September 6, 2023
The Court of Appeals for the Federal Circuit (CAFC), on August 16, 2023, affirmed the U.S. Patent and Trademark Office Patent Trial and Appeal Board’s (PTAB) decision, that the claims of Incept LLC’s U.S. Patent No. 8,257,723 (‘723) and U.S. Patent No. 7,744,913 (‘913) are unpatentable as being anticipated by, or obvious over asserted prior art. The decision on appeal considered whether the PTAB erred in its final decision that Palette Life Sciences, Inc. (Palette) had established the challenged claims to be unpatentable over prior art for the inter partes reviews of the ‘723 and ‘913 patents.
The ‘723 and ‘913 patents related to improved methods for treating cancer, particularly prostate cancer, by using radiation. The methods described in the patents identified introducing a filler between a target tissue and other tissue to increase the distance between the two, which decreased the amount of radiation received by the non-targeted tissue. Independent Claim 1 for the ‘723 patent is shown below:
Claim 1 (‘723): 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 was similar to independent Claim 1 of the ‘723 patent. Claim 1 of the ‘913 patent contained the additional limitation that the filler was introduced specifically between a patient’s prostate gland and rectum. The ‘723 patent was a continuation of the ‘913 patent and both patents’ specifications were identical.
Palette Life Sciences, Inc. filed petitions for inter partes review challenging the claims of the ‘723 and ‘913 patents as unpatentable over prior art, including U.S. Patent No. 6,624,245 to Wallace et al. (Wallace). Wallace described a method for the “rapid formation of a biocompatible gel . . . at a selected site within a patient’s body.” In Wallace, the biocompatible gels could be formed from reaction mixtures that were injected at a specific site of a patient’s body. Further in Wallace, the gels could be formed from polymers including biodegradable segments or blocks that were hydrolyzed in the presence of water or enzymatically cleaved in situ. Wallace’s preferred application of its compositions was for use as a “tissue sealant and adhesive.” Wallace further explained that the compositions could be used as a large space-filling device for organ displacement in a body cavity during surgical or radiation procedures.
Palette’s petition at the PTAB challenged the ‘723 patent by asserting claims 1, 6, 8-12, 15, and 17-22 would have been anticipated by Wallace, claims 1-6, 8-12, and 14-24 would have been obvious over Wallace, and that claims 7 and 13 would have been obvious over Wallace in combination with Griffith-Cima et al. (Griffith-Cima). Additionally, Palette’s petition challenging the ‘913 patent asserted that claims 1-18 and 20-24 would have been obvious over Wallace in combination with Ein-Gal (Ein-Gal), and that claims 19 and 25 would have been obvious over the combination of Wallace, Ein-Gal, and Griffith-Cima. The PTAB ultimately held for Palette, finding that the challenged claims were unpatentable.
In first determining anticipation, Incept argued on appeal that the PTAB engaged in a “patchwork approach,” by picking and choosing from Wallace’s different teachings to piece together the elements of the ‘723 claims. Incept argued that Wallace taught a more complex, multi-step process for its gels, which could ultimately describe numerous possible combinations and relevant properties for the gels. However, the CAFC determined that although Wallace disclosed options for its compositions, the PTAB was correct in its finding that Wallace expressly described compositions having the same characteristics, used for a similar displacement purpose, as the compositions claimed in ’723. The CAFC determined that the method for the ‘723 patent introduced fillers possessing certain general qualities that were described in Wallace.
Incept further argued at the PTAB and on appeal that none of Wallace’s compositions were “entirely removable by biodegradation,” stating that Wallace at most suggested that only a portion of the polymer may be biodegradable. Further, Incept identified a statement that stated the compositions were “not readily biodegradable.” However, the Court agreed with the PTAB’s finding that Wallace’s filler composition was biodegradable to an extent. Further, the Court found that “removable by biodegradation” was sufficient to anticipate the claims of the ‘723 patent. The CAFC held this to be true regardless of the amount of biodegradation or whether biodegradation even occurs.
Incept’s final anticipation argument on appeal highlighted the PTAB’s failure to identify a teaching in Wallace that any of its compositions were placed “between an organ and a nearby tissue.” This was required by the claims of ‘723. The PTAB stated that the compositions of Wallace could be used as a large space-filling device for organ displacement in a body cavity. Further, the PTAB found that Wallace’s teachings support the notion that the compositions could be used in a variety of different applications. As a result, the CAFC found no legal error in the PTAB’s anticipation analysis for the ‘723 patent.
In turning to obviousness, Incept argued on appeal that the PTAB’s analysis was in error for four reasons: (1) the PTAB reiterated its anticipation analysis; (2) the PTAB disregarded statements in Wallace that taught away from the claimed biodegradable compositions; (3) the PTAB did not separately analyze the obviousness of the dependent claims; and (4) the PTAB improperly disregarded Incept’s evidence of commercial success. The CAFC affirmed the PTAB’s findings for all reasons.
