Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`Only the Westlaw citation is currently available.NOT
`FOR CITATION
`
`United States District Court,
`N.D. California.
`MEDTRONIC, INC., et al, Plaintiff,
`v.
`W.L. GORE & ASSOCIATES, INC., Defendants.
`
`No. 06-04455 JSW.
`Dec. 9, 2008.
`
`West KeySummaryPatents 291
`
`99
`
`291 Patents
`291IV Applications and Proceedings Thereon
`291k99 k. Description of Invention in Speci-
`fication. Most Cited Cases
`An alleged infringer of patents directed to meth-
`ods for implanting intravascular stents into a human
`body failed to establish a prima facie case of invalidity
`for lack of enablement that patentee was unable to
`create a self-expanding stent as claimed. A court
`concluded the patents must enable a “self-expanding”
`stent to satisfy the enablement requirement of federal
`patent law. The alleged infringer's evidence neither
`suggested why a patentee had difficulty creating a
`self-expanding stent of the type claimed in the patents
`nor suggested whether he could build such a stent but
`could not achieve other aspects of the invention. This
`did not preclude the alleged infringer from presenting
`additional evidence on the issue at trial. 35 U.S.C.A. §
`112.
`
`Ellen J. Wang, James J. Elacqua, Noemi C. Espinosa,
`Andrew Neil Thomases, Joshua C. Walsh-Benson,
`Tina Park Faris Soriano, Dechert LLP, Mountain
`View, CA, A. James Anderson, Robins Kaplan Miller
`
`Page 1
`
`& Ciresi, Atlanta, GA, Hieu H. Phan, Michelle Wai
`Yang, Dechert LLP, Palo Alto, CA, for Plaintiffs.
`
`Gerard Haddad, Christopher K. Hu, Jennifer Bianrosa,
`John T. Gallagher, Dickstein Shapiro LLP, William S.
`Feiler, David H. Pfeffer, Morgan & Finnegan, LLP,
`New York, NY, Hillary Noll Kalay, Mark Jay
`Linderman, Sonnenschein Nath & Rosenthal LLP,
`San Francisco, CA, William J. Maledon, Osborn
`Maledon, PA, Osborn Maledon, Phoenix, AZ, for
`Defendant.
`
`ORDER DENYING W.L. GORE AND ASSO-
`CIATES, INC.'S MOTION FOR SUMMARY
`JUDGMENT
`JEFFREY S. WHITE, District Judge.
`INTRODUCTION
`*1 Now before the Court for consideration is the
`Motion for Summary Judgment of Patent Invalidity
`filed by Defendant W.L. Gore & Associates, Inc
`(“Gore”). Having considered the parties' papers, rel-
`evant legal authority, the record in this case, and
`having had the benefit of oral argument, the Court
`HEREBY DENIES the motion for summary judg-
`ment.FN1
`
`FN1. The Court notes that the parties each
`have violated Northern District Civil Local
`Rule 3-4(c)(2), which requires footnotes to
`be in 12 point font. The parties are HEREBY
`ADVISED that failure to comply with this
`rule in the future shall result in the Court
`striking papers from the record.
`
`BACKGROUND
`Plaintiffs, Medtronic, Inc., Medtronic USA, Inc.,
`and Medtronic Vascular, Inc. (collectively “Med-
`tronic”), allege that Gore infringes Medtronic's U.S.
`Patent Nos. 5,067,957 (“the '957 Patent”), 5,190,546
`(“the '546 Patent”), and 6,306,141 (“the '141 Patent”)
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`Medtronic Exhibit 2006
`Edwards v. Medtronic
`IPR2014-00362
`
`

`

`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`(collectively, “the Jervis Patents”). FN2 Medtronic also
`alleges that Gore infringes Medtronic's U.S. Patent
`Nos. 4,886,062 (“the '062 Patent”), 6,656,219 (“the
`'219 Patent”), and 6,923,828 (“the '828 Patent”) (col-
`lectively, “the Wiktor Patents”).FN3 The Jervis and
`Wiktor Patents each are directed, in general, to med-
`ical devices or methods for implanting such medical
`devices into a human body.
