Declaration of Ming H. Wu, Ph.D.
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`PETITIONER EDWARDS’ EXHIBIT NO. 1002
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`DECLARATION OF MING H. WU, Ph.D.
`PURSUANT TO 37 C.F.R. §§ 1.68, 42.63, AND 42.65
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`Edwards Exhibit 1002
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`Edwards Exhibit 1002, p. 1
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`PETITIONER EDWARDS’ EXHIBIT NO. 1002
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`DECLARATION OF MING H. WU, Ph.D.
`PURSUANT TO 37 C.F.R. §§ 1.68, 42.63, AND 42.65
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`Edwards Exhibit 1002
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`Edwards Exhibit 1002, p. 1
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`I.
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`Declaration of Ming H. Wu, Ph.D.
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`TABLE OF CONTENTS
`BACKGROUND .................................................................................. 1
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`II. MATERIALS REVIEWED ................................................................. 2
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`III. QUALIFICATIONS ............................................................................. 2
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`IV. DISCUSSION OF SHAPE MEMORY ALLOYS AND NITINOL .... 6
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART ............................. 27
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`VI.
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`THE JERVIS ’141 PATENT .............................................................. 29
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`VII. PRIOR ART TO THE ’141 PATENT ................................................ 36
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`VIII. SUMMARY OF OPINIONS .............................................................. 69
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`Edwards Exhibit 1002, p. 2
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`Declaration of Ming H. Wu, Ph.D.
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`I. BACKGROUND
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`1.
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`I am over the age of 18 and a citizen of United States of America. My
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`permanent residence is 1462 Voyager Drive, Tustin, California.
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`2.
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`I have been asked by the law firm of Meunier Carlin & Curfman,
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`LLC, on behalf of Edwards Lifesciences Corporation (“Edwards”), to provide my
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`technical analysis and opinions regarding prior art references and technology
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`relevant to U.S. Patent No. 6,306,141 to Jervis (“the ’141 Patent”).
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`3.
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`More specifically, I have been asked to explain the physical and
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`inherent properties of shape memory alloys (SMAs), including Nitinol, and to
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`describe the state of technology with regard to Nitinol in the late 1970’s and early
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`1980’s. I have also been asked to determine whether references and patents
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`publicly available at the time the priority application to the ’141 Patent was filed
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`on October 14, 1983 disclose all of the limitations of Claims 1-22 of the ’141
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`Patent. Finally, I have been asked to review U.S. Patent No. 5,597,378 to Jervis
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`(“the ’378 Patent”) to determine whether the claims of the ’141 Patent are
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`distinguishable over the claims in that patent.
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`4.
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`I am not receiving hourly compensation for my time spent working on
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`this matter, nor have I received any additional compensation for the preparation of
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`this report. I have no interest or stake in the outcome of this case aside from being
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`Edwards Exhibit 1002, p. 3
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`Declaration of Ming H. Wu, Ph.D.
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`an Edwards’ employee. Further, my compensation paid by to me by Edwards is
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`completely unrelated to the outcome of this matter.
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`II. MATERIALS REVIEWED
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`5.
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`As part of my work on this declaration, I have reviewed documents
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`provided to me by Meunier Carlin & Curfman in addition to publicly available
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`documents and information. The documents that I have relied on to support my
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`analysis and opinions contained in this declaration are cited herein.
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`III. QUALIFICATIONS
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`6.
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`My curriculum vitae is attached as Exhibit 1003. This is my first
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`time serving as an expert witness, and I have never testified or provided a written
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`report in any prior patent-related cases or proceedings.
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`7.
