1W
`
`7181866
`
`LiML
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`
`May 15 2009
`
`THIS IS TO CERTIFY THAT ANNEXED IS
`TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF
`
`APPLICATION NUMBER 07/956653
`FILING DATE October 02 1992
`PATENT NUMBER 5597378
`ISSUE DATE January 28 1997
`
`By Authority of the
`Under Secretary of Commerce for Intellectual Property
`and Director of the United States
`Trademark Office
`
`Certifying Officer
`
`Edwards Exhibit 1033, p. 1
`
`

`

`-ti
`
`3ERvIs.rmERTONCA
`
`INUINO TAtt/
`
`TED
`
`TJS APPLN
`IS
`WHICH
`IS
`WHICH IS
`WHICH
`IS
`IS
`WHICH
`WHICH
`IS
`
`51U
`DIV
`CON
`CON
`CON
`CON
`
`Cii-
`
`OF
`
`flic
`
`243
`fl7/2F iii
`817
`524
`
`317/04/.
`
`04/09/91 rr
`nA F7
`pN ss 115
`
`n9/77/RP
`03/Sn/SR
`05/05/57
`
`PAT
`
`FTLIWS
`
`LICENSE
`
`LRANTED
`
`10/25/92
`
`tjn priority
`USC 119
`
`.1
`
`condItions
`
`claimed
`
`yes
`
`met
`
`yes
`____________
`
`initials
`
`CA 91101
`
`ir
`
`555
`
`INCORFORAT
`
`StA1E ORI SHEETS
`ORWOL
`Ic0tTRtI
`
`TOTAL
`CLAIMS
`
`AS
`FILED
`
`.1
`
`12301 FE
`
`NO
`
`SIN ALLOY
`
`-H
`
`../I
`
`_--
`
`-3
`
`-/
`
`Edwards Exhibit 1033, p. 2
`
`

`

`PATENT APPLICATION
`
`/956653
`SERLAL NO._______________
`
`U.S DEPARTMETT
`OF COMMERCE
`PATENT
`AND TRADEMARK OFFICE
`FEE RECORD SHEET
`
`160 ME 10/19/92
`
`07956653
`
`101
`
`2190.O0
`
`CK 9438
`
`PTO1 556
`5/87
`
`Edwards Exhibit 1033, p. 3
`
`

`

`T9566531
`
`%99Z
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`
`DocketNe
`
`9438
`
`Anticipated
`
`Classification
`
`of this application
`
`Subclass
`
`_______________________
`
`Prior application
`
`Art Unit
`
`ooney
`
`3301
`
`Box Patent Application
`Commissioner of Patents
`Washington D.C 20231
`TRANSMITFAL OF FILING UNER 37 CFR 1.60b
`
`and Trademarks
`
`WARNING
`
`WARNING
`
`WARNiNG
`
`WARNiNG
`
`c-i-p continuation-in-part
`
`cannot be filed under
`
`37 CFR 1.61
`
`Filing under
`
`37 CFR 1.60 is permitted
`in the prior application
`
`only if filed by the same or less than all the loves3 ors named
`
`as tire United States stage of an international
`The filing of an application
`37CFR 1.61a
`
`oath or declaration
`
`Application
`
`requires an
`
`The claims of this new application may be finally rejected in the first Office
`are drawn to
`claimed
`in the earlier
`of the new application
`the same invention
`have been properly
`would
`finally rejected on the grounds
`they had been entered in the earlier application MPEP
`
`or art of record in the next Office
`
`action if
`
`706.07b
`
`action where all claims
`and
`
`application
`
`This is
`
`request
`
`for
`
`filing
`
`LI Continuation
`
`Divisional
`
`application under 37 CFR 1.60 of pending
`682243
`
`serial no
`
`prior application
`4/9/91
`
`filed on
`date
`
`James
`
`Jervis
`
`MEDICAL DEVIcES
`
`for
`
`ve4s9y EENTS
`
`title of invention
`
`CERTIFICATION
`
`UNDER 37 CFR 1.10
`
`hereby certify that
`
`this 37 CFR 1.60 request and the documenjs refrred to as attched therein
`on this date OL4
`17
`ited with the United States Postal Service
`Es
`959930US
`
`ss
`
`ii
`
`st
`
`Office
`
`to Addressee
`
`service
`
`under
`
`37
`
`CFR
`
`1.10
`
`Mailing
`
`addressed
`
`to the Commissioner
`
`of
`
`are being depos
`
`as
`in an envelope
`Number
`Label
`
`D.C 20231
`
`Type or print name of person mailing paper
`
`Ward
`
`SIgnature
`
`of person mailing paper
`
`NOTE
`
`or fee filed by Express Mail must have the number of
`Each paper
`to mailing 37 CFR 1.10b
`placed thereon ps-icr
`
`the Express Mail mailing label
`
`37 CFR 1.60b 4-31page
`
`of
`
`Edwards Exhibit 1033, p. 4
`
`

