20230 Appendix
`
`PTO/SB/16(6-95)
`
`This is a request for filing a PROVISIONAL APPLICATION under 37 CFR 1 53(b) (2)
`inside this box-->
`
`PROVISIONAL APPLICATION COVER SHEET
`I Docket Number IIOS-101 I Type a plus sign ( + l
`
`I+
`
`INVENTOR(s)/APPLICANTS(s)
`FIRST NAME MIDDLE INITIAL RESIDENCE
`LAST NAME
`(CITY AND EITHER STATE OR FOREIGN COUNTRY)
`Terry
`Ryan
`Palm Coast, FL
`Petersen Kurt
`Sunnyvale, CA
`Partamian Leon
`Chatsworth, CA
`Lee
`David
`Los Angeles
`Kovacs
`Gregory
`Stanford, CA
`TITLE OF INVENTION (280 characters max.)
`Intraocular Pressure Sensor
`
`CORRESPONDENCE ADDRESS
`Marek Alboszta
`LUMEN
`426 LOWELL AVENUE
`PALO ALTO
`I CA
`STATE
`
`I ZIP CODE
`
`94301
`
`I COUNTRY
`
`I UNITED STATES
`
`SPECIFICATION and DRAWINGS
`Small Entity Declaration
`Other (specify)
`
`Number of Pages
`
`79
`
`METHOD OF PAYMENT
`
`A check or money order is enclosed to cover the Provisional filing fee
`The Commissioner is hereby authorized to charge filing fees and credit
`Deposit Account Number~~~~~~~~~~~~-
`
`PROVISIONAL FILING FEE AMOUNT ($): 75.00
`
`The invention was made by an agency of the United States Government or under a
`contract with an agency of the United States Government.
`
`X
`
`No
`Yes, the name of the U.S. Government agency and the Government contract
`number are:
`
`SIGNATURE, B ~
`
`Respectfully submitted,
`
`NAME:
`
`/3
`DATE:
`M~oszta
`REG. NO.: 39,894
`Additional inventors are being named on separately numbered sheets
`attached hereto
`
`Abbott
`Exhibit 1007
`Page 001
`
`

`

`PROVISIONAL
`APPLICATION
`TRANSMITTAL
`
`Attorney Docket No.
`
`IOS-101/PROV
`First Named Inventor
`TERRY RYAN
`
`I Total Pages 34
`
`Title
`INTRAOCULAR PRESSURE SENSOR
`
`APPLICATION ELEMENTS AND ACCOMPANYING PARTS
`. [X] Return Receipt Postcard (MPEP 503)
`[ J Fee Transmittal Form
`( J with Fee
`[ l Small Entity Statement
`[X] Specification and Drawings
`
`[ ] Assignment cover sheet and document(s)
`[ ] Power of Attorney by Assignee
`[ ] with CFR 3.73(b) statement
`[ l Other:
`
`Total Pages: [79]
`
`NAME
`
`CORRESPONDENCE; ADDRESS
`MAREK ALBOSZTA
`LUMEN
`INTELLECTUAL PROPERTY SERVICES
`ADDRESS
`426 LOWELL AVENUE
`PALO ALTO
`CITY
`COUNTRY USA
`
`I ZIP CODE I 94301
`I STATE I CA
`I TELEPHONE I (650) 321-6630 I FAX I (650) 321-1621
`
`I hereby certify that I am mailing this correspondence on the date indicated below to the ASSIST ANT
`COMMISSIONER FOR PATENTS, BOX PROVISIONAL APPLICATION, WASHINGTON, DC 20231 using the
`"Express Mail Post Office to Addressee" service of the United States Postal Service under 37 CFR 1.10.
`olJt:2<-. I t::p '7
`/ 3
`DATE OF MAILING:
`EXPRESS MAIL LABEL NO: EJ136190658US
`
`Abbott
`Exhibit 1007
`Page 002
`
`

`

`IOS-101/PROV
`
`Provisional Patent Application
`of
`Terry Ryan, Kurt Petersen, Leon G. Partamian, David Lee and
`Gregory T. Kovacs
`for
`Intraocular Pressure Sensor
`
`Field of the Invention
`This invention relates to pressure sensors. More particularly
`this invention relates to intraocular pressure sensors.
`
`5
`
`10
`
`Detailed Description
`A detailed description of the invention is provided in the
`attached Appendices:
`
`~~5
`
`~;
`
`Appendix A: Numerical Simulation of a Micro-resonator. pp. 1-4
`
`Appendix B: Graphical Data Interpretation for the IOSensor.
`pp. 1.
`
`~f20
`
`IOSensor; provisional claims and "Final Report
`Appendix C:
`Phase, pp.1-33.
`
`25
`
`Appendix D: Tube Based Resonant Circuit for Implant in the
`Anterior Chamber of the Eye, pp. 1-3.
`
`Appendix E: Concept Notes 1, pp. 1-4.
`
`30
`
`Appendix F: Concept Notes 2, pp. 1-2
`
`Appendix G: Research Plan, pp. 1-16.
`
`Appendix H: Figures pp. 1-6.
`
`1
`
`Abbott
`Exhibit 1007
`Page 003
`
`

