DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim 92 is rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Hartwell US Patent Application Publication 2011/0054421.
As to claim 92, Hartwell teaches a wound dressing 100 comprising:
a backing layer 150 (para. 0044);
a wound contact layer 102 (para. 0036); and
an upper layer 130; and
a lower layer 105 (para. 0037) arranged between the backing layer 150 and the wound contact layer102,
wherein the backing layer 150 and the wound contact layer 102 are arranged to extend beyond the perimeter of the upper layer 130 and the lower layer 105 to form a border portion 200 (Figs. 1-3; para. 0045);
the upper layer 130 being arranged in contact with 150 backing layer (Fig. 1), wherein the upper layer 130 has a surface area (the top surface) being smaller than the surface area of the lower layer 105 (fig 1) and
wherein the upper layer 130 is configured to assist in wicking moisture toward an upper surface of the dressing (para. 0039).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 73-80 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartwell et al. WO 2009/066106 in view of Gilman USPN 5090406 and further in view of Smola WO 2009/068249.
As to claim 73, Hartwell teaches a dressing 100 (Fig. 1) for preventing tissue damage, the dressing comprising:
a cover layer 160;
a first layer 150 disposed beneath the cover layer 160 (Figs. 1 and 3); and
a second layer 110 disposed beneath and in contact with the first layer 150.
Hartwell does not teach a plurality of internal layers, wherein individual layers of the plurality of internal layers are configured to move laterally with respect to other internal layers.
Gilman teaches a vented wound dressing having a base sheet 12, a vent cover 14, and an absorbent layer 16. The vent cover 14 is secured to the base sheet 12, but not the absorbent layer 16 is not as Gilman teaches the absorbent is displaceable and removeable (Gilman col. 2, lines 61-68). Based on the teaching of Gilman, the internal layers can be moved laterally during the removal and replacement of the absorbent layer.
Hartwell/ Gilman do not teach a tissue contact layer disposed beneath the second layer 110, wherein the tissue contact layer is configured to be adhered at a border region to the cover layer. Smola teaches a wound dressing 30 comprising a (superabsorbent) particle layer 33, which is covered on both sides with a tissue (31, 32) made of cellulose fibers (Description of Fig. 3). Smola teaches the wound contact layer may be a knitted fabric or tissue, where the wound contact layer can be stretched or deformed in one or more directions without it contracting or aligning itself again. In addition, the surface of such a wound contact layer conforms precisely to the surface of the skin or wound to be treated (Smola, English translation, page 10; para. 6). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the wound contact layer of Hartwell with a tissue contact layer for the benefits taught in Smola.
As to claim 74, the first layer and the second layer are unbonded – where Gilman teaches the absorbent layer is removable which indicates it is unbonded at least partially in the wound dressing (Gilman col. 2, lines 60-68).
As to claim 75, Hartwell/Gilman/Smola teaches the internal layers are configured to dissipate energy from shear movement – where Hartwell teaches the layer 150 helps distribute pressure generated by a pump so that a whole wound site sees an equalized negative pressure (page 9, lines 6-10). Hartwell also teaches the layer 150 helps distribute pressure across the whole wound site, essentially transferring a too high pressure from a high risk area to a larger area to minimize damage to the wound (page 9, lines 6-10; page 10, lines 33-35).
As to claim 76, Hartwell teaches the cover layer comprises a top film 160 (page 9, lines 13-16).
As to claim 77, Hartwell/Gilman/Smola does not specifically teach the dressing of claim 73, wherein the first layer comprises an absorbent layer. Instead, Hartwell teaches the upper transmission layer 150 is the first layer and the absorbent layer 110 is a second layer beneath the transmission layer 150 (Hartwell Fig. 1). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to use the absorbent as the first layer, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
As to claim 78, Hartwell/Gilman/Smola teaches the absorbent layer 110 comprises a superabsorbent material (Hartwell page 6, lines 25-28).
As to claim 79, Hartwell/Gilman/Smola teaches the layer 150, which is positioned above the absorbent layer is a foam or a nonwoven (Hartwell page 9, lines 6-12), and which is known in the art as materials capable of masking wound exudates as they are not transparent.
As to claim 80, Hartwell/Gilman/Smola teach the dressing of claim 73, further comprising an opaque or semi-opaque component positioned above the first layer, wherein the opaque or semi- opaque component is configured to slide relative to the cover layer and the first layer – where Hartwell teaches a filter layer overlying the cover layer (page , lines 19-20). Hartwell further teaches materials used for the filter layer are generally a microporous membrane that can be treated to obtain surface characteristics that can be hydrophobic or hydrophilic and a precompressed foam material may alternatively be used (page 7, line 27 through page 8, line 3). The foam material provides an opaque or semi-opaque component as they are not known in the art to be transparent.
Claims 81, 82, 84, and 85 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartwell et al. WO 2009/066106 in view of Smola WO 2009/068249.
