Trials@uspto.gov
`§71-272-7822
`
`Paper 9
`Entered: February 24, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR,INC.,
`Petitioner,
`
`Vv.
`
`TELEFLEX LIFE SCEINCES LIMITED,
`Patent Owner.
`
`IPR2020-01344
`Patent RE46,116E
`
`Before SHERIDAN K. SNEDDEN, JAMESA. TARTAL,and
`CHRISTOPHER G. PAULRAJ,Administrative Patent Judges.
`
`TARTAL,Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 US.C. $ 314
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`I.
`
`INTRODUCTION
`
`Medtronic, Inc., and Medtronic Vascular, Inc. (“Petitioner”) filed a
`Petition pursuant to 35 U.S.C. §§ 311-319 requesting an inter partes review
`of claims 25—55 (“the Challenged Claims”) of U.S. Patent No. RE46,116 E
`(Ex. 1401, “the 116 patent”). Paper 1 (“Pet.”). Teleflex Life Sciences
`Limited (“Patent Owner”) filed a Preliminary Response. Paper 7 (“Prelim.
`
`Resp.”).
`
`Wehave authority to determine whetherto institute an inter partes
`
`review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter
`partes review may notbeinstituted “unless. .
`. the information presentedin
`the petition .
`.
`. shows that there is a reasonablelikelihoodthatthe petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the
`Preliminary Response, and the evidence of record, we conclude that the
`information presented showsa reasonable likelihood that Petitioner would
`prevail in showing the unpatentability of at least one of the Challenged
`Claims. Accordingly, we authorize an inter partes reviewto beinstituted as
`to the Challenged Claimsof the 116 patent on the groundsraised in the
`Petition. Our factual findings and conclusionsat this stage of the proceeding
`
`are based on the evidentiary record developed thus far (prior to Patent
`Owner’s Response). This is not a final decision as to patentability of claims
`for which inter partes review is instituted. Any final decision will be based
`
`on the record, as fully developed duringtrial.
`
`Il.
`
`A.
`
`BACKGROUND
`
`The ’116 Patent
`
`The °116 patent, titled “Coaxial Guide Catheter for Interventional
`Cardiology Procedures,” issued August 23, 2016, from Application
`
`2
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`No. 14/195,435, filed March 3, 2014. Ex. 1401, codes (21),(22), (45), (54).
`
`The °116 patent is a reissue of U.S. Patent No. 8,292,850 (“the ’850 patent”)
`from Application No. 13/359,059 (“the ’059 application”) filed on
`January 26, 2012, which the ’116 patentstates is a continuation of an
`
`application filed on November 1, 2013 (issued as U.S. Patent
`
`No. RE45,380), which is an application for the reissue of U.S. Patent
`
`No. 8,292,850, whichis a division of an application filed on June 28, 2010
`(issued as U.S. Patent No. 8,142,413), which is a division of an application
`filed on May 3, 2006 (issued as U.S. Patent No. 8,048,032). Id. codes (60),
`(64). The ’116 patent is directed to “methods and apparatusfor increasing
`backup support for catheters inserted into the coronary arteries from the
`
`aorta.” Jd. at 1:38—40.
`
`The °116 patent explains, as background,that in “[i]nterventional
`cardiology procedures,” guidewires or other instruments, such as balloon
`catheters and stents, are often inserted through guide catheters into coronary
`
`arteries that branch off from the aorta. Jd. at 1:44-50. In coronary artery
`
`disease, “the coronary arteries may be narrowed or occluded by
`
`atherosclerotic plaques or other lesions” in a phenomenon known as
`
`stenosis. Jd. at 1:50-54. In treating the stenosis, “a guide catheteris
`
`inserted through the aorta and into the ostium of the coronary artery,”
`sometimeswith the aid of a guidewire, and is passed beyondthe occlusion
`
`or stenosis. Jd. at 1:59-65. However, “[c]rossing tough lesions can create
`enough backward force to dislodge the guide catheter from the ostium of the
`artery being treated,” which can makeit difficult or impossible for the
`interventionalcardiologist to treat certain forms of coronary artery disease.
`
`Id. at 1:66—2:3.
