UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`GRÜNENTHAL GMBH,
`Petitioner
`
`v.
`
`ANTECIP BIOVENTURES II, LLC,
`Patent Owner.
`
`__________
`
`Case PGR2019-00003
`Patent 9,867,839 B2
`
`__________
`
`Record of Oral Hearing
`Held: February 4, 2020
`__________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`GRÜNENTHAL GMBH,
`Petitioner
`
`v.
`
`ANTECIP BIOVENTURES II, LLC,
`Patent Owner.
`
`__________
`
`Case PGR2019-00003
`Patent 9,867,839 B2
`
`__________
`
`Record of Oral Hearing
`Held: February 4, 2020
`__________
`
`Before TONI R. SCHEINER, GRACE KARAFFA OBERMANN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
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`Case PGR2019-00003
`Patent 9,867,839 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`DANIEL J. MINION, ESQ.
`KATHERINE E. ADAMS, ESQ.
`Venable LLP
`Rockefeller Center
`1270 Avenue of the Americas
`24th Floor
`New York, New York 10020
`212-218-2538 (Minion)
`212-218-2106 (Adams)
`dminion@venable.com
`keadams@venable.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`BRENT A. JOHNSON, Ph.D., ESQ.
`Maschoff Brennan
`100 Spectrum Center Drive
`Suite 1200
`Irvine, California 92618
`949-202-1903
`bjohnson@mabr.com
`
`
`
`
`The above-entitled matter came on for hearing on Tuesday, February 4,
`2020, commencing at 10:00 a.m. at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`P-R-O-C-E-E-D-I-N-G-S
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`10:01 a.m.
`JUDGE SNEDDEN: Good morning. This is final hearing of
`PGR 2019-00003. I am Judge Snedden and with me on our Panel are
`Judge Scheiner and Obermann. Let's begin with Petitioner -- I mean let's
`begin with appearances, starting with Petitioner. Please stand, introduce
`yourself and who you have with you today.
`MR. MINION: Thank you, Your Honor. Daniel Minion from
`Venable on behalf of the Petitioner. With me is Katherine Adams and
`William Solander, also, from Venable.
`MR. JOHNSON: Good morning, Your Honors. Brent Johnson
`for Antecip, and I am by myself.
`JUDGE SNEDDEN: All right, well welcome. Per our order, this
`oral hearing -- per our order granting this oral hearing, each party will have
`60 minutes of total time to present its arguments. Petitioner will open the
`hearing by presenting its case with regard to the challenged claim to which
`we institute a trial. Patent Owner will then respond to the argument, and
`each party may reserve rebuttal time. Mr. Minion, when you're ready, you
`may begin. And will you be reserving rebuttal time?
`MR. MINION: Yes, Your Honor. I'd like to reserve 20 minutes
`of rebuttal time.
`JUDGE SNEDDEN: Okay. You may start when ready.
`MR. MINION: Good morning again, Your Honors. We have six
`grounds that were set forth in the petition. Today I am going to focus on
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`two of those grounds. Ground two, which is obviousness for claims 1
`through 14 of the 839 patent, and then ground six, which is obviousness of
`claims 15 through 30 of the 839 patent.
`So for ground two, the subject matter of these claims -- which I will
`get to in a moment -- will be familiar with the Board. We've been through
`this subject matter now. This will be the third of six PGRs that have been
`instituted, directed to the use of neridronic acid in patients with complex
`regional pain syndrome. As you'll see in Patent Owner's rebuttal, the
`principal argument of the first argument will be, again, whether Petitioner
`has met its burden to demonstrate that its non-prior art references constitute
`printed publications under U.S. Section 35 -- 103. And Your Honors will
`be familiar with these references, I hope. Varenna 2012 -- it's the subject
`of request for re-hearing in the 245 PGR. The first of these three
`proceedings. Muratore and Gatti were also found to be prior art in the -- in
`the 245, though it's not challenged on the request for re-hearing.
`Again, here is the Board's finding as to Varenna 2012 in the 245
`PGR. We find that Varenna qualifies as prior art against the challenged
`claims of the 245 patent, even if we set aside Dr. Robinson's declaration.
`So based on just the indicia on Varenna 2012 itself, this Board found that it
`qualified as prior art. Again, just as in the 245 PGR proceeding, Patent
`Owner -- it did not object to Varenna 2012, and therefore it has waived any
`hearsay, authenticity or evidentiary objection, so the statements in Varenna
`2012 are admitted as evidence for the truth of the matter asserted. They are
`not hearsay.
