Trials@uspto.gov
`571-272-7822
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`Paper No. 44
`Date: September 9, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INTUITIVE SURGICAL, INC,
`Petitioner,
`
`v.
`
`ETHICON, LLC,
`Patent Owner.
`____________
`
`IPR2019-00880
`Patent 7,490,749 B2
`____________
`
`Record of Oral Hearing
`Held: June 9, 2020
`____________
`
`
`
`Before JOSIAH C. COCKS, BENJAMIN D. M. WOOD and
`MATTHEW S. MEYERS, Administrative Patent Judges.
`
`
`
`
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`571-272-7822
`
`
`
`
`Paper No. 44
`Date: September 9, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INTUITIVE SURGICAL, INC,
`Petitioner,
`
`v.
`
`ETHICON, LLC,
`Patent Owner.
`____________
`
`IPR2019-00880
`Patent 7,490,749 B2
`____________
`
`Record of Oral Hearing
`Held: June 9, 2020
`____________
`
`
`
`Before JOSIAH C. COCKS, BENJAMIN D. M. WOOD and
`MATTHEW S. MEYERS, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`KENNETH W. DARBY, JR., ESQ.
`Fish & Richardson, P.C.
`111 Congress Avenue, Suite 810
`Austin, Texas 78701
`
`JOSHUA A. GRISWOLD, ESQ.
`Fish & Richardson, P.C.
`1717 Main Street, Suite 5000
`Dallas, Texas 75201
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`IPR2019-00880
`Patent 7,490,749 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`STEVEN R. KATZ, ESQ.
`Fish & Richardson, P.C.
`One Marina Park Drive
`Boston, Massachusetts 02210
`
`CHRISTOPHER M. PEPE, ESQ.
`Weil, Gotshal & Manges, LLP
`2001 M Street, Suite 600
`Washington, D.C. 20036
`
`ANISH DESAI, ESQ.
`Weil, Gotshal & Manges, LLP
`767 Fifth Avenue
`New York, New York 10153
`
`
`
`
`The above-entitled matter came on for hearing on Thursday, July 9,
`
`2020, commencing at 9:00 a.m. EDT, by video.
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`IPR2019-00880
`Patent 7,490,749 B2
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE MEYERS: -- for IPR 2019-00880. This is Judge Meyers and
`
`here with me are Judges Cocks and Woods. Oh, excuse me, Wood.
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`Will counsel for Petitioner please introduce themselves?
`
`MR. KATZ: Thank you, Your Honor. This is Steven Katz with Fish
`& Richardson. With me is Kenneth Darby and Josh Griswold on the audio
`line and also I believe that Scott Mosko from Intuitive will be joining the
`audio, but I don’t believe he has and today’s argument will be handled by
`Kenneth Darby.
`
`JUDGE MEYERS: All right. Thank you, Mr. Katz.
`
`All right. Will counsel for Patent Owner please introduce
`themselves?
`
`MR. PEPE: Good morning, Your Honor. This is Christopher Pepe.
`I’ll be arguing for Patent Owner. With me on the line and video is Anish
`Desai who is lead counsel and I believe Mike Timmons from -- on behalf of
`Patent Owner is also on the audio line.
`
`MR. TIMMONS: Yes, I am. Thank you, Your Honors.
`
`JUDGE MEYERS: All right. Thank you, Mr. Pepe.
`
`According to the hearing order, I believe both sides will have 45
`minutes; is that correct?
`
`MR. PEPE: Yes, Your Honor. That sounds correct.
`
`JUDGE MEYERS: Okay. Petitioner proceeds first to discuss its case
`and they will reserve rebuttal time to reply to Patent Owner’s arguments.
`Patent Owner will then proceed with its case and may reserve rebuttal time
`to surreply to Petitioner’s reply.
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`Patent 7,490,749 B2
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`Before we begin, I would like to ask the parties to identify their slides
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`by number for the court reporter and for the benefit of the judges that are all
`remote at this time. With that, we’d like to begin.
`
`Petitioner, I don’t really have a clock so I’m going to -- or actually a
`phone with me right now to set a timer. So I will ask Judge Cocks or Judge
`Wood if you could set a timer. How much time would you like to reserve
`for rebuttal?
