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
Claims 1-18 are pending in the current application.
Claims 7-18 are withdrawn from consideration.
Claims 1-6 are examined in the current application.
Claim Rejections - 35 USC § 112
Claims 4 is 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 the use and dosage of (R)-3-hydroxybutyl (R)-3-hydroxybutanoate to attain the benefits of the ketone body, does not reasonably provide enablement for the dosage needed to attain the physiological benefits contemplated. Accordingly, The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with this claim.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by 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. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
the quantity of experimentation necessary,
the amount of direction or guidance provided,
the presence or absence of working examples,
the nature of the invention,
the state of the prior art,
the relative skill of those in the art,
the predictability of the art, and
the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108,427 F.2d 833,839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level
The invention relates to a ketogenic beverage composition comprising R-1,3-butanediol which provides ketone bodies and their benefits to the consumer.
The breadth of the claims
Since the instant specification provides only a mass amounts of R-1,3-butanediol in the beverage composition, without disclosing the total amount of the beverage composition, the specification provides no limiting relative amount of R-1,3-butanediol to be used to attain the benefits contemplated, the relative content of R-1,3-butanediol will be interpreted expansively. The claim is thus very broad insofar as it suggests that relative content of R-1,3-butanediol will provide the contemplated effect.
The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its "full scope". No reasonably specific guidance is provided concerning the relative content of R-1,3-butanediol, and the recited mass content of R-1,3-butanediol, encompasses any possible dilution of R-1,3-butanediol, including dilutions the contemplated effect will not be attained.
The quantity of experimentation necessary
Because of the infinite breath of possible dilutions, and the absence of experimental evidence, no one skilled in the art would accept the assertion that any relative content (i.e., dilution) of the instantly claimed R-1,3-butanediol in the composition could provide the benefits contemplated. Accordingly, the instant claim does not comply with the enablement requirement of §112, since to practice the claimed invention in its "full scope" a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg (USPatPub. 2020/0077690 A1) in view of Millet (USPatPub. 2021/0169831 A1).
Regarding claims 1-4: Steinberg discloses a composition that increases energy, improves insulin sensitivity and enhances physical endurance during increased physical activity comprising caffeine and beta-hydroxybutyrate bonded to R-1,3-butanediol, wherein the caffeine is extracted from green tea leaves (see Steinberg abstract; paragraphs [0004], [0009], [0043] and [0053]), but fails to disclose R-1,3-butanediol; However, Millet discloses that R-1,3-butanediol provides a spike in plasma ketone bodies quicker than beta-hydroxybutyrate (see Millet paragraph [0019] and Figure 1A). Therefore, it would have been obvious to a skilled artisan who desires to attain a product that will quickly increase the plasma content of ketone bodies, and thus arrive at the claimed limitations.
Regarding claim 5: Steinberg discloses the composition comprises glucose and/or fructose (see Steinberg abstract; paragraphs [0009] and [0041]), which reads on “sweeteners”.
Regarding claim 6: Steinberg discloses the composition is blended with water or another drinkable liquid for consumption (see Steinberg paragraph [0042]), which reads on “beverage, drink”.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed on July 7th 2026, with respect to the rejection of claims 1-6 under 35 USC §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Steinberg (USPatPub. 2020/0077690 A1) in view of Millet (USPatPub. 2021/0169831 A1) (see discussion above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
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