Trials@uspto.gov
`571-272-7822
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`
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`Paper No. 24
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2019-00026 (Patent 9,931,352)
` Case PGR2019-00027 (Patent 10,039,774)
` Case PGR2019-00028 (Patent 10,052,338)
`
`____________
`
`Record of Oral Hearing
`Held: April 24, 2020
`____________
`
`
`
`
`Before GRACE K. OBERMANN, CHRISTOPHER M. KAISER, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`Paper No. 24
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2019-00026 (Patent 9,931,352)
` Case PGR2019-00027 (Patent 10,039,774)
` Case PGR2019-00028 (Patent 10,052,338)
`
`____________
`
`Record of Oral Hearing
`Held: April 24, 2020
`____________
`
`
`
`
`Before GRACE K. OBERMANN, CHRISTOPHER M. KAISER, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`DANIEL MINION, ESQ.
`KATHERINE ADAMS, ESQ.
`WILLIAM SOLANDER, ESQ.
`Venable, LLP
`Rockefeller Center
`1270 Avenue of the Americas
`24th Floor
`New York, New York 10020
`(212) 307-5500
`dminion@venable.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`R. PARRISH FREEMAN, ESQ.
`BRENT JOHNSON, ESQ.
`Maschoff Brennan
`1389 Center Drive
`Suite 300
`Park City, Utah 84098
`(435) 252-1360
`pfreeman@mabr.com
`
`
`
`
`The above-entitled matter came on for hearing on Friday, April 24,
`
`2020, commencing at 1:00 p.m., EDT, via video teleconference.
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`P R O C E E D I N G S
`- - - - -
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`
`1:01 p.m.
`JUDGE OBERMANN: This is a consolidated final trial hearing in
`PGR 2019-00026, PGR 2019-00027, and PGR 2019-00028. I am Judge
`Grace Obermann, and we also have on the panel today Judge Christopher
`Kaiser and Judge Wesley Derrick.
`This hearing is open to the public, so please don't reveal any
`confidential information.
`Also, because this hearing is being conducted entirely by video,
`please identify yourself when speaking and state for the record the page
`number of any exhibit that you refer to in your argument.
`We all have electronic access to the demonstratives and also to
`papers and exhibits that were filed in each case.
`But I will ask you please to allow a time -- there may be a time lag in
`the audio, so please mute yourself when you're not speaking.
`The three cases are not consolidated, so please take care to prevent
`blurring of the evidence. For example, don't refer to an exhibit filed in one
`proceeding when arguing a point in a related proceeding in which the same
`exhibit is not of record.
`Each side has a total of 90 minutes to present arguments. I will
`keep track of your time.
`Let me start by asking, who will be presenting argument today for
`Petitioner?
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`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`MR. MINION: Good afternoon, your honors. Dan Minion from
`Venable, LLP. I will be arguing in the entirety for Petitioner.
`JUDGE OBERMANN: Thank you, Mr. Minion. And who will be
`arguing on behalf of Patent Owner today?
`MR. FREEMAN: Good afternoon, your honors. This is Parrish
`Freeman from Maschoff Brennan. I'll be arguing for the Patent Owner
`today.
`
`JUDGE OBERMANN: Thank you, Mr. Freeman. Mr. Minion,
`would you like to introduce anyone else that may be with you today?
`MR. MINION: I have three of my colleagues on the -- joined by
`phone. William Solander, Katherine Adams, and James Tyminski, all of
`Venable, LLP.
`JUDGE OBERMANN: Thank you. Welcome, everyone. Mr.
`Freeman, do you have anyone with you today?
`MR. FREEMAN: Yes, I have Brent Johnson on the line with me.
`He is lead counsel.
`JUDGE OBERMANN: Okay, great. Thank you so much for being
`here, Mr. Johnson. With that, I'm going to start with Petitioner's argument
`and I'm going to start by asking Mr. Minion, would you like to reserve any
`of your argument time, up to 30 minutes? Or no --
`MR. MINION: Yes, your honor --
`JUDGE OBERMANN: -- up to 45 minutes.
`MR. MINION: -- I'd like to -- yes, your honor, I'd like to reserve 20
`minutes.
