`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`
`Patent Owner.
`
`___________
`
`
`IPR2019-01657
`Patent RE47,614 E
`
`___________
`
`Record of Oral Hearing
`Held: January 13, 2021
`
`_____________
`
`
`
`
`Paper # 38
`Entered: 1/27/21
`
`
`
`
`
`
`
`
`Before RICHARD H. MARSCHALL, JASON W. MELVIN, and
`SEAN P. O'HANLON, Administrative Patent Judges.
`
`
`
`
`
`
`IPR2019-01657
`Patent RE47,614E
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`DOUGLAS CARSTEN, ESQUIRE
`Wilson Sonsini Goodrich & Rosati PC
`12235 El Camino Real
`#200
`San Diego, CA 92130
`
`RICHARD TORCZON, ESQUIRE
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street, N.W.
`Washington, D.C. 20006
`
`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`W. KARL RENNER, ESQUIRE
`JOHN S. GOETZ, ESQUIRE
`Fish & Richardson P.C.
`1000 Maine Avenue, S.W.
`Washington, D.C. 2004
`
`
`
`
`The above-entitled matter came on for hearing on Wednesday, January
`13, 2021, commencing at 10:00 a.m., EDT, at the U.S. Patent and
`Trademark Office, by video/by telephone.
`
`
`
`
`
` 2
`
`
`
`IPR2019-01657
`Patent RE47,614E
`
`
`
`
`
`
`
`
`
`P R O C E E D I N G S
` - - - - -
`THE USHER: Hearing IPR 2019- 01657 and we are ready
`
`to go.
`
`JUDGE O'HANLON: Good morning, everyone. You can
`be seated if you're standing. This is a hearing in case IPR 2019-
`01657, Mylan Pharmaceuticals Inc. v. Sanofi-Aventis
`Deutschland GmbH concerning U.S. P atent No. RE47,614. I'd
`like to begin by having counsel for the parties introduce
`themselves, starting with Petitioner please.
`
`MR. TORCZON: Good morning, Your Honors. I'm
`Richard Torczon, lead counsel for Petitioner Mylan
`Pharmaceuticals. With me and presenting argument today is
`Doug Carsten in San Diego and on the audio line we also have
`Tasha Thomas from our team and I believe representatives from
`Mylan are on the line and possibly the other real parties of
`interest.
`JUDGE O'HANLON: Thank you, Mr. Torczon. So Mr.
`Carsten will be presenting all the argument today or will you be
`splitting it?
`MR. TORCZON: Mr. Carsten will present all of the
`argument, your Honor.
`MR. CARSTEN: Good morning.
`JUDGE O'HANLON: Good morning, Mr. Carsten. Thank
`you, and who is representing Patent Owner, please?
`
`
`
`
` 3
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`
`MR. RENNER: Yes. Good morning, Your Honors. This is
`Karl Renner from Fish & Richardson. I'm joined by my
`colleague John Goetz. Also on the line we have several people,
`representatives from Sanofi as well as from Petitioner's, sorry
`Patent Owner's counsel. We'll be splitting our time today. John
`will present on some of the issues. I will present on others. So
`we'll both be speaking.
`JUDGE O'HANLON: So Mr. Renner and Mr. Goetz, is that
`how you pronounce it?
`MR. GOETZ: Yes, sir.
`JUDGE O'HANLON: Goetz, thank you very much. So
`thank you all. I am Judge O'Hanlon. I am joined by Judges
`Melvin and Marschall. A few housekeeping items before we get
`started. First of all, thank you for your flexibility in conducting
`this all video hearing this morning. If at any time during the
`proceeding you encounter technical or other difficulties that you
`feel undermine your ability to adequately represent your client
`please let us know, for example, by contacting the team members
`who provided you with the contact information for today's
`hearing.
`To minimize the potential for distractions, please mute
`yourselves when you're not speaking, and when referencing
`demonstratives, papers, or exhibits, please clearly state the paper
`number or slide number so we can follow along more easily and
`for clarity of the record.
`
`
`
`
` 4
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`
`Per our order dated December 17th, each side will have 45
`minutes of total time to argue. Petitioner will go first followed
`by Patent Owner and each side may reserve time for rebuttal. I
`will be keeping time but with this video hearing there's no
`common clock for us all to look at so please keep track of the
`time yourselves. If you run over during your argument in chief
`I'll let you continue using time that you reserved for rebuttal, but
`again – I'll try and let you know when this happens but please
`also keep track of your time yourselves.