`

`FROM
`
`PHONE NO.
`
`: 818 9935994
`
`DEC. 13 1999 10:36RM P3
`
`Numerical Simulation of A Microresonator
`
`Kenneth Eppley
`(for IOSensor, LLC)
`Introduction
`
`Numerical simulation using time domain methods cannot deal with systems in which the length
`scales are extremely sm.all compared to the RF wavelength at the resonant frequency. This is because
`of the Courant limitiation on the timestep:
`
`(1) c:M s llx
`
`So if Ar <<< ;t then the number of timesteps needed to simulate an RF period becomes extremely
`large. Frequency domain methods which solve for eigenvalues (i.e., the resonant frequencies of the
`various modes of the system) are not well suited to deal with lossy materials. A, method which is
`well suited to deal with this problem is the eddy current technique, in which one drives the system
`with an excitation at a single frequency ()) and finds the solution of Maxwell's equations assurni.og
`that all fields have the time dependence e'(l}f . Maxwell's equations then take the form (MKS units):
`
`(2) V x V x D = ~ ((i) + i q)D + i ~ J a1.
`
`C
`
`8
`
`C
`
`where q is the conductivity, e is the permittivity, J exr is the external current density, and c is the
`
`speed of light in the medium ( c2 = _!_ ). The method used for solving Eq. (2) is called the Residual
`µ&
`Recursive Nom1atizati.on .Method,. and is described in the appendix. The eddy current code was
`originally written by Kang Tsang at Science Applications, Inc. It was designed to solve for the fields
`in a magnetized plasma, and used the values of conductivity and permittivity for such a plasma. We
`rewrote the equations to apply to the general values as given in Eq. (2). The code was benchmarked
`by comparing the solution to the time domain electromagnetic code MASK, which has been in use
`for many years and has been validated in many comparisons to ~eriments. Test cases were run in
`which the dimensions were large enough that MASK could obtain a solution in a reasonable amount
`of time. Good agreement was obtained between the two codes. In additi~ it was verified that the
`eddy current code agreed, in the low frequency limit. with orun·s law and also with the analytic
`expression for the magnetic field for a long solenoid.
`
`Application of the Eddy Current Method to a Mifrore!.2AAfm:
`
`Since one specifies the frequency as an input quantity, one must have at least an initial estimate
`of the correct frequency band. After solving (2) at this frequency, one then has the field distribution.
`With a 3-D version of the eddy current code one could drive the system with an antenna at various
`frequencies and deduce the resonant frequency and Q by the response CUJVe. In this preliminary
`investigation we used a 2-D version, which would not give the same response to an external drive
`because the spiral inductor cannot be exactly modeled in 2-D. Rather. we assumed a constant
`
`Abbott
`Exhibit 1007
`Page 004
`
`

`

`FROM:
`
`PHONE NO.
`
`818 9935994
`
`DEC. 13 1999 10:37AM P4
`
`current flowing through all parts of the inductor. Since the total path length along the inductor is a
`small fraction of the wavelength. this is a good approximation.
`
`The solutions to Eq. (.2) decompose into two orthogonal sets of modes. The TE modes have
`currents and electric fields solely in the atimuthal direction 8. The TM modes have currents and
`fields in the r and z directions. (We define r as the direction radial to the spiral, z the direction
`normal to it, across the gap, and & as the azimuthal direction around the spiral.) For simplicity we
`solved for the two modes separately.
`
`For the TE modes we represented the current in the inductor as an annulus of uniform current
`density. For purposes of calculation we assumed a unit current in the inductor and adjusted the
`current density so that the to~ current was equal to the number of turns in the coil. The 2·D
`approximation is a good one for this mode. It is also a good approximation to use a continuous
`sheet rather than a series of disconnected current sheets to model the inductor. since the average
`azimuthal current density integrated around the circle is the same for all radii.
`
`For the TM modes we modeled the radial current flowing in the inductor. The radial current is
`given by the total current times the change in radius divided by the total path length, i.e.:
`
`(J) 1 =l (r-. -r,..)
`2n:r ,JI
`t«
`rad
`There will also be a radial voltage drop across the inductor given by
`
`The resistance of the inductor is approximated by the usual DC form.u1a:
`
`l
`(5) R=p(cid:173)
`A
`
`Since the thickness of the inductor in the e,cample considered (1 µ) was less than a skin depth (about
`3 µ in aluminum at a frequency of 200 MHz) this is a good approximation. The radial current will
`produce a magnetic field that induces currents in the other elements. The radial voltage drop will
`produce an electric field that also induces currents in the other elements. Because the 2-D model
`cannot represent the spiral inductor. driving the radial current will produce a voltage that is much
`less than would be expeQted by Eq. (4). Therefore we also ran a simulation in which we imposed the
`radial voltage given by Eq. ( 4) to see the effects on the other elements.
`
`Because the end of the inductor is connected to the upper capacitor plate, there will also be a
`voltage drop in the .z direction across the part of the inductor that crosses the gap. However,
`because the length in the z dwection is less than 10-4 of the total length. this voltage is
`proportionately small and can reasonably be neglected.
`
`Abbott
`Exhibit 1007
`Page 005
`
`

