Trials@uspto.gov
`571-272-7822
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`Paper No. 54
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FOUNDATION MEDICINE, INC.,
`Petitioner,
`
`v.
`
`CARIS MPI, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
`____________
`
`Record of Oral Hearing
`Held: March 6, 2020
`____________
`
`Before CHRISTOPHER G. PAULRAJ, KRISTI L. R. SAWERT, and
`DAVID COTTA, Administrative Patent Judges.
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`

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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`VINITA FERRERA, ESQUIRE
`KEVIN YURKERWICH, ESQUIRE
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, Massachusetts 02109
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`JONATHAN E. SINGER, ESQUIRE
`DOROTHY P. WHELAN, ESQUIRE
`Fish & Richardson P.C.
`12390 El Camino Road
`San Diego, California 92130
`
`
`
`
`The above-entitled matter came on for hearing on Friday, March 6,
`2020, commencing at 1:02 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE SAWERT: Good afternoon, everyone. We have our final
`
`consolidated hearing in IPR 2019-00164, IPR 2019-00170, and IPR 2019-
`00171 between Petitioner Foundation Medicine, Inc., and Patent Owner
`Caris MPI, Inc. I am Judge Sawert, and I am joined today by Judge Paulraj,
`here in Alexandria, and by Judge Cotta, who is attending remotely. Judge
`Cotta, can you see and hear us?
`JUDGE COTTA: Yes, I can see and hear you fine.
`JUDGE SAWERT: Okay, great. So, let’s start with the introductions.
`We will start with the petitioner, and, Counsel, will you please introduce
`yourselves, and let us know who will be presenting today?
`
`MS. FERRERA: Good afternoon, Your Honors. My name is Vinita
`Ferrera, and I’m joined by my colleague, Kevin Yurkerwich, and I will be
`presenting today.
`
`JUDGE SAWERT: Okay. Thank you, and I understand you have
`remote viewers from San Diego.
`MS. FERRERA: Yes, that is correct.
`JUDGE SAWERT: Okay. San Diego, can you see and hear us?
`MALE SPEAKER: (inaudible)
`MS. FERRERA: I think they might be in San Jose, but --
`JUDGE SAWERT: Oh, don’t mind me. I don’t know where our
`remote offices are. So, San Jose, they can see and hear us? San Jose, are
`you there?
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`CLERK: Yes, they can see and hear. They’re just on mute
`(overtalking)
`JUDGE SAWERT: Oh, okay, great. Okay, great. Okay, and let’s go
`on to Patent Owner.
`MS. WHELAN: Good afternoon, Your Honor. I’m Dorothy Whelan.
`I’m appearing on behalf of Patent Owner Caris. I’m joined by my colleague,
`Jonathan Singer. Mr. Singer will present the argument on behalf of Caris.
`MR. SINGER: Good afternoon.
`JUDGE SAWERT: Okay, thank you. Just as a reminder for the
`parties to leave your business cards with the Court Reporter, and, if you
`happen to have copies of your presentation, please give those to the Court
`Reporter now.
`(background talking)
`JUDGE SAWERT: So, as you know, each side will have 90 minutes
`to present arguments. Petitioner, you can reserve time for rebuttal, and,
`Patent Owner, you can reserve time for a sur-rebuttal. Very important for
`this hearing, if you would please, while you’re going through your
`presentation, state the number of slide that you’re on because Judge Cotta
`cannot see the screen. Do you have any questions, Petitioner?
`MS. FERRERA: No, thank you.
`JUDGE SAWERT: Do you have any questions, Patent Owner?
`MR. SINGER: No, Your Honor.
`JUDGE SAWERT: Thank you. So, let’s begin with Petitioner. How
`much time would you like to reserve?
`MS. WHELAN: We’d like to reserve 30 minutes for rebuttal, please.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`JUDGE SAWERT: I’m sorry?
`MS. FERRERA: Thirty minutes, for rebuttal. Okay.
`JUDGE SAWERT: So, I will set your timer for 60 minutes. Okay,
`please begin when you’re ready.
`MS. FERRERA: Thank you, Your Honors. May it please the Board?
