Filed March 13, 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: BoxImperative921@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. IPR2025-00728
`Patent No. 11,844,921
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. PATENT NO. 11,844,921
`
`

`

`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION ......................................................................................... 1
`
`II. THE ‘921 PATENT ....................................................................................... 9
`
`A. Overview ............................................................................................. 9
`
`B.
`
`C.
`
`Prosecution History ........................................................................... 16
`
`The Earliest Possible Priority Date ................................................... 16
`
`III. LEVEL OF ORDINARY SKILL ................................................................ 16
`
`IV. CLAIM CONSTRUCTION ........................................................................ 17
`
`V. STATEMENT OF RELIEF REQUESTED ................................................ 20
`
`A.
`
`IPR Grounds ...................................................................................... 20
`
`B.
`
`C.
`
`The Asserted References Are Prior Art ............................................ 20
`
`The Asserted References Are Analogous Art ................................... 21
`
`VI. GROUNDS 1-4: CLAIMS 1-7, 9-10, 15-18, 20-24
`ANTICIPATED BY SCHAFFER OR OBVIOUS OVER
`SCHAFFER ALONE OR IN COMBINATION WITH
`HARTLEY OR ELLER ............................................................................... 21
`
`A.
`
`Claim 1 .............................................................................................. 24
`
`1.
`
`2.
`
`3.
`
`Preamble .................................................................................. 24
`
`Elongate Member .................................................................... 24
`
`Tensioning Mechanism ........................................................... 26
`
`a.
`
`b.
`
`Actuator ........................................................................ 26
`
`Filament ........................................................................ 29
`
`i
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`i.
`
`ii.
`
`Schaffer ............................................................. 29
`
`Hartley ............................................................... 33
`
`iii.
`
`Eller ................................................................... 40
`
`4.
`
`Biasing Member ...................................................................... 46
`
`B.
`
`C.
`
`Claim 2 .............................................................................................. 47
`
`Claim 3 .............................................................................................. 47
`
`1.
`
`2.
`
`3.
`
`Schaffer ................................................................................... 47
`
`Hartley ..................................................................................... 49
`
`Eller ......................................................................................... 51
`
`D.
`
`Claim 4 .............................................................................................. 52
`
`E.
`
`Claim 5 .............................................................................................. 53
`
`1.
`
`2.
`
`3.
`
`Schaffer ................................................................................... 53
`
`Hartley ..................................................................................... 56
`
`Eller ......................................................................................... 57
`
`Claim 6 .............................................................................................. 58
`
`Claim 7 .............................................................................................. 63
`
`Claim 9 .............................................................................................. 63
`
`Claim 10 ............................................................................................ 64
`
`1.
`
`2.
`
`Schaffer ................................................................................... 65
`
`Hartley ..................................................................................... 66
`
`F.
`
`G.
`
`H.
`
`I.
`
`ii
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`3.
`
`Eller ......................................................................................... 69
`
`J.
`
`Claim 15 ............................................................................................ 71
`
`K.
`
`Claim 16 ............................................................................................ 72
`
`L.
`
`Claim 17 ............................................................................................ 72
`
`M. Claim 18 ............................................................................................ 72
`
`N.
`
`O.
`
`P.
`
`Claim 20 ............................................................................................ 72
`
`Claim 21 ............................................................................................ 73
`
`Claim 22 ............................................................................................ 74
`
`Q.
`
`Claim 23 ............................................................................................ 74
`
`R.
`
`Claim 24 ............................................................................................ 74
`
`VII. GROUNDS 5-7: CLAIMS 1-3, 5-6, 9, 15-18, AND 21-24
`OBVIOUS OVER HARTLEY IN COMBINATION WITH
`ELLER ......................................................................................................... 76
`
`A.
`
`Claim 1 .............................................................................................. 76
`
`1.
`
`2.
`
`3.
`
`Preamble .................................................................................. 77
`
`Elongate Member .................................................................... 77
`
`Tensioning Mechanism ........................................................... 78
`
`a.
`
`b.
`
`Actuator ........................................................................ 79
`
`Filament ........................................................................ 80
`
`4.
`
`Biasing Member ...................................................................... 81
`
`iii
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`B.
`
`C.
`
`Claim 2 .............................................................................................. 86
`
`Claim 3 .............................................................................................. 86
`
`D.
`
`Claim 5 .............................................................................................. 87
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
`
`Claim 6 .............................................................................................. 88
`
`Claim 9 .............................................................................................. 90
`
`Claim 15 ............................................................................................ 90
`
`Claim 16 ............................................................................................ 91
`
`Claim 17 ............................................................................................ 91
`
`Claim 18 ............................................................................................ 91
`
`K.
`
`Claim 21 ............................................................................................ 91
`
`L.
`
`Claim 22 ............................................................................................ 92
`
`M. Claim 23 ............................................................................................ 92
`
`N.
`
`Claim 24 ............................................................................................ 92
`
`VIII. SECONDARY CONSIDERATIONS ......................................................... 92
`
`IX. THE BOARD SHOULD NOT DENY INSTITUTION UNDER
`§314(a) OR §325(d) .................................................................................... 93
`
`X. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT ................................................................................ 95
`
`A.
`
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) ............................... 95
`
`B.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ........................................... 95
`
`iv
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`C.
`
`Lead and Backup Counsel (37 C.F.R. §42.8(b)(3)) .......................... 96
`
`D.
`
`Service Information (37 C.F.R. §42.8(b)(4)) .................................... 96
`
`E.
`
`F.
`
`Grounds for Standing (37 C.F.R. §42.104) ....................................... 96
`
`Payment of Fees (37 C.F.R. §42.15(a)) ............................................ 97
`
`XI. CONCLUSION ............................................................................................ 97
`
`
`
`
`
`v
`
`

