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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` GENOME AND COMPANY
` Petitioner,
` v.
` THE UNIVERSITY OF CHICAGO
` Patent Owner.
`
` Case PGR2019-XX
` U.S. Patent No. 9,855,302 B2
`
` DEPOSITION OF JONATHAN BRAUN, M.D., Ph.D.
` Washington, D.C.
` June 19, 2019
`
`Job No. 162380
`Reported by: Linda S. Kinkade RDR CRR RMR RPR CSR
`
`TSG Reporting - Worldwide 877-702-9580
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`Page 3
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`A P P E A R A N C E S:
`
` Covington & Burling
` On Behalf of Patent Owner
` BY: Scott Kamholz, M.D., Ph.D., Esq.
` BY: Jennifer Robbins, Ph.D., Esq.
` 850 Tenth Street, NW
` Washington, DC 20001
`
` Mintz, Levin, Cohn, Ferris, Glovsky and
` Popeo
` On Behalf of Petitioner
` BY: John Bauer, Esq.
` 666 Third Avenue
` New York, New York 10017
`
` Mintz, Levin, Cohn, Ferris, Glovsky and
` Popeo
` On Behalf of Petitioner
` BY: Kongsik Kim, Esq.
` One Financial Center
` Boston, Massachusetts 02111
`
`Page 5
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` J. BRAUN
` P R O C E E D I N G S
` THE REPORTER: Would counsel state their
`appearances for the record, please.
` MR. BAUER: John Bauer for In re Genome.
` MR. KIM: Kongsik Kim from Mintz Levin.
` DR. KAMHOLZ: Scott Kamholz for Patent
`Owner, The University of Chicago.
` MS. ROBBINS: Jennifer Robbins for
`University of Chicago.
` JONATHAN BRAUN, M.D., Ph.D.,
` having been first duly sworn, was thereafter
`examined and testified as follows:
` EXAMINATION
`BY DR. KAMHOLZ:
` Q. Your name is Jonathan Braun?
` A. Yes.
` Q. You reside in or around Los Angeles,
`California?
` A. Yes.
` Q. You recently retired from the University
`of California at Los Angeles?
` A. Correct.
` Q. You're now affiliated with Cedars-Sinai in
`Los Angeles?
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`Page 2
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` Wednesday, June 19, 2019
` 9:10 a.m.
`
` The following is the transcript of the
`deposition of JONATHAN BRAUN, M.D., Ph.D. held at the
`offices of Covington & Burling LLP, One CityCenter,
`850 Tenth Street, NW, Washington, DC 20001, and
`reported by Linda S. Kinkade, RDR, CRR, RMR, RPR,
`CSR, and Notary Public within and for the District of
`Columbia.
`
`Page 4
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` INDEX OF EXAMINATION
`
`EXAMINATION OF JONATHAN BRAUN, M.D., Ph.D. PAGE
` BY DR. KAMHOLZ 5
` BY MR. BAUER 90
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`Page 6
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` J. BRAUN
` A. Cedars-Sinai Medical Center.
` Q. You understand I'm questioning you about
`your expert testimony in the post-grant proceeding
`PGR2019-00002, Genome and Company vs. The University
`of Chicago?
` A. Yes.
` DR. KAMHOLZ: I'm handing the witness a
`copy of a document previously marked Exhibit 1002 in
`this proceeding.
` (Exhibit 1002 previously
` marked for identification and
` referenced herein: Declaration of
` Jonathan Braun, M.D., Ph.D. in
` Support of Petition for Post Grant
` Review of U.S. Patent No. 9,855,302)
` Q. This is your expert declaration in this
`proceeding?
` A. Yes.
` Q. There's no reason you can't give truthful
`and complete testimony today?
` A. That's a double negative. Could you state
`that again, please?
` Q. There's no reason that you could not give
`truthful and complete testimony today?
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`Page 8
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` J. BRAUN
`understood the question. Understood?
` A. Understood.
` Q. And you'll wait until I finish asking a
`question before you answer it, so the court reporter
`can follow us?
` A. I will.
` Q. Counsel for Petitioner may make
`objections, but you must still answer my questions
`unless I withdraw the question or if counsel
`instructs you not to answer. Understood?
