Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 1of17
`
`James J. Elacqua (CSB No. 187897)
`jam es.elacqua@dechert.com
`Noemi C. Espinosa (CSB No. 116753)
`ni cky. espinosa@dechert.com
`Andrew N. Thomases (CSB No. 177339)
`an drew. thomases@dechert.com
`Michelle W. Yang (CSB No. 215199)
`mi ch ell e. yang@dechert.com
`Hieu H. Phan (CSB No. 218216)
`hieu.phan@dechert.com
`Joshua C. Walsh-Benson (CSB No. 228983)
`j oshua. wal sh-benson@dechert.com
`DECHERT LLP
`2440 W. El Camino Real, Suite 700
`Mountain View, California 94040-1499
`Telephone:
`(650) 813-4800
`Facsimile:
`(650) 813-4848
`
`Attorneys for Plaintiffs
`MEDTRONIC, INC., MEDTRONIC USA, INC.,
`AND MEDTRONIC VASCULAR, INC.
`
`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF CALIFORNIA
`
`SAN FRANCISCO DIVISION
`
`MEDTRONIC, INC., a Minnesota
`corporation, MEDTRONIC USA, INC., a
`Minnesota corporation, and MEDTRONIC
`VASCULAR, INC., a Delaware
`corporation,
`
`Case No. C07-00567 MMC
`
`MEDTRONIC'S FED. R. CIV. P. 50(a)
`MOTION FOR JUDGMENT AS A
`MATTER OF LAW
`
`Plaintiffs,
`
`v.
`
`AGA MEDICAL CORPORATION, a
`Minnesota corporation,
`
`Defendant.
`
`Date:
`Time:
`Place:
`Judge:
`
`TBD
`TBD
`Courtroom 7, 191h Floor
`
`Hon. Maxine M. Chesney
`
`I
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`I 0
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`DECHERT LLP
`A TT O RNE YS A T L AW
`
`S ILI CO N V ALLEY
`
`MDT'S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`COOK
`IPR2019-00123
`Cook v. Medtronic
`Exhibit 1030-0001
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 2 of 17
`
`TABLE OF CONTENTS
`
`
`Page
`INTRODUCTION .............................................................................................................. 1
`AGA HAS INFRINGED THE ASSERTED CLAIMS OF THE ‘141 AND ‘957
`PATENTS ........................................................................................................................... 1
`A.
`The Commonalities Among All The Accused Systems.......................................... 2
`1.
`All Accused Systems Function Similarly And Require The Use Of
`AGA’s Delivery Cable And A Loader/Delivery Catheter .......................... 2
`All Accused Devices Exhibit SIM When Restrained ................................. 3
`All Accused Devices Undergo A Load Test............................................... 4
`AGA Makes Or Has Made All Components Of The Accused
`Systems ....................................................................................................... 4
`AGA Instructs Physicians On How To Use The Accused Systems ........... 5
`5.
`Direct Infringement................................................................................................. 5
`1.
`Claim 18 of the ‘141 Patent ........................................................................ 5
`Contributory Infringement ...................................................................................... 6
`1.
`The ‘141 Patent ........................................................................................... 6
`2.
`The ‘957 Patent ........................................................................................... 7
`Infringement Under 35 U.S.C. § 271(f)(2) ............................................................. 7
`1.
`The ‘957 Patent ........................................................................................... 7
`III. MEDTRONIC IS ENTITLED TO DAMAGES IN THE FORM OF A
`REASONABLE ROYALTY EQUAL TO 13.4% OF AGA’S SALES OF
`ACCUSED DEVICES AND DELIVERY SYSTEMS....................................................... 8
`THE ‘141 AND ‘957 PATENTS ARE NOT INVALID .................................................... 9
`A.
`The Patents Are Not Anticipated By The “Work” Of Dr. Cragg Or The
`Cragg II Paper ......................................................................................................... 9
`1.
`The “Work” of Dr. Cragg............................................................................ 9
`2.
