate layer is spaced inwardly of the border of the closing layer (3) for defining the border of the second outer layer.
However, Wright IV discloses a transdermal delivery system that comprises a plurality of patch units, wherein each patch unit comprises a backing layer having one or more borders, a drug layer comprising a drug disposed on the backing layer, and an adhesive layer (claim 1). The patch unit further comprises an impermeable layer between the backing layer and the drug layer (claim 36). It may be necessary to include an impermeable layer on the surface of the backing layer that is in contact with the drug to minimize drug migration into the backing film (col. 5, lines 65-67 – col. 6, line1).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated an impermeable layer (i.e., claimed third intermediate layer) configured to span the opening of the base layer (2) (i.e., claimed first cushion layer) motivated by the desire to minimize drug migration into the closing layer (3) (i.e., claimed second outer layer) since minimizing drug migration into a backing film is desirable in the art as taught by Wright IV.
In regards to claim 1 reciting wherein a periphery of the impermeable layer (i.e., claimed third intermediate layer) is spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) for defining an inner edge of the border of the closing layer (3) (i.e., claimed second outer layer), it would have been obvious to have the periphery of the impermeable layer (i.e., claimed third intermediate layer) spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) since the attachment means (4) may be arranged on the periphery of the lower surface of the closing layer (3) (i.e., claimed second outer layer). Therefore, the periphery of the impermeable layer (i.e., claimed third intermediate layer) needs to be spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) to allow attachment means (4) to attach to the base layer (2) (i.e., claimed first cushion layer).
In regards to instant claim 1 and 2 reciting for use on skin for treatment of a callus using salicylic acid, this is merely a recitation of the intended use the claimed invention. Since the dressing of Fernandez is applied over the eye and allows application of medicaments, the dressing of Fernandez is usable on skin, such as callus, with medicaments, such as salicylic acid, whether the prior art discloses such use or not.
2. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (WO 2014/060625 A1, Apr. 24, 2014) in view of Wright IV (US 8,784,880, Jul. 22, 2014), and further in view of Holmes (US 2010/0247613, Sep. 30, 2010).
The teachings of Fernandez and Wright IV are discussed above. Fernandez and Wright IV do not disclose wherein the dressing comprises a release liner releasably secured to the lower surface of the closing layer (i.e., claimed second outer layer) along the border.
However, Holmes discloses a laminated dressing defining an area adapted to receive and hold medicine. In one embodiment, the dressing comprises a contact layer and a backing layer. The contact layer has an inboard surface and an opposing outboard surface. The outboard surface of the contact layer is adapted to be applied to a patient’s skin surrounding a wound. The contact layer further defines a die-cut through-opening substantially in the center of the contact layer. Medicine is received in the area defined by the through-opening in the contact layer (abstract). The outboard surface of the contact layer is covered with an adhesive (¶ [0024]). In order to prevent contamination of the dressing and maintain the adhesive power of the adhesive until the dressing is applied to a patient’s skin, a removable release film loosely adheres to the outboard surface of the contact layer (¶ [0025]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a removable release film on the lower surface of the closing layer (i.e., claimed second outer layer) along the border motivated by the desire to prevent contamination and maintain the adhesive power of the attachment means (4) (i.e., claimed selectively releasable adhesive material) that is present there as taught by Holmes.
3. Claims 6-8, 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (WO 2014/060625 A1, Apr. 24, 2014) in view of Wright IV (US 8,784,880, Jul. 22, 2014), and further in view of Hathman (US 5,086,763, Feb. 11, 1992).
The teachings of Fernandez and Wright IV are discussed above. Fernandez and Wright IV do not disclose wherein the dressing is for treating skin and wherein salicylic acid is deposited in the central opening (2b).
However, Hathman discloses a disposable, protective reclosable wound dressing or bandage providing wound access that is easy to apply and/or open without disturbing a protective crust of blood and serum that forms over a wound, said crust being more commonly called a scab. In addition, it is convenient to apply medication without removing the bandage and at the same time, the wound may be inspected and otherwise treated while maintaining the bandage in place (abstract).
Wright IV further discloses wherein suitable drugs for the transdermal patch include salicylic acid (col. 12, lines 3-4).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the dressing of Fernandez to treat skin since dressings designed to allow the application of medicaments without the complete removal of the dressing are also desirable for treating skin as taught by Hathman.
It would have been prima facie obvious to one of ordinary skill in the art to have administered salicylic acid with the dressing since it is a known and effective medicament for treating skin as taught by Wright IV.
In regards to instant claims 6 and 11 reciting salicylic acid for treatment of a callus, this is merely a recitation of the intended use of salicylic acid. Since Wright IV discloses substantially the same salicylic acid as claimed, the salicylic acid is usable for treating callus, whether the prior art discloses such use or not.
4. Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (WO 2014/060625 A1, Apr. 24, 2014) in view of Wright IV (US 8,784,880, Jul. 22, 2014), Hathman (US 5,086,763, Feb. 11, 1992), and further in view of Holmes (US 2010/0247613, Sep. 30, 2010).
The teachings of Fernandez, Wright IV, and Hathman are discussed above. Fernandez, Wright IV, and Hathman do not disclose wherein the dressing comprises a release liner releasably secured to the lower surface of the closing layer (i.e., claimed second outer layer) along the border.
However, Holmes discloses a laminated dressing defining an area adapted to receive and hold medicine. In one embodiment, the dressing comprises a contact layer and a backing layer. The contact layer has an inboard surface and an opposing outboard surface. The outboard surface of the contact layer is adapted to be applied to a patient’s skin surrounding a wound. The contact layer further defines a die-cut through-opening substantially in the center of the contact layer. Medicine is received in the area defined by the through-opening in the contact layer (abstract). The outboard surface of the contact layer is covered with an adhesive (¶ [0024]). In order to prevent contamination of the dressing and maintain the adhesive power of the adhesive until the dressing is applied to a patient’s skin, a removable release film loosely adheres to the outboard surface of the contact layer (¶ [0025]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a removable release film on the lower surface of the closing layer (i.e., claimed second outer layer) along the border motivated by the desire to prevent contamination and maintain the adhesive power of the attachment means (4) (i.e., claimed selectively releasable adhesive material) that is present there as taught by Holmes.
Response to Arguments
Applicant argues that the claimed three-layered arrangement is not disclosed or suggested by the cited prior art.
The Examiner disagrees and does not find Applicant’s argument to be persuasive. As discussed in the rejection, Fernandez discloses a base layer (2) (i.e., claimed first cushion layer) and a closing layer (3) (i.e., claimed second outer layer). It would have been prima facie obvious to one of ordinary skill in the art to have incorporated an impermeable layer (i.e., claimed third intermediate layer) configured to span the opening of the base layer (2) (i.e., claimed first cushion layer) motivated by the desire to minimize drug migration into the closing layer (3) (i.e., claimed second outer layer) since minimizing drug migration into a backing film is desirable in the art as taught by Wright IV. It would have been obvious to have the periphery of the impermeable layer (i.e., claimed third intermediate layer) spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) since the attachment means (4) may be arranged on the periphery of the lower surface of the closing layer (3) (i.e., claimed second outer layer). Therefore, the periphery of the impermeable layer (i.e., claimed third intermediate layer) needs to be spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) to allow attachment means (4) to attach to the base layer (2) (i.e., claimed first cushion layer). There’s automatically an inner edge to the border of the closing layer (3) (i.e., claimed second outer layer) when the periphery of the impermeable layer (i.e., claimed third intermediate layer) is spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer). As such, Applicant’s argument is unpersuasive.
Applicant argues that the Wright impermeable layer is not shown in the drawings of Wright. The text of Wright discloses that the impermeable layer of Wright in the embodiment shown in Fig. 3a is sized to form a sealable border on the inner surface of an outer layer, which in Wright is the inner surface of the backing layer 60. However, an adhesive layer 80 is coextensive with the drug matrix 70. Presumably the impermeable layer would also be coextensive with the drug matrix 70 against the backing layer 60. Therefore, neither Wright nor any other cited art shows an impermeable layer on the cushion or the backing layer for preventing migration from the drug matrix with the impermeable layer being sized to form an inner edge of a sealable border.
The Examiner does not find Applicant’s argument to be persuasive. The composition being modified is that of Fernandez. Applicant has not factored in that the composition of Fernandez may have attachment means (4) arranged on the periphery of the lower surface of the closing layer (3) (i.e., claimed second outer layer). When this occurs, it would be impractical for the impermeable layer to not be spaced inwardly since it would interfere with the attachments means (4). Therefore, the periphery of the impermeable layer (i.e., claimed third intermediate layer) needs to be spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer) to allow attachment means (4) to attach to the base layer (2) (i.e., claimed first cushion layer). There’s automatically an inner edge when the periphery of the impermeable layer (i.e., claimed third intermediate layer) is spaced inwardly of the periphery of the closing layer (3) (i.e., claimed second outer layer). As such, Applicant’s argument is unpersuasive.
Applicant argues that the presently claimed arrangement and its function as claimed by the Applicant, and its resultant advantages are not taught or suggested by Fernandez, Wright, Hathman or any other prior art.
The Examiner does not find Applicant’s argument to be persuasive. The claimed arrangement is taught by the prior art as discussed above. Also, Wright teaches an impermeable layer to prevent diffusion of active agents. As such, the claimed function and advantage is taught as well. Therefore, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-15 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614