DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Specification Objection
Content of Specification, Detailed Description of the Invention:
See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
The content of the specification is objected to for the following reasons:
The specification is objected to under 37 CFR § 1.71(c) for lack of clarity and internal inconsistency. More specifically, ¶[0048] of the PGPub defines a “coated particle” as having a diameter of 10⁻⁴-10⁻³ nanometres (i.e., a particle diameter range of 0.1-1 picometer (pm)), which is on the subatomic scale (i.e., about 100x smaller than a hydrogen atom) and is a nuclear-scale particle, not a conventional nanoparticle. In material science and chemistry, nanoparticles are generally defined as 1-100 nanometers, thus, the specification is unclear. It is possible there is an error in the unit notation (e.g., the intended unit is micrometers or meters rather than nanometers). Appropriate correction is required (e.g., “…coated particle is understood to mean a coated particle with a diameter of 1-10 nanometers).
The specification repeatedly refers to bonding and coated particles without identifying whether the interaction is chemical, physical adsorption, encapsulation, or complexation, which renders the nature of the invention unclear. The specification also inconsistently characterizes the invention as a solution, a particle-containing system, and a molecular complex, without reconciling these characterizations. The applicant is required to correct the above inconsistencies.
Claims Status
Claims 1-9 are pending and under current examination in this application.
Claim Objections
Claims 5-9 are objected to under 37 C.F.R. § 1.75(c) and 35 U.S.C. § 112(e) for improper claim dependency.
Claims 5, 6, 8 and 9 are objected to because they improperly depend from multiple claims (“according to one or more of the foregoing claims”, or “according to one or more of the claims 1-4”) and are not drafted in proper form. A multiple dependent claim must refer to other claims in the alternative only. The claim must clearly indicate that the applicant is electing one of the referenced claims as the basis for dependency, not a combination of them (MPEP § 608.01(n)). The language “one or more” is ambiguous and fails to inform the public as to whether the claim depends from a single claim in the alternative, or attempts to incorporate limitations from multiple claims simultaneously. Furthermore, the phrase “one or more” could be interpreted as requiring the examiner or the court to select which of the “one or more” claims applies, rendering the scope of the claim unclear. Claim 7 is include in the rejection because it depends from claim 6.
The applicant is advised to amend the claims to either depend from a single preceding base claim (e.g., “The method of claim 1, wherein...”), or be rewritten in proper alternative form (e.g., “according to claim 1 or claim 4”). If the applicant intends to maintain these as multiple dependent claims, the proper fee under 37 C.F.R. § 1.16(j) must be paid, and the claims must be amended to refer to specific claims in the alternative only. Failure to amend these claims will result in a continued objection and a refusal to enter the claims for substantive examination on the merits. The Examiner notes that, for the purposes of examination under 35 U.S.C. § 102 and § 103, multiple dependent claims will be construed in accordance with 35 U.S.C. § 112(e).
Claims 1-9 are objected to under 37 CFR § 1.75(d)(1)) for being sentence fragments rather than complete sentences, and/or being redundant with the claim in which they depend, and/or for being unduly prolix and complex.
Claim 1 is phrased as a fragment and is not structured as a complete sentence (i.e., lacks a verb and reads as a title not a sentence). The current phrasing does not clearly define what is being claimed as a statutory invention category. The claim appears to claim a composition but “stabilized with” creates ambiguity about the relationship between the elements making it difficult to discern with certainty what statutory category applies. The applicant is advised to revise the claim as such for a composition claim: “A composition comprising hydrogen peroxide and a coated particle, wherein the coated particle comprises one or more antimicrobial plant extracts, and wherein the coated particle stabilizes the hydrogen peroxide.”, or for a process claim: “A stabilized hydrogen peroxide composition prepared by a process comprising combining hydrogen peroxide with one or more antimicrobial plant extracts to form a coated particle of stabilized hydrogen peroxide.”
Claims 2-4 and 9 are objected to for being redundant by repeating the limitation of claim 1. Claim 9 is also phrased as a fragment and is not structured as a complete sentence (i.e., lacks transitional language incorporating multiple previous claims resulting in an incomplete thought). The applicant is advised to amend the claims to remove the redundancy.
Claim 5 is objected to because it is phrased as a fragment and is not structured as a complete sentence (i.e., lacks transitional phrasing). The applicant is advised to revise the claim to read as a complete sentence.
