JONATHAN BRAUN, M.D., Ph.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________
`
`Page 1
`
` GENOME AND COMPANY,
` Petitioner
` v.
` THE UNIVERSITY OF CHICAGO,
` Patent Owner
` _______________
` Case No. PGR2019-XX
` U.S. Patent No. 9,855,302 B2
` _______________
`
` DEPOSITION OF JONATHAN BRAUN, M.D., Ph.D.
` Thursday, November 21, 2019 10:05 a.m.
` Nelson Mullins Riley & Scarborough LLP
` One Post Office Square, Boston, MA
`
`Reported by:
`Janet Sambataro, RMR, CRR, CLR
`JOB NO. 172169
`
`TSG Reporting - Worldwide 877-702-9580
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`Page 3
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` JONATHAN BRAUN, M.D., Ph.D.
` P R O C E E D I N G S
` JONATHAN BRAUN, M.D., Ph.D.,
`having been duly sworn, after presenting
`identification in the form of a driver's license,
`deposes and says as follows:
` CROSS-EXAMINATION
`BY DR. KAMHOLZ:
` Q. Good morning, Dr. Braun.
` My name is Scott Kamholz. I'm representing
`the patent owner in this proceeding. You
`understand that you are here to give testimony
`concerning your reply declaration and post-grant
`review proceeding PGR2019-0002, Genome & Company
`versus the University of Chicago?
` A. I do.
` Q. There's no reason you cannot give
`truthful and complete testimony today?
` A. No reason.
` Q. No medical, health or other conditions
`that would prevent you from giving complete and
`truthful testimony today?
` A. No.
` Q. You understand that you must answer
`your questions truthfully -- answer my questions
`
`Page 5
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` JONATHAN BRAUN, M.D., Ph.D.
`not while a question is pending. Okay?
` A. Okay.
` DR. KAMHOLZ: I'm handing the witness a
`copy of a document previously marked Exhibit 1043
`in this proceeding.
` (Previously marked Exhibit 1043
` incorporated by reference.)
` DR. KAMHOLZ: I just noticed the copies
`that I have do not have an exhibit number marked
`on them.
` MR. BAUER: Can we go off the record
`for a second?
` (Discussion off the record.)
`BY DR. KAMHOLZ:
` Q. Dr. Braun, do you recognize this
`document as your reply declaration in this
`proceeding?
` A. I do.
` DR. KAMHOLZ: I'm handing the witness a
`copy of a document previously marked Exhibit 1002
`in this proceeding.
` (Previously marked Exhibit 1002
` incorporated by reference.)
`
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`Page 2
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` JONATHAN BRAUN, M.D., Ph.D.
`
`APPEARANCES:
`
`COVINGTON & BURLING
`On Behalf of Patent Owner
`BY: Scott Kamholz, M.D., Ph.D., Esquire
`850 Tenth Street, Northwest
`Washington, DC 20001
`
`NELSON MULLINS RILEY & SCARBOROUGH
`On Behalf of Petitioner
`280 Park Avenue
`New York, NY 10017
`BY: John Bauer, Esquire
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`Page 4
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` JONATHAN BRAUN, M.D., Ph.D.
`truthfully and to the best of your ability?
` A. Yes.
` Q. If you don't understand a question,
`tell me, and I will try to rephrase the question.
`Okay?
` A. Okay.
` Q. If you answer a question, it means you
`understood the question. Okay?
` A. Yes.
` Q. Please wait until I finish asking a
`question before you answer it so that the court
`reporter can follow us. Okay?
` A. Okay.
` Q. Counsel for petitioner may make
`objections, but you must still answer the
`question unless I withdraw the question or
`counsel instructs you not to answer. Understood?
` A. I understand.
` Q. You may not talk with counsel for
`petitioner concerning the substance of your
`testimony until my Cross-Examination is complete.
`Understood?
` A. I understand.
