I. INTRODUCTION

This article compares two recent Federal Circuit opinions concerning IPR cases addressing the nexus requirement for objective indicia of non-obviousness. These cases revolve around the patentee's use of a commercial embodiment to establish a presumption of nexus. Notably, in both cases, the individual claim limitations were in the prior art. But a crucial distinction emerged which created opposing results: in one case, the objective indicia was tied to a single claim element that was known in the prior art; in the other case, the objective indicia was effectively tied to the invention as a whole.

II. THE NEXUS REQUIREMENT: BACKGROUND

"Obviousness is a question of law based on underlying facts," where the Supreme Court has long recognized that a patentee can overcome a prima facie showing of obviousness by providing objective indicia of non-obviousness, also known as secondary considerations.1 Secondary-consideration evidence includes commercial success, long-felt but unsolved need, and industry praise, among others that are designed to objectively demonstrate that an invention is not obvious.2 A big challenge in establishing secondary considerations, however, is that it requires the patentee to establish a "legally and factually sufficient connection" or a nexus to the claimed invention.3 In evaluating whether the nexus requirement is satisfied, the objective evidence must be directed to what was not known in the prior art—including patents and publications—which may be an individual claim element or the novel combination of known individual elements.4 A presumption of nexus can be found when a commercial product "is the invention disclosed and claimed in the patent."5 But, this presumption can be rebutted by showing that the objective evidence resulted from features that were known, individually or as a combination, in the prior art rather than the claimed invention as a whole.6 The United States Court of Appeals for the Federal Circuit recently issued two precedential opinions in Yita LLC v. MacNeil IP LLC (Yita)7 and Medtronic, Inc. v. Teleflex Innovations S.A.R.L. (Medtronic),8 both of which analyze establishing a nexus under this particular presumption.

III. YITA V. MACNEIL IP

Yita LLC challenged two of MacNeil IP LLC's patents (U.S. Patents Nos. 8,382,186 and 8,833,834) as obvious in an inter partes review.9 The patents concerned a modified vehicle floor tray.10 With respect to the '186 patent, the PTAB found that the secondary-consideration evidence—MacNeil's marketed WeatherTech® vehicle trays—entitled it to a presumption of nexus because the marketed products embodied the claimed features.11 In IPR 2020-01139, the Board rejected Yita's challenge to all claims of the '186 patent; although the Board found that an artisan would have the motivation to successfully combine the teachings of prior art references to arrive at all challenged claims of the '186 patent, it found MacNeil's evidence of secondary considerations "compelling and indicative of non-obviousness."12 Importantly, the Board made this determination despite finding that the prior art taught the "close conformance" limitation that was central to the objective indicia of non-obviousness.13

On appeal, the Federal Circuit reversed and wrote, "the Board's finding of nexus [] rests on legal errors, and once those errors are corrected, the finding is not supported by substantial evidence."14 The Board first reasoned that a prior art disclosure did not establish that close conformance was "well-known" and thereby did not undermine any determination of nexus.15 The Federal Circuit found error by citing to case law making it clear that for secondary-consideration evidence to lack a nexus, the feature to which the evidence relates needs only be "known" in the prior art, not "well-known."16 The Federal Circuit then held that the Board incorrectly applied the ruling of WBIP, LLC v. Kohler Co. in its second reason behind finding a nexus.17 The Board interpreted the precedent as instructing that "it is the claimed combination as a whole that serves as a nexus for objective evidence"; however, the Federal Circuit later in the precedent ruling recognized that secondary-consideration evidence may be linked to just an individual element of the claimed invention.18 The Federal Circuit emphasized the Board's own factual findings that MacNeil's secondary-consideration evidence "relate[d] entirely" to the close-conformance limitation disclosed in prior art rather than the invention as a whole.19 Accordingly, this compelled the conclusion that the objective evidence is of no relevance to the obviousness inquiry in this case because it did not have a nexus.20 In reversing the Board's judgment that the claims of the '186 are not unpatentable, the Federal Circuit rejected the patentee MacNeil's finding of a nexus.21

IV. MEDTRONIC V. TELEFLEX

Medtronic concerns an IPR proceeding involving guide-extension catheters designed to alleviate stenosis.22 Medtronic challenged Teleflex's patents, alleging the challenged claims would have been obvious over U.S. Patent No. 5,439,445 (Kontos), and citing to secondary references including, U.S. Patent No. 7,604,612 (Ressemann), which discloses an evacuation sheath assembly with a distal side opening.23 Teleflex introduced evidence of objective indicia of non-obviousness tied to its GuideLiner commercial products, undisputedly applying the same commercial-product presumption of nexus.24 Upon review, the Board determined that Medtronic failed to prove the Side Opening Claims—five of the claims in Teleflex's '032 patent (U.S. Patent No. 8,048,032)—would have been obvious25 because the evidence of disclosure by the prior art Kontos reference was outweighed by the persuasive strength of Teleflex's secondary-consideration evidence.26