`My name is Vinita Ferrera, and I’m joined by my colleague, Kevin
`Yurkerwich. Together, we represent the Petitioner in this matter of
`Foundation Medicine. We’ve provided a brief summary of the key
`arguments that we expect to present here, today, but, at a very high level,
`this proceeding involves three patents: the 350 Patent, the 193, and the 365
`Patent, all of which relate, generally, to a system for using an individual
`patient’s molecular profile to identify treatments with a likely benefit for that
`individual. As the Board recognized, in its decision on institution, the
`claimed invention, here, does nothing more than compare a patient’s
`molecular profile with known therapies for known molecular targets, and,
`therefore, the claimed inventions are unpatentable as obvious.
`We’ve provided a brief agenda, just to frame the discussion for today.
`We’ll start by spending a little bit of time on the technology background.
`We’ll turn to the prior art references, that are the primary references relied
`on by Petitioner. We’ll look at the challenge to patents and what, exactly,
`they claim and disclose. We’ll look, briefly, at the obviousness grounds,
`that have been set forth by Petitioner. We’ll turn to claim construction,
`which is a critical issue in this proceeding, as Your Honors know, and then,
`finally, we’ll turn to the other contested issues, that have been the focus of
`the party’s papers, including the obviousness analysis, under Patent Owner’s
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`proposed construction, with which we disagree, obviously, the motivation to
`combine the proper definition of a person of organized skill in the art, and,
`finally, secondary considerations, which are insufficient here, to overcome
`the prima facie case of obviousness.
`So, if we turn to slide five, with respect to the technology background,
`as I indicated, the patents, here, generally, are directed to the idea of
`individualized medical intervention, which entails selecting treatments that
`are targeted to a particular genetic abnormality found in an individual
`patient. There is no dispute here, that, as of 2006, it was well known that
`certain genetic abnormalities were associated with cancer. As of 2006, it
`was also well known that there were numerous therapies available, that were
`targeted towards particular genetic abnormalities associated with cancer.
`It’s also undisputed that, as of 2006, there existed a number of assays for
`testing patient samples, to determine whether or not they had a particular
`genetic abnormality associated with cancer, and, finally, there’s no dispute
`that, as of 2006, the process of automating this analysis and generating a
`report reflecting the results of the molecular profile and any recommended
`therapies was also in the prior art.
`Indeed, as of 2006, there were at least 18 FDA approved targeted
`cancer therapies and many others that were the subject of clinical trials. It’s
`undisputed that, as of 2006, the particular targets, that are recited in the
`claims at issue here, were all known cancer targets that were -- had been
`identified in the art, and each of those targets was known to be associated
`with one or more cancer therapies. Further, as of 2006, there already existed
`databases of information that disclosed these drug-target interactions, and it
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`was known to use the information in those databases to guide cancer
`therapy, and, finally, turning to slide eight, it was known -- the background
`art demonstrates that researchers were already using these databases to
`identify new uses of known cancer therapies. For example, the Rhodes
`publication, that’s described in our papers, talks about something called the
`Oncomine Database, and it talks about how that database was being used to
`identify associations between Her2, which was a known breast cancer gene,
`and other types of cancers, notably lung and ovarian cancer, and it also talks
`about the fact that, based on these associations, Her2 clinical trials of
`Herceptin, which was a targeted therapy directed to Her2, primarily, well,
`approved for use in breast cancer, were already underway in other types of
`cancer, including, in particular, lung cancer.
`So, turning to slide nine, the idea of looking for drug target
`associations, in trying to identify potential new uses of known therapies,
`based on those associations, was a well-known concept, as of 2006. Turning
`to slide 10, in short, all of the claimed elements in the claimed invention
`were known, as of 2006. So, now, we’ll turn to the prior art references, and
`if we go to slide 12, the petition primarily relies on two prior art references,
`neither of which were before the examiner during the prosecution of the
`patents at issue here. The first is the Lu reference, which was a PCT
`publication, that became available as prior art, in February of 2003, and the
`title of that publication is “A Molecular Diagnostic and Computerized
`Decision Support System for Selecting the Optimum Treatment for Human
`Cancer”. So, on its face, it is directed to the exact same concept as the
`claimed inventions here.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`Turning to slide 13, in particular, Lu discloses analyzing sample from
`a patient using a molecular assay. It discloses comparing the results of that
`assay to information, in what it calls a gene and drug database, and it
`discloses generating a report identifying potential therapies, based on the
`individual patient’s genotype, quote unquote, and, if we look at slide 14,
`even though Lu discloses an embodiment that is focused on breast cancer, it
`also expressly discloses that the system that it describes can be used to
`identify treatments for other types of cancer, and, importantly, it makes clear
`that the system is identifying quote “an optimum drug, based on an
`established correlation between a patient genotype and drugs developed to
`treat the general condition”, the general condition, here, being cancer, as
`opposed to a particular type of cancer. So, Lu identifies therapies --
`JUDGE SAWERT: How are you reading that as cancer, generally,
`considered a -- or a type of cancer?