`

`FROM:
`
`PHONE NO.
`
`818 9935994
`
`DEC. 13 1999 10:38AM PS
`
`Calculation of the Circuit Parameters from the Field Solution
`
`Once we have the solution to Eq. (2) we can calculate the various circuit parameters R, L, and C,
`as described below. The resistance in the inductor is given accurately by Eq. (S), but since we don
`not know the eiiective currents flowing in the other elements, we need to calculate the losses from
`the field distribution. The current density in the resistive elements is given by
`
`(6) J=<7£
`
`Therefore the time averaged power dissipated in the resistors is given by:
`<1> p = I ~2d3x
`
`Note that since E (and also V and I) represent peak values and not RMS quantities. there is an extra
`factor of Yz to account for the time averaging. Since
`
`(8) P=!J 2R
`2
`and since we have imposed a known value ofl, we obtain the resistance R by equating Eqs. (7) and
`(8). Since the losses from each resistive element add to the total loss, each separately behaves as a
`series resistance.
`
`To calculate the capacitance between the plates we impose a voltage between the plates and
`calculate the time averaged stored energy in the electric field:
`
`Since we know the voltage V imposed, we also have:
`
`1
`-
`2
`(10) W ,1 = -CV
`4
`and by equating Eqs. (9) and (10) we get the capacitance C. In the calculation for the capacitance
`the spiral inductor is modeled in 2-D as a continuous annulus. This is a. good approximation because
`the separation between the turns is extremely small compared to the wavelength.
`
`Similarlyt the time averaged stored magnetic energy is given by:
`-
`1 JB2
`(11) W-11 =- =-d X
`3
`4 µ
`
`We get B by solving:
`
`®
`
`Abbott
`Exhibit 1007
`Page 006
`
`

`

`FROM:
`
`PHONE NO.
`
`818 9935994
`
`DEC. 13 1999 10:39AM P6
`
`i
`(12) B=-VxE
`(i)
`
`Since we have imposed a cu.uent I we know the stored energy from the inductor is given by:
`
`l
`-
`(13) W-, =-Lli
`4
`By equating Eqs. (11) and (13) we solve for L. Once we have R, L, and Cit is trivial to get the
`frequency and Q by the usual fonnulas:
`
`2
`
`Rz
`1
`(14) w = - - (cid:173)
`LC 4L2
`
`L
`(15) Q = (J)-
`R
`
`t\pplicaticm to Sample Test Case
`The geometry modeled was as follows:Lower capacitor plate:
`Radius =.035 cm
`Thickness (z) :e: 0.1 µ Tungsten, 0.9 µ Alwpinum
`Tungsten resistivity- 5.6 x 104 ohm-cm, Aluminum= 2.82 x IO'"' ohm-cm
`
`Upper capacitor plate:
`Radius ""' 0.05 cm
`Thickness (z) = 0.12 µ Aluminum
`
`Upper silicon plate:
`Radius"" 0.105 cm
`Thickness (z) - 10 µ
`Resistivity ""'1 ohm-cm (1st case) 10 ohm-cm (2nd case)
`Dielectric constant = 11.9
`
`Side silicon plate:
`Inner radius = 0 .1 cm, outer radius = O .105 cm
`Thickness (z) = 12 µ
`(same p ands as upper silicon plate)
`
`Coil:
`20 turns. 10 µ wide (r)
`10 µ separation between turns.
`Thickness (z) = 0.1µ Tungsten, 0.9 µ Alumill\lIJl
`Minimum radius= .035 cm. Maximum radius""' .075 cm
`Total path length = 6.9 cm (unwound)
`
`Abbott
`Exhibit 1007
`Page 007
`
`

