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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by Mike Baldwin | Aug 31, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Obviously Prima Facie Case Overcome by Secondary Considerations

by Benjamin Ediger, Ph.D. | Jun 15, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board, holding that the Board did not err in finding certain challenged claims nonobvious and not unpatentable based on a showing of several objective criteria of nonobviousness and a nexus of the evidence to a commercial product embodying the claimed invention. Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2357 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.) and Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2359 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.)

Teleflex developed and patented a novel catheter-based stenosis intervention system that successfully mitigated long-standing risks intrinsic to existing catheter-based intervention systems, in particular damage to the coronary artery from guide catheter dislodgement or a catheter’s distal tip (i.e., the end of the catheter farthest from the insertion site). The preferred embodiments incorporated into Teleflex’s extremely successful GuideLiner products comprised a proximal substantially rigid portion (yellow), a reinforced portion (blue) and a distal flexible tip (pink), as illustrated below.

The catheters were sized so they could be inserted through standard guide catheters and thus were coined guide extension catheters. This innovative nesting feature increased guide catheter backup support while the guide extension catheter’s soft distal end was less likely to cause tissue damage once deeply inserted into patients. Teleflex’s guide extension catheters also were optimized for receiving interventional cardiological devices. This optimized function was a combination of the catheter’s coaxial lumen, that lumen’s diameter being no more than one French (i.e., 1/3 mm) less than the diameter of the guide catheter, and a proximal side opening that featured a double incline design like that illustrated above.

Teleflex’s GuideLiner was introduced in 2009 and enjoyed “undisputed commercial success and industry praise.” In 2019, Medtronic introduced its competing guide extension catheter (Telescope) and filed six inter partes review (IPR) petitions against Teleflex’s extension guide catheter family. Three of Medtronic’s petitions asserted that the challenged claims in three of Teleflex’s patents were obvious over the evacuation sheath assembly with a distal side opening used to aspirate embolic material while occluding blood flow using sealing balloons disclosed in a prior art reference (Ressemann). The other three petitions challenged claims of the other Teleflex patents as being obvious over a support catheter for delivering angioplasty balloons disclosed in a prior art reference (Kontos).

Medtronic specifically asserted that the following three elements of Teleflex’s claimed catheters were obvious:

A proximal side opening. Medtronic argued that it would have been obvious to replace the proximal funnel structure of Kontos’s support catheter with the distal side opening of Ressemann’s evacuation sheath assembly.
A catheter diameter that is no more than one French less than a corresponding guide catheter. Medtronic argued that in view of prior art mother-and-child dual catheter systems in which the child catheter’s diameter is no [...]

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Objective Indicia of Nonobviousness for Design Patents: Same Nexus Requirement as Utility Patents

by Paul Devinsky | Aug 26, 2021 | Patents

The US Court of Appeals for the Federal Circuit reversed two decisions by the Patent Trial & Appeal Board (Board), finding that a soup company and soup dispenser manufacturing company failed to prove the unpatentability of two design patents covering can dispensers. The Court also concluded that the analysis for objective indicia of nonobviousness for utility patents also applies to design patents. Campbell Soup Co. v. Gamon Plus, Inc., Case Nos. 20-2344, 21-1019 (Fed. Cir. Aug. 19, 2021) (Moore, J.)

Gamon Plus owns two design patents directed to “the ornamental design for a gravity feed dispenser display,” or a can dispenser. Gamon’s commercialized embodiment is called the iQ Maximizer gravity feed dispenser. For nearly a decade, Gamon sold tens of millions of dollars’ worth of its iQ Maximizer to Campbell Soup. Campbell attributed increased soup sales in part to the iQ Maximizer in its 10-K Securities and Exchange Commission reports (an industry publication) and in an internal marketing study. Campbell later began purchasing similar gravity feed dispensers from Trinity Manufacturing.

Gamon sued Campbell and Trinity for design patent infringement. Campbell and Trinity then petitioned for inter partes review (IPR) of Gamon’s patents. In its final written decisions, the Board found that Campbell and Trinity failed to prove unpatentability because the prior art was not similar enough to the claimed designs to constitute a proper primary reference. Trinity (Campbell) appealed.

