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Tawnsaura Group LLC v. Maximum Human Performance LLC

Representative Claim(s)

U.S. Patent No. 6,028,107

  1. A method of improving the health of a subject to increase the plasma concentration of arginine in the subject to a level from a low or normal fasting concentration to a level which is up to three times an average overnight fasting arginine level of about 90 u mole per liter of plasma, comprising orally administering L-citrulline as precursor substance.

U.S. Patent No. 5,874,471

  1. A method of improving the health of a subject to increase the plasma level of arginine in the subject to a level from a low or normal fasting level to a level which is up to three times an average overnight fasting level, comprising orally administering a substance selected from the group consisting of L-citrulline and the calcium salt of L-citrulline.

Posture:

Motion to dismiss

Exception Category: Natural Phenomenon

“There is no question that the claimed methods rely in part on the human body’s natural response to L-citrulline.  The question is whether the challenged claims encompass nothing but a natural phenomena [sic], or one merely coupled with ‘well-understood, routine, conventional activity already engaged in by the scientific community.’ [Citing Mayo v. Prometheus]”

Significantly More: Not Decided

“Defendants argue that ‘[t]o the extent the alleged invention is simply the oral administration of L-Citrulline. . . it is not patentable’ because Mayo invalidated an ‘administering’ claim. But in Mayo, the drug was previously in use for the precise purpose recited in the claim. It is not clear that is the case here.”

“It is also possible that . . . claim construction will be required to resolve the patentable subject matter issue.”

“At this stage, the Court cannot determine whether or not the claims at issue are ‘an application of a law of nature or mathematical formula to a known structure or process,’ ‘which may well be deserving of patent protection.’ [Citing Bilski v. Kappos, emphasis in original]”