Paper No. 11
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`
`
`ARAGEN BIOSCIENCE, INC.,
`AND
`TRANSPOSAGEN BIOPHARMACEUTICALS, INC.,
`
`Petitioners,
`
`v.
`
`KYOWA HAKKO KIRIN CO., LTD.
`Patent Owner
`
`Patent No. 6,946,292
`Issued: September 20, 2005
`Filed: October 9, 2001
`Inventors: Yutaka Kanda, Mitsuo Satoh, Kazuyasu Nakamura, Kazuhisa Uchida,
`Toyohide Shinkawa, Naoko Yamane, Emi Hosaka, Kazuya Yamano, Motoo
`Yamasaki, Nobuo Hanai
`Title: Cells Producing Antibody Compositions with Increased Antibody Dependent
`Cytotoxic Activity
`
`_____________________________
`
`Inter Partes Review No.: IPR2017-01252
`
`
`PETITIONERS’ SUPPLEMENTAL PAPER
`REGARDING EXPERT TESTIMONY OF DR. BRIAN VAN NESS
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`
`
`ARAGEN BIOSCIENCE, INC.,
`AND
`TRANSPOSAGEN BIOPHARMACEUTICALS, INC.,
`
`Petitioners,
`
`v.
`
`KYOWA HAKKO KIRIN CO., LTD.
`Patent Owner
`
`Patent No. 6,946,292
`Issued: September 20, 2005
`Filed: October 9, 2001
`Inventors: Yutaka Kanda, Mitsuo Satoh, Kazuyasu Nakamura, Kazuhisa Uchida,
`Toyohide Shinkawa, Naoko Yamane, Emi Hosaka, Kazuya Yamano, Motoo
`Yamasaki, Nobuo Hanai
`Title: Cells Producing Antibody Compositions with Increased Antibody Dependent
`Cytotoxic Activity
`
`_____________________________
`
`Inter Partes Review No.: IPR2017-01252
`
`
`PETITIONERS’ SUPPLEMENTAL PAPER
`REGARDING EXPERT TESTIMONY OF DR. BRIAN VAN NESS
`
`
`
`
`
`
`Petitioners respectfully refer the Board to the below transcript citations from
`
`Dr. Brian Van Ness’ June 22, 2017 District Court deposition (Ex. 1037).
`
`I.
`
`A.
`
`TESTIMONY CONCERNING TEACHINGS OF PETITIONERS’
`CITED REFERENCES1
`
`Testimony Regarding Rothman (Ex. 1002): Ex. 1037 at 185:9-187:24
`
`Q. And do you recall a line of questioning earlier in the day, Mr. Platt
`asked you to review [Rothman] and whether certain words were used
`in the reference?
`A. Correct.
`Q. Do you recall Mr. Platt asking you, for instance, whether the words
`“alpha-1,6-fucosyltransferase” were present in [Rothman]?
`A. Yes, I remember that.
`Q. And whether the words “FUT8” were present in [Rothman]?
`A. I was asked that as well.
`Q. Are there specific words such as "fucosyltransferase activity",
`“knockout”?
`A. I was asked those as well.
`Q. Also words “deleting a gene” or “mutating a gene”?
`A. I was asked if this paper, those – whether those terms were present
`as well.
`Q. Whether or not those exact words are set forth explicitly in this
`reference, does that influence your opinion as to whether or not the
`claims at issue in this case are obvious?
`
`
`1 To guide the Board’s review, Petitioner has quoted herein select language found
`within the cited transcript excerpts. The quotations omit objections.
`
`
`
`2
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`
`
`A. So let me explain that in the sense of how I came to the conclusion
`that the claims were obvious. The terms that were asked of me were
`not in the paper, but one skilled in the art reads multiple papers. And
`in order to apply the standards of obviousness, the question before me
`was: If one looked at papers that described FUT8 as a gene for
`fucosyltransferase, if one looked at the function of fucosyltransferase
`as an enzyme that puts a fucose on a sugar molecule on an antibody, if
`one looked at publications that describe the fact that fucose interferes
`with ADCC function and if you removed that fucose, you can improve
`ADCC function, all of those papers – in no one paper did all of that
`information occur in one place, but that information was distributed
`through papers that one skilled in the art would have been aware of,
`all of those prior to October of 2000, such that is would have rendered
`the claims that were being made obvious, in my opinion.
`Q. So for instance, the absence of the explicit language “alpha-1,6-
`fucosyltransferase”, that does not impact your overall obviousness
`analysis, correct?
`A. Not at all. Put another way, I can point to lots of papers where
`those words are not used and it does no impact.
`
`B. Testimony Regarding Harris (Ex. 1003): Ex. 1037 at 192:24-194:19
`
`Q. And whether or not any of those exact terms are set forth in
`[Harris], does that affect your obviousness analysis?
