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
Pursuant to the preliminary amendment dated 6/29/2023, claim 9 is amended. No claims are newly added or canceled.
Claims 1-9 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/KR2021/016220, filed on 11/9/2021. The instant application claims foreign priority to KR 10-2021-0001753 filed on 1/7/2021. 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 6/29/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 6/29/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 9 recites, “A method for preventing or treating obesity, comprising administering the composition selected from claim 1 to a subject.” This phrasing is objected to and Applicant is invited to consider amending to, “A method for preventing or treating obesity, comprising administering the composition of
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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.
Claim 9 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for treating obesity, does not reasonably provide enablement for preventing obesity. 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.
With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (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 and those most relevant to the cited claims are discussed below. 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 method of treating or preventing obesity by administering a fermented plant extract. Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of prevention. The specification does not define prevention. Thus, the term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002, PTO-892) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. The full scope of the claims encompasses the entire definition of tertiary prevention, which as defined above covers reducing the occurrence of or eliminating a symptom or condition. Thus, the intent of the claimed method, would include that which reduces the occurrence of, or eliminates obesity.
Amount of guidance/Existence of working examples: There are no working examples demonstrating elimination of obesity.
Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed compositions to both healthy individuals and individuals having obesity, to determine if the claimed method can be used in the fully claimed scope to treat and prevent obesity. 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, e.g., the breadth of the claims, the amount of guidance provided, and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success.
Claim Rejections - 35 USC § 112—Second Paragraph
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.
Claim 5 is rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 recites that, “the fermented Moringa extract is one or more selected from a group consisting of niazirin…”. This phrase renders the claim unclear because claim 5 depends from claim 1, where in the context of claim 1 an extract is a plurality of compounds originating from Moringa oleifera. The manner in which claim 5 is phrased implies that the extract exists as only a single compound, which is inconsistent with claim 1.
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.
(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 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baek et al. (KR 20180089259A, 2018, PTO-892).
Baek et al. discloses a composition that can be formulated as a medicine, pharmaceutical, beverage or food, comprising an extract of Moringa oleifera fermented using Monascus fungus, at 40-45°C and 80-100% humidity for 36-38 hours. (Abstract; pp. 3, 7-8) Baek also discloses that Moringa based compositions are useful for treating obesity. (p. 7)
With respect to claim 6, Baek is silent on the effect of the discloses composition on adipocytes, however because Baek discloses a product which is structurally identical to the instantly claimed structure the property claimed is necessarily present. “Products of identical chemical composition can not have mutually exclusive properties.” 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). (MPEP 2112.01(II))
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (KR 20180089259A, 2018, PTO-892), in view of Zhang et al. (CN 105533068A, 2016, PTO-892).
The disclosure of Baek is referenced as discussed above. Baek does not teach a that the species of Monascus is M. purpureus.
Zhang et al. discloses a composition comprising an extract of Moringa oleifera fermented using Monascus purpureus fungus. (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that M. purpureus could be specifically selected in the fermentation produced composition of Baek, thereby arriving at the instant invention. One would be motivated to use M. purpureus in the fermentation composition of Baek because Zhang teaches that M. purpureus is an appropriate Monascus species in a directly analogous fermentation produced composition based on Moringa oleifera.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (KR 20180089259A, 2018, PTO-892), in view of Athira et al. (Res. Square, 2020, PTO-892).
The disclosure of Baek is referenced as discussed above. Baek does not teach that the extract comprises the compounds claimed.
Athira et al. discloses that Moringa oleifera extracts comprise numerous compounds including astragalin, niazirin, quercetin and kaempferol. (p. 6, 2nd¶; Table 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Baek would contain astragalin, niazirin, quercetin and kaempferol, thereby arriving at the instant invention. This conclusion is reasonable due to Athira teaching that Moringa oleifera extracts comprise numerous compounds including astragalin, niazirin, quercetin and kaempferol.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (KR 20180089259A, 2018, PTO-892).
The disclosure of Baek is referenced as discussed above, Baek does not teach a method for treating obesity by administering a fermented Moringa oleifera extract composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Baek could be employed in a method of treating obesity, thereby arriving at the instant invention. One would be motivated to use the composition of Baek in a method of treating obesity because Baek teaches that Moringa based compositions are useful for treating obesity. Hence, one would have a reasonable expectation of success that using the specific fermented Moringa oleifera extract composition of Baek would be effective o to treat obesity.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
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/DALE R MILLER/Primary Examiner, Art Unit 1693