`Leland Stanford Junior University
`
`Paper __
`
`By: R. Danny Huntington, Lead Counsel
`Sharon E. Crane, Ph.D., Backup Counsel
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Telephone: 202-783-6040
`Facsimile: 202-783-6031
`E-mail: dhuntington@rfem.com
`scrane@rfem.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SEQUENOM, INC.
`Petitioner,
`
`v.
`
`THE BOARD OF TRUSTEES OF
`THE LELAND STANFORD JUNIOR UNIVERSITY
`Patent Owner.
`
`Case IPR2013-00390
`Patent 8,195,415
`
`DECLARATION OF YAIR BLUMENFELD, M.D
`
`1
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`STANFORD EXHIBIT 2134
`SEQUENOM v. STANFORD
`CASE IPR2013-00390
`
`
`
`
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`
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`The undersigned, Yair Blumenfeld, M.D., does hereby declare and
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`state that:
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`1.
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`I make the following declaration based upon my knowledge and
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`belief.
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`2.
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`I am currently an Assistant Professor of Obstetrics and
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`Gynecology (Maternal Fetal Medicine) at the Stanford University Medical
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`Center.
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`3.
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`In 2008, I was a fellow in the Department of Obstetrics and
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`Gynecology (Maternal Fetal Medicine) at the Stanford University Medical
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`Center.
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`4.
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`I have been asked to testify about events associated with
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`providing blood samples to Christina Fan and Stephen Quake related to their
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`performing experiments to non-invasively diagnose fetal aneuploidy by
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`quantifying DNA fragments in the blood of a pregnant patient, which DNA
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`fragments can be aligned to particular chromosomes, and certain of which
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`exist at an elevated level when the fetus is aneuploid, and my role as a co-
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`author on a paper we published on that collaboration.
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`5.
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`I have reviewed Exhibits 2103-2108, 2111, 2112, 2127, 2129,
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`and 2131, which I understand are being submitted in this patent interference
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`2
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`proceeding, and they refresh my recollection as to those events and the dates
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`on which they occurred.
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`6.
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`Toward the end of 2006 and through 2008, I collaborated with
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`Stephen Quake and Christina Fan to provide them with patient blood
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`samples for optimizing their fetal aneuploidy diagnosis test. (Ex. 2103,
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`2104, 2106). I prepared the necessary protocol and consent forms for the
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`Institutional Review Board (“IRB”) in order to collect the samples from
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`patients. (Ex. 2105, 2107, 2108). The IRB consent listed Dr. Usha
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`Chitkara, Dr. Louanne Hudgins, Dr. Quake and me.
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`7.
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`Throughout these studies and through the time we submitted
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`our paper entitled “Noninvasive prenatal diagnosis of fetal chromosomal
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`aneuploidy by massively parallel genomic sequencing of DNA in maternal
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`plasma” (Proc. Natl. Acad. Sci. USA 105(51):20458-20643 [2008]; Ex.
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`1036]), on which I was a coauthor with Drs. Quake, Fan, Chitkara and
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`Hudgins, I corresponded by email with Drs. Quake and Fan to keep updated
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`on the progress of their research.
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`8.
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`On May 28, 2008, Christina Fan sent a graph of the preliminary
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`analysis of a full sequencing run to Dr. Quake and me, which included four
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`trisomy 21 samples and three normal samples. She noted that we should
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`3
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`“pay attention to the distribution of chr21,” and I responded that the results
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`were “awesome.” (Ex. 2127).
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`9.
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`On June 19, 2008, Dr. Fan sent to Stephen Quake and me a
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`“rough draft of the non-invasive study,” (Ex. 2111, 2113) which was based
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`on their first Solexa sequencing run and was to be submitted to the journal
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`Proceedings of the National Academy of Sciences, USA, which ultimately
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`published as the article “Noninvasive diagnosis of fetal aneuploidy by
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`shotgun sequencing DNA from maternal blood,” Proc. Natl. Acad. Sci. USA
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`(2008) 105(42):16266-16271 (“first draft of the PNAS manuscript”; Ex.
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`2113). I was listed as an author on that paper, along with Christina Fan,
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`Usha Chitkara, Louanne Hudgins and Stephen Quake.
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`10. On July 1, Dr. Fan sent a graph including new data points (3
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`Down syndrome [P2, P7, P14] and 2 normal males [P19, P31]) to Dr. Quake
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`and me. (Ex. 2129).
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`11. On July 7, 2008, Drs. Quake, Fan and I discussed revisions to
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`the PNAS manuscript. (Ex. 2112, 2131).
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`12. The PNAS manuscript was received for review on July 13,
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`2008, communicated on August 22, 2008, and published on October 21,
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`2008. (Ex. 1036).
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`4
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`13.
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`In signing this declaration, I understand that the declaration will
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`be filed as evidence in a contested case before the Patent Trial and Appeal
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`Board of the United States Patent and Trademark Office. I acknowledge that
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`I may be subject to cross-examination in the case and that cross-examination
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`will take place within the United States. If cross-examination is required of
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`me, I will appear for cross-examination within the United States during the
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`time allotted for cross-examination.
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`14.
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`I declare that all statements made herein of my own knowledge
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`are true and that all statements made on information and belief are believed
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`to be true. I also declare that these statements were made with the
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`knowledge that willful false statements and the like so made are punishable
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`by fme or imprisonment, or both, under Section 1 00 1 of Title 18 of the
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`United States Code and that such willful false statements may jeopardize the
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`validity of the application or any patent issued thereon.
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`v{UtA __ (lf~
`
`Yair Blumenfeld, M.D.
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`Date
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`5