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 MICHAEL O’KEEFFE
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`
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`
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`
`
`Case No. IPR2019-00123
`__________________________________________________________________
`
`
`
`
`COOK
`Exhibit 1025-0001
`
`

`

`1. My name is Michael O’Keeffe. I make this declaration based on my
`
`own personal knowledge.
`
`2.
`
`I obtained a B.S. degree in Biotechnology from Trinity College,
`
`Dublin, in 1976, and a M.S. degree in Biotechnology from Okayama University
`
`Japan in 1980. I also obtained a Diploma in Japanese from Osaka University of
`
`Foreign Studies in Japan in 1977.
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`3.
`
`English is my native language and I speak, read, and write English
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`fluently. I am also familiar with the Japanese language.
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`4.
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`In 1980, I began working as a translator of materials from Japanese
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`into English, and I have been working as a translator of Japanese language
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`materials for over 30 years (working full time as a translator from 1987 to 1999,
`
`and from 2006 to present). I have worked for clients such as the European Patent
`
`Office and the Japanese Cabinet Office, I have served as a quality manager for the
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`World Patent Index (DWPI), and I have taught Japanese at the Japan-Ireland
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`Society, Dublin.
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`5.
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`I presently work with Transperfect Legal Solutions. My job
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`responsibilities include translating documents from Japanese to English.
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`6.
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`Attached as Exhibit A to this Declaration is a true and correct copy of
`
`excerpts from the Titanium & Zirconium Journal, including the cover page (with
`
`table of contents) and the article entitled, “Shape Memory and Super-elasticity
`
`COOK
`Exhibit 1025-0002
`
`

`

`Effects in NiTi alloys,” by Yuichi Suzuki (the “Suzuki article”). This copy is
`
`written in Japanese.
`
`7.
`
`Attached as Exhibit B to this Declaration is a translation of these
`
`items from the Titanium & Zirconium Journal. This translation is a true and
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`correct translation (from Japanese to English) of these items, including the Suzuki
`
`article.
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`8.
`
`A true and correct copy of the Suzuki article (along with its true and
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`correct translation) has been designated EX. 1012 in this proceeding.
`
`9.
`
`I have been warned that willfiil false statements and the like are
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`punishable by fine or imprisonment, or both. I declare under penalty of perjury
`
`under the laws of the United States of America that the foregoing is true and
`
`correct.
`
`Executed at Najera, La Rioja, Spain on September 26, 2018.
`
`
`
`Michael O’Keeffe
`
`COOK
`
`Exhibit 1025-0003
`
`COOK
`Exhibit 1025-0003
`
`

`

`
`
`
`
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`COOK
`Exhibit 1025-0004
`
`

`

`,f p ~ r7 b . 3}» :1 :_ r71). Vol. 30. No. 4(5Efn57fi510fi28fififi)
`
`CODEN: CHJIA 6
`ISSN 0577-9391
`
`TITAINIUM & ZIRCONIUM
`
`VOL_3O OCTOBER 1982 No.4
`
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`COOK
`Exhibit 1025-0005
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`Shape Memory and Super-elasticity
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`Ni-Ti fifiwfiélfifififlfitflflfi
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`Effects in NiTi Alloys
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`Summary: The equiatomic or near equiatomic NiTi is a unique intermetallic compound. It has good ductility, a
`
`shape memory effect, and a super-elasticity. The alloy undergoes a martemitic transformation at near room temper-
`
`ature. The low temperature phase is characterized by high damping capacity, and the high temperature phase by
`
`excellent abrasion and corrosion resistance. By a shape memory effect we mean that the alloy plastically deformed
`
`in the low temperature phase recovers its original shape in subsequent heating. Super-elasticity is a rubber-like
`
`behavior of the alloy in which a strain attained beyond the elastic limit in loading recovers upon unloading. The
`
`following is a presentation of the general properties and deformation mechanisms of the shape memory effect and
`
`the super-elasticity of the NiTi alloys including its applications such as in jointing devicu, thermal actuators, and
`medical devices.
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`185
`
`COOK
`
`Exhibit 1025-0006
`
`
`
`COOK
`Exhibit 1025-0006
`
`

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`COOK
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`Exhibit 1025-0007
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`COOK
`Exhibit 1025-0007
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`COOK
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`Exhibit 1025-0008
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`COOK
`Exhibit 1025-0008
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`