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`MR. DARBY: I’ll be reserving 10 minutes for rebuttal and 35
`minutes for opening.
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`JUDGE MEYERS: Okay. So 35 minutes for opening, all right. And
`10 for rebuttal. All right.
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`All right. Judge Cocks or Judge Wood, would you mind setting a
`timer?
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`JUDGE COCKS: Judge Meyers, this is Judge Cocks. I’ll go ahead
`and set the timer.
`
`JUDGE MEYERS: Thanks. I appreciate that.
`
`All right. With that, you can begin.
`
`MR. DARBY: Okay. Thank you, Your Honors. This is again
`Kenneth Darby speaking for Petitioner. We’ll start today on Slide 2. It’s a
`-- there’s a quick preview of things we’ll be discussing today so we’ll start
`with an overview of the ‘749 Patent, very brief overview, and then we’ll talk
`about the instituted grounds, in a few words our claim construction and then
`we’ll dive into the arguments and we’re going to talk about all three
`arguments at play with Grounds 1 and Grounds 2.
`
`Ground 1 is the Shelton II ground, Ground 2 is the Swayze ground.
`We’re going to talk about in Ground 1 a unique anticipation argument to
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`IPR2019-00880
`Patent 7,490,749 B2
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`Shelton II and then we’ll talk about another flavor of anticipation that
`applies to both Shelton II and Swayze. We’re going to go a little bit out of
`order here and then we’ll follow-up with obviousness that again both applies
`to both Shelton II and Swayze.
`
`So with that, I’ll move to Slide 4 so we can answer the question what
`is the ‘749 Patent all about. Well, the abstract here tells us that the ‘749
`Patent is about a surgical stapling and severing instrument particularly suited
`for endoscopic procedures. So it’s an endo stapler. And the ‘749 Patent’s
`endo stapler has a retraction system and the abstract tells us that it’s
`manually actuatable and it does not require the use of additional springs or
`other mechanisms to generate retraction forces. So it’s a fully manual
`retraction system. That’s what the ‘749 Patent is about.
`
`So if we turn to the claims, I’m on Slide 5 now, we see how this fully
`manual retraction mechanism (indiscernible) claim. The claim says,
`“Retraction assembly supported by said handle assembly and interfacing
`with said firing drive such that manual actuation of said retraction assembly
`causes said firing drive to generate a sole retraction motion.” And that’s the
`key phrase, “sole retraction motion.” That’s how inventors decided to claim
`a fully retraction -- or excuse me, a fully manual retraction assembly so
`we’re going to focus on that.
`
`I think you see in the briefs that all three of the references in the
`petition; that’s Shelton II, that’s Swayze and that’s Shelton I, all three of
`those references provide this feature. Now, all of the other features of Claim
`1 and Claim 3, the challenged claims and I’m going to focus again on those
`first two references. I’m going to focus on Shelton II and Shelton I -- or
`excuse me, Shelton II and Swayze.
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`IPR2019-00880
`Patent 7,490,749 B2
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`So we turn to Slide 6. We see here that Swayze and Shelton II are
`
`filed on the same day. Now, Swayze is 102B art and Shelton II is 102A art
`and they were published on different days, but they were filed on the same
`day and they have extremely similar disclosures. They’re nearly identical
`and we’ll talk about the differences between them, but they’re nearly
`identical. And they’re also very similar to the ‘749 Patent and we can see
`that if we move to Slide 7.
`
`So it’s the ‘749 Patent, Shelton II, Swayze disclosure, similar type of
`surgical instrument, a pistol-grip style of endo stapler, similar firing drive,
`similar firing trigger. As we see on Slide 8, the bottom of the slide, well
`even the manual retraction assemblies are very similar. Both in the ‘749
`Patent and in Shelton II, Swayze, we see a retraction lever, a driver gear set
`and that gear set interfaces with the firing drive.
`
`
`Now, here you can see that the levers are oriented in an opposite
`direction, but the drive, the gear set, all the same and the gear seat interfaces
`with the firing drive all the same. No debate about that. So we can ask
`ourselves then what’s different. Well, we see the top of the slide. The ‘749
`Patent, well it does not have a retraction spring. ‘749 Patent is on the left
`and on the right we see the Shelton II/Swayze device and this device does
`have a retraction spring, and so what does that spring do?