Claims 6-8 are also objected to for being phrased as fragments rather than structured as complete sentences. Claim 6 contains redundancy (e.g., “Application…as application as”) and is a run-on fragment attempting to list multiple uses without proper verb structure. Claim 7 is a series of descriptive clauses separated by semicolons and commas without a main verb to complete the concept introduced in claim 6. Claim 8 is a long list of prepositional phrases (e.g., “as source of…” and “for enriching…”) that never completes a sentence. The applicant is advised to revise the claim to read as a complete sentence. In addition, the claims are improperly formatted by reciting, “Application of hydrogen peroxide…”, rather than reciting a statutory invention category (e.g., method of use; see separate § 101 rejection below). The term application does not clearly define a process step or actionable method and renders the claims indefinite as to statutory class. Correction is required to rewrite such claims in proper method-of-use format, with each claim directed to a single statutory category.
In addition, claims 6-8 are objected to for improperly combine multiple distinct uses (e.g., disinfectant, biocide, bleaching agent, medical treatment, oxygen source, veterinary use, water treatment, crop protection, COVID treatment) within a single claim, resulting in claims of excessive multiplicity and lack of unity of invention. Claim 7 is particularly unduly prolix and complex, containing multiple independent applications recited in a single claim. The claim recites approximately fifteen distinct fields of use in a single sentence structure, making it difficult to ascertain the boundaries of the subject matter for which protection is sought. Claim 8 is similarly unduly prolix and complex, reciting approximately twelve distinct applications in a single claim. This claim format fails to provide clear notice of the scope of protection sought.
The applicant is required to rewrite claims 7 and 8 to separate the multitude of distinct applications into multiple individual claims or to otherwise restrict to a single invention. The excessive length and complexity of claims 7 and 8 violates the requirement that claims be concise as set forth in 37 CFR 1.75(b) and MPEP § 2173.05(m).
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 Applicant regards as his invention.
Claims 1-9 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, regards as the invention.
Claims 1-9 are rejected for the use of the term "coated particle" directly or indirectly by depending from such a claim. The specification defines a "coated particle" as "a coated particle with a diameter of 10⁻⁴-10⁻³ nanometres" (¶[0048]; 0.0001-0.001 nm) which is smaller than any known atomic nucleus and approaches the scale of subatomic particles. This is physically impossible, a particle cannot be smaller than a single atom, let alone smaller than a proton. Moreover, the specification provides no method for measuring particle diameter at this scale, and the examples provide no particle size measurements. The term "coated particle" as defined is therefore indefinite because a person of ordinary skill cannot determine with reasonable certainty whether a composition falls within the scope of the claim when the defining parameter is physically impossible to achieve or measure.
Furthermore, even if the numerical range were corrected (e.g., 10⁻⁴-10⁻³ millimeters or micrometers), the specification provides does not clearly indicate what material forms the particle and no structure or method for determining what constitutes a "coated particle" (e.g., Is it a hydrogen peroxide molecule surrounded by plant extract? Is the particle made from the extracts or is the particle made of some other material and coated with the extracts? Is it an aggregate or a micelle?). The nature of the coating in terms of continuity and chemistry is not specified. The specification describes what the composition does (i.e., stabilizes) rather than what it is structurally and without any structural definition, the boundaries of the claim cannot be ascertained with reasonable certainty (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)).
Claims 3-5, and therefore also dependent claims 6-9, are rendered indefinite for using the term “preferably” in the claim. The term "preferably" introduces ambiguity as to whether the claimed feature is optional or required. As drafted, a person of ordinary skill cannot determine with reasonable certainty whether an alcohol that is not a polyol (e.g., ethanol) falls within the scope of the claim. Claims must distinctly set forth the subject matter regarded as the invention, and terms like "preferably" make the scope unclear. See Ex parte Porter (1993), where the Board held that terms such as "preferably" create uncertainty about claim boundaries. To overcome this rejection, Applicant should remove the term "preferably" and recite the feature as either mandatory or optional. Alternatively, Applicant may amend the claim to clearly define under what conditions the preferred feature applies.
Claims 6-8 are rejected as indefinite for being structured as “Application of hydrogen peroxide…”, because it is unclear whether these claims are directed to a method (i.e., a process), a composition, or a use. It is unclear whether infringement occurs upon making the composition or upon using it for the recited applications. This hybrid claim mixing composition and method/use elements fails to provide clarity as to the scope of protection. In addition, for claim 7, the claim recites "Application of hydrogen peroxide according to claim 6, as disinfectant and cleaning agent for removing biofilms..." without reciting any method steps. A person of ordinary skill cannot determine whether performing a disinfecting method would infringe, or merely designating the composition for such use would infringe. This ambiguity violates the definiteness requirement.
