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 .
This Office action is responsive to Applicant’s preliminary amendment and remarks, filed 04 Oct 2023, in which claims 4-5 are amended.
This application is the national stage entry of PCT/JP2022/011171, filed 14 March 2022; and claims benefit of foreign priority document JAPAN 2021-066340, filed 09 April 2021. This foreign priority document is not in English.
Claims 1-7 are pending in the current application and are examined on the merits herein.
Specification
The title of the invention includes the word “NOVEL”. MPEP 606 provides a listing of words that are not considered as part of the title of an invention, should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. This listing includes the words “Improved”, “New”, and “Novel”.
In this case the title of the invention will be entered as “POLYPHENOL COMPOUND”.
Claim Objections
Claims 1-2 and 6-7 objected to because of the following informalities:
Claim 1 labels the chemical structure as both [Formula 1] and (I). This is inconsistent with the label “formula (I)” used throughout the claims.
Further, claim 1 recites the chemical structure after the period ending the claim. Either the chemical structure should be moved to immediately following the label “formula (I)” or the period should appear after the chemical structure as recited.
Claim 2 labels the chemical structure as both [Formula 2] and (I).
Further, claim 2 recites the chemical structure after the period ending the claim. Either the chemical structure should be moved to immediately following the label “formula (I)” or the period should appear after the chemical structure as recited.
Claim 6 labels the chemical structure as both [Formula 3] and (I).
Further, claim 6 recites the chemical structure after the period ending the claim. Either the chemical structure should be moved to immediately following the label “formula (I)” or the period should appear after the chemical structure as recited.
Claim 7 labels the chemical structure as both [Formula 4] and (I).
Further, claim 7 recites the chemical structure after the period ending the claim. Either the chemical structure should be moved to immediately following the label “formula (I)” or the period should appear after the chemical structure as recited.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more. The claims recite the compound of formula (I)
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. Claim 1 is drawn to the compound itself. Claim 2 recites a “collagen production-promoting agent comprising” the compound, which is interpreted as reciting the functional properties necessarily possessed by the compound itself and therefore encompass the compound itself. Therefore claims 1-2 do not recite any additional elements beyond the judicial exception. Claim 3 specifies the concentration of the compound in the agent, implying unspecified other material in the agent in order to result in such a concentration, however this does not possess “markedly different characteristics” because the implied unspecified other material is unspecified and the agent or compound possesses the same functional properties necessarily possessed by the compound itself, implying this activity is the same characteristic possessed the compound itself.
The application in working examples 1-2 at pages 19-22 describes this compound of formula (I), referred to as “OLANDU”, is isolated from the pods of locust bean (Ceratonia siliqua), providing evidence that this compound is itself a product of nature.
Rasheed et al. (Mariod, A. A. (ed.), Wild Fruits: Composition, Nutritional Value and Products, 2019, Springer Nature Switzerland AG, pages 481-498, cited in PTO-892) teaches the known natural products of carob or locust bean (Ceratonia siliqua). A myriad of polyphenols are present in the different carob parts mostly in the fruit pulp followed by the leaves and wood (page 486, paragraph 1). Identified metabolite classes from carob include gallic acid (1), vanillic acid (4), and gallic acid bound to glucose (20-22) (page 487, figure 36.2). The claimed compound of formula (I) can be read as the reaction product of vanillic acid, glucose, and gallic acid bound together, supporting the conclusion that the working examples 1-2 of the application describe the isolation of a compound that was naturally occurring, even if not specifically known at the time of Rasheed et al.
This judicial exception is not integrated into a practical application because claims 4-6 recite the agent or compound formulated as a skin external preparation, cosmetic, or food and drink product, respectively, in a generic level of detail which is no more than generally linking the use of the natural product to a field of use. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 3 implies unspecified other material in the agent, and claims 4-6 recite the agent or compound formulated as a skin external preparation, cosmetic, or food and drink product, respectively, in a generic level of detail that would have been well-understood, routine, or conventional activity in the pertinent field of art concerning compounds or agents having a biological activity.
Therefore claims 1-2 are drawn to the judicial exception of a product of nature itself, claim 3 is drawn to the judicial exception which is not markedly different from the product of nature, and claims 4-6 do not integrate the judicial exception into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception itself.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP’999 (JP 2005119999 A, published 12 May 2005, provided by Applicant in IDS filed 04 Oct 2023, EPO English machine translation cited in PTO-892).