` Q. Please tell me if you need a break, but
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`TSG Reporting - Worldwide 877-702-9580
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`2 (Pages 2 to 5)
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`

`

`Page 6
` JONATHAN BRAUN, M.D., Ph.D.
` Q. Do you recognize this document as your
`opening declaration in this proceeding?
` A. I do.
` Q. Please take your reply declaration,
`Exhibit 1043, and turn to Page 1.
` (Witness complies.)
` Q. And look at Paragraph 2.
` Do you see there you refer to your
`"educational background, career history, and
`other qualifications" as provided in your opening
`declaration?
` A. I see it.
` Q. And turn to Page 3, please.
` (Witness complies.)
` Q. The heading on this page is "Extensive
`Human Oncology Clinical Experience."
` Do you see that?
` A. Yes.
` Q. You don't describe in your opening
`declaration or in your reply declaration being
`board-certified in internal medicine; correct?
` A. Correct.
` Q. And, in fact, you're not
`board-certified in internal medicine; right?
`
`Page 8
` JONATHAN BRAUN, M.D., Ph.D.
`is in the manner of pathology consultations;
`correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever prescribed a therapeutic agent to a cancer
`patient; correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever prescribed a checkpoint inhibitor to a
`cancer patient; correct?
` A. These questions misperceive the role of
`pathologists in the planning of care to oncology
`patients.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever prescribed a checkpoint inhibitor to a
`cancer patient; correct?
` A. The role of myself and the pathologists
`on my team in tumor boards play a direct role in
`the decision about the choice of therapies.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
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`Page 7
` JONATHAN BRAUN, M.D., Ph.D.
` A. Correct.
` Q. You don't describe in your opening
`declaration or your reply declaration being
`board-certified in oncology; correct?
` A. Correct.
` Q. And, in fact, you are not
`board-certified in oncology; correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever provided medical care to a patient; correct?
` A. Could you repeat your statement?
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever provided medical care directly to a patient;
`correct?
` A. No. That is not correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever provided medical care directly to a cancer
`patient; is that correct?
` A. No. That is not correct.
` Q. The medical care that you describe
`providing to cancer patients is in the matter --
`
`Page 9
` JONATHAN BRAUN, M.D., Ph.D.
`ever prescribed a checkpoint inhibitor to a
`cancer patient; correct?
` A. I have answered my -- to the best of my
`ability your question.
` Q. You have never prescribed a checkpoint
`inhibitor to a cancer patient; correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever been principal investigator on a clinical
`trial; correct?
` A. Correct.
` Q. You have never been a principal
`investigator on a clinical trial; correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever referred a patient to a checkpoint inhibitor
`clinical trial; correct?
` A. As a pathologist, my clinic activities
`play a direct role in making the ascertainment
`about whether a patient is suitable to be
`referred for a clinical trial.
` Q. But you have never referred a patient
`
`TSG Reporting - Worldwide 877-702-9580
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`

`Page 10
` JONATHAN BRAUN, M.D., Ph.D.
`to a clinical trial for a checkpoint inhibitor,
`have you?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever administered a checkpoint inhibitor to treat
`cancer in a human subject; correct?
` A. My role as a pathologist directly
`involves me in the choice to administer such an
`agent, and my work as a pathologist provides
`critical information in monitoring the patient
`undergoing such therapy.
` Q. But you have never administered to a
`human subject a checkpoint inhibitor to treat
`cancer in that human subject; correct?
` A. Correct.
` Q. You don't describe in your opening
`declaration or in your reply declaration having
`ever administered to a human subject anything to
`treat cancer in that human subject; correct?
` A. Your questions misperceive the role of
`a pathologist in the planning and execution of
`therapeutic interventions for patients. A
`pathologist plays critical roles together with
`
`Page 12
` JONATHAN BRAUN, M.D., Ph.D.
` (Witness complies.)
` Q. In Paragraph 12, you refer to the role
`of pathology consultations to "provide critical
`information for diagnosis or management of cancer
`patients."
