Filed May 19, 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: BoxImperative333@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 IPR2025-01021
`Patent No. 11,969,333
`
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,969,333
`
`
`
`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: BoxImperative333@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 IPR2025-01021
`Patent No. 11,969,333
`
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,969,333
`
`
`
`TABLE OF CONTENTS
`
`Page No(s).
`
`I.
`
`INTRODUCTION .................................................................................... 1
`
`II. THE ’333 PATENT .................................................................................. 7
`
`A. Overview ........................................................................................ 7
`
`B.
`
`Prosecution History ...................................................................... 11
`
`C.
`
`Earliest Possible Priority Date ...................................................... 13
`
`III. LEVEL OF ORDINARY SKILL ........................................................... 13
`
`IV. CLAIM CONSTRUCTION ................................................................... 13
`
`V. STATEMENT OF RELIEF REQUESTED ........................................... 15
`
`A.
`
`IPR Grounds ................................................................................. 15
`
`B.
`
`The Asserted References Are Prior Art ....................................... 17
`
`C.
`
`The Asserted References Are Analogous Art .............................. 17
`
`VI. GROUNDS 1A, 2A, 3A, 4A – LAUB, AKLOG, AND
`GARRISON ............................................................................................ 18
`
`A.
`
`Claim 1 ......................................................................................... 18
`
`1.
`
`Preamble ............................................................................. 18
`
`a.
`
`b.
`
`c.
`
`Laub ......................................................................... 18
`
`Aklog ....................................................................... 19
`
`Garrison and Laub Or Aklog ................................... 20
`
`2.
`
`Advancing Aspiration Catheter.......................................... 30
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`a.
`
`b.
`
`c.
`
`Laub ......................................................................... 30
`
`Aklog ....................................................................... 32
`
`Garrison and Laub or Aklog .................................... 34
`
`3.
`
`Generating Vacuum Pressure With Valve In First
`Position ............................................................................... 36
`
`a.
`
`b.
`
`Garrison ................................................................... 36
`
`Laub or Aklog and Garrison .................................... 38
`
`4. Moving The Valve From First To Second Position........... 41
`
`5.
`
`Filter ................................................................................... 43
`
`B.
`
`Claim 2 ......................................................................................... 43
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 43
`
`Aklog .................................................................................. 43
`
`Garrison and Laub or Aklog .............................................. 44
`
`C.
`
`Claim 3 ......................................................................................... 44
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 45
`
`Aklog .................................................................................. 45
`
`Garrison and Laub or Aklog .............................................. 45
`
`D.
`
`Claim 4 ......................................................................................... 45
`
`E.
`
`Claim 5 ......................................................................................... 46
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 46
`
`Aklog .................................................................................. 47
`
`Garrison .............................................................................. 47
`
`F.
`
`Claim 9 ......................................................................................... 48
`
`G.
`
`Claim 10 ....................................................................................... 49
`
`1.
`
`2.
`
`3.
`
`Garrison .............................................................................. 50
`
`Laub and Garrison .............................................................. 51
`
`Aklog and Garrison ............................................................ 52
`
`H.
`
`Claim 14 ....................................................................................... 52
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 53
`
`Aklog .................................................................................. 53
`
`Garrison .............................................................................. 54
`
`I.
`
`Claim 15 ....................................................................................... 55
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 55
`
`Aklog .................................................................................. 55
`
`Garrison .............................................................................. 56
`
`J.
`
`Claim 16 ....................................................................................... 56
`
`1.
`
`Garrison .............................................................................. 56
`
`-iii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2.
`
`Laub and Aklog .................................................................. 58
`
`K.
`
`Claim 18 ....................................................................................... 60
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 61
`
`Aklog .................................................................................. 61
`
`Garrison and Laub or Aklog .............................................. 62
`
`L.
`
`Claim 19 ....................................................................................... 62
`
`M. Claims 20-24, 28-29, 33-35, 37-38 .............................................. 63
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 63
`
`Aklog .................................................................................. 64
`
`Garrison and Laub or Aklog .............................................. 64
`
`VII. GROUNDS 1B, 2B, 3B, 4B – LAUB, AKLOG, AND
`GARRISON WITH GOFF ..................................................................... 65
`
`A.
`
`Claim 6 ......................................................................................... 65
`
`B.
`
`Claim 7 ......................................................................................... 72
`
`C.
