Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc. (936 F. Supp. 2d 30, 2013)

MEMORANDUM OF DECISION

JANET BOND ARTERTON, District Judge.

Table of Contents

I. Summary of Findings and Conclusions.......................................35

II. Background..............................................................36

A. Overview of Patented Technology..........................:.......36

B. Accused Instruments..................................................36

C. The Asserted Claims of the Patents In Suit........................,......37

D. Claim Construction on Relevant Terms..................................40

1. Camming Mechanisms and Cam Slots...............■................. .40

2. Swivel Member ...................................................40

3. Curved Blade Surface......................................:.......40

III. Infringement.......................................•......................40

A. Findings of Fact on Accused Products and Asserted Claims ................40

1. The '050 Patent...................................:...............43

2. The '286 Patent....................................................44

3. The '544 Patent................................................... .46

B. Discussion and Conclusions of Law on Infringement.......................47

IV. Invalidity ...............................;................................48

A. Prior Invention Defense Under 35 U.S.C. § 102(g) .........................49

1. Factual Findings..................................■................49

B. Discussion and Conclusions of Law as to 35 U.S.C. § 102(g) ................55

1. Prior Conception..................................................55

2. Reduction to Practice..............................................57

3. Reasonable Diligence, Lack, of Abandonment, Concealment.............58

C. Obviousness and 3.5 U.S.C. § 103 Defense................................60

1. Obviousness Findings of Fact.......................................61

2. Discussion and 35 U.S.C. § 103 Conclusions of Law.....................65

V. Damages.................................-................................71

A. Entire Market Value Rule.....".............■............................71

B. Lost Profits.............................................■.............71

1. Demand for the Patented Products..................................71

2. Causation to Lost Sales............................................71

C. Reasonable Royalty.......:..........................."................78

D. Conclusions on Damages...............................................83

E. Other Relief Sought............... 83

1. Willful Infringement...............................................83

2. Permanent Injunction.......................................;......85

3. Prejudgment Interest..............................................86

VI. Conclusion 87

I. Summary of Findings and Conclusions

A bench trial was held from December 3 through December 13, 2007, and July 9 through August 3, 2012 on the claims of Plaintiffs Tyco Healthcare Group LP and United States Surgical Corporation (“Tyco”) that Defendant Ethicon EndoSurgery, Inc.’s (“Ethicon”) ultrasonic surgical tools infringe three patents, and on Defendant’s invalidity defenses. The Court’s findings and conclusions pursuant to Federal Rule of Civil Procedure 52’ are summarized as follows:

(1) Tyco has proved infringement of all asserted claims of the patents in suit;

(2) Ethicon has proved its defense of prior conception and diligence under § 102(g) for claims 1, 5, 9, and 10 of the '050 patent, claims 1, 6, 7, and 8-14 of the '286 patent, and 1, 2, 9-13, 16, 18, and 23-25 of the '544 patent;

(3) Ethicon has failed to prove its § 103 obviousness defense;

(4) Tyco has not proved willful infringement of the patents in suit;

(5) Tyco has not proved that a preliminary injunction is warranted;

(6) Tyco has not proved that it is entitled to lost profits damages; and

(7) Tyco is entitled to 8% royalty damages and 3.25% prejudgment interest for damages in the total amount of $176,500,800.00.

II. Background

A. Overview of Patented Technology

The three patents at issue in this lawsuit are directed to ultrasonic surgical devices, which employ ultrasonic energy to cut and coagulate vessels in surgery. An ultrasonic medical device of the type in the patents in suit is described as including (1) a generator to power a transducer, (2) a transducer to convert electrical energy into ultrasonic mechanical vibrations, and (3) the surgical instrument to deliver ultrasonic energy to tissue. (See Fig. 1, '286 patent [PTX 52].) Ultrasonic energy vibrates a blade at the end of the instrument very rapidly such that the device cuts tissue and provides homeostasis through the generation of frictional heating between the tool and tissue. (See, e.g., Fig. 12, '050 patent [PTX 50].)

The ultrasonic transducer (see id. at 230) is supported within the instrument’s housing. The shaft (id. at 224)' and the'jaw (id. at 232) can be rotated by a rotation knob (id. at 234). The devices at issue are commonly used in laparoscopic surgery in which trocars are used to’ pierce a patient’s body and a narrow hollow tube, or “cannula,” is used to provide a “working pathway” to the target surgical site. (See Expert Report of William Cimino [DTX 1379] ¶¶ 9-10.) The incisions created in laparoscopic surgery are relatively small and the result is shorter hospital stays and periods of convalescence, as well as less post-operative pain and fewer wound complications than in traditional, open surgery. (See id. ¶10.)

The patented technology describes handles that can be used to open and close the clamp jaw. (See stationary handle (228) and movable handle (236), Fig. 25, '050 patent.) In one' embodiment, the clamp jaw is closed by pulling the movable handle towards the stationary' handle ('050 patent at 11:1-9). When the movable handle moves towards the stationary handle, a cam mechanism advances the actuator tube toward the working end of the instrument. (Fig. 24, '050 patent.)

The three patents in suit are similar, but the '050 patent, part of the “Manna” family of patents discloses a cutting jaw with an “angled” blade surface ('050 patent at 1:60-67), while , the '286 and '544 patents disclose a cutting jaw “curved downwardly and outwardly in the distal direction” ('286 patent at 1:65-67; '544 patent [PTX 53] at 1:67-2:2; see also Fig. 19, '050 patent; Fig. 9, '286 patent.)

B. Accused Instruments

Tyco asserts that the Ethicon’s Harmonic Scalpel products, Harmonic ACE products, and Harmonic WAVE products, all ultrasonic cutting and coagulating surgical devices used in laparoscopic and open surgery procedures, infringe claims 10-12 of the'050 patent, claims 8-14 of the '286 patent, and claims 1-3, 6, 8-13, 16, 18, and 23-25 of the '544 patent. Specifically, Tyco contends that the following Ethicon devices infringe the patents in suit:

“CS Products” CS 141 CS14C CS231 CS23C

“LCS Products” LCSC1 LCSC5 LSCS5L

“ACE Products” ACE14S ACE23S ACS36S ACE23P ACE36P ACE23E ACE36E _ACE45E_

“Wave Products” WAVE18S_

Tyco asserts that the LSC, CS, and ACE products infringe claims of the '050, '286, and '544 patents, and that the Wave Products infringe claims of the '544 patent. In the Court’s 2007 Ruling on Motions for Summary Judgment, Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., 514 F.Supp.2d 351 (D.Conn.2007), the LSC, CS, and ACE products were found to infringe claims 1, 5, and 9 of the '050 patent and claims 1, 6, 7 and 15 of the '286 patent.

