Filed: December 13, 2024
`
`
`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: BoxImperative005@knobbe.com
`
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`
`
`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. IPR2025-00289
`Patent No. 11,554,005
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,554,005
`
`
`
`
`
`
`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: BoxImperative005@knobbe.com
`
`
`
`
`
`
`
`
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`
`
`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. IPR2025-00289
`Patent No. 11,554,005
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,554,005
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`INTRODUCTION ......................................................................................... 1
`I.
`II. THE ’005 PATENT ....................................................................................... 9
`A. Overview ............................................................................................. 9
`B.
`Prosecution History ........................................................................... 14
`C.
`Earliest Possible Priority Date ........................................................... 16
`III. LEVEL OF ORDINARY SKILL ................................................................ 17
`IV. CLAIM CONSTRUCTION ........................................................................ 17
`V. STATEMENT OF RELIEF REQUESTED ................................................ 19
`A.
`IPR Grounds ...................................................................................... 19
`B.
`The Asserted References Are Prior Art ............................................ 20
`C.
`The Asserted References Are Analogous Art ................................... 20
`VI. GROUNDS 1-3: GARRISON COMBINED WITH SCHAFFER
`AND OPTIONALLY HARTLEY OR ELLER .......................................... 21
`A.
`Independent Claim 1 ......................................................................... 21
`1.
`Preamble .................................................................................. 21
`2.
`Housing ................................................................................... 22
`3.
`Flow Path ................................................................................ 23
`4.
`On-off Control ......................................................................... 24
`5.
`First Catheter ........................................................................... 26
`6.
`Connector ................................................................................ 27
`
`i
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`7.
`8.
`
`Clot Cannister ......................................................................... 30
`Hemostasis Valve .................................................................... 34
`a.
`Tubular Member ........................................................... 38
`b.
`Constricting Mechanism ............................................... 39
`i.
`Actuator .............................................................. 40
`ii.
`Filament .............................................................. 43
`Biasing System ............................................................. 60
`c.
`Claim 2 .............................................................................................. 61
`Claim 3 .............................................................................................. 62
`1.
`Schaffer ................................................................................... 62
`2.
`Hartley ..................................................................................... 63
`3.
`Eller ......................................................................................... 64
`Claim 4 .............................................................................................. 65
`Claim 5 .............................................................................................. 67
`1.
`Schaffer ................................................................................... 67
`2.
`Hartley ..................................................................................... 69
`3.
`Eller ......................................................................................... 70
`Claim 6 .............................................................................................. 71
`Claim 7 .............................................................................................. 75
`Claim 8 .............................................................................................. 76
`
`B.
`C.
`
`D.
`E.
`
`F.
`G.
`H.
`
`ii
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`I.
`J.
`
`Claim 9 .............................................................................................. 77
`Independent Claim 10 ....................................................................... 78
`1.
`Hemostasis Valve .................................................................... 78
`a.
`Support .......................................................................... 78
`b.
`Actuator ........................................................................ 79
`c.
`Tubular Sidewall ........................................................... 80
`d.
`Filament ........................................................................ 82
`e.
`First Spring ................................................................... 82
`Claim 11 ............................................................................................ 85
`K.
`Claim 12 ............................................................................................ 85
`L.
`M. Claim 13 ............................................................................................ 85
`1.
`Schaffer-Hartley ...................................................................... 86
`2.
`Schaffer-Eller .......................................................................... 86
`Claim 14 ............................................................................................ 87
`N.
`Claim 15 ............................................................................................ 88
`O.
`VII. GROUND 4: GARRISON COMBINED WITH HARTLEY
`AND ELLER ............................................................................................... 88
`A.
`Independent Claim 1 ......................................................................... 88
`1.
`Preamble and Limitations 2-7 ................................................. 88
`2.
`Hemostasis Valve .................................................................... 88
`
`iii
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`a.
`b.
`
`Tubular Member ........................................................... 90
`Constricting Mechanism ............................................... 90
`i.
`Actuator .............................................................. 91
`ii.
`Filament .............................................................. 92
`Biasing System ............................................................. 93
`c.