`As usual, speaking objections are not allowed. If you have
`anything to note you can do so during your time to argue and
`finally, please be aware that members of the public may be
`listening to the hearing today. And with that, I'll invite Mr.
`Carsten to begin. Mr. Carsten, would you like to reserve any
`time for rebuttal?
`MR. CARSTEN: Yes, I would. I'd prefer to use 25 minutes
`now and reserve 20 minutes if possible.
`JUDGE O'HANLON: Okay.
`MR. RENNER: Your Honors, may I -- I’m not seeing the
`video for Your Honors. Are others seeing -- seeing everyone
`involved? I can see all counsel and Alan , I can see a box for
`you and an accordion box for no video for the judges.
`
`(Pause, for technical assistance.)
`JUDGE O'HANLON: Okay. If there are no other technical
`issues, Mr. Carsten, you may begin when you're ready.
`
`
`
`
` 5
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`
`MR. CARSTEN: Thank you. Good morning. Douglas
`Carsten representing Petitioner Mylan and may it please the
`Court. This IPR posits the question is it obvious to use a spring
`washer with leg or fixing elements to link one component or hold
`one component against another and the answer is resoundingly
`yes. We'll spend about 25 minutes up front just sort of walking
`through the level of skill in the art and the application of that
`skill, what that person knew, and so the three references that we
`rely upon.
`I'd like to call your attention to three things that I think
`you'll be hearing from my counterparts repeatedly through their
`proceeding and presentation and I'm going to call them the
`triumvirate of errors. First, you're going to hear Sanofi minimize
`the application of the level of skill in the art, again this is in
`violation of KSR . They're going to have this person not apply
`the normal level of skill in this predictable field. Second, you're
`going to hear them misread patents, the patent at issue here, the
`Harms patent, as well as the prior art. And third, you're going to
`hear a piecemeal response to the art that we cite in connection
`with our obviousness arguments and that was specifically called
`out, for example, in the Board's Institution decision at page 21,
`and Sanofi never rectified that error throughout the proceeding.
`If I may turn to slide 2, there are 18 claims at issue here.
`Four of them are independent. Let's turn to slide 3. This is
`representative claim 1 that claims a complete device, the device
`
`
`
`
` 6
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`that's operational and that device includes a spring washer with
`at least two fixing elements configured to axially and
`rotationally fix the spring washer relative to that housing.
`On slide 4 I've got the other three independent claims here
`and I pointed out some of the slight differences between them,
`but in large part Sanofi has argued this case in bulk. They've
`argued with one or two minor exceptions the claims all together.
`What is the Petitioner's case for obviousness here? I'm at
`slide 5. Petitioner set forth, Mylan set forth in detail how each
`and every element of the asserted claims here is found in the
`Burren reference with additional spring washers and additional
`fixing elements specifically taught in Venezia and De Gennes.
`Slide 6. The Board understood our argument and that's --
`the panel understood. I call the panel's attention to some of the
`slides that my counterparts will present. They won't address
`Burren as a whole. They won't address Venezia as a whole.
`They won't address de Gennes as a whole. They won't address
`all three together. Instead, what they will do is they will parse
`and cut up Burren and say the second specific embodiment of
`Burren doesn’t apply and they'll focus on the first specific
`embodiment of Burren and they won't address the overarching
`disclosure, the broader disclose that we'll see in Burren. That's
`one of the triumvirate of errors.
`Let's turn to Harms. That's the patent that's being
`challenged here. I'm at slide 8, and Harms has a very broad
`
`
`
`
` 7
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`disclosure about spring washers. It says, I've got a portion of the
`specification here at column 5, lines 10 through 20:
`"The loaded spring washer may hold the cartridge and the
`cartridge retaining member in permanent abutment on the distal
`end side."
`What does it say about the same elements of fixing? I'm on
`slide 9. The fixing element disclosure in Harms is similarly
`flawed and it allows expressly motion. I've got a passage here
`on slide 9 from the Harms patent. It is column 5, lines 29
`through 43 and if I may read the penultimate sentence on that
`excerpt:
`"Of course, axial movement of the spring washer 50 for
`loading the spring washer or during relaxing of the spring washer
`is allowed."
`It goes on in the last sentence excerpted here:
`"Fixing elements 52, preferably do not rotate and/or do not
`move axially during operation of the drug delivery device."
