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 .
Summary
Claims 1-3, 5, 8-11, 13-16, 18-19, 21-23, and 27-30 are pending in this office action. Claims 4, 6-7, 12, 17, 20, and 24-26 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on April 28, 2022 is a 371 of PCT/US2020/059390 filed November 6, 2020, which in turn claims domestic priority to provisional patent applications 63/088,015 filed October 6, 2020 and 62/942,422 filed on December 2, 2019.
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 non-obviousness.
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 1-3, 5, 8-11, 13-16, 18-19, 21-23, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sudipta et al. (US2013/0195927A1) in view of Agarwal et al. (US2018/0028713A1), Harrison et al. (US2010/0112087A1), Stabler et al. (US2012/0114729A1), and Hassler et al. (US2011/0002971A1).
[The Examiner is going to introduce each reference and then combine them in the rejection of the instant claims.]
1. Sudipta et al.
Sudipta et al. is considered to be the prior art closest to the present application and teaches cerium oxide nanoparticles and associated methods for promoting wound healing (see title). In addition, Sudipta et al. disclose novel compositions and methods for the treatment and promotion of wound healing. There is included a method for treating a wound including administering to a subject in need thereof a wound composition comprising an effective amount of ceria nanoparticles (see abstract).
2. Agarwal et al.
Agarwal et al. teach methods and compositions for wound healing (see title). In addition, Agarwal et al. disclose that the present invention relates to large scale manufacture of nano scale micro sheets for use in applications such as wound healing or modification of a biological or medical surface (see abstract).
3. Harrison et al.
Harrison et al. teach oxygen-generating compositions for enhancing cell and tissue survival in vivo (see title). Additionally, Harrison et al. disclose a method of treating hypoxic tissue such as wound tissue comprises contacting a composition to the hypoxic tissue in a hypoxia-treatment effective amount, the composition comprising a biodegradable polymer and an inorganic peroxide incorporated into the polymer (see abstract).
4. Stabler et al.
Stabler et al. teach silicone-peroxide compositions for long-term, controlled oxygen release (see title). Furthermore, Stabler et al. disclose a composite for delivering extended-release of oxygen. The composite can include a biocompatible polymeric support having a plurality of solid peroxide particles suspended therein. The polymer support can exhibit an oxygen tension value of at least 40 mmHg for a period of 14 days. The weight ratio of biocompatible polymeric support to solid peroxide particles can range from 1:1 to 99:1. Also disclosed is a method of using the composite to deliver oxygen to cells in both in vivo and in vitro environments (see abstract).
5. Hassler et al.
Hassler et al. teach ceria for use as an antimicrobial barrier and disinfectant in a wound dressing (see title). Also, Hassler et al. disclose protecting a human from an
infection using a disinfecting agent as described herein and a method for use thereof, more particularly to a rare earth containing device for protecting a wound and a method for use thereof (see abstract).
Sudipta et al., Agarwal et al., and Harrison et al.
Regarding instant claim 1, Sudipta et al., Agarwal et al., and Harrison et al. teach a wound healing dressing. The necessary citations within Sudipta et al., Agarwal et al., and Harrison et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Sudipta et al., Agarwal et al., and Harrison et al. Citations
A wound healing dressing, comprising: an oxygen-generating composite material comprising one or more of the following: calcium peroxide, sodium peroxide, magnesium peroxide, lithium peroxide, potassium peroxide, and a combination thereof;
a cerium oxide material comprises a plurality of cerium oxide nanoparticles;
Sudipta et al. disclose novel compositions and methods for the treatment and promotion of wound healing (see title and abstract within Sudipta et al.).
Harrison et al. disclose a method of treating hypoxic tissue such as wound tissue (see title and abstract within Harrison et al.).
Sudipta et al. disclose the use of ceria nanoparticles (Nanoceria) (see paragraphs [0028] “The Nanoceria may include cerium oxides having the formulas CeO2 and Ce2O3” and [0031] “The Nanoceria may be impregnated within, otherwise dispersed within, and/or applied to a surface of the dressing using any suitable technique known in the art, such as by coating, spraying or dipping. It is appreciated that the
dressing may include a polymeric coating or surface to be placed in contact with the wound, such as Teflon®, to avoid sticking of the dressing to the wound.”; both within Sudipta et al.; also see the discussion directly above within Table I).