` A. I understand.
` Q. The Patent Office rules prohibit you from
`having conversations about the substance of your
`testimony today with anyone other than me once the
`deposition has started, and that has already started.
`Do you understand?
` A. I understand.
` Q. You may not talk with counsel for
`Petitioner concerning the substance of your testimony
`until the deposition is entirely over at the end of
`the day. Understood?
` A. I understand.
` Q. I recommend that during breaks you go
`someplace else away from the rest of us until the
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` J. BRAUN
` A. No, there's no reason that I cannot give
`truthful testimony.
` Q. You're an inventor on one or more U.S.
`patents?
` A. Yes.
` Q. But you've never been deposed before in a
`patent case?
` A. Correct.
` Q. And you've never given testimony before in
`a patent case?
` A. Correct.
` Q. You understand that you must answer
`questions truthfully and to the best of your ability?
` A. Yes.
` Q. If you don't understand a question, tell
`me, and I'll try to rephrase it. Okay?
` A. (Nodding head up and down.)
` Q. Okay?
` A. Okay.
` Q. Please make sure that you speak your
`answers so that the court reporter can record them.
`Okay?
` A. Okay.
` Q. If you answer a question, it means you
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`Page 9
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` J. BRAUN
`deposition is over. That's the easiest way to
`comply.
` MR. BAUER: Object to that. The witness
`is not going to talk to counsel during breaks. He
`can be with counsel during his breaks.
` Q. Please tell me if you need a break but not
`while a question is pending. All right?
` A. Okay.
` Q. Finally, if a situation arises where the
`lawyers need to resolve an issue, I may ask you to
`step out of the room until the issue is resolved, and
`then we'll invite you back in. Understood?
` A. Understood.
` Q. All right.
` DR. KAMHOLZ: I'm giving the witness a
`copy of a document previously marked Exhibit 1004 in
`this proceeding.
` (Exhibit 1004 previously
` marked for identification and
` referenced herein: Carcinogenesis
` Vol. 18 Singh | Re Bifidobacterium
` longum)
` Q. Do you recognize this as the Singh paper
`you cite?
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`Page 10
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` J. BRAUN
` A. Yes, I do.
` Q. I'll direct your attention to page 834 of
`this document, which corresponds to Exhibit 2 -- I'm
`sorry -- Exhibit page 2 out of 9. That's page 834 of
`Exhibit 1004. Are you there?
` A. Yes, I am.
` Q. Do you see in the right-hand column of
`that page the heading "Experimental Procedure"?
` A. Yes.
` Q. Now Singh fed rats Bifidobacterium longum
`in their diet, correct?
` A. I see a statement that groups of animals
`were fed the modified AIN 76-A diet containing 0 (for
`controls) 2 percent lyophilized B. longum cultures.
` Q. Singh fed rats Bifidobacterium longum in
`their diet.
` A. I just read what I see.
` Q. Dr. Braun, Singh fed rats Bifidobacterium
`longum in their diet, correct?
` A. Yes.
` Q. And later he injected them with
`azoxymethane, abbreviated AOM?
` A. Yes.
` Q. In the left-hand column of that page,
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`Page 12
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` J. BRAUN
` A. That's what's stated in this article -- in
`this paragraph.
` Q. Turn back to page 837, please. That's
`page 5 of 9 of this exhibit. In the right-hand
`column under the Discussion heading, Singh proposes
`that Bifidobacterium longum inhibits cecal
`beta-glucuronidase, correct?
` A. Yes, I read that they make that statement
`from a prior paper that they had reported.
` Q. It's known that beta-glucuronidase
`bioactivates MAM.
` A. I don't recall that etymology.
` Q. Well, you've held yourself out as an
`expert in this field. Do you know or do you not know
`that beta-glucuronidase bioactivates MAM?
` MR. BAUER: Objection.
` A. That's a particular biochemical detail.
` Q. Dimethylhydrazine, abbreviated DMH, is a
`precursor of AOM, correct?
` A. I don't recall.
` Q. You hold yourself out as an expert in the
`field, but you don't know whether dimethylhydrazine
`is a precursor of AOM?