`
`Well, it does two things. First thing it does is it automatically retracts
`the firing member. It brings the firing member from its fired position to its
`retracted position by pulling on the firing drive. The spring is connected to
`the firing drive in this picture. And the other thing that it does is if it cannot
`generate enough force to automatically retract, well it will provide an
`assisting force to the user who is using the manual retraction assembly.
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`IPR2019-00880
`Patent 7,490,749 B2
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`Those are the two things the spring does.
`
`So if we look at Slide 9, well Shelton II and Swayze, they tell us that
`this spring, sometimes it doesn’t work because it becomes disconnected.
`When it’s disconnected, it doesn’t do anything. Doesn’t do either of those
`two things we just discussed. Doesn’t automatically retract, doesn’t provide
`assistance for manual retraction. It doesn’t do anything. It disconnects. It’s
`just held in the handle assembly.
`
`JUDGE COCKS: Counsel, this is Judge Cocks. I have a question for
`you. So do I understand you correctly to be basing, I guess, an anticipation
`argument on a status of Shelton II in which it is non-functional, it is not
`working and can’t do what it is intended to?
`
`MR. DARBY: I think the answer to that question, Your Honor, is I’ll
`say that we are putting forward an anticipation case based on the spring
`being disconnected, but the device is absolutely still functional. The device
`still functions. The spring doesn’t function to do its job of automatic
`retraction and assisting manual retraction, but the device is absolutely still
`useable and, in fact, Shelton II and Swayze tell us how the device functions.
`
`At this point, the only way to put a retraction motion on that firing
`drive to pull the firing member back to its retracted position, that’s through
`the manual retraction assembly and so that’s our case. We’ll discuss it in a
`little bit more detail here in a bit, but yes, that’s the nature of our case, Your
`Honor.
`
`JUDGE COCKS: Okay. Thank you.
`
`MR. DARBY: So with that, I’ll turn to the instituted grounds. Let’s
`look at Slide 12 together. So there are three grounds instituted. Ground 1 is
`Shelton II, Ground 2 is Swayze, Ground 3 is Shelton I and we’re going to
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`IPR2019-00880
`Patent 7,490,749 B2
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`rest on the briefing for the Shelton I ground, Ground 3, but I will say just a
`quick word on it. If Your Honors are not convinced that the presumption
`against 112(6) have been overcome on this record and if you agree with us
`that Ethicon hasn’t established an early reduction of practice (indiscernible),
`then the claims do fall under Ground 3. Ethicon has not made any argument
`about why Shelton II wouldn’t -- or excuse me, Shelton I wouldn’t anticipate
`under a non-112(6) interpretation, so those arguments are waived.
`
`So we can turn back to Grounds 1 and 2. There are three arguments
`here as I mentioned. The first argument applies only to Shelton II and that
`argument is in the red box and it says that a POSITA would have
`immediately envisioned the device without a retraction spring. So Shelton II
`has an additional disclosure that provides and puts in the mind of a POSITA
`same device minus the spring.
`
`Our second flavor of anticipation is going to apply both to Shelton II
`and to Swayze and that’s in the blue box. And that argument is that every
`limitation is met when the spring becomes disconnected as we just
`discussed. And then finally the third argument is an obviousness argument.
`That argument says that there is ample record -- or excuse me, ample
`evidence on this record to find that a person of skill would have been
`motivated to remove the retraction spring.
`
`Now, if Your Honors agree with us on any one of these three
`arguments then the challenged claims fall. So Slides 13 and 14, I’ll just say
`a brief word on them. We mainly put these slides in here for Your Honors
`convenience just to collect all of the various constructions that have been
`articulated by the parties, by the ITC in that co-pending litigation, but again
`we’re going to rest on the briefing here and I’ll tell you why.
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`IPR2019-00880
`Patent 7,490,749 B2
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` The arguments that we’re going to discuss today, the Shelton I and
`
`Shelton II arguments, they don’t rise or fall with any of these constructions.
