The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Formal Matters
Claims 2, 14, 23, and 26 are cancelled. Claims 1, 3-13, 15-22, 24, 25, and 27-34 are pending and under examination.
The applicant has provided specification and claims amendments within the “Response After Final Action” included with the Request for Continued Examination filed on 8/25/2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2025 has been entered.
Objections and Rejections Withdrawn
The objection to the specification is withdrawn as the applicant has now amended the specification to remove previously unsupported phrases. Applicant’s specification amendment filed on 8/25/2025 is accepted.
The rejection under USC 112(b) for molecular weights is withdrawn per applicant’s amendments to remove these limitations.
The rejections under USC 103 indicated in the final rejection from 03/24/2025 are withdrawn to provide another reference for the wetting composition or ointment and/or cream with emollient mixture that forms an occlusive cover. Note that the Quora reference is being replaced with Svensson in the teachings of the treatment product claims (claims 1 and 12 and their dependent claims).
As these rejections are withdrawn, applicant’s arguments toward the rejections are now moot.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement- Metal containing species
Claims 1, 3-4, 8-13, 15, 16, 20-22, 24, 25, 27, 28, 30-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for zinc oxide, does not reasonably provide enablement for metal-containing species with or without functional language (‘demonstrated to promote desiccation of the wound site and reduction of wound site dimensions”, “contraction of the wound site”, “clinically demonstrated to contribute to positive modulation of immune function responses that are protective against microbial attack”). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce the invention commensurate in scope with these claims. The claims provide for metal containing species and in instances indicates a function of the metal containing species. Metal containing species is a category that would include various metal salts, coordination compounds, clays, minerals and various derivatives thereof that would contain a metal. Even the type of metal is not specified.
SciTechDaily (Scientists Create the Impossible: New Compound Challenges Fundamental Principle of Chemistry, July 2025, https://scitechdaily.com/scientists-create-the-impossible-new-compound-challenges-fundamental-principle-of-chemistry/) teaches that scientists, for the first time, created a new organometallic compound that challenges the 18-electron rule of chemistry. SciTechDaily provides that rule was accepted for more than 100 years. Thus, one of skill in the art would not have been enabled to make such a metal containing species before this point in 2025. Applicant’s filing date is 12/29/2023. It is notable too that metal-containing species would also encompass what would be considered derivatives or analogs of other compounds since it is so extensive of a genus. Note in MPEP 2164.08 (Enablement Commensurate in Scope with the Claims) “The breadth of the claims was a factor considered in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), cert. denied, 502 U.S. 856 (1991). In Amgen, the patent claims were directed to a purified DNA sequence encoding polypeptide analogs of the protein erythropoietin (EPO). The court stated that:
Amgen has not enabled preparation of DNA sequences sufficient to support its all-encompassing claims. . . . [D]espite extensive statements in the specification concerning all the analogs of the EPO gene that can be made, there is little enabling disclosure of particular analogs and how to make them. Details for preparing only a few EPO analog genes are disclosed. . . . This disclosure might well justify a generic claim encompassing these and similar analogs, but it represents inadequate support for Amgen’s desire to claim all EPO gene analogs. There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them.” In applicant’s case, they have only told how to make and use zinc ions or zinc oxide.
Applicant’s disclosure only points out zinc ions and zinc oxide as metal containing species. In regards to functionalities, the desiccation is accomplished by zinc oxide and the contraction/change in dimension of the wound site is due to healing properties of zinc ions. It is known in the art that zinc/zinc ions are important to immune function in the body (see paragraph 48 of applicant’s specification). Thus, applicant’s enablement for these properties comes from what is known about zinc ions and zinc oxide. No other metal containing species are provided by applicant for such functions.
One of skill in the art is a chemist specializing in metal compounds.
As the art recognizes metal-containing species once thought to be impossible that have only been created after applicant’s priority date and applicant’s specification only provides information for zinc ions and zinc oxide as the metal-containing species for its invention while naming no other of the countless other species that can exist, there would be undue experimentation by one of skill in the art to create all the metal-containing species necessary to satisfy enablement to have this full genus. Thus, applicant is enabled for zinc ions or zinc oxide, but is not enabled for the full genus of metal-containing species.