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`I have been employed by Edwards since 2006 and am currently Vice
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`President of Engineering. In that role, I manage both the Advanced Materials
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`Technology and the Advanced Packaging Technology organizations. I provide
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`both technical and managerial leaderships to the Advanced Materials Technology
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`in early product concept development and prototyping, material testing and
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`computational modeling to support Edwards’ product innovation. The Advanced
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`Packaging Technology organization engages in packaging design, testing and
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`technology innovation to support Edwards’ new product development and
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`Edwards Exhibit 1002, p. 4
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`sustaining operation. In my capacity at Edwards, I deal extensively with
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`superelastic Nitinol shape memory alloys.
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`8.
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`In 1977, I received my Bachelor of Science degree in Materials
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`Science and Engineering from the National Tsing Hua University in Taiwan; in
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`1983, I received a Master of Science degree in Materials Science and Engineering
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`from the University of Illinois at Urbana-Champaign; and in 1986, I received a
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`Doctorate of Philosophy degree in Materials Science and Engineering from the
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`University of Illinois at Urbana-Champaign. My focus during both my Masters
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`and Doctorate studies related to phase transformations and the properties and
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`characteristics of shape memory alloys.
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`9.
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`After receiving my doctoral degree, I was an adjunct research
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`professor at the Naval Postgraduate School at Monterey, California from 1985 to
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`1986. My postgraduate and postdoctoral research projects included studies of
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`phase transformations in silver and copper based shape memory alloys as well as
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`those in manganese-copper high damping alloys. These phase transformations
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`were related to the shape memory properties and the acoustic damping effect of the
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`materials.
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`10.
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`I was employed by Memry Corporation from 1986 to 2006 in various
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`positions of increasing responsibilities. From 1986 to 1996, I was Chief
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`Metallurgist. In that role, I was responsible for developing fabrication and heat
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`Edwards Exhibit 1002, p. 5
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`treatment processes for Nitinol and Cu based shape memory actuators as well as
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`superelastic dental and medical devices of Nitinol shape memory alloys.
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`11.
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`From 1996 to 2000, I was promoted to Director, then Vice President
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`of Engineering, and later to General Manager. In these capacities, I managed the
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`engineering function in developing Nitinol commercial, industrial and medical
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`device applications. Later as General Manager, I had added responsibilities of
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`manufacturing and quality assurance of the Memry Eastern Operation’s Nitinol
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`business.
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`12.
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`From 2000 to 2006, I was Vice President Technology and was in
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`charge of directing corporate technology strategy, intellectual properties and key
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`technology development projects. During my tenure at Memry Corporation, my
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`experience on Nitinol medical devices included vascular and non-vascular stents,
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`aortic stentgrafts, closure devices, guidewires, laparoscopic surgical devices and
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`orthopedic instruments.
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`13.
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`I have been a member of Shape Memory and Superelasticity
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`Technologies (SMST) Society since its inception in 1992 and served as a member
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`of the board of directors from 2004 to 2007. I am also a member of the ASM
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`MPMD (Materials and Processes for Medical Devices) Committee and chaired the
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`Committee from 2009 to 2011.
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`Edwards Exhibit 1002, p. 6
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`14. While both are affiliated with ASM International, a materials
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`information society, SMST takes on a mission to promote understanding and
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`applications of both shape memory and superelastic Nitinol and other shape
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`memory alloys through workshops, conferences and publications. The ASM
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`MPMD Committee adopts a similar strategic approach to promote biomaterials in
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`general, including Nitinol.
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`15.
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`I am an active member of ASM F04 subcommittee and participated in
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`the development of all Nitinol related materials and test standards. These
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`standards include Nitinol standard terminology, Nitinol material and tube
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`specifications for medical devices and surgical implants, and test methods such as
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`tension testing as well as thermal analysis and bend and free recovery testing for
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`determination of Nitinol transformation temperatures.
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`16.
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`I have authored over 50 publications in scientific journals and
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`conference proceedings on phase transformations, materials properties, test
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`methods, designs and applications of Nitinol and other shape memory alloys. I
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`have also coauthored a chapter entitled “Characterization of Cardiovascular
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`Implantable Devices” in the book of “Characterization of Biomaterials,” which
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`was published by Elsevier in early 2013. Attached as Appendix A to my report is a
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`list of my publications of which I am aware during the past 10 years.
