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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`REACTIVE SURFACES LTD., LLP,
`Petitioner,
`
`v.
`
`TOYOTA MOTOR CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2016-01914
`Patent 8,394,618
`
`
`
`
`
`
`
`DECLARATION OF JONATHAN DORDICK, Ph.D.
`
`EXHIBIT 2010
`
`TOYOTA EXHIBIT 2010
`Reactive Surfaces LTD., LLP v. Toyota Motor Corporation
`IPR2016-01914
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. QUALIFICATIONS AND EXPERIENCE ..................................................... 3
`
`III. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 15
`
`IV. APPLICABLE LAW ..................................................................................... 17
`
`V. MATERIALS REVIEWED .......................................................................... 19
`
`VI. SUMMARY OF OPINIONS ......................................................................... 21
`
`VII. ANALYSIS .................................................................................................... 26
`A.
`The References Included in the Alleged Grounds
`of Unpatentability All Fail to Teach or Suggest the
`Use of a Lipase-Containing Coating or Substrate
`for Facilitating Fingerprint Removal Through
`Vaporization. ....................................................................................... 27
`
`B. Dr. Rozzell’s Statements About Buchanan Fail to
`Cure the Deficiencies of the References Included
`in the Alleged Grounds of Unpatentability. ........................................ 29
`
`1.
`
`Buchanan Is Not Analogous Art to the ‘618 Patent. ................ 30
`
`a. Buchanan Is Not From the Same Field of
`Endeavor as the ‘618 Patent ........................................... 30
`
`b. Buchanan Is Not Reasonably Pertinent to the
`Problems Faced by the Inventors of the ‘618
`Patent .............................................................................. 32
`
`2.
`
`Buchanan Would Not Have Provided a POSITA
`With a Reasonable Expectation of Success in
`Using Lipase to Facilitate the Removal of a
`Fingerprint by Vaporization. ..................................................... 34
`
`a. The Methods of Buchanan Were Improperly
`Designed and The Data of Buchanan Was
`
`i
`
`
`
`Too Unreliable to Lead a POSITA to
`Properly Conclude That Fingerprints and
`Their Components Disappear by
`Vaporization ................................................................... 37
`
`i. The Experiments of Buchanan Used a
`Fingerprint Detection Technique That
`is Not Affected by Changes to the
`Fingerprint Over Time ......................................... 38
`
`ii.
`
`iii.
`
`The Gas Chromatography/Mass
`Spectrometry Experiments of
`Buchanan Failed to Analyze the
`Composition of Actual Fingerprints ..................... 43
`
`The Experiments of Buchanan Did
`Not Quantify the Volatile and
`Nonvolatile Components of
`Fingerprints .......................................................... 47
`
`b. The Buchanan Data Does Not Support the
`Conclusion That Vaporization Is
`Responsible For Fingerprint Disappearance
`From a Surface ............................................................... 50
`
`i. The Studies Discussed in Buchanan
`Used “Conventional Dusting” for
`Fingerprint Enhancement ..................................... 51
`
`ii. The Fingerprints of Prepubescent
`Children Include Mostly Aqueous
`Saline and Lack a Significant Amount
`of Oily Sebaceous Material .................................. 52
`
`iii. Water is Lost from a Fingerprint Over
`Time ...................................................................... 54
`
`iv.
`
`The Enhanced Clarity of a
`Conventionally Dusted Fingerprint is
`the Result of the Original Quality of
`the Fingerprint, and Not the Result of
`Changes to the Fingerprint Over Time ................. 54
`
`(cid:1)
`
`ii(cid:1)
`(cid:1)
`
`(cid:1)
`
`
`
`v.
`
`vi.
`
`A Fingerprint Undergoes Physical and
`Chemical Changes Through Several
`Different Pathways Besides
`Vaporization ......................................................... 55
`
`These Other Factors Could Have
`Explained the Alleged
`“Disappearance” of Prepubescent
`Children’s Fingerprints ........................................ 56
`
`VIII. CONCLUSION .............................................................................................. 56
`
`(cid:1)
`
`iii(cid:1)
`(cid:1)
`
`(cid:1)
`
`
`
`I.
`
`INTRODUCTION
`
`I, JONATHAN S. DORDICK, Ph.D., hereby declare the following:
`
`1. My name is Dr. Jonathan S. Dordick. I am the Vice President for
`
`Research and the Howard P. Isermann Professor of Chemical and Biological
`
`Engineering, Biomedical Engineering, Materials Science and Engineering, and
`
`Biological Sciences at Rensselaer Polytechnic Institute. My mailing address is
`
`9015 LCII, Rensselaer Polytechnic Institute, Troy, New York 12180. I base the
`
`following on my personal knowledge and experience as well as my review of the
`
`relevant documents listed below in Section V.
`
`2.