Harrison et al. disclose the use of metal peroxides (see paragraph [0029] “The oxygen-generating active agent is preferably an organic or inorganic peroxide such as urea peroxide, calcium peroxide, and magnesium peroxide, and sodium percarbonate. The oxygen-generating active agent is included in the composition in any suitable amount (e.g., from 0.1 or 1 to 10, 20, or 30 percent by weight, or more). In some embodiments calcium peroxide is preferred as it releases oxygen at a desirable rate in situ. The oxygen-generating active agent can be included in the polymer in solid form, such as in the form of a plurality of solid particles thereof.” within Harrison et al.). Therefore, a skilled artisan (POSITA) could combine any of these metal peroxides for the wound dressing.
a substrate having a first side and a second side on the side opposite the first side,
Sudipta et al. teach a wound healing dressing, comprising a substrate having a first side and a second side on the side opposite the first side, wherein the second side is adjacent the wound (see paragraphs [0014] "there is provided a dressing for application to a wound in a subject comprising a substrate"; and [0031] "The substrate defining the dressing may be selected from the group consisting of a transdermal patch, a pad ... a bandage"; it is understood patches, pads, and bandages have two sides opposite each other and one side is adjacent to the wound when applied; both within Sudipta et al.)
wherein the second side is adjacent the wound and at least a first medicant layer, wherein the first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first medicant layer, the first side on the side opposite the wound,
Sudipta et al. disclose wherein at least a first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first layer, the first side on the side opposite the wound, wherein the first medicant layer comprises one or more of the following: oxygen-generating composite material and a cerium oxide material (see paragraph [0031] "the pharmaceutically acceptable carrier may comprise a substrate ... having the Nanoceria disposed on and/or therein to define a dressing that can be applied to, about, or adjacent to a wound."; it is understood this is applied to the second side so that the carrier is applied to the wound and that applying this to a substrate would form a layer with two sides opposite each other, one side adjacent to the second side of the substrate and the other opposite the wound; within Sudipta et al.).
wherein the first medicant layer comprises one or more of the following: the oxygen-generating composite material
and the cerium oxide material;
Therefore, as stated above the first medicant layer comprises:
the oxygen-generating composite material
and/or
the cerium oxide material;
wherein the oxygen-generating composite material further comprises a support material, wherein the support material comprises one or more of: organosilicones. poly(ethersulfone), poly(ethylene oxide terephthalate) block copolymers, and combinations thereof.
Agarwal et al. disclose that in some embodiments, the polymer layer (support layer) comprises collagen, a hydrogel, a hydrocolloid, polyurethane, or silicone (see paragraph [0013] within Agarwal et al.) such as polydimethylsiloxane (PDMS) [an organosilicone] (see paragraph [0018] within Agarwal et al.). Additionally, Agarwal et al. disclose the generic phrase, “a silicone release coating...” (see paragraph [0018] within Agarwal et al.). A skilled artisan (POSITA) would use the Agarwal et al. citation to construct the necessary silicone support materials from PDMS and/or alternative organosilicones. The Examiner acknowledges that Agarwal et al. is not in the field of oxygen-generating or cerium oxide technology. However, Agarwal et al. does disclose a wound healing material (see title and abstract within Agarwal et al.) making the citation analogous art.
[Sudipta et al., Agarwal et al., and Harrison et al. disclose all the elements of instant claim 1 within the remaining instant claims of this 35 U.S.C. 103 section.]
Regarding instant claim 2, Sudipta et al., Agarwal et al., and Harrison et al. teach wherein wound healing dressing has the characteristics of being anti-inflammatory, an antioxidant, and pro-healing for at least 20 days. Sudipta et al. disclose the wherein wound healing dressing has the characteristics of being anti-inflammatory, an antioxidant (see paragraph [0042] "Suitable conjunctive agents may include ... antioxidants ... antiinflammatory agents ... " within Sudipta et al.). Sudipta et al. does not teach the dressing is pro-healing for at least 20 days, but it would have been obvious to one skilled in the art to make the dressing pro-healing for 20 days through routine experimentation based on the needs of the patient.
Regarding instant claim 9, Sudipta et al., Agarwal et al., and Harrison et al. teach wherein the first medicant layer comprises a plurality of cerium oxide material particles dispersed in a layer of the oxygen-generating composite material. Please see the citations and discussions within instant claims 1 and 7.
