Filed May 20, 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: BoxImperative910@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. IPR2025-01025
`Patent No. 11,974,910
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,974,910
`
`
`
`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: BoxImperative910@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. IPR2025-01025
`Patent No. 11,974,910
`__________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,974,910
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................ 1
`
`THE ’910 PATENT ...................................................................................... 8
`
`A.
`
`B.
`
`C.
`
`Overview ............................................................................................ 8
`
`Prosecution History .......................................................................... 15
`
`Earliest Possible Priority Date .......................................................... 18
`
`III.
`
`LEVEL OF ORDINARY SKILL ............................................................... 18
`
`IV. CLAIM CONSTRUCTION ....................................................................... 19
`
`V.
`
`STATEMENT OF RELIEF REQUESTED ............................................... 21
`
`A.
`
`B.
`
`C.
`
`IPR Grounds ..................................................................................... 21
`
`The Asserted References Are Prior Art ........................................... 21
`
`The Asserted References Are Analogous Art .................................. 22
`
`VI. GROUNDS 1-3: GARRISON COMBINED WITH LAUB
`AND/OR AKLOG RENDERS CLAIMS 1-6, 8, 11-15, 18-20
`UNPATENTABLE ..................................................................................... 22
`
`A.
`
`Independent Claim 1 ........................................................................ 22
`
`1.
`
`2.
`
`3.
`
`4.
`
`Preamble ................................................................................. 23
`
`A First Clot Assembly ........................................................... 34
`
`First Fluid Control Device ..................................................... 35
`
`The First Pressure Source is Configured to Generate
`Vacuum Pressure.................................................................... 37
`
`5.
`
`Second Clot Aspiration Assembly ......................................... 39
`
`i
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`a.
`
`b.
`
`c.
`
`Laub ............................................................................. 42
`
`Aklog ........................................................................... 43
`
`Garrison and Laub or Aklog ........................................ 45
`
`6.
`
`7.
`
`8.
`
`Second Pressure Source ......................................................... 48
`
`Second Fluid Control Device ................................................. 49
`
`The Second Pressure Source is Configured to
`Generate Vacuum Pressure .................................................... 54
`
`9.
`
`The Vacuum Pressure is Applied ........................................... 56
`
`Claim 2 ............................................................................................. 57
`
`Claim 3 ............................................................................................. 59
`
`Claim 4 ............................................................................................. 62
`
`Claim 5 ............................................................................................. 65
`
`Claim 6 ............................................................................................. 67
`
`Claim 8 ............................................................................................. 70
`
`Independent Claim 11 ...................................................................... 71
`
`Claim 12 ........................................................................................... 73
`
`Claim 13 ........................................................................................... 73
`
`Claim 14 ........................................................................................... 73
`
`Claim 15 ........................................................................................... 74
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
`
`K.
`
`L.
`
`M.
`
`Claim 18 ........................................................................................... 74
`
`ii
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`N.
`
`O.
`
`Claim 19 ........................................................................................... 74
`
`Claim 20 ........................................................................................... 75
`
`VII. GROUNDS 4-6: GARRISON COMBINED WITH LAUB,
`AKLOG, AND/OR HARTLEY RENDERS CLAIMS 6-7, 20
`UNPATENTABLE ..................................................................................... 75
`
`A.
`
`B.
`
`C.
`
`Claim 6 ............................................................................................. 75
`
`Claim 7 ............................................................................................. 75
`
`Claim 20 ........................................................................................... 82
`
`VIII. GROUNDS 7-9: GARRISON COMBINED WITH LAUB
`AND/OR AKLOG AND PASHA .............................................................. 83
`
`A.
`
`B.
`
`Claim 3 ............................................................................................. 83
`
`Claims 12 and 18 .............................................................................. 85
`
`IX.
`
`SECONDARY CONSIDERATIONS ........................................................ 85
`
`X.
`
`SOTERA STIPULATION ........................................................................... 85
`
`XI. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT ............................................................................... 85
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) .............................. 85
`
`Related Matters (37 C.F.R. §42.8(b)(2)) .......................................... 86
`
`Lead and Backup Counsel (37 C.F.R. §42.8(b)(3)) ......................... 87
`
`Service Information (37 C.F.R. §42.8(b)(4)) ................................... 88
`
`Grounds for Standing (37 C.F.R. §42.104) ...................................... 88
`
`iii
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`F.
