Petitioner: Haag-Streit AG
`Petitioner: Haag-Streit AG
`
`Ex. 100(cid:23)
`
`EX. 1004
`
`

`

`
`ISSUECLASSIFICATION
`
`
`PATENT NUMBER I
`
`
`6547394
`lllllllllllllllllIllllllllllllllllllllllll
`
`
`
`6547394
`
`
`
`
`I
`
`WA
`73
`U.SIno6
`WNW
`MI01/24/01
`7lm
`f
`JC929
`xml?
` APPLICATION NC.
`
`.3; 56337 ’21In:
`(NC! 1‘1»
`,
`
`
`APPLICANTS
`
`, ‘
`
`y
`
`,
`
`I
`
`Fr
`
`I
`
`yyyyyy
`
`StF
`
`
`
`APPLICANTISFMN
`
`V
`
`7W ‘ H V:
`
`I
`
`I
`
`ORIGINAL
`
`r
`
`CLASS
`
`SU -CLASS
`
`Iii-ZII
`‘27 A5’(
`INTERNATIONAL CLASSIFICATION
`
`
`:
`an...
`‘
`5'23?!”
`
`TERMINAL / DRAWINGS
`Sheets Drwg.
`DISCLAIMER/ ~
`Figs. Drwg.
`
`£2
`
`-7
`
`
`
`i
`
`
`
`3
`
`
`
`'
`
`The term of this patent
`bsequent to
`5 been disclaimed.
`
`
`
`L The term of this patent shall
`not extend beyond the expiration date
`of Us Patent. No.
`
`(date)
`
` (Assistant Examiner)
`
`-
`
`M/ "
`(
`Q? m“! ' Maw bt@(
`(P mary Examiner)
`
`.
`
`I
`.
`(CI/24%],
`(Date)
`
`NOTICE OF ALLOWANCE MAILED
`
`I
`[W
`ISSUE FEE
`Amount Due
`Date Paid
`I’CQCI “03
`ISSUE BATCH NUMBER
`
`3 The terminal _months of
`
`this patent have been disclaimed.
`
`(Legal instruments Examiner)
`
`/2/; w(
`
`Date)
`
`WARNING:
`The inlermation disclosed herein may be restricted. Unauthorized disclosure may be prohibited by the United States Code Title 35, Sections 122, 181 and 368.
`Possession outside the U.S. Patent & Trademark Office is restricted to authorized employees and contractors only,
`Form PTO-433A
`5V.
`(R
`6,99)
`FILED WITH: |:| DISK (CRF) D FICHE E] CD-ROM
`(Attached In pocket on right inside Ilap ‘
`
`
`
`«twtvsw ~““”
`
`mew: l‘Et “Ti
`
`,
`
`FTLE:
`
`.
`
`lSSUE; MW I
`
`“wwwm I
`
`(FACE)
`
`

`

`
`
`45.____.__,___* _____
`
`
`46.
`
`~
`
`47.________._ ________
`
`4a.
`
`
`49.
`
`50.
`
`51.
`.
`_
`._
`
`F
`V
`52.
`53.___._________._ ___.v_
`
`
`
`54.
`
`55.
`
`.___._ ._._...
`
`56.
`57.
`15.
`17.___________
`53.
`
`,
`59.
`
`
`18.
`
`,
`
`
`
`
`
`PWfiu’MnuunfixfiufiuTfiu‘fififif'Q“
`”9768731
`W
`
`V
`
`.
`‘X
`
`,
`'i'
`
`-
`
`31392.9- u.s. m.
`
`.
`
`‘
`
`:13.
`
`'
`
`.311111111111111
`i
`‘CON‘TENDEI‘S
`- Date Received
`Dat6‘Frlveceived
`(Incl. C. of M.)
`(Incl. C. of W.)
`or ,
`X
`or
`
`
`Date Mailed
`,.
`Date Mailed
`
`M
`42.
`1.Application
`papers-Fade: '
`
`2
`I
`‘
`43.
`____
`
`44.
`
`.
`
`.
`
`'
`
`.
`j
`3X
`
`‘X
`
`1
`3
`L
`
`‘
`
`.
`i
`
`[
`
`z
`5;
`i
`
`3
`
`19.
`‘
`I 20.__,________
`
`62.
`,
`63.
`-.___ .____‘-
`
`64.
`65.
`
`50.___________, ____.
`
`61.
`
`
`
`
`
`21.;___—
`22.__
`23.
`24.
`
`‘
`
`25._____‘____
`66.
`
`67.
`63.________._ -.-_____
`
`.
`
`
`26.
`27.
`
`
`
`‘ 28._______
`
`29.
`
`-'
`
`_
`
`69.
`
`7o.
`
`
`
`
`
`'
`
`
`71.
`72.__,___+__ ___2:_
`73.
`__ .___...'__
`
`74.
`
`75.
`
`76.
`
`77.
`
`
`
`..
`
`
`_.
`
`'
`
`
`78.
`
`79.
`80.
`
`81.
`‘
`32.
`
`
`
`.
`1
`
`30.
`31.
`32.
`33.
`34.
`
`35.
`
`36.
`
`37.
`
`38.
`39.
`
`4o.
`41.
`
`(LEFT OUTSIDE)
`
`

