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 .
Status of Claims
Claims 1-20 are pending, of which claims 1, 12, & 17 are independent. All claims are examined on the merits.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection is necessitated by the amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re Claim 1, the claim recites “an adhesive interposed between adjacent portions of the mechanical fasteners” and it is unclear if this intends to mean that there is a patch/region of adhesive disposed between two patches of mechanical fasteners (such as hook-and-loop fasteners), or if the clause is reciting that there is adhesive disposed between the complementary elements of each individual mechanical fastener (such as between a hook and a loop). Based on the current disclosure, see e.g., Fig. 5C, Examiner thinks that Applicant intends to claim that the adhesive is disposed between complementary elements of each individual mechanical fastener.
Re Claim 11, the claim recites that “the absorbent pad is detachably coupled to the dressing by a gel adhesive” but it is not clear if this gel adhesive is the adhesive that is interposed between adjacent portions of the mechanical fasteners or it is in addition to that adhesive already recited in Claim 1. Examiner assumes that Applicant intends to recite “wherein the adhesive interposed between adjacent portions of the mechanical fasteners is a gel adhesive.”
Re Claims 12 & 17, each claim recites “an adhesive interposed between a plurality of adjacent interlocking portions” and such a clause is unclear for the same reasons as explained in Claim 1. Examiner thinks that Applicant intends to claim that the adhesive is disposed between complementary elements of each individual mechanical fastener.
The remaining claims are rejected for being dependent from claim 1, 12, or 17.
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.
Claims 1-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Greener (US 2020/0107965) in view of Haggstrom et al. (US 2007/0078366) and Olson (US 2002/0099353).
Re Claim 1, Greener discloses an absorbent dressing system (Fig. 4C), comprising:
a dressing (lower dressing components 450) including a perforated layer (first backing layer 423, which has an aperture 452 and is thus considered to be perforated); and
an absorbent pad (absorbent layer 421 of upper dressing components 460) coupled to the dressing (via intermediate drape 422).
Greener does not disclose that the absorbent dressing system is replaceable or that the absorbent pad is detachably coupled to the dressing by a plurality of mechanical fasteners and an adhesive interposed between adjacent portions of the mechanical fasteners such that the absorbent pad can be separated from and sealingly reattached to the dressing.
Haggstrom discloses a wound dressing (Fig. 1) having a sealing layer (top layer 110) that has an opening closeable by a flap (door 118), wherein the flap provides airtight seal on the sealing layer via releasable mechanical fasteners, such as VELCRO® and tongue and groove arrangement ([0033]). It would have been obvious to one skilled in the art at the time of filing to modify Greener with the releasable mechanical fasteners taught by Haggstrom since this allows a caretaker to remove/peel back the top absorbent pad of Greener and thus better visually monitoring the status of the wound ([0033] in Haggstrom). With the modification of the mechanical fasteners disclosed in Haggstrom, the Greener absorbent pad can be detached from the dressing and subsequently can also be replaced by another one.
Haggstrom also does not disclose that an adhesive is interposed between adjacent portions of the mechanical fasteners and instead discloses mechanical fasteners and adhesive as alternatives of each other ([0033]). Olson discloses a medical product comprising fastening regions (primary and secondary regions, [0042]) formed of a plurality of mechanical fasteners as well as adhesive interposed between complementary elements of each mechanical fastener ([0042] “The primary region comprises a mechanical fastening component, such as hook material, and the secondary region comprises an adhesive disposed on and working in concert with a mechanical fastening component.”). It would have been obvious to one skilled in the art at the time of filing to modify Greener and Haggstrom further with the addition of adhesive to mechanical fasteners, as taught by Olson, as doing so may strengthen the seam at the strips of mechanical fasteners and gives the manufacturer another way for controlling the peel strength of the fasteners.
Re Claim 2, Greener, Haggstrom and Olson combine to disclose claim 1, and Greener also discloses wherein the dressing further includes a foam material (foam layer 424, [0071], Fig. 4C), disposed on a skin facing side of the perforated layer.
Re Claim 3, Greener, Haggstrom and Olson combine to disclose claim 1, and in the combination, Haggstrom already discloses intervening fastening layers including a first fastening layer and a second fastening layer that is detachably coupled to the first fastening layer ([0033], where it is well known that VELCRO® (hook-and-loop) and tongue-and-groove have intervening features that are set on opposing sides/layers.
