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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 2nd, 2026 has been entered.
Claim Status
Claims 18 and 20-35 are currently pending. Claims 1-17 and 19 are cancelled. Claims 21, 27, and 33 have been amended. It is noted that claim 18 has been listed as currently amended, yet has provided no amendment of the claim limitations over the claims submitted on August 11th, 2025.
Response to Arguments
Applicant’s arguments filed January 2nd, 2026 have been fully considered.
Regarding applicant’s arguments pertaining to the 112(a) rejection previously set forth in the final rejection mailed on September 2nd, 2025. The examiner finds these arguments persuasive and has herein withdrawn the 1112(a) rejection and the claim objections under 35 U.S.C. 132(a).
Regarding applicant’s arguments pertaining to the 103 rejections, applicant’s arguments have been fully considered but are not found to be persuasive.
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). Applicant argues that the Office action provides no explanation of how the invention as a whole is obvious or why the ordinary artisan would make five changes to modify the system of Long to alter the dressing itself, examiner points out that the applicant has provided no direct reasoning against the reasoning presented by the examiner in the rejection other than to say that one would not have made so many modification. As such the examiner does not find this argument persuasive.
In response to applicant’s argument that the examiner has not provided sufficient motivation to combine the references and as such suggesting that proper motivation to combine the references present, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, with regards to the rejections of Dorian, the examiner has provided the motivation to have modified the dressing of Long to have included an acquisition layer positioned above the transmission layer and below the absorbent layer comprising horizontally extending fibers configured to horizontally wick fluid across the material as taught by Collinson for the purpose of more evenly distributing fluid throughout the dressing (¶0252 of Collinson), and to have substituted the therapeutic liquid of Dorian that performs the function of providing a therapeutic gas to the wound for the therapeutic liquid of Stenzler since these elements perform the same function of providing a therapeutic gas to a patient wound. Simply substituting one therapeutic gas emitting liquid means for another would yield the predictable result of allowing a(n) wound dressing to provide a therapeutic gas to the wound. See MPEP 2143, as well as for the purpose of optimizing the healing of chronic wounds with specific actions directed at reducing bacterial burden and reducing exudate (¶0003) and one would expect a reasonable success of modification as the device of Dorian is capable of supplying a liquid to the wound and both therapeutic gases of Dorian and Stenzler are supplied through liquid medium means. As such the examiner does not find this argument persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding applicant’s arguments presented to the dependent claims, applicant has provided no further detailed arguments pertaining to the dependent claims other than to state that applicant does not agree with examiners characterization. As such arguments toward the dependent claims are considered addresses herein through the addressal of the independent claim arguments presented above.
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.
Claims 18, 20, 22-25 and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al (U.S. Publication 2021/0085839) in view of Collinson et al. (U.S. Publication 2015/0182677), Augustine (U.S. Patent No.6,406,448) in combination with the teachings of Stone et al. (U.S. Publication 2018/0135948), and Dorian et al. (U.S. Publication 2014/0107562).
Regarding claim 18, Long discloses a wound treatment system 100, comprising: a wound dressing 102 configured to be positioned over a wound (¶0036 tissue interface place over wound) to provide a substantially fluid impermeable seal (¶0043 fluid seal between therapeutic environment and external environment) over the wound, the wound dressing 102 comprising: a wound contact layer 204 configured to be positioned in contact (¶0050 applied to tissue site) with the wound; a transmission layer 108 positioned above (¶0050 applied over 204) the wound contact layer 204, the transmission layer 108 configured to transmit wound fluid away (¶0037 draws toward the source of negative pressure) from the wound; an absorbent layer (¶0049 absorbent core), the absorbent layer configured to absorb (¶0049, capture and store fluids) wound fluid; and a backing layer 106 (¶0049 absorbent core), the backing layer comprising an orifice (Fig. 4 shows connection of tubing for negative pressure would is in fluid communication with the lower layers of the dressing through the backing layer necessitating an orifice where the connection meets the backing layer); and an oxygen generator (114, ¶0012 electrolysis) configured to supply a therapeutic gas (¶0025, delivers oxygen to dressing) to the wound; and a source of negative pressure 104 configured to supply negative pressure to the wound (¶0023 negative pressure distributed in fluid path between negative pressure supply and tissue site).
Long does not expressly disclose the absorbent layer being positioned above the transmission layer, an acquisition distribution layer positioned above the transmission layer and below the absorbent layer, the acquisition distribution layer configured to horizontally wick fluid and increase delivery of oxygen to the wound, the backing layer comprising an orifice; or a nitric oxide generator positioned within the wound dressing, the nitric oxide source configured to supply nitric oxide to the wound through the orifice.