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`Second, again, just as in the 245, Patent Owner has not come forth
`with any evidence calling into question Varenna 2012's stated publication
`and copyright dates, or that it is not -- was not publically available prior to
`the filing of the 839 patent. Instead, we have, from Patent Owners, some
`what I characterize as unsupportable legal arguments. The first is that they
`state that Petitioner did nothing more than point to the date on the face of
`each document as proof of its printed publication status. The law requires
`considerably more than that. That is, of course, incorrect. And as you
`see, if you look at the Patent Owner response, there is no legal authority for
`that position because throughout all of these proceedings and all of the
`stages of these PGRs, Patent Owner has yet to come forth with a single
`instance where a publication in a scientific journal was determined by any
`tribunal -- including the Patent Office or the PTAB -- was not a piece of
`prior art. I am not aware of any instance, and certainly none has been cited.
`Patent Owner continues that they say -- assert that a reference
`standing alone cannot serve as prove of its own dissemination or availability
`before the critical date, even if that reference were to survive an
`admissibility challenge. First of all, we don't have an admissibility
`challenge. And I will get to a case in a moment that says the opposite, that
`a reference alone can actually serve as proof of its own dissemination.
`Last, Patent Owner states that there are profoundly negative policy
`implications for allowing a non-patent reference to qualify as a printed
`publication based solely on its appearance, without evidence of
`dissemination or availability. I'd be happy to get into policy implications
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`here, but I would like to address as what I see as -- I characterize as Patent
`Owner's mantra that there is no evidence in this proceeding that any of these
`prior art references were made publically available. That is false.
`Varenna 2012 is an example, which is the core reference to ground two.
`We see on the top it says Advance Access Publication, 30 November 2012.
`We're talking about the issue of public accessibility.
`Now, all of the cases that are cited by Patent Owner in terms of
`pubic accessibility, the lead case in the request for rehearing was a brochure
`on a table at a conference. The Blue Calypso case that is cited in the first
`slide from Patent Owner is -- was a paper that a graduate student uploaded to
`her own website. This is completely different than a reference in --
`different factual scenario, different analysis than a publication in a journal.
`And what are we talking about, public accessibility? Well this is a
`publication. It is by definition publically accessible. That is the whole
`point of a scientific journal. We see at the bottom here, you have the
`greatest society for rheumatology puts together scientific articles in their
`field and goes to the Oxford University Press, and asks them to publish that
`reference, that journal, on its behalf. I.e., to make it publically available.
`It says right there the date. There is no countervailing evidence. There is
`clearly, clearly prior art.
`The notion that indicia on the face of a reference cannot be used as
`evidence of prior art -- the HULU case, I am sure the Board is aware of from
`December from the Precedential Opinion Panel, stated that indicia on the
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`face of a reference, such as printed dates and stamps, are considered as part
`of the totality of the evidence. So what are we really talking about here?
`Well the evidence that is in this case -- that is admitted -- for
`example, what we have here, we have the copyright date. We have the
`advanced access publication date. We are to weigh that evidence against
`the evidence that is submitted by Patent Owner suggesting that this was not
`publically available, and determined whether that evidence meets the
`preponderance of the evidence standard. Here it is actually the totality of
`the evidence. The totality of the evidence here shows that Varenna 2012 is
`prior art.
`As for the legal argument that a reference itself cannot establish that
`it is a printed publication, in HULU it was a book. And the -- the POP
`determined that -- looked at the book, said that it bears a copyright date of
`1990, a printing date of November 1992 and an ISBN date of 8-94, an
`amicus pointed out that it was an established publisher. And they said, that
`alone was enough to meet the threshold there. And an IPR to meet the
`standard.
`So turning then to the claims at issue -- so these are claims 1 through
`14. They're directed to treatment of pain associated with the joint by
`administering neridronic acid to a patient who has suffered for at least three
`months with pain associated with the joint, and a pain intensity of five or
`greater, or five centimeters or greater on the VAS scale. So let me explain
`what those terms mean.
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`So if you've ever had to go to a physician or a pain management
`person with pain -- back pain, any other type of pain -- you go to the -- you
`go to the waiting room, and you're handed questionnaire. It says: how long
`have you been suffering from this pain? You write down your answer.
