UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________________________________________________
`
`
`
`Cook Incorporated, Cook Group Incorporated, and Cook Medical LLC,
`
`Petitioners
`v.
`Medtronic, Inc.,
`
`Patent Owner
`
`Patent No. 6,306,141
`Issue date: October 23, 2001
`
`______________________________________________________________
`
`DECLARATION OF KAUSHIK BHATTACHARYA, PH.D.
`IN SUPPORT OF PETITION FOR INTER
`PARTES REVIEW OF U.S. PATENT NO. 6,306,141
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2019-00123
`__________________________________________________________________
`
`
`
`
`
`
`
`COOK
`Exhibit 1021-0001
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ......................................................................................... 10 
`A.  Qualifications and Engagement .......................................................... 10 
`1. 
`Education and Work Experience .............................................. 10 
`2. 
`Engagement ............................................................................... 13 
`Statement of Legal Principles ............................................................. 13 
`1. 
`Level Of Ordinary Skill in the Art ............................................ 14 
`2. 
`Claim Construction ................................................................... 14 
`3. 
`Legal Framework ...................................................................... 15 
`OVERVIEW OF SHAPE MEMORY ALLOY
`TECHNOLOGY AND THE ’141 PATENT ................................................. 18 
`A. 
`Shape Memory Alloys ......................................................................... 18 
`1. 
`Ordinary Elasticity .................................................................... 18 
`2. 
`Shape-Memory Effect ............................................................... 19 
`3. 
`Pseudoelasticity ......................................................................... 23 
`4.  Martensitic Phase Transformation ............................................ 27 
`5. 
`TIM Phase Transformations vs. SIM Phase
`Transformations ........................................................................ 30 
`How Martensitic Transformation Gives Rise To
`The Shape-Memory Effect And Pseudoelasticity ..................... 37 
`Ordinary Plasticity .................................................................... 39 
`Shape-Memory Effect And Pseudoelasticity In
`Nitinol ....................................................................................... 40 
`The ’141 Patent ................................................................................... 42 
`1. 
`The Specification ...................................................................... 42 
`2. 
`Prosecution File History ........................................................... 44 
`PRIOR ART REFERENCES ........................................................................ 45 
`A. 
`Cragg (Ex. 1009) ................................................................................. 45 
`B. 
`Pops (Ex. 1010) ................................................................................... 46 
`
`B. 
`
`B. 
`
`6. 
`
`7. 
`8. 
`
`ii
`
`
`
`I. 
`
`II. 
`
`III. 
`
`
`
`COOK
`Exhibit 1021-0002
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`
`
`C. 
`D. 
`E. 
`
`Tanaka (Ex. 1011) ............................................................................... 46 
`Suzuki (Ex. 1012) ................................................................................ 47 
`The Asserted Prior Art Discloses the Alleged
`Distinguishing Features That Applicant Convinced the
`USPTO Were Missing From the Prior Art .......................................... 47 
`IV.  GROUND 1: CLAIMS 1-22 WOULD HAVE BEEN
`OBVIOUS IN VIEW OF CRAGG, POPS, AND TANAKA ....................... 48 
`A. 
`Independent Claim 1 ........................................................................... 48 
`1. 
`“A medical device for insertion into a mammalian
`body, the device comprising” ................................................... 48 
`“(a) a hollow placement device;” .............................................. 48 
`“(b) a memory alloy element formed at least partly
`from pseudoelastic shape-memory alloy, the alloy
`displaying reversible stress-induced martensite at
`about body temperature such that it has a stress-
`induced martensitic state and an austenitic state,” .................... 49 
`“the memory alloy element having (i) a deformed
`shape when the alloy is in its stress-induced
`martensitic state and (ii) a different unstressed
`shape when the alloy is in its austenitic state; and” .................. 70 
`“(c) a guide wire;” ..................................................................... 71 
`“the memory alloy element being within the
`hollow placement device, and the placement
`device being guidable by the guide wire,” ................................ 71 
`“the hollow placement device stressing the
`memory alloy element at a temperature greater
`than the As of the alloy so that the memory alloy
`element is in its deformed shape,” ............................................ 72 
`“wherein the memory alloy element can be
`extruded from the hollow placement device by the
`guide wire at a temperature greater than the As of
`the alloy to transform at least a portion of the alloy
`from its stress-induced martensitic state so that the
`memory alloy element transforms from its
`deformed shape to its unstressed shape,” .................................. 72 
`
`2. 
`3. 
`
`4. 
`
`5. 
`6. 
`
`7. 
`
`8. 
`
`
`
`iii
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`COOK
`Exhibit 1021-0003
`
`