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`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`JUDGE OBERMANN: Twenty minutes, okay, that means you're
`going to have 70 minutes for your primary argument. And, Mr. Freeman,
`before we start, I'll ask you too, do you want to -- well, I can ask you
`afterwards, because you may change your mind after you hear the primary
`argument. Okay. With that, I will start the 70 minutes when you begin
`speaking, Mr. Minion.
`MR. MINION: All right. Thank you, again, your honor. I hope
`everyone is safe and well. This is my first virtual oral hearing, so hopefully
`it all goes smoothly.
`This is actually now our seventh oral hearing between the parties in
`this proceeding. And we have now, this will be Judge Derrick's first
`participation in one of these.
`So, I'd like to give a little bit more of a background and reorient
`everyone as to where things stand and how this fits into the prior
`proceedings. So, if you can turn to Slide Number 2.
`So, these three patents here are among six patents that have been
`challenged by the Petitioner that are directed to the treatment of patients
`with complex regional pain syndrome with the administration of neridronic
`acid.
`
`There were some other proceedings, prior proceedings that were
`directed to the treatment of pain with a different bisphosphonate, zoledronic
`acid. That's not at issue here, just neridronic acid.
`Neridronic acid was invented, developed, and approved in Italy for
`use in patients with CRPS by Abiogen Pharma, which was the real-party-in-
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`interest here, which is why you will see that the three main references have
`Italian authors and two of them are actually in the Italian language.
`Abiogen Pharma is currently seeking FDA approval to market
`neridronic acid for the treatment of CRPS in the United States. There's no
`currently available treatment for CRPS in the United States.
`Conversely, Patent Owner has never done any testing on neridronic
`acid, not in any RAD model, for instance, or certainly not any testing in
`humans.
`So, turning to Slides 3 through 5, each of the three patents we're
`going to be discussing today, each of them has two independent claims.
`And they pretty much have the same claim structure, they're each directed to
`treating patients having a particular sign or symptom of complex regional
`pain syndrome by the administration of neridronic acid in either salt or its
`free acid form.
`To understand what these claims are and where they come from and
`why ultimately we brought, Petitioner brought these petitions on the same
`day and asked to have the same schedule and the same oral hearing, CRPS is
`a disorder that doesn't have a specific diagnostic test. You can't take a
`blood sample, for instance, from a patient for CRPS.
`And what CRPS is is a pain disorder that develops after a patient has
`suffered some sort of tissue trauma. So, it can happen as the result of a
`fracture, it can happen as a result of surgery or other types of trauma. And
`it's characterized by this debilitating pain.
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`So, pain that someone has that a normal person who's broken their
`hand doesn't have to suffer through, and this can last for years and years and
`years for these patients.
`So, because there is no specific test, the disease, and I'll talk a little
`more about these criteria, but the disease is basically characterized by these
`symptoms. And what these symptoms are basically is patients have
`developed a malfunction of their peripheral nervous system.
`Here in the '352 patent, one of the manifestations of that is a
`symptom called hyperalgesia. So, if we're talking about a patient has CRPS
`of the hand, hyperalgesia would be, a pinprick to a normal person would be
`uncomfortable and very short lived, to a patient with CRPS, it's severe, long-
`lasting. It could be hours of burning pain just from a simple pinprick.
`That's hyperalgesia.
`Claim 17 in the '352, edema, actually if you look at the Varenna
`2011 reference, there's a picture of a patient having CRPS in the left hand
`and you can see the swelling, the edema that is present and the difference in
`coloration and texture of the affected hand versus the unaffected limb.
`The '774 patent, other symptoms, changes in skin blood flow. So,
`that would be differences in or asymmetry in terms of temperature or color
`in limbs, abnormal sudomotor activity and asymmetry in terms of sweating,
`so having excessive sweating in the affected limb.
`The '338 discusses allodynia. Allodynia is pain from a sensation
`that should not be painful. So, if you rub the back of the hand of a patient
`with CRPS affecting their limb, that can cause intense pain.
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`
`And then, lastly is the autonomic motor change. According to the
`only expert in this case, that's not a term associated with CRPS. I think it's
`a claim drafting error, combining two different concepts, autonomic changes
`and motor changes.
`But it doesn't really matter as to whether this claim is defined or not.
`If it's defined in the way -- understood by a POSA the way that Patent
`Owner suggests, it's really just a similar claim to what was in the '774. So,
`skin changes, changes in skin blood flow, or abnormal sudomotor activity.
