UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ELYSIUM HEALTH, INC.,
`Petitioner,
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`v.
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`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
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`Case IPR2017-01795
`Patent 8,393,085 B2
`____________
`
`Record of Oral Hearing
`Held: September 28, 2018
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`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
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`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`ELYSIUM HEALTH, INC.,
`Petitioner,
`
`v.
`
`TRUSTEES OF DARTMOUTH COLLEGE,
`Patent Owner.
`____________
`
`Case IPR2017-01795
`Patent 8,393,085 B2
`____________
`
`Record of Oral Hearing
`Held: September 28, 2018
`____________
`
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`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
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`Case IPR2017-01795
`Patent 8,393,085 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`
`BRENDAN JONES, Ph.D., Esquire
`DONALD R. WARE, Esquire
`Foley Hoag, LLP
`Seaport West
`155 Seaport Boulevard
`Boston, Massachusetts 02210-2600
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`
`BEHALF OF PATENT OWNER:
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`JOHN L. ABRAMIC, ESQUIRE
`JAMIE L. LUCIA, ESQUIRE
`Steptoe & Johnson, LLP
`115 South LaSalle Street
`Suite 3100
`Chicago, Illinois 60602
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`The above-entitled matter came on for hearing on Tuesday, October 2,
`2018, commencing at 1:00 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-01795
`Patent 8,393,085 B2
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`P R O C E E D I N G S
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`JUDGE MITCHELL: Good afternoon, everyone. We are here for
`a final hearing this afternoon in IPR2017-01795. I am Judge Mitchell, and
`seated to my right is Judge Paulraj, and appearing remotely is Judge
`Schneider. I would like to get appearances for the parties on the record. So
`if I could start with petitioner.
`MR. JONES: Good afternoon, Your Honor. My name is Brendan
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`Jones --
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`JUDGE MITCHELL: Sorry, if you could go to the podium, just
`because we have a remote judge and so he can hear. Sorry to run you
`around.
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`MR. JONES: No problem. I'm Brendan Jones. I'm the lead
`counsel for petitioners, Elysium Health, and with me today is my backup
`counsel, Don Ware.
`JUDGE MITCHELL: Thank you. And for patent owner.
`MR. ABRAMIC: Good afternoon, Your Honors. My name is
`John Abramic. I'm here on behalf of patent owner, Dartmouth. And with
`me is my colleague, Jamie Lucia.
`JUDGE MITCHELL: Thank you and welcome. So I know we've
`set forth our procedure in our oral hearing order, but I'll just go over a few
`reminders at the beginning. So each party has 60 minutes of total time to
`present argument. And it's very important for the clarity of the record that if
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`you are referring to a slide or an exhibit, please make sure you give us the
`number so when we go back and look at the record, we can make sense of it.
`And also certainly especially for Judge Schneider, who is remote, he won't
`be able to see what you have here. But certainly we have the
`demonstratives, and he can follow along. But again, for him, make sure you
`say what slide number you are on or what you are referring to.
`Petitioner has the burden of showing the unpatentability of the
`challenged claims. So the petitioner will go first to present its argument.
`And then patent owner will have the opportunity to present its response.
`And I know I was going to see, petitioner, do you have time that you would
`like to reserve for rebuttal?
`MR. JONES: Yes, Your Honor. We'll probably reserve around 20
`minutes for rebuttal.
`JUDGE MITCHELL: Okay. I know we have a new procedure for
`patent owner. You can tell me now or wait for yours if your time -- if you
`would like to reserve some of your time for sur-reply.
`MR. ABRAMIC: Thank you, Your Honor. Our plan was to
`reserve ten minutes for sur-rebuttal.
`JUDGE MITCHELL: With that, petitioner, when you are ready.
`MR. JONES: Good afternoon, Your Honors. As I introduced
`myself before, I'm Brendan Jones. I'm lead counsel for Elysium Health.
`With me today is Don Ware. So as everyone here knows, we've challenged
`the validity of all five issued claims of the '086 patent which names Dr.
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`Charles Brenner as the sole inventor. He was formerly of Dartmouth
`College.
