Westlkw.
`
`Not Reported in F.Supp.2d, 2009 WL 1163976 (N.D.Cal.)
`(Cite as: 2009 WL 1163976 (N.D.Cal.))
`
`H
`Only the Westlaw citation is currently available.
`
`United States District Court,
`N.D. California.
`MEDTRONIC, INC., et al., Plaintiffs,
`v.
`AGA MEDICAL CORPORATION, Defendant.
`
`No. C-07-0567 MMC.
`April 28, 2009.
`
`James J. Elacqua, Andrew Neil Thomases, Ellen J.
`Wang, Hieu H. Phan, Joshua C. Walsh-Benson,
`Michelle Wai Yang, Noemi C. Espinosa, Dechert
`LLP, Mountain View, CA, Karen D. McDaniel,
`Merchant & Gould, Minneapolis, MN, for Plaintiffs.
`
`Brian Francis McMahon, Steven Daniel Hemminger,
`Lance A. Lawson, Marissa R. Ducca, Michael S.
`Connor, Alston & Bird LLP, Charlotte, NC, for De-
`fendant.
`
`ORDER DENYING DEFENDANT'S MOTION
`FOR SUMMARY JUDGMENT OF INVALIDI-
`TY; DENYING PLAINTIFFS' MOTION FOR
`SUMMARY JUDGMENT RE: PRIOR ART AND
`ANTICIPATION
`MAXINE M. CHESNEY, District Judge.
`*1 Before the Court are defendant AGA Medical
`Corporation's (“AGA”) “Motion (# 2) for Summary
`Judgment of Invalidity under 35 U.S.C. §§ 101
`(‘Double Patenting’), 102(a) (‘Prior Use’) and 103
`(‘Obviousness'),” filed February 28, 2009, and plain-
`tiffs Medtronic, Inc., Medtronic USA, Inc., and Med-
`tronic Vascular, Inc.'s (collectively, “Medtronic”)
`“Motion that the Cragg Filter Experiments Are Not
`Prior Art under 35 U.S.C. § 102 or § 103 and that the
`Cragg II Paper Is Not Anticipating under § 102,” filed
`
`Page 1
`
`February 27, 2009. With respect to each motion, an
`opposition and a reply have been filed. Having read
`and considered the papers filed in support of and in
`opposition to the motions, the Court rules as follows.
`
`A. Anticipation
`Under 35 U.S.C. § 102(a), a person shall be enti-
`tled to a patent unless “the invention was known or
`used by others in this country ... before the invention
`thereof by the applicant for patent.” See 35 U.S.C. §
`102(a). “Anticipation requires that each element of the
`claim at issue is found, either expressly described or
`under the principles of inherency, in a single prior art
`reference or that the claimed invention was previously
`known or embodied in a single prior art device or
`practice.” See In re Omeprazole Patent Litig., 483
`F.3d 1364, 1377 (Fed.Cir.2007).
`
`1. AGA's Motion
`In its motion, AGA argues that all of the asserted
`independent claims of the three patents-in-suit, United
`States Patens Numbers 5,067,967 (“ '957 patent”),
`5,190,546 (“ '546 patent”), and 6,306,141 (“ '141
`patent”), are invalid, on the ground that such claims
`were practiced by Dr. Andrew Cragg (“Cragg”) and
`Dr. Kurt Amplatz (“Amplatz”) prior to the filing, on
`October 14, 1983, of the application that ultimately
`resulted in the issuance of the patents-in-suit. In par-
`ticular, AGA asserts that Cragg and Amplatz practiced
`the asserted claims during experiments undertaken in
`1982 and 1983 (“Cragg/Amplatz experiments”),
`which experiments were “memorialized” (see Mot. at
`2:16) in an article published in September 1983, spe-
`cifically, Andrew Cragg et al., A New Percutaneous
`Vena Cava Filter, 141 Am. J. Roentgenology 601
`(Sept.1983) ( “Cragg II”). (See Decl. Steven D.