`Claim 2 .............................................................................................. 97
`Claim 3 .............................................................................................. 97
`Claim 5 .............................................................................................. 98
`Claim 6 .............................................................................................. 99
`Claim 9 ............................................................................................ 101
`Independent Claim 10 ..................................................................... 102
`1.
`Preamble and Limitations 2-7 ............................................... 102
`2.
`Hemostasis Valve .................................................................. 102
`a.
`Support ........................................................................ 102
`b.
`Actuator ...................................................................... 103
`c.
`Tubular Sidewall ......................................................... 105
`d.
`Filament ...................................................................... 106
`e.
`First Spring ................................................................. 106
`Claim 11 .......................................................................................... 106
`Claim 12 .......................................................................................... 106
`
`B.
`C.
`D.
`E.
`F.
`G.
`
`H.
`I.
`
`iv
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`J.
`Claim 13 .......................................................................................... 106
`Claim 14 .......................................................................................... 106
`K.
`Claim 15 .......................................................................................... 107
`L.
`VIII. SECONDARY CONSIDERATIONS ....................................................... 107
`IX. THE BOARD SHOULD NOT DENY INSTITUTION UNDER
`§§314(a) OR 325(d) ................................................................................... 107
`X. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT .............................................................................. 109
`A.
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) ............................. 109
`B.
`Related Matters (37 C.F.R. §42.8(b)(2)) ......................................... 109
`C.
`Lead and Backup Counsel (37 C.F.R. §42.8(b)(3)) ........................ 110
`D.
`Service Information (37 C.F.R. §42.8(b)(4)) .................................. 110
`E.
`Grounds for Standing (37 C.F.R. §42.104) ..................................... 110
`F.
`Payment of Fees (37 C.F.R. §42.15(a)) .......................................... 110
`XI. CONCLUSION .......................................................................................... 111
`
`
`
`v
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Biagro W. Sales, Inc. v. Grow More, Inc.,
`423 F.3d 1296 (Fed. Cir. 2005) .......................................................................... 45
`Comcast Cable Commc’ns LLC v. Promptu Sys. Corp.,
`IPR2018-00342 (P.T.A.B. July 19, 2018) ........................................................ 108
`In re Gleave,
`560 F.3d 1331 (Fed. Cir. 2009) .......................................................................... 41
`Imperative Care, Inc. v. Inari Med., Inc.,
`IPR2024-01157 (P.T.A.B. July 8, 2024) ........................................ 19, 44, 51, 109
`Imperative Care, Inc. v. Inari Medical, Inc.,
`IPR2024-01257 (P.T.A.B. Aug. 12, 2024) ....................................................... 109
`Imperative Care, Inc. v. Inari Medical, Inc.,
`IPR2025-00156 (P.T.A.B. Nov. 8, 2024) ......................................................... 109
`Inari Medical, Inc. v. Imperative Care, Inc.,
`No. 24-cv-3117 (N.D. Cal., filed May 22, 2024) .....................107, 108, 109, 110
`Ex Parte Klop,
`Appeal 2019-006763, 2020 WL 2473929 (P.T.A.B. May 7, 2020) ................... 41
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`In re Nilssen,
`851 F.2d 1401 (Fed. Cir. 1988) .......................................................................... 21
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 17
`Sandisk Corp. v. Kingston Tech. Co., Inc.,
`695 F.3d 1348 (Fed. Cir. 2012) .......................................................................... 45
`
`vi
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ............................................................................ 20
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 17
`OTHER AUTHORITIES
`35 U.S.C. §102 ......................................................................................................... 20
`35 U.S.C. §103 ......................................................................................................... 20
`35 U.S.C. §§314 ............................................................................................. 107, 108
`35 U.S.C. §325 ....................................................................................................... 109
`37 C.F.R. §1.11 .......................................................................................................... 6
`37 C.F.R. §42.8 .............................................................................................. 109, 110
`37 C.F.R. §42.15 .................................................................................................... 110
`37 C.F.R. §42.100 .................................................................................................... 17
`37 C.F.R. §42.104 .................................................................................................. 110
`
`
`
`vii
`
`
`
`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Exhibit No.