`

`9. 
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`“and wherein the alloy is selected so that the
`transformation can occur without any change in
`temperature of the placement device or the
`memory alloy element.” ............................................................ 73 
`Claim 2 ................................................................................................ 73 
`Claim 3 ................................................................................................ 73 
`Claim 4 ................................................................................................ 74 
`Claim 5 ................................................................................................ 74 
`Independent Claim 6 ........................................................................... 75 
`1. 
`“A medical device which comprises:” ...................................... 75 
`2. 
`“(a) a stent for endarterial placement within a
`human body so that the stent is substantially at
`human body temperature,” ........................................................ 75 
`“the stent comprising a shape memory alloy which
`displays stress-induced martensite behavior at
`body temperature; and” ............................................................. 75 
`“(b) a restraint holding the stent in a deformed
`configuration at a temperature less than the body
`temperature of the human for endarterial
`positioning of the stent within the human body in
`its deformed configuration, the deformation
`occurring through the formation of stress-induced
`martensite;” ............................................................................... 76 
`“wherein the stent is sufficiently deformed that
`when the stent is at human body temperature
`removal of the restraint from the stent, without
`change in temperature of the device, releases at
`least a portion of the stent from its deformed
`configuration.” .......................................................................... 79 
`Claim 7 ................................................................................................ 79 
`Claim 8 ................................................................................................ 80 
`Claim 9 ................................................................................................ 80 
`Claim 10 .............................................................................................. 81 
`
`3. 
`
`4. 
`
`5. 
`
`iv
`
`
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`
`
`B. 
`C. 
`D. 
`E. 
`F. 
`
`G. 
`H. 
`I. 
`J. 
`
`COOK
`Exhibit 1021-0004
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`K. 
`
`2. 
`
`Independent Claim 11 ......................................................................... 81 
`1. 
`“A medical device suitable for placement within a
`mammalian body for treatment of the mammalian
`body, the device comprising:” .................................................. 81 
`“(a) a stent formed at least partly from a
`pseudoelastic shape-memory alloy, the alloy
`having a reversible stress-induced martensitic state
`and an austenitic state, the memory alloy element
`having (i) a deformed shape when the alloy is in its
`stress-induced martensitic state and (ii) a different,
`unstressed shape; and” .............................................................. 82 
`“(b) restraining means engaging and stressing the
`stent at a temperature less than the body
`temperature of the mammal and greater than the As
`of the alloy for positioning the stent within the
`mammalian body while the stent is in its deformed
`shape;” ....................................................................................... 82 
`“wherein the alloy is selected so that removal of
`the restraining means from the stent at a
`temperature greater than the As of the alloy when
`the device is placed within the mammalian body,
`transforms at least a portion of the alloy from its
`stressed-induced martensitic state so that the stent
`transforms from its deformed relatively
`straightened shape towards its unstressed relatively
`coiled shape, without any change in temperature of
`the restraining means or the stent being required
`for the transformation of the alloy.” ......................................... 83 
`Claim 12 .............................................................................................. 83 
`L. 
`M.  Claim 13 .............................................................................................. 83 
`N. 
`Claim 14 .............................................................................................. 83 
`O. 
`Independent Claim 15 ......................................................................... 84 
`1. 
`“A medical device for treatment of a mammalian
`body, the device comprising:” .................................................. 84 
`
`3. 
`
`4. 
`
`v
`
`
`
`
`
`COOK
`Exhibit 1021-0005
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`“(a) a memory alloy stent formed at least partly
`from a pseudoelastic shape-memory alloy,” ............................. 84 
`“the alloy displaying reversible stress-induced
`martensite at about the mammalian body
`temperature such that it has a stress-induced
`martensitic state and an austenitic state,” ................................. 84 
`“the memory alloy stent having (i) a deformed
`relatively straightened shape when the alloy is in
`its stress-induced martensitic state and (ii) a
`different unstressed relatively coiled shape; and” .................... 85 
`“(b) a hollow restraining member with the memory
`alloy stent being within the restraining member,” .................... 85 
`“the restraining member engaging and stressing the
`memory alloy stent at a temperature less than the
`body temperature of the mammal and greater than
`the As of the alloy for positioning the memory
`alloy stent within the human body while the
`memory alloy coil stent is in its deformed
`relatively straightened shape;” .................................................. 86 
`“wherein the restraining member and the memory
`alloy stent are movable relative to each other to
`transform at least a portion of the alloy from its
`stress-induced martensitic state at a temperature
`greater than the As of the alloy so that the memory
`alloy element transforms from its deformed shape
`towards its unstressed relatively coiled shape,” ....................... 86 
`“and wherein the alloy is selected so that the
`transformation can occur without any change in
`temperature of the restraining member or the
`memory alloy coil stent.” .......................................................... 86 
`Independent Claim 16 ......................................................................... 87 
`1. 
`“A medical device suitable for placement within a
`mammalian body for treatment of the mammalian
`body, the device comprising” ................................................... 87 
`“(i) a restraint” .......................................................................... 87 
`
`7. 
`
`8. 
`
`2. 
`
`vi
`
`
`
`
`
`P. 
`
`COOK
`Exhibit 1021-0006
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`“(ii) a coil stent formed at least partly from a
`pseudoelastic shape-memory alloy,” ........................................ 87 
`“the alloy displaying reversible stress-induced
`martensite by virtue of being above its As and
`above its Ms and below its Md at about body
`temperature;” ............................................................................. 87 
`“such that it has a stress-induced martensitic state
`and an austenitic state,” ............................................................. 88 
`“the element having (i) a relatively straightened
`shape when the alloy is in its stress-induced
`martensitic state and (ii) a different relatively
`coiled shape;” ............................................................................ 88 
`“wherein the restraint is (i) stressing the coil stent
`at a temperature less than the body temperature of
`the mammal for placement of the coil stent in its
`relatively straightened shape in the mammalian
`body” ......................................................................................... 88 
`“wherein the restraint…(ii) is capable of being at
`least partially removed from the coil stent while
`the coil stent is within the body at the body
`temperature and the coil stent is therefore at an
`operating temperature greater than the As and Ms
`and below the Md of the alloy,” ................................................ 88 
`“such removal of the restraint causing at least a
`portion of the alloy to transform from its stress-
`induced martensitic state to its austenitic state so
`that the coil stent spontaneously transforms from
`its relatively straightened shape towards its
`relatively coiled shape,” ............................................................ 89 
`“and such transformation can occur without a
`change in temperature of the restraint or of the coil
`stent from the operating temperature.” ..................................... 89 
`Claim 17 .............................................................................................. 89 
`Independent Claim 18 ......................................................................... 90 
`1. 
`“A medical device comprising:” ............................................... 90 
`
`8. 
`
`9. 
`
`10. 
`
`vii
`
`
`
`
`
`Q. 
`R. 
`
`COOK
`Exhibit 1021-0007
`
`

