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 29 Jan 2024, in which claims 1-8 and 10-12 are amended and claim 9 is canceled.
This application is the national stage entry of PCT/KR2022/005097, filed 08 April 2022; claims benefit of foreign priority document KR 10-2022-0042610, filed 06 April 2022; and claims benefit of foreign priority document KR 10-2021-0049683, filed 16 April 2021. The foreign priority documents are not in English.
Claims 1-8 and 10-12 are pending in the current application and are examined on the merits herein.
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 10-12 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 treating or ameliorating non-alcoholic fatty liver, does not reasonably provide enablement for preventing non-alcoholic fatty liver. 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.
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.
Nature of the invention: A method for preventing, treating, or ameliorating non-alcoholic fatty liver comprising administering a composition comprising Polygalin C as an active ingredient to a subject.
The state of the prior art: The ordinary definition of prevent encompasses the definition “To preclude the occurrence of (an anticipated event, state, etc.); to render (an intended, possible, or likely action or event) impractical or impossible by anticipatory action; to put a stop to.” See provided definition of prevent (definition 9a of prevent, Oxford English Dictionary Online, cited in PTO-892). There is no prior art disclosing making non-alcoholic fatty liver impossible by anticipatory action.
Powell et al. (Lancet, 2021, 397, p2212-2224, published online 21 April 2021, cited in PTO-892) teaches the state of the prior art regarding non-alcoholic fatty liver disease (NAFLD). Powell et al. teaches less than 10% of people with NAFLD develop liver-related complications, and a key challenge is to identify those who are at the highest risk among the many people affected by NAFLD (page 2212, left column, paragraph 1). The predominant drivers of disease can vary substantially among patients with NAFLD. Furthermore, disease progression and response to treatment are heterogeneous (page 2212, right column, paragraph 3). Few studies have examined primary prevention of NAFLD; nevertheless data suggest that improved diet quality and sustained or increased physical activity reduces the risk of developing NAFLD, even among individuals with high genetic risk (page 2217, left column, paragraph 3). There are several barriers to the development of highly effective therapeutic interventions. One of the most important challenges in the field is a continued reliance on liver biopsy for diagnosis. A reliable biomarker that can accurately diagnose and stage NAFLD across the entire disease spectrum does not yet exist. A diagnostic biomarker, in conjunction with a prognostic biomarker (of which some currently hold promise), would allow the identification of high-risk individuals on whom resources should be concentrated. The ability to phenotype patients would permit more accurate prognostication, selection of appropriate therapy, and prediction of treatment response than is currently possible (paragraph spanning page 2220-2221).
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The lack of any prior art disclosing making non-alcoholic fatty liver impossible means that one skilled in the art cannot predict the usefulness of a method to make non-alcoholic fatty liver impossible. Powell et al. teaches the disease progression and treatment response is heterogeneous, suggesting the course of the development of the disease is unpredictable. Further, Powell et al. teaches a reliable biomarker that can accurately diagnose and stage NAFLD across the entire disease spectrum does not yet exist, suggesting that diagnosis or prognostication of whether the disease will develop is unpredictable. Therefore the claimed invention is unpredictable.
The Breadth of the claims: The scope of the claims specifically includes prevention of non-alcoholic fatty liver.
The amount of direction or guidance presented: The specification speaks generally about preventing or treating obesity or non-alcoholic fatty liver by Polygalin C inhibiting differentiation of preadipocytes, inhibiting adipose tissue generation factors and adipogenic factors, and inhibiting inflammatory factors at paragraph 17 of the published application.
The presence or absence of working examples: The only working examples provided are for in vitro effects of Polygalin C to inhibit adipogenic factors, for example at Examples 1-8.
Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as primary prevention of NAFLD. See MPEP 2164.
The quantity of experimentation necessary: In order to practice the invention with the full range of all possible treatment methods beyond those known in the art, (such as lifestyle changes that reduce the risk of developing NAFLD) one skilled in the art would undertake a novel and extensive research program to show that the claimed method made NAFLD impossible. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of patients having different risk profiles, a heterogenous disease in which the course of the development of the disease is unpredictable, and where diagnosis or prognostication of whether the disease will develop is unpredictable, it would constitute an undue and unpredictable experimental burden in order to show prevention of the disease before it develops.
Genentech, 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 “patent 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, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for prevention of NAFLD.
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.
Claim 5 and 8 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 5 recites at line 2 “the adipose tissue generation transcription factor may be one or more selected from the…” (emphasis added) The phrase “may be” renders the claim indefinite because it is unclear if the claim limits the transcription factor to one of the recited group or merely recites non-limiting examples of what the transcription factor may possibly be.
