Human Power Of N Co v. Heartbeet Ltd

1. Case Identification

• Case #: PGR2021-00110
• Patent #: 10,835,555
• Filed: August 17, 2021
• Petitioner(s): Human Power of N Company
• Patent Owner(s): Heartbeet Ltd.
• Challenged Claims: 1-31

2. Patent Overview

• Title: Compositions of nitrates and methods of use thereof
• Brief Description: The ’555 patent discloses methods for increasing exercise endurance in a human by administering a composition comprising a specific amount of inorganic nitrate prior to exercise. Dependent claims cover specific nitrate sources (e.g., beetroot), composition forms (e.g., sport drink), and additional components (e.g., polyphenols, bacteria).

3. Grounds for Unpatentability

Ground 1: Obviousness over NIH2 and Brunton - Claims 1-5, 11-13, and 17-19

• Prior Art Relied Upon: NIH2 (a 2004 report on high blood pressure treatment) and Brunton (a 1909 medical journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that NIH2 taught an evidence-based approach to managing hypertension that included regular aerobic exercise and a diet rich in vegetables (the DASH diet), which are known sources of inorganic nitrate. Brunton disclosed a method of reducing blood pressure by administering inorganic nitrate (potassium nitrate) in a daily morning drink. Petitioner asserted that the combination of NIH2’s lifestyle regimen (exercise and diet) and Brunton’s nitrate treatment taught administering inorganic nitrate prior to exercise. The claimed dosage range of 0.01-10 mmol/kg body weight was argued to be obvious, as calculations showed that both the recommended vegetable servings in the DASH diet and Brunton’s prescribed dose fell within this range when normalized for average adult body weights.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Brunton’s straightforward nitrate treatment with NIH2’s regimen to supplement the dietary recommendations. This combination would facilitate patient compliance for achieving the known anti-hypertensive effects of nitrate, which was the primary goal of the NIH2 regimen.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success because the physiological effects of both exercise and nitrate administration on blood pressure were well-understood. Petitioner contended that the claimed benefit of “increasing exercise endurance” was merely an inherent and obvious result of the known physiological effects of nitric oxide (NO), which is generated from ingested nitrate and known to cause vasodilation, improve oxygen efficiency, and reduce fatigue.

Ground 2: Obviousness over NIH2, Brunton, and Shevach - Claims 6-10 and 31

• Prior Art Relied Upon: NIH2, Brunton, and Shevach (WO 2005/062713).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination of NIH2 and Brunton. Shevach was introduced for its teaching of beetroot juices and powders—containing inorganic nitrate—as a treatment for high blood pressure. Crucially, Shevach disclosed that such compositions could include additives, such as sweeteners, to improve their palatability. Petitioner argued this combination rendered claims requiring at least one additive (claim 6) and specifying additives like sweeteners (claim 31) obvious. The composition in Brunton (potassium nitrate, bicarbonate, sodium nitrite) already included additives, and Shevach further supported adding them to nitrate-based vegetable juices.
  • Motivation to Combine: A POSITA would be motivated to add flavors or sweeteners, as taught by Shevach, to the nitrate compositions derived from the NIH2/Brunton combination. This was presented as a common and predictable formulation strategy to improve taste and thereby enhance patient compliance with the therapeutic regimen.
  • Expectation of Success: Improving the palatability of a composition with well-known additives like sweeteners is a routine formulation technique with a high expectation of success.

Ground 3: Obviousness over NIH2, Brunton, and Chevaux - Claims 14-16 and 25

• Prior Art Relied Upon: NIH2, Brunton, and Chevaux (WO 99/45797).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground also used the NIH2 and Brunton combination as a base. It added Chevaux, which taught administering food products containing polyphenols (e.g., from cocoa or nuts) to modulate NO production, thereby reducing blood pressure and providing other health benefits. Petitioner argued that adding polyphenols as taught by Chevaux to the base nitrate therapy rendered claims comprising a polyphenol (claim 14) obvious. The claimed ratio of nitrate comprising at least 50% of the composition (claim 16) was also argued to be obvious based on calculations using the disclosed polyphenol dose ranges from Chevaux and the nitrate dose from Brunton.
  • Motivation to Combine: A POSITA would combine polyphenols with the nitrate therapy of NIH2/Brunton to achieve enhanced or synergistic effects. Since both inorganic nitrate and polyphenols were known to promote health benefits via the NO pathway, a POSITA would have been motivated to combine them to further facilitate blood pressure reduction and improve exercise performance.
  • Expectation of Success: Combining two agents known to act on the same biological pathway (NO production) to achieve a desired physiological outcome (blood pressure reduction) would have been a predictable strategy with a high expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations with Prinkkilä (Patent 4,853,237) for sport drink formulations and Mäyrä-Mäkinen (Patent 6,890,529) for functional foods containing probiotics. Petitioner also challenged claims 1-11 and 13-31 as invalid under 35 U.S.C. §112 for lacking written description and enablement, arguing the priority documents do not support the full scope of the claims, particularly the administration of what it characterizes as lethal doses of nitrate.

4. Key Claim Construction Positions

• "inorganic nitrate": Petitioner proposed this term be construed as a salt containing a nitrate moiety (NO₃⁻) that exists as a negatively charged ion. This construction was argued to distinguish the claimed invention from organic nitrates (e.g., nitroglycerine), which are esters with covalently bonded nitrooxy functional groups. This distinction was central to applying prior art like Brunton, which discloses potassium nitrate, an inorganic nitrate salt.

5. Relief Requested

• Petitioner requests institution of Post Grant Review and cancellation of claims 1-31 of the ’555 patent as unpatentable.