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`The ’116 patent discusses four categories of previous “attempts to
`provide support to the guiding catheter to prevent backward dislodgement
`from the coronary ostium (referred to as ‘backup support’).” Jd. at 2:4—7.
`
`Onecategory of guiding catheters “are configured to draw backup support
`from engaging the wall of the aortic arch opposing the ostium of the
`coronary artery that is being accessed.” Jd. at 2:8-11. A second category
`are “guiding catheters that include a retractable appendage. Id. at 2:25—26.
`A third category are “guide catheters that have a portion that seeks to expand
`laterally to grip the interior wall of the ostium.” Jd. at 2:36-41. A fourth
`category, or “technique,” of the prior attempts “includes the placementofa
`smaller guide catheter within a larger guide catheter in order to provide
`added support for the crossing of lesionsor for the distal delivery of balloons
`and stents.” Jd. at 2:50-53. The ’116 patent states this fourth technique was
`
`described in Takahashi,’ which uses a guide catheter inserted “more deeply
`
`into the ostium of the coronaryartery than typically has been done before.”
`
`Id. at 2:53-62. The *116 patent states that such “deep seating”by this
`technique “creates the risk that the relatively stiff, fixed curve, guide catheter
`
`will damage the coronary artery.” Id. at 2:63-65.
`The °116 patent purports to resolve issues identified with the prior
`procedures by using “a coaxial guide catheter that is deliverable through
`standard guide catheters by utilizing a guidewire rail segment to permit
`delivery without blocking use of the guide catheter.” Ex. 1401, 3:20-23.
`Accordingto the ’116 patent, the coaxial guide catheter “preferably includes
`a tapered innercatheter that runs over a standard 0.014 inch coronary
`
`1 Saeko Takahashi, et al., New Method to Increase a Backup Support
`ofa 6 French Guiding Coronary Catheter, 63 CATHETERIZATION AND
`CARDIOVASCULAR INTERVENTIONS 452-456 (2004) (Ex. 1410, “Takahashi’’).
`
`4
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`guidewire to allow atraumatic placement within the coronary artery,” and
`this feature allows removal of the tapered inner catheter after the coaxial
`
`guide catheteris in place. Id. at 3:23—28.
`Figures 1 and 2, reproduced below, show a coaxial guide catheter and
`a tapered inner catheter in accordance with the invention described in
`
`the ’116 patent:
`
`Fig. 1
`
`1a~7” 43
`
`
`
`Fig. 2
`v 12
`
`Figure 1 is a schematic depiction of the coaxial guide catheter and tapered
`inner catheter separately, and Figure 2 depicts those two elements assembled
`together. Jd. at 5:51—-56; Figs. 1 and 2. As shownabove,“coaxial guide
`catheter assembly 10”includes coaxial guide catheter 12 and tapered inner
`catheter 14. Id. at 6:42-44. Coaxial guide catheter 12 includes tip
`
`portion 16, reinforced portion 18, and rigid portion 20. Id. at 6:45—46.
`Tapered inner catheter 14 “includes tapered inner catheter tip 42.” Id.
`at 7:26-27. Tapered inner catheter tip 42 includes tapered portion 46at a
`distal end thereof, and straight portion 48. Jd. at 7:30-31. Both tapered
`portion 46 andstraight portion 48 are pierced by lumen 50 (notlabeled in
`figures above). Jd. at 7:31-32. “Tapered inner catheter 14 mayalso include
`
`5
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`clip 54 at a proximal endthereofto releasably join tapered inner catheter 14
`to coaxial guide catheter 12.” Jd. at 7:35-37. “The tapered inner catheter
`provides a gradualtransition from the standard 0.014 inch diameter
`guidewireto the diameter of the coaxial guide catheter whichis typically
`five to eight French.” Jd. at 3:28-31. The coaxial guide catheter is made in
`at least three sizes corresponding to sizes commonly usedin interventional
`
`cardiology procedures. Id. at 3:39-42.
