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 .
Response to Arguments
Applicant’s arguments, see remarks, filed 05/27/26, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. As the arguments are persuasive in that Dagger does not qualify as prior art, a new rejection if made. As there is a new grounds of rejection, this office action is non final.
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.
Claim(s) 1,3-4,16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovaniemi EP 2856987 in view of Wheeler US 2019/0209399, hereafter Rovaniemi and Wheeler, respectively.
Regarding claim 1, Rovaniemi discloses a wound dressing apparatus (figure 1), comprising: an absorbent layer (core (4)) having a wound-facing surface (side facing layer (3)) and an opposite, non-wound facing surface (side facing layer (2); However, Rovaniemi fails to specifically disclose a gel material adhered to the wound-facing surface of the absorbent layer, wherein the gel material comprises a cured patterned structure defining a plurality of fluid channels extending therethrough.
Wheeler teaches an absorbent article and is thus considered analogous to the claimed invention. Wheeler teaches that suitable, absorbents in the art may comprise channels with channel openings in which said openings are impregnated with materials capable of retaining structure and pattern but also convert the region to a gel-like state when in contact with a liquid (para. 0028). Per the abstract, said materials may be a super absorbent polymer, such as a hydrogel. Therefore, as Wheeler teaches that absorbents known in the art may comprise materials, such as hydrogels, impregnated in the absorbent channels as a means to gel the structure and retain the structure and pattern of channels it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the absorbent of Rovaniemi with said gel material. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being absorbing fluid in an absorbent, and thus a prima facie case of obviousness exists. The examiner notes that the as the gel is placed within channels in an absorbent and configured to retain the pattern of the absorbent, it is interpreted that gel is patterned and forms apertures in the absorbent.
Regarding claim 3, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, further comprising a cover layer positioned above the absorbent layer (Rovaniemi backing layer (2)). The examiner notes while the figure shows the layer at the bottom, this is relative to the wound, as layer (3) is a facing layer for facing a wound. Backing layer 2 is seen opposite the facing layer, and thus is the facing layer (3) is positioned downward (opposite as shown in the figures) the backing layer (2) is above the absorbent layer (4).
Regarding claim 4, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 3, further comprising a tissue interface layer (facing layer (3), para. 0094) below the gel material (seen below the absorbent containing the gel, where below is relative to the wound) and adhered to a peripheral portion of the cover layer (seen adhered at (8) to the backing layer (2)), wherein the tissue interface layer comprises a central opening positioned beneath at least a portion of the gel material (where the facing layer is perforated, and thus comprises at least a central opening, where the facing layer is positioned below the gel material).
Regarding claim 16, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, wherein the absorbent layer is perforated. The examiner notes that per the rejection of claim 1, the absorbent layer comprises apertures, as such it is interpreted that the layer is perforated.
Regarding claim 17, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, wherein the gel material is at least partially saturated into the absorbent layer. The examiner notes that per the rejection of claim 1, the absorbent core is impregnated with the gel, and thus it is interpreted that the gel is at least partially saturated into the absorbent.
Regarding claim 19, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, wherein the cured pattern structure has a smaller outer perimeter than an outer perimeter of the absorbent layer. The examiner notes that per the rejection of claim 1, the gel patterned structure is located within the channel openings of the absorbent core. Thus, as the gel is located in the openings and not on the entire perimeter of the absorbent core, it is interpreted that the outer perimeter of the core is larger than the pattern structure of the gel.
Claim(s) 2,6-12,18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovaniemi and Wheeler in view of Wood et al. US 2016/0082142, hereafter Wood.
Regarding claim 2, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, but fail to specifically teach wherein the gel material comprises acidic groups or moieties. The examiner notes however, that Rovaniemi teaches that the system, in any location, may comprise an antimicrobial substance, where said substance may comprise nitric oxide (para. 0034-0036), where said substance may suitably be located within the absorbent core (para. 0034). However, there is no specific disclosure that the gel comprises acidic groups or moieties.
