Patent Law

Obzilla Refined

By Gary Odom and Jordan Kuhn

Whalen et al faced PTO patent board appeal on a chemical composition for embolizing an aneurysm. In a precedential opinion, the BPAI clarified the boundaries of inherency, and reinvigorated the seemingly orphaned stepchild of Queen KSR, grande dame TSM.

In re Thomas J. Whalen II, Chinh N. Tran, Noah M. Roth and Rich, and Richard J. Greff (BPAI 2007-4423)

Inherency must have a scintilla of evidence.

"Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). See also Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986) ("[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner's belief that the functional limitation is an inherent characteristic of the prior art" before the burden is shifted to the applicant to disprove the inherency.).

The Examiner has not provided evidence or scientific reasoning to show that any specific composition disclosed by Evans is within the scope of the instant claims, and therefore has not made out a case of inherent anticipation by Evans.

While "the discovery of an optimum value of a variable in a known process is normally obvious," In re Antonie, 559 F.2d 618, 620 (CCPA 1977), this is not always the case. One exception to the rule is where the parameter optimized was not recognized in the prior art as one that would affect the results. Id.

Here, the Examiner has not pointed to any teaching in the cited references, or provided any explanation based on scientific reasoning, that would support the conclusion that those skilled in the art would have considered it obvious to "optimize" the prior art compositions by increasing their viscosity to the level recited in the claims. No reason to have done so is apparent to us based on the record. On the contrary, the references all suggest that low viscosity was a desired property in embolic compositions.

TSM still stalks the halls of the patent office.

The U.S. Supreme Court recently held that rigid and mandatory application of the "teaching-suggestion-motivation," or TSM, test is incompatible with its precedents. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1741 (2007). The Court did not, however, discard the TSM test completely; it noted that its precedents show that an invention "composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." Id.

The Court held that the TSM test must be applied flexibly, and take into account a number of factors "in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed." Id. at 1740-41. Despite this flexibility, however, the Court stated that "it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the [prior art] elements in the way the claimed new invention does." Id. "To facilitate review, this analysis should be made explicit." Id.

The obviousness rationale addressed in KSR was premised on combining elements known in the prior art. Id. at 1738-39. A parallel analysis applies, however, to a rejection premised on the obviousness of modifying a known composition to change its properties.

The KSR Court noted that obviousness cannot be proven merely by showing that the elements of a claimed device were known in the prior art; it must be shown that those of ordinary skill in the art would have had some "apparent reason to combine the known elements in the fashion claimed." Id. at 1741.

In the same way, when the prior art teaches away from the claimed solution as presented here (FF12, FF20, FF22 and FF 24), obviousness cannot be proven merely by showing that a known composition could have been modified by routine experimentation or solely on the expectation of success; it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition.

The Examiner has not persuasively explained why a person of ordinary skill in the art would have had a reason to modify the compositions taught by Evans, Greff '767, or Taki in a way that would result in the compositions defined by the claims on appeal. Therefore, the Examiner has not made out a prima facie case of obviousness under 35 U.S.C. § 103.

Reversed.

Full post as published by The Patent Prospector on August 14, 2008 (boomark / email).