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 1-16 are pending and under examination herein.
Priority
This application does not claim priority to any application. The effective filing date of the instant application is April 10, 2023.
Information Disclosure Statement
The information disclosure statement filed on April 10, 2023 complies with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references were considered.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
In the instant case, the view numbers for FIG. 8(a) - 8(f); 9(a) - 9(f); 10(a) - 10(b); 10(d) - 10(f); 11(a) - 11(f); 12(a) - 12(f); and 13(a) - 13(e) use lowercase letters instead of capital letters to identify the different views.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-3 and 7-12 are objected to because of the following informalities:
Claim 1 recites “Fusarium oxysporum” in line 2, which does not follow the traditional designation of using italics to denote each genera and species. It is suggested that the phrase be amended to recite “Fusarium oxysporum” in italics.
Claim 1 recites the address of the deposit facility and date of the biological deposit in the claim. It is not customary that this information is included. The specification contains this information, so the deposit facility name and deposit number is all that is needed.
Claims 1-3 contain extraneous periods after “CGMCC NO.14784” in reciting the preservation number. The period should be removed.
Claims 7-9 misspell “cyanindin” in lines 1 and 3, which is correctly spelled as “cyanidin”.
Claims 7-9 contain an extraneous period after “petunidin and malvidin.” in line 2. The period should be removed.
Claims 10-12 contain an extra period after “kaempferol and quercitrin.” in line 4. The period should be removed.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more.
The claims are being interpreted as being directed to a product of Fusarium oxysporum strain CH18 with an intended use of producing anthocyanins and other flavonoid compounds.
The claims recite Applicant’s Fusarium oxysporum strain CH18 with preservation number CGMCC NO. 14784. The specification does not disclose or identify the source of the Fusarium oxysporum strain CH18. There is no indication in the specification that the isolate has been modified in any way from the naturally occurring strain.
Li et al., cited in the 102(a)(1) rejection herein, identifies that the instantly-claimed strain CH18 was obtained and isolated from soil samples (English translation p.4, 1st paragraph). Li describes the process of culturing various samples of soil for colonies, screening the resulting colonies for anthocyanin production, and selecting a strain that was subsequently identified as CH18 (English translation p.4). Li further identifies that the selected strain was named Fusarium oxysporum strain CH18 and preserved in the China Microbiological Culture Collection Management Committee (CGMCC) on October 11, 2017 with preservation number CGMCC NO.14784, which is identical to the strain and deposit number identified in the instant claims (English translation p.5, item 3.3.4).
This judicial exception is not integrated into a practical application because the claims are simply drawn to the naturally occurring strain with an intended use of preparing anthocyanins and other flavonoid compounds. As described by Li et al., Fusarium oxysporum strain CH18 is a naturally occurring strain that was isolated from soil samples and characterized. Characterizing a naturally occurring strain does not add any additional elements to the naturally occurring strain Fusarium oxysporum that results in markedly different characteristics to differentiate it from the naturally occurring strain. Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as demonstrated by Applicant’s examples, the strain was simply cultured in medium and the resulting anthocyanins were characterized using standard liquid chromatography and mass spectrometry methods (Specification p.5, Embodiment 1 [0043] – p.14, Embodiment 5 [00104]). As evidenced by Lebeau et al. (“Isolation of Two Novel Purple Naphthoquinone Pigments Concomitant with the Bioactive Red Bikaverin and Derivates Thereof Produced by Fusarium oxysporum”, Biotechnology Progress, 2019, Vol. 35, Issue 1, article e2738, 13 pages), Fusarium oxysporum LCP531 strain is capable of producing bioactive red bikaverin and two novel purple pigments (abstract). Lebeau teaches culturing the strain in liquid media, separating the culture broth and fungal biomass using centrifugation and analyzing the culture filtrate using colorimetric, spectrometric and HPLC-DAD (p.2, 2nd column 2nd paragraph – p.3 2nd column, 2nd paragraph).
Thus, the application of a strain in preparation of anthocyanins and other flavonoid compounds is directed towards a natural product without significantly more.
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.
