Case IPR2014-00362
`U.S. Patent No. 6,306,141
`
`Paper No.____
`Filed on April 29, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`EDWARDS LIFESCIENCES CORPORATION
`Petitioner
`v.
`
`MEDTRONIC, INC.
`Patent Owner
`____________
`
`Case IPR2014-00362
`U.S. Patent 6,306,141
`____________
`
`MEDTRONIC, INC.’S PRELIMINARY RESPONSE
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Arlington, VA 22313-1450
`
`COOK
`Exhibit 1006-0001
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`2.
`
`2.
`
`3.
`
`I.
`II.
`
`B.
`
`C.
`
`INTRODUCTION..........................................................................................1
`FACTUAL BACKGROUND ........................................................................3
`A.
`The Technology of the ’141 Patent......................................................3
`B.
`The Petition Alleges Nothing More than Previously Considered
`Art, and in Some Cases, Exactly the Same Grounds of
`Invalidity ..............................................................................................9
`Asserted References...........................................................................10
`C.
`III. CLAIM CONSTRUCTION .........................................................................14
`IV.
`THERE IS NO REASONABLE LIKELIHOOD THAT PETITIONER
`WILL PREVAIL AS TO GROUNDS #1-#5 OF THE PETITION.............14
`A.
`Petitioner Is Precluded from Raising ODP in this Proceeding
`(Ground #5)........................................................................................14
`Petitioner Is Not Reasonably Likely to Prevail on Its
`Anticipation Arguments as to Cragg I and Cragg II (Grounds #1
`and #2)................................................................................................16
`1.
`Neither Cragg I nor Cragg II Expressly Discloses the
`SIM Limitation.........................................................................17
`Petitioner’s Argument that Cragg I and Cragg II
`Inherently Disclose the SIM Limitation Is Based Upon
`Expert Opinion that Should Be Accorded No Weight ............18
`Petitioner Is Not Reasonably Likely to Prevail on Its
`Obviousness Arguments (Grounds #2, #3, and #4) ...........................21
`1.
`The Combination of Cragg I and Cragg II Fails, Because
`Neither Reference Teaches the SIM Limitation (Ground
`#2) ............................................................................................21
`The Combinations of (1) Cragg I and Miyauchi and
`(2) Cragg I and Fannon Fail, Because None of the
`References Teach the SIM Limitation (Grounds #3 and
`#4) ............................................................................................22
`Petitioner’s Combinations of References Fail, as Those
`References Teach Away from the Claimed Invention.............24
`
`COOK
`Exhibit 1006-0002
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`

`

`TABLE OF CONTENTS
`(continued)
`
`Page
`
`D.
`
`Petitioner Has Failed to Amend Its Claim Charts to Remove
`Attorney Argument in Contravention of the Board’s Order,
`Thereby Prejudicing Medtronic .........................................................25
`CONCLUSION ............................................................................................26
`
`V.
`
`-ii-
`
`COOK
`Exhibit 1006-0003
`
`

`

`Ex. #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`EXHIBIT LIST
`
`Exhibit Description
`
`D. Stoeckel, “The Shape Memory Effect – Phenomenon,
`Alloys and Applications,” Proceedings: Shape Memory Alloys
`for Power Sys. EPRI, 1-13 (2005)
`
`Biscarini et al., “Enhanced Nitinol Properties for Biomedical
`Applications,” Recent Patents on Biomed. Eng’g, No. 1, 180-
`196 (2008)
`
`Medtronic, Inc. v. AGA Med. Corp., Case No. 07-00567 MMC
`(Trial Exhibit)
`
`Medtronic, Inc. v. AGA Med. Corp., Case No. 07-00567 MMC,
`2009 WL 1163976 (N.D. Cal. Apr. 28, 2009)
`
`Medtronic, Inc. v. AGA Med. Corp., Case No. 07-00567 MMC,
`(N.D. Cal. Aug. 6, 2009) (Verdict Form)
`
`Medtronic, Inc. v. W.L. Gore & Assoc., Inc., Case No. 06-
`04455 JSW, 2008 WL 5191846 (N.D. Cal. Dec. 9, 2008)
`
`Press Release, Medtronic and W.L. Gore & Associates Settle
`Patent Dispute, Sept. 16, 2009
`
`M. Wu, “Fabrication of Nitinol Materials and Components,”
`Proceedings of Int’l Conference on Shape Memory &
`Superelastic Techs., 285-92 (2001)
`
`U.S. Publication No. 2004/0193257 to Wu and Poncet (filed
`Mar. 2004; published Sept. 20, 2004)
`
`-iii-
`
`COOK
`Exhibit 1006-0004
`
`