`Figure 4, reproduced below, showsa coaxial guide catheter in
`
`accordance with the invention described in the ’116 patent:
`
`
`
`Figure 4 is a sectional view of the coaxial guide catheter with tip portion 16
`depicted ontheleft side of the figure (rather than onthe right side as shown
`in Figures 1 and 2). Ex. 1401, 5:60; Fig. 4. As shown above, coaxial guide
`catheter 12 has a rigid portion 20, which “includesfirst full circumference
`portion 34, hemicylindrical portion 36, arcuate portion 38, and secondfull
`circumference portion 40” (second full circumference portion 40 is shownin
`
`Figure 3). Jd. at 7:7-10.
`In operation, a guide catheter and a guidewire are used along with the
`coaxial guide catheter and the tapered inner catheter. Ex. 1401, 8:20—22.
`Figure 8, reproduced below, showsthe operation of the coaxial guide
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`catheter assembly in accordance with the invention described in the °116
`
`patent:
`
`Figure 8 is a schematic view of a guide catheter and a guide wire in use with
`the coaxial guide catheter assembly within the aortic arch and coronary
`artery. Id. at 6:5-8; Fig. 8. First, guidewire 64 is inserted and passed
`through aortic arch 58 into ostium 60 of coronary artery 62. Id. at 7:65—-66.
`Guide catheter 56 is then passed over guidewire 64 until the distal end of
`guide catheter 56 is seated in ostium 60. Id. at 8:4-6. Next, coaxial guide
`catheter 12 with tapered inner catheter 14 is passed through guide
`catheter 56 and over guidewire 64 into coronary artery 62. Id. at 8:22—24.
`The presence of coaxial guide catheter 12 within guide catheter 56 “provides
`stiffer back up support than guide catheter 56 alone.” Id. at 8:38-40. “Once
`the coaxial guide catheter-tapered inner catheter combination has been
`inserted sufficiently into the ostium of the coronary artery to achieve deep
`seating the tapered inner catheter may be removed.” Id. at 4:58-62; see also
`id. at 8:30-32. Thereafter, coaxial guide catheter 12 can “accept a treatment
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`catheter such as a stent or a balloon catheter.” Id. at 8:33-34. “{T]he
`
`presence of coaxial guide catheter provides additional backup supportto
`makeit less likely that the coaxial guide catheter guide catheter combination
`will be dislodged from the ostium of the coronary artery while directing the
`coronary therapeutic device past a tough lesion.” Jd. at 5:2-5:6. “[T]he
`
`invention is deliverable through an existing hemostatic valve arrangement on
`a guide catheter without preventing injections through existing Y adapters.”
`
`Id. at 5:42-44.
`
`B.
`
`Illustrative Claim
`
`Petitioner challenges claims 25—55 of the °116 patent. Pet. 1.
`
`Claims 25, 43, 51, and 52 are independent. Ex. 1401, 13:62—14:25, 15:51—
`
`16:15, 16:53-18:10. Claims 26-42 and 44-50 depend from claim 25,
`claim 46 depends from claim 43, and claims 53-55 depend from claim 52.
`Id. at 14:62-18:26. Claim 25 is illustrative ofthe claimed subject matter and
`
`is reproduced below.
`
`25. A method, comprising:
`advancing a distal end of a guide catheter having a lumen through
`a main blood vesselto an ostium of a coronary artery;
`advancinga distal end of a guide extension catheter through, and
`beyond the distal end of, the guide catheter, including
`advancinga distal end portionof a tubular structure ofthe
`guide extension catheter beyondthedistal end ofthe guide
`catheter while a segment defining a side opening of the
`guide extension catheter remains within the guide catheter
`the side opening extending for a distance along a
`longitudinal axis of the guide extension catheter and
`accessible from a longitudinal side defined transverse to
`the longitudinalaxis, the tubular structure having a cross-
`sectional inner diameter that is not more than one French
`size smaller than a cross-sectional inner diameter of the
`lumen of the guide catheter;
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end
`of the guide catheter; and
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter
`advancing a balloon catheter or stent at
`least partially
`through the guide catheter and the guide extension catheter
`and into the coronary artery,
`including advancing the
`balloon catheter or stent
`through a hemostatic valve
`associated with a proximal end ofthe guide catheter, along
`a substantially rigid segment of the guide extension
`catheter, through the side opening, and through the tubular
`structure.