`
`Payment of Fees (37 C.F.R. §42.15(a)) ........................................... 88
`
`XII. CONCLUSION ........................................................................................... 89
`
`iv
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ............................................. 85
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`In re Nilssen,
`851 F.2d 1401 (Fed. Cir. 1988) .......................................................................... 22
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 19
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ............................................................................ 22
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) ............................................................................ 19
`
`OTHER AUTHORITIES
`
`35 U.S.C. §102 ......................................................................................................... 21
`
`35 U.S.C. §103 ......................................................................................................... 23
`
`35 U.S.C. §112 ......................................................................................................... 62
`
`37 C.F.R. §42.8 ............................................................................................. 85,86, 87
`
`37 C.F.R. §42.15 ...................................................................................................... 88
`
`37 C.F.R. §42.100 .................................................................................................... 19
`
`37 C.F.R. §42.104 .................................................................................................... 88
`
`vi
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Description
`Exhibit No.
` U.S. Patent No. 11,974,910 (“the ’910 patent”)
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`’910 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.
`
`U.S. Patent No. 8,075,510 B2 to Aklog et al.
`
`1020 WIPO Publication No. WO 2018/019829 A1 to Brady et al.
`(“Brady”)
`
`Exhibit List, Page 1
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`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”)
`
`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)
`
`Exhibit List, Page 2
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Exhibit No.
`
`Description
`
`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. 11,697,012 (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.
`Imperative Care, Inc., 24-cv-03117-EKL (N.D. Cal.) (filed March
`26, 2025)
`
`Exhibit List, Page 3
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Exhibit No.
`
`1048
`
`Description
`
`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)
`
`1049
`
`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)
`
`1052
`
`1053
`
`
`
`Interview Summary from U.S. Patent Application No. 18/329,450
`dated January 31, 2024
`
`Claim Construction Expert Report of Troy Thornton in Inari
`Medical, Inc. v. Imperative Care, Inc., 24-cv-03117-EKL (N.D.
`Cal.)
`
`Exhibit List, Page 4
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of claims 1-8, 11-15, and 18-20 (“the challenged claims”) of U.S. Patent
`
`No. 11,974,910 (“the ’910 patent,” Ex.1001), which is assigned to Inari Medical,
`
`Inc. (“Patent Owner” or “PO”).
`
`I. INTRODUCTION
`
`Patent Owner has asserted claims 1-8, 11-15, and 18-20 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 at 2 (representing to Court that “discovery is at an early
`
`stage”); Ex. 1044 (setting case schedule to claim construction).) Therefore,
`
`Petitioner challenges the patentability of the asserted 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 to remove such
`
`undesirable material from the vasculature, including catheter-based systems that
`
`aspirate (i.e., suction) the material from the blood vessel.
`
`The ’910 patent claims such a clot treatment 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
`
`1
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`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.) However, the ’910
`
`patent does not explain how the claimed system addresses these alleged
`
`shortcomings.
`
`Instead, the claims describe a clot treatment system comprised of two clot
`
`aspiration assemblies having conventional aspiration components, including first
`
`and second catheters [orange], first and second pressure sources [red], two valves
`
`[yellow], and first and second fluid control devices [purple] to fluidly connect and
`
`disconnect the pressure source from the catheter:
`
`(Id., Fig. 11.) As demonstrated below, clot treatment systems having these
`
`conventional components were known and used before August 2018, the earliest
`
`
`
`claimed priority date of the ’910 patent.
`
`2
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Garrison, a prior art patent application published in June 2015, describes clot
`
`treatment systems for removing clots from patients. In one embodiment, Garrison
`
`describes an aspiration system having (1) a first clot aspiration assembly with a first
`
`catheter and first pressure source [red] and (2) a second clot aspiration assembly with
`
`a second catheter and a second pressure source [orange]:
`
`(Ex. 1006, [0131]-[0134], Fig. 33). In related embodiments, Garrison incorporates
`
`a valve 3325 (i.e., fluid control device) to fluidly connect and disconnect the pressure
`
`
`
`source from the catheter(s):
`
`3
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., [0132], Fig. 34.)