`

`FROM:
`
`PHONE NO.
`
`: 818 9935994
`
`DEC. 02 1999 10:47AM Pl
`
`~~~-0~ ~
`,~~,.e.ee
`1au, Ro4otJe. &J., #:IIJ8./I
`h,,.t1,..,4., (!,4 91&2.5
`'1J: 1-818-998-lll.2/~ /.llf8-994-$99fl.
`
`James A Gavney. Jr.
`Lumen
`426 Lowell Avenue,
`Palo Alto, CA 94301-3813
`Tel: (650) 321-6630
`
`December 1. t 999
`Ill: 10Sensor Pressure Seaor Patent Appltcatlon
`
`Dear James,
`
`I hereby have enclosed one more set of information:
`Graphical data additional interorel@tion:
`If you look at the bottom of each graph page from the original data he sent, he has
`the pressures fabefed in mmHg. For parts #22 and #28 the pressure shift is labeled
`as 200 mmHg and for part #27 the pressure shift is labeled as - 200 mmHg (note the
`minus sign). The frequency shifts are ,n the correct direction for an three parts once
`the pressure shift direction is taken into account. Using the vacuum hand pump that
`you supplied. Negative pressure created and may have simply presented the results
`from parts '#22 and #28 as though a positive pl"$$$Ure shift occurred (as it does in the
`eye).
`Concerning the resolution e$timate: it is possrble to measure frequency shifts
`with a resolution of 25kHz using practical circuitry. VVhat this means for us is that he
`can build an electronic circuit board that can detect a 25kHz frequency shift in our
`implantable device. So, if our implantable device shifts 2,000 kHz (note: 2mHz =
`2,000 kHz for an intraocular essure $hift of 200 mmH
`that comes out to be:
`000 kHz/ 200 mmH = 10 kHz fOr each 1 mmH
`ressure chan
`Since we assumed we con only resolve a 25 kHz shift, part #27 \l!.Ould be capable of
`measuring;
`
`K2S kHz/10 kHz}x1 mmHg = 2.5 mmHg resoluttoij
`Puttin this into one
`ation:
`sure resofution = total essure shift x 25 kHz / total fr uen
`shift .
`Note that part #28 ( Wlid'l was not as sensitive in amplitude) had a frequency
`shift of 4.1 mHz over the 200 mmHg pre$sure change, yielding a better resolution
`of pressure resolution #2a = 200 mmHg x (25 kHz/ 4, 100 kHz) = 1.2 mmHg.
`
`Please caU me if I can be of any further help.
`
`Sincerely.
`
`Leon G. Partamian. M.D.
`Manager
`10Sensor, LLC
`
`Abbott
`Exhibit 1007
`Page 008
`
`

`

`FROM:
`
`PHONE NO.
`
`818 9935994
`
`DEC. 01 1999 10:09AM P2
`
`~~~'0~
`1(!J$MkJII,, J!l!(J
`181/.33 ROU/11111, IJl,J.., #,201,</
`ho,,tl,1'40, eA 91925
`"1J I /-lfl-991-///,1.
`~· l-111-993-599'-
`
`James A. Gavney. Jr.
`Lumen
`426 Lowell Avenue,
`Palo Alto. CA 94301-3813
`Tel: (650) 321-6630
`
`November 30, 1999
`
`Ill: JOSensor Pressure Sensor Patent AppUc:adon
`
`Dear James,
`
`I hereby have enclosed three pages with new correc.tiOns that can substitute
`(pages to, t t, 12.) or be added to the previous Research Plan package.
`
`In addition, there are a number of statements or data that are not being
`lnduded Into the Research Plan because of their Confidential nature that I have
`hereby endosed for the patent appUc.ation. We should consider each one of
`these as potential dalms:
`(1) The overall diameter of the Implantable Jntraocula.r pressure Sensor will be
`smaller than 2.5 mm.
`(2) The inductor coil·s diameter (or diameter of the coil) should be more than
`IO mlc.rons in diameter (minimum of l O microns), If circular, or 10 microns
`slde. If square or rectangular. for the sensor to function. If the diameter
`goes less than the suggested numbers. the resistance will Increase
`significantly. and measurements cannot be obtained.
`(3) The diameter of the coil of the sensors, to be made a.t JP technologies for
`starters, will start with wm be 20 microns tf circular. In case of rectangular
`coDs. we wUJ use f O by 20 microns and 20 by 20 microns.
`(4) The Q of the system has to be over 10 for the sensor to be functional.
`(5) The number of turns of the Inductor coil have to be at least 10 - 1 S turns or
`more. The higher the number of turns, the better the results.
`
`In addition:
`(a) One of the most Important aspects of the 10Sensor design is It s ~
`lntel[iltlcNl Into one epc:ased !!f'P!AT, rather than the preVious papers and
`anworks. which had the inductor coil outside the confines of me capacitor
`plate (see dam shell fl,gures of the sensor).
`
`Abbott
`Exhibit 1007
`Page 009
`
`

