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 .
Claim Status – Response to Restriction/ Election Requirement
Claims 1-7 and 14-21 are currently pending.
Applicant’s election without traverse of Group I, claims 1-4, in the reply filed on Dec. 29, 2025 is acknowledged.
Claims 1-4 and 14-21 are currently pending and subject to examination. Claims 5-13 are withdrawn.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Withdrawn Rejections – Overcome by Amendment
The rejection of claim(s) 1, 3 and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Rha et al. (Antioxidants, Vol. 8, Issue 8, August 5, 2019, p. 1-15) is withdrawn.
The rejection of claim(s) 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (J. Agric. Food Chem., 2006, Vol. 54, Issue 8, p. 2951−2956) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 112(b) – New Grounds of Rejection Necessitated by Amendment
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 1-4, 14-15, and 19-21 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 1 is directed towards:
A plant extract comprising a kaempferol aglycone in an amount of 1 mg/g or more on a dry-weight basis,
wherein the plant extract is an extract of a cruciferous plant selected from the group consisting of horseradish, kale, arugula, takana also known as Brassica juncea var. integrifolia, mizuna also known as Brassica rapa var. nipposinica, turnip, Japanese radish, broccoli, cabbage, a radish sprout, and bok choy.
One of ordinary skill in the art cannot determine the metes and bounds of claim 1 and its dependent claims (2-4 and 14-15) because one of ordinary skill in the art, presented with a composition reading on the concentration limitation, cannot determine with certainty whether the “cruciferous plant” limitation is satisfied. Kaempferol aglycone is a single, defined chemical species whose structure is identical irrespective of botanical or synthetic origin. The claim places no upper limit on aglycone concentration and by its terms encompasses extracts which read on pure kaempferol aglycone. Because the boundary of the claim turns on a source characteristic that is not ascertainable from the claimed product itself across the claimed range, the claim fails to inform an ordinary artisan about the scope of the claimed invention with reasonable certainty.
Furthermore, the specification merely describes total kaempferol content of various plant extracts from both cruciferous and non-cruciferous plants (Example A1). The specification also provides no disclosure of any analytical method, marker or structural characteristic by which a “cruciferous plant” extract is distinguished from a kaempferol aglycone composition of non-cruciferous or synthetic origin. Absent such guidance, the metes and bounds of the source limitation are unclear, particularly at high aglycone purity. Applicant is invited to identify in the specification where such a determination is shown.
One of ordinary skill in the art, furthermore, cannot determine the metes and bounds of claims 14-15 and 19-21 because they attempt to define the product by a process. For example, claim 14 is directed towards:
The plant extract of claim 1, wherein the plant extract is produced by a method comprising the steps of: (1) subjecting a plant to extraction with a solvent; and (2) subjecting the extract obtained in step (1) to hydrolysis treatment.
Claim 14.
The process by which the product is made does not clearly limit the product. Given a particular composition comprising greater than 1 mg/g of kaempferol aglycone, one of ordinary skill in the art could not ascertain with certainty the process by which the product was obtained. The specification also provides no disclosure of any analytical method, marker or structural characteristic by which an ordinary artisan could determine how the claimed product was made.
Appropriate correction is required.
Claim Rejections – 35 USC § 102 – New Grounds of Rejection Necessitated by Amendment
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.”
Claim(s) 1-4 and 14-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horbowicz et al. (Pol. J. Entomology 73: 273-282, 2004) as evidenced by Calabrone et al. (Food & Nutrition Sciences, 2015, Vol. 6, p. 64-74).
Calabrone is cited to show an inherent disclosure by Horbowicz.
Claim 1 is directed towards a plant extract comprising a kaempferol aglycone in an amount of 1 mg/g or more on a dry-weight basis, wherein the plant extract is an extract of a cruciferous plant selected from the group consisting of horseradish, kale, arugula, takana also known as Brassica juncea var. integrifolia, mizuna also known as Brassica rapa var. nipposinica, turnip, Japanese radish, broccoli, cabbage, a radish sprout, and bok choy.
Horbowicz discloses a horseradish plant extract comprising kaempferol aglycone at amount of at least 1 mg/g on a dry weight basis. At pages 4-5, Horbowicz teaches that horseradish leaf samples (Armoracia rusticana Gaer.) leaf samples were dried overnight at 50°C, pulverized, and that 200 mg samples were extracted with 60% ethanol, subjected to acid hydrolysis at 100°C for 30 minutes to release the aglyones, which were then extracted three times with ehyl acetate, with the separated upper later withdrawn and pooled for HPLC quantification:
The flavonols (quercetin and kaempferol) content were determined according to a method earlier described for onion (HORBOWICZ 1999; HORBOWICZ & KOTLIŃSKA 2000). The method was adopted to horseradish analyses. Plant samples were dried overnight in an oven at 50°C. Dry matter was pulverised and 200 mg samples were extracted with 60% ethanol, an the extracts containing the flavonol glycosides were taken to acid hydrolysis at 100°C during 30 min. Obtained aglycones were extracted by triple vigorous shaking with ethyl acetate. Separated upper layer was withdrew and pooled. For analysis of quercetin and kaempferol an HPLC apparatus equipped with UV detector set at 370 nm was used. The flavonols (quercetin and kaempferol) were separated on Lichrosorb RP18 (4 x 250 mm, 10 µm) column, and a mobile phase was methanol: water mixture (55:45, v/v) containing 0.2% orthophosphoric acid. The flow rate was 0.8 ml/min.
Horbowicz, p. 4-5.