`Where is the pain? There's often a picture of a body and you circle where
`the pain is in your body. And then there is another question that has a line
`from -- two bars, from zero to 10, and a bar in between. And what they ask
`you is, on a scale of zero -- which is no pain at all -- to ten, which is the
`worst imaginable pain -- mark on the scale how much pain you are in right
`now. That is the visual analogue scale. It is a subjective measure of pain
`at that time.
`The numerical rating scale is the same, except that's the physician
`asking you, on a scale of one to 10, how much pain are you in right now?
`So that's what these -- claims are covered. So these are covering the
`patients. Five is considered the -- five on the NRS, or five centimeters on
`the VAS. That's considered moderate pain. So five or greater is moderate
`to severe pain -- joint pain in patients who have suffered at least three
`months. Now we also have claims 10 through 12 --
`JUDGE SNEDDEN: I want to move on to -- move away from
`claim 1. There is some argument in the record about the use of "and" in
`claim 1. And I think -- "and" versus "with," how it should be interpreted
`between the 1 and 2. Can you explain to me what the difference is? What
`difference you are arguing and how it relates to the grounds?
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`MR. MINION: I will. I think, Judge Snedden, it will be helpful if
`I present what is the results of Varenna 2012. And then in light of that we
`can discuss the claim construction, if that's okay?
`JUDGE SNEDDEN: Sure. That sounds okay, yes.
`JUDGE OBERMANN: And before you move on to that, I just
`wondered, do you have anything else on HULU? Because I think that is
`something, as an intervening -- if not a change in the law, it at least clarifies
`something that is really vital to this case. And you mentioned it in passing,
`but do you have anything else to say about how HULU might apply?
`MR. MINION: Well, I mean HULU -- HULU in the IPR is a little
`-- it's really addressing what is the burden to establish that a reference is
`prior art at the institution phase of an IPR? Which is a little different than
`PGR. Here, we've already instituted. So we have -- we, as Petitioners,
`met the threshold showing of establishing --
`JUDGE OBERMANN: That doesn't compel me at all because we
`may have gone forward without having an adequate showing under HULU.
`And I think that's what your friend's argument is, is that they -- they are
`perfectly within their rights to sit on their hands and do nothing and come
`forward with nothing. And we have to look at the indicia that you've
`actually presented in the petition. And we can take a second look at that
`after instituting -- especially after HULU, and -- and we are completely, you
`know, able to say, well actually, you didn't come forward with a modicum of
`proof on this issue. My concern is that your expert says a lot of stuff, but
`never says this is prior art.
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`MR. MINION: Well, I mean this wasn't the first PGR, and these
`references weren't challenged. So we have -- it says on the face of the
`patent -- and we say it on our petition -- it was published on November
`2020.
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`JUDGE OBERMANN: You say it in your petition?
`MR. MINION: Yes.
`JUDGE OBERMANN: How -- if only your expert had said that.
`Does it matter? And if not, why not?
`MR. MINION: It doesn't matter because the expert isn't the one
`who is weighing these evidence -- the evidence.
`(Simultaneous speaking.)
`JUDGE OBERMANN: But we have a cluster of indicia. We
`have the copyright date. We have the publication date. In the other case
`we said that, you know, this is one of the -- Oxford University Press is one
`of the most well-known publishers. Your weakness is that you don't have a
`witness -- other than perhaps Dr. Robinson -- in your reply coming forward
`at the petition state and saying, all these indicia indicate to me that this thing
`was available on the critical date.
`MR. MINION: Well, I think this is -- the answer to the question --
`I don't think an expert saying that that is an indicia to me, that it was
`available, would really add to the evidence submitted. I mean, you know,
`the question is, factually, was it available? Not whether an expert now says
`that I consider that to be available.
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`JUDGE OBERMANN: Okay, so your position is because it's a
`factual inquiry, the attorney can just come forward in the petition and say,
`well, all these indicia indicate availability and public accessibility?
`MR. MINION: We can. And in HULU, they found that was
`sufficient.
`JUDGE OBERMANN: So in other words, HULU does add
`something to your case?
`MR. MINION: Absolutely. Absolutely. HULU eviscerates the
`main position that -- from Patent Owner -- that you cannot rely solely on the
`indicia on the non-patent reference to establish its publically accessibility in
`prior art references. It says very clearly the opposite.
`JUDGE OBERMANN: So your position would be you've got this
`cluster of indicia, and you would weigh that against basically nothing on the
`other side?
`MR. MINION: That's correct.
`JUDGE OBERMANN: Now -- I lost my train of thought. Never
`mind. Go ahead.
