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 .
DETAILED ACTION
Claims 1-19 of A. Capriotti et al., US 18/579,426 (Jun. 27, 2022) are pending and under examination on the merits. Claims 1-19 are rejected.
Claim Interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed to establish a clear record of what applicant intends to claim. See, MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01.
Interpretation of the Claim 1 Terms
The claim 1 terms bolded below are interpreted here in view of the specification:
1. A method for the extraction of policosanols from industrial hemp processing waste, comprising the following steps:
a) saponification of a waxy material in the presence of an inorganic base;
b) separation of a saponifiable fraction from a unsaponifiable fraction thus obtained;
c) isolation of the unsaponifiable fraction containing policosanols.
As well known in the art, policosanol is a mixture of long chain alcohols with carbon chains ranging in length from 24 to 34 carbons, known as tetratriacontanol (C-34), dotriacontanol (C-32), triacontanol (C-30), nonacosanol (C-29), octacosanol (C-28), heptacosanol (C-27), hexacosanol (C-26) and tetracosanol (C-24). J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019) (see page, 351, cols. 1-2.
The specification teaches that:
In fact, hemp wax contains policosanols with C20-C36 chains, mainly in fatty acid esterified form.
Of particular interest, within the scope of the invention, are policosanols having from 24 to 30 carbon atoms and their mixtures.
Specification at page 3, lines 8-10. Similarly, the art teaches that policosanols are a group of long-chain aliphatic alcohols and, in plants, they are rare in the free (non-ester) state but commonly abundant in the form of long-chain aliphatic acid esters. J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019) (See page 351, col. 1). Thus, the specification and art teach that the predominant fraction policosanols present plant-derived waxes are trapped as fatty acid esters. In plants, the surfaces that are exposed to the atmosphere usually have a layer that contains wax, where stems, fruits, petals, and leaves may all be covered with wax. M. Wang et al., 55 Journal of Agricultural and Food Chemistry, 5552-558 (2007) (see page 5552 at col. 1). Thus, in a first step of plant-matter solvent extraction to obtain policosanols generally results in a waxy material that can be further processed to isolate natural product therein.
With respect to the claimed fractions, the most relevant specification portion teaches that saponification of hemp-derived “waxy material” leads to two fractions (i.e., a saponifiable fraction and an unsaponifiable fraction), where the “unsaponifiable fraction”, containing the desired policosanols, is separated:
Typically, the waxy material thus obtained contains the following compounds: hydrocarbons, fatty acids, alcohols, aldehydes, phytosterols, fatty acid esters, phytocannabinoids, terpenes, flavonoids, free policosanols and may contain traces of psychoactive compounds, such as for example tetrahydrocannabinol. According to the method of the invention, the waxy material is first subjected to a saponification reaction (step a).
. . .
The saponification reaction therefore leads to the formation of two fractions, namely a saponifiable fraction and an unsaponifiable fraction.
The saponifiable fraction consists of fatty acids and esters,
while the unsaponifiable fraction consists of hydrocarbons, alcohols, aldehydes, phytosterols, phytocannabinoids, terpenes, policosanols.
In step b) of the method of the invention, the unsaponifiable fraction, which contains the policosanols of interest, is separated from the saponifiable fraction by techniques well known to those skilled in the art, such as for example filtration or liquid-liquid extraction with an organic solvent immiscible with water, preferably ethyl ether.
. . .
in order to obtain a mixture of C24-C30 policosanols1 having a purity of about 95-99%, in which hexacosanol (C26) is the predominant compound. In particular, hexacosanol is present in the mixture of phytocompounds in a percentage between 23-43%.
Specification at page 5, lines 1-6 and 21-29; page 6, lines 3-6 (emphasis added).
In specification working Example 1, a wax by-product of the industrial extraction of cannabidiol (it is not clear that the initial wax is hemp-derived), was subjected to trans-esterification where the wax was dispersed in ethanol and heated with KOH, extracted with of diethyl ether; the organic phase was washed with 10 ml of water, washed with water, and then dried over anhydrous Na2SO4, the solution filtered and evaporated to give a residue that contained 4.3% policosanols, per Table 1. Specification at page 7, lines 1-21. In Examples 2 and 3, the specification teaches the same saponification but starting from different wax sources. Specification at pages 7-9.
Thus, per the art and specification (particularly specification working Examples 1-3), in the claim 1 saponification of the hemp-derived “waxy material” (e.g., the transesterification per Examples 1-3 with base, e.g., KOH/EtOH) the policosanol esters of the waxy material react with base to give the free policosanols as the “unsaponifiable fraction” and undesired esters as the “saponifiable fraction”. F. Chen et al., 70 Journal of Food Engineering, 47-53 (2005); M. Wang et al., 55 Journal of Agricultural and Food Chemistry, 5552-558 (2007); J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019).
