Paper 65
`Date: July 14, 2021
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.;
`GALDERMA LABORATORIES LP; GALDERMA RESEARCH &
`DEVELOPMENT SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN
`HEALTH S.A.; AND NESTLÉ S.A.,
`Petitioner,
`
`v.
`
`MEDY-TOX, INC.,
`Patent Owner.
`____________
`
`PGR2019-00062
`Patent 10,143,728 B2
`____________
`
`Record of Oral Hearing
`Held: March 19, 2021
`
`BEFORE: ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Date: July 14, 2021
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GALDERMA S.A.; GALDERMA LABORATORIES, INC.;
`GALDERMA LABORATORIES LP; GALDERMA RESEARCH &
`DEVELOPMENT SNC; NESTLÉ SKIN HEALTH, INC.; NESTLÉ SKIN
`HEALTH S.A.; AND NESTLÉ S.A.,
`Petitioner,
`
`v.
`
`MEDY-TOX, INC.,
`Patent Owner.
`____________
`
`PGR2019-00062
`Patent 10,143,728 B2
`____________
`
`Record of Oral Hearing
`Held: March 19, 2021
`
`BEFORE: ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
`APPEARANCES:
`
`
`ON BEHALF OF THE PETITIONER:
`
`
`JOSEPH A. MAHONEY, ESQUIRE
`ERICK PALMER, ESQUIRE
`Mayer Brown, LLP
`214 North Tryon Street, Suite 3800
`Charlotte, North Carolina 28202
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`HA KUNG WONG, ESQUIRE
`Venable, LLP
`1290 Avenue of the Americas, 20th Floor
`New York, New York 10104
`
`
`
`
`
`
`The above-entitled matter came on for hearing on Friday, March 19,
`2021, commencing at 1:02 p.m. EST, by video/by telephone.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`
`
` (Proceedings begin at 1:02 p.m.)
` JUDGE PAULRAJ: Good afternoon. This is the final oral hearing for
`PGR2019-00062.
` I'm Judge Paulraj, and also appearing by video today will be Judge
`Majors and Judge Yang.
` So let's go ahead and start with appearances first, starting with
`petitioner's counsel and then patent owner's counsel.
` MR. MAHONEY: Good afternoon.
` I'm Joe Mahoney with the firm Mayer Brown representing petitioners,
`and joined by -- joined on the phone by Erick Palmer, also of Mayer Brown,
`on behalf of the petitioners.
` JUDGE PAULRAJ: Thank you, Mr. Mahoney.
` Will you be primarily arguing for petitioner during the hearing?
` MR. MAHONEY: Yes.
` JUDGE PAULRAJ: Excellent.
` Who do we have on for patent owner?
` MR. WONG: Good afternoon, Your Honors.
` My name is Ha Kung Wong from Venable LLP. I'll be representing the
`patent owners and arguing on behalf of the patent owners today.
` JUDGE PAULRAJ: All right. Thank you, Mr. Wong.
` So I just want to remind the parties that this will be a public hearing,
`and I do believe that we have members of the public listening in on this
`hearing.
` I don't anticipate that any confidential information will need to be
`discussed, but to the extent that confidential information will be discussed, I
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`3
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`would ask counsel to let me know before we get into anything confidential
`so we can mute the public line.
` As set forth in our hearing order, each side will have 60 minutes to
`present their arguments.
` I understand we are only dealing with patent owner's non-contingent
`revised motion to amend in this case, but nonetheless, as petitioner has the
`burden of proof for the unpatentability issues for the proposed substitute
`claims, petitioner will go first and patent owner will respond.
` Each side may reserve some amount of rebuttal or surrebuttal time for
`their respective arguments, but no more than half the total time allocated for
`each argument segment.
` To the extent that there are any objections raised, I would ask that you
`wait until the end of the other side's arguments to raise those objections.
` Please don't interrupt counsel with objections in the middle of their
`arguments.
` Also, if you're not speaking, please make sure you mute your line so
`that we don't have any feedback or background noise.