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`5
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`Edwards Exhibit 1002, p. 7
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`17.
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`Starting with my post-graduate work in 1982, I have spent over 30
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`years working with shape-memory metals, in particular Nitinol. My background
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`and experience with shape-memory metals makes me uniquely qualified to discuss
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`the particular properties and uses of these materials as they would have been
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`known to someone in the art as of late 1983.
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`IV. DISCUSSION OF SHAPE MEMORY ALLOYS AND NITINOL
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`18.
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`To assist the Board in understanding the technology relevant to the
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`’141 Patent, I will explain some of the inherent mechanical and property
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`characteristics of shape-memory alloys and, in particular, Nitinol. This
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`information was well known prior to 1983, as evidenced by the many publications
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`and articles that I have cited in support of my analysis.
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`A. Phase Transformations in SMAs (Austenite and Martensite)
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`19. A basic principle of material science is that materials can assume
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`various phases (e.g., solid, liquid, etc.). For example, water may exist in three
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`phases: (1) solid (ice), (2) liquid, and (3) gas (steam). These phases are dependent
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`on the temperature and pressure of the water. That is, water existing as a steam at
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`one temperature may be turned to liquid by the application of pressure or the
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`reduction of temperature.
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`20.
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`Like water, shape memory alloys (“SMAs”) exhibit multiple phases.
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`These are referred to as the “martensite” phase and the “austenite” phase.
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`Edwards Exhibit 1002, p. 8
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`Martensite and austenite are each different in crystal structure, meaning that the
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`atoms are arranged differently depending on their phase. For Nitinol in its
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`austenite phase, the crystal structure is cubic. However, in the martensite phase –
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`whether induced by temperature or stress – the crystal structure is monoclinic (i.e.,
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`the base unit of the structure has three unequal axes, with one part not at right
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`angles).1
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`21. Notably, SMAs are afforded unique “memory” properties because
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`their martensite phase has the ability to “store” deformation. This memory
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`property exists because, in the martensitic phase, a SMA can be easily deformed
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`without breaking atomic bonds. More specifically, martensite can be deformed by
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`a flip-flopping process called twinning that occurs within the martensite. Because
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`few, if any, atomic bonds are broken when the SMA is deformed, martensite can
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`be very easily deformed and returned to its prior state. This is illustrated below:
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`1 See, e.g., Ling et al., Phase Transitions and Shape Memory in NiTi, Metallurgical
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`Transactions A, Vol. 11A, p. 77 (1980) (Exhibit 1008) at 77-79.
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`Edwards Exhibit 1002, p. 9
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`Figure 1: Martensite to Austenite Transformations
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`22. While martensite can be deformed by twinning without breaking
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`atomic bonds, austenite cannot. Thus, when a martensite crystal structure reverts
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`back to austenite (from release of stress or heating), any deformation that was
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`“stored” in the martensite is erased and the original shape returns. It is because of
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`this that when stress is applied to produce martensite, the SMA may exhibit a new
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`shape, yet the SMA will return to its original shape when the stress is removed and
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`the SMA returns to its austenitic state (as illustrated in Figure 1).
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`23.
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`Thus, SMAs are unique in that they have the capability of
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`remembering their previous shape. When a shape memory alloy is deformed due
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`to the application of temperature (i.e., cooling) or stress (e.g., compression,
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`8
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`Edwards Exhibit 1002, p. 10
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`bending, twisting, etc.), it can return to its original shape upon either the release of
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`the stress or by heating. The temperature diagram illustrates how temperature
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`causes the transition and reversion between austenitic and martensitic phases:
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`Figure 2: SMA Temperature Phase Change Points
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`24.