`
`FN2. Medtronic asserts that Gore infringes
`claims 1-3, 5-7, 9-16, 18, 22, 24, 37 and 40 of
`the '957 Patent, claim 27 of the '546 Patent,
`and claims 1-7, 9, 18-19, and 22 of the '141
`Patent. (Declaration of Ellen J. Wang
`(“Wang Decl.”), Ex. B at 8:7-8, 13:4-5,
`17:22-23.)
`
`FN3. Medtronic asserts that Gore infringes
`claims 5-7, 9-10, and 12-13 of the '062 Pa-
`tent, claims 1,3-4, 6-7 and 9 of the '219 Pa-
`tent, and claims 1, 3-14, and 18-21 of the '828
`Patent. (See Wang Decl., Ex. B at 1:16-17,
`3:15-16, 5:15-16.)
`
`Gore moves for summary judgment on the basis
`that: (1) all asserted claims of the Wiktor Patents are
`invalid for lack of enablement; (2) all asserted claims
`of the Jervis Patents are invalid, because the claims are
`obvious in view of the prior art; and (3) all asserted
`claims of the Jervis Patents are invalid, because the
`claims are indefinite.
`
`A. The Wiktor Patents.
`The Wiktor Patents are directed to intravascular
`stents. In the specification, Wiktor describes his in-
`vention, generally, as comprising “an open-ended wire
`formed device of basically cylindrical shape and made
`of a softer-then [sic ] spring type metal and fitted over
`an inflatable element of a typical balloon type catheter
`.... The wire formed device is intended to act as a
`permanent prosthesis
`stent
`and
`is
`implanted
`transluminarely.” (See, e.g., Declaration of Jennifer
`
`Page 2
`
`BianRosa (“BianRosa Decl.”), Ex. A ('062 Patent at
`1:14-22).) FN4 The '062 Patent was filed on October 19,
`1987, and the '219 and '828 Patents each were filed on
`November 22, 2000. (Bianrosa Decl., Exs. A-C.) FN5 It
`is undisputed that, at the time the ' 062 Patent was
`filed, a person of ordinary skill in the art would have a
`degree in engineering or biomedical engineering and
`familiarity with implantable medical devices.
`
`FN4. The Court cites to references within the
`patents-in-suit
`in
`the following format:
`“column:line” or “column:line-column:line.”
`
`FN5. The '219 and '828 Patents are continu-
`ations-in-part of the ' 062 Patent. Thus, alt-
`hough the specifications of each of the pa-
`tents are largely similar, the specifications of
`the '219 and '828 Patents contain new matter.
`When the Court cites portions of the speci-
`fication that are common to all three patents,
`it shall cite only to the '062 Patent.
`
`Claim 5 of the '062 Patent, which is representative
`of the asserted claims of that patent, provides:
`
`A radially-expandable stent for implantation within
`a body vessel comprising:
`
`a stent body having a wall of generally cylindrical
`shape formed of a helical coil made of a wire, the
`body having a longitudinal axis and a first diameter;
`
`zig-zag means in the wire for allowing radial ex-
`pansion of the cylindrical stent body from the first
`diameter to a second larger diameter without sig-
`nificantly altering the body length along the longi-
`tudinal axis.
`
`('062 Patent at 5:42-6:7.)
`
`Claim 1 of the '219 Patent, which is representative
`of the asserted claims of that patent, provides:
`
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`

`

`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`*2 An intravascular stent, comprising:
`
`a continuous sinusoidal shaped wire, wherein said
`wire is coiled to form a helical-shaped stent body,
`wherein said stent is expandable from a first deliv-
`ery diameter to a second implanted diameter.
`
`(BianRosa Decl., Ex. B ('219 Patent at 8:2-7).)
`
`Claim 1 of the '828 Patent, which is representative
`of the asserted claims of that patent, provides:
`
`An intravascular stent, comprising:
`
`a generally cylindrical body including a helically
`coiled wire, wherein said helically coiled wire has
`generally sinusoidally-shaped waves;
`
`wherein said generally cylindrical body is capable
`of radially expanding.
