UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`
`HOLOGIC, INC.,
`Petitioner
`
`
`
`v.
`
`
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner
`
`__________________
`
`
`
`Case IPR2016-00820
`
`U.S. Patent No. 7,064,197
`TITLE: SYSTEM, ARRAY AND NON-POROUS SOLID SUPPORT
`COMPRISING FIXED OR IMMOBILIZED NUCLEIC ACIDS
`Issue Date: June 20, 2006
`
`__________________
`
`DECLARATION OF BARRY W. WEINER
`
`
`
`
`
`
`
`Enzo Exhibit 2043
`BD v. Enzo
`Case IPR2017-00172
`
`Exhibit 2043 Page 1
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`
`HOLOGIC, INC.,
`Petitioner
`
`
`
`v.
`
`
`
`ENZO LIFE SCIENCES, INC.,
`Patent Owner
`
`__________________
`
`
`
`Case IPR2016-00820
`
`U.S. Patent No. 7,064,197
`TITLE: SYSTEM, ARRAY AND NON-POROUS SOLID SUPPORT
`COMPRISING FIXED OR IMMOBILIZED NUCLEIC ACIDS
`Issue Date: June 20, 2006
`
`__________________
`
`DECLARATION OF BARRY W. WEINER
`
`
`
`
`
`
`
`Enzo Exhibit 2043
`BD v. Enzo
`Case IPR2017-00172
`
`Exhibit 2043 Page 1
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`
`
`
`I, Barry W. Weiner, a resident of New York, New York over 18 years of
`
`age, hereby declare as follows:
`
`
`1.
`
`I have personal knowledge of all of the matters about which I testify
`
`in this declaration.
`
`
`2.
`
`I am currently a Vice President of Enzo Life Sciences, Inc. (“Enzo”)
`
`and have been the President of its parent company, Enzo Biochem, Inc., since
`
`1996. From 1976 until 1996 I was a Vice President of Enzo Biochem, Inc. As
`
`Vice President, I was responsible for managing the operations of Enzo, and I was
`
`aware of Enzo’s program to develop technologies involving nucleic acid
`
`hybridization and detection using non-porous solid supports in the early 1980s.
`
`
`3.
`
`During the period spanning January of 1982 to September of 1982, I
`
`was knowledgeable about the research and development activities of Enzo
`
`scientists Dollie Kirtikar, Ph.D., Barbara Thalenfeld, Ph.D., Elazar Rabbani, Ph.D.,
`
`Jannis Stavrianopoulos, Ph.D., and Kenneth Johnston, Ph.D.—the co-inventors
`
`identified on U.S. Patent No. 7,064,197 (“the ‘197 Patent”). I will hereinafter refer
`
`to those particular scientists collectively as “the Co-Inventors”. During that period,
`
`Dr. Rabbani was Chief Executive Officer of Enzo Biochem and each of the other
`
`Co-Inventors was an employee of Enzo Biochem.
`
`
`4.
`
`From January of 1982 to September of 1982, the Co-Inventors
`
`conducted research and development activities related to nucleic acid hybridization
`
`
`
`Exhibit 2043 Page 2
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`
`
`
`and detection in Enzo Biochem’s facility located at 325 Hudson Street, New York,
`
`New York, 10113. Among the research and development activities conducted by
`
`the Co-Inventors were efforts to develop technologies involving nucleic acid
`
`hybridization and detection using non-porous solid supports. Those efforts
`
`resulted in the inventions that are now claimed in the ‘197 Patent.
`
`
`5.
`
`During the period from January of 1982 to September of 1982, it was
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`the regular practice of all Enzo scientists to keep laboratory notebooks that
`
`recorded the procedures and results of the experiments they performed. Each entry
`
`in those laboratory notebooks was made at or near the time of the experiment and
`
`was recorded by the Enzo scientists performing or overseeing the experiment.
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`Each entry in those laboratory notebooks was made in the course of Enzo’s
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`regularly conducted activities, namely research and development of nucleic acid
`
`technologies.
`
`
`6.
`
`The Co-Inventors followed this regular practice of recording their
`
`research and development activities regarding nucleic acid hybridization and
`
`detection technology using non-porous solid supports (that led to the inventions of
`
`the ‘197 Patent) in laboratory notebooks and other documents. Among those
`
`laboratory notebooks and other documents are Exhibits 2035 and 2037-2041
`
`attached to this Declaration.
`
`
`
`Exhibit 2043 Page 3
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`7.
`
`
`
`
`
`
`Since at least January 1982, Enzo has maintained the laboratory
`
`notebooks of Enzo scientists in the ordinary course of business, storing those
`
`laboratory notebooks at Enzo facilities.
`
`
`8.
`
`Exhibits 2035 and 2037-2041 are documents, including lab notebooks
`
`of certain Co-Inventors, that were created in 1982 and stored at either Enzo’s
`
`facilities or its counsel’s office since that time. Those exhibits were provided to
`
`Enzo’s counsel in connection with an on-going litigation regarding the ‘197 Patent
`
`in approximately August of 2013.