` MR. BAUER: Objection, argumentative.
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` J. BRAUN
`about six lines up from the bottom, it says there
`Singh injected AOM to induce colon tumor genesis,
`correct?
` A. Yes.
` Q. AOM is a carcinogen.
` A. Correct.
` Q. AOM goes through a series of chemical
`changes to produce the ultimate carcinogen, right?
` A. Probably.
` Q. AOM is converted to methylazoxymethanol,
`abbreviated MAM.
` A. I don't recall the pharmacology of AOM.
` Q. Turn to page 838 of this exhibit, 1004.
`That's Exhibit page 6 of 9. In the right-hand
`column, lines 18 to 20, AOM goes through a series of
`chemical changes to produce the ultimate carcinogen,
`correct?
` A. Yes.
` Q. AOM is converted to methylazoxymethanol,
`abbreviated MAM.
` A. That's what's stated in this document.
` Q. And AOM is converted ultimately to
`methyldiazonium ion, which is referred to as the
`ultimate carcinogen.
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` J. BRAUN
` A. There are many carcinogens with sequences
`of their biochemistry. You're asking me a very
`narrow factual question. I would need to refresh
`myself from the literature to confidently answer that
`question.
` Q. Do you have any reason to doubt that
`dimethylhydrazine is a precursor of AOM?
` A. I don't know. I would have to read --
`refresh myself on the literature of that
`pharmacology.
` Q. Turn back to page 838 of Exhibit 1004.
`That's Exhibit page 6 of 9. In the left column, the
`first full paragraph, Singh says the mechanism of
`Bifidobacterium longum inhibition of AOM-induced
`colon cancer is not clear, correct?
` A. Correct.
` Q. Singh proposes several possible
`mechanisms, however, correct?
` A. Correct.
` Q. For example, Singh proposes pH changes
`that may affect resident flora.
` A. That's one stated mechanism in this
`article.
` Q. And continuing on to the right column of
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` J. BRAUN
`that page, around line 10 or so, Singh proposes that
`a possible mechanism of Bifidobacterium longum
`inhibition of AOM-induced colon cancer is modulation
`of microbacterial fecal enzymes that convert the
`procarcinogen, right?
` A. Correct.
` Q. And going down a little further around
`line 15, Singh proposes as a possible mechanism of
`Bifidobacterium longum inhibition of AOM-induced
`colon cancer the cellular uptake of carcinogen
`metabolites, correct?
` A. Correct.
` Q. And continuing down to around line 27,
`Singh proposes a possible mechanism of
`Bifidobacterium longum inhibition of AOM-induced
`colon cancer being that the lactic cultures bind to
`MAM, thereby minimizing its reabsorption, correct?
` A. Correct.
` Q. And continuing down to line 33, Singh
`proposes as a possible mechanism of Bifidobacterium
`longum inhibition of AOM-induced colon cancer to be
`that it affects cytochrome P450 activity, correct?
` A. Correct.
` Q. Singh says that all these proposed
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` J. BRAUN
`tumor themselves, correct?
` A. Correct.
` Q. They're directed against the carcinogen.
` A. No. At least one of them, the last one,
`cites an immunomodulator role.
` Q. The possible mechanisms that we discussed
`are all directed to the carcinogen.
` A. The examples that you called out before
`were examples that relate to metabolizing the
`carcinogen.
` Q. And Singh does not rule out any of these
`possible mechanisms, these anticarcinogen properties.
` A. Correct.
` Q. Go back to the first page of this exhibit,
`please, page 1 of 9. In the abstract, the last
`sentence says, quote, "data suggests that oral
`administration of probiotic B. longum exerts strong
`antitumor activity," correct?
` A. Yes.
` Q. Singh says that the data suggests this,
`correct?
` A. Correct.
` Q. Please go to Exhibit 1002, your
`declaration, page 55 of 186. I'm referring to the
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` J. BRAUN
`mechanisms are possible explanations of his results,
`right?
` A. Correct.
` Q. And Singh says that these antitumor
`mechanisms are actually anticarcinogen properties,
`correct?
` A. Well, the end of that paragraph states
`that Bifido induces an antitumor effect and plays an
`important role as an immunomodulator in the
`intestines.
