Filed May 9, 2025
`
`On behalf of Imperative Care, Inc.
`By:
`Joshua J. Stowell (Reg. No. 64,096)
`Joseph R. Re (Reg. No. 31,291)
`Brian C. Barnes (Reg. No. 75,805)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxImperative291@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`IMPERATIVE CARE, INC.,
`Petitioner,
`
`v.
`
`INARI MEDICAL, INC.,
`Patent Owner.
`__________________________________
`
`Case No. IPR2025-00989
`Patent No. 11,865,291
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. PATENT NO. 11,865,291
`
`
`
`On behalf of Imperative Care, Inc.
`By:
`Joshua J. Stowell (Reg. No. 64,096)
`Joseph R. Re (Reg. No. 31,291)
`Brian C. Barnes (Reg. No. 75,805)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`Email: BoxImperative291@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`IMPERATIVE CARE, INC.,
`Petitioner,
`
`v.
`
`INARI MEDICAL, INC.,
`Patent Owner.
`__________________________________
`
`Case No. IPR2025-00989
`Patent No. 11,865,291
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. PATENT NO. 11,865,291
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION .................................................................................... 1
`
`II. THE ’291 PATENT .................................................................................. 9
`
`A. Overview ........................................................................................ 9
`
`B.
`
`Prosecution History ...................................................................... 15
`
`C.
`
`The Earliest Possible Priority Date .............................................. 15
`
`III. LEVEL OF ORDINARY SKILL ........................................................... 15
`
`IV. CLAIM CONSTRUCTION ................................................................... 16
`
`1.
`
`2.
`
`3.
`
`Support for Petitioner’s Construction of “Filament” ......... 17
`
`The Board’s Prior Analysis of PO’s Attempt to Limit
`Claims to “Flexible” Filaments .......................................... 19
`
`The ’291 Patent Claims Are Not Limited To
`“Flexible” Filaments .......................................................... 21
`
`V. STATEMENT OF RELIEF REQUESTED ........................................... 26
`
`A.
`
`IPR Grounds ................................................................................. 26
`
`B.
`
`The Asserted References Are Prior Art ....................................... 27
`
`C.
`
`The Asserted References Are Analogous Art .............................. 27
`
`VI. GROUNDS 1-4: CLAIMS 1-8 AND 12-17, AND 19
`ANTICIPATED BY SCHAFFER OR OBVIOUS OVER
`SCHAFFER ALONE OR IN COMBINATION WITH
`HARTLEY OR ELLER .......................................................................... 27
`
`A.
`
`Claim 1 ......................................................................................... 30
`
`i
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Preamble ............................................................................. 31
`
`Support ............................................................................... 31
`
`Actuator .............................................................................. 35
`
`Collapsible Tubular Sidewall ............................................. 37
`
`Filament ............................................................................. 39
`
`a.
`
`b.
`
`c.
`
`Schaffer .................................................................... 40
`
`Hartley ..................................................................... 49
`
`Eller .......................................................................... 55
`
`6.
`
`Spring ................................................................................. 62
`
`B.
`
`Claim 2 ......................................................................................... 65
`
`C.
`
`Claim 3 ......................................................................................... 67
`
`D.
`
`Claim 4 ......................................................................................... 70
`
`1.
`
`2.
`
`Schaffer-Hartley ................................................................. 71
`
`Schaffer-Eller ..................................................................... 72
`
`E.
`
`Claim 5 ......................................................................................... 73
`
`F.
`
`Claim 6 ......................................................................................... 77
`
`G.
`
`Claim 7 ......................................................................................... 78
`
`H.
`
`Claim 8 ......................................................................................... 78
`
`ii
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`I.
`
`J.
`
`Claim 12 ....................................................................................... 79
`
`Claim 13 ....................................................................................... 81
`
`K.
`
`Claim 14 ....................................................................................... 82
`
`L.
`
`Claim 15 ....................................................................................... 82
`
`M. Claim 16 ....................................................................................... 85
`
`N.
`
`Claim 17 ....................................................................................... 86
`
`O.
`
`Claim 19 ....................................................................................... 87
`
`VII. GROUNDS 5-7: CLAIMS 18-19 OBVIOUS OVER GARRISON
`COMBINED WITH SCHAFFER AND OPTIONALLY
`HARTLEY OR ELLER .......................................................................... 90
`
`A.