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`If a SMA is in its martensitic phase and is heated, it transforms from
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`martensite to austenite. The phenomenon starts at the austenite start temperature
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`(AS), i.e., the temperature at which, upon heating, martensite begins to phase
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`transform to austenite. The transformation is complete at the austenite finish
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`temperature (Af), above which the SMA is fully austenitic.
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`25. Conversely, when in its austenitic phase, if the SMA is cooled,
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`austenite transforms back to martensite. This phenomenon starts at the martensite
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`start temperature (MS), i.e., the temperature at which, upon cooling, austenite
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`begins to phase transform to martensite. The transformation is complete at the
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`martensite finish temperature (Mf), i.e., the temperature below which the SMA is
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`Edwards Exhibit 1002, p. 11
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`fully martensitic. A simplified view of the temperature phase transformations in
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`Nitinol SMAs is shown below. Between Af and Mf temperatures, both austenite
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`and martensite phases can exist or co-exist depending on the thermal (exposure
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`temperature) and mechanical history of the Nitinol SMA.
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`Figure 3: SMA Temperature Transition Diagram
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`26.
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`The temperature difference between the thermally-induced martensitic
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`and austenitic phases is referred to as “hysteresis,” and it is well known in the art
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`that these temperatures may be controlled based on the chemical composition as
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`well as the cold working and heat treatment of the SMA. Indeed, the Af, As, Mf,
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`and Ms temperatures for a given alloy are all controllable during the manufacturing
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`Edwards Exhibit 1002, p. 12
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`process and can easily be manipulated over a wide range by altering the nickel-
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`titanium ratio of the alloy.2
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`27. Accordingly, I have not provided specific temperature values above
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`for Af, As, Mf, and Ms temperatures because they can easily be altered. That said,
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`the temperatures will undoubtedly be governed by the application for which they
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`are intended. As an example, for self-expanding medical device applications (e.g.,
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`a stent), the Nitinol SMA – which as will be discussed is by far the most
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`commonly used SMA – will undoubtedly have an Af at or below body temperature
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`(~38º C) so that the SMA will fully return to its intended austenite shape when
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`deployed in the body. Further, for this type of Nitinol SMAs, the As temperature is
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`typically 15-20º degrees lower than the Af temperature and the Ms temperature is
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`typically below 0° C.
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`28.
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`Therefore, for certain medical device applications, we can infer based
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`on the application of the Nitinol SMA alone that Ms/Mf temperatures will be less
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`than 0° C, the Af temperature will be at or below approximately 38º C, and the As
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`temperature will be around or below 18-23º C.
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`2 See, e.g., U.S. Pat. No. 4,503,569 to Dotter (March 1983) (Exhibit 1009) at 3:15-
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`27 and 5:5-20.
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`Edwards Exhibit 1002, p. 13
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`Declaration of Ming H. Wu, Ph.D.
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`B. The Shape Memory Effect (Thermal and Mechanical) and
`Pseudoelasticity
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`29.
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`The ability of SMAs to revert to an original shape when changing
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`from martensite to austenite phases due to increase in temperature is called the
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`“shape memory effect.” This term refers to both thermal and mechanical shape
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`memory effects (as explored herein).
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`30.
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`Thermal shape memory (sometimes referred to as “shape memory”)
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`generally refers to the process of cooling a SMA to its martensitic state, deforming
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`the SMA, and then heating the SMA back above its As or Af temperature so that
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`the SMA reverts to its austenitic phase and returns to its undeformed shape.
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`31.
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`This phase transformation from austenite to martensite – when
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`occurring without the influence of stress – is referred to as a “thermally-induced
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`phase transformation” (and the resulting martensite is referred to as “thermally-
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`induced martensite or “TIM”).
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`32. With reference to Figures 2 and 3 above, TIM begins forming in the
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`SMA at the SMA’s Ms temperature, and at the Mf temperature, the SMA
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`transforms completely to thermally-induced martensite. Importantly here, prior to
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`the Ms temperature being reached, the SMA remains fully in its austenitic phase.
