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.
Claim Interpretation
Examiner notes the term “track pad” is used in multiple claims, e.g., claims 7-8. This is not a well-known term in the field of negative pressure wound treatment and it is not readily clear what structures/functions may be covered by this term. For examination, Examiner interprets this term to mean “negative pressure interface” (see [0043] of the Pre-Grant Publication of the current Application, namely US 2024/0335329 A1), which means a connecting structure that connects the replaceable absorbent dressing to a source of negative pressure (e.g., vacuum pump).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, Claim 1 recites that the “absorbent pad is detachably coupled to the dressing such that the absorbent pad can be separated from and reattached to the dressing while still forming a substantially airtight seal with the dressing.” It cannot be envisioned how the absorbent pad forms an airtight seal and be separated and reattached while the airtight seal is intact. Based on the disclosure, a first absorbent pad, after being saturated with wound fluids, is designed to be completely detached from the underlying base dressing, and then a second absorbent pad is affixed to the base dressing (see [0053]-[0054]). The base dressing remains attached to the wound and forming an airtight seal around the wound while the absorbent pad is removed and a new absorbent pad is attached on top of the base dressing. For prior art examination, Examiner assumes that Applicant intended to claim that the absorbent pad can be separated from and reattached to the dressing while the dressing maintains a substantially airtight seal with a wound.
Claims 2-11 are rejected for being dependent from Claim 1.
Re Claim 18, the claim recites both a negative pressure interface and a track pad. However, based on the current Specification, the negative pressure interface and the track pad are the same thing (see e.g., [0038], “The absorbent dressing 108 is detachably coupled to the base dressing 106 and includes the upper cover 104, the absorbent material 124, and the track pad 102 (e.g., a negative pressure interface).”). For examination of Claim 18, Examiner assumes that the two features are the same.
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 1-11, 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, as explained supra, it cannot be understood, with or without the benefit of the current Specification, how an absorbent pad can be separated and reattached while also maintaining an airtight seal with the underlying base dressing. Examiner believes that Applicant intended to claim that the absorbent pad can be separated from and reattached to the dressing while the dressing maintains a substantially airtight seal with a wound.
Claims 2-11 are rejected for being dependent from Claim 1.
Re Claims 6 & 20, it is also confusing what it means that “the first fastening layer comprises a first fastening strip and a second fastening strip positioned on an opposite side of the absorbent pad as the first fastening strip.” In other words, it’s not clear how the second fastening strip is also the first fastening strip, given there is already a first fastening strip on the first fastening layer. For examination, Examiner assumes that the claim recites “the first fastening layer comprises two fastening strips oriented in a direction substantially parallel toa longest dimension of the absorbent pad, the two fastening strips being positioned on opposite sides of the absorbent pad.”
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 1-2 & 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Greener (US 2020/0107965) in view of Andresen et al. (US 2010/0324510).
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 such that the absorbent pad can be separated from and reattached to the dressing while still forming a substantially airtight seal with the dressing. Andresen discloses a wound dressing (see e.g., Fig. 18) having a sealing film (2) that forms an airtight seal over a wound, and a connector (tube 3, which includes fixing member 4, Fig. 1) having one end releasably fixed to the upper surface of the sealing film (via fixing member 4, [0080], “the fixing member can be easily detached and refastened to the sealing film”). It would have been obvious to one skilled in the art at the time of filing to modify Greener by gleaning from the attachment means taught in Andresen, such that a medical professional has the flexibility to choose to use only one set of dressing components (450 or 460 taught by Greener) or to use both sets of dressing components (i.e., both 450 & 460) if the wound is large. The extra set of dressing components in Greener would provide greater absorption capacity for wound fluids. With the modification, the absorbent dressing system can be replaceable because the upper dressing components may be detachably removed and may be replaced by another one if necessary.
Re Claim 2, Greener and Andresen 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 7, Greener and Andresen 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 track pad (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 and Andresen combine to disclose claim 7 wherein the track pad 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 track pad ([0054] “The filter 214 is configured to substantially prevent wound exudate from entering the bridge.”).
Re Claim 9, Greener and Andresen 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 and Andresen 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 (clearly seen in Fig. 4C).