`So no matter which construction the Board were to adopt, the claims would
`be obvious under the three arguments that we’re going to talk about here
`today. Now, the term “retraction assembly,” I’ll note it here, that particular
`term we’ll talk about it with the disconnected spring argument, but even
`there I think you’ll see that the construction is not determinative of the
`outcome of the case.
`
`So with that, I will turn to Slide 18. This is the first argument. This is
`the anticipation by Shelton II. So we talked a bit about Swayze, we talked a
`bit about Shelton II. We said they have nearly identical disclosures. For
`example, both describe that spring being disconnected where the device
`functions, but without the spring doing either of its two that -- doing either
`of its two jobs, but Shelton II provides some additional disclosure.
`
`Shelton II tells us that manual retraction can be utilized without the
`spring. They’re going to focus on that additional disclosure because that’s
`the basis of our anticipation argument here and so let’s look closely at that
`disclosure. If we turn together to Slide 20 and what does Shelton II tell us?
`Well, Shelton II tells us at paragraph 148 here at the top of the slide that the
`illustrated embodiments are not intended to be limiting, that the disclosure is
`broader than those embodiments, those embodiments that show us a spring,
`a retraction spring connected to the firing drive in some conditions and in
`other conditions the spring being disconnected.
`
`So we’re going to talk about something different and new, a
`modification. Paragraph 148 tells us -- and indeed all paragraphs after 148,
`they all describe something that’s not in the illustrated embodiments. That’s
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`IPR2019-00880
`Patent 7,490,749 B2
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`key. And paragraph 154, well that’s no different. It’s describing something
`new, something that’s not in the illustrated embodiments. And so 154 tells
`us that manual retraction mechanism consistent with aspects of the invention
`may be utilized without the assistance of a retraction spring. And so we
`ask ourselves, well how does a person of skill interpret that language? A
`person of skill interprets it as there is no spring in this embodiment. This is
`a modification from the illustrated embodiments. We know the spring
`becomes disconnected. 154 is telling us that we don’t need the spring.
`
`Now, you’ve no doubt read in Ethicon’s briefing that their position on
`this is that automatic retraction is a pivotal feature of Shelton II and that it’s
`so critical to that disclosure that a person of skill in the art couldn’t possibly
`envision that device without a spring, but I think paragraph 152 here says
`otherwise. Paragraph 152, what does it tell us? It tells us that automatic
`retraction may be desirable, it’s not mandatory. In fact, a manual retraction
`can be incorporated without that feature.
`
`And if we turn to the claims, Shelton II -- I’ve got them up on Slide
`22 here, this is Claim 1 of Shelton II and Claim 1 doesn’t tell us that
`automatic retraction or a retraction spring were critical to the disclosure of
`the invention of Shelton II. Here we don’t see anything about an automatic
`retraction or a retraction spring. What we see here are features consistent
`with manual retraction, the manual retraction assembly described in Shelton
`II.
`And so before I move on, the last thing I’ll say is this. I’m going to
`
`answer one of the arguments that’s in Ethicon’s surreply on the issue of Dr.
`Knodel’s testimony. Now, the surreply says that Dr. Knodel in deposition,
`that he disagreed with everything we just discussed despite the clear
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`IPR2019-00880
`Patent 7,490,749 B2
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`language from Shelton II. The surreply says Dr. Knodel, Intuitive’s expert
`disagrees with all of these arguments. That’s not the case, Your Honors. Of
`course I think when you read the testimony in its entirety, and it starts at
`about paragraph -- or excuse me -- page 35 of the deposition, you’ll agree
`with me that Dr. Knodel has not wavered from the key issue here and the
`key issue is would a POSITA reading paragraph 154 understand that there’s
`disclosure and enough there to envision the device without the spring. Dr.
`Knodel never wavered on that.
`
`So with that, I’m going to pause here to see if there are any questions
`before we move onto the disconnected spring argument.
`
`JUDGE MEYERS: I don’t think we have any questions. Why don’t
`you go ahead and move onto that --
`
`JUDGE WOOD: No questions.
`
`JUDGE MEYERS: -- argument.
