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 .
Priority
This application is a National Stage Entry of PCT/EP2023/055030, filed 2/28/2023, which claims priority to foreign patent application EP22382207.3, filed 3/7/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/9/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because:
FIG 2.1 overlaps with the outline of FIG 2.2. 37 C.F.R. 1.84(i) Arrangement of views states that “One view must not be placed upon another or within the outline of another.” For clarity, it is requested that these two figures be placed separate of one another. Further, they are not alternative view or an inset of one view.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Used in various places in the specification, the term “Juglone” (5-hydroxy-1,4-napthalenedione” appears to be a common name for this compound and not a proper noun or a trademarked product. Its noted that the term is capitalized inconsistently throughout the specification. To avoid any source of confusion, the term should not be capitalized, and instead should say “juglone”.
Appropriate correction is required.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
In claim 1, the phrase “5 and15%” is missing a space and should be: “5 and 15%”.
In claim 10, the term “Juglone” appears to be a name for a compound and not a proper noun or a trademarked product. To avoid any source of confusion, the term should not be capitalized, and instead should say “juglone”.
Appropriate correction is required.
Claim Interpretation
The claims have been afforded the Broadest Reasonable Interpretation (B.R.I.), in light of the specification. The terms “silicone elastomer gel”, “silicone fluid base”, and “silicone emulsifier” are embodied in the specification as comprising a cyclomethicone dimethicone crosspolymer, a cyclopentasiloxane, and an alkylmethyl silicone polyether copolymer, respectively (see e.g. Examples 1-3). These may comprise the trade products known as ST-Elasomer-10®; ST-Cyclomethicone 5 NF®; and Dowsil 5200 Formulation Aid®, respectively (see pg. 16 of the specification).
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 3, 4, 11-15 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.
Claim 3 recites the phrase “average molecular weight higher than 5,000” without specifying the units. The resulting claim is indefinite because there is no manner to determine the metes and bounds of the claimed element. The molecular weight of the polymer could be in Daltons (Da), kilodaltons (kDA), atomic mass units, or in terms of g/mol (e.g. relative mol. Weight). Because the means to determine this feature is not recited in the claim or specially defined in the specification, the claim is indefinite.
Claims 3, 4, and 15 each recite the term “about”. As used herein, the term “about” is a relative term which renders the claim indefinite. The amount of variation which determines the definition of about is not defined by the claim, the specification does not provide a standard for ascertaining the allowed variation, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no particular or special definition for the term about in the disclosure. Further, in claim 4, the term is used as “higher than about 95% by weight”. This renders claim 4 indefinite because it is unclear if a value of exactly 95 is included in “higher than about 95%” or not. For claim 15, the claim recites “within a target epidermal depth range from about 30µm to about 120µm”. This is indefinite because it is unclear where the actual claimed target range begins and ends. If a substance of the prior art works at a range of 20µm to 29µm does this infringe on the instant claim? Does efficacy at 25µm infringe?
Because one cannot determine the actual limits of the protection that is sought, claims 3, 4, and 15 are indefinite.
Claim 11 recites “A method of treatment herpes viruses to a patient comprising:”. This phrase renders the claimed method indefinite because one cannot determine the effect of this preamble limitation on the claimed method. The phrase is not in proper English and this improper grammar leads to a preamble which cannot be understood. It is unclear to what extent this language is meant to limit the claimed method. What does “treatment herpes viruses to a patient” mean? Does the claim simply mean a method of treating herpes in a patient?
The recited active method step is: “topically administrating to the patient a dosage regime of the silicone gel composition of claim 1.” The claimed method has been evaluated for patentability based only upon this recitation.
In order to overcome this rejection, it is suggested to amend the claim preamble language to: “A method of treating herpes viruses in a patient in need thereof, comprising:”, or language similar thereto.
Further, claim 15 also recites the phrase “the treatment has efficacy within”. This element is indefinite because there is no manner provided in which to determine the “efficacy” of the treatment. The term “efficacy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree of the effect that is required, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 12-14 depend from claim 11 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-2, 4-11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mtchedlidze (US Pat. No. 8,318,219) in view of McGraw et al. (US PGPub No. 20100080768).
