In Incept v. Palette Life Sciences 21-2063, 21-2065 (Fed. Cir. Aug. 16, 2023), the case addresses the Board’s anticipation and obviousness determinations in two IPRs (IPR2020-00002 and IPR2020-00004), where the Board held the claims in the challenged patents unpatentable as anticipated by, or obvious in view of, the asserted prior art.

Background

Palette Life Sciences, Inc. (“Palette”) filed petitions for inter partes review challenging the claims of U.S. Patent Nos. 8,257,723 (the ’723 patent) and 7,744,913 (the ’913 patent) as unpatentable over prior art, including U.S. Patent No. 6,624,245 to Wallace et al. (“Wallace”). The challenged patents relate to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation target tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue.

Claim 1 of the ’723 patent is reproduced as below:

A method of delivering a therapeutic dose of radiation to a patient comprising

introducing a biocompatible, biodegradable filler between an organ and a nearby tissue to increase a distance between the organ and the tissue, and

treating the tissue with the therapeutic dose of radiation so that the presence of the filler causes the organ to receive less of the dose of radiation compared to the amount of the dose of radiation the organ would receive in the absence of the filler,

wherein the filler is introduced as an injectable material and is a gel in the patient, and wherein the filler is removable by biodegradation in the patient.

Independent claim 1 of the ’913 patent is similar to claim 1 of the ’723 patent but includes the additional limitation that the filler is introduced specifically between a patient’s prostate gland and rectum.

The Board instituted inter partes review and ultimately issued final written decisions in which it held that Palette had established the challenged claims to be unpatentable on the Wallace-based grounds set forth in the two petitions. Incept appealed.

Issue(s)

Whether the Board’s anticipation and obviousness determinations should be reversed.

Holding

The Federal Circuit affirmed the final written decisions.

Reasoning

Regarding the Board’s anticipation finding,Incept first argued on appeal that the Board committed legal error because it engaged in a “patchwork approach” that involved “picking and choosing” from Wallace’s different teachings to piece together the elements of the ’723 patent claims. Relying on Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006), Incept argued that when a prior art reference describes a genus and the challenged claim recites a species of that genus, anticipation turns on whether the genus was of such a defined and limited class that one of ordinary skill in the art could have “at once envisaged” each member of the genus. The Federal Circuit saw no legal error in the Board’s anticipation analysis, and found that the Board did not engage in “picking and choosing” features from different teachings of Wallace but instead found that Wallace expressly describes compositions that have the claimed characteristics of, and are used for the same displacement purpose as, the compositions referred to in the ’723 patent claims challenged as anticipated. Moreover, the Court noted that the claims of the ’723 patent are not directed to a “species” of fillers that fall within the “genus” of compositions described in Wallace, but rather a method of introducing fillers having certain general qualities, which general qualities Wallace’s compositions are also described as having. As the Court noted, “Incept cannot use the fact that Wallace describes multiple compositions to evade an anticipation finding where Wallace provides ‘as complete detail as is contained in the patent claim,’ such that a skilled artisan would have understood that Wallace’s compositions had the same generic properties as those in the ’723 patent claims.”

Incept next took issue with what it referred to as the Board’s failure to identify a teaching in Wallace that any of its compositions are “entirely removable by biodegradation.” The Federal Circuit was not persuaded that the Board’s finding of biodegradability was insufficient, noting that while an excerpt of Wallace alone constitutes substantial evidence to support the Board’s finding, the finding is also supported by the testimony of Palette’s expert that a skilled artisan would have appreciated that Wallace teaches that the filler is removable by biodegradation.

Incept next contended that the Board failed to identify a teaching in Wallace that any of its compositions are placed “between an organ and a nearby tissue,” as required by the ’723 patent claims. The Federal Circuit found the Board’s related findings were supported by substantial evidence in the form of Wallace’s teachings.

Regarding the Board’s obviousness finding, Incept first argued that the Board’s obviousness analysis for both patents was based entirely on its flawed anticipation analysis for the ’723 patent claims. The Federal Circuit noted that it failed to see how the Board’s reliance upon that analysis was in error as it found no error in the Board’s anticipation analysis. The Federal Circuit also disagreed that the Board’s obviousness analysis for the ’913 patent was based entirely on its anticipation analysis for the ’723 patent claims, and that the Board’s findings of motivation to combine were not merely conclusory.

In an argument parallel to its argument regarding anticipation, Incept contended that the Board ignored that Wallace “taught away” from biodegradable compositions. The Federal Circuit disagreed and noted that in any event, a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed (citing UCB, Inc. v. Actavis Laby’s UT, Inc., 65 F.4th 679, 692 (Fed. Cir. 2023)). The Court found that the portions of Wallace that Incept pointed to clearly lack such a teaching, therefore substantial evidence supports the Board’s finding with respect to the scope of Wallace’s teachings.

Incept next contended that the Board did not separately analyze certain dependent claims of the two patents. The Court rejected Incept’s argument, noting that Palette identified disclosures in the prior art that teach each of the elements of these claims, and that Incept did not separately argue their patentability before the Board. The Court further noted that where a party does not raise any arguments with respect to any other claim limitation, or otherwise separately argue for the dependent claim, the dependent claim stands or falls together with the independent claim (citing Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1340 (Fed. Cir. 2020)).

Incept finally argued that the Board erred in its obviousness analysis because it imposed an overly stringent standard for showing commercial success. The Federal Circuit noted that it saw no reversible error in that determination, whether viewed as a factual one about the level of success or a legal one about the weight of any such success in the overall obviousness analysis, and noted that the Board did not require Incept to provide market share data but instead weighed the evidence provided by Incept and merely found that evidence insufficient, alone, to show commercial success.