UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`NATUS MEDICAL INC., NATUS NEUROLOGY INC.,
`EMBLA SYSTEMS LLC., and EMBLA SYSTEMS LTD.,
`Petitioners,
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`v.
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`NOX MEDICAL EHF,
`Patent Owner.
`_____________
`
`Case IPR2016-01822
`Patent 9,059,532 B2
`____________
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`Record of Oral Hearing
`Held: December 14, 2017
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`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and AMANDA
`F. WIEKER, Administrative Patent Judges.
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`NATUS MEDICAL INC., NATUS NEUROLOGY INC.,
`EMBLA SYSTEMS LLC., and EMBLA SYSTEMS LTD.,
`Petitioners,
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`v.
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`NOX MEDICAL EHF,
`Patent Owner.
`_____________
`
`Case IPR2016-01822
`Patent 9,059,532 B2
`____________
`
`Record of Oral Hearing
`Held: December 14, 2017
`____________
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`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and AMANDA
`F. WIEKER, Administrative Patent Judges.
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`Case IPR2016-01822
`Patent 9,059,532 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JEREMY ADELSON, ESQUIRE
`Hanson Reynolds LLC
`316 N. Milwaukee Street
`Suite 200
`Milwaukee, WI 53202
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`CHAD E. NYDEGGER, ESQUIRE
`Workman Nydegger
`60 East South Temple
`Suite 1000
`Salt Lake City, UT 84111
`
`
`
`
`The above-entitled matter came on for hearing on Thursday,
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`December 14, 2017, at 1:01 p.m., at the U.S. Patent and Trademark Office,
`Madison Building East, 600 Dulany Street, Alexandria, Virginia, before
`Walter Murphy, Notary Public.
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`Case IPR2016-01822
`Patent 9,059,532 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE MITCHELL: Thank you everyone. You can be seated.
`Good afternoon everyone and welcome. We have a final hearing this
`afternoon in case IPR2016-01822 between Petitioner Natus Medical Inc.,
`Natus Neurology Inc., Embler Systems LLC, and Embler Systems Ltd., and
`Patent Owner Nox Medical EHF. I know that we have and some
`housekeeping issues to take care of before we get started with the arguments
`and some possible, I know for objections to demonstratives and possible use
`of confidential information here, but before we do that let me get
`appearances for the record. So I’d like to start with Petitioner.
`MR. ADELSON: Thank you, Your Honor. For Petitioner, Jeremy
`Adelson and with me today are Joe B. (phonetic) Reynolds, lead counsel,
`and Marlee Jansen, also of record.
`JUDGE MITCHELL: Hi. Thank you, and welcome. And for Patent
`Owner.
`MR. NYDEGGER: Good afternoon, Your Honors. Chad Nydegger
`from Workman Nydegger. With me I have my partner, David Todd, also
`from Workman Nydegger and then we also have two client representatives.
`We have the CEO of the Patent Owner, Nox Medical, Peter Halldorsson, and
`then we have the Chief Technical Officer and one of the inventors on the
`532 patent also from Nox Medical, Sveinbjorn Hoskuldsson.
`JUDGE MITCHELL: Great. Thank you and welcome. So let me
`start first with the housekeeping matters of dealing with objections to
`demonstratives. The panel has certainly looked at the papers from both sides
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`on the objections to the demonstratives and we feel like we understand
`certainly your respective positions on those demonstratives, and we feel like
`the best way to handle it at this point is just when you’re doing your regular
`argument if you would like to say something about the demonstratives of the
`other side that is certainly fine and in Patent Owner’s case they may need a
`rebuttal of Petitioner. But there was no demonstratives that we saw that we
`would exclude from the presentation at this time, but you’re certainly
`welcome to make comments about whether it’s, you know, you believe it’s a
`correct representation of the record.
