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 .
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.
Claim(s) 1-5, 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holm USPA_20140378923_A1.
Regarding Claims 1, 10, Holm teaches an article fixture for fixing an article on an adherend (Figures 1, 2, 4, 10 and 12; and Abstract). The wound dressing assembly comprises an absorbent body comprising a first skin-facing surface (para [0018]), FIG. 4 is a side view of the wound dressing assembly 10 (corresponds to claimed article) shown in FIG. 1 applied to skin 12 (adherend) (para [0019]). As shown in FIGS. 1-4, at the skin-facing surface, the absorbent body 20 may include a skin-facing contact layer 28; which is a soft, elastomeric adhesive (corresponds to claimed first adhesive layer of claimed adhesive sheet unit) that can be applied to both sides of said core 25 (corresponding to protective layer) (paragraph 0023). When said contact layer 28 is applied to the side of said core 25 that doesn’t face said skin 12 (adherend), then it will correspond to the claimed second main surface side of the core 25 (corresponding to protective layer).The opposing side of core 25 will correspond to the claimed first main surface side that adheres to the skin 12 (corresponds to claimed adherend). Given that said contact layer 28 (corresponds to claimed first adhesive layer of claimed adhesive sheet unit) is an elastomeric, it will therefore be able to be “formed to be stretchable in at least two directions” when it is attached to the core 25 (corresponds to claimed protective layer). Finally, Holm discloses the adhesive should be appropriate for contact with human or animal surfaces to provide closure for wound sites or to secure other medical articles such as catheter tubes (corresponds to claimed articles) (paragraph 0056). Although not all of the claimed limitations are found within a single, exemplified embodiment, the Examiner respectfully submits that it would’ve been obvious for one of ordinary skill in the art at the time the invention was filed to try the different embodiments suggested by Holm out of a desire for optimization as is routinely done in this art.
Regarding Claims 2, 11, Holm discloses plurality of tab portions 38/48 at the leftmost and rightmost portions of the article fixture 10 that are not directly bonded to the protective layer (Figure 2, 3; and para [0046]. It also discloses using a discontinuous adhesive (paragraph 0023) which would seem to indicate that there are some areas where there isn’t a direct bonding.
Regarding Claims 3, 13, Holm discloses Figure 3, this provides tab portions 38/48 which face each other towards the center of the assembly 10, with an attachment position of the article 25 interposed between the at least two of the plurality of tab portions 38/48, in the adhesive sheet unit 34/44 (Figure 2, 3: and para [0046]).
Regarding Claim 4, as described above, the protective layer is interpreted as being formed by the layers 25/26/28. This provides a protective substrate which is effective to protect a wound on the skin 12, formed by absorbent core 25 and backing 26 which forms the second main surface. This also provides a second adhesive layer 28 formed by the first main surface 28 which attaches to the skin adherend 12, which is distinct from the first adhesive layers 34/44, since Holm allows for using adhesive on both sides (paragraph 0023).
Regarding Claims 5, 14, given that Holm discloses using silicone adhesives (paragraph 0056), similar to Applicants, it would be expected for it to inherently possess the same physical properties.
Regarding Claim 9, Holm further teaches a method for removing the article fixed (paras 0010, 0029-0032).
Claim(s) 7, 8, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holm USPA_20140378923_A1, applied to Claims 1 and 10, and in view of Kokubu JP_2020103427_A (see machine English translation).
Regarding Claims 7, 8, and 16, Holm does not disclose the claimed protective layer limitations.
Kokubu discloses applying a base agent comprising a silicone acrylic resin and an alkane solvent to skin to form a solid film on the skin (Abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the protective layer, of Holm, with the protective layer of Kokubu. One of ordinary skill in the art would have been motivated to do so in order to determine if this provides an improved apparatus and method for attaching the article onto skin.
Allowable Subject Matter
Claims 6 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAHSEEN KHAN whose telephone number is (571)270-1140. The examiner can normally be reached Mondays-Saturdays 08:00AM-10:00PM.
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/TAHSEEN KHAN/Primary Examiner, Art Unit 1781 September 25, 2026