`1001
`1002
`
`Description
` U.S. Patent No. 11,554,005 (“the ’005 patent”)
`Excerpts from the prosecution history of the ’005 patent
`
`1003
`
`1004
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`1010
`
`1011
`
`1012
`1013
`
`1014
`
`1015
`1016
`
`1017
`
`Expert Declaration of Troy Thornton
`
`Resume of Troy Thornton
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`U.S. Patent Publication No. 2003/0116731 A1 to Hartley
`(“Hartley”)
`
`U.S. Patent No. 9,980,813 B1 to Eller (“Eller”)
`
`Drawings Submitted During Prosecution of U.S. Patent Application
`No. 10/371,190 dated June 18, 2003
`
`U.S. Patent No. 5,429,616 to Schaffer (“Schaffer ’616”)
`U.S. Patent Publication US 2011/0144592 A1 to Wong et al.
`(“Wong”)
`
`U.S. Patent Publication No. 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`RESERVED
`RESERVED
`
`U.S. Patent No. 4,723,550 to Bales et al.
`
`U.S. Patent No. 5,895,376 to Schwartz et al.
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`U.S. Patent Application No. 16/117,519 (the “’519 application”)
`
`Exhibit List, Page 1
`
`
`
`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Exhibit No.
`1018
`
`Description
`U.S. Patent No. 7,775,501 B2 to Kees (“Kees”)
`
`1019
`
`1020
`
`1021
`
`1022
`1023
`
`U.S. Patent Publication No. 2016/022041 A1 to Garrison et al.
`(“Garrison ’741”)
`U.S. Patent No. 6,776,770 B2 to Treretola
`
`U.S. Patent Publication No. 2010/0042118 A1 to Garrison et al.
`
`U.S. Patent No. 5,938,645 to Gordon (“Gordon”)
`U.S. Patent Publication No. 2014/0296868 A1 to Garrison et al.
`
`1024 WIPO Publication No. WO 2006/124307 A2 to Goff et al.
`
`
`
`Exhibit List, Page 2
`
`
`
`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of claims 1-15 (“the challenged claims”) of U.S. Patent No. 11,554,005
`
`(“the ’005 patent,” Ex.1001), which is assigned to Inari Medical, Inc. (“Patent
`
`Owner” or “PO”).
`
`I. INTRODUCTION
`The accumulation of unwanted material, such as blood clots, in a patient’s
`
`vasculature can cause serious conditions, including stroke and death. Over the last
`
`several decades, medical device companies have developed devices to remove such
`
`undesirable material from the vasculature, including catheter-based systems that
`
`aspirate (i.e., suction) the material from the blood vessel.
`
`The ’005 patent claims such an aspiration system. However, the patent
`
`provides little description regarding what is new and nonobvious about the claimed
`
`system. The patent generically states, “there exists a need for improved systems and
`
`methods for embolic extraction” and argues that prior art systems were “highly
`
`complex,” “cause trauma to the treatment vessel,” and “may not completely capture
`
`and/or collect all of the clot material.” (Ex. 1001, 2:26-39.) However, the ’005
`
`patent does not explain how the claimed system addresses these alleged
`
`shortcomings.
`
`Instead, the claims merely list conventional aspiration components, including
`
`a catheter, an aspiration source, a connector placing the aspiration source in
`
`1
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`
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`communication with a flow path through the device, an on-off control, and a clot
`
`cannister:
`
`
`
`(Id., Fig. 20C.) As demonstrated below, aspiration catheters having these
`
`conventional components were known and used before August 2018, the earliest
`
`claimed priority date of the ’005 patent.
`
`The challenged claims also require a specific hemostasis valve having a
`
`“tubular member” that can “slidably receive a second catheter,” “a constricting
`
`mechanism including a filament” that extends “around at least a portion of the
`
`tubular member,” “an actuator coupled to the filament,” and a “biasing system.”