Interpretation of “unsaponifiable fraction” and “saponifiable fraction”
The saponification of working Examples 1-3 is summarized by the Examiner in the Scheme below, with claim mapping:
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Consistently with the specification as discussed above, the claim 1 “unsaponifiable fraction” is broadly and reasonably interpreted as a saponified product fraction that contains the desired policosanols. The “saponifiable fraction” is broadly and reasonably interpreted as the undesired ester-ester containing fraction (also obtained from the saponification).
Interpretation of the Claim 1 Preamble and “waxy material”
Claim 1 recites the following preamble:2
1. A method for the extraction of policosanols from industrial hemp processing waste, comprising the following steps:
and requires “a) saponification of a waxy material in the presence of an inorganic base”. The specification defines the claim 1 preamble term “processing waste” as the “waxy material” obtained as a by-product of the cannabidiol extraction process from hemp inflorescences.
The term “processing waste” according to the present invention refers to the waxy material obtained as a by-product of the cannabidiol extraction process from hemp inflorescences.3
The waxy material to be subjected to the process of the present invention can be obtained as a by-product of any of the industrial hemp extraction processes known in the art, such as for example in Attard, T. M. et al., Ind. Crops Prod. 2018, 112, 38-46. According to a preferred embodiment of the present invention, the waxy material is obtained starting from inflorescences of industrial hemp, comprising extraction of industrial hemp with an organic solvent and subsequent winterization of the extract thus obtained.
Specification at page 3, lines 24-33 (emphasis added).
The specification emphasizes that the invention is directed to extracting policosanols from industrial hemp processing waste. See e.g., specification at page 3, lines 19-20. This weighs toward interpreting the claim 1 preamble as a claim limitation. See, footnote 2.
Claim 1 requires the step of “a) saponification of a waxy material in the presence of an inorganic base”. The preamble is reasonably interpreted, in view of the specification, in that the claim 1 “waxy material” must be derived from the preamble term “industrial hemp processing waste”. In a sense, the preamble recitation of “industrial hemp processing waste” provides antecedent basis for the recitation of “a waxy material” in the claim 1 body. The preamble is therefore interpreted as a claim limitation. See footnote 2.
In view of the foregoing, the claim 1 term “a waxy material” is broadly and reasonably interpreted, consistently with the specification, as the substance derived from the by-product of an industrial hemp extraction process.
Product-by-Process Limitations--“a waxy material” and “industrial hemp processing waste”
In view of the above discussion, consistently with the specification, the claim 1 terms “a waxy material” and “industrial hemp processing waste” are interpreted as a product-by-process limitations, because the specification teaches that their identity is a function of their preparation. MPEP § 2113(I). See also, dependent claims 3 and 13, further supporting this interpretation.4 MPEP § 2113(I). Although the cited product-by-process terms are nested within a method claim, this does not change the proper construction of the product-by-process limitation itself. MPEP § 2113(I); Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334 (Fed. Cir. 2020) (“[t]he nesting of the product-by-process limitation within a method . . . claim does not change the proper construction of the product-by-process limitation itself”); see also non-binding, non-precedential opinion in Ex parte Wohaibi, Appeal No. 2024-004112, 17/750,212 (PTAB 2025) discussing this Federal Circuit decision.
Claim Rejections - 35 USC § 102 (AIA )
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.
35 U.S.C. § 102(a)(1) over C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”)
Claims 1-5, 8-9, 13-15, and 18-19 are rejected under 35 U.S.C. § 102(a)(1) as being unpatentable over C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”).
Prior Art Effect of Montone
Montone is effective prior art under 35 USC § 102(a)(1) because Montone’s publication date of August 2, 2021, is before the presumptive5 effective filing date of July 22, 2022 and Montone names common and some additional inventors. MPEP § 717(I)/(III). The instant application’s effective filing date is less than one year before Montone’s publication date. As such, Applicant may consider an exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). MPEP § 717(I)/(III). Alternatively, Applicant may file an English-language translation of priority application IT 102021000020228 (July 29, 2021), provided is supports the claims pursuant to § 112(a), together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Teachings of Montone
Montone teaches the following procedure:
Phytocannabinoids from hemp inflorescence were extracted according to previously published procedures with some modifications and the wax material purified by winterization.
Hemp inflorescence (10 g) was extracted in an ultrasonic bath (Elmasonic S 60 H, Elma, Singen, Germany) for 30 min in 120 mL hexane (twice). The mixture was centrifuged at 8000×g for 10 min and the supernatants pooled. Hexane was evaporated under low pressure and room temperature.
