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 .
Claims 1-13 have been presented for examination on the merits.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1, line 4, contains a dash (-) before “are” which is objected to as it is not clear why it is placed in that position.
Claims 2-7 begin with the article “A”. This should be changed to article -The-, as the claims refer to the production method of claim 1.
Claim 4 is objected to for capitalizing general chemical names Phosphatidylcholine, Phosphatidylserine, Lysophosphatidylcholine, Phosphatidylinositol. The said names also appear capitalized in the Specification (which should be corrected).
Claim 5, line 3, contains a colon (:) before “less” which is objected to as it is not clear why it is placed in that position.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-13 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claims 1-8 are indefinite because it is not clear what sequence of steps are being claimed for the said production method. It is difficult to examine the claims since it is not comprehensible what step is following what step.
Claim 1 is indefinite for reciting the term “deionizing water” in lines 7 and 14. It is not clear what is meant by deionizing water. The term is typically recited as deionized water, since it is the water that has been deionized and not that the water is deionizing another compound. The Specification also does not support the term “deionizing water”.
Claim 1 is also indefinite for reciting the limitation “total polyphenols more than 1800 mg/l gallic acid equivalents”. It is not clear what is meant by this limitation. Is the total amount of polyphenol more than 1800, or the total amount of gallic acid? It is also not clear what is meant by gallic acid equivalent.
Claim 1 is also indefinite for reciting the limitation “more than 1800 mg/l gallic acid equivalents”. This is indefinite because “more than” is a one-sided range that encompasses infinity. Specification does not show that the amount can be infinite.
Claim 1 recites the limitation "in a third container that has already produced a liposomal system" in last step. There is insufficient antecedent basis for this limitation in the claim. The method of claim 1 does not recite a liposomal system preceding this recitation and there is no recitation of it being produced before this step.
Claim 1 recites the limitation "of vine leaves system and propolis system” in last step. There is insufficient antecedent basis for this limitation in the claim. The method of claim 1 does not recite a vine leaves system and propolis system preceding this recitation.
Claim 1 is further indefinite for reciting the limitation “a ratio of 75-25% to 50-50%”. This is indefinite because ratio is typically recited as 75:25 to 50:50, and not in percentages. Thus, it is not clear what is meant by the recited range.
Claim 2 recites the limitation "before a step of spraying and drying… “. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a step of spraying and drying.
Claim 2 is also indefinite for reciting the limitation “total polyphenols more than 2000 mg/l gallic acid equivalents”. It is not clear what is meant by this limitation. Is the total amount of polyphenol more than 2000, or the total amount of gallic acid? It is also not clear what is meant by gallic acid equivalent.
Claim 2 is also indefinite for reciting the limitation “more than 2000 mg/l gallic acid equivalents”. This is indefinite because “more than” is a one-sided range that encompasses infinity. Specification does not show that the amount can be infinite.
Claim 3 recites the limitation " wherein the extraction solvent system comprises deionized water and either vegetable 1,3-propanediol or glycerol”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support an extraction solvent system comprising water and either vegetable 1,3-propanediol or glycerol.
Claim 3 is further indianite for placing a recition in parenthesis -1,3 propanediol (or glycerol)/water:- . This is indefinite because recitations or limitations placed in paragraph are not considered part of the claim.
Claim 4 is indefinite for reciting the limitation “a ratio ranging from 20/80 to 80/20% w/w”. This is indefinite because 1- it is not clear what the said ratio range is referring to. 2- ratio is typically recited as 20:80 to 80:20 and not in percentages. It is also not clear what w/w is referring to in a ratio. Thus, it is not clear what is meant by the recited range.
Claim 6 is directed to the production method of claim and further comprising at least one of the recited steps. Claim 6 recites the limitation " a step of adding the vine leaves in the solvent system with cyclodextrin to the liposomal system”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a step of adding cyclodextrin or the third container comprising liposomal system comprising a solvent.
-The said cyclodextrin and solvent are present in multiple steps in claim 6 which lack antecedent basis in claim 1.
Claim 6 is indefinite for reciting the step of “adjusting the system pH in the range of 5.0-8.0” twice. It is not clear why this step is presented twice.
Claim 6 is indefinite for reciting the step of “stirring at 4000 rpm for 3 hours”. It is not clear what is being stirred with this step.
Claim 6 is further indefinite for reciting the limitation “a ratio of 5-20%”. This is indefinite because ratio is typically recited as 5:20, and not in percentages. Thus, it is not clear what is meant by the recited range.
