`571-272-7822
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`Paper # 30
`Entered: February 16, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`______________
`
`IPR2020-01526
`Patent 6,771,994 B2
`_____________
`
`Record of Oral Hearing
`Held: January 19, 2022
`______________
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`
`
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`
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`Before JOSIAH C. COCKS, ROBERT L. KINDER, and
`AMANDA F. WIEKER, Administrative Patent Judges.
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`IPR2020-01526
`Patent 6,771,994 B2
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`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`ANDREW PATRICK, ESQUIRE
`W. KARL RENNER, ESQUIRE
`DAN SMITH, ESQUIRE
`Fish & Richardson
`1000 Maine Avenue, S.W.
`Washington, D.C. 20024
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`
`
`ON BEHALF OF PATENT OWNER:
`
`
`JEREMIAH S. HELM, ESQUIRE
`Knobbe, Martens, Olson & Bear, LLP
`2040 Main Street
`Irvine, CA 92614
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`
`
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`The above-entitled matter came on for hearing on Wednesday,
`January 19, 2022, commencing at 3:59 p.m., EDT, at the U.S. Patent and
`Trademark Office, by video/by telephone, before Chris Hofer, Notary
`Public.
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`P R O C E E D I N G S
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`JUDGE COCKS: All right. We have arrived at the fourth session of
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`our oral argument today. This session involves IPR2020-01526 concerning
`patent 6,771,994. I'm Judge Cocks and I'm joined by Judges Wieker and
`Kinder on the panel. Let's begin with introduction of counsel. Would
`Petitioner state their appearance for this session.
`
`MR. PATRICK: Thank you, Your Honors. My name is Andrew
`Patrick. I'm joined by my colleagues Karl Renner and Dan Smith.
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`JUDGE COCKS: Thank you, Mr. Patrick, and would counsel for
`Patent Owner please state their appearance today.
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`MR. HELM: Thank you, Your Honor. Jeremiah Helm from Knobbe,
`Martens on behalf of the Patent Owner Masimo.
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`JUDGE COCKS: All right. Thank you, Mr. Helm. All right. With
`that being said, each side has 40 minutes and as usual Petitioner will argue
`their case first and they may reserve rebuttal time. Patent Owner will then
`argue their opposition to Petitioner's case and may reserve surrebuttal time
`and will conclude with rebuttal and surrebuttals. So, counsel for Petitioner,
`whenever you're ready you may begin.
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`MR. PATRICK: Thank you, Your Honors. If I could I'd like to ask
`you to turn to the table of contents on slide 2. We plan today to focus a
`direct of approximately 30 minutes on issues 1 and 2 as identified within the
`table of contents which address the '994 patent's obviousness over
`respectively the combinations of Diab, Benjamin and Melby and Webster
`and Melby. Now there are a number of related sub-issues on which the
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`IPR2020-01526
`Patent 6,771,994 B2
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`parties are briefed during this proceeding and they are identified within our
`table of contents as issues 1A through 1D and as 2A and 2B.
`MR. PATRICK: I would like to ask Your Honors to turn to slide 5
`which begins our treatment of issue 1A and --
`JUDGE COCKS: Counsel, before you begin just --
`MR. PATRICK: -- there you'll see the issues --
`JUDGE COCKS: Counsel? Just to double check you said ten
`minutes of rebuttal time; is that accurate?
`MR. PATRICK: Yes, Your Honor, that's right. Thank you.
`JUDGE COCKS: Go ahead, please.
`MR. PATRICK: Thank you, Your Honor. So, slide 5 shows our
`treatment of issue 1A that a POSITA would have understood and found it
`obvious to apply light control film as taught by Benjamin and further
`detailed by Melby to Diab's system to improve that system's consistency and
`accuracy.
`So, turning to slide 5. We can see that Diab describes an optical probe
`for measurements that in the embodiment shown in figure 24 at the top right
`of this slide includes a light source consisting of two LEDs operating in
`different wavelengths and a photodetector that detects light emitted by the
`LEDs ideally only after it has passed through user tissue and as Dr. Anthony
`explained --
`JUDGE KINDER: This is Judge Kinder. Sorry to interrupt you. If I
`could ask a quick question. This is Judge Kinder.
`MR. PATRICK: Yes, Your Honor.