` Before we proceed, are there any preliminary matters we need to
`discuss?
` MR. MAHONEY: No, Your Honor.
` MR. WONG: No, Your Honor.
` JUDGE PAULRAJ: Excellent. If not, then petitioner's counsel, Mr.
`Mahoney, we're ready to proceed whenever you are.
` MR. MAHONEY: Thank you.
` If I may, I'd like to start with our slides.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`4
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` JUDGE PAULRAJ: Okay. Before you get into your slides, could you
`let me know how much time you'd like for rebuttal?
` MR. MAHONEY: I would say 15 or 20 minutes, something like that.
` JUDGE PAULRAJ: All right. So I'll go ahead and give you 15
`minutes right now, but if you need to adjust that as we go, that's fine.
` I'll give you a warning with about five minutes left, and then again
`another warning as we wind down. I'll try to keep track of it. But I would
`also ask that you keep track of your own time and kind of self-police a little
`bit in terms of your time.
` So let me know whenever you're ready.
` MR. MAHONEY: Understood, and I'm ready --
` JUDGE PAULRAJ: Okay.
` MR. MAHONEY: -- to begin.
` If I could ask that everyone turn to our third slide. That's -- that's
`where I would like to start.
` And to set the stage here a little bit for today's hearing, as everyone
`will recall, the granted claims had a comparable dose requirement, and by
`that I mean there is -- there was a dose of an animal-free toxin that is given
`in a comparable amount to an animal-containing toxin. Those claims were
`then amended whereby the animal-containing limitation of the claim was
`narrowed to 20 units of Botox in the motion to amend.
` And now where we are is the revised motion to amend that the claims
`have been further amended such that it's to an amount of botulinum toxin A
`present in about 20 units of MT10109L.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`5
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` And so, you know, this -- when you go through this case, there's been a
`lot of discovery, briefing about comparability, comparable amounts, and the
`parties are in agreement that botulinum toxin A, serotype As, that their
`activity units are not interchangeable across products, and therefore, that
`made comparable dosing difficult because it requires comparative clinical
`studies and comparing it to an animal-containing product, those studies are
`expensive. Also, doing a clinical study for the purpose of patent
`infringement, we submit, is not ethical.
` Then turning to Slide 4, please.
` So as I mentioned, the patent owner has rewritten the claims to
`eliminate that comparable dose limitation and has instead included
`administering broad class of the type A formulations in an amount, and by
`"amount" we mean -- or they mean amount by weight present in 20 units of
`MT10109.
` But here's the problem. This isn't a small molecule, we're talking about
`a biologic.
` So, you know, unlike something like aspirin or other small molecule
`where an amount by weight of a drug substance will have uniform activity
`because of the active ingredient being the same, that's not a case -- this is --
`this is not the case here.
` So it's just -- it's not a case where it's just math. All right? And because
`the biological activities vary by manufacturer, patent owner has now said in
`their demonstratives that this amount by weight present in 20 units of
`MT10109, they're saying now that that's 0.18 nanograms. Okay? But that's
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`6
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`not universal or the same across the various type A botulinum toxins in terms
`of the activity. Okay? And the activity is what is important.
` So we submit that it's not scientifically correct to say that 0.18
`nanograms of any type A toxin has this universal activity across
`manufacturers.
` And so this is a common theme for our arguments because we submit
`that by taking that approach in the revised claims, that that fundamentally
`changes the scope of the claims and runs afoul of Section 326(d)(3). It also
`highlights a lack of written description, lack of enablement and
`indefiniteness.
` So if we turn next to Slide 5.
` JUDGE PAULRAJ: Counsel, where are you getting the 0.18
`nanograms number?
` I understand, I think, from Jung I that at least patent owner's alleging
`that it was 1 nanogram for 20 units, but I'm not sure I saw the 0.18 nanogram
`number anywhere.