Claim 6 recites the limitation "stirring for another 10 minutes at 1000 rpm”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a step of stirring, thus it is not clear what is meant by another 10 minutes.
Claim 6 is indefinite for reciting the step of “stirring for another 10 minutes at 1000 rpm”. It is not clear what is being stirred with this step.
Claim 6 recites the limitation "part of the propolis-cyclodextrin complex being encapsulated inside the liposomes”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a propolis-cyclodextrin complex, encapsulated or free.
Claim 6 is indefinite for reciting the step of “leaving the mixture in a hermetically sealed container at 5-7° C. for 24 hours”. This is indefinite because it is not clear what mixture is sealed here.
Claim 6 recites the limitation “a step of retesting the pH, if necessary, the pH is readjusted in the range of 3.5-6.2”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a step of setting or adjusting the pH.
Claim 6 is indefinite for reciting the “a step of measuring a mean hydrodynamic diameter of the particles, wherein if said mean hydrodynamic diameter is outside a range from 200 nm to 600 nm with a polydispersity index less than 0.7”. This statement appears to be incomplete as it is not clear what steps are taken after measuring the mean diameter.
Claim 6 recites the limitation “a step of a second filtering at room temperature through an array of cartridge filters with a pore size of 0.45 μm and then 0.2 μm follows, and then”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a step of filtering, thus there is no support for second filtering.
Claim 6 is indefinite for reciting the limitation “more than 1600 mg/l gallic acid equivalents”. This is indefinite because “more than” is a one-sided range that encompasses infinity. Specification does not show that the amount can be infinite.
Claim 6 recites the limitation “a step of determining a release rate of encapsulated polyphenols in a buffer solution at pH 7.2 at 37° C”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support encapsulated polyphenols.
Claim 6 is indefinite for reciting the limitation “a step of storage the system in a dark container”. This appears to be typographical error as it is not clear what is meant by “of storage the system”.
Claim 7 recites the limitation “a specified amount of a colloid in dialysis … “. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claim 1 does not recite or support a colloid”.
Claim 7 recites the limitation “measurement of their concentration in polyphenols…”. It is not clear what “their concentration” is referring to.
Claim 7 recites the limitation “while the water removed is replaced”. There is insufficient antecedent basis for this limitation in parent claim 1. The method of claims 1 or claim 7 preceding to this recitation do not support a water removal step.
Claims 8-13 are indefinite because they recite “a composition obtained by the method of claim 1” (in claim 8) or “a method of using the composition of claim 8 or a composition obtained by the method of claim 1”. Because “the formulation” is a product and “a method of producing” is an active step of production and a method of using the product, the claim is directed to more than one statutory class of invention. Note: MPEP 2173.05(p)(II). A single claim which claims both an apparatus (or product) and the method steps of using the apparatus (or product) is indefinite because it creates confusion as to when direct infringement occurs. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
Claims 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
The recitation of the “a method of use” a composition is not directed to a specific and substantial asserted utility. The claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define “things” or “products” while the first category defines “actions” (i.e., inventions that consist of a series of steps or acts to be performed). Recitation of the use of a composition is not an action with a series of steps or acts to be performed.
Claims 28-29 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 8 is a product-by-process claim. Product-by-process claims are examined on the limitations of the product. MPEP 2113, citing In re Thorpe, 111 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Furthermore, upon establishing a prima facie case, the burden of persuasion shifts to the Applicant. MPEP 2113, citing In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974) “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion.
Claims 9-11 and 13 recite “to counteract stress-induced changes in skin cells, “to protect skin cells against pollution”, “to protect skin cells against UVA and/or against microparticles” and “to protect skin cells against pollution” are intended use recitations. For the sake of examination, the recitations of intended use/result will be considered inherent to a method which teaches administering the instantly claimed composition to a subject or their skin.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gardikis et al (WO 2017089842 or US 20200085744) (recitations from the US document) in view of Lantzouraki et al (Antioxidant profiles of vitis vinifera l. and salvia triloba l. leaves using high-energy extraction methodologies).