`JUDGE KINDER: I kind of understood what the scattering medium
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`is but can you describe the purpose of the scattering medium because I know
`that's kind of one of the issues we'll talk about later.
`MR. PATRICK: Thank you, Your Honor. I appreciate that question.
`So Diab actually describes the scattering medium and you may see some
`description with respect to that actually on slide 6 as offering an improved
`optical signal-to-noise ratio and it does that in a few portions. It details it in
`a few portions. In the section appearing on slide 6 of Diab which is column
`3, lines 63 through column, line 12, it talks about actually a number of
`preferred embodiments of its invention in which the scattering medium is
`used and in some of those embodiments the scattering medium is said to be
`positioned between the user tissue and a photodetector and others it's said to
`be placed between LEDs and user tissue and yet other it's said to be placed
`in both locations. Now all of those embodiments are said to result in an
`improved optical signal-to-noise ratio and I don't have the clipping available
`on this slide but this could be better understood I think with respect to
`column 20 of Diab and in particular column 20, lines 1 through 13 and there
`Diab explains that by scattering the signal either prior to or posterior to the
`material interface and by material interface I believe they're referring to the
`user tissue, perturbations of a locality within the area of exposure will have
`less effect and in that regard, at least the way I'm thinking about this and as
`it's been explained on the record, the locality within an area of exposure
`would refer to structures within user tissue and so Diab speaks to reduction
`of noise related to user motion because as a user of the device is moving and
`light is passing through that tissue particular structures within the tissue can,
`you know, have an effect on the way that the light passes and so through use
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`of the scattering medium it's actually possible to arrive at a more consistent
`scattering, if you will, which would reduce the overall impact of the
`structures and particularly localities and so within the section at column 20
`when it's referring to scattering a signal either prior to or posterior to the
`material interface I believe there it's referring back to what is shown on this
`slide in terms of being able to place the scattering medium either between
`the LEDs and the user tissue or instead between the photodetector and the
`user tissue. In either case as Diab explains the embodiments would result in
`an improved optical signal-to-noise ratio.
`JUDGE KINDER: Thank you. That was very helpful. I'm just trying
`to get a grasp on how to achieve the improved signal-to-noise ratio.
`MR. PATRICK: Thank you, Your Honor. I appreciate the question
`and actually with that I think we're through what I was hoping to accomplish
`with slide 6. It was a timely question and if we could move on to slide 7. At
`slide 7 we see at top right a depiction from Benjamin, one of our secondary
`references and that figure actually shows from Benjamin an optical sensor
`device in which a light control film is placed over a photodetector. Now, it's
`important to understand why Benjamin does that and as Dr. Anthony
`explains at length at paragraph 43 of his declaration which is shown at the
`left of this slide, Benjamin's photo-sensitive cell -- you can see this in green
`in the figure -- responds to light that passes through user tissue such that the
`amount of pulsing light it registers is proportional to the amount of pulsing
`arterial blood within its field of detection.
`Benjamin explains that the light control film improves the accuracy of
`that cell's response by collimating the light passing through so as to prevent
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`scattered incident light from reaching the cell thereby making the cell more
`immediately dependent upon the light being directly from the field being
`measured and so again with Benjamin and its use of light control film there
`is achieved better accuracy and consistency by collimating light as it is
`escaped from user tissue.
`JUDGE KINDER: This is Judge Kinder.
`MR. PATRICK: But if we would move to slide --
`JUDGE KINDER: And I know you're trying to do this orderly and I
`might be jumping the gun here a little bit so I apologize but it kind of goes to
`the heart of the Patent Owner's argument here and it's, you know, the
`purpose of each of these references according to Patent Owner is distinct and
`it doesn't make sense to combine them because Benjamin, like you said,
`prevents scattering -- the scattered light from reaching the surface if you will
`but the purpose of Diab is actually to scatter, it's a scattering medium. So, I
`mean that's kind of the heart of the matter here and I guess the biggest issue
`at least on my mind. Can you address it?
`MR. PATRICK: Thank you, Your Honor. I appreciate the question.
`In that regard we might actually benefit from moving all the way to slide 14
`and that's actually --
`JUDGE KINDER: Do you want to keep going in the -- I'm sorry if I
`interrupted you. If you want to keep going in a set order you can feel free to
`do that. If it makes more sense to kind of build up to that keep going the
`way you were.