The oily residue, which contained cannabidiol and a mixture of other lipophilic compounds (fatty acids, long-chain aldehydes and alcohols, esters and hydrocarbons), was dissolved in 30 mL of warm ethanol (75 °C) and the sample placed at - 20 °C for winterization (24 h).
The wax precipitate was isolated by centrifugation at 4 °C, 8000 × g for 30 min, washed with 5 mL of ethanol, and dried under vacuum.
The wax material was then hydrolyzed according to a previously described procedure. Wax was dispersed in 50 mL of ethanol, added with 5.6 g of KOH and reacted in reflux apparatus at 80 °C for 6 h under magnetic stirring.
The mixture was then added with 50 mL of brine and extracted (three times) with 50 mL of diethyl ether.
The organic phases were pooled and dried on Na2SO4, evaporated to dryness under low pressure and the residue dissolved in 5 mL of chloroform.
Before chromatography, 10 μL of the chloroform solution was diluted to 200 μL final volume with water and methanol to reach the composition of methanol/ water/chloroform, 80:15:5 (v/v/v). Sample preparation was performed in triplicate for each hemp type.
Montone at page 2, col. 2 (citations omitted) (emphasis added). This is the same procedure as the specification working example. Specification at pages 7-9.
The claim 1 steps of:
Claim 1 . . . b) separation of a saponifiable fraction from a unsaponifiable fraction thus obtained;
c) isolation of the unsaponifiable fraction containing policosanols.
occur in the following portion of Montone:
The mixture was then added with 50 mL of brine and extracted (three times) with 50 mL of diethyl ether.
The organic phases were pooled and dried on Na2SO4, evaporated to dryness under low pressure and the residue dissolved in 5 mL of chloroform.
Montone at page 2, col. 2 (citations omitted) (emphasis added).
The claim 1 term “waxy material” and preamble recitation of “industrial hemp processing waste” are met by Montone’s extraction procedure for the following reasons. Montone’s process (as indicated above by the bold-underlined text) meets the specification definition for “processing waste”.
The term “processing waste” according to the present invention refers to the waxy material obtained as a by-product of the cannabidiol extraction process from hemp inflorescences.
Specification at page 3, lines 24-33. The claim 1 qualifier “industrial” is simply a product-by-process limitation that does differentiate the structure of Montone’s waxy material from the claim 1 waxy material. MPEP § 2113(I) (see Claim Interpretation above).
Montone therefore teaches every element of claim 1 and claim 1 is anticipated.
The further limitations of claim 2 are met because Montone teaches further purification by chromatography. Montone at page 2, col. 2.
The further limitations of claims 3 and 13 are clearly met.
The further limitations of claims 4, 5, 14 and 15 are met because Montone teaches:
The five industrial hemp types used in this study included three monoecious varieties (Futura 75, Felina 32 and Fedora 17), and two dioecious varieties (Kompolti and Finola).
Montone at page 2, col. 1.
The limitations of claims 8 and 9 (product-by-process claims) are clearly met. See Montone at page 5, col. 2, Table 2 (results of policosanol quantitation in the five hemp inflorescences, where results are provided as [Symbol font/0x6D]g of each policosanol compound/g hemp inflorescence).
The limitations of claim 18 and 19 are met because Montone’s separation of the saponifiable fraction from the unsaponifiable fraction occurs in the presence ether.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under AIA 35 U.S.C. 103(a) 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 6, 7, 10-12, and 16-17 are rejected under AIA 35 U.S.C. 103 as being unpatentable over C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”) and/or A. Granja et al., US 5,856,316 (1999) (“Granja); T. Attard et al., 112 Industrial Crops & Products, 38-46 (2018) (“Attard”); and/or J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019) as these secondary references are respectively cited below.
C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”)
Montone was discussed in detail above in the § 102 rejection.
Obviousness Rationale
Claim 6 and its dependent claim 7 require “a weight ratio between waxy material/ inorganic base is between 1.5 and 3”.
6. The method according to claim 5, wherein a weight ratio between waxy material/ inorganic base is between 1.5 and 3.
Montone’s procedure (relevant portion reproduced below) does not disclose the wax weight.
The wax material was then hydrolyzed according to a previously described procedure [27]. Wax was dispersed in 50 mL of ethanol, added with 5.6 g of KOH and reacted in reflux apparatus at 80 °C for 6 h under magnetic stirring.
