UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Before Steven M. Amitrani, Trial Paralegal
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`DECLARATION OF MATTHEW J. SCHURMAN, Ph.D.
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`DEXCOM, INC.
`Petitioner,
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`v.
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`AGAMATRIX, INC.
`Patent Owner
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`IPR2016-01679
`Patent 7,146,202
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`AGAMATRIX, INC.
`Exhibit 2003-1 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Before Steven M. Amitrani, Trial Paralegal
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`DECLARATION OF MATTHEW J. SCHURMAN, Ph.D.
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`DEXCOM, INC.
`Petitioner,
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`v.
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`AGAMATRIX, INC.
`Patent Owner
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`IPR2016-01679
`Patent 7,146,202
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`AGAMATRIX, INC.
`Exhibit 2003-1 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`I.
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`II.
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`Table of Contents
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`IPR2016-01679
`Patent 7,146,202
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`Page
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`Assignment and overview ............................................................................... 1
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`Summary of opinions ....................................................................................... 1
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`III. Qualifications and Experience ......................................................................... 2
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`IV.
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`Information Considered in Forming Opinions ................................................ 3
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`V.
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`Compensation .................................................................................................. 5
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`VI. Person of Ordinary Skill in the Art .................................................................. 5
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`VII. Claim Construction .......................................................................................... 6
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`VIII. Hagiwara does not disclose a structurally flexible core ................................10
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`IX. Differences between Rosenblatt and the ’202 Patent ....................................14
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`A.
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`B.
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`C.
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`The ’202 patent ....................................................................................14
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`Rosenblatt ............................................................................................17
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`Rosenblatt is not a two-layer structure like the one recited in the
`’202 Patent Claims ..............................................................................21
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`X. Analysis of Gross (U.S. Patent No. 6,275,717) .............................................22
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`XI. Concluding Statements ..................................................................................30
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`- i -
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`AGAMATRIX, INC.
`Exhibit 2003-2 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`I.
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`IPR2016-01679
`Patent 7,146,202
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`ASSIGNMENT AND OVERVIEW
`I have been retained by Patent Owner AgaMatrix, Inc. (“AgaMatrix”),
`1.
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`through its counsel, to review and provide opinions in connection with U.S. Patent
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`No. 7,146,202 (“the ’202 patent”) belonging to AgaMatrix, and certain prior art
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`references relied upon by Petitioner Dexcom, Inc., including a translation of
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`Japanese Application No. S57-110236 to Hagiwara (“Hagiwara”), U.S. Patent No.
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`2,719,797 to Rosenblatt (“Rosenblatt”) and U.S. Patent No. 6,275,717 to Gross
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`(“Gross”).
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`II.
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`SUMMARY OF OPINIONS
`As explained more fully in this declaration, in my expert opinion:
`2.
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`a.
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`b.
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`Hagiwara does not disclose a structurally flexible core.
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`Gross discloses a stainless steel sensor core that is rigid and not
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`structurally flexible.
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`c.
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`Rosenblatt discloses a process of platinizing tantalum that
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`forms a three layer composite – (1) platinum on the outer surface; (2) a platinum-
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`tantalum alloy intermediate layer that is not electrochemically active; and (3) a
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`tantalum core. In contrast, the ’202 patent discloses a two layer composite with a
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`structurally flexible core, such as tantalum, covered by an electrochemically active
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`metal, such as platinum.
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`- 1 -
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`AGAMATRIX, INC.
`Exhibit 2003-3 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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` QUALIFICATIONS AND EXPERIENCE III.
`I am a consultant in the areas of material sciences and medical
`3.
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`IPR2016-01679
`Patent 7,146,202
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`devices. I hold a Bachelor of Arts degree in Physics from Franklin and Marshall
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`College and a Ph.D. in materials science and engineering from Rutgers University.
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`4.
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`I have over 20 years of experience in material sciences, and, in
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`particular, metals.
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`5.