` Do you see that?
` A. Yes, I do.
` Q. That critical information includes the
`type of cancer; correct?
` A. Yes. It also includes many other types
`of information that I use to make the decision
`about what treatments to use and how to monitor
`the response to treatment.
` Q. In Paragraph 12, you refer to "surgical
`pathology cases."
` Do you see that?
` A. Yes.
` Q. In the typical surgical pathology case,
`the pathologist receives a tissue specimen from
`the patient; right?
` A. Correct. Sometimes it's received.
`Sometimes the pathologist does the intervention
`to collect the specimen.
` Q. The pathologist analyzes the tissue
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`Page 11
` JONATHAN BRAUN, M.D., Ph.D.
`the oncologist and other members of the team on
`deciding what therapies to administer, how to
`monitor adverse reactions, and to assess the
`response to treatment. It also is critical to
`decide if that therapy should be maintained or
`changed to another therapy.
` So I've been regularly involved in all
`phases of the management of cancer patients.
` Q. But you don't describe in your opening
`declaration or in your reply declaration having
`ever administered to a human subject anything to
`treat cancer in that human subject?
` A. I've given you my best answer to your
`question.
` Q. And you, in fact, have never
`administered to a human subject anything to treat
`cancer in that human subject; correct?
` A. In my years of medicine, there's been
`times when I have directly prescribed and
`administered therapies to patients.
` Q. To treat cancer?
` A. Yes.
` Q. Turn to Page 3 of your reply
`declaration.
`
`Page 13
` JONATHAN BRAUN, M.D., Ph.D.
`specimen to confirm the presence or absence of
`cancer in the tissue specimen if it's a cancer
`case; right?
` A. That's one of the activities that the
`pathologist -- the pathologist also produces
`other information to determine the biologic
`features of the tumor that can be used to predict
`or make the best choice for therapies that would
`be most beneficial to the patient and also to
`decide on biomarkers that can be used to monitor
`care.
` Q. Your role as a pathologist in a
`surgical pathology case involves analyzing a
`tissue specimen received from a patient; right?
` A. Correct.
` Q. And the treatment is determined based,
`at least in part, on the information the
`pathologist provides, including the type of
`cancer and the other things you mentioned?
` A. Correct. In addition, the pathologist
`participates in the treatment planning conference
`with the oncologist and other members of the team
`to discuss and together come to a consensus about
`the treatment plan, the management and monitoring
`
`4 (Pages 10 to 13)
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`Page 14
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` JONATHAN BRAUN, M.D., Ph.D.
`plan.
` Q. And those treatments, if successful,
`will stop progression of the cancer; right?
` A. That's one possible outcome.
` DR. KAMHOLZ: I'm giving the witness a
`copy of a document previously marked Exhibit 1045
`in this proceeding.
` (Previously marked Exhibit 1045
` incorporated by reference.)
` Q. Do you recognize this as the Ridaura
`article you cited in your reply declaration?
` A. I do.
` Q. You see that Ridaura reports on
`experiments using germ-free rodents?
` A. That's one part of the design of the
`research. There are other parts to the design as
`well.
` Q. But no part of this research involves
`the use of specific pathogen-free rodents?
` A. When the mice were recolonized, that
`would be considered a specific pathogen-free
`animal.
` Q. Ridaura does not identify any animals
`in this case as specific pathogen-free; correct?
`
`Page 16
` JONATHAN BRAUN, M.D., Ph.D.
` Q. Ridaura does not discuss breeding;
`correct?
` A. Ridaura describes a well-established
`process of establishing a microbial community in
`a mouse and the dynamics in which it sustained
`that mouse over time.
` Q. But Ridaura does not describe or
`discuss breeding.
` A. Well, a person with ordinary experience
`would understand that this article teaches how a
`microbial community is established in a mouse or
`in a colony.
` Q. But Ridaura does not discuss breeding;
`correct?
` A. A person of ordinary skill would
`understand that organisms are vertically
`transferred from mothers to babies by co-housing.
