`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`___________
`
`Record of Oral Hearing
`Held: February 7, 2019
`____________
`
`
`
`Before GRACE KARAFFA OBERMANN, TONI R. SCHEINER, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
`DANIEL J. MINION, ESQUIRE
`BRUCE C. HAAS, ESQUIRE
`JAMES R. TYMINSKI, ESQUIRE
`Venable, LLP
`1290 Avenue of the Americas
`Twentieth Floor
`New York, New York 10104
`
`ON BEHALF OF PATENT OWNER:
`BRENT A. JOHNSON, Ph.D., ESQUIRE
`Maschoff Brennan
`100 Spectrum Center Drive
`Suite 1200
`Irvine, California 92618
`
`
`
`
`
`The above-entitled matter came on for hearing on Thursday,
`
`
`February 7, 2019, commencing at 1:05 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE OBERMANN: This is a final oral hearing in
`PGR2018-00001. The case is Grünenthal GMBH versus Antecip
`Bioventures II, LLC. At issue is the patentability of claims 3 through 30 of
`U.S. patent number 9,539,268. I'm Judge Grace Obermann. On my right
`here is Judge Toni Scheiner, and we also have Judge Sheridan Snedden.
`Let's start with counsel introductions. Who do we have in the
`courtroom for petitioner today?
`MR. MINION: Your Honor, Daniel Minion of Venable. Also
`with me is James Tyminski and lead counsel, Bruce Haas.
`JUDGE OBERMANN: Thank you. And who will be presenting
`argument today?
`MR. MINION: I will, Your Honor.
`JUDGE OBERMANN: Thank you very much, Mr. Minion. Who
`do we have for patent owner?
`MR. JOHNSON: Your Honor, Brent Johnson. I'm the only one.
`JUDGE OBERMANN: Great. Thank you so much.
`Okay. We are in receipt of both parties' demonstrative exhibits.
`We did not receive any objections. I just want to confirm, petitioner, you
`have no objections with patent owner's demonstratives?
`MR. MINION: That's correct, Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 3
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE OBERMANN: And a patent owner has no objections with
`petitioner's?
`MR. JOHNSON: No objections.
`JUDGE OBERMANN: Thank you so much, counsel. I appreciate
`that. I also looked at the record last night and I saw no introduction of any
`confidential information in the record. So we don't have to worry about that
`either; is that correct?
`MR. MINION: That's correct.
`JUDGE OBERMANN: Both sides have 60 minutes of total
`argument time. Petitioner's counsel will present first and you may reserve
`some reply time. Then patent owner will present second, and you also may
`reserve some sur-reply time. Would petitioner like to reserve some time?
`MR. MINION: Yes, Your Honor, I would like to reserve
`15 minutes.
`JUDGE OBERMANN: I'm going to set the clock then for
`45 minutes. Fifteen minutes will remain. And I'll start the clock running
`when you begin speaking, Mr. Minion.
`MR. MINION: Thank you, Your Honor. I did bring extra copies,
`if that makes a difference to anybody.
`JUDGE OBERMANN: I actually prefer -- we have everything on
`the computer screen, but would either of my colleagues like a copy?
`JUDGE SCHEINER: Actually, I would. I sometimes take notes
`on it temporarily. Thank you.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 4
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE SNEDDEN: Thank you.
`JUDGE OBERMANN: Mr. Minion, I didn't see your name on the
`briefs. Are you pro hoc vice?
`MR. MINION: I'm admitted to the bar.
`JUDGE OBERMANN: Thank you very much. I'll start when you
`are ready.
`MR. MINION: Thank you, Your Honor. May it please the Board,
`in the '268 patent we have two different independent claims. I'm going to
`start with claim 23. And for Judges Obermann and Scheiner, this will look
`familiar to you, this slide. I have arranged the claim in a shorthand as I did
`before in the '862 PGR. This is -- there are four elements of the claim dosage
`form for oral administration containing zoledronic acid in a salt form free of
`other therapeutically active agents having a bioavailability in humans of 1.2
`to 4 percent. The only difference between this claim and the claims in the
`'268 -- or the '862 patent, sorry, PGR, that were found unpatentable is that
`these claims are specifically directed to salt forms of zoledronic acid.