In that appeal, the Federal Circuit disagreed, vacated and remanded. On remand, the Board again held that Campbell and Trinity failed to prove unpatentability, finding that the claimed designs would not have been obvious over the prior art. The Board reasoned that although the prior art alone had the same overall visual appearance as the claimed designs, there existed objective indicia of nonobviousness, including Gamon’s commercial success in selling iQ Maximizers to Campbell, Campbell’s praise of—and commercial success in—using the iQ Maximizer and Trinity’s copying of the iQ Maximizer. The Board presumed a nexus between those objective indicia evidences and the claimed designs because it found the iQ Maximizer to be coextensive with the claims, meaning that the product was essentially the disclosed invention with unclaimed features being insignificant. The Board also found that Gamon established such a nexus regardless of the presumption. Campbell and Trinity again appealed.

Again the Federal Circuit reversed, concluding that the claimed designs would have been obvious over the prior art. In doing so, the Court confirmed the Board’s finding that the prior art and the claimed designs shared the same overall visual appearance (which Gamon did not challenge) but found that the Board’s presumption of nexus and finding of a nexus-in-fact between the claimed designs and the evidence of commercial success and praise were not supported by substantial evidence. As for the presumption, the Court considered whether the iQ Maximizer was coextensive with the claimed invention. Nexus is presumed if the objective indicia evidence is tied to a specific product that is “coextensive” with the claimed invention. The Board recognized that the claimed portions of [...]

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Even Judges Have a Boss: PTAB Must Sufficiently Articulate its Obviousness Reasoning

by Paul Devinsky | Jul 29, 2021 | Patents

Addressing the sufficiency of the Patent Trial & Appeal Board’s (PTAB) justification of its inter partes review (IPR) determination, the US Court of Appeals for the Federal Circuit reversed the PTAB’s obviousness determinations, concluding that the PTAB’s findings regarding motivation to combine were not supported by substantial evidence. Chemours Company FC, LLC v. Daikin Industries, Ltd., Daikin America, Inc., Case No. 20-1289, -1290 (Fed. Cir., July 21, 2021) (Reyna, J.) (Dyk, J., concurring in part and dissenting in part).

Chemours, owner of the challenged patents, appealed the PTAB’s final written decisions in two IPRs initiated by Daikin. The challenged claims relate to a unique polymer for insulating communication cables formed by pulling wires through melted polymer to coat and insulate the wires, a process known as “extrusion.” The challenged claims of the patents recite that the polymer has a specific melt flow range of about 30+/- g/10 mins. The polymer’s melt flow range correlates with how fast the melted polymer can flow under pressure during extrusion. A higher melt flow rate means a faster coating of the polymer onto a wire. During the IPRs, the PTAB found all challenged claims unpatentable as obvious.

The Federal Circuit reviews the PTAB’s legal determinations de novo and its factual findings for substantial evidence, which “requires more than a ‘mere scintilla’ and must be enough such that a reasonable mind could accept the evidence as adequate to support the conclusion.” Obviousness is a question of law necessarily made on underlying findings of fact, and in making factual findings, the PTAB “must have both an adequate evidentiary basis for its findings and articulate a satisfactory explanation for those findings.”

In this instance, the Federal Circuit found that the PTAB’s obviousness findings were not supported by substantial evidence. According to the Court, while the PTAB may rely on prior art other than the references being applied or combined to inform itself of the state of the art at the time of the invention, the scope of the relevant prior art encompasses only that which is “’reasonably pertinent to the particular problem with which the inventor was involved.”’ Here, the Court explained that the only prior art reference relied on was not appropriate because it expressly taught away from the claimed invention and relied on teachings from other references that were not concerned with the particular problems the prior art sought to solve. As the Court noted, the PTAB “did not adequately grapple with why a skilled artisan would find it obvious to increase [the reference’s] melt flow rate to [the] claimed range while retaining its critical ‘very narrow molecular-weight distribution.’” To support its obviousness conclusion, the PTAB needed “competent proof showing a skilled artisan would have been motivated to, and reasonably expected to be able to, increase the melt flow rate of [the reference’s] polymer to the claimed range when all known methods for doing so would go against [the reference’s] invention by broadening molecular weight distribution.” By failing to provide its reasoning, the PTAB relied [...]

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