`

`FROM:
`
`PHONE NO.
`
`818 9935994
`
`DEC. 01 1999 10:09AM P3
`
`(b) The unique (IOSensor) manufacturing process or techniques (descrtt>ed and
`utilized in the past) to build the sensors.
`(c) the location of the capadtor plates in the IOSensor design. not present In
`other previous de.signs by CoUins or the Swedes,
`(d) the placement of the sensor on the glaucoma shunt next to the maJn tube
`"double barrel tube flgure10
`(e) design of the ·Nao-shaped" lnsertable device with the 10{) sensor at Its tip.
`(f) See descrlptton regarding hermetic sealing.
`
`Two additional items that are patentable (those you may want to indude them
`in a later (another) patent):
`(a) The external device where there is no description In the literature regarding
`such a device that will be ponable, and in the sJze of around a cigarette
`pack.
`(b) The external deVlce will have multiple (namely three) antennas. A single
`antenna. (which a very knowledgeable person ~out this matter would
`presume), will always have null points. 3 antennas will eliminate this
`problem.
`
`Please call me if I can be of any further help.
`
`Leon G. Partamtan. M.D.
`Manager
`10Sensor, LlC
`
`LGP
`c::\• .•
`
`Abbott
`Exhibit 1007
`Page 010
`
`

`

`FROM:
`
`10
`
`PHONE NO.
`
`818 9935994
`
`DEC. 01 1999 10:10AM P4
`
`technology coutrJ 1eag to le§Mr routine meg;ca1 visits with e(JSUina economic savings. and
`more irnporq,ntty. it would p,eyent alaucogtous optic nerve damage. and reduce cost.sand
`consequences as§OCiated with blindness. and diminish the burden thi8 disease poses on
`society.
`Advantages in animal studies s,e that the ,ensorcou/d offer advantages of contmuqus
`IOP monitoring of pharmacpltJaical elfects Artifacts caused by handling, tonomet,y.
`circadian cyclJnq orwgr drinking could bf measured and th§ ohatmaqo/oaicBI effegs of
`medications/chfmicafs could be d8tecle(J with the use of a w,xsmall numbers of animals.
`31 IFINAL BEFQBTPHASE It;
`Pressure ffP:!Ors complffld durinp the Phf!I I grant_,,,:
`Original samples ¢the micmcfllp pnysure s,nsors, fabJic§teed quring the Phsse I term.
`are enclosed on page s1' of.the highly detailed olfginal Phase J Final Rem subt!lit/.$d to the
`NatiOnal Eye /n#ituf.8 In June of 1998. After the completion af the Ph@ I q(IQt period. a
`detailed analysis of these inf§(lted chip sensors revealed that thfy aid not perform as
`expect.ed becaJ.H;
`1) De$pite four qifferent eyo/viqg fabrication proceBSe§. we determineq that the chips
`sampled in the Final Report did nm worlc, mainl't, due to the lack of adequate Q* Of the
`svstems fQ of a,pund 1.4>. After carefyl analysis of the data obtained fmm these chips. the
`19sufts wn mathematically scrutinized in fight of the newly disooveted fact§1 and cotJ.91udecl
`that despite scaling adiustments. the low Qs w,n> caused by high e{ectlfcal tesi§tlnce
`i{lhfrentin the coil Wires due to their small C~ I Bl88.
`{* :on gm bs defined as the ability of the resonant cirouit to respond and talk to an extem§,I
`device.}
`2) Obtaining reaspnable Os (Os above 10 are desirable) are kel! to @ funcqona{ LC s"l{em
`p,essute sen§Or.
`3) Although it is desirable to hafE! an Integrated swtem. in the inductor;eapacitordesiqn. the
`capaeitor and coil neither ha"! to be in the same plane. nor encased together.
`4) The inductor-caoscitor design f'patent oendina? yields much hiah;r Qs. and thus win ki
`much more sen§itive to pressyre variatkms than an fKl!Jivalent double coil design tde§cribed
`bvColllns>.1
`
`Abbott
`Exhibit 1007
`Page 011
`
`

`

`FROM:
`
`12
`
`PHONE MO.
`
`: 818 9935994
`
`DEC. 01 1999 10:11AM P5
`
`Prototvaef
`
`Sfl.nso, #22
`
`:5!nSor#2,7
`
`s,,nsor#28
`
`Table§
`
`Pressf/!i:
`OmmHq
`
`Pressure·:
`200mmt[q
`
`_ ...... ~- ..
`
`...
`
`---
`
`Abbott
`Exhibit 1007
`Page 012
`
`