`So, and I know there was the possibility of Patent Owner -- oh, and let
`me introduce the panel, I’m sorry. I just went through. I am Judge Mitchell
`who is presiding, and with me to my right is Judge Franklin, and appearing
`remotely is Judge Wieker. So that is the panel. Forgive me for not doing
`that earlier.
`So let me see, with Patent Owner I know there was maybe a
`possibility of you presenting confidential information during the hearing and
`did not know, or at least it was in a demonstrative, so did not know if either
`party was prepared to present confidential information in oral argument
`today. So either of you.
`Mr. NYDEGGER: You would like me to go over this?
`JUDGE MITCHELL: Sure, that would be great.
`MR. NYDEGGER : Your Honor, on the part of Patent Owner our
`primary concern was with the demonstrative of Petitioners that contains
`contractual information of the Patent Owner with their distributors, and so
`that’s the confidential information that we were concerned about. We didn’t
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`feel that our demonstratives contained particularly sensitive information or
`that we would be getting into sales figures or actual numbers or things,
`maybe talking about some general trends, but we didn’t feel that we’d be
`getting into the level of confidentiality in the discussion that would require
`exclusion for the purposes of what Patent Owner is presenting.
`JUDGE MITCHELL: Okay, great.
`MR. NYDEGGER: And obviously because it’s Patent Owner’s
`contract that Patent Owner representatives are certainly welcome to be here
`for that portion of it.
`JUDGE MITCHELL: Sure. Thank you. And for Petitioner, and I’m
`sorry I got that confused as to who was talking about the confidential
`information.
`MR. ADELSON: Thank you, Your Honor. We have some materials
`in our presentation that are both confidential information of the Patent
`Owners, as well as of Petitioners. We have spoken with our client and have
`clearance from our client to reveal the confidential -- actually information
`that was derived from highly confidential information in this proceeding but,
`again, at a high level and that will not constitute a waiver of the underlying
`documents or any of that information, as long as we keep it at a high level,
`that should be fine.
`JUDGE MITCHELL: Okay, wonderful. So at this point I understand
`we’re not going to present in open hearing today any confidential
`information for which I need to clear the courtroom?
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`MR. ADELSON: That’s correct as far as I understand. I notice there
`are two other gentlemen that were not identified. I’m not sure who those
`gentlemen are. That would be the only question I have.
`JUDGE MITCHELL: Okay.
`MR. NYDEGGER: I can identify the two other gentlemen. The two
`other gentlemen are also from the law firm of Workman Nydegger. We’ve
`got Justin Cassell who is partner at the law firm, and then also Peter
`Shiozawa who is – have you graduated yet?
`MR. SHIOZAWA: No.
`MR. NYDEGGER: Yes, he’s a law student who is clerking with our
`law firm.
`JUDGE MITCHELL: Great. Thank you, and welcome. Is that, for
`Petitioner is that --
`MR. ADELSON: That’s fine. I was just making sure if we had
`members of the public in here or not.
`JUDGE MITCHELL: Okay. Thank you. Well let me just run over a
`couple of housekeeping matters that I generally like to go over before the
`hearing. I know we’ve got the Oral Hearing Order which is sort of how
`things are going to work in the oral argument. We set forth our procedure in
`the Oral Hearing Order and each party is given 45 minutes a side for
`argument, of total time for argument. It is very important for the clarity of
`the record that you refer to an exhibit, especially for our remote judge, and
`that you state what the exhibit is, and the page number to which you are
`referring, and if you’re referring to a demonstrative please state the slide
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`number and certainly for the remote judge and for the clarity of the record
`when we go back through it.
`The parties must at all times -- oh, sorry, that’s not pertinent, we just
`have one case. Petitioner has the burden of showing unpatentability of the
`challenged claims, so the Petitioner is going to go first and present
`arguments and may reserve some time for rebuttal on the main case and then
`Patent Owner will have an opportunity to present its arguments, and I think
`that’s all.
`MR. NYDEGGER: Your Honor?
`JUDGE MITCHELL: Yes.