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`For the past 7 years, I have consulted on materials selection and
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`performance in the fields of medical devices, particularly in the field of glucose
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`monitoring and insulin delivery, semiconductors, and alternative energy. Much of
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`my medical device work has centered around the interaction of materials and living
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`tissue as this relates to device performance.
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`6.
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`I am currently the managing partner of a specialty engineering firm
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`that develops products, performs contract research, and consults on science and
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`engineering issues in the medical device, semiconductor, space power, and
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`alternative energy industries. Much of our work includes the testing, analysis, and
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`selection of materials such as metals for various applications.
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`7.
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`Prior to being a consultant, I was a founder of GlucoLight
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`Corporation, a non-invasive glucose sensor company. During my time at
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`GlucoLight, I developed several generations of Optical Coherence Tomography
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`based glucose sensors and systems. I co-designed over 12 clinical trials with over
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`- 2 -
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`AGAMATRIX, INC.
`Exhibit 2003-4 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`
`Patent 7,146,202
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`500 subjects for system validation and am named as an inventor on 15 U.S. patents
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`relating to glucose sensors.
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`8.
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`For over a decade I worked in the compound semiconductor field
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`where I developed micro- and nano-scaled semiconductor and metal structures and
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`alloys for high performance optical and electrical devices.
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`9.
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`In the past four years, I have not testified as an expert witness in any
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`lawsuit.
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`10. The full details of my education, employment, and consulting history
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`are in my curriculum vitae, attached hereto as Appendix A.
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`IV.
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`INFORMATION CONSIDERED IN FORMING OPINIONS
`In addition to my considerable experience in material sciences, I
`11.
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`considered the following documents in forming the expert opinions expressed in
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`this declaration:
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`• Ex. 1001 – the ’202 patent;
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`• Ex. 1003 – Gross;
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`• Ex. 1005 – Rosenblatt;
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`• Ex. 1006 – Declaration of David Vachon.
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`• Ex. 1007 – Hagiwara;
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`- 3 -
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`AGAMATRIX, INC.
`Exhibit 2003-5 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`• Ex. 2006 – Availability of Stainless Steel Grades, British
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`Stainless Steel Association, (available at
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`http://www.bssa.org.uk/topics.php?article=684&featured=1)
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`(last accessed Nov. 17, 2016);
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`• Ex. 2007 – Dictionary of Metals. Reference Information
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`Library, added to ASM Handbooks Online: Desk Editions and
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`General References, ASM International, 2013, pp. 5, 16 and 70;
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`• Ex. 2008 – Tantalum – An Overview, Azo Materials, available
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`at http://www.azom.com/properties.aspx?ArticleID=1207) (last
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`accessed September 30, 2016);
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`• Ex. 2009 – Stainless Steel – Grade 316 (UNS S31600), Azo
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`Materials, available at
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`http://www.azom.com/properties.aspx?ArticleID=863 (last
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`accessed September 30, 2016);
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`• Ex. 2010 – D. Wilson and L.A. Carlsson, Mechanical Testing
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`of Fiber-Reinforced Composites, Mechanical Testing and
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`Evaluation, Vol. 8, ASM Handbook, ASM International, 2000,
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`p. 905–932;
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`- 4 -
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`AGAMATRIX, INC.
`Exhibit 2003-6 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`• Ex. 2011 – Richard G. Sass, available at
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`IPR2016-01679
`Patent 7,146,202
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`https://contactwellness.org/?page_id=53 (last accessed
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`December 5, 2016);
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`• Ex. 2012 – W. Kenneth Ward, MD, available at
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`https://contactwellness.org/?page_id=236 (last accessed
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`December 5, 2016);
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`• Ex. 2013 – L.C. Casteletti, A.L. Neto, G.E. Totten, Nitriding of
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`Stainless Steels, Heat Treating of Irons and Steels. Vol
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`4D, ASM Handbook, ASM International, 2014, p 418–438; and
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`• Ex. 2014 – Morris, ed. Academic Press Dictionary of Science
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`and Technology, 1992 by ACADEMIC PRESS, Inc., p. 1357.