`This provides documentation of the details about
`how that transfer occurs.
` Q. But Ridaura does not discuss breeding?
` A. I've given you my best answer to your
`question.
` Q. Ridaura termed transfer of
`microorganisms between co-housed rodents as
`
`Page 15
` JONATHAN BRAUN, M.D., Ph.D.
` A. A person with ordinary skill in the art
`would understand that the reconstituted animal
`would fall into the category of specific
`pathogen-free.
` Q. Ridaura reports on experiments using
`gnotobiotic rodents; correct?
` A. Correct.
` Q. Gnotobiotic refers to a facility in
`which the microorganisms are either known or
`excluded; right?
` A. Ridaura describes mice that start as
`germ-free, meaning by a set of definitions that
`the Washington University facility defines that
`they lack identifiable microorganisms. The work
`mainly describes those mice after they were
`recolonized with microbiota from different human
`sources.
` Q. Ridaura investigated transplantation of
`microorganisms by gavage of germ-free rodents;
`right?
` A. Correct.
` Q. Ridaura also investigated transfer of
`microorganisms between co-housed rodents; right?
` A. Correct.
`
`Page 17
`
` JONATHAN BRAUN, M.D., Ph.D.
`"invasion"; correct?
` A. On Page 1, the term "invasion" is used
`to describe the dynamic of a genus of bacteria
`when encountered by co-housing between two mice.
` Q. Turn to Page 5, please.
` (Witness complies.)
` Q. Do you see at the top of Page 5, in the
`middle column, Ridaura says, "The most successful
`LNch invaders of the OBch microbiota were members
`of the Bacteroidetes"?
` A. I see that statement.
` Q. And continuing on to Page 6, left-hand
`column at the top, do you see Ridaura reported
`that "In contrast, co-housing did not result in
`significant invasion of LNch intestines with
`members of the OBch microbiota"?
` A. I see that.
` Q. Ridaura found that some microbiota
`invaded the intestines of co-housed rodents
`readily, but others did not; right?
` A. That misunderstands the ecology here.
`Ridaura is describing the dynamics of the ecology
`between mice with two different ecologies, a
`distinct one in the obese mouse; another one in
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`Page 18
` JONATHAN BRAUN, M.D., Ph.D.
`the lean mouse.
` In the co-housing where those organisms are
`mutually challenged, certain taxa are efficient
`at competing for the niche.
` So this is a statement about the dynamic
`between two different ecologies and a small
`number of organisms present in one compared to
`the other.
` Q. Ridaura did not report that co-housed
`rodents -- co-housed rodents reached a shared
`baseline microbiome composition; correct?
` A. That's incorrect. The Ridaura
`describes a homogeneity among co-housed mice in
`the one setting, which is a certain set of
`feeding resulting in the obese phenotype and
`homogeneity among mice that were kept in another
`mouse housing condition which resulted in the
`lean phenotype.
` Those were -- the premise of the design and
`the analysis was that kept under standard staple
`housing conditions, the mice would have a
`relatively homogeneous composition.
` Q. When you say "the mice," you refer to
`mice of one of the phenotypes?
`
`Page 20
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` JONATHAN BRAUN, M.D., Ph.D.
`with mice from a separate animal husbandry and
`see what happens.
` Q. An obese phenotype mouse and a lean
`phenotype mouse were placed together in a single
`cage; correct?
` A. I think you're misusing the -- that
`descriptor of being lean or obese. These mice
`are not lean or obese because they have
`particular autonomous properties. Instead,
`they're one state or the other because they've
`been maintained in a particular animal husbandry.
`So that is a reflection of the animal husbandry
`under which they've been maintained.
` Q. The lean-state mouse and an obese-state
`mouse were housed together in a single cage;
`correct?
` A. That was the special intervention. The
`other conditions, which are the starting point of
`this study, were to stably maintain mice in a --
`in a condition of husbandry where they had
`established a microbiome composition and had been
`maintained under those standard feeding
`conditions.