Gardikis et al teach a method for preparing a stable controlled-release propolis colloidal dispersion system, characterized in that in order to produce the system, propolis -after being frozen for 24 hours- is micronized (<1 mm) and then dispersed at a rate of 1 kg/min in the solvent system, which is under stirring at 500-3000 rpm and consists of deionized water of <=1 μS/cm at 25 ° C. and either natural 1,3-propanediol or glycerol at a mixture ratio 1,3-propanediol (or glycerol)/water from 15%/85% to 80%/20%, in which deionized water hydroxypropyl-β-cyclodextrin or β-cyclodextrin has been pre dissolved to 2-10% w/w, and as the propolis/cyclodextrin/solvents system is under intense stirring (2000-3000 rpm) for 30-45 min and at a temperature of 20° C. to 38° C., a liposomal suspension is added thereto at a ratio of 0.3 to 3.5% w/w, and stirring is performed for 1 to 4 hours under continuous measurement of the total content in polyphenols by the Folin-Ciocalteu method and of the % encapsulation efficiency, until the specific parameters reach the desired values so that the stirring process is ended and the colloidal system is filtrated through suitable cartridge filters with a pore size of 0.45 μm, its pH is adjusted at the range of 5.0-8.0 and the size of dispersed particles as well as the release rate of the polyphenols of propolis in a buffer solution at pH 7.2 and 37° C. are measured and the colloidal system is stored in a dark-coloured container at a temperature of 5-7° C., where it is kept stable for 2 years (See abstract, [0030]-[0032] and claim 1).
Further disclosed is that to prepare a system, propolis is initially micronized (<1 mm) after being frozen for 24 hours. Any propolis may be used without previous treatment, as long as it contains total polyphenols >1600 mg/I gallic acid after dissolution of 10% (w/w) propolis in ethanol (See [0031] and claim 2).
Regarding claim 4, Gardikis et al further teach that the lipid composition of the said liposomal suspension is:
50%-90% phosphatidylcholine
2%-10% phosphatidylethanolamine
1%-3% lysophosphatidylcholine
1%-3% phosphatidylinositol
1%-3% phosphatidic acid
0%-40% cholesterol and
0-20% cholate salts (See [0037] and claim 4).
Regrading claims 6-7, Gardikis et al teach a method for preparing a stable controlled-release propolis dispersion colloidal system, wherein the size of produced liposomes is in the range of 70 to 700 nm and their polydispersity index is less than 0.5 (<0.5), the cumulative release of the polyphenols at pH 7.2 and a temperature of 37° C is 25-60% within 8 hours, while the system releases all encapsulated polyphenols within 24 hours. The size of dispersed particles and the release rate of the polyphenols of propolis is measured in a buffer solution at pH 7.2 at 37° C. and the colloid is stored in a dark-coloured container at a temperature of 5-7° C., where it is kept stable for 2 years (See [0050]-[0051] and claim 6).
Further regarding claims 1-7, Gardikis et al teach the results tabulated in Tables 1 and 2 below.
PNG
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139
355
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Greyscale
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120
360
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Greyscale
Regarding claim 8, Gardikis et al teach a preparation of a stable propolis colloidal dispersion system with a novel method where the components of propolis are extracted and at the same time encapsulated in combinatorial liposome-cyclodextrin carriers. The final preparation is suitable for antioxidant, photoprotective, antimicrobial, angiogenic and immunostimulatory use, either alone or after incorporation in cosmetic or pharmaceutical formulations (See [0015]).
Regarding claims 9-13, Gardikis et al teach that the said colloidal system may be used directly on the human skin and mucosa or encapsulated in cosmetic or pharmaceutical formulations for topical or systematic delivery. In cosmetic or pharmaceutical formulations, it may provide clear liquids as required, e.g. in the preparation of gels (See [0027]).
Gardikis et al do not disclose the presence of vine leaves in their method of preparation. This would have been obvious over the teachings of the art including Lantzouraki et al and Fiume et al.
Lantzouraki et al teach antioxidant profiles of vitis vinifera l. and salvia triloba l. leaves using high-energy extraction methodologies. The enhanced liquid extraction or accelerated solvent extraction, emerge as ideal tools for the recovery of bioactive thermolabile compounds such as phenolic acids, polyphenols, flavonoids and carotenoids (See title and page 413).
Regarding the production method of claims 1-7, Lantzouraki et al teach that the leaves were manually separated. V. vinifera L. leaves of the ancient variety of Athiri, indigenous to Greece, were collected from conventional grapevines in October 2016 from the Greek island of Santorini in the southern Aegean Sea. The leaves of each plant were carefully washed with cold distilled water and naturally drained, followed by air drying in a dark chamber at ambient temperature for 10 days. Part of the leaves from each species was ground into powder using a high-speed grinder. Each dried plant material sample was fully homogenized, and the ground or whole leaves were stored in hermitically sealed paper bags in the dark at 7°C until further use within 3 months post collection (See page 414, 2nd col, 2nd para).