Mtchedlidze (US Pat. No. 8,318,219) pertains to an isolated extract of walnuts of high efficiency and stability over time useful for the manufacture of a medicament for the treatment of viral, fungal and bacterial diseases (Abstract). Mtchedlidze teaches that walnut extract contains naphthoquinones including juglone that has anti-microbial, anti-neoplastic, anti-parasitic, anti-fungal, and antiseptic properties (Col 1, lines 29-45). Mtchedlidze discusses that one aspect of the invention is for the walnut extract to be used in the manufacture of a medicament for the treatment of viral, fungal and bacterial diseases (Col 2, lines 46-50).
Mtchedlidze teaches that the extract of walnuts has application in the treatment of herpes, and other skin diseases (Col 4, lines 50-55). Mtchedlidze teaches the administration of the extract according to the present invention can be carried out by topical, intraperitoneal or oral application such as, e.g. liquid form, creams or tablets (Col 4, lines 56-65; Claims 17 and 20).
Mtchedlidze also demonstrates, by reduction to practice, that the walnut extract containing natural naphthoquinone (i.e. juglone) has anti-viral activity, specifically against herpes simplex virus (HSV) (Col 7, line 25- Col 8, line 4).
Mtchedlidze also recites a method of treating a viral infection in a patient, said method comprising the step of administering to the patient a therapeutically effective dose of a walnut extract (see Claim 13), wherein the viral infection is caused by herpes simplex virus (HSV) (see Claim 14). Mtchedlidze also discloses that the extract is at a concentration between about 5% and about 50% (see claim 19).
However, Mtchedlidze does not explicitly teach that the walnut extract is prepared with a silicone gel composition comprising a silicone mixture consisting of: a silicone elastomer gel, a silicone fluid base, and a silicone emulsifier, wherein the silicone elastomer gel is in an amount between 60 and 75%, the silicone fluid base is in an amount between 12 and 25%, the silicone emulsifier is in an amount between 2 and 6%, as recited in the instant claim 1.
McGraw is drawn to a composition for the delivery of pharmaceutically-active substances for the treatment of inflammatory dermatosis and other pathological conditions of the skin (i.e. is “used as a vehicle for percutaneous absorption of pharmaceutical and cosmeceutical active agents”, Abstract) that comprises the silicone-polymer components dimethiconol (hydroxyl-terminated polydimethylsiloxane), dimethicone-350 (polydimethylsiloxane-350), cyclomethicone-5 NF (decamethylcyclopentasiloxane), alkymeth siloxane copolyol-lauryl peg/ppg 18/18 methicone (alkymethyl siloxane copolyol), cyclopentasiloxane and dimethicone crosspolymer (silicone elastomer and decamethylcyclopentasiloxane), stearoxytrimethylsilane and stearyl alcohol (silicone wax), and deionized water (Abstract, [0002]).
McGraw states that the composition of the present invention is suitable for topical administration in the form of, inter alia, an oil/water/silicone emulsion, hydro-alcohol gel, cream, or an ointment ([0020] and [0044]).
Regarding the proportions of the ingredients in the topical silicone composition of McGraw, one embodiment ([0036]) is describes as comprising inter alia:
Dimethiconol (hydroxyl-terminated polydimethylsiloxane) (1.0-35.0% w/w)
Dimethicone-350 (Polydimethylsiloxane-350) (1.0-20.0% w/w);
Cyclopentasiloxane and Dimethicone Crosspolymer (silicone elastomer and decamethylcyclopentasiloxane) (1.0-75.0% w/w).
Cyclomethicone-5 nf (decamethylcyclopentasiloxane) (1.0-40.0% w/w);
Alkymethyl Siloxane copolyol-lauryl peg/ppg 18/18 methicone (1.0-5.0% w/w);
In regards to the instantly claimed components, McGraw teaches using various silicone elastomer gel compounds, including the dimethiconol (hydroxyl-terminated polydimethylsiloxane) and dimethicone-350 (polydimethylsiloxane-350) of Phase A; the cyclopentasiloxane and dimethicone crosspolymer (e.g. that of phase D), and the sodium polyacrylate and dimethicone and cyclopentasiloxane and trideceth-6 and peg/ppg-18/18 dimethicone (sodium polyacrylate in dimethicone) polymers of Phase E therein (see e.g. [0036]).
McGraw teaches that the copolymer may be present in amounts up to 75% (e.g. [0036]). Additional silicone components such as the dimethicol and dimethicone-350 polymers are described as being present in up to 35% and 20%, respectively (w/w).