`The '086 patent describes discovery by Dr. Brenner of a new
`pathway in eukaryotic cells in which the eukaryotic cells are able to convert
`nicotinamide riboside into nicotinamide. That was a pathway that was
`previously known to be present in bacteria, but not in eukaryotics as far as
`the patent describes. This is somewhat important because the NAD+ is
`known to be a coenzyme involved in a number of biological processes. For
`example, NAD+ deficiency results in a disease called pellagra. That's a
`disease that ran rampant through the rural south during the turn of the last
`century due to a lack of NAD precursors in their diet. There's a version of
`pellagra of NAD deficiency that's also present in dogs called blacktongue.
`Claim 1 of the '086 patent is pretty much as straightforward claim
`as you could imagine for this kind of case. There's a preamble. There's a
`pharmaceutical composition. There's a requirement that the composition
`needs to be formulated for oral administration, that a transition phrase
`comprising which of course is a term of art which really means including,
`and then what's in the composition is nicotinamide riboside in admixture
`with a carrier.
`Now, as we'll talk later, this ends up being a very broad claim.
`Pharmaceutical composition is defined both in the spec and in the dependent
`claims as including compositions of food. The admixture with a carrier,
`admixture isn't even used in the spec, but it's general meaning is in mixture
`with, and a carrier is defined pretty broadly in the spec to include, among
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`other things, sugar such as lactose. So what's left is the presence of
`nicotinamide riboside. And as we've shown through various evidence and as
`was discovered by Dr. Brenner himself, nicotinamide riboside is actually
`present in milk.
`The consequence of this is that a number of studies that occurred in
`the early part of the 20th century by Dr. Joseph Goldberger, actually, in
`which he was endeavoring to treat pellagra using milk products such as skim
`milk and buttermilk actually end up reading on the scope of these claims. In
`the first one, Goldberger, et al., which was published in 1928, so more than
`90 years ago, so I think it qualifies as art under 102(b), this study describes
`the administration of skim milk to a number of dogs who are otherwise on
`the blacktongue diet that inevitably results in the dogs getting blacktongue.
`Most of the dogs that were subjected to this ended up not getting
`blacktongue. From this, Dr. Goldberger concluded that skim milk contained
`the pellagra-preventative factor.
`A similar study from 1924 also by Dr. Goldberger and Goldberger
`and Tanner described the treatment of a number of women who were highly
`susceptible to pellagra with buttermilk. So buttermilk is the form of milk
`most commonly available in the rural south. It's the byproduct after milk is
`churned and butter is removed. When these patients were treated with
`buttermilk three times a day, none of them ended up getting pellagra when it
`was Dr. Goldberger's experience that under similar conditions in similar
`populations, you would expect at least half -- about half of them to get
`pellagra.
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`Now, the dispute here really comes down to one of claim
`construction. So oddly, it comes -- involves claim construction of a very
`innocuous seeming phrase. The phrase is "a pharmaceutical composition
`comprising nicotinamide riboside." On its face this phrase seems to be very
`straightforward in its language. As we said, pharmaceutical compositions
`include compositions such as food. Comprising is just a transition word that
`usually in the art means including. And nicotinamide riboside is a well-
`defined molecule in the art. Despite the plain language of this claim being
`very straightforward, patent owner has proposed a construction in which
`they have added the limitation that would require nicotinamide riboside to be
`in the formulation as the active agent.
`JUDGE MITCHELL: Counsel, what do we make of
`pharmaceutical in that preamble pharmaceutical composition? Does that not
`add some weight to patent owner's argument?
`MR. JONES: I don't think so. So pharmaceutical composition, to
`the extent it is a limiting -- to the extent it is limiting would imply that the
`composition as a whole has some kind of pharmaceutical property. It
`doesn't necessarily mean that any particular agent in the pharmaceutical
`composition has a pharmaceutical -- has a pharmaceutical effect.
`JUDGE MITCHELL: But the only thing they have named, at least
`in claim 1, is the nicotinamide riboside. So wouldn't the assumption be
`when we're reading this claim, if it's a pharmaceutical composition, that we
`are talking about that as an active agent, the nicotinamide riboside?
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`MR. JONES: Your Honor, I think there are a couple problems
`with that. One is I think pharmaceutical composition more implies the
`intended use of the composition rather than a specific activity. And we'll get
`into that because it's not really clear what this nicotinamide riboside would
`need to be active for under the construction of the patent owner's.
