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`CONTENTS
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`N ................................. Non-elected
`= ................................. Allowed
`|
`................................. Interference
`— (Through numeral)... Canceled
`A ................................. Appeal
`+ ................................. Restricted
`0 ................................. Objected
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`Bib Data Sheet
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`CONFIRMATION NO.1784
`
`SERIAL NUMBER
`09/758,731
`
`A PPLICANTS
`
`FILING DATE
`01,2
`0
`4’20 1
`RULE
`
`‘
`
`Victor J. Doherty, Wellesley, MA;
`
`* CONTINUING DATA *fi*fi*******fi****fl****i*iv*i
`THIS APPLICATION IS A CIP OF 09/175,79610/20/1998 ABN
`
`* FOREIGN APPLICATIONS *Ri****t*tk****k*w*k
`
`"
`GROUP ART UNIT
`2872
`
`ATTORNEY
`DOCKET No.
`389841
`
`Foreign Priority claimed
`,.
`35 USC119(a-d)condmons
`erified and
`me‘
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`1‘
`E] yes B’no D Metafter
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`STATE 0R
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`CLAIMS
`20
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`Curtis A, Vock, Esq.
`Lathrop, Gage & Sullivan
`Suite 302
`. 845 Pearl East Circle
`Boulder ,CO 80301
`TITLE
`
`Hand-held Ophthalmic illuminator
`
`FILING FEE FEES: Authority has been given in Paper
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`710
`201
`355
`Design filing fee
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`106
`320
`206
`160
`Plant filing fee
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`107
`490
`207
`245
`Reissue filing fee
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`108
`710
`208
`355
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`150
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`105
`127
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`139
`147
`112
`
`113
`
`115
`116
`117
`118
`128
`119
`120'
`121
`138
`140
`‘ 141
`142
`143
`144
`122
`123
`
`‘
`
`,
`
`179
`
`130
`50
`
`205
`227
`
`139
`130
`147
`2,520
`920* ' 112
`
`1,840‘ 113
`
`.
`
`110
`390
`890
`1,390
`1, E90
`310 4
`310
`270
`1,510
`110
`1,240
`1,240
`440
`600
`130
`50
`2/10
`
`40
`
`710
`710
`
`710
`
`1
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`65
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`Practitioner’s Docket No. 389841
`
`’
`
`.
`
`PA TENT '
`
`
`
`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 ILLUMINATOR
`
`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
`
`,
`
`at;
`
`.
`
`.
`
`»_
`
`.
`
`.
`
`'
`
`i a
`
`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
`
`7 8 9
`
`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
`
`ay-
`
`
`
`
`
`
`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 electrical switch 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
`illuminator, 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 pltirality
`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.
`
`fig,
`
`
`
`”1
`
`
`
`‘y. Docket No. 389841
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`Hand-Held Qphthalmic llluminator
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`Related Applications
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`This applicationis a continuation--1n—part of, and claims priority to, commonlyowngdgpd
`{U
`‘3»
`co--pending US Application No. 09/175,,796 filed on October 20, 1998\and 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 ab1as1ons -.
`di1t or foreign bodies The current technology utilizes a battery operated hand—held 7
`pcnlight illuminatorin conjunction with a solution of Sodium Fluorescein. Anexample of”:
`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.
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`
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`The fluorescein dye, which is typically impregnated in sterile paper, is administered by
`the physician in the following manner. The ,patient’s 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 conjunctiva]
`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
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`,1»
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`
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`fluorescenceis most observable. The amount of fluorescence observable is proportional
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`to the accumulation of the fluorescein or the magnitude of the defect. However,
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`the
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`magnitude of the fluorescence is also proportional to both the intensity and spectral purity
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`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.
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`Summary of the Invention
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`The subject of this invention is a device which is used to illuminate a patient’s eye that
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`has been administered with a fluorescent dye for the purpose of examining the eye for
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`epithelial defects. The invention in its simplest form utilizes four components: a battery.
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`an electrical resistor, an electrical switch and a blue light emitting diode,
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`Brief Description of the Invention
`
`Figure 1 depicts an electrical schematic of an ophthalmicilluminator utilizing a blueLED
`source according to the invention
`Figure 2 shows an alternative ophthalmic illuminator of the invention.
`Figuie 3 shows a perspective View of a hand held eye illuminator constructed according
`to the invention.
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`Figure 4 shows a perspective View of another hand held eye illuminator constructed
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`according to the invention.
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`Figure 5 shows a perspective interior view of the illuminator of Figure 4.
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`Figure 6 shows a perspective View of another hand held eye illuminator constructed
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`according to the invention.