Lantzouraki et al further teach that about 30 g intact leaves (to prevent the formation of precipitates) from each plant species were placed in a filter bag (50 μm pore size; Tecnolab), and they were loaded into a stainless-steel cell of the extraction chamber. Five GRAS mixtures of aqueous Glyc were used for the PLE, as aqueous combinations of Glyc have been shown to significantly increase (poly)phenolic yield compared to plain Glyc. In detail, 1:4, 2:3, 1:1, and 3:2 (v/v) of Glyc–H2O as well as plain H2O were tested as solvent systems at a ratio of 40:1 (w/w) solvent(s):plant material. The solvent circulated through the filter bag throughout the extraction procedure. Each extraction procedure of 88 min included eight cycles with sequential pressure and depression phases of 5 and 6 s, respectively. A dynamic phase was obtained via a programmed pressure ranging from 4 to 9 bars, and the temperature was set at 25 ± 1°C. At the end of each cycle, the plant material was pressed to achieve the maximum extraction by applying automatic pressure control in the extraction chamber; subsequently, the solvent recirculated in the extraction chamber for another cycle. The final extracts were filtered through mixed cellulose ester filter paper of 0.45 μm pore size to retain the solid plant material, and the clarified extracts remained sealed in glass vials at 10°C until further use (See page 415, 1st col. 3rd para).
Regarding claims 8-13, Lantzouraki et al teach that the significant concentration of total flavonoids in V. vinifera UAE MeOH – H2O 4:1 (v/v) dried extract combined with S. triloba PLE aqueous extract could be used for developing novel natural broad-spectrum sunscreens in lieu of synthetic ingredients. In fact, flavonoids have been associated with several photoprotection effects, including UV absorption, direct and indirect antioxidant properties, and prevention of UV-induced oxygen free radical generation. Similarly, V. vinifera MeOH – H2O 1:1 and S. triloba MeOH – H2O 4:1 (v/v) UAE dry extracts could be incorporated in skin anti-aging and antioxidant treatments, considering their high phenolic content as well as their antiradical and antioxidant properties. Plant phenolics have been proved effective to inhibit or even reverse the signs of aging, such as wrinkles or hyperpigmentation marks. Furthermore, studies have shown that (poly)phenols could be effective in the treatment of skin injuries and also for the healing of wounds and burns. On the top of that, the glycerolic extracts possesses humectant and moisturizing properties. Hence, an admixture of Salvia flavonoid rich UAE MeOH – H2O 1:1 (v/v) dry extract and V. vinifera and S. triloba Glyc – H2O 1:4 (w/w) PLE extracts, which both exhibited high phenolic content and strong antioxidant activity, could be potentially exploited for a series of pharmaceutical formulations targeting the prevention or attenuation of skin disorder symptoms and the reduction of the healing time for burns and wounds (See page 418, 2nd col., 3rd para).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Lantzouraki et al with Gardikis et al to arrive at the instant invention. It would have been obvious to do so because Gardikis et al teach a method of producing a stable controlled-release propolis dispersion colloidal system containing total polyphenols of more than 1600 mg/l gallic acid in a liposomal suspension. The said preparations are said to be effective when applied to the skin in treating skin conditions such as UV irradiation, wrinkles, etc. Lantzouraki et al also teach a method of preparing extracts of vine leaves, specially the athiri variety, comprising antioxidants such as polyphenols and their significant effect on treating skin conditions such as UV damage, wrinkles and skin injuries.
Thus, one of ordinary skill in the art would have been motivated to have combined the teachings and methods of Lantzouraki et al in the methods and formulations of Gardikis et al with a reasonable expectation of success because both extracts are said to contain high levels of antioxidants such as polyphenols and be effective in treating skin conditions. That is it would have been obvious to combine both methods in order to make combinatorial preparation for added benefits.
As the courts have held, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Thus, this rejection is based on the well established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 1943 C.D. 518.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Regarding the production method of claims 1-7, the references do not expressly teach certain limitations such as the three variety of vine leaves or chopping the levs in pieces less than 0.8 mm. However, the said limitations are obvious to one of ordinary skill in the art. For example, it is known in the art that different varieties of vines contain different concentrations of antioxidants. Thus, it would have been obvious to one of ordinary skill in the art to mix different varieties in order to obtain different concentration of compounds such as polyphenols.
It also would have been obvious to one ordinary skill in the art to cut the leaves before the preparation as they may be easier to handle. While the references do not teach this step, it is not an inventive step and obvious to person skilled in the art of extraction.
Regarding the composition of claim 8 and the methods of use in claims 9-13, as stated above, the method of production steps are irrelevant of the said composition or method of use, thus, the references in combination render the claims obvious.
Claims 1-13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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