`MR. NYDEGGER: On the issue of that, whereas the Patent Owner
`has the burden of the initial production with regard to secondary
`considerations evidence, we would request that we would be able to have a
`reply on that portion because we do carry the initial burden of production on
`that issue.
`JUDGE MITCHELL: Generally because it’s still Petitioner’s burden,
`overall burden, we generally don’t permit reply at that point on secondary
`considerations because that is, you know, something you raised to rebut or
`for us to look at on the overall obviousness context, but because it is
`Petitioner’s burden we generally do not have time reserved for Patent
`Owner. I mean, for motions to exclude I have done that where you carry the
`burden on the motion to exclude, exclusively for that you can reserve time
`for rebuttal, but not for the main case.
`MR. NYDEGGER: Thank you.
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`JUDGE MITCHELL: Thank you. And Petitioner, would you like to
`reserve some time for rebuttal?
`MR. ADELSON: Yes, Your Honor. If we could reserve 20 minutes.
`JUDGE MITCHELL: Okay. So 25 minutes for your main case?
`MR. ADELSON: Please.
`JUDGE MITCHELL: Okay. And whenever you’re ready.
`MR. ADELSON: Your Honor, did you want me to hand out
`demonstratives at this point?
`JUDGE MITCHELL: That would be fantastic, yes, thank you.
`MR. NYDEGGER: Would you like us to hand ours out now as well?
`JUDGE MITCHELL: That would be fine too. Thank you.
`MR. ADELSON: Your Honors, we appreciate the opportunity to
`address the Board today and we have a brief presentation as to why the
`Board was correct in instituting these proceedings and why the challenged
`claims of the 532 patent should be cancelled. As I present these materials, if
`you have any questions please let me know.
`Turning to slide 2. In instituting these proceedings the Board made a
`preliminary decision that the challenged claims were likely invalid based on
`the presented prior art. Because Nox does not contest the validity or the
`invalidity of dependent claims 2 through 9 and 13 on separate grounds other
`than the underlying issues of ground claim 1, this proceeding can be largely
`addressed with respect to claim 1. As claim 1 falls, so do all the dependent
`claims.
`To the extent Nox challenges the invalidity of claim 1 it relies on
`narrow claim constructions to create minor disputes as to the disclosures of
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`the prior art. It argues whether there is sufficient motivation to combine the
`references of record and it tries to rely on secondary considerations despite
`the fact that it has not demonstrated the requisite nexus. But Nox’s expert
`could not identify any new technology in the 532 patent or any unpredictable
`way in which these known elements were combined and that Nox’s expert
`confirms that all limitations were known in the prior art is important for
`three main reasons.
`First, it affirms what is disclosed by the prior art of record and known
`by PHOSITA’s. Second, when all the limitations are known an obviousness
`analysis focuses on whether these old elements have been arranged in any
`new and unpredictable way. There is nothing unpredictable to a degreed
`engineer, the agreed upon PHOSITA, about wrapping a conductor around an
`engaging member adjacent to receiving hole to make electrical contact with
`a male snap inserted into that receiving hole. Third, when all the limitations
`of a claim are known any presumption of a nexus between the claims and the
`purported secondary factors, and I quote from Ormco v. Align Tech., Inc.,
`“are clearly rebutted.”
`We will address these issues in greater detail and demonstrate that
`claims 1 through 9 and 13 of the 532 patent are invalid and that the Board
`should cancel these claims.
`Turning to slide 3. As noted, Nox does not separately contest the
`dependent claims 2 through 9 and 13, so with claim 1 they all fall together.
`Nox also does not contest that most of the elements of claim 1 are taught by
`the prior art of record. All of the limitations, other than the second
`limitation, which relates to a fastener configured to fasten the frame are
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`taught by McIntyre and Nox does not contest that the frame fastener
`limitation as you might call the second limitation is taught by Linville and
`Kristbjarnarson.