`The second problem is if they had intended -- there are all sorts of
`claims to pharmaceutical compositions that are out there, you can imagine,
`where, it comprises any kind of thing, a filler, excipient or anything else
`where it's not the active agent. So just because it's a pharmaceutical
`composition doesn't mean that the one thing that's named in it has to be the
`active agent.
`And the third thing is, the third problem is saying that it's the
`active agent makes it really problematic because many pharmaceutical
`compositions don't have a single active agent. They might have multiple
`agents that act in congress to each other where neither one of them alone
`would be sufficient to treat the disease or they may have multiple active
`agents where there are redundant with each other and if you remove one, it
`doesn't really change the effect. Either way, even if pharmaceutical
`composition is a limiting and it would imply it has some kind of health-
`related activity, then it still wouldn't be sufficient to impose, to incorporate
`into the argument -- into the construction the limitation that the nicotinamide
`riboside itself has to be the active agent. At best, it implies that the
`composition as a whole has to have some kind of activity.
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`JUDGE MITCHELL: Can I ask you, do you have a position as to
`whether a pharmaceutical composition is limiting?
`MR. JONES: So we haven't taken a definitive position on this
`because we didn't feel it was relevant to the outcome of the case. I do think
`this is a classic case where the pharmaceutical composition is describing the
`intended use of the composition, especially in this context where there's no
`specific disease or anything listed here. I don't know how you would say
`that it has -- if you are given just a pill, right, that has nicotinamide riboside
`in it, you would say, well, is this a pharmaceutical composition? I think,
`yeah, probably because it's a pill, which is pharmaceutical form of
`something. But you don't know whether or not it has an activity and might
`have an activity against some diseases and not have activities against others.
`When we start importing these activities, these specific activities into it, you
`are really looking at more method claims. If this was a method of treatment
`claim, then maybe it would have more weight.
`JUDGE MITCHELL: So your position is because it's not naming
`a particular disease to be treated, then we can't really know whether
`nicotinamide riboside is the active agent?
`MR. JONES: Exactly. And I'll actually jump ahead because I
`have a couple slides here that actually address this. So this was actually one
`of the things that we were confused about when we read the initial response
`by the patent owner. That was if it has to be an active agent, what does it
`have to be active for. And the response doesn't actually say one way or
`another what activity this nicotinamide riboside would have to have. So we
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`asked the patent owner's expert, Dr. Zhou, what does it mean to have an
`active ingredient. And Dr. Zhou, if you looked at page 31, you see that he's
`using active ingredient, active agent interchangeably.
`JUDGE SCHNEIDER: Counsel, if you are referring to a specific
`slide, I would like to know.
`MR. JONES: I apologize. I'm looking at slide 11 of 54. I jumped
`ahead and I didn't give you warning. So in this specific question that was
`asked of Dr. Zhou, what does it mean, active ingredient, Dr. Zhou answered
`that it exhibits or confers therapeutic or preventive effects. So this still
`doesn't tell us what preventative or therapeutic effect it needs to be. I don't
`think someone could look at a pill and know whether or not it exhibits any
`particular therapeutic or preventive effect. And if you actually look in the
`specification of the '086 application, it lists all sorts of diseases that could
`potentially be treated as method of treatment for using the pharmaceutical
`compositions, but it doesn't give any specific disease and doesn't show any
`actual treatment.
`And when asked whether or not this active agent would require it
`to be an effective amount in the pill, in other words, whether there would
`need to be enough of the active agent in the pill, enough of the composition
`in the pill in order to actually treat the disease, Dr. Zhou confusingly said
`that he did not think this was part of claim 1 at all.
`I can understand why this would be a problem, because as we said,
`there's no specific disease here. If you are talking about a method of
`treatment claim, then saying that some compound is the active agent or that
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`it is an effective amount of it to treat a specific disease, then maybe it's
`reasonable to have that limitation there because you can actually test, okay,
`or maybe one of skill in the art would know you need to have this much of
`the compound in order to treat that disease. But when you are just looking at
`a pill without any connection with any kind of activity or disease, then
`whether or not -- I mean, for example, if it would require 10 milligrams of
`something to treat the disease, then if you had a pill with 10 milligrams, I
`suppose, would be the active agent. If you had a pill with 5 milligrams, then
`maybe it wouldn't be an active agent. But then, of course, we are dealing
`with two pills of 5 milligrams and then maybe you have enough. So when
`you are talking about a composition of matter, when you start importing
`these activity limitations into there without defining what the activity is, it
`renders a claim really nonsensical and impossible to show infringement or
`anticipation.