`

`37 CFR 1.60 permits
`the omission of
`in 37 CFR 1.51a name the prior application
`claim or claims
`drawings when necessary
`declaration
`37 CFR 1.60 does not permit
`as presently worded
`and retention
`but only the processing
`is pending
`application
`nere the declaration was not
`
`declaration
`
`only if
`
`the prior application
`
`was complete
`
`as set
`
`comprised at least
`
`and
`
`filing fee Ac
`the prescribed
`to be used where
`the prior
`this procedure
`fee required by 37 CFR 1.211
`
`specification including
`
`is paid or
`
`filtid
`
`as Filed Which
`
`is Attached
`
`NOTE
`
`forth
`
`cordingly
`
`Copy of Prior Application
`NOTE
`
`Under
`
`37 CFFI
`signing and execution of the application
`1.60 practice
`is supplied by and accompanied
`provided the copy
`by
`the application
`ney or agent
`no amendments
`
`statement
`
`true
`
`prior application
`
`by the applicant may be omitted
`or his or her attor
`by the applicant
`as filed and that
`copy of the
`new
`
`the prior application
`
`introduced
`
`filed to complete
`
`that
`
`papers comprise
`referred to in the declaration
`
`matter
`
`therein
`
`NOTE
`
`This
`
`statement need not be verified
`CFR 1.60b
`
`it made by an attorney
`
`registered
`
`to practice
`
`before
`
`the PTO 37
`
`verify
`
`that
`
`hereby
`the attached
`records to be the above
`identified
`ration originally filed 37 CFR 1.60
`
`papers are
`
`true copy
`
`prior application including
`
`of what
`in my
`the oath or decla
`
`is shown
`
`The copy of the papers
`19
`
`of prior application as filed which are attached
`
`are as follows
`
`pages of specification
`
`pages of claims
`
`pages of abstract
`
`sheets of drawing
`
`Also complete
`
`part
`
`below if drawings
`
`are to be transferred
`
`pages of declaration and power of attorney
`
`If the copy of the declaration being filed does not show appllcants
`and complete
`dicate thereon
`it was signed
`that
`
`signature in
`
`in accordance with the indication
`
`the following
`required by 37 CFR 60b my re
`cords
`declaration
`the original
`reflect
`that
`signed
`showing
`appli
`cants signature was filed on __________________________
`
`the amendment
`tion and
`
`that
`
`hereby
`this amendment
`
`the prior applica
`referred to in the declaration filed to complete
`the requirements of 37 CFR 1.60b
`state in accordance with
`did not introduce new matter therein
`
`Amendments
`
`WARNING
`
`where
`
`tion
`
`The claim of
`new application may be finally rejected in the first Office
`the new application
`for an earlier applica
`continuing
`application
`to the same invention
`and
`all the claims of the new application
`the earlier application
`finally rejected on the grounds
`and
`have been property
`would
`if they had been entered
`record
`in the next Office
`
`is
`
`o1 or
`
`substitute
`
`are drawn
`
`action
`
`in the earlier
`
`application
`
`claimed in
`
`or art of
`MPEP
`
`action in those situations
`
`706.07b
`
`El Cancel
`
`in this application original
`claims ___________________
`fee At least
`the filing
`before calculating
`one
`plication
`claim must be retained for filing
`purposes
`
`of
`
`the prior ap
`independent
`
`original
`
`by this amendment
`is enclosed Claims added
`preliminary amendment
`been properly numbered consecutively
`the number next
`with
`beginning
`the highest numbered original claim in the prior application
`
`have
`
`following
`
`NOTE
`
`ffling under
`
`Rule
`
`1.60 retain
`
`the number of claims or adding
`Only amendments
`reference to the prior application
`reducing
`the flhing fee and granting the filing date 37 CFR 1.60b
`1.78a will be entered before calculating
`NOTE When
`
`at least
`
`claim from the patent
`one original
`19861064 QG 37-38
`
`Rule
`
`application
`
`to assure
`
`complete
`
`application
`
`Notice of March
`
`37 CFR 1.60b
`
`of
`
`Edwards Exhibit 1033, p. 5
`
`

`

`Petition
`
`of Prosecution
`
`for the Time Necessary to File an Amendmert
`
`appli
`
`for Suspension
`NOTE Where it is possible
`the claims on file will give rise to
`first action final
`for this continuation
`that
`be filed promptly .e.g experimental
`cation and-for some reason an amendment
`data is being-
`ii may be desirable to file
`of prosecution
`for the time necessary
`for suspension
`
`gathered
`
`cannot
`
`petition
`
`check
`
`the next item if applicable
`
`LI There is provided
`For The Time
`To Suspend
`herewith-
`Prosecution
`to File An Amendment New Application Filed Concurrently
`Necessary
`Disclosure Statement
`
`PetitLon
`
`Information
`
`check
`
`this item if applicable
`
`An information disclosure statement
`
`is-submitted herewith
`
`Fee Calculation 37 CFR 1.16
`
`CLA1MS
`
`AS FILED
`
`fla1JDG PRIIvffNPRY
`
`Number
`
`filed
`
`Number Extra
`
`Rate
`
`Basic Fee
`37 CFR 1.16a
`$690.00
`
`Total
`Claims 37 CFR 1.16c
`
`Independent
`Claims 37 CFR 1.16b
`
`52 20 32
`
`Multiple dependent claims if any
`37 CFR 1.16d
`
`20.00
`
`72.00
`
`640
`
`360
`
`$220.00
`
`1100
`
`LI
`
`Fee for extra
`
`claims is not being paid at this time 37 CFR 1.16d
`
`NOTE
`
`If
`
`the fees for extra
`
`claims are not paid on filing
`
`of the time period set
`
`for
`
`response
`
`by amend
`they must be paid or the claims cancelled
`by the PTO in any notice of fee defi
`
`Filing Fee Calculation
`
`2190
`
`ment prior
`to the expiration
`ciency 37CFR 1.16d
`
`Small Entity Status
`
`and such
`
`status is stilt proper and
`
`verified
`
`statement
`
`that
`
`this filing
`
`is by
`
`small entity
`
`is attached
`
`has been filed in the parent application
`desired 37 CFR .1.28a
`Filing Fee Calculation 50% of above
`fee paid will be refunded if
`
`NOTE Any excess
`
`of thit
`
`full
`
`verified
`
`statement
`
`is filed within
`
`months of the
`37 CFR
`on request
`
`date of
`
`timely
`
`payment
`
`of
`
`full
`
`fee then the
`
`excess
`
`fee paid will be refunded
`
`1.28a
`NOTE 37 GFR 1.28a
`clude
`reference
`
`and desired
`
`last sentence
`
`states
`
`4ppllcations
`
`filed under
`
`1.60 or
`
`to
`
`verified
`
`statement
`
`in
`
`parent application
`
`if status as
`
`1.62 of this part must in
`small entity
`is still proper
`
`37 CFR 1.60b
`
`of
`
`Edwards Exhibit 1033, p. 6
`
`--
`--
`