`

`ISSUE SLIP STAPLE AREA (for additional crpss references)
`
`DATE
`ID No.
`‘
`T”'W¥\Iifihg,
`EOSITION
`,
`r—~————‘-——»~—,—-I——————1———-—I——-—
`
`FEE DETERMINATION
`'
`I
`
`0.I.P.E. CLASSIFIER’ *
`
`
`
`
`
`
`
`
`FORMALITY REVIEW
`RESPONSE FORMALITY REVIEW
`
`‘1
`
`..
`
`»
`
`.
`1 ,
`5 43 {.42 4
`0 “t @647 ‘
`
`’
`
`_
`
`«
`”43:“
`Zfl
`'44 4
`121 L _,
`14:2,
`INDEX OF CLAIMS
`................................. Rejected
`N ................................. Non-elected
`./
`= ................................. Allowed
`|
`................................. Interference
`— (Through numeral)... Canceled
`A ................................. Appeal
`+ ................................. Restricted
`0 ................................. Objected
`
`
`Q9.) 3
`9E.3
`Date
`Claim
`.
`Date
`Date
`
`07i—I’lfil
`me#m~AOrigial'
`FInal §OrIgInal
`F' R;‘3Original
`
` 4_€‘J\Plo3r"4-F=nal
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` "1103309
`
`
`
`
`
`l
`
`E
`
`',
`
`'
`
`‘
`
`‘
`
`A
`
`d32' «I?» 1104
`
`0.
`Inal
`L..—
`
`i}r’
`C.
`
` . 4 4
`
`l
`102
`4
`
`103
`53
`,
`l_
`p,
`01J)
`104
`.
`.
`T
`
`
`
`105
`r
`55
`57
`1107»
`I
`108.
`‘
`I
`453
`_______
`__
`L
`.
`109
`_A O
`1101
`'
`”1:1:
`
`111
`.
`
`
`112
`I
`l
`
`11
`.
`‘114
`
`115
`113'
`—
`1.1
`
`118
`
`119
`'
`120
`
`121
`
`122
`
`12s
`.
`124
`t
`
`125 I‘
`
`
`127
`I
`
`128
`1
`l
`129
`«'
`
`130
`
`.131
` l
`133
`
`l-
`
`
`
`
`137
`
`1*
`38
`
`139’
`
`40
`
`141
`L——-
`
`1421
`
`14d
`
`
`144
`l
`5
`1
`
`H46
`147
`
`
`_1
`148
`
`149
`[150
`;
`
`i
`
`.
`
`(LEFT INSIDE)
`
`. llTnore than 150 claims or 10 actions
`staple additional sheet here
`
`
`
`
`
`

`

`
`
` SEARCH NOTES
`
`SEARCHED
`
`(INCLUDING SEARCH STRATEGY)
`
`
`INTERFESRENCE SEARCHED
`
`I
`
`(RIGHT OUTSIDE)
`
`
`
`

`

`Page I ofl
`
`
`COMMISSIONER FOR PATENTS
`UNITED STATES PATENT AND TRADEMARK OFFICE
`WASHINGTON, DC, 2023!
`
`wwmusptogov CONFIRMATION NO. 1784
`
`Bib Data Sheet
`
`
`
`FILING DATE
`ATTORNEY
`
`
`
`
`GROUP ART UNIT
`SERIAL NUMBER
`DOCKET NO.
`01/24/2001
`
`
`
`
`2872
`09/768,731
`
`389841
`RULE
`
`
`
`A PPLICANTS
`
`
`Victor J. Doherty, Weilesley, MA;
`
`
` it CONTINUING DATA *ticfikiflfirkkRtfiifllfiflfiwkifllki‘fI
`
`THIS APPLICATION IS A CIP OF 09/175,796 10/20/1998 ABN
`
`it FOREIGN APPL‘CATIONS *anmrmmmtuuucmm
`
`
`IF REQUIRED, FOREIGN FILING LICENSE GRANTEDH
`H
`
`SMALL ENTITY _
`* 02/15/2001
`
`
`Foreign Priority claimed
`
`D yes
`no
`
`STATE OR
`SHEETS
`
`
`
`CLAIMS
`E] yes Elm D Met we,
`:5 use 119 (a-d) Conditions
`COUNTRY
`DRAWING
`
`
`2O
`
`
`\
`.
`MA
`6
`erified and
`
`met
`Alle ance
`
`
`
`Examiner‘s Signature Initials
`
`
`Curtis A. Vock, Esq.
`
`
`Lathrop, Gage & Sullivan
`
`Suite 302
`845 Pearl East Circle
`
`Boulder ,CO 80301
`
`
`
`
`
`Hand-held Ophthalmic iiiuminator
`'
`I
`
`CI Ail Fees
`
`[31.15 Fees(Filing)
`
`
`I
`FILING FEE FEES: Authority has been given in Paper
`
`
`
`RECEIVED No.
`to charge/credit DEPOSIT ACCOUNT
`
`No.
`for following:
`‘
`
`D1.18Fees(lssue)
`
`
`WWfiW,,,,,,W.W...”MW/Wm................
`
`
`
`
`
`
`TITLE
`
`V
`
`CI 1,17 Fees (Processing Ext of
`time)
`‘
`
`
`
`.5.
`
`
`
`