`JUDGE OBERMANN: Did the other claims have the
`bioavailability?
`MR. MINION: The same range, Your Honor.
`JUDGE OBERMANN: And what was that PGR number?
`MR. MINION: That was 2107.
`JUDGE OBERMANN: Is that 0022?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 5
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`MR. MINION: That's right. And just like in that PGR, there are
`also method claims here, the only difference being that in the last PGR those
`claims were directed to humans suffering from knee pain. Here you have
`claims directed to humans suffering from arthritis.
`I do want to note, as to the dosage form claim, claim 23 is directed
`to salts in particular. The method claims are directed to salts or the free acid
`form. We have several grounds of unpatentability with an anticipation
`ground obvious over different combinations for the claims and then lack of
`enablement. And before -- I'll address each of these grounds in turn, but
`before I do so, I would like to first address what it is that patent owner
`alleges has been invented here. And again, for Judge Obermann and Judge
`Scheiner, this will look familiar. There's been different iterations of this, but
`the current allegation is that the '268 patent teaches two things that a POSA
`would not have known, the first that a bioavailability range of 1.1 to
`4 percent is effective and that one can achieve that range without the use of
`bioavailability enhancers.
`JUDGE OBERMANN: But the claims permit enhancers. They
`are comprising claims.
`MR. MINION: That's absolutely correct, Your Honor. So I'll get
`to the second point in a moment. The idea that they can do it without the use
`of enhancers is really irrelevant to the question of obviousness of the claim.
`JUDGE OBERMANN: We are focusing on enablement, right?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 6
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`MR. MINION: This is primarily focused on invalidity,
`obviousness and anticipation.
`JUDGE OBERMANN: In our DI we found that your petition was
`insufficient to support review on those other grounds.
`MR. MINION: They were still instituted, of course, in terms of
`SAS. And I think we've addressed the particular concerns that Your Honor
`had --
`
`JUDGE OBERMANN: Well, we specifically said in the DI that it
`was not an invitation to bolster your petition.
`MR. MINION: All of our arguments are the same that was set
`forth in the petition. It's just I think there's just a question of -- there's a
`specific claim term that we put in evidence in the petition that I think there
`was a question in the institution decision whether that was taught by the
`claims.
`
`JUDGE OBERMANN: Which term is that?
`MR. MINION: That's the salt form claim. So there's a question of
`whether the Leonard reference taught the salt form claim. And the second
`issue was with the specific combination of Leonard, Aronhime and the
`Merrion poster, the Board found that the Merrion poster was -- at that stage
`there was insufficient evidence to find the Merrion poster prior art, so that
`ground was not instituted.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`
`
`
`
`
`
`
`
` 7
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE OBERMANN: Well, it was instituted, but we gave you
`guidance that it was -- that the evidence was insufficient to support review
`on that ground.
`MR. MINION: That's right, and I would like to address that issue
`too. And I think for the first point on that, it doesn't really matter whether
`the Merrion poster is in or not. The claims are still obvious over Leonard
`and Aronhime. So that ground -- it should be found unpatentable over that
`ground.
`
`JUDGE OBERMANN: You can't change your ground now.
`MR. MINION: It's the same ground, Your Honor. In the petition,
`we set forth and we said, all right, these claims are obvious over Leonard
`and Aronhime alone, and there's also support, additional evidence of
`obviousness from the Merrion poster. So if the claims are obvious over
`Leonard and Aronhime, they should be corollarily obvious over Leonard,
`Aronhime and Merrion poster.
`JUDGE OBERMANN: You did not state a ground based on
`Leonard and Aronhime that includes the Merrion poster.