`

`
`
`2. 
`
`3. 
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`4. 
`
`5. 
`
`6. 
`
`“(a) a wire stent formed at least partly from a
`pseudoelastic shape memory alloy,” ......................................... 90 
`“the alloy displaying reversible stress-induced
`martensite at about human body temperature such
`as it has a deformed shape when the alloy is in its
`stress-induced martensitic state and a different
`unstressed shape when the alloy is in its austenitic
`state; and” .................................................................................. 90 
`“(b) a restraint stressing the wire stent at a
`temperature greater than the As of the alloy so that
`the wire stent is in its deformed shape,” ................................... 90 
`“wherein the stent can be disengaged from the
`restraint upon placement in a human so that the
`stent transforms from its deformed shape to its
`unstressed shape, and” .............................................................. 91 
`“wherein the alloy is selected so that the
`transformation can occur without any change in
`temperature of the restraint or the wire stent.” ......................... 91 
`Claim 19 .............................................................................................. 91 
`S. 
`Claim 20 .............................................................................................. 91 
`T. 
`Claim 21 .............................................................................................. 92 
`U. 
`Claim 22 .............................................................................................. 92 
`V. 
`V.  GROUND 2: CLAIMS 1-22 WOULD HAVE BEEN
`OBVIOUS IN VIEW OF CRAGG, TANAKA, AND SUZUKI .................. 92 
`A. 
`Independent Claim 1 ........................................................................... 92 
`B. 
`Claim 2 ................................................................................................ 96 
`C. 
`Claim 3 ................................................................................................ 96 
`D. 
`Claim 4 ................................................................................................ 96 
`E. 
`Claim 5 ................................................................................................ 96 
`F. 
`Independent Claim 6 ........................................................................... 97 
`G. 
`Claim 7 ................................................................................................ 98 
`H. 
`Claim 8 ................................................................................................ 99 
`
`
`
`viii
`
`COOK
`Exhibit 1021-0008
`
`