`MS. FERRERA: Sure. So, Lu discloses that you can identify
`therapies, based on the person’s molecular profile, the patient’s genotype,
`and drugs that were developed to treat cancer, as a whole, as opposed to a
`drug that was directed to breast cancer, or lung cancer, or the -- in the
`particular type of cancer that the patient may have been suffering from. So,
`it’s disclosing to persons of ordinary skill in the art that the key correlation,
`here, is between the patient’s molecular profile and the target, as opposed to
`the particular type of cancer at issue.
`The second reference that Petitioner is relying on, as its primary
`reference, is the Illumina Technical Bulletin, which was published on
`November 16, 2005. Now, prior to institution, the Patent Owner had
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`disputed whether or not this reference was publicly available, as of the
`priority date. The appear to have dropped that issue from their response in
`surreply. So, we believe that that is no longer in dispute. The Illumina
`publication describes a commercially available assay, called the DASL
`assay, and the DASL assay, as disclosed in the Illumina publication, used a
`cancer panel, comprised of 502 gene targets, and these were targets that
`were selected from 10 publicly available cancer gene lists, and they were
`also selected on the basis of a frequency of their appearance in those gene
`lists, as well as in the cancer literature, as a whole.
`Table 1, if we turn to slide 16, Table 1, in Illumina, identifies the 502
`targets that are contained within the cancer panel of Illumina, and,
`importantly, all the DASL assay would look at all of these targets
`simultaneously. So, this was not a situation where a person would have to
`select which of the 502 targets it wanted to assay. All of these targets were
`analyzed at the same time, and there is no dispute that the DASL cancer
`panel includes all of the targets recited in the disputed claims here.
`So, if we turn, now, to the challenged patents, and to slide 18, the
`patents all share the title “System and Method for Determining
`Individualized Medical Intervention for a Diseased State”, and the effective
`priority date of the patents is May 18, 2006. If we look at slide 19, the
`claims in dispute, largely, mirror one another. So, we’re focusing on claim 1
`of 350 patent, as representative, and, as you can see, it claims a system for
`generating a report, identifying at least one therapeutic agent for an
`individual with cancer. It comprises a device to assay a plurality of
`molecular targets. Each of the patents lists a slightly different set of gene
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
`
`
`targets, that are included within the plurality, but, importantly, that the
`claims use the comprising language to indicate that the panel can include
`other targets, besides the ones that are listed here.
`The claims require a database, which contains reference values for the
`various targets, as well as a listing of available therapeutic agents, and the
`claims require software to compare the test values with those reference
`values, and, finally, the claims require software for identifying quote “at
`least one therapeutic agent” close quote associated with a likely benefit and
`generating report, identifying that agent, as well as the corresponding target,
`and, if we look at slide 20, you can see that when we map the primary prior
`art references, Illumina and Lu, to the requirements of claim 1, there is no
`dispute that all elements are disclosed. Lu discloses each of the system’s
`components, minus the specific set of panels of targets that are contained
`within the panel, and Illumina discloses the device configured to assay a
`plurality of targets that comprises the specific targets recited in limitation
`1A.
`
`JUDGE SAWERT: Is it fair to say the dispute this case is all about
`claim construction?
