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`IPR2015-00529, Paper No. 50
`April 15, 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,
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`v.
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`INO THERAPEUTICS LLC,
`Patent Owner.
`____________
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`Case IPR2015-00529
`Patent 8,846,112 B2
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`Held: March 29, 2016
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`BEFORE: LORA M. GREEN, TINA E. HULSE, and ROBERT
`A. POLLOCK, Administrative Patent Judges.
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`The above-entitled matter came on for hearing on Tuesday,
`March 29, 2016, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`SANJAY MURTHY, ESQ.
`MARIA DOUKAS, ESQ.
`Morgan Lewis
`77 West Wacker Drive
`Chicago, Illinois 60601
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`Case IPR2015-00529
`Patent 8,846,112 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`BOB STEINBERG, ESQ.
`KENNETH G. SCHULER, ESQ.
`Latham & Watkins
`355 South Grand Avenue
`Los Angeles, California 90071
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`Case IPR2015-00529
`Patent 8,846,112 B2
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`P R O C E E D I N G S
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`JUDGE POLLOCK: Please be seated. Good afternoon.
`This is the final hearing in IPR2015-00529. I am Judge Pollock.
`To my right is lead Judge Green. Judge Hulse is joining us by
`teleconference from California.
`As set forth in the hearing order, each side will have 45
`minutes. Petitioner will go first, followed by Patent Owner.
`Petitioner may reserve time for rebuttal. Before we begin with
`the substance of the hearing, I would like the parties to introduce
`themselves.
`Petitioner, would you please introduce yourself and
`your colleagues?
`MR. MURTHY: Good afternoon, Your Honor. Sanjay
`Murthy on behalf of Petitioner, and with me is my colleague,
`Maria Doukas.
`JUDGE POLLOCK: Mr. Murthy, would you like to
`reserve time for rebuttal?
`MR. MURTHY: I would, Your Honor. I would like to
`reserve 20 minutes for rebuttal.
`JUDGE POLLOCK: Very good. Patent Owner, would
`you please introduce yourself and your colleagues.
`MR. STEINBERG: Your Honor, Bob Steinberg as
`lead, let me introduce you to Ken Schuler who is going to argue
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`today. To his right is Chi Cheung, who is going to have the hot
`seat.
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`JUDGE POLLOCK: Gentlemen.
`A few matters of housekeeping before we begin. First I
`would like to remind the parties that this hearing is open to the
`public and a full transcript of the hearing will be made part of the
`record. Second, we are aware of Petitioner's objections into
`evidence of paper 31, we will address them in the final written
`decision. And we also note that both parties have raised
`objections to certain demonstrative exhibits setting forth
`arguments not raised in the briefs. While you certainly will be
`able to refer to your demonstratives during the hearing, the
`demonstratives will not be part of the record of the hearing, nor
`will we rely on new arguments in the final written decision.
`Accordingly, we take your objections under advisement.
`Finally, when discussing any particular demonstrative
`today, please refer to it by slide number or page number,
`particularly today, where one of our judges is presiding by
`teleconference.
`Petitioner, you have the burden of showing
`unpatentability of the challenged claims, if you would like to
`begin.
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`MR. MURTHY: Good afternoon, Judges Green,
`Pollock and Hulse. My name is Sanjay Murthy and I will be
`presenting on behalf of Petitioner today.
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`Nitric oxide was first approved by the FDA in 2000,
`nearly 16 years ago. Accepting the Patent Owner's arguments
`here in this case would mean that any person, including the Patent
`Owner, could continue patenting their invention indefinitely
`merely by providing a set of instructions with that product. That's
`the entire reason the printed subject matter doctrine exists, is to
`prevent this sort of perpetual claiming throughout entirety.
`All of the arguments that the Patent Owner has made in
`its written submissions here have been rejected multiple times by
`the Federal Circuit in decisions such as AstraZeneca, In Re: Kao,
`and King. So, I think the issues that we're here to talk about
`today are fairly straightforward, and just very quickly, I want to
`present the Board very briefly with just an overview of what
`we're going to be talking about today.
`Obviously the Board in its initial decision provided
`some guidance on claim construction, and the issue of printed
`matter. We believe that the Board's analysis of the claims was
`correct. In addition, we believe that there is no evidence here of
`any functional relationship tying the limitations in the claims to
`the printed matter.
