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Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 11
`October 13, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01293
`Patent 8,992,608 B2
`____________
`
`
`Before NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`
`I.
`
`INTRODUCTION
`
`On April 18, 2017, Edwards Lifesciences Corporation (“Petitioner”)
`
`filed a Petition (Paper 2, “Pet.”) requesting institution of inter partes review
`
`of claims 1–9 of U.S. Patent No. 8,992,608 B2 (Ex. 1101, “the ’608 patent”).
`
`Boston Scientific Scimed, Inc. (“Patent Owner”) filed a Preliminary
`
`Response (Paper 10, “Prelim. Resp.”). We have jurisdiction under
`
`35 U.S.C. § 314(a), which provides that 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.”
`
`The Petition is the second petition filed by Petitioner challenging
`
`claims of the ’608 patent. Petitioner filed its first petition challenging claims
`
`1–4 of the ’608 patent on October 12, 2016, in IPR2017-00060 (“IPR-060”).
`
`Edwards Lifesciences Corp., Edwards Lifesciences LLC, and Edwards
`
`Lifesciences AG v. Boston Scientific Scimed, Inc., Case IPR2017-00060,
`
`Paper 1 (the “IPR-060 Petition”), 46–75. On March 29, 2017, we instituted
`
`inter partes review of each of the ’608 patent claims challenged in IPR-060.
`
`IPR-060, Paper 7 (the “IPR-060 Institution Decision”), 24. Oral argument in
`
`IPR-060, if requested by the parties, is scheduled for December 19, 2017.
`
`IPR-060, Paper 8, 8.
`
`Petitioner also filed a motion to join this case with IPR-060. Paper 3.
`
`Patent Owner opposed the joinder motion. Paper 7. Petitioner filed a Reply
`
`in support of the motion (Paper 8) and a proposed revised schedule for the
`
`joined cases (Paper 9).
`
`Institution of inter partes review is discretionary. See 35 U.S.C.
`
`§ 314(a); 37 C.F.R. § 42.108(a). For the reasons explained below, we
`
`2
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`exercise our discretion to not institute inter partes review on any of claims
`
`1–9 of the ’608 patent in this case. Petitioner’s Motion for Joinder is denied
`
`as moot.
`
`II.
`
`BACKGROUND
`
`A.
`
`The ’608 Patent
`
`The ’608 patent, titled “Everting Heart Valve,” issued March 31,
`
`2015, from U.S. Application No. 12/492,512 (the ’512 application), filed
`
`June 26, 2009. Ex. 1101. The ’512 application was a divisional of U.S.
`
`Application No. 12/269,213, filed on November 12, 2008 (issued as U.S.
`
`Patent No. 8,668,733), which was a continuation of U.S. Application
`
`No. 10/870,340, filed on June 16, 2004 (issued as U.S. Patent
`
`No. 7,780,725). Id. The ’608 patent generally relates to “methods and
`
`apparatus for endovascularly replacing a patient’s heart valve.” Ex. 1101,
`
`Abstract.
`
`Figures 32, 33, and 34 of the ’608 patent are reproduced below.
`
`
`
`
`
`
`
`An embodiment of the replacement heart valve and anchor is illustrated in
`
`Figure 32 in an undeployed configuration, and in Figure 33 in a deployed
`
`3
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`configuration. Ex. 1101 4:38–42. Figure 34 illustrates the replacement
`
`heart valve deployed in a patient’s heart valve. Id. at 4:43–44. The
`
`’608 patent further explains:
`
`FIGS. 32–34 show another way to seal the replacement
`valve against leakage. A fabric seal 380 extends from the distal
`end of valve 20 and back proximally over anchor 30 during
`delivery. When deployed, as shown in FIGS. 33 and 34, fabric
`seal 380 bunches up to create fabric flaps and pockets that extend
`into spaces formed by the native valve leaflets 382, particularly
`when the pockets are filled with blood in response to backflow
`blood pressure. This arrangement creates a seal around the
`replacement valve.
`
`Id. at 14:21–29.
`
`Figure 3B of the ’608 patent is reproduced below.
`
`
`
`Figure 3B illustrates the deployment of a replacement heart valve.
`
`The ’608 patent states that “[a]nnular 60 base 22 of replacement valve
`
`20 preferably is coupled to skirt region 34 of anchor 30, while
`
`commissures 24 of replacement valve leaflets 26 are coupled to and
`
`supported by posts 38.” Ex. 1101, 5:60–63. “Replacement valve 20
`
`4
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`is preferably made from biologic tissues, e.g. porcine valve leaflets or
`
`bovine or equine pericardium tissues or human cadaver tissue.” Id. at
`
`5:51–53.
`
`B.