In (1), Incept contended that there was a “conclusory” finding of motivation to combine, particularly with respect to the combination of Wallace with Ein-Gal for the ‘913 patent. The CAFC found that Wallace disclosed the use of a gel that was both biodegradable and biocompatible. Further, the CAFC disagreed that the PTAB’s obviousness analysis for the ‘913 was based entirely on its anticipation analysis for the ‘723 patent. The PTAB had found that both Wallace and Ein-Gal recognized and appreciated the benefit of displacing tissue away from a site intended to be irradiated. As a result, the PTAB found that in combination, Wallace and Ein-Gal taught or suggested Claim 1’s limitations for the ‘913 patent. The CAFC agreed with the PTAB and rejected Incept’s arguments of conclusory findings and that the obviousness analysis was based entirely on the anticipation analysis.
In (2), the CAFC noted the PTAB’s argument that Wallace taught that all the suitable polymers disclosed could become biodegradable over a period of several months. Although the teaching in Wallace identified that the polymers were not biodegradable for several months, the Court took the position that disclosure meant that eventually, these polymers would become biodegradable. The Court therefore agreed with the PTAB’s analysis and found that Wallace does teach or suggest biodegradability. The Court highlighted that a preference for an alternate invention does not substantially change the obviousness analysis.
In (3), Palette identified disclosures in the prior art that taught each element of dependent claim 16 for the ‘723 patent and dependent claim 6 for the ‘913 patent, both of which provide biodegradability time limits. The CAFC found that Incept did not separately argue the patentability of dependent claims 6 and 16 before the PTAB. Rather, the Court indicated that Incept merely included claim 16 of the ‘723 patent within its arguments relating to the independent claim. For claim 6 of the ‘913 patent, the Court found that the PTAB had reached an obviousness conclusion when applying Wallace. Thus, the CAFC found that the patentability of these dependent claims also failed with the independent claim.
In (4), Incept argued that clear evidence of commercial success was presented and erroneously ignored by the PTAB. The CAFC noted that commercial success was “usually shown by significant sales in a relevant market.” The Court found that Incept’s evidence including a table of “annual unit shipments” was inadequate. By agreeing with the PTAB, the Court determined that sales numbers were not limited to just sales, but rather included both replacement and free sample units. Incept’s expert witness had testified that the number of replacements and samples was “small.” However, the PTAB found the record did not demonstrate whether the year-over-year increase in units shipped was attributable to increased sales, as opposed to an increase in samples and replacements that were shipped. The CAFC agreed that the evidence Incept provided was insufficient to demonstrate commercial success.
Circuit Judge Newman issued a concurring-in-part and dissenting-in-part opinion. Judge Newman concurred that Claim 1 of both the ‘723 and ‘913 patents were invalid over the prior art under either §102 or §103. However, Judge Newman disagreed with the majority’s finding that the dependent claims of the ‘723 patent were invalid. Judge Newman emphasized that each claim must be considered as a whole, including all its limitations. Judge Newman indicated that the majority expanded the law of anticipation in its holding. Judge Newman stated the appears to hold, “when the broader claim is anticipated, the dependent claims are automatically anticipated.” Judge Newman found that Wallace could not support anticipation of claim limitations that were not explicitly described in the reference, particularly, noting this expansion for the limitation concerning “biodegradation.” Contrary to the majority, Judge Newman gave substantive weight to the disclosure where Wallace highlighted the difficulties and further uncertainties of biodegradation. As a result, Judge Newman viewed the majority’s conclusion of the narrower claims being anticipated to disregard the teachings of Wallace. Finally, Judge Newman additionally dissented on the Court’s holding for commercial success. Judge Newman stated that the provision of free samples does not render the commercial sales and market share data irrelevant in measuring commercial success.
The decision in Incept LLC v. Palette Life Sciences, Inc., took a broader view of what is required for determining anticipation. The CAFC determined that Wallace anticipated the ‘723 patent’s claims, including the dependent claims, by describing the general qualities of the compositions. Further, the CAFC found the claims to be anticipated because Wallace’s compositions could become biodegradable and additionally be used as a space-filling device. Part of the reason why the court took this broader approach as to what constitutes anticipation may be because the claims themselves were broad, or not sufficiently specific, in the recitation of these features.
Judge Newman disagreed with the majority’s view that the dependent claims were anticipated, indicating that the dependent claims recited specific features, e.g., of “biodegradation”, that were not explicitly described in the reference. In fact, the reference disclosed that biodegradation was uncertain. However, although Incept mentioned their dependent claims in their appellate brief, the majority determined that these claims failed along with the independent claim because the dependent claims were not separately argued. Care should be taken to provide separate arguments for the dependent claims, and to expand on these arguments so that they are not lost during the appeal process. Simply mentioning the dependent claims within arguments for the independent claim may not be sufficient for separate consideration of the dependent claims by the courts on appeal.
Finally, evidence of commercial success should clearly provide the facts or commercial sales and market share data. This decision highlights that accounting information must be properly presented. The court determined that Incept needed to provide a breakdown of the number of units sold, as compared to those given away for free or provided as a replacement. Further, actual evidence will likely be given more weight than one’s expert testimony. Incept’s expert estimated that 55% of all prostate cancer radiation therapy treatments in the United States in 2019 included SpaceOar® placement. However, the court found this to be insufficient and required stronger evidence. Any other data, such as free samples and replacements, should be accurately identified. This decision provides a clear lesson that accounting information must be properly presented.