Obviousness

Analysis of Obviousness under 35 U.S.C. § 103

This analysis evaluates whether the invention claimed in US Patent 11,760,963 would have been obvious to a "person having ordinary skill in the art" (PHOSITA) at the time the invention was made. An invention is considered obvious if the differences between the claimed invention and the prior art are such that the subject matter as a whole would have been obvious to a PHOSITA. This analysis relies on the prior art references identified in the preceding section.

A PHOSITA in this context would be a food scientist or biochemist with experience in formulating functional beverages and nutritional supplements, particularly those related to the ketogenic diet. This person would be familiar with ketone bodies, their metabolic precursors, and methods for creating palatable consumer beverages.

Obviousness of Independent Claim 1

Claim 1: A beverage comprising water and at least 0.5 percent by volume D-1,3-butanediol and no, or substantially no, L-1,3-butanediol, the beverage further optionally comprising one or more additives...

A strong argument for the obviousness of Claim 1 can be made by combining the teachings of US 2015/0065571 A1 ('571) and general knowledge in beverage formulation, as exemplified by US 2003/0138384 A1 ('384).

1. Core Components and Motivation to Combine:

   • The '571 patent application explicitly discloses compositions containing a monoester of D-β-hydroxybutyrate and R-1,3-butanediol (the "D" form claimed in the '963 patent). It teaches using this specific, non-racemic isomer for a therapeutic purpose (reducing muscle breakdown), establishing its utility as a ketogenic precursor for oral administration.
   • The '384 patent application teaches the general art of creating beverage compositions, including adding functional ingredients to a water-based medium for consumer use.

   A PHOSITA, aware of the ketogenic benefits of D-1,3-butanediol from '571, would have been motivated to create a consumer-friendly product for oral delivery. A liquid beverage is one of the most common and predictable delivery systems for nutritional supplements. The motivation would be to take the functional compound identified in '571 and place it into a standard, palatable delivery vehicle as taught by '384, thereby making the basic combination of water and D-1,3-butanediol in a beverage obvious.

2. Addressing Specific Claim Limitations:

   • "no, or substantially no, L-1,3-butanediol": The '571 reference specifically teaches the use of the R-1,3-butanediol isomer. In biochemistry and pharmacology, it is a well-established principle that different stereoisomers of a molecule can have different biological effects. A PHOSITA, seeking to maximize the desired ketogenic effect taught by '571 and minimize any potential unknown or undesirable effects from the L-isomer, would have been naturally led to use the D-1,3-butanediol in a substantially pure form. This constitutes an obvious optimization step to enhance product efficacy and safety.
   • "at least 0.5 percent by volume": This concentration is not explicitly taught in the prior art combination. However, the '963 patent positions its invention as a "ketogenic beer" and an alternative "alcoholic beverage." The threshold for a beverage to be legally considered non-alcoholic in the US is typically less than 0.5% alcohol by volume (ABV). A PHOSITA tasked with creating an alternative alcoholic beverage that provides a physiological effect (in this case, ketosis and potential intoxicating effects described in the patent) would have been motivated to formulate the beverage with a concentration of the active ingredient at or above this 0.5% threshold. Arriving at a specific effective dose would have been a matter of routine experimentation and optimization, not invention.

Therefore, it would have been obvious to a PHOSITA to combine the D-1,3-butanediol taught in '571 with water in a beverage format as taught by '384, using the specific D-isomer for efficacy and formulating it at a concentration of at least 0.5% to create a functional beverage akin to an alcoholic drink.

Obviousness of Independent Claims 7 and 17

Claim 7: A beverage comprising at least 0.5 percent by volume D-1,3-butanediol... and one or more additives selected from the group consisting of D ethyl 3-hydroxybutyrate; D beta hydroxybutyrate salts...

Claim 17: A beverage comprising water, at least 0.5 percent by volume D-1,3-butanediol, D beta hydroxybutyrate salts, and D beta hydroxybutyrate...

The obviousness of these more specific claims can be argued by extending the previous combination to include the teachings of US 9,138,420 B2 ('420).

1. Motivation to Add Further Ketogenic Compounds:

   • The '420 patent is a foundational text in the field, teaching compositions for inducing "elevated and sustained ketosis" by using beta-hydroxybutyrate (BHB) mineral salts. It establishes the desirability of using exogenous ketone salts to support a ketogenic state.
   • A PHOSITA, starting with the obvious beverage from the '571 and '384 combination, would be aware of other methods for inducing ketosis, such as the BHB salts from '420. The motivation to combine these teachings would be to create a more effective, multi-faceted product. It is common practice in the dietary supplement field to combine multiple ingredients that work towards a common goal via similar or complementary mechanisms.

2. Reasonable Expectation of Success:

   • A PHOSITA would have a reasonable expectation of success in combining D-1,3-butanediol with BHB salts and/or D-beta-hydroxybutyrate. Both are known ketogenic precursors that are converted into ketone bodies in the liver. Combining them would be expected to provide a more robust and potentially more sustained elevation of blood ketones than either compound alone. This would be seen as an obvious way to improve upon the base product.

Thus, claims 7 and 17, which require the addition of other ketogenic compounds like BHB salts to the base D-1,3-butanediol beverage, would have been obvious by combining the teachings of '571, '420, and general beverage formulation knowledge ('384). The combination is a predictable amalgamation of known ketogenic agents into a conventional delivery format to achieve a superior ketogenic effect.