Re Claim 4, Greener, Haggstrom and Olson combine to disclose claim 3, and Haggstrom also implies wherein the first fastening layer includes a strip (hook-loop fasteners are always formed as a strip), the strip comprising a plurality of stems (hooks of a hook-loop fastener necessarily have stems) that are configured to mechanically fasten the first fastening layer to the second fastening layer when the first fastening layer is pressed against the second fastening layer (e.g., the hooks engage the loops when the two layers are pressed together). While none of the references explicitly discloses that the strip extends along a perimeter portion of the absorbent pad, merely rearranging the relative location of an element requires only routine skills in the art. In this case, putting the fastening/adhering strip along the perimeter of the absorbent pad would prevent the edges of the upper dressing from flipping up and therefore prevent accidental detachment of the upper dressing from the lower dressing.
Re Claim 5, Greener, Haggstrom and Olson combine to disclose claim 3, Haggstrom also implies that wherein the first fastening layer includes a female interlocking member, and wherein the second fastening layer includes a male interlocking member configured to sealingly engage with the female interlocking member (i.e., a tongue-and-groove fastener has a tongue/male interlocking member and a groove/female interlocking member).
Re Claim 6, Greener, Haggstrom and Olson combine to disclose claim 3. None of the references expressly disclose wherein the first fastening layer comprises two fastening strips oriented in a direction that is substantially parallel to a longest dimension of the absorbent pad and positioned on opposite sides of the absorbent pad. However, merely rearranging the relative location of an element requires only routine skills in the art. In this case, putting the fastening/adhering strip along both long edges of the absorbent pad would prevent the edges of the upper dressing from flipping up and therefore prevent accidental detachment of the upper dressing from the lower dressing.
Re Claim 7, Greener, Haggstrom and Olson combine to disclose claim 1, and Greener also discloses wherein the absorbent pad (421, Fig. 4C) forms part of an absorbent dressing (460), the absorbent dressing further comprising:
an upper cover (second backing layer 420) coupled to the absorbent pad and covering an upper surface of the absorbent pad (Fig. 4C); and
a negative pressure interface (fluidic connector 440) coupled to the upper cover and fluidly coupled to an area of the upper cover that contains the absorbent pad (Fig. 4C).
Re Claim 8, Greener, Haggstrom and Olson combine to disclose claim 7 wherein the negative pressure interface further includes a hydrophobic filter (filter 414, which corresponds to the filter 212 of Fig. 2B embodiment) that substantially prevents fluid from passing through the negative pressure interface ([0054] “The filter 214 is configured to substantially prevent wound exudate from entering the bridge.”).
Re Claim 9, Greener, Haggstrom and Olson combine to disclose claim 1, and Greener also discloses wherein the perforated layer fluidly couples the absorbent pad with a patient facing side of the dressing (evident from Fig. 4C). While Greener does not disclose that the perforated layer comprises a plurality of openings, simply duplicating apertures requires only routine skills in the art and would be obvious to one skilled in the art. Additionally Greener discloses the layer underneath the perforated layer would have a plurality of openings (see [0048]) and that apertures from various layer generally align ([0072]), therefore it is likely that one would also have a plurality of openings for the perforated layer to align with the ones in the underlying layer.
Re Claim 10, Greener, Haggstrom and Olson combine to disclose claim 9, and Greener also discloses wherein the absorbent pad is aligned with the perforated layer such that the absorbent pad is positioned above at least some of the plurality of openings (see Fig. 4C).
Re Claim 12, Greener discloses a negative pressure wound therapy system, comprising:
a first dressing (460) including an absorbent material and a negative pressure interface (440); and
a second dressing (450) including a perforated layer (423); and
a negative pressure source (150) coupled to the negative pressure interface.
Greener does not disclose a touch fastener including an adhesive interposed between a plurality of adjacent interlocking portions, the touch fastener disposed between the first dressing and the second dressing and configured to detachably couple the first dressing to the second dressing and form a substantially airtight seal between the first dressing and the second dressing.
Haggstrom discloses a wound dressing (Fig. 1) having a sealing layer (top layer 110) that has an opening closeable by a flap (door 118), wherein the flap provides airtight seal on the sealing layer via releasable touch/mechanical fasteners, such as VELCRO® and tongue and groove arrangement ([0033]). It would have been obvious to one skilled in the art at the time of filing to modify Greener with the releasable mechanical fasteners taught by Haggstrom since this allows a caretaker to remove/peel back the top absorbent pad of Greener and thus better visually monitoring the status of the wound ([0033] in Haggstrom). With the modification of the mechanical fasteners disclosed in Haggstrom, the Greener absorbent pad can be detached from the dressing.