`
`(Id, Ex. C ('828 Patent at 7:47-53.)
`
`On August 14, 2007, the Court issued an Order
`construing the term “stent,” as used in the Wiktor
`Patents, to mean “a supporting device.” (Docket No.
`91 (Claim Construction Order at 16:21-22); Docket
`No. 116 (Order Granting Plaintiffs' Motion for Re-
`consideration at 2:13-25).) In so doing, the Court
`rejected Gore's proposed construction that the term
`“stent” should include a “low memory metal” limita-
`tion. (Claim Construction Order at 14:15-16:10). FN6
`The Court also concluded that Wiktor “did not disa-
`vow clearly the use of self-expanding or resilient
`stents,” based in part on its conclusion that “Wiktor
`does not say resilient metal is unsuitable to achieve the
`object of his invention, namely a stent that expands
`radially.” (Id. at 15:15-17.)
`
`FN6. In its Claim Construction Order, the
`
`Page 3
`
`Court stated that a “low memory metal” lim-
`itation was the only meaningful difference
`between independent Claim 14 and depend-
`ent Claim 17 of the '062 Patent. (Claim
`Construction Order at 14:20-21.) The refer-
`ence to the '062 Patent was a typographical
`error, and the Court intended to refer to
`Claims 14 and 17 of the '828 Patent.
`
`B. The Jervis Patents.
`The Jervis Patents are directed to medical devic-
`es, or methods for implanting such devices, that utilize
`shape memory alloys (“SMAs”) and improvements
`thereon. (See, e.g., BianRosa Deck, Ex. D ('957 Patent
`at 1:19-20).) The ' 957 Patent was filed on September
`27, 1988. The '546 Patent was filed on April 9, 1991,
`and the '141 Patent was filed on June 7, 1995. It is
`undisputed that, at the time the first Jervis Patent was
`filed, a person or ordinary skill in the art would pos-
`sess a degree in materials sciences or related engi-
`neering degree and have some familiarity with im-
`plantable medical devices.
`
`in his patents,
`acknowledges
`Jervis
`As
`“[m]aterials, both organic and metallic, capable of
`possessing shape memory are well known.” ('957
`Patent at 1:23-24.) Jervis also explains that:
`
`[a]n article made of [a material capable of pos-
`sessing shape memory] can be deformed from an
`original, heat-stable configuration to a second,
`heat-unstable configuration. The article is said to
`have shape memory for the reason that, upon the
`application of heat alone, it can be caused to revert,
`or to attempt to revert, from its heat-unstable con-
`figuration to its original, heatstable configuration,
`i.e. it “remembers” its original shape.
`
`Among metallic alloys, the ability to possess shape
`memory is a result of the fact that the alloy under-
`goes a reversible transformation from an austenitic
`state to a martensitic state with a change in temper-
`
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`

`

`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`ature. This transformation is sometimes referred to
`as a thermoelastic martensitic transformation. An
`article made from such an alloy ... is easily de-
`formed from its original configuration to a new
`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 temper-
`ature at which the reversion is complete) the de-
`formed object will begin to return to its original
`configuration.
`
`Page 4
`
`I have discovered that if, in a medical device con-
`taining a shape memory alloy element which uses
`the shape memory property of that alloy, an element
`which shows the property of stress-induced mar-
`tensite is used instead, an improved device results.
`
`Accordingly, this invention provides a medical de-
`vice intended for use within a mammalian body, or
`in such proximity to a mammalian body that the
`device is substantially at body temperature, which
`device comprises a shape memory alloy element,
`the improvement in which comprises the substitu-
`tion of an alloy element which displays
`stress-induced martensite at said body temperature
`for the shape memory alloy element.
`
`*3 ('957 Patent at 1:23-49).)
`
`(Id. at 2:43-66; see also id. at 3:1-6.)
`
`Jervis describes the disadvantages associated with
`using SMA devices for medical purposes, including
`the fact that “it is difficult to control the transfor-
`mation temperatures of shape memory alloys with
`accuracy,
`as
`they
`are
`usually
`composi-
`tion-sensitive[.]” (Id. at 2:32-35.)