Claims 1-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3 recite the phrase “Application of a strain CH18 in preparation of …” in line 1. It is unclear whether “application of a strain” is to be interpreted as a method or method of use, or if it is to be interpreted as product claim with an intended use to prepare anthocyanins. For the purposes of prior art, claims 1 and 2 will be interpreted as claiming a strain CH18 with an intended use of preparing anthocyanins and other flavonoid compounds. For the purposes of prior art, claim 3 will be interpreted as claiming a strain CH18 with an intended use of providing the functions of resisting bacteria and virus, increasing leucocytes, resisting tumors, reducing blood pressure, blood lipid and natural pigment, scavenging free radicals or exciting the central nervous system.
Claims 4-16 are rejected for depending from rejected claims 1-3 but failing to remedy the indefiniteness therein.
Regarding claims 4-12, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4-6 recite “wherein the anthocyanins are anthocyanins or proanthocyanidins; preferably, the proanthocyanidins comprise proanthocyanidins A and proanthocyanidins B; the proanthocyanidins A are proanthocyanidins A2; and preferably, the proanthocyanidins B are proanthocyanidins B2”.
Claims 7-9 recite “wherein the anthocyanins comprise one or more of cyanindin, pelargonidin, delphinidin, peonidin, petunidin and malvidin;
preferably, the cyanindin comprises one or more of cyanidin, cyanidin glucoside and cyanirin-3-O- arabinoside;
preferably, the pelargonidin comprises one or more of pelargonin, pelargonin 3-sophorose 5-glucoside, pelargonin-3,5-glucoside and pelargonin-3-glucoside;
preferably, the delphinidin comprises one or more of delphinidin glucoside and delphinidin-3-O-arabinoside;
preferably, the peonidin comprises one or more of peonidin 3-rhamnose-5-glucoside, peonidin glucoside and pconidin-3-O-arabinoside;
preferably, the petunidin comprises petunidin glucoside or petunidin-3-O-arabinoside;
preferably, the malvidin refers to malvidin-3-O-glucoside.
Claims 10-12 recite “wherein the other flavonoid compounds belong to one or more of flavonol, isoflavone, flavanone, flavonoid, chalcone and dihydroflavone (dihydroflavonol);
preferably, the flavonol comprises one or more of quercetin, rutin, myricetrin, kaempferide, troxerutin, icariin, hyperoside, fisetin, isorhamnetin, astragalin, myricetin, kaempferol and quercitrin;
preferably, the isoflavone comprises one or more of puerarin, genistein, morin, daidzin, genistin, biochanin A, glycitin and glycitein;
preferably, the flavanone (flavanonol) comprises one or more of (+)-catechin, epigallocatechin gallate and epicatechin;
preferably, the chalcone comprises one to more of phloretin and isoliquiritigenin;
preferably, the dihydroflavone (dihydroflavonol) comprises one or more of silybin, hesperidin, distylin, neohesperidin, astilbin, naringenin, hesperetin, dihydroquercetin, dihydrokaempferol and dihydromyricetin;
preferably, the flavonoid comprises one or more of apigenin, baicalein, baicalin, luteolin, diosmin, chrysin, vitexin, acacetin and tangeretin.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 1-3, it is apparent that the Fusarium oxysporum CH18 strain with deposit number CGMCC NO.14784 is required to practice the claimed invention. As such, the biological materials must be known and readily available or obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements may be satisfied by a deposit of Fusarium oxysporum.
The specification does not identify the source of the Fusarium oxysporum strain CH18.
It is noted that Applicant has deposited biological material Fusarium oxysporum strain CH18 with deposit number CGMCC 14784 according to the terms of the Budapest Treaty, as evidenced by the Certificate of Deposit with the China General Microbiological Culture Collection Center on October 11, 2017.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein.
Claim Rejections - 35 USC § 102
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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Li et al. (English translation of CN 108823101 A, published November 16, 2018). The rejection of claims 7-9 I further evidenced by Fang (“Classification of fruits based on anthocyanin types and relevance to their health effects”, Nutrition, 2015, Vol. 31, Issue 11-12, pp.1302-1306). The rejection of claims 10-12 is further evidenced by Legeay et al. (“Epigallocatechin Gallate: A Review of Its Beneficial Properties to Prevent Metabolic Syndrome”, Nutrients, 2015, Vol. 7, Issue 7, 5443-5468).