C. The Asserted Claims of the Patents In Suit

This chart summarizes Tyco’s infringement claims against the accused devices. An indication of “infringed” in the far-right column means that the Court, in its 2007 Ruling on Motions for Summary Judgment, found that the accused products infringe those claims:

The remaining claims of the '050 patent at issue are:

Claim 10: The surgical instrument of claim 1, further comprising at least one ring positioned on the vibration coupler to seal the flow of fluids between the vibration coupler and the actuator tube.

Claim 11: The surgical instrument of claim 1, wherein the clamp member includes a pair of pivot pins and a pair of camming members spaced from the pivot pins.

Claim 12: The surgical instrument of Claim 1, wherein the actuator tube includes a pair of slots engageable with a pair of camming members of the clamp member.

('050 patent.)

The remaining claims of the '286 patent that Tyco asserts are infringed by Ethicon’s products are:

Claim 8: An ultrasonic instrument according to claim 7, further including an actuator tube slidably positioned about the vibration coupler, a distal end of the actuator tube including a cam slot configured to receive cam members formed on the clamp member, the actuator tube being moveable between advanced and retracted positions about the vibration coupler in response to actuation of the handle assembly to effect movement of the clamp member between the open and closed positions.

Claim 9: An ultrasonic instrument according to claim 8, wherein the handle assembly includes a stationary handle and a moveable handle, the movable handle being operably connected to a proximal end of the actuator tube.

Claim 10: An ultrasonic instrument according to claim 9, further including a coupling member, the coupling member interconnecting the actuator tube and the moveable handle.

Claim 11: An ultrasonic instrument according to claim 10, wherein the coupling member includes a swivel member, the swivel member being positioned to permit rotation of the coupling member in relation to the moveable handle.

Claim 12: An ultrasonic instrument according to claim 11, wherein the coupling member is operably connected to a rotatable knob positioned adjacent the handle assembly, the rotatable knob being rotatably secured to the handle assembly such that rotation of the rotatable knob in relation to the handle assembly effects corresponding rotation of the coupling member and the clamp member.

Claim 13: An ultrasonic instrument according to claim 12, wherein the vibration coupler is rotatably fixed to the rotatable knob such that rotation of the rotatable knob in relation to the handle assembly effects corresponding rotation of the vibration coupler and the cutting jaw.

Claim 14: An ultrasonic instrument according to claim 8, further including an outer tube positioned about the actuator tube, the clamp member being pivotally connected to the outer tube.

('286 patent.)

Tyco also asserts that claims 1-3, 6, 8-13, 16, 18, and 23-25 of the '544 patent are infringed by Ethicon’s LSC, CS, ACE, and WAVE products:

Claim 1: An ultrasonic instrument comprising: an outer tube defining a longitudinal axis and having a proximal end and a distal end; an actuation member positioned within the outer tube; a vibration coupler positioned within the outer tube, the vibration coupler having a distal end and a proximal end; a jaw member extending from the distal end of the vibration coupler; a clamp pivot-ally mounted adjacent the -distal end of the outer tube, the clamp being movable in relation to the jaw member between open and clamped positions, the clamp including a camming member which operatively engages the actuation member such that movement of the actuation member pivots the clamp between the open and clamped positions.

Claim 2: An ultrasonic instrument according to claim 1, wherein the actuation member includes a slot for receiving the camming member of the clamp.

Claim 3: An ultrasonic instrument according to claim 2, wherein the claim includes a pair of camming members and the actuation member includes a pair of slots, each one of the pair of slots being positioned to receive one of the pair of camming members.

Claim 6: An ultrasonic instrument according to claim 1, wherein the jaw member includes a curved blade surface.

Claim 8: An ultrasonic instrument according to claim 6, wherein the curved blade surface includes a longitudinally extending cutting edge.

Claim 9: An ultrasonic instrument according to claim 1, further including a handle assembly, the proximal end of the outer tube being supported adjacent the handle assembly.

Claim 10: An ultrasonic instrument according to claim 9, further including a rotatable collar operatively associated with the vibration coupler, the clamp and the jaw member such that rotation of the vibration coupler causes corresponding rotation of the clamp and the jaw member.

Claim 11: An ultrasonic instrument according to claim 10, wherein the clamp and the jaw member are rotatable about the longitudinal axis of the outer tube.

Claim 12: An ultrasonic instrument acr cording tq claim 10, wherein the rotatable collar is positioned adjacent the handle assembly.

Claim 13: An ultrasonic instrument ac•cording to claim 9, further including a transducer removably supported on the handle assembly. ,

Claim 16: An ultrasonic instrument according to claim 13, wherein the transducer includes a transducer horn adapted to engage a proximal end of the vibration coupler.

Claim 18: An ultrasonic instrument according -to claim 1, wherein the outer tube is dimensioned to be received within a 5 mm trocar assembly.

Claim 23: An ultrasonic instrument according to claim 1, wherein the clamp includes at least one tissue receiving stop which is positioned adjacent the jaw member.

Claim 24: An ultrasonic instrument according to claim 23, wherein the jaw member includes a blade surface having a proximal and a distal end, ... at least one tissue receiving stop being positioned adjacent the proximal end of the blade surface.

Claim 25: An ultrasonic instrument according to claim 1, wherein the clamp is pivotally mounted on the distal end of the outer tube.

('544 patent.)

At trial, the main focus of the parties’ infringement dispute was on the camming members and the curved blade surface claims.

D. Claim Construction on Relevant Terms

1. Camming Mechanisms and Cam Slots

Claims 11 and 12 of the "050 patent disclose a pah* of “camming members,” and claim 8 of the '286 discloses “a cam slot configured to receive cam members.” Claim 3 of the '544 patent claims a clamp including “a pair of camming members.” The Court construed “cam members” and “camming members” identically as: “the follower parts of the cam mechanism that are imparted motion by the cam slots and whose motion is guided by the cam slots.” (Cl. Construction [Doc. # 62] at 10.) The Court construed “slots engageable with a pair of camming members” ('050 Patent, Cl. 12; '544 Patent, Cl. 2-3) and “cam slot” ('286 Patent, Cl. 8) as “openings or grooves that impart motion to and guide the motion of the camming members.” (Claim Construction at 11.)

2. Swivel Member (Claim 11 and All Dependent Claims of '286 Patent)

The Court construed the term “swivel member” as “[a] component designed to permit the coupling member to swivel or rotate.” (Id. at 19.)