`
`The combination of these factors with the limitation
`that (a) it is inconvenient to have to engage in any
`temperature manipulation, and (b) human tissue
`cannot be heated or cooled beyond certain relatively
`narrow limits ... without suffering temporary or
`permanent damage is expected to limit the use of
`SMA medical devices. It would thus be desirable to
`develop a way in which the advantageous properties
`of shape memory alloys, i.e. their ability to return to
`an original shape after relatively substantial defor-
`mation, could be used in medical devices without
`requiring the delicacy of alloying control and/or the
`temperature control of placement or removal needed
`by present shape memory alloy devices.
`
`...
`
`ANALYSIS
`A. Legal Standards Applicable to Motions for
`Summary Judgment.
`Summary judgment is appropriate when there is
`no genuine issue as to any material fact and the mov-
`ing party is entitled to judgment as a matter of
`law. Union States Gypsum Co. v. Nat'l Gypsum Co.,
`74 F.3d 1209, 1212 (Fed.Cir.1996). The burden of
`demonstrating the absence of any genuine issue of
`material fact rests with the moving party. SRI Int'l v.
`Matsushita Elec. Corp., 775 F.2d 1107, 1116
`(Fed.Cir.1985). Where, as here, the moving party will
`bear the burden of proof at trial, that party must come
`forth with “evidence which would entitle it to a di-
`rected verdict if the evidence went uncontradicted at
`trial.” Houghton v. South, 965 F.2d 1532, 1536 (9th
`Cir.1992); cf. Eli Lilly & Co. v. Barr Labs., Inc., 251
`F.3d 955, 962 (Fed.Cir.2001). In order to defeat
`summary judgment, the non-moving party must do
`“more than simply show that there is some meta-
`physical doubt as to the material facts.” Matsushita
`Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,
`586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). Rather,
`the non-moving party must set forth “specific facts
`showing that there is a genuine issue for trial.”
`
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`Page 5
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`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`Fed.R.Civ.P. 56(c); Matsushita Elec., 475 U.S. at 587.
`
`this time.
`
`*4 “Because a patent is presumed to be valid,”
`Gore's “evidentiary burden to show facts supporting a
`conclusion of invalidity is one of clear and convincing
`evidence.” Automotive Tech. Int'l Inc. v. BMW of
`North Am., Inc., 501 F.3d 1274, 1281 (Fed.Cir.2007)
`(citing AK Steel Corp. v. Sollac & Ugine, 344 F.3d
`1234, 1238-39 (Fed.Cir.2003)). Gore also must
`overcome “deference to the [United States Patent and
`Trademark Office's (“PTO”) ] findings and decisions
`in prosecuting the patent application. Deference to the
`PTO is due ‘[w]hen no prior art other than that which
`was considered by the PTO examiner is relied on’ ” by
`the party attacking the patent's validity. Boston Scien-
`tific Corp. v. Johnson & Johnson, 534 F.Supp.2d
`1062, 1068 (N.D.Cal.2007) (quoting American Hoist
`& Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1359
`(Fed.Cir.), cert denied, 469 U.S. 821, 105 S.Ct. 95, 83
`L.Ed.2d 41 (1984)).
`
`B. Evidentiary Objections.
`the
`to
`Medtronic objects
`to Exhibits G-H
`BianRosa Declaration, on the ground that the docu-
`ments contain inadmissible hearsay.FN7 Gore argues
`that the documents are admissible under Federal Rule
`of Evidence 801(d)(2)(D), which provides that a
`statement is not hearsay if “the statement is offered
`against a party and is ... a statement by the party's
`agent or servant concerning a matter within the scope
`of the agency or employment, made during the exist-
`ence of the relationship.” Medtronic responds that at
`the time Wiktor made the statements reflected in these
`exhibits, he was an independent contractor and not
`Medtronic's agent. See Merrick v. Farmers Ins.
`Group, 892 F.2d 1434, 1440 (9th Cir.1990) (finding
`that district court properly excluded statements where
`plaintiff had not established statements were made by
`agents as opposed to independent contractors).