`

`DrawIngs
`WARNING
`
`Do not check
`
`the following
`
`box if prior
`
`case
`
`is not
`
`to be abandonei
`
`Transfer
`
`said prior application
`
`to this application and sublect
`date accorded
`as of the filing
`
`isenclosed
`
`for filing
`
`the drawings
`from the prior application
`to item 17 below abandon
`this application
`in the prior
`duplicate copy of this request
`of re
`application file May onFy be used if signed
`by
`applicant
`assiinee
`attorney or agent of record authorized by 37 CFR 1.138 and before
`cord or
`payment of issue fee
`NOTE -A registered
`attorney or agent
`pressly abandon
`such
`
`continuing
`
`as of the filing
`prior application
`37 CFR 1.138
`
`application
`
`dale granted to
`
`acting under
`
`the provisions
`
`of
`
`1.34a or of record may also ex
`when filing
`
`continuing
`
`application
`
`Transfer
`
`the following sheets
`
`of drawing
`
`from the prior application to this
`
`application
`
`NOTE
`
`Transferred
`
`sheets must be cancelled in pnor application
`
`37 CFR 1.88
`
`copy
`
`of
`
`the amendment
`
`cancelling these
`
`sheets
`
`of drawing
`
`in the prior
`
`application is attached
`
`New drawings
`
`are enclosed
`
`formal
`
`informal
`
`WARNING
`
`DO NOT submit
`
`original
`
`drawings
`
`high quality
`
`The
`
`that
`
`to
`
`1.84.11
`
`are
`
`copy of drawings should be supplied when filing
`the Office must be on strong
`are submitted
`white
`patent
`application
`drawings
`the standards of
`smooth and non-shiny paper and meet
`corrections
`to the drawings
`they should be made to the original
`drawings and
`copy of the corrected
`high-quality
`is required or desired Comments
`on
`to the Office Only one copy
`then submitted
`drawing
`1988 1090 QG 57-62
`proposed new 37 CFR 1.84 Notice of March
`
`necessaiy
`
`original
`
`NOTE
`
`Identifying indicia
`numbei
`
`inventors
`
`placed in
`
`centered
`
`art
`
`uni1
`
`title of the
`
`inventor
`
`attorneys
`
`docket
`
`to exceed
`
`2/4
`
`three fourths
`
`the serial numbe group
`such
`as
`inches 7.0 cm in width may be
`name number of sheets
`etc not
`inch 19.1 mm of the top
`between
`location
`the side edges within
`the drawing or the placement
`edge Either this marking technique
`not pre
`on the front of
`although
`on the back of the drawings is acceptable Pro
`and the title of the invention
`ferred of this information
`posed 37 CFR 1.841 Notice of March
`O.G 57.62
`
`19881090
`
`Priority35 U.S.C 119
`
`Priority
`
`of
`
`serial
`
`application
`_______________________________
`35 U.S.C 119
`
`is claimed
`
`under
`
`no
`in _______________________________
`
`/________________
`
`filed
`
`countiy
`
`serial no
`
`copy has been filed in prior U.S application
`The certified
`/____________
`on _____________________
`
`The certified
`
`LI
`copy will
`Relate Back35 U.S.C 120
`Amend the specification
`
`follow
`
`by inserting
`
`before the first
`
`line the sentence
`
`This is
`
`continuation
`
`divisional
`
`of copending applications
`
`Serial number
`
`on __________
`
`/________________
`
`tiled
`
`LI
`
`International
`
`Application
`the U.S
`which designated
`
`filed on ____________________
`
`37 CFR 1.60b
`
`on
`
`and
`
`of
`
`Edwards Exhibit 1033, p. 7
`
`