`
`MR. DARBY: Okay. Will do. Thank you. So with that, we can
`move together to Slide 42. So here again is the disconnected spring we see
`on Slide 42. And so again Shelton II and Swayze, they tell us that
`sometimes this spring becomes disconnected, but the device still functions.
`Paragraph 144 of Shelton II describes how the device still functions to
`retract the firing drive. And then at this moment when the device is in this
`condition that’s clearly disclosed in the prior art, Shelton II and Swayze, at
`this moment there’s only one way to place a retraction motion on the firing
`drive and that is through a manual retraction assembly. And so at this
`moment in this condition, the claims are anticipated.
`
`Now, if we turn back together to Slide 40, you’ll see the legal basis
`for this argument that we discussed again in briefing. That’s the Broadcom
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`IPR2019-00880
`Patent 7,490,749 B2
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`and Brown federal circuit cases here. So what do they tell us? Well,
`Broadcom says that, “an accused device” -- and again, we’re talking about a
`device claim; endo device. When “an accused device that sometimes, but not
`always, embodies the claim nonetheless infringes.” And the Brown case
`tells us, “That which infringes if later anticipates.”
`
`And so what we have here is disclosure of a device, and again we’re
`talking about a device claim, disclosure of a device that sometimes, but not
`always, embodies the claim. It embodies the claim when the spring is
`disconnected and that disclosure came a full two years before the ‘749
`Patent and that’s why the ‘749 Patent’s claims are anticipated.
`
`Now, interestingly here, I had previewed that I was going to talk about
`claim construction, so I’ll do that here. So I mentioned at the beginning of
`our conversation that the sole retraction motion is the -- what appeared to be
`the key claim language in the ‘749 Patent, but, in fact, Ethicon is not arguing
`that sole retraction motion is not met by the disconnected spring. What
`Ethicon is arguing as we can see on Slide 46, bottom of the slide, what
`Ethicon is arguing here in this proceeding is about the term “retraction
`assembly”. It’s a disavowal claim construction argument that attempts to
`read in a negative limitation to the claims.
`
`So Ethicon says that a retraction assembly would exclude “a retraction
`spring that serves to place a drag on the firing system.” There are two
`problems with this argument. The first is, as I said at the beginning, it’s not
`outcome determinative. It’s irrelevant. We’ll talk about that, but it also
`doesn’t meet the legal standard. It’s not supported by the specification and
`we’ll talk about that as well.
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`So the first one of those, why is this claim construction irrelevant?
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`IPR2019-00880
`Patent 7,490,749 B2
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`Well, when that spring becomes disconnected, that’s the condition of the
`device we’re talking about. We’re not talking about when a spring is
`connected and places drag on the firing drive. Again, we’re talking about a
`device claim not a method of use claim.
`
`Now, the second reason is that when that spring becomes
`disconnected, well it’s certainly not part of the retraction assembly and
`we’re talking about an open-ended comprising claim and a comprising claim
`doesn’t exclude extraneous components like, for example, a disconnected
`spring. That’s why the argument, this claim construction argument, is
`irrelevant. It doesn’t affect the outcome of the case.
`
`But why does it not meet the legal standard? Let’s talk about that.
`Well, the standard for a disavowal theory which is what Ethicon is
`advancing here has a very high -- it’s a high bar. The parties agree here that
`the standard is clear and unequivocal evidence. Clear and unequivocal
`evidence that the inventor intended to limit his claims. So there cannot be
`any doubt. There can’t be any doubt, but when we turn to the ‘749 Patent
`and look at the specification we don’t have that unequivocal evidence here.
`So let’s look at the ‘749 Patent, Slide 47.
`
`There we see highlighted in yellow language that’s consistent with
`Ethicon’s drag argument. So the ‘749 Patent talks about a retraction spring
`that places a force on the firing drive that has to be overcome during firing.
`That’s what they mean by drag. But in red we see here that the ‘749 Patent,
`it’s going to preface those statements with “in various embodiments.” In
`fact, that’s consistent throughout the specification. “In this embodiment,”
`“in various embodiments” as it relates to this notion of drag.