`To focus these proceedings we have highlighted the limitations that
`Nox contests are not present in McIntyre. Now Nox relies upon
`unreasonably narrow claim constructions for its -- upon these terms. But the
`Board has already rejected Nox’s narrow construction of passing through
`holding that the BRI of that term does not require exiting and there is no
`basis for Nox’s construction of wrapped around to require any amount or
`degree of being wrapped around. The claim itself tells you what these words
`mean. It’s just they need to be wrapped around and passing through just so
`that when a male snap is inserted into the receiving hole, the conductor
`makes physical contact with a lateral surface of a male snap. That is it.
`To advance its narrower claim constructions, Nox however relies on
`extrinsic dictionary definitions which the Federal Circuit generally regards
`as unreliable and Nox misrepresents the prosecution history and Dr.
`Williams’s report in the related litigation. Nothing in Nox’s amendments of
`its claims during prosecution required a conductor to exit the receiving hole.
`JUDGE MITCHELL: Let me ask you a quick question. Where do
`you stand in the District Court litigation? Where is that in that proceeding?
`MR. ADELSON: We are past summary judgement briefing in that
`proceeding. We have a summary judgement hearing coming up in January
`and the trial date I believe that is set for late April at this time.
`JUDGE MITCHELL: Okay. Thank you.
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`MR. ADELSON: Dr. Williams acknowledged the District Court’s
`construction of passing through that was consistent with a PHOSITA’s
`understanding does not mean that the District Court’s construction is co-
`extensive with the full meaning of that term. As the entirety of Dr.
`Williams’s report explains, a PHOSITA would not limit that term, and with
`particular attention to the entirety of paragraph 59 of Exhibit 2020. Nox’s
`constructions are incorrect but as we will discuss, even after these
`differences between what Nox says its claims require and what is disclosed
`by the prior art are so insignificant and obvious to a PHOSITA that they
`cannot save the claims.
`Turning to slide 4. The Board instituted these proceedings on three
`prior art references; Exhibit 1018, McIntyre; Exhibit 1012, Kristbjarnarson;
`and Exhibit 1013, Linville. These are just examples of the many electrode
`belt and belt connectors that are known in the industry and admitted to exist
`by the 532 patent. In particular, the 532 patent admits that electrode belts
`and connectors are known for use in respiratory inductance
`plethysmography, which has been referred to as RIP, in various papers and
`in these proceedings and for cardiography measurements and have various
`connectors. This can be found in Exhibit 1001 at column 1, lines 12 through
`16. Numerous other prior art belts exist as evidenced by the other prior art
`of record in the petition as well as in Dr. Williams’s reports.
`Turning to slide 5. The Board agreed with Petitioners and found that
`all the limitations of claim 1, save the frame fastener limitation we already
`discussed, were found in the embodiment of figure 14 of McIntyre shown on
`this slide. For ease of viewing we have highlighted the conductor that
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`appears 622 in the upper right hand corner of this figure and that conductor
`passes through the receiving hole 650 while wrapping around the retention
`member 648 or retention plate of that device as they follow that S shaped
`pathway around the form of the retention plate, and –
`JUDGE MITCHELL: Can I ask you a question? Can you point to
`any evidence in record either way in McIntyre to whether that conductor
`exits or does not exit that receiving hole?
`MR. ADELSON: Sure, Your Honor. If you look in the lower right
`hand corner, we have a depiction there, it’s a cross-section of the channel
`that’s described in the text that’s on the slide where McIntyre expressly
`describes that there is a channel that holds the conductor. So in a sense the
`conductor is kind of partially in the receiving hole and partially out of the
`receiving hole so to the extent that there would need to be an exiting, there is
`at least a portion of the conductor that lies outside the receiving hole.
`In addition, during deposition with Mr. Oslan, Nox’s expert, he agreed
`that an obvious variant of this design would be to include a slot so that it
`would allow the end of the conductor to extend out of it. That variant is
`depicted in Exhibit 1055 and the record is clear on this point. Nox has
`disputed whether Mr. Oslan so agreed, but at Exhibit 1060 at page 178, line
`24 to page 179, line 1, he agreed that a PHOSITA would consider such
`variation stating, and I quote, “It might, yes.”