Regarding the fluid base, McGraw teaches that the mixture comprises cyclomethicone-5 nf (decamethylcyclopentasiloxane), the same compound ST-Cyclomethicone 5 NF® used in the instant invention as the fluid base. In some embodiments it is used at a concentration of between 12 and 25% (see the Examples in [0099]-[0162] of McGraw, where Phase B comprising “Cyclomethicone-5 nf” is provided at 15%, 12%, and 20% of the total composition).
Further, McGraw teaches an emulsifier, namely the use of an alkymethyl siloxane copolyol-lauryl peg/ppg 18/18 methicone at 1.0-5.0% w/w ([0036]), the same as the alkylmethyl silicone polyether copolymer of the instant claims.
McGraw teaches that the compositions can be used by themselves or in admixture with one or more medicaments or excipients, and teaches that the product may include, inter alia, antiviral additives ([0048]). McGraw states that “the present invention relates to a method of providing the composition as a transdermal base used for the percutaneous absorption of pharmaceutical and cosmeceutical active agent”, including antibiotics and other an anti-inflammatory agents ([0052]).
McGraw teaches that polydimethylsiloxane polymers or silicone gums have been shown to improve the substantivity of actives on the skin, and teaches that PDMS is permeable to the diffusion of various substances including active drugs ([0057]; “Each of these described properties is appropriate for transdermal and topical delivery applications.”).
Therefore, before the effective filing date of the instant invention, to one of ordinary skill in the art, it would have been prima facie obvious to combine the walnut extract taught in Mtchedlidze containing the naphthoquinone juglone having anti-viral properties and the topical silicone composition of McGraw, with the predictable result of a topical silicone gel comprising a silicone elastomer gel (e.g. hydroxyl-terminated polydimethylsiloxane, polydimethylsiloxane-350, cyclopentasiloxane and dimethicone crosspolymer), a silicone fluid base (e.g. cyclomethicone-5/decamethylcyclopentasiloxane), and a silicone emulsifier (e.g. alkymethyl siloxane copolyol-lauryl peg/ppg 18/18 methicone), which delivers the anti-viral walnut extract and provides proactive anti-inflammatory benefits. Further, it would have been obvious to one having ordinary skill in the art to arrive at the instantly claimed concentrations, based upon the disclosure of McGraw, to optimize the concentrations of the included silicone gel components within the ranges disclosed in the prior art.
One would have been motivated because Mtchedlidze suggests administering the walnut extract topically in a suitable form such as a cream for the treatment of herpes virus. One having an ordinary level of skill and knowledge in the art of topical ointment or cream preparation would be well aware of silicone gel (i.e. gum or cream) compositions, comprising the components and compositions taught in McGraw. Providing a known silicone-based elastomer using commercial available or other-wise well-known materials would have been well within the level of ordinary skill in the art. McGraw teaches the skin protective and anti-inflammatory benefits of the drug-delivery composition described therein.
Further, KSR Rationale A (See MPEP § 2143.I.A) describes that it is obvious to combine prior art elements according to known methods to yield predictable results, without an explicit teaching suggestion or motivation to do so. In the instant case, the combination of the pharmaceutically useful walnut extract containing juglone of Mtchedlidze with the silicone-based composition for pharmaceutical delivery taught in McGraw would have been obvious, with the predictable effect of yielding an anti-viral and anti-inflammatory silicone gel emulsion for topical application.
With regard to the amounts, and ratios, proportions, and concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components.
MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition (or performing a known method) can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Regardless, in the instant case, all of the claimed concentrations fall near or within the range of concentrations taught in the art. It would have been a matter of routine optimization to arrive at the instantly recited concentration ranges, using the guidelines of the cited art as a starting place.
Regarding claim 2, it appears that the instantly claimed material is the same or essentially the same as that recited in McGraw, including a silicone elastomer gel comprising polydimethylsiloxanes, decamethylcyclopentasiloxane and dimethicone crosspolymer, a silicone fluid base that comprises a cyclopentasiloxane, and a silicone emulsifier comprising alkymethyl siloxane copolyol-lauryl peg/ppg 18/18 methicone. Arriving at the particulars of the instantly claimed composition (i.e. the D5 in a network backbone of PDMS) would have been prima facie obvious to one of ordinary skill in the art of preparing silicone emulsions.