`
`Importantly, the ’005 patent specification does not describe or illustrate a hemostasis
`
`valve having these components. Any written description for the claimed valve must
`
`2
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`
`
`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`come from another patent application (the ’519 application) purportedly
`
`incorporated by reference. (Id., 5:49-54.)
`
`
`
`(Ex. 1017, Fig. 2.) However, even if PO successfully incorporated the valve
`
`disclosure, tightening a loop around a collapsible tube in a valve to create a seal was
`
`well known in August 2018. Further, biasing the valve to the constricted
`
`configuration was also known and predictably used because the biasing system
`
`automatically closed the valve, minimized blood loss, and avoided excessive manual
`
`manipulation of the valve.
`
`Garrison, a prior art patent application published in June 2015, describes an
`
`aspiration system for removing unwanted material from a patient’s vasculature. As
`
`3
`
`
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`illustrated below, Garrison’s aspiration system includes the components claimed in
`
`the ’005 patent, including a catheter [orange], aspiration source [red], connector
`
`[green] placing the aspiration source in communication with a flow path, on/off
`
`control [purple], and clot cannister [blue]:
`
`
`
`(Ex. 1011, Fig. 34.)
`
`Garrison’s aspiration system can also include various hemostasis valves
`
`including, “an adjustable-opening valve” and a “rotating hemostasis valve.” (Id.,
`
`[0062].) Garrison explains that the hemostasis valves “allow for the introduction of
`
`4
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`devices therein while preventing or minimizing blood loss via the internal lumen
`
`during the procedure.” (Id.) Garrison presumes a person of ordinary skill in the art
`
`(“POSITA”) would have been familiar with the available hemostasis valves and,
`
`therefore, does not describe their structures. However, other prior art references do.
`
`For example, Schaffer, a patent application published in 2003, describes an
`
`adjustable-opening hemostasis valve for use during minimally invasive intravascular
`
`procedures. (Ex. 1005, [0002], [0008].) Schaffer was not before the Examiner
`
`during prosecution of the ’005 patent. Like the claimed valves, Schaffer’s valve
`
`includes a tubular member that can slidably receive a second catheter, a constricting
`
`mechanism including a filament, an actuator coupled to the filament, and a biasing
`
`system (e.g., spring):
`
`
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`5
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`
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`(Id., Fig. 32.)1 As illustrated below, Schaffer’s valve has the same components, in
`
`the same arrangement, as the valve claimed in the ’005 patent (and described in the
`
`’519 application):
`
`
`
`A POSITA would have found it obvious to combine Garrison’s aspiration system
`
`with Schaffer’s hemostasis valve for the reasons presented in this Petition.
`
`Additionally, Hartley, a patent application published in 2003, describes a
`
`rotating hemostasis valve for use with catheters to prevent blood loss. (Ex. 1006,
`
`[0002]-[0003].) Hartley’s valve also includes a tubular member that can slidably
`
`
`1 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.
`
`6
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`receive a second catheter, a constricting mechanism including a filament, and an
`
`actuator coupled to the filament:
`
`
`
`(Ex. 1006, [0031], Fig. 1.)
`
`During prosecution of the ’005 patent, the Examiner found that Hartley
`
`disclosed every hemostasis-valve limitation in the challenged claims except a
`
`movable actuator coupled to a spring. (Ex. 1002, 214-215.) However, as shown
`
`above, Schaffer discloses movable actuator buttons coupled to springs and satisfies
`
`this limitation. If Schaffer does not disclose a “filament,” Schaffer combined with
`
`Hartley does.
`
`Likewise, Eller, a patent published in 2015, describes a rotating hemostasis
`
`valve having a filament that constricts a tubular member upon rotation of an actuator:
`
`7
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`
`
`(Ex. 1007, 5:1-12, Fig. 2.) Eller’s valve also includes an optional biasing system,
`
`such as a torsion spring, that biases the valve toward the sealed state. (Id., 19:22-
`
`30.) As explained herein, a POSITA would have found it obvious to combine Eller’s
`
`torsion spring with Hartley’s rotatable hemostasis valve and, therefore the
`
`combination of Garrison with Hartley and Eller also renders the challenged claims
`
`obvious. Eller’s publication was listed in an Invention Disclosure Statement (“IDS”)
`
`during prosecution but was not discussed or applied by the Examiner. Thus, the
`
`Examiner never addressed the combination of Eller’s torsion spring with Hartley’s
`
`valve.