`MR. MINION: It does, Your Honor. It does include the Merrion
`poster, but we did not rely on the Merrion poster to teach a specific
`limitation of the claim. It was included in the claims as supplementary
`evidence of obviousness of the claims. I'll present evidence as we --
`JUDGE OBERMANN: So are you conceding that it's not prior
`
`art?
`
`
`
`
`
`
`
`
` 8
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`MR. MINION: I am not, Your Honor. I do believe there is
`sufficient evidence in the petition that the Merrion poster should be
`determined prior art.
`JUDGE OBERMANN: In the petition?
`MR. MINION: In the petition, yes, Your Honor.
`JUDGE OBERMANN: There's two sentences in the petition, and
`it's complete bare attorney argument. In the petition, on page 48 of the
`petition I see two sentences that are complete bare attorney argument.
`MR. MINION: Well, I think what we also have outside of the
`petition is patent owner's own evidence submitted in the preliminary patent
`response on their co-pending '669 application, the '485 patent application
`where they submitted the Merrion poster in an IDS prior to May 2014, and
`as of that date when the patent became -- the patent prosecution became
`public --
`JUDGE OBERMANN: And you argue this in your petition
`
`where?
`
`MR. MINION: We did not argue that in the petition. We argued
`this in the reply and also with respect to the motion to exclude.
`JUDGE OBERMANN: Okay.
`MR. MINION: But in addition to what, Judge, you note on
`page 48 of the petition, we also submitted, I believe it's Exhibit 1085,
`showing that the Merrion poster was publicly available online. It's either
`1065 or 1085. 1065, Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 9
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE OBERMANN: Let me just take a look. That's in the file.
`1065, what is this? This doesn't -- this is something that you did recently? I
`mean, what do we know about this exhibit?
`MR. MINION: This exhibit was submitted in the petition.
`JUDGE OBERMANN: And where does the petition discuss this?
`MR. MINION: It's cited but it's not specifically discussed. But it
`
`is.
`
`JUDGE SNEDDEN: Are you relying on the web archive date at
`the top of the screen?
`MR. MINION: This is just -- what this exhibit and why this
`exhibit was submitted is to show that the Merrion poster, Exhibit 1040, was
`obtained by petitioner from the internet. So this, originally we found this
`from the Merrion Pharma website, but showing that this was -- it still is.
`You can still go to this address, go to the web archive, it shows the date on
`here that it was archived and then the original address that internet archives
`found.
`
`JUDGE OBERMANN: Where is it cited in your petition?
`MR. MINION: Page 36, Your Honor.
`JUDGE OBERMANN: All right. I don't want to take up too
`much of your time by asking questions, so just carry on.
`MR. MINION: Well, as to -- I'll start back with your first
`question, Your Honor, noting that when talking about what the invention
`allegedly discloses, and you'll see from patent owner's expert, Dr. Wargin,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 10
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`acknowledging that the inventor of the '268 patent was not the first to
`develop an oral formulation of zoledronic acid with a bioavailability
`between 1.1 and 4 percent, agreeing that that was already taught by Leonard.
`Now, you can see in Dr. Wargin's answer, his pushback a little
`saying, well, those formulations would have used enhancers or other
`mechanisms. Indeed, in the excerpt that I have here from Dr. Wargin's
`declaration that without the use of enhancers is emphasized. But as I
`mentioned before, that's irrelevant. The claims are not limited to oral dosage
`forms of zoledronic acid that are substantially free or free of the use of
`bioavailability enhancers. So what they have essentially claimed here is
`what's already been taught in Leonard and the POSA already had access to,
`and that is not inventive.
`So let me start there with the issue of Leonard, and I'll get Your
`Honor to the question of the salt form. And this is really focused on claim 2
`of Leonard. Claim 2 of Leonard discloses the oral dosage forms of
`zoledronic acid having a bioavailability of 2.5 to 13 percent, which overlaps
`the range in claim 23. So that gives you the first and last elements of the
`claim.