`Hemminger (“Hemminger Decl.”) Ex. 24.) As set
`forth below, the Court finds AGA has failed to show it
`is entitled to summary judgment of invalidity on the
`ground of anticipation on
`the basis of
`the
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`Medtronic Exhibit 2004
`Edwards v. Medtronic
`IPR2014-00362
`
`Medtronic Exhibit 2004
`Cook v. Medtronic
`IPR2019-00123
`Page 00001
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`

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`Not Reported in F.Supp.2d, 2009 WL 1163976 (N.D.Cal.)
`(Cite as: 2009 WL 1163976 (N.D.Cal.))
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`Cragg/Amplatz experiments.
`
`To prevail on its motion, AGA must show the
`Cragg/Amplatz experiments, as memorialized in the
`Cragg II article, employed a shape memory alloy that
`“displays” stress-induced martensite. The “display” of
`stress-induced martensite is a limitation of each of the
`asserted claims of the patents-in-suit. (See Order
`Construing Claims, filed Feb. 6, 2008, at 2:3-10.) In
`support of its argument that Cragg II describes such an
`alloy, AGA points to the following statement therein:
`“If the position of the filter was not optimal, it could
`be withdrawn into the catheter and positioned again.”
`(See Cragg II at 602.) Thomas W. Duerig (“Duerig”),
`AGA's expert, opines that because such withdrawal
`occurred at a temperature above the temperature at
`which the filter's transformation from its martensitic to
`its austenitic state was complete, if martensite was
`displayed during such withdrawal, it had to have been
`induced by stress rather than by a change in temper-
`ature. (See Decl. Dr. Thomas W. Duerig in Supp.
`AGA's Opp'n (“Duerig Opp'n Decl.”) ¶ 6.) Addition-
`ally, Kaushik Bhattacharya, another of AGA's experts,
`“rules out ordinary elasticity” as a “deformation
`mechanism,” for the reason that, in Bhattacharya's
`opinion, the filter used by Cragg and Amplatz suffered
`strains in the range of 2.3% to 4.4%, as compared with
`the ordinary elasticity of austenite generally, which
`“can accommodate strains of at most 0.5% to about
`1%.” (See Duerig Opp'n Decl. Ex. B (“Expert Report
`of Prof. Kaushik Bhattacharya”) ¶¶ 26-27, 30-31.)
`
`*2 As Medtronic's expert, Robert Sinclair (“Sin-
`clair”), notes, however, Cragg II does not disclose the
`chemical composition of the alloy used by Cragg and
`Amplatz, or whether the filters at issue “fully de-
`ployed” or “achieved body temperature” before being
`retracted. (See Decl. Dr. Robert Sinclair, PhD (“Sin-
`clair Decl .”) ¶¶ 161.) According to Sinclair “there is
`insufficient evidence to determine,” under such cir-
`cumstances, whether the filters changed shape due to
`the presence of stress-induced martensite or were
`merely “plastically or elastically deformed.” (See id. ¶
`
`Page 2
`
`166.) FN1 Further, as Medtronic points out, Cragg II
`never uses the term “stress-induced martensite” and,
`instead, is focused exclusively on the use of an alloy
`with a “heat-sensitive memory.” (See Cragg II at 601.)
`
`FN1. Although AGA has challenged, under
`Daubert v. Merrell Dow Pharms., Inc., 509
`U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469
`(1993), certain of Sinclair's opinions, that
`challenge is not made with respect to the
`opinions referenced above.
`
`A review of the Cragg II reference reveals that the
`display of stress-induced martensite is not expressly
`disclosed therein. AGA, although arguing to the con-
`trary, also asserts, in essence, that stress-induced
`martensite was “necessarily present, or inherent,” in
`the alloy used in the experiments. See Schering Corp.
`v. Geneva Pharms., Inc., 339 F.3d 1373, 1377
`(Fed.Cir.2003) (holding “a prior art reference may
`anticipate without disclosing a feature of the claimed
`invention if that missing characteristic is necessarily
`present, or inherent, in the single anticipating refer-
`ence”)
`(internal
`citation
`omitted).