`MS. FERRERA: Claim construction is probably the key issue in this
`case. The Patent Owner has put forth the claim construction and its
`arguments, with respect to non-obviousness, all assume that claim
`construction. The Patent Owner has not set forth any non-obviousness
`position that does not rely on the lineage independence construction. So,
`with that, maybe we’ll make sense to turn to the issue of claim construction,
`and I will direct Your Honors to slide 29, or 30.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`This proceeding is being governed by the broadest reasonable
`construction, or interpretation standard, and although the Patent Owner tries,
`creatively, to argue that the construction that it’s putting forward is, in fact,
`the broadest reasonable interpretation, the fact of the matter is that adding a
`limitation to the claims, logically, cannot be the broadest reasonable
`interpretation. The Patent Owner’s construction is that the claims should be
`interpreted to require a system that identifies therapeutic agents for a patient
`independent of cancer lineage. Clearly, the goal of that construction is to try
`to narrow the claims, in order to avoid the prior art. However, by adding
`that limitation, the claims are, clearly, no longer being interpreted according
`to the broadest reasonable interpretation.
`JUDGE SAWERT: So, can I get your take on -- what do you
`understand lineage independence and lineage dependence to mean?
`MS. FERRERA: Well, the Patent Owner has not been entirely clear
`about that. However, what they seem to be arguing is that, in order to be a
`lineage independent system, the system has to be capable of identifying
`available therapeutics, that are both lineage independent, as well as ones that
`are lineage dependent. So, in their papers, they say that the system has to be
`capable of identifying all available therapeutics. We don’t think that
`language is supported by the claim language, or the specification, or the
`prosecution history. However, even if that were the case, the prior art, here,
`does disclose such a system.
`JUDGE SAWERT: So, I think my question’s a little bit more basic
`than that. What do you understand cancer lineage independence to mean,
`and cancer lineage dependence to mean?
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`MS. FERRERA: I believe that what the Patent Owner is trying to
`articulate, when they use those terms, is that a lineage independent system
`would be one that would be capable of identifying therapies that are not
`necessarily associated with the particular cancer that the patient has been
`diagnosed with, whereas a lineage dependent system would only identify the
`therapies that are already approved or have been associated in cancer
`literature, with that patient’s cancer. So --
`JUDGE SAWERT: Go ahead.
`MS. FERRERA: So, what we understand the Patent Owner to be
`arguing, here, is that the claims should be interpreted as requiring a system
`that’s capable of identifying therapies that both have been approved or have
`been associated with the patient’s particular cancer, as well as therapies that
`have not been associated with a particular cancer.
`JUDGE SAWERT: It seems to me, when I look at the written
`description of the patent, the inventors’ breakthrough, in the art, was they,
`for the first time, understood that you, a cancer patient, could be treated with
`drugs that weren’t necessarily associated with that type of cancer, and that
`seems to be pretty consistent throughout the specification. Is your position
`that, even though the written description describes that invention, the claims
`do not recite that invention?
`MS. FERRERA: I have two responses to that, Your Honor. First,
`there, certainly, is reference in the specification to this concept of lineage
`independence. However, there are also embodiments in the specification
`that do not require lineage independence.
`JUDGE SAWERT: Can we discuss those?
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`MS. FERRERA: Certainly. So, if you turn to column 2, line 39,
`continuing to column 3, line 48 --
`JUDGE SAWERT: Now, just give us one moment to get there. So,
`you said column 2?
`MS. FERRERA: Yes, column 2, starting at line 39 --
`JUDGE SAWERT: Okay.
`MS. FERRERA: -- and continuing to column 3, line 48. This, this
`section, starts off by saying that it’s -- make -- let me make sure I’m looking
`at the right place. One exemplary method of the present invention, et cetera,
`et cetera. So, this section is talking about one embodiment of the invention,
`and this would be a lineage independent embodiment. It talks about -- start
`at about line 47 or so, starting at line 45, identifying a drug therapy used to
`interact with a gene and or gene expressed proteins, that exhibited a change
`of expression that is not single disease restricted. So, this is a lineage
`independent embodiment, but, if you turn, then, to column 3, starting at line
`49, and then continuing to line 67, it talks about another exemplary
`embodiment, and you’ll see nowhere, in the description of that embodiment,
`any reference to lineage independence, to being not single disease restricted,
`or any of the other language that the Patent Owner used to describe this
`lineage independence concept. Similarly, if you --
`JUDGE PAULRAJ: Does it say anywhere, in the portions you
`quoted, that it is single disease restricted? In other words, are you reading
`something into the absence of the language you quoted, from column 2,
`about not single disease restricted?