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`Exhibit 1025-0009
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`S. Miyazaki, K. Otsuka and Y. Suzuki:
`Scripla Met., [5, 287 (l981)
`'
`9) L. C. Chang and T. A. Read: Tram.
`AIME, 189, 47 (1951)
`
`10)
`
`\V. J. Buehler, J. W. Gilfrich and R. C. Wiley;
`J. apply. Phys., 34, 1475 (1963)
`11) K. Otsuka and K. Shimizu: Scripta Met., 4,
`469 (1970)
`I2) xmfiffi : 525mg, 27, 245 (1971)
`13)
`7§Ufi§lk : 7/»?V‘*J‘4 ”magma; it.
`awn
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`14)
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`J. D. Harrison and D. E. Hodgson: Shape
`Memory Efforts in Alloys, Plenum, New York,
`517 {1975)
`B. J. Mulder: Vacuum, 26, 31 (1975)
`15)
`16) R. F. Otte and C. I. Fischer: U. S. Patent No.
`3, 740, 839 (1973)
`17) Ed. by D. M. Goldstcin and L. McNamara:
`Proc. Nitinol Hcat Engine Conference, 2-1,
`(1978)
`saxae— : fig, 5], 15 (1981—11)
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`\‘V. J. Buchler: U. S. Patent No. 3, I74, 851
`(1965)
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`Exhibit 1025-0013
`
`

`

`
`
`
`
`
`
`
`EXHIBIT B
`
`EXHIBIT B
`
`COOK
`Exhibit 1025-0014
`
`

`

`
`
`Titanium Zirconium Vol. 30, No. 4 (Published 28 of Oct 1982) CODEN: CHJIA 6 ISSN 0577-9391
`[handwritten:] 217-358
`Titanium & Zirconium
`Titanium & Zirconium
`Vol. 30, Published 28 of Oct 1982 No. 4
`Table of Contents
`Photograph of the International Conference Center, Kobe venue main hall ............................................................................... Cover Page
`
`Shape Memory and Super-elasticity Effects in NiTi Alloys ......................................................................................... Yuichi Suzuki ...... 1
`
`Evaluation of a thin titanium tube used in devices for turning sea water into fresh water using evaporation method Koshi
`Sato, Bunsho Kamikubo, et al. .................................................................................................................................................................... 10
`
`Summary of the lecture by Professor Yotaro Murakami “the organizational structure of titanium alloys” ...................... Jun Hirano .... 17
`
`Impressions of the metallic hydrides symposium ............................................................................................................... Seio Sasaki .... 19
`
`The recent adaptation of titanium to audio apparatus ......................................................................... Koichi Higashi, Kono Sugihara .... 21
`
`The usage of titanium in camera shutters ...................................................................................................................... Kuno Uematsu .... 25
`
`Test method for deep vortices in Titanium welded pipes TIS 8218 Titanium Society Standard-Non-destructive testing subcommittee 31
`
`Fifth (1984) titanium international conference announcement .................................................................................... Keizou Kimura .... 41
`
`The development of an underwater filming and image capture system by NHK, a titanium alloy VTR cover ....................................... 44
`
`A record of a study tour of the Chubu Power Hamaoka atomic power generation facility- ... Non-destructive testing subcommittee ... 45
`
`Announcement of the holding of the 46th corrosion prevention symposium Corrosion Prevention Association (Corp) .................... 46
`
`Abstracts of journal papers.......................................................................................................................................................................... 47
`
`Main news of May to July 1982 .............................................................................................................................................................. 49
`
`Committee reports ....................................................................................................................................................................................... 53
`
`Index of 30 years of Titanium Zirconium Journal ................................................................................................. Edited by T. Suzuki .... 55
`
`[seal:] Japanese National Diet Library 26th of November 1982
`
`
`
`
`
`
`
`
`
`JAPAN TITANIUM SOCIETY
`
` 
`
`COOK
`Exhibit 1025-0015
`
`