`

`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`
`
`Claim 9 ................................................................................................ 99 
`I. 
`Claim 10 .............................................................................................. 99 
`J. 
`Independent Claim 11 ......................................................................... 99 
`K. 
`Claim 12 ............................................................................................ 100 
`L. 
`M.  Claim 13 ............................................................................................ 100 
`N. 
`Claim 14 ............................................................................................ 100 
`O. 
`Independent Claim 15 ....................................................................... 100 
`P. 
`Independent Claim 16 ....................................................................... 101 
`Q. 
`Claim 17 ............................................................................................ 101 
`R. 
`Independent Claim 18 ....................................................................... 101 
`S. 
`Claim 19 ............................................................................................ 102 
`T. 
`Claim 20 ............................................................................................ 102 
`U. 
`Claim 21 ............................................................................................ 102 
`V. 
`Claim 22 ............................................................................................ 102 
`VI.  SECONDARY CONSIDERATIONS ......................................................... 103 
`VII.  CONCLUSION ............................................................................................ 103 
`
`
`
`
`
`
`
`
`
`
`
`ix
`
`COOK
`Exhibit 1021-0009
`
`

`

`
`I.
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`INTRODUCTION
`1. My name is Kaushik Bhattacharya. I have been retained to investigate
`
`and provide testimony regarding claims 1-22 of U.S. Patent No. 6,306,141 (Ex.
`
`1001, “the ’141 Patent”), including background relating to the ’141 Patent, on
`
`behalf of Petitioners, Cook Incorporated, Cook Group Incorporated, and Cook
`
`Medical LLC (collectively “Petitioners”).
`
`2.
`
`This declaration is based on information currently available to me. To
`
`the extent that additional information becomes available, I reserve the right to
`
`revise, amend, or supplement this declaration.
`
`3.
`
`In forming my opinions, I have reviewed and relied on the ’141 Patent
`
`(Ex. 1001) and its prosecution history (Ex. 1002), the materials listed in Exhibit A
`
`and cited in this declaration, and my own experience and expertise.
`
`A. Qualifications and Engagement
`1.
`Education and Work Experience
`I am the Howell N. Tyson, Sr., Professor of Mechanics and Professor
`
`4.
`
`of Materials Science, as well as Vice Provost at the California Institute of
`
`Technology. I have been on the faculty there since 1993.
`
`5.
`
`I received my Bachelor of Technology degree from the Indian
`
`Institute of Technology, Madras, India in 1986. I received my Ph.D. degree in
`
`Mechanics from the University of Minnesota in 1991, and I did my post-doctoral
`
`
`
`10
`
`COOK
`Exhibit 1021-0010
`
`

`

`
`training at the New York University Courant Institute for Mathematical Sciences
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`during 1991-1993. I have held visiting positions at Cornell University (1988),
`
`Heriot-Watt University in Scotland (1992), Max-Planck-Institute at Leipzig (1997-
`
`98), Isaac Newton Institute for Mathematical Sciences at the University of
`
`Cambridge (1999), Indian Institute of Science at Bangalore (2001), the National
`
`Aeronautics and Space Administration Jet Propulsion Laboratory (2006), and the
`
`University of Cambridge (2008-09).
`
`6. My research broadly concerns various aspects of the behavior of
`
`materials, including mechanical/thermal behavior. I have authored over 150
`
`publications in peer-reviewed publications in the fields of mechanics of materials,
`
`continuum mechanics, active materials, shape-memory alloys, heterogeneous
`
`materials, and density functional theory. I have delivered numerous plenary,
`
`keynote, and named lectures on these subjects around the world. I have extensive
`
`experience with the mechanical/thermal behavior of materials, including shape
`
`memory alloys.
`
`7.
`
`Among other awards, I received the Warner T. Koiter Medal for
`
`distinguished contributions to the field of solid mechanics from the American
`
`Society of Mechanical Engineers (2015), and the Special Achievements Award for
`
`Young Investigators in Applied Mechanics from the American Society of
`
`Mechanical Engineers (2004).
`
`
`
`11
`
`COOK
`Exhibit 1021-0011
`
`