Additionally, claim 6, and therefore the dependent claim 7, is rejected for the use of “signalling agent”, which is not defined in the specification. A person of ordinary skill in the art would have no way to determine what “signalling agent” means in the context of stabilized hydrogen peroxide. Claim 8 recites “viruses such as COVID”, however, COVID is a disease not a virus (e.g., SARS-CoV-2). Even if corrected to reflect the proper virus name, using a specific virus name in a broad claim creates uncertainty as to whether the claim covers all viruses or only the listed viruses. Claim 9 recites, “medical aid”, wherein the term is not mentioned in the specification and has no definition and could encompass everything from bandages to diagnostic equipment, leaving the scope of the claim completely uncertain. In claim 9, “for use as medicine or medical aid”, without identifying disease indication, route of administration, dosage, treatment protocol, renders the claim indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-8 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter.
Claims 6-8 are directed to an “application of hydrogen peroxide” for a broad list of results or intended uses. These claims merely recite intended outcomes (e.g., disinfecting, preventing microorganisms, enriching oxygen, treating COVID, reducing nitrite) without reciting affirmative method steps. The claims fail to define a process, machine, manufacture, or composition of matter, as required by 35 U.S.C. § 101.
Accordingly, claims 6-8 do not fall within a statutory category and are rejected.
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 (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 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 and 6-9 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Huang et al. (WO2010101844A1; published 10 Sep 2010, hereinafter referred to as “Huang”).
Huang teaches a biochemical composition comprising a combination of a plant polyphenol and hydrogen peroxide. The hydrogen peroxide is sequestered or stabilized within the reactive proximity of the polyphenol via non-covalent bond opportunities, charge attraction, and physical sequestration (¶[0028], ¶[0069]-[0070]). Thus, Huang teaches the stabilization of hydrogen peroxide via sequestration, essentially a protective layer covering the surface (i.e., coating), by the polyphenol, in which discrete particles are formed (as evidence by reference to particle size in ¶[0115]) that may be in a mobile solid form (¶[0109]; see also evidentiary reference Kobayashi et al. (US-5824414-A; published 20 Oct 1998), explicitly disclosing wherein polyphenols prepared a discrete spherical particles). Huang teaches in some embodiments, the compositions are aqueous solutions and in alternative embodiments, hydrogels, microporous media, micelles, emulsions, and other structures physically encapsulate the oxidizer composition or mixtures of dry powders, granules, or other non-liquid materials may be combined to produce a useful polyphenol-oxidizer solution (¶[0074]).
In addition, the bioactive and germicidal system may contain a mixture of a plant-based material, such as polyphenols in which, “A person of ordinary skill in the art would appreciate that any macromolecules, polymers, aggregate of small molecules, cellular membrane fragments, cross linked compounds containing a multiplicity of exposed phenolic units and an activation precursor (e.g., an oxidizer, such as hydrogen peroxide), or combinations thereof are applicable.” (¶[0026]).
Polyphenols and polysaccharides produced by plant extracts may form antimicrobial compounds (e.g., polyquinonic compounds and analogues; ¶[0033]; ¶[0061]-[0063]; ¶[0098]), wherein, “In many situations, it can be beneficial to promote heterogeneous mixtures of activated biopolymers to maximize bio-activity/bioavailability against a broader range of pathogens.” (¶[0055]). Thus, Huang teaches functional stabilization of hydrogen peroxide by association with one or more antimicrobial plant material extracts forming stabilized oxidizing molecular complexes, thereby imparting prolonged antimicrobial activity. A person of ordinary skill reading Huang would understand that the sequestered hydrogen peroxide-polyphenol complex is a form of a "coated particle", wherein the coated particle structural limitation is intrinsic. Accordingly, claim 1 is anticipated under § 102 by Huang.
Huang discloses extensive uses of compositions of hydrogen peroxide with plant extracts. The disclosure of these uses spans bacteria, fungi, viruses, and algae, which corresponds directly to the applications recited in instant claims 6-9.