Written Description – Antimicrobial Emollient
Claims 25, 28-30 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 25 includes “therapeutically effective antimicrobial emollient” which is in reference to a large group of possible emollient compounds defined by a function to inhibit the growth of or destroy microorganisms (e.g. bacteria) and the function of being an emollient. Emollients have a variety of chemical structures with some having antimicrobial ability and some not. For example, glycerol, hyaluronic acid, petroleum jelly, and octyl stearate are emollients that have uniquely different structures (glycerol, a short chain diol; hyaluronic acid, a glycosaminoglycan; petroleum jelly, mixture of hydrocarbons; and octyl stearate (a fatty acid ester)). The applicant has only previously indicated that eugenol was included in antimicrobial emollient (art recognized eugenol as having antimicrobial activity). When applicant mentions “therapeutically effective antimicrobial emollient”, it does not provide for a species of such a component/compound as a particular emollient compound having both functions of being an emollient and having antimicrobial activity (see paragraphs 19 and 71 of specification). Note that for a claimed genus- MPEP 2163 II “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").” Thus, applicant has description of emollient having waxy ester combined with eugenol (the one probable species serving as an antimicrobial emollient that would have description in the specification) for their invention, but not full description of the genus of antimicrobial emollients.
Written Description – Compositions mixtures that form occlusive covers and allow transport of dry powder components
Claims 1, 3-22, and 28-34 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant provides for an occlusive cover formed with no mention of ingredients or broad categories of ingredients (non-water soluble ingredients based on molecular weight being high or low) in claims 1, 12 and 25. The claim dictates that solubilized components of the powder aid in transporting the components through the occlusive cover (claims 12 and 25) or the metal-containing species is transported through the occlusive cover (claim 1). To this point, applicant only points out that eugenol (one species) allows for the transport of the dry powder components (paragraph 76 of the specification). Furthermore, this is applicable to systems where the occlusive cover is made up of waxy esters or polyunsaturated hydrocarbons where eugenol would be allowed to migrate out of the occlusive cover for solubilization and transport of the dry powder components. There is no description of occlusive covers made from cellulose polymers or other polymers for instance where the inventor made this occur. Thus, applicant has description for an emollient mixture with waxy esters (or likely polyunsaturated hydrocarbons) and eugenol that would allow for formation of an occlusive cover and the transport of dry powder components or metal-containing species, but does not have adequate description for all the genus of various mixtures/compositions that would form such occlusive covers with such ability. Note that for a claimed genus- MPEP 2163 II “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").”
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, 8-13, 15, 16, 20-22, 24, 25, 27, 28, and 30-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 9, 12, 21, 24, and 25 are indefinite for the recitation of “metal-containing species” in the claims while only providing for one or two such species in the originally filed disclosure which is zinc oxide or zinc ions. There is no definition in the specification that limits metal-containing species. The disclosure seems to recognize importance of zinc oxide and/or zinc ions that were important to the invention. As metal-containing species would possibly cover various inorganic and organic salts, coordination compounds, minerals, clays, various compositions having metal or metal ions, and any derivatives or analogs thereof, it is not clear how the metes and bounds of this limitation would be construed based on what is indicated in the specification. If the prior art teaches any metal species, it may be used as prior art.
Claims 3-4, 8, 10-11, 13, 15, 16, 20, 22, 27, 28, 30-34 are rejected as being dependent on indefinite claims without repairing the issue of indefiniteness.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 3, 5 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Bakhtar (Iran Journal of Public Health, Nov 2013, volume 42, pages 1327-1328) and Svensson US 20160081968.
The treatment claims are treated as a treatment product with two parts as the drying composition and wetting composition are only being indicated as how they would be applied (intended use of the product) and not with action steps such as with the use of “applying” or other actionable “ing” verbs. Thus, they are examined for the components that the treatment contains. If the prior art teaches the two compositions with their ingredients with motivation to allow combined use, then it will read on the claims.
In regards to occlusive cover, applicant’s specification does provide they can prevent evaporative drying of the wound site (paragraph 17 of applicant’s specification), however, it also allows for transport of agents/components of the dry powder therethrough as stated in the claims. Thus, the occlusive nature of the cover will be considered as partially occlusive based on fair interpretation of the applicant’s specification (occlusive to evaporating water, but not to all elements).
Bakhtar teaches amazing topical products and novel powder dressing formula in treatment of diabetic foot wounds (abstract and title). Bakhtar teaches “In the fourth step powder combination of ethacridine lactate (0.1%), zinc oxide, oak fruit and ginkgo biloba was used. This novel powder dressing is very effective in healing of diabetic wound, and in this study was sprinkled on wound two times every day (BiD).” There is no water indicated in this formulation so it is considered a dry powder.
Bakhtar teaches the claims as provided above. Bakhtar provides for a method of cleansing the wound with a solution and provides for combining the different methods, which would allow the cleansing to occur before the powder was applied.