`

`I.
`
`INTRODUCTION
`
`Patent Owner Medtronic, Inc. (“Medtronic”) respectfully submits this
`
`Preliminary Response to the Petition filed by Edwards Lifesciences Corporation
`
`(“Petitioner”) seeking inter partes review of Claims 1-22 of U.S. Patent No.
`
`6,306,141 (the “’141 patent”). The Petition for inter partes review of the ’141
`
`patent should be denied, as it fails to demonstrate a reasonable likelihood of
`
`prevailing as to any claim on any of Petitioner’s five asserted Grounds.
`
`As for obviousness-type double patenting (“ODP”) (Ground #5), this
`
`argument is not a permissible Ground on which to base inter partes review. Such
`
`proceedings may only be based on patents or printed publications under 35 U.S.C.
`
`§§ 102 or 103. The ODP doctrine, by contrast, is judicially-created and rooted in
`
`35 U.S.C. § 101.
`
`As for anticipation, Grounds #1 (Cragg I) and #2 (Cragg II) fail for at least
`
`two reasons. First, Cragg I and Cragg II fail to expressly disclose a key limitation
`
`recited in all of the claims, namely the stress-induced martensite limitation. That is
`
`because those references exclusively teach medical devices made of shape memory
`
`alloys (“SMA devices”) that are deployed in the body by temperature-induced
`
`martensite (“TIM”), while the ’141 patent claims SMA devices deployed in the
`
`body by stress-induced martensite (“SIM”). Second, Petitioner’s argument that
`
`Cragg I and Cragg II inherently teach the SIM limitation is based upon an expert
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`1
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`COOK
`Exhibit 1006-0005
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`

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`opinion that should be given no weight. Dr. Ming Wu calculated transition
`
`temperatures for the disclosed SMA devices without any reference to a crucial
`
`factor in generating such temperatures, namely the specific chemical composition
`
`of the Nitinol used in the disclosed SMA devices. Dr. Wu’s failure to account for
`
`this factor is particularly striking given that Dr. Wu himself has noted the
`
`importance of the specific chemical composition of Nitinol in calculating transition
`
`temperatures, and even Cragg I teaches that point.
`
`With respect to obviousness, Grounds #2 (Cragg I and Cragg II), #3 (Cragg I
`
`and Miyauchi) and #4 (Cragg I and Fannon) likewise fail for at least two reasons.
`
`First, as with anticipation, all of the asserted references fail to disclose the SIM
`
`limitation. Second, those references teach away from the claimed invention, as
`
`they exclusively teach the use of TIM to introduce SMA devices into the body, not
`
`SIM.
`
`Lastly, Petitioner impermissibly incorporated attorney argument into its
`
`claim charts in contravention of the Board’s rules. Petitioner has yet to comply
`
`with the Board’s instruction three months ago to correct its Petition, thereby
`
`prejudicing Medtronic’s ability to prepare its Response through circumvention of
`
`the page limit.
`
`2
`
`COOK
`Exhibit 1006-0006
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`

`

`For all of these reasons, Petitioner has failed to show a reasonable likelihood
`
`of prevailing with respect to any claims on any of the five asserted Grounds, such
`
`that the Petition for inter partes review of the ’141 patent should be denied.
`
`II.
`
`FACTUAL BACKGROUND
`
`A.
`
`The Technology of the ’141 Patent
`
`The ’141 patent is directed to medical devices made of shape memory alloys
`
`(“SMAs”) such as Nitinol, a term which refers to a range of alloys that can be
`
`made of varying amounts of nickel and titanium. (Ex. 1001 at col. 1, ll. 21-23; Ex.
`
`1004 at 1-2 (defining Nitinol and discussing Nitinol compositions).) SMAs can
`
`“remember” their original shape and revert back to it after they have been
`
`deformed. (Ex. 1001 at col. 1, ll. 26-34.) This property has the advantage of
`
`enabling medical devices made with SMAs (“SMA devices”) to adopt a smaller
`
`configuration for insertion into a placement device, e.g., a catheter, and in turn,
`
`deployment into the body. (Id. at col. 2, ll. 23-28.) Once deployed, an SMA
`
`device can remember, and thereby return to, its original, larger configuration. (Id.)
`
`The ability of an SMA to remember its original shape is a consequence of its
`
`ability to exist in two different states (or crystal structures) that occur at the atomic
`
`level, namely “austenite” and “martensite.” (See, e.g., id. at col. 1, ll. 35-38.) The
`
`transformation between austenitic and martensitic states can be effected one of two
`
`ways: by temperature or mechanical stress. In the case of temperature, martensite
`
`3
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`COOK
`Exhibit 1006-0007
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`