`
`Id. at 13:62—14:25.
`
`C.
`
` Asserted Grounds of Unpatentability
`
`Petitioner asserts that the Challenged Claims are unpatentable based
`
`on the following grounds:
`
`
`
`
`Claim(s)
`i
`Challenged
`
`25-40, 42, 44-48
`
`25-55
`
`45, 46
`
`
`
`
`
`
`
`
`References/Basis
`
`3
`
`3
`
`5
`U.S.C. §
`
`10
`
`3
`
`10
`
`10
`
`Kontos, Ressemann, Takahashi
`Kontos, Ressemann, Takahashi, Kataishi*
`Root?
`
`Kontos, Ressemann, Takahashi, Root
`
`Pet. 8.
`
`2 U.S. Patent No. 5,439,445, issued August 8, 1995 (Ex. 1409, “Kontos”).
`3 U.S. Patent No. 7,604,612 B2, issued October 20, 2009 (Ex. 1408,
`“Ressemann’’).
`4 US 2005/0015073 Al, published January 20, 2005 (Ex. 1425, “Kataishi”).
`5 US 2007/0260219 Al, published November8, 2007 (Ex. 1512, “Root”)
`(publication of App. No. 11/416,629 (Ex. 1500), filed May 3, 2006,issued
`as U.S. Patent No. 8,048,032).
`~
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`Petitioner relies on the supporting Declarations of Jon David
`
`Brecker, M.D., dated July 31, 2020 (Ex. 1405), and Richard A. Hillstead,
`
`Ph.D., dated July 30, 2020 (Ex. 1442).
`
`D.
`
`Related Proceedings
`
`Theparties identify the ’116 patent as a subject of: (1) Vascular
`Solutions LLC,et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.),
`
`and (2) OXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-01969
`
`(D. Minn.). Pet. 5; Paper 4, 2. Patent Ownerstates that both of these
`district court proceedings are currently stayed. Paper 4,2. The parties
`furtherstate that the ’116 patent is a reissue of the ’850 patent and that the
`
`’850 patent was previously the subject of: (1) Vascular Solutions, Inc. v.
`
`Boston Scientific Corp., No. 13-cv-01172 (D. Minn.), and (2) Boston
`
`Scientific Corp. v. Vascular Solutions, Inc. , 1PR2014-00762, IPR2014-
`
`00763 (PTAB, terminated). Pet. 5—6.
`
`Petitioner challenges claims 25—40, 42, 44-48, 52, and 53 of the
`
`°116 patent in IPR2020-01343 through anotherpetition filed concurrently
`with the Petition in this case, which we address further below. Pet. 6
`
`Additionally, Petitioner identifies the following patents related to
`the ’116 patentthat are the subject of inter partes review proceedings
`initiated by Petitioner: U.S. Patent Nos. 8,048,032 (IPR2020-00126;
`
`IPR2020-00127), RE45,830 ([PR2020-00128; IPR2020-00129; IPR2020-
`
`00130), RE45,760 (IPR2020-00132; IPR2020-00134), RE45,776 (IPR2020-
`00135; IPR2020-00136), RE47,379 (IPR2020-00137; IPR2020-00138), and
`
`8,142,413 (IPR2020-01341; IPR2020-01342). Id.
`
`E.
`
`Real Parties in Interest
`
`Petitioner identifies itself and Medtronic Vascular, Inc., as real
`
`parties in interest and notes “Medtronic ple is the ultimate parent of
`
`10
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`Medtronic, Inc.” Pet. 5. Patent Owneridentifies itself, Vascular Solutions
`
`LLC,Arrow International, Inc., and Teleflex LLC asreal parties in interest.
`
`Paper 4, 2. Patent Owner also notes “Teleflex Incorporatedis the ultimate
`
`parentofthe entities listed above.” Jd.
`
`il. ANALYSIS
`
`A.
`
`Discretionary Denial ofthe Petition Under 35 U.S.C. § 314(a)
`
`Patent Ownerargues weshould exercise our discretion
`
`under 35 U.S.C. § 314(a) to denyinstitution due to the commonissues being
`
`litigated in parallel district court cases. Prelim. Resp. 1-8. Patent Owner
`also argues we should exercise our discretion and deny institution because
`Petitioner has not justified multiple petitions challenging the ’116 patent. Id.
