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`IPR2015-00884, Paper No. 53
`IPR2015-00888, Paper No. 53
`IPR2015-00889, Paper No. 53
`IPR2015-00891, Paper No. 53
` IPR2015-00893, Paper No. 52
`August 17, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
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`INO THERAPEUTICS, LLC,
`Patent Owner.
`____________
`
`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
`____________
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`Held: May 16, 2016
`____________
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`
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`BEFORE: KEN B. BARRETT, MICHAEL J. FITZPATRICK,
`and SCOTT A. DANIELS, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Monday, May
`16, 2016, commencing at 10:00 a.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`571-272-7822
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`IPR2015-00884, Paper No. 53
`IPR2015-00888, Paper No. 53
`IPR2015-00889, Paper No. 53
`IPR2015-00891, Paper No. 53
` IPR2015-00893, Paper No. 52
`August 17, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`INO THERAPEUTICS, LLC,
`Patent Owner.
`____________
`
`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
`____________
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`Held: May 16, 2016
`____________
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`
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`BEFORE: KEN B. BARRETT, MICHAEL J. FITZPATRICK,
`and SCOTT A. DANIELS, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Monday, May
`16, 2016, commencing at 10:00 a.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`SANJAY K. MURTHY, ESQUIRE
`Morgan Lewis
`77 West Wacker Drive
`Chicago, Illinois 60601-5094
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`and
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`BENJAMIN E. WEED, ESQUIRE
`K&L Gates, LLP
`70 West Madison Street, Suite 3100
`Chicago, Illinois 60602-4207
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`DAVID K. CALLAHAN, ESQUIRE
`BOB STEINBERG, ESQUIRE
`Latham & Watkins, LLP
`330 North Wabash Avenue, Suite 2800
`Chicago, Illinois 60611
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`ON BEHALF OF PATENT OWNER:
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`P R O C E E D I N G S
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`JUDGE FITZPATRICK: Good morning. Judge
`Daniels, are you hearing us?
`JUDGE DANIELS: Good morning. I can hear you just
`fine. I'll keep my microphone off so there's no feedback for the
`time being.
`JUDGE FITZPATRICK: Excellent. I am Judge
`Fitzpatrick. This is Judge Barrett to my right, and Judge Daniels
`is joining us remotely. This is the hearing for five related IPRs,
`IPR2015-00884, 00888, 00889, 00891 and 00893. And why don't
`we have the counsel, starting with the petitioner, introduce who is
`here. If you could go to the podium to introduce yourself so the
`microphone -- so Judge Daniels can hear you.
`MR. MURTHY: Good morning, Your Honor. Sanjay
`Murthy on behalf of petitioner, and with me is Ben Weed.
`JUDGE FITZPATRICK: Will you both be arguing?
`MR. MURTHY: I'll be presenting the argument for
`petitioner, Your Honor.
`MR. STEINBERG: Good morning, Your Honor. Bob
`Steinberg, Latham & Watkins for the patent owner. Dave
`Callahan is going to -- also with Latham & Watkins -- do the
`presentation today.
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`MR. CALLAHAN: Good morning, Your Honor.
`JUDGE FITZPATRICK: Each side has 60 minutes.
`We'll obviously start with petitioner. If patent owner is going to
`argue orally its motion to exclude, it's going to have to bring that
`up during its time, which will come second.
`I know there were objections to the demonstratives. To
`the extent that either side wants to use their limited time to
`address those, they can, but it's going to -- there's no additional
`time to do so. And there was a lot of demonstratives that were
`provided by both sides, and to the extent that they are not used
`today, I can't imagine them being relied on. So they are not going
`in the record. So keep that in mind.
`And because Judge Daniels is remote, when you have a
`demonstrative up on the slide, for example, petitioner's slide 1, if
`you are going to reference it, mention the slide number so that
`Judge Daniels can hear you.
`With that, we'll begin with petitioner. I'm going to
`manually keep track of time here. So let me know if you want to
`reserve some time, and I can let you know when you're getting
`close to the cutoff.
`MR. MURTHY: Yes, Your Honor. I was actually
`planning on reserving 20 minutes for rebuttal.
`JUDGE FITZPATRICK: Okay. You may proceed.
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`MR. MURTHY: Thank you, Your Honor. May it
`please the Board, this case presents a classic KSR scenario. The
`patent claims at issue in these proceedings all relate to
`off-the-shelf components that are performing functions that were
`previously described in the art.