Wood teaches a dressing system and is thus considered analogous to the claimed invention. Wood teaches that the dressing may for a nitric oxide producing system where the system comprises a nitrite containing layer and a hydrogel containing hydrogen ions (See abstract). Wood teaches that the gel layer is located on top of the nitrite containing layer (see figure 1), where the nitrite layer may be a mesh (para. 0012). Per para. 0026, the layer comprising the hydrogen ions (thus acidic groups see para. 0026 where the pH of the layer is below 7 and thus acidic) is formed of a hydrogel. Thus, as Rovaniemi and Wheeler teach a hydrogel impregnated absorbent core, where nitric oxide may suitable be provided by the dressing of Rovaniemi, and Wood teaches that a suitable nitric oxide delivery system in dressings comprises hydrogen ions with a hydrogel interacting with a layer comprising nitrite, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the nitric oxide producing structure of Wood with the dressing of Rovaniemi as Rovaniemi teaches that said dressing suitably can provide nitric oxide. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being the delivery of nitric oxide to a wound. The examiner notes that as the hydrogen ions are within an hydrogel (per Wood), and the absorbent core of Rovaniemi is suitably impregnated with hydrogel (per Wheeler) and may provide the device with the nitric oxide, said combination would reasonably provide the hydrogel in the core with the hydrogen ions with the nitrite containing mesh located in contact with said absorbent as a means to produce the nitric oxide.
Regarding claim 6, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 3, but fails to teach the apparatus further comprising one or more nitrite providing layers. The examiner notes however, that Rovaniemi teaches that the system, in any location, may comprise an antimicrobial substance, where said substance may comprise nitric oxide (para. 0034-0036), where said substance may suitably be located within the absorbent core (para. 0034).
Wood teaches a dressing system and is thus considered analogous to the claimed invention. Wood teaches that the dressing may for a nitric oxide producing system where the system comprises a nitrite containing layer and a hydrogel containing hydrogen ions (See abstract). Wood teaches that the gel layer is located on top of the nitrite containing layer (see figure 1), where the nitrite layer may be a mesh (para. 0012). Per para. 0026, the layer comprising the hydrogen ions (thus acidic groups see para. 0026 where the pH of the layer is below 7 and thus acidic) is formed of a hydrogel. Thus, as Rovaniemi and Wheeler teach a hydrogel impregnated absorbent core, where nitric oxide may suitable be provided by the dressing of Rovaniemi, and Wood teaches that a suitable nitric oxide delivery system in dressings comprises hydrogen ions with a hydrogel interacting with a layer comprising nitrite, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the nitric oxide producing structure of Wood with the dressing of Rovaniemi as Rovaniemi teaches that said dressing suitably can provide nitric oxide. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being the delivery of nitric oxide to a wound. As such the combination device would include a nitrite producing layer in the form of a mesh.
Regarding claim 7, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 6, wherein the one or more nitrite providing layers is positioned beneath the cover layer. The examiner notes that as the nitrite providing layer is adjacent to the absorbent (4) and the absorbent is below the cover layer (3), the nitrite layer would also be below the cover layer.
Regarding claim 8, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 6, wherein the one or more nitrite providing layers is positioned beneath the gel material. As seen in the cited figure 1 of Wood, the nitrite layer is seen to be positioned below the gel material.
Regarding claim 9, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 6, but fails to specifically teach wherein the one or more nitrite providing layers is positioned between the cover layer and the absorbent layer. Per the previous citations of Wood, the device functions to produce nitric oxide when the gel (containing protons)and the nitrite layers contact one another. As the gel is impregnated within the absorbent (per combination under claim 6), and is thus located throughout the gel, the nitrite producing layer being placed on top of the gel (between the backing layer and the absorbent) would still allow for contact between the nitrite and the gel. Per MPEP Section 2144.04 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Therefore, as placing the nitrite layer between the cover and the absorbent core would still allow for said layer to contact the gel and thus form nitric oxide, and thus perform the same function as in its previous location, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the nitrite layer to be between the cover and the gel material in view of an obviousness rearrangement of parts rationale.
Regarding claim 10, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 6, but fails to specifically teach the dressing further comprising an acquisition distribution layer. Rovaniemi teaches an absorbent (4), however, in an alternate embodiment the absorbent may comprise sublayers (4a and 4b), where layer 4a acts as a storage layer and 4b acts as a distribution layer (Rovaniemi para. 0129, 0131). Therefore, as Rovaniemi teaches that a distribution layer may be provided in addition to a absorbent storage layer, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a distribution layer with the prior art device.