Montone at page 2, col. 2. Thus, the claim 6 weight ratio cannot be calculated. However, the claimed weight ratio is obvious in view of A. Granja et al., US 5,856,316 (1999) (“Granja) for the following reasons. Granja teaches a method to obtain, isolate and purify the mixture of higher primary aliphatic alcohols (M.H.P.A.A.) of 24 to 34 carbon atoms (i.e., policosanols) from saponification of sugarcane wax, both from raw and refined wax. Granja at col. 2, lines 20-25. With respect to the claimed weight ratio, Granja teaches that:
The concentration of the hydroxide solutions must be such that the ratio in weight of the corresponding hydroxide with that of the wax to be processed must be over 5% on, especially from 8 to 25%, and more especially from 15 to 25%.
Granja at col. 2, lines 30-35. Granja’s disclosed ranges overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05(I). Although Granja is directed to a wax derived from sugar cane and the claim 6 wax source is derived from the by-product of and industrial hemp extraction processes, still one of ordinary skill is motivated to explore the ranges taught by Granja. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP § 2144.05(II)(A) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claim 7 (dependent upon claim 6) is obvious because Montone already teaches that separation of the saponifiable fraction from the unsaponifiable fraction occurs in the presence ether.
Claims 10 and 12 are obvious over Montone in view of T. Attard et al., 112 Industrial Crops & Products, 38-46 (2018) (“Attard”). The compositions of claims 10 and 12 require particular weight percentages of policosanols.
10. The mixture according to claim 9 wherein the mixture has a composition by weight of: 9-23% tetracosanol (C24), 23-43% hexacosanol (C26), 2-22% heptacosanol (C27), 15-40% octacosanol (C28), 6-29% triacontanol (C30).
12 The mixture according to claim 8, wherein the mixture has a composition by weight of: 9-23% tetracosanol (C24), 23-43% hexacosanol (C26), 2-22% heptacosanol (C27), 15-40% octacosanol (C28), 6-29% triacontanol (C30).
Although not necessarily relevant to the following § 103 rationale, claims 10 and 12 are clearly product-by-process claims. See footnote 4. Also note that the weight percentages and relative amounts of policosanols obtained in the claim 1 saponification method are clearly dependent upon the hemp wax source, and how it was processed. See, e.g., V. Marques et al., 101 Bioresource Technology, 260-267 (2010) (see Table 2 at pages 262-263 showing different amounts of policosanols and ester waxes depending upon how the hemp was processed).
In any case claims 10 and 12 are obvious in view of T. Attard et al., 112 Industrial Crops & Products, 38-46 (2018) (“Attard”) for the following reasons. Attard teaches a lipid extraction study carried out on a variety of different hemp dust samples, obtained from different parts of an industrial hemp processing plant. Attard at page 39, col. 1. Attard teaches that heptane soxhlet extractions, as well as scCO2 extractions were carried out on dust samples collected from various parts of the hemp plant to identify value added products and highlight potential uses for such waste streams. Attard at page 39, col. 1. Attard teaches that eight hemp dust samples (see Table 1) were dried in a vacuum oven to constant weight and extracted with heptane, filtered to remove any biomass, solvent removed in vacuo, further dried to remove trace solvent to afford a crude wax. Attard at page 39, col. 2; Attard at page 40, col. 2 (“3. Results and discussion”). Attard teaches that wax esters having chain lengths of C38 to C58 were present in all samples. Attard at page 41, col. 2.
One of ordinary skill apprised by Montone that hemp wax comprises fatty esters saponifiable to policosanols reasonably concludes that the that Attard wax esters having chain lengths of C38 to C58, present in Attard’s hemp-derived waxes, are also saponifiable to produce policosanols. One of ordinary skill is therefore motivated, with a reasonably expectation of success, to saponify Attard’s hemp-derived waxes according to the method of Montone to arrive at a mixture of policosanols. In fact, the instant specification teaches that Attard’s hemp-derived waxes can be the waxy material source of claims 1:
The waxy material to be subjected to the process of the present invention can be obtained as a by-product of any of the industrial hemp extraction processes known in the art, such as for example in Attard, T. M. et al., Ind. Crops Prod. 2018, 112, 38--46.
Specification at page 2, lines 27-29 (emphasis added). In view of this specification teaching, subject to Applicant’s rebuttal, it is asserted that the above-proposed practice of Montone with the Attard hemp-derived waxes necessarily produces the claim 10 and 12 policosanol composition.6 Claims 10 and 12 are therefore obvious.
Claim 11 is obvious over Montone in view of J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019). Shen teaches that policosanol has been used as a lipid-lowering agent in the alternative medicine and ancillary drugs for ischemic stroke, dyslipidemia and other diseases. Shen at page 351, col. 2. Claim 11 is obvious because one of ordinary skill is motivated by Shen to use the policosanol composition taught by Montone to produce at least one of a pharmaceutical, nutraceutical, food or cosmetic.