`
`Claim 18 ....................................................................................... 90
`
`1.
`
`2.
`
`3.
`
`Preamble ............................................................................. 90
`
`Aspiration Catheter ............................................................ 91
`
`Hemostasis Valve ............................................................... 92
`
`a.
`
`b.
`
`c.
`
`d.
`
`Support and Actuator ............................................... 95
`
`Tubular Sidewall ...................................................... 95
`
`Filament ................................................................... 96
`
`Spring ....................................................................... 96
`
`B.
`
`Claim 19 ....................................................................................... 96
`
`iii
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`VIII. SECONDARY CONSIDERATIONS .................................................... 97
`
`IX. SOTERA STIPULATION ....................................................................... 97
`
`X. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT ........................................................................... 97
`
`A.
`
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) .......................... 97
`
`B.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ...................................... 97
`
`C.
`
`Lead and Backup Counsel (37 C.F.R. §42.8(b)(3)) ..................... 99
`
`D.
`
`Service Information (37 C.F.R. §42.8(b)(4)) ............................... 99
`
`E.
`
`Grounds for Standing (37 C.F.R. §42.104) ................................ 100
`
`F.
`
`Payment of Fees (37 C.F.R. §42.15(a)) ..................................... 100
`
`XI. CONCLUSION ..................................................................................... 100
`
`
`
`
`
`iv
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ...................................... 97
`
`Bardford Co. v. Conteyor N. Am., Inc.,
`603 F.3d 1262 (Fed. Cir. 2010) ................................................................... 22
`
`Biagro W. Sales, Inc. v. Grow More, Inc.,
`423 F.3d 1296 (Fed. Cir. 2005) ................................................................... 45
`
`Fitbit, Inc. v. Valencell, Inc.,
`964 F.3d 1112 (Fed. Cir. 2020) ................................................................... 88
`
`Imperative Care, Inc. v. Inari Medical, Inc.,
`IPR2025-00289, Paper 5 .............................................................................. 25
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,
`381 F.3d 1111 (Fed. Cir. 2004) ............................................................. 25, 26
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ................................................................... 51, 52, 58, 94
`
`Nautilus, Inc. v. BiosigInstruments, Inc.,
`572 U.S. 898 (2014) ............................................................................... 21, 34
`
`In re Nilssen,
`851 F.2d 1401 (Fed. Cir. 1988) ................................................................... 27
`
`Ortho-McNeil Pharm., Inc. v. Mylan Lab’ys., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) ................................................................... 22
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ................................................... 16
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) ....................................................... 19, 30, 35
`
`v
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Ruckus Wireless, Inc. v. Innovative Wireless Sols., LLC,
`824 F.3d 999 (Fed. Cir. 2016) ..................................................................... 21
`
`SanDisk Corp. v. Kingston Tech. Co., Inc.,
`695 F.3d 1348 (Fed. Cir. 2012) ................................................................... 45
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ..................................................................... 27
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ..................................................................... 17
`
`OTHER AUTHORITIES
`
`35 U.S.C. §102 ...................................................................................... 26, 27, 30
`
`35 U.S.C. §103 ............................................................................................ 26, 30
`
`35 U.S.C. §112 .................................................................................................. 45
`
`37 C.F.R. §1.11 ................................................................................................... 5
`
`37 C.F.R. §42.100 ............................................................................................. 16
`
`
`
`
`
`vi
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
` U.S. Patent No. 11,865,291 (“the ’291 patent”)
`
`1002
`
`Prosecution History of the ’291 Patent
`
`1003
`
`Expert Declaration of Troy Thornton
`
`1004
`
`Resume of Troy Thornton
`
`1005
`
`1006
`
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`
`U.S. Patent Publication US 2003/0116731 A1 to Hartley
`(“Hartley”)
`
`1007
`
`U.S. Patent No. 9,980,813 B1 to Eller (“Eller”)
`
`1008
`
`Certified File History of U.S. Patent Application 10/371,190
`(Schaffer File History)
`
`1009
`
`U.S. Patent No. 5,429,616 to Schaffer (“Schaffer ’616”)
`
`1010
`
`RESERVED
`
`1011
`
`U.S. Patent Publication US 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`1012
`
`U.S. Patent No. 11,697,011 (“the ’011 patent”)
`
`1013
`
`Inari’s Supplemental Infringement Contentions (without claim
`charts) from Inari Medical, Inc. v. Imperative Care, Inc., No. 24-
`cv-3117 (N.D. Cal.) (served February 7, 2025).