However, regarding the absorbent layer being positioned above the transmission layer and an acquisition distribution layer positioned above the transmission layer and below the absorbent layer, the acquisition distribution layer configured to horizontally wick fluid and increase delivery of oxygen to the wound, Collinson, in the same field of endeavor of negative pressure wound dressings, discloses an absorbent layer positioned above a transmission layer, and an acquisition distribution layer ¶0252 positioned above the transmission layer and below the absorbent layer, the acquisition distribution layer comprising horizontally extending fibers (¶0252 substantially all of the fibers span a distance perpendicular to the thickness of the ADL material, a horizontal distance) configured to horizontally wick fluid across the material for the purpose of more evenly distributing fluid throughout the acquisition distribution layer material ¶0252 and inherently thus the dressing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing of Long to have included an acquisition layer positioned above the transmission layer and below the absorbent layer comprising horizontally extending fibers configured to horizontally wick fluid across the material as taught by Collinson for the purpose of more evenly distributing fluid throughout the dressing (¶0252 of Collinson).
Regarding the generator configured to generate nitric oxide to the wound, Augustine, in the same field of endeavor of wound treatment, teaches the ability to supply either oxygen to increase oxygen availability to growing cells in the wound, or supplying nitric oxide to a wound for the purpose of being absorbed across the wound surface to increase localized blood flow due to Nitric oxides known effect of vasodilation (Col. 14 lines 56-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the generator disclosed by Long to have generated nitric oxide as an alternative to the oxygen disclosed by Long as Augustine teaches that nitric oxide can be supplied alternatively to oxygen for the purpose of increasing localized blood flow through vasodilation (Col. 14 lines 56-67 of Augustine).
Furthermore, Stone, in the same field of endeavor of therapeutic gas generation, teaches that it would have been within the capabilities of one of the ordinary skill in the art to generate nitric oxide rather than oxygen through the process of electrolysis (¶0004 although hydrogen and oxygen are two of the more common gasses produced by electrolytic gas generators, electrolytic gas generators can be used to produce other gases such as nitric oxide) and as Long discloses using electrolysis to generate the oxygen, it would have been obvious to one of ordinary skill in the art to have also used the same method of gas generation, electrolysis, to generate the nitric oxide alternative as taught by Stone.
Regarding the nitric oxide generator being positioned within the wound dressing, Dorian, in the same field of endeavor of wound dressings supplying gas to the patient, discloses positioning the gas source (oxygen reservoir 124) within the wound dressing ¶0096.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the therapeutic gas generator disclosed by Long, as modified by Augustine and Stone et al. to include nitric oxide rather than oxygen, to have been positioned within the wound dressing for the purpose of integrating it with the dressing such that the patient does not have to be attached to an external source of gas which would have the benefit of reducing the complication of having multiple connections leading from the dressing.
Furthermore, positioning of the therapeutic gas generator within the wound dressing would merely involve a rearrangement of parts of the apparatus. Since applicant has not given any criticality to why the position of the nitric oxide source disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 20, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses the transmission layer 106 comprising a material with a three dimensional structure (has length, width, and height).
Regarding claim 22, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long in view of Collinson do not expressly disclose or suggest the wound contact layer comprising adhesive on a wound facing side, the adhesive configured to provide a substantially gas tight seal over the wound. However, Long does disclose an adhesive on a wound facing side (¶0044, attach to epidermis) of the cover 106 being pressed through ¶0050 the wound contact layer 204 during adhesion to epidermis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the adhesive to be on the wound facing side of the wound contact layer since this claimed position of adhesive being on the wound facing side of the wound contact layer does not change the adhesive’s ability to adhere the device to the epidermis. Since applicant has not given any criticality to why the position of the adhesive disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 23, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 22. Long further discloses the adhesive being a silicone adhesive (¶0044, silicone gel).
Regarding claim 24, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses the wound contact layer 204 comprises a plurality of slits (¶0049, perforations) configured to distribute nitric oxide (therapeutic gas of Long as modified by Augustine to be nitric oxide) over the wound and further configured to transmit wound fluid away (permeable to fluid and thus transmits through when negative pressure is applied) from the wound.
Regarding claim 25, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses the backing layer 106 is substantially oxygen and fluid impermeable (¶0009 contains and sustains pressure; ¶0043 fluid seal).
Regarding claim 28, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses a pressure sensor 120 positioned in (¶0052 measures pressure in dressing) the wound dressing 102 and a controller 110 configured to regulate supply of nitric oxide based on feedback (¶0052, feedback regulates control valve which regulates therapeutic gas and negative pressure sources) from the pressure sensor 120.
Regarding claim 29, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 28. Long further discloses the controller 110 is further configured to regulate application of negative pressure to the wound (¶0026 controller coupled to control valve 116 which is coupled to both negative pressure and oxygen sources).
