Paper: 11
`Trials@uspto.gov
`571-272-7822 Entered: June 11, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COOK INCORPORATED, COOK GROUP INCORPORATED, AND
`COOK MEDICAL LLC,
`Petitioner,
`
`v.
`
`MEDTRONIC, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00123
`Patent 6,306,141 B1
`____________
`
`
`
`Before JAMESON LEE, KEN B. BARRETT, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`BARRETT, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`Trials@uspto.gov
`571-272-7822 Entered: June 11, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COOK INCORPORATED, COOK GROUP INCORPORATED, AND
`COOK MEDICAL LLC,
`Petitioner,
`
`v.
`
`MEDTRONIC, INC.,
`Patent Owner.
`____________
`
`Case IPR2019-00123
`Patent 6,306,141 B1
`____________
`
`
`
`Before JAMESON LEE, KEN B. BARRETT, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`BARRETT, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`I.
`
`INTRODUCTION
`
`A. Background and Summary
`
`
`
`Cook Incorporated, Cook Group Incorporated, and Cook Medical
`
`LLC (collectively, “Petitioner”)1 filed a Petition requesting inter partes
`
`review of U.S. Patent No. 6,306,141 B1 (“the ’141 patent,” Ex. 1001).
`
`Paper 1 (“Pet.”). The Petition challenges the patentability of claims 1–22 of
`
`the ’141 patent. Medtronic, Inc., (“Patent Owner”)2 filed a Preliminary
`
`Response to the Petition. Paper 6 (“Prelim. Resp.”). Petitioner, pursuant to
`
`our authorization, Paper 9, filed a Reply to Patent Owner’s Preliminary
`
`Response, Paper 10 (“Pet. Reply to Prelim. Resp.”).
`
`
`
`An inter partes review may not be instituted “unless . . . the
`
`information presented in the petition . . . shows that there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challenged in the petition.” 35 U.S.C. § 314(a). Having considered
`
`the arguments and evidence presented by Petitioner and Patent Owner, we
`
`determine that Petitioner has demonstrated a reasonable likelihood of
`
`prevailing in showing that at least one of the challenged claims of the ’141
`
`patent is unpatentable. Accordingly, we institute an inter partes review as to
`
`all the challenged claims of the ’141 patent on all the grounds of
`
`unpatentability set forth in the Petition.
`
`
`
`1 Petitioner identifies Cook Incorporated, Cook Group Incorporated, and
`Cook Medical LLC as real parties-in-interest. Pet. 1.
`2 Patent Owner, under the heading “Real Party-In-Interest,” states that
`Medtronic, Inc. is the owner of the ’141 patent and that “Medtronic plc is the
`ultimate parent of Medtronic, Inc.” Paper 3, 1–2.
`
`2
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`B. Related Proceedings
`
`
`
`One or both parties identify, as matters involving or related to
`
`the ’141 patent, Medtronic, Inc. v. W.L. Gore & Assocs., Inc., No. 06-cv-
`
`04455 (N.D. Cal.), and Medtronic, Inc. v. AGA Med. Corp., No. 07-cv-
`
`00567 (N.D. Cal.) and Patent Trial and Appeal Board cases IPR2013-00269
`
`and IPR2014-00362. Pet. 1; Paper 3.
`
`C. The ’141 Patent
`
`
`
`The ’141 patent pertains to medical devices incorporating shape
`
`memory alloys (SMAs) and, specifically, to medical devices incorporating
`
`stress-induced martensite (SIM) alloys. Ex. 1001, Abstract, 1:21–23.
`
`According to the Abstract of the ’141 patent:
`
`Medical devices which are currently proposed to use
`
`elements made from shape memory alloys may be improved by
`the use of stress-induced martensite alloy elements instead. The
`use of stress-induced martensite decreases the temperature
`sensitivity of the devices, thereby making them easier to install
`and/or remove.
`
`Ex. 1001, Abstract.
`
`
`
`The Specification explains that shape memory alloys were well
`
`known. Id. at 1:26–27. An article made from a shape memory alloy can be
`
`deformed from its original, heat stable configuration to a second, heat
`
`unstable configuration, and, upon application of heat alone, can be caused to
`
`revert to its original configuration. Id. at 1:27–34.