`

`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ............................................. 93
`
`Comcast Cable Commc’ns LLC v. Promptu Sys. Corp.,
`IPR2018-00342, Paper 13 (P.T.A.B. July 19, 2018) .......................................... 94
`
`Imperative Care v. Inari Medical, Inc.,
`IPR2024-01157, Paper 5 (Oct. 29, 2024) ........................................................... 85
`
`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) (en banc) .......................................................... 17
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) .................................................................... 18, 24
`
`SanDisk Corp. v. Kingston Tech. Co., Inc.,
`695 F.3d 1348 (Fed. Cir. 2012) .......................................................................... 49
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ............................................................................ 21
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 19
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 102 .................................................................................................. 20, 24
`
`35 U.S.C. § 103 .................................................................................................. 20, 24
`
`vi
`
`

`

`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`35 U.S.C. §314 ................................................................................................... 93, 94
`
`35 U.S.C. §325 ................................................................................................... 93, 94
`
`37 C.F.R. §1.11 .......................................................................................................... 4
`
`37 C.F.R. §42.100 .................................................................................................... 17
`
`
`
`
`
`
`vii
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
`U.S. Patent No. 11,844,921 (“the ’921 patent”)
`
`1002
`
`’921 Patent Prosecution History Excerpt
`
`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
`
`U.S. Patent No. 3,438,607 to Williams et al.
`
`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
`
`Google Dictionary Definition of “String”
`
`1015
`
`Cambridge Dictionary Definition of “String”
`
`1016
`
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`Exhibit List, Page 1
`
`