`
`I have been retained by counsel as an independent expert for Toyota
`
`Motor Corporation (the (cid:147)Patent Owner(cid:148)) in this Inter Partes Review proceeding,
`
`Reactive Surfaces LTD., LLP v. Toyota Motor Corporation, IPR2016-01914,
`
`before the Patent Trial and Appeal Board (the (cid:147)Board(cid:148)). I am being compensated
`
`for the time I spend on this matter at my customary rate of $500 per hour, but no
`
`part of my compensation is dependent on the outcome of this proceeding.
`
`3.
`
`I understand that this proceeding involves U.S Patent No. 8,394,618
`
`((cid:147)the (cid:145)618 Patent(cid:148)) (Ex. 1001). I understand that the application for the (cid:145)618 Patent
`
`was filed on June 21, 2010, as U.S. Patent Application No. 12/820,063 ((cid:147)the (cid:145)063
`
`Application(cid:148)) (Ex. 1002). I also understand that the (cid:145)618 Patent is assigned to the
`
`
`
`1
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`
`
`
`
`
`Patent Owner. I therefore have considered the state of the art and the prior art
`
`available as of June 10, 2010.
`
`4.
`
`In light of the Board(cid:146)s institution of Inter Partes Review of the (cid:145)618
`
`Patent, I have been asked to provide an opinion as to whether claims 1-11 of the
`
`(cid:145)618 Patent (Ex. 1001) are obvious over the references relied upon by Reactive
`
`Surfaces LTD., LLP (the (cid:147)Petitioner(cid:148)) and in the Declaration of Dr. David Rozzell
`
`(Ex. 1010), specifically Schneider (Ex. 1), Van Antwerp (Ex. 1005), Drevon (Ex.
`
`1003), McDaniel (Ex. 1008), Moon (Ex. 1006), Hamade (Ex. 1007), and Bostek
`
`(Ex. 1009).
`
`5.
`
`I understand that the Board instituted an Inter Partes Review
`
`proceeding with respect to claims 1-11 of the (cid:145)618 Patent. Specifically, the Board
`
`instituted a review on the following grounds: claims 1-3 of the (cid:145)618 Patent as
`
`obvious under §103(a) over Van Antwerp; claims 4 and 5 as obvious under
`
`§103(a) over Van Antwerp and Bostek; claims 6-9 as obvious under §103(a) over
`
`Van Antwerp and Moon; claims 10 and 11 as obvious under §103(a) over Van
`
`Antwerp and Hamade; claims 1-8, 10, and 11 as obvious under §103(a) over
`
`Schneider; claim 9 as obvious under §103(a) over Schneider and McDaniel; claims
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`1-9 as obvious under §103(a) over Drevon; and claims 10 and 11 as obvious under
`
`§103(a) over Drevon and Schneider.
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`
`
`2
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`
`
`6.
`
`This declaration identifies my opinions to date. I reserve the right to
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`supplement this declaration, if allowed by the Board under relevant rules, to
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`address any new issues raised by the Petitioner or its expert(s) or resulting from
`
`further rulings of the Board or otherwise from further or related proceedings.
`
`7.
`
`After reviewing the Board(cid:146)s decision instituting the Inter Partes
`
`Review of the (cid:145)618 Patent, the documents listed in Section V, the exhibits listed in
`
`the Petition, and the documents and other material relied upon by Dr. Rozzell in
`
`his Declaration, it is my opinion that claims 1-11 of the (cid:145)295 Patent are non-
`
`obvious over Van Antwerp, Schneider, Drevon, Bostek, Moon, Hamade, and
`
`McDaniel, alone or in any combination.
`
`II. QUALIFICATIONS AND EXPERIENCE
`
`8.
`
`A copy of my curriculum vitae is attached to this declaration as
`
`Appendix A.
`
`9.
`
`I received a Bachelor of Arts degree in Biochemistry and Chemistry
`
`in 1980 from Brandeis University, Waltham, Massachusetts, a Masters of Science
`
`degree
`
`in Biochemical Engineering from
`
`the Massachusetts Institute of
`
`Technology, Cambridge, Massachusetts in 1983, and a Doctorate in Biochemical
`
`Engineering, also from the Massachusetts Institute of Technology, in 1986.
`
`10. Following my Ph.D., I joined industry as a postdoctoral research
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`fellow at Tate & Lyle, PLC in Reading, UK. My work at the company was on the
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`3
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`
`
`
`
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`use of enzymes to generate carbohydrate analogs. I was involved in developing
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`biotransformations for use as alternatives in the synthesis of the company(cid:146)s
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`primary low-calorie sweetener, 4, 1(cid:146), 6(cid:146)-trichlorogalactosucrose (sucralose), which
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`is now sold as Splendafi. Sucralose undergoes minimal intestinal absorption and
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`essentially no first-pass metabolism, and therefore is eliminated unchanged. In this
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`work, I focused on hydrolytic enzymes, including proteases and lipases that
`
`catalyzed the esterification of sugars and de-esterification (hydrolysis) of sugar
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`esters. I identified specific enzymes that could generate a series of sugar ester
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`derivatives, including aliphatic and aromatic esters (some these were amino acid
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`esters) of glucose, galactose, sucrose, maltose, lactose, and related mono- and
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`disaccharides.
