DETAILED ACTION
Claims 13-18, 20 and 22 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant’s election of Group II, drawn to claims 17-18, 20 and 22 in the reply filed on 09/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/17/2025.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 06/28/2022 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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 18 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 18 recites the limitation “reducing the metabolic aging of an individual”. However, it is unclear what is meant by this limitation. The Specification states that “Metabolic age aligns the metabolic status of an individual to the average metabolic status of individuals having a given chronological age”. However, the Specification fails to define how the average metabolic status of an individual can be defined (i.e. what is considered average? What kind of population pool is used to determine average?). According to https://www.hellolingo.com/blog/metabolic-age, metabolic age is not a medical term, rather a wellness concept, see p. 2). Further, there isn’t a specific metabolic age test. Websites may claim to give you your metabolic age by inputting some personal information into an online calculator, but there is no universal test for metabolic age (see p. 3). As metabolic age does not appear to have an absolute basis or a specified calculation, it is unclear what is required by the claims to meet the limitation “reducing the metabolic aging”. Examiner notes that the term “the metabolic ageing” does not appear to have proper antecedent basis in the claims. MPEP 2173.05(e). Thus, claims 18 and 22 are rejected.
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 17 and 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 treating diabetes and obesity, does not reasonably provide enablement for preventing diabetes and 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 make/use the invention commensurate in scope with these claims. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988).
In In re Wands. 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
In the instant case, the nature of the invention for treating or preventing obesity, insulin resistance and diabetes.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening invitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can prevent obesity and diabetes). 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 that contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any preventive regimen on its fact.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427F.2d833, 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. The burden of enabling one skilled in the art to prevent diabetes and obesity would be much greater than that of enabling the therapeutic treatment diabetes and obesity. In the instant case, the specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing diabetes and obesity. Nor is there any guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing diabetes and obesity.
"To prevent" actually means to anticipate or counter in advance, to keep from happening etc. (as per Webster's II Dictionary) and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compositions can be administered to order to have the "prevention" effect. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with diabetes or obesity in general. Since applicants "preventive" assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits.
According to Cleveland Clinic (https://my.clevelandclinic.org/health/diseases/21500-type-1-diabetes), there’s nothing you can do to prevent developing Type 1 diabetes (see p. 18). Since Type 1 diabetes can run in families, your healthcare provider can test your family members for the autoantibodies that cause the disease. Further it is well known that type I diabetes is due to the fact the body does not produce insulin while type 2 diabetes is characterized by insulin resistance. As a result, the treatment for type II diabetes differs from that of type I. Treatment for type II diabetes falls into categories of drugs that improve insulin sensitivity and those that increase insulin secretion from ß cells. The compounds of the instant invention act on FMO5 receptor. However, the FMO5 receptor has not been linked to actual production of insulin, which is necessary for the treatment for type I diabetes.
The amount of direction or guidance present and the presence or absence
of working examples
The specification does not provide examples of prevention of diabetes and obesity. It discusses how Fmo5-/- mice are resistant to age-related changes in glucose homeostasis and maintain the higher glucose tolerance and insulin sensitivity characteristic of young animals and 2,3-butanediol may be efficacious in treatment of conditions such as obesity, insulin resistance and diabetes.
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include prevention of obesity and diabetes. However the specification only provides evidence that 2,3-butanediol treatment of these wildtype (C57BL/6) mice caused significant reductions in: fat to body weight ratio; plasma cholesterol triglycerides; free fatty acids and lactate dehydrogenase.
The quantity or experimentation needed and the level of skill in the art
It would require undue experimentation of one of ordinary skill in the art to ascertain the effectiveness of the compound in preventing obesity and diabetes. Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instant case for the composition with intended use claims. Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, it is apparent that undue experimentation is necessary because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
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.
Claims 17-18, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TAHARA (see WO 2004/080484, pub. 09/23/2004, cited in IDS filed 02/28/2022, machine translation enclosed). TAHARA teaches compound
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(see p. 2 of machine translation), which corresponds to an ester of 2,3-butanediol. The compounds are taught to inhibit differentiation preadipocytes into adipocytes. They can be used as anti-obesity agents and thus promote weight loss (see p. 4 and 11 of machine translation). The compounds are administered to human fat precursor cells (see p. 6 of machine translation).
Claims 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RAO (see WO 2017/046730, pub. 03/23/2017, cited in IDS filed 02/28/2022). RAO teaches compound Dapagliflozin 2,3-butanediol solvate (see claim 69) as a SGLT2 inhibitor which are taught to be used for treatment of type 2 diabetes (see p. 1, lines 27-30).
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.
Claims 17-18, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over D’AGOSTINO (see WO Pub No. 2019/118624, pub 06/20/2019, cited in IDS filed 02/28/2022). D’AGOSTINO teaches ketogenic supplement comprises compound 1,3-butanediol (see p. 14, line 7) as a method for inducing weight loss, increasing metabolic inefficiency, resetting metabolic set point, treating patients who are obese, have type-2 diabetes or a metabolic syndrome (see p. 16, lines 4-19). According to MPEP 2144.09, Section II, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
In the absence of unexpected results, one skilled in the art would expect that the instant claims which are directed to compounds that are positional isomers to the compound of D’AGOSTINO to be prima facie. One skilled in the art would be motivated to synthesize structurally similar compounds with the expectation that they would have similar properties and utilities. The explicit teaching of D’AGOSTINO would have motivated one skilled in the art to synthesize compounds such as 2,3-butanediol, which is a positional isomer of 1,3-butanediol, with such generic teaching with the expectation that they would have similar utility as inducing weight loss, increasing metabolic inefficiency, resetting metabolic set point, treating patients who are obese, have type-2 diabetes or a metabolic syndrome.
Claims 18 and 22 are rejected is/are rejected under 35 U.S.C. 103 as being unpatentable over RAO (see WO 2017/046730, pub. 03/23/2017, cited in IDS filed 02/28/2022) in view of HEERSPINK (see Circulation, 2016, Vol. 134, p. 752-772). RAO teaches compound Dapagliflozin 2,3-butanediol solvate (see claim 69) as a SGLT2 inhibitor which are taught to be used for treatment of type 2 diabetes (see p. 1, lines 27-30). HEERSPINK teaches SGLT2 inhibitors, which include dapagliflozin, also reduce weight. Thus the compound of RAO which is taught to be a SGLT2 inhibitor can also be used to reduce weight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623