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`MS. FERRERA: No, Your Honor, and our construction doesn’t
`require that the system be single disease restricted. Our construction is that
`the claims are agnostic. The system could be either lineage independent, or
`lineage dependent, or both. So, the construction that the Petitioner is putting
`forward, here, is that lineage independence is not required, but it could be
`permitted by the claims.
`JUDGE SAWERT: I guess my question is that, even under broadest
`reasonable interpretation, it has to be consistent with the written description.
`It’s not what’s possible. It’s what’s described, and I believe there have been
`some recent cases about that, telling the Board that we were reading claims
`too broadly and not consistently with the specifications, and, so, do you have
`anything in the specification discussing -- I see you have an example of
`lineage independent. Do you have anything that more closely describes
`lineage dependency, versus just the absence of words?
`MS. FERRERA: Well, Your Honor, I think the specification
`discloses embodiments that do, expressly, require lineage independence.
`There is the embodiment on -- in column 2. There’s another embodiment
`that contains similar language, but it also discloses multiple embodiments
`that do not require lineage independence. They are agnostic.
`JUDGE SAWERT: Okay. Let’s go through those. So --
`MS. FERRERA: So, there is the --
`JUDGE SAWERT: -- column 3, line 49 --
`MS. FERRERA: Correct. Down --
`JUDGE SAWERT: -- that sounds, to me, like that’s just the absence
`of a language, rather than actual words saying lineage dependency.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`MS. FERRERA: Well, that is correct, Your Honor. It does not
`require the system to be lineage independence, which is consistent with the
`Petitioner’s proposed claim construction, that the claims do not require
`lineage independence.
`JUDGE SAWERT: Okay.
`MS. FERRERA: They could include it, but they don’t require it.
`Similarly --
`JUDGE PAULRAJ: Ms. Ferrera, I’m not sure I follow what you
`mean by the claims are agnostic because, the way I read the claims, the
`claims can be either lineage independent, or lineage dependent. You seem
`to want to kind of say it’s -- it could be both, and I’m trying to -- because, to
`me, lineage independence is agnostic. You know, I don’t see how that can
`be the agnostic version of how to interpret the claims.
`MS. FERRERA: Lineage -- I think I understand your -- the
`confusion, here, Your Honor. I think what Patent Owner is arguing is that
`the claims have to be lineage independent. So, they have to be capable of
`identifying off-label therapies. On the other hand, the Petitioner’s proposed
`construction is that the system could be capable of identifying off-label
`therapies, but it doesn’t have to be capable of doing that, and there’s nothing
`in the claims that require it to be capable of doing that. So, for example, if
`you had a system, that included the same panel of targets that are recited in
`claim 1 of the 350 patent, but the only therapies that it identified were ones
`that were approved or associated with those particular targets, that would
`arguably be a lineage dependent system. That would be covered by the
`language of claim 1, and there’s nothing in the language of claim 1 that
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`requires the system to be capable of identifying the lineage independent, or
`off-label therapies, as well.
`When the -- in the specification, when it talks about embodiments that
`require lineage independence, it’s primarily talking about what types of
`therapies are being recommended by the system and which are not. In some
`of the embodiments, it makes clear that the therapies that are recommended
`are not previously associated with the patient’s particular cancer or not
`single disease restricted, but, in some of the embodiments, such as the
`embodiment starting at column 3, line 49, and, in addition, there’s also an
`embodiment starting at column 4, line 1, and continuing down to line 33,
`which also doesn’t require the therapies to either be -- off-label, on-label.
`It’s just silent, as to whether or not that’s required.
`JUDGE SAWERT: So, you said you had multiple embodiments? So,
`the one at 3, 49, one at 4, 1. What else are you relying on?