`

`
`'-¢//—2545/
`”0/?
`Bros (oavoo)
`woved for use through 10/31/2002. OMB 0651-303
`us. Patent e
`‘1
`Please type a plus sign (+) inside this L.
`Semark Office; U.S. DEPARTMENT OF COMMERCE
`
`Under the Pa-erwcrk Reflection Act of 1995 no ~ersons are re-ulred to res-0nd to a collection oi nullimation unless it dis-la s a valid OMB control number”
`
`
`
`
`
`‘ UTILITY
`389841
`Attorney Docket No.
`
`
`PATENT APPLICATION
`
`
`
`
`-3.1lifillillllli
`TRANSMITTAL
`
`
`
`
`HAND HELD OPHTHALMIC ILLUMINATOR
`“Title
`
`,,8IIIllll”59161In!
`
`
`, ; Min/y for new nonprovisional application under 37 OFF?
`» ‘- {bi}
`'
`
`Express Mail Label No.
`ELeeé2454eous
`
`
`
`
`
`
`
`APPLICATION ELEMENTS
`
`Assistant Commissioner for Patents
`
`Box Patent Application
`ADDRESS TO:
`Washington, DC 20231
` See MPEP chapter 800 concerning utility patent application contents.
`
`
`
`
`Fee Transmittal Form (e.g, PTO/SB/17)
`
`
`
`{Submlt an afiglnalanda (mu-care my” pmsssmg)
`7.
`CD-HOM or CD-Ft in duplicate, large table or Computer
`
`Applicant claims small entity status.
`See 37 CFFi1.27.
`
`8. Nucleotide and/or Amino Acide sequence Submission
`
`
`
` {if applicable, all necessary)
`Specification
`[Total Pages _10_ ]
`
`{preferred arrangement set lon‘h below)
`
`
`21.
`Computer Readable Form (CHF)
`~ Descriptive title of the invention
`b. Specification Sequence Listing on:
`
`
`- Cross Reference to Related Applications
`
`
`i.
`CD-FtOM or CD-H (2 copies); or
`
`
`~ Statement Regarding Fed sponsored R & D
`
`ii.
`paper
`- Reference to sequence listing, a table,
`
`
`
`or a computer program listing appendix
`
`- Background oithe Invention
`Statements verifying identity of above copies
`o.
`
`
`~ Briet Summary otthe Invention
`
`- Brief Description of the Drawings (if filed)
`- Detailed Description
`
`- Claim(s)
`
`- Abstract of the Disclosure
`
`.r
`.
`.
`
`
`mam”) (35 U‘S'C' ”3)
`I Tm" 5’7““ 5—4
`AccomPANYlNGAPPLICATION PARTSm
`
`
`
`
`9.
`Asstgnment Papers (cover sheet a-dooumentist)
`Oath Of Declaration
`[ Total Pages _4._]
`
`
`
` 10. 3mm 3.73m) Statement
`x ‘Poilver of Attorney
`a.
`Newly executed (original or copy)
`(wh
`are is an assrgnee}
`~
`.
`
`b. X Copy from a prior application (37 CFR 1.63(d))
`
`11.,
`Eng“ .ti’Franslatlon Document (1r applicable)
`{for continuation/divisional v'vith Box 1.7 completed)
`
`
`12.
`information Disclosure
`_
`Copies of lDS Citations
`
`
`Statement (lDS)/PTQ:1449
`I.
`DELEI'ION OF INVENTOFI S
`13.
`PreliminaryAmendrnent
`Signed statemenl attached deleting inventor(s)
`named in the prior application, see 37 CFR
`1.63(d)(2) and Laarb).
`
`
`
`
`Application Data Sheet. See 37 CFFI 1.76
`
`
`
`
`
`
`14. X Fleturnfieceipt Postcard (MPEP 503)
`(Should be specifically itemized)
`Certified Copy of Priority Document(s))
`{if foreign priority is claimed}
`
`if a CONTINUING APPLICATION, check appropriate box, and supply the requisite Information
`17.
`and in a preliminary amendment, or in an
`Application Data Sheet under 37 CFR 1.76:
`
`15.
`
`
`
`
`
`
`
`
`
`Continuation
`Prior application information
`
`Divrsronal
`Examiner
`
`J Treae
`
`X Continuation (CIP)
`
`oi prior application No; 09/175,796
`
`
`
`mSo.m3 IoE 9L“.m3a;5'.
`
`u
`
`—l2'”-913
`M—.3‘9;m‘\a. a im .0N 3cEm 6' oo3E9;m
`:I3m E {(111Q a3mag:3 Ea3
`
`_>
`3mm2‘ 2 3m 5,QS.g g(n
`)>
`comments on the amount ct time you
`are requiredto complete this term should be sent to the Chlel Information Officer, US. Patent andTrademark Otiice, Washington, DC 20231. DO NOT SEND FEES OFi COMPLETED
`.1
`8647271
`
`
`
`
`
`