`The
`above-discussed evidence submitted by Medtronic is
`sufficient, however, to raise a triable issue with respect
`to the inherency of stress-induced martensite in the
`alloy used by Cragg and Amplatz. FN2
`
`FN2. In light of such finding, the Court does
`not reach Medtronic's argument that a triable
`issue exists as to whether the Cragg/Amplatz
`experiments were publicly accessible. See
`Minn. Min. & Mfg. Co. v. Chemque, Inc., 303
`F.3d 1294, 1306 (Fed.Cir.2002) (“For pur-
`poses of anticipation, a use must be accessi-
`ble to the public”).
`
`Accordingly, to the extent AGA seeks summary
`judgment of invalidity on the ground of anticipation,
`AGA's motion will be denied.
`
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`Not Reported in F.Supp.2d, 2009 WL 1163976 (N.D.Cal.)
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`
`2. Medtronic's Motion
`the
`that
`In
`its motion, Medtronic argues
`Cragg/Amplatz experiments do not constitute either
`prior art or an invalidating prior use and that the Cragg
`II article does not anticipate any of the asserted claims
`of the patents-in-suit. As set forth below, the Court
`finds Medtronic is not entitled to summary judgment
`with respect to either the Cragg/Amplatz experiments
`or the Cragg II article.
`
`Medtronic first argues that, even assuming the
`filters at issue exhibited stress-induced martensite, the
`Cragg/Amplatz experiments cannot constitute prior
`art or an invalidating prior use because Cragg did not
`appreciate what he assertedly had discovered. The
`Court disagrees. In particular, in the context of prior
`use under § 102(a), “it is irrelevant that those using the
`invention may not have appreciated the results.” See
`W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d
`1540, 1548 (Fed.Cir.1983). As AGA points out, the
`cases cited by Medtronic in support of its argument to
`the contrary are distinguishable. Most of those cases
`deal either with prior invention under § 102(g) or an
`earlier statute,FN3 see Coffin v. Ogden, 18 Wall. 120,
`85 U.S. 120, 124-25, 21 L.Ed. 821 (1873); Invitrogen
`Corp. v. Clontech Labs., 429 F.3d 1052, 1063
`(Fed.Cir.2005); Mycogen Plant Sci., Inc. v. Monsanto
`Co., 243 F.3d 1316, 1331 (Fed.Cir.2001); Int'l Glass
`Co. v. United States, 187 Ct.Cl. 376, 408 F.2d 395,
`402 (Ct.Cl.1969), or with prior knowledge, see In re
`Borst, 52 C.C.P.A. 1398, 345 F.2d 851, 853
`(C.C.P.A.1965); In re Schlitter, 43 C.C.P.A. 986, 234
`F.2d 882, 884 (C.C.P.A.1956), rather than prior use.
`Although one case, Eibel Process Co. v. Minn. &
`Ontario Paper Co., 261 U.S. 45, 66, 43 S.Ct. 322, 67
`L.Ed. 523 (1923), discusses what the Federal Circuit
`has called “ ‘accidental, unwitting, and unappreciated’
`anticipation,” see Schering Corp., 339 F.3d at 1378,
`even Eibel, according to the Federal Circuit, “do[es]
`not show that inherency requires recognition,” see
`id.FN4
`
`FN3. AGA “is not asserting an invalidity
`
`Page 3
`
`defense based on prior invention by Dr.
`Cragg and others.” (See Def.'s Opp'n at
`8:13-15.)
`
`FN4. Medtronic also relies on Medtronic,
`Inc. v. Daig Corp., 611 F.Supp. 1498
`(D.Minn.1985), in which the court stated:
`“When a party asserts that a prior use antic-
`ipates a patent claim under § 102(a) or (b),
`that party must also establish that such a use
`was of a complete invention, i.e., conceived
`and reduced to practice, and public,” see id.
`at 1508. In support of this statement, how-
`ever, the district court relied on Coffin and
`Int'l Glass Co., both of which, as noted, deal
`with prior invention rather than prior use.
`
`*3 Medtronic next argues that AGA has no evi-
`dence Cragg II “enable[s]” any asserted claim of the
`patents-in-suit. “In order to be anticipating, a prior art
`reference must be enabling so that the claimed subject
`matter may be made or used by one skilled in the art.”