`Again, preferably. Some motion is allowed. Now as an
`aside I'd like to dispatch of an argument most easily shown in
`Sanofi's surreply. Sanofi, I'm here at slide 10, in their surreply
`had a footnote. They made the argument before but this is the
`most clean excerpt of it. It says Sanofi disagrees with Mylan's
`assertion in the petition that the Harms patent provides an
`alternative fixing element structure. This portion of the
`specification citing column 5, lines 61 through 67, describes
`
`
`
`
` 8
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`characteristic features of a "positioning element." Well we can
`look at column 5. I've got it excerpted immediately underneath.
`Each and every instance in the specification there talks about
`positioning and fixing elements interchangeably. You can look
`through it yourself.
`JUDGE O'HANLON: Mr. Carsten, that seems to be I guess
`directed to the Patent Owner's proposed construction of fixing
`elements. But if you look at the claims, looking at claim 1 for
`example, it requires that the fixing elements be configured to
`axially and rotationally fix the spring washer relative to the
`housing. So don't the claims specify that the spring does not
`move relative to the housing regardless of whether there may be
`instances in the specification that say in some embodiments it
`may move relative to the housing?
`MR. CARSTEN: I don't believe so. So there isn't -- what
`Sanofi is trying to do is to read the word completely into the
`claims, to completely fix, to not move at all and that's simply not
`found anywhere in the art. So in each instance, a person of skill
`in the art as Dr. Erdman identified understands the way that
`these spring washers operate. They operate by flexing. They
`operate by giving a bit in order to press one component up
`against another. So there will always be some degree of motion
`or some degree of latitude required during the setting of the
`device and that's the way the spring washers move, spring
`washers operate. They have to have that ability to give, ability
`
`
`
`
` 9
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`to move slightly in order to make that (indiscernible.)
`JUDGE O'HANLON: So you're referring to simply the
`flexion of the spring but not movement of the fixing elements;
`correct?
`MR. CARSTEN: Well, but if you move the spring
`obviously the fixing elements will need to accommodate that
`motion as well and that's I think what's being taught in the
`Harms reference and throughout the art that we've cited. Let's
`talk about Venezia, if I may. Venezia for example has the
`tongue and the slot iteration. The slot is defined to accept the
`tongue to hold it fixed. Is there some play in that? Probably. In
`part because the tongue is on the hump piece of the spring
`washer. You could minimize that moving and maybe eradicate it
`all together by moving the tongue elements on to the flat sides of
`the spring washer.
`Let's also look at the second specific embodiment of Burren
`which has the snap -fit. That snap-fit once you click it in it
`should hold it relatively fast but given tolerances, there will or
`inevitably be the ability for there to be some motion. The claims
`cannot require perfection because that -- the entire premise of
`the point here, the invention which is known from Schofield and
`others which we'll get to, is to account for tolerances,
`differences between, for example cartridges, in holding them
`steady in the device and so as a result, you know, to say that a
`spring washer which itself has tolerances that fits into another
`
`
`
`
` 10
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`piece of a device which itself has tolerances to require no
`movement at all simply undermines the reality of the world. It
`just doesn't make any sense and that's what Dr. Erdman said and
`that's a second version or iteration of the triumvirate of errors
`that we see here is that Sanofi sort of glides over the way that a
`person of skill in the art would understand this predictable art to
`operate by requiring, for example, this fundamental perfection in
`fixation. You know, you can say that a boat anchors and that
`boat is fixed, but it still allows the boat to move with the tides.
`That's still fixed. It's attached and it's attached securely, but it
`still accounts for what we're talking about here. There are
`tolerances. There are real world consequences and springs have
`to flex. That's the way that springs operate. So I would disagree
`with Sanofi's construction but I think the construction issue may
`well also be a red herring in a sense.
`Let me talk about the petition here. So we relied upon
`these three references. Burren as the overarching reference and
`then supplemented by two more specific references that added
`color to the spring washer and fixing element and those two
`references are identified and were included in part because we
`read the term fixing elements as we were preparing the petition
`and said aha, Sanofi might come back and say this is means plus
`function and if it's means plus function that would be the
`narrowest possible construction you would have. You'd have
`simply the disclosed structures for that function as well as
`
`
`
`
` 11
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`statutory equivalence. Any construction that Sanofi can provide
`would necessarily be broader than that construction, the means
`plus function and I submit with respect that we satisfied our
`burden, that we've rendered obvious the claim based upon the
`arguments in the petition under even that most narrow and most
`stringent claim construction. So I don't believe that there's a
`claim construction issue that needs to be addressed given that
`Sanofi in its first paper raised a red flag on means plus function
`112(6) this issue.