`
`8
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`As demonstrated herein, the challenged claims merely combine known
`
`aspiration systems and hemostasis valves according to their known functions to yield
`
`predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
`
`Petitioner has demonstrated a reasonable likelihood that at least one claim of the
`
`’005 patent is unpatentable. Accordingly, Petitioner requests that the Board institute
`
`this IPR to reconsider the patentability of the ’005 patent.
`
`II. THE ’005 PATENT
`
`A. Overview
`The ’005 patent describes an aspiration system for intravascular treatment of
`
`clot material. (Ex. 1001, 4:10-4:26.) The aspiration system includes a catheter 102
`
`“comprising an elongated shaft defining a lumen 104,” and a “valve 106” with a
`
`“lumen 109 extending therethrough.” (Id., 5:18-5:43.) The valve “is configured to
`
`maintain hemostasis during a clot removal procedure by preventing fluid flow in the
`
`proximal direction through the valve 106” when other components are inserted, such
`
`as “interventional devices” or “other aspiration catheters.” (Id.)
`
`9
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`The tubing subsystem “fluidly couples the catheter subsystem 100 to the
`
`pressure source 140.” (Id., 5:66-67.) The tubing subsystem can include “one or
`
`more tubing sections 124,” at least one “fluid control device 126” such a stopcock,
`
`and at least one “connector 128 for fluidly coupling the tubing subsystem 120 to the
`
`pressure source 140 and/or other suitable components.” (Id., 5:66-6:6.)
`
`10
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`
`
`The ’005 patent also describes embodiments and modifications of the
`
`aspiration system. For example, the patent describes embodiments having a
`
`“pressure source 1900” with a “secondary syringe 460” and a “canister 1940.” (Id.,
`
`31:9-19, Fig. 19.) The “canister 1940 further includes a filter 1942.” (Id., 31:28-
`
`29.)
`
`11
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`
`
`(Id., Fig. 19.)
`
`The ’005 patent does not describe the structure of any hemostasis valve.
`
`However, the ’005 patent purports to incorporate by reference “U.S. patent
`
`application Ser. No. 16/117,519” (the “’519 application” (Ex. 1017)). (Id., 5:49-
`
`53.)2 The ’519 application describes a valve having an “elongate member 132” that
`
`
`2 Petitioner reserves its right to challenge written description and the incorporation
`by reference in future proceedings.
`
`12
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`extends through the valve. (Ex. 1017, [0039].) The elongate member has a “thin-
`
`walled compliant tubular structure” that facilitates “the uniform collapse of the
`
`elongate member 132 and the sealing of the elongate member 132”:
`
`
`
`(Id., [0039], Fig. 2.)
`
`The valve also includes a “constricting mechanism 141” that can “collapse
`
`and seal the elongate member 132 via compression and/or constriction, and
`
`specifically via constriction with at least one filament 150.” (Id., [0042-0043], Fig.
`
`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.) The “filament
`
`13
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`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., [0048].)
`
`The valve also includes a “bias feature,” such as a spring, that biases the
`
`actuator toward the open or closed configuration. (Id., [0045].) In Figure 2 (above),
`
`the springs bias the valve toward the closed configuration. (Id.) Depressing the
`
`actuator buttons releases 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., [0050], Fig. 3.)
`
`B.
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`Prosecution History
`The Examiner issued a single Office Action rejecting original claim 1 as
`
`anticipated by U.S. 2016/0220741 (“Garrison ’741,” Ex. 1019).3 (Ex. 1002, 209-
`
`217.) Original claim 1 resembled final claim 1 but excluded the hemostasis-valve
`
`limitations reciting the “tubular member,” “constricting mechanism,” and “biasing
`
`system.” (Compare Ex. 1002, 406 with Ex. 1001, claim 1.) The Examiner found
`
`that Garrison ’741 disclosed a vacuum aspiration system (100) having a hemostasis
`
`valve (234) in a housing (220), a connector (240) for connecting to a source of
`
`aspiration, and first (320) and second (400) catheters:
`
`
`3 Garrison (relied on herein) and Garrison ’741 both describe aspiration systems
`but have different specifications.