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`11. From 1987 to 1991, I was an Assistant Professor in the Department of
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`Chemical and Biochemical Engineering at the University of Iowa. From 1991-
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`1994 I was an Associate Professor in the Department of Chemical and Biochemical
`
`Engineering at the University of Iowa. From 1994 to 1998, I was a Professor in
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`the Department of Chemical and Biochemical Engineering at the University of
`
`Iowa, while also serving as the Chairman from 1995-1998. I also served as the
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`founding Associate Director of the Center for Biocatalysis and Bioprocessing at
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`the University of Iowa from 1991-1998. At the University of Iowa I performed and
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`oversaw research in the area of enzyme technology. This included developing
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`4
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`
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`enzyme-polymer composite materials, the most recognized being (cid:147)biocatalytic
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`plastics(cid:148) wherein enzymes are covalently incorporated into polymers. These
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`composites can be used as biocatalysts that contain functional bioactive enzymes in
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`the form of paints, coatings, films, and bulk materials.
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`12. From 1998 to the present I have served as the Howard P. Isermann
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`Professor in the Department of Chemical and Biological Engineering at Rensselaer
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`Polytechnic Institute. From 1998-2002, I served as the Chairman of the
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`department. From 2012 to the present I have served as the VP for Research at
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`Rensselaer Polytechnic Institute. At Rensselaer Polytechnic Institute, my research
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`has focused on both enzyme technology and microscale cell culture bioprocessing.
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`With respect to the former, I have developed enzyme-nanomaterial polymer
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`composites that can be used in myriad applications, including antimicrobial and
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`antifouling paints, coatings and films.
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`13.
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`I have graduated 55 Ph.D. students and have had over 70 postdoctoral
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`scientists and research scientists work in my laboratory since joining academia in
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`1987. These researchers have taken leading positions in the pharmaceutical,
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`biotechnology, and chemical industries, as well as positions as faculty in
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`universities in the U.S. and elsewhere. My current laboratory consists of 12
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`postdoctoral research scientists plus 9 Ph.D. students.
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`5
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`14.
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` I have founded three companies in the pharmaceutical and materials
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`science areas. I have served on numerous scientific advisory boards and have
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`consulted for nearly 40 companies in the area of enzyme technology.
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`15.
`
` I have received numerous honors, awards and named lectureships
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`based on my research. These are indicated below:
`
`a.
`
`2016 Robert Pigford Memorial Lecture, University of
`
`Delaware;
`
`b.
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`2015 Food, Pharmaceutical and Bioengineering Award,
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`American Institute of Chemical Engineers;
`
`c.
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`2015 Elected to the National Academy of Inventors;
`
`d.
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`2011 Inaugural Mylan Lecture, University of West Virginia;
`
`e.
`
`f.
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`2011 Merck Lecture, University of Virginia;
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`2010 Elected Fellow, American Chemical Society;
`
`g.
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`2009 Outstanding Scientific Achievement Award, Defense
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`Threat Reduction Agency;
`
`h.
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`2007 Marvin J. Johnson Award, American Chemical Society
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`Division of Biochemical Technology;
`
`i.
`
`2007 Elmer Gaden Award, John Wiley & Sons and American
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`Chemical Society Division of Biochemical Technology;
`
`j.
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`2007 Trustees Lecture, Rensselaer Polytechnic Institute;
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`
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`6
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`
`
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`
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`k.
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`2007 School of Engineering Research Award, Rensselaer
`
`Polytechnic Institute;
`
`l.
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`2004 Elected Fellow, American Association
`
`for
`
`the
`
`Advancement of Science;
`
`m.
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`2003 International Enzyme Engineering Award;
`
`n.
`
`2003 School of Engineering Research Award, Rensselaer
`
`Polytechnic Institute;
`
`o.
`
`2000 Alan Berman Research Publications Award, U.S.
`
`Department of Defense;
`
`p.
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`Howard P. Isermann Professorship, Department of Chemical
`
`Engineering, Rensselaer Polytechnic Institute;
`
`q.
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`1998 American Chemical Society Iowa Section Award;
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`r.
`
`s.
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`1998 Who(cid:146)s Who in America;
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`1997 Trapp Lecture
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`in Biotechnology, Departments of
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`Chemistry and Food Science and Engineering, Iowa State
`
`University;
`
`t.
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`1996 Elected Fellow, American Institute of Medical and
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`Biological Engineers;
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`u.