8. Curved Blade Surface

Claim 6 of the '544 Patent discloses a “curved blade surface,” and dependent claim 8 discloses that that surface includes “a longitudinally extending cutting edge.” The Court construed claim 6’s “curved blade surface” as a “[b]lade surface that has a deviation from a straight line” (Id. at 31), and construed the surface disclosed in claim 8 as “[t]he edge of the blade surface designed for cutting that extends along the lengthwise dimension.” (Id. at 34.)

III. Infringement

A. Findings of Fact on Accused Products and Asserted Claims

Tyco’s infringement expert Dr. William Durfee testified that he examined each of the accused products and that they infringe all of the asserted patent claims in suit because the accused products each have cam slots and cam members as claimed in each of the asserted patents. Defendant’s technical expert Dr. William Cimino challenges the fundamental premise of Dr. Durfee’s conclusion — that the mechanism at use in the accused products is a camming mechanism — concluding that it is instead a rack-and-pinion mechanism and thus no claims are infringed by the accused products.

L Camming

Dr. Durfee defined a “camming mechanism” as:

A mechanical mechanism that transmits forces and motions through two members, a cam and a follower. And it’s through the direct contact of the surface of the cam and the follower that the motions are transmitted back and forth between. Typically, a cam would be the input, and the follower would be the output, so that the cam would give motion to the follower. ■

(2007 Tr. at 692.) In 2012, Dr. Durfee’s analysis continued:

the first thing you need to determine is whether there is a cam mechanism, and' then the second thing you need to determine ... is in part of that cam mechanism if you’ve got camming members whose — where motion is imparted to and motion guided by the cam slots.... [TJhat’s what I used when looking at the accused products in relation to the claim terms of the patents.

(2012 Tr. 298:16-294:1.)

In considering the clamp on the accused instruments, Dr. Durfee observed that the pivot pin “constrains that clamp to travel' in a circle” which he détermined to be a “key component” of his opinion that the accused products each possess a camming mechanism as disclosed in the asserted claims of the patents in suit. (Id. at 295.) Though he conceded that the mechanisms used in the accused products looked different from the drawn images included in the patents, in his opinion, they are, from an engineering standpoint, the same mechanism:

I want to point out where there’s a small difference between the two, if you look on the left, the cam follower, the part 472 [of Fig. 33 of '050 patent] in blue is located above the pivot pin, and if you look on the right on the instrument, it’s located below the pivot pin. And so while these two are going to be the same mechanism, that turns out to have a consequence where when they’re actuated, in one case you move the tube one way, the other way you move the tube the other way.

(Id. at 295:25-296:9.) When asked if that changed his analysis in any way, Dr. Durfee responded, “No, it doesn’t. I just wanted to make it clear it’s all the same mechanism, but they might look like they’re different because of that choice of where the follower is in relation to the pin. But it’s the same mechanism.” (Id. at 296:13-17 (emphasis added).)

Dr. Durfee noted that in the '050 patent and in the accused instruments, the tube-in-a-tube design, and the tubes sliding back and forth initiated the process of opening and closing the clamp. (Id.- at 297.) He described the process in the accused instrument, “as that clamp moves to the right, it takes the protrusion along with it, but that protrusion has to travel in a circle: It’s traveling in a circle about its pin, and then in turn it is taking the clamp along with it in a counterclockwise circle as well to close the clamp.” (Id. at 298:22-299:2.) After discussing how the clamp arm worked, he explained:

The cam mechanism, it’s a mechanism that transfers motion from a cam to a follower through a cam edge or cam surface. Let’s take a look at the patent. The cam is that slot which is moving left and right, and the follower is the protrusion in blue that is moving in a circle. So the slot — the slot is transferring this motion to the follower through a sliding action on the cam surface, which is the sides of the slot.

The same thing in the photograph of the accused instrument on the right. The cam part of the cam mechanism is the slot and it is transferring its motion to the follower part of the cam mechanism, which is the protrusion. The cam goes back and forth and the follower goes in a circle. So the follower, in order to accommodate that motion, the follower slides against the slot surface. So, again, like the one on the left, the cam surface is the edges of the slot.

(Id. at 299:8-300:2.)

Dr. Durfee emphasized that the “angle of the slot ... in the patent is different than the angle of the slot ... on the accused product.... But that’s a particular design choice----that is a choice- the designers make, but it doesn’t change the fundamental characteristic of this being a cam mechanism.” (Id. at 300:3-15.) Using the Court’s construction that “slots” are “openings or grooves that impart motion to and guide the motion of the camming members,” he opined that, as to the accused products, “while that follower can only travel in a circle, its timing of how it gets around the circle is dictated by the slot.... So that’s the sense that the.slots are guiding the motion of the cam members or the followers. (Id. at 301:4-11.)

Dr. Cimino disagrees that the acchsed instruments possess a cam mechanism as' disclosed in the patents. Instead, he concluded that in the case of the accused instrument, the “rectangular shaped opening” has a pin used “to engage the actuation member” (id. at 847:20), “this is a pin in a slot” (id. at 848:21), and testified that “the pin, for intents and purposes, fills the entire slot. I mean, the width of the pin is approximately the width of the slot [so] I do not have any path along which the pin is being guided. I am imparting motion to this pin, but I’m not guiding it down any pathway.” (Id. at 847:23-848:3.) Though he agreed that the pin does have a small amount of movement within the slot (see id. at 854:4), his opinion was that if one were to change the shape of the “opening” in the accused devices’ mechanisms, for example, from a rectangle to a circle, it would have no effect on the motion of the pin, and therefore, “it cannot be a cam” (id. at 858:8).

Concluding that it could not be a cam mechanism, Dr. Cimino instead identified the mechanism in the accused products as a “very rudimentary rack and pinion” mechanism (id. at 858:22-23), which he defined as “a pulling gear, which is the gear on top that’s rotating, and ... a rack on the bottom. A rack and pinion gear system-is really two gears” (id. at 859:5-8). On cross-examination, when asked whether “the amount of sliding” between the tooth and the rack “determine[s] whether or not it’s a rack and pinion mechanism” (id. at 1032:17-19), Dr. Cimino clarified that “[a] rack and pinion is determined by having the elements of a rack and pinion system. So, you would need a rack and a pinned piece to rotate, and they interact through a protrusion or a tooth between the two. That’s what would define a rack and pinion mechanism” (id. at 1032:20-25).

