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 Remarks Regarding Restriction Requirement
Examiner previously required restriction based on an earlier set of claims that were different from the pending claims. The pending claims do not require restriction. Therefore, the restriction is withdrawn. All pending claims are examined.
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 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 16, 18, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jezek (WO 2021069876 A1).
Regarding claim 1, Jezek teaches a composite article comprising: a source layer comprising a nitric oxide precursor; and an activation layer overlying the source layer and comprising a thiol-containing compound (pg. 5 par. 3: The solid material is conveniently in the form of a sheet, layer or film, typically having a thickness in the range 0.01 to 1.0mm, preferably in the range 0.05 to 0.5mm. Preferably the nitrite will be provided in one sheet, layer or film and the thiol will be provided in another sheet, layer or film. The two sheets can then be placed together to form the first component);
wherein the nitric oxide precursor and the thiol-containing compound are capable of reacting in the presence of a solvent to form nitric oxide (pg. 3 par. 1: As the nitrite and thiol are in dry condition the treatment composition is in an inactive state. However, the treatment composition can be activated, by bringing the first and second components into contact with each other, allowing the nitrite and thiol to react to form S- nitrosothiol immediately prior to use, to allow the active delivery of the S-nitrosothiols to the skin site to be treated; pg. 1 par. 5: Nitric oxide spontaneously reacts with thiol groups (e.g. on proteins) to form S-nitrosothiol functional groups, in which form the nitric oxide can be safely and efficiently stored or transported. S-Nitrosothiols are compounds capable of releasing nitric oxide. Therefore nitric oxide can also be readily released on demand via the degradation of S-nitrosothiols; pg. 8 par. 4: Mixing of the nitrite with the thiol in acidic solution results in slow generation of S-nitrosothiol).
Regarding claim 2, Jezek teaches the composite article of claim 1, as set forth above, and teaches wherein the nitric oxide precursor and the thiol- containing compound are capable of reacting in the presence of the solvent to form a nitrosothiol, and wherein the nitrosothiol is capable of decomposing to form the nitric oxide (pg. 3 par. 1: As the nitrite and thiol are in dry condition the treatment composition is in an inactive state. However, the treatment composition can be activated, by bringing the first and second components into contact with each other, allowing the nitrite and thiol to react to form S- nitrosothiol immediately prior to use, to allow the active delivery of the S-nitrosothiols to the skin site to be treated; pg. 1 par. 5: Nitric oxide spontaneously reacts with thiol groups (e.g. on proteins) to form S-nitrosothiol functional groups, in which form the nitric oxide can be safely and efficiently stored or transported. S-Nitrosothiols are compounds capable of releasing nitric oxide. Therefore nitric oxide can also be readily released on demand via the degradation of S-nitrosothiols).
Regarding claim 3, Jezek teaches the composite article of claim 1, as set forth above, and teaches wherein the nitric oxide precursor comprises a nitrite (pg. 5 par. 3: The solid material is conveniently in the form of a sheet, layer or film, typically having a thickness in the range 0.01 to 1.0mm, preferably in the range 0.05 to 0.5mm. Preferably the nitrite will be provided in one sheet).
Regarding claim 4, Jezek teaches the composite article of claim 3, as set forth above, and teaches wherein the nitrite is selected from the group of sodium nitrite (pg. 4 par. 2: The source of nitrite is preferably a nitrite salt such as sodium nitrite), sodium nitrite, calcium nitrite, potassium nitrite (pg. 4 par. 2: The source of nitrite is preferably a nitrite salt such as sodium nitrite or potassium nitrite), tetrabutylammonium nitrite, dicyclohexylammonium nitrite, butylnitrite, isobutylnitrite, t- butylnitrite, amylnitrite, pentylnittrite, a nitrite salt, an ion paired nitrite, silver nitrite, zinc nitrite, iron nitrite, copper nitrite, and a transition metal-nitrite compound.