`JUDGE MITCHELL: Did Mr. Williams testify as to why one of skill
`in the art would do that variant?
`MR. ADELSON: I’m sorry, Dr. Williams or Petitioner’s expert?
`JUDGE MITCHELL: I’m sorry, Dr. Williams.
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`MR. ADELSON: No, he did not specifically testify as to why one
`would make that particular modification.
`JUDGE MITCHELL: Okay.
`MR. ADELSON: If you have no further questions on figure 14, I’ll
`proceed.
`JUDGE MITCHELL: Let me ask you. This did not come from
`McIntyre, right? This is a figure that Dr. Williams drew or where does this
`figure come from?
`MR. ADELSON: The figure in the lower right hand corner?
`JUDGE MITCHELL: Yes.
`MR. ADELSON: It’s a representation of the text that’s there on the
`screen. There’s been some confusion on the part of Nox as to whether or not
`there is a channel or not in the device. There have been allegations that Dr.
`Williams has changed his position throughout this proceeding but it has
`always been that there is a channel that holds the conductor and whether we
`say that the structure of that channel includes a floor or walls or a ridge, it’s
`all the same position.
`JUDGE MITCHELL: Okay. Thank you.
`MR. ADELSON: Turning to slide 6. As explained in the petition,
`McIntyre teaches multiple different electrode connector designs and
`expressly teaches PHOSITA’s that these different embodiments should be
`combined. In addition to the embodiment of figure 14 we just discussed, the
`embodiments of figure 12 and 13 also teach the limitations of claim 1. Both
`embodiments include plastic frames with receiving holes specifically that are
`designed to be resilient to snap on to a male snap. Figure 13 shown in the
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`lower left corner has a conductor that wraps around and passes through a
`receiving hole. That conductor is highlighted again in yellow and then in the
`upper left hand corner we have figure 12 which includes slots and elongated
`members which are other parts of the claim limitations.
`On the right we have a visualization of the description in the reply at
`page 17 where it was discussed the idea of combining these two
`embodiments. This is a representation of that express discussion.
`JUDGE MITCHELL: Did Dr. Williams opine on this particular
`representation?
`MR. ADELSON: Dr. Williams opined on the structures in general in
`support of the petition in the opening report and talked about those, but he
`did not render a specific opinion on this depiction.
`JUDGE MITCHELL: And let me ask you before we move on. In
`Petitioner’s view this is an alternative in McIntyre that also shows the claim
`limitations or teaches the claim limitations of these particular
`representations, do we need to use components of figures 12 and 13 in
`combination with 14 to arrive at the claimed invention?
`MR. ADELSON: No, Your Honor. We believe that this is a separate
`combination of elements in McIntyre, so figure 14 includes all the
`limitations save the belt fastener limitation. Figures 12 and 13 likewise have
`all of the relevant elements save the belt limitation.
`There is also -- in addition to the motivation that McIntyre expressly
`teaches to degreed engineers that they should combine his teachings, Nox’s
`expert also agreed that PHOSITA’s know that receiving holes with a slot
`therein are more radially flexible and that there is a benefit when you have a
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`radially flexible hole to accommodate male snaps of different tolerances, and
`Nox has contested, and Mr. Oslan so testified in slides 35 through 37 of their
`presentation, but Mr. Oslan did expressly testify that he would want to
`include holes that have radial flexibility to “avoid over specifying the
`tolerance” of those parts, and Mr. Oslan’s testimony can be found in the
`record in Exhibit 1060, page 69, line 1 through page 70, line 23. If you
`don’t have any further questions on this slide, I will move on.
`JUDGE MITCHELL: Well, let me ask you. In the petition what
`motivation did Petitioner provide for combining figures 12 and 13 with that
`radial flexibility into that configuration?
