Human Power Of N Co v. Heartbeet Ltd

1. Case Identification

• Case #: PGR2021-00094
• Patent #: 10,842,813
• Filed: June 22, 2021
• Petitioner(s): Human Power of N Company
• Patent Owner(s): Heartbeet Ltd.
• Challenged Claims: 1-24

2. Patent Overview

• Title: Compositions of Nitrates and Methods of Use Thereof
• Brief Description: The ’813 patent relates to methods of decreasing systolic blood pressure by administering inorganic nitrate to an adult human subject requiring such a reduction. The claims cover various forms and sources of administration, including beetroot juice, and specific weight-normalized dosages.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-2 and 22-23 under 35 U.S.C. §102 over Brunton

• Prior Art Relied Upon: Brunton (a 1909 article in The British Medical Journal).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Brunton disclosed every limitation of the challenged claims. Brunton described a method to "keep[] blood[] pressure down" for adult patients with "high tension," which Petitioner equated to high systolic blood pressure. The disclosed treatment was the oral administration of ten grains of potassium nitrate (an inorganic nitrate) dissolved in water, which is a liquid composition. Petitioner asserted this treatment inherently met the limitations of a method for decreasing systolic blood pressure (claim 1) in subjects with systolic hypertension (claim 2), administered orally (claim 22) in a liquid form (claim 23).

Ground 2: Obviousness of Claims 3-13 and 24 over Brunton in view of Shevach

• Prior Art Relied Upon: Brunton (1909 article) and Shevach (International Publication No. WO 2005/062713).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Brunton taught the foundational method of administering inorganic nitrate (potassium nitrate powder in water) to reduce blood pressure in hypertensive adults. Shevach taught that beetroot juices, which are a natural source of nitrate, are used as a "treatment for high blood pressure" and provide other therapeutic benefits.
  • Motivation to Combine: A POSITA would combine these teachings by substituting the powdered potassium nitrate in Brunton's treatment with the beetroot juice taught by Shevach. The motivations cited were to use a natural, "whole food" source of nitrate, to achieve additional therapeutic effects taught by Shevach (e.g., antioxidant effects), and to satisfy consumer preference for natural products over chemical powders. Adding additives like sweeteners (claim 8) was argued to be a simple and obvious modification to improve palatability.
  • Expectation of Success: Because beetroot juice was a known, potent source of inorganic nitrate and was already used for treating high blood pressure, a POSITA would have had a reasonable expectation of success in achieving a reduction in systolic blood pressure by incorporating it into Brunton’s established method.

Ground 3: Obviousness of Claims 1-7, 14-18, 22, and 23 under 35 U.S.C. §103 over Webb

• Prior Art Relied Upon: Webb (a 2007 abstract from the Journal of Human Hypertension).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner first argued that Webb qualifies as prior art because the ’813 patent is not entitled to a priority date before Webb’s publication. Webb disclosed that ingesting 500 mL of beetroot juice, a known source of dietary nitrate, caused a significant reduction in systolic blood pressure in healthy volunteers that was sustained for 24 hours. Webb explicitly concluded that dietary nitrate has "therapeutic potential...in the prevention and treatment of hypertension."
  • Motivation to Combine: A POSITA would have been motivated to apply Webb's findings to subjects requiring a reduction in systolic blood pressure based on Webb’s explicit suggestion. Petitioner argued this was not just a general hope but a specific application, supported by the DASH study (cited by Webb), which found that dietary interventions have a greater blood-pressure-lowering effect in hypertensive subjects than in healthy ones. This provided a strong rationale to treat the claimed patient population with the methods disclosed in Webb.
  • Expectation of Success: Given Webb’s positive results in healthy volunteers and the known principle that such dietary effects are often amplified in hypertensive individuals, a POSITA would have had a strong and reasonable expectation of success. Petitioner also argued that the dosage levels and administration frequencies in the dependent claims were obvious extrapolations from Webb's disclosure.

• Additional Grounds: Petitioner asserted numerous other grounds, including that claims 16-18 were obvious over Brunton in view of Brunton2 (a 1906 article teaching higher nitrate doses). Further combinations involving Chevaux (WO 99/45797) were used to challenge claims related to adding polyphenols (claims 19-21) and using arginine nitrate (claim 13). Petitioner also challenged all claims under 35 U.S.C. §112 for lack of written description and enablement, arguing the specification fails to support the full scope of the claims, particularly the broad dosage ranges and the application to non-hypertensive subjects. Claim 21 was also challenged as indefinite under §112(b).

4. Key Claim Construction Positions

• “inorganic nitrate”: Petitioner proposed this term be construed as a salt having a nitrate moiety (NO₃⁻) that exists as a negatively charged ion. This construction was used to distinguish the claimed invention from organic nitrates (esters) and to argue that nitrate from natural sources like beetroot juice is structurally identical to synthetic nitrate salts.
• “requiring a reduction in systolic blood pressure”: Petitioner argued this phrase means "having a systolic blood pressure in excess of 142.8 mmHg." This was derived from the specification’s definition of "normal" systolic BP as "about 140 mmHg" and its definition of "about" in this context as ±2%. This threshold was critical to Petitioner's analysis of which subjects disclosed in the prior art met the claim limitations.

5. Relief Requested

• Petitioner requests institution of post-grant review and cancellation of claims 1-24 of the ’813 patent as unpatentable.