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`So then we ask ourselves, “Well, what does the ‘749 Patent tell us
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`IPR2019-00880
`Patent 7,490,749 B2
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`about its embodiment,” and we can look at Slide 48 together and see. The
`‘749 Patent tells us that the illustrative embodiments are not limiting. It says
`here that, “It is not the intention of the Applicant to restrict or in any way
`limit the scope of the appended claims to such detail as the illustrated
`embodiments.
`
`So at the bare minimum, this is introducing doubt as to whether or a
`person of skill -- or excuse me, whether or not the inventors intended to limit
`their claims, but I would go further. I would go further here Your Honors
`and I’d say -- and, in fact, this is telling us something in unequivocal
`language. Now, (indiscernible) that the claims are not intended to be
`limiting -- limited by those illustrative embodiments.
`
`And so just to recap, our position is that when the spring becomes
`disconnected, at that point the device is still functional and every element of
`the claim is met and thus the claim is anticipated. Ethicon responds that the
`claim construction argument -- that that claim construction argument is
`irrelevant, doesn’t change the outcome here. That claim construction
`argument also is not supported by the specification.
`
`So I’ll pause here one more time before we switch gears to talk about
`obviousness.
`
`JUDGE COCKS: Counsel, actually I do have one question and not to
`belabor this, but does Shelton II ever describe intentional disconnection of
`the spring or is it always described as some sort of state of dysfunction of the
`device?
`
`MR. DARBY: It said in this very -- well, it doesn’t say that the
`device isn’t functional. It just says that the spring is disconnected I guess is
`what I’m trying to say. It just says it’s not --
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`JUDGE COCKS: Just let me rephrase. Does Shelton II anticipate
`
`disconnection of the spring intentionally?
`
`MR. DARBY: The term I’m struggling with is “intentionally”. I
`think that Shelton II intentionally describes, and Swayze as well, that the
`spring becomes disconnected and so I would say that there is definitely
`anticipation of the spring becoming disconnected.
`
`JUDGE COCKS: Thank you.
`
`MR. DARBY: I’m not sure how it becomes --
`
`JUDGE COCKS: Mr. Darby.
`
`MR. DARBY: -- (indiscernible).
`
`JUDGE COCKS: I understand the point that -- what you’re saying. I
`guess my question though is that Shelton II does not desire the spring to be
`disconnected. I understand it contemplates that that might occur, but that’s
`not a desired result or desired occurrence; is that correct?
`
`MR. DARBY: I think that is correct, Your Honor. It’s not disclosed
`as a desired occurrence. That’s correct.
`
`JUDGE COCKS: Okay. Thank you.
`
`MR. DARBY: Absolutely. So with that, we can turn to obviousness.
`If we could turn to Slide 27 together and just rest here to do a quick recap
`because we’ve covered quite a bit. We’ve talked about Shelton II’s
`disclosure of a device that doesn’t utilize the retraction spring. That was our
`first argument. We talked about Shelton II and Swayze and the disconnected
`spring disclosure. Now we’re going to talk about why the record also
`supports that a person of skill in the art would have been motivated to
`remove the spring and thus the claims are rendered obvious.
`
`Before we talk about those reasons, why a person of skill in the art
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`would remove the spring, let’s flip back to Slide 10. Let’s talk about the
`state of the art (indiscernible) of the ‘749 Patent. So there’s been some
`debate in the briefing about conventional wisdom. What was the
`conventional wisdom at the time of the ‘749? Well, Ethicon’s position is
`that conventional wisdom was automatic retraction, but the record doesn’t
`support that.
`
`What the record shows is that both automatic retraction and fully
`manual retraction were known in the art. They were both part of the
`conventional wisdom. We could see here at the top of the slide in the patent
`disclosure which is one of several that Dr. Knodel explains in his declaration
`that is a pistol grip endo stapler, very similar to the ‘749, very similar to
`Shelton II, Shelton I and Swayze. Pistol grip endo stapler and it’s got a fully
`manual retraction mechanism. The user pulls back on these manual
`retraction knobs to effect retraction.
`
`And this embodiment, it was not just in the patent literature. It had
`also made its way up the market we see at the bottom of the slide. The
`commercial embodiment of the patented disclosure at the top of the slide.
