Ethicon Endo-Surgery, Inc. v. Covidien LP

ETHICON ENDO-SURGERY, INC., et al., Plaintiffs and Counterclaim-Defendants, v. COVIDIEN LP, et al., Defendants and Counterclaim-Plaintiffs.

Civil No. 16-12556-LTS

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

April 24, 2020

FINDINGS OF FACT, RULINGS OF LAW, AND ORDER FOR JUDGMENT

SOROKIN, J.

Ethicon Endo-Surgery, Inc. and Ethicon Endo-Surgery, LLC (collectively, "Ethicon") sued Covidien LP, Covidien Sales LLC, and Covidien AG (collectively, "Covidien") for a declaration that Ethicon's Enseal X1 Large Jaw vessel sealer does not infringe certain Covidien patents and that the patents are invalid. Doc. No. 1.¹ Covidien counterclaimed for infringement and asserted validity of the patents. Doc. No. 34.

The Court held a claim construction hearing, after which it issued an Order construing the disputed claim terms. Doc. No. 144. During the litigation, the parties stipulated to the dismissal of all but two patents: United States Patent Nos. 9,241,759 ("the '759 patent") and 8,323,310 ("the '310 patent"). Ethicon asserts non-infringement and invalidity as to all asserted claims of both remaining patents. Doc. No. 50; Doc. No. 264.

The Court held a bench trial from September 23, 2019 to October 3, 2019, Doc. Nos. 234-241, resolved a motion to strike certain testimony presented at trial, Doc. No. 253, resumed trial on January 15 and January 16, 2020 to hear an expert witness who had been ill in the fall, Doc. Nos. 212, 258, 260, received post-trial filings in February, Doc. Nos. 262-270, and heard closing arguments in March, Doc. No. 272.

The Court now makes the following factual findings and rulings of law pursuant to Rule 52(a) of the Federal Rules of Civil Procedure.² The Court concludes that Ethicon has failed to establish invalidity and that Covidien has failed to establish infringement.

I. BACKGROUND

The patents at issue generally relate to features of advanced bipolar surgical instruments used to seal and cut tissue or blood vessels. Both Ethicon and Covidien produce and sell such instruments. The devices permit surgeons to grasp a vessel or tissue between two opposing jaws at the distal end of the instrument, apply energy to the vessel or tissue to form a seal—thereby stopping the blood flowing through it—and then cut the sealed tissue using a knife that moves along the length of the opposing jaws.

A. The '759 Patent - the Asserted Claims

The '759 patent is entitled "Vessel Sealer and Divider for Use with Small Trocars and Cannulas." '759 patent, cover. The Abstract describes "[a]n endoscopic bipolar forceps [that]includes a housing, a shaft affixed to the housing, and a pair of jaw members attached to a distal end of the shaft." Id.

Covidien asserts infringement of independent claim 1 and dependent claims 4, 6, 7, 10, and 11 of the '759 patent. The dependent claims all depend from claim 1, which recites:

1. An endoscopic bipolar forceps, comprising:

a housing;

a shaft defining a longitudinal axis, extending distally from the housing, and having a movable jaw member and a fixed jaw member at a distal end thereof, each of the movable and fixed jaw members adapted to connect to a source of electrosurgical energy such that the movable and fixed jaw members are capable of conducting energy through tissue grasped therebetween;

a drive sleeve defining a proximal end and a distal end, the drive sleeve operably coupled to the movable jaw member at the distal end of the drive sleeve and configured to move the movable jaw member relative to the fixed jaw member from a first position wherein the movable jaw member is disposed in spaced relation relative to the fixed jaw member to a second position wherein the movable jaw member is closer to the fixed jaw member;

a movable handle of unitary construction having a finger loop positioned towards a first end thereof, a drive flange positioned towards a second end thereof, and a locking flange disposed between the finger loop and the drive flange, the drive flange operably coupled to the drive sleeve towards the proximal end of the drive sleeve such that movement of the movable handle from an open position to a closed position moves the movable jaw member relative to the fixed jaw member from the first position to the second position;

a selectively advanceable knife operable to cut the tissue grasped between the movable and fixed jaw members in a distal direction; and

a selectively actuatable finger actuator operably coupled to the selectively advanceable knife,

wherein, when the movable handle is disposed in the open position, the locking flange impedes actuation of the finger actuator and advancement of the selectively advanceable knife to cut the tissue grasped between the movable and fixed jaw members.

Id. at 23:5-41 (emphasis added).

