Opinion ID: 4471484
Heading Depth: 2
Heading Rank: 1

Heading: anticipation by wo ’389

Text: The Board determined that claims 1 and 5 are anticipated by WO ’389. ’837 Decision, 2018 WL 1187484, at . WO ’389 teaches a method for purifying certain antibodies of the IgG class, which are proteins comprising the 6 GENENTECH, INC. v. HOSPIRA, INC. CH2/CH3 region, including a step wherein HCCF is subject to protein A affinity chromatography. J.A. 511 at 2:37, 522 at 13:9–13. WO ’389 Example 1 discloses a washing step after HCCF is applied to the chromatography column, whereupon the HCCF composition is washed with at least three column volumes of buffer before the antibody is eluted. J.A. 523 at 14:20–23. WO ’389 teaches that “[a]ll steps are carried out at room temperature (18–25°C).” J.A. 522 at 13:13. Claim 1, the sole challenged independent claim of the ’799 patent, requires “subjecting a composition . . . to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C.” ’799 patent at claim 1. The temperature range disclosed in WO ’389, “18–25°C,” overlaps with the claimed range of “about 10°C to about 18°C,” regardless of the construction of “about 18°C.” Indeed, Genentech’s own proposed construction for “about 18°C” embraces temperatures up to 19°C, which further reinforces the overlap with WO ’389’s disclosed temperature range. A prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range. See Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 870–71 (Fed. Cir. 2015) (affirming summary judgment of anticipation of patent claims for composition with “0.05 to 0.5% by weight of at least one saturated fatty acid amide” lubricant in view of a prior art reference disclosing the same class of lubricant in an overlapping range of “0.1 to 5 parts by weight,” and the parties agreed that a measurement in “% by weight” was equivalent to one in “parts by weight”). Once the patent challenger has established, through overlapping ranges, its prima facie case of anticipation, “the court must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention.” Id. at 871; see also E.I. DuPont de Nemours & Co. v. GENENTECH, INC. v. HOSPIRA, INC. 7 Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018) (“‘where there is a range disclosed in the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come forward with evidence’ of . . . criticality”) (quoting Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013)). Here, the Board found that Genentech failed to establish that the claimed temperature range of “about 10°C to about 18°C” is critical to performing protein A chromatography. ’837 Decision, 2018 WL 1187484, at –11. Genentech does not challenge the Board’s finding as to criticality, and accordingly, whether or not the claimed temperature range achieves different performance results than WO ’389’s disclosed temperature range is not at issue on appeal. Appellee’s Br. at 15. Aside from the overlapping range issue, the Board construed the limitation “subjecting a composition . . . to protein A affinity chromatography at a temperature in the range from about 10°C to about 18°C” as referring to the temperature of the composition prior to and/or during protein A affinity chromatography. ’837 Decision, 2018 WL 1187484, at  (emphasis added). The Board found that WO ’389’s disclosed temperature range applies to all components used in the purification process, including the HCCF composition being purified. ’837 Decision, 2018 WL 1187484, at . In that way, it found WO ’389 discloses that prior to protein A affinity chromatography, the HCCF composition is at a temperature within the claimed range of “about 10°C to about 18°C.” Additionally, the Board found that WO ’389’s disclosed composition’s temperature reaches the claimed temperature range during protein A affinity chromatography. ’837 Decision, 2018 WL 1187484, at . The Board read WO ’389’s teaching that “[a]ll steps are carried out at room temperature (18–25°C)” to mean that the apparatus of the chromatography column and column buffers are all within that temperature range. Id. Based on WO ’389 Example 1’s disclosure of washing the 8 GENENTECH, INC. v. HOSPIRA, INC. composition with at least three column volumes of buffer, the Board inferred that the composition would reach “18– 25°C” during the washing step, and thus be within the claimed temperature range. Id. On appeal, Genentech argues that WO ’389’s statement that “[a]ll steps are carried out at room temperature (18– 25°C)” refers only to the temperature of the laboratory where each step was performed, and not to the temperature of the HCCF composition applied to the chromatography column. Appellant’s Br. at 33–34. Genentech contends this statement cannot be referring to the temperature of the HCCF composition because WO ’389 discloses some “steps” being carried out where the composition was cold or frozen. J.A. 523–24 (disclosing that after the viral inactivation step “[t]he resulting solution is . . . held in sterile containers at 4°C, or frozen and held at -70°C”). Both parties’ experts testified that HCCF comes from a bioreactor in which cells are typically cultured around 37°C. J.A. 1351–52 ¶ 77 (Dr. Cramer’s testimony); J.A. 1531 (Dr. Przybycien’s testimony). Both parties’ experts also testified that WO ’389 does not specify how long the HCCF was held before being subjected to protein A affinity chromatography. J.A. 1352 ¶ 78 (Dr. Cramer’s testimony); J.A. 1554 (Dr. Przybycien’s testimony). According to Genentech’s expert, Dr. Cramer, efficiency is typically a goal of industrial processes, and absent an instruction to wait to allow the HCCF to cool to room temperature, a skilled artisan would have interpreted WO ’389 as allowing the disclosed process to be performed with HCCF that was potentially warmer than room temperature. J.A. 1352 ¶ 78. Genentech contends that even if the laboratory was at “room temperature (18–25°C),” the HCCF composition need not have been. Appellant’s Br. at 33. 