`MS. FERRERA: Those are the two embodiments that are specifically
`described, and then there are two embodiments where lineage independence
`is required. So, I think it’s the comparison of those two embodiments that is
`noteworthy. In addition to the claim language, itself, though, Your Honors,
`the prosecution history, here, is extremely telling. So, Patent Owner
`previously filed a provisional application, on May 18, 2006. It’s the
`application that these patents claim priority to, and I’m looking at slide 32,
`for Judge Cotta’s benefit, and, in that provisional application, they included
`specific -- they included claims that had specific language requiring this
`lineage independence concept.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`For example, in claim 1, they had a limitation which required
`identifying a drug therapy used to interact with at least one of the genes and
`or gene expressed proteins, that exhibited a change in expression that is not
`single disease restricted, and, similarly, in the 745 application, their 721
`application, that was filed in May of 2007, the claims also had specific
`language requiring lineage independence. So, for example, in claim 1, it --
`they recited identifying treatment that has not previously been associated
`with treating the diagnosed disease; also, claim 52, which --
`JUDGE SAWERT: And remind me of the 721 application, that --
`MS. FERRERA: The 72 -- sorry, Your Honor.
`JUDGE SAWERT: What did that -- did that issue -- is that the 350?
`MS. FERRERA: It did not issue as a 350. It issued as the 335 patent,
`Your Honor, but it is the parent application for the 350, the 193, and 365
`applications. They are all continuations of the 721 application. So, there
`are, at least, two different phrases that the inventors used in the 721
`application, to, specifically, claim this concept of lineage independence, and,
`in addition, Your Honor, the Patent Owners place great weight on the
`particular panel of targets that’s recited in each of these patents, and has
`argued that, somehow, because those targets are not associated with a
`particular cancer, that, necessarily, makes the system lineage independent,
`but, even in the 721 application, there were dependent claims flowing from
`claim 1, for example, which recited, essentially, the same or an overlapping
`panel of targets. So, the mere fact that you have this panel of targets is not
`enough to make these claims lineage independent.
`JUDGE SAWERT: Let me ask you a question about that.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
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`MS. FERRERA: Certainly, Your Honor.
`JUDGE SAWERT: Let’s say that, in the earlier application, they said
`has not previously been associated with treating it, the diagnosed disease,
`but, instead of using that language, they put in these particular molecular
`targets, and, now, they’re saying, well, someone skilled in the art would
`understand, by looking at those targets, because the targets were, generally,
`correlated with a bunch of different cancer diseases, that it’s, basically, a one
`to one exchange of language, if you will. So, by taking out this disease, or
`lineage independence, or, yes, independence language, by putting in those
`molecular targets, someone skilled in the art would understand they,
`basically, mean the same thing. So, can you respond to that question?
`MS. FERRERA: Certainly, Your Honor. So, I think the clearest
`evidence that that’s not the case is the 721 application, itself. So, in claim 1
`of the 721 application, there is this language about not being previously
`associated with treating the diagnosed disease, but, if you look at claims 5
`and 6 of that same application --
`JUDGE SAWERT: Do you have a slide for that?
`MS. FERRERA: Yes. It is exhibit 1141.
`JUDGE SAWERT: Okay. One second while we get there. 1141?
`Okay.
`MS. FERRERA: Okay. Exhibit 1141, and it is page 531. Continuing
`to 500 --
`JUDGE SAWERT: Okay. Give us a minute.
`MS. FERRERA: Sure.
`JUDGE SAWERT: I could do a lot of scrolling, here.
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`Case IPR2019-00164 (Patent 8,880,350 B2)
`Case IPR2019-00170 (Patent 9,372,193 B2)
`Case IPR2019-00171 (Patent 9,383,365 B2)
`
`
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`MS. FERRERA: I may be able to -- I’m not sure if this is on. I don’t
`think this is doing anything.
`JUDGE SAWERT: One moment.
`MS. FERRERA: Are you there, Your Honor? May I proceed?
`JUDGE SAWERT: One moment.
`MS. FERRERA: Okay.
`JUDGE SAWERT: Okay, we’re there.
`MS. FERRERA: Okay. So, on page 531 of exhibit 1141, claim 1
`contains the requirement that the -- requiring identifying a personalized drug
`therapy, that has not previously been associated with treating the diagnosed
`disease, and then, if you go down to claim 5, it’s a method of claim 3, which,
`if you look, also, depends from claim 1, where the step of performing an
`IHC analysis comprises the step of performing that analysis, for the named
`targets that appear on page 532, and claim 6, similarly, is the method of
`claim 3, requiring performing an assay or an analysis on a list of specific
`targets, and the targets that are listed in claims 5 and 6 are overlapping with
`the targets in claims -- clai