Re Claim 11, Greener and Andresen combine to disclose claim 1, and Andresen also discloses wherein the absorbent pad is detachably coupled to the dressing by a gel adhesive (bonding agent 13, [0080]-[0081] “Suitable characteristics for a silicone adhesive for achieving good sealing characteristics … are described in WO 2006/075950.” Said WIPO reference discloses “Silgel 612, supplied by Wacker Chemie GmbH, Germany”).
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Greener and Andresen as applied to claim 1 above, and further in view of Haggstrom et al. (US 2007/0078366).
Re Claim 3, Greener and Andresen combine to disclose claim 1, while Andresen discloses a detachable coupling between an upper dressing and a lower dressing, neither Greener nor Andresen discloses that the coupling is by intervening fastening layers including a first fastening layer and a second fastening layer that is detachably coupled to the first fastening layer. 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 fasteners, such as VELCRO®, tongue and groove arrangement and adhesive, thus establishing that adhesive and touch/mechanical fasteners are considered as equivalents in wound dressings. It would have been obvious to one skilled in the art at the time of filing to modify Greener further with the releasable fastener taught by Haggstrom since substituting equivalents known for the same purpose establishes a prima facie case of obviousness (MPEP 2144.06). It is well known that VELCRO® (hook-and-loop) and tongue-and-groove have intervening features, i.e., hooks and loops are set on opposing layers and therefore such a fastener reads on the current claim language “intervening fastening layers including a first fastening layer and a second fastening layer that is detachably coupled to the first fastening layer.”
Re Claim 4, Greener, Andresen and Haggstrom 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, Andresen and Haggstrom 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, Andresen and Haggstrom 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.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Greener in view of Andresen and Haggstrom.
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 disposed between the first dressing and the second dressing, the touch fastener 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.
Andresen discloses a wound dressing (see e.g., Fig. 18) having a sealing film (2) that forms an airtight seal over a wound, and a connector (tube 3, which includes fixing member 4, Fig. 1) having one end releasably fixed to the upper surface of the sealing film (via fixing member 4, [0080], “the fixing member can be easily detached and refastened to the sealing film”). It would have been obvious to one skilled in the art at the time of filing to modify Greener by gleaning from the attachment means taught in Andresen, such that a medical professional has the flexibility to choose to use only one set of dressing components (450 or 460 taught by Greener) or to use both sets of dressing components (i.e., both 450 & 460) if the wound is large. The extra set of dressing components in Greener would provide greater absorption capacity for wound fluids.
Andresen also does not disclose a touch fastener. 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 fasteners, such as VELCRO®, tongue and groove arrangement and adhesive, thus establishing that adhesive and touch/mechanical fasteners are considered as equivalents in wound dressings. It would have been obvious to one skilled in the art at the time of filing to modify Greener further with the releasable fastener taught by Haggstrom since substituting equivalents known for the same purpose establishes a prima facie case of obviousness (MPEP 2144.06).
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 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.
Andresen discloses a wound dressing (see e.g., Fig. 18) having a sealing film (2) that forms an airtight seal over a wound, and a connector (tube 3, which includes fixing member 4, Fig. 1) having one end releasably fixed to the upper surface of the sealing film (via fixing member 4, [0080], “the fixing member can be easily detached and refastened to the sealing film”). It would have been obvious to one skilled in the art at the time of filing to modify Greener by gleaning from the attachment means taught in Andresen, such that a medical professional has the flexibility to choose to use only one set of dressing components (450 or 460 taught by Greener) or to use both sets of dressing components (i.e., both 450 & 460) if the wound is large. The extra set of dressing components in Greener would provide greater absorption capacity for wound fluids. With the modification, the absorbent dressing system can be replaceable because the upper dressing components may be detachably removed and may be replaced by another one if necessary.
Andresen also does not disclose a touch fastener. 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 fasteners, such as VELCRO®, tongue and groove arrangement and adhesive, thus establishing that adhesive and touch/mechanical fasteners are considered as equivalents in wound dressings. It would have been obvious to one skilled in the art at the time of filing to modify Greener further with the releasable fastener taught by Haggstrom since substituting equivalents known for the same purpose establishes a prima facie case of obviousness (MPEP 2144.06).
Re Claim 18, Greener, Andresen and Haggstrom combine to disclose claim 17, and Greener also discloses wherein the upper cover, and subsequently the absorbent dressing, further includes a track pad (440).
Re Claims 19-20, the limitations are taught by the combination of references as explained under Claims 8 & 6, respectively.
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 28 January 2026