Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc. v. Teleflex Life Sciences Ltd.

The case arose in two IPR proceedings involving U.S. Patent No. 8,142,413, owned by Teleflex and related to methods for using a coaxial guide catheter in interventional cardiology procedures. Claims 1, 2, 4, 5, and 7-14 were challenged by Medtronic for being unpatentable for anticipation* or obviousness; claim 1 was considered to be representative by the Court in this appeal:

A method of providing backup support for an interventional cardiology device [ICD]
     for use in the coronary vasculature, the [ICD] being adapted to be passed through a standard guide catheter, the standard guide catheter having continuous lumen extending for a predefined length from a proximal end at a hemostatic valve
    to a distal end adapted to be placed in a branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that [ICDs] are insertable into and through the lumen, the method comprising:
     [1.a] inserting the standard guide catheter into a first artery over a guidewire, the standard guide catheter having a distal end;
     [1.b] positioning the distal end of the standard guide catheter in a branch artery that branches off from the first artery;
     [1.c] inserting a flexible tip portion of a coaxial guide catheter defining a tubular structure having a circular cross-section and a length that is shorter than the predefined length of the continuous lumen of the standard guide catheter, into the continuous lumen of the standard guide catheter, and,
     [1.d] further inserting a substantially rigid portion that is proximal of, operably connected to, and more rigid along a longitudinal axis than the flexible tip portion, into the continuous lumen of the standard guide catheter, the substantially rigid portion defining a rail structure without a lumen and having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the flexible tip portion and having a length that, when combined with the length of the flexible distal tip portion, defines a total length of the device along the longitudinal axis that is longer than the length of the continuous lumen of the guide catheter;
     [1.e] advancing a distal portion of the flexible tip portion distally beyond the distal end of the standard guide catheter and into the second artery such that the distal portion extends into the second artery and such that at least a portion of the proximal portion of the substantially rigid portion extends proximally through the hemostatic valve;
and
     [1.f] inserting the [ICD] into and through the continuous lumen of the standard guide catheter alongside of the substantially rigid portion and advancing the [ICD] through and beyond a lumen of the flexible tip portion into contact with or past a lesion in the second artery.

wherein the italicized language in step 1.f is relevant to the issues before the Court. (The opinion reduces the steps from the complexity of the claim language to the following shorthand regarding the ordered and simplified steps:

1.a: inserting the standard guide catheter;
1.b: positioning the standard guide catheter;
1.c: inserting a coaxial guide catheter;
1.d: inserting a substantially rigid portion;
1.e: advancing the flexible tip portion;
1.f: inserting and advancing the ICD.)

The opinion explains that the claimed method relates to introducing a catheter into coronary arteries through the aorta, and the occasional difficulties arising from "tough lesions"(including stenosis and chronic arterial occlusion) therein which make such introductions difficult and problematic, which are addressed in the claims by using a combination of a guide catheter and a coaxial guide catheter. The coaxial guide catheter comprises "a tip portion, a reinforced portion, and a substantially rigid portion," with the tip being distal (inserted further into the artery) to the rigid portion. This arrangement is illustrated by Figs. 8 and 9:

with the following explanation from the '413 patent:

In operation, a guide catheter 56 is inserted into a major blood vessel in the body such as aortic arch 58 over guidewire 64 and the distal end 68 of guide catheter 56 is brought into proximity of ostium 60 of a smaller branch blood vessel, such as coronary artery 62, that it is desired to enter. Coaxial guide catheter 12, with tapered inner catheter 14, is inserted through guide catheter 56 and over guidewire 64. Guide catheter 56, guidewire 64, coaxial guide catheter 12, and tapered inner catheter 14 are manipulated to insert tapered inner catheter tip 42 into the ostium 60 of the blood vessel that branches off from the major blood vessel. The bump tip 22 of coaxial guide catheter 12 is inserted with tapered inner catheter tip 42 well into ostium 60 of coronary artery 62 or other blood vessel until bump tip 22 of coaxial guide catheter 12 achieves a deep-seated position. Tapered inner catheter 14 is then withdrawn from the lumen of coaxial guide catheter 12. An interventional cardiology treatment device such as a catheter bearing a stent or a balloon (not shown) is then inserted through the lumen of coaxial guide catheter 12 which remains inside guide catheter 56.

Medtronic challenged these claims in the '413 patent over U.S. Patent No. 7,736,355 (for anticipation) and 7,604,612 (for obviousness, in combination with the '355 patent) in a first IPR and for obviousness over U.S. Patent No. 5,439,445 taken alone or in combination with U.S. Patent Application Publication No. US 2004/0010280. In rendering its Final Written Decision that the challenged claims were non-obvious over any of these combinations of the asserted prior art, the PTAB construed claim 1 to require that the steps be performed in the recited order. In both IPRs, the Board further held in its non-obviousness determination that the skilled worker would not have been motivated to combine either set of references.