`So, if you turn to Slide 6, where do these symptoms come from?
`What are these claims?
`Well, the IASP, which is the International Association for the Study
`of Pain, because there was no particular way to test to determine whether
`someone had CRPS, they established these diagnostic criteria over time.
`And you'll see those symptoms, allodynia, hyperalgesia, edema,
`changes in skin blood flow, abnormal sudomotor activity, are exactly the
`symptoms that are claimed in the three patents at issue here.
`Now, over time, the IASP and leaders in the field looked at these
`diagnostic criteria and did a study to determine whether those were valid.
`And in 2010, they further revised those criteria and adopted them, they're
`referred to as the Budapest Criteria, and they were published by the IASP in
`the Harden reference, which is a subject matter today.
`So, you can understand why these petitions were brought together
`and why we've asked to consolidate oral hearing today.
`And as, Judge Obermann, you cautioned the parties to avoid blurring
`of the evidence, if you turn to page 7, sorry, Slide 7, I don't think that's going
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`to be of any concern here today, because all of the arguments are the same
`for both parties throughout the three patents.
`So, I don't think either party is at risk of there being any blurring of
`the evidence. And really, at the end of the day, the claims should rise and
`fall on all patents together. I don't think there's anything distinguishing
`them.
`
`In particular, Patent Owner is not alleging any sort of unexpected
`result or patentability basis on any of the symptom limitations. They're not
`saying that there's a study out there that shows or they have data that shows
`that neridronic acid is particularly effective in addressing edema in patients
`with CRPS. There's no argument being set forth there. All the arguments
`are really the same for the various symptom limitations.
`Similarly, in each patent, there are several dependent claims with
`various limitations and some of them, even in the '774, have these pain
`intensity limitations.
`Patent Owner is not alleging patentability based on the dependent
`claims. So, with the exception of what the parties refer to as the Claim 12
`limitation, which I will address at the end of my presentation today.
`So, what we're really talking about when it comes to the claims and
`what the issue is was based on the prior art, would it have been obvious to
`administer neridronic acid to a patient with CRPS? And the answer to that
`question is, absolutely yes.
`Prior to the priority date of the three patents at issue today, there was
`disclosed in the art the effectiveness of neridronic acid in three separate
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`clinical trials conducted in Italy. Those prior art references disclosing the
`effectiveness of those are Varenna 2011, Gatti, and Muratore.
`And in particular, if we go to Slide 8, Varenna 2011 reports that the
`bisphosphonate molecule that has most recently demonstrated efficacy is
`neridronic acid, which seems to possess an excellent efficacy profile when
`administered every fourth day at a dose of 100 milligrams.
`Gatti looked at neridronic acid intravenously over four days and
`reports the result of the study wherein 80 percent of the patients that were
`treated with neridronic acid saw greater than 70 percent symptomatic
`improvement.
`Muratore reports on a comparison study between neridronic acid and
`clodronic acid in patients with CRPS and concluded that both drugs are
`efficacious in the treatment of CRPS, but that the speed of improvement of
`pain symptoms was statistically more significant in patients treated with
`neridronate.
`So, three separate prior art publications, three separate clinical
`studies, each saying the same thing, that neridronic acid is efficacious in
`treating the symptoms of CRPS.
`So, on Slide 9, so the obviousness grounds here are basically any one
`of those three references, those prior art disclosures of the effectiveness of
`neridronic acid, either Varenna 2011, Gatti, or Muratore, in combination
`with Harden, that sets forth the Budapest Criteria, renders each of the claims
`of all three patents obvious.
`For the '774 patent, Claims 1 through 15, and the '338 patent, Claims
`17 through 30, we've included the Drummond reference, which gives further
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`information regarding the effects of the changes in skin blood flow in
`patients with CRPS.
`So, on Slide 10, just to discuss two of the prior petitions in this case
`directed to neridronic acid. The first petition was the '245 patent. The
`second was the '999 patent. Both of those, all of the claims were found
`unpatentable. And those claims were directed to the use of neridronic acid
`in the treatment of CRPS, wherein the patients had bone fracture as a
`predisposing event for CRPS.
`Now, in that case, because of the presence of the limitation bone
`fracture, there was an additional reference that formed the main basis for the
`unpatentability, which is Varenna 2012, which is not at issue today, although
`the Gatti and Muratore references were included in that decision.