Bakhtar does not provide for a wetting composition that can form an occlusive wound cover on the wound.
Svensson teaches a composition that reduces scab formation and promoting healing of injuries and wounds in mammals (claim 1 of Svensson). Svensson teaches forms of ointment or cream (claim 10 of Svensson). Svensson teaches an emollient for the composition chosen from fat and vegetable oil, wax, petrolatum and others (claim 6 of Svensson). Svensson teaches long chain hydrocarbons as an emollient (paragraph 37). Svensson teaches the compositions form semi-occlusive moisturizing protective film in the wound (paragraph 16). Svensson teaches formation of the film for occlusion and that emollients provide some occlusivity (paragraphs 34 and 37). Svensson teaches solvent such as ethanol or isopropyl alcohol that are low molecular weight (paragraph 22). The semi-occlusive nature of Svensson’s formulation would allow transport of some compounds therethrough. Svensson teaches the composition delivering moisture to the wound and will maintain moisture control (paragraph 34, example 6). Thus, there is also water expected to be present in this wound covering. Svensson teaches cream products in examples (viscosity relatively high) (paragraph 46, also table 1). Svensson teaches monolgycerides, a main component, are natural low molecular weight amphiphiles (paragraph 25). Svensson teaches high molecular weight polymers such as cellulose based polymers and polyacrylic acid (paragraph 38). Svensson also provides for diabetic leg and foot ulcers and ulcers caused by poor blood circulation (claim 3 of Svensson). Svensson teaches cleaning and applying the cream (paragraph 66). Svensson teaches covering of the wound sites (paragraph 59). Svensson teaches its semi-occlusive compositions can have antimicrobial activity and antimicrobial agents (paragraphs 22 and 35 and 39-40).
One of ordinary skill in the art before the time of filing would have included administration of powders of Bakhtar with use of the semi-occlusive products of Svennson to both treat and cover/protect a wound such as a diabetic ulcer that is in need of healing as both provide for treatment of wounds where one has the ability to disinfect and the other has the ability to cover the wound (including diabetic ulcer in each) and reduce scab formation. As the claim is toward a treatment (product) containing two compositions rather than a method, the way it is applied only matters in that the prior art teaches compositions capable of such application and actions. Since Bakhtar teaches a powder containing ethacridine lactate and zinc oxide, it is capable of performing the respective functions of each while Svensson teaches a cream or ointment with low molecular weight monoglyceride and high molecular weight polymer(s) that is semi-occlusive and has or can hold water/moisture. The semi-occlusive nature of Svensson’s composition would allow components to pass through. The composition of Svensson is capable of covering the wound bed being a cream or ointment and having teachings of covering the wound site. Thus, there was a reasonable expectation of success in combining the teachings of Bakhtar and Svensson and obtaining a product that had both compositions for the improved treatment of wounds based on their recognized and respective abilities to treat wounds (antibiotic composition and barrier composition).
Claims 1, 3, 5, 10-13, 15, 17, 22, 24, 31, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Bakhtar (Iran Journal of Public Health, Nov 2013, volume 42, pages 1327-1328), Svensson US 20160081968, and Marraccini US 20070224271.
The treatment claims are treated as a treatment product with two parts as the drying composition and wetting composition are only being indicated as how they would be applied and not steps such as with the use of “applying” or other actionable “ing” verbs. Thus, they are examined for the components that the treatment contains. If the prior art teaches the two compositions with their ingredients with motivation to allow combined use, then it will read on the claims.
In regards to occlusive cover, applicant’s specification does provide they can prevent evaporative drying of the wound site (paragraph 17 of applicant’s specification), however, it also allows for transport of agents/components of the dry powder therethrough as stated in the claims. Thus, the occlusive nature of the cover will be considered as partially occlusive based on fair interpretation of the applicant’s specification (occlusive to evaporating water, but not to all elements).
Bakhtar teaches amazing topical products and novel powder dressing formula in treatment of diabetic foot wounds (abstract and title). Bakhtar teaches “In the fourth step powder combination of ethacridine lactate (0.1%), zinc oxide, oak fruit and ginkgo biloba was used. This novel powder dressing is very effective in healing of diabetic wound, and in this study was sprinkled on wound two times every day (BiD).” It is noted that 0.1% ethacridine lactate is also an effective amount of applicant’s claims.
Bakhtar teaches the claims as provided above. Bakhtar provides for a method of cleansing the wound with a solution and provides for combining the different methods, which would allow the cleansing to occur before the powder was applied.