`
`JUDGE OBERMANN: Not for the salt.
`MR. MINION: Well, for the salt form, in the specification it
`makes clear when they were referring to embodiments containing a
`bisphosphonate, and specifically zoledronic acid, when they say zoledronic
`acid, they are referring to both the free acid and biologically acceptable salts
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 11
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`thereof. Now, what Mr. Johnson is going to say is, and I think in the
`institution decision there was a statement that nothing in the Leonard -- or
`salt forms of zoledronic acid aren't discussed in Leonard. And we pointed to
`this particular section here, which is why I'm addressing that here.
`What Mr. Johnson is going to say with respect to this, if you go to
`claim 2, when the inventors discuss the medium-chain fatty acid, they say
`medium-chain fatty acid or a salt of a medium-chain fatty acid, and they
`don't do that with a zoledronic acid, the person of ordinary skill in the art is
`going to read that to mean they are specifically claiming just the free acid of
`zoledronic acid. But that is a matter of claim construction. That's not the
`proper way to construe this claim. The proper way to construe this claim is
`how it's defined in the patent. And they say very clearly when we are
`referring to bisphosphonates and we are referring to the acid form, we mean
`not only the free acid form, but also the salt form. So claim 2 will be
`understood by the POSA to cover not only the free acid form of zoledronic
`acid but any biologically acceptable salts thereof.
`And then the only other element is, of course -- sorry, if we go
`back to claim 2 of Leonard, the only other element of the claim 23 is
`substantially free of other therapeutically active agents. Zoledronic acid is
`the only therapeutically active agent in claim 2. And the example in the
`specification, example 17, of course, all the examples are just solely
`zoledronic acid. So you have all three -- sorry, all four elements present in
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 12
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`claim 2, and therefore, it should be found anticipated because they haven't
`suggested any criticality to the claimed range.
`But to the extent that Your Honors find that claim 2 does not
`include a salt form, it certainly should be obvious from the Leonard patent
`that talks about salt forms of zoledronic acid, gives data on other
`bisphosphonates that have salt forms that show, just like the free acid, you
`also get an enhancing property with sodium caprate that it should be found
`obvious over Leonard alone.
`We also have, Your Honor, anticipation over Aronhime.
`Aronhime is a reference that teaches a number of different -- discloses a
`number of different salts of zoledronic acid, in particular, this form 7, and
`includes pharmaceutical compositions containing those forms. And as it
`turns out --
`JUDGE OBERMANN: Excuse me. Did you say anticipation over
`Aronhime?
`MR. MINION: Anticipation, Your Honor, yes.
`JUDGE OBERMANN: I don't see that in your grounds chart.
`MR. MINION: I will get there, Your Honor. We have an
`obviousness ground including Aronhime. And of course, anticipation is the
`obvious --
`JUDGE OBERMANN: No, no, no, you can't do that, counsel.
`Your petition is based on obviousness with a combination of Leonard and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 13
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`Merrion poster. You can't rewrite your grounds at this stage. You don't
`have an anticipation ground based on Aronhime.
`MR. MINION: Well, Your Honor, I think the way that I look at it
`is if you have -- if you are presenting a ground with three pieces of prior art
`and you say reference A renders all those limitations obvious, separately --
`JUDGE OBERMANN: You are trying to say that -- this is not
`notice pleading, counsel. You can't just say here are my references; oh, by
`the way, I'm going to rely on 103; and then later say, well, it could be 102
`with just one of them. It's not notice pleading. You have to state your
`arguments in your petition.
`MR. MINION: I understand, Your Honor. I understand. So let
`me get now to that specific ground, the combination of Leonard, Aronhime
`and the Merrion poster that we discussed for a moment. I just want to show
`Your Honor that you have obviousness over Leonard and Aronhime in
`combination.