In response, Dr. Durfee offered a graphic representation of the “single-toothed-gear” that Dr. Cimino had identified as a component of a rack and pinion mechanism, but which he defined as a cam mechanism. He demonstrated that by moving the slot to the left and right, “the tooth has pivoted about its axis and has a certain angle” (id. at 1777:13-14), emphasizing that “there is a sliding of that tooth on the corner of the ... slots” (id. at 1777:17-18), and “you can clearly see that that transfer of motion is done through the sliding as it is done with the cam” (id. at 1777:20-22). Dr. Durfee agreed with Dr. Cimino that if something is “really a cam and I change the cam profile, I’ll get a change in the input/output relationship, in other words, a different result” (id. at 1778:1-4), and noted that by changing the cam surface of the slot, “I would need a new equation to describe this cam compared to the previous cam because we’ve changed the input/output relationship” (id. 1779:8-11). Dr. Durfee also testified that a rack and pinion mechanism could be made up of a series of cams, depending on the interaction between the two parts. (Id. at 1898.)

When asked about Dr. Cimino’s testimony that “if you change the shape of the rectangular slot in the accused devices to a circle it would still operate the same and, therefore, you’ve changed the profile, you haven’t changed the input/output, so therefore you don’t have a cam mechanism” (id. at 1779:19-25), Dr. Durfee disagreed because:

[t]he point .is when you go from a vertical slot to a circular slot you are going to change the input/output relationship of the cam to the follower. So, you need a new equation to describe the angular excursion of the follower compared to the horizontal version of the cam. So, I would disagree that you are not changing anything about the cam. You are changing the input/output relationship.

(Id. at 1780:7-15.) Using Dr. Cimino’s slides for his explanation, Dr. Durfee testified that “the amount of sliding does not change whether or not this is a cam mechanism.” (Id. at ,1782:1-2.) Even if the motion of the cam is restricted, “it’s still a cam causing transfer motion between.the cam and follower ... it still is a cam that we’ve got up here no matter how much or how little sliding there is.” (Id. at 1782:21-23 (emphasis added).) Both experts have testified that there is “sliding contact” between the pin and the slot in the devices, and Dr. Cimino agreed that there is no definite amount of sliding contact that is required for a cam mechanism, as the “amount of sliding in a cam design can vary” (2007 Tr. at 1032:5-6).

Dr. Durfee further testified that Dr.: Cimino’s reference to the movement of the pin in the rectangular slots of the accused instruments as “mechanical slop” or “mechanical tolerance” was an incorrect characterization, because

[t]he reason why that pin moves in the slot is because'the slot moves in a horizontal motion and the pin moves in a circular motion. So, there has to be sliding between those two for the motions to be compatible. And that’s how this cam mechanism is designed. So. it’s not due to the tolerance of the instrument, it’s due to how the components áre arranged.

(Id. at 1785:7-14.)

The question of whether the mechanism contained in the accused products is a camming mechanism presents a close question that necessitated this trial. The Court finds persuasive Dr. Durfee’s explanation of how the mechanisms in the accused products both impart motion and guide along a path, in the same manner that the Court has construed the terms “camming members” and “cam slots” during claim construction. Defendant’s evidence does not show absence of movement between the pins and the slots (i.e., the “pin” is not truly “pinned” in the slot, and there is some sliding), nor have they shown that the sliding of the actuator tube does not impart motion and guide the pin within the slot, which in turn results in the opening of the jaws of the clamp members. Both parties’ experts agree that the structures used in the WAVE, LCS, CS, and ACE products are the same for purposes of the camming analysis (id. at 846), and therefore, the Court finds that all of the accused products possess a, cam mechanism as described in the Court’s claim construction.

1. The '050 Patent

Dr. Durfee opined that Claim 10 of the '050 Patent, which does not require a cam mechanism or member, is infringed by the accused ACE instruments. His expert report describes claim 10 as requiring “at least one ring positioned on the vibration coupler to seal the flow of fluids between the vibration coupler and the ■ actuator tube” is satisfied because the “ACE instruments have a series of rings positioned on the vibration coupler.... The rings form a tight fit between the vibration coupler and the actuator tube to seal the flow of fluids between the vibration coupler and the actuator tube.” (Durfee Report [PTX 538] ¶ 39.) Though he admitted on cross-examination that he had not actually tested the “rings” with liquid to see if they in fact function as sealing rings (see 2012 Tr. at 348:1-13), he said that it was unnecessary to form his opinion (id. at 348:5). In the 2007 phase, Dr. Durfee did testify about a “test” of sorts “to determine that the sealing ring was tightly fit about the vibration coupler and that the sealing ring tightly fit in the actuator tpbe.” (2007 Tr. at 718.) Defendant offered no evidence disputing his opinion, and the Court finds it more likely than not that the ACE, CS, and LSC instruments meet claim 10'of the '050 patent.

As to remaining claims 11 and 12, since each requires “camming members,” and based on his conclusion that the accused products had camming members and cam slots as specified in '050 patent, Dr. Durfee then concluded that these claims are met by the accused products’ camming members and cam slots. Dr. Durfee further opined that the pair of pivot pins in the accused products are either two pivot pins or “equivalent of pivot pins” (2012 Tr. at 306:12-13), thus completely satisfying claim 11 of the '050 patent. As to claim 12, Dr. Durfee demonstrated that the accused instrument’s actuator tube- “includes a pair of slots engageable with a pair of camming members” (id. at 308), in. support of his opinion that the accused products met all remaining claims of the '050 patent. From this evidence the Court finds that the accused products contain both pivot pins and a pair of slots engageable with, a pair of camming members, as required .by claims 11 and 12 of the '050 patent and Defendant’s accused products meet claims.11 and 12 as well.

2. The '286 Patent

As to claim 8 of the '286 patent, Dr. Durfee noted that claim 8 “added” to claim 7, which has already been found infringed by the Court. (Id. at 334.) Dr. Durfee explained claim 8 as follows:

[W]e need an actuator tube slidably positioned about the vibration coupler. That’s the tube that moves left and right that we are talking about before, and I could see it’s positioned oútside the vibration coupler and it slides with respect to the vibration coupler.

Then we nee.d a distal end of the actuator tube including a cam slot.... So again, in the '286 patent it talks about cam slots and cam members, ... and then again the Court’s definition is the one that I used when I was analyzing cam slot and cam members.

(Id. at 335:2-19.) Using an ACE instrument [PTX 603], Dr. Durfee identified where on the distal end of the actuator tube the cam slots and camming members were located (id. at 336:7-14), showed how the actuator tube was slidably positioned about the coupler, noting that “I can move the actuator tube to retracted position by squeezing the handle, to the advanced position by letting go of the handle” (id. at 336:19-24), and concluded that the “ACE instrument satisfies claim 8” (id. at 337:2-3). At the 2007 trial, Dr. Durfee had concluded that the CS, LCS, and ACE products all satisfied the elements of claim 8. (See 2007 Tr. at 769-775; see also Durfee Expert Report [PTX 115] ¶¶ 126-28.)