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` COMPENSATION V.
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`I am being compensated for my time in this matter at the rate of
`12.
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`$375/hr and I will receive reimbursement for any out-of-pocket expenses incurred
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`in my work on this matter. My compensation does not depend on the outcome of
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`this disputed matter.
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` PERSON OF ORDINARY SKILL IN THE ART VI.
`I have been informed by counsel that construing the claims of a patent
`13.
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`requires identifying the level of skill that would be considered ordinary skill in the
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`art. I understand that, in determining that level of skill, I am to consider six
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`factors: (1) the educational level of the inventor; (2) type of problems encountered
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`- 5 -
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`AGAMATRIX, INC.
`Exhibit 2003-7 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`
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`IPR2016-01679
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`
`Patent 7,146,202
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`in the art; (3) prior art solutions to those problems; (4) rapidity with which
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`innovations are made; (5) sophistication of the technology; and (6) educational
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`level of active workers in the field.
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`14.
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`I am under the understanding that Richard Sass, a co- inventor of
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`the ’202 , has a BA degree in Business Administration.1 Ken Ward, M.D., another
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`co-inventor of the ’202 , has bachelor degrees in chemistry and biology.2
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`15. Considering all of the relevant factors, in my opinion, a person of
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`ordinary skill in the art would have at least a bachelor degree in mechanical
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`engineering, biomedical engineering, chemical engineering, chemistry, or physics
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`and at least 3 years of experience working with biosensors .3
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` CLAIM CONSTRUCTION VII.
`I understand that any opinion I have regarding the meaning of the
`16.
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`terms in the ’202 patent is to be based on the broadest reasonable interpretation. I
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`understand that the broadest reasonable interpretation is the understanding that a
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`person of ordinary skill in the art would reach after reviewing the patent. I also
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`understand that in construing terms, the person of ordinary skill in the art is
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`1 Ex. 2011.
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`2 Ex. 2012.
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`3 I reserve the right to amend or supplement my opinion regarding the level of
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`ordinary skill in the art if additional information is made available to me.
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`- 6 -
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`AGAMATRIX, INC.
`Exhibit 2003-8 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`
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`IPR2016-01679
`
`
`Patent 7,146,202
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`deemed to read the claim term not only in the context of the particular claim in
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`which the disputed term appears, but in the context of the entire patent, including
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`the specification. I also understand that claims are to be construed as of the time of
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`the patent—in this case, circa 2003.
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`17.
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`I have been asked to provide factual information and expert opinions
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`that are relevant to the meaning of the claim term “structurally flexible” recited in
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`independent claim 1 of the ’202 patent.
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`18. The ’202 patent generally claims a method for using a sensor to
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`measure the concentration of an analyte in an animal body having body fluid.
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`19. With respect to the ’202 patent, the most relevant materials property
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`used to describe “structurally flexible” is the ability for the core to be repeatedly
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`flexed without fracturing or breaking.
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`20. The ’202 patent’s Background of the Invention explains the problem:
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`“[w]ith the advent of indwelling wire sensors has come the danger to the patient of
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`having a cylindrical wire sensor fatigue from the flexure caused by bodily
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`movement and break off inside the body.” (Ex. 1001, 1:12-15). The disclosure
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`further explains that “the typical metal used for such a wire sensor is platinum,
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`which is electrochemically active and generally very useful in sensing
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`applications.” (Id., at 1:19-21). “Platinum, however, is a weak metal that is easily
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`broken with only a little flexure.” (Id., at 1:21-23).
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`- 7 -
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`AGAMATRIX, INC.
`Exhibit 2003-9 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`21. The Detailed Description of the Preferred Embodiment describes the
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`preferred embodiment as having a
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`wire core . . . of any structurally robust material, such as
`tantalum, stainless steel or nitinol. Tantalum and nitinol,
`although both fairly expensive, are desirable because
`they are both naturally flexible. This is of particular
`importance if sensing element 12 is to be inserted in a
`patient and worn for a period of days.
