Filed July 8, 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: BoxImperative580@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. IPR2025-01264
`Patent No. 12,016,580
`__________________________________
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`
`U.S. PATENET NO. 12,016,580
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION .................................................................................... 1
`
`II. THE ’580 PATENT .................................................................................. 5
`
`A. Overview ........................................................................................ 5
`
`B.
`
`Prosecution History ...................................................................... 10
`
`C.
`
`Earliest Possible Priority Date ...................................................... 11
`
`III. LEVEL OF ORDINARY SKILL ........................................................... 11
`
`IV. CLAIM CONSTRUCTION ................................................................... 11
`
`V. STATEMENT OF RELIEF REQUESTED ........................................... 14
`
`A.
`
`IPR Grounds ................................................................................. 14
`
`B.
`
`The Asserted References Are Prior Art ....................................... 14
`
`C.
`
`The Asserted References Are Analogous Art .............................. 15
`
`VI. GROUNDS 1-8: GARRISON ALONE OR COMBINED WITH
`HARTLEY, SCHAFFER, AND/OR GOFF RENDERS CLAIMS
`1, 5-6, 9, 11-30, 33-34 UNPATENTABLE ............................................ 16
`
`A.
`
`Independent Claim 1 .................................................................... 16
`
`1.
`
`2.
`
`3.
`
`Preamble [1]: “A method for the intravascular
`treatment of clot material within a blood vessel” .............. 16
`
`Limitation [1A]: “positioning a distal portion of an
`elongated shaft proximate to the clot material within
`the blood vessel” ................................................................ 18
`
`Limitation [1B]: “pre-charging a vacuum in a
`pressure source” ................................................................. 19
`
`i
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`4.
`
`Limitation [1C]: “fluidly connecting the pressure
`source to the elongated shaft to apply the pre-charged
`vacuum to the elongated shaft to aspirate a first
`portion of the clot material into the elongated shaft” ........ 22
`
`5.
`
`Limitation [1D]: “unsealing an attachment member
`coupled to a proximal portion of the elongated shaft” ...... 23
`
`a.
`
`b.
`
`c.
`
`Garrison ................................................................... 23
`
`Garrison and Schaffer .............................................. 26
`
`Garrison and Hartley ............................................... 29
`
`6.
`
`7.
`
`Limitation [1E]: “advancing an interventional device
`distally through the attachment member and the
`elongated shaft” .................................................................. 32
`
`Limitation [1F]: “engaging the interventional device
`with a second portion of the clot material remaining
`in the blood vessel” ............................................................ 35
`
`B.
`
`Claim 5 ......................................................................................... 37
`
`C.
`
`Claim 6 ......................................................................................... 41
`
`D.
`
`Claim 9 ......................................................................................... 43
`
`E.
`
`F.
`
`Claim 11 ....................................................................................... 43
`
`Claim 12 ....................................................................................... 45
`
`G.
`
`Claim 13 ....................................................................................... 45
`
`H.
`
`Claim 14 ....................................................................................... 45
`
`I.
`
`Claim 15 ....................................................................................... 46
`
`ii
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`Tubular Member ................................................................ 46
`
`Filament ............................................................................. 47
`
`a.
`
`b.
`
`Schaffer .................................................................... 47
`
`Schaffer and Hartley ................................................ 49
`
`3.
`
`Button ................................................................................. 55
`
`J.
`
`Claim 16 ....................................................................................... 55
`
`K.
`
`Claim 17 ....................................................................................... 57
`
`L.
`
`Claim 18 ....................................................................................... 58
`
`M. Claim 19 ....................................................................................... 63
`
`N.
`
`Claim 20 ....................................................................................... 66
`
`O.
`
`Claim 21 ....................................................................................... 67
`
`P.
`
`Claim 22 ....................................................................................... 70
`
`Q.
`
`Claim 23 ....................................................................................... 71
`
`R.
`
`Claim 24 ....................................................................................... 71
`
`S.
`
`Claim 25 ....................................................................................... 71
`
`1.
`
`2.
`
`Garrison .............................................................................. 71
`
`Garrison and Goff .............................................................. 74
`
`T.
`
`Claim 26 ....................................................................................... 77
`
`U.