`

`forms at relatively lower temperatures, and austenite forms at relatively higher
`
`temperatures. (Id.) In the case of stress, martensite forms through the application
`
`of stress, and austenite forms when that stress is relieved. (Id. at col. 1, ll. 52-65.)
`
`Significantly, the prior art references cited in the Petition are concerned with
`
`effecting this transformation by way of temperature.
`
`By way of example, in the asserted Cragg I reference, the desired SMA
`
`device was a coiled wire to be used as an aortic stent. (Ex. 1004 at 1.) A Nitinol
`
`wire was shaped into a coil and heated to its “annealing temperature” to confer
`
`memory. (Id.) In this coiled configuration, the SMA device was in its “austenitic”
`
`state. By decreasing its temperature via submersion in sterile ice water, the coiled
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`wire was transformed into its martensitic state, allowing it to be deformed into a
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`straight wire, so that it could fit into a catheter for deployment (Id.) Once deployed
`
`from the catheter and into the aorta, the increased temperature in the aorta
`
`transformed the temperature-induced martensitic state (straight wire) back to its
`
`austenitic state (coil). (Id. at 2.)
`
`As seen in Cragg I and the other references asserted by Petitioner, the
`
`medical community
`
`initially employed
`
`temperature
`
`to control SMA
`
`transformations between austenite and martensite, thereby exploiting the property
`
`known as temperature-induced martensite (“TIM”). (Ex. 1001 at col. 2, ll. 16-28.)
`
`As pertinent here, the temperature at which austenite begins transforming to
`
`4
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`COOK
`Exhibit 1006-0008
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`

`

`martensite is the martensite start temperature (Ms); the temperature at which the
`transformation is complete is the martensite finish temperature (Mf). (Id. at col. 1,
`ll. 44-46.) Corresponding temperatures for the martensite to austenite conversion
`
`are austenite start (As) and austenite finish (Af). (Id. at col. 1, ll. 46-51.) These
`transition temperatures may be graphically depicted as follows:
`
`(Ex. 2001, D. Stoeckel, “The Shape Memory Effect – Phenomenon, Alloys and
`
`Applications,” Proceedings: Shape Memory Alloys for Power Sys. EPRI, 1, 2
`
`(2005). As will be explained infra, these transition temperatures are highly
`
`dependent on the chemical composition of the SMA. (See Section IV.B.2.) In the
`
`case of Nitinol, for example, transition temperatures can vary dramatically based
`
`upon the ratio of nickel and titanium in the alloy. (Id.) As such, simply knowing
`
`that an SMA device is made of Nitinol reveals nothing with respect to the
`
`temperatures at which the foregoing phase transitions will occur. (Id.)
`
`Significantly, the TIM approach had at least three problems. First, the TIM
`
`approach required very precise temperature control for deploying an SMA device.
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`5
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`COOK
`Exhibit 1006-0009
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`