`MR. PATRICK: Thank you, Judge Kinder. I should think it does
`make sense to go to slide 14 and, you know, there again you'll see a clipping
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`from Diab -- the clipping we were just discussing a few moment ago
`discussing its improved optical signal-to-noise ratio received through
`various embodiments and, you know, one of those embodiments, actually
`more than one including scattering medium between the LED and the user
`tissue and notably as you'll see on the following slide, slide 15, an
`embodiment in which the scattering medium is not located within Diab's
`chamber; right? And in that regard Diab is clear in contemplating that that
`embodiment too without a scattering medium in the chamber improves your
`optical signal-to-noise ratio and more specifically it does it through the
`positioning of the scattering medium between Diab's LEDs and the user
`tissue and so one way that you could think about this is you could say that,
`you know, we are starting with Diab as a base reference and Dr. Anthony in
`the declaration that accompanied the petition explained that the person of
`skill would have found it obvious in view of the teachings of both Benjamin
`and Melby to use light control film in place of the scattering medium if that
`were the scattering medium that in some embodiments is located above the
`photodetector.
`Notably it leaves open the possibility of maintaining the scattering
`medium between the LEDs and the user tissue and in that regard actually far
`from being contrary to one another in terms of their effects they would work
`in concert, each of them addressing a different problem, if you will, with
`respect to noise in the signal-to-noise ratio and so as we were earlier
`discussing the scattering medium reduces noise by lessening the impact of
`local structures within the user tissue and then the light control film that
`Benjamin and Melby describes reduces noise by actually reducing the
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`amount of ambient light, for example, that can leak and strike the
`photodetector and from Diab's description, for example again at column 20,
`lines 1 through 13, it's clear that the scattering medium would accomplish its
`purpose if only located between the LEDs and the user tissue and in that
`regard, again, that section of the reference itself explains to us that by
`scattering the signal either prior to or posterior to the material interface the
`perturbations of locality within the area of exposure will have less effect and
`so in that regard if you think about LEDs as shown at the upper right of this
`slide within Diab's system emitting light into the user tissue but doing so
`through a scattering medium, Diab explains to us that the perturbations
`caused by the local tissues would be reduced and so you would have an
`improvement in the optical signal-to-noise ratio and then as the light
`continues on its path toward the photodetector shown in green at the bottom,
`you would have a further improvement in terms of the light control film and
`collimation of light that's accomplished through the louvered nature of that
`film as explained by both Benjamin and Melby and it may be helpful if we
`were to look at slide --
`JUDGE KINDER: This is Judge Kinder. This is Judge Kinder. I
`know the references don't have to have this kind of purpose but is there
`anything in Diab that says hey, you know, something like this would
`improve us. I just -- I'm having a hard time, I think the Patent Owner made
`some arguments that well, Diab kind of works as it serves its purpose, it
`works fine. You know, getting to the why. I know that motivation doesn't
`have to come from the references but is there anything in Diab that you've
`cited that sticks out that says hey, bringing this control film would make
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`sense?
`MR. PATRICK: Thank you, Your Honor. It's actually very
`interesting question and in that regard, you know, Diab I don't believe
`specifically discusses the collimation of light that would be accomplished by
`the control film. I could say that Benjamin, one of the secondary references
`that is applied in the ground 1 combination contemplates noise both in the
`form of perturbations caused through user motion as well as noise from
`other sources and in that respect there is some additional disclosure from the
`Benjamin reference that might be worth considering and specifically it's
`actually within the Benjamin background section where there is discussion
`at column 1, lines 35 and actually extending into the summary of its
`invention at line 66 there is identified that one of the problems involved in
`the photo phethysmographic pick-up of the blood flow pulse is that
`variations in the amount of scattered light reaching the photocell cause
`variations in the operating point of the photocell and then that is said to
`inversely affect the accuracy of the measurement and so that's one problem.