`
`1014
`
`New Oxford American Dictionary, 3rd ed. (2010) – definitions of
`“diameter,” “filament,” and “loop”
`
`1015
`
`RESERVED
`
`1016
`
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`Exhibit List, Page 1
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`1017
`
`Description
`
`Decision Granting Institution of Inter Partes Review for U.S.
`Patent No. 11,697,011 (Paper 7) in Imperative Care, Inc. v. Inari
`Medical, Inc., IPR2024-01157 (P.T.A.B. Jan. 23, 2025)
`
`1018
`
`PCT Patent Publication WO 2018/019829 A1 to Brady et al.
`
`1019
`
`Inari’s Notice of Motion and Motion for Leave to File Third
`Amended Complaint (Dkt. #88) in Inari Medical, Inc. v. Imperative
`Care, Inc., 24-cv-03117-EKL (N.D. Cal.) (filed March 5, 2025)
`
`1020
`
`U.S. Patent No. 6,776,770 B2 to Trerotola
`
`1021
`
`Case Management & Scheduling Order (Dkt. #54) in Inari
`Medical, Inc. v. Imperative Care, Inc., 24-cv-03117-EKL (N.D.
`Cal.) (issued December 19, 2024)
`
`1022
`
`U.S. Patent No. 11,697,012 B2 (“the ’012 patent”)
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`Decision Granting Institution of Inter Partes Review for U.S.
`Patent No. 11,697,012 (Paper 6) in Imperative Care, Inc. v. Inari
`Medical, Inc., IPR2025-00156 (P.T.A.B. Apr. 22, 2025)
`
`Imperative Care’s Opposition to Inari’s Motion for Leave to File
`Third Amended Complaint (Dkt. #98) in Inari Medical, Inc. v.
`Imperative Care, Inc., 24-cv-03117-EKL (N.D. Cal.) (filed March
`26, 2025)
`
`Imperative Care’s Notice of Motion and Motion to Stay Pending
`Inter Partes Review (Dkt. #100) in Inari Medical, Inc. v.
`Imperative Care, Inc., 24-cv-03117-EKL (N.D. Cal.) (filed April 2,
`2025)
`
`Patent Owner’s Exhibit 2002 filed in Imperative Care, Inc. v. Inari
`Medical, Inc., IPR2025-00289 (P.T.A.B.)
`
`Claim Construction Excerpt Report of Troy Thornton in Inari
`Medical, Inc. v. Imperative Care, Inc., 24-cv-03117-EKL (N.D.
`Cal.)
`
`
`
`Exhibit List, Page 2
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of claims 1-8, and 12-19 (“the challenged claims”) of U.S. Patent No.
`
`11,865,291 (“the ’291 patent,” Ex. 1001), which is assigned to Inari Medical, Inc.
`
`(“Patent Owner” or “PO”).
`
`I. INTRODUCTION
`
`Patent Owner has asserted claims 1-8, 12-17, and 19 against Petitioner in the
`
`co-pending district court litigation (the “Litigation”). See Ex. 1013 (PO’s
`
`infringement contentions). The Litigation is in its early stages and no trial date has
`
`been set. (See Ex. 1019 at 2 (representing to Court that “discovery is at an early
`
`stage); Ex. 1021 (setting case schedule to claim construction).) Therefore, Petitioner
`
`challenges the patentability of those asserted claims, and the claims from which they
`
`may1 depend, in this IPR.
`
`Additionally, the challenged ’291 patent is a divisional of U.S. Patent No.
`
`11,697,011 (“the ’011 patent,” Ex. 1012) and the parent of U.S. Patent No.
`
`11,697,012 (“the ’012 patent,” Ex. 1022). The Board instituted Petitioner’s IPRs
`
`challenging the patentability of the ’011 and ’012 patents. (Ex. 1017; Ex. 1023.) In
`
`the institution decisions, the Board preliminarily addressed claim limitations similar
`
`to those found in the ’291 patent.