`MR. ADELSON: Well, in the petition it specifically references that
`these are embodiments of McIntyre that teach radially or sorry, resilient
`plastic frames that are designed to fit on to male snaps and within the
`petition there are several explanations about the fact that PHOSITA’s would
`know and understand that adding a slot would increase the radial flexibility
`of a receiving hole.
`Turning to slide 7. As far as motivations to combine are concerned,
`let us be clear we’re talking about combining an electrode belt with an
`electrode connector which the 532 patent admits were well known and to the
`extent different embodiments in McIntyre are combined, McIntyre again
`expressly instructs PHOSITA’s who are degreed engineers with experience
`in the medical device field to combine its various teachings.
`In the top point the Board cited each of the prior art references noting
`that they each teach PHOSITA’s to combine their respective teachings what
`reflects the basic understanding of an engineer to combine and modify prior
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`art for different applications. In the second bullet point we note that these
`references also expressly disclose and document known motivation to the
`industry including making lower cost, easier to use, simpler devices, and the
`Federal Circuit in its Dystar case recognized a long line of cases that held
`that these types of motivations are inherent in motivating PHOSITA’s to
`combine prior art teachings. These same types of motivations fit within the
`broad framework of KSR which deal away with all formulaic tests for
`determining combinations of prior art recognizing that there’s no need to
`seek out precise teachings as courts can consider the inferences and creative
`steps PHOSITA’s, like engineers, will take.
`Now in questioning the motivation of a PHOSITA to combine the
`teachings of McIntyre, Nox has tried to make much of Dr. Williams’ honest
`appraisal about the teachings of McIntyre that could be combined in
`numerous ways. McIntyre does teach various obvious variants of the
`disclosed embodiments. Different materials, different wire types, different
`insulations, so naturally there will be many different ways that these things
`can be put together, but none of that changes that which a PHOSITA would
`know that these embodiments can be readily combined with a high degree of
`success.
`JUDGE MITCHELL: And as I understand Patent Owner’s argument,
`Patent Owner is saying what? Dr. Williams didn’t weigh in and tell us why
`our, you know, embodiment that would render the patent, you know, the
`claims obvious would really result in lower cost and so where has Dr.
`Williams really opined as to why you would combine 12 and 13 the way that
`he did for the reason of less cost or more efficient design?
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`MR. ADELSON: Well, all of the designs reflect McIntyre’s overall
`goal which is stated in the petition and expressly in McIntyre of a low cost
`easier to manufacture device, and so it’s somewhat inherent that each of the
`embodiments of McIntyre represent different approaches towards that goal
`which would therefore motivate a person of ordinary skill in the art to look
`at those teachings and determine the combination that works best in a given
`application.
`JUDGE MITCHELL: Okay. So why then would one of skill in the
`art arrive at the combination of 12 and 13 that you have in that figure?
`MR. ADELSON: Well, in 12 and 13 in particular the wire wrapping
`around and passing through, as Dr. Williams opined, is kind of the simplest
`and straightforward approach as opposed to many numerous other ways that
`Patent Owner has suggested like serrating the back of the wire and other
`things like this. The other thing is that PHOSITAs as Mr. Oslan even
`recognized would not want to over-tolerance a part, as is understood over-
`tolerancing means that you have to make the part more expensive because it
`has to be more tightly controlled. By avoiding that you allow the retention
`plate to fit a wide variety of male snaps without having to quality control the
`male portion and the female portion so that they fit just right so you get the
`electrical connection.
`Turning to slide 8. Just for completeness, we wanted to touch on the
`dependent claims. Again, Nox really hasn’t disputed the invalidity of these
`challenged claims, say for its challenge on claim 1. As shown on this slide
`and presented in Petition, the dependent claims are invalid based on the
`same prior art already discussed with respect to claim 1 on which the Board
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`instituted these proceedings. Unless the Board has specific questions on
`these, I’m going to continue with my presentation.