`
`FN7. The Court has not relied on Exhibit G to
`the BianRosa Declaration. Therefore, it shall
`not address the admissibility of the exhibit at
`
`The consulting agreement between Wiktor and
`Medtronic is governed by Minnesota law. (Reply
`Declaration of Jennifer BianRosa (“BianRosa Reply
`Decl.”), Ex. W at 7.) Under Minnesota law, the factors
`to be applied to distinguish between an independent
`contractor and agency relationship are “(1) [t]he right
`to control the means and manner of performance; (2)
`the mode of payment; (3) the furnishing of material or
`tools; (4) the control of the premises where the work is
`done; and (5) the right of the employer to discharge....
`In determining whether the status is one of employee
`or independent contractor, the most important factor
`considered in light of the nature of the work involved
`is the right of the employer to control the means and
`manner of performance.” Guhlke v. Roberts Truck
`Lines, 268 Minn. 141, 143, 128 N.W.2d 324 (1964).
`
`The consulting agreement does not state that
`Wiktor is an independent contractor. Moreover, it
`provides that Wiktor agrees to consult with Medtronic
`“and perform development work for Medtronic in the
`area of vascular stents, as directed by Medtronic.”
`(Bian Rosa Reply Deck, Ex. W at 2-3 (emphasis
`added).) Medtronic paid Wiktor for his services and at
`least some of the documents Gore submits suggest that
`Medtronic furnished Wiktor with materials during the
`course of their agreement. The Court concludes that
`Gore has presented sufficient evidence to establish
`that Wiktor acted as Medtronic's agent at the time the
`statements were made. (See Docket No. 285, Gore's
`Motion for Leave to File Post Summary Judgment
`Hearing Submission, Exs. A, B.) Further, the state-
`ments were made within the scope of Wiktor's con-
`sulting agreement.
`
`*5 Therefore, the Court concludes that the
`statements are non-hearsay and OVERRULES the
`objections to BianRosa Declaration Exhibits H and I.
`See Metro Goldwyn Meyers Studio v. Grokster, Ltd .,
`454 F.Supp.2d 966, 973-74 (C.D.Cal.2006) (noting
`that “statement is admissible under Rule 801(d)(2)(D)
`
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`

`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
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`
`so long as it is made by an agent within the scope of
`agency, regardless of the precise contractual rela-
`tionship between the agent and the party against whom
`the evidence is offered”); cf. Beck v. Haik, 311 F .3d
`624, 639-40 & n. 4 (6th Cir.2004) (citing, inter alia,
`United States ex rel Remtech, Inc. v. National Union
`Fire Ins. Co., 2000 WL 1171139 at *3 n. 4 (9th Cir.
`Aug.17, 2000)) (concluding that statement by a
`“consultant” qualified as non-hearsay pursuant to Rule
`801(d)(2)(D)).
`
`C. Gore Has Not Met Its Burden to Show That the
`Claims of the Wiktor Patents Are Invalid.
`
`1. Legal Standards Applicable to Enablement.
`
`The specification [of a patent] shall contain a writ-
`ten description of the invention, and of the manner
`and process of making and using it, in such full,
`clear, concise, and exact terms as to enable any
`person skilled in the art to which it pertains, or with
`which it is most nearly connected, to make and use
`the same, and shall set forth the best mode contem-
`plated by the inventor of carrying out his invention.
`35 U.S.C. § 112, ¶ 1 (hereinafter “Section 112,
`paragraph 1”).
`
`“Whether the subject matter of a patent claim
`satisfies the enablement requirement under [Section
`112, paragraph 1] is a question of law ... based on
`underlying facts.” Automotive Tech. Int'l, 501 F.3d at
`1281. The “enablement requirement is satisfied when
`one skilled in the art, after reading the specification,
`could practice the claimed invention without undue
`experimentation.” A.K. Steel, 344 F.3d at 1244. “The
`full scope of the claimed invention must be enabled.”
`Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999
`(Fed.Cir.2008). Thus, if a patentee “chooses broad
`claim language,” he or she “must make sure the broad
`claims are fully enabled.” Id.