Haggstrom also does not disclose that an adhesive is interposed between adjacent interlocking portions and instead discloses mechanical fasteners and adhesive as alternatives of each other ([0033]). Olson discloses a medical product comprising fastening regions (primary and secondary regions, [0042]) formed of a plurality of mechanical fasteners as well as adhesive interposed between complementary elements of each mechanical fastener ([0042] “The primary region comprises a mechanical fastening component, such as hook material, and the secondary region comprises an adhesive disposed on and working in concert with a mechanical fastening component.”). It would have been obvious to one skilled in the art at the time of filing to modify Greener and Haggstrom further with the addition of adhesive to mechanical fasteners, as taught by Olson, as doing so may strengthen the seam at the strips of mechanical fasteners and gives the manufacturer another way for controlling the peel strength of the fasteners.
Re Claims 13-16, the limitations are disclosed by Greener as explained under Claims 2 & 7-9, respectively.
Re Claim 17, Greener discloses an absorbent dressing, comprising:
an upper cover (420 of upper dressing components 460) defining a recessed area on a patient facing side of the upper cover;
an absorbent material (421) disposed within the recessed area; and
the upper cover is coupled (see Fig. 4C) to a dressing (lower dressing components 450) and form a substantially airtight seal between the upper cover and the dressing (implied because suction is delivered to the wound through both upper and lower dressings).
Greener does not disclose the dressing is replaceable or a touch fastener including an adhesive interposed between a plurality of adjacent interlocking portions coupled to the upper cover along a perimeter portion of the upper cover, the touch fastener configured to detachably couple the upper cover to a dressing and form a substantially airtight seal between the upper cover and the dressing.
Haggstrom discloses a wound dressing (Fig. 1) having a sealing layer (top layer 110) that has an opening closeable by a flap (door 118), wherein the flap provides airtight seal on the sealing layer via releasable touch/mechanical fasteners, such as VELCRO® and tongue and groove arrangement ([0033]). It would have been obvious to one skilled in the art at the time of filing to modify Greener with the releasable mechanical fasteners taught by Haggstrom since this allows a caretaker to remove/peel back the top absorbent pad of Greener and thus better visually monitoring the status of the wound ([0033] in Haggstrom). With the modification of the mechanical fasteners disclosed in Haggstrom, the Greener absorbent pad can be detached from the dressing and subsequently can also be replaced by another one.
Haggstrom also does not disclose that an adhesive is interposed between adjacent portions of the mechanical fasteners and instead discloses mechanical fasteners and adhesive as alternatives of each other ([0033]). Olson discloses a medical product comprising fastening regions (primary and secondary regions, [0042]) formed of a plurality of mechanical fasteners as well as adhesive interposed between complementary elements of each mechanical fastener ([0042] “The primary region comprises a mechanical fastening component, such as hook material, and the secondary region comprises an adhesive disposed on and working in concert with a mechanical fastening component.”). It would have been obvious to one skilled in the art at the time of filing to modify Greener and Haggstrom further with the addition of adhesive to mechanical fasteners, as taught by Olson, as doing so may strengthen the seam at the strips of mechanical fasteners and gives the manufacturer another way for controlling the peel strength of the fasteners.
Re Claim 18, Greener, Haggstrom and Olson combine to disclose claim 17, and Greener also discloses wherein the upper cover, and subsequently the absorbent dressing, further includes a negative pressure interface (440).
Re Claims 19-20, the limitations are taught by the combination of references as explained under Claims 8 & 6, respectively.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Greener, Haggstrom and Olson as applied to claim 1 above, and further in view of Carr et al. (US 2019/0134255).
Re Claim 11, Greener, Haggstrom and Olson combine to disclose claim 1, but none discloses that the adhesive is a gel adhesive. Olson discloses that the adhesive would be tacky and may be made of SBS ([0042]). Carr discloses a gel adhesive suitable for medical applications, wherein the gel adhesive is tacky and may be made of SBS ([0038]), thus establishing that gel adhesives can also be made of SBS. It would have been obvious to one skilled in the art at the time of filing to modify with Carr since the selection of a material suitable for its intended use establishes a prima facie case of obviousness (MPEP 2144.07).
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.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 2 July 2026
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