Dr. Durfee also testified that claim 9 was infringed:

On the ACE product, I’m holding on to the stationery handle,- and I’m now holding on to. the movable handle, which moves in relation to the stationery handle. I’ve also got that indicated in Figure A-36 on the screen. And then that movable handle is operably connected to the proximal end of the actuator tube because that’s on the inside of the instrument.

(2012 Tr. at 337:20-338:2.) He showed a close-up cross-section photograph of' the ACE instrument to demonstrate how the movable handle is “operably connected to a proximal end of the actuator tube.” (Id. at 338:8-9.)

Claim 10 calls for a “coupling member,” which the Court construed as “a component that connects two other parts.” (Cl. Construction at 4.) Dr. Durfee showed a cross-section photograph of an ACE instrument and pointed out the “coupling member” that is “kind of like a collar that tightly attaches to the actuator tube, and that also connects down to the movable handle. So, it forms a connection between the actuator tube and the movable handle.” (Id. at 339:4-8.) Dr. Durfee also opined that the CS and LCS products each have a coupling member that tightly fits to the actuator tube. (See 2007 Tr. 778-81.)

As to claim 11, which adds to claim , 10 by requiring that the coupling member include a “swivel member,” the .Court construed “swivel member” to mean “a component designed to permit the coupling member to swivel or rotate.” Dr. Durfee opined that “[t]he swivel member is included on the coupling member and it’s an open circular slot, and it’s that open circular slot that allows that coupling member to rotate in relation to the movable handle. So the ACE instrument includes the swivel member.” (2012 Tr, at 340:1-6.) Dr. Durfee also opined that the CS and LCS products had a swivel member attached to the coupling member. (See 2007 Tr. at 782-83.)

Claim 12 requires the instrument of claim 11, with the coupling member operably connected to the rotatable knob, which Dr. Durfee testified is satisfied by the ACE products, as

[t]he coupling member tightly wraps around the outer — the actuator tube. And the knob is pinned to the actuator tube. So, that’s how the coupling member is- operably connected to a rotatable knob. That rotatable knob is positioned next to the handle assembly. You can see it on the instrument I’m holding or you can see it in Figure A-40. And that rotatable knob is rotatably secured to the handle assembly so I can rotate it and it doesn’t fall off. And you can rotate that knob in relation to the handle assembly, as I’m doing now. And as I can see, I can see the clamp member rotate. And then you can’t see because it’s on the inside, but because that rotatable knob is pinned to the actuator tube, which is in turn attached to the coupling member, as you rotate that rotatable knob, the coupling member also rotates.

(Id. at 341:2-18.) Dr. Durfee also opined that this claim limitation is satisfied in the accused CS and LCS products. (See Durfee Expert Report ¶¶ 138-140.)

. Claim 13 requires that the rotation coupler be rotatably fixed to the rotatable knob, a limitation that is found in the ACE products. Dr. Durfee demonstrated that “when I rotate the rotation knob, ... the vibration coupler and the cutting jaw at the distal end of the instrument also rotate, ... and that pin goes right through the knob and right through the vibration coupler so that they all rotate together.” (2012 Tr. at 342:4-12.) There are no meaningful design differences between the ACE, CS,. and LCS products (see Durfee Expert Report at ¶¶ 141-43), and thus the Court concludes that all products are shown to satisfy the element of claim 13.

Finally, claim 14 requires an outer tube positioned about the actuator tube, with the clamp member pivotally connected to the outer tube, and the ACE products were shown to have both an outer tube and an inner, actuator tube, with the clamp member “pivotally connected,” i.e., there is a pin that runs through the clamp to the outer tube, from which Dr. Durfee concluded that claim 14 was also infringed by the ACE instruments. As with claim 13 above, there are no meaningful design differences between the ACE, CS, and LCS products (see Durfee Expert Report at ¶¶ 144r-46), and thus the Court finds that all of these accused products satisfy this claim.

3. The '5kU Patent

Dr. Durfee opined that the accused products — CS, LCS, ACE, and WAVE— embody the asserted claim limitations of the '544 patent:

As to claim 1, the accused products are ultrasound surgical instruments, with an outer tube defining a longitudinal axis, with a proximal and distal end. (Durfee Expert Report ¶¶ 65-68; 2012 Tr. at 311.) The ACE and WAVE products also include an actuation member “positioned within the outer tube” (id. at 312) and a' vibration coupler positioned within the outer tube, which has a distal and proximal end (id. at 313). All of the accused products have a jaw member extending from the distal end of the vibration coupler (id. at 314), and “a clamp pivotally mounted adjacent the distal end of the outer tube” (id. at 315). The clamps in the ACE and WAVE products are “movable in relation to the jaw member” (id.), and, using the Court’s construction of the term “camming member,” for the same reasons he used in his analysis of camming member in the '050 patent, Dr. Durfee concluded that the ACE and WAVE products also have camming members which Operatively engage the actuation member such that movement of the actuation member pivots the clamp between the open and clamped positions (id. at 316-17), thus satisfying all requirements of claim 1. As discussed supra in connection with the claims of the '050 patent, the Court finds that the accused products contain camming members and meet the remaining elements of claim 1 as well.

• Dr. Durfee concluded that claim 2 of the '544, which requires an ultrasonic instrument of claim 1, “wherein the actuation member includes a slot for receiving the camming member of the clamp,” was satisfied by the slots on the actuation members of the ACE and WAVE products (id. at 318; see also Figs A-51, B-10), which the Court also finds. Claim 3, which depends on the presence of “cam slots” is found to be satisfied by the ACE and WAVE products.

The remaining claims of .the '544 patent build on these earlier dependent and independent claims, and Dr. Durfee testified that the limitations of claims 9-13, 16, 18, 23-25 are met by the accused products. Each of these claims disclose limitations similar to those already found in the asserted claims of the '050 patent, and Dr. Durfée showed how both the ACE products embody the limitations of claims 9 (handle assembly), 10 (rotatable collar), 11 (clamp and jaw member rotatable about the longitudinal axis of outer tube), 12 (rotatable collar adjacent to handle assembly), 13 (transducer removably supported on the handle assembly), 16 (transducer horn adapted to engage a proximal end of vibration coupler), 18 (outer tube dimension to be received within a 5mm trocar assembly), 23 (at least one tissue receiving stop), 24 (jaw member and blade surface having a proximal and distal end with at least one tissue receiving stop next to proximal end of blade surface), and 25 (clamp pivotally mounted on distal end of outer tube). (See id. at 322-332). During the 2007 phase of the trial, Dr. Durfee demonstrated how, in his opinion, the accused ACE, CS, arid LCS products met all of the above claim limitations. Dr. Cimino’s dispute was limited to his view that no cam mechanism can be found in the accused products. (See, e.g., 2007 Tr. at 741.)

