Ex parte Whalen

When the prior art teaches away from the claimed solution, as where every reference favors low viscosity and the claims require a much higher viscosity, an examiner cannot establish obviousness merely by asserting that a known composition could be modified by routine experimentation to optimize a variable or by an expectation of success. The examiner must show some apparent reason for those of ordinary skill to modify the known composition so that it results in the claimed composition. Inherency also cannot rest on probabilities or possibilities: the examiner must provide evidence or scientific reasoning that the claimed characteristic is inherent in the prior art before the burden shifts to the applicant. No prior Board precedent is named as overruled. The decision applies In re Antonie's optimum-value rule and its exception, Ex parte Skinner on inherency, and KSR's requirement of an explicit apparent reason, and extends KSR's reasoning from combining known elements to modifying a known composition to change its properties. For examiners, a rejection that calls a parameter obvious to optimize by routine experimentation fails without a cited teaching or scientific reasoning supporting the change, particularly when the references favor the opposite direction. Inherency rejections based on similar components in overlapping concentration ranges also fail without evidence that the claimed property is necessarily present. For applicants, showing that the references teach away or never treated the variable as one to be raised is enough to defeat a prima facie case, and here it led to reversal of every rejection. The Board relied on In re Antonie (CCPA 1977), In re Oelrich (CCPA 1981), Verdegaal Bros. v. Union Oil (Fed. Cir. 1987), and KSR v. Teleflex (2007). LEGAL TEST OR STANDARD: Inherency: a claim is anticipated only if each element is found, expressly or inherently, in a single reference, and inherency may not be established by probabilities or possibilities. The examiner must provide some evidence or scientific reasoning to establish the reasonableness of the belief that the limitation is inherent before the burden shifts. Obviousness: discovery of an optimum value of a variable in a known process is normally obvious, but not where the parameter was not recognized in the prior art as affecting the results. When the prior art teaches away, obviousness cannot be proven merely by routine experimentation or an expectation of success. It must be shown that those of ordinary skill would have had some apparent reason to modify the known composition so as to result in the claimed composition. TRIGGERING FACTS: Claims to an embolizing composition required a viscosity of at least about 150 cSt at 40 degrees C, while the components were known. The Examiner relied on similar components in overlapping concentration ranges to find inherent viscosity, and on a general motivation to optimize viscosity for safe clinical outcome. The references (Evans, Greff '767, Taki) indicated that low viscosity was desirable. Evans preferred 60 centipoise or less at 20 degrees C, which was less than 75 cSt at 40 degrees C, and Greff '767 said a 145 cSt composition made injection significantly more difficult. The Examiner pointed to no specific prior art composition meeting the limitation and gave no scientific reasoning. KEY QUOTE: "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." (p. 16) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The decision follows Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986), on the examiner's burden to supply evidence or scientific reasoning for inherency. It applies In re Antonie, 559 F.2d 618, 620 (CCPA 1977), In re Oelrich, 666 F.2d 578, 581 (CCPA 1981), and KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727 (2007). PRACTICE TIP: In an appeal brief, answer an optimization or inherency rejection by pointing to what the references say about the variable. Show that they treat the claimed direction as undesirable or never recognize the parameter, and that the examiner offered no evidence or scientific reasoning that the claimed property is necessarily present or that anyone had reason to move toward the claimed range.