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`(Ex. 1001 at col. 2, ll. 37-41.) This process included using low temperatures for
`
`converting the device to its martensitic state for insertion into a placement device,
`
`followed by using higher temperatures to transform the device into its austenitic
`
`state for deployment. Because such temperature manipulation would partly occur
`
`in the patient’s body, tissue damage could result. (Id. at col. 2, ll. 43-48.) Second,
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`transition temperatures could vary greatly due to the variability of the chemical
`
`composition and heat treatment processing of the SMA. (Id. at col. 2, ll. 31-37.)
`
`Lastly, the need for temperature manipulation was a source of substantial
`
`inconvenience for physicians. (Id. at col. 2, ll. 41-43.) Indeed, as demonstrated by
`
`the asserted references, temperature manipulation would involve such cumbersome
`
`techniques as the use of ice baths, cooling elements, and heating elements during
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`surgical procedures. (Ex. 1004 at 1; Ex. 1005 at 3; Ex. 1006 at 4.)
`
`The invention of the ’141 patent overcame these problems by controlling
`
`SMA transformations between austenite and martensite by applying or removing
`
`stress to an SMA device, thereby exploiting the property known as stress-induced
`
`martensite (“SIM”). (Id. at col. 2, l. 64 to col. 3, l. 4.) The application of stress to
`
`an SMA device at a temperature above its As transforms austenite to martensite,
`and removal of the stress transforms the SMA device back to its original austenitic
`
`state, irrespective of the temperature of the SMA device. (Id. at col. 4, ll. 6-11.)
`
`Thus, while the prior art is exclusively concerned with the temperature-dependent
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`6
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`COOK
`Exhibit 1006-0010
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`

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`creation and reversion of martensite for the deployment of SMA devices, the ’141
`
`patent sets forth a stress based approach that is controllable, safe and much more
`
`convenient to use. (Id. at col. 2, ll. 31-54.)
`
`Claim 1 recites as follows, with pertinent limitations highlighted:
`
`1. A medical device for insertion into a mammalian body, the
`device comprising
`
`(a) a hollow placement device;
`
`(b) a memory alloy element formed at least partly from
`pseudoelastic shape-memory alloy, the alloy displaying reversible
`stress-induced martensite at about body temperature such that it
`has a stress-induced martensitic state and an austenitic state, the
`memory alloy element having (i) a deformed shape when the alloy
`is in its stress-induced martensitic state and (ii) a different
`unstressed shape when the alloy is in its austenitic state; and
`
`(c) a guide wire;
`
`[(d)] the memory alloy element being within the hollow placement
`device, and the placement device being guidable by the guide wire,
`the hollow placement device stressing the memory alloy element
`at a temperature greater than the As of the alloy so that the
`memory alloy element is in its deformed shape,
`
`[(e)] wherein the memory alloy element can be extruded from the
`hollow placement device by the guide wire at a temperature greater
`than the As of the alloy to transform at least a portion of the alloy
`from its stress-induced martensitic state so that the memory alloy
`
`7
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`COOK
`Exhibit 1006-0011
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`

`

`element transforms from its deformed shape to its unstressed
`shape, and wherein the alloy is selected so that the transformation
`can occur without any change in temperature of the placement
`device or the memory alloy element.
`
`(Id. at col. 10, l. 60 to col. 11, l. 20 (emphases and bracketing added).)
`
`Thus, the claimed invention provides a combination of an SMA device and a
`
`hollow placement device such that the hollow placement device has a structure that
`
`stresses the SMA device into its deformed shape. (Id.) Because the SMA device
`
`displays reversible SIM at about body temperature and the placement device keeps
`
`the SMA device in its stress-induced martensitic state, the SMA device can
`
`transform its shape without a change in temperature when deployed from the
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`placement device into the body. (Id. at col. 2, l. 64 to col. 3, l. 4.)
`
`It should be noted that the ’141 patent’s approach of employing SIM to
`
`deploy SMA devices was a transformational invention in the medical device
`
`industry, leading to widespread application and industry-wide adoption. As
`
`explained in one article:
`
`A great number of medical devices are based on stress
`induced martensite. The most commercially important
`patents now pending
`for
`the medical devices
`incorporating SIM alloys include the Jervis’s series
`which is listed in Jervis patent [37].
`
`8
`
`COOK
`Exhibit 1006-0012
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`