As to claim 81, Hartwell teaches a dressing 100 (Fig. 1) for preventing tissue damage, the dressing comprising:
a cover layer 160;
a masking layer 150 disposed beneath the cover layer 160:
an absorbent layer 110 disposed beneath the masking layer 150, wherein the masking layer 150 covers at least a portion of the absorbent layer 110 (Hartwell Fig. 1);
a transmission layer 105 (Hartwell page 10, lines 31-35) disposed beneath the absorbent layer 110. Hartwell does not specifically teach the transmission layer is unbonded to the absorbent layer and is able to move laterally with respect to the transmission layer. Hartwell teaches an intermediate transmission layer 112 having columns 406 (Fig. 4; page 12, lines 27-29); and a lower transmission layer 105 having columns 402 (Fig. 4; page 12, lines 10-12). Hartwell teaches the columns 402 from transmission layer 105 coincide with bores 103 in the absorbent layer 110 (page 12, lines 20-25). Hartwell further teaches the height of columns 402, 406 of the lower 105 and intermediate transmission layers contact when the wound dressing is put together (Fig. 4; page 12, lines 33-36); providing fluid transmission paths through the absorbent layer so that fluid is drawn from the lower region upwardly through the absorbent layer when the pump 170 is operating (Fig. 4; page 13, lines 1-3). This construction does not create a ‘bonded’ structure for the absorbent and underlying transmission layer. Additionally, Hartwell teaches in certain embodiments of the present invention fluid communication paths through which fluid can be transmitted from the lower transmission layer to the intermediate transmission layer can be made by pinching together peripheral regions of the lower and intermediate regions. Fluid transmission would thus proceed around the peripheral edges of the wound dressing. Such fluid paths may replace the fluid paths formed by the columns passing through apertures in the absorbent layer or may alternatively take the place of such passageways (Hartwell page 14, lines 20-28). Based on the teaching of Hartwell it would have been obvious to provide an absorbent layer unbonded to an underlying transmission layer 105 since the columns and bores structure is not required for fluid transmission. The unbonded structure allows the absorbent and/or transmission layers to move with respect to one another.
Hartwell does not teach a tissue contact layer disposed beneath the transmission layer, wherein the tissue contact layer is configured to be adhered at a border region to the cover layer. Smola teaches a wound dressing 30 comprising a (superabsorbent) particle layer 33, which is covered on both sides with a tissue (31, 32) made of cellulose fibers (Description of Fig. 3). Smola teaches the wound contact layer may be a knitted fabric or tissue, where the wound contact layer can be stretched or deformed in one or more directions without it contracting or aligning itself again. In addition, the surface of such a wound contact layer conforms precisely to the surface of the skin or wound to be treated (Smola, English translation, page 10; para. 6). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the wound contact layer of Hartwell with a tissue contact layer for the benefits taught in Smola. Hartwell/Smola teach the wound contact layer (tissue layer) is adhered to the cover layer (Hartwell Figs. 1 and 2; page 10, lines 14-17).
As to claim 82, Hartwell/Smola teaches the dressing of claim 81, wherein the masking layer 150 covers a first portion of the absorbent layer 110 and a second portion of the absorbent layer 110 is not covered by the masking layer 150 – where Hartwell teaches Fig. 3 shows a border region 200 of the wound dressing where the cover layer is secured to the sealing layer 140 and the wound contact layer 102. A space 301 is indicated underneath the sealing layer 140 and above the sound contact layer 102 and ends of transmission layers 105, 112, and absorbent layer 110. Hartwell teaches in practice the transmission layers and absorbent layers will be beveled somewhat so as to reduce the space (Fig. 3; page 10, lines 14-23). The examiner submits that the beveled portion of the absorbent layer represents an extension of the absorbent layer since its purpose is to reduce the space 301. This extended portion of the absorbent layer is a portion not covered by the masking layer 150.
As to claim 84, Hartwell/Smola teaches the absorbent layer 110 comprises a superabsorbent material (Hartwell page 6, lines 25-28).
As to claim 85, Hartwell/Smola teaches the cover layer 160 comprises a top film (Hartwell page 9, lines 13-16).
Claim 83 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartwell et al. WO 2009/066106 in view of Smola WO 2009/068249 and further in view of Nielsen et al. US 2003/0153860.
As to claim 83, Hartwell/Smola teaches the invention of claim 81 substantially as claimed. Hartwell/Smola does not teach the masking layer is able to move laterally with respect to the absorbent layer and the cover layer. Nielson teaches a wound dressing comprising a backing layer, a skin facing layer, and an absorbent layer between the backing layer and the skin facing layer (Nielsen Abstract). Nielson teaches the backing layer and the absorbent layer are mutually displaceable. Nielson teaches by locating the backing layer and the absorbent layer adjacent to each other and mutually displaceable, an enhanced flexibility and permeability is obtained. The flexibility is enhanced due to the higher bending and twisting flexibility, as well as when the absorbent layer absorbs exudate and thereby expands, the free movement of the backing layer will allow more space over the expanding region of the absorbent layer and thus a larger surface for evaporation (Nielson paras. 0030-0031). While Hartwell/Smola/Nielson do not specifically teach the masking layer is able to move laterally with respect to the absorbent and cover layer, Nielson does teach the general condition of having layers that can be displaced to enhance flexibility. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Hartwell/Smola to provide a masking layer capable of lateral movement for the benefits taught in Nielson.