`This is the Endo-GIA by US Surgical and it was a commercial success
`before the ‘749 Patent and so a person of skill in the art, they would have
`known. They would have known about this device. They would have
`known that a fully manual retraction mechanism was in -- was known in the
`art, it was in the market and had been successful. I think that’s important
`that we keep that in mind as we turn to the reasons why a person of skill
`would take out that retraction spring from Shelton II and Swayze.
`
`If we turn to Slide 34, so the first reason is that removing the spring
`will lower the firing force and what we mean by that, lowering the firing
`
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`force, it would be easier to squeeze the trigger of the instrument to fire it and
`there’s no dispute on this record that removing the spring would lower the
`firing force.
`
`If we turn to Slide 35, it’s also indisputable on this record that a
`person of skill in the art would have considered force to fire as something to
`account for in a design, so
`Dr. Knodel knows that from personal experience as he testified here. And so
`how does he know? Well, Dr. Knodel has been designing medical devices
`for 30 years and he spent several of those years at Ethicon designing pistol
`grip endo staplers or endo staplers, some of which were pistol grip, Your
`Honors.
`
`And so why is that important to lower the firing force? If we turn to
`Slide 36, we can see in the contemporaneous literature that there was a quest
`in the art to lower firing force. They want to lower it “to a level that all or a
`great majority of surgeons can handle,” and the reason for that is two-fold.
`Well, one we want a low firing force because surgeons are -- come in all
`different shapes and sizes and some have greater hand-strength than others
`and so we want to make a device that’s useable by many different surgeons.
`We want to broaden out that customer base and that’s important for
`marketability.
`
`Now, another reason is that lowering firing force makes it easier for
`the surgeon to keep their hand still and during an endoscopic procedure,
`that’s of paramount importance. Just to bring this to life a little bit, I mean,
`you can imagine yourself holding this device. You’ve got the handle
`assembly here and I’ll point it your way, is the end effector, and it’s inserted
`into the patient’s body in a small incision and you’re trying to keep your
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`hand very steady during the firing process. Now, it’s going to be a lot easier
`to do that if there’s a low firing force. If it’s a high firing force, you might
`start to see some shaking which could damage -- this can be damaging for
`the surrounding tissue. So those are reasons why a person of skill in the art
`would want to have a low firing force.
`
`Now, Ethicon says that Shelton II and Swayze, they don’t have a
`force-to-fire problem because there are measures that are already based into
`the design that help with reducing firing force and I’d answer that with this.
`First, we don’t need a problem articulated in the prior art. We don’t need the
`prior art to tell us there’s a problem, not for obviousness. That would be the
`TSM test that was rejected by the Supreme Court in KSR. I would also say
`that two things can be true at once. So the Shelton II /Swayze device can
`have measures in place to help with firing force, but it can also be true that
`removing the spring and, in fact, this is undisputed, removing the spring
`lowers that force even more and helps with these benefits that we’ve just
`described.
`
`Now, Slide 37. We have yet another reason, it’s the second reason
`and there are more in the petition, there are more in the reply, but we’ll
`discuss these two. Lowering of manufacturing costs. So when we talk about
`eliminating the spring, taking the spring out, we don’t just mean the spring.
`We mean all of its supporting componentry as well.
`For example,
`there’s anti-backup mechanism in Shelton II/Swayze and its job is to prevent
`the spring from prematurely retracting the firing member. Well, if we don’t
`have the spring, we can take that out and then we can also take out the
`automatic retraction mechanism and its job is to release the backup
`mechanism when the firing member gets to the end of its firing stroke.
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`And so we’re talking about taking out a full suite of components from
`
`this device and that’s going to significantly reduce the number of parts,
`streamline assembly and the device is going to work just fine and we know
`that because Shelton II and Swayze tell us that the device can work without
`the spring. When the spring is disconnected, it still works. So we’re going
`to have lower --
`
`JUDGE COCKS: Counsel?
`
`MR. DARBY: -- manufacturing --
`
`JUDGE COCKS: Counsel?
`
`MR. DARBY: Ye s?
`
`JUDGE COCKS: This is Judge Cocks. Sorry to interrupt. I have one
`question. Is there any example, any item of prior art in the record that shows
`an endoscopic
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