`The main difference between the '245 and the '999 patent was, as you
`see highlighted here on Slide 10, is that in the '999 patent, there was a
`specific efficacy limitation added to the claim. So, the claim included the
`limitation, wherein the treatment is effective in reducing pain. So, that
`changed the analysis a little from the '245.
`Now, in the '999, it had to be demonstrated, petitioner had to
`demonstrate that there was a reasonable expectation that the administration
`of neridronic acid to a patient with CRPS that was triggered by bone
`fracture, that there would be a reduction in pain.
`Now, notably, if we go to Slide 11, there is no efficacy limitation
`here. So, when in the prior case, in the '999, when Patent Owner wanted to
`include an efficacy limitation, they did. They did not do that here.
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`Now, in the Patent Owner response and surreply, they're arguing that
`there was an efficacy limitation brought through the preamble as a
`limitation. But here, the preambles are not limiting.
`As a general rule, preambles are not limitations of the claim and the
`specific exceptions to that general rule are simply not present here. So,
`there is not, if we go to --
`JUDGE OBERMANN: Mr. Minion?
`MR. MINION: -- Slide 12 -- yes, sorry.
`JUDGE OBERMANN: Mr. Minion, I just wanted to ask you a
`question. If we disagree and find that the preamble is limiting, what does
`that do to your case?
`MR. MINION: It doesn't change it at all, your honor. I think, as
`Judge Kaiser pointed out very well in the '352 Decision to Institute, that the
`term efficacy, as it's defined -- or sorry, the term treatment, as it's defined in
`the specification, is extremely broad. It can cover pretty much anything,
`diagnosing, affecting some structure in the body.
`So, even under that claim construction, it wouldn't change much.
`And I'll go even further, there clearly is evidence based on the prior art,
`Muratore, Gatti, and Varenna 2011, that provide a reasonable expectation of
`success of reducing pain or efficacy.
`So, no matter what the claim construction, the claim is still
`unpatentable.
`JUDGE OBERMANN: Okay. And you argued all of that in the
`petitions?
`MR. MINION: Yes. Yes --
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`PGR2019-00026 (Patent 9,931,352)
`PGR2019-00027 (Patent 10,039,774)
`PGR2019-00028 (Patent 10,052,338)
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`JUDGE OBERMANN: Okay.
`MR. MINION: -- your honor.
`JUDGE OBERMANN: Thank you.
`MR. MINION: So, what we're really left with is, without limiting
`preambles and without an efficacy limitation, the claims are simply
`administering neridronic acid to a patient with CRPS.
`And on Slide 13, as Patent Owner acknowledges, that is not
`inventive. This is from the Patent Owner's surreply, that if the preamble
`language is ignored as having no bearing on the rest of the claim, then the
`invention is simply administering neridronic acid to a human being suffering
`from the condition, without regard to treatment efficacy. That is not even
`an invention, let alone the invention at issue in this case.
`I think that's exactly right, there is no invention in any of these
`claims.
`So, if we turn to Slide 14, I'm going to address each of these
`arguments in order. And there are five of them in the Patent Owner's
`response and surreply.
`Patent Owner first says that the claims should not be found
`unpatentable because the grounds are vague because of the use of the and/or
`conjunction.
`Number 2, as we are familiar with from prior proceedings, the
`argument in those proceedings that there was a particular reference that
`wasn't established as a prior art printed publication. Here, they've expanded
`those arguments and said that none of the references at issue here today
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`qualify as prior art. And we're going to focus on that probably quite a bit
`today.
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`The third argument from Patent Owner is that the Gatti, Varenna
`2011, and Muratore, the information regarding the effectiveness or efficacy
`of neridronic acid should be completely disregarded, because they, quote,
`contain no data. I'll address that point.
`Fourth, this allegation that somehow Petitioner has admitted that
`neridronic acid is not effective and that somehow negates backward in time
`any reasonable expectation of success.
`And then, lastly, I will finish, as I mentioned before, there are
`specific arguments on the Claim 12 dependent claim limitation. And I'll
`end with that.
`So, on Slide 15, turning to the first argument, I'm not sure if Mr.
`Freeman is maintaining this argument, I don't see it in the slides, but this
`idea of you cannot have and/or in a ground, that renders it vague.