`

` ‘
`
`PTO/SHIN (us—00)
`Approved for use through 10/31/2002. OMB 0651-0032
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 19951 no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`.
`
`FEE TRANSMITTAL
`
`mum
`
`
`
`
`1.
`
`2.
`
`The commissioner is hereby authorized to charge indicated fees and
`mid-I" any ovemayments t0?
`Deposit Account Number 120600
`Deposit Account Name
`Lathrop & Gage LC
`X
`Charge Any Additional Fee Required Under 37 CFR 1.16 and 1 17
`
`X
`Applicant claims small entity status. See 37 CFR 1.27
`
`X
`Payment Enclosed:
`
`X
`Check
`_ Other
`
`Credit Card
`
`Money Order
`
`BASIC F1141): G FEE
`Large
`Entity Small Entity
`Fee
`Fee
`Fee
`Fee
`COdC
`(3;)
`C0616
`(3)
`Utility filing fee
`101
`710
`201
`355
`Desigt filing fee
`106
`320
`206
`160
`Plant filing fee
`10'?
`490
`207
`245
`Reissue filingfee
`108
`710
`208
`355
`Provisional filingfee
`114
`150
`214
`75
`SUBTOTAL (1)
`(5)
`
`FEE CALCULATION
`
`Fee Description
`
`.
`
`Fee Paid
`
`ll‘l'tt
`
`I
`
`1
`
`,
`
`ADDITIONAL FEES
`Large
`Entity Small Entity
`Fee
`Fee
`Fee
`Fee
`Code
`(5)
`Code
`(s)
`105
`130
`205
`65
`127
`50
`227
`25
`
`139
`147
`112
`
`113
`
`115
`116
`117
`118
`128
`119
`120
`121
`138
`140
`‘ 141
`142
`143
`144
`122
`123
`
`.
`
`139
`130
`147
`2,520
`920* ' 112
`
`1,840“ 113
`‘
`215
`110
`216
`390
`217
`890
`218
`1,390
`228
`1.890
`219
`310 ’
`220
`310
`221
`270
`138
`1,510
`240
`110
`241
`1,240
`1,240 242
`440
`600
`244
`130
`122
`50
`123
`240
`
`‘
`
`,
`
`179
`
`40
`
`710
`710
`
`710
`
`900
`169
`Other fee (specify)
`
`Fee Descriptimi
`Surcharge - late filing fee or oath
`Surcharge » late provisional tiling
`fee or cover sheet
`Nun-English specification
`130
`2520 Wm H ling a request in; ex pane
`reexamination
`920‘ Requestingpublimtion ofSlR prior
`to Examiner action
`'.
`1840* Requesting ptiblicatiorrof SIR after
`;’ ‘ Examine-Indian
`55
`Extension for reply within first month
`195
`Extension for reply Within second month
`445
`Extension for reply within third month
`695
`Extension for reply within [otuth month
`945,
`Extension for reply Within fifth month
`155
`Notice of Appeal
`155
`Filing a brief in support of an appeal
`135
`Request for oral hearing
`1.5.10 Petition to institute a public use
`;
`Proceeding
`55
`Petition to revive ~ unavoidable
`620
`Petition to revive - lurinteniional
`620
`Utility issue fee (or reissue)
`220
`Design issue fee
`300
`Plant issue fee
`130
`Petitions to the Comiissioner
`50
`Petitions related to provisional
`Applications
`240
`Submission ofInformation
`Disclosure Statement
`Recording each patent assignment
`Per property (times numher ofproperties)
`Filing a submission after final
`Rejection (37 CFR§ 1.129la))
`For each additional invention (0 be
`Examined (37 CPR § 1.129(h))
`Request for Continued Examination
`(RC5)
`Request for expedited examination
`of a design application
`
`40
`
`. ..
`
`Fee Paid
`
`
`
`someone)
`
`($1445.00
`
`Complete (if applicable)
`
`Telephone
`
`303-4496 Kilt)
`
`*Roduced by Basie Filing Fee Paid SUBMITTED BY
`
`EXTRA CLAIM FEES
`
`Fee from
`Fee Paid
`below
`Extra Claims
`= _
`X _
`otul Claims __ -20** = _
`dependent
`lairns
`__
`- 3”“ = ~_ X _ = _
`Multiple Dependent
`__
`= _
`* *or number previously paid, ifgreazer,’ For Rtissues, see below
`
`
`
`Large
`Fee
`Code
`103
`102
`104
`109
`110
`
`Entity Small Entity
`Fee
`Fee
`Fee
`(3)
`Code
`(ii)
`13
`203
`9
`80
`202
`40
`270
`204
`135
`80
`209
`40
`1%
`210
`9
`
`Fee Description
`
`Claims in excess of 20
`Independent claims in excess of 3
`Multiple dependent claim, if not paid
`”Reissue independent claims over orignal patent
`* ‘Reissue claims in excess of 20 and over original
`patent
`
`SUBTOTAL (2)
`
`to
`
`
`
`Name (Print/Type)
`
`Curtis A. Vook
`
`(Attomey/Agcnt)
`
`Signature
`
`i la 1
`.
`
`4 r
`l
`
`'
`
`Date
`
`I
`
`.
`‘ D
`
`WARNING: Infoi'nmtion on this form may become public. Credit card infunnation should not be included on this font]. Provide credit card hifunnatiml and authorization
`
`onPTO-ZDSS.
`
`a.
`
`