Regarding claim 11, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 10, wherein the acquisition distribution layer is a composite material comprising a gel material comprising acidic groups or moieties. The examiner notes that as the distribution layer is a sublayer of the absorbent, where the absorbent comprises, the gel comprising acidic groups, the distribution layer as defined would also comprise the gel containing acidic groups.
Regarding claim 12, Rovaniemi, Wheeler, and Wood teach the wound dressing apparatus of Claim 6, wherein the gel material adhered to the wound-facing surface of the absorbent layer is configured to provide acid to the one or more nitrite providing layers to release nitric oxide (see rejection of claim 6, para. 0026 of Wood).
Regarding claim 18, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 16, wherein the perforated absorbent layer is saturated with the gel material (see rejection of claim 1, where the gel is disclosed to be impregnated into the core and thus saturates the layer), but fails to teach the apparatus further comprising a second gel material adhered to the perforated absorbent layer.
Rovaniemi teaches that the device may comprises carrier layers (6) that may suitably contain the antimicrobial substance (para. 0061, where the anti-microbial substance may be nitric oxide per para. 0036). However, said layer is not a second gel.
Wood teaches a dressing system and is thus considered analogous to the claimed invention. Wood teaches that the dressing may for a nitric oxide producing system where the system comprises a nitrite containing layer and a hydrogel containing hydrogen ions (See abstract). Wood teaches that the gel layer is located on top of the nitrite containing layer (see figure 1), where the nitrite layer may be a mesh (para. 0012). Per para. 0026, the layer comprising the hydrogen ions (thus acidic groups see para. 0026 where the pH of the layer is below 7 and thus acidic) is formed of a hydrogel. Rovaniemi and Wheeler teach an absorbent core comprising a first gel, and a carrier layer suitable for containing nitric oxide suitable to be provided by the dressing of Rovaniemi, and Wood teaches that a suitable nitric oxide delivery system in dressings comprises hydrogen ions with a hydrogel interacting with a layer comprising nitrite, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the nitric oxide producing structure of Wood with the dressing of Rovaniemi (in the form of the carrier layer) as Rovaniemi teaches that said dressing suitably can provide nitric oxide. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being the delivery of nitric oxide to a wound. The examiner notes that as the hydrogen ions are within an hydrogel (per Wood), and the absorbent core of Rovaniemi comprises (a first) gel (per Wheeler) and may provide the device with the nitric oxide, said combination would reasonably provide a second gel (in the form of the proton containing hydrogel as the carrier layer) adjacent to and in contact with said absorbent, as a means to produce the nitric oxide.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rovaniemi and Wheeler in view of Aschenbrenner et al. DE112014006804 , hereafter Aschenbrenner.
Regarding claim 14, Rovaniemi and Wheeler teach the wound dressing apparatus of Claim 1, but fails to specifically teach wherein the gel material is provided on a mesh. Wheeler, as previously combined teaches that a suitable absorbent core may include a plurality of portions of absorbent material enmeshed in the absorbent core (column 11, lines 22-32). Therefore, as a suitable absorbent core may comprise further absorbent components enmeshed within the core, it is interpreted that Wheeler teaches that the absorbent may be a mesh. As such it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide further absorbent pieces within the core of Rovaniemi and Wheeler to form a mesh. Doing so would merely require the simple substitution of one known element (absorbent material) for another (absorbent material with further enmeshed absorbent pieces) to obtain predictable results, that being the formation of an absorbent core, and thus a prima facie case of obviousness exists. The examiner notes that as such the gel would be provided on a mesh since the core is a mesh.
However, should applicant argue than enmeshed is not a mesh, the examiner provides Aschenbrenner. Aschenbrenner teaches an absorbent article and is thus considered analogous to the claimed invention. Aschenbrenner teaches that the absorbent core can be made from a variety of materials including mesh fabrics (para. 0082). Therefore, as Aschenbrenner teaches that an absorbent core may suitably be made from a mesh fabric, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a mesh fabric as the material of the absorbent core of the prior art. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the formation of an absorbent core and thus a prima facie case of obviousness exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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