DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on February 2, 2024. The priority date is July 12, 2021.
Information Disclosure Statement
The IDS contains references in a foreign language which have been considered to the
extent presented in the English language; as presented and accompanied by reference document
which is an English language equivalent or translation, to the extent cited in the instant
Application' s disclosure, or as cited by the Examiner in a PTO-892. Additional references which
have been considered have been initialed (fully considered) or also annotated in the IDS (to
indicate the extent considered). References which have not been considered have been lined
through. An initialed copy of the IDS has been placed in the instant Application file.
For Foreign Patent Document No. 2 on the filed IDS, the examiner noted that a truncation of the registration number was given in place of a publication number on the filed IDS.
The examiner has included a digital copy of the following reference and cited it on the PTO-892 form because of illegibility in Figure 1 of the reference:
Chang, B. Y.; Kim, H. J.; Kim, T. Y.; Kim, S. Y. Enzyme-Treated Zizania latifolia Extract Protects against Alcohol-Induced Liver Injury by Regulating the NRF2 Pathway. Antioxidants 2021, 10, 960. DOI: 10.3390/antiox1006
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Fig. . Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites that the food composition of claim 11 is a health functional food. Claim 11 already recited a food composition for ameliorating or preventing a liver disease and liver dysfunction. Therefore claim 11 already recited a type of health functional food. Therefore, dependent claim 12 does not further limit the subject matter of independent claim 11. There is no structural food that is added to identify a different food composition in claim 12. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
(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.
Claims 1-4, 9, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gong et al. (KR-20160076145-A; 12/26/2023 IDS, Foreign Patent Doc #1).
Gong et al. recites a pharmaceutical composition for treating alcoholic liver disease, which includes a Zizania latifolia extract (reference claim 1; instant claim 1). Gong et al. recites that the liver disease recited in reference claim 1 is acute and chronic hepatitis, fatty liver, pseudocirrhosis or the liver or liver cancer (reference claim 6, instant claims 2, 3, and 4). Gong et al. further recites a health food embodiment of their invention including vitamins B1, C, folic acid, and calcium pantothenate (among other vitamins and minerals) (Gong et al. Description of Embodiments, page 14 of 15, Health Food Production; instant claims 9, 11, and 12). Gong et al. recites examples of food embodiments of their invention, such as dairy products and soups, among others (Gong et al. Description of Embodiments, page 10 of 15, paragraphs 6-8; instant claims 11 and 12).
Claim Rejections - 35 USC § 103
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 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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (KR-20160076145-A; 12/26/2023 IDS, Foreign Patent Doc #1) in view of Yue et al. (CN-102040578-A) and Kim et al. (KR-101995807-B1).
The claims and teachings of the cited references are as of record above.
Claim 1 is drawn to “A pharmaceutical composition for treating or ameliorating a liver disease and liver dysfunction, comprising a Zizania latifolia extract”.
The claims are further distinguished in that: claim 5 recites the extract of Zizania latifolia comprising an enzyme-treated extract of Zizania latifolia, and a solvent extract (polar or non-polar) of the residue remaining after obtaining the enzyme-treated extract. Claim 6 recites the enzyme in the enzyme-treated extraction (claim 5) as at least one of the following: a pectinase, a hemicellulase, an arabinanase, an arabanase, a cellulase, a beta-glucanase, and a xylanase. Claim 7 recites “the Zizania latifolia extract comprises at least one selected from flavonoid glycosides and flavonoid aglycones”. Claim 8 recites the Zizania latifolia extract comprising at least one of a number of listed chemical compounds, of which tricin is one. Claim 10 recites “the Zizania latifolia extract comprises 0.1% by weight to 90% by weight of tricin”.
The use of a Zizania latifolia extract in a composition for treating liver disease is already anticipated by Gong et al., as discussed under the 35 USC 102 rejection supra. Yue et al. recites a use of high-purity tricin as useful for preparing an antitumor drug, where the tumor is lung or liver cancer (abstract). Kim et al. recites a method of making Zizania latifolia enzyme-treated extracts containing tricin (abstract). It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to produce a composition for treating a liver disease comprising a Zizania latifolia extract containing tricin, which is a flavonoid aglycone (instant claims 7 and 8), because Kim et al. disclose a method of making Zizania latifolia enzyme-treated extracts containing tricin and Guo et al. disclose the use of tricin to treat liver cancer. Kim et al. further recites that their extraction method comprises adding water (a polar solvent) (Kim et al. claim 1), cooling and adding an enzyme selected from the following: lipase, tannase, cellulase, hemicellulase, pectinase, and beta-glucosidase (Kim et al. claim 2; instant claims 5 and 6), and following enzyme treatment extracting the residue with water, a C1-C4 alcohol, or a mixture thereof (broadly understood as polar solvents; Kim et al. claim 3; instant claim 5). Therefore, the limitations recited in claims 5 and 6 are steps that would have been obvious to try for the preparation of a composition for treating a liver disease comprising a Zizania latifolia extract containing tricin.
Yue et al. teaches a composition with a percent weight of more than 95% tricin (abstract), whereas the instant application claims an extract that is 0.1-90% tricin by weight (claim 10). However, one of ordinary skill in the art would have been able to change extraction solvents, times, and temperatures to obtain extracts with varying tricin weight percent content (Kim et al., Preliminary Experiment 1). Having obtained extracts with varying tricin content, one of ordinary skill in the art would have been able to conduct both in vitro and in vivo tests to demonstrate how effective they are at treating liver pathologies (instant specification, Experimental Examples 1 and 2, Example 3). Therefore, the weight percents of 0.1-90% tricin, recited in claim 10, would have been obvious over the course of routine optimization to one of ordinary skill in the art before the effective filing date of the claimed invention.
Gong et al., Yue et al., and Kim et al. are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the extraction times, temperatures, solvents, and resulting weight percents of tricin, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the Zizania latifolia extract comprising 0.1-90 weight percent tricin), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Gong et al. in view of Yue et al. and Kim et al., the invention as a whole, drawn to a pharmaceutical composition comprising a Zizania latifolia extract as described, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to produce a composition for treating a liver disease comprising a Zizania latifolia extract containing tricin, which is a flavonoid aglycone, because Kim et al. disclose a method of making Zizania latifolia enzyme-treated extracts containing tricin and Guo et al. disclose the use of tricin to treat liver cancer
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67,
205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to
manufacture products by the myriad of processes put before it and then obtain prior art products
and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688
(CCPA 1972).
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655