`
`
`9.
`
`Exhibit 2035 is true and correct copy of “Invention Record and Report
`
`for the ‘469 Application” made by Barbara Thalenfeld and Kenneth Johnston, who
`
`had knowledge of the research and development activities described therein, at or
`
`near the time those activities took place in February through May of 1982. Exhibit
`
`2035 is an invention record and report kept by Enzo in the ordinary course of
`
`regularly conducted research and development activities. The preparation of
`
`Exhibit 2035 was a regular practice of Enzo and its scientists in connection with
`
`regularly conducted research and development activities.
`
` Exhibit 2037 is true and correct copy of a laboratory notebook made
`10.
`
`by Dollie Kirtikar, who had knowledge of the experiments described therein, at or
`
`near the time those experiments took place in May through August of 1982.
`
`Exhibit 2037 contains Dollie Kirtikar’s laboratory notebook records which were
`
`
`
`Exhibit 2043 Page 4
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`
`
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`recorded in a binder entitled “T4 Expts” behind a tab entitled “Lectin Binding to t4
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`DNA.” Exhibit 2037 contains laboratory notebook records kept by Enzo in the
`
`ordinary course of regularly conducted research and development activities. The
`
`preparation of Exhibit 2037 was a regular practice of Enzo and its scientists in
`
`connection with regularly conducted research and development activities.
`
` Some of the pages of Exhibit 2037 included records that were folded
`11.
`
`or stapled to the handwritten pages. In order to provide a full view of the
`
`information contained on each page, multiple copies of these pages are provided so
`
`that all data and information can be observed.
`
` Exhibit 2038 is true and correct copy of a laboratory notebook made
`12.
`
`by Barbara Thalenfeld, who had knowledge of the experiments described therein,
`
`at or near the time those experiments took place in July through August of 1982.
`
`Exhibit 2038 contains laboratory notebook records kept by Enzo in the ordinary
`
`course of regularly conducted research and development activities.
`
` The
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`preparation of Exhibit 2038 was a regular practice of Enzo and its scientists in
`
`connection with regularly conducted research and development activities.
`
` Some of the pages of Exhibit 2038 included records that were folded
`13.
`
`or stapled to the handwritten pages. In order to provide a full view of the
`
`information contained on each page, multiple copies of these pages are provided so
`
`that all data and information can be observed. See e.g. Exhibit 2038 at 10-12.
`
`
`
`Exhibit 2043 Page 5
`
`
`
`Case IPR2016-00820
`
`U.S. Patent No. 7,064,197
`
`
` Exhibit 2039 is true and correct copy of a laboratory notebook made
`14.
`
`by Barbara Thalenfeld, who had knowledge of the experiments described therein,
`
`at or near the time those experiments took place in July through September of
`
`1982. Exhibit 2039 contains laboratory notebook records kept by Enzo in the
`
`ordinary course of regularly conducted research and development activities. The
`
`preparation of Exhibit 2039 was a regular practice of Enzo and its scientists in
`
`connection with regularly conducted research and development activities.
`
` Some of the pages of Exhibit 2039 included records that were folded
`15.
`
`or stapled to the handwritten pages. In order to provide a full view of the
`
`information contained on each page, multiple copies of these pages are provided so
`
`that all data and information can be observed. See e.g. Exhibit 2039 at 5-7.
`
` Exhibit 2040 is true and correct copy of a document prepared by
`16.
`
`Barbara Thalenfeld and Kenneth Johnston, who both had knowledge of the
`
`experiments described therein, at or near the time those experiments took place in
`
`June of 1982. Exhibit 2040 contains experiment records kept by Enzo in the
`
`ordinary course of regularly conducted research and development activities. The
`
`preparation of Exhibit 2040 was a regular practice of Enzo and its scientists in
`
`connection with regularly conducted research and development activities.
`
` Exhibit 2041 is true and correct copy of photocopies of a laboratory
`17.
`
`notebook prepared by Barbara Thalenfeld, who had knowledge of the experiments
`
`
`
`Exhibit 2043 Page 6
`
`
`
`Case IPR2016-00820
`U.S. Patent No. 7,064,197
`
`
`
`
`
`
`described therein, at or near the time those experiments took place in May through
`
`September of 1982. Each page of Exhibit 2041 was signed or initialed by Barbara
`
`Thalenfeld and Kenneth Johnson after the copy was made. Exhibit 2041 contains
`
`laboratory notebook records kept by Enzo in the ordinary course of regularly
`
`conducted research and development activities. The preparation of Exhibit 2041
`
`was a regular practice of Enzo and its scientists in connection with regularly
`
`conducted research and development activities.
`
`
`
`I hereby declare that all statements made herein of my knowledge are true
`
`and that all statements made on information and belief are believed to be true, and
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`further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code.
`
`
`
`January 11, 2017
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`_______________________
`
`Date
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`/s/ Barry W. Weiner
`
`_______________________
`
`BARRY W. WEINER
`
`
`
`Exhibit 2043 Page 7
`
`
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