`What the patent owner has done here is literally taken
`its preexisting device and added a transceiver to it to perform an
`otherwise known and established verification function. That's the
`sum and substance of the inventions that are claimed here. And
`the specification barely mentions the transceiver at all other than
`to say that it exists. The patent owner certainly did not invent a
`new transceiver in developing this invention and they don't claim
`anywhere in their papers to have done so.
`In preparing for this argument, I went back and again
`reread the patents very closely to see if there was any new
`hardware described in the specification, and I found none. The
`patent owner has provided voluminous slides. There are over 100
`slides in their presentation. The Board will look in vain for any
`new hardware in any of those slides. There simply is none.
`You had an established nitric oxide delivery device
`that's described in the '083 patent. You had the '510 patent which
`describes a smart handle specifically designed for use with the
`nitric oxide delivery system of the '083 patent. That smart handle
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`had a wireless transceiver and it had memory and the ability to
`store all kinds of different types of data. You had in the French
`reference, the Paoli patent, a description of a safety check, the
`pre-use safety check, the very same pre-use safety check that the
`patent owner later decided to incorporate into their device. There
`really is nothing new here.
`So the question really boils down to this: Would one of
`ordinary skill in the art have been motivated to incorporate the
`safety check that's described in the Paoli reference into patent
`owner's own combination of the '083 and '510 patent. I think the
`Paoli reference itself describes the advantages of such a
`combination. It tells you that this pre-use safety check is a good
`idea. It cuts down on user error. That in and of itself answers the
`question.
`I also think that common sense provides the motivation
`to combine here. Improving safety is of paramount importance in
`the medical device industry. That's what medical devices are all
`about. So the fact that the patent owner decided to incorporate a
`safety feature into their device, a safety feature that somebody
`else had already described really isn't inventive. That's just the
`exercise of ordinary due diligence and common sense, anything
`that anybody skilled in the field would do.
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`So what does the patent owner say in the face of all
`this? Well, their arguments really kind of boil down to a couple
`of different variants. The first argument that I think we are going
`to hear today is, well, we were the first to do it. Well, that doesn't
`really take them very far because this is an obviousness case. It's
`not an anticipation case. So the fact that maybe they were the
`first to cobble together the elements as explicitly described in
`their claim doesn't really helps answer the question that we are
`here to talk about today.
`What else do they say? They spent a lot of time
`attacking the references individually. As the Board noted in its
`institution decision, however, attacking the references
`individually cannot overcome a prima facie case of obviousness.
`It's legally deficient.
`Then they turn to motivation to combine. And they
`spent a lot of time addressing motivation to combine. They
`basically take the position that somebody skilled in the field
`wouldn't piece together what they describe as disparate
`references. But let's analyze that a little more closely. Three of
`the references, the '083, the '510 patent and the INOmax label that
`we are here to discuss today, they concede in their papers that
`they filed here, that those three references would be combined by
`one of ordinary skill in the art. The fourth reference, the Paoli
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`reference, is assigned to Air Liquide, the only other real
`manufacturer of any nitric oxide delivery device in Europe, and
`specifically mentions that it can be used in health facilities.
`So this is just not a case where these references are from
`completely disparate fields or would be unknown to one of
`ordinary skill in the art. It seems to me in analyzing the papers
`and preparing for this argument that the patent owner wants to
`take us back to the pre-KSR world where the person of ordinary
`skill in the art was an automaton and where you needed an
`explicit reference in the teachings of the prior art that would
`motivate one to combine references. That's simply not the law
`anymore. Justice Kennedy dispensed with all that when KSR was
`handed down in 2007. So I don't think the Board should entertain
`patent owner's attempt to take us back to the pre-KSR world.
`So where does that leave us? At the end of the day the
`patent owner is left to dispute the testimony of Dr. Stone. And
`they have spent a lot of time criticizing Dr. Stone and the analysis
`that he performed.
`Dr. Stone was never asked to opine on the ultimate
`conclusion of obviousness. Therefore, there was no requirement
`that he go through every single claim and do a claim chart-type
`analysis. This isn't a District Court proceeding in front of a jury,
`and Dr. Stone's testimony isn't designed to be the only thing to
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`support an invalidity conclusion under a clear and convincing
`evidentiary standard. So there simply was no requirement that he
`perform that analysis.
`Why else was there no requirement? Well, 80 percent
`of the limitations in these claims, the support for those limitations
`are admitted prior art. This case comes down to one narrow
`limitation, the wireless transmission of data from memory to a
`control module. That's it. Other than that, the patent owner in the
`specification uses admitted prior art as the foundation for the
`claims. So under these circumstances, I simply don't understand
`why such an analysis would be helpful to the Board.