`A. Not at all.
`Q. Why not?
`A. Because there are other publications where fucosyltransferase is
`described, its activity is described, its clones and sequence are
`
`
`
`3
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`described, its impact on ADCC is described. So there are other papers
`that describe those activities. The choice of these particular papers
`were -- have no impact on -- on the fact that there is plenty of
`literature out there that would have made the attempts, the ideas, and
`methodologies in each of these patents obvious.
`Q. So the specific claim language terms – for instance, alpha-1,6-
`fucosyltransferase, how would -- how would you believe that to be
`obvious in something like this when it doesn't necessarily explicitly
`set forth that word?
`A. There is, within these manuscripts, approaches and -- and
`discussion about the impact of sugars on antibody structure and
`function. So one who is skilled in the art could easily put together the
`fact that as this paper is discussing the importance of sugars and the
`like and some of these other papers, that you would start building a
`repertoire of information that support the obvious conclusion that if I
`knock out and – and get rid of fucose on an antibody, I will improve
`ADCC function. So again, I think this is a conglomerate of all of the
`pieces of these papers put together, despite the fact that these
`particular papers don’t use the words.
`
`C. Testimony Regarding Umaña (Ex. 1004): Ex. 1037 at 194:20-196:8
`
`Q. Whether or not the series of specific words that Mr. Platt asked you
`about, whether or not those are present explicitly in [Umaña], does
`that affect your obviousness analysis?
`A. It does not. In fact, in this one, they say things like there are certain
`generalities that can be made about the importance of sugars, and so
`this alerts and informs one skilled in the art that these are important
`
`
`
`4
`
`
`
`components that can be modified to improve ADCC activity. So it
`does not effect -- the lack of those terms in this document do not --
`does not affect my opinion on obviousness.
`
`D. Testimony Regarding Malý (Ex. 1005): Ex. 1037 at 196:11-197:17
`
`Q. And whether or not any of those exact words that Mr. Platt asked
`you about, whether or not those are explicitly set forth in [Malý], does
`that affect your obviousness analysis?
`A. It does -- it does not, no.
`Q. Why not?
`A. Because again, there is sufficient information among many papers
`about methodologies, about the importance of fucosyltransferase, and
`specifically alpha-1,6 in other publications that would lead one to
`understand that the claims that are put forward in the patents were
`obvious to anyone skilled in the art.
`
`II. TESTIMONY CONCERNING DR. VAN NESS’ CREDENTIALS
`
`
`Ex. 1037 at 172:6-174:14
`
`See also Ex. 1037 at 29:24-30:25, 46:25-49:6, 114:22-121:22, 179:21-181:9
`
`III. PETITIONERS’ OBJECTIONS TO THE SCOPE OF QUESTIONING
`
`Ex. 1037 at 93:14-94:7,197:18-198:13
`
`See also Ex. 1037 at 138:14-21, 155:23-156:2
`
`IV. TESTIMONY CONCERNING CLAIM ELEMENTS
`
`
`Ex. 1037 at 58:23-59:17, 122:8-23, 124:19-127:2
`
`
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`5
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`Date: August 18, 2017
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`RESPECTFULLY SUBMITTED,
`ROBINS KAPLAN LLP
`
`
`
`/s/ Bryan J. Vogel
`Bryan J. Vogel (Reg. No. 44,389)
`399 Park Avenue, Suite 3600
`New York, NY 10022
`212.980.7400
`bvogel@robinskaplan.com
`
`Attorney for Petitioners
`Aragen Bioscience, Inc. and Transposagen
`Biopharmaceuticals, Inc.
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4)(i), the undersigned certifies that on
`
`August 18, 2017 a copy of the foregoing PETITIONERS’ SUPPLEMENTAL
`
`PAPER REGARDING EXPERT TESTIMONY OF DR. BRIAN VAN NESS was
`
`served via electronic mail on Patent Owner’s counsel at the following addresses
`
`indicated in the Patent Owner’s Mandatory Notices.
`
`Anthony M. Insogna
`Jones Day
`Email: aminsogna@jonesday.com
`
`S. Christian Platt
`Jones Day
`Email: cplatt@jonesday.com
`
`Astrid R. Spain
`Jones Day
`Email: arspain@jonesday.com
`
`
`
`
`/s/ Bryan J. Vogel
`Bryan J. Vogel (Reg. No. 44,389)
`399 Park Avenue, Suite 3600
`New York, NY 10022
`212.980.7400
`bvogel@robinskaplan.com
`
`Attorney for Petitioners
`Aragen Bioscience, Inc. and Transposagen
`Biopharmaceuticals, Inc.
`
`7
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`Date: August 18, 2017
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