The ethyl acetate extract of Horbowicz is the “plant extract” as recited. The kaempferol therein is present in an aglycone form as Horbowicz expressly hydrolyzed the parent glycosides and characterized the resulting species as “aglycones.” This is the same analytical sequence described in the specification: alcoholic extraction, acid hydrolysis, ethyl acetate partition, HPLC (Instant Specification, para. [0067]).
Horbowicz teaches that dry horseradish leaves contain an amount of up to about 60 mg/g on a dry weight (dry matter (DM)) basis):
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Horbowicz, Fig. 1, p. 15.
Because the entirety of kaempferol released by hydrolysis is partitioned into and quantified in the ethyl aetate phase, and because that phase necessarily comprises less than the whole of the leaf dry matter, the concentration of kaempferol aglycone in the Horbowicz extract necessarily exceed 1 mg/g on a dry weight basis. Therefore, claim 1 is anticipated.
Claim 2 is directed towards the plant extract of claim 1, wherein the kaempferol aglycone is present in an amount of 100 mg/g or more on a dry-weight basis.
Horbowicz’s leaf extract necessarily contains 100 mg/g or more of kaempferol aglycone on a dry weight basis.
As shown in Figure 1 of Horbowicz, horseradish leaves can contain up to about 60 mg/g of kaempferol. Taking a kaempferol content of 35.5 mg/g as admitted in Table 1 (para. [0070]) of the Specification, 1 g of horseradish dry leaf matter contains 35.5 mg of kaempferol. For the resulting extract to contain less than 100 mg/g kaempferol aglycone on a dry-weight basis, the total extracted solids recovered from 1 g leaf material would have to exceed 355 mg (i.e. recover more than 35.5% of horseradish dry leaf matter as extract).
Alcoholic extraction of horseradish leaf does not approach this high yield as shown by Calabrone et al. Calabrone extracted 10 g of lyophilized A. rusticana leaf powder with methanol, methanol/water (70/30), and methanol/water (50/50), and determined percent yield gravimetrically as the weight of evaporated extract over the weight of sample. Calabrone teaches that high yields of phenolics are obtained from “polar solvents such as aqueous methanol or ethanol solutions” (Calabrone, p. 67). Cabrone Table 1 reports leaf extract yields ranging from 15.44% to 21.31%:
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Calabrone, p. 67.
Because the starting material was lyophilized, the yields are necessarily expressed on a dry matter basis.
Applying the highest single leaf value reported by Calabrone (21.31%), 1 g of horseradish leaf dry matter yields 213 mg of extract containing 35.5 mg of kaempferol aglycone, or approximately 167 mg/g. This demonstrates that Horbowicz’s leaf extract necessarily contains 100 mg/g or more of kaempferol aglycone on a dry weight basis.
This calculation is conservative in the Applicant’s favor in three independent aspects. First, it adopts Applicant’s admitted 35.5 mg/g figure rather than the approximately 60 mg/g shown in Horbowicz’s Fig. 1. Second, Calabrone’s figures are for crude alcoholic extract, whereas Horbowicz subjects the alcoholic extract to acid hydrolysis, which cleaves and removes the sugar moieties from the flavonol glycosides to the aqueous phase and thereby reduces the organic phase mass while retaining the kaempferol. Third, Horbowicz further partitions into ethyl acetate, a step that further purifies the kaempferol and removes other solid material.
Applicant’s specification does not adopt a different extraction regime that would alter this analysis. Paragraph [0063] specifies extraction techniques with water or organic solvents including ethanol and methanol, preferably performed at 30 to 70°C by using an aqueous solution of 30 to 70% ethanol, conditions encompassing Horbowicz. Paragraph [0067] teaches a detailed extraction and quantification technique substantially identical to Horbowicz.
Where the prior art product appears to be substantially identical to that claimed and is produced by a substantially identical process, the burden shifts to the Applicant to establish that the prior art does not possess the claimed characteristic (MPEP § 2112.V). As the above analysis demonstrates a sound basis for believing the products are the same, claim 2 is anticipated.
Claims 3 and 4 are directed towards the plant extracts of claims 1 and 2 respectively, further comprising quercetin in an amount of 0.1 mg/g or more on a dry weight basis. Horbowicz Fig. 2 reports quercetin levels in horseradish leaves ranging up to about 15 mg/g of leaf dry matter:
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Horbowicz, Fig. 2, p. 16.
The quercetin is liberated and partitioned in the same ethanol extraction, acid hydrolysis and ethyl acetate steps as the kaempferol and quantified with the same HPLC method. Applying the extract yields of Calabrone Table 1 as above, even the lowest quercetin values disclosed by Horbowicz correspond to a quercetin concentration well over 10 mg/g on a dry-weight basis, well above the claimed 0.1 mg/g. Therefore, claims 3-4 are anticipated.
Claims 14-15 are product by process claims which fail to further limit the product because the production method does not change the resulting kaempferol aglycone containing plant extract. “‘[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.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)” (MPEP § 2113). As Horbowicz discloses a product which is identical to the claimed product, claims 14-15 are anticipated.
Claims 16-18 have the same limitations of claims 1, 2, and 4 respectively, except that the plant extract is a horseradish leaf extract. As shown in the rejection of claims 1-4, Horbowicz teaches a horseradish leaf extract with these characteristics. Therefore, claims 16-18 are anticipated on the basis given in the rejection of claims 1-4.
Claims 19-21 are directed towards the horseradish leaf extract of claim 16, prepared by a specific method. The method does not impart patentable weight on the product and patentability is determined by the product itself. As shown in the rejection above, the claimed product is identical to that of Horbowicz’s horseradish leaf extract. Therefore, claims 19-21 are anticipated.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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