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`(Id., at 2:33-39).
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`22. Due to their combination of robustness and natural flexibility,
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`tantalum and nitinol sensor wires are described as being particularly well-suited for
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`withstanding the repeated flexures caused by an ambulatory animal body when
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`worn for a period of days. Thus, despite their relatively high cost, these two
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`“structurally flexible” metals are preferred for such uses.
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`23. One of the key properties of the sensor in the ’202 patent has been
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`identified as the resistance to fatigue and breakage due to repeated flexure. (Ex.
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`1001, 1:11-14). Materials fatigue is defined as:
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`fatigue. The phenomenon leading to fracture under
`repeated or fluctuating stresses having a maximum value
`less than the tensile strength of the material. Fatigue
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`- 8 -
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`AGAMATRIX, INC.
`Exhibit 2003-10 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`fractures are progressive, beginning as minute cracks that
`grow under the action of the fluctuating stress.4
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`24. Dexcom’s expert uses Young’s modulus as a measure of flexibility.
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`Young’s modulus is not relevant to the issue of structural flexibility as that term is
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`used in the ’202 patent. Young’s modulus relates to the amount an object will
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`deform in relation to the amount of force applied to it. For example, rubber bends
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`more than steel when the same force is applied to it. But Young’s modulus does
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`not inform the amount of force necessary for an item to break. The measure of a
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`material’s ability to withstand breakage under transverse or torsional force is
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`known as the “modulus of rupture.” Transverse force in a wire sensor is force
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`applied perpendicular to a length of the sensor; and torsional force is force applied
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`by twisting the wire around its length. The modulus of rupture for transverse force
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`is typically measured using a three point flexural test such as described in the
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`Wilson and Carlsson reference.5 In brief, a metal specimen is supported at each
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`end while a force is applied to the center of the specimen until a crack forms.
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`25. Young’s modulus also does not relate to the ability of an item to
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`withstand breaking or fracturing with repeated stress.
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`4 Ex. 2007, p. 3.
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`5 Ex. 2010, pp. 905–932.
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`- 9 -
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`AGAMATRIX, INC.
`Exhibit 2003-11 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`26. My review of the ’202 patent, its prosecution history, and my
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`knowledge in the art indicates that the term “structurally flexible,” as used in the
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`claims of the ’202 patent, means “a material, such as nitinol or tantalum, that is
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`able to be repeatedly flexed without breaking.”
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`
` HAGIWARA DOES NOT DISCLOSE A STRUCTURALLY VIII.
`FLEXIBLE CORE
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`27. Hagiwara generally discloses the use of heparin as an anticoagulant on
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`polarography sensors that are used intravenously in animals. The sensor has a wire
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`made of a single precious metal, such as platinum or gold. (Ex. 1007, p. 3).
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`Hagiwara includes a brief reference to plating (or vapor depositing) a precious
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`metal on the front end of a base metal instead. (Ex. 1007, p. 7). This does not
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`disclose the use of a structurally flexible core metal. Base metal is a generic term
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`that has a variety of different definitions.6 For example, in relation to the art of
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`plating metals, it used to describe the metal to which the plating is applied. It can
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`6 Base metal. (1) The metal present in the largest proportion in an alloy; brass, for
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`example, is a copper-base alloy. (2) The metal to be brazed, cut, soldered, or
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`welded. (3) After welding, that part of the metal which was not melted. (4) A metal
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`that readily oxidizes, or that dissolves to form ions. Contrast with noble metal (2).
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`(Ex. 2007, p. 2).
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`- 10 -
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`AGAMATRIX, INC.
`Exhibit 2003-12 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`
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`IPR2016-01679
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`
`Patent 7,146,202
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`include rigid metals such as iron and titanium, or any metal (including alloys), for
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`that matter.