`
`During prosecution of the ’910 patent, the Examiner found that Garrison
`
`disclosed almost every limitation of claim 1. (Ex. 1002, 43-51.) The only limitations
`
`the Examiner did not find in Garrison were a description of using Garrison’s system
`
`to treat a pulmonary embolism (“PE”) and a second catheter having a size of 16
`
`French or greater.
`
`4
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Garrison describes using its clot treatment system to remove cerebral clots but
`
`does not expressly mention PEs. (Ex. 1006, [0002].) Garrison discloses removing
`
`the clots with varying sizes of catheter, which generally range from 5 French to 10
`
`French. (See e.g., id., [0063], [0066], [0082], [0124].) The Examiner mistakenly
`
`allowed the ’910 patent over Garrison based on an interview with one of the named
`
`inventors in which the Examiner was convinced that “[i]t would be unreasonable to
`
`modify the clot treatment device of Garrison to be used for pulmonary embolisms.”
`
`(Ex. 1002, 43-51.) As shown herein, this is not true.
`
`Treating PEs with a catheter size 16 French or greater was not new. Laub, a
`
`prior art patent application published in February 2017, discloses a clot treatment
`
`“system for removing thrombi and other unwanted material from the body of a
`
`patient, particularly from the patient’s vasculature.” (Ex. 1007, [0005].) Laub was
`
`not before the Examiner. Laub expressly describes using aspiration catheters having
`
`a size of 16 French or greater to treat PE, the very limitations that were allegedly
`
`missing from the prior art. (Id.; see also id., [0028].) Like Garrison, Laub’s clot
`
`treatment system includes an aspiration catheter connected to a pump (i.e., pressure
`
`source) and a filter:
`
`5
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`(Id., [0024], [0039]-[0040], Fig. 1A.) Laub discloses using catheters ranging from
`
`5 French to 20 French and specifically describes, “[i]n some embodiments,
`
`aspiration catheter 200 has a French size of at least 16 Fr.” (Id., [0028] (emphasis
`
`
`
`added).)
`
`Aklog, a prior art patent issued in May 2014, also discloses a clot treatment
`
`system for removing PEs from blood vessels. (Ex. 1005, 2:7-32, 7:27-42.) Aklog
`
`also was not before the Examiner. Like Garrison and Laub, Aklog’s system includes
`
`an aspiration catheter [orange] coupled to a pump (i.e., pressure source) [red], and a
`
`filter device [blue].
`
`6
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., Fig. 7.) Aklog discloses that the catheter “may be of any sufficient size, so long
`
`as it can be accommodated within a predetermined vessel, such as a medium to large
`
`size blood vessel.” (Id., 11:12-15.) Aklog specifically discloses use of its catheters
`
`in the “pulmonary circulation (e.g., pulmonary arteries).” (Id., 5:34-35.)
`
`
`
`As demonstrated below, a person of ordinary skill in the art (“POSITA”)
`
`would have found it obvious to use Garrison’s clot treatment system to treat PE and
`
`7
`
`
`
`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`to upsize one or more of Garrison’s catheters to 16 French or larger based on Laub
`
`and Aklog. The challenged claims merely recite using known clot treatment systems
`
`and prior art catheter components according to their known functions to predictably
`
`aspirate known clots (i.e., PE). KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
`
`(2007). Thus, the prior art grounds identified in this Petition show a reasonable
`
`likelihood that one or more claims of the ’910 patent are unpatentable. Accordingly,
`
`Petitioner requests that the Board institute this IPR to reconsider the patentability of
`
`the ’910 patent.
`
`A. Overview
`
`II. THE ’910 PATENT
`
`The ’910 patent describes an aspiration system for intravascular removal of
`
`clot material and alleges that the system can treat various clots including PE, cerebral
`
`embolism, and DVT. (Ex. 1001, 4:17-58.) The aspiration system includes an
`
`“assembly 10” having a “catheter subsystem 100,” “pressure source 140,” and
`
`“tubing subsystem 120.” (Id., 5:25-30.) The catheter subsystem also has a catheter
`
`102 [orange below] “comprising an elongated shaft defining a lumen 104,” and a
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`“valve 106” [yellow below] with a “lumen 109 extending therethrough.” (Id., 5:30-
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`40.)
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`The ’910 patent discloses the pressure source [red] is “configured to generate
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`(e.g., form, create, charge, build-up, etc.) a vacuum (e.g., negative relative pressure)
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`8
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`and store the vacuum for subsequent applications to the catheter subsystem 100.”