`And finally, they say, well, Dr. Stone used hindsight in
`his analysis. And they get to that conclusion by saying, Aha,
`Dr. Stone, the first thing he did was read the patent. I have been
`doing this for a while. In every case I have ever been involved in
`that's ever come across my desk, the first thing that I have read is
`the patent. I think that in any case where any competent expert
`would start is by reading the patent first. That's not an admission
`that you used hindsight in your analysis. That's just basic
`common sense. You want to know what the issues are. You
`want to know what the invention is. So you start with the patent.
`So I think sort of analyzing the issues under that framework will
`give us a good guideline for what we are here to talk about today.
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`Turning to slide 2, we talked a lot about some of these
`points already. I'm not going to repeat them now. Just a couple
`of things that I think are new and worth mentioning here, a lot of
`effort has been spent by the patent owner that there was some
`unknown problem that nobody before us had perceived that this
`problem existed. I think the Paoli reference itself, I think the
`INOvent manual itself both describe the fact that a pre-use safety
`check is a good idea. So this isn't some unknown problem that
`existed in the field. I don't think that's going to be supported by
`the record.
`I actually flew out here with counsel for the patent
`owner. We were on the same flight. Before the flight took off,
`the pilot got on the announcement and said, I'm going to go
`through my pre-use safety checks before we take off. A pre-use
`safety check was not a novel concept when these patents were
`filed in 2010. And the fact that the pre-use safety check
`described in the INOvent manual was done manually and now the
`patent owner has described an invention that does it using
`computers, that's not inventive either, especially when you realize
`it's just off-the-shelf technology that they used to perform that
`functionality.
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`JUDGE FITZPATRICK: There's also an argument by
`patent owner that it was already solved or that it was not in need
`of remediating. So can you address that as well.
`MR. MURTHY: Sure. They make an argument that
`the CGA connectors had already solved the problem and that
`nobody would have been motivated to include an electronic check
`because, well, we had manual connectors that already solved the
`problem. Well, I think you'll find that the art and just common
`sense as technology improves, people want to improve that which
`is done manually with electronic and computer technology to
`perform that same functionality. I also think the Paoli reference
`specifically refutes the notion that merely because existing
`connectors may have alleviated some concerns, they didn't
`completely address it. So I don't think that the evidence doesn't
`support the conclusion that there was no unknown problem here.
`The Paoli reference --
`JUDGE FITZPATRICK: That remained unsolved?
`MR. MURTHY: That remained unsolved. I think the
`Paoli reference itself which came out after the FDA guidance and
`came out after CGA connectors had long been used in the field
`clearly suggest that people saw a reason to do this using computer
`and wireless technology. So the manual solutions, while
`probably pretty sufficient, weren't completely foolproof. Hence
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`the reason for why one of ordinary skill in the art would want to
`use the Paoli reference to replace the manual connections. Did I
`answer Your Honor's question?
`JUDGE FITZPATRICK: You did, thank you.
`MR. MURTHY: Very briefly, the patent owner also
`makes a number of arguments about FDA submissions. I think
`again here the evidence isn't going to support the conclusion that
`they want to reach. There has been no Federal Circuit case that
`I'm aware of that has ever held that the motivation to combine
`must come from FDA guidance or that FDA guidance can defeat
`a motivation to combine that exists in the art. In fact, the case
`law that I'm aware of from the Federal Circuit says just the
`opposite. It says the FDA guidance does not limit motivation to
`combine. And that's the Allergan case. So I don't understand
`how patent owner can come here and make the argument that it's
`made that because the FDA guidance says this, one of ordinary
`skill in the art wouldn't have been motivated to make the
`invention.
`And finally, very briefly, on the issue of secondary
`considerations, again, a lot of this is a rehash of their
`anticipation-type argument, well, we were the first to do it; other
`people in the field didn't come up with the claimed invention.
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`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`There are a number of commercial, business, et cetera, reasons
`why people do or do not put certain features into their device.
`What is completely lacking in the record here is any
`evidence that anybody failed to develop this invention. And I
`also think it's important to remember there's no possibility that
`anybody would fail to develop this invention because it's all
`off-the-shelf components. It's literally the patent owner's own
`preexisting devices paired up with an off-the-shelf transceiver.
`Nobody skilled in the art would have any difficulty connecting a
`transceiver to a device, and I think their own FDA submissions
`confirm that.
`Turning to slide 3, there are a number of elements here.
`I don't want to spend too much time on this. I think the Board has
`zeroed in correctly on the right issues. But again, a number of the
`key elements in the independent claims, they are not disputed by
`the patent owner.