`

` 
`
`Shape Memory and Super-elasticity Effects in NiTi Alloys
`
`1
`
`
`
`
`
`
`
`
`
`
`
`Yuichi Suzuki
`
`
`
`Summary: The equiatomic or near equiatomic NiTi is a unique intermetallic compound. It has good
`ductility, a shape memory effect, and a super-elasticity. The alloy undergoes a martensitic transformation
`at near room temperature. The low temperature phase is characterized by high damping capacity, and the
`high temperature phase by excellent abrasion and corrosion resistance. By a shape memory effect we
`mean that the alloy plastically deforms in the low temperature phase and recovers its original shape in
`subsequent heating. Super-elasticity is a rubber-like behavior of the alloy in which a strain loading
`beyond the elastic limit recovers upon unloading. The following is a presentation of the general properties
`and transformation mechanisms of the shape memory effect and the super-elasticity of the NiTi alloys
`including its application such as in jointing devices, thermal actuators, and medical devices.
`
`
`1. Ni-Ti alloys have various characteristics
`A Ni-Ti alloy containing nickel and titanium in
`the atomic ratio of 1:1 shows unique characteristics.
`Although it is an intermetallic compound, it can be
`worked plastically. Furthermore,
`the
`alloy
`undergoes a martensitic transformation at a certain
`temperature near room temperature. The alloy
`shows various unique forms of behavior
`in
`accordance with the martensitic transformation.
`
`The central Research Laboratory
`The Furukawa Electric Co., Ltd.
`9-15, 2-chome, Futaba,
`Shinagawa-ku, Tokyo
`
`It has been known that this alloy has a great
`damping
`capacity
`at
`temperatures
`below
`martensitic
`transformation
`temperature
`(abbreviated
`to M-transformation
`temperature
`hereinafter; this M-transformation will be described
`in the section on mechanisms below, but it is to be
`understood here to be a certain temperature or the
`like.1) The alloy was developed by the Naval
`Ordnance Laboratory (NOL) as a soundproofing
`material for submarines as a countermeasure
`against SONAR. The damping capacity can be
`called the first feature. The damping characteristic
`could therefore conceivably be used as a damping
`material or a soundproofing material.2)
`
`
`
`Titanium Zirconium Vol. 30, No. 4 (Published 28 of Oct 1982)
`
`185
`
` 
`
`COOK
`Exhibit 1025-0016
`
`

`

`2
`
`Photograph 1
`
`Shape memory alloy and super-elastic alloy 
`
`Super‐Elastic Alloy 
`
`The second feature of the alloy is characterized by a shape
`memory effect which appears when the M-transformation and a reverse
`M-transformation are cycled in a temperature domain near the M-
`transformation temperature, precisely speaking, one that straddles the
`M-transformation temperature. This phenomenon is characterized in
`that when the alloy is heated to a temperature higher than the M-
`transformation temperature after it has been deformed at a temperature
`lower than the M-transformation temperature, its shape recovers to its
`original form.3) - 5)
`The third feature of the alloy, super-elasticity appears in a
`temperature domain slightly higher than the M-transformation
`temperature. This is a rubber-like behavior in which a deformation
`strain of several percent which significantly exceeds the yield point is
`recovered only upon unloading, so this behavior is sometimes called
`false elasticity or rubber elasticity.6)
`Although these unique phenomena do not appear in a temperature
`region much higher than the M-transformation temperature, these
`characteristics of the alloy become significantly advantageous in a
`structured material having both excellent corrosion and abrasion
`resistances. The fourth feature has been previously made use of in
`certain portions of chemical plants or the like where rubbing takes
`place and where corrosion resistance is required.
`
`186
`
`
`
`
`Titanium Zirconium Vol. 30, No. 4 (Published 28 of Oct 1982)
`
` 
`
`COOK
`Exhibit 1025-0017
`
`