Regarding instant claim 10, Sudipta et al., Agarwal et al., and Harrison et al. teach the wound dressing of instant claim 1, further comprising a second medicant layer, wherein the second medicant layer has a first side and a second side opposite the first side, wherein the first side of the second medicant layer is adjacent the second side of the first medicant layer, wherein the second medicant layer comprises one or more of the following: the oxygen-generating composite material and the cerium oxide material. Please see the citations and discussions within instant claims 1 and 7. Additionally, the use of a second medicant layer within the wound dressing is implied within the Sudipta et al. disclosure [see paragraph [0032] “It is understood that the active ingredient(s) and pharmaceutically acceptable carrier may be provided individually (with or without instructions for future mixing) or together (mixed,
non-mixed, or with instructions for future mixing) in the respective formulation. Further, the wound composition may be prepared by known methods for the preparation of pharmaceutically acceptable compositions suitable for administration to a patient, such that an effective quantity of the active ingredients is combined in a mixture with a pharmaceutically acceptable carrier. Suitable pharmaceutically acceptable carriers
are described, for example, in Remington's Pharmaceutical Sciences (Remington's Pharmaceutical Sciences, Mack Publishing Company, Easton, Pa., USA 1985) within Sudipta et al.]. Thus, a skilled artisan (POSITA) would add another layer within the dressing under routine conditions.
Regarding instant claim 13, Sudipta et al., Agarwal et al., and Harrison et al. teach a wound healing dressing, comprising: an oxygen-generating composite material; a cerium oxide material; a substrate having a first side and a second side on the side opposite the first side, wherein the second side is adjacent the wound and at least a first medicant layer, wherein the first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first medicant layer, the second side adjacent the wound, wherein the first medicant layer comprises one or more of the following: the oxygen-generating composite material and the cerium oxide material; wherein the oxygen-generating composite material is a flexible sheet that has a thickness of about 200 to 1000 mm, wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters, wherein the flexible sheet generates greater than about 0.32 mM/day of oxygen for at least 5 days, and wherein the oxygen-generating composite material further comprises a support material, wherein the support material comprises one or more of: organosilicones. poly(ethersulfone), poly(ethylene oxide terephthalate) block copolymers, and combinations thereof. Please see the discussion and citations within instant claim 1.
Additionally, Harrison et al. disclose a wound healing dressing (see paragraph [0051] "The aid can be in any suitable form, such as ... wound dressing (gauze, adhesive bandage, etc.)." within Harrison et al.), comprising a substrate having a first side and a second side on the side opposite the first side, wherein the second side is adjacent the wound (see paragraph [0051] "A support material for the biodegradable polymer can be provided if desired"; it is understood gauze and bandages have two sides opposite each other and one side is adjacent to the wound when applied within Harrison et al.), wherein at least a first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first layer, the first side on the side opposite the wound (see paragraph [0051] "Such aids generally comprise a biodegradable polymer and an inorganic peroxide incorporated into said polymer in solid form ... with the polymer contacted to the support material in the form of a sheet"; it is understood this is applied to the second side so that the carrier is applied to the wound and that applying this film to a substrate would form a layer with two sides opposite each other, one side adjacent to the second side of the substrate and the other opposite the wound; within Harrison et al.), wherein the first medicant layer comprises one or more of the following: oxygen-generating composite material and a cerium oxide material (see paragraph [0029] ''The oxygen-generating active agent is preferably an organic or inorganic peroxide"; it is understood the incorporated into the polymer makes it a composite within Harrison et al.), wherein the oxygen-generating composite material is a flexible sheet that has a thickness of about 200 to 1000 mm (see paragraph [0033] "the compositions are formed into articles such as sheet materials or other formed articles that have a thickness of at least 100 micrometers"; it is understood if this is made into a bandage or gauze it would need to be flexible; within Harrison et al.). Harrison et al. does not teach wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters, and wherein the flexible sheet generates oxygen greater than about 0.32 mM/day for at least 5 days. However, it would have been obvious to one skilled in the art to achieve these metrics through routine experimentation depending on the needs of the patient. Furthermore, please see the discussion and citations within instant claim 1 regarding the silicone support material. A skilled artisan (POSITA) would be able to select one or more of the silicone polymers.sa
Regarding instant claims 16 and 28, Sudipta et al., Agarwal et al., and Harrison et al. teach wherein the oxygen-generating composite material is calcium peroxide. Harrison et al. disclose the use of metal peroxides (see paragraph [0029] “The oxygen-generating active agent is preferably an organic or inorganic peroxide such as urea peroxide, calcium peroxide, and magnesium peroxide, and sodium percarbonate. The oxygen-generating active agent is included in the composition in any suitable amount (e.g., from 0.1 or 1 to 10, 20, or 30 percent by weight, or more). In some embodiments calcium peroxide is preferred as it releases oxygen at a desirable rate in situ. The oxygen-generating active agent can be included in the polymer in solid form, such as in the form of a plurality of solid particles thereof.” within Harrison et al.). Therefore, a skilled artisan (POSITA) could combine any of these metal peroxides for the wound dressing.