`
`The Federal Circuit has identified several factors
`
`Page 6
`
`to consider “in determining whether a disclosure
`would require undue experimentation.” In re Wands,
`858 F.2d 731, 737 (Fed.Cir.1988). Those factors in-
`clude: “(1) the quantity of experimentation necessary,
`(2) the amount of direction or guidance presented, (3)
`the presence or absence of working examples, (4) the
`nature of the invention, (5) the state of the prior art, (6)
`the relative skill of those in the art, (7) the predicta-
`bility or unpredictability of the art, and (8) the breadth
`of the claims.” Id. These factors are “illustrative, not
`mandatory. What is relevant depends on the facts[.]
`Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d
`1200, 1213 (Fed.Cir.2000).
`
`2. Analysis.
`Gore argues that the Wiktor Patents do not enable
`a “self-expanding zig-zag” stent. To support its posi-
`tion, Gore relies on the specifications of the Wiktor
`Patents and on Wiktor's statements that he tried to
`make a self-expanding “Wiktor stent” but failed.
`Medtronic counters that Gore focuses on unrecited
`claim elements and that Gore has not pointed to par-
`ticular claim language that is not enabled. The Court
`does not find Medtronic's argument persuasive.
`
`*6 Gore's enablement argument is premised the
`Court's construction of the term stent, which is broad
`enough to cover a self-expanding or a stent that is
`expanded by external means. (See Claim Construction
`Order at 14:10-16:21.) Gore correctly argues that, in
`light of this broad construction, the Wiktor Patents
`must enable the full scope of embodiments that would
`fall within the claims. See, e.g., Sitrick, 516 F.3d at
`999-1000 (noting that plaintiff had argued for a claim
`construction that would encompass both movies and
`video games and concluding that patent must enable
`both embodiments of the invention); Automotive Tech.
`Int'l, 501 F.3d at 1282 (concluding that where district
`court construed claim term to include both mechanical
`and electronic sensors, “that full scope must be ena-
`bled”); Leibel-Flarsheim Co. v. Medrad, Inc., 481
`F.3d 1371, 1379 (Fed.Cir.2007).
`
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`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`“An enablement analysis begins with the disclo-
`sure in the specification.” Sitrick, 516 F.3d at 1000.
`Gore argues that the Wiktor Patents “teach against”
`self-expanding stents and cites to Wiktor's reference to
`his U.S. Patent No. 4,649,922, which Medtronic does
`not dispute is a self-expanding stent. The Federal
`Circuit has concluded that where a specification
`teaches against a particular embodiment, that fact can
`provide evidence that undue experimentation would
`be necessary. See, e.g., Liebel-Flarsheim, 481 F.3d at
`1379; A.K. Steel, 344 F.3d at 1244. Wiktor acknowl-
`edges that the stent of the '922 Patent has “some
`drawbacks,” including the fact that “the spring has a
`fixed diameter and as such is unable to fully conform
`to the inside wall of the vessel....” (See '062 Patent at
`1:28-42.) Wiktor then notes that two prior art devices,
`U.S. Patent No. 4,553,545 (the “'545 Patent”) and U.S.
`Patent No. 3,868,956 (the “'956 Patent”), teach a
`method of expanding the diameter of a stent. (Id. at
`1:45-53.) He criticizes those devices because of the
`complexity of the methods used and because of the
`possibility of “blood coagulation and possible
`thrombosis.” Wiktor's criticism of the prior art devices
`does not expressly relate to or encompass the materials
`from which those devices were made. (Id. at 1:54-56.)
`
`In addition to the '545 Patent and the '956 Patent,
`Wiktor references several other prior art devices,
`which, like the '545 Patent and the '956 Patent, en-
`compass self-expanding stents as well as stents that
`are expanded by external means. Wiktor notes that
`those “references describe and teach various methods
`of providing or otherwise offering and introducing
`stents of different types and designs for applications
`similar to the one described herein in this invention.”
