BPAI Precedential Opinion: Examiners Must Provide "Reasoned, Fact-Based" Evidence For Prior Art Rejections
Ex Parte Whalen II, Appeal 2007-4423, July 23, 2008
Whalen's application claimed a composition for embolizing an aneurism, which the Examiner rejected for anticipation, and obviousness.
The primary issue in the rejections centered around a claim element reciting embolic compositions having a viscosity of at least 150cSt (centiStokes) at 40 degrees C. While the prior art disclosed embolyc compositions, they did not disclose the exact viscosity specified in the claim.
The examiner's rejection stated that the prior art "inherently" contained the same viscosity because they "comprise similar components used in overlapping ranges of concentrations as those claimed." Alternately, the Examiner concluded that the claimed compositions would have been obvious because "it would have been prima facie obvious to optimize the viscosity range of [the known] compositions by routine experimentation."
The BAPI reversed the examiner on both inherency and obviousness.
The Examiner has not provided an adequate basis – based on evidence or scientific reasoning – to support the finding that the “compositions disclosed by Evans inherently possess the same viscosity . . . as the instantly claimed invention” . . . The Examiner reasons that “Evans’ compositions comprise similar component[s] used in overlapping ranges of concentrations,” but even if some of the compositions encompassed by Evans’ broad disclosure might have a viscosity of 150 cSt at 40° C, that possibility is not adequate to support a finding of inherent anticipation.
“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.).
On obviousness, the Board stated:
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.
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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.
[W]hen the prior art teaches away from the claimed solution as presented here . . . 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.