`
`Claim 8 ......................................................................................... 72
`
`1.
`
`2.
`
`3.
`
`Laub.................................................................................... 73
`
`Aklog .................................................................................. 74
`
`Garrison .............................................................................. 74
`
`D.
`
`Claim 17 ....................................................................................... 75
`
`-iv-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`E.
`
`Claims 25-27 and 36..................................................................... 76
`
`VIII. GROUNDS 1C-1D, 2C-2D, 3C-3D, 4C-4D – LAUB, AKLOG,
`AND GARRISON WITH SCHAFFER AND OPTIONALLY
`HARTLEY .............................................................................................. 77
`
`A.
`
`Claim 11 ....................................................................................... 77
`
`1.
`
`2.
`
`Schaffer .............................................................................. 78
`
`Schaffer and Hartley .......................................................... 83
`
`B.
`
`Claim 12 ....................................................................................... 88
`
`C.
`
`Claims 30-31 ................................................................................ 89
`
`IX. SECONDARY CONSIDERATIONS .................................................... 90
`
`X.
`
`SOTERA STIPULATION ....................................................................... 90
`
`XI. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT ........................................................................... 90
`
`A.
`
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) .......................... 90
`
`B.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ...................................... 90
`
`C.
`
`Lead and Backup Counsel (37 C.F.R. §42.8(b)(3)) ..................... 92
`
`D.
`
`Service Information (37 C.F.R. §42.8(b)(4)) ............................... 92
`
`E.
`
`Grounds for Standing (37 C.F.R. §42.104) .................................. 93
`
`F.
`
`Payment of Fees (37 C.F.R. §42.15(a)) ....................................... 93
`
`XII. CONCLUSION ....................................................................................... 93
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ...................................... 90
`
`Imperative Care v. Inari Medical, Inc.,
`IPR2024-01157, Paper 5 (Oct. 29, 2024) .............................................. 79, 85
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................. passim
`
`In re Nilssen,
`851 F.2d 1401 (Fed. Cir. 1988) ................................................................... 18
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ................................................................... 13
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ..................................................................... 17
`
`OTHER AUTHORITIES
`
`35 U.S.C. §102 .................................................................................................. 17
`
`37 C.F.R. §1.11 ................................................................................................. 79
`
`37 C.F.R. §42.100 ............................................................................................. 13
`
`
`
`-vi-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
` U.S. Patent No. 11,969,333 (“the ’333 patent”)
`
`’333 Patent Prosecution History
`
`Expert Declaration of Troy Thornton
`
`Resume of Troy Thornton
`
`U.S. Patent No. 8,734,374 B2 to Aklog et al. (“Aklog”)
`
`U.S. Patent Publication No. 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`1007 WIPO Publication No. WO 2006/124307 A2 to Goff et al. (“Goff”)
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`U.S. Patent Publication No. 2003/0116731 A1 to Hartley
`(“Hartley”)
`
`U.S. Patent No. 6,776,770 B2 to Trerotola (“Trerotola”)
`
`U.S. Patent Publication No. 2010/0042118 A1 to Garrison et al.
`
`U.S. Patent No. 8,535,283 B2 to Heaton et al. (“Heaton”)
`
`U.S. Patent Publication No. 2017/0043066 A1 to Laub (“Laub”)
`
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`
`U.S. Patent No. 5,938,645 to Gordon (“Gordon”)
`
`U.S. Patent Publication No. 2014/0296868 A1 to Garrison et al.
`
`U.S. Patent No. 7,998,104 B2 to Chang (“Chang”)
`
`U.S. Patent No. 8,157,760 B2 to Criado et al. (“Criado”)
`
`U.S. Patent No. 6,481,439 B1 to Lewis et al. (“Lewis”)
`
`U.S. Patent No. 8,075,510 B2 to Aklog et al.
`
`Exhibit List, Page 1
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1020 WIPO Publication No. WO 2018/019829 A1 to Brady et al.
`(“Brady”)
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`U.S. Patent Application No. 16/117,519 (the “519 application”)
`
`Expert Declaration of Dr. Aquilla S. Turk, III, DO
`
`Resume of Dr. Aquilla Turk, III, D.O.