`(Id. at2:10-31.) Wiktor then describes the benefits of
`his improved invention, which include: requiring only
`a “single procedure;” allowing for and “maintain[ing]
`a very low profile and a small frontal area, so very
`important for purposes of percutaneous insertion;” and
`having an “inherent post-expansion radial rigidity and
`linear flexibility.” (Id. at 2:4-9, 2:38-41, 3:25-29.)
`Wiktor states that the invention is “characterized” by a
`
`Page 7
`
`“low memory metal,” which assures that “the radially
`expanded stent stays expanded thus fulfilling its pri-
`mary intent and function.” (Id. at 3:21-24.) Wiktor
`also states that the use of a “flexible wire ... allows
`easy radial expansion and subsequent retention of the
`radially expanded shape well anchored within a ves-
`sel.” (Id. at 3:35-37 .)
`
`*7 In Liebel-Flarsheim, the inventors argued for
`and obtained a claim construction that included an
`injector with and without a pressure jacket. However,
`in the specification, they stated that “[w]ithout a
`pressure jacket, syringes that are able to withstand ...
`high pressures are expensive and therefore impractical
`where the syringes are to be disposed.” 481 F.3d at
`1379. The Federal Circuit found that critique of the
`prior art, in combination with the fact that the speci-
`fication provided “no guidance or suggestion of how
`to make or use a disposable syringe for high pressure
`use without a pressure jacket,” supported a conclusion
`that the claims were invalid for lack of enablement. Id.
`at 1379-80.
`
`Similarly, in A.K. Steel, the inventors argued for
`an obtained a claim construction that encompassed
`two types of aluminum coating, Type 1 and Type 2.
`The court also noted that the claims required that the
`“coating wet well.” 344 F.3d at 1244. The court con-
`cluded, however, that the disclosure did not enable an
`embodiment that used Type 1 coating, because “the
`specification clearly and strongly warns that such an
`embodiment would not wet well. In particular, the
`specification warns that silicon content above 0.5% in
`the aluminum coating causes coating problems.” Id.
`The court found that such language “discourages ex-
`perimentation with coatings having more than 0.5%
`silicon, undue or otherwise.” Id. In contrast, and as the
`Court previously noted, Wiktor does not state that the
`use of resilient metal would be either unsuitable or
`impractical to achieve the object of the invention. (See
`Claim Construction Order at 15:16-17.) Moreover, it
`is undisputed that self-expanding stents were known
`in the prior art. Thus, this is not a situation where the
`
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`

`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
`
`specification disclosed a new field of art. See, e.g.,
`Automotive Techs., 501 F.3d at 1284 (concluding that
`defendant met its burden to show disclosure did not
`enable a particular embodiment of the invention
`based, in part, on the fact that the particular embodi-
`ment was a new field and no prior art devices existed).
`
`Gore also relies on Wiktor's statements that sug-
`gest he tried to create a stent that was “self-expanding”
`but did not succeed. Specifically, Gore submits a
`memorandum dated March 31, 1990, in which Wiktor
`states that “I have done some preliminary design and
`model work on the proposed self-expanding stent,
`initial work indicates it will be quite difficult, but I
`shall not give up and will continue to pursue it.” Gore
`also submits a letter dated May 30, 1995, in which
`Wiktor states that “[a]fter several discussions with you
`on this subject, I find myself spending more time
`dreaming and fantasizing about a self-expanding stent;
`hopefully those mental calisthenics will develop into
`something tangible.” (BianRosa Deck, Exs. H-I.)
`
`There is no evidence in the record that Wiktor had
`a degree in engineering or biomedical engineering, as
`well as a familiarity with implantable medical devices.
`Assuming that Wiktor was a person of ordinary skill in
`the art, the fact that Wiktor had “difficulty” in creating
`a self-expanding stent provides some evidence that
`further experimentation might be necessary. See
`Liebel-Flarsheim, 481 F.3d at 1371 (finding lack of
`enablement based, in part, on inventors' admission that
`they tried, but failed, to produce a pressure-jacketless
`system and decided not to pursue it because it was “to
`risky”); A.K. Steel, 344 F.3d at 1244 (finding lack of
`enablement based, in part, on failure to utilize Type 1
`aluminum coating at the time of filing). However, the
`applicable standard is whether “undue experimenta-
`tion” would be required. Gore's evidence neither
`suggests why Wiktor had difficulty creating a
`self-expanding stent of the type claimed in the Wiktor
`Patents nor suggests whether he could build such a
`stent but could not achieve other aspects of the in-
`vention.