For claim 4, McGraw teaches that the mixture comprises cyclomethicone-5 nf (decamethylcyclopentasiloxane), which appears to be the same compound ST-Cyclomethicone 5 NF® used in the instant invention as the fluid base. Although McGraw doesn’t explicitly teach that the compound is 95% pure (e.g. D5 is in an amount higher than about 95% by weight), the use of the same compound as that which is instantly recited renders this limitation obvious.
Regarding claim 5, as described above, McGraw teaches that the compositions includes alkymethyl siloxane copolyol-lauryl peg/ppg 18/18 methicone, which fulfills the instantly claimed element of an alkylmethyl silicone polyether copolymer. It also appears to be the same product exemplified in the instant specification (e.g. an alkylmethyl silicone polyether copolymer available commercially as DOWSIL™ 5200 Formulation Aid). Thus, because McGraw uses this alkymethyl siloxane copolyol-lauryl peg/ppg 18/18 methicone at concentrations within the range that is instantly recited, one would have likewise been motivated to use the same ingredients when producing a topical composition with walnut extract.
Regarding claims 6-9, these specific concentrations fall within the broad concentrations taught in the art. Further, there is no data that indicates unexpected results of selecting any of these concentration. Thus, as described above, all of these claimed concentrations fall near or within the range of concentrations taught in the art. It would have been a matter of routine optimization to arrive at the instantly recited concentration ranges, using the guidelines of the cited art as a starting place. See MPEP § 2144.05, “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Further, for claim 9, Mtchedlidze teaches that the extract is at a concentration of 5% - 50%, while indicating that the upper range may have skin toxicity effects (see Col 7, lines 5-11). Because of these teachings, and the general teachings therein that the 5% solution was effective, one could have been expected to optimize the concentration of walnut extract, and the instantly claimed range of 8-12% falling near to the low end of 5% as taught in Mtchedlidze. It is therefore highly predictable with a high likelihood of success, that an ordinary artisan would have arrive at the instantly claimed concentrations, especially in the absence of evidence of the criticality of these concentrations, as previously discussed.
Regarding claim 10, Mtchedlidze teaches that the walnut extract disclosed therein had about 0.3 to 0.5 % concentration of juglone, which falls within the instantly cited range. It would have been obvious in view of the teachings of Mtchedlidze to use this same extract.
Regarding claim 11, Mtchedlidze also recites a method of treating a viral infection in a patient, said method comprising the step of administering to the patient a therapeutically effective dose of a walnut extract (see Claim 13), wherein the viral infection is caused by herpes simplex virus (HSV) (see Claim 14). Thus, in light of the combined teachings of McGraw and Mtchedlidze, it would have been prima facie obvious to administer the silicone gel containing composition in a method of treating herpes in a patient in need thereof.
Regarding claim 15, McGraw teaches that the silicone-containing materials used therein are known for drug delivery and skin-treating properties. McGraw teaches that the silicone composition is used to deliver various topical medicines including antibiotics and anti-inflammatory drugs. Given the disclosure regarding PDMS and other silicone containing vehicles discussed therein, one of ordinary skill in the art would predict the combinations efficacy in the upper layer of the epidermis, traditionally said to range from about 0.05 mm (50µm) to 1.5 mm (1500µm), depending on the location on the body. Thus, it is reasonable to predict that the epidermis-penetrating composition taught in McGraw would have efficacy of at least 30µM, according to the lower end of the claimed range. Regardless, the components used in the instant invention are essentially the same as that recited in McGraw, and thus the referenced composition is likely to inherently possess the same characteristics of the claimed composition such as the depth of epidermis penetration that is achieved. The depth of treatment that is achieved by the delivery of the silicone gel composition would be obvious in view of all the teachings of the prior art, and it would have been obvious to optimize the treatment depth, especially absence of sufficient, clear, and convincing evidence of unexpected results.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because McGraw teaches topical silicone gels for delivering pharmaceuticals and Mtchedlidze suggests that the walnut extract is to be applied topically for anti-viral action. Thus, it would be predictable that the anti-viral walnut extract containing juglone could successfully be formulated in the manner suggested by McGraw.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Mtchedlidze (US Pat. No. 8,318,219) in view of McGraw et al. (US PGPub No. 20100080768), as applied to claim 1 above, and further in view of “Liveo™ ST-Elastomer 10” (2020, product information brochure, cited on IDS filed 7/9/2024).