Regarding instant claims 29 and 30, Sudipta et al., Agarwal et al., and Harrison et al. teach wherein the cerium oxide nanoparticle has a longest dimension of about 1 to 20 nanometers. Sudipta et al. disclose the cerium oxide nanoparticles have an average particle size ( e.g., diameter) of <20 nm, preferably in the range from 1 to 10 nm, and more preferably from 3 to 5 nm (see paragraph [0029] within Sudipta et al.).
Combination of Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al.
Regarding instant claim 3, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the wound healing dressing has the characteristics of free radical scavenging and oxygen generation. In a similar invention for wound healing (see paragraph [0050] "The composites can be used in ... wound healing device" within Stabler et al.), Stabler et al. disclose that the composite has the characteristics of free radical scavenging (see paragraph [0054] "Exemplary free radical scavengers include, but are not limited to, cerium oxide" within Stabler et al.) and oxygen generation (see paragraph [0106] "using the inventive composites for delivering oxygen generating material" within Stabler et al.). It would have been obvious to one skilled in the art to combine these references and use the composite taught by Stabler et al. in the dressing taught by Sudipta et al. through routine experimentation depending on the characteristics desired.
Regarding instant claim 5, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the cerium oxide material further comprises at least one biopolymer selected from alginate, hyaluronic acid (HA), chitosan, agarose, collagen, fibrin, gelatin, dextran, and any combination thereof, as well as derivatives of each of these, wherein the biopolymer is a hydrogel. Stabler et al. teach the use of biopolymer fibrin (see paragraph [0102] “…the composite for providing extended release of oxygen can be a plurality of microparticles. The microparticle composites can be incorporated into other biomaterials. For example, the peroxide containing composite microparticles can be embedded in fibrin.” within Stabler et al.) Fibrin is a biopolymer that is a hydrogel (see PTO-892 NPL U]. Therefore, a skilled artisan (POSITA; person having ordinary skill in the art) could expand the other biomaterials mentioned above to include alginate, hyaluronic acid (HA), chitosan, agarose, collagen, gelatin, dextran, and any combination thereof, as well as derivatives of each of these.
Regarding instant claim 8, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the oxygen-generating composite material is a flexible sheet that has a thickness of about 200 to 1000 mm. Stabler et al. disclose an oxygen-generating composite (see instant claim 7). Harrison et al. disclose a flexible sheet with a thickness greater than 100 micrometers (see paragraph [0033] "the compositions are formed into articles such as sheet materials or other formed articles that have a thickness of at least 100 micrometers"; it is understood if this is made into a bandage or gauze it would need to be flexible). Harrison et al. does not specifically teach wherein the flexible sheet has a thickness of about 200 to 1000 mm. However, it would have been obvious to one skilled in the art to achieve these metrics through routine experimentation depending on the needs of the patient.
Regarding instant claim 11, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the first medicant layer includes the oxygen-generating composite material, wherein the second medicant layer comprises the cerium oxide material dispersed in a biopolymer, wherein the biopolymer is a hydrogel. Please see the citations and discussion within instant claims 1, 5, 7, and 10.
Regarding instant claim 18, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach a wound healing dressing, comprising: a substrate having a first side and a second side on the side opposite the first side, wherein the second side is adjacent the wound; a first medicant layer wherein the first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first medicant layer; and a second medicant layer, wherein the second medicant layer has a first side and a second side opposite the first side, wherein the first side of the second medicant layer is adjacent the second side of the first medicant layer; wherein the first medicant layer comprises one or more of an oxygen-generating composite material and a cerium oxide material, and wherein the second medicant layer comprises the cerium oxide material and a biopolymer, wherein the biopolymer is a hydrogel. Please see the discussion and citations within instant claim 1 for Sudipta et al.