The parties have stipulated that the accused Enseal X1 device practices all the limitations of the asserted claims except for those in bold text above. Doc. No. 255 ¶¶ 1-11. That is, they dispute whether the preamble of claim 1, which recites "[an] endoscopic bipolar forceps" is limiting and also whether the Enseal X1 practices the following three claim limitations: (1) a movable handle "of unitary construction" that includes (2) "a finger loop" and (3) "a drive flange" that is "operably coupled to the drive sleeve." Doc. Nos. 262, 264.

B. The '759 Patent - Findings of Fact

1. The Enseal X1 device and the "finger loop" limitation

1. The "finger loop" described and claimed in the '759 patent and illustrated in Figure 30 below allows a user to open and close the jaws by inserting one or more of her fingers into the opening of the handle and pushing forward on the front (or distal) part of the handle to open the jaws, and pulling on the back (or proximal) part of the handle to close the jaws. Doc. No. 234 (9/23 Tr.) at 100:1-9.

Image materials not available for display.

'759 patent, Fig. 30 (annotated).

2. The Enseal X1 has a movable handle design called a "shepherd's hook." Doc. No. 237 (9/26 Tr.) at 114:21-115:2.

3. The shepherd's hook is not a closed curve. As the following figure illustrates, the shepherd's hook design is curved at the top and open on the distal side of the handle:

Image materials not available for display.

PTX-110 (Assembly Drawing of Enseal X1).³

4. The Enseal X1 shepherd's hook handle allows the user to pull back on the handle to move the jaws to a closed position and to push forward on the front part of the handle with one or more fingers—those that fit behind the front part of the handle—to move the jaws to an open position. Doc. No. 238 (9/27 Tr.) at 160:20-161:21.

5. Because it is a closed curve, a finger loop allows a user to employ more of her fingers than does a shepherd's hook to push the handle forward to open the jaws of the instrument. Unlike the shepherd's hook, which only allows the user to use the fingers that fit behind the front part of the handle structure, the finger loop allows a user to employ all the fingers that fit within the loop to push the handle forward. Doc. No. 238 (9/27 Tr.) at 91:10-17, 160:20-161:21; Doc. No. 260 (1/16 Tr.) at 22:12-23:6, 26:21-27:3; Doc. No. 237 (9/26 Tr.) at 153:15-25.

6. The finger loop handle is grasped by inserting one or more fingers into the opening of the closed loop.

7. A finger loop receives a user's fingers and contains them in such a way as to prevent fingers from slipping off of the handle. Doc. No. 238 (9/27 Tr.) at 92:25-93:5; Doc. No. 260 (1/16 Tr.) at 28:23-29:24, 71:2-15. The user must pull her fingers out of the finger loop when extricating her hand from the handle

8. Surgeons hold devices like the Enseal X1 in all sorts of ways, including upside down. Doc. No. 237 (9/26 Tr.) at 116:7-10.

9. By virtue of being a closed loop, the finger loop handle contains the user's fingers when the handle is held in every direction—right side up or upside down, and backwards- or forwards-facing.

10. The shepherd's hook is grasped by holding on to the non-movable part of the handle and sliding one or more fingers against the front part of the handle—the hook—from below or the side.

11. The shepherd's hook handle does not hold the fingers in place. To remove her hand from the shepherd's hook handle, the user simply slips her fingers out of or away from the hook.

12. The shepherd's hook handle does not hold the user's fingers when the instrument is upside down because there is nothing to contain the fingers in place. The shepherd's hook handle does not even hold the user's fingers in place when the instrument is right side up. The fingers below the end of the end of the hook do not contact the hook part of the handle at all; those above the end of the hook are held in place by the user, not by the handle.

13. The finger loop allows the user to use all of her fingers in the loop to push the handle forward and to exert forward pressure with all her contained fingers—that is, if the user's fingers press or slide down on the front part of the handle, the closed loop will still contain them and facilitate continued forward pressure.

14. The shepherd's hook design allows only for some of the fingers—those fitting behind the hook—to push the handle forward. The user must hold those fingers in place. If the user's fingers slide down, the handle will not contain them and they will exert no forward pressure.

2. The Enseal X1 device and the "drive flange" limitation

15. The Enseal X1 includes added material in the form of raised structures projecting from each side of the movable handle as shown in the images below:

Image materials not available for display.

PTX-150 (Leinsing's Expert Report on Non-infringement), ¶ 196.

16. The raised structures were added to the movable handle in part to add strength at the location where force is being exerted on a pin that links the proximal end of the handle to the drive assembly. Doc. No. 237 (9/26 Tr.) at 120:17-122:19; Doc. No. 239 (10/1 Tr.) at 11:5-13:6, 30:1-14; Doc. No. 258 (1/15 Tr.) at 108:3-109:25.

17. The raised structures on the Enseal...