As JP 2005119999 A is not in English, citations to JP’999 will be found in the EPO English machine translation. JP’999 teaches a locust bean extract extracted from locust bean. The locust bean extract (also known as carob bean extract) can be obtained by performing the extraction process, the adsorption process, and the elution process. In the extraction step, a ground bean pulverized product or a locust bean extraction residue is extracted with a polar solvent to obtain a crude extract. Here, the crushed product of carob is obtained by chopping carob into pieces, crashing, pulverizing, etc., and these treatments make it easier to extract the extract from carob belongs to (page 2, paragraph 4). Said polar solvent is chosen from water, methanol, ethanol, acetone, acetonitrile, etc., or the mixture of these can be used (page 2, paragraph 6). Next, in the adsorption step, the crude extract is passed through a column filled with a hydrophobic adsorption resin to adsorb the crude extract of carob bean contained in the crude extract (page 2, paragraph 7). Next, in the elution step, locust bean extract is eluted through the column through a hydrophilic organic solvent, for example, methanol, ethanol, acetone, acetonitrile, or a mixture of these organic solvents and water (page 2, paragraph 8). The locust bean extract can be used for diet foods, food additives, and pharmaceuticals (page 2, paragraph 1), addressing limitations of claim 6.
JP’999 is silent as to the extract containing the claimed compound of formula (I). MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case JP’999 discloses a locust bean extract extracted with a polar solvent such as water or alcohol or a mixture thereof (corresponding to the claimed hydroalcoholic extract), passed through a column filled with a hydrophobic adsorption resin to remove hydrophobic materials (functionally equivalent to liquid-liquid extraction using the hydrophobic solvent petroleum ether), and eluted through the column through a hydrophilic organic solvent such as acetone or acetonitrile (functionally equivalent to liquid-liquid extraction using the hydrophilic solvent ethyl acetate). Therefore there is reason to believe that the extraction of JP’999 necessarily includes the compound of claimed compound of formula (I). Further, MPEP 2112 at II. provides “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)” In this case there is no requirement that JP’999 recognizes the presence of the claimed compound of formula (I), and a conclusion of anticipation can be supported by the reasoning above that the subject matter is in fact inherent in the prior art reference.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FR’857 (FR 2905857 A1, published 21 March 2008, cited in PTO-892, EPO English machine translation cited in PTO-892).
As FR 2905857 A1 is not in English, citations to FR’857 will be found in the EPO English machine translation. FR’857 teaches a cosmetic composition containing an extract of carob (Ceratonia siliqua) pulp for use in a process caring for human skin, to hydrate and/or to protect against dryness (page 1, paragraph 1). This extract can be obtained using any solvent and preferably using an alcoholic solvent. In working example 1 the carob pulp extract is prepared by extracting dried and ground carob pods with ethanol, the solvent is evaporated under vacuum. The extract is combined mixed with activated carbon in ethanol, filtered, and the filtrate is recovered (page 7, paragraphs 1-3). The composition of the invention is in any form suitable for topical application to the skin (page 4, paragraph 3), addressing limitations of claims 4-5.
FR’857 is silent as to the extract containing the claimed compound of formula (I). MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case FR’857 discloses dried and ground carob pods extracted with ethanol (corresponding to the claimed hydroalcoholic extract) and treated with activated carbon. Therefore there is reason to believe that the extraction of FR’857 necessarily includes the compound of claimed compound of formula (I). Further, MPEP 2112 at II. provides “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)” In this case there is no requirement that FR’857 recognizes the presence of the claimed compound of formula (I), and a conclusion of anticipation can be supported by the reasoning above that the subject matter is in fact inherent in the prior art reference.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art to the subject matter of claim 7 is JP’999 (JP 2005119999 A, published 12 May 2005, provided by Applicant in IDS filed 04 Oct 2023, EPO English machine translation cited in PTO-892) in view of Rasheed et al. (A. A. Mariod (ed.), Wild Fruits: Composition, Nutritional Value and Products, 2019, Springer Nature Switzerland AG, pages 481-498, cited in PTO-892).
JP’999 teaches a method of preparing a locust bean extract as above.
JP’999 does not specifically disclose a method for producing a compound represented by formula (I), or subjecting a hydroalcoholic extract with liquid-liquid extraction with petroleum ether an ethyl acetate (claim 7).
Rasheed et al. teaches the state of the art as detailed above. Rasheed et al. teaches known metabolite classes from carob or locust bean (Ceratonia siliqua).
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of JP’999 in a manner that arrives at the claimed invention. As detailed above, JP’999 is silent as to the extract containing the claimed compound of formula (I) and does not specifically identify what phenolic metabolites are present in the disclosed extract. While Rasheed et al. teaches identified metabolite classes from carob include gallic acid, vanillic acid, and gallic acid bound to glucose, the combined teachings of the prior art do not provide sufficient guidance to select the claimed compound of formula (I) as a compound present in the extract of JP’999, sufficient motivation to modify the extraction method of JP’999 in order to produce a compound which was not identified at that time to be present, or a reasonable expectation of success to produce a compound which was not identified at that time.
Conclusion
Claim 7 is objected to because of informalities.
No claim is currently in condition for allowance.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693