` They observed in that that mice kept in the
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`Page 19
`
` JONATHAN BRAUN, M.D., Ph.D.
` A. Correct. Those are examples of animal
`husbandry, of a consistent animal husbandry. So
`when one keeps mice in a particular husbandry
`condition, there will be homogeneity in the
`composition of the intestinal microorganisms.
` Q. Ridaura describes the co-housing of
`lean phenotype and obese phenotype mice; correct?
` A. Ridaura describes both. It describes
`the housing of mice in each of those conditions
`and the curious outcome when mice are mixed from
`those two different husbandry conditions.
` Q. And by "mixed," do you mean a lean
`phenotype mouse living in the same cage with an
`obese phenotype mouse?
` A. That is the intervention which is
`distinct from the other interventions, which are
`animal husbandry -- stable animal husbandry
`conditions.
` Q. But one of the interventions in Ridaura
`was housing a lean phenotype mouse together in
`the same cage with an obese phenotype mouse;
`right?
` A. A more accurate way to frame that is to
`take mice with one animal husbandry and mix them
`
`Page 21
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` JONATHAN BRAUN, M.D., Ph.D.
`one husbandry condition, when the other husbandry
`condition were stable and homogeneous in the
`microbial composition.
` Q. But in this special intervention, as
`you put it, the lean-state mice and the
`obese-state mice were not kept in different
`husbandry conditions. They were kept in the same
`husbandry conditions; correct?
` A. Right. That's the special experiment
`of this that was added in this study.
` Q. And Ridaura concluded that the
`lean-state and obese-state mice that were
`co-housed in the same husbandry conditions in
`this special intervention did not reach a shared
`microbiome composition because some microbiota
`invaded and others did not?
` A. I think that that misstates the
`description of what they observed.
` When they co-housed the mice, they
`established a third ecology, which was shared
`among the mice kept in that third husbandry with
`a particular set of compositions which define the
`husbandry of that third resulting -- the
`colonization state that was the result of that
`
`6 (Pages 18 to 21)
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`Page 22
`
` JONATHAN BRAUN, M.D., Ph.D.
`third type of husbandry.
` DR. KAMHOLZ: I'm giving the witness a
`copy of a document previously marked Exhibit 1017
`in this proceeding.
` (Previously marked Exhibit 1017
` incorporated by reference.)
` Q. Do you recognize this document as the
`O'Mahoney patent application publication?
` A. I do.
` Q. The page numbers I'll refer to are
`printed in the bottom right-hand corner of the
`pages.
` Do you see that?
` A. I do.
` Q. Turn to Page 4 of 25, please.
` (Witness complies.)
` Q. Do you see Figure 4 printed on Page 4?
` A. I do.
` Q. Figure 4 reports data on strain 1714;
`correct?
` A. Correct.
` Q. Figure 4 does not report data on strain
`35624; correct?
` A. Correct.
`
`Page 24
` JONATHAN BRAUN, M.D., Ph.D.
`strain other than 1714; correct?
` A. Correct.
` Q. Look at Figure 7. Figure 7 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 7 does not report data on strain
`35624; correct?
` A. Correct.
` Q. Figure 7 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Look at Figure 8. Figure 8 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 8 does not report data on strain
`35624; correct?
` A. Correct.
` Q. Figure 8 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 6, please.
` (Witness complies.)
` Q. Look at Figure 9. Figure 9 reports
`data on strain 1714; correct?
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`Page 23
` JONATHAN BRAUN, M.D., Ph.D.
` Q. Figure 4 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Look at Figure 5. Figure 5 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 5 does not report data on strain
`35624; correct?
` A. Correct.
` Q. Figure 5 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 5, please.
` (Witness complies.)
` Q. Figure 6, do you see at the top of
`Page 5?
` A. I do.
` Q. Figure 6 does not report data on strain
`35624; correct?
` A. Correct.