Dr. Durfee also opined, which Dr. Cimino did not dispute, that the WAVE products satisfied the limitations of claims 9 and 13 (2012 Tr. at 326:5-5 (“[T]he transducer screws into the back of the WAVE and is supported on to the handle assembly.”)), 16 (Durfee Expert Report ¶ 91 (“[T]he WAVE instruments have no meaningful design differences when compared to the ACE instruments, and contain the claim element.”)), and 25 (id. ¶ 96.)

Claims 6 and 8 of the '544 patent describe specifications as to' the jaw member and cutting surface of the instrument. Dr. Durfee testified that after examining the attributes of the accused CS, LCSj and ACE products, it was his opinion that they infringed claims 6 and 8 of the '544 patent.

As to Claim 6,

[Claim 6] calls for a jaw member including a — well, it adds to claim 1, and then it calls also for a jaw member that includes a curved blade surface.... It is found in the ACE product.... I can see that the jaw member is curved.

(2012 Tr. at 320:6-15; see also 2007 Tr. at 735:17-25.) Dr. Durfee also pointed out a close-up photograph of an ACE product [Fig. A-53], in which the blade surface visibly curved downward. The Court finds that the accused ACE, CS, and LCS products have jaw members that include a curved blade surface.

As to claim 8, the “curved blade surface” must include a “longitudinally extending cutting edge,” which the Court construed to mean “the edge of the blade surface designed for cutting that extends along the lengthwise dimension.” (Cl. Construction at 34.) Pointing to the same close-up photograph, Dr. Durfee explained how the cutting edge of the blade surface extended longitudinally:

It means that as you imagine yourself travelling along that cutting edge from proximal to distal end, you are going to be walking along a curved path, but as you walk, you are continually moving forward. So, you are curving and moving forward in the lengthwise dimension. So, that’s why it’s a longitudinally extending cutting edge on the ACE instrument, and this is figure A-54 that I’m referring to.

(2012 Tr. at 321:17-25.) Dr. Durfee also opined that the accused CS and LCS products had no meaningful design differences with respect to this claim, and satisfied claim 8 of the '544 patent. (See 2007 Tr. at 737-38.)

In sum, Dr. Durfee testified that he found that all the asserted claims of the '544 patent either were infringed by the CS, LCS, and the ACE or by the ACE and the Harmonic WAVE. (2012 Tr. at 333.) Based on the Court’s above conclusion that the accused products possess a camming mechanism as contained in the '544 patent and construed by the Court, the Court finds that the contested camming elements of the '544 patent are satisfied by the CS, LCS, ACE, and WAVE products. The Court also finds that the CS, LCS, and ACE products meet the claim limitations of claims 6 and 8.

B. Discussion and Conclusions of Law on Infringement

Infringement analysis entails a two-step process: “First, the court determines the scope and meaning of the patent claims asserted ... and second, the properly construed claims are compared to the allegedly infringing device.” Planet Bingo, LLC v. GameTech Int’l, Inc., 472 F.3d 1338, 1341 (Fed.Cir.2006) (internal citations and alterations omitted). “[F]or a court to find' infringement, the plaintiff must show the presence of every element or its substantial equivalent in the accused device.” Terlep v. Brinkmann Corp., 418 F.3d 1379, 1384 (Fed.Cir.2005) (internal citations omitted). To prove infringement, Plaintiffs must meet the “usual civil law standard,” that is, proof by a preponderance of the evidence. See Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed.Cir.2008).

The only testimony Defendant offered at trial to oppose Plaintiffs’ claims of infringement focused on whether the accused products contained camming mechanisms. Under this Court’s construction, the camming mechanism disclosed by the asserted claims must have “openings or grooves that impart motion to and guide the motion of the camming members.” (Cl. Construction at 11.) As Dr. Durfee testified, even if the mechanisms disclosed in the patent and in the accused devices look different, there is no requirement, that the mechanisms contained in the accused devices contain a mechanism that looks precisely like the embodiment in the patent. It can still be the same mechanism, and “absent a clear disclaimer in the specification, the embodiments in the specification do not limit broader claim language.” Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1336 (Fed.Cir.2005).

In post-trial briefing, Defendant contends that because Dr. Durfee testified on rebuttal that the single-toothed gear shown by Dr. Cimino could be both part of a rack-and-pinion mechanism and' á cam mechanism, his infringement opinion that the accused devices contain camming mechanisms should be disregarded. However, Defendant has not offered evidence to explain why a device could not, as Dr. Durfee has opined, have both the characteristics of a single-toothed gear and a cam mechanism. That the particular mechanism employed in the Defendant’s accused products may share characteristics with both a cam and rack and pinion does not have any bearing on the Court’s task in its infringement analysis, which is to inquire whether every element of the claims at issue is present in the accused devices. Planet Bingo, 472 F.3d at 1341.

As discussed above, the Court finds that Plaintiffs have met their burden of proving by a preponderance of the evidence that the mechanism contained in the accused devices is a cam mechanism. Further, Defendant offered no testimony as to non-infringement of claim 10 of the '050 patent regarding a “sealing ring,” or as to claims 10-13 of the '286 patent concerning the “coupling” and “swivel” member, or as to claims 6 and 8 of the '544 patent, which require a curved blade surface, and, as discussed above, the Court finds it more likely than not that the accused devices meet all of these claim limitations.

Accordingly, the Court finds that Tyco has proved that the accused CS, LCS, and ACE products have every element of claims 10, 11, and 12 of the '050 patent, and thus finds these claims infringed. The Court also finds that Tyco has established that claims 8-14 of the '286 patent are present in the CS, LCS, and ACE products, and thus that these claims are infringed. Finally, Tyco has shown that the CS, LCS, and ACE products infringe claims 1-3, 6, 8, 9-13, 16, 18, and 23-25 of the '544 patent, and that the WAVE 18S infringes claims 1-3, 9, 13, 16, and 25 of the '544 patent.

IV. Invalidity

These parties are neck-and-neck competitors whose race to create and patent in the advanced energy surgical device field can be seen from the following descriptions of the trajectories of their respective stages of development. These stages of development form the basis of Defendant’s claims that Tyco’s patents are invalid because of prior invention and obviousness. The Court addresses Ethicon’s defense of prior invention under 85 U.S.C. § 102(g) first, and then its 35 U.S.C. § 103 defense of obviousness.