`
`Illustrative Claim
`
`Challenged claim 1 is the sole independent claim challenged, from
`
`which challenged claims 2–9 depend. Claim 1 is illustrative of the claimed
`
`subject matter and is reproduced below:
`
`1. A system for replacing a heart valve, comprising:
`an expandable anchor having a collapsed delivery configuration
`and an expanded configuration, the expandable anchor
`comprising a distal end;
`a replacement valve commissure support element attached to the
`expandable anchor;
`a commissure portion of a replacement valve leaflet attached to
`the commissure support element; and
`a fabric seal at least partially disposed around an exterior portion
`of the expandable anchor when the anchor is in the expanded
`configuration, the fabric seal having an undeployed state and
`a deployed state, wherein in the deployed state the fabric seal
`comprises flaps that extend into spaces formed by native
`valve leaflets;
`wherein a distal end of the replacement valve leaflet is attached
`to the fabric seal and when the expandable anchor is in the
`collapsed delivery configuration, the fabric seal extends from
`the distal end of the replacement valve and back proximally
`over the expandable anchor, the fabric seal being adapted to
`prevent blood from flowing between the fabric seal and heart
`tissue.
`
`Ex. 1101, 22:22–42.
`
`C.
`
`Related Proceedings
`
`In addition to the pending challenge to claims 1–4 of the ’608 patent
`
`in IPR-060, discussed above, the parties indicate that the ’608 patent is
`
`asserted in the United States District Court for the District of Delaware, in a
`
`5
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`case captioned Boston Scientific Corp. et al. v. Edwards Lifesciences Corp.,
`
`Case No. 1:16-cv-00275 (D. Del.). Pet. 28; Paper 4, 2. Petitioner also states
`
`that “there is at least one pending U.S. patent application, serial number
`
`14/873,462, that claims priority to the ’608 Patent.” Pet. 28.
`
`D.
`
`Real Parties in Interest
`
`Petitioner identifies Edwards Lifesciences Corporation, Edwards
`
`Lifesciences LLC, and Edwards Lifesciences AG as real parties in interest.
`
`Pet. 28. Patent Owner identifies Boston Scientific Scimed, Inc. and Boston
`
`Scientific Corp. as real parties in interest. Paper 4, 2.
`
`E.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1–9 of the ’608 patent
`
`on the following grounds:
`
`Reference(s)
`
`Basis Claims Challenged
`
`Haug1
`
`§ 102
`
`Seguin,2 Lazarus,3 and Lawrence-Brown4
`
`§ 103
`
`1–9
`
`1–4
`
`Petitioner relies on the Declaration by Nigel P. Buller, M.D., dated
`
`October 10, 2016 (Ex. 1007), previously filed by Petitioner in IPR2017-
`
`00060, and the Second Declaration by Dr. Buller, dated April 18, 2017,
`
`(Ex. 1136) as support for its challenge.
`
`
`1 U.S. Patent App. Pub. No. 2005/0283231 A1, published
`December 22, 2005 (Ex. 1135, “Haug”).
`2 WO 03/003949 A2, published January 16, 2003 (Ex. 1150, “Seguin”).
`3 U.S. Patent No. 5,693,088, issued December 2, 1997 (Ex. 1147,
`“Lazarus”).
`4 U.S. Patent App. Pub. No. 2003/0093145 A1, published May 15, 2003
`(Ex. 1149, “Lawrence-Brown”).
`
`6
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`
`III. ANALYSIS
`
`A. Discretionary Non-Institution Under 35 U.S.C. § 314(a)
`
`The Board has discretion not to institute an inter partes review.
`
`35 U.S.C. § 314(a); 37 C.F.R. § 42.108(a); Harmonic Inc. v. Avid Tech, Inc.,
`
`815 F.3d 1356, 1367 (Fed. Cir. 2016) (“First of all, the PTO is permitted, but
`
`never compelled, to institute an IPR proceeding.”). When considering
`
`whether to exercise this discretion, we look to factors, including:
`
`1. whether the petitioner filed a prior petition directed to the same
`
`claims of the same patent;
`
`2. whether the petitioner filed the subsequent petition after the
`
`petitioner received the patent owner’s preliminary response to the
`
`prior petition or the Board’s institution decision on the prior petition;
`
`3. whether the petitioner knew, or should have known, of the
`
`references newly asserted in the subsequent petition when the
`
`petitioner filed the prior petition, and the length of time from when the
`
`petitioner learned of the references newly asserted in the subsequent
`
`petition to when the subsequent petition was filed;
`
`4. whether the petitioner provided an adequate explanation for the
`
`time elapsed between filing the prior petition and the subsequent
`
`petition; and
`
`5. whether the subsequent petition weighs on the finite resources
`
`of the Board and the requirement, absent good cause, to issue a final
`
`determination not later than one year after the date on which the
`
`Director notices institution of review.