`
`at 7.
`
`1.
`
`Parallel Litigation
`
`Petitioner and Patent Ownerpresent arguments about ourdiscretion
`
`under 35 U.S.C. § 314(a). Pet. 13-14; Prelim. Resp. 5-8. Under 35 U.S.C.
`
`§ 314(a), the Director has discretion to deny institution of an inter partes
`review. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016)
`(“{T]he agency’s decision to denya petition is a matter committed to the
`Patent Office’s discretion.”’); SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356
`(2018) (“[Section] 314(a) invests the Director with discretion on the
`question whetherto institute review.” (emphasis omitted)); Harmonic v.
`Avid Tech., Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (“[T]he PTO is
`permitted, but never compelled,to institute an IPR proceeding.”).
`In determining whether to exercise discretion to denyinstitution
`
`under 35 U.S.C. § 314(a), the Board considers an earlytrial date in related
`litigation as part of an assessmentofall relevant circumstancesof the case,
`including the merits, in an effort to balance considerations such as system
`
`11
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`efficiency, fairness, and patent quality. Apple Inc. v. Fintiv, Inc., IPR2020-
`00019, Paper 11, 5-6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”); see
`also NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper8,
`19-20 (PTAB Sept. 12, 2018) (precedential) (denying institution relying, in
`part, on § 314(a) because the parallel district court proceeding was
`scheduledto finish before the Board reacheda final decision).
`
`In considering whetherto institute trial when there is a parallel, co-
`pendinglitigation, the Board evaluates the following factors (“Fintiv
`
`factors”):
`1. whether the court granted a stay or evidence exists that one
`maybe grantedif a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline fora final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
`4. overlap between issues raised in the petition and in the
`parallel proceeding;
`5. whether the petitioner and the defendant
`proceeding are the same party; and
`6. other circumstances that
`impact the Board’s exercise of
`discretion, including the merits.
`Fintiv, 5—6. In evaluating these factors, “the Board takes a holistic view of
`whetherefficiency and integrity of the system are best served by denying or
`instituting review.” Id. at 6. We have considered the circumstances and
`facts before us in view of the Fintiv factors and determinethat the
`
`in the parallel
`
`circumstances presented here weigh against exercising discretion under
`§ 314(a) to deny institution of inter partes review.
`Relevant to Fintiv factors 1 and 2, the parties acknowledgethat the
`
`parallel district court proceeding is stayed. Pet. 13; Prelim. Resp.1;
`
`12
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`Paper 4, 2. The granting of a stay pending inter partes review has weighed
`strongly against exercising discretion to deny institution asit is a strong
`indication that the district court has a preference to wait for the Board’s final
`
`resolution of the patentability issues raised in the petition before proceeding
`with the parallel litigation. See Fintiv at 6-7. Accordingly, consideration of
`the first and second Fintiv factors weighs strongly against exercising
`
`discretion to deny institution.
`
`Thethird Fintiv factor provides that a petitioner’s diligence or delay
`
`in filing a petition may be relevant. See Fintiv at 11-12. If the evidence
`shows that a petitioner filed its petition expeditiously, such as promptly after
`becoming aware ofthe claims being asserted, this fact has weighed against
`denying institution. See id. at 11 (citing Intel Corp. v. VLSI Tech. LLC,
`IPR2019-01192, Paper 15 at 12-13 (PTAB Jan.9, 2020); I/umina Inc. v.
`Natera, Inc., 1PR2019-01201, Paper 19 at 8 (PTAB Dec. 18, 2019)). If,
`
`however, the evidence showsthatthe petitioner did notfile its petition
`
`expeditiously, such as at or around the sametime that the patent owner
`respondedto the petitioner’s invalidity contentions, or evenif a petitioner
`cannot explain the delayin filing its petition, these facts have favored denial.
`See Fintiv at 11-12 (citing Next Caller, Inc. v. TRUSTID, Inc., IPR2019-
`
`00961, Paper 10 at 16 (PTAB Oct. 16, 2019)).