`

`8.
`
`I served as Editor of the Journal of the Mechanics and Physics of
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`
`
`Solids, a leading scientific publication, for twelve years (2004-15). I also served
`
`on visiting committees of a number of departments and universities around the
`
`world. My research has been supported, at least in part, by the National Science
`
`Foundation, Air Force Office of Scientific Research, and the United States Army
`
`Research Laboratory.
`
`9.
`
`I have conducted research in the area of shape-memory alloys,
`
`including nitinol, for three decades. Among my publications relating to shape-
`
`memory alloys, I have written a book entitled, “Microstructure of martensite: why
`
`it forms and how it gives rise to the shape-memory effect,” that was published by
`
`Oxford University Press in 2004 and is used worldwide as a graduate textbook on
`
`the subject. I also co-authored the publication entitled, “Stress-induced phase
`
`transformations in shape-memory polycrystals,” that was published in 2009 in the
`
`Archive for Rational Mechanics and Analysis, which is a scientific journal devoted
`
`to research in mechanics.
`
`10.
`
`I have also given plenary lectures at the major international
`
`conferences on shape-memory alloys, including at the International Conference on
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`Shape Memory and Superelastic Technologies (SMST), International Conference
`
`on Martensitic Transformations (ICOMAT), and the Conference on Smart
`
`Materials, Adaptive Structures and Intelligent Systems (SMASIS).
`
`
`
`12
`
`COOK
`Exhibit 1021-0012
`
`

`

`11.
`
`I have been engaged as a consultant by a number of medical device
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`
`
`companies to advise them on technological aspects of shape memory alloys, such
`
`as nitinol, and use of such alloys in medical devices. I also have experience
`
`designing medical devices, including building models of medical devices.
`
`12.
`
`I am named as an inventor on at least five U.S. patents.
`
`13. My Curriculum Vitae, including publications and patents, is submitted
`
`herewith as Exhibit B, and it further highlights my experience and expertise. My
`
`Curriculum Vitae reflects my publications in the last ten years.
`
`14.
`
`In view of my education and experience, I believe I am qualified to
`
`offer the testimony provided in this declaration.
`
`2.
`Engagement
`I am being compensated at a rate of $500 per hour for my study and
`
`15.
`
`time in this matter. I am also being reimbursed for reasonable and customary
`
`expenses associated with my work and time in this investigation. My
`
`compensation is not contingent on the outcome of this matter or the specifics of my
`
`testimony.
`
`B.
`16.
`
`Statement of Legal Principles
`I am a technical expert and do not offer any legal opinions. I applied
`
`the legal framework outlined below in rendering the opinions reflected in this
`
`declaration.
`
`
`
`13
`
`COOK
`Exhibit 1021-0013
`
`

`

`
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`1.
`Level Of Ordinary Skill in the Art
`I understand that a person having ordinary skill in the art is a
`
`17.
`
`hypothetical person who is presumed to know the relevant prior art. I have been
`
`advised that factors that guide the determination of the level of ordinary skill in the
`
`art may include: (1) type of problems encountered in the art; (2) prior art solutions
`
`to those problems; (3) rapidity with which innovations are made; (4) sophistication
`
`of the technology; and (5) educational level of active workers in the field.
`
`18.
`
`It is my opinion that the person having ordinary skill in the art
`
`(“PHOSITA”) at the time the first patent application leading to the ’141 Patent was
`
`filed on October 14, 1983, would have possessed the knowledge and skill known
`
`by an engineer, physician, or similar professional, having knowledge of, or
`
`experience with: (1) shape memory alloys exhibiting reversible stress-induced
`
`martensite behavior, and/or (2) designing medical devices using such shape
`
`memory alloys. The opinions and statements made in this declaration, unless
`
`otherwise noted, are made from the perspective of a PHOSITA as of October 14,
`
`1983, although the same opinions and statements apply in the surrounding
`
`timeframe as well.
`
`2.
`Claim Construction
`I understand that, in a proceeding for inter partes review, a claim in
`
`19.
`
`an unexpired patent is to be given its broadest reasonable interpretation in light of
`
`
`
`14
`
`COOK
`Exhibit 1021-0014
`
`