`
`Among metallic alloys, the ability to possess shape
`
`memory is a result of the fact that the alloy undergoes a reversible
`transformation from an austenitic state to a martensitic state with
`a change in temperature. This transformation is sometimes
`referred to as a thermoelastic martensitic transformation. An
`article made from such an alloy, for example a hollow sleeve, is
`easily deformed from its original configuration to a new
`
`3
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`configuration when cooled below the temperature at which the
`alloy is transformed from the austenitic state to the martensitic
`state. The temperature at which this transformation begins is
`usually referred to as Ms and the temperature at which it finishes
`Mf. When an article thus deformed is warmed to the temperature
`at which the alloy starts to revert back to austenite, referred to as
`As (Af being the temperature at which the reversion is complete)
`the deformed object will begin to return to its original
`configuration.
`
`Id. at 1:35–51. The parties refer to the property or behavior associated with
`
`an austenitic-to-martensitic transformation related to a temperature change
`
`as “temperature-induced martensite” or “TIM.” See, e.g., Prelim. Resp. 6;
`
`Pet. 7, 10.
`
`
`
`The Specification further explains that a martensite state also may be
`
`induced by stress:
`
`Many shape memory alloys (SHAs [sic, SMAs]) are
`
`known to display stress-induced martensite (SIM). When an
`SMA sample exhibiting stress-induced martensite is stressed at a
`temperature above Ms (so that the austenitic state is initially
`stable), but below Md (the maximum temperature at which
`martensite formation can occur even under stress) it first deforms
`elastically and then, at a critical stress, begins to transform by the
`formation of stress-induced martensite. Depending on whether
`the temperature is above or below As, the behavior when the
`deforming stress is released differs. If the temperature is below
`As, the stress-induced martensite is stable; but if the temperature
`is above As, the martensite is unstable and transforms back to
`austenite, with the sample returning (or attempting to return) to
`its original shape. The effect is seen in almost all alloys which
`exhibit a thermoelastic martensitic transformation, along with
`the shape memory effect. However, the extent of the temperature
`range over which SIM is seen and the stress and strain ranges for
`the effect vary greatly with the alloy.
`
`4
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`Ex. 1001, 1:52–2:3. “The recoverable deformation associated with the
`
`formation and reversion of stress-induced martensite has been referred to as
`
`pseudoelasticity.” Id. at 4:12–15.
`
`
`
`“Various proposals have also been made to employ shape memory
`
`alloys in the medical field . . . [and t]hese medical SMA devices . . . rely on
`
`the fact that when an SMA element is cooled to its martensitic state and is
`
`subsequently deformed, it will retain its new shape; but when it is warmed to
`
`its austenitic state, the original shape will be recovered.” Id. at 2:15–28.
`
`According to the Specification, there were two principal disadvantages with
`
`this use of SMAs—it was difficult to control the transformation
`
`temperatures of SMAs with accuracy and many SMAs had a large hysteresis
`
`associated with the state transformation thus requiring a significant
`
`temperature excursion to reverse the state. Id. at 2:29–41. Additionally, it
`
`was “inconvenient to have to engage in any temperature manipulation” and
`
`human tissue could be damaged by temperatures outside of narrow limits.
`
`Id. at 2:41–48.
`
`
`
`The ’141 patent purports to disclose the discovery “that if, in a
`
`medical device containing a shape memory alloy element which uses the
`
`shape memory property of that alloy, an element which shows the property
`
`of stress-induced martensite is used instead, an improved device results.” Id.
`
`at 2:59–63. The Specification characterizes the improvement due to the
`
`claimed invention as “compris[ing] the substitution of an alloy element
`
`which displays stress induced martensite at said body temperature for the
`
`shape memory alloy element [in a medical device intended for use in a
`
`mammalian body or a device that is substantially at body temperature].” Id.
`
`at 2:64–3:4.
`
`5
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`
`“Suitable alloy for this invention i.e. those displaying stress-induced
`
`martensite at temperatures near mammalian body temperature (35°–40° C.),
`
`may be selected from known SMAs by those of ordinary skill in theart [sic],
`
`having regard to this disclosure by testing for the existence of the SIM effect
`
`at the desired temperature.” Id. at 4:22–27.