`

`(Ex. 2002, Biscarini et al., “Enhanced Nitinol Properties for Biomedical
`
`Applications,” Recent Patents on Biomed. Eng’g, No. 1, 180, 183 (2008).) Indeed,
`
`many of the major players in the medical device industry have taken licenses to the
`
`’141 patent, including Johnson & Johnson, Boston Scientific, U.S. Surgical, and
`
`Lombard Medical. (Ex. 2003, Medtronic, Inc. v. AGA Med. Corp., Case No. 07-
`
`00567 MMC, Trial Exhibit (providing partial list of licensees).)
`
`B.
`
`The Petition Alleges Nothing More than Previously Considered
`Art, and in Some Cases, Exactly the Same Grounds of Invalidity
`
`The ’141 patent underwent extensive prosecution, and because of its seminal
`
`nature and adoption by others in the medical device industry, it was the subject of
`
`two hotly contested litigations in the Northern District of California. Petitioner’s
`
`present challenge raises nothing more previously considered art, and some cases,
`
`exactly the same invalidity grounds.
`
`With respect to prosecution of the ’141 patent, the Examiner considered two
`
`of the four asserted references, namely Cragg I and Fannon. (Ex. 1025, Form
`
`PTO-1449 at 447.)
`
` In fact, both references feature prominently in the
`
`specification. (Ex. 1001 at col. 6, l. 58 to col. 7, l. 5; col. 9, ll. 41-57.)
`
`With respect to litigation, the ’141 patent was challenged in Medtronic, Inc.
`
`v. AGA Medical Corp., Case No. 07-00567 MMC (N.D. Cal.). In that case, AGA
`
`asserted what is now Petitioner’s anticipation argument in Ground #2 (§ 102(a) in
`
`view of Cragg II) and obviousness argument in Ground #3 (§ 103(a) based on
`
`9
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`COOK
`Exhibit 1006-0013
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`

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`combination of Cragg I and Miyauchi). Judge Chesney denied AGA’s motion for
`
`summary judgment of invalidity on both grounds, and the jury likewise refused to
`
`invalidate the claims on those grounds. (Ex. 2004, Medtronic, Inc. v. AGA Med.
`
`Corp., No. 07-00567 MMC, 2009 WL 1163976, at *2-*5 (N.D. Cal. Apr. 28,
`
`2009); Ex. 2005, Verdict Form at 4-5.)
`
`The ’141 patent was also challenged in Medtronic, Inc. v. W.L. Gore &
`
`Associates, Inc., Case No. 06-04455 JSW (N.D. Cal.). W.L. Gore asserted that the
`
`’141 patent was obvious in light of certain prior art references, including Cragg I.
`
`Judge White denied summary judgment, holding that Cragg I taught away from
`
`deploying an SMA device by way of SIM. (Ex. 2006, Medtronic, Inc. v. W.L.
`
`Gore & Assoc., Inc., Case No. 06-04455 JSW, 2008 WL 5191846, at *9 (N.D. Cal.
`
`Dec. 9, 2008).) The W.L. Gore case settled shortly after the AGA verdict in favor
`
`of Medtronic. (Ex. 2007, Press Release.)
`
`C.
`
`Asserted References
`
`As described below, each of the four asserted references discloses the same
`
`temperature-dependent approach for deploying an SMA device into the body.
`
`Stated simply, this approach involves (1) cooling the SMA device to its martensitic
`
`state, which allows the SMA device to be deformed from its original configuration,
`
`usually resulting in a smaller configuration that enables it to fit into a placement
`
`device, e.g., a catheter, and (2) deploying the SMA device from the placement
`
`10
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`COOK
`Exhibit 1006-0014
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`

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`device into the body where it is warmed, causing the SMA device to revert to its
`
`austenitic state and reform its original configuration. This approach, which relies
`
`exclusively on TIM to deploy the SMA device, is in marked contrast to the ’141
`
`patent, which relies exclusively on SIM to deploy the SMA device.
`
`Cragg I. Cragg et al., Nonsurgical Placement of Arterial Endoprostheses: A New
`
`Technique Using Nitinol Wire, 147 Radiology No. 1, 261-63 (April 1983)
`
`Cragg I discloses an endovascular prosthesis, i.e., a coiled wire made from
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`Nitinol, for deployment into the aorta of four canine subjects. (Ex. 1004 at 1.) To
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`deploy the coil via a catheter, the coiled wire was straightened by cooling “in a
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`bath of sterile ice water,” which converted the Nitinol wire to its martensitic state.
`
`(Id.) The wire was maintained in the straightened configuration i.e. in its
`
`martensitic state, by flushing “a cold saline solution (10o C)” through the catheter.
`
`(Id.) Once the wire was deployed from the catheter into the aorta, body
`
`temperature converted the straightened wire back to the austenitic state, causing
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`the wire to resume its original coiled shape. (Id. at 2.) Cragg I thus discloses a
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`temperature-dependent approach for deploying a Nitinol coiled wire into a canine
`
`aorta.
`
`Cragg II. Cragg et al., A New Percutaneous Vena Cava Filter, 141 Am. J.
`
`Radiology, 601-04 (Sept. 1983)
`
`11
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`COOK
`Exhibit 1006-0015
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`