`JUDGE MITCHELL: No. But I do want to make clear because I
`know you’re using a little bit of a shorthand that Patent Owner does not
`necessarily contest, that just so the record’s clear and certainly that people
`understand it’s Petitioner’s burden to establish obviousness for each claim, a
`little different than the ex parte context. We just want to make that clear on
`the record.
`MR. ADELSON: Understood, and we believe that that has already
`been made clear in the Petition so there aren’t points in dispute, that’s
`basically the point I’m trying to make.
`JUDGE MITCHELL: Yes. Thank you.
`MR. ADELSON: Turning to slide 9. Secondary considerations do
`not save otherwise obvious claims for invalidity. As the Federal Circuit
`recently held in its Intercontinental Great Brands decision, even when
`objective evidence is substantial and compelling, which is not the case here,
`invalid obvious claims are not made valid. The Intercontinental Great
`Brands decision is not new law. It follows a long line of legal precedent
`going back even to the 1950’s in the Supreme Court A. & P. case where they
`explained commercial success without invention does not make
`patentability, and in this case Nox has not demonstrated with credible
`evidence that there are secondary considerations that could be even
`attributed to its patent, and moreover, Nox has not demonstrated the
`requisite nexus between its claims and the reported secondary
`considerations.
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`JUDGE MITCHELL: Well one thing we have a presumption here
`with nexus if the Patent Owner can show what its claimed invention is
`embodied in the commercial product itself, why wouldn’t we then say okay,
`we’ve got the presumption of a nexus to the secondary considerations?
`MR. ADELSON: To be clear, if they had demonstrated -- and we do
`not contest that they have demonstrated that they have a commercial
`embodiment that meets the claim limitations -- there can be a presumption
`there, but it’s a rebuttable presumption and the cases that Nox even relies
`upon, its PPC and WPIP case, both cite Ormco v. Align Tech., Inc., and
`recognize that any of, I quote,
`“Any presumption of a nexus has been clearly rebutted when the
`features allegedly responsible for secondary considerations are known to
`exist in the art.”
`This can be found at PPC, 815 F.3rd at 747 and WPIP, 829 F.3rd at
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`1317.
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`As we have just discussed, all of the limitations of the claims are
`known in the art and Nox’s expert could not identify any new technology in
`the patent, and that’s basically the reason why Nox is not entitled to a
`presumption because they have relied on the presumption without any
`showing of evidence tying their purported secondary considerations to the
`claims. The secondary considerations really should not be an issue in this
`case. On top of that, Petitioners have also produced substantial evidence,
`much of which is Nox’s own documents to refute any evidence of secondary
`considerations.
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`Turning to slide 10, Nox has grossly overblown its claims of failures
`in the prior art. In particular, they’ve made several incorrect claims about
`the “XactTrace” belt which has also been called the “cut to length belt” in
`these proceedings, and there is no identified failure of that belt in Exhibit
`2014 which is a 2008 study Nox has relied upon. That paper attributes
`failures to other portions of the sleep system, patient compliance and Nox’s
`former CEO even admitted that he had no knowledge what percentage of
`failure rates, if any, were due to a particular issue with the XactTrace belt.
`There has also been in this evidence of unbiased head to head sales
`showing that the XactTrace belt exceeds those of the accused device, again
`showing no failings with that earlier product, and Nox has now admitted
`most recently in Paper 43 that to get FDA approval for its device it
`compared its current belt to the XactTrace belt and determined them to be
`“substantially equivalent.” Nox’s claims of the RES belt failures are also
`overblown as sales data or requests from Nox’s customer two years after the
`release of its current belt they were still asking for the old belt and wanted to
`sell that.
`Turning to slide 11, there are also no unexpected results attributed to
`the 532 patent. Nox created a “white paper” to try to show that in a kind of
`an ad hoc way that the signal quality of its current belt is improved and that
`it’s suggesting that it now allows practitioner’s to detect heart beats. First of
`all that Nox
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