`The Cragg II Paper.................................................................................... 10
`Obviousness .......................................................................................................... 10
`1.
`Cragg et al., Nonsurgical Placement of Arterial Endoprostheses: A
`New Technique Using Nitinol Wire, Radiology (April 1983)
`(“Cragg I”) and Patent Application S56-144326 to Miyauchi et al.
`(“Miyauchi”) ............................................................................................. 10
`Miyauchi And Patent No. 4,512,338 (“Balko”)........................................ 11
`Miyauchi And Palestrant, Comparative In Vitro Evaluation of the
`Nitinol Inferior Vena Cava Filter, Radiology 145: 351-355,
`November 1982......................................................................................... 11
`Secondary Considerations of Non-Obviousness....................................... 12
`4.
`CONCLUSION................................................................................................................. 13
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`I.
`II.
`
`IV.
`
`V.
`
`B.
`
`C.
`
`D.
`
`B.
`
`2.
`3.
`4.
`
`2.
`3.
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`
`
`
`
`- i -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`IPR2019-00123
`Exhibit 1030-0002
`
`

`

`
`
`
`
`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 3 of 17
`
`TABLE OF AUTHORITIES
`
`FEDERAL CASES
`
`Page
`
`
`Waymark Corp. v. Porta Sys. Corp.,
`245 F.3d 1364 (Fed. Cir. 2001)....................................................................................... 8, 9
`
`
`
`FEDERAL STATUTES
`
`
`
`Federal Rule of Civil Procedure 50(a) .................................................................................... 1, 2, 3
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`
`
`ii
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`IPR2019-00123
`Exhibit 1030-0003
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 4 of 17
`
`
`
`NOTICE OF MOTION AND MOTION
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD, PLEASE TAKE
`
`NOTICE that Medtronic will and hereby does move this Court, pursuant to Federal Rule of Civil
`
`Procedure 50(a), for an Order granting judgment as a matter of law that (1) AGA has infringed
`
`U.S. Patent No. 6,306,141 (hereinafter “the ’141 patent”) and U.S. Patent No. 5,067,957
`
`(hereinafter “the ’957 patent”), (2) the ‘141 and ‘957 patents are not invalid, and (3) Medtronic is
`
`entitled to damages in the form of a reasonable royalty equal to 13.4% of AGA’s sales of accused
`
`devices and delivery systems. This Motion is based upon this Notice of Motion and Motion,
`
`Memorandum of Points and Authorities, the evidence and testimony of record, other papers and
`
`pleadings on file, and on such other argument and evidence as may be presented to the Court at or
`
`prior to the hearing on this Motion.
`
`MEMORANDUM OF POINTS AND AUTHORITIES
`
`I.
`
`INTRODUCTION
`
`Pursuant to Federal Rule of Civil Procedure 50(a), Medtronic hereby moves for judgment
`
`as a matter of law on all factual issues that have been presented to the jury regarding AGA’s
`
`infringement of the ‘141 and ‘957 patents, the validity of the ‘141 and ‘957 patents, and the
`
`amount of damages owed to Medtronic as a result of AGA’s infringement. The trial record
`
`establishes that no reasonable jury could find that AGA has not infringed the asserted claims of
`
`the ‘141 and ‘957 patents, that the asserted claims of the ‘141 and ‘957 patents are invalid, or that
`
`Medtronic is not entitled to damages in the form of a reasonable royalty equal to 13.4% of AGA’s
`sales of the accused products.1
`
`II.
`
`AGA HAS INFRINGED THE ASSERTED CLAIMS OF THE ‘141 AND ‘957
`PATENTS
`
`Medtronic accuses AGA of infringement of the asserted claims of the ‘141 and/or ‘957
`
`patents with respect to the following AGA devices and their corresponding delivery systems: the
`
`AMPLATZER® Septal Occluder and Multi-Fenestrated Septal Occluder, the AMPLATZER®
`
`1 Medtronic also moves for judgment as a matter of law on AGA’s counterclaims for declaratory
`judgment of noninfringement and invalidity of the ‘141 and ‘957 patents because no reasonable
`juror could find that the patents are not infringed or are invalid.