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`28. Hagiwara discloses a single embodiment, FIG. 1(B), that it asserts is
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`“flexible.” That embodiment is approximately four feet long (1200 mm) and has
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`“a flexible tube 8 made of Teflon, silicon, or the like.” (Id., p. 6).
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`29. The wire is small in relation to the overall sensor (the sensor has a
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`diameter of up to 2mm). As a result, the Hagiwara sensor wire only has to
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`conform to any flexing of the surrounding insulation and tube, which provide the
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`structural integrity of the sensor. The wire itself has little stress placed on it. This
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`is a very different configuration from the analyte sensor disclosed and claimed in
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`the ’202 patent, in which the structurally flexible core is large relative to the sensor
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`as a whole, and supplies the chief source of structural integrity for the sensor.
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`Unlike Hagiwara, which is not designed for use in ambulatory patients, the
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`structural flexible core of the ’202 patent bears most of the stress caused by bodily
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`movements of the ambulatory patient.
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`30. Hagiwara states “most of this polarography sensor is flexible and can
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`thus be inserted deep (for example to the heart) along the inside of a vein.” (Ex.
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`1007, p. 6).
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`- 11 -
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`AGAMATRIX, INC.
`Exhibit 2003-13 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`31. Dexcom suggests that, because the FIG. 1(B) embodiment “is
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`required to be flexible,” the central wire must be “structurally flexible.” (Petition,
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`p. 34). But, as I explain in paragraphs 19-23 and 26, “structurally flexible” in the
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`context of the ’202 patent refers to a robust wire that can be repeatedly flexed
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`without breaking when inserted into a patient for a number of days. In contrast,
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`Hagiwara appears to use the term “flexible” in a general sense (perhaps relating to
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`a low Young’s modulus), and does not describe a core metal that is “structurally
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`flexible” as that term is used in the ’202 patent.
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`32. More specifically, Hagiwara FIG. 1(B) is a device used for short-term
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`procedures, such as for measuring oxygen levels in the hearts of sedated animals.
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`It is not designed to be worn in an active, ambulatory body for an extended period.
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`The considerations for the types of materials used for short-term intravenous
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`applications like Hagiwara FIG. 1(B) are different from the considerations for
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`constructing an indwelling device that is lodged beneath the skin, and the
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`requirements regarding its ability to “flex” are dramatically different.
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`33. When routing a device through the vasculature, as in the case of
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`Hagiwara, it is important that the device be able to bend easily without much force.
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`This is in part because the physician pushes the wire from the proximal end into
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`the vasculature, often through a catheter that has been placed in the vasculature in
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`- 12 -
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`AGAMATRIX, INC.
`Exhibit 2003-14 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`advance.7 As the sensor moves through the vasculature, various forces, including
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`torsional forces, are asserted on the wire. If too much force is required to bend the
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`device around the corners of the arteries or veins, it may cause damage to the
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`vasculature. But breakage with repeated use is not a concern because intravascular
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`sensor wires generally are not used for multiple procedures. Therefore, breakage
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`over time and with extended use is not a concern. And with Hagiwara’s wire, the
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`substantial outer tube and insulation layer provide adequate protection against
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`breakage.
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`34. Moreover, the outer portion of Hagiwara can be made of a soft,
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`smooth polymer, such as Teflon, and is designed to move easily through catheters
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`or the vasculature.
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`35. On the other hand, when inserting a very thin indwelling device into
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`soft tissue under the skin, where it is to be worn for an extended period of time, it
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`is less important that the device be capable of bending with little force. The ’202
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`patent describes a sensor that, when placed under the skin of an ambulatory patient,
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`is subject to transverse forces as the body moves. As explained in the patent, it is
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`more important that it be robust and able to be repeatedly flexed without breaking.
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`7 Hagiwara used a catheter when testing his sensor.
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`- 13 -
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`AGAMATRIX, INC.
`Exhibit 2003-15 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`IPR2016-01679
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`Patent 7,146,202
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`36. A person of ordinary skill in the art would understand that these
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`applications are substantially different, and that the forces applied for these
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`applications, and the stresses on the wire, are also very different.