Regarding claim 30, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 29. Long further discloses the controller 110 is further configured to regulate application of simultaneous (¶0051, therapeutic gas delivered while negative-pressure therapy is administered; Claim 23 has supply of nitric oxide under negative pressure environment showing simultaneous use of nitric oxide and negative pressure) supply of nitric oxide and negative pressure to the wound.
Regarding claim 31, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 29. Long further discloses the controller 110 is further configured to regulate application of sequential (¶0059, alternating) supply of nitric oxide, and negative pressure to the wound.
Regarding claim 32, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses a method of treating a wound using the system ¶0051.
Regarding claim 33, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long further discloses the nitric oxide source providing nitric oxide to the wound in a controlled amount (nitric oxide provision controlled by controller 110 based on pressure sensor data which equates to an amount of nitric oxide present creating the pressure).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Long et al (U.S. Publication 2021/0085839) in view of Augustine (U.S. Patent No.6,406,448) in combination with the teachings of Stone et al. (U.S. Publication 2018/0135948), Dorian et al. (U.S. Publication 2014/0107562), and Collinson et al. (U.S. Publication 2015/0182677) and further in view of Khan et al. (U.S. Publication 2016/0024326).
Regarding claim 26, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 25. Long further discloses the backing layer comprising polyvinyl alcohol, but does not expressly disclose the backing layer comprising ethylene vinyl alcohol (EVA) when applying a barrier layer that stiffens upon evaporation of a volatile plasticizer.
However, Khan, in the same field of endeavor of gas barrier layers, teaches including ethylene vinyl alcohol in barrier layers with polyvinyl alcohol ¶0002 for the purpose of providing a barrier that can tolerate higher proportions of organic solvents, in particular lower alcohols, in aqueous blends in order to produce faster drying barrier coating formulations ¶0002.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polyvinyl alcohol backing layer of Long to have included ethylene vinyl alcohol (EVA) as taught by Khan for the purpose of providing a barrier that can tolerate higher proportions of organic solvents, in particular lower alcohols, in aqueous blends in order to produce faster drying barrier coating formulations ¶0002.
Claims 21, 27, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al (U.S. Publication 2021/0085839) in view of Augustine (U.S. Patent No.6,406,448) in combination with the teachings of Stone et al. (U.S. Publication 2018/0135948), Dorian et al. (U.S. Publication 2014/0107562) and Collinson et al. (U.S. Publication 2015/0182677), and further in view of Sarangapani et al (U.S. Publication 2016/0166781).
Regarding claim 21, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long in view of Augustine, Dorian, and Collinson does not teach an absorbent layer comprising an opening configured to provide direct fluidic communication between nitric oxide source and the transmission layer
However, Sarangapani, in the same field of endeavor of negative pressure wound therapy devices configured to supply therapeutic gas to a wound, teaches an absorbent layer 132 comprising an opening (see below illustrative diagram of Fig. 6) configured to provide direct fluidic communication between nitric oxide source and the transmission layer (see below illustrative diagram of Figure 6) for the purpose of encouraging topical delivery of oxygen to the wound ¶0093.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the absorbent layer of Long in view of Collinson to have included an opening configured to provide direct fluidic communication between the nitric oxide source and the transmission layer, as taught by Sarangapani for the purpose of encouraging topical delivery of the therapeutic gas to the wound (¶0093 of Sarangapani).
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Illustrative diagram of Figure 6 of Sarangapani (U.S. Publication 2016/0166781).
Regarding claim 27, Long in view of Augustine, Dorian, and Collinson suggest the wound treatment system of claim 18. Long do not expressly disclose or suggest the wound dressing further comprising a filter configured to prevent wound fluid from reaching the nitric oxide source.
However, Sarangapani, in the same field of endeavor of negative pressure wound therapy devices configured to supply therapeutic gas to a wound, teaches a filter 110 configured to prevent fluid from reaching a therapeutic gas source 106 for the purpose of protecting the therapeutic gas source, which otherwise might be damaged by contaminating foreign solids or liquids ¶0066.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the wound dressing of Long in view of Sarangapani to have included a filter configured to prevent fluid from reaching the nitic oxide source, as taught by Sarangapani, for the purpose of protecting the nitric oxide source, which otherwise might be damaged by contaminating foreign solids or liquids (¶0066 of Sarangapani) As the nitric oxide source is positioned within the dressing, it would have been obvious to have the filter be positioned within the dressing as well as the filter is the interaction between the dressing and the nitric oxide source and therefore would need to be placed in the fluid pathway from the nitric oxide source which would be positioned within the dressing.