`- 1 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0004
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 5 of 17
`
`
`
`Duct Occluder I and II, the AMPLATZER® PFO Occluder, the AMPLATZER® VSD Occluders
`
`(including the Membranous VSD Occluder, the Muscular VSD Occluder, and the P.I. Muscular
`
`VSD Occluder), and the AMPLATZER® Vascular Plug, Vascular Plug II, and Vascular Plug III.
`
`The occluders and plugs are collectively referred to as the “Accused Devices.”
`A.
`
`The Commonalities Among All The Accused Systems
`
`1.
`
`All Accused Systems Function Similarly And Require The Use Of
`AGA’s Delivery Cable And A Loader/Delivery Catheter
`
`All sizes of the Accused Devices and their delivery systems function similarly. Dkt. 812
`
`(Feinstein testimony) at 245-303. All of the Accused Devices are designed and made so that each
`
`occluder or plug device can be implanted into patients using minimally invasive techniques,
`
`requiring only a small incision allowing the device to be implanted via the patient’s vascular
`
`system. Id.
`
`Although AGA sells several components of the Accused Systems separately, every
`
`Accused Device requires a loader, AGA’s delivery cable/wire and a delivery catheter in order to
`
`function. See, e.g., Dkt. 812 at 258:1-3; TX Nos. 22, 23, 36, 346, 347, 457, 460, 474, 502, 503-
`
`506, 1558-1560, 1999, 1185, 1186, 2451-2454. The occluders are sold separately from their
`
`corresponding delivery systems, which include a loader, a sheath, and a delivery cable. See, e.g.,
`
`Dkt. 812 at 258:1-3; TX Nos. 22, 23, 36, 346, 347, 457, 460, 502, 504-506, 1558-1560, 1999,
`
`1185, 1186, 2451, 2452, and 2454. Because an AGA loader and sheath are bundled with the
`
`required delivery cable, the vast majority of the time the physicians also use AGA’s sheath and
`
`loader. See, e.g., Dkt. 812 at 257:18-258:7. The vascular plugs are sold preloaded and pre-
`
`connected to the delivery wire. See, e.g., TX Nos. 474, 503, 2453, and 2462. The sheaths used
`
`with the plugs are sold separately. See, e.g., TX 474, 503, and 453.
`
`For implantation, each occluder must first be affixed onto the end of AGA’s delivery
`
`cable with a threaded connector. See, e.g., Dkt. 812 at 258:1-3, TX Nos. 22, 23, 36, 346, 347,
`
`457, 460, 502, 504-506, 1558-1560, 1999, 1185, 1186, 2451, 2452, and 2454. Using the AGA
`
`delivery cable to manipulate the device, the physician pulls the device into a loader so that the
`
`device is restrained in a deformed shape. See, e.g., Dkt. 812 at 280-287. The loader is connected
`
`- 2 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0005
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 6 of 17
`
`
`
`to the delivery catheter, which has already been threaded into the patient’s vascular system via a
`
`small incision, to provide a path towards the desired location for the device to be implanted. Id.
`
`The device is delivered into the patient by pushing on the delivery cable to push the device
`
`through the loader and delivery catheter to transport the device to the desired location in the body
`
`for deployment. Id. Once the occluder or plug device has reached the position for deployment,
`
`the restraint of the catheter is pulled back from the device by holding the delivery cable stationary
`
`and retracting the delivery catheter so that the device is exposed. Id. Once the restraint of the
`
`delivery catheter is removed from the device, causing the stress to be removed, the device
`
`spontaneously transforms back towards its original, unstressed shape. Id. If the positioning of
`
`the device is acceptable, the device can be removed from the delivery cable by unscrewing the
`
`threaded connector, and implantation is complete. Id. If the physician decides that the device is
`
`to be repositioned or removed from the body, the device can be retracted back inside of the
`
`delivery catheter by pulling on the delivery cable. Id. The device can then be either repositioned
`
`and redeployed at a different location or removed from the body entirely. Id. According to the
`
`Instructions for Use for the Accused Devices, every size of each device is implanted,
`
`repositioned, or removed in the same manner. See, e.g., Id.; TX Nos. 22, 23, 36, 346, 347, 457,
`
`460, 474, 502, 503-506, 1558-1560, 1999, 1185, 1186, 2451-2454.