`

`NOTE
`
`filed PCT application
`reference
`The proper
`serial number and the filing date of the PCT application
`
`prior
`
`to
`
`which
`
`which
`
`entered the U.S national phase is the U.S
`the U.S
`
`designated
`
`10
`Inventorship
`NOTE
`
`Statement
`
`cation
`
`application
`
`is filed by less than all the inventors named in the prior appli
`If the continuation or divisional
`application
`of the names of the
`when filed requesting
`statement must accompany
`the application
`who are not
`inventors of the invention being claimed in the continuation
`person or persons
`37 CFR 1.60b emphasis addedJ
`
`deletion
`
`or divisional
`
`complete
`
`appropriate items
`
`and
`
`With
`
`respect
`
`claims benefit
`
`U.S application
`from which
`to the prior copending
`under 35 Usc 120 the inventors in this application
`
`this application
`is are
`
`complete
`
`applicable item below
`
`the same
`
`less than those named in the prior application and it
`is reqUested
`be deleted
`above for the prior application
`following inventors identified
`
`that
`
`the
`
`The inventorship for all the claims in this application are
`
`Type names of inventors
`
`to be deleted
`
`the same
`
`not
`
`the same and an explanation
`claims at the time the last claimed
`
`of the various
`including the ownership
`invention was made is submitted
`
`11 Assignment
`
`The prior application is assigned
`of record to
`Paychem Corporation
`
`LI
`
`an assignment
`
`of the invention to
`
`_______________________________________
`
`ASSIGNMENT COVER LE1TER ACCOMPANYING
`is attached
`separate
`NEW PATENT APPLICATION
`is also attached
`
`NOTE
`
`12
`
`new application
`If an asgnment is submitted with
`1990 1114
`tion and one for the assignment Notice
`of May
`Fee Payment Being Made At This Time
`
`send two
`
`separate letters
`77-78
`
`one for
`
`the applica
`
`LI Not Enclosed
`Li No filing
`1.16e
`
`Enclosed
`
`fee is submitted This and the surcharge
`can be paid subsequenily
`
`required by 37 CFR
`
`basic filing
`
`fee
`
`fl
`
`recording assignmertt
`37 CFR
`$40.00
`1.21h
`
`and retention fee
`processing
`37 CFR 1.53
`$130.00
`and 1.211
`
`690
`
`Additional Claims
`
`$1500
`
`37 CFR 1.60b
`
`of
`
`Edwards Exhibit 1033, p. 8
`
`

`

`$7 CFR 2fJ establishes
`
`fee
`
`that
`
`and retaining
`which
`is abandoned
`any application
`for processing
`to 37 CFFI 153d and this as well as the changes
`pursuant
`in oder to obtain the benefit
`prior U.S appllcation
`of
`the basic
`
`for
`
`to 37
`
`either
`
`the application
`/0 complete
`feiIn9
`CFR 1.53 and 1.78 indicate
`fee must be paid or else
`53d
`
`filing
`
`flvm notification
`
`under
`
`the processing
`
`and retention
`
`fee of
`
`1.211 must be paid within
`
`year
`
`Total
`
`fees enclosed
`
`2190
`
`13 Method
`
`of Payment of Fees
`
`enclosed
`
`is
`
`check
`
`in the amount of
`
`2190
`
`charge AcOount
`
`duplicate
`
`NO ________________
`of this request is attached
`
`in the amount of $________________
`
`NOTE
`
`Fees should be itemized in such
`122b
`
`manner
`
`that
`
`is clear
`
`for which
`
`purpose
`
`the
`
`fees are paid 37 CFR
`
`14
`
`Authorization
`
`To Charge Additional Fees
`
`WARNING
`
`WARNING
`
`If no fees are beingpaidon
`
`filing
`
`do not complete
`
`this item
`
`Accurately
`
`count
`
`claims
`
`especially
`
`multiple
`
`dependent
`
`claims
`
`to avoid unexpected
`
`high charges
`
`if
`
`ex/r.p
`
`claim charges
`
`are authorized
`
`The Commissioner is hereby authorized to charge the foUowing
`by this paper and during the entire pendency of the appli
`which may be required
`i92u90
`No
`to Account
`cation
`
`additional
`
`fees
`
`37 CFR 1.16
`
`37 CFR 1.16
`
`Because
`
`additional
`
`or
`
`thing fees
`
`and ci presentation
`
`of extra
`
`claims
`
`NOTE
`
`fees for excess
`claims not paid on filing or on later presenta
`or multiple
`dependent
`of the time per
`tion must only be paid or these claims cancelled by amendment prior
`to the
`by the PTO in any notice of fee del idency 37 CFR 1.16d it might be best not
`oil set
`for response
`the PTO to charge
`claim fees except possibly when dealing with amendments af
`
`expiration
`
`to
`
`authorize
`
`additional
`
`ter final action
`
`37 CFR 1.17 application processing
`
`fees
`
`WARNING
`
`under
`
`While 37 CFFI 1.17a
`lion should be made only with
`knowledge
`37 CFR 1.136a is to no avail unless
`request or petition
`lOSOaG 27
`added Notice of November
`
`deal with extensions of time under
`
`1.136a this authoriza
`
`that Submission
`
`of the appropriate
`
`extension fee
`
`for extension is filed femphasis
`
`and
`
`the
`
`1985
`
`El
`
`37 CFR 1.18 issue fee at or before mailing Notice
`to 37 CFR 1.311b
`
`of Allowance
`
`pursuant
`
`NOTE
`
`Where
`
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`
`to charge
`
`the
`
`issue fee to
`
`deposit account
`
`has been filed before the mailing
`
`of
`
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`will be automatically
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`
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`0/mailing
`
`charged
`
`to the deposit
`
`account
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`the ime
`
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`
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`
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`issue fee
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`
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`to paying or at the
`of status must be made even
`
`of change
`
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`
`NOTE
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`entity
`
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`of any change
`status must be filed in the application
`From the wording of 37 CFFI 128b
`is paid as ther than
`small entity and
`
`no notification
`
`is
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`required if the
`
`change
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`
`entity
`
`15
`
`Power of Attorney
`
`The power of attorney in the prior application
`Sheldon
`Jeffrey
`
`is to
`
`Attorney
`
`27953
`
`Reg No
`
`The power appears
`
`in the original papers
`
`in the prior application
`
`37 CFR 1.60b 4-3page
`
`of
`
`Edwards Exhibit 1033, p. 9
`
`