In addition, Harrison et al. disclose a wound healing dressing (see paragraph [0051] "The aid can be in any suitable form, such as ... Wound dressing (gauze, adhesive bandage, etc.)."; within Harrison et al.), comprising a substrate having a first side and a second side on the side opposite the first side, wherein the second side is adjacent the wound (see paragraph [0051] "A support material for the biodegradable polymer can be provided if desired"; it is understood gauze and bandages have two sides opposite each other and one side is adjacent to the wound when applied; within Harrison et al.), wherein a first medicant layer is disposed on the second side of the substrate, wherein the first medicant layer has a first side adjacent the second side of the substrate and the first medicant layer has a second side opposite the first side of the first layer (see paragraph [0051] "Such aids generally comprise a biodegradable polymer and an inorganic peroxide incorporated into said polymer in solid form ... with the polymer contacted to the support material in the form of a sheet"; it is understood that applying this film to a substrate would form a layer with two sides opposite each other, one side adjacent to the second side of the substrate; within Harrison et al.), wherein the first medicant layer comprises one or more of the following: an oxygen-generating composite material and a cerium oxide material (see paragraph [0029] "The oxygen-generating active agent is preferably an organic or inorganic peroxide"; it is understood the incorporated into the polymer makes it a composite; within Harrison et al.). Harrison et al. does not teach wherein the substrate includes a second medicant layer, wherein the second medicant layer has a first side and a second side opposite the first side, wherein the first side of the second medicant layer is adjacent the second side of the first medicant layer, and wherein the second medicant layer comprises one or more of the following: the oxygen-generating composite material and the cerium oxide material.
Sudipta et al. disclose the use of Nanoceria which may include cerium oxides….” (see paragraph [0031] within Sudipta et al.). Furthermore, Harrison et al. disclose the use of a biodegradable polymer which can act as a second medicant layer (see claims 1 and 11 within Harrison et al.). Moreover, the biopolymer (fibrin hydrogel) disclosed by Stabler et al. can also act as a second medicant layer (see PTO-892 NPL U).
In a similar invention for wound healing (see paragraph [0050] "The composites can be used in ... wound healing device" within Stabler et al.), Stabler et al. disclose using a composition comprising a plurality of cerium oxide material dispersed in a layer of oxygen-generating composite material (see paragraphs [0054] "The biocompatible polymeric support can include a variety of components that can include, but are not limited to...free radical scavengers, Exemplary free radical scavengers include, but are not limited to, cerium oxide"; and paragraph [0055] "The solid peroxide particles can include ... "; and paragraph [0056] "It is believed this is related to the delayed reaction between the solid peroxide and water, which generates the oxygen."; therefore the cerium oxide are in the composition with oxygen generating peroxide; all within Stabler et al.).
It would have been obvious to one skilled in the art to combine these references and use this composition in the first medicant layer through routine experimentation to obtain the desired result and patient needs. The combination of Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach all of the above claim limitations.
Regarding instant claim 19, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the first medicant layer comprises a plurality of cerium oxide material particles dispersed in a layer of the oxygen-generating composite material, and wherein the second medicant layer comprises the cerium oxide material dispersed in a biopolymer.
Please see the citations and discussion within instant claim 18. Sudipta et al. disclose the use of ceria nanoparticles (see section 1.2 within Sudipta et al).
In a similar invention for wound healing (see paragraph [0050] "The composites can be used in ... wound healing device" within Stabler et al.), Stabler et al. disclose using a composition comprising a plurality of cerium oxide material dispersed in a layer of oxygen-generating composite material (see paragraphs [0054] "The biocompatible polymeric support can include a variety of components that can include, but are not limited to...free radical scavengers, Exemplary free radical scavengers include, but are not limited to, cerium oxide"; and paragraph [0055] "The solid peroxide particles can include ... "; and paragraph [0056] "It is believed this is related to the delayed reaction between the solid peroxide and water, which generates the oxygen."; therefore the cerium oxide are in the composition with oxygen generating peroxide; all within Stabler et al.).
It would have been obvious to one skilled in the art to combine these references and use this composition in the first medicant layer through routine experimentation to obtain the desired result and patient needs. The combination of Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach all of the above claim limitations.
Regarding instant claim 22, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the first medicant layer is a flexible sheet that has a thickness of about 200 to 1000 mm, wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters.
Please see the citations and discussion within instant claim 18.