` MR. MAHONEY: Your Honor, the first time that I saw it was in their
`demonstratives that they submitted, and I'll get you the page of their
`demonstratives, but --
` JUDGE PAULRAJ: I certainly see it in your --
`I see it in your demonstratives. Right? I see it, I think, in Slide 7 in the table
`where you pointed out Botox has, for the 900 kilodalton botulinum toxin
`complex, I assume, for 20 units it's 0.18 nanograms, but I just wasn't sure, is
`that something that patent owner has alleged and you just adopted it for
`purposes of your argument?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`7
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` MR. MAHONEY: Well, what they proposed was the 1 nanograms of a
`900 kilodalton botulinum A toxin.
` We, for the sake of argument only -- because of course in our papers
`we dispute that Jung I and the '728 patent are connected in terms of Jung I's
`statement about LD50, we dispute that. But for the sake of argument, our
`expert, Dr. Ramzan, did some calculations and calculated 0.18 nanogram.
` But I don't think patent owner ever said 0.18 nanogram in their papers
`or in their deposition testimony, and we saw it from them for the first time
`yesterday on their Slide No. 10. Okay?
` But our point -- my point about the amount by weight of MT10109 is
`we just don't think it's scientifically correct and valid to use that across all of
`type A toxins given the different activity that each one of these things will
`have because of the manufacturer.
` So again, looking at Slide 5, they're saying that they can get this 1
`nanogram, about 900 kilodalton type A toxin from Jung I in the LD50 test,
`but it's unclear what amount by weight that must be because, again, the type
`A toxins are assayed different and they're going to have different activities.
`And even the active portion, which is 150 kilodalton, that has different
`activity depending on which manufacturer makes it, depending on the
`manufacturing process.
` And this is highlighted on page 6, Slide 6 of our slides where we have
`some pop-outs from a reference by Brin. It's Exhibit 1031.
` And what's important here is these manufacturers all use different LD50
`mouse assays. They're proprietary, they're trade secrets, and that means that
`they're not standardized.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`8
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` And -- but this -- these LD50 tests are the only way to detect the
`activity -- the biological activity of that 150 kilodalton portion, but that --
`those LD50 tests are public, so the only way you can do the comparison is
`by way of a clinical trial.
` So if we turn to page 7 of our slides.
` There's -- we're citing to Exhibit 2051, and we've cited to other exhibits.
`Exhibit 1092 by Field, Field 2018 paper, Exhibit 1092, page 5, Table 3.
`We've also cited in our papers to Frevert 2010 paper, which is Exhibit 1026.
` But on Table 7, we've got a pop-out which illustrates the problem that
`their amount by weight claiming creates.
` And so looking there at the table on page 7.
` So in terms of activity, 0.18 nanograms of the 150 kilodalton
`neurotoxin in Botox, it's not equivalent to 0.18 nanograms of that neurotoxin
`in Dysport, and it's not equivalent to that neurotoxin Xeomin.
` And that lack of equivalence makes sense given the different
`manufacturing processes because those manufacturing processes produce
`different amounts of the inactive portion -- of the inactive portion of the 150
`kilodalton, so the proportion of active to inactive will vary across
`manufacturers.
` And so that's why we see here that, even though 20 units of Xeomin is
`clinically comparable to 20 units of Botox -- that's been established through
`human clinical trials -- so even though 20 units of Xeomin is comparable to
`20 units of Botox, the amount of Xeomin that you give is far lower than the
`amount you give of Botox.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`9
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` And so this amount by weight that they're pulling out of Jung I and
`applying to all serotype A toxins is just -- it just doesn't work. It doesn't
`apply.
` JUDGE PAULRAJ: I'm frankly a little confused by -- I understand
`they shifted from basing the comparison based on comparable activity units,
`as would be determined using the LD50 assay, and I see your point about the
`LD50 assay being perhaps proprietary and different for each Botox -- or
`botulinum toxin formulation.