`2.
`According to AGA’s documents, AGA designs and makes the Accused Devices from a
`
`All Accused Devices Exhibit SIM When Restrained
`
`particular shape memory alloy known as “nitinol,” which is a shape memory alloy made from
`
`nickel and titanium. See, e.g., TX Nos. 2480, 2482, 2483, 1531-1544. The same nitinol
`
`composition, specified as 56% nickel and about 44% titanium, was selected by AGA for use in
`
`every Accused Device. Id. AGA obtains its nitinol in the form of wire from Fort Wayne Metals,
`
`a supplier of medical grade nitinol. See, e.g., TX 2472. These devices also undergo substantially
`
`the same manufacturing processes. See, e.g., TX Nos. 2451, 2472, 427-434, 620-621, 784-789,
`
`795, 797-799, 802, 805, 807, 810-811, 813, 815, 818, 820, 1003, 1005, 1008-1011, 1014-1015,
`
`1018, 1020, 1139, 1143, 1145, 1147-1148, 1185-1186, 2171-2172, 2180-2181, 2186, 2192,
`
`21992206, 2213, 2219, 2225, 2230, and 2236. The DSC (“Differential Scanning Calorimetry”)
`
`- 3 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0006
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 7 of 17
`
`
`
`tests conducted for AGA indicate that their nitinol transforms to austenite at room and human
`
`body temperature because, at those temperatures, is above its As (austenite start) temperature.
`
`See, e.g., Dkt. 815 (Sinclair testimony) at 374-456; 112, 113, 114, 115A, 118, 122, 125, and 130.
`
`Thus, at room or body temperature, when the device is restrained by the loader or delivery
`
`catheter and stressed into its deformed shape, the austenite of the alloy transforms to SIM due to
`
`the stress. See, e.g., Dkt. 815 at 374-456. When the device is deployed, the SIM in the nitinol
`
`reverts to its austenitic state when the device is released from the restraint of the delivery catheter.
`
`Id. In order to reposition or remove the device from the body, the device is retracted back into the
`
`delivery catheter (and back into its deformed shape) and thus, the austenite in the nitinol again
`
`transforms back to SIM. Id. The Accused Devices are deployed, repositioned, and removed
`
`without any need for a change in temperature of the nitinol or the delivery catheter in accordance
`
`with the claims. See, e.g., Id.; Dkt. 812 at 245-303.
`3.
`As part of AGA’s final inspection for its manufacturing process, each and every Accused
`
`All Accused Devices Undergo A Load Test
`
`Device shipped for sale is subjected to a Load Test where AGA ensures that the device will
`
`properly deploy to its unstressed shape. See, e.g., TX Nos. 2451, 2462, 2472, 94, 2172, 2182.
`
`The Load Test requires that a formed device is attached to a delivery cable and then is pulled in
`
`and out of a loader several times to verify that the device will return to its original shape. Id. This
`
`test is performed on every Accused Device as part of AGA’s quality control process before it is
`
`packaged and sold. Id. Each time this test is performed, SIM is created in the alloy because, as
`
`explained above, stress causes the austenite in the alloy to transform to SIM. See, e.g., Dkt. 815
`
`at 374-456.
`
`4.