`
`See Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357
`
`(PTAB Sept. 6, 2017) (Paper 19, 15–16) (informative) (“Gen. Plastic”).
`
`7
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`
`In applying these factors, we consider not only the congressional
`
`intent that inter partes review proceedings provide an effective and efficient
`
`alternative to district court litigation, but also the potential for abuse of the
`
`review process through repeated attacks by the same petitioner with respect
`
`to the same patent. See Gen. Plastic, slip. op. at 16–17 (citing H.R. Rep.
`
`No. 112-98, pt.1, at 40 (2011)). We address each of these factors in turn, but
`
`note that not all the factors need to weigh against institution for us to
`
`exercise our discretion under § 314(a).
`
`Whether Petitioner Previously Filed a Petition Directed to the Same Claims
`of the Same Patent
`
`Petitioner challenged claims 1–4 of the ’608 patent in its prior petition
`
`in IPR-060. IPR-060 Petition, 46–75. In this case, Petitioner’s obviousness
`
`contentions based on Seguin, Lazarus, and Lawrence-Brown are also
`
`directed to claims 1–4 of the ’608 patent. Pet. 50–72. With regard to its
`
`anticipation challenge based on Haug in this case, Petitioner states that it:
`
`challenges five claims of the ’608 Patent not previously raised in
`any prior petition (Claims 5–9), and because a challenge to these
`dependent claims necessarily requires addressing the substance
`of independent Claim 1, the inclusion of previously-challenged
`Claims 1–4 in this new ground does not add meaningfully to the
`burden on the Board or Patent Owner.
`
`Pet. 6. As noted above, we instituted an inter partes review of each of the
`
`’608 patent claims challenged in IPR2017-00060. IPR-060 Institution
`
`Decision, 24. Petitioner offers no additional explanation for why it
`
`challenged five dependent claims in this case that it did not challenge in its
`
`prior petition. Thus, on the whole, the Petition substantially challenges the
`
`same claims as the prior petition filed in IPR-060, including the only
`
`independent claim of the ’608 patent – claim 1. Accordingly, this factor is
`
`8
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`either neutral or weighs against institution.
`
`Whether the Petition Was Filed after Petitioner Received Patent Owner’s
`Preliminary Response to the Prior Petition or the Board’s Institution
`Decision on the Prior Petition
`
`Patent Owner filed its preliminary response to the prior petition in
`
`IPR-060 on January 23, 2017. IPR-060, Paper 6. We issued our Decision
`
`on Institution addressing the prior petition in IPR-060 on March 29, 2017.
`
`IPR-060 Institution Decision. Accordingly, when Petitioner filed the
`
`Petition in this case on April 18, 2017, Petitioner had both Patent Owner’s
`
`preliminary response in IPR-060 and the Board’s Decision on whether to
`
`institute review addressing the prior petition in IPR-060. Thus, Petitioner
`
`not only had the relevant materials in IPR-060 from Patent Owner and the
`
`Board when it filed the Petition, but had ample time to take advantage of
`
`those materials in crafting its arguments in the Petition. Consequently, this
`
`factor weighs against institution.
`
`Whether Petitioner Knew, or Should Have Known, of the References
`Asserted in the Petition When It Filed the Prior Petition and the Length of
`Time Between Learning of the References and Filing the Petition
`
`Petitioner contends claims 1–9 of the ’608 patent are anticipated by
`
`Haug, the ’608 patent’s grandparent application, under the premise that the
`
`’608 patent may not claim priority to Haug because Haug fails to provide
`
`sufficient written description support for the claims of the ’608 patent.
`
`Pet. 1–6. Haug is expressly identified in the ’608 patent. Ex. 1101,
`
`References Cited. Thus, Petitioner knew, or should have known, of Haug
`
`when it filed the prior petition in IPR-060.
`
`Petitioner also contends claims 1–4 would have been obvious over
`
`Seguin, Lazarus, and Lawrence-Brown. Pet. 50–72. According to
`
`Petitioner, “Seguin is the primary reference” of this ground. Id. at 8.
`
`9
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`Petitioner states that it relied on Seguin in opposition proceedings before the
`
`European Patent Office in a filing dated June 23, 2016. Pet. 35 n.13;
`
`Ex. 1152, 1–2. Lazarus is also listed by Petitioner on the same European
`
`Patent Office filing. Ex. 1152, 2. Thus, the information provided
`
`demonstrates that Petitioner knew of Seguin and Lazarus when it filed the
`
`prior petition in IPR-060 on October 12, 2016. Similarly, a reference
`
`identified as “WO 03/03722 (‘Lawrence-Brown’)” is also listed by
`
`Petitioner on the same European Patent Office filing, though it is not certain
`
`from the record whether it is identical to Lawrence-Brown asserted in this
`
`case. Nevertheless, the information suggests Petitioner reasonably should
`
`have known about Lawrence-Brown when it filed the prior petition in
`
`IPR-060.