`In addition, with respect to the limitation
`"pharmaceutically acceptable nitric oxide gas," we don't believe
`that that is a limitation of the claim. It only appears in the
`preamble. In fact, if you remove that limitation from the claim,
`everything else in the claim would remain the same.
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`And, finally, Patent Owner here has conceded that
`claims 12 through 19 are invalid.
`JUDGE GREEN: Has he really conceded -- I mean, has
`Patent Owner really conceded that they're invalid, or do they just
`state that they do not address those claims? I mean, there's a
`difference there. You know, you can let them go without
`admitting that they're invalid.
`MR. MURTHY: Sure, Your Honor. I think for
`purposes of the Pretrial Practice Guide, they're required in their
`Patent Owner's response to address every single claim that they
`believe is patentable --
`JUDGE GREEN: No, I understand that. They're not
`required, they can let go of the claims without saying they're
`invalid, they can just say this isn't worth our time, we're just
`going to pursue the other claims and this is where we want to
`focus our energy, but that doesn't mean that there is an admission
`there that these claims are invalid.
`MR. MURTHY: I would agree, Your Honor. I would
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`agree.
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`JUDGE GREEN: Okay.
`MR. MURTHY: Turning here to slide 3, just on the
`issue again, the Patent Owner has presented certain evidence
`regarding secondary considerations. We believe that evidence is
`improper for the reasons enumerated in our papers. In particular,
`there is no nexus that exists related to the unexpected results that
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`they cite, and, finally, as laid out in the petition, we believe that
`claims 1 through 19 are obvious in view of the prior art.
`Turning to slide 4, I've put up here on the screen claim 1
`of the '112 patent, and again, as you can see, the
`"pharmaceutically acceptable nitric oxide gas" language only
`appears in the preamble, it appears nowhere else in the claim. It
`provides no antecedent basis for any other limitation that's found
`in the claim.
`In addition, the printed matter steps, which I've
`highlighted in red here below, they don't relate back to any of the
`other method steps that are described, in particular the obtaining a
`cylinder containing compressed nitric oxide gas or the supplying
`the cylinder of containing compressed nitric oxide gas.
`JUDGE GREEN: Now, couldn't you argue that the
`pharmaceutically acceptable is brought into the body of the claim
`by providing it to a medical provider? I mean, you would expect
`it to be pharmaceutically acceptable?
`MR. MURTHY: I would agree that the concept of
`whether or not the nitric oxide gas is pharmaceutically acceptable
`is found in the body of the claim, which further reinforces the fact
`that the language in the preamble is not providing any limitation
`to the claim. As I mentioned before, if you removed the language
`of "pharmaceutically acceptable nitric oxide gas" from the claim,
`everything else would be the same.
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`MR. SCHULER: Just for the record, we do object to
`this line of argument. There's a single sentence in both the
`petition and in the reply brief that cursorily and conclusorily says
`that they contend that the preamble is not a limitation. Anything
`beyond that we believe has been waived. Just for the record.
`JUDGE POLLOCK: Noted.
`MR. MURTHY: Did I answer Your Honor's question?
`JUDGE GREEN: Yes, you did.
`MR. MURTHY: Thank you, Your Honor.
`Turning to slide 5, again the very same structure that we
`saw in claim 1, again, "pharmaceutically acceptable gas" only
`appears in the preamble, provides no antecedent basis for
`anything else in the claim, and again, printed matter steps are
`provided below and they don't refer back to any of the other
`method steps in the claim.
`Turning to slide 6, again, as the Board noted in its initial
`decision here, "a cylinder containing compressed nitric oxide
`gas," you can provide that to the medical provider with or without
`the information that's recited elsewhere in the claim.
`Turning to slide 7, again, reinforcing the fact that the
`printed matter is not functionally related to or even tied to the
`other method steps, as the Board found in its initial decision,
`there is no administration step required by these claims.
`Turning now to slide 9, the Federal Circuit has
`obviously given a two-step test to determine whether or not
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`elements in the claim are printed matter and whether or not there's
`a new and unobvious functional relationship that's provided by
`those elements.
`And here, as on slide 10, the providing information and
`providing a recommendation steps are undeniably printed matter.