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` Cragg II discloses a percutaneous filter for embolic capture in the canine
`
`inferior vena cava. (Ex. 1005 at 2.) The filter consists of a Nitinol wire formed
`
`into the shape of a helical spiral. (Id.) To allow the helically spiraled filter to be
`
`deployed via catheter, Cragg II follows the same basic approach as Cragg I: the
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`filter was straightened by cooling it in sterile ice water (saline solution), thereby
`
`converting the filter to its martensitic state. (Id. at 3.) And as with Cragg I, the
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`straightened wire was then deployed into the body (inferior vena cava) via catheter,
`
`where body temperature converted the straightened wire back to the austenitic
`
`state, causing the wire to resume its original helical spiral shape. (Id.) Thus, like
`
`Cragg I, Cragg II exclusively discloses a temperature-dependent approach for
`
`deploying an SMA device into the body.
`
`Miyauchi. Japanese Patent Publication No. S58-46923 entitled “Endoscope”
`
`Miyauchi discloses an endoscope equipped with a “manipulation tool” for
`
`use in surgical applications. (Ex. 1006 at 2.) The manipulation tool can be an
`
`SMA wherein the reverse transformation temperature is at or about body
`
`temperature. (Id. at 3.) To insert the tool into the endoscope, the manipulation tool
`
`is “temporarily deform[ed] into a shape long in the lengthwise direction.” (Id. at
`
`4.) As in Cragg I and Cragg II, Miyauchi teaches that the tool be deformed to its
`
`martensitic state by being “cooled in advance” (Id.), and further discloses that the
`
`tool may be maintained in that state “by cooling the surroundings of the tube-
`
`12
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`COOK
`Exhibit 1006-0016
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`

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`shaped path 16 with a water line, etc.” (Id.) Restoring the shape of the tool to its
`
`austenitic state is accomplished by either body temperature as in Cragg I and Cragg
`
`II, or by a heating means. (Id.) Thus, like Cragg I and Cragg II, Miyauchi
`
`exclusively discloses a temperature-dependent approach for deploying an SMA
`
`device into the body.
`
`Fannon. U.S. Patent No. 3,620,212 entitled “Intrauterine Contraceptive Device”
`
`Fannon discloses an intrauterine contraceptive device (“IUD”) comprised of
`
`a Nitinol alloy. (Ex. 1007 at 3.) To insert the device into the uterus, the IUD is
`
`deformed into a straight strand or a compact fold configuration and inserted into a
`
`cannula for insertion. (Id. at 3-4.) As with Cragg I, Cragg II, and Miyauchi,
`
`Fannon teaches that this deformation is accomplished by keeping the IUD at a
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`relatively lower temperature, in this case below 70° F. (Id. at 4.) And in a manner
`
`similar to those references, once the deformed IUD is inserted into the body, it
`
`returns to the austenitic state, and assumes its original shape. (Id.; see also
`
`Abstract (“The device will gradually resume its free shape as it is heated to
`
`temperature near the human body temperature.”).) Thus, Fannon, like Cragg I,
`
`Cragg II, and Miyauchi, once again exclusively discloses a temperature-dependent
`
`approach for deploying an SMA device into the body.
`
`As may be observed from the foregoing, all of the asserted references
`
`exclusively disclose a temperature-dependent approach for deploying an SMA
`
`13
`
`COOK
`Exhibit 1006-0017
`
`