`As I mentioned here turning to slide 4, this argument
`really boils down to one element: Storing gas data in memory and
`conveying that gas data wirelessly to a control module. That's
`really the only element that's in dispute. I think you'll hear from
`the patent owner that that's really what this dispute is all about.
`Turning to slide 5, I also think it's important to highlight
`here very briefly, what's not in dispute. What's not in dispute,
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`well, other than the dependent claims that are identified here on
`slide 5, the patent owner has presented no separate arguments for
`patentability for any of the other dependent claims in any of its
`papers or in the Heim declaration.
`As to the dependent claims, it really boils down to
`emitting of an alarm related to the first valve status and
`terminating delivery of the therapy. And the gas data is provided
`on a bar code.
`Turning to slide 8 -- actually, turning to slide 9, again, I
`don't want to spend too much time on this, but again, as the Board
`already found in its initial decision, a lot of the elements in the
`claims, turning to slide 10, there's no dispute about. There's no
`dispute that these elements are met by the prior art.
`Turning to slide 11, a valve attachable to the gas source,
`that's the next key limitation. Patent owner doesn't dispute that
`that's met.
`A valve actuator to open or close the valve here on
`slide 12, again, patent owner is not disputing that that limitation is
`met.
`
`I talked a little bit about this here, turning to slide 15,
`the patents admittedly use known elements. How do we know
`that? We look at the specification and it tells us. We incorporate
`the '510 patent in its entirety. What does the '510 patent teach
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`here on slide 16? It's a smart handle with a valve that can store
`data for a number of different purposes, including, it mentions
`here in the abstract, for control functions.
`Turning to slide 17, what did the patent owner do here?
`They took their preexisting device and they used it with their
`invention. How do we know? Right here on slide 17. You have
`the prior art here on the left-hand side from the '510 patent,
`virtually identical figure here from the '794 patent. As the Board
`noted in its institution decision, the handle is identical other than
`it's identified in the '794 patent as an actuator.
`Again, turning to slide 18, how do we know that the
`claims are using known elements? They incorporate by reference
`their own '083 patent. Slide 19, how do we know that the method
`of treatment steps described in the claims are old? Again, they
`relate to their own commercial product which was FDA-approved
`back in 2000. Old, known technology and off-the-shelf drug.
`The therapy steps are not novel and they don't claim otherwise.
`Turning to slide 20, I mentioned this very briefly
`before, the patent owner has made a very, very big deal, so this is
`really important, that this combination that we have proposed
`here requires a lot of references. Well, here right from their
`patent owner's response on page 43, footnote 15, they have
`admitted that one of ordinary skill in the art would use the '083,
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`the '510 to deliver nitric oxide. That's the combination, three of
`the four combination of references that we've proposed. They
`admit right here in their paper that one of ordinary skill in the art
`would use those three things together. So it really boils down to
`whether one of ordinary skill in the art, reading the Paoli
`reference, would incorporate that safety check.
`So this isn't one of those cases where somebody is
`trying to stitch together a bunch of disparate prior art references
`that aren't linked together. Here the patent owner has conceded
`that at least three of the four references are linked together and
`would have been combined.
`Turning to slide 21, one of the questions the Board may
`be asking -- and again, the specification refutes any notion that
`there is some new technology that was developed to implement
`this invention. But here on slide 21, we have a statement that the
`patent owner submitted to the FDA where they said, Okay, we've
`implemented this new hardware into our device.
`One of the questions someone may ask is, well, did that
`otherwise change the functionality of the device? Did any of the
`other components of the device have to be modified or changed in
`any way to implement this change? Absolutely not. Everything
`else functioned exactly how it had before. That's what they told
`the FDA. So --
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`JUDGE FITZPATRICK: Are you submitting this as it
`would be a reasonable expectation of success?
`MR. MURTHY: Absolutely. And the reasonable
`expectation of success, it's confirmed by the fact that this
`transceiver, they don't describe anything special about it. It's an
`off-the-shelf component. But again, this is their statement to the
`FDA. It's just further evidence that what the specification itself
`describes as the invention, it didn't require any new or novel
`hardware. It didn't require any change in the underlying
`functionality of the device. That's what they told the government
`when they filed their 510(k) application.
`I want to jump ahead now to motivation to combine
`because I think the Board understands the combination and how
`we've proposed that the references be combined. On the issue of
`motivation to combine, the French -- sorry. Turning to slide 30,
`Judge Daniels. Turning to slide 30, the French reference itself
`describes pre-use safety check just like the one that's described in
`the challenged patents. It also describes it as advantageous, that it
`cuts down on user error. That in and of itself provides the
`motivation for one of ordinary skill in the art to want to
`incorporate that into the combined device of the '083 and '510
`patents. That's it. That's sufficient in and of itself. You don't
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`need to go any further. You can stop right there. Common sense
`and the teaching of the prior art itself gets you there.