`AGA makes (or has made) all of the Accused Devices and their corresponding delivery
`
`AGA Makes Or Has Made All Components Of The Accused Systems
`
`systems in the United States, and offers for sale and sells the Accused Systems in the United
`
`States and elsewhere. See, e.g., TX Nos. 1827, 1903, 2045, 2445, 2462, 2463, and 2475.
`
`The Accused Occluders and the Vascular Plug III are all sold in their fully formed,
`
`expanded shape and are constrained by the physician just prior to implantation. See, e.g., Dkt.
`
`- 4 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0007
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 8 of 17
`
`
`
`No. 812 at 245-303; Dkt. 886 (Mullins testimony) at 1389-1446; TX Nos. 22, 23, 36, 346, 347,
`
`457, 460, 474, 502, 503-506, 1558-1560, 1999, 1185, 1186, 2451-2454. The Vascular Plug and
`
`Vascular Plug II are made and sold pre-constrained by AGA in a “loader.” See, e.g., TX Nos.
`
`474, 503, 2453, and 2462.
`5.
`AGA instructs physicians to use the Accused Systems in accordance with procedures
`
`AGA Instructs Physicians On How To Use The Accused Systems
`
`contained in the Instructions for Use (“IFUs”). See, e.g., Dkt. 812 at 245-303, See, e.g., TX Nos.,
`
`2463, 22, 23, 36, 346, 347, 457, 460, 474, 502, 503-506, 1558-1560, 1999, 1185, 1186, 2451-
`
`2454. These IFUs, which are subject to strict governmental regulations and scrutiny, contain
`
`detailed step by step directions on how to restrain, implant, recapture, reposition, and/or remove
`
`the Accused Devices to treat patients. Id. Although AGA argues that some doctors use the
`
`Accused Systems in an “off-label” manner, the steps of implantation, repositioning, or removal
`
`do not vary. Id.
`
`Before physicians can purchase Accused Systems, AGA requires the physicians to
`
`undergo mandatory training sessions where they are instructed how to implant the Accused
`
`Devices. See, e.g., Dkt. 812 at 245-303; TX Nos. 2463, 31-33. For instance, prior to being
`
`allowed to implant certain devices in the U.S., AGA requires physicians to undergo simulation
`
`training, which replicates implantation in accordance with the Instructions For Use for these
`
`Accused Products. See, e.g.,Dkt. 812 at 245-303; TX Nos. 2463, 35, 6278.
`
`AGA also hires and utilizes proctors to assist in training physicians in the use of the
`
`Accused Systems. See, e.g., Dkt. 812 at 245-303; TX Nos. 2463, 44-45, 1649-1651. AGA’s
`
`proctors’ duties include training on product selection, treatment, product deployment, recapturing,
`
`repositioning and release. Id. Thus, AGA directs physicians on how to use and implant the
`
`Accused Devices.
`B.
`
`Direct Infringement
`1.
`All models and sizes of the accused occluders directly infringe Claim 18 of the ‘141
`
`Claim 18 of the ‘141 Patent
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`patent when they undergo a “load test” prior to being sold. See, e.g., Dkt. 815 at 374-456. As
`
`- 5 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`IPR2019-00123
`Exhibit 1030-0008
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 9 of 17
`
`
`
`part of AGA’s final inspection process before packaging and sale, each accused occluder is
`
`subjected to a load test where AGA ensures that the device will properly deploy to its unstressed
`
`shape. See, e.g., TX Nos. 2451, 2462, 2472, 94, 2172, 2182. AGA’s documents show that during
`
`load test procedures each occluder is screwed to its corresponding delivery cable, inserted into a
`
`loader, and then pushed back out and deployed. Id.
`
`Each time the load test is performed, all the limitations of Claim 18 are met. See, e.g.,
`
`Dkt. 815 at 374-456. During the load tests, the unstressed occluders are restrained by the loader
`
`at room temperature and are stressed into their deformed shape, transforming the austenite of the
`
`nitinol to SIM. Id. When the occluders are then deployed from loader, the SIM in the nitinol
`
`reverts to its austenitic state. Id. During the load tests, the Accused Products are inserted into the
`
`loader then pushed back out and deployed without any need for a change in the temperature of the
`
`nitinol in accordance with Claim 18. Id.