`JUDGE OBERMANN: I don't want you to argue grounds that are
`not in your petition, counsel.
`MR. MINION: Okay. I need to walk through, Your Honor, the
`elements that are taught by Leonard and Aronhime, and then I'll get to the
`Merrion poster, bringing that in. Thank you.
`So the substantive issue, aside from the challenge to the Merrion
`poster as prior art as to the combination of Leonard and Aronhime, is that
`Leonard and Aronhime do not teach or suggest the combination of a salt
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 14
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`form of zoledronic acid and one of the particular ranges identified by
`petitioner. This is sort of a strange construct, this idea of combining a salt
`form with one of their theoretical ranges. This is Dr. Wargin commenting
`on that that he has an issue with the word "combine" here.
`The issue isn't whether Leonard and Aronhime together or Merrion
`poster together suggests the combination of a salt form and disclosing the
`particular range that is claimed in the claim. The question is whether a
`person of ordinary skill in the art would have been motivated to take one of
`the salts in Aronhime and use Leonard and Leonard and the Merrion poster
`to enhance that bioavailability to obtain a dosage form, a salt form of
`zoledronic acid having a bioavailability within the claimed range. That's the
`question of obviousness here, motivation to combine with a reasonable
`expectation of success. And we have that.
`We have the motivation to select salts from Aronhime. This is not
`disputed. The idea that salt forms of zoledronic acid have improved physical
`chemical properties over the free acid that's taught by textbooks such as
`Remmington, we have that in the petition as well. And really this idea that
`zoledronic acid salt forms have improved solubility is the basis of
`patentability set forth in the '268 patent, the idea that increasing solubility
`may potentially enhance bioavailability.
`We also have motivation because of the generally low
`bioavailability of forms of zoledronic acid, a POSA was motivated as of
`May 2014 to find ways of increasing the bioavailability of zoledronic acid
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 15
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`dosage forms. That was agreed to by Dr. Wargin. And of course, a person
`of ordinary skill in the art would have had a reasonable expectation of
`success. So I'm asking the question prior to May 2014 whether a POSA
`could have formulated a salt form of zoledronic acid with sodium caprate to
`achieve a bioavailability between 1.1 and 4 percent, and they could do so
`with the guidance of the '268 patent. So just on Aronhime and Merrion
`poster alone, we have obviousness of the claimed invention.
`JUDGE OBERMANN: I think you meant Leonard. Not the
`Merrion poster.
`MR. MINION: Leonard, yes.
`JUDGE OBERMANN: Am I right that the Merrion poster is sort
`of -- is it the same people that did Leonard and it's just more detailed?
`MR. MINION: Yes, Your Honor. So actually, I mean, if you look
`at the citation to what we referred to as the Merrion poster, it's actually
`Leonard, et al.
`JUDGE OBERMANN: I have a question about that before you get
`too far, before I forget. You put as the Merrion poster in the record with
`your petition Exhibit 1040, and then in your reply you came forward with
`the Butler declaration for the Wayback Machine, and it doesn't appear to me
`that the Butler declaration includes as the exhibit the same thing.
`MR. MINION: The reason for that, Your Honor, is that the
`Wayback Machine, they have these web crawler programs, and they found
`the Merrion poster, and then they put the date of it; and then they found it
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 16
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`again and they put the other date of it. And it's just that the one that we cited
`was the different one.
`JUDGE OBERMANN: I don't understand. Can you explain that?
`Because I'm looking at the two of them and they don't look alike at all.
`MR. MINION: I know, Your Honor. In the Butler affidavit,
`there's also evidence showing that it is separate. Both of them are in there,
`in the Butler affidavit. So if you go to the last page, the last page is the
`Merrion poster, and before that is some additional information that's not
`really relevant to the issue of whether the poster is prior art. It is just
`additional information that is found on the Merrion Pharma poster website
`that was originally part of the consideration of the Klopfenstein factors of
`how long it was available in the circumstances of the poster presentation.