Huang teaches the use of stabilized hydrogen peroxide in applications including agriculture applications, pond water sanitation, animal nutritional supplements, pathogen barrier formation, exogenous addition of oxidative enzyme for biocidal applications, hydrogen peroxide sequestration, pathogen metabolic halt, medicinal beverages, microbial flocculants, biological substance preservation, antimicrobial wash, agriculture applications, pond water sanitation, medical device surface treatments, medicine delivery vehicles (¶[0085]), plant washes, killing or suppress surface bacteria in live crops or agricultural produce, groundwater remediation, animal feed sterilization, food or water additives for preservation and prevention of disease transmission(¶[0103]), pond water sanitation, disease treatment for aquatic plants and animals, aquarium sanitizers, preservative additives for liquid-containing products, disinfectant ingredients for surface cleaners, quinone REDOX cycling coatings for medical devices, clothing and food preparation equipment, hospital environment and instrument sanitization, organic anti-corrosive treatments for metals (¶[0104]), water shock, preservatives, antifoulants, hot tub and swimming pool water sanitation, small molecule therapeutic compounds, stabilizers for oxidizers, modification of food flavors, and injection into tumors and cysts (¶[0105]), water sanitizers, flocculants, biofilm preventions, disinfectants, oxidizing cleaners and for antimicrobial sprays to reduce pathogens and protect from invasion by the pathogens, such as bacteria, viruses (e.g., COVID-19), and fungi (¶[0100]) and can be dosed by spraying, immersion rinses/soaking, ingested by humans or animals to treat or prevent pathogen infections and fed to animals (¶[0100] and ¶[0112]), used as an aerosol (¶[0102]) and used on the skin (¶[0101]). In addition, Huang teaches wherein binding to multiple pathogens causes agglomeration or removal of microorganisms, proteins or proteinaceous structures from solution or the method further comprises removing or inactivating an oxidoreductase or a reducing compound that reacts with an oxidizer (¶[0014]). The triggering catalyst can also be of non-biologic origins such as a metal that causes reduction of the activation precursor to cause auto-oxidation of the plant-based material into its activated form (¶[0025]).
In some aspects, contaminated water sources can be treated with the compositions of the invention causing aggregation of the microorganisms into masses that either precipitate out or can be more easily filtered out by mechanical means or deposition on mechanical filter media to trap proteins and microorganisms while imparting germicidal characteristics and treating bacterial biofilms with many recirculating and single-pass filtration applications (¶[0076]).
Hydrogen peroxide is known to be effective at breaking down crop protection agents (e.g., organophosphates, carbamates fungicides) and some medicinal compounds (e.g., antibiotics and hormones), reducing residues to or below the maximum residue limit standards by acting as a strong oxidizing agent, effectively breaking down complex organic molecules into simpler, non-toxic, or less toxic by-products (e.g., water and carbon dioxide). Huang’s disclosure of oxidizing cleaners application, inherently encompasses use of hydrogen peroxide as an oxidant known to degrade organic compounds and break down organic pesticides and pharmaceuticals. This is an inherent property of hydrogen peroxide compositions. Hydrogen peroxide also inherently acts as an oxidizing agent, which oxidizes nitrite to nitrate, lowering toxic nitrite levels and is known to be used for this purpose to eliminate nitrite and ammonia in aquaculture.
Huang discloses that hydrogen peroxide-containing gel ointment as a vehicle for carrying oxygen for use as a disinfectant for contact lenses (¶[0044]). Hydrogen peroxide decomposes to water and oxygen (¶[0071]), and this inherent property is well known has been exploited for decades to oxygenate water, soil, and growth media and to act as a source of oxygen for humans, animals, and plants (e.g., used to oxygenate stored blood, to provide oxygen in aquaculture for fish, and to deliver oxygen to plant roots and help prevent root rot) long before the instant effective filing date. The use of the hydrogen peroxide containing composition as a vehicle for carrying oxygen is an inherent property of hydrogen peroxide compositions. A person of ordinary skill would have immediately recognized that Huang’s hydrogen peroxide-containing composition inherently serves the purpose of acting as source of oxygen.
Thus, Huang discloses the full range of disinfectant, biocide, biofilm removal, cleaning, agricultural, veterinary, human hygiene, surface and equipment treatment applications recited in instant claims 6-9 or they are well known inherent properties of hydrogen peroxide compositions that would be immediately recognized by a person of ordinary skill. Accordingly, instant claims 6-9 are anticipated by the teachings of Huang.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. § 103 as being unpatentable over Huang et al. (US-20190000909-A1; published 03 Jan 2019, hereinafter referred to as “Huang”) in view of Howard et al. (US-6642277-B1; published 04 Nov 2003, hereinafter referred to as “Howard”).
