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