`
`
`1 Claim 19 includes an error so it is not clear whether the claim depends from claim
`1 or claim 18. Infra §VI.O.
`
`1
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`The challenged claims in the ’291 patent describe a known type of
`
`“hemostasis valve” for sealing medical devices. Many medical procedures require
`
`physicians to insert tubes, such as catheters, into a patient’s vascular system.
`
`However, once the catheter is placed inside the patient’s vasculature, the catheter
`
`fills with blood. If the end of the catheter nearest the physician is not sealed, blood
`
`can leak out of the catheter and into the operating room. Decades ago, medical
`
`device companies developed hemostasis valves to seal the end of catheters and
`
`minimize blood loss during such procedures.
`
`The challenged claims describe a hemostasis valve that includes a “collapsible
`
`tubular sidewall defining a lumen.” The term “collapsible tubular sidewall” does
`
`not appear in the ’291 patent specification and, therefore, it is not specifically
`
`identified in any figures. Rather, the specification describes hemostasis valves
`
`having an “elongate member 132” or “tubular member 132” with a “central lumen
`
`138”:2
`
`
`2 Petitioner added all colors and annotations except where otherwise noted.
`
`2
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Ex. 1001, 7:11-45, Fig. 2.) The specification explains that the “elongate member
`
`132 can comprise a compliant tubular structure” that “can facilitate the collapse” of
`
`the elongate member 132. (Id., 7:17-31.)
`
`The claimed hemostasis valve also includes an “actuator” having a “first
`
`member” (i.e., a button) and a “filament formed in a loop around the tubular
`
`sidewall” and connected to the button. The specification explains that when tension
`
`is applied to the ends of the filament, the filament constricts the elongate member,
`
`collapsing and sealing the lumen of the tubular member. The filament can have a
`
`variety of configurations, as shown below.
`
`
`
`3
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`(Id., Figs. 6-8.)
`
`The claimed hemostasis valve also includes a “spring” that moves the first
`
`member (i.e., button) in a direction that pulls on the filament to reduce the diameter
`
`of the filament loop. (Id., 8:38-56, Fig. 2.) In Figure 2, springs 148-A and 148-B
`
`move the actuator buttons to close the valve. (Id.)
`
`
`
`Hemostasis valves having a filament looped around a collapsible tube and
`
`springs to move a button to close a valve were well known before September 6, 2017,
`
`the earliest claimed priority date for the ’291 patent. Schaffer, a patent application
`
`published in 2003, describes hemostasis valves for use with catheters during
`
`intravascular procedures. (Ex. 1005, [0002], [0008].) Schaffer was not before the
`
`Examiner during prosecution of the ’291 patent. Like the claimed valves, Schaffer’s
`
`4
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`hemostasis valve includes opposing actuator buttons attached to springs that apply
`
`or release tension on a filament (e.g., actuating members) to collapse a tube (e.g.,
`
`seal module) within the valve:
`
`(Id., Fig. 32.)3 As shown below, Schaffer’s valve has the same components, in the
`
`same arrangement, as the valve claimed in the ’291 patent. Thus, Schaffer
`
`anticipates or renders obvious the challenged claims.
`
`
`
`
`3 Petitioner uses the versions of Schaffer’s drawings submitted during prosecution
`on June 18, 2003 (Ex. 1008) because they are clearer. The drawings became publicly
`available when Schaffer published on December 4, 2003. 37 C.F.R. §1.11.
`
`5
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`Schaffer also renders the challenged claims obvious in combination with the
`
`“filaments” described in Hartley or Eller. In the IPR institution decisions for both
`
`the ’011 patent and ’012 patent, the Board found a reasonable likelihood that
`
`Petitioner will prevail in showing that at least claim 1 of the challenged patents
`
`unpatentable based on the combination of Schaffer and Hartley. (Ex. 1017, 35, 41;
`
`Ex. 1023, 48.) Notably, claim 1 of the ’011 and ’012 patents includes similar
`
`limitations to those in independent claims 1 and 18 of the ’291 patent.