`C.
`
`Contributory Infringement
`1.
`AGA contributes to the infringement of claims 1, 2, 5, 17, 18 and 21 of the ‘141 Patent by
`
`The ‘141 Patent
`
`making, offering to sell, and selling the accused occluders. See, e.g., Dkt. 812 at 245-303; Dkt.
`
`815 at 374-456. AGA also contributes to the infringement of Claims 1 and 17 of the ‘141 Patent
`
`by making, offering to sell, and selling the accused vascular plugs. Id.
`
`AGA supplies to physicians the Accused Devices as components of systems that infringe
`
`the asserted apparatus claims of the ‘141 Patent. Id. Because the physicians purchase the
`
`Accused Devices and assemble them into infringing systems, those physicians directly infringe.
`
`Id. The Accused Devices are material parts of the infringing systems and are not staple articles of
`
`commerce capable of substantial non-infringing use. See, e.g., Dkt. 812 at 257:18-258:7; 276:13-
`
`20; 277:6-13; 293:13-19; TX Nos. 22, 23, 31-33, 35, 36, 44-45, 273-274, 290, 295, 298, 299, 300,
`
`321, 322, 324-327, 346, 347, 457, 460, 474, 502, 503-506, 1558-1560, 1649-1651, 1999, 1185,
`
`1186, 2451-2454, and 6278. AGA makes, offers to sell, and sells the Accused Devices with
`
`knowledge of the ‘141 Patent and with knowledge that the devices are especially made or adapted
`
`for a use that practices the asserted claims of the ‘141 Patent. See, e.g., TX Nos. 83, 142, 2451,
`
`- 6 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0009
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 10 of 17
`
`
`
`The ‘957 Patent
`
`2463, and 2472.
`2.
`AGA contributes to the infringement of claims 1, 5, 6, 10, 11, 16, and 17 of the ‘957
`Patent by making, offering to sell, and selling the following AGA devices: AMPLATZER®
`Septal Occluder, Multi-Fenestrated Septal Occluder, PFO Occluder, Duct Occluder I,
`
`Membranous VSD Occluder, Muscular VSD Occluder, P.I. Muscular VSD Occluder, and
`
`Vascular Plug I.
`
`AGA is liable for contributory infringement of the ‘957 Patent because AGA supplies
`
`these devices as components of systems that are used by physicians to perform all of the method
`
`steps of the asserted claims. See, e.g., Dkt. 812 at 245-303; Dkt. 815 at 374-456. The devices are
`
`material parts of the infringing systems used in practicing the methods and are not staple articles
`
`of commerce capable of substantial non-infringing use. See, e.g., Dkt. 812 at 257:18-258:7;
`
`276:13-20; 277:6-13; 293:13-19; TX Nos. 22, 23, 31-33, 35, 36, 44-45, 273-274, 290, 295, 298,
`
`299, 300, 321, 322, 324-327, 346, 347, 457, 460, 474, 502, 503-506, 1558-1560, 1649-1651,
`
`1999, 1185, 1186, 2451-2454, and 6278. AGA makes, offers to sell, and sells these accused
`
`devices with knowledge of the ‘957 Patent and with knowledge that the devices are especially
`
`made or adapted for use in practicing the asserted method claims of the ‘957 Patent. See, e.g., TX
`
`Nos. 83, 142, 2451, 2463, and 2472.
`D.
`
`Infringement Under 35 U.S.C. § 271(f)(2)
`1.