`JUDGE SCHNEIDER: Counsel, going back to the term
`"pharmaceutical," I note that patent owner has submitted Exhibit 2004 which
`is a McGraw-Hill scientific dictionary. And there the definition for
`pharmaceutical includes a chemical produced industrially for a medicinal
`drug which is useful in preventive or therapeutic treatment of a physical,
`mental or behavioral condition.
`Now, that would sort of imply that you have got to actually make
`something up rather than milk which just occurs naturally. How does that fit
`into your definition that milk is a pharmaceutical composition?
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`MR. JONES: So first it's pretty clear that even from claim 2 of this
`which says that the nicotinamide riboside is isolated from a natural or
`synthetic source that these claims don't actually require the physical or
`chemical manufacture of any of the agents within here. I think what ends up
`happening is the claims -- I mean, we need to look at what the patent owner
`says himself. And in claim 4 he expressly says that it's a formulation that
`comprises a food. And I think when you look at that and in the specification
`where it talks about oral formulations can be in the form of food, then I think
`especially when you are talking about something like this skim milk or
`buttermilk where there are pieces removed from the food by essentially the
`hand of man in order to create a different formulation, then you are looking
`at something that if it's used pharmaceutically, then it could be a
`pharmaceutical formulation.
`And also, I just wanted to add that that definition, I don't think, is
`really applicable here. And that's a definition for the word "pharmaceutical,"
`which is a noun. That's one thing. I think in this case, a pharmaceutical
`composition, the pharmaceutical is being used as an adjective to describe the
`composition itself. In other words, getting the intended use of the
`composition for pharmaceutical purposes. Not that it necessarily contains a
`particular pharmaceutical.
`JUDGE PAULRAJ: Counsel, you bring up the intended use
`argument. I mean, one of the well established principles about intended use
`or at least preamble limitations such as this is that if it does breathe life and
`meaning into the rest of the claims, it should be given some weight. I'm
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`having some trouble as to why we should ignore pharmaceutical all together.
`If the idea here is that you are trying to treat some disease and you said the
`claims don't require a disease, require any particular disease to be treated,
`but the specification, the very first paragraph of the specification talks about
`pellagra and some other diseases, why shouldn't we consider that in the
`context of interpreting this claim?
`MR. JONES: Your Honor, I think it's a very legitimate argument,
`and I think the case law goes both ways as to whether or not something like
`this would be a limiting preamble. But my point is not that pharmaceutical
`composition can't be a limiting preamble. It's not even that it doesn't have a
`limitation. What's not here is -- I mean, if you look at the language of claim
`1 itself which I am going -- I'll just go to our other construction, so slide 7.
`So pharmaceutical composition comprising nicotinamide riboside. So I'm
`not trying to read out of this limitation the word "pharmaceutical
`composition" because as I said, a food can be a pharmaceutical composition
`if it's being used to supplement someone's diet in order to treat a disease or
`disorder.
`What I'm reading out is that the requirement, the imported
`limitation that nicotinamide riboside specifically needs to be an active agent
`in the food. I think if they wanted -- first of all, as I said, I think out of the
`context of a particular disease, it's impossible to say whether one thing is an
`active agent or not because whether it's an active agent is going to depend on
`the context in which it is used.
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`Secondly, I think the plain meaning of this language dictates that
`all that is required is a pharmaceutical composition which the composition,
`maybe it needs to have some kind of at least therapeutic purpose, and that it
`needs to have within it nicotinamide riboside. There's no nexus that says the
`nicotinamide riboside needs to effectuate that therapeutic purpose. As I said,
`this is a claim to a composition of matter. Not a method of treatment. So
`there's no way to know whether or not in some composition of matter
`whether a particular compound has a particular therapeutic purpose.
`JUDGE PAULRAJ: What is an active agent as you understand it
`to be in patent owner's proposed construction?