`MR. MINION: Okay. So let's talk about -- sorry, I was going on
`
`--
`
`JUDGE OBERMANN: Oh, I know what my question was --
`before you go on.
`MR. MINION: Yes.
`JUDGE OBERMANN: HULU -- does HULU distinguish between
`things like theses that are -- you know --
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`MR. MINION: Yes.
`JUDGE OBERMANN: Oh, they do?
`MR. MINION: Yes.
`JUDGE OBERMANN: Okay, so that's also significant because I
`think that really persuaded the Panel previously, that because this was a
`well-known publication, just the way that it fits within the Board procedure -
`- you know, we have things like patents which we take at face value. And
`then we also have a second-tier of documents that are basically printed
`publications that come from very established publishers, or publications.
`The problem here is that you didn't go to a library and get a copy of that.
`You got a downloaded copy from an Internet, you know, site. Is that
`correct?
`MR. MINION: In the case of Varenna 2012, yes, we got it from a
`downloaded site. Yes.
`JUDGE OBERMANN: And do you have Dr. Robinson's
`declaration in this case as well?
`MR. MINION: No, no we do not.
`JUDGE OBERMANN: So you have nothing in your reply. So
`now this is a bit different from --
`MR. MINION: Nothing other than, you know, pointing out --
`although, I don't think it really matters that, as Your Honors found, that
`Oxford University Press is a well-known, established -- I think the point of
`the issue is, there hasn't been any challenge raised, or any deficiency for us
`to correct. I mean, if Patent Owner had come forth and said, this was on
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`the website -- although according to the website, it wasn't uploaded until
`later. Then we could go back and correct that, but --
`JUDGE OBERMANN: Well, you're assuming that you've met the
`threshold, and that sort of the burden of production has shifted. My real
`inquiry has to be: did you meet a threshold showing that sufficient under
`HULU and any other, you know, authority that is out there? And I think
`Patent Owner's position is you have not.
`MR. MINION: I mean, I think the answer is absolutely yes. I
`mean, there is no question that Varenna 2012 is prior art and publically
`accessible.
`JUDGE OBERMANN: Why is that?
`MR. MINION: It's -- well --
`(Simultaneous speaking.)
`JUDGE OBERMANN: What do you have? You have a
`publication date on the face of the document. You have no one on the
`record saying what Oxford University Press is. You have a prior opinion
`of the Board recognizing -- taking judicial notice of the fact that it's a very
`well-known publisher. My concern is that you have just a -- you know, a
`few clusters. You have the date. You have the copyright notice. Do we
`have in this case the whole thing about it having been submitted during
`prosecution?
`MR. MINION: No.
`JUDGE OBERMANN: That wasn't raised. So you -- you have a
`weaker case here than you did in the prior PGR.
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`MR. MINION: I don't think the case is any different, because in
`the prior PGR, it was -- the Board found just on -- the indicia on the face of
`Varenna 2012 alone was sufficient.
`JUDGE OBERMANN: So we had the part about, in the
`alternative, you know, we don't need to look at Dr. Robinson's declaration?
`MR. MINION: That's -- I mean, adding in Dr. Robinson's
`declaration raises it to 100-percent proof. But I am not aware -- and Patent
`Owner has never explained what the possible scenario would be that
`Varenna 2012 was not actually made publically accessible on the date that it
`says. There's no --
`(Simultaneous speaking.)
`JUDGE OBERMANN: So your position is that under HULU, can
`someone come in with basically a thesis that just has, you know, Joe Jones --
`you know, I don't know -- Waterford College, 2012?
`MR. MINION: No, Your Honor. That's not sufficient.
`JUDGE OBERMANN: What -- why?
`MR. MINION: Because that's a thesis. That is not a -- that is not
`a journal article in a scientific publication. The thesis has to be indexed in
`a library. If that thesis is -- if there's evidence that it was indexed and on
`the shelf in one library, that's enough to make it publically accessible.
`JUDGE OBERMANN: So that would require a declarant?
`MR. MINION: You have to -- it doesn't necessarily require a
`declarant, but it would have to require some sort of evidence that it was
`indexed. So if I go down to the library and I check out a thesis, and if you
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`look at the card and someone checked it out in 2012, then I know it was
`publically available. I don't need a declarant to come in and say, oh, well,
`that card -- I am the head of the library, and this card means it's publically
`accessible. I mean we talk about these policy implications. They have
`challenged every single reference without providing any evidence that -- a
`countervailing evidence that they were publically accessible. Every single
`evidence. So now we --
`JUDGE OBERMANN: I understand that. But my concern is that
`this case presents a very unique set of facts that I am starting to come to
`grips with, and that's that you have what appears to be a copy of an article
`that was published by the Oxford University Press in 2012. It was
`downloaded from a website after the critical date. Does that -- now, setting
`aside whatever Patent Owner, you know, has done -- they're allowed to do
`nothing -- why is that cluster of facts, within this very strong presumption of
`accessibility that you would get if you had copied the article from, say, the
`actual journal that you found in the library?