`The claims lack any administration step. And I know Patent
`Owner has made a big deal about the fact that the invention
`relates to the exclusion of certain patients from treatment. There
`is no exclusion step found in any of these independent claims, in
`particular claim 1 and claim 7. There is simply no basis to say
`that there's an exclusion step in these claims. If you read them, it
`leaves it up to the provider whether or not they want to treat the
`patient or not.
`JUDGE GREEN: What about claim 9?
`MR. MURTHY: I beg your pardon?
`JUDGE GREEN: Claim 9.
`MR. MURTHY: So, I would like to, if I can just jump
`ahead, I would like to address claim 9, because Patent Owner
`raised the issue of claim 9 for the first time in its surreply, that
`was the first time that they ever presented the argument that
`they've made. And I believe that if you actually look -- I don't
`think I have a slide on claim 9, but the limitation in claim 9
`doesn't actually refer back or require you to take any action with
`respect to the other language in the claim.
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`And in particular, as the Board noted in its initial
`decision, it merely requires that the step is in accordance with,
`which you interpreted in your initial decision as in agreement.
`That doesn't require it to be actually based on the information
`that's provided.
`Now, they could --
`JUDGE GREEN: Well, we do have an active step,
`right, discontinue the treatment?
`MR. MURTHY: You do have an active step, but it's
`not based on the information that's provided, and that's what the
`case law requires. And actually, again, another decision that they
`cited for the first time in their surreply was the In Re: Kao
`decision, and I think the In Re: Kao decision nicely makes the
`point that when you're talking about a functional relationship
`between the printed matter and the other steps in the claim, what
`you require is an adjustment to be made in response to the
`informing step. And that's right out of In Re: Kao, the case that
`they have cited in their surreply. And based on that articulation
`of the standard, from the Federal Circuit, claim 9 doesn't meet it.
`JUDGE HULSE: Mr. Murthy?
`MR. MURTHY: Yes, Your Honor?
`JUDGE HULSE: On page 4 of your reply, it says, "the
`Board's construction" -- this is right under heading A -- "the
`discontinuing ... based on a recommendation step of dependent
`claim 9 is correct." Are you with me?
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`MR. MURTHY: I apologize, Your Honor, what page?
`JUDGE HULSE: Take your time. Page 4 of your
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`reply.
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`MR. MURTHY: Yes.
`JUDGE HULSE: It says, "discontinuing ... based on a
`recommendation step of dependent claim 9 is correct." So, I don't
`see discontinuing based on a recommendation in dependent claim
`9; rather, it says, you know, in accordance with the
`recommendation, discontinuing the treatment. Does that mean
`that you --
`MR. MURTHY: Sorry, Your Honor.
`JUDGE HULSE: Are you construing "in accordance
`with" to mean "based on?"
`MR. MURTHY: No, Your Honor, I think that was just
`a typographical error in our paper. We're certainly not suggesting
`that "in accordance" means "based on." In fact, consistent with
`the way the Board interpreted it in its initial decision, and the
`Patent Owner has not contested the Board's construction of "in
`accordance with," I believe that that's just a typographical error in
`our paper.
`JUDGE HULSE: Would it be consistent with the
`specification, though, to construe "in accordance with" as "based
`on?"
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`MR. MURTHY: Your Honor, if they had wanted to
`draft the claims to require that it be based on the
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`recommendation, that would have been an easy change for them
`to make when they drafted these claims, but they wanted these
`claims drafted extraordinarily broadly, and they wanted them
`drafted in a way that would allow them to capture as many
`infringers as possible. And that goes back to my original point,
`there is no exclusion step in these claims, and the reason is, they
`didn't want to pin themselves down that way when it came to this
`invention.
`Now, the other patents that were the subject of the IPRs
`that are related to this patent, they required an explicit exclusion
`step, and they also have clear language about what it is that
`they're trying to accomplish with their invention. But that
`language here is lacking. And at the end of the day, they're the
`ones that made the choice about what language to include in their
`claims, and they chose very broad language. They didn't want it
`to be necessarily tied to the printed matter. And if they had
`wanted to, they could have filed a motion to amend to make that
`explicit, or at the very least, they could have offered a competing
`construction along the lines of what Your Honor has just
`articulated, but they haven't done that here.
`JUDGE HULSE: I had questions, actually, about some
`of the other dependent claims, unless my other colleagues have
`questions about claim 9.
`JUDGE GREEN: We're good.