`See Impax Labs., Inc. v. Aventis Pharms. Inc., 468
`F.3d 1366, 1381 (Fed.Cir.2006). “In order to enable,
`the prior art reference must teach one of ordinary skill
`in the art to make or carry out the claimed invention
`without undue experimentation.” See Minn. Min. &
`Mfg. Co., 303 F.3d at 1306.
`
`Here, AGA has presented evidence that Cragg II
`discloses “the size of nitinol wire used, the annealing
`time, temperature and method, the size of the catheter
`used, the Af temperature, and experimental results”
`and that, consequently, the article “includes all the
`information that is required to enable one of ordinary
`skill in the art to duplicate what Dr. Cragg and his
`team did ... without undue experimentation.” (See
`Duerig Opp'n Decl. ¶ 7.) Medtronic has failed to show
`anything more is required in order to raise a triable
`issue as to enablement. Cf. Amgen, Inc. v. Hoescht
`Marion Roussel, Inc., 314 F.3d 1313, 1355 & n. 22
`(Fed.Cir.2003) (holding “an accused infringer should
`be ... entitled to have the district court presume the
`
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`enablement of unclaimed (and claimed) material in a
`prior art patent defendant asserts against a plaintiff”;
`noting “by logical extension, our reasoning here might
`also apply to prior art printed publications as well”).
`
`Medtronic next argues that the Cragg/Amplatz
`experiments did not employ a shape memory alloy that
`displays stress-induced martensite and that the Cragg
`II article does not disclose such an alloy. As discussed
`above, however, a triable issue exists as to whether the
`experiments, as described in the article, employed an
`alloy that necessarily displayed stress-induced mar-
`tensite.
`
`Accordingly, to the extent Medtronic seeks
`summary judgment on AGA's defense of invalidity on
`the basis of anticipation, Medtronic's motion will be
`denied.
`
`B. Obviousness
`Under 35 U.S.C. § 103, a patent is invalid “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.”
`See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127
`S.Ct. 1727, 1734, 167 L.Ed.2d 705 (2007) (internal
`quotation and citation omitted); see also 35 U.S.C. §
`103.
`
`1. AGA's Motion
`AGA argues that all of the asserted claims of the
`patents-in-suit
`that are not anticipated by
`the
`Cragg/Amplatz experiments or the Cragg II article are
`obvious variants of asserted claims that are anticipated
`by such experiments or such article. As discussed
`above, however, the Court has found a triable issue
`exists as to whether any of the asserted independent
`claims is anticipated, and, consequently, AGA's ar-
`gument necessarily fails.
`
`Page 4
`
`*4 AGA next argues that the asserted claims are
`rendered obvious by a combination of three prior art
`references, specifically, (1) Andrew Cragg, et al.,
`Nonsurgical Placement of Arterial Endoprostheses: A
`New Technique Using Nitinol Wire, 147 Radiology
`261 (Apr.1983) (“Cragg I”), (2) Japanese Patent Ap-
`plication No. S56-144326
`(Sept. 12, 1981)
`(“Miyauchi”), and (3) United States Patent Number
`(See
`4,490,112
`(Sept. 2, 1982)
`(“Tanaka”).
`Hemminger Decl. Exs. 10, 16, 24.) Although a party
`seeking to demonstrate obviousness on the basis of a
`combination of prior art references need not show that
`“some motivation or suggestion to combine the prior
`art teachings can be found in the prior art, the nature of
`the problem, or the knowledge of a person having
`ordinary skill in the art,” see KSR, 127 S.Ct. at 1734
`(internal quotation and citation omitted), such party
`nevertheless must show there was “an apparent reason
`to combine the known elements in the fashion claimed
`by the patent at issue,” see id. at 1740-41.
`
`Here, AGA argues that “one of ordinary skill in
`the art would have been motivated to combine these
`references to address the problem stated in the appli-
`cation [for the patents-in-suit], i.e., avoiding the need
`for controlling the temperature of [a shape memory
`alloy] medical device when implanting it in a body.”
`(See Def.'s Mot. at 12:25-27); see also KSR, 127 S.Ct.