`MR. MINION: Because, Your Honor, the burden is much lower
`than Patent Owner is making it out to be. We don't have to disprove all
`these conspiracy theories. We have to show by a preponderance of the
`evidence, is this -- if you look at this -- I mean, you know, given this, do we
`say this is more likely than not to have been published in November 30,
`2012? I mean, that's the question here. And I can't think of any way why
`that wouldn't be the case here. Is it --
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`JUDGE OBERMANN: So, in your view, that falls squarely within
`the HULU, you know, established publication?
`MR. MINION: I think this is -- Varenna 2012 is much more
`clearly established as publically accessible than the book in HULU.
`JUDGE OBERMANN: And did the book in HULU have a
`declarant behind it?
`MR. MINION: The book in HULU did have a declarant behind it.
`And there were all sorts of problems with the declaration. And the
`Petitioner withdrew the declaration. The Patent Owner actually said no, we
`want to rely on the declaration because it puts into question whether that
`book was actually publically available. And -- and the Board said, they can
`set aside their declaration. We can look at the book itself. The book has
`all these indicia. If you want to come back, Patent Owner, in your Patent
`Owner response and -- and provide evidence that suggests that this was not
`publically available, you can do so and then we can weigh that evidence.
`JUDGE OBERMANN: So then HULU really did, implicitly at
`least, do a Dynamic Drinkware shifting of the burden of production at that
`point?
`
`MR. MINION: Yes.
`JUDGE OBERMANN: Okay.
`MR. MINION: Yes, Your Honor. Although I do want to point
`out, just to -- that that is an IPR. So the standard is slightly different. So
`there can be --
`JUDGE OBERMANN: How does it differ?
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`MR. MINION: So the -- the -- there's a lower standard for
`institution in an IPR than a PGR. So you could meet the -- it -- for -- for a
`PGR, if you meet the standard --
`JUDGE OBERMANN: So you're talking about -- reasonable --
`MR. MINION: The standard is the same.
`JUDGE OBERMANN: -- reasonable likelihood versus more likely
`than not?
`MR. MINION: Right.
`JUDGE OBERMANN: Okay.
`MR. MINION: So, in an IPR, you can meet the institution decision
`and fall below the burden for the -- in the final written decision. For a
`PGR, the burden is the same. So if you meet the burden at the institution
`decision and there's no evidence submitted to the contrary, you should meet
`the burden at the end of the day. Because they're the same.
`JUDGE OBERMANN: Really? Okay.
`MR. MINION: So we went through claims 1 through 3, described
`what patients are talking about. There are -- claims 10 through 12 are
`dependent claims where the patient is suffering from CRPS. I am going to
`focus on those claims, because if the dependent claims fall, the broader
`claims fall with it. We've talked about CRS before. It is characterized by
`severe continuing regional pain. In Varenna 2012, the authors
`characterized CRPS as severe debilitating pain. And, you know, we're
`talking about, well -- is CRPS understood to be associated with the joint?
`Yes, it was. We have Dowd that teaches that -- that CRPS can affect the
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`joint knee. And this is commonly happened when someone has a blow to
`the knee, or has arthroscopic surgery and they develop this -- this tricky pain
`syndrome.
`And in terms of the relationship between CRPS pain and a joint, as I
`-- there were three recent PGRs that were instituted on what we call the
`Budapest Criteria. And CRPS is diagnosed by these specific symptoms.
`One of them is hyperalgesia, which is when you take a pin and you prick --
`let's say you have CRPS related with your hand, a pin prick results in really
`severe, sharp pain. The other is called allodynia. And allodynia is from --
`you have pain caused by something that should not be usually painful. So
`what they do is they'll take a brush and brush it across the hand and that
`could be painful. But the other diagnostic sign of CRPS is deep joint
`pressure. So if you squeeze your finger on the joint, or you squeeze your
`wrist, or you squeeze your ankle -- that's very painful, or you have limited
`range of motion of your wrist or your fingers, or you have pain when you're
`moving your joints. So those are characteristic diagnostic signs of CRPS.