` Q. Turn to page 833 of this exhibit, which is
`page 1 out of 9. In the right column, starting at
`about line 11, Singh explains that these lactic
`cultures have been shown to possess anticarcinogenic
`properties, among other things, correct?
` A. Correct.
` Q. Now going back to page 838, which is page
`6 of 9 of this exhibit, you agreed that Singh
`identifies a number of several possible mechanisms of
`Bifidobacterium longum inhibition of AOM-induced
`colon cancer a moment ago.
` A. Yes.
` Q. Each of these mechanisms that we discussed
`that Singh proposes are not directed against the
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` J. BRAUN
`page numbers in the lower right-hand corner.
` In paragraph 122 of your declaration you quote
`that sentence from Singh's abstract.
` A. Correct.
` Q. But you left out the words "data
`suggests."
` A. Those are not part of the quote that I
`used.
` Q. You left out the words "data suggests."
` A. Correct.
` Q. Instead you say, quote, "Singh, et al.
`showed," unquote, correct?
` A. Correct.
` Q. Singh didn't say "showed"; Singh said
`"suggests."
` A. It's the normal understanding of readers
`of such articles that in the peer-review process
`words like "suggest" are used as a -- as a manner of
`speaking and not a -- and not a qualifier in the
`sense that you imply.
` Q. Singh didn't say "show"; Singh said
`"suggests."
` A. Correct.
` Q. So the declaration deceptively misquotes
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` J. BRAUN
`Singh.
` MR. BAUER: Objection.
` A. The declaration reflects what an ordinary
`reading of the article would construe.
` Q. You didn't explain that in your
`declaration, though.
` A. My declaration is a declaration from the
`standpoint of one with an ordinary understanding of
`the -- of the art.
` Q. Singh proposed a number of mechanisms to
`explain his observations.
` A. Yes.
` Q. He didn't prove that any of them was the
`cause of his observations. He couldn't rule any of
`them out.
` A. Correct.
` Q. He could not rule out any of the several
`mechanisms by which Bifidobacterium longum acted to
`prevent the chemical activation or delivery of the
`carcinogen.
` A. He noted that there are many potential
`mechanisms by which it might act.
` Q. So he couldn't rule out any of those
`possible mechanisms, most of which were directed
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` J. BRAUN
` Carcinogenesis)
` Q. Do you recognize this as the Reddy paper
`you cited?
` A. Yes.
` Q. Now the Reddy -- and Reddy is the same
`person who is senior author in Singh.
` A. Most likely.
` Q. Most likely. In the same laboratory?
` A. He has the same name and from the same
`laboratory.
` Q. So it's the same Reddy studying
`carcinogen-induced cancer.
` A. Probably.
` Q. But this time it's imidazo quinoline (IQ)
`he's studying instead of AOM.
` A. Correct.
` Q. Turn to page 3917, which is Exhibit page 4
`out of 5. In the left column, first full
`paragraph -- excuse me, the second full paragraph --
`close to the bottom of the column, Reddy says the
`exact mechanisms by which the cultures of B. longum
`inhibit IQ-induced carcinogenesis in the target
`organs are not understood at present, correct?
` A. Correct.
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` J. BRAUN
`against the carcinogen, and yet you conclude that he
`showed that Bifidobacterium has strong antitumor
`activity.
` A. An ordinary understanding of antitumor
`activity is that it reduces the amount of tumor,
`which has occurred in the animal bearing the tumor.
` Q. But Singh can't conclude whether that
`antitumor activity was directed against the tumor or
`against the carcinogen.
` A. In my statements of 122 I quote the
`antitumor effect activity. I didn't specify which
`mechanism of antitumor activity was at play.
` Q. Singh can't conclude whether that
`antitumor activity was directed against the tumor or
`against the carcinogen, correct?
` A. Correct.
` DR. KAMHOLZ: I'm giving the witness a
`copy of an exhibit previously marked 1040 in this
`proceeding.
` (Exhibit 1040 previously
` marked for identification and
` referenced herein: Reddy |
` Inhibitory Effect of Bifidobacterium
` longum on Colon, Mammary, and Liver
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` J. BRAUN
` Q. Reddy again proposes possible mechanisms,
`correct?