`MR. JONES: That's a good question. And I'm honestly not really
`sure. I can tell you that there are disclosure, there's disclosure throughout
`the specification where it talks about methods of use where it says a method
`of use of nicotinamide riboside in order to treat a specific disease and then
`nicotinamide riboside needs to be added in an effective amount. So in that
`case I think it makes sense to have there be an active agent there or an
`effective amount where you have a specific method of treating a particular
`disease. You can see whether, okay, is this agent actually using to treat that
`disease.
`But in a pure pharmaceutical composition like claim 1 is, devoid of
`any disease or method of treatment, I don't know if there's any way to say
`whether something is an active agent. And just to give an example, active
`agent is, of course, something that's pulled out of pharmaceutical language.
`When you go to the drugstore, you'll see the active agents in this compound
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`are this, this and this. In that context they have particular indications they
`are talking about. So that active agent is attributed to a specific indication.
`If there's no indication or requirement, there's no active agent -- there's
`nothing inherently an active agent in a pill.
`JUDGE PAULRAJ: So then would you agree that at least under
`patent owner's construction, nicotinamide riboside is not an active agent and
`just milk or buttermilk as it occurs naturally?
`MR. JONES: No, I don't agree with that either necessarily. I
`believe that by far the most likely conclusion you would reach from
`Goldberger or from -- from either of the Goldberger articles is that the
`nicotinamide riboside in the milk was contributing to the NAD+
`biosynthesis in these patients.
`JUDGE PAULRAJ: Let me follow up with a question I asked you
`before. Is what you consider to be an active agent something that
`contributes to the treatment of some type of disease condition, whether or
`not it's recognized or highlighted like you would see in a pill bottle or a
`label? In this case even though we have milk and buttermilk and it's
`naturally occurring product, is it your position that NR is an active agent
`because it contributes to the treatment of pellagra or blacktongue? Is that
`your position?
`MR. JONES: Your Honor, I completely agree that in the methods
`that are being practiced by Goldberger in these examples in which he's
`actually treating pellagra or blacktongue, then nicotinamide riboside is
`almost certainly acting as an active agent here based on what we know
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`scientifically. What I'm saying is that in the actual claims themselves,
`there's no requirement for an active agent.
`JUDGE PAULRAJ: I understand your position that at least the
`claims don't recite the term "active agent." We are trying to figure out
`whether pharmaceutical composition would be understood to require the
`nicotinamide riboside as an active agent. So let me flat out ask you, what is
`your understanding of active agent? If I were to ask you how do you define
`active agent, what is your answer?
`MR. JONES: So in the context of a specific treatment, I think an
`active agent is the combination -- is either the individual or combination of
`compounds that mediate the effect. However, I don't think active agent is
`applicable to just a pharmaceutical composition devoid of actually being
`used for something because I don't think -- there's no activity there. It's just
`sitting there. I don't think there is an active agent in a pill as it sits there on a
`desk.
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`And I think part of looking at your question is whether or not
`nicotinamide riboside needs to be read in as an active agent into this claim.
`And I think one of the things that's illustrative of this, I'm on slide 8, is there
`are two uses of the word "pharmaceutical composition" in the body of the
`'086 patent. In the first one, it doesn't have anything to do with nicotinamide
`riboside itself. It actually describes using a pharmaceutical composition
`comprising nucleic acids, including the nicotinamide riboside kinase protein,
`the vectors containing that or the NRK polypeptides that can be administered
`to a subject.
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`So I believe above this comment it also mentions nicotinamide
`riboside. But this passage does not actually include reference to
`pharmaceutical compositions comprising nicotinamide riboside.
`And the second use is, I think, a little bit illustrative. It says a
`physician -- it's on the patent in column 31 where it says a physician or
`veterinarian having ordinary skill in the art can readily determine and
`prescribe the effective amount of a pharmaceutical composition required for
`prevention or treatment of an animal subject or human. So there are two
`things. One is this is again talking about the determining what the effective
`amount of the pharmaceutical composition is in the context of a disease or
`animal to be treated.
`JUDGE SCHNEIDER: Counsel, what about the teachings in
`column 4 beginning about line 19 where it says that the method involves
`administering to a patient having a disease or condition associated with the
`nicotinamide riboside kinase pathway and NAD+ biosynthesis, an effective
`amount of nicotinamide riboside composition so that the signs or symptoms
`of the disease or condition are prevented or reduced, doesn't that directly tie
`the nicotinamide riboside to treating a specific disease and showing that the
`NR is the active agent?