`Another relates to artifactual noise produced by motion of the photo-
`sensitive cell and the light source with respect to the pick-up site. Again, the
`pick-up site there I believe referring to the user tissue to which the sensor is
`applied and so Benjamin at least within its description contemplates two
`sources of noise. One of them actually correlating to the source of noise to
`which Diab's scattering medium is applied Diab applies that scattering
`medium in order to reduce noise associated with user motion and then there
`is another problem that is dealt with in terms of variations in the amount of
`scattered light reaching the photocell and it's actually that second problem
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`that I believe is addressed through the use of Benjamin's light control film as
`well as the further description in terms of implementation detail that's
`offered by the Melby reference in terms of being able to collimate light and
`so acknowledging within the references that there are multiple sources of
`noise that you would want to control in order to improve your optical signal-
`to-noise ratio. You know, we believe and Dr. Anthony has testified that the
`person of skill viewing these references would have understood that the Diab
`system could be improved through the use of a light control film. Again,
`that film actually addressing a problem other than the motion problem and
`doing so by preventing ambient light from striking the photodetectors and
`thereby creating adverse noise.
`I don't know if that answered your question. I hope so. Certainly,
`we're willing to speak in more detail to those points.
`JUDGE KINDER: Thank you.
`MR. PATRICK: Okay. Thank you, Judge Kinder. Now, if we were
`to briefly go back I think it may be useful again if we were to look at the
`description within Benjamin and the evidence of record and the form of Dr.
`Anthony's testimony as to what Benjamin is accomplishing and in that
`regard if I could I'd like to ask you to turn back to slide 7 and on slide 7 we
`see at top right a depiction from Benjamin of an optical sensor device in
`which the light control film is placed and again, the photo-sensitive cell in
`Benjamin is set to respond to light that passes through user tissue and the
`light control film is set to improve the accuracy of its cell's response by
`collimating the light passing through so as to prevent scattered incident light
`from reaching the cell and thereby making the cell more nearly dependent on
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`the light being directly from the field being measured and the scattered
`incident light, again, being light that is undesirable because it's not providing
`a signal, rather it would be in the form of ambient light for instance or even
`light that has come from an LED and yet is returning after not having
`previously passed through user tissue.
`On slide 8 actually we can see there's more –
`JUDGE KINDER: Counsel? I'm sorry, can I ask one more question
`and I think --
`MR. PATRICK: Yes, certainly, Your Honor.
`JUDGE KINDER: -- in regard to slides 6 and 7 if you will, but
`doesn't Diab already minimize the effects of local artifacts?
`MR. PATRICK: Your Honor, you are correct that Diab minimizes
`the effect of local artifacts through use of the scattering medium an in some
`of its embodiments it talks about doing that by placing the scattering
`medium in different locations, right, some of them being between the LED
`and user tissue, others between the photodetector and user tissue and yet
`others in both places and so through use of the scattering medium you
`reduce the impact of the local artifacts as the device is in motion and yet still
`remaining even after having solved that problem is the potential impact on
`the signal of unwanted noise in the form of ambient light and the scattering
`medium in that regard actually would not offer any assistance and one way
`to think about this if we were to turn to a slide showing the Diab
`combination and one of those slides actually would be slide 10.
`You could see there actually located in green the LEDs in Diab and
`the photodetector in blue and finally the light control film placed at the top
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`of the photodetector. Now as the light is transmitted through this
`transmittance-type pulse oximetry device through the user tissue by the
`LEDs the scattering medium that Diab teaches would assist in doing what
`Diab describes and that light would eventually pass through the tissue and
`before striking the photodetector reach the light control film which would
`then further collimate.
`Now the collimation is helpful and important with respect to light not
`emitted from the LEDs themselves for instance, but rather light coming in
`from ambient sources surrounding the device and the light from those
`different sources it could be the sun, it could be the, you know, the lights
`above your head, that would be unwanted because it would include as a
`component part wavelengths that are similar to the wavelengths to which
`this pulse oximeter is sensitive and yet, that light striking the photodetectors
`would not have passed through the user tissue and so it comes in as noise
`that would end up corrupting the signal.
