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 .
Priority
This application was filed 09/27/2024 and is 371 of PCT/US2023/016541 (03/2/2023) which claims PRO 63/324515 (03/8/2022). Claims 1-19 are before the Examiner.
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.
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.
Claims 1-14 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. Specifically, for claims 4-6, these claims are drawn to the “method of claim 1” but claim 1 is drawn to a composition. Specifically, for claims 1-3 and 7-14, the instant claims are drawn to a composition comprising a “therapeutically effective amount” of one flavanone and a “therapeutically effective amount” of at least one flavonol. First, the claims are drawn to a composition and not a treatment, so the words “therapeutically effective amount” have no patentable weight. Second, “therapeutically effective amount” to do what? Third, where is the enablement for the claimed composition such that the ordinary artisan would be able to distinguish an amount of a flavanone that naturally occurs in a natural food substance (citrus fruit or blue berry to name two) as compared to a specific amount to be therapeutically effective? Correction is required.
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 15-19 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is the method of treating a metabolic disorder (claims 16-19) or local fat reduction (claim 15) by administering a composition that has a flavanol and a flavanone.
The state of the prior art: The state of the prior art is that it involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face. Amakura teaches that flavonoids have some health-enhancing properties but more detailed studies are needed. Dawilai teaches that further trials must be performed to determine if the suggested health benefits of flavonoids is valid. Jomova teaches that flavonoids show promise for their health benefits. Mahmud teaches that there is insufficient evidence for any amount or dose to give good effects or to prevent side effects.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the therapeutic effects of metabolic diseases or in fat reduction, whether or not the instant flavonoid composition would make a difference in the disease/fat reduction. Hence, in there is no showing of a nexus between the flavonoid composition and the treatment of any metabolic disease or fat reduction. There is almost no testing to prove a connection between the composition and a treatment.
The presence or absence of working examples: The composition instantly claimed has not been tested for the treatment of any metabolic disease specifically or for fat reduction. The composition calls for “an effective amount”. However, there is no showing of what constitutes an effective amount. The examples given in the specification are vague tests showing in vitro activity but do not provide a nexus between the test and diabetes management or fat reduction.
The amount of direction or guidance present: The guidance present in the specification is that of the compositions are antioxidants and are known to treat many conditions. However, there is a link between antioxidants and health, but a direct link between the specific composition and a treatment of a disease is not given or enabled. Antioxidants are known to support health and are thought to play an important role in a variety of diseases and health. The specification does not seem to enable a correlation between the specific flavonoid composition and the treatment of metabolic diseases or fat reduction.
The breadth of the claims: The claims are drawn to the treatment of metabolic diseases an fat reduction by giving a composition of flavonoids.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what diseases out of all known metabolic diseases would be benefited by the mediation of flavonoids and then would further need to determine which of the claimed compositions would provide treatment of the disease.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of any disease. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, 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 and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