`
`
`
`In the Specification, the Cragg reference3 is discussed as an example
`
`of how a SIM element could be implemented in a medical device using a
`
`shape memory alloy. Id. at 9:10–10:7. In Cragg, an SMA wire, of the alloy
`
`nitinol, was used to form a tubular coiled wire stent4 that was straightened
`
`and introduced into the aorta via a catheter and precisely placed by use of
`
`guide wire upon extrusion from the catheter. Id. at 9:14–49. “Because of
`
`the difficulty of controlling the transformation temperature accurately, it has
`
`proved necessary to cool the straightened wire during insertion and/or to
`
`heat the wire to form the coil after insertion.” Id. at 9:53–56. “These
`
`procedures add to the complexity of the operation.” Id. at 9:56–57.
`
`
`
`To address these issues, the Specification explains that:
`
`If an SIM pseudoelastic wire is used to form the coil,
`
`which is then isothermally deformed by loading into a catheter,
`then the need for temperature control is avoided. The wire
`remains straight when in the catheter, but re-forms the coil
`spontaneously when it is extruded from the catheter. Accurate
`
`
`
`3 Cragg is in the record as Exhibit 1009 and is identified and discussed
`further below.
`4 The described stent is “a compacted nitinol coil [that] is readily positioned
`in a narrowed arterial segment and then expanded to its original form with a
`luminal diameter approximately equal to that of the adjacent, relatively
`normal, blood vessel. Expansion of the coil anchors it against the slightly
`stretched, but otherwise intact, surrounding blood vessel.” Ex. 1001, 9:25–
`32.
`
`6
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`placement is thus readily obtainable, since there is no urgency as
`might be required with a conventional shape memory effect
`element.
`
`Id. at 9:57–65.
`
`D. Illustrative Claim
`
`
`
`Of the challenged claims of the ’141 patent, claims 1, 6, 11, 15, 16,
`
`and 18 are independent claims. The remaining challenged claims depend
`
`directly or indirectly from one of these independent claims. Claim 1,
`
`reproduced below, is illustrative:
`
`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;
`
`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,
`
`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 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.
`
`7
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`Ex. 1001, 10:60–11:20.
`
`
`
`Petitioner relies on the following references:
`
`E. Evidence
`
`Reference
`
`Andrew Cragg et al., Nonsurgical Placement of Arterial
`Endoprostheses: A New Technique Using Nitinol Wire, 147
`RADIOLOGY 261 (1983) (“Cragg”)
`
`Horace Pops, Stress-Induced Pseudoelasticity in Ternary
`Cu-Zn Based Beta Prime Phase Alloys, 1 METALLURGICAL
`TRANSACTIONS 251 (1970) (“Pops”)
`
`U.S. Patent No. 4,490,112; filed Sept. 2, 1982; issued
`Dec. 25, 1984 (“Tanaka”)
`
`Yuichi Suzuki, Shape Memory and Super-elasticity Effects
`in NiTi Alloys, TITANIUM & ZIRCONIUM, Vol. 30, No. 4
`(1982) (“Suzuki”)
`
`Exhibit No.
`
`Ex. 1009
`
`Ex. 1010
`
`Ex. 1011
`
`Ex. 1012
`
`
`
`Petitioner also relies on the Declaration of Kaushik Bhattacharya,
`
`Ph.D, dated September 28, 2018 (Ex. 1021), in support of its arguments.
`
`Patent Owner relies on the Declaration of Dr. Christopher K. Zarins, M.D.,
`
`dated March 12, 2009 (Ex. 2003), filed in earlier litigation, and the
`
`declaration of Dr. Lee Middleman (Ex. 1002, 128–133), filed during the
`
`prosecution of the application that issued as the ’141 patent, in support of its
`
`arguments. The parties rely on other exhibits as discussed below.
`
`F. Asserted Grounds of Unpatentability
`
`
`
`Petitioner asserts the following grounds of unpatentability:
`
`References
`
`Cragg, Pops, and Tanaka
`
`Cragg, Tanaka, and Suzuki
`
`Basis
`
`Claims
`
`§ 103(a) 1–22
`
`§ 103(a) 1–22
`
`8
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`II. ANALYSIS
`
`A. Principles of Law
`
`
`
`Petitioner bears the burden of persuasion to prove unpatentability of
`
`the claims challenged in the Petition, and that burden never shifts to Patent
`
`Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
`
`1378 (Fed. Cir. 2015).