A. Prior Invention Defense Under 35 U.S.C. § 102(g)

Ethicon asserts that claims 1, 5, 9-10 of the '050 patent, claims 1, 6, 7, and 8-14 of the '286 patent, and claims 1, 2, 9-13, 16, 18, and 23-25 of the '544 patent are-invalid on account of their prior art. Drs. Cimino and Durfee were in agreement that Defendant’s prototypes all contain those claims. Ethicon also contends, but Tyco disputes, that the curved blade claims — claim 15 of the '286 patent and claims 6 and 8 of the '544 patent are invalid because of the blades contained in the UltraCision and Ethicon prototypes.

1. Factual Findings

Ethicon’s witnesses Dr. .Tom Davison, Mark Tsonton, Gary Whipple, Dr. Joseph Amaral, and Dr. Laura Gallagher testified extensively about the development and testing on the harmonic instruments created by Ethicon in the mid-1990s. In the late 1980s, Dr. Tom Davison, an entrepreneur with a PhD in physiology, began to investigate the potential for using ultrasonic energy to cut and coagulate tissue in laparoscopic surgical procedures (see 2007 Tr. at 1285:9-1287:21), and formed Ultracision, Inc. in 1988 for the purpose of exploring and developing ultrasonic laparoscopic surgical tools (id. at 1287:22-1291:2). The ultrasonic instruments that Dr. Davison and his partners were working on use a generator that provides power to a transducer, and the transducer is coupled to an elongate metal rod called a vibration coupler (see id. at 1647:14-1649:3), with the ultrasonic vibrations carried from the proximal end of the vibration coupler to the distal end, causing the tool to vibrate very rapidly (id. at 1783:16-1784:17). Dr. Davison testified that UltraCision introduced the first commercial, ultrasonic surgical instrument, the LCS10, in 1993. (Id. at 1301:9-20.) In 1995, Ethicon-EndoSurgery acquired UltraCision.

The LCS10 was a lQ-millimeter surgical device that used ultrasonic energy. As disclosed in the Davison Patent No. 5,322,-055 (“'055 patent,” or “Davison patent” [DTX 1169]), it had a curved blade, a curved blade surface, a clamp and clamping surface, a removable transducer, tissue stop, an actuation rod, a pair of pivot pins, and a rotation knob. (See Fig. la, '055 Patent.) Gary Whipple testified that he drew a picture of a prototype of a “5-millimeter version of the 10” that was developed at UltraCision (2007 Tr. at 1363:7-8), and that picture was dated May .17, 1996 (id. at 1367:11).

The earliest date that Tyco has alleged that it conceived of its product is January 8,1997, and Tyco maintains that it reduced its invention to practice as of March 10, 1997. (See Joint Timeline [Doc. # 223] at 2; see also Surgical Response to Requests for Admission Nos. 1 & 2 [DTX 1700].) It is undisputed by the parties, and the Court finds, that this “UltraCision Prototype” was an ultrasonic-instrument created for the goal of cutting and coagulating tissue, in the same manner as the LCS 10, but with the ability to fit down a 5mm trocar, and that it was developed prior to Tyco’s invention. It is similarly undisputed that the Ethicon.Prototype was conceived of in a drawing dated November 22, 1996, and that the physical prototype went through a series of tests and modifications subsequent to that date. The only dispute at trial was whether either of these prototypes actually worked for its intended purpose, and/or whether Ethicon’s changes in these prototypes constituted “abandonment” of these initial conceptions, such that their ultimate release of the LSC5 was sufficiently different so as to not constitute “prior” art.- •

a) UltraCision Prototype

Dr. Joseph Amaral, a doctor trained in clinical surgery and the former President of Rhode Island Hospital, who assisted with the testing of the UltraCision prototype, testified at the -2007 portion of the trial that when Ethicon first acquired UltraCision back in 1995, the 5-millimeter product was already working. (2007 Tr. at 1544:9-1544-20.) ■ He testified further that: 1 '■

The product as it existed back after the acquisition worked effectively, but my interpretation what was going on is that Ethicon was also trying to understand the technology, so there were a lot of iterations that were going on ... one might clamp better, one might grasp better, one might do this better, and I remember being frustrated thinking, “Can’t you just release this thing,” and ... I really felt pretty strongly about that, because the really significant thing about this device was that it was 5-millimeter and it was a lot easier -to see.... So there was an iterative process going on, and it was frustrating, because it worked right — it worked early, right when they bought it. . < .

(Id. at 1545:24-1546:14.) He testified that very early on, prior to Ethicon’s announcement that it had acquired UltraCision, he did a demonstration for Ethicon in which he successfully “divided” the iliac artery in a pig with the UltraCision 5mm prototype. (Id. at 1543:15-1544:3.)

Dr. Laura Gallagher, Clinical Research Director at Ethicon and a trained Doctor of Veterinary Medicine, testified that between 1995 and 1998 she was responsible for the UltraCision projects, and that she “learned about the technology and observed surgery out in the field, identified the methods ,.. to test the products, develop the animal models and tested the products in preparation for 510(k) [FDA] submission.” (2012 Tr. at 428:10-14.) Dr. Gallagher testified that there were two “teams” working on the “UT5.5 team” — a Cincinnati team, of which she was a member, and a Smithfield team, of which “lead engineers” Gary Whipple and Paul Smith were members. (Id. at 434-35.) She testified that they kept diligent notes and submitted weekly reports documenting the progress of their tests. (See, e.g., Weekly Reports [DTX 1383-1459].)

In 1996, a number of tests were performed on porcine models by Dr. Gallagher and her team. She testified that “[t]he pig model is the standard for evaluating medical devices and the standard that we use for training surgeons with the technology.” (Id. at 444:8-10.) For example, in a test performed in April 1996, Dr. Gallagher identified the objective as “seefing] how [the prototype] performed in ligating and transecting vessels and soft tissue, and it was fired on the jejunal mesentery and ovarian pedicle, vascular structures in the abdomen of the pig.” (Id. at 444:14-18.) The results were that “[t]he prototype achieved good hemostasis on the jejunal mesentery and the ovarian pedicle” ' (see April 1996 Lab [DTX 1460] at 3). The prototype was also applied to the renal vein, which was measured to be approximately 4-5mm in diameter, but hemostasis was not achieved on this larger vessel. (Id. at 3.) Dr. Gallagher reflected that she was not surprised that hemostasis was not achieved on this “very large” vessel, stating, “[w]e knew it was a large vessel and it was a severe test of’the device.” (2012 Tr. at 446:24-25.)