`AGA infringes the ‘957 Patent under § 271(f)(2) by supplying or causing to be supplied
`
`The ‘957 Patent
`
`from the United States to a foreign country the Accused Devices and their delivery systems,
`
`which are uncombined, especially made or adapted for use in practicing the asserted method
`
`claims, and have no substantial non-infringing use. See, e.g., Dkt. 812 at 245-303; Dkt. 815 at
`
`374-456. AGA knew the device and delivery-system components were especially made or
`
`adapted for use in the claimed methods and AGA intended for the components to be used in a
`
`way that would have infringe the method claims of the ‘957 Patent if the use had occurred in the
`
`United States. See, e.g., TX Nos. 22, 23, 31-33, 35, 36, 44-45, 273-274, 290, 295, 298, 299, 300,
`
`- 7 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0010
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 11 of 17
`
`
`
`321, 322, 324-327, 346, 347, 457, 460, 474, 502, 503-506, 1558-1560, 1649-1651, 1999, 1185,
`
`1186, 2451-2454, 6278’ 83, 142, 2451, 2463, and 2472. Infringement under § 271(f)(2) does not
`
`require proof of direct infringement overseas. See, e.g., Waymark Corp. v. Porta Sys. Corp., 245
`
`F.3d 1364, 1368 (Fed. Cir. 2001).
`
`III. MEDTRONIC IS ENTITLED TO DAMAGES IN THE FORM OF A
`REASONABLE ROYALTY EQUAL TO 13.4% OF AGA’S SALES OF ACCUSED
`DEVICES AND DELIVERY SYSTEMS
`No reasonable juror could find that Medtronic is not entitled to reasonable royalty
`
`damages equal to 13.4% of AGA’s sales of accused devices and delivery systems. Medtronic’s
`
`expert, Dr. Christopher Vellturo, has opined that 13.4% is the reasonable royalty rate that
`
`Medtronic and AGA would have agreed to for a license to the ‘141 and ‘957 patents at a
`
`hypothetical negotiation taking place in February of 1998. See, e.g., Dkt. 861 (Vellturo
`
`testimony) at 835-883. Dr. Vellturo and AGA’s expert, Michael Wagner, agree as to the dollar
`
`amount of sales upon which to apply the rate. See, e.g., Dkt. 907 (Wagner testimony) at 1631-
`
`1673. Their only disagreement is as to the rate. Id.
`
`Dr. Vellturo reached his opinion regarding the reasonable royalty rate by studying AGA’s
`
`business and financial documents and the market for occluders and plugs. See, e.g., Dkt. 861 at
`
`835-883. From this, he determined that AGA’s maximum willingness to pay for a license to the
`
`patents-in-suit was 27.8% and Medtronic’s minimum willingness to accept was 8.6%. Id. He then
`
`applied the Georgia-Pacific factors, giving most weight to factors 6, 9, and 13 to arrive at his
`
`13.4% rate.
`
`Mr. Wagner, on the other hand, began his analysis by applying a 25% Rule of Thumb to
`
`AGA’s recorded pre-tax profit to reach a starting point of 5%. See, e.g., Dkt. 907 at 1631-1673.
`
`He then applied the Georgia Pacific factors to lower his reasonable royalty rate to 3%. Id. Mr.
`
`Wagner used the 25% Rule of Thumb as a starting point despite admitting that he had not even
`
`seen summaries of the licenses that form the basis for the Rule. Id. Mr. Wagner also applied the
`
`25% Rule to AGA’s pre-tax profit despite acknowledging that the paper upon which he relied for
`
`his application of the 25% Rule explicitly states that the Rule should be applied to operating
`
`profit, not pre-tax profit. Id. Further, Mr. Wagner’s opinion relied heavily on AGA’s alleged
`
`- 8 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0011
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 12 of 17
`
`
`
`noninfringing alternatives of moving its manufacturing facilities overseas in 1998 or
`
`implementing a cooling step to its manufacturing process in 1998. Id. Yet, AGA’s only evidence
`
`of its ability to move its manufacturing facilities overseas in 1998 was the testimony of Jackie
`
`Robinson, an employee who did not join AGA until 2006. See, e.g., Dkt 907 at 1564-1578, 1631-
`
`1673. Moreover, the evidence of record is clear that AGA has never moved its manufacturing
`
`facilities overseas. Id. As to the cooling step alternative, there is no evidence of record that would
`
`suggest that the cooling step was available to AGA in 1998, that it would have been acceptable to
`
`physicians if implemented, or that it would even be noninfringing. The trial record is absolutely
`
`devoid of any evidence to support AGA’s alleged cooling step alternative other than the
`
`conclusory statements of Mr. Wagner.