` Q. It reports data on strain 1714;
`correct?
` A. Correct.
` Q. Figure 6 does not report data on any
`
`Page 25
` JONATHAN BRAUN, M.D., Ph.D.
` A. Correct.
` Q. Figure 9 does not report data on strain
`35624; correct?
` A. Correct.
` Q. Figure 9 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 7, please.
` (Witness complies.)
` Q. Do you see Figure 10?
` A. Yes.
` Q. Figure 10 reports data on strain 1714;
`correct?
` A. Correct.
` Q. Figure 10 does not report data on
`strain 35624; correct?
` A. Correct.
` Q. Figure 10 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 8, please.
` (Witness complies.)
` Q. Look at Figure 11. Figure 11 reports
`data on strain 1714; correct?
`
`7 (Pages 22 to 25)
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`

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`Page 26
` JONATHAN BRAUN, M.D., Ph.D.
` A. Correct.
` Q. Figure 11 does not report data on
`strain 35624; correct?
` A. Correct.
` Q. Figure 11 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Look at Figure 12.
` (Witness complies.)
` Q. Figure 12 reports data on strain 1714;
`correct?
` A. Correct.
` Q. Figure 12 does not report data on
`strain 35624; correct?
` A. Correct.
` Q. Figure 12 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 9, please.
` (Witness complies.)
` Q. Look at Figure 13. Figure 13 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 13 does not report data on
`
`Page 28
` JONATHAN BRAUN, M.D., Ph.D.
` A. Correct.
` Q. Look at Figure 16. Figure 16 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 16 does not report data on any
`strain other than 1714; correct?
` A. The printout is illegible, so I am not
`certain whether any of the labelings might
`reflect something else.
` Q. As far as you can tell, Figure 16 does
`not report data on strain 35624; correct?
` MR. BAUER: Objection.
` DR. KAMHOLZ: What is the nature of
`your objection?
` MR. BAUER: That the witness already
`said that he can't read it because it's
`illegible, and you're asking him the same
`question about Figure 16.
` DR. KAMHOLZ: Would you repeat my
`question, please.
` (The question was read by the
` reporter, as requested.)
` MR. BAUER: Objection.
` A. I've answered the question to the best
`
`Page 27
` JONATHAN BRAUN, M.D., Ph.D.
`strain 35624; correct?
` A. Correct.
` Q. Figure 13 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Look at Figure 14. Figure 14 reports
`data on strain 1714; correct?
` A. Yes.
` Q. Figure 14 does not report data on
`strain 35624; correct?
` A. Correct.
` Q. Figure 14 does not report data on any
`strain other than 1714; correct?
` A. Correct.
` Q. Turn to Page 10, please.
` (Witness complies.)
` Q. Look at Figure 15. Figure 15 reports
`data on strain 1714; correct?
` A. Correct.
` Q. Figure 15 does not report data on
`strain 35624; correct?
` A. Correct.
` Q. Figure 15 does not report data on any
`strain other than 1714; correct?
`
`Page 29
` JONATHAN BRAUN, M.D., Ph.D.
`of my ability.
` Q. And your answer is that the figure is
`illegible and you can't tell?
` A. Correct.
` Q. Turn back to Page 4, please.
` (Witness complies.)
` Q. Looking at Page 4 and then also Page 5,
`Figures 4 through 6 present data only for strain
`1714 and not for any other strain; correct?
` A. Correct. They also include data about
`another bacterial product, which is LPS.
` Q. But in all of these figures we've
`discussed, the only bifido strain reported is
`1714; correct?
` A. The source of the LPS isn't defined in
`the figures as I look at them directly.
` Q. Meaning you can't tell whether the LPS
`was obtained from bifidobacterium?
` A. Correct.
` Q. But, otherwise, the only strain you see
`reported there is 1714; correct?
` A. I've answered to the best of my
`ability.
` Q. Go back to your reply declaration,
`
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`8 (Pages 26 to 29)
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`

`Page 30
` JONATHAN BRAUN, M.D., Ph.D.