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`37. Therefore, merely describing something as “flexible” does not
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`disclose whether it is “structurally flexible” as that term is used in the ’202 patent,
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`and Hagiwara does not disclose a sensor that has a “structurally flexible” core.
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`
` DIFFERENCES BETWEEN ROSENBLATT AND THE ’202 PATENT IX.
`A. The ’202 patent
`38. Claim 1 of the ’202 Patent recites the following:
`
`1. A method for measuring the concentration of an
`analyte within an animal body having body fluids,
`comprising:
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`(a) providing a sensor having:
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`(i) a structurally flexible core having an outer surface;
`and
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`(ii) a layer of electrochemically active metal
`surrounding, covering, and in contact with said outer
`surface of said core;
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`(b) placing at least a portion of said sensor into said
`animal body; and
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`- 14 -
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`AGAMATRIX, INC.
`Exhibit 2003-16 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
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`(c) measuring any electric current produced by said
`sensor and forming a measurement of analyte
`concentration based on said current measurement.
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`IPR2016-01679
`Patent 7,146,202
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`39. The ’202 patent therefore recites a two-layer sensor wire having a
`
`“structurally flexible core” and an “electrochemically active metal” that
`
`“surround[s], cover[s], and [is] in contact with” the outer surface of the core. The
`
`’202 patent provides five different processes that can be used for cladding an
`
`electrochemically active metal directly onto a core: a “drawn filled tube” process,
`
`electroplating, mechanical cladding, plasma vapor deposition, and sputtering. (Ex.
`
`1001, 2:47-3:39).
`
`40. An example of a sensor design disclosed in the ’202 patent can be
`
`seen in FIG. 1 (reproduced below, with colors added). Item 24 (brown) is the
`
`structurally flexible core, and item 26 (silver) is the electrochemically active metal
`
`that is in contact with the core:
`
`- 15 -
`
`AGAMATRIX, INC.
`Exhibit 2003-17 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`
`
`
`IPR2016-01679
`Patent 7,146,202
`
`
`
`41. A tantalum wire core is structurally flexible. It is described as both
`
`robust and naturally flexible in the ’202 patent (id., 2:34-38), and it is recited in
`
`claim 5 of that patent as a specific type of structurally flexible core material.
`
`Platinum is an electrochemically active metal. (Id., 1:42-44). Therefore, a cross-
`
`section of a sensor using these two metals as the core and electrochemically active
`
`metal cladding, respectively, would take the following general configuration:
`
`platinum
`
`tantalum
`
`- 16 -
`
`
`
`AGAMATRIX, INC.
`Exhibit 2003-18 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`
`
`
`IPR2016-01679
`Patent 7,146,202
`
`
`
`B. Rosenblatt
`42. Rosenblatt describes a process “to produce platinized tantalum for use
`
`as non-corroding anodes in electrochemical processes.” (Ex. 1005, 1:21-23).
`
`Contrary to the description of Rosenblatt in Dexcom’s Petition, Rosenblatt does
`
`not disclose an electrochemical sensor, or a sensor of any kind. Instead, it
`
`discloses a method for making a conductive electrode for use in chemical synthesis
`
`processes. (Ex. 1005, 2:29-32). In my opinion, a person of ordinary skill in the art
`
`of implantable analyte sensors would not look to Rosenblatt as a relevant prior art
`
`reference.
`
`43.
`
`In the background section, Rosenblatt explains that there are several
`
`drawbacks to plating platinum directly to tantalum:
`
`It has been suggested that coating with a platinum metal
`be accomplished by such methods as electrolysis,
`hammering, welding, rolling, and-the like; however, none
`of these methods have been found to be satisfactory.
`They do not produce a coat of platinum metal which
`adheres with sufficient tenacity to the tantalum base that
`
`- 17 -
`
`AGAMATRIX, INC.