Regarding claim 5, Jezek teaches the composite article of claim 3, as set forth above, and teaches wherein the thiol-containing compound comprises a cysteine or derivative thereof, a thiol-derivatized polymer or filler, or a combination thereof (pg. 4 par. 2: the thiol is preferably thioglycerol, thioglucose or glutathione; NOTE: in view of claim 6, Applicant reads glutathione as a cysteine or derivative thereof).
Regarding claim 6, Jezek teaches the composite article of claim 5, as set forth above, and teaches wherein the cysteine or derivative thereof is selected from the group of cysteine, glutathione (pg. 4 par. 2: the thiol is preferably thioglycerol, thioglucose or glutathione), acetyl cysteine, penicillamine, acetylpenicillamine, S-nitroso-n-acetylpenicillamine, bucillamine, and combinations thereof.
Regarding claim 16, Jezek teaches the composite article of claim 1, as set forth above, and teaches wherein at least one of the source layer and the activation layer comprises a carrier material formed from a cellulose, a hydrogel, a polyvinyl chloride (pg. 4 par. 4-5: In a preferred embodiment, the first component may be provided as a solid material with the dry nitrite and thiol provided therein. The solid material preferably comprises a polymer material. Preferred polymers include water-soluble polymers such as polyvinyl alcohol (PVA), polyvinyl pyrrolidone, cellulose or modified cellulose (such as carboxymethylcellulose). One preferred polymer material comprises PVA), a polyurethane, a carbosil, a polydimethylsiloxane, an acrylic polymer, a polyester, a poly(lactic acid), a poly(lactic-co-glycolic acid), poly(vinyl acetate), ethylene vinyl acetate, tecothane, pellethane, a hydrogel (pg. 10 last par.: Thus, in one preferred embodiment the invention comprises a first component comprising two layers of dry polymeric matrix, preferably dried PVA, containing the nitrite and thiol respectively and a second component comprising a layer of hydrated hydrogel), a polytetrafluoroethylene, a copolymer thereof, or combinations thereof.
Regarding claim 18, Jezek teaches the composite article of claim 16, as set forth above, and does not have to teach wherein the hydrogel comprises a material selected from the group of a polymacron, a polyacrylamide, a collagen, an agarose, a hyaluronic acid, a poly(organophosphazenes), a chitosan, a poly(ethylene glycol), and poly(vinyl alcohol (Jezek teaches a different carrier material than hydrogel, and claim 16 does not require that the carrier material be a hydrogel).
Regarding claim 25, Jezek teaches the composite article of claim 1, as set forth above, and reads on wherein the article is configured as a food packaging article, a vehicle headliner, a washing machine component, or a sealant (NOTE: this is a recitation of intended use, and the device of Jezek could be used in these contexts; for example, to seal a wound).
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 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.
Claims 7-8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jezek in view of Batchelor (US 7763283 B2) and Duckett (US 6340480 B1).
Regarding claim 7, Jezek teaches the composite article of claim 1, as set forth above, but does not teach further comprising a catalyst.
Batchelor teaches a nitric oxide releasing material with a catalyst coated on its surface (abstract; Biocompatible materials that have the ability to release nitric oxide (NO) in situ at the surface-blood interface when in contact with blood. The materials which may be polymers (e.g., polyurethane, poly(vinyl chloride), silicone rubbers), metals, such as stainless steel, carbon, and the like are provided with biocatalysts or biomimetic catalysts on their surface that have nitrite, nitrate, and/or nitrosothiol-reducing capability. Illustratively, the catalysts are adsorbed or immobilized at the surface of the material.) Batchelor teaches placing the catalyst on similar materials to that taught by Jezek, such as polyurethane, and for the same purpose of initiating a reaction to produce nitric oxide, involving a nitrosothiol. Batchelor specifically teaches placing the catalyst on a surface containing nitrite (C3L26-30: In an embodiment, the polymer substrate may include lipophilic salts of nitrite, nitrates, or nitrosothiols within its matrix to create a reservoir of nitrite, nitrate, or nitrosothiol that can continuously leak to the catalytic surface). The catalyst can be a transition metal such as copper (abstract: In another illustrative embodiment, a biomimetic catalyst is a copper).