`
`Claim 27 ....................................................................................... 77
`
`V.
`
`Claim 28 ....................................................................................... 78
`
`iii
`
`

`

`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`W. Claim 29 ....................................................................................... 78
`
`X.
`
`Claim 30 ....................................................................................... 78
`
`Y.
`
`Claim 33 ....................................................................................... 80
`
`Z.
`
`Claim 34 ....................................................................................... 81
`
`VII. GROUNDS 9-14: GARRISON, SCHAFFER, HARTLEY
`AND/OR GOFF COMBINED WITH AKLOG AND/OR LAUB
`RENDERS CLAIM 10 UNPATENTABLE .......................................... 81
`
`A.
`
`Claim 10 ....................................................................................... 81
`
`VIII. SECONDARY CONSIDERATIONS .................................................... 90
`
`IX. SOTERA STIPULATION ....................................................................... 90
`
`X. MANDATORY NOTICES, GROUNDS FOR STANDING,
`AND FEE PAYMENT ........................................................................... 91
`
`A.
`
`Real Parties-In-Interest (37 C.F.R. §42.8(b)(1)) .......................... 91
`
`B.
`
`Related Matters (37 C.F.R. §42.8(b)(2)) ...................................... 91
`
`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)) ............................... 93
`
`E.
`
`F.
`
`Grounds for Standing (37 C.F.R. §42.104) .................................. 93
`
`Payment of Fees (37 C.F.R. §42.15(a)) ....................................... 93
`
`XI. CONCLUSION ....................................................................................... 94
`
`
`
`
`
`iv
`
`

`

`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ...................................... 91
`
`Imperative Care v. Inari Medical, Inc.,
`IPR2024-01157, Paper 5 (PTAB Oct. 29, 2024) ................................... 48, 52
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................. passim
`
`In re Nilssen,
`851 F.2d 1401 (Fed. Cir. 1988) ................................................................... 15
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ................................................................... 11
`
`Unwired Planet, LLC v. Google Inc.,
`841 F.3d 995 (Fed. Cir. 2016) ..................................................................... 15
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 102 ........................................................................................... 10, 14
`
`35 U.S.C. § 103 ................................................................................................. 14
`
`37 C.F.R. §42.8 ..................................................................................... 91, 92, 93
`
`37 C.F.R. §42.15 ............................................................................................... 93
`
`37 C.F.R. § 42.24 .............................................................................................. 95
`
`37 C.F.R. §42.100 ............................................................................................. 11
`
`37 C.F.R. §42.104 ............................................................................................. 93
`
`
`
`
`
`v
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
` U.S. Patent No. 12,016,580 (“the ’580 patent”)
`
`1002
`
`’580 Patent Prosecution History
`
`1003
`
`Expert Declaration of Troy Thornton
`
`1004
`
`Resume of Troy Thornton
`
`1005 WIPO Publication No. WO 2006/124307 A2 to Goff et al. (“Goff”)
`
`1006
`
`1007
`
`1008
`
`U.S. Patent Publication No. 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`
`U.S. Patent Publication No. 2003/0116731 A1 to Hartley
`(“Hartley”)
`
`1009
`
`U.S. Patent Publication No. 2015/0352325 A1 to Quick (“Quick”)
`
`1010
`
`U.S. Patent Publication No. 2010/0042118 A1 to Garrison et al.
`
`1011
`
`U.S. Patent No. 8,734,374 B2 to Aklog et al. (“Aklog”)
`
`1012
`
`U.S. Patent Publication No. 2017/0043066 A1 to Laub (“Laub”)
`
`1013
`
`U.S. Patent No. 6,776,770 B2 to Trerotola (“Trerotola”)
`
`1014
`
`U.S. Patent No. 5,938,645 to Gordon (“Gordon”)
`
`1015
`
`U.S. Patent Publication No. 2014/0296868 A1 to Garrison et al.
`
`1016
`
`1017
`
`Certified File History of U.S. Patent Application 10/371,190
`(Schaffer File History)
`
`U.S. Provisional Patent Application No. 62/554,931 (the “’931
`application”)
`
`Exhibit List, Page 1
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1018
`
`U.S. Patent No. 6,481,439 B1 to Lewis et al.