`
`
`
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`
`differences between the claimed subject matter and the prior art are such that
`
`the subject matter, as a whole, would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations including: (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
`
`(3) the level of skill in the art; and (4) any objective evidence of
`
`non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`B. The Level of Ordinary Skill in the Art
`
`
`
`Petitioner’s declarant, Dr. Bhattacharya, opines that:
`
`[T]he person having ordinary skill in the art (“PHOSITA”) at the
`time the first patent application leading to the ’141 Patent was
`filed on October 14, 1983, would have possessed the knowledge
`and skill known by an engineer, physician, or similar
`professional, having knowledge of, or experience with: (1) shape
`memory alloys exhibiting reversible stress-induced martensite
`behavior, and/or (2) designing medical devices using such shape
`memory alloys.
`
`Ex. 1021 ¶ 18; see Pet. 4. At this stage of the proceeding, Patent Owner
`
`does not disagree. See generally Prelim. Resp. (not addressing explicitly the
`
`level of ordinary skill in the art). Based on the current record and for the
`
`9
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`purposes of this Decision, we adopt Petitioner’s declarant’s proposed
`
`description of the person of ordinary skill in the art. Further, we determine
`
`that the prior art of record reflects the level of skill in the art at the time of
`
`the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
`
`2001). We will make a final determination as to the level of ordinary skill in
`
`the art, however, based on the full trial record.
`
`C. Claim Construction
`
`
`
`In an inter partes review, claim terms in an unexpired patent are given
`
`their broadest reasonable construction in light of the specification of the
`
`patent in which they appear.5 37 C.F.R. § 42.100(b) (2018)6; see also
`
`Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). “Under
`
`a broadest reasonable interpretation, words of the claim must be given their
`
`plain meaning, unless such meaning is inconsistent with the specification
`
`and prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062
`
`(Fed. Cir. 2016).
`
`
`
`In this case, neither party’s brief includes, under the “claim
`
`construction” heading, a proposed construction for any term. Pet. 5; Prelim.
`
`Resp. 14–15. Patent Owner, however, in arguing that Petitioner has failed to
`
`account for a limitation, sets forth a proposed construction as to what it
`
`
`
`5 Patent Owner asserts that the ’141 patent will expire in 2022 and that the
`broadest reasonable construction standard should be applied in this case.
`Prelim. Resp. 14–15; see also Pet. 5 (Petitioner also advocating the
`application of the broadest reasonable construction standard.).
`6 A recent amendment to this rule does not apply here because the Petition
`was filed before November 13, 2018. See Changes to the Claim
`Construction Standard for Interpreting Claims in Trial Proceedings Before
`the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340, 51,340
`(Oct. 11, 2018).
`
`10
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`characterizes as “a key aspect of all the challenged intendent claims.”
`
`Prelim. Resp. 2. Patent Owner contends that “all independent claims require
`
`a device or a component stressing the SIM alloy to induce the martensitic
`
`state and disengaging the SIM alloy from the stress-inducing device or
`
`component to revert the SIM alloy to its austenitic, non-deformed state,
`
`without having to change the temperature.” Id. at 2 n.1; see also id.
`
`at 12, 21.
`
`
`
`We find it helpful to address Patent Owner’s proposed construction.
`
`The following discussion pertains to the language of independent claim 1,
`
`and applies similarly to the other challenged independent claims. Our claim
`
`construction analysis here is preliminary, and we encourage the parties to
`
`address the matters further in future briefing.
`
`1. Patent Owner’s “Disengaging” Position
`
`
`
`Independent claim 1 is an apparatus claim and recites “[a] medical
`
`device” comprising three components. Ex. 1001, 10:60–11:20. Generally
`
`speaking, those three components are: a hollow placement device, a
`
`memory alloy formed from a shape-memory alloy, and a guide wire. Id.