Claims 16 and 17 are obvious for the same reasons as claim 6 and 7.
Claim Rejections - 35 USC § 101
Claims 8-12 are rejected under 35 U.S.C. 101 on the grounds that the claimed invention is directed to patent ineligible subject matter. In summary, the claims recite a multi-component product of nature that lacks markedly different characteristics from its naturally occurring counterpart. MPEP 2106.04(b)(II). The claims are therefore directed to a judicial exception under Step 2A, Prong 1. MPEP 2106.04(b)(II). Continuing the analysis, under Step 2A, Prong 2, the claims do not integrate the recited judicial exception into a practical application of the product of nature exception. 2106.04(II)(A)(2). Finally, under Step 2B, the claims do not recite more than well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, which are not sufficient to establish subject matter eligibility for the recited judicial exception. MPEP § 2106.05(II).
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1: The Current Claims Recite a Judicial Exception
In Prong One of Revised Step 2A, evaluation is conducted to determine whether the claim recites a judicial exception. MPEP 2106.04(II)(A)(1); Federal Register, 2019 Revised Patent Subject Matter Eligibility Guidance, 50-57 (2019) (“Federal Register 2019”) (see page 54 col. 1).
Claims 8-10 and 12 are clearly product-by-process claims, therefore, the determination of patentability is based on the product itself. MPEP § 2113(I).7 Claims 8-12 all claim policosanols, which are nature-based products, that can be extracted from plants. MPEP § 2106.04(b)(II) (laws of nature and natural phenomena, as identified by the courts, include nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature). As taught by the instant specification, policosanols are present in free form in numerous matrices, both of animal and vegetable origin, such as beeswax, rice bran, wheat germ, fruit and dried fruit. Specification at page 1, lines 8-13. For example, P. Adhikari et al, 54 Journal of Agricultural and Food Chemistry, 5359-5369 (2006) (“Adhikari”) teaches that policosanols in the waxy materials from perilla seeds of both origins were composed of 66-67% octacosanol, 16-17% hexacosanol, 6-9% triacontanol, 2-3% heptacosanol, 1-3% nonacosanol, and 1-2% tetracosanol (Table 3, Figure 3). See Adhikari at page 5361.
Step 2A, Prong 1-- Markedly Different Characteristics
When a claim recites a nature-based product limitation, the markedly different characteristics analysis is applied to determine if the claimed nature-based product is a judicial exception (Step 2A, Prong 1). MPEP 2106.04(b)(II); MPEP § 2106.04(c)(I)(A). If the claim includes a nature-based product that has markedly different characteristics from the naturally occurring counterpart, then the claim does not recite a product of nature exception and is eligible. MPEP § 2106.04(c).
Further, where the claims (as in the current facts) are to a nature-based product produced by combining multiple nature-based components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. MPEP § 2106.04(b)(II); MPEP § 2106.04(c)(I)(A).
Performing the markedly different characteristics analysis, includes (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different". MPEP § 2106.04(c)(II).
(a) Selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product. MPEP § 2106.04(c)(II)(A).
In the current case, the appropriate nature-based counterpart to the claimed policosanols are the policosanols as they exist in nature themselves, within the matrices of plants as discussed above.
(b) Identifying appropriate characteristics for analysis and (c) evaluating characteristics to determine whether they are "markedly different"
Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare. MPEP § 2106.04(c)(II)(B). 8Changes in physical form or structure and form, whether chemical, genetic or physical are examples of appropriate characteristics to be analyzed. MPEP § 2106.04(c)(II)(B). In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. MPEP § 2106.04(c)(II)(C)(2) (citing Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75).
The claims do not recite nor does the specification teach that the claimed policosanols have any characteristic different from the natural counterpart. The only different characteristic is that the claimed policosanol mixture is synthetically produced by saponifying a corresponding fatty-acid-ester mixture (where the fatty esters themselves are natural products). However, as the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible. MPEP § 2106.04(b)(II) (citing University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014)).
Respecting claim 11, the policosanol mixture derived from base claim 8 is itself a “a pharmaceutical, nutraceutical, food or cosmetic product” without any further processing. The claim 1 step of “using” imparts no clear processing steps that structurally differentiate claim 11 from claim 8.
In summary, the claimed policosanols do no exhibit markedly different characteristics and are therefore directed to a judicial exception; that is, a natural product mixture where is policosanol in the mixture exhibits no characteristic different from the natural counterpart.