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`1996 Who(cid:146)s who in Science and Engineering;
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`7
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`
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`v.
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`1993 Leo Rettger Society Lecturer, American Society of
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`Microbiology, Connecticut Chapter;
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`w.
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`1992 Chairman, Division of Biochemical Technology,
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`American Chemical Society;
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`x.
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`1991 Observer for National Academy of Sciences for IUPAC
`
`Meeting in Hamburg;
`
`y.
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`1991 U.S. Delegate for U.S. - Korea Joint Seminar on
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`Bioprocess Technology, Seoul;
`
`z.
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`1989 Presidential Young Investigator Award, National Science
`
`Foundation;
`
`aa.
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`1989 Faculty Scholars Award, University of Iowa;
`
`bb.
`
`1989 NASA Technical Innovation Brief;
`
`cc.
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`1988 Old Gold Summer Faculty Fellowship, University of
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`Iowa;
`
`dd.
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`1983 Interox Predoctoral Fellowship, MIT.
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`16.
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`I have published over 360 publications in peer-reviewed journals
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`arising from my research, including many in the areas of enzymes and bioactive
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`coatings. I have also been invited to deliver over 150 lectures in the
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`aforementioned research areas. These were given at universities, companies, and
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`national and international conferences.
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`8
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`17.
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`I am a named inventor on 40 United States Patents or pending U.S.
`
`Patent Applications arising from my research, which are listed below:
`
`a.
`
`A.M. Klibanov and
`
`J.S. Dordick
`
`(1989), (cid:147)Enzymic
`
`Temperature Change Indicator,(cid:148) U.S. Patent No. 4,826,762;
`
`b.
`
` E.B. Rathbone, K.S. Mufti, R.A. Khan, P.S.J. Cheetham, A.J.
`
`Hacking, and J.S. Dordick (l989), (cid:147)Tetrachlororaffinose and Its
`
`Use in the Preparation of Sucralose,(cid:148) U.S. Patent No.
`
`4,826,962;
`
`c.
`
`J.S. Dordick, A.J. Hacking, and R.A. Khan (1992), (cid:147)Selective
`
`Acylation of Sugars,(cid:148) U.S. Patent No. 5,128,248;
`
`d.
`
`S. Bornemann, J.M. Cassells, C.L. Combes, J.S. Dordick, and
`
`A.J. Hacking (1992), (cid:147)Preparation of Acylated Sucrose
`
`Derivatives,(cid:148) U.S. Patent No. 5,141,860;
`
`e.
`
`J.S. Dordick, D.G. Rethwisch, and D.R. Patil (1993), (cid:147)Sugar-
`
`Based Polymers,(cid:148) U.S. Patent No. 5,270,421;
`
`f.
`
`J.S. Dordick, A.J. Hacking, and R.A. Khan (1993), (cid:147)Sucrose
`
`6,4’-Dicarboxylic Esters,(cid:148) U.S. Patent No. 5,270,460;
`
`g.
`
`J.S. Dordick, Y.L. Khmelnitsky, and D.S. Clark (1995),
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`(cid:147)Reacting an Enzyme in a Non-Aqueous Solvent by Adding a
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`
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`9
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`
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`Lyophilizate of Enzyme and Salt to the Solvent,(cid:148) U.S. Patent
`
`No. 5,449,613;
`
`h.
`
`J.S. Dordick. B.D. Martin, and R.J. Linhardt (1995), (cid:147)Method
`
`of Making Poly(Sugar Acrylates) Using Hydrolytic Enzymes,(cid:148)
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`U.S. Patent No. 5,474,915;
`
`i.
`
`J.S. Dordick, D.G. Rethwisch, and D.R. Patil (1997), (cid:147)Sugar-
`
`Based Polymers,(cid:148) U.S. Patent No. 5,618,933;
`
`j.
`
`J.S. Dordick and V.M. Paradkar (1998), (cid:147)Enzyme-Surfactant
`
`Ion-Pair Complex Catalyzed Reactions in Organic Solvents,(cid:148)
`
`U.S. Patent No. 5,719,039;
`
`k.
`
`J.S. Dordick, R.J. Linhardt, and B.D. Martin (1998), (cid:147)Sugar-
`
`Based Hydrogels,(cid:148) U.S. Patent No. 5,854,030;
`
`l.
`
`J.S. Dordick, P. Wang, M.V. Sergeeva, and S.J. Novick (1999).
`
`(cid:147)Biocatalytic Plastics,(cid:148) U.S. Patent No. 5,914,367;
`
`m.
`
`J.A. Akkara, D.L. Kaplan, F.F. Bruno, and J.S. Dordick (2000),
`
`(cid:147)Transesterification of Insoluble Polysaccharides,(cid:148) U. S. Patent
`
`No. 6,063,916;
`
`n.