`at 1742 (“[A]ny need or problem known in the field of
`endeavor at the time of invention and addressed by the
`patent can provide a reason for combining elements in
`the manner claimed.”). As Medtronic points out,
`however, AGA has failed to present any evidence in
`support of this assertion, nor has AGA presented any
`evidence suggesting the above-referenced “problem”
`was “known” in the field at the time of the application
`for the patents-in-suit. Consequently, AGA has failed
`to demonstrate a reason to combine the references at
`issue existed.FN5
`
`FN5. In light of such finding, the Court does
`not reach Medtronic's argument (a) that there
`is a triable issue as to the ordinary level of
`
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`skill in the art in 1983, (b) that there is a tri-
`able issue as to whether the combination of
`the three references discloses every limita-
`tion of any asserted claim of the pa-
`tents-in-suit, and (c) that objective indicia of
`nonobviousness preclude summary judgment
`in favor of AGA.
`
`Accordingly, to the extent AGA seeks summary
`judgment of invalidity on the basis of obviousness,
`AGA's motion will be denied.
`
`2. Medtronic's Motion
`Medtronic argues that the Cragg/Amplatz ex-
`periments cannot render the asserted claims of the
`patents-in-suit obvious, on the ground that the ex-
`periments do not qualify as prior art under § 102. As
`discussed above, however, the Court has found a tri-
`able issue exists as to whether the experiments con-
`stitute prior art, and, consequently, Medtronic's ar-
`gument necessarily fails.
`
`Accordingly, to the extent Medtronic seeks
`summary judgment on AGA's defense of invalidity on
`the basis of obviousness, Medtronic's motion will be
`denied.
`
`C. Obviousness Type Double Patenting
`Obviousness type double patenting (“OTDP”) is
`“a judicially created doctrine grounded in public pol-
`icy,” the purpose of which “is to prevent the extension
`of the term of a patent, even where an express statu-
`tory basis for [ ] rejection is missing, by prohibiting
`the issuance of the claims in a second patent not
`patentably distinct from the claims of the first patent.”
`See In re Longi, 759 F.2d 887, 892 (Fed.Cir.1985).FN6
`The doctrine “preclude[s] a second patent on an in-
`vention which would have been obvious from the
`subject matter of the claims in the first patent, in light
`of the prior art.” See Ortho Pharm. Corp. v. Smith, 959
`F.2d 936, 940 (Fed.Cir.1992) (internal quotation and
`citation omitted).
`
`Page 5
`
`FN6. Although, as Medtronic points out,
`AGA's obviousness type double patenting
`defense was not pled at the time AGA filed
`its motion for summary judgment of invalid-
`ity, the Court, on April 21, 2009, afforded
`AGA leave to amend its Answer and Coun-
`terclaims to assert such defense.
`
`*5 The “common-place situation” where a
`“broader claim ‘embraces' or ‘encompasses' the sub-
`ject matter defined by [a] narrower claim,” however,
`“is not, per se, double patenting.” See In re Kaplan,
`789 F.2d 1574, 1577-78 (Fed.Cir.1986). Instead, to
`establish an OTDP defense, “there must be some clear
`evidence to establish why the variation [between the
`two claims] would have been obvious which can
`properly qualify as ‘prior art.’ ” See id. at 1580.
`
`Here, AGA argues that the asserted claims of the
`'141 patent are invalid on the basis of OTDP in light of
`United States Patent Number 5,597,378 (“ '378 pa-
`tent”).FN7 In particular, AGA argues that any differ-
`ences between the asserted claims of the '141 patent
`and certain claims of the '378 patent are “not [ ] pa-
`tentable difference[s].” (See, e.g., Def.'s Mot. at 18:1.)
`As to some of these differences, AGA has presented
`evidence of prior art that, AGA asserts, renders the
`difference not patentable. For example, although
`claim 11 of the '141 patent uses the term “stent,”
`whereas claim 9 of the '378 patent uses the term
`“memory allow element” (see '141 patent col. 11, l.