`So I submit that simply reading the claim under its plain
`and ordinary meaning or even under Sanofi's construction which
`means to securely attach and these are securely attached, as in
`view of the Harms disclosure. I don't think that we have a claim
`construction issue and I believe Mylan has met its burden. I see
`perhaps a member of the panel has a question.
`JUDGE MELVIN: Yes, I do. This is Judge Melvin. So I
`just want to make sure I understand your point about relative
`motion. I mean you argue on one hand that because the spring
`must flex it is a moving element and so there must be some
`motion of the spring permitted, right? But then you use the
`analogy of an anchor and that matches fairly closely to the
`analogy I was thinking of, which is holding oneself still while
`standing on a subway train, right? So in both of those examples,
`the anchor point itself may be perfectly fixed while allowing
`relative motion at the other end, right? So the boat moves with
`
`
`
`
` 12
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`the tide. You might jostle a bit on the subway train but
`nonetheless, that doesn't necessarily mean that the anchor point
`itself moves, right? So, you know, here it's the fixing element. I
`think that maybe what I want to understand is that there are two
`arguments you're making and I want to make sure I understand
`them correctly.
`So one is the spring itself has to flex and so that requires
`some relative motion but I think you would agree that that's not
`necessarily relative motion at the fixing element and then you
`have another argument that is well, because of the practical
`realities of the world, the fixing element itself also needs some
`tolerance and therefore will allow some relative motion of the
`fixing element itself. Is that accurate?
`MR. CARSTEN: That's absolutely correct. So there are,
`well as we all know every action has an equal and opposite
`reaction and so there are consequences to the spring requiring a
`flexure.
`JUDGE MELVIN: Right.
`MR. CARSTEN: And so, well for example when you're on
`the subway train and the voice comes over the speaker hold on,
`we're pulling into the station, it's time to stop. You know, your
`feet may well shuffle. Your fixed point, your anchor may well
`shuffle simply because of there's a consequence of the effects
`going on your upper body where your center of gravity is for
`example; correct? So I think that you need to -- a person of
`
`
`
`
` 13
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`skill, a skilled artisan understands that there has to be some
`accounting at the fixing point that allow for that kind of, for the
`stresses that the spring washer itself will encounter.
`Secondly and separately I think that there is the
`requirement, just a real world requirement that there's going to
`be tolerances between where the item fixes and the fixing
`element or structure, whatever it might be, snap-fit, slot- fit,
`whatever, and you can by design -- you know, it's tongue slot as
`in Venezia for example -- you can minimize the parameters of
`construction of manufacture such that that tongue is held very,
`very tightly and may not move perceptibly at all. But if you're
`going to say that fixed securely means absolutely still during the
`entire operation of the device, then that can't happen and that's I
`think one of the points that Dr. Erdman makes.
`So yes, there are two arguments there and I think frankly
`based upon the disclosure we just saw of Harms I think that
`Sanofi's construction is wrong. But again, I think it may be a red
`herring because to my mind we've already established
`obviousness under the most stringent possible claim construction
`which is 112(6) and so whatever claim construction Sanofi
`wishes to build upon or put upon that's consistent with Harms,
`we would meet that as well.
`JUDGE MELVIN: Are you sure that it's necessarily true
`that any construction other than a means plus function
`construction will be broader than the means plus function
`
`
`
`
` 14
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`construction?
`MR. CARSTEN: Well, the only wrinkle I have -- so the
`construction is obviously the structures that are disclosed in
`Harms that propose the function if it were means plus function,
`right?
`JUDGE MELVIN: Right.
`MR. CARSTEN: Hold on to the statutory equivalence, so I
`suppose theoretically you might be able to come up with a
`construction that accomplishes or that builds and meets all of the
`disclosed structures would somehow thread a needle through and
`doesn't capture all of the statutory range of constructions. But
`I've wracked my brain on this, Your Honor, and I can't think of a
`possible construction that would do that here that would be
`consistent with the structures in Harms.
`JUDGE MELVIN: Well, maybe your view is that Patent
`Owner is taking too narrow a view of the required function and
`actually has nothing to do with the structure itself, right? That
`the function Patent Owner is reading from the claim is one of
`absolute securement or fixation --
`MR. CARSTON: Exactly, Your Honor.
`JUDGE MELVIN: -- and that's where you take issue.
`Okay.