`
`D.S. Clark, J.S. Dordick, M.T. Ru, and J.A. Reimer (2000),
`
`(cid:147)Optimizing the Salt Induced Activation of Enzymes in
`
`Organic Solvents,(cid:148) U. S. Patent Pending;
`
`
`
`10
`
`
`
`
`
`
`o.
`
`J.S. Dordick, D.S. Clark, P.C. Michels, and Y.L. Khmelnitsky
`
`(2000), (cid:147)Biocatalytic methods for synthesizing and identifying
`
`biologically active compounds,(cid:148) U.S. Patent No. 6,136,961;
`
`p.
`
`J.S. Dordick, V.M. Paradkar, and M.V. Sergeeva (2001),
`
`(cid:147)Enzyme catalysis in organic solutions containing water,(cid:148) U.S.
`
`Patent No. 6,171,813;
`
`q.
`
`J.A. Akkara, D.L. Kaplan, F.F. Bruno, and J.S. Dordick (2001),
`
`(cid:147)Transesterification of Insoluble Polysaccharides,(cid:148) U.S. Patent
`
`6,228,997;
`
`r.
`
`Y.L. Khmelnitsky, C.L. Budde, J.M. Arnold, J.O. Rich, A.Y.
`
`Usyatinsky, D.S. Clark, and J.S. Dordick (2001), (cid:147)Two-step
`
`enzymatic acylation,(cid:148) U.S. Patent No. 6,261,813;
`
`s.
`
`J.S. Dordick, D.S. Clark, P.C. Michels, and Yu.L. Khmelnitsky
`
`(2001), (cid:147)Taxol derivatives,(cid:148) U.S. Patent No. 6,465,625;
`
`t.
`
`J.S. Dordick, P. Wang, M.V. Sergeeva, and S.J. Novick (2001),
`
`(cid:147)Polymer-protein composites and methods for their purification
`
`and use,(cid:148) U.S. Patent No. 6,291,582.
`
`u. M.A. Markowitz, P.E. Schoen, B.P. Gaber, B.R. Ratna, P.R.
`
`Kust, D.C. Turner, D.S. Clark, and J.S. Dordick (2001),
`
`
`
`11
`
`
`
`
`
`
`(cid:147)Molecularly-Imprinted Material Made by Template-Directed
`
`Synthesis,(cid:148) U.S. Patent No. 6,310,110;
`
`v.
`
`J.S. Dordick, J. Kim, and X. Wu (2002), (cid:147)Sensing Array and
`
`Sensor Structure,(cid:148) U.S. Patent No. 6,406,668;
`
`w. M. A. Markowitz, P. E. Schoen, B. P. Gaber, B. R. Ratna, P. R.
`
`Kust, D. C. Turner, D. S. Clark, and J. S. Dordick (2003),
`
`(cid:147)Molecularly-Imprinted Material Made by Template-Directed
`
`Synthesis,(cid:148) U. S. Patent No. 6,583,191;
`
`x. M. A. Markowitz, P. E. Schoen, B. P. Gaber, B. R. Ratna, P. R.
`
`Kust, D. C. Turner, D. S. Clark, and J. S. Dordick (2003),
`
`(cid:147)Molecularly-Imprinted Material Made by Template-Directed
`
`Synthesis,(cid:148) U. S. Patent No. 6,660,780;
`
`y.
`
`S.M. Cramer, K. Rege, and J.S. Dordick (2005), (cid:147)High-
`
`throughput screening of potential displacer molecules,(cid:148) U.S.
`
`Patent No. 6,881,540;
`
`z.
`
`J.S. Dordick and D.S. Clark (2007), (cid:147)Biocatalytic Sol-Gel
`
`Microarrays,(cid:148) U.S. Patent No. 7,267,958.
`
`aa.
`
`J.S. Dordick, A. Srinivasan, J. Kim, M.-Y. Lee, D. Sherman,
`
`and D.S. Clark (2002), (cid:147)In vitro Metabolic Engineering on
`
`Microscale Devices,(cid:148) U.S. Patent No. 7,427,497;
`
`
`
`12
`
`
`
`
`
`
`bb.
`
`J.S. Dordick, J.A. Holland, L. Santhanam, and M. Hogg (2007),
`
`(cid:147)Solid-Phase Array-Based Biocatalytic Transformations,(cid:148) U.S.
`
`Patent No. 7,202,030;
`
`cc.
`
`J.S. Dordick, M.-Y. Lee, A. Srinivasan, and B. Ku (2007),
`
`(cid:147)Enzyme Immobilization for Electroosmotic Flow,(cid:148) U.S. Patent
`
`No. 7,172,682;
`
`dd. M. A. Markowitz, P. E. Schoen, B. P. Gaber, B. R. Ratna, P. R.