`

`IPR Petition – Patent 11,844,921
`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 Treretola
`
`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)
`
`
`
`Exhibit List, Page 2
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of claims 1-7, 9-10, and 15-18, and 20-24 (“the challenged claims”) of U.S.
`
`Patent No. 11,844,921 (“the ’921 patent,” Ex. 1001), which is assigned to Inari
`
`Medical, Inc. (“Patent Owner” or “PO”).
`
`I. INTRODUCTION
`
`Patent Owner has asserted claims 1-3, 5-7, and 9-10 against Petitioner in the
`
`co-pending district court litigation (the “Litigation”). See Ex. 1013 (contentions).
`
`In this IPR, Petitioner challenges the patentability of those asserted claims, as well
`
`claims having similar limitations.
`
`The challenged ’921 patent is the parent of U.S. Patent No. 11,697,011 (“the
`
`’011 patent,” Ex. 1012). The Board recently instituted Petitioner’s IPR challenging
`
`the patentability of the ’011 patent. (Ex. 1017.) In that institution decision, the
`
`Board preliminarily addressed the same or similar claim limitations to those included
`
`in the ’921 patent.
`
`The challenged claims in both the ’011 and ’921 patents describe a known
`
`type of “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
`
`1
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`device companies developed valves to seal the end of catheters and minimize blood
`
`loss during medical procedures.
`
`The challenged claims require a valve having a collapsible “elongate
`
`member” that extends through the center of the valve. The elongate member has a
`
`“lumen.”1
`
`
`
`(Ex. 1001, Fig. 2.) The claimed valve also includes an actuator (e.g., button) and a
`
`“filament” extending around the elongate member. When the actuator applies
`
`tension to the ends of the filament, the filament constricts the elongate member to
`
`seal the lumen. The filament can have a variety of configurations, as shown below.
`
`
`1 Petitioner added all colors and annotations except where otherwise noted.
`
`2
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`(Id., Figs. 6-8.)
`
`The claimed valve also includes a “biasing member” (e.g., spring) that biases
`
`the actuator toward a first position wherein the valve is constricted:
`
`
`
`
`
`
`
`Valves having a filament looped around a collapsible tube and springs to bias
`
`the valve toward its closed configuration were well known before September 6,
`
`2017, the earliest claimed priority date for the ’921 patent. Schaffer, a patent
`
`application published in 2003, describes a hemostasis valve for use during minimally
`
`3
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`invasive intravascular procedures. Schaffer was not before the Examiner during
`
`prosecution of the ’921 patent. Like the claimed valves, Schaffer’s valve includes
`
`an elongate member having a lumen, an actuator (e.g., button) coupled to a filament
`
`(e.g., actuating members), and a biasing system (e.g., spring):
`
`(Id., Fig. 32.)2 As illustrated below, Schaffer’s valve has the same components, in
`
`the same arrangement, as the valve claimed in the ’921 patent. Thus, Schaffer
`
`anticipates or renders obvious the challenged claims.
`
`
`
`
`2 Petitioner uses the versions of Schaffer’s drawings submitted during prosecution
`on June 18, 2003 (Ex. 1008, 66-84.) because they are clearer. The drawings became
`publicly available when Schaffer published on December 4, 2003. 37 C.F.R. §1.11.
`
`4
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`In the IPR institution decision for the ’011 patent, the Board found, “based on
`
`the preliminary record,” “that Petitioner has established a reasonable likelihood that
`
`it will prevail in showing that at least claim 1 [of the ’011 patent] is anticipated by
`
`Schaffer.” (Ex. 1017 at 33.) Notably, claim 1 of the ’011 patent includes similar
`
`limitations to those in claim 1 of the ’921 patent.
`
`Schaffer also renders the challenged claims obvious in combination with the
`
`“filaments” described in Hartley or Eller. Hartley, another patent application
`
`published in 2003, describes a hemostasis valve having a filament that constricts the
`
`lumen of an elongate member:
`
`5
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Ex. 1006, [0031], Fig. 3.) Hartley’s filament is attached to a rotary actuator that
`
`applies tension to the filament. Rotation of the 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
`
`constricts the lumen of an elongate member:
`
`6
`
`