`You know, another way to think about how it is that the louvers
`within the louvered plastic film that Melby describes would assist with this
`problem would be actually to look at the figures on slide 11 which show
`Melby's film and there the important point to see is that in providing its
`implementation details consistent with the teachings of Benjamin the person
`of skill would have been motivated to incorporate the film to further increase
`the directionality of the light and thereby make the device less susceptible to
`the influence of noise in the form of ambient light and the manner in which
`Melby accomplishes this, and you can see in figure 1 for instance, is that it
`has clear regions within he film that are then separated by darker regions and
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`the dark regions serve to absorb light that is striking from undesirable
`angles, light that very likely came from ambient sources whereas the clear
`regions within the film allow light to pass straight through and if we were to
`turn to slide 12, you'll see that within Diab with the LEDs having been
`positioned directly above the user tissue and then emitting light through the
`tissue to a detector located beneath it stands to reason that the collimation
`accomplished through the light control film would actually allow for light
`emitted from the LEDs, the desirable light to pass through while actually
`preventing the undesirable noise from ambient sources and that is --
`JUDGE KINDER: Hi, this is Judge Kinder again. I'm sorry to
`interrupt. There's like a three second lag so it's hard to get in a question.
`Just to clarify, your proposed combination removes the scattering medium of
`Diab or does it leave it in place?
`MR. PATRICK: It's a good question, Your Honor, and the way that it
`was expressed within the petition and by Dr. Anthony in his original
`declaration we said that the light control film would be in place of the
`scattering medium that would have been located in the chamber of Diab and
`so that's how it was originally expressed and that would be of course with
`respect to an embodiment in which the scattering medium was already
`present. However, not addressed there is the scattering medium that is
`between the LED and the user tissue and, you know, certainly the person of
`skill would have understood from Diab's consistent description throughout
`both in column 20, lines 1 through 13 and from the earlier portion that's
`clipped into these slides that the effect of a scattering medium could still be
`accomplished even if there were only the one scattering medium placed
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`between the LEDs and the user tissue and so, again, as originally expressed
`the scattering medium would have been removed from the chamber and yet
`there would still be scattering medium capable of improving optical signal-
`to-noise ratio as expressed by Diab.
`JUDGE KINDER: Thank you.
`MR. PATRICK: Thank you, Your Honor. I do appreciate that
`question. So interestingly enough I think through your questions we've
`addressed a lot of what I'd intended to accomplish with slides 1 through 18
`but it may be worth actually moving to slide 18 to address some of the
`positions that have been raised in Patent Owner's briefing and in that regard,
`we’ve called this issue 1C that incorporation of the light control film reduces
`noise from ambient light. The reason I'm bringing you here is that within
`the Patent Owner's response they argued that the combination of Diab's
`absorbing chamber wall and Melby's light control film would reduce the
`total light received by the photodetector in a way that they claim would
`make the signal more difficult to interpret.
`Now, if we were to move to slide 19 frankly we think that Masimo's
`contention ignores that Melby's light control film would have the opposite
`effect that, as shown on slide 19 and as we've been discussing, it would
`actually increase the signal-to-noise ratio by blocking noise in the form of
`ambient light and turning to slide 20 Dr. Anthony's testimony on that slide
`underscores this very point, that the person of skill would have been
`motivated to incorporate Melby's film specifically because they would have
`expected that film to reduce Diab's susceptibility to the influence of ambient
`light and in the way that would produce more accurate readings and so, in
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`other words, even if the total light received by the photodetector were
`reduced by the introduction of light control film, as Masimo contends, much
`of the light constituting the reduction would be ambient light thereby on
`balance increasing the signal-to-noise ratio and contrary to Masimo's
`argument making the signal easier to interpret.
`Now, if I could there was, unless there are questions on that
`specifically, there's another argument that has been raised by Masimo that I'd
`like to address with respect to this combination and in that regard if we
`could turn to slide 22. This is dealing with regulatory approval processes
`and, you know, frankly we don't think that those would have dissuaded the
`person of skill from improving Diab and in more detail Masimo has argued
`that without a compelling motivation to modify Diab's optical system that
`the person of skill would not risk what they say is a costly and time-
`consuming drawbacks of updating Diab's calibration curve and preparing a
`new FDA submission for regulatory approval.
