“The court held that, even though a petitioner bears the burden of proof in PTAB proceedings, that does not eliminate the patentee’s burden to offer opposing evidence against the petitioner’s claim.”
On May 23, in a nonprecedential decision, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the Patent Trial and Appeal Board (PTAB) from an inter partes review (IPR) proceeding where the PTAB concluded that the challenged claims of U.S. Patent No. 9,844,379 B2 (the ‘379 patent) were unpatentable as obvious. Ethicon on appeal contended that the PTAB improperly placed the burden of proof on them and that the PTAB’s finding of reasonable expectation of success when the asserted prior art was combined was unsupported by substantial evidence.
Ethicon owns the ‘379 patent, which relates to an endoscopic surgical stapling tool. The supposed novelty of the ‘379 patent is “the use of both an I-beam firing member and a no-cartridge safety lockout, such that the lockout blocks the advancement of an I-beam firing member when there is no staple cartridge loaded in the stapling assembly.” The safety mechanism is particularly helpful for endoscopic procedures that require a surgeon to work with reduced visual and tactile feedback when compared to open surgery.
In October of 2019, Intuitive Surgical filed two petitions for IPR of the ‘379 patent for claims 1-3. The PTAB instituted the IPRs in March of 2020 on the grounds that claims 1-3 of the ‘379 patent were unpatentable as obvious over U.S. Patent No. 4,429,695 (Green) in view of U.S. Patent No. 5,413,267 (Solyntjes). Green describes a surgical stapling instrument having an upper and lower jaw for receiving a staple cartridge and an anvil. Green accounts for most of the claimed features of the ‘379 patent. Solyntjes teaches the benefit of equipping a surgical stapler instrument with a locking pin for safety reasons as a means of preventing the instrument from firing when loaded with an empty stapler cartridge.
PTAB’s Final Written Decision
Ethicon conceded during the IPR that, together, Green and Solyntjes disclose all the claimed elements of claims 1-3 of the ‘379 patent. Ethicon argued that a person of ordinary skill in the art (PHOSITA) would not have a reasonable expectation of success in combining the cited prior art and a PHOSITA would not have been motivated to combine them.
Regarding the motivation to combine, Intuitive relied on the expert testimony of Dr. Knodel to argue that a PHOSITA would have recognized that the locking mechanism of Solyntjes would make the surgical instrument claimed in Green safer and more efficient. Ethicon, in response, relied on their own expert’s testimony, Dr. Fronczak, to argue that there would have been no motivation to combine Green and Solyntjes because Green already provided their users with visual and tactile feedback regarding the presence or absence of a staple cartridge. The Green instrument was for use in open surgery meaning that the instrument was in the Surgeon’s field of vision.
The PTAB determined that Dr. Fronczak’s opinion overly relied on “speculation as to a user’s awareness or cognizance during use of Green’s surgical stapler instrument as to the presence or absence of a stapler cartridge.” The PTAB found that a PHOSITA would have been motivated to combine both Green and Solyntjes because Solyntjes clearly sets forth that a locking mechanism is valuable because the dangers are firing a stapler instrument without a stapler cartridge is significant. The PTAB stated that it defies reason to reach the conclusion that a PHOSITA would not have recognized the benefit of employing a locking mechanism to prevent such dangerous firings. Additionally, Dr. Fronczak admitted that it would be a hazard if a user failed to notice the lack of a stapler cartridge before firing the instrument. The PTAB determined that Intuitive sufficiently established a motivation to combine Green and Solyntjes.
Regarding the reasonable expectation of success, Ethicon offered the testimony of Dr. Fronczak to support their contention that a PHOSITA “would be incapable of implementing a ‘spring-and-pin lockout mechanism,’ such as that disclosed in Solyntjes, into a surgical stapler instrument having the particular structural characteristic of Green’s instrument.” The PTAB did not find this testimony persuasive because it was based on little evidentiary support and was premised on Dr. Fronczak’s speculation that the physical difficulties in modifying Green would have been insurmountable.
The PTAB credited the testimony of Dr. Knodel that a PHOSITA would have known how to modify Green to include the safety mechanism taught in Solyntjes. Dr. Knodel’s testimony was credible and logical, according to the PTAB. The PTAB thus concluded that a motivated PHOSITA would have been able to combine the locking mechanism of Solyntjes with the surgical instrument of Green, ultimately finding that Intuitive established by a preponderance of the evidence that claims 1-3 of the ‘379 patent were unpatentable as obvious.
On appeal, Ethicon argued the PTAB improperly placed the burden on them as the patentee to disprove that a PHOSITA would have a reasonable expectation of success in combining Green and Solyntjes. Ethicon additionally argued that the finding of a reasonable expectation of success was not supported by substantial evidence.
The CAFC first addressed whether the PTAB incorrectly placed the burden on Ethicon. The court held that, even though a petitioner bears the burden of proof in PTAB proceedings, that does not eliminate the patentee’s burden to offer opposing evidence against the petitioner’s claim. The PTAB must consider the totality of the evidence offered by each party when resolving a claim of obviousness. The CAFC ultimately determined that the PTAB did not improperly shift the burden of proof to Ethicon but, rather, weighed competing evidence when making a determination on the record as a whole.
The court additionally held that substantial evidence supported the PTAB’s finding that a PHOSITA would have had a reasonable expectation of success in combining Green and Solyntjes. The evidence of a reasonable expectation of success can come from prior art references, knowledge of a PHOSITA, or from the nature of the problem to be solved. The PTAB credited the testimony of Dr. Knodel that a PHOSITA would have had a reasonable expectation of success regarding combining Green’s instrument and the locking mechanism of Solyntjes. The PTAB acknowledged Ethicon’s argument modification would be required to fit the pieces of the inventions together, but by relying on the testimony of Dr. Knodel that a PHOSITA would know how to combine the two instruments and discrediting Dr. Fronczak’s conclusions as speculative, the PTAB’s finding was supported by substantial evidence.
The CAFC ultimately concluded that “the Board did not misplace the burden of proof on the patentee and that substantial evidence supports the Board’s finding that a POSITA would have had a reasonable expectation of success in combining the asserted references. Thus, we affirm the Board’s final written decision concluding that claims 1–3 of the ’379 Patent are unpatentable as obvious.”
Judge Newman’s Dissent
In dissent, Judge Pauline Newman noted that the majority rebuilt a novel surgical device from components of known devices, using the ‘379 patent as a template. She explained that the patentability question is whether the prior art teaches the structure as a whole of the ‘379 patent and not whether a PHOSITA would be capable of designing the ‘379 patent. The CAFC found that it would be obvious to combine Green and Solyntjes, but simply combining the two references would not produce the ‘379 instrument, because Solyntjes uses a spring-and-pin mechanism, not a spent-cartridge lockout. She added: “The panel majority finds the elements of the ’379 invention in assorted prior art references, which the majority then plugs into the claims. Such judicial hindsight was negated in KSR International.”
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