` I think the question I have is, it does appear that they shifted to a
`comparison based on weight rather than activity units, and they're saying --
`leaving aside whether or not you agreed with the actual weight amount
`whether or not 1 nanogram -- there is actually 1 nanogram of neurotoxin in
`20 units of MT10109L -- it seems like the claims as proposed in the
`proposed substitute claims really focus on trying to make sure that you have
`a botulinum toxin composition that contains 1 nanogram of serotype A
`botulinum toxin.
` Is that disputed?
` MR. MAHONEY: Well, that -- but -- yes, it is disputed because --
`because the -- that activity of that amount by weight in about 20 units of
`MT10109 is not the same across serotype As. They're all different in terms
`of their activity. So when these botulinum toxin are manufactured, you're
`going to get different proportions of active to inactive neurotoxins in the
`drug substance.
` JUDGE PAULRAJ: I understand --
` MR. MAHONEY: The amount --
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` JUDGE PAULRAJ: -- I understand that point, counsel.
` I think my question, though, is, just focusing on the phrase "serotype A
`botulinum toxin in an amount present in about 20 units of MT10109L".
` You know, Jung I, which is incorporated by reference, does appear to
`suggest that there's 1 nanogram of the botulinum toxin in 20 units of
`MT10109L, so it almost seems like you can -- while it is written in
`somewhat of a circuitous fashion, it almost seems like you could have
`written the claims to just recite "comprising 1 nanogram of serotype A
`botulinum toxin".
` Is that not a fair interpretation of the claims?
` MR. MAHONEY: I don't think so. I think it -- I think -- well, two
`reasons. We don't see the connection, the correlation between Jung I and
`MT10109. That's not there.
` And the LD50 assay in Jung I in any event can't be replicated because
`those (inaudible) -- but (inaudible) noise there.
` JUDGE PAULRAJ: I'm sorry. If you could repeat the last part of your
`argument. There was some background noise. I apologize for that.
` MR. MAHONEY: The LD --
` Well, we dispute that the LD50 in Jung I refers to or is connected to
`MT10109.
` Number two, even if it were, there's not enough information about that
`proprietary LD50 assay in Jung I to even replicate it. Okay? And there's
`nothing -- there's nothing -- there's nothing in the prior art or the '728 patent
`or Jung I that describes how much of the neurotoxin in MT10109 is active
`versus inactive. There isn't that information.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`11
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` So when one refers to 1 nanogram of a 900 kilodalton type A, what is
`that? That's indefinite. There's no evidence of what that is.
` Furthermore, the claim started with comparable amount. Okay?
`Animal-free compared to animal-containing. Now we're just going to a
`strict mathematical or a strict nanogram amount, if you will, amount by
`weight.
` We fundamentally don't see that that has anything to do with
`comparability of the original claims. It's not a subset. This is -- and the
`evidence that we presented shows that the dosing that you would get and the
`activity by applying this mathematical approach is far different than
`comparability.
` So -- and that's why --
` JUDGE PAULRAJ: I mean, I think your -- the gist of your argument,
`at least on that point, is that it broadened the claims. But I'm not sure -- I see
`your argument kind of saying that they did shift the point of comparison
`from comparability based on, you know, using activity units to
`comparability based on using weight.
` Is that -- you know, it seems like they shifted from comparing to apples
`to comparing to oranges. Right?
` But what I don't see -- I'm not sure it's clear to me is how that perhaps
`broadened the claims. And you kind of alluded to this a little bit by saying
`that we don't see a subset, but to the extent that you could perhaps mentally
`draw some type of Venn diagram where there's, you know, some claims that
`might be within the scope of the original claims, and now all the sudden
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`12
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`we've expanded the scope to include compositions beyond what was
`originally -- with the -- beyond the scope of what was in the original claims.
` I don't know if you can kind of clarify that point.
` JUDGE MAJORS: Yes. I'm sorry to jump in real quick. This is Judge
`Majors. And if I could just sort of add to that so you can tackle this issue, I
`think, once, Mr. Mahoney.