`

`3
`
`Since the fourth feature consisting of corrosion and abrasion
`resistances as described above has been previously disclosed in this
`magazine,7) the shape memory effect and super-elasticity which have
`recently become of major interest for functional materials will now be
`described with introducing practical examples.
`2.
`Shape memory effect and super-elasticity
`As described above, the shape memory effect and super-elasticity
`are phenomena in which a deformation strain exceeding the yield point
`can be reversed only by heating or unloading. These phenomena will
`now be more specifically described with reference to actual
`photographs and stress-strain diagrams (Fig. 1).
`
`On the other hand, a super-elastic alloy does not require heating
`for recovering from strain. If the load is removed after the alloy has
`been deformed to the yield region, the strain, as shown in Fig. 1, returns
`to zero, exhibiting a behavior which is the opposite of the yield
`phenomenon.
`It must be noted here that the amount of strain which can be
`reversed by the shape memory effect or super-elasticity has a certain
`limitation. Strain sometimes cannot be recovered from, depending on
`the manner of deformation. The point will now be described with
`reference to a stress-strain diagram covering a high strain domain (Fig.
`2).8)
`When a shape memory alloy is deformed at a temperature below
`
`Normal metallic materials 
`
` 
`
`Super‐elastic alloys 
`
` 
`
`Shape memory alloys 
`
`
`
`Fig. 1 Stress-strain diagrams of shape memory alloy, super-elastic alloy, and normal metallic material
`
`the M-transformation
`
`temperature, yield occurs after elastic
`
`deformation ①, and the stress becomes approximately constant. If the
`load is removed at an intermediate portion of the flat portion ②,
`apparent plastic strain ③ remains, but this strain is removed by
`work hardening has progressed to a certain degree ④ the strain ⑤ also
`permanent deformation ⑥. If the deformation strain further increases,
`breaks. A material which has been extensively work-hardened ⑦ will
`
`heating, as mentioned above. However, if the deformation strain
`increases so as to exceed the flat portion, the stress again begins to
`increase, and work hardening begins. If the load is removed when the
`
`remains, but this strain cannot be recovered from by heating to a
`temperature beyond the M-transformation temperature, resulting in a
`
`the increase in stress becomes moderate, and finally the material
`
`not recover its shape by heating.
`
`Therefore, it is necessary to restrict the amount of strain to below
`a certain value (7.5% in Ni-Ti alloy) in order to obtain an excellent
`shape recovery characteristic. This is exactly the same as the condition
`for super-elasticity.
`
`Both the shape memory effect and super-elasticity were
`accidently discovered in an alloy consisting of gold and cadmium in
`the early 1950s,9) but they did not attract much attention at the time
`because of the rarity of the alloy. The shape memory effect was not
`studied much until after significant shape memory effects were
`discovered in Ni-Ti alloys by the NOL (as described above).10) Since
`
`
`
`Strain 
`Fig. 2 Stress-strain diagram of shape memory Ni-Ti alloy
`A normal metallic material completely recovers from a
`deformation strain below its elastic limit upon unloading, but if the
`strain enters the yield region after exceeding the elastic limit, only the
`elastic deformation can be reversed upon unloading, leaving plastic
`deformation which creates permanent deformation.
`
`If deformation strain is applied to an alloy exhibiting the shape
`memory effect, that is, a shape memory alloy, yield is similarly seen
`after the straight-line region caused by elastic deformation, and
`apparent plastic deformation
`remains after unloading. This
`deformation does not depend on displacement slip which is seen in
`usual metallic materials, but it is a kind of hemitrope deformation, but
`the appearance bears no relation to the plastic deformation due to slip.
`However, these deformation strains can be cancelled and the original,
`strain-free, shape can be regained by heating the alloy to a temperature
`above the M-transformation temperature.
`
`
`
`
`Titanium Zirconium Vol. 30, No. 4 (Published 28 of Oct 1982)
`
`187
`
` 
`
`COOK
`Exhibit 1025-0018
`
`

`

`4
`
`
`then, numerous research results have been disclosed, and more than a
`dozen alloys having the shape memory effect have been discovered.
`
`However, when this effect was discovered in Ni-Ti alloys, the
`fact that these alloys have super-elasticity was not known. Therefore,
`super-elasticity has mainly been studied in Cu-Al-Ni alloys as a
`phenomenon which is independent from the shape memory effect. The
`super-elasticity of the Ni-Ti alloys was discovered at the beginning of
`the 1970s, immediately before it was clarified that the two phenomena
`depend
`upon
`super-elastic
`M-transformation.11) 12)
`Materials which have corrosion and abrasion resistances in the
`high temperature phase have been developed for structural materials,
`completely independently of their shape memory effects as functional
`materials. These materials were realized as the functional materials
`much earlier.
`
`3. Mechanisms of shape memory effect and super-elasticity.
`The reasons governing the occurrence of the shape memory effect
`and super-elasticity are complicated, and not many details have been
`clarified scientifically. Therefore, only the mechanism which has been
`clarified will now be simply described (see Fig. 3).
`
`When a shape memory alloy which is in an austenitic phase
`(abbreviated to A phase hereinafter) at a high temperature is cooled and
`the alloy passes a certain temperature (M-transformation start
`temperature, called the Ms point), the alloy M-transforms from the A
`phase to the M phase. The M phase is a well-known phenomenon
`which occurs when steels are rapidly cooled down. This phase also
`occurs in metals such as titanium or zirconium, or in alloys. This
`phenomenon is due to a phase transformation in which the crystal
`structure changes mainly by shear transformation, without any
`accompanying diffusion, with the solid phase thereof retained.13)
`When the M phase is heated to a temperature at which the M phase is
`returned back again to the A phase (This temperature is slightly higher
`than the Ms point reached during cooling, and is called the Af point.
`The previously described M-transformation temperature is this Af
`point.), the A phase is again realized. If no external force is applied, the
`
`macrostructure of the alloys are not changed by
`this cycle consisting of transformation and
`inverse transformation. However, the case is
`different if an external force is applied to the M
`phase. In this case, if the stress exceeds the
`yield-stress, apparent plastic deformation occurs
`as mentioned above, but this deformation is a
`sort of hemitrope