`But we are not arguing under the Klopfenstein factors.
`JUDGE OBERMANN: So the thing that appears on page
`number 7 is an attachment to --
`MR. MINION: The Butler affidavit.
`JUDGE OBERMANN: Is that the same as 1040?
`MR. MINION: Yes.
`JUDGE SCHEINER: But all of this came in after the petitioner; is
`that correct? The Butler declaration?
`MR. MINION: The Butler affidavit came after the petition. The
`Exhibit 1065 from the Wayback Machine was submitted with the petition,
`Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 17
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE SCHEINER: I just wanted to go back a slide before we
`move on. I just wanted to correct the record. If you could go back a couple
`of slides where you were talking about whether or not -- this slide. And they
`could do so without the guidance of the '268 patent in question, and I believe
`when you were discussing that for the record, you read it as they could do so
`with the guidance of the '268 patent. I just wanted to correct that before we
`move on.
`MR. MINION: Thank you, Your Honor.
`JUDGE SNEDDEN: I have one question. When we are looking at
`this affidavit of Christopher Butler, page 7 of that Exhibit 1094, we are
`supposed to read that in combination with your Exhibit 1065 that actually
`shows the date? Is that a screen shot of the poster on a computer at 1065?
`MR. MINION: That is what's found. So on the link here, if you
`go to this website, this is a PDF that pops up.
`JUDGE OBERMANN: And that's if you do it today?
`MR. MINION: If you do it today, yes.
`JUDGE SNEDDEN: And that's a paper copy of Exhibit 1065 you
`are holding?
`MR. MINION: This is a paper copy of 1065, which is a screen
`shot of the web browser showing the link where you can download it from.
`JUDGE SNEDDEN: Then that date is the same date that appears
`in that affidavit at 1094?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
`
`
`
`
`
`
` 18
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`MR. MINION: I think in 1094 they show two dates of which --
`and if you go, you can go to the website now and it shows those two dates.
`JUDGE SNEDDEN: At page 6 we just have a page with the
`
`same --
`
`MR. MINION: Page 6 is the version of the Merrion poster that
`was archived on that date in 2011, which it was archived twice in 2011. And
`this is the other time that it was archived in 2011. Does that answer your
`question?
`JUDGE SNEDDEN: I think so.
`JUDGE OBERMANN: We have a lot of case law on this, counsel,
`and we've got a lot of decisions that deal with this kind of issue where there's
`an allegation that a poster has been displayed at a technical conference. Do
`you have any evidence that this was actually displayed at the conference, for
`how long, how many people attended the conference?
`MR. MINION: We are not arguing that anymore. We are not --
`we did not put in the petition the specific circumstances meeting all of the
`Klopfenstein stats. We are relying on --
`JUDGE OBERMANN: The URL?
`MR. MINION: -- the availability of it online from the Wayback
`Machine.
`JUDGE OBERMANN: Let me ask you this. I'm looking at that
`URL, and it doesn't say anything about zoledronic acid. It doesn't say
`anything about arthritis. How do we know that somebody who is interested
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 19
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`in this particular field, why on earth would they go to a URL that says
`MerrionPharma.com/80?
`MR. MINION: Well, it's known from Leonard, the patent
`Leonard, that Merrion Pharma was developing an oral dosage form of
`zoledronic acid that was abbreviated MER 101.
`JUDGE OBERMANN: Do you have any person of ordinary skill
`in the art or someone qualified to opine from the perspective of a person of
`ordinary skill in the art saying that someone in this field would have done a
`Merrion Pharma search at that particular time?
`MR. MINION: We do not, Your Honor. The only evidence that
`we have is the fact that not only did petitioner find it on Merrion poster's
`website, not only did the internet archive find it, but also patent owner found
`it and submitted it to the Patent Office.
`JUDGE OBERMANN: That's great, but what we need is we need
`some evidence that a person of ordinary skill in the art just exercising
`ordinary diligence would have habitually done some kind of a search that
`would have pulled this up at the relevant time. Your expert or your witness
`didn't testify about any of that?