`please, Exhibit 1043.
` (Witness complies.)
` Q. On Page 20, Paragraph 73 begins, and it
`continues on to Page 21.
` Do you see that?
` A. Yes, I do.
` Q. At the very end of Paragraph 73, do you
`see your testimony, "Many tumors for which
`reported response rates are extremely low (<10%)
`or nonexistent"?
` A. I do.
` Q. By reported response rates being
`nonexistent, you meant that there are tumors for
`which response rates were not reported; correct?
` A. Correct. Also, there were examples of
`tumors that did not yield a detectable response
`rate as reported.
` DR. KAMHOLZ: I have no further
`questions.
` MR. BAUER: All right. Give me about
`ten minutes, then I'll be back.
` (A recess was taken.)
` REDIRECT EXAMINATION
`
`Page 32
` JONATHAN BRAUN, M.D., Ph.D.
`Paragraph 12 of your reply declaration. There
`were a number of questions this morning regarding
`your clinical experience.
` A. Correct.
` Q. And many of the questions dealt with
`whether or not you actually physically
`administered the -- an oncologic agent; correct?
` A. Correct.
` Q. But you also mentioned that you were
`involved in planning and execution of clinical
`therapies.
` Do you recall that?
` A. I do.
` Q. And what did you mean in your
`declaration, and I'm reading from Paragraph 12,
`where you say, "In performing these clinical
`cancer services, I directed the activities of
`over 100 pathology-specialist clinicians and over
`600 technical staff, as well their roles in the
`12 concurrent biweekly cancer patient-management
`tumor boards where oncologists, radiation
`oncologists, and subspecialist pathologists,
`radiologists together performed patient-level
`diagnosis and treatment planning"?
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`Page 31
`
` JONATHAN BRAUN, M.D., Ph.D.
`BY MR. BAUER:
` Q. Dr. Braun, can I direct you to
`Paragraph 18 of your declaration, which is
`Exhibit 1043.
` DR. KAMHOLZ: Did you say Paragraph 18?
` MR. BAUER: Yes.
` DR. KAMHOLZ: I object as beyond the
`scope of Cross.
` Q. And the last sentence, it says "And
`Exhibit 2016 describes an anti-TIM-3 antibody."
`Do you see that?
` DR. KAMHOLZ: Objection. Beyond the
`scope of Cross.
` A. I do.
` Q. Was that a mistake?
` DR. KAMHOLZ: Objection. Beyond the
`scope of Cross.
` A. Yes. That was an inadvertent mistake.
`The topic of Exhibit 2016 was the adenosine
`type 2 receptor antagonist.
` Q. Was the anti-TIM-3 antibody referenced
`in Exhibit 2015?
` A. Yes, it was.
` Q. I want to direct your attention to
`
`Page 33
` JONATHAN BRAUN, M.D., Ph.D.
` A. At our medical center, like most
`medical centers, the decisions about diagnosis,
`the creation of the treatment plan and monitoring
`of the patient are not done by a single medical
`individual. They're done by a team of
`complementary medical experts in these different
`areas that I specified.
` I'd also point out that administering of the
`agents is not done by any of those people. It's
`done by yet other members of the team, like
`nurses or technicians in infusion centers and the
`like.
` Q. Now, you said in "creating the
`treatment plan." Does that mean determining what
`regimen to administer to the cancer patient?
` A. That's correct. At these treatment
`planning meetings, the case of an individual
`patient is considered by the team together. The
`options for treatment are proposed and discussed
`together by the members of the team. And the
`choice of what to do is done by consensus.
` Q. And you were involved in these
`meetings; correct?
` A. Correct.
`
`9 (Pages 30 to 33)
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`Page 34
` JONATHAN BRAUN, M.D., Ph.D.
` Q. And in terms of the actual regimen
`which would be approved for each individual
`patient, would the choice of therapeutic
`agents -- what would that choice include in te