`
`1019
`
`U.S. Patent No. 5,256,150 to Quiachon et al.
`
`1020 WIPO Publication No. WO 2018/019829 A1 to Brady et al.
`(“Brady”)
`
`1021
`
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`1022
`
`Expert Declaration of Dr. Aquilla S. Turk, III, DO
`
`1023
`
`Resume of Dr. Aquilla Turk, III, D.O.
`
`1024
`
`1025
`
`1026
`
`1027
`
`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)
`
`1028
`
`April 24, 2024 Letter from Inari to Imperative Care
`
`1029
`
`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)
`
`1030
`
`Save, Jeffrey L., Time is Brain – Quantified, American Heart
`Association Journals, available at http://www.stokeaha.org (2005).
`
`Exhibit List, Page 2
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`Exhibit No.
`
`Description
`
`1031
`
`1032
`
`1033
`
`Decision Granting Institution of IPR, IPR2024-01157, U.S. Patent
`No. 11,697,011 B2
`
`Decision Granting Institution of IPR, IPR2025-00156, U.S. Patent
`No. 11,697,012 B2
`
`Decision Granting Institution of IPR, IPR2025-00289, U.S. Patent
`No. 11,554,005 B2
`
`1034 Merriam-Webster’s Collegiate Dictionary – Previously Submitted
`by Patent Owner as Ex. 2002 in IPR2024-00289 – Definition of
`“Loosen”
`
`1035
`
`U.S. Patent No. 7,998,104 B2 to Chang
`
`1036
`
`U.S. Patent No. 8,157,760 B2 to Craido et al.
`
`1037
`
`1038
`
`1039
`
`1040
`
`Plaintiff Inari’s Supplemental Preliminary Disclosure of Asserted
`Claims and Infringement Contentions Pursuant to Patent Local
`Rules 3-1 and 3-2 in Inari Medical, Inc. v. Imperative Care, Inc.,
`5:24-cv-03117-EKL (N.D. Cal.)
`
`Case Management and Scheduling Order (Dkt. #54) in Inari
`Medical, Inc. v. Imperative Care, Inc., 5:24-cv-03117-EKL (N.D.
`Cal.)
`
`Imperative Care, Inc.’s Notice of Motion and Motion to Stay
`Pending Inter Partes Review in Inari Medical, Inc. v. Imperative
`Care, Inc., 5:24-cv-03117-EKL (N.D. Cal.)
`
`Order Regarding Case Schedule and Motion to Stay in Inari
`Medical, Inc. v. Imperative Care, Inc., 5:24-cv-03117-EKL (N.D.
`Cal.)
`
`
`
`Exhibit List, Page 3
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Petitioner Imperative Care, Inc. (“Petitioner”) requests inter partes review
`
`(“IPR”) of claims 1, 5-6, 9-30, and 33-34 (“the challenged claims”) of U.S. Patent
`
`No. 12,016,580 (“the ’580 patent,” Ex. 1001), which is assigned to Inari Medical,
`
`Inc. (“Patent Owner” or “PO”).
`
`I. INTRODUCTION
`
`Patent Owner has asserted claims 1, 5-6, 9-30, and 33-34 of the ’580 patent
`
`against Petitioner in the co-pending district court litigation (the “Litigation”). (See
`
`Ex. 1037 (PO’s infringement contentions).) The ’580 Patent recently issued, and the
`
`Litigation is in its early stages with no trial date being set. (Ex. 1038 (setting
`
`schedule to only claim construction).) The Court also recently vacated the existing
`
`claim construction schedule and indicated it may set a new case schedule after
`
`hearing argument on Petitioner’s motion to stay the Litigation pending resolution of
`
`the IPRs. (Ex. 1040.) Given the early stage of the Litigation, 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 methods and devices to
`
`remove such clot material from the vasculature, including catheter-based systems
`
`that aspirate (i.e., suction) the clot material from the blood vessel.
`
`1
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`The ’580 patent claims methods of treating clot material, as do several other
`
`patents assigned to PO and challenged in pending IPRs. (Infra §X.B.) The ’580
`
`patent alleges that “there exists a need for an improved embolic extraction device”
`
`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, 2:30-54.) Yet, the ’580 patent does not explain how the
`
`claimed system addresses these alleged shortcomings. The ’580 patent also asserts
`
`that with “many” prior-art systems, “it is difficult or not possible to make repeated
`
`attempts at removing clot material (e.g., to make multiple passes with a device).”