Duckett teaches a composition for delivering nitric oxide to affect relaxation and vasodilation (abstract: A composition and method for treating circulatory conditions by promoting systemic vascular relaxation and dilation. Exemplary circulatory conditions are disclosed and include wound healing and/or reduction of hypertension. The composition is a natural combination of L-arginine, ginseng and Zizyphi fructus in an orally or topically administered dosage. The combination works synergistically to synthesize NO and thereby promote systemic vascular relaxation and dilation. The mechanism works in the wound compartment to promote and sustain the wound healing process. Likewise, the combined constituents, when administered orally or topically in proper concentration, work to maintain a critical threshold level of NO in areas that cannot themselves produce it, thereby promoting systemic vascular relaxation and dilation in order to reduce hypertension).
That is, for the purpose of vasodilation and relaxation to reduce hypertension, a faster acting nitric oxide release via a catalyst is advantageous (C3L22-30: The combination of ingredients, when administered in proper concentration, works to maintain a critical threshold level of NO in either the wound compartment or NO-synthesase impaired area in order to promote the healing process. The effect is sufficient to increase the speed and quality of systemic vascular relaxation and dilation, thereby promoting wound healing and/or reducing hypertension. The composition and topical and/or oral use thereof is entirely natural and harmless to the immune system). Therefore, Duckett provides the motivation to add a catalytic layer to the composition of Jezek in order to adapt the composition for affecting vascular relaxation and dilation. Batchelor provides the means for doing so.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Jezek to have a catalytic layer comprising copper on its nitrite layer, as taught by Batchelor and Duckett, in order to increase the rate of nitric oxide release so that vascular relaxation and dilation can be affected more effectively.
Regarding claim 8, Jezek modified by Batchelor and Duckett teaches the composite article of claim 7, as set forth above, and teaches wherein the catalyst comprises a transition metal, a non-metal, or a combination thereof, and optionally wherein the catalyst comprises a transition metal selected from the group of copper (Cu) (see Batchelor and Duckett modification in claim 7 rejection), zinc (Zn), silver (Ag),
gold (Au), lead (Pb), platinum (Pt), iron (Fe), magnesium (Mg), manganese (Mn), cobalt (Co), nickel (Ni), and zinc chloride, or optionally wherein the non-metal is selected from the group consisting of selenium (Se), tellurium, (Te), and an organometal compound.
Regarding claim 13, Jezek modified by Batchelor and Duckett teaches the composite article of claim 1, as set forth above, but does not teach wherein the activation layer further comprises a catalyst.
The Batchelor and Duckett modifications inserted a catalytic layer on the nitrite (source) layer. This can be between the two layers or spaced from the activation layer. Batchelor itself teaches wherein the catalytic layer and polymer are at a blood interface (C1L21-25: This invention relates generally to biocompatible materials, such as polymers or metals, and more particularly, to biocompatible materials having blood interface surfaces that are capable of biocatalytic or biomimetic generation of nitric oxide in situ when contacted with endogenous nitrite, nitrate, or nitrosothiols in blood). That is, there is already motivation to provide the catalyst at the interface between two reactants in order to better catalyze the reaction.
Furthermore, in the absence of any teaching to the contrary, the location of the catalytic layer does not affect operation so long as it is in contact with the reactants. Absent a showing of significance or unexpected results, the claimed locations of the components are prima facie obvious and do not modify the operation of the invention and further, do not add patentable significance. The Manual of Patent Examining Procedures discloses that in In re Japikse, 181 F.2d 1019, 86 USPQ 70(CCPA 1950), a mere rearrangement of parts for a design change has no patentable significance unless a new and unexpected result is produced. In this case, there is the expected effect that the catalytic layer being placed at the interface between two reactants would allow it to better catalyze the reaction. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catalyst of Jezek modified by Batchelor and Duckett to be placed at the interface between the nitrite and thiol layers, such that the thiol/activation layer can be said to comprise the catalyst on its surface, with a reasonable expectation that the catalyst would be able to catalyze the reaction between the two layers readily.