Claims 86, 87, and 91 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartwell et al. WO 2009/066106 in view of Buglino et al. USPN 6011194.
As to claims 86 and 87, Hartwell teaches a wound dressing 100 for providing protection at a wound site, comprising:
a wound contact layer 102;
an absorbent layer 110 for absorbing wound exudate, the absorbent layer 110 positioned above the wound contact layer 102 and comprising a border region 200 extending around its radially outer perimeter and a central region within the border region (Fig. 4);
a cover layer 160 positioned above the absorbent layer 110 (Fig. 4); and
an obscuring element 150 positioned between the absorbent layer 110 and the cover layer 160 for at least partially obscuring a view of wound exudate absorbed by the absorbent layer in use – where Hartwell teaches the layer 150, which is positioned above the absorbent layer is a foam or a nonwoven (Hartwell page 9, lines 6-12), which is known in the art as materials capable of masking wound exudates as they are not transparent.
The obscuring element 150 is provided over the central region of the absorbent layer and not over at least a portion of the border region of the absorbent layer – where Hartwell teaches Fig. 3 shows a border region 200 of the wound dressing where the cover layer is secured to the sealing layer 140 and the wound contact layer 102. A space 301 is indicated underneath the sealing layer 140 and above the sound contact layer 102 and ends of transmission layers 105, 112, and absorbent layer 110. Hartwell teaches in practice the transmission layers and absorbent layers will be beveled somewhat so as to reduce the space (Fig. 3; page 10, lines 14-23). The examiner submits that the beveled portion of the absorbent layer represents an extension of the absorbent layer since its purpose is to reduce the space 301. This extended portion of the absorbent layer is a portion not covered by the obscuring element 150.
Wherein at least a portion of the border region 200 of the absorbent layer 110 is directly adjacent to the cover layer 160 in space 301.
Hartwell does not specifically teach that wound exudate reaching the border region 200 is visible through the cover layer as Hartwell does not teach the cover layer is transparent. Buglino teaches a wound dressing having a protective cover backing film 20 which can be transparent to permit visualization (Buglino col. 4, lines 50-52). It would have been obvious to one having ordinary skill in the art to provide the cover layer 160 with a transparent film to permit visualization of the wound exudate as taught in Buglino.
As to claim 91, Hartwell/Buglino teaches the wound dressing of claim 86, further comprising a porous layer 105 positioned between the wound contact layer 102 and the absorbent layer 110, the porous layer 105 configured to draw exudate away from the wound site (Hartwell Fig. 4; page 10, line 30 through page 11, line 5).
Claims 88-90 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hartwell et al. WO 2009/066106 in view of Buglino et al. USPN 6011194 and further in view of Martz USPN 5061258.
As to claims 88-90, Hartwell/Buglino teach the present invention substantially as claimed. Hartwell/Buglino does not teach the dressing is shaped to include a number of lobes. Martz teaches a wound dressing/bandage that can be shaped in the form of a cartoon (Fig. 6), where the cartoon shape features a number of lobes (i.e. face and ears). Martz teaches the cartoon aspect of the dressing 20 is embellished still further by extending the fabric of the layer 32 well beyond the perimeter of the film 24, and by cutting the outer edge of the fabric to have the physical shape of a cartoon character. Martz teaches as used, the term “cartoon” is not limited to only facial configuration, but is intended to include shapes of other objects frequently found in children’s literature, such as rainbows, bells, and stars. Since Martz teaches a variety of shapes are possible for the wound dressing (Fig 6; col. 8, lines 39-51). It would have been an obvious matter of design choice to provide the article of Hartwell/Martz with shapes as claimed in claims 88 and 89, since such a modification would have involved a mere change in the shape of the component, which Martz teaches is acceptable. A change in shape is generally recognized as being within the level of ordinary skill in the art. In Re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Martz teaches providing a wound dressing with a cartoon character printed directly on the surface is an aid to cheering children who may have undergone a surgical procedure and, by reducing mental stress associated with the recovery process, aids a return to good health (Martz col. 8, lines 5-10). It would have been obvious to modify the wound dressing of Hartwell/Buglino with the shapes taught in Martz for the benefits Martz teaches.
Hartwell/Buglino/Martz, further teaches the positioning of the obscuring element enables visibility of wound exudate – where Martz teaches a window 38 in the fabric layer 32 covered by film 24. The window 38 permits a viewing of the skin without removal of the fabric layer 32. To close off viewing by the patient, a window shade 40 (obscuring element) is removably secured about the window 38 (Martz Figs. 1, 2, 3, and 6; col. 7, lines 35-53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kolte et al. US Patent Application Publication 2004/0049146 is cited to show a multi-lobal wound structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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