`
`Petitioner’s filing of the Petition on April 18, 2017, in this case
`
`reflects a delay in excess of six months from when the prior petition was
`
`filed in IPR-060. Accordingly, because Petitioner knew, or should have
`
`known, of the references it asserts in this case at the time it filed the prior
`
`petition in IPR-060, but waited over six months to file a second petition, this
`
`factor weighs against institution.
`
`Whether Petitioner Provided an Adequate Explanation for the Time Elapsed
`Between Filing the Petitions
`
`Petitioner argues that we should not exercise discretion to deny
`
`institution in this case because the Petition is distinct from the IPR-060
`
`Petition. Pet. 6–9. With regard to the anticipation contentions based on
`
`Haug in this case, Petitioner states that “the interests of justice and efficiency
`
`are best served by reaching these significant questions together for all
`
`claims.” Id. at 6. With regard to the obviousness contentions based on
`
`Seguin, Lazarus, and Lawrence-Brown, Petitioner states that its argument “is
`
`10
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`premised on claim construction positions asserted by Boston Scientific in a
`
`January 2017 trial in the United Kingdom involving a European counterpart
`
`patent to the ’608 Patent.” Pet. 7. Petitioner argues that Patent Owner’s
`
`arguments in the United Kingdom are contrary both to the position Patent
`
`Owner took during prosecution before the Office and to the Office’s
`
`conclusion during prosecution. Id. In response, Patent Owner argues that
`
`Petitioner mischaracterizes statements from the United Kingdom proceeding
`
`and that Petitioner’s reliance on arguments in foreign proceedings is
`
`improper. Prelim. Resp. 15–19.
`
`Petitioner does not provide a persuasive explanation for its decision
`
`not to assert Haug at the time Petitioner filed the IPR-060 Petition or its
`
`decision to wait over six months after filing the IPR-060 Petition before
`
`asserting Haug in a second petition in this case. Petitioner also offers no
`
`explanation for the time that elapsed from when it contends it learned of
`
`Patent Owner’s claim construction in the United Kingdom in January of
`
`2017 until the date it filed the Petition in April of 2017.
`
`We are not persuaded by Petitioner’s unsupported assertion that
`
`delaying proceedings six months would promote the interests of justice or
`
`efficiency. We also are not persuaded that statements made by Patent
`
`Owner in a foreign tribunal that are purportedly contrary to positions Patent
`
`Owner has taken in proceedings before the Office justify permitting
`
`Petitioner to wait to file a subsequent petition on references Petitioner knew,
`
`or should have known of, when the IPR-060 Petition was filed.
`
`Consequently, this factor also weighs against institution.
`
`11
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`Board Resources and Issuance of a Final Determination
`
`Analysis of “multiple, staggered petition filings” is, in general, “an
`
`inefficient use of the inter partes review process and the Board’s resources.”
`
`Gen. Plastic, slip. op. 21. Moreover, the final hearing in IPR-060 is
`
`scheduled for December 19, 2017, and it would be impractical to accelerate
`
`the schedule in the current proceeding, if instituted, to allow the two cases to
`
`be joined. See IPR-060, Paper 8, 8. Indeed, Petitioner’s proposed schedule
`
`were this case to be joined with IPR-060 seeks to delay the final hearing six
`
`months, until June 19, 2018. Paper 9. Thus, we consider this factor to favor
`
`non-institution.
`
`B.
`
`Conclusion
`
`For the reasons discussed above, we find that a majority of factors we
`
`consider in determining whether to exercise our discretion not to institute an
`
`inter partes review favor non-institution in this case. Thus, we exercise our
`
`discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) not to
`
`institute review with respect to claims 1–9 of the ’608 patent in this case.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that the Petition is denied as to all challenged claims of
`
`the ’608 patent, and no trial is instituted, and
`
`FURTHER ORDERED that Petitioner’s Motion for Joinder is denied
`
`as moot.
`
`
`
`
`
`12
`
`

`

`IPR2017-01293
`Patent 8,992,608 B2
`
`Patent Owner:
`
`Gregory Cordrey
`gcordrey@jmbm.com
`
`Brian Egan
`began@mnat.com
`
`Catherine Nyarady
`cnyarady@paulweiss.com
`
`
`Petitioner:
`
`Jennifer Sklenar
`Jennifer.sklenar@apks.com
`
`Wallace Wu
`Wallace.wu@apks.com
`
`
`
`
`13
`
`

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