`MR. MINION: Not in the petition stage, Your Honor.
`JUDGE OBERMANN: For the sake of argument, what did they
`do for the reply?
`MR. MINION: In the reply, we didn't discuss the specifics of what
`you are asking, of whether a person of ordinary skill in the art, what searches
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 20
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`they would have done to do so. But we did, of course, point out in the reply
`that not only did we find it on the site, but they found it on the site.
`JUDGE OBERMANN: You are looking at it today in hindsight.
`We have lots of cases, this comes up with theses where they are not
`particularly organized, and we have a lot of cases where we look and we
`have to have some kind of evidence that for this particular field, you know,
`people are going to be habitually checking like the FDA website or they are
`going to be habitually searching theses in the library. Just the fact of
`availability, I'm having trouble with that.
`MR. MINION: I think the law is, Your Honor -- I understand the
`case that was cited that there has to be a showing, and it just has to be a
`reasonable showing that a person of ordinary skill in the art can, in fact, find
`this document on the internet. And it's not just whether they would be
`motivated to go to the Merrion Pharma website, which I believe they would.
`JUDGE OBERMANN: You have no evidence.
`MR. MINION: I'm arguing that. But we also can look at the
`Merrion poster itself and see in the poster it says zoledronic acid.
`JUDGE OBERMANN: I have been on cases like that, and you
`can't look at the document and say that would have prompted the search
`because they wouldn't have had the document in front of them.
`MR. MINION: I understand, Your Honor. And I think whether --
`that whole question becomes moot as soon as petitioner submitted it to the
`Patent Office and that file history became public. As soon as it is publicly
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
`
`
`
` 21
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`available in the Patent Office as prior art, it is publicly available. There is no
`showing of saying, well, we have to prove that a person of ordinary skill in
`the art would have known how to contact the Patent Office and obtain a
`copy of the file history.
`JUDGE OBERMANN: Let's talk about that. When did it become
`publicly available in the Patent Office?
`MR. MINION: May 2013, Your Honor.
`JUDGE OBERMANN: Well, that's not before the critical date,
`
`right?
`
`MR. MINION: May 2014 is the critical date.
`JUDGE OBERMANN: And it became when? So it was cited a
`year before the critical date?
`MR. MINION: That's correct, Your Honor. That's right. So this
`'485 published application is the application that patent owner is relying on
`for enablement of their claims as saying why their claims are enabled. So
`they looked to the '485 application. They say it's a co-pending application.
`They specifically say that a POSA would have known about the '485
`application. Obviously, if they know about the published application, they
`would have known about the public file history.
`JUDGE OBERMANN: This is not in the chain of our patent at
`
`MR. MINION: It is not in the chain, I don't believe so.
`JUDGE OBERMANN: All right. Fair enough.
`
` 22
`
`issue?
`
`
`
`
`
`
`
`
`
`
`Case PGR2018-00001
`Patent 9,539,268 B2
`
`
`JUDGE SNEDDEN: Just to be clear, in your reply you argue that
`your ground does not fail even if we do not find the Merrion poster is prior
`art because essentially all the teachings that you rely on for the Merrion
`poster can also be found on Leonard. So it is actually supplemental
`evidence to Leonard?
`MR. MINION: That's correct, Your Honor. With respect to
`grounds -- sorry, claims 23 through 29, the only claim -- and this is
`unfortunately a function of having limited space in the petition. So instead
`of having a ground for every claim and saying, all right, well, claims 24
`through 29 are obvious over Aronhime and Leonard alone and then claim
`30, they are obvious over Aronhime, Leonard and the Merrion poster, you
`say collectively they are obvious over Aronhime, Leonard and the Merrion
`poster and then go through them individually instead of having 50
`different --
`JUDGE SNEDDEN: So you are sa
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