`

`Since the power does not appear in the original papers
`is enclosed
`the prior application
`
`copy of the power in
`
`new power has been executed
`
`and is attached
`
`Address
`
`all
`
`future communications
`
`ry Sheldon Esq
`Sheldon Mak
`
`to
`
`818 7964000
`
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`
`Lake Av nue
`iiw
`CA
`Pasadena
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`by /fic(cid:226)t
`
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`if
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`the petition
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`tiled in the prior application
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`sponse
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`the papers constituting
`ber5 1985 1060 QG 27
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`the filing
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`of the Continuation Appilcation
`
`term for re
`the
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`Notice of Novem
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`tached
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`NOTE
`
`The PTO finds
`
`it useful
`
`if
`
`copy of the petition
`
`sponse
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`is filed with the paper
`O.G 27
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`the fIling
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`tiled in the prior application
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`extending
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`as of the filing
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`
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`
`continuingapplication
`
`1.34a or of record may also ex
`when filing
`
`continuing application
`
`Please
`
`pending
`
`is granted
`
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`time while the prior application
`the prior application
`or when the petition
`for extension of time or to revive
`and when this application
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`at
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`is
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`
`filing
`
`date so as to make this
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`in that application
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`copending
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`with
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`said prior application
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`37 CFR 1.60b
`
`of
`
`Edwards Exhibit 1033, p. 10
`
`

`

`19 Notification In Parent Application
`
`of the Filing of This Continuation Application
`
`Li
`
`notification
`
`of the filing
`
`of
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`this continuation
`
`is being
`
`filed in the
`
`parent application
`35USC 120
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`claims priorityunder
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`like so made are punishable
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`18 of the United States Code and that
`issuing thereon
`of the application
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`Type or
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`Avenue
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`
`Mak
`
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`
`of Signatory
`
`Inventor
`
`Tel No 8l 7964000
`
`Reg.No 27953
`if appiji
`
`LI
`
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`
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`
`of complete
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`
`authorized
`
`to sign on behalf of assignee
`
`Attorneyoragentof
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`record
`
`LI
`
`Filed
`
`under Rule 34a
`
`Complete the following if applicable
`
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`Type name of ass gnee
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`of assignee
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`Title of person authorized to sign on behalf
`
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`recorded
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`in PTO on
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`Reel _________
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`DOCUMENT COVER LEUER ACCOMPANYING
`
`NEW
`
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`PATENT APPLICATION
`
`37 CFR 1.60b
`
`of
`
`Edwards Exhibit 1033, p. 11
`
`

`

`U.S 5erai
`
`i-c
`
`Fiid October
`
`ci
`
`01/956653
`
`MPD8L_U51
`
`CONFORMED COPY
`
`MEDICAL
`
`DEVICES
`
`INCORPORATING
`
`SIN ALLOY ELEMENTS
`
`James
`
`Jervis
`
`ABSTRACT OF THE DISCLOSURE
`
`Medical
`
`devices which
`
`are currently proposed to use
`elements made
`from shape memory alloys may be
`improved
`by
`instead
`use of stressinduced martensite alloy elements
`use of stressinduced martensite decreases
`the
`temperature
`them easier
`sensitivity of
`the devices thereby making
`remove
`install and/or
`
`the
`
`The
`
`to
`
`Edwards Exhibit 1033, p. 12
`
`

`

`1992
`
`.j
`
`MPO8BLU51
`
`BACKCROUWD
`
`OF
`
`THE
`
`INVENTION
`
`Field of
`
`the
`
`Invention
`
`This
`
`invention
`
`relates to medical
`
`devices
`
`incorporating
`
`shape memory alloys and to improvements
`
`therein
`
`Introduction
`
`to the
`
`Invention
`
`shape memory
`
`are well
`
`known
`
`Afl article
`
`and metallic capable
`
`Materials both organic
`of possessing
`made of
`such materials can be deformed
`heatstable configuration
`
`to
`
`second
`
`from an original
`
`heatunstable
`
`10
`
`configuration
`
`The article is said to have
`
`memory
`
`for
`
`the
`
`reason that
`
`heat alone it can be
`
`caused
`
`shape
`upon the application of
`to revert or
`
`to attempt-
`
`to revert
`configuration
`oriinal heatstable configuration
`shape
`
`from its heatunstable
`
`i.e it
`
`to its
`
`remembers
`
`its original
`
`Among metallic alloys the ability to possess
`result of
`fact
`that
`
`memory
`
`is
`
`the
`
`the alloy undergoes
`
`shape
`
`reversible transformation
`
`from an austenitic
`
`state to
`
`martensitic
`
`state with
`
`transformation
`
`is sometimes
`
`martensitic
`
`transformation
`
`alloy for example
`
`This
`
`an
`
`from
`
`15
`
`20
`
`in temperature
`change
`referred to as athermoelastic
`An article maa from such
`hollow-sleeve is easily deformed
`its origina1 configuration
`cooled
`below the
`
`25
`
`formed from the austenitic
`
`temperature
`
`to
`
`new configuration
`at which the alloy is trans
`state to the martensitic state
`
`-when
`
`Edwards Exhibit 1033, p. 13
`
`