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`Figure 7 shows a perspective interior View of the illuminator of Figure 6.
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`Detailed Description of the Invention
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`In schematic 10 of Figure 1, when the switch 12 is closed electrical energy from the
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`battery 14 flows through the circuit 10 and causes the blue LED 16 to produce blue light
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`
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`«23
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`a)“
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`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—amps. Certain LED’s have an
`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 the-order of 0.50 candle or
`more at a wavelength of 450 nano—meters with a typical bandpass of 50mm. 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.
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`The ophthalmic illuminator as depicted in Figure l 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 and thus 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.
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`ll
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`There are a number of enhancements that can be made to the basic invention as shown in
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`Figure 1. First, a lens 24 may be added close to the LED 18. between the LED 18 and the
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`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 10 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 16 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
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`
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`“l
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`a»
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`
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`between 2x and 10x. A variable focal length zoom lens could also be substituted as the
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`simple magnifier to provide a range of magnification for the physician user.
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`The invention described here can be manufactured as a stand-alone hand held device or
`incorporated into other ophthalmic diagnostic instruments such as a table—top or hand
`held slit lamp.
`
`Figure 2 shows an alternative system 100 of an ophthalmic illuminator constructed
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`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.
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`System 100 preferably integrates to a common housing 110 such“ that a user can «hold the
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`system 100 during treatment of the eye 102. Although I;
`hown, the circuit of Figure 1
`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.
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`I,
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`System 100 can also include a magnifier 114 coupled to the housing 110 such that the
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`physician’s eye 116 can view the patient’seye 102 with increased magnifier. A zoom
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`lens (known in the art can replace the magnifier 114 such that selective control of that
`magnification is achieved.
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`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
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`of Figure l. A button 204 is arranged with housing 202 such that a user may press to
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`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
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`
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`4R
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`«4'
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`
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`of the invention. Sources for generating energy 206 include a LED such as LED 16,
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`Figure 1. Sources may be integrated with housing 202 in various ways as illustrated
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`below.
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`In accord with the invention, energy 206 delivered from sources (e.g., LEDs)
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`may be considered a transmit channel while path 212 may be considered a receive
`channel. 1n 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
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`green filter thin film coating to filter light along the receive channel.
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`Figure 4 shows a hand held illuminator 214 constructed according to the invention.
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`llluminator 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
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`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.
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`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
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`internal battery 224. Battery 224 for example operates as in battery 14, Figure 1, to power
`LED 220. Element 216a forms the back of housing‘216.
`
`
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`ith housing 232 to generate light
`patient eye 236. A plurality of LEDs 238 integrate
`energy 234. Each of LEDs 238 may Optionally include a
`cusing lens, though one is not
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`
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`b
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`1m
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`
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`required. Although
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`departing from the scop
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`LEDs 238 are shown, more or fewer LEDs can be used without
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`e invention.
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`Figure 7 shows an interior portion 240 of illuminator 230. Specifically, interior portion
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`240 shows further features of button 234 and LEDs 238, each connected in circuit to
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`internal battery 242. Battery 242 for example operates as in battery 14, Figure 1, to power
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`LEDs 238. Element 232a forms the back of housing 232.
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`In addition to the advantages apparent in the foregoing description, the invention may
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`have application in other fields outside of ophthalmology. For example, in the field of
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`dermatology, an illuminator of the invention may be used to illuminate skin, along the
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`transmit channel, and to View the skin along the receive channel,
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`In View of the foregoing, what is claimed is:
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`
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`a.
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`
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`1.
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`An ophthalmic illuminator, comprising:
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`a battery;
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`an electrical resistor in circuit with the battery;
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`an electrical switch in circuit with the resistor;
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`at least one light emitting diode,
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`in circuit with the switch, for generating blue light
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`energy in response to activation of the switch; and
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`a fluorescein dye administered to a patent’s eye, the dye being responsive to the energy to
`fluoresce.
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`
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`2.
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`An illuminator of claim 1,
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`further comprising an optical element disposed
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`between the diode and the eye to increase blue light energy reaching the’eye.
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`,
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`V,
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`An illuminator of claim 2, wherein the element is one of a lens or a poWered
`3.
`reflector.
`_V
`,
`7
`,.
`g
`‘
`,
`_
`,
`f-
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`An illuminator of claim 1, further comprising electronics fOr cyclically energizing
`4.
`the diode, wherein the diode generates the blue light at a predetermined frequency in
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`order to increase the illumination appearance of the energy.
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`5.
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`An illuminator of claim 1, further, comprising a housing for integrating the
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`battery, switch, resistor and diode into an integral package, the diode being positioned to
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`generate blue light energy away from the package, and further comprising a magnifier
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`lens coupled to the housing for providing a magnified image of the patient’s eye to a user
`of the illuminator.