` A. To which mechanisms are you referring?
` Q. Well, look in that column across, roughly
`across from reference 19. Reddy proposes that
`inhibition of beta-glucuronidase decreases production
`of active metabolites of IQ.
` A. Correct.
` Q. And then if you look a little further
`down, across from reference 21, Reddy proposes that
`Bifidobacterium longum binds IQ, so that it is
`eliminated in the feces rather than being reabsorbed.
` A. Correct.
` Q. So, again, the mechanisms that Reddy
`proposes are not directed against the tumors.
` A. The primary mechanism in this paper is
`cancer inhibition, so that is one level of mechanism.
`He also -- and that's the findings presented in this
`paper.
` Q. Reddy proposes as a mechanism by which
`Bifidobacterium longum acts is by inhibition of
`beta-glucuronidase decreasing production of active
`metabolites. You agreed.
` A. No, he doesn't propose that. He lists
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` J. BRAUN
`that as a potential mechanism.
` Q. He says, it is, therefore, possible that a
`similar decrease in the beta-glucuronidase activity
`in the colon due to B. longum, a lactic bacillus, may
`result in the decreased production of active
`metabolites of IQ.
` A. That was a scholarly speculation.
` Q. He proposes that as a mechanism.
` A. His paper only addresses the effect of the
`agent as -- as an inhibitor of tumor growth.
` Q. Dr. Braun, he proposes that as a
`mechanism.
` MR. BAUER: Can you keep your voice down?
` A. He speculates that as a potential
`explanation for the finding in the paper.
` Q. And he also proposes as a mechanism that
`Bifidobacterium binds IQ.
` A. Correct.
` Q. And these mechanisms are directed against
`IQ, not against the tumor.
` A. Correct.
` Q. Turn back to page 3914, please, the first
`page of Exhibit 1040 in the abstract. The last
`sentence of the abstract says, quote, "these findings
`
`Page 24
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` J. BRAUN
`because he couldn't rule out the other possible
`causes.
` A. My statement didn't speak to the mechanism
`of the antitumor effect.
` Q. Reddy proposed a number of possible
`explanations for the data he observed but could not
`rule out any of them as the cause of the results he
`observed.
` MR. BAUER: Objection, asked and answered.
` Go ahead. You can still answer.
` A. Correct.
` DR. KAMHOLZ: I'm giving the witness a
`copy of an exhibit previously marked 1011 in this
`proceeding.
` (Exhibit 1011 previously
` marked for identification and
` referenced herein: BMC Cancer |
` Anti-proliferative effects of
` Bifidobacterium adolescentis SPM0212
` extract on human colon cancer cell
` lines)
` Q. Do you recognize this as the Lee paper you
`cited?
` A. Yes, I do.
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` J. BRAUN
`suggest that Bifidobacterium supplements in the diet
`inhibit IQ-induced colon and liver tumors and, to a
`lesser extent, mammary tumors in F344 rats," right?
` A. Correct.
` Q. Turn to your declaration, Exhibit 1002,
`page 54. In paragraph 121 of your declaration you
`testified that Reddy, et al. showed the inhibitory
`effect of Bifidobacterium longum on IQ-induced
`carcinogenesis.
` A. Yes.
` Q. But, again, you left out the words "these
`findings suggest."
` A. An ordinary reading of this paper -- my
`statement reflects an ordinary reading of this paper.
`The terminology "these findings suggest" is the
`social parlance of writing scientific articles.
` Q. But Reddy didn't show that one of the
`possible mechanisms he identified was the cause of
`his observations because he could not rule out the
`other possibilities.
` A. You're talking about mechanism, not
`whether the agent had an antitumor effect.
` Q. He could not show that one proposed
`mechanism was the cause of his observed results
`
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` J. BRAUN
` Q. Turn to your declaration, Exhibit 1002, to
`page 55 of 186. In paragraph 123 you testify that an
`n-butanol extracted sample had the effects Lee
`observed.
` A. Yes.
` Q. You don't testify that Bifidobacterium
`adolescentis had the observed effects.
` A. Correct.