`

`a3
`
`HPOBBAUS1
`
`The
`
`temperature
`
`at which
`
`this transformation
`
`begins
`
`is
`
`usually
`
`finishes
`
`referred
`
`to as
`
`H5
`
`and
`
`the temperature
`
`at which
`
`it
`
`When
`
`an article thus deformed
`
`is warmed
`
`to
`
`the temperature
`
`at which
`
`the alloy starts to revert
`
`bsck
`
`to
`
`austenite
`
`referred
`
`to
`
`as
`
`A5
`
`being the
`
`temperature
`
`at which
`
`the reversion
`
`is complete
`
`the deformed
`
`object will
`
`begin to
`
`return
`
`to
`
`its origirl configuration
`
`to display
`
`an
`
`memory alloys SHAm are known
`Hanyshape
`stressinduced jnartensite SIM When
`SMA sample exhibit
`ing stressinduced martensite
`M5 so that
`stable but
`below
`
`10
`
`is stressed
`
`at
`
`temperature
`
`above
`
`the austenitic
`
`state is initially
`
`the maximum
`
`temperature
`
`at which
`
`Md
`
`martensite
`
`formation
`
`can
`
`occur
`
`even
`
`under stress it first
`
`deforms elastically
`
`and
`
`then
`
`at
`
`critical
`
`stress begins
`
`to
`
`of stressinduced martensite
`
`transform by the formation
`
`Depending
`
`on whether
`
`the temperature
`
`is above
`
`or below
`
`the behavior
`
`when
`
`the deforming
`
`stress
`
`is released differs
`
`If the temperature
`
`is stable
`
`but
`
`is below
`
`A5 the stressinduced martensite
`is above
`the martensite
`if the temperature
`
`is unstable
`transforms
`returning or attempting
`is seen in almost all alloys which
`
`and
`
`back
`
`to austenite with the
`
`to
`
`return to its original
`
`sample
`
`shape
`
`The effect
`
`20
`
`25
`
`exhibit
`
`thermoelastic martensitic
`
`transformation
`
`along
`
`with the shape memory effect
`
`However
`
`the extent
`
`of
`
`the
`
`temperature
`
`range
`
`over which
`
`SIM is seen
`
`and
`
`the stress
`
`and
`
`strain ranges
`
`for
`
`the effect
`
`vary greatly with the alloy
`
`In
`
`copending
`
`and
`
`commonly
`
`ation
`
`assigned U.. Patent Applic
`fl
`L2..5kJcttCr1
`to Quin the disclosure
`
`of
`
`flokJ
`
`which
`
`is incorporated
`
`herein
`
`by reference
`
`nickel/titanium
`
`.0
`
`vanadium
`
`alloy having
`
`SIM over
`
`wide
`
`temperature
`
`range
`
`is
`
`disclosed
`
`Edwards Exhibit 1033, p. 14
`
`

`

`a4
`
`MPO88L-US1
`
`Shape memory alloys have
`
`found
`
`use in recent
`
`for example pipe couplings
`Pat Nos 4035007
`
`electrical
`
`connectors
`
`and 4198081
`such as are described
`
`to Harrison
`
`such as are described
`
`years in
`in U.S
`
`and Jervis
`
`in U.S Pat
`
`No
`
`as are described
`
`such
`Fischer
`3740839
`to Otte
`switches
`in U.S Patent No 4205293 actuators etc
`
`Various
`
`proposals
`
`have
`
`memory
`
`alloys in the medical
`
`field
`
`also been made
`to employ
`shape
`For example U.S Pat
`et al proposes
`the use of
`SMA
`an
`device U.S Pat No 3786806
`
`No 3620212
`
`to
`
`Fannon
`
`10
`
`intrauterine
`
`contraceptive
`et al proposes
`Johnson
`to
`U.S Pat No 3890977
`
`element
`
`to bend
`
`catheter
`
`the use of
`
`an
`
`SHA
`
`bone plate
`
`Wilson proposes
`or cannula etc
`
`the use of
`
`an
`
`SNA
`
`These medical
`
`SHA devices
`
`rely on
`
`the property
`
`of
`
`shape
`
`memory
`
`to
`
`achieve
`
`their desired effects
`
`That
`
`is to say
`
`the fact
`
`that
`
`when
`
`they
`
`rely on
`
`an
`
`SMA element
`
`is cooled
`
`to
`
`its martensitic
`
`state and
`
`is subsequently
`
`deformed it will
`
`retain its new shape
`
`but when
`
`it is warmed
`
`to its austeriitic
`
`state the original
`
`shape will
`
`be
`
`recovered
`
`20
`
`However
`
`the use of
`
`the shape memory
`
`effect
`
`in medicai
`
`applications
`
`is attended with two principal
`
`disadvantages
`
`First
`
`it is difficult
`
`to control
`
`the transformation
`
`temper
`
`atures
`
`of shape memory
`
`alloys with accuracy
`
`as
`
`they are
`
`usually
`
`extremely
`
`compositionsensitive
`
`although
`
`various
`
`have
`
`been
`
`proposed
`
`the blending
`
`including
`tec7iques
`e-rraetallurgy of alreadymade alloys of differing
`see 13.5 Pat No 4310354
`
`formation
`
`Fountain
`
`temperatures
`et al. Second
`
`in many
`
`shape memory
`
`alloys there
`
`by
`
`trans
`
`to
`
`Edwards Exhibit 1033, p. 15
`
`