`
`Kust, D. C. Turner, D. S. Clark, and J. S. Dordick (2004),
`
`(cid:147)Molecularly-Imprinted Material Made by Template-Directed
`
`Synthesis,(cid:148) U. S. Patent No. 6,713,416;
`
`ee. M. A. Markowitz, P. E. Schoen, B. P. Gaber, B. R. Ratna, P. R.
`
`Kust, D. C. Turner, D. S. Clark, and J. S. Dordick (2003),
`
`(cid:147)Molecularly-Imprinted Material Made by Template-Directed
`
`Synthesis,(cid:148) U. S. Patent No. 6,660,780;
`
`ff. M.Y. Lee, S.J. Kwon, J.S. Dordick, D.S. Clark, and J.
`
`McKinley (2010), (cid:147)Method of Nucleic Acid Delivery Into
`
`Three-Dimensional Cell Culture Arrays,(cid:148) U.S. Patent Pending;
`
`gg. R.J. Linhardt and J.S. Dordick (2010), (cid:147)An Artificial Organelle
`
`on a Digital Microfluidic Chip Used to Redesign the Biological
`
`Activities of Heparan Sulfate,(cid:148) U.S. Patent Pending;
`
`
`
`13
`
`
`
`
`
`
`hh.
`
`J.S. Dordick and D.S. Clark (2010), (cid:147)Biocatalytic Sol-Gel
`
`Microarrays,(cid:148) U.S. Patent No. 7,846,747;
`
`ii.
`
`K. Rege, S. Hu, J.S. Dordick, and S.M. Cramer (2008),
`
`(cid:147)Aminoglycoside-Polyamine Displacers and Methods of Use in
`
`Displacement Chromatography,(cid:148) U.S. Patent No. 7,439,343;
`
`jj.
`
`R.J. Linhardt, J.S. Dordick, T.J. Simmons, M. Miyauchi, and
`
`S.H. Lee (2014), (cid:147)Synthetic Wood Composite,(cid:148) U.S. Patent No.
`
`8,772,406;
`
`kk. Z. Wang, R.J. Linhardt, J.S. Dordick, and U. Bhaskar (2014),
`
`(cid:147)K5 Heparosan Fermentation and Purification,(cid:148) U.S. Patent No.
`
`8,883,452;
`
`ll. M. Miyauchi, J. Miao, T.J. Simmons, J.W. Lee, T.V. Doherty,
`
`J.S. Dordick, and R.J. Linhardt (2015), (cid:147)Cellulose Sheathed
`
`Nanotube Fiber,(cid:148) U.S. Patent No. 9,061,904.
`
`mm. J.S. Dordick, R.S. Kane, P. Asuri, S.S. Karajanagi, A.A.
`
`Vertegel, and R.W. Siegel (2016), (cid:147)Enhanced Stability of
`
`Proteins Immobilized on Nanoparticles,(cid:148) U.S. Patent 9,360,475.
`
`nn. X. Qian, J.E. Gagner, J.S. Dordick, and R.W. Siegel (2016),
`
`(cid:147)Internalization
`
`of
`
`Proteins
`
`into Hollowed Gold
`
`Nanostructures,(cid:148) U.S. Patent 9,562,225.
`
`
`
`14
`
`
`
`
`
`
`
`
`18.
`
`In total, I have over 30 years of technical experience since receiving
`
`my Ph.D. degree in working with enzymes and biofunctional coatings. This
`
`experience has provided me with in-depth knowledge and skill related to the
`
`science, technology, and practical application of enzymes and biofunctional
`
`coatings, including the complications and associated specialized techniques for
`
`distributing and stabilizing bioactive materials such as proteins (e.g., enzymes) or
`
`peptides in non-aqueous formulations.
`
`19.
`
`I am not, and never was, an employee of the owner of the patents at
`
`issue and have no pecuniary interest in the patents at issue in this case. I was
`
`engaged by the Patent Owner in this case to provide my independent analysis
`
`based upon my experience and skill in the art of enzyme technology, including
`
`enzyme-containing polymers and coatings, and I received no compensation for this
`
`declaration beyond my standard compensation for time spent reviewing the
`
`pertinent documents described below and providing my independent analysis. I
`
`will not receive any added compensation based on the outcome of the above-
`
`mentioned case.
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`
`20.
`
`I understand that patents are viewed from the perspective of a person
`
`of ordinary skill in the art ((cid:147)POSITA(cid:148)) at the time of the invention of the subject
`
`
`
`15
`
`
`
`
`
`
`matter claimed in the (cid:145)618 Patent. Based on the filing date of the (cid:145)063 Application,
`
`I understand that the relevant date in this regard to be not later than June 10, 2010.
`
`21.
`
`I have reviewed the declaration of Dr. David Rozzell (Ex. 1010). In
`
`his declaration, Dr. Rozzell opines as to the level of skill in the art disclosed in the
`
`(cid:145)618 Patent. Ex. 1008 ¶¶ 30(cid:150)31. I disagree with Dr. Rozzell(cid:146)s opinion with regard
`
`to the skill level of a POSITA.