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`JUDGE HULSE: So, claims 3, 4 and 9 recite the step
`of "determining that the first neonatal patient has pre-existing left
`ventricular dysfunction," right? So, those are all steps that are not
`within the printed matter, right?
`MR. MURTHY: That's correct, Your Honor.
`JUDGE HULSE: So, I mean, I think that's what the
`Patent Owner is interpreting as the identification step, identifying
`patients with LVD, right?
`MR. MURTHY: I believe that's the case, Your Honor,
`but again, if you look at the limitations that are found in claims 3
`and 4, none of them explicitly tie back to or, again, say that any
`of these steps are performed based on the printed matter
`limitations. As I read these claims, again, if you removed the
`printed matter limitations from, for example, claim 1, and you
`read claim 3, there would be no inconsistency in the claim, as it's
`written.
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`JUDGE HULSE: Sure, I actually am not asking about
`the printed matter functional relationship, this is sort of a separate
`issue. So, where in the prior art is it taught or suggested that, you
`know, whoever it is that's performing this method should first
`identify the -- whether the neonate has LVD?
`MR. MURTHY: I believe the Bernasconi reference,
`Your Honor, discusses the treatment of neonates with LVD, and
`the identification of patients as well as careful monitoring once
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`those patients are put on nitric oxide therapy, which could include
`discontinuing that therapy as well.
`Does that answer your question sufficiently?
`JUDGE HULSE: I'm not sure that's correct. I think
`Bernasconi talks about LVD generally, but not necessarily with
`neonates. I mean, that was the issue with those cases that we
`denied, right?
`So, my question is, where in the record is there anything
`in the art that teaches identifying -- you know, that a person of
`skill in the art should identify whether the patient has LVD or not
`first, before applying the iNO?
`MR. MURTHY: I think consistent with the way that
`Dr. Beghetti has put his expert declaration together, what a
`physician in the real world would do in identifying an appropriate
`patient to treat would certainly include steps to make sure of
`identifying what patients can and cannot be treated with a
`particular drug. And I understand Your Honor's point that the
`Bernasconi reference may not explicitly tie his treatment steps to
`neonates, but the disclosure does, at least in part, relate to
`neonates, as well as adults, and I believe that a fair reading of that
`reference certainly suggests to one of ordinary skill in the art that
`a part of the process in treating one of these neonates would at
`least include an identification of what class of patients can and
`cannot be treated with the drug.
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`JUDGE HULSE: But would that be inconsistent, then?
`If we agreed with you here, wouldn't that be inconsistent with our
`prior decisions, or decision?
`MR. MURTHY: Again, here, Your Honor, I don't
`believe it would be inconsistent with your prior decisions,
`because I think that the issue about an identification of a patient is
`really tied back to the limitations that the Board has construed as
`printed matter, not -- not necessarily the other limitations in the
`claim.
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`JUDGE HULSE: I'm sorry, I don't think I quite
`understand how the determining step is tied back to the printed
`matter. Can you point me to the claim language as to where that
`would be?
`MR. MURTHY: Sure, Your Honor. I'm looking at the
`'112 patent here, and in particular, claim 4.
`Maybe I misunderstood Your Honor's question. So, just
`to clarify, I believe that the Bernasconi reference, a fair reading of
`it, based on the understanding of one of ordinary skill in the art,
`one reading that reference would understand that you have to
`identify what patients can and cannot be appropriately treated
`with nitric oxide. So, I do believe that it is a limitation that's
`taught in the art.
`What may not be --
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`JUDGE HULSE: But they didn't know at the time that
`neonates with LVD should be -- should or should not be treated
`with iNO, isn't that contrary to your argument?
`MR. MURTHY: No, I don't believe so, Your Honor,
`because the reference itself discusses the risk of patients with
`LVD in treating them with nitric oxide, and I think the limitation
`that the Board found absent from the prior art was focused more
`on the exclusion step, it wasn't necessarily tied to merely
`identifying a patient that may or may not have had LVD.
`As I read Your Honor's decision in the other IPRs, the
`limitation that was found missing was this alleged exclusion step,
`and that's --
`JUDGE HULSE: We were silent as to the determining
`step, right? We didn't necessarily -- it didn't turn on our decision
`as to whether that was there, we only focused on the exclusion
`limitation. Because that's all we had to do, right?