`
`(Id., 2:44-46.) The ’580 patent alleges that the described system allows for
`
`“repeatedly deploying an interventional device[.]” (Id., 1:24-27.)
`
`The prior art, however, already described methods of repeatedly deploying a
`
`clot treatment system having the conventional components described in the
`
`challenged claims (e.g., catheter, pressure source, hemostasis valve, filter). For
`
`example, Garrison, a prior-art patent application published in June 2015, describes
`
`an aspiration system for removing unwanted material from a patient’s vasculature.
`
`As illustrated below, Garrison’s aspiration system includes the conventional
`
`components listed in the challenged claims: a pressure source (e.g., pump or syringe)
`
`[red], elongated shaft (e.g., catheter) [orange and pink], filter [blue], attachment
`
`member having a hemostasis valve [yellow], and a fluid control device [purple]:
`
`2
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Ex. 1006, Fig. 34.)
`
`The Patent Trial and Appeal Board (“Board”) recently instituted an IPR filed
`
`by Petitioner against a patent claiming similar components, including a “catheter,”
`
`“on-off control,” “clot cannister,” and “hemostasis valve.” (Ex. 1033 at 28-32.) In
`
`that IPR, the Board preliminarily determined that Garrison and Schaffer disclose
`
`these conventional components. (Id.)
`
`3
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Garrison also discloses methods of repeatedly deploying an interventional
`
`device to remove multiple clot portions. For example, Garrison describes the steps
`
`of removing a first clot and then, “if a secondary more distal treatment site needs to
`
`be reached after removal of a first occlusion, a second, smaller diameter catheter
`
`may be inserted through the first catheter, and positioned at the distal treatment site.”
`
`(Ex. 1006, [0166] (emphasis added).) Garrison also describes methods and devices
`
`for breaking up a clot within a blood vessel to aspirate portions of the clot. (Id.,
`
`[0126].) As demonstrated herein, Garrison anticipates or renders obvious the
`
`challenged claims.
`
`
`
`PO listed Garrison on an Invention Disclosure Statement (“IDS”) during
`
`prosecution of the ’580 patent along with hundreds of other references. The
`
`Examiner issued a single office action that did not apply or discuss Garrison. In
`
`allowing the challenged claims, the Examiner concluded that the closest reference
`
`“fails to disclose the step of pre-charging a vacuum in a pressure source and fluidly
`
`connecting the pressure source to the elongated shaft to apply the pre-charged
`
`vacuum to the elongated shaft to aspirate a first portion of the clot material into the
`
`elongated shaft.” (Ex. 1002, 1050.)
`
`Yet, Garrison discloses this precise step. Garrison describes pre-charging a
`
`vacuum in a syringe (pressure source) connected to the aspiration catheter (elongated
`
`shaft) by pulling back the plunger on the syringe “while the connection to the flow
`
`4
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`line is closed[.]” (Ex. 1006, [0134].) Garrison further discloses that when the tip of
`
`the aspiration catheter (elongated shaft) is positioned near the clot, “the user may
`
`open the connection to the aspiration syringe,” which “would enable the maximum
`
`level of aspiration in a rapid fashion with one user[.]” (Id.) The Examiner
`
`overlooked this disclosure in Garrison and, thus, erred in allowing the challenged
`
`claims.
`
`
`
`As demonstrated above and below, the challenged claims merely recite
`
`methods of using known clot treatment systems and known catheter components
`
`according to their conventional functions to predictably aspirate clots. 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 ’580 patent
`
`are unpatentable. Accordingly, Petitioner requests that the Board institute this IPR
`
`to reconsider the patentability of the ’580 patent.