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`This is true even though a SMA that is cooled may be more malleable at a lower
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`temperature. That is, the fact that the alloy is more malleable (e.g., like solder)
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`12
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`Edwards Exhibit 1002, p. 14
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`does not mean a phase change has occurred. Indeed, a SMA may be much more
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`malleable below its As temperature, yet still remain in an austenitic state.
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`33. As illustrated in Figure 1 above, phase transformations in SMAs can
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`be equally driven by temperature or stress. That is, one can thermally induce
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`martensite or one can stress induce martensite. Stress-induced martensite or
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`“SIM” occurs whenever stress is applied to an SMA above its Mf temperature.3
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`34.
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`The relationship between inducing TIM or SIM is a linear
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`equivalence,4 as shown below. This linear relationship is derived from the
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`3 See, e.g., Delaey, et al., Thermoelasticity, Pseudoelasticity and the Memory
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`Effects Associated with Martensitic Transformations. Part 1: Structural and
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`Microstructural Changes Associated with the Transformations, Journal of
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`Materials Science, Vol. 9, p. 1521 (1974) (“Delaey,” Exhibit 1010) at 1521-22
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`(“martensite transformations can be induced by the application of stress as well as
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`by changes in temperature”).
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`4 Krishnan, et al., Thermoplasticity, Pseudoeleasticity and the Memory Effects
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`Associated with Martensitic Transformations. Part 2: The Macroscopic
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`Mechanical Behavior, Journal of Materials Science, Vol. 9, p. 1536 (1974)
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`(Exhibit 1011) at 1536-37.
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`Edwards Exhibit 1002, p. 15
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`Clausius-Clapeyron equation,5 a mathematical equation explaining fundamental
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`thermodynamic principles, which was first published in 1834. As shown in this
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`figure, as well as Figure 1, phase transformations in SMAs can be driven equally
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`by temperature or stress.
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`Figure 4: Linear Equivalence of SIM/TIM
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`35.
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`Therefore, either stress and/or temperature may be adjusted to
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`determine which phase of the two crystal structures is stable at any given moment.6
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`5 See, e.g., Otsuka et al., Pseudoelasticity, Metals Forum, Vol. 4:3, p. 142 (1981) at
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`143 (“Otsuka 1981,” Exhibit 1012).
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`6 See generally Patel et al., Criterion for the Action of Applied Stress in the
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`Maternsitic Transformation, ACTA Metallurgica, Vol. 1, p. 531 (1953) (Exhibit
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`1013) at 531-538.
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`Edwards Exhibit 1002, p. 16
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`This equivalence is analogous to the phase change of water from liquid to steam
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`through the application of heat or pressure. In either case, the water possesses the
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`inherent quality of being able to change from liquid or steam through either
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`process, just like a SMA may change from austenite to martensite through the
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`application of either temperature or stress.
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`36.
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`This equivalence has been known for many years, and indeed was
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`well known prior to the filing date of the priority application for the ’141 Patent.
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`For example, as noted in the JOURNAL OF MATERIALS SCIENCE in a 1974 article,
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`“[t]he pseudoelastic behavior [of an SMA] is a complete mechanical analogue to
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`the thermoelastic transformation. In this case the transformation [to martensite]
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`proceeds continuously with increasing applied stress … and is reversed
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`continuously when the stress is decreased.”7
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`37.
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`This behavior, which is termed “pseudoelasticity” or
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`“superelasticity” means that a SMA will exhibit elastic (sometimes referred to as
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`“plastic”) deformation well beyond normal strain (i.e., deformation per unit
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`dimension) limits by phase changing from austenite to stress-induced martensite,
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`and will recover, changing back from SIM to austenite when the stress is relieved.
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`For example, some SMAs may be stressed many orders of magnitude (e.g., 30x)
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`7 Delaey (Exhibit 1010) at 1522.