`Now, a first point if we turn to slide 23 is that the document that the
`Patent Owner is relying upon which is entered in this proceeding I believe as
`Exhibit 2005 is an FDA guidance document that was issued on March 4th,
`2013 and in that regard Masimo has not explained what relevance, if any,
`purported guidance from over a decade after the '994 patent's released
`effective filing date might possibly have. That said, even if there were
`evidence of similar FDA guidance from a relevant time period on the record,
`and there is not, Masimo frankly appears to wrongly conflate the issue of
`whether the alleged difficulty of a regulatory approval process might
`dissuade an inventor from bringing a product to market with whether an
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`inventor, a person of skill, would have been motivated to apply a known
`technique in a manner expected to improve an existing device and expected
`to have success. We think that these are frankly different standards and that
`whatever goes on in regulatory approval processes is of a different nature
`than the obviousness analysis at issue in our proceeding today and further if
`we were to turn to slide 24 and as we've discussed, Dr. Anthony has
`repeatedly -- well, he's testified to the existence of compelling motivations
`for improving Diab's system namely the improved consistency and accuracy
`that would come from use of the light control film recommended by
`Benjamin and provided with more detail in terms of its louvered nature by
`Melby.
`I suppose I'll pause now to ask whether Your Honor's currently have
`more questions with respect to Diab before I move on to issue 2 addressing
`the combination of Webster and Melby.
`JUDGE COCKS: I think you can move on. Thank you.
`MR. PATRICK: Thank you, Your Honors. All right. So, turning to
`slide 27. We'll see that as Dr. Anthony testified in the clipping shown on
`this slide Webster describes pulse oximetry devices which provide an
`empirical measure of our arterial oxygen saturation and as shown at the right
`of this slide you'll see an exemplary device, as illustrated in the Webster
`textbook, and then further annotated by Dr. Anthony and it's a transmittance-
`type pulse oximeter featuring two LEDs that emit light of different
`wavelengths. These LEDs are identified in the figure in blue as well as a
`light sensitive detector that's identified in this annotated version of the figure
`in green. Now the light, as Webster explains and as Dr. Anthony testified,
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`from the LEDs ends up being partially reflected, transmitted, absorbed and
`scattered by the user tissue prior to reaching the detector and thus less than
`all of the light from the LEDs ultimately reaches the detector and Webster
`explains at length in the portions that are quoted by Dr. Anthony in
`paragraph 77, it's therefore important that the detector be protected from the
`ambient light from the wavelengths to which the photodiode is sensitive.
`As earlier discussed and as shown on slide 28 Melby specifically
`offers a louvered plastic film that collimates light and that therefore reduces
`the influence of ambient light and on slide 29 as we can see here Dr.
`Anthony testified in paragraphs 101 and 104 of his declaration that one of
`ordinary skill would have been motivated and would have found it obvious
`to combine Webster and Melby to provide a pulse oximeter that minimizes
`errors by limiting the light reaching the photodiode to that which has
`travelled through tissue containing arterial blood.
`Now, on slide 31 we can see that Masimo attempts to establish
`because --
`JUDGE KINDER: I'm sorry. You might be addressing it and I think
`I was just trying to get to the heart of the Patent Owner's arguments here and
`if you're going to address them that's fine but I believe they're talking about
`Webster's wavelength filter and the light impervious barriers are different
`components and different embodiments in Webster's optical system. So, if
`you could kind of address that argument I think that's one of Patent Owner's
`main arguments.
`MR. PATRICK: Thank you, Your Honor, I do appreciate that and we
`think that that argument is actually debunked by Webster itself and it may be
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`helpful to turn to slide 32 and there what we'll see are excerpts from page 79
`of the Webster textbook and there Webster recognizes a benefit of
`positioning a film or as it calls it here, some type of light filter atop its
`photodiode to help minimize unwanted incident light, and so in the first
`segment from Webster that's shown here there is description of an
`exemplary wavelength specific filter that demonstrates to a person of skill
`that a film atop a photodiode would certainly not render a diode inoperable.
`That's one of the things that Masimo has suggested.
`Webster goes on and explains in the second clipping from 6.3.2 of
`Webster. It recognizes additional measures that would reduce excessive
`ambient light, among them it suggests decreasing the angle of incidence of
`light to the photodiode which happens to be one of the goals of Melby and in
`that regard Melby's film would, by reducing the angle of incidence for light
`of all wavelengths, work in precisely the manner that Webster contemplates
`in order to achieve precisely the end contemplated by each of Melby and
`Webster, that in being a reduction of optical interference in the form of
`excessive ambient light and it may actually