`

`Practitioner’s Docket No. 389841
`
`’
`
`~
`
`PATENT "
`
`'
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of;
`Application No.:
`Filed:
`
`Victor J. Doherty
`09/175,796
`October 20, 1998
`
`Group No.:
`Examiner:
`
`2872
`I. Treas
`
`For:
`
`HAND HELD OPHTHALMIC ILLUMJNATOR
`
`Box Patent Application
`Commissioner for Patents
`Washington, DC. 20231
`
`EXPRESS MAIL CERTIFICATE
`
`"Express Mail" label number EL656245460US
`Date of Deposit: January 24, 2000
`
`Ihereby state that the following attached papers
`
`,
`
`.
`
`m
`
`.
`
`»_
`
`.
`
`.
`
`‘
`
`i
`
`
`
`'35%
`
`l”
`
`1. Utility/CIP Patent Application Transmittal (1 page)
`2. Fee Transmittal (1 page)
`3 Check No. 2061 in the amount of $445.00
`4
`Specification (6 pages)
`5. Claims (3 pages, claims numbered 1—20)
`6. Abstract (1 page)
`Drawings (6 pages, figures 1-7
`Declaration and Power of Attorney (4 pages)
`Petition for 3 Month Extension (1 page)
`0. Certificate of Mailing — 1 page
`
`1
`
`are being deposited with the United States Postal Service ‘Express Mail Post Office to Addressee‘ service
`under 37 CFR 1.10 on the date indicated above and1s addressed to: Box Patent Application Commissioner
`for Patents Washington, D.C. 20231.
`
`
`
`Nancy Halas
`
`a».
`
`’
`
`7 8 9
`
`.
`
`
`
`
`
`

`

`
`
`Abstract
`
`including a battery, an electrical
`The invention provides an ophthalmic illuminator,
`resistor, an electrical switch and an LED. The battery is in circuit with the battery; and
`the electricalswitch is in circuit with the resistor, where electrical energy flows through
`the circuit when the switch is in the closed position. The light emitting diode is in circuit
`with the switch and generates blue light energy which in turn causes fluorescence in a
`
`fluorescien dye administered to the patient’s eye when the 'switch is in the closed
`
`position. An optical element (eg, a lens or reflector) can be disposed between the diode
`and the eye to increase blue light energy reaching the eye. The energy can be “pulsed”
`such that the diode generates the blue light at‘a predetermined frequency. A user of the
`illurninator, e.g., a physician, can hold the system by hand to operate the switch (e.g.,
`through a button). A magnifier coupled to the system provides a magnified image of the
`patient’s eye,’ if desired. Preferably, an annular housing integrates the LED (or a plurality
`of LEDs) together suchthat a button activates and generates the blue light energy, and a
`user views through the center of the housing, through a magnifier therein, to View the
`patient’s eye.
`
`
`
`10‘
`
`g-
`
`
`
`
`
`

`

`‘y. Docket No. 389841
`
`Hand-Held Qphthalmic Illuminator
`
`Related Applications
`
`This applicationis a continuation--1n--part of, and claims priority to, commonly owne and
`TUUC I)“
`co--pending US. Application No. 09/175H796 filed on October 20,1998kand hereby
`incorporated by reference.
`
`Background of the Invention
`
`Ophthalmologists, optometrists and other medical doctors and health care professionals
`frequently are required to examine the cornea of the human eye for scrapes abiasions, .
`dirt or f01eign bodies The current technology utilizes a battery operated hand-held
`pcnlight illuminatorin conjunction with a solution of Sodium Fluorescein. Anexample of 4“
`an existing prior art device is the Solan Blu-Slit® manufactured by Xomed Surgical
`Products, Inc. of Jacksonville, FL. The penlight illuminator typically uses conventional
`batteries as a power source and an incandescent or halogen light bulb, A cobalt blue filter
`attached over the lamp filters the white light emitted bythe bulb to produce a blue beam.
`This blue beam is used to illuminate the patients eye after application of the Sodium
`Fluorescein dye.
`
`
`
`The fluorescein dye, which is typically impregnated in sterile paper, is administered by
`the physician in the following manner. The patients upper eyelid is retracted and the
`sodium fluorescein impregnated paper applicator
`is made to contact
`the bulbar
`conjunctiva of the eye at the temporal side. The applicator is removed and the eyelid is
`opened and closed several times to allow diffusion of the dye over the entire conjunctival
`area and cornea.
`
`The fluorescein dye tends to accumulate in epithelial defects of the cornea and
`illumination of the eye will cause the defect to fluoresce vividly. By using blue filtered
`light to illuminate the eye of the patient, which. has been dyed with fluorescein,
`this
`
`
`
`
`
`Just
`
`