Regarding claims 1-2, “application of a strain CH18 in preparation of anthocyanins and other flavonoid compounds” is being interpreted as being directed towards a product comprising a strain CH18, with an intended use for preparing anthocyanins and other flavonoid compounds. There are no active method steps recited. The “application” part of the claim is being interpreted to refer to a functional effect of producing anthocyanins, which is inherent to the claimed strain.
Li teaches an anthocyanin-producing strain CH18 and its application (English translation – abstract). Li teaches the identified strain CH18 is Fusarium oxysporum, and the preservation number is CGMCC NO.14784 (English translation – abstract). Li teaches that the strain can use various media to ferment and produce anthocyanins (English translation – abstract).
Regarding claim 3, “application of a strain CH18 in preparation of products for resisting bacteria and virus, increasing leucocytes, resisting tumors, reducing blood pressure, blood lipid and natural pigment, scavenging free radicals or exciting the central nervous system” is being interpreted as being directed towards a product comprising a strain CH18, with an intended use of preparing anthocyanins and other flavonoid compounds. There are no active method steps recited.
Li teaches an anthocyanin-producing strain CH18 and its application (English translation – abstract). Li teaches the identified strain CH18 is Fusarium oxysporum, and the preservation number is CGMCC NO.14784 (English translation – abstract). Li teaches that anthocyanidin belongs to flavonoid compounds and has a variety of biologically active functions, such as anti-oxidation, scavenging free radicals, anti-cancer, anti-inflammatory (English translation p.2, Background technique – 1st paragraph).
Regarding claims 4-6, Li teaches the anthocyanin-producing strain CH18 can grow and produce anthocyanins (relevant to wherein the anthocyanins are anthocyanins) (English translation p.2, 4th paragraph from bottom).
Regarding claims 7-9, Li teaches the anthocyanin-producing strain CH18 can grow and produce anthocyanins (relevant to wherein the anthocyanins are anthocyanins) (English translation p.2, 4th paragraph from bottom).
Li is silent on whether “the anthocyanins comprise one or more of cyanindin, pelargonidin, delphinidin, peonidin, petunidin and malvidin”.
However, as evidenced by Fang, anthocyanins can be divided into three groups based on the types of aglycones of their anthocyanins: pelargonidin group, cyanidin/peonidin group, and multiple anthocyanidins group (abstract). Fang teaches the structures of common anthocyanidins include pelargonidin, cyanidin, delphinidin, peonidin, petunidin and malvidin (p.1302, 1st column Table 1). Thus, the anthocyanins taught by Li would necessarily include the common anthocyanidins taught by Fang, because those compounds are known to be common anthocyanins.
Regarding claims 10-12, Li teaches that anthocyanidin belongs to flavonoid compounds (English translation p.2, Background technique – first paragraph). Li further teaches that the fermentation of the strain CH18 could produce flavonoids (English translation p.4, 2. Screening of anthocyanin-producing strains - (2) qualitative color reaction of flavonoids).
Li is silent on whether “other flavonoid compounds belong to one or more of flavanol, isoflavone, flavanone, flavonoid or chalcone”.
However, as evidenced by Legeay, flavonoids represent 60% of dietary polyphenols and are classified into seven groups: flavones, flavonols, flavanones, isoflavones, flavanols, anthocyanins and chalcones (p.5444, 2nd paragraph).
Thus, it is inherent to the other flavonoid compounds produced by the CH18 strain taught by Li would necessarily belong to one or more of flavanol, isoflavones, flavanone, flavonoid or chalcone taught by Legeay because those are known classifications for flavonoids.
Regarding claim 13, Li teaches that the products are foods, health care products, medicines, cosmetics and agricultural or daily chemical products (English translation p.3, [0025]).
Regarding claim 14, Li teaches that the foods are dairy products, meat products, wine processed products, alcoholic beverages, acid beverage, flour product or pickles (English translation, p.3, [0026]).
Regarding claim 15, Li teaches the healthcare products, medicines, cosmetics or natural pigments are bacteria powder, tablets, capsules, paste or liquid (English translation p.3, [0027]).
Regarding claim 16, Li teaches the agricultural or daily chemical products are pH test liquid, test powder, test paper and additives (English translation p.3, [0028]).
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 9:30am - 3:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEEPA MISHRA/Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657