Regarding claim 14, Jezek modified by Batchelor and Duckett teaches the composite article of claim 1, as set forth above, and teaches further comprising a catalytic layer, wherein the catalytic layer comprises the catalyst (see Batchelor and Duckett modifications in claim 7 rejection, wherein the catalyst being deposited on the surface of the nitrite layer is interpreted to comprise a catalytic layer).
Regarding claim 15, Jezek modified by Batchelor and Duckett teaches the composite article of claim 14, as set forth above, and teaches wherein the catalytic layer is:
(a) disposed between the source layer and the activation layer;
(b) disposed on the source layer and optionally spaced from the activation layer;
(c) disposed on the activation layer and optionally spaced from the source layer; or (d) combinations thereof (see Batchelor and Duckett modification in claim 7 rejection, wherein the catalyst being disposed on the nitrite layer would read on at least one of these limitations).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jezek in view of Locklin (WO 2019079765 A1).
Regarding claim 19, Jezek teaches the composite article of claim 16, as set forth above, and teaches a support in the form of a mesh or a fiber; and a material disposed within the support and formed from a cellulose, a polyvinyl chloride,
a polyurethane, a carbosil, a polydimethylsiloxane, an acrylic polymer, a polyester, a poly(lactic acid), a poly(lactic-co-glycolic acid), poly(vinyl acetate), ethylene vinyl acetate, tecothane, pellethane, a hydrogel, another polytetrafluoroethylene, a copolymer thereof, or combinations thereof (pg. 6 par. 1: Alternatively, the first component may be provided in the form of a porous water-absorbable material such as a mesh or foam, onto which the nitrite or thiol is provided in dried form. Such a mesh or foam is preferably made from a solid water-absorbent polymer, e.g. silicone, polyethylene, polypropylene polystyrene, polyurethane, polyacrylate and polyamide),
but does not teach
comprising polytetrafluoroethylene.
Jezek teaches wherein a mixture of polymer materials may be used (pg. 5 par. 1: Mixtures of polymer materials may be used).
Polytetrafluoroethylene is a hydrophobic substance.
Locklin teaches an NO-releasing compositions comprising polymers (abstract: The copolymers can include hydrophilic repeat units, and in particular zwitterionic repeat units such as repeat units containing phosphorylcholine groups. In some aspects, the coating compositions are applied to a surface of a polymer substrate, wherein the polymer substrate had nitric oxide releasing properties. The coating compositions and the coated articles can have antifouling, antithrombotic, and/or antibacterial properties).
Locklin teaches the advantage of having both hydrophilic and hydrophobic materials as part of the NO-releasing composition (par. 68: he present disclosure provides polymer materials and/or coatings that provide a branched polymer surface chemistry to provide hydrophobic and steric hindrances to adhesion by proteins, bacteria and other microbes, while simultaneously providing active antifouling and antimicrobial activity from surface immobilized NO-donors; par. 74: In embodiments, the article is further impregnated with silicone oil, which increases the hydrophobicity of the surface, further increasing the antifouling, anti-thrombotic, and anti-microbial properties; par. 151: SNAP based NO releasing polymers have many desirable properties from a translational perspective such as the long-term storage stability (6 months), ease of sterilization, and extended NO release (> 2 weeks) without negatively affecting the physical characteristics, biocompatibility, and hemocompatibility of the polymer [42, 59, 60]. Similarly, the surface grafted BPAM has been reported to exhibit excellent antimicrobial activity against Gram-positive and Gram-negative bacteria on instant contact due to high surface charge density of the deposited BPAM thin film [20]. However, this is the first example that combines SNAP and BPAM together to demonstrate their antibacterial potential; par. 152: The present example demonstrated that the SNAP-BPAM combination has better antibacterial properties than SNAP or BPAM alone. BPAM is highly regarded as a bactericidal agent, but, it can only act on bacteria that are in direct contact. NO molecule through its diffusive nature allows acting on bacteria that are beyond the direct contact. This property is useful to act on biofilm matrix that otherwise prevents the penetration of antibacterial agent and keeps the bacteria immune. BPAM however, imparts a relatively hydrophilic surface to SNAP-CarboSil as apparent from a decrease in the contact angle. Studies have shown higher NO release from the hydrophilic surface when compared to the hydrophobic surfaces which in turn resulted in higher bacterial killing). In particular, a hydrophobic substance the polymer can increase antifouling, anti-thrombotic, and anti-microbial properties.