`66; '378 patent col. 11, l. 14), AGA has pointed to
`prior art that discloses the use a “stent” made from an
`(see
`alloy with
`“shape-memory
`properties”
`Hemminger Decl. Ex. 24 (Charles T. Dotter, et al.,
`Transluminal Expandable Nitinol Coil Stent Grafting:
`Preliminary Report, 147 Radiology 259 (Apr.1983) (
`“Dotter”))). Similarly, although claim 1 of the '141
`patent requires a “guide wire,” whereas claim 34 of the
`'378 patent does not (see '141 patent col. 11, l. 5; '378
`patent col. 14, ll. 39-69), AGA has pointed to prior art
`that discloses the use of a “guiding wire” to place an
`
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`“endovascular prosthesis” in the body of a mammal
`(see Cragg I at 261).
`
`FN7. In light of the very recent amendment
`to add an OTDP defense, Medtronic has not
`moved for summary judgment thereon.
`
`Each of the three asserted independent claims of
`the '141 patent, i.e., claims 1, 11, and 18, however,
`contains at least one term that is narrower than the
`corresponding term in the '378 patent and that AGA
`has failed to address other than by the conclusory
`statement of its expert that the difference between
`such terms is a “design choice” or a “distinction
`without a difference .” FN8 (See Decl. Dr. Thomas W.
`Duerig in Supp. AGA's Mot. (“Duerig Decl.”) ¶ 52
`(stating “[t]he specific shapes of ‘relatively straight-
`ened’ and ‘relatively coiled’ in claim 11 of the '141
`patent are design choices of the more generic ‘shape’
`claimed in the '378 patent”); id. ¶ 57 (stating “[t]he
`terms ‘easily inserted shape’ and ‘deformed shape’
`[used in claim 18 of the '141 patent] merely describe
`the shape of the memory alloy in the stressed shape
`and are design choices of the more generic ‘shape’
`claimed in the '378 patent”); id. ¶ 61 (stating “[t]he
`language ‘hollow tubular restraining member’ of
`claim 34 of the '378 patent versus the language ‘hol-
`low placement device’ of claim 1 of the '141 patent is a
`distinction without a difference when considered in
`light of the entire claim [of] the function of those
`elements”).) Such statements are insufficient to carry
`AGA's burden on summary judgment with respect to
`the issue of OTDP. See Kaplan, 789 F.2d at 1580; see
`also Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1359
`(Fed.Cir.2007) (holding “the patent challenger bears
`the burden of proving the factual elements of invalid-
`ity by clear and convincing evidence”; noting “[t]hat
`burden of proof never shifts to the patentee to prove
`validity”). FN9
`
`Page 6
`
`between the ' 141 patent and the '378 patent,
`on the ground that Medtronic, according to
`AGA, represented to the United States Patent
`and Trademark Office (“PTO”) that the only
`“invention” in either patent was the “use of
`the stress-induced martensite [ ] properties of
`the shape memory alloy at body tempera-
`ture.” (See Def.'s Mot. at 14:19-23.) In par-
`ticular, AGA has failed to present any evi-
`dence suggesting Medtronic's “assertions in
`favor of patentability” before the PTO
`“evince[d] a clear and unmistakable surren-
`der of subject matter” other than the use of
`stress-induced martensite at body tempera-
`ture. See Pharmacia & Upjohn Co. v. Mylan
`Pharms.,
`Inc.,
`170 F.3d 1373, 1377
`(Fed.Cir.1999).
`
`FN9. In light of the above, the Court does not
`reach Medtronic's argument that AGA's
`OTDP defense is precluded by “the ‘safe
`harbor’ provision” (see Pls.' Opp'n at 17:7-8)
`of 35 U.S.C. § 121.
`
`*6 Accordingly, to the extent AGA seeks sum-
`mary judgment of invalidity of the '141 patent on the
`basis of obviousness type double patenting, AGA's
`motion will be denied.
`
`CONCLUSION
`For the reasons stated above, each party's motion
`is hereby DENIED.
`
`IT IS SO ORDERED.
`
`N.D.Cal.,2009.
`Medtronic, Inc. v. AGA Medical Corp.
`Not Reported in F.Supp.2d, 2009 WL 1163976
`(N.D.Cal.)
`
`FN8. The Court finds unpersuasive AGA's
`argument that Medtronic is estopped from
`asserting there are any patentable differences
`
`END OF DOCUMENT
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