` I think it would be helpful, to the extent we could try to put things into
`an apples/apples, oranges/oranges comparison. And I gathered from your
`argument that that was, in part, what you were trying to do by saying, in the
`table, where you said, okay, the original claims take this -- this Dysport
`product, and in the original claims the appropriate comparison would have
`been, you know, 50 to 20, the comparable dosing amount.
` MR. MAHONEY: Right.
` JUDGE MAJORS: But in the as-amended claims, then the Dysport
`amount would be 26, I think it was, or somewhere in that neighborhood.
` And so I tend to think about this issue in part from the standpoint of
`call it what the claims encompass or almost like an infringement analysis,
`and I think it might be helpful if you could say here's the difference. The
`original claims would have been infringed by this hypothetical product that's
`pad X, that product would not infringe or would infringe, you know, sort of
`tackling it from that perspective, if that makes sense.
` MR. MAHONEY: Yeah. Well, right.
` So if we look at Slide 8. Okay?
` And that's what we've done, Judge Majors, is our expert, assuming
`arguendo the LD50 connection between Jung I and MT10109, for the sake
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`13
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`of argument, he looked at, okay, what does that mean in terms of
`comparability? And he looked at --
` Because what is established in the clinical literature is that 20 units of
`Xeomin is comparable to 20 units of Botox. And that also in the clinical
`literature, 50 units of Dysport is comparable to 20 units of Botox.
` But if you apply -- if you apply patent owner's amount by weight, you
`get doses that are far, far different. If you're going to compare Xeomin to
`Botox, under the revised claim closed trials, you're going to see 100 percent
`increase in the dose of Xeomin and a 50 percent decrease in the dose of
`Dysport.
` So that's why we're saying that this new dosing scheme is not a subset
`of comparable amount.
` (Pause in the proceedings)
` MR. MAHONEY: Okay. Shall I continue?
` JUDGE PAULRAJ: Yes, please.
` MR. MAHONEY: Okay. Thank you, Your Honor.
` So then if we go to page 9 of our slides.
` So again, as I've said in our papers, we don't think that the prior art, or
`the Jung I, '728 patent describes how much neurotoxin active versus inactive
`of MT10109. And --
` But even if you assume arguendo what they're saying about 1
`nanogram of a 20 (inaudible) nanogram of 900 kilodalton, they say that 1
`nanogram of MT10109L is equivalent to 20 units of Botox, but that doesn't
`mean that 1 nanogram of a different botulinum toxin, abobotulinumtoxin, is
`equivalent to 20 units of Botox.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`14
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` In other words, the practical science and what's been shown in the
`literature doesn't show that transitive effect, and that's -- it makes sense
`because units -- I don't think there's any dispute in this case that units are not
`standardized.
` But here's the thing. The amount by weight comes from the LD50 test
`and it's tied to the units. So the amount by weight is connected to the units,
`it's inextricably bound up with the units analysis, and that's why the amount
`by weight is not standardized either, and that's why we're seeing in the
`literature, you know, if you try to practice patent owner's revised claims,
`you're getting fundamentally different dosing than what's shown in the
`published literature of the comparative studies.
` So I think that if we skip to Slide 11.
` Here again, you know, the efficacy, it varies
`by the proportion of the active denatured neurotoxin which is really driven
`by the manufacturing process.
` Now, Dr. Middaugh, who is patent owner's declarant, he said that the --
`you know, this amount by weight, it works and is equivalent for 20 units of
`MT10109 and 20 units of Botox, but he limited it to that specific case. And
`he was unable to extend it to other serotype A toxins because he didn't know
`the products well enough.
` And what we submit is the evidence that we cited shows that you can't
`do that. You can't extrapolate across all these different products.
` The other thing I want to mention is that, you know, let's not forget that
`these products, these botulinum A products are dosed in terms of units, so
`there's practicalities for how they're administered.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`15
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` And Dr. Singh, who is patent owner's declarant, and he's someone who
`administers these drugs to hundreds of patients a month, he testified the
`dosing by weight, it would be -- because it's so small, we're talking
`picogram, nanogram amounts, that's why he doses it in units. And that's at
`Exhibit 1045 -- Exhibit 1045, page 100, lines 1 through 21.