`

`, W__m..v._.W..,.,......_._,W._.,_._._~_w ,
`
`...‘WW....‘.
`
`,
`
`.ww.
`
`.M . W... «Hmwwm
`
`fluorescence is most observable. The amount of fluorescence observable is proportional
`
`to the accumulation of the fluorescein or the magnitude of the defect. However,
`
`the
`
`magnitude of the fluorescence is also proportional to both the intensity and spectral purity
`
`of the light illuminating the patient’s eye. In other words, a'brighter and more spectrally
`pure beam will show more detail and thus is more desirable to the physician.
`
`Summary of the Invention
`
`The subject of this invention is a device which is used to illuminate a patient’s eye that
`
`has been administered with a fluorescent dye for the purpose of examining the eye for
`
`epithelial defects. The invention in its simplest form utilizes four components: a battery,
`
`an electrical resistor, an electrical switch and a blue light emitting diode.
`
`Brief Description of the Invention
`
`Figure 1 depicts an electrical schematic of an ophthalmic’illuminator utilizing a' blueLED
`source according to the invention
`Figure 2 shows an alternative ophthalmic flluminator of the invention.
`Figure 3 shows a perspective View of a hand held eye illuminator constructed according
`to the invention.
`
`Figure 4 shows a perspective View of another hand held eye illuminator constructed
`
`according to the invention.
`
`Figure 5 shows a perspective interior view of the illuminator of Figure 4.
`
`Figure 6 shows a perspective View of another hand held eye illuminator constructed
`
`according to the invention.
`
`Figure 7 shows a perspective interior view of the illuminator of Figure 6.
`
`Detailed Description of the Invention
`
`In schematic 10 of Figure 1, when the switch 12 is closed electrical energy from the
`
`battery 14 flows through the circuit 10 and causes the blue LED 16 to produce blue light
`
`
`
`is
`
`5‘0.
`
`

`

`18. The resistor 20 is used to limit the current that is applied to the LED 16 as per the
`manufacturer specification: which is typically 20 to 30 milli-ampsi Certain LED’s have any
`internal resistor 20 built into the LED package, as known in the art. Battery 14 voltage is
`typically four to twelve volts DC. The blue LED’s are for example manufactured by both
`CREE and NICHIA and typically produce illumination on theporder of 0.50 candle or
`more at a wavelength of 450 nano—meters with a typical bandpass of 50nm. These LED ’s
`typically are comprised of Gallium Nitride on a Silicon Carbide substrate (NICHIA) or
`just Silicon Carbide (CREE). In one embodiment of the invention, resistor 20 is not
`required; rather, battery 14 serves as the resistor for circuit 10.
`
`The ophthalmic illuminator as depicted in Figure 1 is superior to the current incandescent
`technology for the following reasons: first, the blue LED 16 emits more illumination in
`the desired blue spectrum (425 to 475 NM) than the filtered incandescent lamp, which
`results in more fluorescence of the fluorescein dyed eye 22 andthus has better sensitivity;
`second, the blue LED 18 uses less power than a blue optically filtered incandescent or
`halogen bulb so that the battery power source 14 should last significantly longer; third,
`the invention is simpler to the prior art technology in that there is no need for a blue
`bandpass Optical filter.
`
`There are a number of enhancements that can be made to the basic invention as shown in
`
`Figure 1. First, a lens 24 may be added close to the LED 18. between the LED 18 and the
`
`patient’s eye 22 to maximize the light collection efficiency of the system. A reflector
`could be added separately or used in conjunction with a lens for the same purpose.
`Second, the electrical circuit l0 could be modified with a pulse means 13 to cause the
`blue LED 16 to operate in a pulsed mode instead of continuous mode. This would enable
`higher peak current to be applied to the blue LED l6 to produce the appearance of an
`even brighter beam and hence more fluorescence sensitivity to the physician. Third, a
`simple magnifier tens could be added to the device 10 to provide a magnified View of the
`patient’s eye 22 to the physician or user (see Figure 2). The fixed magnification of this
`lens would typically be chosen to between 1.5x and 15x. Typically the magnifications are
`
`
`
`
`
`“r
`
`a»
`
`

`

`“PM. afl_.......a._..._.,a,4,.....-WWWM“MMNHHM ,
`
`,_ 2.. ., -, W.wwm.W...M.._...~.w..v...._2.“.
`
`,
`
`_
`
`between 2x and 10x. A variable focal length zoom lens could also be substituted as the
`
`simple magnifier to provide a range of magnification for the physician user.
`
`The invention described here can be manufactured as a stand-alone hand held device or
`incorporated into other ophthalmic diagnostic instruments such as a tabletop or hand
`held slit lamp.
`
`Figure 2 shows an alternative system 100 of an ophthalmic illuminator constructed
`
`according to the invention. Figure 2 also shows the patient’s eye 102 illuminated by blue
`light 104 generated by the diode 106. The light 104 is preferably coupled to the eye 102
`through an optical lens (or reflector, known in the art) 108 to increase the blue light
`energy at the eye 102.
`
`
`
`System 100 preferably integrates to a common housing 110 such: that a user can hold the
`y
`
`system 100 during treatment of the eye 102. Although It
`hown, the circuit of Figure l
`can reside within the housing 110; and a button 112 can be used to operate the switch 12
`(Figure 1) which in turn causes the generation of light 104. The button 112 is for example
`operated by a physician’s finger.
`
`System 100 can also include a magnifier 114 coupled to the housing 110 such that the
`
`physician’s eye 116 can view the patient’seye 102 with increased magnifier. A zoom
`lens (known in the art can replace the magnifier 114 such that selective control of that
`magnification is achieved.
`
`
`
`
`
`Figure 3 shows a hand held illuminator 200 constructed according to the invention.
`
`Illuminator 200 has an annular housing 202 that contains circuitry such as schematic 10
`
`of Figure 1. A button 204 is arranged with housing 202 such that a user may press to
`
`generate light energy 206 to illuminate a patient’s eye 208. Button 204 for example
`functions as switch 12, Figure l. A user of illuminator 200 may then peer through
`aperture 210, along path 212, to conveniently view patient eye 208. Aperture 210 may
`optionally include a magnifying lens, or zoom lens, according to preferred embodiments
`
`if)
`
`in.
`
`