Harrison et al. disclose the wound healing dressing wherein the first medicant layer is a flexible sheet that has a thickness of about 200 to 1000 mm (see paragraph [0033] "the compositions are formed into articles such as sheet materials or other formed articles that have a thickness of at least 100 micrometers"; it is understood if this is made into a bandage or gauze it would need to be flexible; within Harrison et al.). Harrison et al. does not teach wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters. However, it would have been obvious to one skilled in the art to achieve these metrics through routine experimentation depending on the needs of the patient. The combination of Sudipta et al., Agarwal et al., Stabler et al., and Harrison et al. teach all of the above claim limitations.
Regarding instant claim 23, Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach wherein the first medicant layer and the second medicant layer form a flexible sheet that has a thickness of about 200 to 1000 mm, wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters.
Please see the citations and discussion within instant claim 18.
Harrison et al. disclose the wound healing dressing wherein the first medicant layer and the second medicant layer form a flexible sheet that has a thickness of about 200 to 1000 mm (see paragraph [0033] "the compositions are formed into articles such as sheet materials or other formed articles that have a thickness of at least 100 micrometers"; it is understood if this is made into a bandage or gauze it would need to be flexible and that the second layer would be a similar sheet with similar thickness; within Harrison et al.). Harrison et al. does not teach wherein the flexible sheet has a length of about 1 centimeter to 10 centimeters and a width of about 1 centimeter to 10 centimeters. However, it would have been obvious to one skilled in the art to achieve these metrics through routine experimentation depending on the needs of the patient. The combination of Sudipta et al., Agarwal et al., Harrison et al., and Stabler et al. teach all of the above claim limitations.
Combination of Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al.
Regarding instant claim 14, Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach wherein cerium oxide material comprises a plurality of cerium oxide nanoparticles, wherein the cerium oxide nanoparticle has a longest dimension of about 1 to 20 nanometers. Hassler et al. disclose using cerium oxide material (see paragraph [0034] "In one embodiment, one of the one or more rare earth-containing compositions comprises cerium ... Preferably, cerium-containing composition includes cerium oxide" within Hassler et al.) that comprises a plurality of cerium oxide nanoparticles, wherein the cerium oxide nanoparticle has a longest dimension of about 1 to 20 nanometers (see paragraph [0030] "The one or more rare earth-containing compositions comprise particles. In a first particle size embodiment, the particles have a typical average particle size of from about 0.1 nanometers to about 1,000 microns" within Hassler et al.). It would have been obvious to one skilled in the art to combine these references and use cerium oxide nanoparticles in the dressing taught by Harrison et al. to increase the effectiveness of the wound healing.
Regarding instant claim 15, Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach wherein the cerium oxide material further comprises at least one biopolymer selected from alginate, hyaluronic acid (HA), chitosan, agarose, collagen, fibrin, gelatin, dextran, and any combination thereof, as well as derivatives of each of these. Hassler et al. disclose wherein the cerium oxide material further comprises at least one biopolymer selected from alginate, hyaluronic acid (HA), chitosan, agarose, collagen, fibrin, gelatin, dextran, and any combination thereof, as well as derivatives of each of these (see paragraph [0194] "Various embodiments the therapeutic formulation of the present invention may comprise a thickening agent, such as but not limited to ... algin, alginic acid, ammonium alginate ... " within Hassler et al.). Furthermore, please see the discussion and citations within instant claim 5.
Regarding instant claim 21, Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach wherein the oxygen-generating composite material includes a peroxide material, a support material, or both.
Please see the citations and discussion within instant claim 18.
Hassler et al. disclose using cerium oxide material (see paragraph [0034] "In one embodiment, one of the one or more rare earth-containing compositions comprises cerium ... Preferably, cerium-containing composition includes cerium oxide") and a biopolymer (see paragraph [0194] "Various embodiments the therapeutic formulation of the present invention may comprise a thickening agent, such as but not limited to ... algin, alginic acid, ammonium alginate ... "; both within Hassler et al.). It would have been obvious to one skilled in the art to combine these references use cerium oxide particles in biopolymer as the second layer through routine experimentation to achieve the desired result. The combination of Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach all of the above claim limitations.
Regarding instant claim 27, Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach wherein the biopolymer is selected from alginate, hyaluronic acid (HA), chitosan, agarose, collagen, fibrin, gelatin, dextran, and any combination thereof, as well as derivatives of each of these.