` If we go to Slide 11.
` In the interest of time, I'll say this about the construction of serotype A.
`We submit -- petitioners submit that the proper construction is how patent
`owner defined it in the specification.
` They, as the lexicographer, said what it is. They now -- patent owner
`now seems to be trying to narrow that, that it says a minimum of 150
`kilodalton protein.
` If we flip to Slide 13.
` Slide 13, here's why it matters. And why it matters is the claims aren't
`limited just to MT10109. The MT10109 is the only serotype A that they
`studied in the patent, and it's reported to be a 900 kilodalton complex. And
`again, because the proportion of active to inactive varies by manufacturers,
`these things aren't interchangeable. So, again, we believe it should be
`construed with how it's stated and defined in the specification.
` Turning next to Slide 14.
` As you may have seen from the papers --
` JUDGE PAULRAJ: Counsel, if I could perhaps go back to the claim
`construction issue. Right?
` So you would like us to construe it consistent with how patent owner
`defined it in the specification as "encompassing any complex or non-
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`16
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`complex form", right? Whether it's the 900 kilodalton complex with the
`NAPs -- right? -- the neurotoxin-associated proteins, in addition to the actual
`150 kilodalton protein.
` Is that right? You would like us to construe serotype A botulinum
`toxin to include both the complex form of it and perhaps just the 150
`kilodalton neurotoxin protein by itself?
` MR. MAHONEY: Yeah. What -- our position is what is stated in the
`spec.
` JUDGE PAULRAJ: Right. So I think the question is, as stated in the
`spec, and as you quoted in Slide 12, it includes either a non-complex form or
`in a complex form. Right? So it's either the non-complex form, which is
`just 150 kilodalton protein by itself, or complex form, which can go up to
`900 kilodaltons; is that right?
` MR. MAHONEY: That's right.
` JUDGE PAULRAJ: All right. So my question is, to the extent that
`there's a dispute, it appears that the patent owner -- you're saying that patent
`owner would like us to construe the term to be "at a minimum contain the
`900 kilodalton neurotoxin protein".
` I'm not sure they -- at least as you presented it, I'm not sure what the
`dispute is. Because it seems like, at a minimum, you would need the 150
`kilodalton protein, and then beyond that you would include the NAPs to
`form the complexes. Is that not right?
` MR. MAHONEY: We're not entirely sure. But the spec says the
`complexes have molecular weight of approximately 900, 500, or 300, and at
`a minimum could be -- you know, theoretically, it could be 325, 450, 575,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`17
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
`and, you know, we think that that is something different than what's
`described in the specification.
` JUDGE PAULRAJ: So let me try to pin this down a little bit.
` So at least the way you framed it, so we have specific molecular
`weight for the complex forms. Right? We have a 900 kilodalton complex,
`we have a 500 kilodalton complex, and we have a 300 kilodalton complex,
`and we also have just a protein by itself, the 150 kilodalton neurotoxin
`protein.
` Am I correct so far on that?
` MR. MAHONEY: Yes.
` JUDGE PAULRAJ: All right. Is your concern with patent owner's
`construction then that they're not limited to those specific discrete complexes
`as disclosed or not even just a 150 kilodalton neurotoxin protein by itself? Is
`that what your concern is?
` MR. MAHONEY: Yes. Those are both our concerns.
` JUDGE PAULRAJ: Okay. And how does that relate -- and I see
`you're trying to explain why it matters in Slide 13, but could you kind of
`explain, you know, why we should construe it? Because, frankly, I wasn't
`clear as to why claim construction was necessary here.
` MR. MAHONEY: Well, I think that it -- well, our client -- our clients,
`our respective clients, are competitors. Okay? And that's one aspect.