`

`IPR Petition – Patent 11,844,921
`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. The Board preliminarily addressed the combination of
`
`Schaffer and Hartley or Eller in the ’011 patent IPR. (Ex. 1017 at 33-41.) There,
`
`PO argued that a POSITA would not have been motivated to combine Schaffer and
`
`Hartley or Eller with a reasonable expectation of success. Id. at 36. The Board
`
`preliminarily rejected PO’s argument, finding that “Petitioner advances multiple
`
`reasons why the skilled artisan would have been motivated to combine Schaffer and
`
`Hartley with a reasonable expectation of success.” Id.
`
`7
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Hartley combined with Eller also renders many of the challenged claims
`
`obvious. The Examiner of the ’921 patent did not issue any office actions or make
`
`any prior-art based rejections. However, in the Notice of Allowance, the Examiner
`
`concluded that Hartley taught each limitation of the ’921 patent’s independent
`
`claims except the “biasing member.” (Ex. 1002, 25.) The Examiner never addressed
`
`whether a POSITA would have found it obvious to combine a biasing mechanism
`
`with Hartley. Yet, valves combining a biasing mechanism with a rotating actuator
`
`were known by September 2017.
`
`Eller, for example, combines a torsion spring with a rotating actuator to bias
`
`Eller’s valve toward the closed position. (Ex. 1007, 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. While Eller was listed in an Information
`
`Disclosure Statement (“IDS”) during prosecution, it was not discussed or applied by
`
`the Examiner.
`
`The Board preliminarily addressed the combination of Hartley and Eller in the
`
`’011 patent IPR institution decision. Ex. 1017 at 42. The Board was unpersuaded
`
`at that time that Hartley and Eller rendered the claims of the ’011 patent
`
`unpatentable. The ’011 patent claims required an actuator with a “first member” and
`
`“second member.” The Board was not convinced that Hartley and Eller disclosed
`
`8
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`two members. However, the challenged claims in this IPR do not require two
`
`members. Therefore, the Board is addressing a new issue in this IPR.
`
`For the reasons presented herein, Petitioner has demonstrated a reasonable
`
`likelihood that at least one claim of the ’921 patent is unpatentable. Accordingly,
`
`Petitioner requests that the Board institute this IPR to review the patentability of the
`
`’921 patent.
`
`A. Overview
`
`II. THE ‘921 PATENT
`
`The ’921 patent describes hemostasis (or “garrot”) valves for use during
`
`minimally invasive intravascular procedures. (Ex. 1001, 5:49-67). The hemostasis
`
`valve is used with a catheter inserted into the patient’s vasculature to provide a seal.
`
`(Id. at 1:35-38). The ’921 patent states that the valve “can seal with or without a
`
`tool extending through the valve.” (Id., 5:50-52.)
`
`The described valve includes a “housing 128” that defines a “interior channel
`
`130,” and a collapsible “elongate member 132” that extends through the housing:
`
`9
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Id., 6:49-7:24, Fig. 2.) The elongate member 132 has a “thin-walled compliant
`
`tubular structure,” which helps facilitate “the uniform collapse of the elongate
`
`member 132 and the sealing of the elongate member 132.” (Id., 7:10-16.)
`
`The valve also has a “constricting mechanism,” which can “collapse and seal
`
`the elongate member 132 via compression and/or constriction, and specifically via
`
`constriction with at least one filament 150.” (Id., 8:1-4.)
`
`10
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`
`(Id., 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., 8:1-5.)
`
`The “filament 150 can be coupled to the actuator 142 such that the filament 150
`
`11
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`selectively constricts, collapses, and/or seals the elongate member 132 … based on
`
`the movement and/or position of the actuator 142.” (Id., 9:18-22.)
`
`The valve also includes a “bias feature,” such a spring (148-A and 148-B),
`
`which biases the actuator toward the open or closed configuration. (Id., 8:32-51.)
`
`Figure 4 shows the valve biased toward a first, closed position:
`
`(Id., 8:32-51, Fig. 2.) 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”:
`
`
`
`12
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Id., 9:48-56, Fig. 3).
`
`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:
`
`13
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Id., 11:64-12:8, 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 8-9:
`
`
`
`14
`
`