Furthermore, Locklin teaches combining polymers already taught by Jezek with polytetrafluroethylene (par. 70: In embodiments polymer substrate/polymer material can include polymers such as, but not limited to polyurethane, silicone, polyvinyl chloride, ketone polymers (including, but not limited to, polyether ether ketone), polyethylene (including, but not limited to, ethylene vinyl acetate), bioresorbable polymers (including, but not limited to, polylactic acid, polyglycolic acid, and polycaprolactone), fluoropolymers (including, but not limited to, polytetrafluoroethylene, perfluoroether, and fluorinated ethylene propylene), and combinations thereof).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer mesh of Jezek to also comprise a finite amount of polytetrafluoroethylene, as taught by Locklin, in order to provide some hydrophobicity, which increases antifouling, anti-thromotic, and anti-microbial properties, which are advantageous since Jezek is directed towards treating skin.
Claims 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Jezek in view of Stasko (WO 2011022680 A2).
Regarding claim 20, Jezek teaches the composite article of claim 1, as set forth above, but does not teach wherein at least one of the source layer or the activation layer has a permeability in an amount of at least 0.001 g/(m-s-Pa) in accordance with ASTM E2945 - 14(2021) for permitting movement of at least one of the nitric oxide precursor or the solvent to or through the activation layer.
Stasko teaches a nitric oxide releasing polymer for treating wounds (abstract: Provided according to some embodiments of the invention are wound dressings that include a polymer matrix and nitric oxide-releasing polysiloxane macromolecules within and/or on the polymer matrix). Stasko teaches wherein the pore size and permeability of the polymer layer can be chosen based on how the wound is to be treated (par. 106: Thus, the polymer matrix and the NO-releasing polysiloxane macromolecules may be selected based on at least one property of the polymer matrix and at least one property of the NO-releasing polysiloxane macromolecules such that the interaction of the properties of the polymer matrix and the NO-releasing polysiloxane macromolecules provides a predetermined characteristic to the wound dressing. In some embodiments of the invention, the at least one property of the polymer matrix may include moisture uptake/retention, moisture vapor transfer rate (MVTR), surface energy, oxygen permeability, nitric oxide permeability, pore size biodegradability/bioabsorbability, tensile strength, biocompatibility, ionic character and/or transparency… The predetermined characteristic may be the ability of the nitric oxide in the wound dressing to signal one or more wound healing cascades, to act as an anti-inflammatory agent and/or to act as an antimicrobial agent).
Furthermore, a mere change in proportion, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in proportions can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, Jezek already teaches that the rate of nitric oxide transfer is an important variable to control for treating skin (pg. 4 par. 1: because of its relatively slow rate of decomposition to generate nitric oxide, resulting in satisfactory stability of the S-nitrosothiol in the dressing and consequential slow release of nitric oxide at an appropriate rate for skin benefits). The rate of nitric oxide transfer has to be steady yet fast enough to provide a healing effect, such that, as Stasko teaches, the nitric oxide releasing article functions well as an antimicrobial, anti-inflammatory, or wound healing article. In turn, one of ordinary skill in the art would understand that the permeability of the polymer layer (specifically, the pore size and thickness) affects the rate of nitric oxide transference to the skin.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size and thickness of the nitrite and thiol layers of Jezek such that the permeability of the layers is at least 0.0001 g/(m-s-Pa), as taught by Stasko, in order to affect a rate of transfer that is optimized for both healing effect and stability.