`MR. MURTHY: Sure. Well, as I read Your Honors'
`decision, it seemed to me that you were under the impression that
`everything else was there other than the exclusion step, and I
`believe others on my team probably shared that view, but if that's
`not the case, I believe that there is prior art that explicitly teaches
`this limitation. It's not at issue in these proceedings, but there is
`certainly art that's available that teaches the identification as well
`as the exclusion of these patients.
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`JUDGE HULSE: Okay. Well, I'll let you move on.
`Thank you.
`MR. MURTHY: Turning back really quickly to --
`turning now to slide 12, again, as I understand the Patent Owner's
`argument, it turns entirely on whether or not the preamble can be
`construed as a limitation of the claim, and here we believe that
`none of the typical standards that one applies in construing the
`preamble as a limitation is met. You don't have -- as I mentioned
`before in response to Your Honor's question, you don't have a
`situation here where you're providing antecedent basis for a
`limitation found elsewhere in the claim. You don't have a
`situation where you're breathing life or meaning into the claim,
`and if you actually remove the "pharmaceutically acceptable
`nitric oxide gas" limitation entirely from the claim, it would look
`no different than claim 12, and it would just say, a method
`comprising, and the steps below, I don't think anybody would
`dispute are a complete method that can be performed.
`Turning to slide 13, the Patent Owner has argued that
`the preamble's limitation here, because it was added to overcome
`prior art, and in particular, they cite the Catalina Marketing v.
`Coolsavings case, on pages 19 and 20 of their Patent Owner's
`response, and on slide 14 here, this is the actual portion of the file
`history, the Patent Owner didn't actually put this in its Patent
`Owner's response, but if you actually read the file history and the
`arguments that were made, it wasn't a situation where they were
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`trying to overcome prior art. It was just the opposite. The
`examiner had raised an objection about whether or not the
`language in the preamble was fairly supported by the priority
`document, and here's their response to that on slide 15. And we
`only wanted to highlight that to the Board because it wasn't
`mentioned in the Patent Owner's response.
`Turning to slide 16, again, with respect to this language
`of "pharmaceutically acceptable," the Patent Owner has advanced
`a theory here that it should be construed as "suitably safe for
`pharmaceutical use." And I believe that there are a number of
`problems with that. The biggest is that they've offered this
`opinion that the words "suitably safe" could vary over time. In
`other words, I could be infringing the claim today, but based on
`information that's discovered elsewhere in the future, at some
`point in time, I wouldn't be infringing the claim.
`And likewise, I could be in a situation where I'm
`infringing the claim now, but based on information that becomes
`available at a later date, I'm no longer infringing the claim. And
`I'm not aware of any precedent that has ever held that the
`meaning of a claim term could actually vary over time. I've never
`seen a case that suggested anything of the sort, and I think it
`would eviscerate the public notice function of Markman to allow
`claims to be interpreted in this fashion.
`And, in addition, the "suitably safe" language appears
`nowhere in the specification, it appears nowhere in connection
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`with this limitation. So, it seems to me that what the Patent
`Owner has done here is essentially crafted new language that they
`would have liked to have included in their patent to describe
`something other than what's there.
`JUDGE GREEN: Now, is it your understanding that
`they're using the "pharmaceutically acceptable" to make -- to read
`in that inclusion of certain classifications?
`MR. MURTHY: I believe that they are trying to do
`that, Your Honor. I also think that they --
`JUDGE GREEN: So, "pharmaceutically acceptable," as
`you understand how Patent Owner's arguing it, is it may only
`apply to this class of patients but not this class of patients when
`you are administering the same gas?
`MR. MURTHY: I think they're doing two things. I
`think that maybe part of it is trying to establish that there's an
`exclusion step when their claims don't require it, but the other
`part of it is I think that what they're trying to argue is somehow
`the instructions make the gas pharmaceutically acceptable. So,
`I'm not sure, maybe you can ask them what precisely it is they're
`arguing. I think that the --
`JUDGE GREEN: I was just curious what your view of
`their argument was.
`MR. MURTHY: Yeah, my view is it's probably more
`of the latter, that they're trying to say that "pharmaceutically
`acceptable" somehow ties back to the printed matter, but again,
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`I'm not aware of any case that's ever said that you could adopt a
`claim construction that would vary over time or that somehow the
`claims could read in that fashion.
