Prior art

Based on a technical analysis of the citations for US patent 12,037,567, the following prior art references are identified as most relevant for assessing the novelty of the patent's claims. The analysis focuses on the potential for these references to anticipate the claims under 35 U.S.C. § 102, which requires that a single prior art reference discloses every element of a claimed invention.

The independent claims of US patent 12,037,567 (claims 1 and 11) describe a method of increasing or maintaining ketone bodies in a subject's blood above 0.5 mmol/L. This is achieved by administering a beverage containing at least 0.5% by volume of D-1,3-butanediol with substantially no L-1,3-butanediol.

Key Prior Art References

Here are the most relevant prior art references cited during the patent's examination and an analysis of their potential impact on the claims.

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1. U.S. Patent Application Publication No. US 2014/0308719 A1

• Full Citation: US 2014/0308719 A1
• Title: Process for producing (r)-3-hydroxybutyl (r)-3-hydroxybutyrate
• Publication Date: October 16, 2014
• Assignee: Government Of The Usa, As Represented By The Secretary, Department Of Health And Human Services
• Brief Description: This patent application discloses a method for synthesizing the ketone ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate. The background section explicitly discusses the metabolic effects of this ester and its components. It states that upon oral ingestion, the ester breaks down into (R)-3-hydroxybutyrate and (R)-1,3-butanediol. It further teaches that the liver converts (R)-1,3-butanediol into (R)-3-hydroxybutyrate, which elevates blood levels of ketone bodies. Note that (R)-1,3-butanediol is chemically identical to D-1,3-butanediol.
• Potential Anticipation Analysis:
  • This reference clearly discloses that administering (R)-1,3-butanediol (the D-enantiomer) results in an increase in blood ketone levels. This teaches the core physiological mechanism underlying the claims of patent 12,037,567.
  • However, the primary focus of the document is on the synthesis of a ketone ester. It does not appear to explicitly describe a method of administering D-1,3-butanediol itself in a beverage at a concentration of at least 0.5% for the specific purpose of increasing or maintaining blood ketone levels above 0.5 mmol/L. While it discloses the effect, it does not lay out all the specific steps and parameters of the claimed method. Therefore, it is highly relevant art but may not fully anticipate the claims on its own. It would be a strong reference for an obviousness challenge under 35 U.S.C. § 103.

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2. U.S. Patent No. US 9,138,420 B2

• Full Citation: US 9,138,420 B2
• Title: Compositions and methods for producing elevated and sustained ketosis
• Issue Date: September 22, 2015
• Assignee: University Of South Florida
• Brief Description: This patent describes compositions that combine a medium-chain triglyceride (MCT) source with a ketone precursor to induce a state of "elevated and sustained ketosis." The document lists "1,3-butanediol" as one of several potential ketone precursors that can be used in these compositions. The goal is to rapidly raise and maintain blood ketone levels for therapeutic or performance benefits.
• Potential Anticipation Analysis:
  • This reference discloses a method for producing elevated ketosis using 1,3-butanediol. The term "elevated ketosis" is consistent with the target of over 0.5 mmol/L cited in patent 12,037,567.
  • A key distinction is that patent 12,037,567 claims the use of D-1,3-butanediol specifically (the non-racemic form). The '420 patent broadly discloses "1,3-butanediol" without specifying a particular enantiomer, which would typically be interpreted as the racemic mixture (containing both D and L forms). Since the claims of patent 12,037,567 are limited to the D-enantiomer with "substantially no" L-enantiomer, the '420 patent does not appear to anticipate this specific limitation.

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3. U.S. Patent No. US 6,207,856 B1

• Full Citation: US 6,207,856 B1
• Title: Therapeutic compositions
• Issue Date: March 27, 2001
• Assignee: Btg International Limited
• Brief Description: This patent discloses therapeutic compositions containing ketone bodies or their precursors. It specifically claims an ester of (R)-3-hydroxybutyric acid and an alcohol, explicitly naming (R)-1,3-butanediol as a suitable alcohol. The patent teaches that these compositions can be administered orally as a liquid or drink to elevate blood ketone levels.
• Potential Anticipation Analysis:
  • This reference is significant because it recognizes the utility of the specific (R)-enantiomer of 1,3-butanediol in a composition designed to raise ketone levels.
  • However, the claims and description are focused on the administration of a ketone ester (i.e., (R)-3-hydroxybutyrate bonded to (R)-1,3-butanediol), not the administration of D-1,3-butanediol itself. The claims of patent 12,037,567 are directed to a method of administering the alcohol D-1,3-butanediol directly, not as part of an ester compound. This chemical difference is a critical distinction that likely prevents the '856 patent from anticipating the claims of patent 12,037,567.