DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 03/15/2024 has been entered. Claims 1-20 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/JP2022/034704 09/16/2022 and claims foreign priority of JAPAN 2021-152615 09/17/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/13/22024 and 10/28/2025 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 9-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for improvement of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage, does not reasonably provide enablement for prophylaxis of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Claim 10 depends from claim 9, claim 12 depends from claim 11, claim 14 depends from claim 13, claim 16 depends from claim 15, claim 18 depends from claim 17, and claim 20 depends from claim 19.
Applicants claim a pharmaceutical product or food for prophylaxis of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage recited in claims 9, 11, 13, 15, 17, and 19. However, no limiting definition of “prophylaxis" or “prevention” is given in the instant Specification. In the absence of a limiting definition by the Applicants, "prevention" as described according to the Institute for International Medical Education (pages 15 and 16), is a preventive measure, such as preserving physical fitness in primary prevention and effective intervention to correct departures from good health in secondary prevention. More specifically, tertiary prevention, which is most relevant as used in the context of the instant invention, "consists of the measures available to reduce or eliminate long-term impairments and disabilities, [and to] minimize suffering caused by existing departures from good health". Thus, the claimed prophylaxis of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage as interpreted by a skilled practitioner of the medical or pharmaceutical arts would be to reduce for long-term the occurrence of or to eliminate a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to a pharmaceutical product or food comprising a glycoside of liquiritigenin for prophylaxis of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage recited in claims 9, 11, 13, 15, 17, and 19.
Relative skill of those in the art: The relative skill of those in the art is from biomedical field (see the cited reference below).
Breadth of claims: The claim is extremely broad in that it encompasses the prophylaxis of a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical product can prevent a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage. Gao et al. (Journal of Functional Foods 33:142–148, 2017, listed in IDS filed on 10/28/2025) disclosed that liquiritin is one of flavone compounds derived from licorice, a common flavoring and sweetening agent in food products. Liquiritin exerts an anti-inflammatory effect via modulating JNK, p38, activator protein-1 (AP-1), AMPK and nuclear factor-κB (NF-κB) pathways in IL-1ß-induced human synovial cells, which is a useful tool to study the inflammatory response of rheumatoid arthritis. However, the in vivo beneficial effects of liquiritin on RA remain unclear (page 142, Abstract; page 147, left col., para. 1). One of skilled artisan would understand that contemporary treatment or management of a symptom or disease caused by damage or inflammation of cartilage, such as rheumatoid arthritis (RA), is to minimize RA symptoms, not to prevent, RA.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in the instant application to show that the claimed product or food is effective for preventing a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage as recited in the claim. The exemplary embodiments of the Specification merely present in vitro assays of chondrocyte differentiation, chondrocyte proliferation, and cartilage matrix production (pages 27/31 to 30/31).
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that a preventive measure can be achieved after applying the claimed product or food. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any method can be used to prevent a symptom or disease caused by damage or inflammation of cartilage, or a symptom or disease showing the loss of cartilage. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in prevention of a symptom or disease caused by damage or inflammation of cartilage, or showing the loss of cartilage, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-20 recite a product or food comprising a glycoside of liquiritigenin (or liquiritin), which is product of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that different intended purposes in the preamble changes the structure, function, or other properties of the glycoside of liquiritigenin (or liquiritin) in any marked way. Instead, the glycoside of liquiritigenin (or liquiritin) retains its naturally occurring structure and properties (e.g., anti-inflammatory activity). Thus, the claimed product or food as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, different intended purposes in the preamble are well-understood, routine and conventional in the field, as evidenced by the reference under the 102 rejection below. The recitation of specific disease does not affect this analysis, because it was also well-understood, routine and conventional at the time of filing. Thus, the claimed product or food, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
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.
(I) Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. (Journal of Functional Foods 33:142–148, 2017, hereinafter referred to as Gao ‘2017, also listed in IDS filed on 10/28/2025).
With regard to the structural limitation “a promoter for differentiation into chondrocytes (or for chondrocyte proliferation; or a cartilaginous matrix production promoter; or a cartilage regenerant; or a pharmaceutical product; or a food) comprising a glycoside of liquiritigenin (or liquiritin)” (claims 1-20):
Gao ‘2017 disclosed that liquiritin is one of flavone compounds derived from licorice, a common flavoring and sweetening agent in food products. Liquiritin exerts an anti-inflammatory effect via modulating JNK, p38, activator protein-1 (AP-1), AMPK and nuclear factor-κB (NF-κB) pathways in IL-1ß-induced human synovial cells, which is a useful tool to study the inflammatory response of rheumatoid arthritis (page 142, Abstract).
Thus, these teachings of Gao ‘2017 for the product or food containing liquiritin anticipate Applicant’s claims 1-20, including the intended purposes in the preamble or the intended disease, such as osteoarthritis.
(II) Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen (US 2008/031905, Dec. 25, 2008, hereinafter referred to as Cohen ‘905).
With regard to the structural limitation “a promoter for differentiation into chondrocytes (or for chondrocyte proliferation; or a cartilaginous matrix production promoter; or a cartilage regenerant; or a pharmaceutical product; or a food) comprising a glycoside of liquiritigenin (or liquiritin)” (claims 1-20):
Cohen ‘905 disclosed a composition comprising a liquiritigenin, or a liquiritigenin derivative selected from a compound of formula (II):
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. In a specific aspect, the composition comprises liquiritin. In a further specific embodiment, the composition comprises liquiritigenin-glycoside-apiofuranoside. A method of treating pain from, for example, arthritis, osteoarthritis, and dysmenorrhea, the method comprising administration of a composition comprising liquiritigenin, or a liquiritigenin derivative. Any suitable route of administration may be employed for providing the patient with an effective dosage of liquiritigenin or derivative or prodrug ( e.g., oral, sublingual). Botanical dietary supplements used in Traditional Chinese Medicine (TCM) are used by many patients to relieve their menopausal symptoms. Active compounds were isolated from the individual plant components of MF101, including Glycyrrhiza uralensis (page 15/24, [0061]; page 16/24, [0079]; page 17/24, [0092]; page 9/24, [0005]; page 13/24, [0034]).
Thus, these teachings of Cohen ‘905 for the product or food containing liquiritin anticipate Applicant’s claims 1-20, including the intended purposes in the preamble or the intended disease, such as osteoarthritis.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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