`Exhibit 2003-19 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`IPR2016-01679
`
`Patent 7,146,202
`
`the coated tantalum metal will be commercially suited for
`use as an anode
`in electrochemical processes.
`Electroplating of a platinum metal onto a tantalum base
`results in a coating that may easily be stripped from the
`base. Attempts to cover the tantalum strip with a
`platinum metal foil and to hold the metals together as by
`sweating, rolling or hammering, have proved to be
`unsatisfactory because the platinum metal foil is held to
`the tantalum only by mechanical contact which is not
`sufficient to permit of its use as an anode. The coats of
`platinum metal that have been made by any of these
`processes are not truly bonded to the tantalum, i.e. the
`tantalum is not platinized in the sense that the platinum
`metal is united with the tantalum by atomic attraction
`forces . . .
`
`(Id., 2:1-21).
`
`44. Rosenblatt purports to solve the problems created by plating platinum
`
`on tantalum by describing a method of first creating an alloy on the surface of the
`
`tantalum. As Rosenblatt states, “it is desirable, . . . to coat the tantalum base [such
`
`that] the platinum metal film . . . will be firmly bonded to the tantalum base by the
`
`formation of a thin layer of platinum-tantalum alloy.” (Id., 4:46-51). Starting with
`
`tantalum, the alloy is formed on the surface of the tantalum by applying a coat of
`
`platinum and causing “the platinum and tantalum metals to interdiffuse and
`
`become alloyed.” (Id., 4:22-24). The alloy therefore coats the tantalum core,
`
`- 18 -
`
`AGAMATRIX, INC.
`Exhibit 2003-20 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`IPR2016-01679
`
`
`Patent 7,146,202
`
`
`creating an intervening layer on the tantalum. The platinum surface is then bonded
`
`to the outer surface of the alloy, rather than the outer surface of the tantalum base
`
`itself.
`
`45. The Rosenblatt process requires the following series of steps:
`
`• “The tantalum base is preferably washed as with carbon tetrachloride
`and acetone.” (Ex. 1005, 2:71 – 3:1).
`• “The surface of the tantalum metal is then cleaned and roughened ....”
`(Id., 3:1-3).
`• “The cleaned and roughened tantalum is then dipped into or otherwise
`coated with a solution of, e.g., chloroplatinic acid (H2PtCl6), which
`has been dissolved in a suitable volatile solvent.” (Id., 3:8-12).
`• “After dipping the tantalum into this solution, the excess solution is
`removed and the solvent is evaporated off at a relatively slow [sic]
`temperature.” (Id., 3:19-22).
`• “The coated tantalum is then heated above the decomposition
`temperature (approximately 250° C.) of the chloroplatinic acid.” (Id.,
`3:22-24).
`• “[The t]antlum strips . . . are placed into a cold furnace.” (Id., 3:67-
`69).
`• “The furnace is evacuated to about 10-4 mm. of mercury and is then
`heated to a temperature . . . [of] 800° C. to 1400° C. . . .” (Id., 3:69-
`74).
`• “After the bonding temperature has been maintained for
`approximately 15 minutes, the heating is discontinued, and when the
`
`- 19 -
`
`AGAMATRIX, INC.
`Exhibit 2003-21 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`IPR2016-01679
`
`Patent 7,146,202
`
`temperature in the furnace has substantially dropped the evacuation is
`stopped and the coated tantalum is removed.” (Id., 4:1-5).
`• “The secondary coat [of platinum] may be applied in several separate
`layers and between the periods of the deposition of these several
`layers, the metals may be subjected to bonding treatment.” (Id., 5:30-
`33).
`46. The result is a three-metal structure, with tantalum at the core, an
`
`alloy coated on the tantalum, and platinum on the outside, as depicted in the
`
`platinum
`platinum-tantalum alloy
`
`tantalum
`
`figures below:
`
`
`
`
`
`- 20 -
`
`AGAMATRIX, INC.
`Exhibit 2003-22 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`IPR2016-01679
`
`Patent 7,146,202
`
`47. Each of the three layers is a different metal with different properties.