3 3 Although the dissent believes that WO ’389’s “room temperature” would not be understood to encompass GENENTECH, INC. v. HOSPIRA, INC. 9 Hospira responds that WO ’389 uses the term, “room temperature (18–25°C),” to describe the temperature for conducting protein A affinity chromatography, and all the components involved in that process, including the composition to be purified. Appellee’s Br. at 29. According to Hospira’s expert, Dr. Przybycien, in the field of antibody purification, absent contrary language, a skilled artisan would understand that experiments are being conducted at ambient temperature with all materials equilibrated in order to obtain robust scientific data. J.A. 946 ¶ 26. Based on WO ’389’s disclosure that the composition was cold or frozen after the viral inactivation step, Hospira contends that WO ’389 specifically called out the temperature of the composition when requiring it to be at a temperature other than room temperature. Appellee’s Br. at 31–32 (citing J.A. 523–24). Here, substantial evidence supports the Board’s finding that the HCCF subject to protein A affinity chromatography in WO ’389 is within the claimed temperature range of claim 1. ’837 Decision, 2018 WL 1187484, at –10. The Board reasoned that it would have been redundant to specifically call out the temperature of the HCCF during protein A affinity chromatography in light of WO ’389’s blanket statement to carry out all steps at “18–25°C.” Id. at . The Board considered, but disagreed with, Dr. Cramer’s interpretation of WO ’389 as disclosing a process with HCCF that was warmer than “18–25°C” because his opinion was predicated on the view that the ’799 patent is directed to large-scale, industrial processes, which it is not. Id. Further, Dr. Cramer testified that even for large-scale, temperatures as low as 18°C, WO ’389 expressly discloses a temperature range that includes 18°C. Thus, the Board reasonably read the temperature range of WO ’389 to encompass temperatures as low as 18°C. Genentech does not contend otherwise. 10 GENENTECH, INC. v. HOSPIRA, INC. industrial processes, he was not aware of any process where HCCF was applied directly into the chromatography column after being removed from the bioreactor and filtered. Id. at  (citing J.A. 1075 at 85:6–15). The Board instead credited Dr. Przybycien’s testimony that no skilled artisan would contact 37°C HCCF to the chromatography column, and report having performed the step at “room temperature (18–25°C)” because using HCCF that was warmer than the chromatography column would raise the temperature of the entire system, making it impossible to conduct “[a]ll steps . . . at room temperature.” ’837 Decision, 2018 WL 1187484, at  (citing J.A. 947 ¶ 27). To the extent that the experts disagreed with each other, the Board reasonably chose to credit the testimony of Dr. Przybycien over the testimony of Dr. Cramer. Id. at –10. See Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (“[T]he Board was well within its discretion to give more credibility to [one expert’s] testimony over [another’s] unless no reasonable trier of fact could have done so.”). We discern no reversible error in that choice. We are not persuaded by Genentech’s arguments that this result is contrary to the case law. Appellant’s Br. at 36. Nidec Motor Corp. v. Zhongshan Board Ocean Motor Co., cited by Genentech, holds that a reference missing a limitation cannot anticipate even if a skilled artisan would “at once envisage” the missing limitation. 851 F.3d 1270, 1274–75 (Fed. Cir. 2017). We do not agree with Genentech’s argument that there is a “missing limitation.” As discussed above, the Board reasonably found that a skilled artisan would have understood that WO ’389’s disclosed composition is within the claimed temperature range prior to or during protein A affinity chromatography. “Anticipation is established when ‘one skilled in the art would reasonably understand or infer from the prior art reference’s teaching that every claim [limitation] was disclosed in that single reference.’” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1338 (Fed. Cir. 2017) (quoting Akamai Techs., Inc. v. GENENTECH, INC. v. HOSPIRA, INC. 11 Cable & Wireless Internet Servs., Inc., 344 F.3d 1186, 1192– 93 (Fed. Cir. 2003)). That is the case here. Genentech does not raise any arguments with respect to any other claim limitation, nor does it separately argue dependent claim 5. Thus, dependent claim 5 stands or falls together with independent claim 1. See In re Kaslow, 707 F.2d 1366, 1376 (Fed. Cir. 1983). We therefore conclude that substantial evidence supports the Board’s finding that WO ’389 anticipates claims 1 and 5 of the ’799 patent.