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`device into the body. For that reason, the Board should deny the Petition given
`
`that those references fail to anticipate or render the claimed invention obvious, as
`
`the claims exclusively employ a stress-based approach for employing an SMA into
`
`the body. (See Section IV, infra.)
`
`Should the Board decide to institute a trial, Medtronic urges the Board to
`
`limit the Grounds upon which it proceeds given the highly duplicative disclosures
`
`of the references upon which those Grounds are based. See, e.g., Amkor Tech., Inc.
`
`v. Tessera, Inc., Case IPR2013-00242, Paper No. 37 at 33 (PTAB Oct. 11, 2013)
`
`(denying institution of inter partes review as to Grounds based upon cumulative
`
`prior art).
`
`III. CLAIM CONSTRUCTION
`
`Medtronic believes that no claim construction issues impact the arguments
`
`raised in this Preliminary Response, but reserves the right to raise issues of claim
`
`construction in the event that trial is instituted.
`
`IV. THERE IS NO REASONABLE LIKELIHOOD THAT PETITIONER
`WILL PREVAIL AS TO GROUNDS #1-#5 OF THE PETITION
`
`A.
`
`Petitioner Is Precluded from Raising ODP in this Proceeding
`(Ground #5)
`
`Ground #5 seeks to invalidate Claims 1-22 of the ’141 patent for
`
`obviousness-type double patenting (“ODP”) in view of U.S. Patent No. 5,597,378
`
`14
`
`COOK
`Exhibit 1006-0018
`
`

`

`(the “’378 patent”). (Petition at 50-60.) A trial should not be instituted on this
`
`Ground, as there is no statutory basis for raising ODP in this proceeding.
`
`The America Invents Act strictly limits the grounds on which a petitioner
`
`can seek inter partes review to those “that could be raised under section 102 or 103
`
`and only on the basis of prior art consisting of patents or printed publications.” 35
`
`U.S.C. § 311(b); see also 37 C.F.R. § 42.104(b)(2). Petitioner’s ODP challenge is
`
`impermissible for two reasons: (1) it is based on a judicially-created doctrine
`
`stemming from Section 101, and (2) the ’378 patent is not prior art to the ’141
`
`patent, because both patents are in the same family.
`
`ODP is a non-statutory, judicially-created doctrine rooted in public policy.
`
`Apple Inc. v. SightSound Techs., LLC, CBM2013-00021, Paper No. 13 at 24
`
`(PTAB Oct. 8, 2013). While non-statutory, the origins of ODP may be traced to 35
`
`U.S.C. § 101, which prohibits patenting of the same invention twice. Eli Lilly &
`
`Co. v. Teva Pharm. USA., Inc., 619 F.3d 1329, 1341 (Fed. Cir. 2010)
`
`(“Nonstatutory double patenting [ODP] was borne out of 35 U.S.C. § 101, not §
`
`103.”). ODP thus cannot be the basis for inter partes review, because it is the
`
`wrong sort of claim rejection (based on judicial doctrine, rather than statute), and
`
`derives from the wrong statute (Section § 101). See Apple, CBM2013-00021,
`
`Paper No. 13 at 25 (dismissing ODP ground in CBM petition, reasoning that ODP
`
`“is a judicially created, policy based doctrine” rather than a statutory one).
`
`15
`
`COOK
`Exhibit 1006-0019
`
`

`

`Moreover, it is well established that “the patent principally underlying the
`
`double patenting rejection is not considered prior art.” M.P.E.P. § 804(II)(B)(1)
`
`(8th ed. Rev. 7, July 2008). In this case, the ’378 patent and the ’141 patent both
`
`claim ultimate priority to the same patent application, Appl. Ser. No. 06/541,852,
`
`filed October 14, 1983. Thus, the ’378 patent is not prior art to the ’141 patent.
`
`Because ODP is a non-statutory, non-prior-art-based argument, it is not a
`
`permissible basis for inter partes review under 35 U.S.C. § 311(b). Therefore,
`
`review of Claims 1-22 should not be instituted based on Ground #5.
`
`B.
`
`Petitioner Is Not Reasonably Likely to Prevail on Its Anticipation
`Arguments as to Cragg I and Cragg II (Grounds #1 and #2)
`
`Grounds #1 and #2 seek to invalidate Claims 1-22 of the ’141 patent under
`
`§ 102(a) in view of Cragg I or Cragg II. (Petition at 13-17.) A trial should not be
`
`instituted on those Grounds, as both references teach SMA medical devices
`
`deployed by way of TIM, while the ’141 patent claims SMA devices deployed by
`
`way of SIM. (Ex. 1004 at 2; Ex. 1005 at 3.) As such, Petitioner cannot show that
`
`Cragg I or Cragg II teaches the SIM limitation recited in Claims 1-22, either
`
`expressly or inherently. This deficiency is fatal to Petitioner’s anticipation
`
`arguments. See, e.g., Atofina v. Great Lakes Chem. Corp., 441 F. 3d 991, 999
`
`(Fed. Cir. 2006) (“Anticipation requires a showing that each limitation of a claim is
`
`found in a single reference, either expressly or inherently.”); In re Oelrich, 666
`
`F.2d 578, 581 (C.C.P.A. 1981) (“Inherency, however, may not be established by
`
`16
`
`COOK
`Exhibit 1006-0020
`
`