`
`The alloy displays “reversible stress-induced martensite at about body
`
`temperature such that it has a stress-induced martensitic state and an
`
`austenitic state.” Id. at 10:63–67. The claim further recites that the memory
`
`alloy element is within the hollow placement device, and “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.” Id. at 11:6–11; see also id. at 1:47–48 (“As” is the
`
`temperature at which the alloy starts to revert back to austenite).
`
`11
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`
`The last recitation of claim 1, and that which pertains to Patent
`
`Owner’s arguments, see, e.g., Prelim. Resp. 21–22, states:
`
`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 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.
`
`Ex. 1001, 11:12–21 (emphasis added).
`
`
`
`Patent Owner, pointing to this language, argues that “[e]ach
`
`independent claim requires . . . disengaging the SIM alloy from the same
`
`device/restraint (i.e. removing stress) in order to revert the SIM alloy to its
`
`austenitic/unstressed state, without having to change the temperature.”
`
`Prelim. Resp. 21–22 (emphasis in original).
`
`
`
`At this initial stage and on the limited record, we do not agree with
`
`Patent Owner’s argument. First, “disengaging” is an act or step, whereas
`
`claim 1 (as well as each of the other challenged claims) is an apparatus claim
`
`that should be defined by structure, not by acts or steps that may be
`
`performed with or to an apparatus. Second, the claim language quoted
`
`above refers to the structure of the memory alloy element and of the alloy
`
`itself in functional terms—the element “can be extruded” and the alloy “is
`
`selected so that the transformation can occur without any change in
`
`temperature.” The claim does not require the completion of the act of
`
`extruding or the act of transformation, but rather requires structure capable
`
`of performing the recited functions.
`
`
`
`We preliminarily determine that the last recitation of claim 1 requires,
`
`using functional language, a structural relationship defined by, at least, the
`
`12
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`alloy properties, the size and configuration of the memory alloy element
`
`(e.g., the stent), and the size and configuration of the hollow placement
`
`device (e.g., a catheter).
`
`2. Patent Owner’s Arguments Concerning Transformation
`Without the Use of Temperature
`
`
`
`Patent Owner also argues that the claims of the’141 patent “require
`
`stressing and releasing the SIM alloy to effect changes between states
`
`without the use of temperature.” Prelim. Resp. 26; see also id. at 12
`
`(“Importantly, the claims require that the application and removal of stress
`
`induce the transition between austenitic and martensitic states, without any
`
`change in temperature.”). In addition to the questionable assertions that the
`
`claimed apparatus is defined by acts or steps, Patent Owner appears to argue
`
`that the claims preclude an act involving the use of temperature.
`
`
`
`The complete pertinent phrase of claim 1 recites: “the alloy is
`
`selected so that the transformation can occur without any change in
`
`temperature of the placement device or the memory alloy element.”
`
`Ex. 1001, 11:17–20 (emphasis added). Thus, the drafter defined the alloy
`
`functionally as one that is capable of transformation without a temperature
`
`change. On the record before us, it is not clear that the capability to
`
`transform via temperature and the capability to transform via stress are
`
`mutually exclusive. In other words, we cannot determine at this time that a
`
`given alloy could not display both temperature-induced martensite and
`
`stress-induced martensite in appropriate conditions. The Specification
`
`suggests that some shape-memory alloys exhibit both characteristics. See
`
`Ex. 1001, 1:35–2:3 (explaining, inter alia, that “the ability to possess shape
`
`memory is a result of the fact that the alloy undergoes a reversible
`
`transformation from an austenitic state to a martensitic state with a change in
`
`13
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`temperature [and m]any shape memory alloys (SHAs [sic, SMAs]) are
`
`known to display stress-induced martensite (SIM).”); id. at 22–25 (“Suitable
`
`alloy for this invention i.e. those displaying stress-induced martensite at
`
`temperatures near mammalian body temperature (35°—40° C.), may be
`
`selected from known SMAs.”). Thus, it may be that Patent Owner implicitly
`
`is advocating for a limitation based on the intended use of the device. We
`
`decline to construe the challenged apparatus claims as being limited based
`
`on how the apparatus is used.
`
`
`
`In light of the above, we preliminarily determine that claim 1 requires
`
`an alloy having the capability of transformation without a change in
`
`temperature, and that claim 1 does not preclude that same alloy from also
`
`having the capability of transformation due to a temperature change.