`

`FROM
`
`PHONE NO.
`
`818 9935994
`
`DEC. 01 1999 10:12AM P6
`
`12
`
`Tables
`
`s,nsor#27 .
`
`sensQ.£#28
`
`Prototvoe#
`
`Sensor#.22
`. ,_...., ........
`
`... l:"'.'""'T'...,....-r'•'"r' -;-....... ""-.i-'m'::. "'';;l'r=:.
`
`Pressure:
`OmmHq
`
`1
`
`.. -
`
`I
`\ I
`
`-· , ... -
`... --
`
`.. ., ~ ..........
`
`. ..._ -·-......
`
`P,essure:
`2QOmmHg
`
`JT(P' . . _ . . . . .
`
`. .... ___ ,..,
`•.. ·-- .. ... , ... ,, ...
`·····--
`... r. ,-1
`-. ... ..
`±±o
`
`\
`
`/
`
`dl...-,'IM r.lUllt ..
`
`. .... ,. ...... ,... &""_ ..
`'" "' .....
`;... .......
`
`'""
`
`L
`
`.....
`
`w
`
`·-" ,. __ __
`
`,flf/1' . . . -
`
`- -
`
`., ........ ".,, ...
`• .... *'' •• _.
`
`l "'.I . . . ...
`r-11 r-
`-
`
`\ I
`I
`
`.. -... __ ....
`
`--·- -
`
`, .. _, ... -... -.
`
`........ -----
`
`Abbott
`Exhibit 1007
`Page 013
`
`

`

`FROM:
`
`PHONE NO.
`
`: 818 9935994
`
`DEC. 01 1999 10:12AM P7
`
`Variable Gap Capacitor
`Pressure Sensor
`
`Deformable Membrane & Upper Cap_acitor Plate
`
`/
`
`Inductor Lines
`
`"
`
`~ower Capacitor Plate
`
`Cross Sectional View
`
`Rough Equivalent Circuit
`L
`C
`
`R
`
`Abbott
`Exhibit 1007
`Page 014
`
`

`

`FROM:
`
`PHONE NO.
`
`: 818 9935994
`
`DEC. 01 1999 10:13AM P8
`
`Octagonal Spiral Inductor
`& Lower Capacitor Plate·
`
`Contacts to upper capacitor plate
`
`Lower Capacitor Plate
`
`2mm Square. chip
`
`Abbott
`Exhibit 1007
`Page 015
`
`

`

`FROM:
`
`PHONE NO.
`
`: 818 9935994
`
`DEC. 01199910:13AM P9
`
`Pressure sensor chip attached to
`Glaucoma shunt/tube/seton tube
`
`Glaucoma
`shunt/reservoir
`
`Pressure sensor
`-----tnr,wusieeddinin a connected second barrel)
`
`Glaucoma shunt
`and tube
`
`corneal limbus
`
`Anterior chamber
`
`®
`
`Abbott
`Exhibit 1007
`Page 016
`
`

`

`FROM:
`
`11
`
`PHONE NO.
`
`818 9935994
`
`DEC. 01 1999 10:14AM P10
`
`The following ,esults tt'§I! tabulated in Table 3:
`Table 3
`
`#4
`#6
`#7
`#14
`#17
`These results clearly indicated that the design should work. and perform as predicted.
`Based on the above information. we built several otOtotype models made with lathe-wound
`coils and hand assembled sensors, with and without capacitor plates. depending on the
`particular design. using 64-micron and 26.4-micron diameter wires to conwuot the OOils fsee
`photographs>. AR of these mqgelS wee, sent to Saar Associates, tnc. for Jndspend,at
`testtaa iO a PtH§Ut! chamber. Ibt oreto.tYRU wn t•# ia,idf, lo« maa, and
`pressurized wilh a pump attsched to a p,sssu,s gauge. The Resonant fl'l(l9ueQCY msponses
`went tutea with M HP 8753.D network analvzer: the teft@nteoat ma 4 tum coil about 1
`cm. in diameter <w following parsarap,h fora summa,y ot th@ findings. a1009. With the
`enclosed letter In the ipdex section with printouts of the resulting traciJ19$ on some of the
`p,ptotypes that wem tested independsntlyby Saar Assqclates, Inc tested on June 26,
`1999). TM best resuJt§ we,e obtain,,d with ,orototve, #27 (double pla#t t;flRIICitor, non(cid:173)
`coaxial coilde§ionl, Good t9SUlt§ WM obtained from prqtotypt #2e fdouble Dlate qapacilor,
`~ coil). The f&ubl& §Pir&I cgiJ d&siqn of p,pfotype # 22 lno diSCtel& capacitor) was
`fpund to be functional although thft signal strength measul8d waa somewhat le,s than
`Q(9totype.s fiZ and #28. Tbffe te§Ultf W,19 re-yermed by Mr; Teamc, Ryan. PJOtotype 127
`exhibited a frequency shift of aqpmximate/v z MHz in l9§D9ll§f to a Pffl§§Yte Change of 200
`mmHq. Fn,quencv ahllts of 25 MHz should be easily obtainable with practloal ciref.litrli
`viB/dino a Pt!fSYll resolutign of 2.5 mmHg, Improvement§ in PIOlolYP@ ~n and
`electronic circuit,y could make 1 mmHg resolution Mfi!Y achie'(Qble. Uable 4) talso see
`index - letter from SaarA,ssociates, Inc.}
`Tabft 4 (§ample§ tested with an HP8753D "9Cto(o,twork an,lyzen
`sensor
`Diameter
`fJ!JtDJ.
`
`Weak
`>1.1 MHz
`Weak
`Weak
`
`54
`
`nsesthan
`
`Abbott
`Exhibit 1007
`Page 017
`
`