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`Edwards Exhibit 1002, p. 17
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`Declaration of Ming H. Wu, Ph.D.
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`beyond the elastic strain limit of traditional non-pseudoelastic materials (such as
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`steel) while exhibiting a full recovery.
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`38.
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`Importantly, as discussed in further detail below, if a SMA exhibits
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`thermally-induced martensite, it will also inherently exhibit stress-induced
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`martensite.
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`39. Martensite formation in SMAs can be graphically illustrated by the
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`following stress-strain curve, which was included in Schetky’s publication in
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`1979:8
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`8 Schetky, Shape Memory Alloys, Scientific American, Vol. 241:5, p. 74 (1979)
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`(“Schetky,” Exhibit 1014) at 80.
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`Edwards Exhibit 1002, p. 18
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`Declaration of Ming H. Wu, Ph.D.
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`40.
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`This shows graphically how the shape memory effect produced
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`through superelasticity (i.e., pseudoelasticity) is caused by the ability of the SMA
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`to change its phase from austenite to martensite with continued application of
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`stress, allowing a SMA to exhibit “super” elastic deformation. When the stress is
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`released, the SIM transforms back into austenite and the SMA returns back to its
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`original unstressed shape. This behavior of pseudoelasticity is defined in Figure 2
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`of the ‘141 patent.
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`41.
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`In practice, the temperature ranges for formation of stress-induced
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`martensite and resulting pseudoelasticity may be illustrated as follows:
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`Edwards Exhibit 1002, p. 19
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`Figure 5: Temperature Range for SIM and Pseudoelasticity
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`42. As shown, pseudoelasticity occurs over a temperature range between
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`As and Md, where Md is the temperature above which one can no longer stress
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`induce martensite. In most SMA variations (and especially in pseudoelastic
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`Nitinol, as discussed in more detail below), the Md temperature is about 150
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`degrees (well above most medical applications).9
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`43. Also, while SIM will develop with the application of stress between
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`the Mf and Md temperatures (as noted in the figure), pseudoelasticity will not occur
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`if the temperature of the SMA remains below the SMA’s austenite start (As)
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`temperature That is, while austenite may be converted to martensite between Mf
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`9 T.W. Duerig et al., Ti-Ni Shape Memory Alloys, Materials Properties Handbook:
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`Titanium Alloys, p. 1035 (1994) (Exhibit 1028) at 1035-48.
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`Edwards Exhibit 1002, p. 20
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`Declaration of Ming H. Wu, Ph.D.
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`and Md through compression or stress (i.e., SIM), the SMA will not return to its
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`prior shape when the compression or stress is relieved unless the temperature of the
`
`device rises above its As temperature (because below the As temperature, the
`
`stress-induced martensite remains stable). This behavior of shape recovery due to
`
`the reversion of SIM back to the austenitic state on heating above As (and Af)
`
`temperature is described in the detailed description on Figure 1 of the ‘141 patent.
`
`This property of SMA was well known before 1983. For example, Krishnan
`
`described this as one mechanism for shape memory effect, i.e., “memory effect by
`
`(stress-induced) transformation” in Figure 11 of their 1974 article (Krishnan, et al.,
`
`Thermoplasticity, Pseudoeleasticity and the Memory Effects Associated with
`
`Martensitic Transformations. Part 2: The Macroscopic Mechanical Behavior,
`
`Journal of Materials Science, Vol. 9, p. 1536 (1974) (Exhibit 1011) at 1536-37).
`
`For the ease of discussion and to differentiate it from thermal shape memory effect
`
`associated with thermally induced martensite, I refer to this behavior herein as
`
`“mechanical shape memory effect.”
`
`44. As noted previously in paragraphs 27 and 28, for self-expanding
`
`medical devices, the Af temperature will by design almost always be at about or
`
`below body temperature to ensure that the material exhibits a full shape memory
`
`recovery when released into the body. Otherwise, the purpose of the device (i.e.,
`
`to self-expand in the body) would not occur.