`
`
`
`In sum, Petitioner, to meet its burden at this initial stage, must
`
`demonstrate a likelihood of prevailing on its assertion of obviousness of a
`
`device having, inter alia, a memory alloy element that “can be extruded”
`
`from the hollow placement device to transform the device and an alloy
`
`selected such that “the transformation can occur without any change in
`
`temperature.” Ex. 1001, 11:11–20. In other words, the proposed
`
`combination needs to render obvious a device having a structure such that
`
`certain actions can occur, but the prior art need not disclose the actual
`
`occurrence of the act of extruding or the act of transformation without a
`
`change in temperature.
`
`D. The Alleged Obviousness of
`Claims 1–22 Over Cragg, Pops, and Tanaka
`
`
`
`Petitioner alleges that all of the challenged claims of the ’141 patent,
`
`claims 1–22, would have been obvious over Cragg, Pops, and Tanaka. See
`
`14
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`Pet. 17–41 (addressing claim 1). Petitioner relies on Cragg for disclosure of
`
`much of the claimed device and proposes a modification where the alloy of
`
`Pops is substituted for the material used to make Cragg’s stent. See Pet. 14,
`
`31. Petitioner argues that Tanaka discloses the use of such alloys in a
`
`medical device. See id. at 14.
`
`
`
`Patent Owner argues that Petitioner has failed to demonstrate that the
`
`prior art disclosed a “key aspect” of the challenged claims, has failed to
`
`demonstrate “any sufficient motivation to combine” the references, and has
`
`failed “to address known secondary considerations of obviousness.” Prelim.
`
`Resp. 2–4.
`
`
`
`For the reasons that follow, we determine that Petitioner has made an
`
`adequate showing at this stage that at least claim 1 would have been obvious
`
`over Cragg, Pops, and Tanaka.
`
`1. Cragg (Ex. 1009)
`
`
`
`Cragg discloses the use of a coil shaped stent made from a “thermal
`
`shape memory alloy (nitinol).” Ex. 1009, 1. “Nitinol is a specially
`
`formulated alloy of nickel and titanium . . . [with t]he striking property . . .
`
`that it undergoes a phase change at a certain temperature.” Id. “The
`
`‘transition temperature’ is determined by the composition of the alloy.” Id.
`
`The nitinol alloy was drawn into a wire, which was annealed while being
`
`constrained in the desired coil shape. Id.
`
`After cooling, the wire can be straightened and introduced via
`catheter into the body. At or near body temperature the wire
`transforms into its original shape. This property of the wire
`allows one to introduce into the body various complex,
`preformed shapes via catheter.
`
`Id.
`
`15
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`
`The coils of Cragg’s stent, after straightening in ice water, were
`
`fastened to a guide wire to allow accurate placement and were passed
`
`through a catheter to the abdominal aorta. Id. “To minimize transformation
`
`of the wire to its original shape in the catheter, a cold saline solution (10° C)
`
`was flushed continuously through the catheter during introduction of the
`
`wire.” Id. “[T]he wire was extruded from the catheter.” Id.
`
`
`
`Cragg explains:
`
`At room temperature, the nitinol coil is a straight, pliable wire
`that can be passed through a catheter. As the coil is extruded
`from the catheter and warmed to body temperature, it reverts to
`its “memorized” shape, (i.e., a coil). By regulating the
`composition of the alloy, the transition temperature of nitinol
`wire can be adjusted to provide transformation over a narrow
`temperature range (e.g., 36–38° C). The wire we used in this
`study transformed over a broad temperature range (25–38° C),
`which required flushing the introducing catheter with cold saline
`to minimize transformation of the wire in the catheter. We also
`used a 10-F Teflon introducing catheter to reduce friction of the
`partially transformed coil in the catheter. These difficulties can
`be overcome by the development of a wire with a more precise
`transition temperature.
`
`Id. at 2.
`
`
`
`Cragg concludes that, “[w]ith the development of a suitable alloy with
`
`optimal transformation characteristics, nitinol coil grafts may offer a simple,
`
`inexpensive alternative to surgery in numerous forms of cardiovascular
`
`disease.” Id.