`Here, I have a quote from the Decision to Institute in the '352 PGR
`that says, the phrase and/or appears in the argument sections of the petition
`and indicates an intention to include a challenge based on Harden in
`combination with any one of the other three asserted references.
`That's exactly right. The grounds seem very clear in our mind. I
`won't address the two cases cited by Patent Owner right now, but I can do in
`response, if it's brought up.
`JUDGE OBERMANN: I do have a question about Adaptics,
`because that's an informative Board decision. So, under our SOP 2, it's
`supposed to set forth norms that should be followed in most cases.
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`Do you admit that the Adaptics case, the informative case, carries
`that same sort of special sort of guidance post-institution? In other words,
`is that something that -- we know that the Patent Owner doesn't waive
`anything by not raising an argument in a preliminary response, but where
`Adaptics related to the propriety of instituting, is it still applicable?
`Like, could we still say, after institution, oh, by the way, we
`shouldn't have instituted, because under Adaptics, the petition does not
`articulate the grounds with sufficient particularity?
`MR. MINION: I think that would be pretty manifestly unfair. It
`should not be allowed, because in that case, especially when we have this
`principle of preclusion down the line, if there is a decision to institute, then
`that can create preclusive effects. So, taking that decision to institute and
`then, taking away that institution decision afterwards, I don't think that
`would permitted, your honor.
`And I think we can look to also the recent decision on the
`unappealability of the time bar of IPRs as well from the Federal Circuit, that
`basically says the decision to institute is the final decision. So, I think that
`would be implicated there.
`JUDGE OBERMANN: But we're not bound by our DI. I can
`understand where the Federal Circuit has to take a hands-off approach on
`what we do in the DI, but there's certainly no sort of issue preclusive effect
`that attaches to a DI. Is that correct, Mr. Minion?
`MR. MINION: That's true, the Board can change its mind.
`Although, here, I think that's in response to arguments made by the Patent
`Owner. But here, I mean, if we have the grounds being clear in the Board's
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`mind in the institution decision, I don't know how that could be disturbed at
`the end of the day.
`JUDGE OBERMANN: Okay.
`MR. MINION: There would have to be some particular reason that
`there was something that made these grounds vague. And that hasn't been
`pointed to.
`JUDGE OBERMANN: Okay, thank you.
`MR. MINION: But in terms of the Adaptics case, as we note on
`Slide 15, that is not a case that says that the use of and/or, on its own,
`renders a ground vague or unintelligible. I mean, there was a lot going on
`in that case. They had extra references they're relying on that weren't in the
`ground. They had ten references.
`And it stands for the decision that if you can't understand what the
`bounds of the claim are, that renders it vague and you should not institute in
`that case.
`Turning now to the cited references and this argument that Petitioner
`has not met its burden to establish them as printed publications, I'd like to
`start on Slide 17.
`And what I plan to do is, there's five references, I'd like to walk
`through the evidence for each reference, both in the petition and submitted in
`reply, and then, directly address for each one the various arguments or
`assertions coming from Patent Owner.
`And I thought it was a good place to start with the Muratore
`reference, because there was a colloquy, if you recall, Judge Obermann,
`between you and Mr. Johnson about this issue of what is Patent Owner's
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`position of what evidence needs to be presented to establish a scientific
`reference as a prior art printed publication.
`And this was his response, and we were talking about the Varenna
`2012 article that the Board, again, affirmed was a printed publication in the
`recent denial of the request for hearing.
`Mr. Johnson said, what I would do with this Varenna reference, he
`said, it's not hard. I would have gone to the University of California, Irvine
`Medical Center, their library, found the journal, found the reference,
`photocopied the date stamp on the journal, the copy of the journal issue
`itself, copied the pages from the journal, and gotten the declaration from the
`librarian with respect to its routine practices with these kinds of references.
`Well, for Muratore, if we go to Slide 18, that's exactly what we did.
`JUDGE OBERMANN: Just for the record, Mr. Minion, I believe
`that statement was made before the precedential decision came down in
`Hulu and I'm not sure it's appropriate to try to import Mr. Johnson's
`statement, the pre-Hulu statement, from PGR '092 into this proceeding.
`MR. MINION: This was from the most recent proceeding, I
`believe, is the '839, which was after Hulu.
`JUDGE OBERMANN: What's your authority for importing a
`statement made during an oral hearing in a different PGR into this case?