`MR. JONES: Your Honor, in this case it's exactly what I was
`talking about where they are actually talking about actual therapeutic use of
`a particular disease where there's an active agent that's in the composition
`because it's being used for a specific purpose. The nicotinamide riboside,
`absent anything else, doesn't have an active agent because it's not doing
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`anything active. It's only when the composition is put to a specific method
`of use where it's actually curing or treating a disease that any of the agents
`have any activity. There's no imbued activity.
`JUDGE SCHNEIDER: How do you divorce the composition from
`the method? I mean, here it's talking about a composition that has an
`effective amount of NR present in it.
`MR. JONES: So in the context of the method, it has an effective
`amount. The problem with effective amount here is that that's going to be a
`different value depending on what you are trying to treat. So for one disease
`it's going to be a small amount and another disease it's going to be a large
`amount. So absent a specific disease, there's no knowing what the effective
`amount is. The metes and bounds of the claim, you are just given a pill and
`trying to figure out whether this falls within the scope of the claim. There
`would be no way of telling whether or not this pill falls within the scope of
`the claim because there would be no way of knowing whether it has an
`effective amount unless you know a particular disease to test.
`JUDGE SCHNEIDER: So you are saying basically by putting in
`either active agent or effective amount, you render the claim indefinite. Is
`that what you're saying?
`MR. JONES: Yes. I think if you actually added effective amount
`into these purely composition claims without a disease or disorder without
`saying it has to be an effective amount for what, then the claim ends up
`being meaningless and indefinite. I just don't think looking at the plain
`meaning of this phrase that there's any need to complicate. So this is a very
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`straightforward phrase which would have a very bright line test of whether
`or not something infringes or not. It's a pharmaceutical composition
`comprising nicotinamide riboside. You look at a pharmaceutical
`composition, say does this contain nicotinamide riboside? Yes, it falls
`within the scope of this element; no, it doesn't fall within the scope of the
`element.
`By adding this limitation to active agent, you make something that
`was inherently very simple and straightforward based on its plain language
`and make it impossibly complex. And I'll draw your attention to slide
`number 14 of the demonstratives.
`And this was when we were trying to figure out from Dr. Zhou
`exactly what you would need to do in order to find out whether or not an
`active agent is in -- whether nicotinamide riboside is an active agent in claim
`1. The answer he gives is that that's not -- let's see. It's what they claim or
`report the activity. Then I need to show the evidence of whether the
`experimental procedure shows without NR. So he's tying the desired
`activity to an experiment to show whether it has NR or not. Then he says,
`There are many, many complicated experiments one has to conduct to see,
`for example, whether NR and the absence of NR has the same effect or not.
`It's, you know, hundreds and thousands of experiments one has to conduct,
`and there's always caveats on how to interpret the data.
`I just don't think when you have something as simple as a
`pharmaceutical composition comprising nicotinamide riboside that there's
`any need to import a limitation that takes it from a straightforward
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`construction that everyone would understand and be able to tell whether or
`not something fell within the scope of and make it this impossibly complex
`test in which you'd need to do dozens of complicated experiments to try and
`figure out whether it has activity for any possible disease or disorder. I just
`don't think if that construction was out there that there would be any way of
`showing whether or not a particular composition actually falls within the
`scope of the claims.
`I wanted to -- if you have specific further questions, I'm happy to
`go on, but I also wanted to be able to talk a little bit about isolated during
`this. And would that be okay for me to move on or is there something else
`you wanted me to particularly address?
`JUDGE PAULRAJ: Is isolated still at issue in this case, counsel?
`MR. JONES: I believe isolated is still an issue because claim 2
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`was --
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`JUDGE PAULRAJ: We brought that back in after our post-SAS
`decision; is that right?
`MR. JONES: Yes. So of course, I am jumping ahead to slide 44
`here. And this is a slide that shows the language of claim 2 which describes
`-- I built it as an independent form for context. So it has the language of
`claim 1 and then the added limitation to claim 2 which is wherein, the
`nicotinamide riboside is isolated from a natural or synthetic source.
`So in this case I understand the Board, of course, c
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