`MR. CARSTEN: And the fixing element, you know, it's
`required to be configured to hold that spring washer, right? I
`mean the word fixed appears there of course but it doesn't
`
`
`
`
` 15
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`require that the fixing element be completely irretrievably, you
`know, motionless. I don't see the word motionless. I don't see
`complete. I don't see any of those concepts in the claim
`language and when I read the Harms disclosure as a person of
`skill, a skilled artisan would, I see a lot of talk about preferably
`and I see a lot of talk about allowing tolerance for movement.
`So I think that the construction is just incorrect but again, I don't
`believe that that's dispositive. I don't think that -- I think under
`any construction that's consistent with Harms patent .
`JUDGE MELVIN: Thank you.
`MR. CARSTEN: If I may I'd like to -- I've got maybe, I
`did a lot of the things I wanted to talk about up front. I've got
`about seven minutes according to my clock. I think it's
`important to know sort of or point out just a couple of ideas here.
`I'm at slide 13 and 13 is a discussion about what a person of skill
`in the art knew. Here is an excerpt from a textbook, a 2000
`textbook by Norton and identifies spring washers. These spring
`washers are ubiquitous and tellingly at page 802 it talks about
`spring washers and what a person of skill in the art, a skilled
`artisan, would know about them. It says,
`"All provide a push force and are commonly used to load
`something axially, such as the take up end play on a bearing."
`So, you know, these things are well known taught to first
`year mechanical engineers and on the next slide 14, we've got a
`patent from the 1950s, the Schofield patent which talks
`
`
`
`
` 16
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`specifically about accommodating various lengths of cartridges
`in an injection device and they do that by using a spring washer.
`So this concept has been around forever and the tool box in
`this predictable art that a skilled artisan sees before him or her is
`replete with spring washers. This is nothing new and moreover I
`think an interesting point that Dr. Erdman raised is the Harms
`patent itself requires that the skilled artisan apply that level of
`skill, that knowledge by virtue, and here I've got on slide 16 a
`passage or paragraph from Dr. Erdman's declaration. You know,
`those broad disclosures in Harms require the use of the person of
`skill in the art to put on their thinking caps to implement what it
`is that's being taught. There's very little detail provided.
`Now, I'd like to just turn to a couple of other issues. I've
`got about five minutes left on the clock here but obviously I
`want to make sure that I'm addressing whatever issues or
`questions or concerns that the panel has, so feel free. I talked
`earlier about the triumvirate of errors that --
`JUDGE MARSCHALL: Excuse me. I'm going to step in
`here, Judge Marschall.
`MR. CARSTEN: Yes.
`JUDGE MARSCHALL: I know you probably are ready for
`it in rebuttal given the layout of your slides, but I'd like you to
`address the argument that de Gennes is not analogous art and in
`particular like to know how you define the problem to be
`addressed.
`
`
`
`
` 17
`
`
`
`IPR2019-01657
`Patent RE47,614E
`
`
`MR. CARSTEN: Okay. Certainly. So I think that de
`Gennes, well de Gennes is analogous art. I mean we know that
`by virtue of the Donner case, the Donner case that both sides
`have cited, the recent Federal Circuit case from November of last
`year. So obviously it's a two question analysis. We're not
`saying that automotive art, for example, are identical to medical
`device art.
`So the first prong we can see no, that's not accurate. But
`on the second prong the question is reasonable pertinence, right?
`Is the solution provided here in de Gennes reasonably pertinent
`to a person of skill in the art, a skilled artisan, in solving the
`problem. The problem here as I see it that I think as Dr. Erdman
`tellingly identifies in his declaration is the holding of -- the
`accounting for tolerances among cartridges in this medical
`device. The abutment of one component against another using a
`spring washer with these to fixing. So that's what we're looking
`at and when we look at that problem we see that Schofield solved
`that problem of abutting a cartridge against another by using
`spring washers. We see that Burren taught spring washers using
`legs or using fixing elements, the snap-fit in the second iteration,
`second specific embodiment for example plus the disclosure.
`But remember we just looked at --
`JUDGE O'HANLON: I'm sorry. Is it your position that
`Burren discloses a spring washer?
`MR. CARSTEN: Burren, well Burren certainly I believe
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 18
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`teaches a spring washer in the specification, the broad disclosure
`of Burren. To my mind there's no question. The specific
`embodiments --
`JUDGE O'HANLON: And it discloses a spring washer with
`fixing elements? Is that what I just understood you to say ?