`
`Because Dr. Vellturo’s proposed 13.4% reasonable royalty rate is supported by the
`
`evidence of record and Mr. Wagner’s 3% rate is based on the improper application of a rule that
`
`he has not shown should be applied to the specific facts of this case, the Court should rule on
`
`judgment as a matter of law that no reasonable juror could find that Medtronic is not entitled to
`
`reasonable royalty damages equal to 13.4% of AGA’s sales of accused devices and delivery
`
`systems.
`IV.
`
`THE ‘141 AND ‘957 PATENTS ARE NOT INVALID
`
`A.
`
`The Patents Are Not Anticipated By The “Work” Of Dr. Cragg Or The
`Cragg II Paper
`
`1.
`AGA’s prior use defense is based solely on the work of Dr. Andrew Cragg regarding vena
`
`The “Work” of Dr. Cragg
`
`cava filters implanted in dogs (“Cragg Filter Experiments”). AGA did not establish by clear and
`
`convincing evidence that Dr. Cragg’s work was publicly accessible, i.e., accessible by persons of
`
`skill in the field. AGA also did not provide any evidence to corroborate Dr. Cragg’s alleged
`
`public use. Moreover, AGA did not establish that Dr. Cragg’s work met each and every element
`
`of the asserted claims. In particular, AGA failed to show that SIM was used.
`
`The evidence of record suggests that Dr. Cragg used only temperature-induced martensite
`
`not SIM. Furthermore, the temperature at which Dr. Cragg repositioned the filters is unknown,
`
`- 9 -
`
`MDT’S MOTION FOR JUDGMENT AS A MATTER OF LAW;
`CASE NO. C07-00567
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`DECHERT LLP
`ATTORNEYS AT LAW
`SILICON VALLEY
`
`IPR2019-00123
`Exhibit 1030-0012
`
`

`

`Case 3:07-cv-00567-MMC Document 966 Filed 08/03/09 Page 13 of 17
`
`
`
`the precise composition of the alloy Dr. Cragg used is unknown, the precise transformation
`
`temperatures of the alloy he used is unknown, and the shape of the repositioned filters prior to
`
`and upon repositioning are unknown. There is also no evidence that the vena cava filters returned
`
`to their original, unstressed shape. Certainly, there is no evidence that any filter was in its
`
`austenitic state during repositioning or that any austenite transformed to martensite due to stress,
`
`as required by the claim construction of SIM. Thus, as a matter of law, Dr. Cragg did not perform
`
`a prior use of the patented invention.
`2.
`A. Cragg et al., A New Percutaneous Vena Cava Filter, American J. Roentgenology (Sep.
`
`The Cragg II Paper
`
`1983) (“Cragg II”) does not anticipate the asserted claims of the ‘141 and ‘957 patents because
`
`the Cragg II Paper is not prior art. Cragg II has a publication date of September 30, 1983. Jim
`
`Jervis conceived his inventions prior to that date, as evidenced by two invention disclosures dated
`
`July 1983 and August 1983. Mr. Jervis diligently worked with the prosecuting attorneys to get
`
`the ‘852 patent application on file on October 14, 1983. The evidence of record reveals that Mr.
`
`Jervis and the prosecuting attorneys showed diligence from before the publication date of the
`
`Cragg II Paper to the date of constructive reduction to practice (October 14, 1983). Accordingly,
`
`the Jervis invention was conceived before the publication date of the Cragg II Paper, and thus
`
`Cragg II is not prior art.
`
`Crag