`

`probabilities or possibilities. The mere fact that a certain thing may result from a
`
`given set of circumstances is not sufficient.”).
`
`1.
`
`Neither Cragg I nor Cragg II
`Expressly Discloses the SIM Limitation
`
`As an initial matter, Cragg I and Cragg II both fail to expressly disclose the
`
`SIM limitation recited in Claims 1-22. As explained in detail in Section II.C,
`
`supra, both references employ the same temperature-dependent deployment
`
`approach: (1) cooling the SMA device to its martensitic state, thereby allowing for
`
`the deformation of the device so it to fits into a placement device (Ex. 1004 at 1;
`
`Ex. 1005 at 3), and (2) deploying the SMA device into the body where it is
`
`warmed, causing it to revert to its austenitic state and reassume its original shape,
`
`(Id.). Both references exclusively teach the use of temperature to transform the
`
`SMA device (austenite to martensite), and then deploy the SMA device into the
`
`body (martensite to austenite). The application of stress to create martensite and
`
`the release of stress to create austenite is nowhere taught or suggested. As such,
`
`neither reference provides an express teaching of the SIM limitation, and Petitioner
`
`has failed to point to any such disclosure. See AGA Med., 2009 WL 1163976 at *2
`
`(“A review of the Cragg II reference reveals that the display of stress-induced
`
`martensite is not expressly disclosed therein.”).
`
`17
`
`COOK
`Exhibit 1006-0021
`
`

`

`2.
`
`Petitioner’s Argument that Cragg I and Cragg II Inherently
`Disclose the SIM Limitation Is Based Upon Expert Opinion
`that Should Be Accorded No Weight
`
`Petitioner appears to argue that Cragg I and Cragg II inherently disclose the
`
`SIM limitation. (Petition at 13-17.) In support of this position, Petitioner relies
`
`upon Dr. Ming Wu’s declaration, which contains a series of transition temperature
`
`calculations that purportedly demonstrate the inherent disclosure of the SIM
`
`limitation in Cragg I and Cragg II. Notably absent from his analysis is any
`
`disclosure of a crucial factor for performing these calculations, namely the ratio of
`
`nickel to titanium in the Nitinol SMA devices disclosed in those references. As
`
`Dr. Wu himself has acknowledged, this factor is essential to calculating transition
`
`temperatures. (See, e.g., Ex. 1002, ¶ 26.) Accordingly, his opinion is unsupported
`
`and fatally defective, and Petitioner’s arguments based upon it should be rejected.
`
`Section 42.65(a) provides that “[e]xpert testimony that does not disclose the
`
`underlying facts or data on which the opinion is based is entitled to little or no
`
`weight.” 37 C.F.R. § 42.65(a). The Board has thus made clear that expert
`
`affidavits accompanying petitions “must disclose the underlying facts or data upon
`
`which the opinion is based.” Office Patent Trial Practice Guide, 77 Fed. Reg.
`
`48,756, 48,763 (Aug. 14, 2012) (emphasis added).
`
`As applied to this case, Dr. Wu provides purported calculations for the As,
`Ms, and Mf temperatures of the Nitinol alloys employed in the Cragg I and Cragg II
`
`18
`
`COOK
`Exhibit 1006-0022
`
`

`

`SMA devices. (Ex. 1002, ¶¶ 100, 102, 114, 116-117.) What is glaringly absent
`
`from those calculations is any discussion of the ratio of nickel to titanium in those
`
`Nitinol compositions. Dr. Wu fails to account for these critically important ratios
`
`for the simple reason that he cannot: neither Cragg I nor Cragg II discloses the
`
`ratio of nickel and titanium used to make the disclosed SMA devices.
`
`The importance of these ratios in calculating transition temperatures cannot
`
`be understated. As Dr. Wu himself has admitted, transition temperatures of Nitinol
`
`alloys are governed in part by the relative proportions of nickel and titanium in the
`
`composition, and even small changes in the ratio may lead to drastic changes in the
`
`transition temperatures. (Id., ¶ 26 (“[