Claim 8 recites the limitation "the pharmaceutical composition" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 1, which recites administering “a health functional food”.
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 1-7 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kou et al. (Fitoterapia, 2006, 77, p411-415, cited in PTO-892) with evidence provided by Li et al. (Journal of Asian Natural Products Research, 2006, 8(5), p401-409, cited in PTO-892).
Kou et al. discloses the antiinflammatory activity of the aqueous extract of Polygala japonica (AEPJ) was investigated in mice and rats to find the pharmacological basis for its ethnomedical use (page 411, abstract). The AEPJ was prepared by macerating Polygala japonica Houtt. in water, boiling, and filtering (page 411, paragraph 2 to page 412, paragraph 1). The experimental rats were treated orally with the AEPJ (page 412, paragraph 3; section 3. Results spanning pages 413-414; tables 1-5). P. japonica, a traditional Chinese herb, exerts significant antiinflammatory activity, and further investigations are required to find the active components of the extract (page 414, paragraph 6).
Li et al. provides evidence that polygalin C is a known compound isolated from Polygala japonica HOUTT (page 401, abstract). The dried and powdered aerial part of P. japonica (7 kg) was extracted with 70% aqueous ethanol by infiltration to give the crude extract containing polygalin C (compound 12) (page 405, paragraph 3).
Regarding claims 1, 10, and 12, Kou et al. does not specifically disclose the AEPJ having antiinflammatory activity to comprise polygalin C as an active ingredient. 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 Li et al. provides evidence that polygalin C is a known compound extracted from the same plant Polygala japonica HOUTT using aqueous ethanol, and the published application at paragraph 17 states that polygalin C has activity inhibiting inflammatory factors. Therefore there is reason to believe that the antiinflammatory AEPJ administered in the method disclosed in Kou et al. necessarily contains some amount of polygalin C as an active ingredient. While Kou et al. discloses further investigations are required to find the active components of the extract, MPEP 2112 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.” In this case the evidence provided by Li et al. and the factual evidence in the application itself supports a conclusion that the claimed subject matter is in fact inherent in the prior art reference, even if it was not recognized in the prior art.
Regarding claims 1 and 12, Kou et al. does not describe the AEPJ as a health functional food. Regarding claim 10, Kou et al. does not describe the AEPJ as a pharmaceutical composition. However, the application does not provide a limiting definition of the structure of a health functional food or a pharmaceutical composition, and Kou et al. describes the AEPJ administered orally to produce a functional or pharmaceutical effect and acknowledges that P. japonica is a traditional Chinese herbal medicine, therefore the AEPJ disclosed is interpreted as falling within the scope of a health functional food or a pharmaceutical composition as understood by one of skill in the art.
Regarding claims 1 and 10-12, Kou et al. does not disclose the intended use of the method of “reducing body fat”, “preventing or treating non-alcoholic fatty liver”, or “preventing or ameliorating non-alcoholic fatty liver”. However, the body of the claims 1 and 10-12 recite administering a composition comprising Polygalin C as an active ingredient to a subject, and do not limit the composition administered to a specific or effective amount or administering to a specific subject in need thereof. Therefore these claims are interpreted to encompass administering a composition comprising any amount of Polygalin C as an active ingredient to any subject, such the method disclosed in Kou et al. of administering AEPJ to the experimental rat animal model to measure antiinflammatory activity.
Regarding claims 2-7 and 11, these claims are interpreted as reciting functional limitations. MPEP 2173.05(g) provides “A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step.” In this case, as detailed above, the claims do not limit the composition administered to a specific amount or administering to a specific subject, therefore the claimed capability is met by Kou et al. in describing the AEPJ administered orally to the experimental rat animal model to produce a functional or pharmaceutical effect because the functional capability of the same compound would be the same after being administered to the rat to produce a functional or pharmaceutical effect.
Therefore method disclosed in Kou et al. necessarily falls within the scope of the claimed method and anticipates claims 1-7 and 10-12.
Claims 1-7 and 10-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US 2024/0115645, PCT filed 29 Dec 2021, cited in PTO-892).
The foreign priority documents are not in English, particularly KR 10-2021-0049683 filed 16 April 2021, and the record is not clear that the claims find descriptive support in the foreign priority documents. Therefore the effective filing date of the claims is deemed to be that of PCT/KR2022/005097 filed 08 April 2022. Based on this date Zhang et al. qualifies as prior art under 35 U.S.C. 102(a)(2).