Huang teaches the limitation of instant claim 1, as described above, from which instant claim 2 depends, however does not explicitly teach the specific limitations of instant claims 2.
Huang teaches the use of plant extracts including Camellia sinensis (tea) and Punica granatum (pomegranate rind) as sources of polyphenols (¶[0011]) and further teaches effective compositions can be produced from many different plant species including rye seeds, mung beans, daikon skin, pomegranate rinds, bearberries, aloe vera skin, organ pipe cactus, Chinese gall, oregano leaves, persimmon fruit, wheat germ, barley seeds, and coffee beans (¶[0063]), showing the ubiquitous nature of this mechanism in the plant kingdom. While Huang does not explicitly recite plant extracts selected from Allium, Solanaceae, Magnoliaceae, Salicaceae, Cupressaceae, or Chamaecyparis, the selection of additional plant families from the vast array of polyphenol-bearing plants would have been obvious. Plant extracts from many plant families, including Allium spp. (e.g., garlic (Allium sativum) and onion (Allium cepa), have been used for centuries as antimicrobial agents, are well known in the antimicrobial literature. A person of ordinary skill seeking an antimicrobial plant extract would have immediately considered garlic and onion extracts as obvious choices.
Moreover, Howard teaches polyphenols (including flavonols) may be obtained from bell peppers (e.g. var. “Yolo wonder”), tomatoes and potatoes and onions (column 8, lines 13-15), members of the Solanaceae and Allium families, respectively. Thus, identifying an additional species within a different family to achieve a similar or identical result of stabilizing hydrogen peroxide with polyphenols is a routine optimization and would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention. The selection of a particular antimicrobial plant extract from among the many known antimicrobial plant extracts is a routine optimization exercise that yields predictable results (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003), wherein selection of a particular species from a known genus is obvious where the species has predictable properties).
Claims 1 and 3-5 are rejected under 35 U.S.C. § 103 as being unpatentable over Huang et al. (US-20190000909-A1; published 03 Jan 2019, hereinafter referred to as “Huang”) in view of Van Geetruy et al. (WO-2005075350-A1; published 18 Aug 2005, hereinafter referred to as “Van Geetruy”) and in further view of Young et al. (WO-2013093877-A2; published 27 June 2013, hereinafter referred to as “Young”).
Huang teaches the limitation of instant claim 1, as described above, from which instant claims 3-5 depend, however does not explicitly teach the specific limitations of instant claims 3-5.
Huang does not explicitly teach the use of generally considered non-toxic polyols or polyhydric alcohols including polyethylene glycol (multiple hydroxyl groups), glycerol (glycerin; 3 hydroxyl groups), erythritol (4 hydroxyl groups), xylitol (5 hydroxyl groups), sorbitol (6 hydroxyl groups), mannitol (6 hydroxyl groups), maltitol (8 hydroxyl groups), or lactitol (8 hydroxyl groups).
However, glycerol/glycerin is well known and has been used extensively in pharmaceutical grade peroxide solutions as a stabilizer for decades as a stabilizer, as it scavenges free radicals, chelates metal ions, and reduces decomposition rate. Similarly, sorbitol is well established as an effective stabilizer for formulations containing peroxides in the art pharmaceutical and cosmetic formulations and coatings are commonly used to protect the peroxygen component in oral care applications (e.g., for bleaching agents like carbamide peroxide (hydrogen peroxide and urea)). Thus, the addition of well-known stabilizers in known compositions is obvious (see In re Boe, 355 F.2d 961, 965 (CCPA 1966)).
For example, Van Geetruy teaches that glycerol/glycerin is a traditionally used stabilizer, that mannitol has been described as a suitable stabilizer (page 1, lines 15-19), and established that sorbitol may also be used to stabilize hydrogen peroxide, suitable as a disinfectant (page 1, lines 32-36), reducing the deterioration of hydrogen peroxide (page 2, lines 24-26). Further Young teaches the use of the polyol polyethylene glycol in a microparticle encapsulating a bleaching agent within as part of the shell coating to modify release rate of the hydrogen peroxide on contact with water (claim 7 and 9 and Abstract and Figure 6).