The teachings of Mtchedlidze and McGraw et al. include all those discussed above.
The combination of Mtchedlidze and McGraw makes obvious the silicone elastomer gel comprising a walnut extract having anti-viral natural naphthoquinones as set forth above.
However, this combination does not explicitly teach that the silicone elastomer gel includes D5 in an amount of about 85% weight and a crosslinked polymer of molecular weight higher than 5,000 in an amount of about 12% weight, as recited in claim 3.
“Liveo™ ST-Elastomer 10” is a product brochure that describes a commercial elastomer product, a silicone topical excipient for pharmaceutical applications. The reference teaches that the product is a mixture of high molecular weight silicone elastomer (12%) in decamethylcyclopentasiloxane (D5), and that this is a cross-linked silicone elastomer gel. Further, the reference also teaches that the product is a cyclopentasiloxane and dimethicone crosspolymer (e.g. essentially the same product as taught in McGraw).
To one of ordinary skill in the art, before the effective filing date of the instant invention, it would have been prima facie obvious when producing the walnut extract containing silicone gel made obvious by the combined teachings of Mtchedlidze and McGraw, to select and include the cyclopentasiloxane and dimethicone component taught in “Liveo™ ST-Elastomer 10”, which would result in providing an elastomer gel comprising D5 in an amount of about 85% weight and a crosslinked polymer of molecular weight higher than 5,000 in an amount of about 12% weight.
One would have been motivated because Mtchedlidze teaches an anti-viral walnut extract and suggest providing it in topical form, while McGraw teaches a known silicone gel composition that includes a polymer composition of cyclopentasiloxane and dimethicone (the same as the elastomer gel of the instant invention). Providing a known silicone-based elastomer using commercial available material, including the product taught in “Liveo™ ST-Elastomer 10” would have been well within the level of ordinary skill in the art. It is obvious to select and provide a composition that is known in the art. One having ordinary skill would be aware of suitable elastomer products for producing a silicone-based pharmaceutical composition.
From the B.R.I. of the claim discussed above, in view of the specification, it is evident that the commercial compound ST-Elasomer-10® fulfills all of the claim limitations, including the requirement for D5 at 85% by weight. Because this compound is essentially the same as that taught in the art, it would have been obvious to select and provide. Further all of the properties and composition thereof (i.e. 85% D5 and 12% high molecular weight polymer having an average MW higher than 5,000) must be present if this product is selected.
With regard to the amounts, and ratios, proportions, and concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. See MPEP § 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
There would have been a reasonable expectation of success in selecting this commercial silicone elastomer because it has the same composition as one of the components taught in McGraw and it would have been predictable to include a known silicone elastomer.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bindra et al. (U.S. Pat. No. 6,296,838) teaches an anti-fungal composition, for topical application, for the treatment and prevention of the human nails infected with fungi. In particular, Bindra et al. describes that an extract with synergic effects contains a mixture of 10-15% of juglone extract from walnut hull (Col 2, lines 54-65; claim 1).
Babula (“Noteworthy secondary metabolites naphthoquinones-their occurrence, pharmacological properties and analysis. Current Pharmaceutical Analysis. 2009 Feb 1;5(1):47-68)) reviews the uses of naphthoquinones for medicinal purposes and their occurrence in nature (Abstract). Babula teaches that naphthoquinones have multiple biological activities, including antibacterial, fungicidal, antiparasitic and insecticidal uses (Abstract and pg. 47, left col, under Introduction). Babula states that “Naphthoquinones, especially juglone, are widely studied for allelopathic activity” (pg. 47, right col). Babula teaches that plants of the family Juglandaceae, including predominantly those of the genus Juglans (e.g. walnut trees, a valuable source of edible nuts) contain the naphthoquinone juglone (pg. 51, under “Juglandaceae”). The reference teaches that these walnut plant extracts (from e.g. black walnut Juglans nigra) have long traditions of use in folk medicines for acne, allergies, gastrointestinal disorders and intestinal parasitosis treatment. Babula states that “External use is reserved for fungal, bacterial and viral infections (herpes) therapy.” (pg. 51, under “Juglandaceae”).
Conclusion
No claims are allowable.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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