`
`Hartley, a patent application published in 2003, describes a hemostasis valve
`
`having a filament that constricts the lumen of an elongate member:
`
`6
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Ex. 1006, [0031], Fig. 1.) Hartley’s filament is attached to a “rotary actuator” that
`
`applies tension to the filament. Rotation of the rotary actuator in one direction
`
`constricts the lumen while rotation in the opposite direction opens the lumen.
`
`Eller, a patent published in 2015, discloses a rotatable hemostasis valve like
`
`the valve disclosed in Hartley. Eller’s hemostasis valve also includes a filament that
`
`loops around a collapsible sleeve to constrict the lumen of the sleeve:
`
`7
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`(Ex. 1007, 5:1-12, Fig. 2.)
`
`
`
`
`
`If Schaffer does not disclose the “filament” required by the challenged claims,
`
`a person of ordinary skill in the art (“POSITA”) would have found it obvious to
`
`replace Schaffer’s actuating members with the filaments in Hartley or Eller for the
`
`reasons discussed herein. As discussed above, the Board preliminarily addressed
`
`the combination of Schaffer with Hartley’s or Eller’s filaments in the institution
`
`decisions for the ’011 patent and ’012 patent IPRs. (Ex. 1017, 33-41; Ex. 1023, 34-
`
`48.) The Board found that “Petitioner advances multiple reasons why the skilled
`
`artisan would have been motivated to combine Schaffer and Hartley with a
`
`reasonable expectation of success.” (Ex. 1017, 36; see also Ex. 1023, 38 (“We find
`
`8
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Petitioner’s argument and evidence summarized above sufficient, at this stage, to
`
`support the rationale for modifying Schaffer in view of Hartley as proposed with a
`
`reasonable expectation of success ….”).)
`
`For the reasons presented herein, Petitioner has demonstrated a reasonable
`
`likelihood that at least one claim of the ’291 patent is unpatentable. Accordingly,
`
`Petitioner requests that the Board institute this IPR to review the patentability of the
`
`’291 patent.
`
`A. Overview
`
`II. THE ’291 PATENT
`
`The ’291 patent describes hemostasis (or “garrote”) valves for use during
`
`minimally invasive intravascular procedures. (Ex. 1001, 5:55-6:6.) The hemostasis
`
`valve is used with a catheter inserted into the patient’s vasculature to provide a seal.
`
`(Id., 1:41-1:44.) The ’291 patent states that the hemostasis valve “can seal with or
`
`without a tool extending through the valve.” (Id., 5:56-5:58.)
`
`The described valve includes a “housing 128” that defines an “interior channel
`
`130,” and a collapsible “elongate member 132” that extends through the housing:
`
`9
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., 6:56-7:31, Fig. 2.) The elongate member 132 has a “thin-walled compliant
`
`tubular structure” that helps facilitate “the uniform collapse of the elongate member
`
`132 and the sealing of the elongate member 132”. (Id., 7:17-23.)
`
`The valve also includes a “constricting mechanism 141,” which can “collapse
`
`and seal the elongate member 132 via compression and/or constriction, and
`
`specifically via constriction with at least one filament 150”:
`
`
`
`10
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., 8:5-8, Figs. 1, 2.) The constricting mechanism includes “an actuator 142 which
`
`can be a manual actuator such as one or several buttons 144; and the at least one
`
`filament 150 that can extend at least partially around the elongate member 132.”
`
`(Id., 8:5-12.) The “filament 150 can be coupled to the actuator 142 such that the
`
`filament 150 selectively constricts, collapses, and/or seals the elongate member
`
`132 … based on the movement and/or position of the actuator 142.” (Id., 9:24-28.)
`
`The valve also includes a “bias feature,” such as a spring (148-A and 148-B),
`
`which biases the actuator toward the open or closed configuration. (Id., 8:38-56.)
`
`In Figure 4, springs 148-A and 148-B bias the valve toward the closed configuration:
`
`11
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`(Id., 8:38-56, Fig. 4.) Depressing the actuator buttons releases the tension on the
`
`filament, “thereby allowing the expansion of the elongate member 132 and the
`
`unsealing of the central lumen 138 of the elongate member 132”:
`
`
`
`(Id., 9:44-62, Fig. 3.)