Bakhtar does not provide two compositions as it does not include a wetting composition as claimed. Bakhtar does not provide for an excipient or corn starch.
Svensson teaches a composition that reduces scab formation and promoting healing of injuries and wounds in mammals (claim 1 of Svensson). Svensson teaches forms of ointment or cream (claim 10 of Svensson). Svensson teaches an emollient for the composition chosen from fat and vegetable oil, wax, petrolatum and others (claim 6 of Svensson). Svensson teaches long chain hydrocarbons as an emollient (paragraph 37). Svensson teaches the compositions form semi-occlusive moisturizing protective film in the wound (paragraph 16). Svensson teaches formation of the film for occlusion and that emollients provide some occlusivity (paragraphs 34 and 37). Svensson teaches solvent such as ethanol or isopropyl alcohol that are low molecular weight (paragraph 22). The semi-occlusive nature of Svensson’s formulation would allow transport of some compounds therethrough. Svensson teaches the composition delivering moisture to the wound and will maintain moisture control (paragraph 34, example 6). Thus, there is also water expected to be present in this wound covering. Svensson teaches cream products in examples (viscosity relatively high) (paragraph 46, also table 1). Svensson teaches monoglycerides, a main component, are natural low molecular weight amphiphiles (paragraph 25). Svensson teaches high molecular weight polymers such as cellulose based polymers and polyacrylic acid (paragraph 38). Svensson also provides for diabetic leg and foot ulcers and ulcers caused by poor blood circulation (claim 3 of Svensson). Svensson teaches cleaning and applying the cream (paragraph 66). Svensson teaches covering of the wound sites (paragraph 59). Svensson teaches its semi-occlusive compositions can have antimicrobial activity and antimicrobial agents (paragraphs 22 and 35 and 39-40). Svensson teaches “wax-subgroup of lipids including natural or synthetic esters of fatty acids with long chain hydrocarbons” in the group of emollients (paragraph 37). These would be waxy esters.
Marraccini teaches a powder mixture as a healing powder (abstract). Marraccini teaches cornstarch where the starch acts as a matrix for tissue regeneration (paragraphs 37-39 and 51).
One of ordinary skill in the art at the time of filing would have included moisturizing/emollient products with the powder agent in a product as they are both good for treating wounds with Bakhtar’s and Svensson’s products both noted for better wound healing, Svensson’s adding for occlusion of the wound site. Thus, one of ordinary skill in the art with the teachings of Bakhtar (powder), Svensson (antimicrobial emollient occlusive cover) and Marraccini (powder as well for healing) would have reasonably considered using Bakhtar’s antimicrobial/antibiotic with use of an excipient like cornstarch in teachings of Marraccini in the dry powder as it helps with tissue regeneration to obtain a reasonable expectation of success in better treating wounds. Regarding an assessment of the amount of dry powder to apply, since the prior art recognizes the amounts have effectiveness, it has assessed the amount needed to be effective. Marraccini motivates cornstarch as a matrix ingredient for healing powder formulations.
Claims 4, 9, 16, 21 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Bakhtar (Iran Journal of Public Health, Nov 2013, volume 42, pages 1327-1328); Svensson US 20160081968, Marraccini US 20070224271, and Leung US 20140276493 as evidenced by Khalil et al (Royal Society of Chemistry, 2017, volume 7, pages 32669-37681) and as evidenced by Pramod et al (Natural Product Communications, 2010, volume 5, pages 1999-2006).
Bakhtar, Svensson and Marraccini as evidenced by Khalil teach the claims as discussed above.
Bakhtar, Svensson and Marraccini as evidenced by Khalil do not teach about 1 wt% of ethacridine lactate or the metal containing species being nanoparticles.
Leung teaches compositions to treat wounds having antimicrobial agents (abstract). Leung teaches clove essential oil (claim 11 of Leung). Leung teaches moisturizing and cleansing the tissue (paragraph 12). Leung teaches “The compositions provided herein may be formulated for debriding, irrigating, moisturizing, cleansing, lubricating, and/or disinfecting a tissue site.” (paragraphs 21 and 36). Antimicrobial agents provided in Leung are aloe vera components, ashitaba, bacteriophage, beta-defensin, quaternary ammonium compound, chlorhexidine, copper, dispersin B, essential oil, gentamicin (noted antibiotic), lactoferrin, lysostaphin N-halamines, nitric oxide, oleic acid, PLUNC protein, polyhexanide biguanide (PHMB), bacteriocin, selenium, silver compound, triclosan, zinc, and combinations thereof (claim 7 of Leung). Leung teaches many types of topical formulations including creams, gels, ointments and powders (paragraph 21). Leung teaches 0.05% to 1% of antimicrobial agents (paragraph 30). Thus, 1% of an antimicrobial agent like an antibiotic is within teachings of Leung. Leung teaches silver nanoparticles (paragraph 30), a metal containing nanoparticle. Leung teaches pharmaceutically acceptable carriers include starches and esters (paragraph 19). Khalil evidences that eugenol is found in clove oil (abstract and Eugenol: at a glance). Pramod evidences that eugenol has skin benefits and also acts as a skin absorption/penetration agent (Abstract and page 2001). Thus, eugenol will penetrate/migrate into skin from a skin composition. Pramod notes and evidences that eugenol can increase skin retention, solubility and skin penetration of active compounds (second column of page 2001).