Zhang et al. discloses a pharmaceutically active ingredient extract extracted from Polygala japonica Houtt., useful in the treatment of urolithiasis and urinary tract infections or kidney damage caused by urolithiasis (abstract). In a preferred technical solution, the active ingredient is selected from the compounds (F-7Q-1), (F-7K-1), and (F-74Q-1) (paragraph 37 spanning pages 5-6), where the compound (F-74Q-1) is also known as polygalin C (entry 13 in table 2 at page 13). In a working example the extract containing the compound F-74Q-1 as an active agent were administered by intragastric administration to the experimental rat animal model (page 15, paragraph 161 to page 16, paragraph 177). Zhang et al. discloses the pharmaceutically active ingredient extract of Polygala japonica Houtt. can also be prepared into various dosage forms by conventional methods of pharmacy, such as gastrointestinal administration dosage forms such as capsules, tablets, pills, oral liquids, granules, tinctures, sustained release agents, and parenteral dosage forms (page 8, paragraph 62).
Regarding claims 1 and 12, Zhang et al. does not describe the AEPJ as a health functional food. However, the application does not provide a limiting definition of the structure of a health functional food, and Zhang et al. describes the pharmaceutically active ingredient extract of Polygala japonica Houtt. prepared into various dosage forms by conventional methods of pharmacy such as oral liquids and tinctures is interpreted as falling within the scope of a health functional food as understood by one of skill in the art.
Regarding claims 1 and 10-12, Kou et al. does not disclose the intended use of the method of “reducing body fat”, “preventing or treating non-alcoholic fatty liver”, or “preventing or ameliorating non-alcoholic fatty liver”. However, the body of the claims 1 and 10-12 recite administering a composition comprising Polygalin C as an active ingredient to a subject, and do not limit the composition administered to a specific amount or administering to a specific subject. Therefore these claims are interpreted to encompass administering a composition comprising any amount of Polygalin C as an active ingredient to a subject, such the method disclosed in Zhang et al. of administering the extract to the experimental rat animal model or the disclosed intended use for the treatment of urolithiasis and urinary tract infections or kidney damage caused by urolithiasis.
Regarding claims 2-7 and 11, these claims are interpreted as reciting functional limitations. MPEP 2173.05(g) provides “A functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step.” In this case, as detailed above, the claims do not limit the composition administered to a specific amount or administering to a specific subject, therefore the claimed capability is met by Zhang et al. in describing the composition comprising Polygalin C as an active ingredient administered orally to the experimental rat animal model to produce a pharmaceutical effect because the functional capability of the same compound would be the same after being administered to the rat to produce a functional or pharmaceutical effect. See also MPEP 2112.01 at II. providing ““Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” In this case Zhang et al. discloses the method comprising administering a compound having the identical chemical structure to a subject, Polygalin C, therefore the properties applicant discloses and/or claims are necessarily present.
Therefore method disclosed in Zhang et al. necessarily falls within the scope of the claimed method and anticipates claims 1-7 and 10-12.
Claim Rejections - 35 USC § 103
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.
Claim 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2024/0115645, PCT filed 29 Dec 2021, cited in PTO-892) as applied to claims 1-7 and 10-12 above.
As detailed above, Zhang et al. is deemed to qualify as prior art under 35 U.S.C. 102(a)(2).
Zhang et al. teaches as above.
Zhang et al. does not specifically disclose amount of polygalin C in the composition administered (claim 8).
Zhang et al. further teaches in a further preferred technical solution, in the pharmaceutically active ingredient extract of Polygala japonica Houtt., the total content of the flavonol compound of formula (I) as the first active ingredient accounts for 20-100% of the total extract of Polygala japonica Houtt (page 6, paragraph 39), where the compound F-74Q-1 is a flavonol compound of formula (I). Zhang et al. further teaches the pharmaceutically active ingredient extract of Polygala japonica Houtt. can also be prepared into various dosage forms by conventional methods of pharmacy.
It would 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 Zhang et al. in order to select the optimum or workable amount of the active ingredient in the composition through routine experimentation. One of ordinary skill in the art would have been motivated to modify the teachings of Zhang et al. with a reasonable expectation of success because Zhang et al. further teaches select the amount of the flavonol compound of formula (I) as a percent of the total extract, and teaches the extract can also be prepared into various dosage forms by conventional methods of pharmacy, suggesting selection of the amount of the flavonol compound of formula (I) through routine and conventional experimentation. See also MPEP 2144.05 at II. providing “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Conclusion
No claim is currently in condition for allowance.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693