`

`~Q~'O~ D
`J(!)~.e.ee
`181/.33 Rodc/Je, 8bxt, #:mall
`N~e/191325
`"1.t: 1-818-998-flt,2,
`~ l l-818-998-599/f.
`
`James A Gavney, Jr.
`Lumen
`426 Lowell Avenue.
`Palo Alto, CA 94301-3813
`Tel: (650) 321·6630
`
`&,r,{"f I Q £.r.S"TI t4-<....
`RE.: 10Sensor Pressure Sensor Patent Application
`
`November 20, 1999
`
`Dear James.
`
`I hereby have FedExed to you the material regarding the Patent Application of
`the Continuous Telemetric Pressure Sensor under development by 10Sensor,
`LLC. The material consists of the detailed Research Plan that will be submitted
`to the SBIR Phase II grant application. It also contains detailed diagrams and
`designs. along with an enumerated list of references related to the subject of
`glaucoma and the importance of pressure monitoring. I have also endosed an
`extra figure that will replace the figure on page 13.
`
`As we had agreed on the telephone, we will proceed with the Provisional
`application, as our funds are limited until we get funded, and we will proceed
`with the full application before the year Is up. Please call me or Dr. (Kurt)
`Petersen (whom you had met in February or March of this year) if questions
`arise.
`
`Sincerely.
`
`Leon G. Partamlan, M.D.
`Manager, 10Sensor. LLC
`
`Enclosures: (1) CONFIDENTIAL MATERIAL total of 31 + 1 pages
`(2) Floppy disc containing SBIR Phase I application material and templates
`
`LGP
`c:\*.*
`
`Abbott
`Exhibit 1007
`Page 018
`
`

`

`1
`
`RI.SEAR.CH PIAN
`
`1 J Specific Aims:
`The need for constant monitoring of intraocular pressure (IOP) in glaucoma patients,
`especially in diagnosing the disease and managing its subsequent t~tment, has prompted us
`to develop an IOP measuring sensor.
`In 1967, Collins described the concept for a rather large pressure sensor made of
`opposing coils placed on glass malleable membranes 1
`• Based on Col/ins's concept we
`fabricated several prototypes, with various modifications. of lathe~wound and hand-(cid:173)
`assembled sen
`rs. A few of the
`ro
`sensors have
`rfo
`sat sfactoril
`The sensors c nsist of a ca
`· atiVi
`inductive ciroult formed from a s iral
`inductor-diaphragm based capacitor. When the IOP level is altered, the pressure induced
`displacement of the diaphragm changes the value of the circuit capacitance. which in tum
`changes toe resonant frequency of the LC cirouit. The terminology "L" designates an
`inductor element and "C" designates a capacitor element.
`10Sensor's pressure sensor chip has a pressure sensing capacitor and inductor in one
`single small chip. Our device is much improved over prior attempts (10Sensor patent
`pending). While another group 2 3 has worked on a prototype IOP pressure sensor based on
`this principle, the device required hand assembly of the inductors external to the sensor chip,
`greatly increasing the volume of the implant and complicating its practicality and eventual
`manufacturing. The key distinction we can make between our device and the design
`described previously is the full integration of the coil and electrical interconnections.
`The objective of our research project is to make the continuous IOP measuring device
`commercially available for use in glaucoma research, and for eventual human utilization in
`patients with glaucoma. An implantable microsensor will furnish and allow continuous
`monitoring of IOPs, help evaluate and subsequently modify glaucoma treatment. The IOP
`sensor can be used for glaucoma research in animals, but more importantly it will help to
`diagnose glaucoma, monitor IOPs, modify and regulate glaucoma therapy in humans. The
`resonant frequency of the resonant circuit and hence the correlated IOP can be measured
`continuously.
`The IOP monitoring and measurement is performed telemetricaHy, without coming into
`direct contact with the eye, using an external electromagnetic excitation and receiving pickup
`coil, which can be placed in a device, such as spectacles, that can be worn safely,
`comfortably and conveniently without disturbance of vision or ocular physiology. The
`extemal energy source is used to excite the LC circuit and the resulting signal emitted by the
`circuit is received remotely via the external detector pickup coif. The signal is electronically
`processed to determine its resonant frequency and in tum correlated to the IOP level. The
`implanted device contains no internal energy source; thus there are no concerns about
`implantable power sources such as batteries.
`
`The specific aims of this proi§tcl and the researoh plan are:
`(1) To refine the prototype and automate the fabrication. of the pressure sensors, using:
`(aJ Micromachining. to be manufactured by JP Technologies
`lbJ Microfabrication to be followed by Nanofabrication using the MEMS approach. to be
`performed at Stanford University1s NSF sponsored NNUN microfabrication facility.
`(2) Development of the Extemal Interface for the IOP sensor.
`(3) Perform biocompatibilitv stuqies, in preparation for eventual FDA submission.
`(4} Vertebrate animal stUdies.
`fa) Rabbit experiments to be performed by Dr. David Lee and
`fbJ Monkey experiments to be performed by Dr. Paul Kaufman.
`
`Abbott
`Exhibit 1007
`Page 019
`
`