` Q. Only that the n-butanol extracted sample
`had the effects.
` A. In section 123 I stated that the n-butanol
`sample had suppressive activity.
` Q. Turn to page 3 of 8 of Exhibit 1011,
`please. In the left-hand column Lee explains that an
`XTT assay was used.
` A. Yes.
` Q. You've never used an XTT assay in your
`published work.
` A. I don't recall. I've used a closely
`related MTT assay.
` Q. Now Lee explains that the control was
`simply tumor cells without butanol extract.
` A. The control for what?
` Q. About six lines down in that paragraph
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` J. BRAUN
`headed "Tumor Cell Proliferation by XTT Assay," Lee
`says, "control was only cells (no treated)."
` A. Correct.
` Q. So Lee's control was simply tumor cells
`without butanol extract.
` A. That's what's stated.
` Q. Lee does not identify what in the butanol
`extract caused the observed effect.
` A. What do you mean by "what"?
` Q. The only difference between the test and
`the control was the presence of the n-butanol
`extract.
` A. Correct.
` Q. And Lee does not report the contents of
`the n-butanol extract.
` A. In page 2 of that reference, under
`"Preparation of B. adolescentis SPM0212 Extract," he
`describes how the extract was made.
` Q. Lee does not report the contents of the
`n-butanol extract.
` A. Well, he describes that it was the -- an
`extraction process, and, hence, the contents are what
`was extracted in his process.
` Q. Dr. Braun, Lee does not identify the
`
`Page 28
`
` J. BRAUN
` A. Yes, I am.
` Q. Turn to page 4 of 8 of this exhibit.
`Fig. 1 reports effects of growth inhibition by
`B. adolescentis, correct?
` A. Tell me again the page and location?
` Q. Page 4 of 8, Fig. 1 reports effects of
`growth inhibition by B. adolescentis.
` A. B. adolescentis SPM0212.
` Q. And Fig. 2 reports effects of B.
`adolescentis SPM0212?
` A. Correct.
` Q. And Fig. 3 reports effects of
`B. adolescentis SPM0212.
` A. Correct.
` Q. And Fig. 4 on page 5 reports
`characterization of B. adolescentis SPM0212.
` A. Correct.
` Q. And none of those figures report any data
`for any other species.
` A. Correct.
` Q. So Lee has no control with bacteria other
`than Bifidobacterium adolescentis.
` A. There are many meanings of the word
`"control." What's your meaning?
`
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` J. BRAUN
`contents of the n-butanol extract.
` A. I've just responded to your question.
` Q. Turn to page 6 of Exhibit 1011. In the
`right-hand column, a few lines above the "Conclusion"
`heading, Lee says, "further studies are needed to
`identify the effective component in the extract."
` A. Correct.
` Q. Lee reports no studies in this paper with
`bacteria other than Bifidobacterium adolescentis.
` A. In the section on bacterial culture, at
`the -- in the first paragraph he describes fecal
`samples from 20 healthy individuals that were placed
`on selective BL agar and grown under anaerobic
`conditions.
` He then goes on to state that, in the second
`paragraph, which starts with fructose-6-phosphate
`phosphoketolase, that he selected colonies and
`further characterized them by 16S and species level.
`He doesn't indicate how.
` So that would indicate to me that at least
`part of this study included work with Bifidobacterium
`that was not -- was not fully specified in this
`paper.
` Q. You're familiar with 16S rRNA sequencing?
`
`Page 29
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` J. BRAUN
` Q. What's your meaning?
` A. As I say, there are many meanings of
`control depending on the particular experiment.
` Q. Well, all of the experiments reported in
`these figures do not report any data for any species
`other than Bifidobacterium adolescentis, correct?
` A. Correct.
` Q. Lee does not report results from any of
`the other extract fractions.
` A. Correct.
` Q. Lee reports no results of the XTT assay
`from any wavelength other than 490 nanometers.
` A. That's a nonsensical comment.
` Q. Turn back to page 3 of 8. In the left
`column, the section heading "Tumor Cell Proliferation
`by XTT Assay," at the very end of that section, the
`samples were measured with an ELISA reader at 490
`nanometers.
` A. Your implied critique of that wavelength
`is nonsensical to me.