`MR. CARSTEN: I believe it does disclose that or that it
`teaches that to a person of skill in the art in the specification. I
`do believe, yes and I think that was our position. I understand
`that the Patent Owner had some difficulty with some of the --
`that perhaps previously issued decision but I believe that that is
`correct. If I may just complete my response to the analogous art,
`then I can switch over to the Burren disclosure because I think
`that's an important point.
`We just looked at the Norton reference which identified
`spring washers ubiquitously and said hey, spring washers are
`used to load axially and even to take up end play in bearings. I
`mean look at de Gennes. It is using a spring washer, although
`it's called a cover, it is a spring washer with these fixing
`elements to bias one component against another in very much the
`same way that Harms talks about that and specifically in the tool
`kit the person of skill in the art, the skilled artisan, understands
`that spring washers are used to take up end play with bearings.
`de Gennes is a bearing reference. I mean, and this is
`fundamental. So I believe that the use of the cover of the spring
`washer with the fixing element in de Gennes is absolutely
`
`
`
`
` 19
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`analogous art and meets every reasonable pertinent case out there
`including the recent Donner .
`JUDGE MARSCHALL: When you're looking to define the
`scope of the problem, are you looking to Burren for that
`definition of the problem or are you looking to Harms itself, or
`both?
`MR. CARSTEN: Thank you for the question. It doesn't
`really matter. I know that Sanofi has made a big deal about that
`but I point the panel to the Chamberlain case, 944 F.3d 919
`which talks about, sorry, do we have that? I apologize. Not the
`Chamberlain case. The Talkowski case which I think we cited in
`our opening paper and so --
`JUDGE O'HANLON: The Board opinion case, correct?
`MR. CARSTEN: Yes, exactly. And so, you know, I think
`that the error or the problem to be solved, excuse me, is really
`identical presented between Burren and Harms. They're both
`interesting in solving the same issue and that is on the Burren
`side accommodating various cartridge lengths and on the Harms
`side identifying the cartridges. So whether you look at this as
`focusing in on the problem described in the prior art or the
`problem that's encountering -- that the patent is attempting to
`solve -- it's the same problem. In addition to that, the cases that
`I cited absolutely allow for an examination of the prior art to
`identify the problem and it's consistent and 100 percent on all
`fours with the problems being identified in Harms. So I don't
`
`
`
`
` 20
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`think --
`JUDGE O'HANLON: Did d e Gennes focus on that same
`problem? I think you defined it as accommodating a cartridge
`length, varying cartridge lengths. It doesn't seem that de Gennes
`is addressing that problem at all.
`MR. CARSTEN: Well, I think it is addressing the holding,
`the taking up end play in a bearing by applying axial force to
`hold one component and abut it against another and that's exactly
`the problem that -- and that's exactly the thing that spring
`washers are known to be used for by, even from fundamental
`knowledge based upon the Norton textbook that we saw. So it's
`all absolutely consistent and the problem is the same problem. It
`just happens to be a different thing.
`Now what Sanofi wants to do here is to define a problem in
`a way that excludes much of the spring washer art. But if you
`allow Sanofi to play with the definition and description of the
`problem, you can always come up with a problem that essentially
`makes almost every piece of art out there not analogous, and so I
`think that what we've got here is Sanofi trying to make the
`problem or position the problem in a way that excludes so much
`art. But even if the panel were to decide that d e Gennes were not
`analogous art here, I still think that we've met our obligations to
`prove obviousness here.
`I see I'm already two minutes or so over the time I've
`allotted. I would like to address about the Burren disclosure if I
`
`
`
`
` 21
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`IPR2019-01657
`Patent RE47,614E
`
`may very, very briefly and I think, you know, you're looking at
`the Burren disclosure of springs -- I've got slide 19 -- it talks in
`great detail about compensating springs, et cetera, and then in
`addition to that at slide 23 this is from paragraph 16. This is the
`broad disclosure of Burren divorced from one of the two specific
`embodiments:
`"A spring in accordance with the present invention may be
`a tension spring, flexion spring or torsion spring and, in some
`preferred embodiments, a compression spring. Its shape may be
`that of a coil spring, leaf spring, plate spring, a spring with legs,
`for example, or any suitable configuration."
`That is about as broad of a disclosure as you can imagine
`with respect to springs so I submit that a person of skill in the
`art, as confirmed by Dr. Erdman, that a person of skill in the art
`would understand that Burren teaches spring washers and of
`course it also teaches the use of fixing elements. So yes, I
`believe that a person of skill in the art would unders
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