`
`Shani, Jacob M.D., et al., Mechanical Manipulation of Thrombus:
`Coronary Thrombectomy, Intracoronary Clot Displacement, and
`Transcatheter Aspiration, 72 Am. J. Cardiol. 116G-118G (1993)
`
`Bose, A et al., The Penumbra System: A Mechanical Device for the
`Treatment of Acute Stroke due to Thromboembolism, 29 Am. J.
`Neuroradiol. 1409-1413 (Aug. 2008)
`
`Turk, Aquilla S. et al., Initial clinical experience with the ADAPT
`technique: A direct aspiration first pass technique for stroke
`thrombectomy, 6 J. NeuroIntervent. Surg. 231-237 (2014)
`
`Turk, Aquilla S. et al., ADAPT FAST study: a direct aspiration first
`pass technique for acute stroke thrombectomy, 6 J. NeuroIntervent.
`Surg. 260-264 (2014)
`
`April 24, 2024 Letter from Inari to Imperative Care
`
`Turk, Aquilla S. et al., Aspiration thrombectomy versus stent
`retriever thrombectomy as first-line approach for large vessel
`occlusion (COMPASS): a multicentre, randomized, open label,
`blinded outcome, non-inferiority trial, 393 Lancet 998-1008 (March
`2019)
`
`Save, Jeffrey L., Time is Brain – Quantified, American Heart
`Association Journals, available at http://www.stokeaha.org (2005).
`
`U.S. Patent No. 9,980,813 B1 to Eller (“Eller”)
`
`US 2018/0064453 Al (“Garrison II”)
`
`US 2005/0054995 Al (“Barzell”)
`
`Exhibit List, Page 2
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`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)
`
`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)
`
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`Patent Owner’s Exhibit 2002 filed in Imperative Care, Inc. v. Inari
`Medical, Inc., IPR2025-00289 (P.T.A.B.)
`
`Indigo Aspiration System-Penumbra Engine Pump and Canister,
`510(k) No. K180105 (Mar. 8, 2018) (“Indigo Aspiration System”)
`
`AXS Universal Aspiration Set Brochure (2017)
`
`VacLok Negative Pressure Syringe Brochure
`
`O. Nikoubashman et al., Under Pressure: Comparison of Aspiration
`Techniques for Endovascular Mechanical Thrombectomy, 39 Am.
`J. Neuroradiol. 905-909 (May 2018) (“Nikoubashman”)
`
`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)
`
`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)
`
`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)
`
`Decision Denying Institution of Inter Partes Review for U.S.
`Patent No. 11,744,691 (Paper 10) in Imperative Care, Inc. v. Inari
`Medical, Inc., IPR2024-01257 (P.T.A.B. Feb. 7, 2025)
`
`U.S. Patent No. 7,984,730 B2 to Ziv et al.
`
`Imperative Care’s Opposition to Inari’s Motion for Leave to File
`Third Amended Complaint (Dkt. #98) in Inari Medical, Inc. v.
`
`Exhibit List, Page 3
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1048
`
`1049
`
`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)
`
`Ahmed Pasha et al., Successful Management of Acute Massive
`Pulmonary Embolism Using Angiovac Suction Catheter Technique
`in a Hemodynamically Unstable Patient, 15 Cardiovasc. Revasc.
`Med. 240-243 (2014)
`
`1050
`
`Certified File History of U.S. Patent Application 10/371,190
`(Schaffer File History)
`
`1051 Maureen Kohi, Catheter Directed Interventions for Acute Deep
`Vein Thrombosis, 6 Cardiovasc. Diagn. Ther. 599-611 (2016)
`
`
`
`Exhibit List, Page 4
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of Claims 1-12, 14-31, and 33-38 of U.S. Patent No. 11,969,333 (“the ’333
`
`patent,” Ex. 1001), which is assigned to Inari Medical, Inc. (“Patent Owner” or
`
`“PO”).
`
`I. INTRODUCTION
`
`Patent Owner has asserted Claims 1-4, 6-12, 14-23, 25-31, and 33-38 against
`
`Petitioner in the co-pending district court litigation (the “Litigation”). See Ex. 1042
`
`(PO’s infringement contentions). The Litigation is in its early stages and no trial
`
`date has been set. (See Ex. 1043, 2 (representing that “discovery is at an early
`
`stage”); Ex. 1044 (setting case schedule to claim construction).) PO has also alleged
`
`that Petitioner’s future products may infringe Claims 5 and 24. Therefore, Petitioner
`
`challenges the patentability of these claims in this IPR.