Please see the citations and discussion within instant claim 18.
Stabler et al. teach the use of biopolymer fibrin (see paragraph [0102] “…the composite for providing extended release of oxygen can be a plurality of microparticles. The microparticle composites can be incorporated into other biomaterials. For example, the peroxide containing composite microparticles can be embedded in fibrin.” within Stabler et al.) In addition, Hassler et al. disclose wherein the cerium oxide material further comprises at least one biopolymer selected from alginate, hyaluronic acid (HA), chitosan, agarose, collagen, fibrin, gelatin, dextran, and any combination thereof, as well as derivatives of each of these (see paragraph [0194] "Various embodiments the therapeutic formulation of the present invention may comprise a thickening agent, such as but not limited to ...ammonium alginate, HA gelatin, sodium carboxymethyl dextran ... " within Hassler et al.). The combination of Sudipta et al., Agarwal et al., Harrison et al., and Hassler et al. teach all of the above claim limitations.
Analogous Art
The Sudipta et al., Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. references are applicable to the endeavor of the instant application. Therefore, these teachings make the references relevant to instant claims 1-5, 7-11, 13-16, 18-19, 21-23 and 27.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cerium oxide wound dressing composition disclosed by Sudipta et al. using the teachings of Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. to incorporate the necessary claim limitations. Starting with Sudipta et al., the skilled person only had to try the necessary claim limitations disclosed by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. The combination of Sudipta et al., Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. would allow one to arrive at the present application without employing inventive skill. This combination of the cerium oxide wound dressing composition taught by Sudipta et al. along with the use of the necessary claim limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the cerium oxide wound dressing composition disclosed by Sudipta et al. with the use of the necessary claim limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. This combined modification would have led to an enhanced cerium oxide wound dressing composition that would be beneficial for patients and consumers.
Response to Arguments
Applicant's arguments filed November 17, 2025 have been fully considered but they are not persuasive.
The claim amendments to instant claim 13 were sufficient to address the 35 U.S.C. 112(b) rejection. Therefore, that rejection is withdrawn from the record.
The Applicant’s claim amendments did not necessitate a new ground of rejection.
Applicant argument: The Applicant argues that a suitable 35 U.S.C. §103 obviousness analysis has not been delineated by the Examiner.
Examiner’s Rebuttal: The Examiner respectfully disagrees. A more detailed obviousness analysis is presented:
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cerium oxide wound dressing composition disclosed by Sudipta et al., using the teachings of Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. in order to arrive at the subject matter of the instant claims.
The Sudipta et al., Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. references all have considerable overlap within the wound healing arts. In this instance, Sudipta et al. supplies a wound dressing comprising ceria nanoparticles, Agarwal et al. and Harrison et al. supply the silicone polymer support and metal peroxides for wound healing, respectively, Stabler et al. supplies the radical scavenging and biopolymer, while Hassler et al. supplies claim-specific features comprising cerium oxide material additional biopolymers for wound healing. All references are directed to the wound healing arts and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the five references when seeking to develop a layered cerium oxide wound dressing composition.
Starting with Sudipta et al., the skilled person only had to try the necessary claim limitations disclosed by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. The combination of Sudipta et al., Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. would allow one to arrive at the present application without employing inventive skill. This combination of the cerium oxide wound dressing composition taught by Sudipta et al. along with the use of the necessary claim limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the cerium oxide wound dressing composition disclosed by Sudipta et al. with the use of the necessary claim limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. Incorporating the disclosure of Sudipta et al. into the wound dressing and healing limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. would have been viewed by a POSITA as routine design optimizations or known modifications for wound dressings and healing for a subject. Implementing these features in Sudipta et al.’s cerium oxide wound dressing composition would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Sudipta et al., supplemented by Agarwal et al., Harrison et al., Stabler et al., and Hassler et al. provides all the elements of the claimed invention. The resulting layered cerium oxide wound dressing constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Applicant argument: The Applicant argues that regarding claim 1 that Sudipta et al., Harrison et al., and Agarwal et al. are not combinable for the reason that Sudipta et al. disclose “excessive oxidative stress can impair wound healing.”