`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Id., 13:10-14:27, 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
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`filaments,” such as in Figures 7-9, where “each of the multiple filaments can have a
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`first end 700 and a second end 702”:
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`(Id., 13:1-9, Fig. 8.)
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`15
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`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`B.
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`Prosecution History
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`In the Notice of Allowance, the Examiner stated that Hartley and Williams
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`(Ex. 1010) were the “closest prior art of record.” (Ex. 1002, 25.) The Examiner
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`found that Hartley disclosed every limitation of several claims except “a biasing
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`member configured to bias the actuator to the first position.” (Id.) While the
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`Examiner found that Williams disclosed a biasing member, the Examiner concluded
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`that Williams failed to disclose “a filament extending around the elongate member.”
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`(Id., 26.) The Examiner did not address the combination of any references.
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`C. The Earliest Possible Priority Date
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`The ’921 patent claims priority to provisional application No. 62/554,931,
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`filed September 6, 2017, which is the earliest possible priority date for the ’921
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`patent. (Ex. 1001.) Petitioner applies this earliest priority date in this Petition;
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`however, Petitioner preserves its right to challenge the priority date in subsequent
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`proceedings.
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`III. LEVEL OF ORDINARY SKILL
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`A POSITA in September 2017 would have had an undergraduate degree in
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`mechanical engineering or a related engineering discipline and 2-4 years of product
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`design or engineering experience. (Ex. 1003, ¶35.) This is the same level of ordinary
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`skill that Petitioner proposed in the ’011 patent IPR and that was applied by PO and
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`the Board. (Ex. 1017, 11.)
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`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`IV. CLAIM CONSTRUCTION
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`The claim terms should receive their ordinary and customary meaning as
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`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) (en banc). However, “the specification may
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`reveal a special definition given to a claim term by the patentee that differs from the
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`meaning it would otherwise possess [and] [i]n such cases, the inventor's
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`lexicography governs.” Id. at 1316.
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`The challenged claims require a hemostasis valve having a “filament.” A
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`POSITA would have understood the term “filament” to mean at least “one or more
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`threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes” based on the intrinsic
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`record. (Ex. 1003, ¶¶49-59.) This is the same construction of “filament” that
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`Petitioner proposed in the ’011 patent IPR. (Ex. 1017, 12.) There, the Board
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`preliminarily found that it did not need to “expressly construe the term ‘filament’ in
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`the manner urged by Petitioner.” (Id., 13.) However, the Board agreed with
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`“Petitioner that a filament as claimed encompasses one or more threads, lines, cords,
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`ropes, ribbons, flat wires, sheets, or tapes.” (Id. (emphasis in original).) The Board
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`correctly observed that the ’011 patent “lists those structures explicitly, but suggests
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`that those are only examples and, thus, the term ‘filament’ may be broader than those
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`structures.” (Id.) Petitioner agrees with the Board that “filament” may be construed
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`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`more broadly. However, the Board needs to construe the terms only to the extent
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`necessary to resolve the controversy. Realtime Data, LLC v. Iancu, 912 F.3d 1368,
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`1375 (Fed. Cir. 2019). Here, Petitioner’s construction of “filament” resolves the
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`dispute because the structures listed in the construction (e.g., threads, flat wires) are
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`found in the prior art references, even if a full construction of “filament” would
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`include additional structures.
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`The Board also addressed PO’s argument in the ’011 patent IPR that the
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`“filament” must be “thin and flexible.” (Ex. 1017, 13.) The Board did not adopt
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`PO’s construction in the institution decision. (Id., 15.) The Board observed that
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`“the ’011 patent never uses the words ‘thin’ or ‘flexible’ to describe the ‘filament.’”
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`(Id.) The Board also observed that “the words ‘thin’ and ‘flexible’ inject potential
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`ambiguities as a relative term” because “flexibility and rigidity exist along a
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`spectrum ….” (Id.) Petitioner agrees that PO’s proposed construction is incorrect
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`for these reasons and others. (Ex. 1003, ¶¶51-54.) For example, in a related patent,
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`PO specifically claims a filament that “is flexible,” demonstrating that flexibility is
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`not an inherent property of the filament. (Ex. 1016, claim 1.) PO’s proposed
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`construction in the ’011 patent IPR also required “one or more strands,” which would
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`improperly exclude specific “filaments” identified in the ’921 application, such as a
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`“sheet” of metal.” (Ex. 1003, ¶52.) For at least these reasons, PO’s previously
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`proposed construction is incorrect.
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`18
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`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Petitioner’s construction of “filament” is supported by the intrinsic record.
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`Claim construction generally begins with the claim language. Vitronics Corp. v.
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`Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, however, the claims
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`provide little information regarding the “filament.” For example, claim 1 recites “a
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`filament … extending at least partially around the elongate member.” Claims 15
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`and 21 require “a filament coupled to the elongate member.” Claim 25 requires “a
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`first filament” and “a second filament” where a first actuator is “coupled to the
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`elongate member via a first filament” and a second actuator is “coupled to the
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`elongate member via a second filament.” This claim language does not provide a
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`POSITA with guidance on the “filament” structure.
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`However, the ’921 patent specification (like the ’011 patent) identifies
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`examples of “filaments.” The ’921 patent states, “the filament 150 can comprise one
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`or several threads, lines, cords, rope, ribbon, flat wire, sheet, or tape.” (Ex. 1001,
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`9:15-17.) Petitioner has adopted this description for its construction of “filament.”
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`The remainder of the specification is consistent with this description, stating
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`that, “[t]he filament can be made from a variety of materials including, for example,
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`a polymer, a synthetic, and/or a metal.” (Id., 9:7-9.) The specification also discloses,
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`“the filament can comprise a single strand such as, for example, a monofilament,
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`[or] the filament can comprise a plurality of strands that can be, for example, twisted,
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`woven, grouped, and/or fused to form the filament.” (Id., 9:10-15.) Additionally,
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`19
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`

`IPR Petition – Patent 11,844,921
`Imperative Care, Inc. v. Inari Medical Inc.
`
`the specification explains that “the filament 150 can comprise multiple filaments,
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`and specifically, as shown in FIGS. 7 through 9, the filament 150 can comprise a
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`first filament 150-A and a second filament 150-B.” (Id., 12:54-57.)
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`Petitioner does not believe any other terms require construction to resolve the
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`patentability issues herein.
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`V. STATEMENT OF RELIEF REQUESTED
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`A.
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`IPR Grounds
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`Petitioner asserts the following grounds of unpatentabili