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`An illuminator of claim 5, wherein the magnifier lens has a magnification
`6.
`between about 1.5X and 15X.
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`7.
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`An illuminator of claim 1, further comprising a housing for integrating the
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`battery, switch, resistor and diode into an integral package, the diode being positioned to
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`a
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`.5»
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`
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`generate blue light energy away from the package, and further comprising a zoom lens
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`coupled to the housing for providing a selective magnified image of the patient’s eye to a
`user of the illuminator.
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`8.
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`9.
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`An illuminator of claim 1, wherein the dye comprises’Sodium Fluorescein.
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`An illuminator of claim 1, wherein the diode comprises Gallium nitride.
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`10.
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`An illuminator of claim 1, wherein the diode comprises Silicon Carbide.
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`
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`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
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`viewing through an aperture in the housing to view the patient’s eye.
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`An illuminatorcf claim 11,rfurther comprising a magmfying lens constructed
`12.
`and arranged with the aperture, for magnifying the patient’s eye for theus'er;
`4
`
`its
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`An illuminator of claim ll, further, comprising a plurality of light emitting
`13.
`diodes, each diode responsive to activation by the button to generate the blue-light.
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`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.
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`15.
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`A method for
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`illuminating a patient’s eye for ophthalmic examination,
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`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.
`
`us
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`
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`16.
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`A method of claim 15, wherein the step of administering a fluorescein dye
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`comprises administering Sodium Fluorescein to the eye.
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`17.
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`A method of claim 15, wherein the step of illuminating the eye comprises
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`pressing a button on an annular-shaped housing, and wheiéin the step of Viewing the
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`patient‘s eye comprises viewing through a center of the housing.
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`18.
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`A method of claim 15, wherein the step of illuminating comprises generating
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`light from a plurality of light emitting diodes.
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`19.
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`A method of claim 15, wherein the step of Viewing comprises Viewing through a
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`magnifying lens coupled with a housing that supports the diodes.
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`20.
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`A method of claim 15, further comprising the step of focusing the blue light
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`energy onto the patient’ ”sceye.
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`,.
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`'
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`--
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`4‘
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`Atty Docket No. 389841
`Express Mail Label No. EL656245460US
`
`
`PATENT
`
`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
`
`
`
`My residence post office address and citizenship are as stated below nextto my name. I
`bel1eve I am the original, first and sole inventor (if only one name is listed below) or an original
`first and joint inventor (if plural names are listed below)of the subject matter which1s claimed
`and for which a patent is sought on the invention entitled:
`,
`,,
`,
`y
`>
`
`HAND HELD OPHTHALMIC ILUMINATORI
`
`J
`
`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 known 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
`
`
`
`
`
`PATENT
`
`Atty Docket No. 389841
`Express Mail Label No. EL656245460US
`
`CLAIM FOR BENEFIT OF EARLIER U.S./PCT APPLICATION(S)
`UNDER 35 USC. 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 INTERNATIONAL APPLICATION(S)
`DESIGNATING THE U. S. FOR BENEFIT UNDER 35 USC 120
`
`U.S. APPLICATION(S)
`
`
`WPATENTEDA?PENDING ABANDONED
`US FILING DATE
`US APPLICATION(S)
`
`X 09/175 796 10/20/98 ' ‘
`
`
`
`
`
`
`STATUS (Check One)
`
`PRIORITY CLAIM
`
`I hereby claim foreign prion'ty benefits under Title 35 United States Code § 119 of any
`foreign application(s) for patent or inventor‘s certificate or of any PCT international application(s)
`designating at least one country other than the United States of America listed below and have also
`identified below any foreign application(s) for patent or inventor's certificate or any PCT
`international application(s) designating at least one country other than the United States of America
`filed by me on the same subject matter having a filing date before that of the application(s) of which
`priority is claimed.
`
`X
`
`No such applications have been filed.
`Such applications have been filed as follows.
`
`.1»
`
`
`
`
`
`PATENT
`
`‘ Atty Docket No. 389841
`Express Mail Label No. EL656245460US
`
`POWER OF ATTORNEY
`
`As a named inventor, I hereby appoint the following attorney(s) and/or agent(s) to prosecute
`this application and transact all business in the Patent and Trademark Office connected therewith:
`
`William A. Rudy, Reg. No. 34,916; Peter C. Knops, Reg. No. 37,659; Curtis A. Vock, Reg.
`No. 38,356; Dan Cleveland, Jr., Reg. No. 36,106, Thomas Swenson, Reg. No. 36,696; Patri