`
`12
`
`
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`The filament can constrict the elongate member around a tool inserted through
`
`the central lumen of the elongate member, “create[ing] a seal between the elongate
`
`member 132 and the tool,” as illustrated in Figure 4:
`
`
`
`(Id., 12:4-12:15, Fig. 4.)
`
`The “filament 150 can be arranged in a variety of configurations” including a
`
`“single loop 604 that can extend around the elongate member 132” as shown in
`
`Figure 6, multiple loops as shown in Figure 7, or a “U-shaped section between the
`
`two ends of the filament 150” as shown in Figures 8 and 9:
`
`13
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., 13:17-14:34, Figs. 6-9.) The patent also discloses that “[t]he filament can be
`
`made from a variety of materials including, for example, a polymer, a synthetic,
`
`and/or a metal.” (Id., 9:13-15.) The filament may also “comprise multiple
`
`filaments,” such as in Figures 7-9, where “each of the multiple filaments can have a
`
`first end 700 and a second end 702.”:
`
`(Id., 12:61-67, Fig. 8.)
`
`14
`
`
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`B.
`
`Prosecution History
`
`The Examiner of the ’291 patent did not issue any office actions and did not
`
`make any prior-art based rejections. In the Notice of Allowance, the Examiner stated
`
`that Hartley (Ex. 1006) was the “closest prior art of record.” (Ex. 1002, 393.) The
`
`Examiner found that Hartley disclosed every limitation of the independent claims
`
`except a spring that “perform[s] a function required in the claimed invention, i.e. the
`
`spring configured to move the first member in a direction that pulls the first end
`
`portion away from the tubular sidewall, reducing a diameter of the lumen in response
`
`to reducing a diameter of the loop.” (Id., 393-394.) The Examiner did not address
`
`the combination of any references.
`
`C. The Earliest Possible Priority Date
`
`The ’291 patent claims priority to provisional application No. 62/554,931,
`
`filed September 6, 2017, which is the earliest possible priority date for the ’291
`
`patent. (Ex. 1001.) Petitioner applies this earliest priority date in this Petition;
`
`however, Petitioner reserves its right to challenge the priority date in subsequent
`
`proceeding(s).
`
`III. LEVEL OF ORDINARY SKILL
`
`A POSITA in September 2017 would have had an undergraduate degree in
`
`mechanical engineering or a related engineering discipline and 2-4 years of product
`
`design or engineering experience. (Ex. 1003, ¶36.) This is the same level of ordinary
`
`15
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`skill that Petitioner proposed in the ’011 and ’012 patent IPRs and that was applied
`
`by PO and the Board. (Ex. 1017, 11; Ex. 1023, 11.)
`
`IV. CLAIM CONSTRUCTION
`
`The claim terms should receive their ordinary and customary meaning as
`
`understood by a POSITA at the time of filing and in accordance with the
`
`specification and the prosecution history. 37 C.F.R. §42.100(b); see Phillips v. AWH
`
`Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). However, “the specification may
`
`reveal a special definition given to a claim term by the patentee that differs from the
`
`meaning it would otherwise possess [and] [i]n such cases, the inventor's
`
`lexicography governs.” Id. at 1316.
`
`The challenged claims require a hemostasis valve having a “filament.” A
`
`POSITA would have understood the term “filament” in the ’291 patent to mean at
`
`least “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes”
`
`based on the intrinsic record. (Ex. 1003, ¶¶50-72.) This is the same construction of
`
`“filament” that Petitioner proposed in the ’011 and ’012 patent IPRs. (Ex. 1017, 12;
`
`Ex. 1023, 14.)
`
`In those prior IPRs, PO argued that Petitioner’s construction was incomplete
`
`because it did not limit the claims to “flexible” filaments. (Ex. 1023, 21, n.13.) PO
`
`also sought to import other limitations into the construction of “filament” (e.g.,
`
`“thin”). (Id., 14.) Importantly, however, the construction of “filament” potentially
`
`16
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`impacts only whether Schaffer anticipates the claims or renders them obvious. (Ex.
`
`1023, 21, n.13.) The construction does not impact whether Schaffer in combination
`
`with Hartley or Eller renders the claims obvious because PO “does not dispute that
`
`Hartley and/or Eller disclose a flexible filament (e.g., flexible string or flexible
`
`wire).” (Id.)