`
`16
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`2. Pops (Ex. 1010)
`
`
`
`Pops discloses the composition and testing at various temperatures of
`
`copper-zirconium based shape memory alloys7 with “stress induced
`
`pseudoelastic” (STRIPE) properties. Ex. 1010, 5, 10. Pops states that
`
`“[v]ery large ‘pseudo’ elastic strains are produced as a result of a stress
`
`induced reversible martensitic transformation; the phenomenon may be
`
`called stress induced pseudoelasticity (STRIPE),” and that “[t]he stress
`
`induced martensite phase is elastically balanced within the matrix, so that it
`
`disappears upon unloading.” Id. at 11.
`
`3. Tanaka (Ex. 1011)
`
`
`
`Tanaka discloses “[a]n orthodontic system including an ultraelastic
`
`arch wire [of a nickel-titanium alloy] having a transformation temperature of
`
`normal body temperature of about 37° C.” Ex. 1011, Abstract, 3:67–4:1.
`
`“An ultraelastic material returns to its original shape upon removal of the
`
`deforming load even if deformation of about 8% is imposed during a tensile
`
`test.” Id. at 4:4–7. “This high elastic deformability permits bending or
`
`pulling required for any orthodontic purposes.” Id. at 4:7–8.
`
`In order to provide an orthodontic device having these
`
`desired properties, it is not sufficient merely to utilize an
`ultraelastic Ni-Ti alloy, but it is necessary to select an appropriate
`alloy composition. Additionally, it is necessary to select
`appropriate conditions for the preparation of the orthodontic
`device by appropriate heat treatment. The utlimate [sic]
`properties of the orthodontic device can also vary with the shape
`of the device, for example the diameter of the wire or the cross-
`section. When these factors are appropriately considered with
`
`
`
`7 The parties agree that Pops discloses shape memory alloys. See Pet. 13;
`Prelim. Resp. 16; see also Ex. 1021 ¶ 70.
`
`17
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`respect to one another, it is possible to provide the properties
`required for varying orthodontic purposes.
`
`Id. at 4:21–33.
`
`
`
`Alloys that may be utilized in Tanaka’s device:
`
`are of the “thermoelastic” type having a superlattice and which
`undergo a martensitic transformation. Their ultraelasticity is
`derived from the martensitic transformation caused by stress at a
`temperature
`range above
`the martensitic
`transformation
`temperature and the inverse transformation thereof. There is
`only a small degree of hysteresis in the normal and reverse
`transformation between the austenite and the martensite;
`therefore, these alloys undergo crystallographically reversible
`transformation.
`
`Id. at 4:42–51.
`
`
`
`An ultraeleastic wire is prepared in a straight form and fastened to
`
`tooth 2 to be moved and to normal teeth 3, 4 on either side. Id. at 6:39–40,
`
`48–51, Fig. 3. “Archwire 1 is placed under bending and tensile stresses
`
`along an array of teeth 3, 2 and 4 and a force (or load) which urges wire 1 to
`
`recover its original shape bears on tooth 2 in the direction of the arrow
`
`[shown in Figure 3].” Id. at 6:58–61. The “orthodontic member . . . applies
`
`variable orthodontic load in response to a difference between normal body
`
`temperature and the temperature prevailing upon placement of a temperature
`
`affecting material in the mouth is provided.” Id. at 1:61–66. Tanaka
`
`explains:
`
`Tooth 2 is moved gradually by the load applied thereto and
`aligned correctly. Under normal circumstances, the temperature
`in the mouth is equal to the normal body temperature of 37° C.,
`and therefore, ultraelastic wire 1 in accordance with the invention
`produces only a slight stress or load. However, once hot tea or
`coffee is taken into the mouth, or during a meal, the temperature
`of the wire is raised temporarily to a higher temperature in the
`range of, for example, 50° C. to 60° C. This elevated temperature
`
`18
`
`
`
`IPR2019-00123
`Patent 6,306,141 B1
`
`
`produces a higher stress or load which serves to move tooth 2
`orthdontically. If on the other hand, cold water, ice or any other
`substance having a lower temperature than the normal mouth
`temperature is taken in, wire 1 produces a smaller stress or load
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