`
`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 and methods to
`
`remove such undesirable material from the vasculature, including catheter-based
`
`systems that aspirate (i.e., suction) the material from the blood vessel.
`
`The ’333 patent claims methods of aspirating clot material to treat a
`
`pulmonary embolism (“PE”) or deep vein thrombosis (“DVT”). However, the patent
`
`provides little description regarding what is new and nonobvious about the claimed
`
`-1-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`methods. 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, 2:33-46.) Yet, the ’333 patent
`
`does not explain how the claimed methods address these alleged shortcomings.
`
`Instead, the claims merely recite a method of treating clots using conventional
`
`aspiration components, including an aspiration source (e.g., pump or syringe) [red],
`
`an aspiration catheter [orange], a filter [blue], a valve positioned in the fluid path
`
`[purple], and a hemostasis valve [yellow]:
`
`(Id., Fig. 20C.) Aspiration catheters having these conventional components were
`
`known before August 2018, the earliest claimed priority date of the ’333 patent.
`
`
`
`-2-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Laub, a prior art patent application published in February 2017, discloses an
`
`aspiration “system for removing thrombi and other unwanted material from the body
`
`of a patient, particularly from the patient’s vasculature.” (Ex. 1012, [0005].) Laub
`
`describes using its system to treat PE or DVT. (Id., [0005], [0025].) Like the
`
`aspiration systems in the ’333 patent, Laub’s system includes an aspiration catheter
`
`200 [orange], a fluid path 250 [green] that places the catheter in communication with
`
`a pump 400 [red], and a filter [blue] positioned between the catheter and pump:
`
`(Ex. 1012, [0024], [0039]-[0040], Fig. 1A.) Laub was not of record during
`
`prosecution of the ’333 patent.
`
`
`
`-3-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Aklog, a prior art patent issued in May 2014, also discloses an aspiration
`
`system for removing PEs and DVTs from blood vessels. (Ex. 1005, 2:7-32, 7:27-
`
`42.) Aklog’s system includes an aspiration source [red], an aspiration catheter
`
`[orange], and a clot canister with a filter [blue].
`
`(Id., Fig. 7.) Aklog also discloses ways to optimize aspiration systems to treat PE
`
`and DVT, including returning the aspirated blood to the patient to reduce blood loss.
`
`(Id., 1:17-24.) Aklog was not of record during prosecution of the ’333 patent.
`
`
`
`-4-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Aklog’s parent (Patent No. 8,075,510), which does not include Figure 7 above, was
`
`listed on an IDS but not applied by the Examiner.
`
`The ’333 patent claims also recite the steps of (1) generating vacuum pressure
`
`within the clot canister while a valve along the fluid path is in a first position that
`
`inhibits flow along the fluid path and (2) moving the valve to a second position to
`
`open the valve and apply vacuum pressure to aspirate the clot material into clot
`
`canister. The ’333 patent speculates that “pre-charging or storing the vacuum before
`
`applying the vacuum to the lumen 104 of the catheter 102 is expected to generate
`
`greater suction forces (and corresponding fluid flow velocities) at and/or near the
`
`distal portion 103a of the catheter 102 compared to simply activating the pressure
`
`source 140.” (Ex. 1001, 6:55-7:23.) However, as shown below, aspiration catheters
`
`that could release a stored vacuum were not new.
`
`Garrison, a prior art patent application published in June 2015, describes an
`
`aspiration system for removing unwanted material from a patient’s vasculature.
`
`Garrison’s aspiration system includes the same components as Claim 1 of the ’333
`
`patent: an aspiration source [red], an aspiration catheter [orange], a clot canister with
`
`a filter [blue], hemostasis valves [yellow], and a user-actuatable valve [purple] that
`
`is closed while the aspiration source generates vacuum pressure and opened after the
`
`pressure is generated to cause aspiration through the catheter.
`
`-5-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`(Ex. 1006, [0134], Fig. 34.)
`
`The ’333 patent claims are directed to methods of treating a PE or DVT.