Step 2A, Prong 2: The Claims do not Recite Additional Elements that Integrate the Judicial Exception into a Practical Application
Next, under analysis in Step 2A Prong Two, if the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (and thus is eligible. MPEP § 2106.04(II)(A)(2); MPEP § 2106.04(d). Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. MPEP § 2106.04(d)(I). The specificity of the claim limitations is relevant to the evaluation. MPEP § 2106.04(d)(I).
The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, the analysis includes: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. MPEP § 2106(d)(II). Here the claims do not recite additional elements beyond the judicial exception. That is, the claims are directed to the policosanols themselves and recite no additional limitations regarding integration into a practical application. See MPEP § 2106.04(d)(I) (giving examples of integrating claim elements into a practical application).
Respecting claim 11, the policosanol mixture derived from base claim 8 is itself a “a pharmaceutical, nutraceutical, food or cosmetic product” without any further processing. The claim 1 step of “using” imparts no clear processing steps that structurally differentiate claim 11 from claim 8.
One consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two and whether a claim recites significantly more in Step 2B is whether the claim effects a transformation or reduction of a particular article to a different state or thing. MPEP § 2106.05(c). Here there is no application or transformation, each of the policosanol components merely exist together in the claimed composition.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
Under Step 2B the claims are further analyzed to determine if additional elements are recited that amount to significantly more than the judicial exception. MPEP § 2106.05(II). The analysis is conducted by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). MPEP § 2106.05(II). That is, the claims are evaluated to determine whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. MPEP § 2106.05(II).
Here, claims 8-10 and 12 do not recite elements in addition to the judicial exception, other than it is inherently required that claimed policosanols.
Respecting claim 11, the policosanol mixture derived from base claim 8 is itself a “a pharmaceutical, nutraceutical, food or cosmetic product” without any further processing. The claim 1 step of “using” imparts no clear processing steps that structurally differentiate claim 11 from claim 8.
Combining or mixing specific compounds to form a mixture does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. As the claims involve no more than the judicial exception and well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which are not sufficient to establish that the claimed compound mixture is more than a judicial exception; that is the claims do not establish and inventive concept over the judicial exception. MPEP § 2106.05(II).
In Considering the above Factors, the Claims are Patent Ineligible
Claims 8-10 and 12 are properly rejected under 35 U.S.C. 101 on the grounds that the claimed invention is directed to patent ineligible subject matter because the claims recite a multi-component product of nature that lacks markedly different characteristics from its naturally occurring counterpart. MPEP 2106.04(b)(II). The claims are therefore directed to a judicial exception under Step 2A, Prong 1. MPEP 2106.04(b)(II). Further, under Step 2A, Prong 2, the claims do not integrate the recited judicial exception into a practical application of the product of nature exception. 2106.04(II)(A)(2). Finally, under Step 2B, the claims do not recite more than well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, which are not sufficient to establish subject matter eligibility for the recited judicial exception. MPEP § 2106.05(II).
ADDITIONAL ART NOT CITED AGAINST CLAIMS 1-19
If Applicant overcomes the §§ 102/103 rejections by removing C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”) as prior art, then claims 1-19 are otherwise free of the art of record.
Claims 1-7, 10, and 12-19 Are Free of the Art of Record if Montone Is Not Prior art
If Applicant overcomes the §§ 102/103 rejections by removing C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”) as prior art, then claims 1-7, 10, and 12-19 are otherwise free of the art of record. In such case, the closest art of record is T. Attard et al., 112 Industrial Crops & Products, 38-46 (2018) (“Attard”).
Attard teaches that in hemp fiber extraction, the fibers are separated out from the shiv. The latter is normally used for animal bedding. During fiber extraction, large amounts of hemp dust are generated, which could be a potential source of valuable chemicals. Attard at page 38, col. 2.
Attard teaches a lipid extraction study carried out on a variety of different hemp dust samples, obtained from different parts of an industrial hemp processing plant. Attard at page 39, col. 1. Attard teaches that Heptane soxhlet extractions, as well as scCO2 extractions were carried out on dust samples collected from various parts of the hemp plant to identify value added products and highlight potential uses for such waste streams. Attard at page 39, col. 1.
Attard teaches that eight hemp dust samples (see Table 1) were dried in a vacuum oven to constant weight and extracted with heptane, filtered to remove any biomass, solvent removed in vacuo, further dried to remove trace solvent to afford a crude wax. Attard at page 39, col. 2; Attard at page 40, col. 2 (“3. Results and discussion”).
Significantly, Attard teaches that that wax esters having chain lengths of C38 to C58 were present in all samples. Attard at page 41, col. 2.