`
`22. The (cid:145)618 Patent is directed to bioactive coatings. Dr. Rozzell asserts
`
`that one of ordinary skill in the art would have at least a bachelor(cid:146)s degree plus 5 or
`
`more years experience, or a Masters or Ph.D. with two or more years experience in
`
`chemistry, biochemistry, molecular biology, biochemical engineering, or a related
`
`discipline. However, Dr. Rozzell(cid:146)s definition of one or ordinary skill in the art
`
`could include a person without experience in preparing, characterizing and using
`
`bioactive coatings. A person lacking such experience would not be familiar with
`
`the complications and associated specialized techniques for distributing and
`
`stabilizing bioactive materials such as proteins (e.g., enzymes) or peptides in
`
`nonaqueous formulations, such as the bioactive coatings involved in the method
`
`claims of the (cid:145)618 Patent. Accordingly, it is my opinion that one or ordinary skill
`
`in the art would have had at least a bachelor(cid:146)s degree in Biochemistry,
`
`Biochemical Engineering, Chemical Engineering, Materials Science or the like,
`
`and at least 3-5 years of experience in research and development of bioactive
`
`
`
`16
`
`
`
`
`
`
`coatings. In particular, experience in bioactive coatings would include skill in
`
`enzyme structure, function and applications, and polymer chemistry, and therefore,
`
`inherently skill in synthetic chemistry and analytical methodologies. Dr. Rozzell(cid:146)s
`
`definition of a POSITA only addresses some of the key areas of skill needed to
`
`understand and operate the (cid:145)618 Patent. Based on my education and experience in
`
`enzymes with a particular focus in bioactive coatings, I qualify as a POSITA of the
`
`invention described in the (cid:145)618 Patent, and I did as of the filing date of the (cid:145)063
`
`Application. Indeed, a great many of my past students and postdoctoral scientists
`
`also would qualify as POSITAs of the invention described in the (cid:145)618 Patent.
`
`23. Based on my education, experience, and knowledge of the requisite
`
`art, I also qualify as a POSITA as Dr. Rozzell would define such in his declaration.
`
`Ex 1010 ¶¶ 30-31.
`
`IV. APPLICABLE LAW
`
`24. My opinions stated herein have been formed by my understanding of
`
`the relevant law.
`
`25.
`
`I have been informed by counsel and understand that patentability
`
`analysis is conducted on a claim-by-claim basis.
`
`26.
`
`I also have been informed and understand that a patent claim is invalid
`
`as being (cid:147)obvious(cid:148) if the differences between the claimed invention and the prior
`
`art are such that the subject matter of the invention as a whole would have been
`
`
`
`17
`
`
`
`
`
`
`obvious at the time the invention was made to a POSITA to which the subject
`
`matter pertains. I further have been informed and understand that there are four
`
`factors to be considered in an obviousness analysis: (1) the scope and content of
`
`the prior art, (2) the differences between the invention and the prior art, (3) the
`
`level of skill in the art at the time of the invention, and (4) secondary
`
`considerations of non-obviousness.
`
`27.
`
`I further understand that in order to establish a claim as obvious based
`
`on a combination of elements in the prior art, the law requires some articulated
`
`reasoning with some rational underpinning that would have lead a POSITA to
`
`modify a single reference or a combination of references in a particular manner
`
`required to reach the claimed invention.
`
`28.
`
`I understand that to establish a claim as obvious, the prior art
`
`publication(s) must be (cid:147)analogous art(cid:148) to the invention described and claimed in
`
`the patent at issue. I further understand that to be analogous art to the claimed
`
`invention, a prior art publication must satisfy one of two requirements: (1) the prior
`
`art publication must be from the same filed of endeavor as the patent at issue,
`
`regardless of the problem addressed; or (2) the prior art publication must be
`
`reasonably pertinent to the problem faced by the inventor of the patent at issue.
`
`
`
`18
`
`
`
`
`
`
`29.
`
`I have applied the standards described above to the best of my ability
`
`in my analysis of the patentability of claims 1-11 of the (cid:145)618 Patent as described
`
`herein.
`
`V. MATERIALS REVIEWED
`
`30. To form my opinions, I considered and relied upon the contents of the
`
`following documents:
`
`a.
`
`The Petition for Inter Partes Review of U.S. Patent No.
`
`8,394,618 B2 and all associated exhibits;
`
`b.
`
`The Decision on Institution of Inter Partes Review of U.S.
`
`Patent No. 8,394,618 B2 by the Patent Trial and Appeal Board
`
`c.
`
`d.
`
`((cid:147)Decision(cid:148));
`
`The (cid:145)618 Patent (Ex. 1001);
`
`U.S. Appl. Pub. No. 2011/0312057 A1 for U.S. Pat. Appl. No.