`
`1.
`
`Support for Petitioner’s Construction of “Filament”
`
`Petitioner’s construction of “filament” is supported by the intrinsic record.
`
`Claim construction generally begins with the claim language. Vitronics Corp. v.
`
`Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, however, the claims
`
`provide little information regarding the structure forming the “filament.” For
`
`example, claim 1 recites “a filament formed in a loop around the tubular sidewall,
`
`the filament having at least a first end portion extending away from the loop to the
`
`first member.” Dependent claim 3 adds that the filament can optionally include a
`
`second end portion extending away from the loop to a second member. Dependent
`
`claim 4 adds that “the first end portion, the loop, and the second end portion are one
`
`continuous filament.” While the dependent claims identify some optional features
`
`of a filament, they do not define the scope of structures that comprise the “filament”
`
`in claim 1.
`
`However, the ’291 patent specification (like the ’011 patent) identifies express
`
`examples of “filaments.” The ’291 patent states, “the filament 150 can comprise one
`
`17
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`or several threads, lines, cords, rope, ribbon, flat wire, sheet, or tape.” (Ex. 1001,
`
`9:21-23.) Petitioner has adopted this description for its construction of “filament.”
`
`The remainder of the specification is consistent with this description, stating
`
`that, “[t]he filament can be made from a variety of materials including, for example,
`
`a polymer, a synthetic, and/or a metal.” (Id., 9:13-15.) The specification also
`
`discloses, “the filament can comprise a single strand such as, for example, a
`
`monofilament, [or] the filament can comprise a plurality of strands that can be, for
`
`example, twisted, woven, grouped, and/or fused to form the filament.” (Id., 9:16-
`
`21.) Additionally, the specification explains that “the filament 150 can comprise
`
`multiple filaments, and specifically, as shown in FIGS. 7 through 9, the filament 150
`
`can comprise a first filament 150-A and a second filament 150-B.” (Id., 12:61-64.)
`
`In the ’011 patent IPR, the Board preliminarily found that it did not need to
`
`“expressly construe the term ‘filament’ in the manner urged by Petitioner.” (Ex.
`
`1017, 13.) However, the Board agreed with “Petitioner that a filament as claimed
`
`encompasses one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or
`
`tapes.” (Id. (emphasis in original).) The Board correctly observed that the ’011
`
`patent “lists those structures explicitly, but suggests that those are only examples
`
`and, thus, the term ‘filament’ may be broader than those structures.” (Id.) Similarly,
`
`in the ’012 patent IPR, the Board stated, “We agree with Petitioner that a ‘filament’
`
`18
`
`
`
`IPR Petition – Patent 11,865,291
`Imperative Care, Inc. v. Inari Medical Inc.
`
`may encompass one or several threads, lines, cords, robes [sic], ribbons, flat wires,
`
`sheets or tapes. The Specification supports such interpretation.” (Ex. 1023, 15.)
`
`Petitioner agrees with the Board that “filament” may be construed more
`
`broadly. However, the Board needs to construe the terms only to the extent
`
`necessary to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368,
`
`1375 (Fed. Cir. 2019). Here, Petitioner’s construction of “filament” resolves the
`
`dispute because the structures listed in the construction (e.g., threads, flat wires) are
`
`found in the prior art references identified herein, even if a full construction of
`
`“filament” would include additional structures.
`
`2.
`
`The Board’s Prior Analysis of PO’s Attempt to Limit Claims to
`“Flexible” Filaments
`
`The Board addressed PO’s attempts to limit the claims of the ’011 and ’012
`
`patents to “flexible” filaments in the prior IPRs. In the ’011 patent IPR, PO argued
`
`the “filament” must be “thin and flexible.” (Ex. 1017, 13.) The Board did not adopt
`
`PO’s construction in the institution decision. (Id., 15.) The Board observed that
`
`“the ’011 patent never uses the words ‘thin’ or ‘flexible’ to describe the ‘filament.’”
`
`(Id.) The Board also observed that “the words ‘thin’ and ‘flexible’ inject potential
`
`ambiguities as relative terms” because “flexibility and rigidity exist along a spectrum
`
`….” (Id.)
`
`The Board reached a different preliminary construction in the ’012 patent IPR.
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