`So when we're talking about claims that are directed to patients who
`have CRPS, moderate to severe pain, and pain associated with the joint,
`we're talking about your average CRPS patient. That's what we're talking
`about. So the question here really boils down to -- and we'll talk about the
`specifics and the results -- but the question really boils down to -- is would it
`have been obvious to use neridronic acid to treat a patient with CRPS?
`And the Board has already answered that question. And we just have these
`specific limitations that are all specifically taught by Varenna 2012.
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`If we look at the inclusion criteria for Varenna 2012, these are
`patients who had the disease no longer than four months. So it included
`patients who had the disease between three and four months. So that
`satisfies that limitation of the claim. All of the patients to be included in
`the study had to have a pain of 50 millimeters or more on the VAS scale.
`So that corresponds exactly with the range in the claim.
`And counsel for Patent Owner is going to note in the inclusion
`criteria that they're talking about pain in the affected limb. It doesn't
`specify pain in the joint. We should note that all of the patients in Varenna
`2012 had CRPS either in the hand or the foot. And what they did in the
`study is they did two things. How are they going to determine whether
`neridronic acid provides a benefit to patients over the placebo? So they
`take half the patients in neridronic acid, and half the patients in placebo.
`And what they do is at the beginning of the study, they have them draw the
`line on that little, 10-centimeter chart. How much pain are you in? And
`at the end of the study they do the same thing and they see if there's a
`decrease or not.
`The other thing they did is -- and this is on the -- on the slide 11 here
`-- on the bottom they said additional clinical assessment included pain
`evoked by passive motion. So those who have CRPS in the foot, that's --
`move your ankle. Move your ankle, and how painful is that? Zero, none;
`one, mild; two, moderate; three, severe. If you have CRPS in your hand
`move your wrist, move your fingers. Is that painful? They ask them in
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`the beginning, and they ask them at the end of the trial. And what were the
`results?
`So in terms of the VAS score, in 73 percent of the patients treated
`with neridronic acid -- 73 percent of the patients treated with neridronic acid
`had a greater than or equal 50-percent VAS score. So that line they drew
`between five and 10 became less than five. And most importantly here,
`this right here -- pain invoked by passive motion -- in the baseline, those
`patients had moderate to severe joint pain by doing that test. And after
`given neridronic acid, they had clinically relevant and persistent benefits, a
`drop from 2.32 to 0.78. So that pain from moving their joints was relieved
`by neridronic acid. And most significantly, when they go to the open label
`portion of the study, where they took all of the placebo patients, they put
`them on neridronic acid -- at the end of that phase, that pain that the patients
`had from moving their joints -- that allodynia -- was gone in all of the
`patients from neridronic acid.
`So it is unquestionably true that Varenna 2012 teaches effective
`treatment with neridronic acid in patients with pain associated with a joint.
`Now, Judge Snedden, your question about this issue of the claim
`construction. So we had Dr. Poree opine on what his definition of -- or his
`construction of pain associated with joint. There is no definition in the
`specification. So he said, well the plain language in medicine, when you
`talk about associate means bring together in a relationship. So we're
`talking about broadest reasonable interpretation, and this was before the
`change in the standard. And Dr. Poree opined that under the broadest
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`reasonable interpretation, that means any pain related to a joint in any way.
`And I don't fully understand what Patent Owner's argument is, but it has to
`do -- and here is from the Patent Owner response, is when we're talking
`about the -- when they did the clinical assessment of the joint pain in the
`patients in Varenna 2012, they used zero, one, two and three -- two being
`moderate, three being severe. And they found at start the patients had
`moderate to severe joint pain.
`And what their response is, well, our claim of pain intensity of five
`or greater in a joint. Not five or greater generally. So they're using a
`different scale to measure pain in the joint than we are in the claim. But
`that's not significant. That's not patentable. Just because you're
`describing pain in a different way, we know from the specification that pain
`of five or higher is referred to moderate or severe pain. And then the scale
`that is described by the joint pain in Varenna 2012, moderate is two, and
`three is severe. Some patients had 2.3, so they had -- also had moderate to
`severe pain. So, you know, I think about it this way. I can't say, you
`know, I am going to now create the Minion Scale of Pain, on a scale of Q to
`Z where U is moderate and Z is very severe and say, well, I am going to
`claim patients who have a W on the Minion Pain Scale and pain in their hip
`joint. And say, well, the patients of Varenna 2012 -- there w
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