`
`Page 8
`
`*8 The Court concludes that the Wiktor Patents
`must enable a “self-expanding” stent to satisfy the
`requirements of Section 112, paragraph 1. However,
`on this record Gore has not met its burden to establish
`a prima facie case of invalidity for lack of enablement.
`Accordingly, Gore's motion is denied on this basis.
`This ruling is not intended to preclude Gore from
`presenting additional evidence on the issue at trial.
`
`D. Gore Has Not Met Its Burden to Show That the
`Claims of the Jervis Patents Are Invalid for Ob-
`viousness.
`Gore argues that the asserted claims of the Jervis
`Patents are obvious, because Jervis merely substituted
`an SMA displaying stress-induced martensite for an
`SMA displaying temperature-induced martensite in
`existing medical devices and achieved a predictable
`result.
`
`1. Legal Standards Applicable to a Determination
`of Obviousness.
`“Section 103 forbids issuance of a patent when
`‘the differences between the subject matter sought to
`be patented 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, 127 S.Ct.
`1727, 1743, 167 L.Ed.2d 705 (2008) (quoting 35
`U.S.C. § 103(a)). “[T]he ultimate conclusion of ob-
`viousness is for the court to decide as a matter of law,
`[however] several factual inquiries underlie this de-
`termination.” SIBIA Neurosciences, Inc. v. Cadus
`Pharm. Corp., 225 F.3d 1349, 1355 (Fed.Cir.2000).
`As set forth in the KSR case, those factual considera-
`tions, which should be judged objectively, are:
`
`the scope and content of the prior art ...; differences
`between the prior art and the claims at issue ...; and
`the level of ordinary skill in the pertinent art ....
`Against
`this background
`the obviousness or
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`Not Reported in F.Supp.2d, 2008 WL 5191846 (N.D.Cal.)
`(Cite as: 2008 WL 5191846 (N.D.Cal.))
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`nonobviousness of the subject matter is determined.
`Such secondary considerations as commercial suc-
`cess, long felt but unresolved needs, failure of oth-
`ers, etc. might be utilized to give light to the cir-
`cumstances surrounding the origin of the subj ect
`matter sought to be patented.
`
`KSR, 127 S.Ct. at 1734 (quoting Graham v. John
`Deere Co. of Kansas City, 383 U.S. 1, 17-18, 86 S.Ct.
`684, 15 L.Ed.2d 545 (1966)); see also SIBIA, 225 F.3d
`at 1355. “The combination of familiar elements ac-
`cording to known methods is likely to be obvious
`when it does no more than yield predictable results.”
`KSR, 127 S.Ct. at 1739.
`
`2. Analysis.
`In support of its argument that the claims of the
`Jervis Patent are invalid for obviousness, Gore relies
`on three prior art references: (1) L. Delaey, et al.,
`“Thermoelasticity, Pseudoelasticity and the Memory
`Effects Associated with Martensitic Transfor-
`mations,” 9 J. Materials Science 1521-1555 (1974) (
`“Delaey”
`);
`(2) L. McDonald
`Schetky,
`“Shape-Memory Alloys,” 241 Scientific American 5,
`74-82 (Nov.1979) (“Schetky” ); and (3) Dr. Andrew
`Cragg, et al., “Nonsurgical Placement of Arterial
`Endoprostheses: A New Technique Using Nitinol
`Wire,” 147 Radiology 1, 261-63 (April 1983) (“Cragg
`Stent”).
`
`*9 It is undisputed that shape memory alloys were
`known to display stress-induced martensite at the time
`Jervis filed the '957 Patent. (See, e.g., ' 957 Patent at
`1:50-51.) Although the Jervis Patents discuss known
`prior a