`

`of the invention. Sources for generating energy 206 include a LED such as LED 16,
`
`Figure 1. Sources may be integrated with housing 202 in various ways as illustrated
`
`below.
`
`In accord with the invention, energy 206 delivered from sources (e.g., LEDs)
`
`may be considered a transmit channel while path 212 may be considered a receive
`channel. In one embodiment of the invention, the energy is blue light that creates green
`fluorescence from the eye; and thus a lens in aperture 210 is preferably coated with a
`
`green filter thin film coating to filter light along the receive channel.
`
`Figure 4 shows a hand held i11uminator 214 constructed according to the invention.
`
`Illuminator 214 has an annular housing 216 that contains circuitry such as schematic 10
`
`of Figure 1. A button 218 is arranged with housing 216 such that a user may press to
`
`generate light energy 221 to illuminate a patient’s eye 217, as above. Eutton 218 for
`example functions as switch 12, Figure 1. Illuminator 214 further has an optical
`magnifier in the form of a lens 219 for a user to peer through to conveniently View patient
`eye 217. A LED 220 integrates with housing 216 to generate light energy 218. LED 220
`may optionally include a focusing lens, though one is not required.
`
`\jfi
`
`mg,
`at
`
`Figure 5 shows an interior portion 222 of illuminator 21.4. Specifically, interior portion
`222 shows further features of button 218 and LED 220, each. connected in circuit to
`
`internal battery 224. Battery 224 for example operates as in battery 14, Figure 1, to power
`LED 220. Element 216a forms the back of housingi216.
`
`
`
`
`
`5Q
`
`a;
`
`

`

`
`required. Although
`e LEDs 238 are shown, more or fewer LEDs can be used without
`
`departing from the scop
`Figure 7 shows an interior portion 240 of illuminator 230. Specifically, interior portion
`240 shows further features of button 234 and LEDs 238, Each connected in circuit to
`
`e invention.
`
`internal battery 242. Battery 242 for example operates as in battery 14, Figure l, to power
`LEDs 238. Element 232a forms the back of housing 232.
`
`In addition to the advantages apparent in the foregoing description, the invention may
`
`have application in other fields outside of ophthalmology. For example, in the field of
`
`dermatology, an illuminator of the invention may be used to illuminate skin, along the
`
`transmit channel, and to View the skin along the receive channel.
`
`In View of the foregoing, what is claimed is:
`
`
`
`
`
`
`
`a“.
`
`

`

`
`
`1.
`
`An ophthalmic illuminator, comprising:
`
`a battery;
`
`an electrical resistor in circuit with the battery;
`
`an electrical switch in circuit with the resistor;
`
`at least one light emitting diode,
`
`in circuit with the switch, for generating blue light
`
`energy in response to activation of the switch; and
`
`a fluorescein dye administered to a patent’s eye, the dye being responsive to the energy to
`fluoresce.
`
`
`
`2.
`
`An illuminator of claim 1,
`
`further comprising an optical element disposed
`
`between the diode and the eye to increase blue light energy reaching the eye.
`
`. J
`
`3.
`
`An illuminator of claim 2, wherein the element is one of a lens or a poWered
`
`reflector.
`
`..
`
`,
`
`r
`
`H
`
`'
`
`»
`
`_
`
`.
`
`f-
`
`4.
`
`An illuminator of claim 1, further comprising electronicstr cyclically energizing
`
`the diode, wherein the diode generates the blue light at a predetermined frequency in
`
`order to increase the illumination appearance of the energy.
`
`5.
`
`An illuminator of claim 1, further, comprising a housing for integrating the
`
`battery, switch, resistor and diode into an integral package, the diode being positioned to
`
`generate blue light energy away from the package, and further comprising a magnifier
`
`lens coupled to the housing for providing a magnified image of the patient’s eye to a user
`of the illuminator.
`
`An illurninator of claim 5, wherein the magnifier lens has a magnification
`6.
`between about 1.5X and 15X.
`
`7.
`
`An illuminator of claim 1, further comprising a housing for integrating the
`
`battery, switch, resistor and diode into an integral package, the diode being positioned to
`
`
`
`
`
`79%
`
`an
`
`