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`(Id., 6:57-60.) “[T]he pressure source can be a pump (e.g., an electric pump coupled
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`to a vacuum chamber) while, in other embodiments, the pressure source can include
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`one or more syringes that can be actuated or otherwise activated by a user of the
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`assembly 10 to generate and store a vacuum therein.” (Id., 7:36-41.)
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`
`
`
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`(Id., Figs. 1, 3D.)
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`9
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`The ’910 patent explains that the tubing subsystem “fluidly couples the
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`catheter subsystem 100 to the pressure source 140.” (Id., 6:6-7.) The tubing
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`subsystem can include “one or more tubing sections 124” [green], at least one “fluid
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`control device 126” [purple] such as a stopcock, and at least one “connector 128 for
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`fluidly coupling the tubing subsystem 120 to the pressure source 140 and/or other
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`suitable components.” (Id. 6:6-24.)
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`
`
`(Id., Fig. 1.)
`
`The ’910 patent explains that a user “can first close the fluid control device
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`126 before activating the pressure source 140 to build up vacuum pressure within
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`the pressure source 140 (e.g., a vacuum chamber of the pressure source 140).” (Id.,
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`10
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`6:62-66.) After pressure is generated, “the user can actuate (e.g., twist a handle of)
`
`the fluid control device 126 to open the fluid control device 126.” (Id., 18:44-48.)
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`Opening the fluid control device 126 will “fluidly connect the pressure source 140
`
`to the catheter subsystem 100 and thereby apply or release the vacuum stored in the
`
`pressure source 140 to the lumen 104 of the catheter 102.” (Id., 7:3-8.)
`
`
`
`(Id., Fig. 9C.) The ’910 patent also explains that “[o]pening of the fluid control
`
`device 126 instantaneously or nearly instantaneously applies the stored vacuum
`
`pressure to the tubing subsystem 120 and the catheter 102, thereby generating
`
`suction throughout the catheter 102.” (Id., 7:8-12.)
`
`The ’910 patent describes variations of the aspiration system described above.
`
`For example, the ’910 patent describes a variation with “a first aspiration assembly
`
`11
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`20 and a second aspiration assembly 30.” (Id., 20:60-62.) The ’910 patent explains
`
`that “the first and second aspiration assemblies 20, 30 (“assemblies 20, 30”) include
`
`some features generally similar to the features of the aspiration assembly 10
`
`described in detail above with reference to FIGS. 1-10B.” (Id., 20:62-66.) For
`
`example, the ’910 patent explains that the aspiration system includes a first
`
`aspiration assembly 20 having a “first catheter subsystem 1000,” “first pressure
`
`source 1040,” and “first tubing subsystem 1020.” (Id., 20:65-21:5.) Similarly, the
`
`aspiration system includes a second aspiration assembly 30 having a “second
`
`catheter subsystem 1100,” “second pressure source 1140,” and “second tubing
`
`subsystem 1120.” (Id., 21:5-12.)
`
`The ’910 patent explains that the first tubing subsystem fluidly couples the
`
`first catheter subsystem 1000 to the first pressure source 1040 [red], and the second
`
`tubing subsystem fluidly couples the second catheter subsystem 1100 to the second
`
`pressure source 1140 [red]. (Id., 20:65-21:12.) The first catheter subsystem also has
`
`a first catheter 1002 [red] “comprising an elongated shaft defining a lumen 1004,” a
`
`“valve 1006” [yellow] with a “lumen 1009… extending therethrough”, and a “first
`
`fluid control device 1026” [purple]. (Id., 21:13-23.) The second catheter subsystem
`
`has a “second catheter… 1102” [orange] defining a “lumen… 1104,” and a “second
`
`valve… 1106” [yellow] with a “lumen… 1109 extending therethrough,” and a
`
`“second fluid control device 1126” [purple]. (Id.) The first fluid control device 1026
`
`12
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`is configured to “regulate or control fluid flow between (e.g., fluidly connect or
`
`disconnect) the first pressure source 1040 and the first catheter subsystem 1000”.
`
`(Id., 21:20-23.) Likewise, the second fluid control device 1126 is configured to
`
`“regulate or control fluid flow between (e.g., fluidly connect or disconnect) the
`
`second pressure source 1140 and the second catheter subsystem 1100”:
`
`
`
`(Id., 21:23-27, Figure 11.)