`
`For example, in materials sciences, in addition to the metal elements, an alloy,
`
`which is a metallically bonded atomic lattice, is a distinct “metal.”8
`
`48. Here, the platinum-tantalum alloy is a separate metal from either the
`
`platinum or the tantalum to which it is bonded, and it has unique characteristics.
`
`For example, unlike pure platinum, a platinum-tantalum alloy is not an
`
`electrochemically active metal since it will form an oxide that will passivate (i.e.
`
`electrically insulate) the surface.
`
`C. Rosenblatt is not a two-layer structure like the one recited in the
`’202 Patent Claims
`49. As explained above, Rosenblatt uses three metals. It does not disclose
`
`a layer of electrochemically active metal surrounding, covering, and in contact
`
`with an outer surface of a structurally flexible core, as recited in the ’202 patent.
`
`The electrochemically active metal platinum does not contact the tantalum core.
`
`And the alloy layer, which continuously and completely surrounds, covers, and
`
`contacts the tantalum core, is not electrochemically active.
`
`
`8 See Ex. 2014, defining “metal” as (in addition to the metallic elements), “ an
`
`alloy or mixture that is composed of metals.” See also Ex. 2007, p. 1 (“Alloy: A
`
`substance having metallic properties and being composed of two or more chemical
`
`elements of which at least one is a metal.”)
`
`- 21 -
`
`AGAMATRIX, INC.
`Exhibit 2003-23 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
` ANALYSIS OF GROSS (U.S. PATENT NO. 6,275,717) X.
`
`
`
`
`50. Gross concerns a sensor that can be self-calibrated when inserted into
`
`IPR2016-01679
`Patent 7,146,202
`
`the body. As stated in the Background of the Invention Section of Gross, “It is
`
`thus an object of the present invention to provide a quick and accurate method of in
`
`vivo calibration of an analyte sensor.” (Ex. 1003, 1:56-58). In particular, the
`
`inventors describe a method of electrical pulse measurements to compensate for
`
`the sensor degradation and drift when the sensor is placed in tissue.
`
`51. Referring to Gross’s Fig. 1A (reproduced below):
`
`The sensor has a needle electrode (15) which is inserted into the skin and coated
`
`with a glucose oxidase enzyme with two electrodes placed on either side (16 and
`
`
`
`17).
`
`52. As illustrated in Fig. 3 (reproduced below), the needle is 300 microns
`
`in diameter (d) and 5 mm in length (l). (Id., 10:54-59).
`
`- 22 -
`
`AGAMATRIX, INC.
`Exhibit 2003-24 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`
`
`
`IPR2016-01679
`Patent 7,146,202
`
`
`
`53. As can be seen in Fig. 13 (reproduced below), the needle (15) is
`
`designed to puncture the skin of the subject. However, only a portion of the needle
`
`enters the skin. When depressed, a portion of the needle remains outside of the
`
`skin, between portions of the housing (14).
`
`54.
`
`I understand that Dexcom and Dr. Vachon assert that Gross’s stainless
`
`steel needle is a “structurally flexible core.” I do not agree with that assertion.
`
`
`
`- 23 -
`
`AGAMATRIX, INC.
`Exhibit 2003-25 (IPR2016-01679)
`Dexcom, Inc. v. AgaMatrix, Inc.
`
`
`
`
`
`
`IPR2016-01679
`
`Patent 7,146,202
`
`55. Gross provides no indication of the type of stainless steel used.
`
`“Stainless steel” is not a single material or element, but rather is a term used to
`
`describe a variety of iron (Fe) alloys formulated for their superior strength and
`
`corrosion resistance over base Fe. The different “stainless steel” alloys use varying
`
`amounts of different metals and other elements, including chromium, nickel,
`
`titanium, aluminum, molybdenum, nobium, silicon, nitrogen, vanadium, copper,
`
`tungsten, manganese, cerium, sulfur, and/or boron. There ar
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