`

`generate blue light energy away from the package, and further comprising a zoom lens
`coupled to the housing for providing a selective magnified image of the patient‘s eye to a
`user of the illuminator.
`
`8.
`
`9.
`
`An illuminator of claim 1, wherein the dye comprisest‘Sodium Fluorescein.
`
`An illuminator of claim 1, wherein the diode comprises Gallium nitride.
`
`10.
`
`An illuminator of claim 1, wherein the diode comprises Silicon Carbide.
`
`
`
`An illuminator of claim 1, further comprising a substantially annular housing
`11.
`constructed and arranged with a button for operating the switch, a user of the illuminator
`
`viewing through an aperture in the housing to View the patient’s eye.
`
`An illuminator..of claim 11,.further comprising a magmvfying lens constructed
`12.
`and arranged with the aperture, for magnifying the patient’s eye for theius'er;
`\
`
`‘3;
`
`An illuminator of claim 11, further, comprising a plurality of light emitting
`13.
`diodes, each diode responsive to activation by the button to generate the blue-light.
`
`An illuminator of claim 1, further comprising a focusing lens constructed and
`14.
`arranged with at least one of the diodes to focus the blue light energy onto the patient’s
`eye.
`
`15.
`
`A method for
`
`illuminating a patient’s eye for ophthalmic examination,
`
`comprising the steps of: administering a fluorescein dye to the patent’s eye, illuminating
`the eye with blue light energy generated from one or more light emitting diodes, the dye
`being responsive to the blue light energy to fluoresce, and viewing the patient’s eye, and
`viewing the eye while the dye fluoresces.
`
`,9.
`
`

`

`16.
`
`A method of claim 15, wherein the step of administering a fluorescein dye
`
`comprises administering Sodium Fluorescein to the eye.
`
`17.
`
`A method of claim 15, wherein the step of illuminating the eye comprises
`
`pressing a button on an annular-shaped housing, and whei’éin the step of Viewing the
`
`patient’s eye comprises viewing through a center of the housing.
`
`18.
`
`A method of claim 15, wherein the step of illuminating comprises generating
`
`light from a plurality of light emitting diodes.
`
`19.
`
`A method of claim 15, wherein the step of viewing comprises viewing through a
`
`magnifying lens coupled with a housing that supports the diodes.
`
`20.
`
`A method of claim 15, further comprising-the step of focusing the blue light
`
`3’
`
`energy onto the patient’ seye.
`
`,.
`
`‘
`
`”’
`
`—
`
`
`
`
`
`
`
`a.»
`
`

`

`PATENT
`
`Atty Docket No. 389841
`Express Mail Label No. EL656245460US
`
`COMBINED DECLARATION AND POWER OF ATTORNEY
`
`(ORIGINAL, DESIGN, NATIONAL STAGE OF PCT,
`SUPPLEMENTAL, DIVISIONAL, CONTINUATION OR CIP)
`
`As a below named inventor, I hereby declare that:
`
`TYPE OF DECLARATION
`
`This declaration is of the following type:
`
`X
`
`Continuation—impart
`
`INVENTORSHIP IDENTIFICATION
`
`
`
`I
`My residence post office address and citizenship are as stated below next to my name.
`believe I am the original, first and sole inventor (if only one name is listed below) or an original'7‘
`first and joint inventor (if plural names are listed below) of the subject matter whichis claimed
`and for which a patent is sought on the invention entitled:
`»
`,
`,
`>
`
`?
`
`HAND HELD OPHTHALMIC ILUMINATOR I
`
`’
`
`SPECIFICATION IDENTIFICATION
`
`The specification
`
`X
`
`is attached hereto.
`
`ACKNOWLEDGMENT OF REVIEW_ OF PAPERS AND DUTY OF CANDOR
`
`I hereby state that I have reviewed and understand the contents of the above-mentioned
`specification, including the claims, as amended by any amendment referred to above (if any).
`
`I acknowledge the duty to disclose all information knoan to me to be material to
`patentability of this application in accordance with Title 37, Code of Federal Regulations, § 1.56
`(a).
`
`and which is material to the examination of this application, namely, information where
`there is a substantial likelihood that a reasonable examiner would consider it important in
`deciding whether to allow the application to issue as a patent, and
`
`"a
`
`

`

`
`
`
`
`PATENT
`
`Atty Docket No. 389841
`Express Mail Label No. EL656245460US
`
`CLAIM FOR BENEFIT OF EARLIER U.S./PCT APPLICATION(S)
`UNDER 35 U.S.C. 120
`
`I hereby claim the benefit under Title 35, United States Code,§ 120 of any United States
`application(s) or PCT international application(s) designating the United States of America that
`is/are listed below and, insofar as the subject matter of each of the Claims of the application is not
`disclosed in that/those prior application(s) in the manner provided by the first paragraph of Title
`35, United States Code, § 112, I acknowledge the duty to disclose material information as
`defined in Title 37, Code of Federal Regulations, § 1.56(a) which occurred between the filing
`date of the prior application(s) and the national or PCT international filing date of this
`application.
`
`PRIOR U.S. APPLICATIONS OR PCT lNTERNATIONAL APPLICATION(S)
`DESIGNATING THE U.S. FOR BENEFIT UNDER 35 USC 120
`
`U.S. APPLICATION(S)
`
`STATUS (Check One)M
`
`
`PATENTE1%PENDING ABANDONED
`US FILING DATE
`US APPLICATION(S)
`
`x 09/175 796 10/20/98 ' ‘
`
`
`
`
`
`
`PRIORITY CLAIM
`
`I hereby claim foreign priciity benefits under Title 35 United States Code, § 119 of any
`fOieign application(s) for patent or inventor‘s certificate or of any PCT intemational application(s)
`designating at least one country other than the United States of America listed below and have also
`identified below any foreign ap