`Especially if it's not cited in one of your briefs, which I guess you say --
`MR. MINION: It is --
`JUDGE OBERMANN: -- you did in the reply.
`MR. MINION: We did cite this in the reply.
`JUDGE OBERMANN: And there was no objection made?
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`MR. MINION: No, there was not.
`JUDGE OBERMANN: Okay, thank you.
`MR. MINION: I just got a message, but, your honor, just to correct
`myself, this is from the '999, so I think you are correct that this would have
`come before the Hulu decision.
`But I'm point this not to establish some sort of admission that this is
`what you need to establish a reference as prior art, but I just want to point
`out that this was the example that was provided and this was exactly what
`we've done. And now, the bar has been -- they're trying to move the bar
`even further.
`Here, in Slide 18, is a picture of the Muratore reference that was
`provided in the petition. And exactly what we did, I have a colleague I've
`worked with my entire career, we said, hey, can you get us a copy of this
`Muratore reference?
`He went to the National Library of Medicine outside of Washington,
`D.C., where he lives, got the journal, the actual journal, took a photocopy of
`the cover of it that has the actual stamp, the computer-generated stamp of
`when the reference was obtained or when it was received by the National
`Library of Medicine.
`In reply, we had Mr. Cannady, in Slide 19, set forth a declaration
`that this is how he obtained the Muratore reference. And from his nearly 40
`years of experience of retrieving articles from the NLM, he understands that
`the date/time stamp was when it was received from the National Library of
`Medicine. And then, it would have been available within seven to ten days
`of receipt of the publication, depending on staff availability to process that.
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`PGR2019-00027 (Patent 10,039,774)
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`Now, in response, on Slide 20, we have a whole host of reasons why
`Patent Owner now suggests that that is still insufficient to establish a
`scientific reference as a printed publication.
`They're basically in two buckets, and I think that's the way this is
`going to be addressed by Patent Owner when he gets up in rebuttal.
`The first is that all of this needs to be submitted in the petition, that
`you cannot submit a declaration in reply. The Hulu case expressly
`permitted such evidence to be put in in reply, in response to a question
`regarding the prior art status of a publication set forth in either preliminary
`Patent Owner response or the Patent Owner response.
`The second idea really stems from this, what I will characterize as a
`misunderstanding of the law regarding establishing a prior art reference or a
`reference as a printed publication.
`And I'll list them and then, I'd like to turn briefly to Patent Owner's
`demonstratives, and I think I can finally understand or clarify where there is
`the disconnect between Patent Owner's argument and the actual law and
`what needs to be shown, what evidence needs to be supplied to establish
`something as a printed publication.
`So, the arguments against the Cannady declaration, first, is that the
`declarant is not a POSA. So, the argument that in order to establish a
`reference, you cannot now rely on a librarian or someone else, it has to be a
`POSA and they have to establish that a person of ordinary skill in the art
`would have specifically thought to go to the National Library of Medicine
`and would have specifically done searches within that library to find
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`Muratore. That you now have to present evidence that someone would
`have actually found Muratore.
`They criticized Mr. Cannady's testimony, because they assert that it's
`not based on firsthand knowledge and it's based completely on hearsay.
`They did not depose Mr. Cannady, they don't have any basis to say either of
`those statements.
`They have what I'll refer to as continued confusion regarding
`reputability. So, one of the arguments is -- or circulation numbers. You
`see in the motion to exclude and the surreply the assertion that in order to
`establish a prior art reference, you have to get testimony from an actual
`POSA that this was a go-to reference that they would have looked at, which
`is contrary to the law.
`And then, lastly, the idea that because these references are in the
`Italian language, that they should be discounted.
`So, if you can, your honors, very briefly go to Patent Owner's
`demonstratives, in particular, Slide Number 6.
`JUDGE OBERMANN: I'm there.
`MR. MINION: Okay. And I think -- like I said before, I've
`struggled to understand, where is the disconnect here between Patent
`Owner's standard and what has always been the law?
`And I think having this language and looking at the language of
`these cases very clearly and understanding what the facts of these cases are
`sets that forth very clearly.
`And Blue Calypso, the quote at the top, and I'll just read it out loud.
`A reference will be considered publicly accessible if it was disseminated.
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`That's point number one. Or, two, otherwise made available to the extent
`that persons interested and ordinarily skilled in the subject matter of art
`ex
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