Opinion ID: 4471484
Heading Depth: 2
Heading Rank: 2

Heading: obviousness grounds based on wo ’389

Text: The Board determined that claims 1 and 5 would have been obvious over WO ’389; claims 1–3 and 5 would have been obvious in view of WO ’389, Balint, 4 and Potier 5; and claims 2–3 and 6–11 would have been obvious in view of WO ’389, Balint, Potier and/or U.S. Patent 6,127,526. As with anticipation, Genentech challenges the Board’s determination that WO ’389’s disclosed temperature range renders the claimed temperature range obvious. If the relevant comparison between a disputed claim limitation and the prior art pertains to a range of overlapping values, “we and our predecessor court have consistently held that even a slight overlap in range establishes a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). We have said such an overlap creates a presumption of obviousness, and that the burden 4 Joseph P. Balint, Jr. and Frank R. Jones, Evidence for Proteolytic Cleavage of Covalently Bound Protein A from a Silica Based Extracorporeal Immunoadsorbent and Lack of Relationship to Treatment Effects, 16 TRANSFUS. SCI. 85 (1995), J.A. 578–87 (Balint). 5 P. Potier et al., Temperature-Dependent Changes in Proteolytic Activities and Protein Composition in the Psychrotrophic Bacterium Arthrobacter Globiformis S155, 136 J. GEN. MICROBIOL. 283 (1990), J.A. 592–600 (Potier). 12 GENENTECH, INC. v. HOSPIRA, INC. of production falls upon the patentee to come forward with pertinent evidence that the overlapping range would not have been obvious in light of the prior art. E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006, 1008 (Fed. Cir. 2018) (collecting cases). One way in which the patentee may rebut the pre- sumption of obviousness is by showing “that there is something special or critical about the claimed range.” Id. The presumption of obviousness applies here, and the Board found that Genentech failed to establish criticality for the claimed temperature range. ’837 Decision, 2018 WL 1187484, at . On appeal, Genentech does not argue that this Board finding lacks substantial evidence. Appellee’s Br. at 15. Another way in which the presumption can be rebutted is by showing that a process parameter, such as temperature, was not recognized as “result-effective.” DuPont, 904 F.3d at 1006 (citing Applied Materials, 692 F.3d at 1295). “The idea behind the ‘result-effective variable’ analysis is . . . that a person of ordinary skill would not always be motivated to optimize a parameter ‘if there is no evidence in the record that the prior art recognized that [that] particular parameter affected the result.’” Id. at 1008 (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). But where the prior art recognizes that the process parameter affects the relevant property or result, then the process parameter is “result-effective.” Id. at 1009. The Board found that a skilled artisan would have recognized that the temperature for conducting protein A affinity chromatography was a result-effective variable. ’837 Decision, 2018 WL 1187484, at . The Board found that it was recognized in the prior art at the time of the invention that leaching was caused by proteolysis of matrixbound protein A (as illustrated in Balint and other prior art references), and that proteolysis was affected by temperature (as illustrated in Potier). Id.; see id. at ; J.A. 594, GENENTECH, INC. v. HOSPIRA, INC. 13 596 (Potier demonstrating that the extent of protein degradation caused by proteolysis increased with temperature). Moreover, the Board found that a skilled artisan would have expected that lowering temperature would reduce proteolysis of matrix-bound protein A, and consequently, would reduce protein A leaching. Id. at ; see id. at . “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of . . . ranges is the optimum combination.” Peterson, 315 F.3d at 1330. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (citing In re Aller, 220 F.2d 454, 456 (1955)). The Board reasonably found that a skilled artisan would have been motivated to optimize the temperature given the teachings of the prior art, and that given the ease with which temperature can be varied, finding an optimal temperature range would have been nothing more than routine experimentation. ’837 Decision, 2018 WL 1187484, at –19. On appeal, Genentech does not appear to contest that temperature is a result-effective variable in the claimed process. Instead, Genentech argues that the desire to reduce protein A leaching applies only to the large-scale, industrial purification of therapeutic antibodies for clinical applications, because non-clinical applications do not involve concerns about product purity that require the elimination of leached protein A. Appellant’s Br. at 41. Genentech further contends that chilling HCCF for largescale, industrial processes would have been inconvenient, costly, and impractical. Appellant’s Br. at 45. Hospira responds that it would be desirable to reduce protein A leaching for non-clinical applications because protein A leaching degrades chromatography columns, reducing their usable capacity and life span. Appellee Br. at 14 GENENTECH, INC. v. HOSPIRA, INC. 46 (citing J.A. 932). The Board correctly noted that neither the challenged claims nor the disclosure of WO ’389 are limited to large-scale, industrial processes. ’837 Decision, 2018 WL 1187484, at . The evidence in the record supports the Board’s finding that the temperature of the chromatography column could be readily controlled. We hold that substantial evidence supports the Board’s conclusion that it would have been routine experimentation to explore the temperature dependence of protein A leaching. Genentech has not shown that the Board’s factual findings are unsupported by substantial evidence. The Board considered Genentech’s evidence of objective indicia of nonobviousness but found it to be unpersuasive. ’837 Decision, 2018 WL 1187484, at . Genentech alleged industry praise and recognition by others in the field based on the selection of a presentation relating to the claimed method at the American Chemical Society’s National Meeting in 2005. Genentech contends that the fact that its research was selected for presentation undermines the Board’s conclusion that the claimed method would have been the obvious result of “routine optimization.” Appellant’s Br. at 52–53. Hospira responds, and we agree, that Genentech fails to establish a nexus between the objective indicia and the claimed method because there was no evidence that the presentation was selected due to the claimed method. Appellee Br. at 53. Substantial evidence supports the Board’s decision to accord little weight to Genentech’s evidence of objective indicia. The Board next determined that claims 2–3 and 6–11 would have been obvious over WO ’389, Balint, Potier and/or U.S. Patent 6,127,526. Genentech does not separately argue the dependent claims and relies on the arguments it raised for anticipation and obviousness over WO ’389. Thus, the dependent claims stand or fall together with the independent claim 1. See Kaslow, 707 F.2d at 1376. We therefore conclude that the Board did not err in concluding that claims 1–3 and 5–11 of the ’799 patent GENENTECH, INC. v. HOSPIRA, INC. 15 would have been obvious over WO ’389 alone or in combination with other prior art references.