Attard teaches that free policosanols were also present in the extracted wax.
n-Policosanols having chain lengths from C22 to C32 were detected in all samples. Sample 7 had the largest amount of n-policosanols (2040.2 ± 101.7 μg/g of dust) followed by sample 4 (1209.8 μg/g of dust) and sample 10 (893 ± 9 μg/g of dust). Interestingly, there was a difference in the dominant alcohol chain length between sample 7 and the other samples (Fig. S3–supplementary information). 1-octacosanol was the dominant alcohol chain length in sample 7 (comprising 46% of the total fatty alcohol composition) while 1-triacontanol was found to predominate in the remaining samples. This suggests that there is a drastic change in the n-policosanol composition of the hemp waste residues generated when the hemp fibres passes through the main cyclone. It is only in this sample that 1-octacosanol is obtained in such significant quantities (939.9 ± 46.9 μg/g of dust or 38.2 ± 1.9 mg/g of wax).
Attard at page 41, col. 1.
Differences between Attard and Claim 1
Attard does not teach the claim 1 step of:
Claim 1 . . . a) saponification of a waxy material in the presence of an inorganic base . . .
as the claim 1 term “waxy material” is interpreted per Claim Interpretation above.
Claims 1-7, 10, and 12-19 Are Not Obvious in view of Attard
The following important points are noted:
Attard teaches that that wax esters of chain lengths of C38 to C58 were present in all hemp-derived wax samples. Attard at page 41, col. 2.
Attard teaches that n-policosanols having chain lengths from C22 to C32 were detected in all hemp-derived wax samples. Attard at page 41, col. 1.
Claim 1 is not obvious because, absent the teachings of C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”) or the instant specification, one of ordinary skill is not motivated to saponify the Attard waste-hemp-derived wax samples. For example, one of ordinary skill is not motivated to saponify the Attard hemp-derived wax samples to convert the esters of chain lengths of C38-C58 to policosanols (i.e., C24-C34-alcohols), because Attard does not teach the structure of these esters. That is, one of ordinary skill has no basis to conclude that the Attard’s C38-C58-esters present in the hemp-derived wax have C24-C34-oxy portions that would saponify to the corresponding policosanols. In another example, while Attard does teach that free policosanols are already present in the wax; however, there is no reason to saponify a free policosanol.
It is true that the instant specification teaches that Attard’s hemp-derived waxes can be the waxy material source of claims 1:
The waxy material to be subjected to the process of the present invention can be obtained as a by-product of any of the industrial hemp extraction processes known in the art, such as for example in Attard, T. M. et al., Ind. Crops Prod. 2018, 112, 38--46.
Specification at page 2, lines 27-29. However, absent the teachings of C. Montone et al., 235 Talanta, 1-8 (2021) (“Montone”) or the instant specification of one of ordinary skill is not motivated to saponify the hemp-derived waxy material taught by Attard because there is no teaching that Attard’s C38-C58-esters present in the hemp-derived wax have C24-C34-oxy portions that would saponify to the corresponding policosanols.
Claims 8-10 and 12 Are Free of the Art of Record if Montone Is Not Prior art
Subject to the § 101 rejection, product-by-process claims 8-10 and 12 are also free of the art of record, absent the teachings of Montone. Here, the closest art of record is A. Granja et al., US 5,856,316 (1999) (“Granja).
As well known in the art, policosanol is a mixture of long chain alcohols with carbon chains ranging in length from 24 to 34 carbons, known as tetratriacontanol (C-34), dotriacontanol (C-32), triacontanol (C-30), nonacosanol (C-29), octacosanol (C-28), heptacosanol (C-27), hexacosanol (C-26) and tetracosanol (C-24). J. Shen et al., 57 Journal of Functional Foods, 351-360 (2019) (see page, 351, cols. 1-2.
Claims 8-10 and 12 are clearly product-by-process claims directed to a mixture of policosanols.9 However, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I) (citing In re Gamero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (“[t]he structure should be considered when assessing the patentability of product-by-process claims over the prior art, especially . . . where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product)); see also, Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012); Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 (Fed. Cir. 2009).
Considering the structure imparted by the method of claim 1, product-by-process claims 8-10 and 12 require, under a plain language interpretation, the relative policosanol amounts that are obtained in the method of claim 1, upon the claim 1 step of saponification of the “waxy material” (where per Claim Interpretation above, the “waxy material” is a substance derived from the by-product of an industrial hemp extraction process).
The relative amounts of policosanols and their saponifiable precursor fatty acid esters vary widely depending upon the natural source. V. Marques et al., 101 Bioresource Technology, 260-267 (2010) (see Table 2 at pages 262-263 showing different amounts of policosanols and ester waxes between flax, hemp, sisal and abaca); S. Harrabi et al., 17 Lipids in Health and Disease, 1-7 (2018) (see page 4).