`
`Patent Ownerstates that Petitioner had “knowledge of the °116 patent
`
`since at least February 2019”andthatit “informed Petitionerof its plan to
`
`assert the °116 patent on January 24, 2020,” three weeks before Patent
`Ownerfiled its Amended Complaint. Prelim. Resp. 5—7. Patent Owner
`arguesthat Petitioner unjustifiably delayed filing the Petition until nine
`monthsafter Petitionerfiled petitions challenging related patents on similar
`art and arguments. Prelim. Resp. 5—6 (identifying the following proceedings
`
`13
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`betweenthe parties in which Kontos, Ressemann, Takahashi, and/or
`
`Kataishi are relied upon by Petitioner: IPR2020-00127 (Kontos and
`
`Takahashi), IPR2020-00129 (Ressemann, Takahashi, and Kataishi),
`
`IPR2020-00130 (Kontos and Takahashi), IPR2020-00131 (Kontos,
`
`Takahashi, and Kataishi), IPR2020-00133 (Ressemann, Takahashi, and
`
`Kataishi), IPR2020-00136 (Kontos, Ressemann, Takahashi, and Kataishi),
`
`IPR2020-00138 (Ressemann, Takahashi, and Kataishi)). Patent Owner
`
`argues that Petitioner’s “unjustified delay”in filing the Petition prejudices
`Patent Owner. Prelim. Resp. 7. In particular, Patent Owner contendsas
`
`follows:
`
`Petitioner has already relied on the present IPR petitions as a
`basis to seek an unprecedented extension of the one year
`statutory deadline in the eleven pending IPRs, even thoughit
`expressly and repeatedly relied on that one year deadline to
`convince the district court to stay the litigation.
`See, eg.,
`IPR20[20]-00126, Paper Nos. 56 and 61.
`If the present IPR
`petitions are granted, Petitioner will undoubtedly continue such
`delay tactics, such as by asking the district court to maintain the
`stay as to all patents in view of the present Petition.
`
`Prelim. Resp. 7-8.
`
`Petitioner explains the 9-month differencein its filing of the current
`
`Petition by noting as follows:
`
`WhenPetitioner filed IPR Petitions against related patents in
`Fall 2019, Patent Ownerhad notyet asserted the °116 patent. As
`a result, Petitioner did not file an IPR at that time. Then, on
`February 14, 2020, Patent Ownerfiled an Amended Complaint
`asserting the °116 patent. Ex-1514. Thereafter, Petitioner
`diligently prepared its IPRs andfiled this Petition roughly five
`months later and more than seven months before the statutory
`deadline.
`
`Pet. 14.
`
`14
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`We determine the evidence does not support a finding that the Petition
`
`wasfiled with delay. Rather, the filing of the Petition was timely and in
`
`response to Patent Owner’s Amended Complaint adding the °116 patent to
`the related litigation. We further find unsupported and not persuasive Patent
`Owner’s argument that “because Petitioner buried Itou and the otherpriorart
`
`it intendedto rely on in its August 2019 discovery response,”it was
`
`Petitioner’s fault Patent Owner amendedits complaint to add the ’116 patent
`
`whenit did. Prelim. Resp. 6-7. No persuasive evidence suggests Petitioner
`bears responsibility for Patent Owner’s knowledge of relevantpriorart or for
`Patent Owner’s determination of whether and when to amend its complaint.
`
`With respect to Fintiv Factor 4 (overlap of issues) and Fintiv Factor 5
`(whether the sameparties are involved), we find there is an overlap of issues
`and parties between the district court case and this proceeding. In Fintiv, the
`Board noted “‘if the petition includes the same or substantially the same
`claims, grounds, arguments, and evidence as presented in the parallel
`proceeding, this fact has favored denial.” Fintiv, 12. In this case, however,
`any concerns aboutinefficiency andthe possibility of conflicting decisions
`may be mitigated by the fact that the district court has stayedthe parallel
`litigation and thus will not reach the merits of Petitioner’s invalidity
`defenses before we issue ourfinal written decision.