The Federal Circuit affirmed, in an opinion by Judge Prost, joined by Judges Lourie and Chen. Regarding the Board's claim construction, the panel affirmed the construction that "inserting the ICD can occur only after advancing the flexible tip portion")(emphasis in opinion); Medtronic advanced a broader interpretation for simultaneous insertion of the ICD and coaxial guide catheter. The Court reviewed the Board's interpretation of the claim language and support therefor in the specification in arriving at its conclusion. The relevant portion of the claim language was in 1.e (advancing the flexible tip portion) and 1.f (inserting and advancing the ICD), according to the opinion, which indicates that the tip is advanced before the ICD if (as the Court affirms) in the proper "in order" recitation of the claimed method steps. As stated in the opinion, "when the current step of a method claim refers to a previous step using the definite article 'the,' the claim language indicates that the previous step occurs sequentially before the current step," citing Wi-Lan, Inc. v. Apple Inc., 811 F.3d 455, 462 (Fed. Cir. 2016) (although qualifying this principle as not being "an ironclad rule"). This interpretation is further supported by the panel's consideration of the "physical requirements of the substantially rigid portion," in light of the arrangements of the elements (with the tip being "distal" and the rigid portion being "proximal" and that they are "operably connected"). Further recitation of the timing of the insertions also support this interpretation according to the opinion ("the logic of claim 1 suggests that the inserting and advancing the ICD step must occur after advancing the flexible tip portion"). Disclosure in the specification is also consistent with this construction, according to the Court, because it also discloses "an ordered performance of the recited steps in claim 1" as well as the advantages of doing so.

While characterizing Medtronic's construction to the contrary as being "plausible" "in a vacuum," the panel rejects it because Teleflex's construction as adopted by the Board is consistent with the context of the claim language and specification, citing Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016). Medtronic's acquiescence to the requirement for the other steps in the method of claim 1 to be performed in the recited order suggests to the panel that this order should not be interpreted any differently for steps 1.e and 1.f, analogous to the circumstances in Mformation Techs., Inc. v. Rsch. in Motion Ltd., 764 F.3d 1392, 1398 (Fed. Cir. 2014). And cases that have found disparate step order to be a proper interpretation were cases where such an interpretation was expressly supported by the specification, such as Niazi Licensing Corp. v. St. Jude Med. S.C., Inc., 30 F.4th 1339, 1351–53 (Fed. Cir. 2022), or based on claim differentiation, see Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1345 (Fed. Cir. 2008). Nor were Medtronic's distinctions based on additional recitations in dependent claims 6, 10, and 11 persuasive, the panel stating that the argument "has no support in our reasoning here or the logic and grammar of the claims."

Regarding the Board's finding that the skilled artisan would not have had a reason to combine the '355 and '612 patents, the panel applied the substantial evidence standard of review for what are factual questions supporting the Board's legal determination of non-obviousness. According to the opinion, the '355 patent discloses an "intravascular foreign matter suction assembly" for removing foreign matter from a blood vessel, whereas the '612 patent discloses emboli protection devices. The Court rejected Medtronic's assertion of error because, first the Board had expressly considered Medtronic's proposed motivations to combine and its conclusions were supported by substantial evidence; second, the Board compared Medtronic's evidence in favor of a reason to combine the references with Teleflex's contrary evidence and found the latter evidence more persuasive, based in part on expert testimony cited extensively in the Court's opinion; and third, that the Board had not contravened the Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007), the panel finding that the Board had not improperly applied the "teaching, suggestion, or motivation test" in arriving at its non-obviousness determination.

Turning to the Board's determination that the '445 patent considered alone did not support Medtronic's obviousness challenge, the opinion sets forth the teachings of this patent to be a support catheter (corresponding to the coaxial guide catheter of claim 1) that "protects the fragile balloon of a balloon catheter" (corresponding to the ICD) as that balloon catheter passes through a guide catheter. The Board determined that the '445 patent had no disclosure of the requirement in claim 1 that the ICD was advanced after advancing the flexible tip portion. The panel countered Medtronic's assertion of error by noting the "narrow presentation of the evidence" supporting Medtronic's contentions in this regard, including only one paragraph from the '445 patent plus certain expert testimony in support of Medtronic's position. The Court also found that Medtronic's evidence in support of its position before the Board was wanting, citing Netflix, Inc. v. DivX, LLC, 84 F.4th 1371, 1377 (Fed. Cir. 2023), for the principle that "the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made." Also supporting the Board's findings, in the Court's view, was that this argument relied alone on the disclosures of the '445 patent plus the understanding and "ordinary creativity" of the skilled worker, which the Board found insufficient to support an obviousness determination.

Finally, the Court turned to the Board's determination that the combination of the '445 patent and '280 application did not render obvious the challenged claims. In this regard the panel understood the '280 application to disclose "an emboli protection system that occludes blood flow" by deploying a filter to catch dislodged emboli. The Board rejected this combination for supporting obviousness because, inter alia, "[the] sealing device [disclosed in the '280 application] is withdrawn before inserting a treatment device like a stent or a balloon because occluding blood flow, which sealing device . . . does, is undesirable," a characterization supported by Teleflex's expert testimony that "occluding blood flow is undesirable, and therefore teaches that the guide seal is deployed only during deployment of the filter and not during the subsequent delivery of [ICDs] such as balloons and stents." This understanding of the consequences of the combination "undermined what Medtronic['s interpretation] proposed - keeping [the] sealing device . . . in [the] guide catheter . . . during the insertion of a treatment device like [the '445]'s balloon catheter." The panel rejected Medtronic's argument that the Board had not considered the proposed combination, finding that the Board had done so and come to a contrary conclusion supported by substantial evidence. The panel held that the Board also properly considered the consequences of the combination of the references and concluded, "in light of the drawbacks of Medtronic's proposed combination" that the skilled worker would not have combined these references as Medtronic contended.

* The Board's decision that the asserted prior art reference did not anticipate the challenged claims was not appealed.

Medtronic, Inc. v. Teleflex Life Sciences Ltd. (Fed. Cir. 2024)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Prost, and Chen
Opinion by Circuit Judge Prost

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