Regarding claim 21, Jezek modified by Stasko teaches the composite article of claim 20, as set forth above, and teaches further comprising a metering layer capable of modulating the movement of at least one of the nitric oxide precursor or the solvent to or through the activation layer (pg. 3 par. 1-2: Thus, the present invention provides a skin application composition comprising a first component in dry condition comprising a source of nitrite and a thiol and a second component comprising a source of water. As the nitrite and thiol are in dry condition the treatment composition is in an inactive state. However, the treatment composition can be activated, by bringing the first and second components into contact with each other, allowing the nitrite and thiol to react to form S- nitrosothiol immediately prior to use, to allow the active delivery of the S-nitrosothiols to the skin site to be treated; pg. 8 par. 1: Buffer may be included in one or both of the first and second components NOTE: the triggering of the reaction and the buffer affect the transfer of the nitrite to react with the thiol in the first component).
Regarding claim 22, Jezek modified by Stasko teaches the composite article of claim 21, as set forth above, and teaches wherein the metering layer is:
(a) disposed between the source layer and the activation layer;
(b) disposed on the source layer and optionally spaced from the activation layer;
(c) disposed on the activation layer and optionally spaced from the source layer; or (d) combinations thereof (pg. 7 par. 4: The composition is activated, by bringing the first component into contact with the second component; NOTE: bringing the second component in contact with the first component necessarily brings it into contact with either one of the layers in any of the configurations claimed here).
Regarding claim 23, Jezek modified by Stasko teaches the composite article of claim 21, as set forth above, but does not teach wherein the metering layer is disposed on the activation layer and spaced from the source layer, and wherein the metering layer only partially overlies the activation layer such that a portion of the activation layer is free of the metering layer.
However, in the absence of any teaching to the contrary, the location of the second component does not affect operation because so long as there is adequate contact with the first component, the second component would be capable to initiating the reaction between the nitrite and thiol layers. Absent a showing of significance or unexpected results, the claimed locations of the components are prima facie obvious and do not modify the operation of the invention and further, do not add patentable significance. The Manual of Patent Examining Procedures discloses that in In re Japikse, 181 F.2d 1019, 86 USPQ 70(CCPA 1950), a mere rearrangement of parts for a design change has no patentable significance unless a new and unexpected result is produced. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second component of Jezek modified by Stasko to be disposed on the activation layer, spaced from the source layer, wherein the second component only partially overlies the activation layer, with a reasonable expectation that the second component would still be capable of initiating the reaction between the nitrite and thiol layers.
Regarding claim 24, Jezek modified by Stasko teaches the composite article of claim 21, as set forth above, but does not teach wherein the metering layer has a permeability different than the permeability of at least one of the source layer or the activation layer.
Jezek teaches a range of materials for both the first and second components (pg. 6 par. 1; pg. 8 last par.). Any given combination of these two materials would most likely have two different permeabilities. Unless there is an unexpected effect, one of ordinary skill in the art would find it at least obvious to try any one of these combinations that result in having two different permeabilities because they would be equally capable of initiating the nitrite-thiol reaction.
In addition, the rationale from the rejection to claim 20 still applies. Jezek already teaches that the rate of nitric oxide transfer is an important variable to control for treating skin (pg. 4 par. 1: because of its relatively slow rate of decomposition to generate nitric oxide, resulting in satisfactory stability of the S-nitrosothiol in the dressing and consequential slow release of nitric oxide at an appropriate rate for skin benefits). The rate of nitric oxide transfer has to be steady yet fast enough to provide a healing effect, such that, as Stasko teaches, the nitric oxide releasing article functions well as an antimicrobial, anti-inflammatory, or wound healing article. In turn, one of ordinary skill in the art would understand that the permeability of the second component (specifically, the pore size and thickness) affects the rate of nitric oxide transference to the skin.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second component to comprise a material with a different permeability than the nitrite and thiol layers, as taught by Stasko, in order to provide an equally effective means of initiating the nitrite-thiol reaction and/or to optimize the rate of nitric oxide release to the skin.
Conclusion
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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