`
`The ’910 patent explains that the second catheter 1102 can be inserted through
`
`the “first valve 1006” and “can be telescoped through the lumen 1004 of the first
`
`catheter 1002”. (Id., 21:28-36.) The second catheter 1102 can “have a size of 16
`
`French or smaller” and the first catheter 1102 can “have a size of 20 French or
`
`greater.” (Id., 21:36-40.) The ’910 patent further explains that the first pressure
`
`source and second pressure source can “be activated to generate and store a vacuum”
`
`13
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`for subsequent application. (Id., 23:26-29.) The first fluid control device 1026 can
`
`be opened “to generate suction at the distal portion 1003a of the first catheter 1002.”
`
`(Id., 23:48-52.) Similarly, the second fluid control device 1126 can be opened “to
`
`apply the vacuum stored in second pressure source 1140 to the lumen 1104 of the
`
`second catheter 1102.” (Id., 23:30-33.)
`
`The ’910 patent does not describe the structure of any hemostasis valve.
`
`However, the ’910 patent purports to incorporate by reference “U.S. patent
`
`application Ser. No. 16/117,519” (the “’519 application” (Ex. 1017)). (Id., 5:56-61.)
`
`The ’519 application describes a valve having an “elongate member 132” that
`
`extends through the valve. (Ex. 1021, [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.)
`
`
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`14
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`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
`
`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].)
`
`B.
`
`Prosecution History
`
`The Examiner issued a single non-final rejection during prosecution. In the
`
`rejection, the Examiner found original claim 18 anticipated by Garrison. (Ex. 1002,
`
`373-382.) The Examiner also found that Garrison disclosed all the limitations of the
`
`other claims except “a second catheter advanceable through the first catheter.” (Id.)
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`The Examiner stated, “The second catheter (2045) does not advance through first
`
`catheter (2025), as shown in Figure 33.” (Id.) The Examiner continued, “There is
`
`no reason to advance the second catheter through the first catheter of Garrison.” (Id.)
`
`Clearly, the Examiner was confused about Garrison because items 2025 and 2045
`
`are not catheters, but “flow lines”:
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`15
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
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`
`
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`(Ex. 1006, [0131], Fig. 33.) Garrison’s catheter 2030 is clearly advanced through
`
`catheter 2010. (Id.)
`
`PO subsequently cancelled rejected claim 18 and amended the remaining
`
`claims to require a system “for treating clot material comprising a pulmonary
`
`embolism in the vasculature of a patient” and to specify that the second catheter in
`
`the system has a “size of 16 French or greater.” (Ex. 1002, 141-149.) PO argued
`
`that the amended claims “are further patentable over Garrison at least for the reasons
`
`16
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`
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`IPR Petition – Patent 11,974,910
`Imperative Care, Inc. v. Inari Medical Inc.
`
`discussed during the January 25th videoconference interview with the Examiner and
`
`his supervisor in the related U.S. Patent Application No. 18/329,450 (‘the ’450
`
`application’), and specifically the Examiner’s comments in the Applicant-Initiated
`
`Interview Summary mailed January 31, 2024 that ‘Attorney and Examiner agree that
`
`incorporating more structural claim language, i.e. diameter of the catheter, would
`
`make the claim 1 allowable over the prior art of Garrison.’” (Id.)
`
`The Summary was not made of record in the ’910 patent prosecution history.
`
`However, the Summary has been included as an exhibit here and it does not
`
`specifically state why the Attorney and Examiner reached their agreement. (Ex.
`
`1052.) The Summary merely adds that “Attorney and Examiner agree that the newly
`
`added method claims would be allowable for reciting the specific use in pulmonary
`
`embolism applications” and that “Dr. Tu [a named inventor on the ’910 Patent]
`
`discussed the differences between catheters used in cerebral occlusions vs.
`
`pulmonary embolisms and deep vein thrombosis.” (Id.) Notably, the ’910 patent
`
`does not include “method claims,” adding further ambiguity to the role the interview
`
`played during the ’910 patent prosecution.
`
`The Examiner subsequently allowed the claims of the ‘910 Patent. (Ex. 1002,
`
`43-51.) The Examiner found that Garrison teaches all the limitations of the cla
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