Regarding claim 35, Long in view of Augustine, Dorian, and Collinson and further in view of Sarangapani suggest the wound treatment system of claim 27. Long, Augustine, Dorian, and Collison do not teach the filter being a hydrophobic filter. However, Sarangapani teaches the filter being a hydrophobic filter (110 formed from ePTFE, expanded polytetrafluoroethylene, which is inherent possesses hydrophobic properties). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the wound dressing of Long in view of Sarangapani to have included a hydrophobic filter configured to prevent fluid from reaching the nitic oxide source, as taught by Sarangapani, for the purpose of protecting the nitric oxide source, which otherwise might be damaged by contaminating foreign liquids (¶0066 of Sarangapani) As the nitric oxide source is positioned within the dressing, it would have been obvious to have the hydrophobic filter be positioned within the dressing as well as the filter is the interaction between the dressing and the nitric oxide source and therefore would need to be placed in the fluid pathway from the nitric oxide source which would be positioned within the dressing.
Claims 18 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (U.S. Publication 2014/0107562) in view of Collinson et al. (U.S. Publication 2015/0182677) and Stenzler et al. (U.S. Publication 2015/0328256).
Regarding claims 18 and 34, Dorian discloses a wound dressing 90 configured to be positioned over a wound to provide a substantially fluid impermeable seal over the wound (¶0083 sealed for preventing dehydration of wound), the wound dressing comprising;
a wound contact layer (¶0081 layer of silicone film applied over layer 74 to modify the surface) configured to be positioned in contact with the wound (¶0081, contacting),
a transmission layer 74 positioned above the wound contact layer, the transmission layer configured to transmit wound fluid away from the wound (¶0082 portion of dressing which contacts the wound may define one or more through holes which extend from the wound to wick any exudate through the holes and into the absorbent material),
an absorbent layer 72 positioned above the transmission layer, the absorbent layer configured to absorb wound fluid (¶0084 exudate is absorbed into the material),
a backing layer 76 positioned above the absorbent layer, the backing layer comprising an orifice 92,
and a therapeutic liquid source 124 positioned within the wound dressing (¶0096 integrated with), the source configured to supply therapeutic liquid (¶0028 oxygenated water) to the wound; and
a source of negative pressure configured to supply negative pressure to the wound (Claim 14 comprising a vacuum apparatus fluidly coupled to the access port for removing exudate from the wound dressing).
Dorian does not expressly disclose an acquisition layer, or the therapeutic source being a nitric oxide generator wherein the nitric oxide is provided to the wound in liquid form.
However, regarding an acquisition distribution layer positioned above the transmission layer and below the absorbent layer, the acquisition distribution layer configured to horizontally wick fluid and increase delivery of oxygen to the wound, Collinson, in the same field of endeavor of negative pressure wound dressings, discloses an absorbent layer positioned above a transmission layer, and an acquisition distribution layer ¶0252 positioned above the transmission layer and below the absorbent layer, the acquisition distribution layer comprising horizontally extending fibers (¶0252 substantially all of the fibers span a distance perpendicular to the thickness of the ADL material, a horizontal distance) configured to horizontally wick fluid across the material for the purpose of more evenly distributing fluid throughout the acquisition distribution layer material ¶0252 and inherently thus the dressing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dressing of Long to have included an acquisition layer positioned above the transmission layer and below the absorbent layer comprising horizontally extending fibers configured to horizontally wick fluid across the material as taught by Collinson for the purpose of more evenly distributing fluid throughout the dressing (¶0252 of Collinson).
Regarding the source being a nitric oxide generator wherein the nitric oxide is provided to the wound in liquid form, Stenzler, in the same field of endeavor of wound dressings (¶0027 instilled on a dressing below a gas impermeable cover), teaches using a liquid nitric oxide generator (¶0026 liquid nitric oxide releasing solution (NORS) generates nitric oxide through the interation of nitrite compound and acidifying agent) for the purpose of optimizing the healing of chronic wounds with specific actions directed at reducing bacterial burden and reducing exudate (¶0003).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the therapeutic liquid of Dorian that performs the function of providing a therapeutic gas to the wound for the therapeutic liquid of Stenzler since these elements perform the same function of providing a therapeutic gas to a patient wound. Simply substituting one therapeutic gas emitting liquid means for another would yield the predictable result of allowing a(n) wound dressing to provide a therapeutic gas to the wound. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the oxygenated water of Dorian to have been the liquid nitric oxide generating solution of Stenzler for the purpose of optimizing the healing of chronic wounds with specific actions directed at reducing bacterial burden and reducing exudate (¶0003) and one would expect a reasonable success of modification as the device of Dorian is capable of supplying a liquid to the wound and both therapeutic gases of Dorian and Stenzler are supplied through liquid medium means.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781