`
`Garrison discloses methods of removing cerebral occlusions but does not
`
`specifically mention PE or DVT. However, as shown herein, similar aspiration
`
`-6-
`
`
`
`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`systems were disclosed in both Laub and Aklog for treating PE and DVT, and a
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`person of ordinary skill in the art (“POSITA”) would have found it obvious to
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`incorporate Garrison’s valve (e.g., stopcock) into Laub’s or Aklog’s systems to
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`enable “the maximum level of aspiration in a rapid fashion.” (Id., [0134].) POSITAs
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`would have also found it obvious to use and optimize Garrison’s aspiration system
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`to treat PE or DVT based on Laub and Aklog.
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`Fundamentally, the challenged claims merely recite methods of using known
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`aspiration systems or combinations of known aspiration systems with prior art
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`components according to their known functions to predictably aspirate known clots.
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The prior art grounds
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`identified in this Petition show a reasonable likelihood that one or more claims of
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`the ’333 patent are unpatentable. Thus, Petitioner requests that the Board institute
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`this IPR to reconsider the patentability of the ’333 patent.
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`II. THE ’333 PATENT
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`A. Overview
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`The ’333 patent describes an aspiration system for intravascular removal of
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`clot material. (Ex. 1001, 4:17-4:33.) The ’333 patent alleges that the system can
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`treat various clots including PE, cerebral embolism, and DVT. (Id., 4:51-4:58.) The
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`aspiration system comprises an “assembly 10” including “catheter subsystem 100”,
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`“pressure source 140,” and “tubing subsystem 120.” (Id., 5:28-5:30.)
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`The catheter subsystem includes an aspiration catheter 102 [orange]
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`“comprising an elongated shaft defining a lumen 104,” and a “valve 106” [yellow]
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`with a “lumen 109 extending therethrough.” (Id., 5:23-5:50.) The valve “is
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`configured to maintain hemostasis during a clot removal procedure by preventing
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`fluid [blood] flow in the proximal direction through the valve 106.” (Id.)
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`(Id., Fig. 1.)
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`The pressure source [red, below] is “configured to generate (e.g., form, create,
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`charge, build-up, etc.) a vacuum (e.g., negative relative pressure) and store the
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`vacuum for subsequent application to the catheter subsystem 100.” (Id., 6:57-6:60.)
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`“[T]he pressure source can be a pump (e.g., an electric pump coupled to a vacuum
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`chamber) while, in other embodiments, the pressure source can include one or more
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`syringes ….” (Id., 7:33-7:41.)
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`(Id., Figs. 1, 3D.) The tubing subsystem “fluidly couples the catheter subsystem 100
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`to the pressure source 140.” (Id., 6:6-6:7.) The tubing subsystem can include “one
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`or more tubing sections 124,” at least one “fluid control device 126” such a stopcock,
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`and at least one “connector 128 for fluidly coupling the tubing subsystem 120 to the
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`pressure source 140 and/or other suitable components.” (Id., 6:6-6:23.)
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`
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`(Id., Fig. 1.)
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`During operation, a user “can first close the fluid control device 126 before
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`activating the pressure source 140 to build up vacuum pressure within the pressure
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`source 140 (e.g., a vacuum chamber of the pressure source 140).” (Id., 6:62-6:66.)
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`After pressure is generated, “the user can actuate (e.g., twist a handle of) the fluid
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`control device 126 to open the fluid control device 126.” (Id., 18:42-18:48.)
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`Opening the fluid control device 126 will “fluidly connect the pressure source 140
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`to the catheter subsystem 100 and thereby apply or release the vacuum stored in the
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`pressure source 140 to the lumen 104 of the catheter 102.” (Id., 7:1-7:8.)
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`
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`(Id., Fig. 9C.)
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`B.
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`Prosecution History
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`The Examiner rejected the original Claims 1-6, 11-14, 16-18, and 20-22 as
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`obvious in view of US 2018/0064453 Al (“Garrison II”) 1 (Ex. 1032) in combination
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`
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`1 Garrison II is not in the same patent family as Garrison (Ex. 1006) and does
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`not disclose the embodiments relied on in this Petition, including those in Figures
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`33-34. Infra §§VI.A.2.
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`-11-
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`
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`with US 2005/0054995 Al (“Barzell”) (Ex. 1033) and US 8535283 B2 (“Heaton”)
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`(Ex. 1011). (Ex. 1002, 156-173.) The Examiner found that Garrison II disclosed
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`every limitation of the independent claim except: (1) a filter positioned within the
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`clot canister and configured to filter blood from the clot material and (2) a flow path
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`extending from the lumen of the aspiration catheter, through the clot canister, and to
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`the aspiration source. (Id., 157-159.) The Examiner cited Barzell for a filter and
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`Heaton for the flow path. (Id., 159-160.)
