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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Middaugh et al. (US 10,046,095).
With reference to claim 1, Middaugh et al. (hereinafter “Middaugh”) discloses a negative pressure wound dressing (abstract), comprising:
an island (figure 4) comprising a fluid permeable non-adhesive skin contact layer (32) connected to and spanning below a fluid absorbent layer (34), the absorbent layer having peripheral edges and the skin contact layer having peripheral edges extending past the peripheral edges of the absorbent layer a distance (see figure 4), the skin contact layer being positionable onto skin of a patient surrounding a wound (col. 5, lines 21-41);
a negative pressure drape (102) overlying the island and having an adhesive lower surface (60) and peripheral edges extending past the peripheral edges of the skin contact layer (figure 4); and
a suction layer (78,120) connected to the negative pressure drape and in fluid communication with a source of negative pressure and the absorbent layer (figure 4) to enable negative pressure to be applied through the absorbent layer to the wound (col. 7, lines 26-59; col. 9, lines 42-52), wherein the drape steps down from the peripheral edges of the absorbent layer at a first step down and the drape steps down from the peripheral edges of the skin contact layer at a second step down spaced outward from the first step down as shown in figure 4.
Middaugh discloses that the drape is adhesively securable to the skin of the patient surrounding the wound at a juncture of the negative pressure drape and the peripheral edges of the skin contact layer defined by the second step down as shown in figure 4.
The difference between Middaugh and claim 1 is the provision that the second step down having a height that is shorter than that of the first step down and the explicit recitation that the adhesive provides a drape/skin juncture to enable negative pressure to be applied to the wound via the dressing, and the second step down reduces damage to the skin at the drape/skin juncture during application of negative pressure to the wound.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the height of the step down as desired in order to adjust the desired sealing of the drape about the wound. Modification of the step down would also be adjusted depending on the type of wound to be sealed.
With respect to the explicit recitation that the adhesive provides a drape/skin juncture to enable negative pressure to be applied to the wound via the dressing, and the second step down reduces damage to the skin at the drape/skin juncture during application of negative pressure to the wound, the examiner contends that the article of Middaugh provide adhesive (60) in the same location of the article for the same purpose and the article also includes a second step down as claimed. Since the article of Middaugh includes the same elements in the same location as recited, it is reasonable to presume that the elements of Middaugh would provide the same function as recited since the function as recited is a direct result of the elements provided in the locations as recited.
With reference to claim 2, Middaugh teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Middaugh and claim 2 is the provision that the peripheral edges of the skin contact layer extend a distance beyond the peripheral edges of the absorbent layer of from about 0.25 inches to about 1.0 inches.
Middaugh teaches an article where peripheral edges of the skin contact layer extend a distance beyond the peripheral edges of the absorbent layer as shown in figure 4.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the specific distance amount as desired in order to cover the desired portion of the dressing.
Response to Arguments
Applicant’s arguments with respect to claims 1-2 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 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 MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
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