Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312

Background

Ethicon sued Covidien for alleged infringement of two utility patents (the ’501 and ’275) and four design patents (D’801–D’804) related to ultrasonic surgical shears; district court granted Covidien summary judgment (invalidity and/or noninfringement) and entered final judgment for Covidien.
The ’501 patent claims ultrasonic shears with a clamping surface area producing an average clamping/coaptation pressure of 60–210 psi with means to limit user-applied force. District court found claims indefinite for lack of a measurement method/location.
The ’275 patent claims an ultrasonic device with a transmission rod and a damping sheath “configured to loosely contact” the rod and “adapted to absorb undesired vibrations.” District court granted summary judgment of noninfringement after construing “loosely contact.”
The Design Patents claim particular ornamental forms of an open U-shaped trigger, a fluted torque knob, and a rounded activation button on the handpiece. District court found the designs functional (invalid) and alternatively noninfringing.
On appeal, the Federal Circuit: reversed the ’501 indefiniteness ruling (specification plus extrinsic physics evidence adequately informs a skilled artisan where/how to measure average pressure); vacated the ’275 noninfringement ruling (affirmed claim construction of “loosely contact” but found genuine fact disputes on contact and vibration absorption); reversed invalidity of the design patents (court used too high a level of abstraction) but affirmed noninfringement (ornamental features plainly dissimilar).

Issues

Issue	Ethicon's Argument	Covidien's Argument	Held
Whether ’501 claims are indefinite for failing to specify where/how to measure clamping pressure	Specification and a skilled artisan would understand pressures are average pressures measured at the clamping surface midpoint when clamp is closed; extrinsic physics supports measurement	Specification lacks a defined measurement method/location and industry standard, yielding ambiguity	Reversed: claims not indefinite — specification + ordinary skill provide reasonable certainty
Whether Covidien’s products infringe ’275 claims requiring a damping sheath “configured to loosely contact” and “adapted to absorb undesired vibrations”	There is evidence (imaging, droplet tests, expert op.) showing sheath contacts rod at non-node points and absorbs transverse vibrations	Sheath contacts only at nodal ribs; design intentionally avoids loose contact and produces no undesired transverse vibrations	Construction affirmed ("loosely contact" excludes only fixed support points), but summary judgment vacated — genuine factual disputes remain on contact and vibration absorption
Whether Design Patents are invalid as primarily functional	Ornamental features (specific curved U‑trigger shape, flat-front fluted knob, football-shaped button) are not dictated by function; alternative designs exist	Claimed shapes are dictated by ergonomic/functional needs of the shears, so designs are functional and invalid	Reversed: district court erred — patents not proven invalid as functional (Covidien failed to meet clear-and-convincing burden)
Whether Covidien’s accused design infringes Design Patents under ordinary-observer test	Claimed ornamental details, when considered as a whole, are similar enough to raise infringement question; ordinary observer could be a surgeon	Even excluding functional elements, the remaining ornamental aspects are plainly dissimilar; ordinary observer (purchaser or sophisticated buyer) would not be deceived	Affirmed noninfringement: after excluding functional elements, ornamental designs are plainly dissimilar; no infringement

Key Cases Cited

Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014) (definiteness requires reasonable certainty to skilled artisans)
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (deference to district court subsidiary factual findings in claim construction)
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim terms given ordinary meaning in view of specification)
Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665 (Fed. Cir. 2008) (design-patent infringement ordinary-observer test and claim-scope guidance)
Honeywell Int’l, Inc. v. Int’l Trade Comm’n, 341 F.3d 1332 (Fed. Cir. 2003) (indefiniteness where claim scope depends critically on undisclosed measurement method)
PHG Techs. v. St. John Companies, 469 F.3d 1361 (Fed. Cir. 2006) (functionality analysis for design-patent invalidity)
Best Lock Corp. v. Ilco Unican Corp., 94 F.3d 1563 (Fed. Cir. 1996) (design invalid as functional when no alternative designs exist)
L.A. Gear, Inc. v. Thom McAn Shoe Co., 988 F.2d 1117 (Fed. Cir. 1993) (design-patent functionality and importance of alternatives)
Richardson v. Stanley Works, Inc., 597 F.3d 1288 (Fed. Cir. 2010) (limit design-claim scope to ornamental aspects when functional elements exist)
Gorham Co. v. White, 81 U.S. 511 (1871) (formulation of ordinary-observer test for design patents)