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`Following the Examiner’s rejection, PO conducted an interview and filed an
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`amendment cancelling all pending claims and adding new Claims 23-60 (which
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`issued as Claims 1-38). (Id., 98-100, 109-115.) During the interview, PO argued
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`that a POSITA would not have found it obvious to treat PE or DVT with the
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`aspiration system in Garrison II as modified by Barzell and Heaton. (Id., 98-100,
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`116.) Relying on PO’s representations, the Examiner allowed the new claims,
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`stating that a POSITA “would not have looked to use the Garrison device” to treat
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`PE or DVT and that “the device of Garrison would not be combinable with the device
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`of Garrison [SIC] to teach a method of treating [PE] or [DVT].” (Id., 46-47.) The
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`Examiner cited no evidentiary support but merely stated: “Garrison [II] specifically
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`teaches the aspiration catheter being used for neurovascular procedures.” (Id., 47.)
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`C. Earliest Possible Priority Date
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`The ’333 patent claims priority to two provisional applications 62/554,931
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`and 62/718,269, both filed August 13, 2018, which is the earliest possible priority
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`date for the ’333 patent. (Ex. 1001.) Petitioner applies this earliest priority date in
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`this Petition; however, Petitioner reserves its right to challenge the priority date of
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`the ’333 patent in subsequent proceedings.
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`III. LEVEL OF ORDINARY SKILL
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`A POSITA in August 2018 would have had an undergraduate degree in
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`mechanical engineering or a related engineering discipline and 2-4 years of catheter
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`design experience and, where necessary, would have consulted with a physician
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`regarding the methods of treatment. (Ex. 1003, ¶35.)
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`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). However, “the specification may reveal a
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`special definition given to a claim term by the patentee that differs from the meaning
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`it would otherwise possess [and i]n such cases, the inventor's lexicography governs.”
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`Id. at 1316.
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`Claims 11-12 and 30-31 of the ’333 patent require a hemostasis valve having
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`a “filament” and that decreasing/increasing tension on the filament opens/closes the
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`valve. (Ex. 1001, Claims 11, 30.) The claim language does not provide a POSITA
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`with guidance on the meaning of “filament,” other than reciting that altering tension
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`on the filament provides or inhibits fluid access to the aspiration catheter.
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`Further, the ’333 patent specification does not describe a hemostasis valve
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`having a filament. In fact, the word “filament” does not appear in the ’333 patent
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`(other than in Claims 11-12 and 30-31). If this limitation has support in the ’333
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`patent, the support must be incorporated by reference from another patent
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`application describing a filament.2 (See Ex. 1001, 5:56-61 (purporting to incorporate
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`by reference “U.S. patent application Ser. No. 16/117,519 … titled ‘HEMOSTASIS
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`VALVES AND METHODS OF USE’”) (the “’519 application”, Ex. 1021.))
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`The ’519 application identifies examples of “filaments” that expand the
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`meaning of “filament” beyond the plain and ordinary meaning. The ’519 application
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`states, “the filament 150 can comprise one or several threads, lines, cords, rope,
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`ribbon, flat wire, sheet, or tape.” (Ex. 1021, [0047].) The patent also states, “the
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`filament can be made from a variety of materials including, for example, a polymer,
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`2 Petitioner reserves its right to challenge in future proceedings whether PO
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`has effectively incorporated the material into the ’333 patent.
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`IPR Petition – Patent 11,969,333
`Imperative Care, Inc. v. Inari Medical Inc.
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`a synthetic, and/or a metal.” (Id.) The application further states, “the filament can
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`comprise a single strand such as, for example, a monofilament, [or] the filament can
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`comprise a plurality of strands that can be, for example, twisted, woven, grouped,
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`and/or fused to form the filament.” (Id.) Additionally, the ’519 application explains
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`that “the filament 150 can comprise multiple filaments and specifically, as shown in
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`Figures 7 through 9, the filament 150 can comprise a first filament 150-A and a
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`second filament 150-B.” (Id., [0065].)
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`Given the above descriptions, a POSITA would have understood the claim
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`term “filament” to mean at least “one or more
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