`

`aS
`
`MPO8BLU51
`
`is
`
`large hysteresis
`
`as
`
`the alloy is transformed
`
`between
`
`austenitic
`
`and martensitic
`
`states
`
`so
`
`that
`
`reversing
`
`of
`
`the
`
`state of
`
`an
`
`SMA element may
`
`require
`
`temperature
`
`excursion
`
`of several
`
`tens
`
`of degrees Celsius
`
`The combination
`
`of
`
`these
`
`factors with.the
`
`limitation that
`
`it is inconvenient
`
`to
`
`have
`
`to
`
`engage
`
`in any
`
`temperature manipulation and
`
`human
`
`tissue cannot
`
`be
`
`heated
`
`or cooled beyond
`60C for short
`
`certain
`
`relatively
`
`narrow limits approximately
`
`periods without
`
`suffering
`
`temporary
`
`or permanent
`
`damage
`
`is
`
`10
`
`expected
`
`devices
`
`to
`
`limit the
`
`use that
`
`can
`
`be made of
`
`SMA medical
`
`It would
`
`thus be desirable
`
`to
`
`develop
`
`way
`
`in
`
`which
`the advantageous
`i.e their ability
`
`to
`
`property
`
`of
`
`shape memory alloys
`
`return to
`
`an original
`
`shape after
`
`relatively
`
`substantial
`
`deformation could be
`
`used
`
`in medical
`
`15
`
`devices without
`
`requiring
`
`control
`
`and/or
`
`the temperature
`
`control
`
`of placement
`
`or
`
`rempval
`
`needed
`
`by present
`
`shape memory
`
`alloy devices
`
`the delicacy
`
`of alloying
`
`DESCRIPTION
`
`OF
`
`THE
`
`INVENTIDN
`
`Summary
`
`of
`
`the Invention
`
`20
`
`25
`
`30
`
`have
`
`discovered
`
`that if in
`
`medical
`
`device
`
`containing
`
`shape memory
`
`alloy element which
`
`uses
`
`the shape memory
`
`property
`
`of
`
`that alloy an element which
`
`shows
`
`the property
`
`of stressinduced
`
`ma rtensite is used
`
`instead an
`
`improved
`
`device
`
`results
`
`Accordingly
`
`this invention
`
`provides
`
`medical
`
`device
`
`intended
`
`for use within
`
`mammalian
`
`body
`
`or
`
`in such proximity
`
`to
`
`mammalian
`
`body
`
`that
`
`the device
`
`is substantially
`
`at
`
`body
`
`temperature
`
`which
`
`device
`
`comprises
`
`shape memory
`
`alloy
`
`element
`
`the improvement
`
`in which
`
`comprises
`
`the substitution
`
`of
`
`an alloy element which
`
`displays
`
`stressinduced martensite
`
`at said body
`
`temperature
`
`for
`
`the shape memory alloy element
`
`Edwards Exhibit 1033, p. 16
`
`

`

`a6
`
`4P0B5LLJS1
`
`Brief Descriotion
`
`of
`
`the Drawinq
`
`Figures
`
`and
`
`illustrate
`
`the stressstrain behavior
`
`of
`
`behavior
`
`exhibits
`constant
`stress versus
`an alloy which
`to stressinduced martensite
`
`due
`
`strain
`
`Detailed
`
`Description of
`
`the Preferred
`
`Embodiments
`
`The
`
`invention will
`
`be discussed
`
`first by introducing
`
`the concept
`
`of stressinduced martensite
`
`and
`
`the effect
`
`achievable
`
`by
`
`its use and
`
`then by examples
`
`showing
`
`how SI1
`
`alloy elements
`
`can
`
`be substituted
`
`for
`
`conventional
`
`SMA
`
`10
`
`elements
`
`in medical
`
`devices
`
`to
`
`achieve
`
`the beneficial
`
`effect
`
`of
`
`the invention
`
`The Ficures
`
`illustrate
`
`the phenomenon
`
`of stress
`
`induced martensite by means
`
`of stressstrain curves
`
`In
`
`both Figure
`
`the alloy is at
`
`temperature
`
`and Figure
`
`.15
`
`between
`
`and
`
`it will
`
`so
`
`and Md
`be
`assumed
`
`that
`
`it is initially austenitic
`
`for
`
`the puposes
`
`of
`
`this discussion
`
`that
`
`is equal
`
`shows
`
`the case
`
`and
`
`to Mf
`A5 equal
`when
`the temperature
`
`to Af
`is below
`
`Figure
`
`so
`
`triat
`
`any martensite formed by
`
`the applied
`
`stress
`
`is stable while
`
`20
`
`Figure -2 shows
`
`the case where
`
`the temperature
`
`is above
`
`so
`
`that austenite
`
`is the only stable
`
`phase
`
`at
`
`zero stress
`
`In Figure
`
`when
`
`stress
`
`is applied
`
`it deforms elastically along
`
`the line OA
`
`to
`
`At
`
`the alloy
`
`critical
`
`applied
`
`stress
`
`the austenitic
`
`alloy begins
`
`to
`
`trans
`
`25
`
`form to stressinduced martensite
`
`This
`
`transformation
`
`Edwards Exhibit 1033, p. 17
`
`