Over the course of performing tests similar to the April 1996 test (see, e.g., July 1996 Lab [DTX 1461]), Dr. Gallagher and her team developed a grading scale that specifically addressed the transaction (or cutting) profile and the hemostasis profile.' She testified that while these standards were not “industry standards,” they helped her and her team to “be consistent in recording what [they] observed” (id. at 453:6-13). She testified that in terms of the hemostasis profile, on a scale of 1 to 5, “1 through 3 were considered acceptable and would represent what a surgeon might see in a case and be able to address.” (Id. at 454:4-7.) By the end of July 1996, Dr. Gallagher sent an email to the rest of the UT5.5 team (see 7/31/96 Email [DTX 1462] ) recommending that they invite different surgeons from various specialty areas in order to solicit their feedback. She testified that her recommendation to solicit outside feedback meant that “the prototypes were working well and that it was worth the time of the surgeons to come in and take a look at them and give us feedback.” (2012 Tr. at 456:20-23.)

On some occasions, the devices did not perform as intended. For example, during ah evaluation performed by an outside surgeon on August 23, 1996, two of the devices had problems: the UTD #3 device “generated a solid tone,” which indicated that the blade was not able to move appropriately (see 8/23/96 Evaluation [DTX 1463] ); see also 2012 Tr. at 460:7-11), and the UTD # 7 device’s “Teflon pad” that is attached to the clamp arm “curled off after 1 or 2 applications” of the device to the animal model (see DTX 1463 at 3). During that particular evaluation, only the UTK device “functioned acceptably” and was used for the dissection. (Id.) The individual UltraCision prototype devices were reused over the course of testing, and Dr. Gallagher explained that “[i]t was very routine to use them more than once. They were few in number and ... considered precious,' basically assembled by hand. Each one was unique and very unlike a manufactured device where it would have gone through very rigorous specifications for manufacturing.” . (2012 Tr. at 463.) Dr. Gallagher testified that in general, ultrasonic devices are “intended to be used for one surgery, but ... we used these multiple times due to the limited quantity.” (Id. at 463:10-13.)

Overall, it was Dr. Gallagher’s testimony, corroborating the record of successful tests on porcine models, that the Ultracision prototypes worked to cut and coagulate small vessels as of late 1996. (See, e.g., September 1996 Lab [DTX 1465].) She testified that while her team discussed whether to launch the product in December 1996, “[t]he decision was made to not launch the product ... solely for smaller vessels. Again, our predicate device was the LCS-10. That device was approved for use in vessels up to — actually including 3mm, and we had not demonstrated the capability of these devices to seal larger vessels in the labs up to this point.” (2012 Tr. at 483:1-7.)

b) Ethicon Prototype

According to mechanical engineer Marc Tsonton, in November 1996, the Ethicon prototype design was completed, as corroborated by an “exploded view drawing of a UT5.5 from the Ethicon design” dated November 22, 1996. (2007 Tr. at 1658:16-17; see also UT5.5 Drawing [DTX 1791].) Mr. Tsonton described the decision to “make changes to the design of ... the original UltraCision prototype” (2007 Tr. at 1652:18-20), and testified that the goal was “to improve the manufacturability, to improve the ergonomics of the device and to -overall reduce part count” (id. at 1652:23-1653:1). When asked what specific, changes were made to the prototypes, he testified;-“[t]here were changes made at the clamp arm attachment configuration. There were changes made to the detent mechanism that was in the handle. There were ergonomic changes made to the rotation knob and to the general handle configuration.” (Id. at 1653:3-8.) Mr. Tsonton testified that these changes did not affect the instrument’s tube-within-a-tube design, its ability to fit through a 5-millimeter trocar, or its ■ rotation knob and handle mechanism. (Id. at 1656.) He stated that his team made the “first batches” of Ethicon prototypes in December 1996, (Id. at 1657.) He also noted that “changes were made throughout the program. As we developed and we learned more about the device and how it interacted in tissue, we would make minor modifications to it.” (Id. at 1679.)

When asked by the Court about the extent-of-the changes between the UltraCision and Ethicon prototypes, Dr. Gallagher testified that she

wanted to remain unbiased to what the changes were to the deviee[s] when they brought them into the lab. They had a ... parts list or a description of the device, but I didn’t know what was different about it. So, I would use it in a normal fashion and observe what was occurring. So, there were times when I wasn’t aware, and certainly wasn’t aware if it was . anything besides the blade that had changed.

(Id. at 722:23-723:8.)

Dr; Gallagher testified about a February 1997 lab conducted by Dr. Amaral, in which he performed an ovario-hysterectomy on a goat model, in which she assisted, using an Ethicon prototype. (See 2012 Tr. at 484:21-22; see also DVD [DTX 1182].) Dr. Gallagher testified that “[a]s is often the case, at the end of the lab, you know, there is an interest to place the device on a large vessel, and so he fires it across the iliac artery of the goat.” (2012 Tr. at 485:24-486:2.) She estimated that the iliac artery that he was able to cut and seal successfully was approximately three millimeters in size. (Id. at 486:6.) Dr. Gallagher noted that once Dr. Amaral had cut across the iliac artery, in order to “severely” test the quality of the seal that he had created, he asked that the animal be given epinephrine to elevate the animal’s blood pressure. (Id. at 488.) Under these “severe conditions,” the Ethicon prototype was able to cut and seal the right iliac artery. (Id. at 489:15-19.)

Mr. Tsonton testified on cross-examination that in July 1997, the UT5.5 team met and discussed whether there was a design with which “it could move forward with the release or whether it needed to take a step back and do additional research” (2007 Tr. at 1766:8-13), and that they concluded that additional research and brainstorming was required (id. at 1766). Ultimately, the UT5.5 team prepared a 510(k) submission for the FDA on January 9, 1998. (See 2012 Tr. at 565:1-3.) They received notice from the FDA that their submission was approved on April 20, 1998 (see DTX 1817 at EES0253636), and Ethicon launched its first two 5mm products, the LCS-B5 and LCS-K5, later that year. Tyco had filed for FDA approval in May 1997, and received FDA approval and introduced AutoSonix to the commercial market in July 1997. (See Joint Timeline [Doc. # 223] at 2.) As discussed above, Tyco filed its patent applications for the '050, '286, and '544 patents on August 14, 1997. (Id. at 3.)

c) Issues with the Prototypes

Tyco points to Ethicon’s President’s Award Submission [DTX 1538], which Dr. Gallagher described as “including] the story of the development of the 5-millime-ter prototypes,” to show that the prototypes were unable to successfully cut and coagulate, that is, achieve their intended purpose. The President’s Quality Award Submission was described by Dr. Gallagher as “a contest of demonstrating proper use of processes, quality processes to assess — identify a problem, effectively look at the causal elements of it, and then create a plan to address those problems and demonstrate ultimately a successful device from that with an impact on the market” (2012 Tr. at 568:6-12). Dr. Gallagher further defined their “submission” as “demonstrating ... what the issues were before we established that process in some, you know, rigidity requirements around the process, and what happened after we