PTAB

PGR2022-00004

Human Power Of N Co v. Heartbeet Ltd

Key Events

Petition

petition

Title: Compositions of Nitrates and Methods of Use Thereof
Brief Description: The ’747 patent discloses methods for decreasing systolic blood pressure in an adult human by administering inorganic nitrate. The dependent claims cover associated diastolic blood pressure reduction and various formulations, including nutritional supplements containing additives and nitrates from natural sources.

Prior Art Relied Upon: Brunton (a 1909 article in The British Medical Journal titled "An Address on Blood Pressure In Man").
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Brunton disclosed every limitation of claims 1-3. Brunton taught a method of reducing blood pressure in adult patients with "high tension" (i.e., high systolic blood pressure) by administering "ten grains of potassium nitrate," an inorganic nitrate. This treatment was administered as a powder dissolved in hot water, meeting the "liquid" form limitation of claim 3. Petitioner asserted that the administration of a known vasodilator like potassium nitrate to reduce systolic blood pressure would inherently and necessarily reduce diastolic blood pressure as well, thus anticipating claim 2.

Prior Art Relied Upon: Brunton (the 1909 medical journal article) and Shevach (WO 2005/062713).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner contended that Brunton taught the foundational method of administering inorganic nitrate to reduce blood pressure. Claims 5-7 build on this by requiring the nitrate to be in a composition "consisting of" the nitrate and at least one additive, where the composition can be a nutritional supplement (claim 6) with the nitrate from a natural source (claim 7). Shevach disclosed using beetroot juices and powders—a natural source of nitrate—as a treatment for high blood pressure, and further taught that these compositions include additives like sweeteners.
- Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Brunton's therapeutic method with Shevach's formulation to improve the palatability of the treatment, a common and predictable modification. Shevach provided a clear motivation by teaching that its nitrate-and-additive compositions were specifically for treating high blood pressure.
- Expectation of Success: A POSITA would have a reasonable expectation of success, as adding a common excipient like a sweetener to an oral therapeutic was a simple, routine formulation step known not to interfere with the active ingredient's efficacy.

Prior Art Relied Upon: Not applicable (this ground is based on the patent's specification).
Core Argument for this Ground:
- Written Description & Enablement: Petitioner argued the challenged claims lacked adequate written description and were not enabled across their full scope. The specification taught administering inorganic nitrate in a dose range of 0.01 to 100 mmol/kg body weight. Petitioner asserted this range is unsupported, as the high end (100 mmol/kg) would be lethal, and the low end (0.01 mmol/kg) would be therapeutically ineffective based on the available science. The patent's own working examples only disclosed a 0.10 mmol/kg dose. Petitioner argued this failure to describe or enable the full claimed range—from ineffective to lethal doses—meant the patentee did not possess the full scope of the invention, rendering the claims invalid under 35 U.S.C. §112.
Additional Grounds: Petitioner asserted additional obviousness challenges, including that claims 1-4 were obvious over Brunton alone and that claim 4 was obvious over the combination of Brunton and a second reference, Brunton2 (a 1906 article in The Lancet), which taught higher doses of potassium nitrate for blood pressure reduction.

"inorganic nitrate": Petitioner argued this term should be construed as a salt containing a nitrate moiety as a negatively charged ion (NO3-). This construction distinguishes it from "organic nitrates" (esters with covalent bonds) and was used to map prior art disclosing potassium nitrate (a salt) to the claims.
"nutritional supplement": Petitioner proposed this term be construed to include products intended for ingestion to supplement the diet by providing a dietary substance (e.g., a mineral like nitrate). This construction was asserted to be consistent with the patent's disclosure and its use in the art, allowing Brunton's administration of potassium nitrate to be viewed as a nutritional supplement.

Petitioner requests institution of a post grant review and cancellation of claims 1-7 of Patent 11,083,747 as unpatentable under 35 U.S.C. §§ 102, 103, and 112.