`The French patent takes it one step further and describes
`that you can do it wirelessly whereas, before what you needed to
`do was do it manually. Again, the '510 patent describes a storage
`device and includes a wireless transmitter. Again, nothing
`complicated here. Nothing difficult at all.
`And Dr. Stone, to the extent the Board needs additional
`confirmation that this combination makes sense, that it's
`something one of ordinary skill in the art would have been
`motivated to do, he looked at the prior art. He said based on the
`combined teachings of these references, this makes sense. The
`'510 patent already described that you could store all different
`types of gas data. It described that you could wirelessly transmit
`that data to other devices.
`The French reference describes a pre-use safety check
`being performed wirelessly. Again, not a huge technical leap to
`say maybe I could store the gas data, the type of data in that same
`memory module which I already have and transmit it to the
`control device just like the French Paoli reference describes.
`JUDGE DANIELS: Counsel, are you implying that we
`don't really need any of Dr. Stone's testimony here to reach the
`conclusion of obviousness? Taking what patent owner has said in
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`their response that his testimony didn't go through the full
`Graham analysis, do we need it?
`MR. MURTHY: Your Honor, Judge Daniels, I don't
`believe you need Dr. Stone's analysis to reach the conclusion of
`obviousness in this case. I think the references themselves and
`the teachings of the references provide the motivation to
`combine. Dr. Stone is merely providing technical assistance to
`the Board in this matter about, okay, would there be anything
`complex from a technology standpoint by combining these
`references? And the answer to that is no. That's all he's really
`providing. So I don't believe the Board needs Dr. Stone's analysis
`to reach its conclusions in this case.
`JUDGE DANIELS: Thank you.
`MR. MURTHY: Your Honors, unless you have any
`additional questions, I would like to reserve the remainder of my
`time for rebuttal.
`JUDGE FITZPATRICK: That's fine. I think actually
`you had 24 minutes used time, 36 remaining.
`MR. CALLAHAN: Your Honor, I'm only going to save
`about five minutes. My sense is that we have moved largely, if
`not entirely, through the Dr. Stone issue. I'm going to save five
`minutes in the event that that calculation is incorrect. But I'm
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`going to try to go through our main presentation in this part of my
`presentation.
`We are chasing it a little bit here, Your Honors. And
`the reason we are chasing it a little bit here is because what they
`are arguing here today is pretty significantly different from what
`they were arguing in their institution petition. And the reason
`that it's different is because Dr. Stone has, as I think we just heard
`here, Dr. Stone blew up. They did not tell this Board that
`Dr. Stone was just saying whether this was doable. In their
`papers and in their institution request and in this Board's decision
`instituting this IPR, there was significant reliance on Dr. Stone.
`And we'll talk about that. They made significant reliance on
`Dr. Stone. They are now backing away from that because they
`have to. And we'll talk at the end here about why we think that
`leaves them pretty far short in the first instance. But what's most
`important is that they are arguing something different today than
`they did in their institution petition.
`They tried to cure that group of defects in their 25-page
`reply brief, which raises all kinds of new evidence. Two of the
`things that my colleague for the petitioner talked about in detail
`are those new things. The FDA guidance is a document not
`submitted in the petition, the INOvent manual not submitted in
`the petition. And we talked about this a little bit, but I want to
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`IPR2015-00884 (Patent 8,291,904 B2)
`IPR2015-00888 (Patent 8,776,794 B2)
`IPR2015-00889 (Patent 8,573,209 B2)
`IPR2015-00891 (Patent 8,573,210 B2)
` IPR2015-00893 (Patent 8,776,795 B2)
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`preview it here. We talked about this a little bit in our slides.
`Had we been able to reply to this, the Board told us that we could
`never reply, but we could come to this hearing and argue the
`problems with their reply paper. Had we been able to respond to
`that reply, what we would have said is it is improper under the
`statute governing these proceedings. It's improper under the
`regulations that implement that statute and it's improper under
`this Board's guidance to judges for how to implement the statute
`and the regulations.
`What it says is if there is something new in reply, and
`there is indisputably at least two things new in reply, huge
`sections of the brief are brand new, the Board doesn't have to go
`through and we don't have to go through here at the hearing,
`which is the first time for us to address this, we don't have to go
`through and say it's this paragraph and these two pages and this
`piece of evidence. What the Board does is the Board looks at that
`reply, determines
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