`

`
`the specification in which it appears. I also understand that the words in the claims
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`are to be evaluated from the perspective of a PHOSITA.
`
`3.
`Legal Framework
`I understand that a patent claim may be unpatentable for a number of
`
`20.
`
`reasons, including, for example, if it recites subject matter that is not new or that
`
`would have been obvious to a PHOSITA.
`
`21.
`
`I understand that a claim is not new if all of the elements of the claim
`
`are present in a single printed publication or patent. In these cases, I understand
`
`that the claim is said to be “anticipated.” I understand that to anticipate a claim,
`
`the prior art does not have to use the same words as the claim, but all of the
`
`requirements of the claim must have been disclosed, either inherently or expressly,
`
`to a PHOSITA.
`
`22.
`
`I also understand that, even though every element of a claim is not
`
`disclosed in a single printed publication or patent, the claim may still be
`
`unpatentable if it would have been obvious to a PHOSITA at the time of the
`
`invention. In determining whether a claimed invention is obvious, I understand
`
`that a number of factors must be considered including the level of ordinary skill in
`
`the art at the time the invention was made, the scope and content of the prior art,
`
`and any differences between the prior art and the claimed invention.
`
`
`
`15
`
`COOK
`Exhibit 1021-0015
`
`

`

`23.
`
`I also understand that obviousness is not necessarily proved simply by
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
`
`
`
`showing the existence of each and every element of the claimed invention in the
`
`prior art. I understand that I should also consider whether there were reasons that
`
`would have prompted a PHOSITA to combine the known elements in a way the
`
`claimed invention does, including:
`
`
`
`
`
`
`
`
`
`
`
`
`
`common sense;
`
`whether the claimed invention was merely the predictable result of
`
`using prior art elements according to their known function(s);
`
`whether the claimed invention provides an obvious solution to a
`
`known problem in the relevant field;
`
`whether the prior art teaches or suggests the desirability of combining
`
`elements in the manner claimed in the invention;
`
`whether the prior art teaches away from combining elements in the
`
`manner claimed in the invention;
`
`whether it would have been obvious to try the combination of
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`elements, such as when there is a design need or market pressure to
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`solve a problem and there are a finite number of identified, predictable
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`solutions; and,
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`
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`whether the modification or combination would have resulted from
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`design incentives or other market forces.
`16
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`
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`COOK
`Exhibit 1021-0016
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`

`

`24. Moreover, I am advised that the prior art must provide a reasonable
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
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`
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`expectation of success. In addition, I understand that the use of hindsight is
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`improper, and that only what was known at the time of the invention can be
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`considered.
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`25.
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`In addition, I also understand that objective evidence, or “secondary
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`considerations,” that existed at the time of the invention and afterwards may shed
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`light on the non-obviousness or obviousness of the claimed invention, and should
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`be taken into account. These considerations include, for example:
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`
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`whether products incorporating the claimed invention have been
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`commercially successful and, if so, whether the commercial success
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`
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`
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`
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`
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`
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`
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`can be attributed to the claimed invention;
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`whether the invention satisfied a long-felt, unmet need;
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`whether others had tried and failed to make the invention;
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`whether others copied the invention;
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`whether the invention achieved unexpected results;
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`whether others in the field praised the invention;
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`whether persons having ordinary skill in the art in the technology of
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`the invention expressed surprise or disbelief regarding the invention;
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`17
`
`COOK
`Exhibit 1021-0017
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`

`

`
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`
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`
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`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
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`whether the inventor proceeded contrary to the accepted wisdom in
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`the field; and,
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`whether there were independently made, simultaneous inventions
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`made within a comparatively short space of time.
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`26.
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`I also understand that, in order to be relevant to the issue of
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`obviousness, any such secondary consideration must have some connection (or
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`nexus) to the claimed invention.
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`II. OVERVIEW OF SHAPE MEMORY ALLOY TECHNOLOGY AND
`THE ’141 PATENT
`A.
`Shape Memory Alloys
`1. Ordinary Elasticity
`27. When a force is applied to a solid body, the body deforms by some
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`amount. The amount of deformation is proportional to the amount of applied
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`force. When the deforming force is released, the body may return back to its
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`original state. This is known as elasticity. However, the amount of elasticity that
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`any material has is limited: if we apply too much force, i.e., cause too much
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`deformation, then the material undergoes permanent deformation. In engineering
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`practice, deformation is quantified by:
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`Strain = Change in length of a segment / Original length of the segment
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`18
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`
`
`COOK
`Exhibit 1021-0018
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`

`

`
`
`Bhattacharya Declaration
`U.S. Patent No. 6,306,141
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`2.
`Shape-Memory Effect
`28. The shape-memory effect is the ability of shape memory alloys
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`(SMAs) to recover or “remember” a shape after deformation. For example, the
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`following figure illustrates shape memory effect based on temperature transitions.
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`
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`Fig. 1: Schematic of shape-memory effect based on temperature transitions
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`29. The basic phenomenon of shape-memory effect is illustrated in
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`Figure 1 above. The temperature values on the y-axis are defined as