` But also, I think it affects the -- it affects our other arguments. So the
`scope of the serotype A, it affects other arguments, it affects the scope of the
`prior art, and it has a potential effect related to, you know, possible future
`litigation activity.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`18
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` So I think that --
` JUDGE PAULRAJ: Well, what I'm a little concerned about is
`construing it just for perhaps future litigation activities, as you said. We're
`not in the business of just giving advisory claim construction.
` So what I would ask you, as you get into kind of the specific
`patentability issues, the written description or enablement or indefiniteness
`issues, kind of point back to why you think we should construe the claims in
`the manner that you proposed and why that matters for the dispute.
` MR. MAHONEY: Yeah. And again -- but the -- it relates to the
`breadth. So for example, for enablement and written description, we think
`that serotype A should be interpreted broadly as is stated in the specification.
`That's our basic reasoning.
` JUDGE PAULRAJ: Okay.
` MR. MAHONEY: Okay. If we go to Slide 14.
` Our friends on the other side and their declarants have said that --
`things like onabotulinumtoxinA is the final formulated product with all the
`excipients.
` We just think the record is clear that that's not the case.
`OnabotulinumtoxinA refers to the drug substance itself, the excipients are
`something different. We've given you a couple citations for why that's the
`case.
` And, you know, the FDA and the naming authorities have made it clear
`that it relates to the active drug substance, and that's --
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`19
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` And so using onabotulinum, abobotulinum, inco[botulinum], that those
`are the different names to show different manufacturing, to show differences
`in the drug substance, not that it's in its final formulation.
` Your Honor, am I at -- am I at basically 40 minutes of my presentation?
`I think so.
` Your Honor, I can't hear you all of a sudden.
` JUDGE PAULRAJ: I apologize.
` So I have about -- actually, about nine minutes left on your -- on your
`clock.
` MR. MAHONEY: Okay.
` (Talking over each other)
` MR. MAHONEY: I will -- for the balance of our argument, I'll rest on
`the slides, and also our papers, and I'd like to reserve the balance of my time
`for rebuttal.
` JUDGE PAULRAJ: Okay. I will give you -- so you had 15 minutes
`left, so I'll give you 15, plus eight, about 23, 24 minutes for rebuttal.
` MR. MAHONEY: Okay.
` JUDGE PAULRAJ: Thanks.
` MR. MAHONEY: Okay. Thank you.
` JUDGE PAULRAJ: All right. Mr. Wong, whenever you're ready, I'll
`start the clock for you.
` MR. WONG: Thank you, Your Honor.
` Can you hear me okay?
` JUDGE PAULRAJ: I can. Just give me a second and let me restart the
`clock.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`20
`
`
`
`
`PGR2019-00062
`Patent 10,143,728 B2
` MR. WONG: Sure. No problem.
` JUDGE PAULRAJ: And how much time did you want to save for
`surrebuttal?
` MR. WONG: Ten minutes, Your Honor.
` JUDGE PAULRAJ: All right. So I'll start the clock at 50 minutes for
`you.
` And just --
` MR. WONG: Thank you.
` JUDGE PAULRAJ: -- for my own notes, I've put down 23 minutes
`left for Mr. Mahoney's rebuttal argument. Okay?
` Ready whenever you are, Mr. Wong.
` MR. WONG: Okay. And just a technical issue, Your Honors. For
`some reason, you disappear -- you all disappear off my screen occasionally,
`and I'm not sure why that's happening, so I apologize if I don't see you if you
`motion to me. I apologize for that.
` JUDGE PAULRAJ: Okay. All right. Hopefully we'll --
` MR. WONG: A technical glitch, I think.
` JUDGE PAULRAJ: -- get back on. I know we've all dealt with
`various technical issues over the last several months, so --
` MR. WONG: Yeah. That's very true.
` JUDGE PAULRAJ: -- just so we can hear you, and you can hear us, I
`think that's more critical, so let's proceed that way.
` MR. WONG: Okay. Thank you, You
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