` Q. I'm simply asking you to confirm that Lee
`reports no measurements at any wavelength other than
`490 nanometers.
` A. The tetrazolium growth assay measures a
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` J. BRAUN
`product which changes metabolically by a living cell.
`That product can be detected at a particular
`wavelength, which they have indicated there.
` So it would not make sense to test -- to use
`the XTT assay at a wavelength besides the one that
`they report.
` Q. Lee measures only at 490 nanometers.
` MR. BAUER: Objection, asked and answered.
` A. That's the wavelength that you use to
`detect the oxidized tetrazolium molecule.
` Q. And there's no measurement reported of a
`cell-free preparation for baseline.
` A. That's a nonsensical comment based on the
`nature of this assay.
` Q. Well, four lines up from the bottom of
`that section Lee says, "the butanol extract (no
`cells) was not tested."
` A. That's what the sentence says.
` Q. And Lee reports no correction for
`background absorbance.
` A. This is a very common assay, and there are
`ways to set up the measurement, which are obvious to
`anybody who uses it. So it's not surprising to me
`that the full details of how the experiment -- how
`
`Page 32
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` J. BRAUN
`wavelengths.
` Q. Turn to page 55 of your declaration,
`Exhibit 1002. Sorry. I withdraw that.
` DR. KAMHOLZ: I'm giving the witness a
`copy of an exhibit previously marked 1008 in this
`proceeding.
` (Exhibit 1008 previously
` marked for identification and
` referenced herein: Mohania |
` Modulation of expression of
` Programmed Death-1 by administration
` of probiotic Dahi in DMH-induced
` colorectal carcinogenesis in rats)
` Q. Do you recognize this as the Mohania paper
`you cited?
` A. Yes.
` Q. Do you see from the title Mohania is
`reporting on DMH-induced colorectal carcinogenesis in
`rats?
` A. Yes.
` Q. And DMH is the abbreviation for
`1,2-dimethylhydrazine?
` A. Correct.
` DR. KAMHOLZ: I'd like to take a 15-minute
`
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` J. BRAUN
`the measurement was made was not elaborated here.
` Q. You agree Lee reports no correction for
`background absorbance.
` A. An ordinary scientist reading this would
`presume that, that the background -- that the assay
`was set up in an appropriate manner for this
`technology.
` Q. You didn't testify to that in your
`declaration.
` A. Testify to what?
` Q. What you just said.
` A. I didn't make a declaration on the
`performance of an XTT assay, on the technology of
`performing an XTT assay, no, I didn't.
` Q. Lee -- I'm sorry.
` A. I'm done.
` Q. Lee reports no correction for absorbance
`at 630 nanometers.
` MR. BAUER: That's about the fifth time
`you've asked that question.
` A. I have no more comments to make about --
` MR. BAUER: You can -- please answer.
`Please answer. Please answer the question.
` A. He doesn't report measuring at other
`
`Page 33
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` J. BRAUN
`recess.
` (Proceedings recessed at 10:08 a.m.)
` (In session at 10:26 a.m.)
` DR. KAMHOLZ: I'm giving the witness an
`exhibit that we will mark 2010.
` (Exhibit 2010 marked for
` identification: Megaraj | Role of
` Hepatic and Intestinal P450 Enzymes
` in the Metabolic Activation of the
` Colon Carcinogen Azoxymethane in
` Mice)
` Q. Please look on the cover page of this
`exhibit, 2010. Do you see in the introduction
`section this paper states:
` "Azoxymethane (AOM) and its
` metabolic precursor,
` 1,2-dimethylhydrazine (DMH), are
` commonly used carcinogens to study
` the molecular mechanisms of colon
` carcinogenesis in rodents"?
` A. Yes.
` Q. Thank you. Please turn back to Exhibit
`1008. As we discussed earlier, Mohania reports
`studies conducted in DMH-induced colorectal
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` J. BRAUN
`carcinogenesis in rats.
` A. Correct.
` Q. And as discussed in Exhibit 2010, DMH is a
`precursor to AOM.
` A. Yes.
` Q. DMH is metabolized to AOM, which then
`follows the same metabolic pathways describ