`19
`
`Edwards Exhibit 1002
`
`Edwards Exhibit 1002, p. 21
`
`
`
`
`
`
`
`Declaration of Ming H. Wu, Ph.D.
`
`
`
`45.
`
`This means that when SMAs are used for self-expanding medical
`
`devices in the body, the SMA will exhibit an As well below body temperature,
`
`resulting in the practical effect of inducing mechanical shape memory and
`
`pseudoelasticity through the use of SIM.
`
`46.
`
`This is because, as previously noted, the As temperature for self-
`
`expanding medical device applications will be around or below 20° C, and the
`
`temperature-induced martensitic temperature (Ms) will be well below 0° C. Thus,
`
`even in applications where a SMA is cooled in ice water or saline prior to use,
`
`stress-induced martensitic state is still utilized (and thermally induced martensite is
`
`not used).
`
`47.
`
`For example, in Cragg I (Exhibit 1004), a publication from early
`
`1983 that is cited in the ’141 Patent, a Nitinol stent that exists in its austenitic state
`
`at body temperature is cooled in ice water, deformed, and placed in a catheter for
`
`insertion into the body. This process does not involve TIM. Indeed, the SMA
`
`(Nitinol in Cragg I) has been annealed at a high temperature to “memorize” its coil
`
`shape, and it possesses a martensite temperature (Ms) that is well below 0° C.
`
`Thus, there is no formation of martensite through TIM when the SMA is cooled in
`
`the ice water (because the ice water naturally has a temperature above 0° C).
`
`48.
`
`Instead, when Cragg I teaches cooling, it is reducing the SMA below
`
`its As temperature such that – when the SMA is deformed – it exhibits deformation
`20
`
`Edwards Exhibit 1002
`
`Edwards Exhibit 1002, p. 22
`
`
`
`
`
`
`
`Declaration of Ming H. Wu, Ph.D.
`
`
`
`through stress-induced martensite not thermally-induced martensite. Because the
`
`temperature of the SMA is below As, the device does not immediately start to form
`
`its original shape (i.e., exhibit mechanical shape memory upon warming to body
`
`temperature) because the stress-induced martensite is stable.
`
`49. When the SMA in Cragg I eventually reaches its As temperature,
`
`which happens at least when the device is inserted into the body, the mechanical
`
`shape memory effect takes place, causing the SMA to attempt to revert back to its
`
`unstressed shape. However, because the Nitinol wire is within a catheter, the
`
`catheter prevents the transformation from occurring, thus keeping the SMA in its
`
`constrained stress-induced martensitic state.
`
`50. Cragg I acknowledges that the catheter constrains the Nitinol wire by
`
`stating that friction develops within the catheter upon insertion of the catheter into
`
`the body.10 Thus, because the SMA coil stent in Cragg I remains constrained
`
`within the confines of the narrow catheter, the SMA cannot fully expand, but
`
`
`10 Cragg I at 262 (“The wire we used in this study transformed over a broad
`
`temperature range (25-38° C), which required flushing the introducing catheter
`
`with cold saline to minimize transformation of the wire in the catheter. We also
`
`used a 10-F Teflon introducing catheter to reduce friction of the partially
`
`transformed coil in the catheter.”) (emphasis added).
`
`21
`
`Edwards Exhibit 1002
`
`Edwards Exhibit 1002, p. 23
`
`
`
`
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`
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`Declaration of Ming H. Wu, Ph.D.
`
`
`
`instead remains in a stress-induced martensitic state due to SIM. Only upon
`
`deployment from the catheter is the stress relieved, allowing the SMA stent to self-
`
`expand due to the conversion of martensite to austenite and the inherent property
`
`of mechanical shape memory.
`
`51.
