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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “20” has been used to designate both a suction layer and a dressing layer. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the dressing layer as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 Jaeb et al. (US 2009/0227969).
With reference to claim 1, Jaeb et al. (hereinafter “Jaeb”) discloses a negative pressure wound dressing [0037,0041], comprising:
an island (see annotated figure 2 below) comprising a fluid permeable non-adhesive skin contact layer (232) connected to a fluid absorbent layer (228), 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 2), the skin contact layer being positionable onto skin of a patient surrounding a wound (figure 2);
a negative pressure drape (244) overlying the island and having an adhesive lower surface [0078] and peripheral edges extending past the peripheral edges of the skin contact layer (figure 2); and
a suction layer (266) connected to the negative pressure drape and in fluid communication with a source of negative pressure (110) and the absorbent layer (figure 2) to enable negative pressure to be applied through the absorbent layer to the wound [0093-0094], 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 annotated figure 2 below.
Jaeb 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 set forth in [0078].
The difference between Jaeb 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.
Initially, the examiner contends that the second step down may be considered to have a shorter height than that of the first step down as shown by double sided arrows in annotated figure 2 below.
Alternatively, 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 Jaeb provide adhesive 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 Jaeb includes the same elements in the same location as recited, it is reasonable to presume that the elements of Jaeb 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.
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With reference to claim 2, Jaeb teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Jaeb 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.
Jaeb 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 2.
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 as taught by Jaeb in [0095].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zochowski et al. (US 2019/0350764) discloses coverings and/or dressings for negative pressure tissue sites.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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