`
`12/820,063 to Buthe et al. (Ex. 1002);
`
`e.
`
`Drevon, (cid:147)Enzyme Immobilization into Polymers and Coatings(cid:148)
`
`((cid:147)Drevon(cid:148)) (Ex. 1003);
`
`f.
`
`Schneider et al., U.S. Appl. Pub. No. 2005/0147579, entitled
`
`(cid:147)Antifouling Composition Comprising an Enzyme in the
`
`Absence of its Substrate(cid:148) ((cid:147)Schneider(cid:148)) (Ex. 1004);
`
`
`
`19
`
`
`
`
`
`
`g.
`
`Van Antwerp, United States Patent 5,868,720, entitled
`
`(cid:147)Indwelling Catheter with Stable Enzyme Coating(cid:148) ((cid:147)Van
`
`Antwerp(cid:148)) (Ex. 1005);
`
`h. Moon et al., U.S. Appl. Pub. No. 2005/0176905, entitled
`
`(cid:147)Monomer with anti-microbial character, polymer using the
`
`same, and manufacturing method thereof(cid:148) ((cid:147)Moon(cid:148)) (Ex.
`
`1006);
`
`i.
`
`Hamade et al., United States Patent 6,150,146, entitled (cid:147)Method
`
`for controlled release of compounds having antimicrobial
`
`activity and coating composition(cid:148) ((cid:147)Hamade(cid:148)) (Ex. 1007);
`
`j.
`
`McDaniel, U.S. Appl. Pub. No. 2004/0109853, entitled
`
`(cid:147)Biological Active Coating Components, Coatings, and Coated
`
`Surfaces(cid:148) ((cid:147)McDaniel (cid:145)853(cid:148)) (Ex. 1007);
`
`k.
`
`C. Bostek. (cid:147)Effective Methods of In-Line Intravenous Fluid
`
`Warming at Low to Moderate Infusion Rates(cid:148) ((cid:147)Bostek(cid:148)) (Ex.
`
`1009);
`
`l.
`
`Declaration of Dr. David Rozzell (Ex. 1010);
`
`m. Office Action dated August 14, 2012 in the (cid:145)063 Application
`
`((cid:147)the (cid:145)063 OA(cid:148)) (Ex. 1011).
`
`
`
`20
`
`
`
`
`
`
`n.
`
`Office Action Response filed on October 22, 2012 in the (cid:145)063
`
`Application (Ex. 1012);
`
`o.
`
`Buchanan et al., (cid:147)Chemical Characterization of Fingerprints
`
`from Adults and Children(cid:148) ((cid:147)Buchanan(cid:148)) (Ex. 1013);
`
`p.
`
`Barnett et al., (cid:147)The Effects of Temperature and Humidity on the
`
`Permanency of Latent Fingerprints(cid:148) J. Forensic Sci. Soc. 16(3)
`
`(1976) 249-254. (Ex. 2011);
`
`q.
`
`Oral Deposition of David Rozzell, Ph.D. (Ex. 2012);
`
`r. Mong et al., (cid:147)Advanced Fingerprint Analysis Project
`
`Fingerprint Constituents(cid:148) Technical Report, 1999, Pacific
`
`Northwest Laboratory. (Ex. 2013);
`
`s.
`
`Publication Information for Mong et al., (cid:147)Advanced Fingerprint
`
`Analysis Project Fingerprint Constituents(cid:148) (Ex. 2014);
`
`t.
`
` (cid:147)How does fingerprint powder work?(cid:148) Scientific American,
`
`Sep 2, 2002 (Ex. 2015);
`
`u.
`
`Publication Information for (cid:147)How does fingerprint work?(cid:148) (Ex.
`
`2016).
`
`31. To further interpret and explain the contents of the above documents, I
`
`relied on my educational background and work experience.
`
`
`
`
`
`21
`
`
`
`
`
`
`VI. SUMMARY OF OPINIONS
`
`32.
`
`It is my opinion that claims 1-11 are non-obvious over the cited prior
`
`art for several reasons.
`
`33. The references included in the alleged grounds of unpatentability all
`
`fail to teach or suggest the use of a lipase-containing coating or substrate for
`
`facilitating fingerprint removal through vaporization. This was admitted by the
`
`Petitioner. Pet. 37, 47, 55. Indeed, the Institution Decision recognized that the
`
`references included in the alleged grounds of unpatentability all fail to teach or
`
`suggest the evaporation of bioorganic stains. Inst. Dec. 7-8, 16-17, 23-24.
`
`34. The Institution Decision further recognized that Petitioner relies solely
`
`on the statements of Dr. Rozzell (cid:147)to show that lipase facilitates the vaporization of
`
`fingerprints inherently when the fingerprints are (cid:145)in an environment that would
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