One of ordinary skill in the art before the time of filing would have been able to adjust the amount of an antimicrobial/antibiotic agent up to 1% and that metal species can be provided in nanoparticle form in a product to treat wounds based on the combined teachings of Leung. Leung provides for overlapping antibiotic ranges and forms of metal components that were known in the prior art for wound products. Thus, there was a reasonable expectation of success in providing other metal components as nanoparticles and making adjustments within ranges of the prior art (MPEP 2144.05) to achieve effective wound treatment products when combining the teachings of the references.
Claims 6, 7, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bakhtar (Iran Journal of Public Health, Nov 2013, volume 42, pages 1327-1328); Svensson US 20160081968, Marraccini US 20070224271, and JP 6847569 B2 (Published 3-24-2021, Google English translation).as evidenced by Khalil et al (Royal Society of Chemistry, 2017, volume 7, pages 32669-37681).
Bakhtar, Svensson, and Marraccini as evidenced by Khalil teach the claims as discussed above.
Bakhtar, Svensson, and Marraccini as evidenced by Khalil do not teach an amount of the zinc oxide as in applicant’s claims.
JP ‘569 provides for zinc oxide as an anti-inflammatory agent and as a metal powder where metal powder may be present from 0.5 to 20% by weight (English translation of disclosure and claim). JP ‘569 teaches acrinol (aka ethacridine lactate) as an antimicrobial component (English translation of disclosure).
One of ordinary skill in the art at the time of filing would have adjusted the concentration of zinc oxide to values between 0.5 to 20% by weight based on the combined teachings of the prior art as Bakhtar provides for a formulation with ethacridine lactate and zinc oxide and JP ‘569 provides amounts of zinc oxide powder, which serves as an anti-inflammatory for a topically applied formulation. Therefore, there was a reasonable expectation of success of adjusting the zinc oxide powder according to amounts disclosed in the prior art to obtain other topical formulations for treatment of sites with inflammation such as wounds.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bakhtar (Iran Journal of Public Health, Nov 2013, volume 42, pages 1327-1328); Svensson US 20160081968, Marraccini US 20070224271, and Lee et al (Frontiers in Pharmacology, October 2019, volume 10, pages 1-10). as evidenced by Khalil et al (Royal Society of Chemistry, 2017, volume 7, pages 32669-37681).
Bakhtar, Svensson, and Marraccini as evidenced by Khalil teach the claims as discussed above.
Bakhtar, Svensson and Marraccini as evidenced by Khalil do not teach nanoparticles of the antibiotic.
Lee teaches nanoparticles can penetrate the cell membrane of pathogenic microorganisms and that in combination with antibiotics, nanoparticles show synergy (abstract). Lee provides for NPs conjugated with antibiotics (page 2).
One of ordinary skill in the art at the time of filing would provide antibiotics in the form of nanoparticles into a formulation as they would provide the benefit of increasing the antimicrobial activity of the antibiotic based on teachings of Lee. There would be a reasonable expectation of success in utilizing antibiotic compounds as nanoparticles and getting increasing antimicrobial efficacy based on the combination of the prior art.
Advisory Notice
Claim 25 and its dependent claims to the method due to the powder having to be placed on the occlusive cover for its transport to the wound bed are now free of the prior art, however, applicant should note the 112(a) and (b) rejections above that need to be addressed before having claim 25 in condition for allowance. Import of the both the limitations of claims 27 and 29 into claim 25 should address these issues sufficiently.
In regards to claims 1 and 12, bringing both the products in line with the more particular items that will offer the functionalities as indicated in the claims (including zinc oxide, waxy esters and eugenol limitations together into each of claims 1 and 12) should bring the claims into sufficient scope with applicant’s invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613