Ex parte Batteux
Board of Patent Appeals and Interferences
Holding
Informative decision only: persuasive authority, not binding precedent. When a prior art reference discloses administering the claimed compound to a patient within a broadly construed method claim, the Board may find inherent anticipation under § 102(b) even though the reference discloses no intent to treat the claimed condition and no one in the art recognized the result, so long as treating the condition is the "natural result flowing from" the disclosed administration and would "necessarily result." Where Jansen and Rapoport cannot be distinguished, the Board follows the line of cases culminating in Perricone, because unless the claim language distinguishes the claimed method, the subject matter is already in the public domain.
Why It Matters
No prior Board precedential or informative decision is named as being overruled or modified. The decision does note that two earlier Board panels, in Ex parte Hempstead and Ex parte Renshaw, had distinguished Jansen and/or Rapoport in similar circumstances, and it treats Jansen v. Rexall Sundown and Rapoport v. Dement as distinguishable or as less persuasive than Perricone. For an examiner, the decision supports an inherent anticipation rejection of a new-use method claim without any showing that the reference recognized the use or intended the treatment. For an applicant, a claim to a new use of a known compound is not patentable when the claim is broad (no dosage, no effective amount, no duration) and the prior art administration necessarily yields the claimed result. The Board relied on Federal Circuit authority, namely Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, Schering Corp. v. Geneva Pharms., 339 F.3d 1373, and MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, together with In re American Academy of Science Tech Center, 367 F.3d 1359, on broadest reasonable interpretation.
Full Summary
Key Points
- LEGAL TEST OR STANDARD: Claims receive their broadest reasonable interpretation during prosecution. Anticipation may be express or inherent. Inherency requires that the prior art necessarily functions in accordance with, or includes, the claim's limitations; it may not be established by probabilities or possibilities. It is enough if the "natural result flowing from" the explicit disclosure is performance of the claimed method, regardless of whether the art recognized it. The Board framed two questions: do the references inherently anticipate even though neither discloses intent to treat hepatocellular deficiency, and would the disclosed methods necessarily result in "treating hepatocellular deficiency"?
- TRIGGERING FACTS: Claim 1 recited treating hepatocellular deficiency by administering mangafodipir to a patient in need, with no dosage, no effective amount and no duration. The term was read broadly to include hepatocellular carcinoma and total absence of the liver, and patients to include mice and rabbits. Yicheng administered MnDPDP to mice and rabbits with chemically induced liver tumors. Karlsson taught administering MnDPDP to a liver transplant donor or recipient before, during or after surgery. Substantially all liver transplants are due at least in part to hepatocellular deficiency. Neither reference intended to treat that condition.
- KEY QUOTE: "Unless the claim language distinguishes the claimed method, the subject matter cannot be patented, as it is already in the public domain." (p. 10)
- PRIOR PRECEDENT AFFECTED: No prior precedential or informative decision is directly affected. The Board noted that Ex parte Hempstead, App. No. 2006-0611 (decided April 5, 2006), and Ex Parte Renshaw, App. No. 2006-1066 (2006 WL 2558174), previously distinguished Jansen and/or Rapoport in similar circumstances. It distinguished Jansen v. Rexall Sundown Inc., 342 F.3d 1329, and Rapoport v. Dement, 254 F.3d 1053, and, to the extent they could not be distinguished, preferred the line culminating in Perricone.
- PRACTICE TIP: When claiming a new use of a known compound, do not rely on the prior art's lack of intent or recognition of the use; recite limitations such as a specific patient population, dose, regimen or effective amount that distinguish the claimed method from the prior art. Do not rely on Jansen or Rapoport for a broad claim in prosecution, since the Board distinguished them as infringement and substantial-evidence review cases.
- Anticipation and prior art (§ 102) →
- Claim construction →
- PTAB precedential and informative decisions →
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