Examiner’s Rebuttal: The combination of Sudipta et al., Agarwal et al., and Harrison et al. teach all the elements of instant claim 1 including the use of ceria nanoparticles in combination with an oxygen-generating composite material. Sudipta et al. does disclose that excessive oxidative stress can impair wound healing (see paragraph [0070] within Sudipta et al.). Figures 5A and 5B illustrate collectively, these that these findings suggest that topical application of Nanoceria to wounds reduces oxidative stress in the cells involved in wound healing (see paragraph [0070] within Sudipta et al.). In conclusion, the above-described cell culture studies demonstrate that Nanoceria enhance the proliferation and migration of keratinocytes and fibroblasts, and accelerate the migration and tube-forming ability of vascular endothelial cells (see paragraph [0071] within Sudipta et al.). Yes, excessive oxidative stress impairs wound healing. However, the use of Nanoceria does not provide excessive oxidative stress. A skilled artisan (POSITA) would be aware of this fact and monitor wound healing under for excessive oxidative stress.
Harrison et al. disclose a method of treating hypoxic tissue in need thereof, comprising contacting a composition to the hypoxic tissue in a hypoxia-treatment effective amount, the composition comprising a biodegradable polymer and an inorganic peroxide incorporated into the polymer, preferably in solid form (and optionally a radical trap or decomposing catalyst incorporated into and/or onto the polymer in solid form) (see paragraph [0006] within Harisson et al.). Harrison et al. disclose the use inorganic peroxide within a wound healing capacity (see instant claim 1).
Hypoxic tissue is defined as tissue deprived of adequate oxygen. A skilled artisan (POSITA) would understand the need for oxidative stress up to a certain threshold for effective wound healing therapy.
Finally, the Agarwal et al. reference relates to large scale manufacture of nano scale microsheets for use in applications such as wound healing or modification of a biological or medical surface (see paragraph [0005] within Agarwal et al.). Agarwal et al. does have a nanoscale polymer disclosed (see paragraph [0006] within Agarwal et al.). However, since the Applicant uses the transitional term “comprising,” a skilled artisan (POSITA) can include this material and be within the scope of instant claim 1. The Agarwal et al. reference is within the wound healing arts and focuses on the large scale manufacture of nano scale microsheets for use in applications such as wound healing or modification of a biological or medical surface. Therefore, this invention is not required to disclose oxygen generating composite materials and/or cerium oxide.
All of the prior art references are analogous art within the wound healing dressing art.
Moreover, the text within instant claim 1 states “wherein the first medicant layer comprises one or more of the following: an oxygen-generating composite material comprising one or more of the following: calcium peroxide, sodium peroxide, magnesium peroxide, lithium peroxide, potassium peroxide, and a combination thereof; and a cerium oxide material comprises a plurality of cerium oxide nanoparticles. Indicating to the skilled artisan (POSITA) that at a minimum only one of the elements needs to be included to meet the limitation.
Applicant argument: The Applicant argues that the Sudipta et al. reference does not teach a second medicant layer, and the administration method is not suitable for combination.
Examiner’s Rebuttal: Yes, within paragraph [0032] of Sudipta et al. it is stated that “the wound compositions of the present invention may be provided and/or manufactured as a pharmaceutical composition for topical administration, parenteral administration, and/or any other suitable administration.” A broad coverage such as this is common within the patent literature. Sudipta et al. is not confined to one type of administration.
Sudipta et al. disclose “the pharmaceutically acceptable carrier may comprise a substrate, such as a natural or synthetic non-woven or woven material, having the Nanoceria disposed on and/or therein to define a dressing that can be applied to, about, or adjacent to a wound. The substrate defining the dressing may be selected from the group consisting of a transdermal patch, a pad, a powder, a bandage, a host matrix,
or any other suitable substrate configured to be applied to, over, and/or adjacent the wound (see paragraph [0031] within Sudpta et al.). This is used for the first medicant layer.
Sudipta et al. does not disclose a second medicant layer.
The biopolymer (fibrin hydrogel) disclosed by Stabler et al. can act as a second medicant layer (see PTO-892 NPL U-V). Hassler et al. currently not included in the rejection of instant claim 18 expands upon this biopolymer (see instant claim 27).
Applicant argument: The Applicant argues that the dependent claims linked to instant claims 1, 13, and 18 should be allowed.
Examiner’s Rebuttal: All of the claim limitations have been successfully addressed above. Therefore, the instant claims 1, 13, and 18 dependent claims remain rejected.
Thus, the 35 U.S.C. §103 rejection of instant claims 1-3, 5, 8-11, 13-16, 18-19, 21-23, and 27-30 is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC)
at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615