`

`MPD8SL1JS1
`
`takes
`
`place
`
`at essentially
`
`constant
`
`stress until
`
`the alloy
`
`becomes
`
`fully martens itic at point
`
`From that point
`
`on
`
`as
`
`further
`
`stress
`
`is applied
`
`the martensite
`
`yields first
`
`elastically
`
`and
`
`then plastically
`
`only elastic deformation
`
`is shown
`
`at point
`
`When
`
`the stress
`
`is released the
`
`martensite
`
`recovers
`
`elastically
`
`to point
`
`at which
`
`there
`
`is zero residual
`
`stress but
`
`nonzero
`
`residual strain
`
`Because
`
`the alloy is below
`
`the deformation
`
`is not
`
`recoverable
`
`until heating
`
`above
`
`results in
`
`reversion
`
`10
`
`to austenite
`
`At
`
`that point
`
`if the sample
`
`is unrestrained
`
`the original shape will
`
`be essentially
`
`completely
`
`recovered
`
`if not
`
`it willbe recovered
`
`to
`
`the extent
`
`permitted
`
`restraint
`
`However
`
`if tHe material
`
`is then allowed
`
`recool
`or
`
`to
`
`the original
`
`temperature
`
`at which
`
`temperature
`
`where
`
`51W behavior
`
`of
`
`the
`
`by
`
`to
`
`deformed
`
`the stress
`
`produced
`
`in the sample will
`
`be
`
`constant
`
`regardless
`
`of
`
`the strain provided
`
`that
`
`the strain lies within
`
`the
`
`it was
`this type is seen
`
`plateau
`
`region
`
`of
`
`th
`
`stressstrain
`
`and the strain will
`
`curve
`
`That
`
`is for
`
`be
`
`This
`
`20
`
`means
`
`that
`
`known
`
`constant
`
`force calculable
`
`from
`
`can
`
`be applied
`
`over
`
`wide
`
`up to
`
`or more for certain Ni/Ti
`
`alloys
`
`strain range
`
`Thus
`
`thouoh
`
`this resembles
`
`the
`
`conventional
`
`shape memory effect
`
`because
`
`the alloy shows
`
`SIM
`
`and
`
`is below
`
`A5
`
`constant
`
`force can
`
`be achieved
`
`In Figure
`
`when
`
`it deforms elastically
`
`stress
`
`is applied
`along line DA then by
`
`to
`
`the alloy
`
`51W along
`
`line
`
`A3 and
`
`by deformation
`
`of
`
`the mertensi.te to point
`
`just as
`
`in Figure
`
`However
`
`the stressstrain
`
`behavior
`
`on
`
`unloading
`
`is significantly
`
`different
`
`since
`
`the alloy is above
`
`Edwards Exhibit 1033, p. 18
`
`

`

`and
`
`the stable phase
`
`is removed
`then at acritcsl
`
`the a1lov
`
`is therefore austenite
`recovers elastral rcc
`
`As
`
`trie stress
`
`stress
`
`tne ailo reverts
`
`austerute
`
`without
`
`requiring
`
`change
`
`in terperature
`
`Ihuc
`
`reversion
`
`occurs
`
`at essentially
`
`constant
`
`stress
`
`Finally
`
`if
`
`the stress
`
`is removed
`
`recovers
`
`elastically
`
`from the reverted
`along line ED
`
`The
`
`austenite
`
`it
`
`rec6verable
`
`deform
`
`ation
`
`associated
`
`with the
`
`formation and
`
`reversion
`
`of stress-
`
`induced
`
`rnartensite
`
`has
`
`been
`
`referred
`
`to
`
`as pseudoelasticity
`
`10
`
`While
`
`usually
`
`be
`
`high e.g 50 ksi
`may
`cA
`substantially lowere.g less than 13 ksi
`
`comparatively
`
`is
`
`thereby
`
`working
`
`creating
`
`range
`
`of about
`
`constantforce
`ce
`in the SMA is thus mechanically
`
`spring with an effective
`
`The
`
`shape
`
`chanoe
`
`available
`
`rather
`
`than thermally
`
`15
`
`actuated
`
`and controlled permitting
`
`greater
`
`control
`
`over
`
`device
`
`incorporating
`
`it.
`
`for this invention
`
`i.e those displaying
`
`Suitable alloy
`
`body
`
`by those
`
`disclosure
`
`by
`
`temperatures
`
`near mammalian
`
`be
`
`selected
`
`from known
`
`SMAs
`
`having
`
`recard
`
`to
`
`this
`
`the SIN effect
`
`at
`
`stressinduced martensite at
`temperature 35LLDC may
`of ordinary skill
`i_or the exitence of
`alloy is
`the desired
`temperature
`particularly
`preferred
`the nickel/titanium/vanadium alloy of U.S Patent Application
`us P-kT i1 iO/Th7
`No
`to previously
`
`Ji3
`
`The
`
`inventin will
`
`now be
`
`discussed
`
`in detail
`
`by
`