Medtronic appealed, arguing that the Board erred in finding a nexus between Teleflex's objective evidence and the Side Opening Claims based on three specific features of the GuideLiner that were collectively disclosed in the prior art Resseman reference, and therefore not indicative of non-obviousness.27 The Federal Circuit held that the Board did not err in its finding.28 Although the Board acknowledged that Medtronic showed every element of the Side Opening Claims was individually known in the prior art, the Board correctly concluded this did not preclude finding a nexus where the evidence was "tied to the combination of features as a whole" and the combination was not previously known.29 Here, the Board found that the GuideLiner devices as a whole resulted in the secondary-consideration evidence, not any individual feature.30 The Board explicitly grounded its nexus finding on a combination of GuideLiner features it found to form a new, commercially successful product not disclosed as a combination in the prior art.31 The Federal Circuit found no legal error and accordingly affirmed the Board's nexus judgment.

V. COMPARISON OF YITA AND MEDTRONIC

In both opinions, the patentee grounded its secondary-consideration evidence in a presumption of nexus tied to a marketable, commercial product that "is the invention disclosed and claimed in the patent."32 Where Yita focused on a nexus directed at an individual claim element—the "close-conformance" limitation33—Medtronic focused on a nexus directed at a combination of elements as a whole—the combination of three specific device features.34 Despite the different outcomes for the patentee in the respective cases—a patentee win in Medtronic and a loss in Yita—these opinions emphasize the central roles that secondary considerations and the nexus requirement play in evaluating obviousness.35 Ultimately, these Federal Circuit decisions demonstrate that tying the indicia of non-obviousness to a combination of features may not guarantee success, but it may be potentially more difficult to rebut than tying the indicia to an individual feature that could be disclosed in prior art.

Footnotes

1. Henny Penny Corp. v. Fry-master LLC, 938 F.3d 1324, 1331 (Fed. Cir. 2019) (citing Graham v. John Deere Co.,

383 U.S. 1, 17-18 (1966)).

2. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).

3. Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019).

4. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1331 (Fed. Cir. 2017); WBIP, LLC v. Kohler Co.,

829 F.3d 1317, 1332 (Fed. Cir. 2016).

5. Immunex Corp. v. Sandoz Inc., 964 F.3d 1049, 1067 (Fed. Cir. 2020) (quoting WBIP, 829 F.3d at 1329).

6. WBIP, 829 F.3d at 1329.

7. Yita LLC v. MacNeil IP LLC, Case No. 22-1373 (Fed. Cir. June 6, 2023) ("Yita").

8. Medtronic, Inc. v. Teleflex Inns. S.A.R.L., Case No. 21-2357 (Fed. Cir. June 5, 2023) ("Medtronic").

9. Yita at 2.

10. Id.

11. Id. at 8.

12. Id. at 2.

13. Id. at 7.

14. Id. at 12.

15. Id. (emphasis added).

16. Id. at 13 (emphasis added) (citing Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)); see also Ethicon

Endo-Surgery, Inc. v. Covidien LP

, 812 F.3d 1023, 1034 (Fed. Cir. 2016) ("[I]f the feature that creates the commercial

success was known in the prior art, the success is not pertinent." (quoting Ormco Corp. v. Align Tech., Inc.,

463 F.3d 1299, 1312 (Fed. Cir. 2006))).

17. Yita at 13.

18. Id. (quoting WBIP, 829 F.3d at 1332).

19. Id. at 14-15.

20. Id.

21. Id. at 15.

22. Medtronic at 2-3.

23. Id. at 4-5.

24. See id. at 8; Yita at 8.

25. Medtronic at 5-6.

26. Medtronic, Inc. v. Teleflex Inns. S.A.R.L., No. IPR2020-00127, 2021 WL 2518685, at *20-21 (P.T.A.B. June 7, 2021).

27. Medtronic at 9.

28. Id. at 12.

29. Id. at 9 (citing WBIP, 829 F.3d at 1331-32).

30. See id. (emphasis added).

31. Id. at 10 (emphasis added).

32. Immunex Corp. v. Sandoz Inc., 964 F.3d 1049, 1067 (Fed. Cir. 2020) (quoting WBIP, 829 F.3d at 1329); see Yita at 8;

Medtronic at 8.

33. Yita at 7.

34. Medtronic at 9.

35. See id. at 10-11; Yita at 13-15.

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