`
`Furthermore, the district court’s stay of the litigation pending denial
`
`of institution or a final written decision allays concerns aboutinefficiency
`
`and duplication of efforts. Jd. To the contrary, exercising our discretionto
`deny the Petition would force inefficiency and the possibility of conflicting
`decisions because thedistrict court would then have to resolve similar and
`
`overlapping issues presented in the context of only the ’116 patent, one of
`
`15
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`several related patents being asserted by Patent Ownerin the related
`litigation.
`.
`Finally, under Fintiv Factor 6, we have taken into account the merits
`of Petitioner’s challenges, as discussed below,andfind this factor favors
`
`institution. Balancing all of the Fintiv factors, on this record, we determine
`
`the circumstances presented here weigh against exercising discretion under
`
`§ 314(a) to denyinstitution of inter partes review.
`
`2.
`
`Multiple Petitions
`
`Petitioner challenges claims 25-40, 42, 44-48, 52, and 53 of the
`°116 patent in IPR2020-01343 through anotherpetition filed concurrently
`with the Petition in this case. Pet. 6. In accordance with our Trial Practice
`
`Guide, Petitioner provides an explanation of material differences between
`the twopetitions and seeks consideration of the petition in IPR2020-01343
`prior to the Petition in this case. Paper 3. The petition in IPR2020-01343
`relies on Ressemann,Itou,° and Kataishi as the asserted priorart.
`
`Concurrent with this Decision we enter a decision instituting inter partes
`
`review in IPR2020-01343.
`
`Patent Ownerarguesthe Petition in this case “is merely a ‘backup’”
`
`that gives Petitioner “anotherbite at the apple,” which compoundsthe
`“inefficiency and unfairness that will result if any of Petitioner’s petitions
`are instituted.” Prelim Resp. 7. Patent Owner further argues Petitioner
`
`“made a deliberate choice .
`
`.
`
`. to rely on a §102(e) reference that Petitioner
`
`knew wasnotpriorart.” Id.
`
`The Board’s Trial Practice Guide addresses the situation where there
`
`are parallel petitions challenging the same patent, as here, and notes “[t]wo
`
`6 U.S. Patent No. 7,736,355 B2, issued June 15, 2010 (Ex. 1407, “Ttou”).
`
`16
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`or morepetitions filed against the samepatent at or about the same time
`(e.g., before the first preliminary response by the patent owner) mayplace a
`substantial and unnecessary burden on the Board and the patent owner and
`
`could raise fairness, timing, and efficiency concerns”andthat “multiple
`
`petitions by a petitioner are not necessary in the vast majority of cases.”
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(“Consolidated Practice Guide”) (Nov. 2019) 59; see also 84 Fed.
`Reg. 64,280 (Nov. 21, 2019). “Nonetheless, the Board recognizes that there
`may be circumstances in which more than onepetition may be necessary,
`including, for example, when the patent ownerhasasserted a large number
`of claims in litigation or whenthere is a dispute about priority date requiring
`
`arguments under multiple prior art references.” Id.
`Petitioner states that Itou is the primary reference in IPR2020-01343
`_andthat “Petitioner[] anticipate[s] that Patent Owner may allege that the
`’116 Patent inventors conceived of and reduced to practice the underlying
`
`invention”priorto the priority date of Itou. Paper 3, 2. Petitioner argues the
`Board previously instituted inter partes review of a related patent in
`proceedings betweenthe parties based on two petitions in IPR2020-00135
`and IPR2020-00136 under the samecircumstances presentedin this
`
`proceeding. Jd. at 2-3. Petitioner argues “twopetitionsare justified” for the
`samereasonshere, including because of the length and numberof claims
`
`asserted by Patent Ownerin district court. Jd. at 4—5.
`
`Wehaveconsidered the respective arguments of the parties and
`
`determine the circumstancesin this case support declining to exercise our
`
`discretion under § 314(a) to deny the Petition for substantially the same
`
`reasonsset forth in IPR2020-00136. In that case, the Board declined to deny
`
`institution of a secondpetition between theparties, explaining as follows:
`
`17
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`Given the possibility that we may determine that Itou does not
`qualify as priorart after fully considering Patent Owner’s priority
`date arguments, we determine that Petitioner provides a
`sufficient explanation as to why it was necessary to rely upon the
`obviousness challenges presented here asan alternative basis for
`unpatentability.