`

`2
`
`Continuous monitoring of the IOP wilt allow us to understand the disease of glaucoma better,
`and wilt help us monitor and modify glaucoma therapy. For the first time, the making of a
`practical implantable ocular pressure sensor is attainabte. 10Sensor has the capability of
`making these chips through the micromachining capabilities of JP Technologies, and the
`Nanofabrication Facility/Center for Integrated Systems at Stanford University. 10Sensor has
`assembled a group of distinguished experts in the fields of nanofabrication, micromachined
`pressure sensors and actuators, electromagnetic and communications systems, biomedical
`telemetry, and clinical as well as laboratory glaucoma researchers. 10Sensor has the
`expertise, design, technology and available facilities to accomplish this project.· This
`technological innovation will be a breakthrough in the diagnosis and treatment of glaucoma.
`The number of studies that can be designed around measuring /OP by telemetry is limited onlv
`by the imagination of the investigators.
`
`2) SIGNIFICANCE:
`The discovery of a continuous intraocular pressure sensing device has long bee1t
`considered to be the "Holly grail" of glaucoma by some of the most notable figures in
`Glaucoma. such as Drs. Bernard Becker. W. Morton Grant and Paul Chandler (personal
`communications). Attempts to devise and build devices that could perform this task have
`been ongoing by researchers and investigators for over 50 years. but with little success.
`The causal retatlonshlo betwe§.n level of IOP and qlaucomatou§ optic nerve damage:
`An editorial summarized Primary Open Angle Glaucoma (POAG> as: "Clearfv. in POAG
`there is abnormal resistance to aqueous humor outflow throygh the trabecular meshwork.
`resulting in elevation of intraocular oressure that. depending on the susceptibility of the optic
`nerve. leads to nerve fiberdeath." 4
`There is ample evidence to suow., the causal relationship between level of /OP and
`glaucomatous optic nerve damage~ 8 9 16 11 12 Clarif,cation of the relationship between /OP
`and Primary Glaucoma is available from detailed correlative data on the status of the o~tic
`nerve and /OP in larae, repre"Sentative population samples. The Baltimore Eye Survev
`In addition to the Baltimore Eye
`confirmed that /OP is an important factor in glaucoma.
`Survey. four other are consistent with the'Se findi~s: the Ferndale Study in Wales 9: the
`Framingham Eye Survey 10: the St. Lucia Survev1.· and the Dalby study in Sweden. 12
`Reports from longitudinal studies strongly indicate that risk of visual field defects
`developing in a patient is directly related to the height of their preexisting IOP. 13 1
`15 The fact
`~
`that the risk rises precipitously at higher /OP levels suga@sts a strong causal relationship at
`those levels.
`
`Circadian (diurnal) variations of lQP and Its slqn/flcance:
`The IOP in humans varies thtoughout the day and is dynamic. Diurnal {circadian)
`variations in IOP were first reported by Sidler-Huguenin in 1898.16 The topic has been so
`widely studied since then that a review in 1961 contained over 300 references.17 Cycles of
`physiologic rhythm vary from intervals of seconds, as in respiratory and cardiac cycles, to
`months, such as menses.18 lt is generally accepted that the IOP varies over a 24-hour
`period. The term diurnal or circadian variation of the IOP refers to the continuous
`oscillations of the IOP during a 24-hour period. It is the impression of most experts that the
`IOPs peaks could occur. with a significant probability. at all hours of the day. 19 Except for the
`findings of Kitazawa and associatesf" and Merritt and associates.21 the probability of
`pressure peaks being tamer in the morning than at other times is similar to tht in normal
`subiects and circ