`JUDGE GREEN: But if "pharmaceutically acceptable"
`does tie back to the printed matter, could that be the functional
`relationship between the gas and instructions that would take it
`out of the printed matter doctrine?
`MR. MURTHY: I still don't think it would meet the
`test, Your Honor, as articulated in In Re: Kao, you actually have
`to do something based on the printed matter. You actually have
`to make a change. And even if you were to find that
`"pharmaceutically acceptable" is a limitation, even if you were to
`accept their claim construction, which I don't think is correct, I
`still don't think the claims would meet the standards set forth in In
`Re: Kao.
`In Re: Kao sets a very high bar that says that you
`actually have to tie something that you're changing or adjusting
`based on the printed matter and the other limitations in the claim,
`and here you will not find that in these claims.
`JUDGE POLLOCK: Mr. Murthy, you have three and a
`half minutes.
`MR. MURTHY: Thank you, Your Honor.
`Just very quickly, I want to briefly go to slide 19. We
`obviously address the AstraZeneca case in our papers, but just to
`highlight that the similarities between the claims that are at issue
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`in AstraZeneca and the claims that are at issue here, you have a
`drug element, you have elements providing dosage and safety
`information, but again, not relating back to any sort of method
`step or not relating back to any sort of product step that's
`elsewhere in the claims.
`And, so, at the end of the day, this case is really no
`different than AstraZeneca, and the Patent Owner has raised a
`number of complaints saying, well, AstraZeneca is a product case
`and we're talking about method claims. Both King
`Pharmaceuticals and In Re: Kao are method claims, and in both
`those cases, they said there is no distinction between the printed
`matter doctrine when you're looking at method claims as opposed
`to product claims.
`The thing that matters is are you modifying another
`element in the claim, in this case -- in this particular case, the
`drug element, and there's no such modification being made.
`I want to briefly touch on the issue of whether or not a
`functional or novel and unobvious relationship can be established
`here. Again, the fact that nitric oxide is dangerous to a certain
`class of patients, that's an inherent property of nitric oxide. It's
`not like the Patent Owner here changed the drug in any way, it's
`not like nitric oxide that's offered today in pharmaceutical context
`is any different than it was when it was first approved in 2000.
`It's identical.
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`The only thing that they have allegedly discovered is
`that there is some inherent dangerous property that exists when
`you apply this nitric oxide to a certain class of patients, and
`recognizing an inherent feature of a drug is not the sort of thing
`that creates a novel and unobvious relationship.
`The Patent Owner on slide 22, I just want to very briefly
`highlight one of the things that they cite in support of their
`argument that they have established this functional relationship
`were declarations that were submitted to the PTO. They did not
`make any of those declarants available to us to depose in this
`matter.
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`Finally, one of the complaints that's been raised about
`the Board's actions in this case is whether or not the Board
`instituted on grounds that were beyond what we raised in our
`petition. This is a well-accepted practice. The Board has the
`authority to rely upon arguments and evidence that are presented
`in the record, and not on grounds not raised in our petition, and
`that issue has been addressed by the Federal Circuit as well in the
`Cuozzo decision.
`And, finally, I just want to highlight with respect to the
`dependent claims, Your Honor mentioned claims 3 and 4. The
`Patent Owner never made any specific argument in its Patent
`Owner's response specific to claims 3 and 4. The first time that
`they ever articulated this theory that these dependent claims were
`separately patentable was when they filed their surreply. The
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`only argument they made with respect to claims 3 and 4 in their
`Patent Owner's response was they criticized the Board for
`essentially doing a 101 analysis and finding that the limitations
`were mental steps. That was the sum and substance of their
`argument on those dependent claims.
`So, we never had a chance in writing to respond to their
`arguments that these dependent claims were separately
`patentable, but again, for the reasons I've already discussed, I
`think even if you look at those claims, they don't tie back to the
`printed matter and they don't establish the necessary functional
`relationship.
`So, unless Your Honors have any other questions for
`me, I'll conclude my presentation.
`(No response.)
`MR. MURTHY: Thank you, Your Honors.
`JUDGE POLLOCK: Thank you very much.
`(Brief pause in the proceedings.)
`MR. SCHULER: Thank you for your patience.
`JUDGE POLLOCK: Take your time. We're no
`strangers to