`Indeed,
`this
`is precisely one of
`the
`circumstances recognized in our Trial Practice Guide “in which
`more than one petition may be necessary.” Consolidated Practice
`Guide at 59.
`Moreover, wefind that the challenges presented in the two
`petitions are not excessive or duplicative. Although Petitioner
`challenges the same claims in each petition, the prior art and
`issues to be decided do notsignificantly overlap with each other.
`For instance, the obviousness challenges presented here require
`an assessment of the motivation to combine the teachings of
`Kontos and Ressemann, reasonable expectation of success, and
`secondary considerations that are not relevant to the anticipation
`challenge presented in [the related case challenging the same
`patent]. And although there were also obviousness challenges
`presented in the first petition that relied upon Ressemann or
`Kataishi for certain additional claims, the manner in which those
`references are relied upon in combination with Kontos in this
`second Petition is different. Finally, given the number and length
`of the 26 challenged claims (including 3 independent claims),
`which are
`all potentially the basis
`for Patent Owner’s
`infringement allegations in the parallel
`litigation, and the
`complexity ofthe arguments that have beenraised by bothparties
`for each challenge, we determine that it was appropriate for
`Petitioner to rely upon multiple petitions for its alternative
`challenges in light of the word countlimits for each petition.
`Medtronic, Inc. and Medtronic Vascular, Inc. v. Teleflex Innovations
`
`S.A.R.L., IPR2020-00136, Paper 20, 39-40 (PTAB June 26, 2020).
`Accordingly, for the same reasons, we decline to exercise our discretion
`under§ 314(a) in this proceedingto deny institution based on the multiple
`
`petitions challenging the ’116 patent.
`
`18
`
`

`

`IPR2020-01344
`Patent RE46,116E
`
`B.
`
`Legal Standards
`
`A claim is anticipated if a single prior art reference either expressly or
`inherently discloses every limitation of the claim. Orion IP, LLC v. Hyundai
`Motor Am., 605 F.3d 967, 975 (Fed. Cir. 2010). ‘A single prior art reference
`mayanticipate withoutdisclosing a feature of the claimed inventionif
`such feature is necessarily present, or inherent, in that reference.”
`Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014) (citing
`Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003)).
`A patent claim is unpatentable under 35 U.S.C. § 103’ if the
`differences between the claimed subject matter andthe prior art are such
`
`that the subject matter, as a whole, would have been obviousat the time the
`invention was madeto a person having ordinary skill in the art to which
`
`said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 US. 398,
`406 (2007). In Graham vy. John Deere Co., 383 U.S. 1 (1966), the
`Supreme Court set out a framework for assessing obviousness under § 103
`that requires consideration of four factors: (1) the “level of ordinary skill
`in the pertinentart,” (2) the “scope and content ofthe priorart,” (3) the
`“differences between thepriorart and the claimsat issue,”
`and (4) “secondary considerations” of nonobviousnesssuchas “commercial
`success,long felt but unsolved needs, failure of others, etc.” Jd. at 17-18;
`KSR, 550 U.S. at 407. At this stage of the proceeding, neither party presents
`
`7 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112-29, 125 Stat. 284 (2011) took effect on March 16, 2013.
`Becausethe application that issued as the ’116 patent states that its priority
`application wasfiled before March 16, 2013, we apply the pre-AIA versions
`of these statutes. See 35 U.S.C. § 100(i).
`
`19
`
`

`

`IPR2020-01344
`Patent RE46,116 E
`
`evidence directed to secondary considerations. See Pet. 76-77; see also
`
`generally Prelim. Resp.
`
`C.
`
`Level of Ordinary Skill in the Art
`
`In determiningthe level of ordinary skill in the art, various factors
`may be considered, including the “type of problems encounteredin the art;
`prior art solutions to those problems; rapidity with which innovationsare
`made;sophistication of the technology; and educationallevel of active
`
`workersin the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed.
`
`Cir. 1995) (citation omitted). Petitioner contends a person of ordinary skill
`
`in the art at the time of the invention would have “(a) a medical
`
`degree, (b) completed a coronary intervention training program,
`
`and (c