January 23, 2023Update by Kasumi Kanetaka & Grace Kim
Last month, the Federal Circuit issued a non-precedential decision affirming the PTAB’s holdings in two final written decisions. P Tech, LLC (herein “P Tech”) appealed the PTAB decisions holding that claims 1 and 4 of U.S. Patent 9,192,395 (herein “’395 patent”) and claims 1-20 of U.S. Patent 9,149,281 (herein “’281 patent”) are unpatentable because they would have been obvious over the cited prior art, U.S. Patent 6,331,181 (herein “Tierney”) in view of U.S. Patent 5,518,163 (herein “Hooven”).P Tech, LLC, v. Intuitive Surgical, Inc., No. 22-1102, No. 22-1115 (December 15, 2022)
In the IPR petitions, Intuitive Surgical, Inc. (herein “Intuitive”) had challenged claims in the ’395 patent and ’281 patent directed to “robotic surgical systems for fastening body tissue.”
Claim 1 of the ’395 patent recites
1. A robotic fastening system comprising:
a robotic mechanism including an adaptive arm configured to position a staple relative to a body portion of a patient;
a robotic arm interface configured to operate the adaptive arm of the robotic mechanism;
a staple having first and second legs;
a fastening member coupled to the adaptive arm, the fastening member having fist and second force transmitting portions and configured to secure the body portion with the staple by applying a force from the first and second force transmitting portions to move the first and second legs of the staple toward each other;
at least one of a position sensor configured to indicate a distance moved by the staple and a force measurement device configured to indicate a resistance required to move the staple relative to the body portion; and
a tissue retractor assembly coupled to the robotic mechanism, the tissue retractor assembly including a cannula configured to facilitate insertion of the fastening member through the cannula into a working space inside the patient.
Claim 1 of the ’281 patent recites
1. A robotic system for engaging a fastener with a body tissue; the system comprising:
a robotic mechanism including an adaptive arm, the robotic mechanism configured to position a fastener relative to the body tissue, the robotic mechanism having first and second force transmitting portions configured to apply at least one of an axial force and a transverse force relative to the fastener;
a computer configured to control the robotic mechanism; and
an adaptive arm interface coupled to the adaptive arm and the computer, the adaptive arm interface configured to operate the computer,
wherein a magnitude of the at least one axial force and transverse force applied to the fastener is limited by the computer.
Tierney teaches robotic surgical systems comprising robotic arms to which surgical tools, including staplers, may be attached. Hooven teaches a handheld endoscopic stapling and cutting instrument.
The parties agreed that the claims of the ’395 patent and ’281 patent do not require an articulating joint near the head of the claimed robotic surgical stapler. Both parties also agreed that Intuitive’s petitions did not prove that such an articulating joint would have been obvious.
Lack of motivation to combine
P Tech focused its arguments in both proceedings on an asserted lack of motivation to combine Tierney with Hooven. In particular, P Tech asserted that although the challenged claims did not require an articulable joint near the head of the stapling device, the cited art described benefits of such articulation. However, as the proposed combination of Tierney with Hooven would lack the articulable joint in order to satisfy the claims of the ’395 and ’281 patents, a skilled artisan would have lacked motivation to combine the references, because the proposed combination would result in some loss of desired advantages described in Tierney. P Tech similarly asserted that the combined device would lack other beneficial features, including providing force-feed-back to the surgeon operating the device.
The PTAB found that “even if Petitioner’s proposed combination did result in some loss of a desired ‘dexterity and other advantages built into’” Tierney, “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate a motivation to combine.” In other words, the PTAB found that even if the combination of prior art references does not provide a desired benefit, such a result does not necessarily negate a motivation to combine.
The PTAB also found that Intuitive had sufficiently proven a motivation to combine by “adequately establish[ing] that incorporating Hooven’s handheld tool into Tierney’s robotic system would have resulted in benefits including increased accuracy compared to manually operated instruments, and would have allowed the surgeon to use Tierney’s robotic system throughout surgery, rather than having to switch to Hooven’s handheld tool.”
P Tech contended that the asserted prior art highlighted the need for, or at least the benefit of, such a joint, but Intuitive’s proposed combination lacked such a joint, and thus, a skilled artisan would not have been motivated to combine the references as Intuitive asserted. P Tech’s arguments emphasized that, by improperly ignoring or excluding the prior arts’ disclosures describing the benefit of the articulating joint, the PTAB erred in conducting its motivation to combine analyses.
The CAFC decision acknowledged that P Tech is correct that “a motivation to combine analysis must account for ‘reasons not to combine,’ which are facts relevant to the overall consideration of obviousness.” Thus, “there may not be a motivation to combine where the combination would be inoperable, present undesirable qualities.”
However, the panel clarified that “the relevance of foregone, unclaimed benefits to the motivation-to-combine analysis is, however, uncertain.” The panel concluded that the PTAB expressly considered all the evidence, and found it insufficient to rebut Intuitive’s showing of a motivation to combine based on other advantages resulting from the combination.
Here, the issue was whether the alleged motivation to combine references can be rebutted by a showing of a lack of unclaimed benefits, where the references disclose such benefits. The PTAB had concluded that the showing of the lack of unclaimed benefits cannot rebut the motivation to combine analysis, and the CAFC affirmed the decision. However, as the CAFC decision discusses, the PTAB also found some other benefits were achieved by combining the references to support its conclusion that there is still a motivation to combine the references. The takeaway here is the emphasis that an evaluation of whether there is a proper motivation to combine is dependent on what the factual evidence suggests, and if arguing that there is no motivation to combine by showing a lack of benefits that are not instantly claimed, one should also consider whether other benefits are still achieved by combining the references.