Here, as discussed above with respect to claim 1, absent the teachings of the specification or Montone, one of ordinary skill is not motivated to saponify (per claim 1) a waxy material derived from the by-product of an industrial hemp extraction process. Absent knowledge that the claim 1 waxy material is policosanol source by saponification, one of ordinary skill cannot arrived as the policosanol composition of claims 8-10 and 12, having the particular relative policosanol amounts imparted by the claim 1 process. For example, the specification teaches the relative amounts of policosanols required to meet the compositional requirements of claims 8-10 and 12.
The mixture of policosanols obtained through the process of the invention has the following percentage abundances by weight: 9-23% tetracosanol (C24), 23-43% hexacosanol (C26), 2-22% heptacosanol (C27), 15-40% octacosanol (C28), 6-29% triacontanol (C30) and represents a further object of the present invention.
Specification at page 6, lines 21-24.
A. Granja et al., US 5,856,316 (1999) (“Granja) teaches a method to obtain, isolate and purify the mixture of higher primary aliphatic alcohols (M.H.P.A.A.) of 24 to 34 carbon atoms (i.e., policosanols) from saponification of sugarcane wax, both from raw and refined wax. Granja at col. 2, lines 20-25. In Example 1, Granja teaches saponification of refined wax from sugar cane that meets the limitations of claim 1, except that the wax source is not a substance derived from the by-product of an industrial hemp extraction process as required by claim 1. Granja at col. 8, lines 35-64. Granja teaches the following policosanol composition was obtained:
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Granja at col. 8, lines 50-64. Since claims 8-10 and 12 are product-by-process, Granja’s policosanol composition could be the basis of prior art rejection merely for disclosing the composition itself, regardless of how it is prepared. However, as discussed above, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I). Claims 8-10 and 12 are not anticipated by or obvious in view of Granja because the relative amounts of policosanols of the Granja composition are very different from those claimed per the above discussion. Searches conducted did not identify plant-wax sources that can be saponified to produce policosanol compositions having the relative policosanol amounts required by claims 8-10 and 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER R PAGANO whose telephone number is (571)270-3764. The examiner can normally be reached 8:00 AM through 5:00 PM.
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ALEXANDER R. PAGANO
Examiner
Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692
1 The specification teaches that “[o]f particular interest, within the scope of the invention, are policosanols having from 24 to 30 carbon atoms and their mixtures”. Specification at page 3, lines 8-10.
2 The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim. MPEP § 2111.02 (citing Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir. 2002)). As a general rule preamble language is not treated as limiting. Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019). Exceptions arise where, for example, the preamble (1) recites essential structure or steps; (2) provides antecedent basis for terms in the claim body; or (3) was relied on during prosecution to distinguish the claimed invention from prior art. Catalina Mktg. Int’l, Inc. v. Cool savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP § 2112.02(II) (citing Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")).
3 Plant inflorescences are branches that bear flowers. B. Spitzer-Rimon et al., 10 Frontiers in Plant Science, 1-11 (2020).
4 Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. MPEP § 2113(I). The patentability of a product does not depend on its method of production. MPEP § 2113(I). 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. MPEP § 2113(I) (citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)). However, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I).
5 Applicant cannot rely upon the certified copy of the foreign priority application IT 102021000020228 (July 29, 2021) for an effective filing date to obviate Montone as prior art because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English-language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
6 When the examiner "has reason to believe" that the prior art reference inherently teaches the functional limitation, the burden shifts to the patent applicant to show that the functional limitation cannot be met by the prior art reference. MPEP 2112(V), see also, In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997); In re Chudik, 674 F. App'x 1011, 1012 (Fed. Cir. 2017) (both citing In re Swinehart, 439 F.2d 210, 212, 58 C.C.P.A. 1027 (C.C.P.A. 1971)); In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977).
7 Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. MPEP § 2113(I). The patentability of a product does not depend on its method of production. MPEP § 2113(I). 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. MPEP § 2113(I) (citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
8 The appropriate characteristics analyzed must be possessed by the claimed product, because it is the claim that must define the invention to be patented. MPEP § 2106.04(c)(II)(B) (citing Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility)). Characteristics possessed by the claimed products are identified by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. MPEP § 2106.04(c)(II)(B). If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception. MPEP § 2106.04(c).
9 Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. MPEP § 2113(I). The patentability of a product does not depend on its method of production. MPEP § 2113(I). 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. MPEP § 2113(I) (citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