Thus, the combination of the prior art teaches stabilization of hydrogen peroxide with polyols such as glycerol, mannitol and sorbitol to reduce decomposition and improve shelf life, wherein polyols such as polyethylene glycol have specifically been used in coating applications of bleaching agents to modify hydrogen peroxide release. Combining the known polyol stabilization techniques taught by Van Geetruy and Young with the peroxide–plant extract combinations of Huang would have been obvious to enhance peroxide stability and extend shelf life. The motivation to do so would be the desire to create a commercially viable product with adequate stability for storage, transport, and use. It would have been routine to coat plant extract particles with polyols to improve compatibility and stability due to common formulation practices for liquid oxidizers with organic additives. Therefore, instant claims 3 and 4 are obvious modifications of Huang’s peroxide–plant extract compositions in view of polyol stabilizer teachings of Van Geetruy and Young.
The claimed "hydrogen-absorbing properties" is a functional limitation that does not distinguish the composition from known polyol-stabilized compositions. Glycerol and sorbitol were known to have hydrogen-absorbing properties, and a person of ordinary skill would have selected them for this very reason. The recitation of "preferably" does not limit the claim to polyols.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to select a polyol with three to ten hydroxyl groups from among the well-known polyol stabilizers available in the art. The claimed range of three to ten hydroxyl groups is broad enough to encompass the most common and commercially significant polyol stabilizers. Again, the recitation of "preferably" does not limit the claim to the narrower preferred range of three to eight hydroxyl groups, however, this still encompasses glycerol, erythritol, xylitol, sorbitol, mannitol, and maltitol, which are all common and all well-known polyol stabilizers.
A person of ordinary skill would have had a reasonable expectation of success in using any of these polyols based on their established use as stabilizers in analogous compositions. The optimization of the number of hydroxyl groups within the instant claimed range would have been a matter of routine experimentation based on factors such as cost, availability, solubility, hygroscopicity, and desired physical properties (see In re Aller, 220 F.2d 454, 456 (CCPA 1955), wherein the mere optimization of a range, through routine experimentation, does not render a claim non-obvious).
Huang teaches in Experiment 3, a preparation of the antimicrobial plant extracts from 1 gram of green tea powder mixed with 1 liter of deionized water (0.1% weight/volume), “allowed to extract at room temperature [approximately 20-25°C] for 6 hours”, followed by the addition of 35% hydrogen peroxide to the solution for 4 hours presumptively at room temperature, since no other temperature change is indicated, achieving a functional antibacterial product of hydrogen peroxide stabilized with the antimicrobial plant extract (¶[0118] and ¶[0119]), wherein in mixing is inherent and alternative embodiments the composition may include stabilizers for oxidizers ¶[0105]. When describing the process for preparing a plant-based composition in accordance with one embodiment of the present invention Huang notes that the sequence of the steps can be in any order and other variations are applicable (¶[0082]).
Young teaches the use of release rate modifiers at a concentration from 0.5-40% wt., such as polyethylene glycols and glycerol (page 8, lines 7, 8, 13 and 17), wherein, “In one embodiment, a combination of PEGs…may be mixed on appropriate amounts to provide a mixture which is liquid at a temperature of 35-70°C, such as 45-60°C.” (page 9, lines 2-5). In the example embodiments by Young, PEG was added “while stirring” (page 16, lines 27-28). Continuous stirring is a routine operation for mixing. Van Geetruy teaches the addition of other polyols to stabilize hydrogen peroxide, such as sorbitol, at 0.5-10 % by weight with the use of 10-50% by weight of hydrogen peroxide (claim 1).
Thus, the basic method for preparing stabilized hydrogen peroxide is taught by Huang, wherein the addition of a polyol to coat a peroxide, exemplified by PEG, is taught generally by Young. As noted previously, the recitation of "preferably" does not limit the claims as in instant claim 5. The broad temperature range of the instant claims encompasses ambient conditions and gentle heating, which is common for improving solubility or mixing and aligns with range detailed by Young to ensure PEG remains liquid.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the prior art teaching with reasonable expectation to mix plant extracts in water, add known polyol stabilizers, and then add hydrogen peroxide to form a stabilized composition. A person of ordinary skill seeking to commercialize Huang’s composition would have been motivated to optimize process parameters such as concentration, temperature, mixing time, and order of addition to achieve consistent, scalable production.
Huang teaches mixing by allowing the solution to "sit" but does not explicitly require continuous stirring. A person of ordinary skill would recognize that stirring or agitation promotes uniform mixing and reaction. The addition of "continuous stirring" to Huang process would have been an obvious improvement to ensure homogeneity. Therefore, the instant claimed method represents an obvious and routine combination of known preparation steps. A person of ordinary skill would have been motivated to optimize Huang’s process using conventional parameters and the teachings of Young would have arrived at the instant claimed method through routine experimentation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615