`
`This illustrates that even when cooling is used in medical device
`
`applications in the prior art, it does not disclose invoking thermal shape memory
`
`(i.e., thermally-induced martensite), but instead relies on the principles of stress-
`
`induced martensite and mechanical shape memory inherent in the selected SMA –
`
`exactly the same as what is claimed in the ’141 patent.
`
`C. The Widely Used SMA “Nitinol”
`
`52. Having provided an overview of SMAs generally, I will now focus on
`
`Nitinol, which is by far the most notable and widely used SMA. The shape-
`
`memory effects of Nitinol were discovered by William J. Buehler and Dr.
`
`Frederick E. Wang of the U.S. Naval Ordnance Laboratory in 1962.11 The word
`
`“Nitinol” in fact derives its name from “nickel-titanium Naval Ordnance
`
`Laboratory.” It has also been called several other names, including Tinel, Flexon,
`
`
`11 Kauffman et al., The Story of Nitinol: The Serendipitous Discovery of the
`
`Memory Metal and Its Applications, The Chemical Educator 1, Vol. 2:2, pp. 4-6
`
`(1996) (“Kauffman,” Exhibit 1027).
`
`22
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`Edwards Exhibit 1002
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`Edwards Exhibit 1002, p. 24
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`
`
`
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`
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`Declaration of Ming H. Wu, Ph.D.
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`
`
`and Ni-Ti, Ti-Ni, and simply nickel-titanium.
`
`53. Nitinol generally refers to a range of alloys containing nickel and
`
`titanium, usually in relatively equal amounts. The property features of the SMA
`
`have been well documented in the literature since well before 1983.12 Moreover,
`
`all prior art references that I have relied on for my analysis of the invalidity of the
`
`’141 Patent claims involve the use of SMAs that include Nitinol.
`
`54. Nitinol is widely used in part because in 1979 a leading researcher in
`
`the field of SMAs, Dr. L. McDonald Schetky, popularized the use of Nitinol in
`
`various commercial applications, including medical devices. In his article entitled
`
`Shape-Memory Alloys, which was published in SCIENTIFIC AMERICAN – a widely
`
`circulated periodical at that time – Dr. Schetky discussed the use of Nitinol in
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`space exploration, aircraft design, electrical connections, writing utensils, and
`
`medical devices, among others.13
`
`
`12 See, e.g., Frederick E. Wang et. al, The Irreversible Critical Range in the NiTi
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`Transition, Journal of Applied Physics, Vol. 39:5, pp. 2166-2175 (April 1968)
`
`(Exhibit 1032); D.B. Chernov, et. al., The Multiplicity of Structural Transitions in
`
`Alloy Based on TiNi, Soviet Physics Doklady, Vol. 24:8, pp. 664-666 (August
`
`1979) (Exhibit 1023).
`
`13 See Schetky (Exhibit 1014) at 79.
`
`23
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`Edwards Exhibit 1002
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`Edwards Exhibit 1002, p. 25
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`Declaration of Ming H. Wu, Ph.D.
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`
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`55.
`
`Specifically related to medical devices, Schetky noted that “Nitinol
`
`does not react adversely with living tissue” and described using Nitinol to fasten
`
`artificial joints, facilitate the alignment of fractured bones, and filtering blood clots
`
`out of the circulatory system. As to a medical application intended for filtering
`
`clots, Schetky provided the following:
`
`Morris Simon of Beth Israel Hospital in Boston and the
`Harvard Medical School conceived the idea of fabricating a
`screenlike filter with a mesh size of about two millimeters from
`a continuous length of Nitinol wire. The wire can be
`straightened out when it is cooled below the martensite-
`transformation temperature, chosen to be well below body
`temperature. As the wire is chilled to maintain its straightened
`condition, it can be inserted through a catheter in an arm vein
`into the vena cava, the large vein that feeds into the heart. As
`the wire warms up it assumes the screenlike form. Experiments
`on dogs have been encouraging.14
`
`56.
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