BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ILLUMINA, INC.
`
`Petitioner
`
`v.
`
`THE SCRIPPS RESEARCH INSTITUTE
`
`Patent Owner
`
`Case IPR2016-01619
`
`Patent 6,060,596
`
`PATENT OWNER THE SCRIPPS RESEARCH INSTITUTE
`
`DECLARATION OF DONALD MONTGOMERY, PHD
`
`
`
`1
`
`
`
`
`
`
`
`ILLUMINA, INC.
`
`Petitioner
`
`v.
`
`THE SCRIPPS RESEARCH INSTITUTE
`
`Patent Owner
`
`Case IPR2016-01619
`
`Patent 6,060,596
`
`PATENT OWNER THE SCRIPPS RESEARCH INSTITUTE
`
`DECLARATION OF DONALD MONTGOMERY, PHD
`
`
`
`1
`
`
`
`
`
`
`
`I, Donald Montgomery, declare as follows:
`
`
`
`1.
`
`I am currently the President of Nanomaterials Discovery Corporation,
`
`aka NDCPower, in Seattle Washington and Cheyenne, Wyoming. I received my
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`AB degree in chemistry at Grinnell College in 1984, a Ph.D. degree in chemistry
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`from Caltech in 1990 and was a post-doctoral fellow in physics at The Joint
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`Institute for Laboratory Astrophysics, a joint institute between the University of
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`Colorado (Boulder) and the National Institute for Standards and Technology for
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`three years. I began my industry career as a scientist at Nanogen in San Diego in
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`1994. I founded a genetic analysis DNA microarray company called CombiMatrix
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`in 1996 to make oligonucleotides on electrode array solid phases using local
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`electrochemical reactions. CombiMatrix was founded based on my inventions to
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`synthesize oligonucleotides and other linear polymers on solid supports, I am not
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`being compensated for my time spent reviewing documents and preparing this
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`statement because it is part of my exchanging my efforts for legal work being
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`performed for NDCPower by counsel for Patent Owner, Jeff Oster. I do not receive
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`any compensation or consideration depending on the outcome of this proceeding or
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`a concurrent litigation proceeding involving a TSRI patent.
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`
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`2.
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`I have reviewed (a) Dower et al. patent (Ex. 1008), (b) the Petition; (c)
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`the Stoltz Declaration (Ex. 1007) paragraphs 14 through 15 regarding a person of
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`ordinary skill in the art (POSA) in 1992; (d) Stoltz Declaration (Ex. 1007)
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`
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`2
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`
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`paragraphs 103-122 regarding what Dr. Stoltz alleges a person of ordinary skill in
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`the art familiar with Dower et al. (such as me) and Needels et al. (Ex. 2008) could
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`or would have done or have been motivated to do. Based upon my experiences
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`synthesizing bifunctional molecules and linear polymers at CombiMatrix in the
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`later 1990’s, I did not believe that switching to a solution based combinatorial
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`screening (such as the system described in Brenner and Lerner Ex. 2001, which
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`was published in June 1992) would provide any advantages over Dower/Affymax
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`with a solid phase screening. Therefore, the speculation by Dr. Stoltz in Ex. 1007
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`paragraphs 103-122 does not reflect my first-hand experience of doing
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`combinatorial screening with any preference to solution-based screening.
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`
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`3.
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`I have reviewed the ‘596 patent specification and claims for the
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`purposes of determining what I think is meant by the term “linker molecule” or the
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`B component of the A-B-C structure in claim 1. Based on my review of the entire
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`specification, it is clear to me that the specification distinguishes polymers, such as
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`oligonucleotides and peptides that are made from multiple repeating units or
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`“mers,” from its use of the term “molecule.” A molecule is a defined chemical
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`structure. As a person who was actively working in the field of combinatorial
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`chemical synthesis in the 1990’s, I did not consider a solid phase bead structure as
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`a linker molecule.
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`
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`3
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`
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`4.
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`As is shown in Dower (Ex. 1008), Dower/Affymax accomplished
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`combinatorial screening after a biological assay by using a FACS cell sorter to
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`segregate beads with bound antibodies. There was no need and no suggestion that
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`Dower would or should replace its solid phase method with a soluble bifunctional
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`molecular linker for soluble combinatorial screening.
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`
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`5.
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`The passage in Needels et al. (Ex. 2006) acknowledging the Brenner
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`and Lerner publication (Ex. 2001) and what it provides in the form of a
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`bifunctional molecule for soluble combinatorial screening does not indicate, in my
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`opinion, that it is obvious over the solid phase bead with two polymers attached in
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`Dower and Needels et al. (Ex. 2006). Because, for example, the assays used for
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`combinatorial screening for solid phase or for solution are materially different.
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`
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`6.
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`I read the file history of the priority patent application of the ‘596
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`patent family (Ex. 2003) and found a restriction requirement indicating that the
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`method to synthesize the bifunctional molecule and the bifunctional molecule
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`composition were restricted into separately patentable inventions. The applicants
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`did not fight this restriction requirement.
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`
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`7.
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`I have reviewed Nielson et al. (Ex. 2005) that showed, in my opinion,
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`that the Nelson linker molecule did not work well because the amino acid addition
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`was not efficient. Based on these findings, the authors speculated that the reason
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`was due to steric hindrance.
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`
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`4
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`
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`8.
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`I declare that all statements made herein of my knowledge are true,
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`and that all statements made on information and belief are believed to be true, and
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`
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`By:
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`
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`
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`Donald Montgomery, Ph.D.
`
`5
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`
`
`Dated: 21 November 2016
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