`
`14
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`(Id., 211-212; Ex. 1019, Fig. 1.) The Examiner also found that Garrison ’741
`
`disclosed an on-off control (242) and clot cannister:
`
`
`
`(Ex. 1002, 211-212; Ex. 1019, Fig. 11.)
`
`
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`15
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`The Examiner found original claims 2 and 11 allowable because they included
`
`the additional hemostasis-valve limitations (e.g., “constricting mechanism”) now in
`
`final claims 1 and 10. (Ex. 1002, 212-215.) The Examiner determined the closest
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`prior art of record was Wong (Ex. 1010), Kees (Ex. 1018), and Hartley (Ex. 1006).
`
`Id. The Examiner found that Hartley disclosed all the hemostasis-valve limitations
`
`except an “actuator having a first member movable coupled to the support and the
`
`first spring configured to move the first member.” (Id.) The Examiner also found
`
`that Wong and Kees did not disclose a “filament.” (Id.) Further, the Examiner
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`concluded that while “Hartley discloses a filament, a person skilled in the art would
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`recognize that it would [sic] improper to add the filament of Hartley to either device
`
`of Wong or Kees for this would conflict with the operation of the devices.” (Id.)
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`The Examiner did not further explain this position.
`
`PO did not dispute the Examiner’s findings. Rather, PO cancelled rejected
`
`claim 1 and rewrote claim 2 (final claim 1) in independent form to include the
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`hemostasis-valve limitations. (Id., 191-199.)
`
`C. Earliest Possible Priority Date
`The ’005 patent claims priority to two provisional applications 62/718,248
`
`and 62/718,269, filed August 13, 2018, which is the earliest possible priority date
`
`for the ’005 patent. (Ex. 1001.) Petitioner applies this earliest priority date in this
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`16
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`Petition; however, Petitioner reserves its right to challenge the priority date in
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`subsequent proceedings.
`
`III. LEVEL OF ORDINARY SKILL
`A POSITA in August 2018 would have had an undergraduate degree in
`
`mechanical engineering or a related engineering discipline and 2-4 years of catheter
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`design experience. (Ex. 1003, ¶35.)
`
`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
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`specification and the prosecution history. 37 C.F.R. §42.100(b); see Phillips v. AWH
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`Corp., 415 F.3d 1303 (Fed. Cir. 2005). 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” to mean at least “one or more
`
`threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes” based on the intrinsic
`
`record. (Ex. 1003, ¶¶54-60.)
`
`Claim construction generally begins with the claim language. Vitronics Corp.
`
`v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, however, the
`
`17
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`claims provide little information regarding the “filament.” For example, claim 1
`
`describes the “filament” as having “a first portion extending around at least a portion
`
`of the tubular member” and ends that extend in different directions, wherein the
`
`filament is moveable between a first and second position. Claim 10 includes similar
`
`limitations. This claim language does not provide a POSITA with guidance on the
`
`“filament” structure.
`
`Further, the ’005 patent does not describe a hemostasis valve having a
`
`filament. In fact, the word “filament” does not appear in the ’005 patent outside the
`
`challenged claims. If this limitation has support, it must be incorporated by reference
`
`from the ’519 application. The ’519 application identifies examples of “filaments”
`
`that expand the meaning of “filament” beyond the plain and ordinary meaning. The
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`’519 application states, “the filament 150 can comprise one or several threads, lines,
`
`cords, rope, ribbon, flat wire, sheet, or tape.” (Ex. 1017, [0047].) 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.) 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.) Additionally, the specification
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`18
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`IPR Petition – Patent 11,554,005
`Imperative Care, Inc. v. Inari Medical Inc.
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`explains that “the filament 150 can comprise multiple filaments, and specifical
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