`
`II. THE ’580 PATENT
`
`A. Overview
`
`The ’580 patent describes a retrieval system for engaging and removing clot
`
`material from a blood vessel. (Ex. 1001, 3:46-49.) The ’580 patent alleges that the
`
`system can treat various clots, including pulmonary embolisms (“PE”) and cerebral
`
`embolisms. (Id., 3:64-4:3.) The retrieval system comprises “clot retrieval system
`
`1” including “retraction and aspiration device 100 (‘RA device 100’),” “catheter
`
`5
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`system 200,” and “tubing system 300.” (Id., 4:42-49.) The ’580 patent explains that
`
`in some embodiments, “catheter system 200” may comprise a “guide catheter 206”
`
`and “delivery sheath 204,” which “individually comprise an elongated shaft”
`
`[orange]. (Id., 5:4-13.) The system also includes an “attachment/valve member
`
`208” [yellow] that can “secure the catheter 200 to the RA device 100” and “can
`
`fluidly couple an aspiration lumen of the catheter system 200 […] to the tubing
`
`system 300”:
`
`
`
`(Id., 5:4-6:18; Fig. 1A)
`
`
`
`The ’580 patent also states that “an interventional device ID, such as a clot
`
`removal and/or clot treatment device” [blue] can be “housed within delivery sheath
`
`204 [orange]” and “positioned at least partially within the clot material PE” [pink]:
`
`6
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`
`
`(Id., 5:18-27; Fig. 2A)
`
`The ’580 patent explains “tubing system 300 of the clot retrieval system 1
`
`fluidly couples the pressure source of the RA device 100 to the aspiration lumen of
`
`the catheter system 200.” (Id., 6:49-51.) The tubing system 300 can comprise a
`
`“first portion 314” [red] coupled to a pressure source, and a “second portion 316”
`
`[green]. (Id., 6:49-59.) Second portion 316 comprises “clot reservoir 306” [blue]
`
`and “second fluid control unit 310” [purple] which may “be a stopcock or a clamp
`
`7
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`that is externally operated to regulate the flow of liquid through the second portion
`
`316 of the tubing system 300.”:
`
`(Id., 7:15-19, Fig. 1A.)
`
`
`
`The ’580 patent further explains “clot reservoir 306 includes a housing 322”
`
`[blue] and “a filter 321 [brown] configured to be positioned within the housing 322”:
`
`
`
`(Id., 8:61-67; Fig. 3C.)
`
`8
`
`
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`The ’580 patent explains that the attachment member “can be, for example, a
`
`hemostasis valve configured to maintain hemostasis […] as the delivery sheath 204,
`
`[…] and/or other components of the catheter system 200 are inserted through the
`
`valve 445.” (Id., 10:3-11:5; Fig. 7A.) The ’580 patent describes a valve having a
`
`“tubular member (e.g., an elongate member) 1372” that extends through the valve.
`
`(Id., 18:5-8.) The tubular member has a “thin-walled compliant tubular structure”
`
`that facilitates “the uniform collapse of the tubular member 1372 and the sealing of
`
`the tubular member 1372”:
`
`(Id., 18:8-14, Fig. 19.)
`
`The valve also includes an “actuation mechanism 1375” that can “collapse
`
`and seal the tubular member 1372 via compression and/or constriction of one or
`
`
`
`9
`
`

`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`more filaments 1376[.]” (Id., 18:15-20.) The actuation mechanism “can be a manual
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`actuator such as one or several buttons 1378.” (Id., 18:21-23.) The “actuation
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`mechanism 1375 can tighten the filament 1376 to constrict or compress the tubular
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`member 1372 to seal the central lumen 1374 of the tubular member 1372.” (Id.,
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`18:35-40.) The valve also includes a “bias feature,” such as a spring, that biases the
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`actuator toward the open or closed configuration. (Id., 18:32-35.)
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`B.
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`Prosecution History
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`The Examiner issued a single, non-final rejection during prosecution. In the
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`rejection, the Examiner allowed claims 21-31 and rejected claims 32-40. The
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`Examiner found that Quick (US 20150352325, Ex. 1009) was the best reference and
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`disclosed all the limitations of independent claim 21 [issuing claim 1] except the step
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`of “pre-charging a vacuum in a pressure source and fluidly connecting the pressure
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`source to the elongated shaft to apply the pre-charged vacuum to the elongated shaft
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`to aspirate a first portion of the clot material into the elongated shaft.” (Ex. 1002,
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`1050-1051.)
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`However, in the same Office Action, the Examiner rejected independent
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`claim 32 under 35 U.S.C. § 102(a)(1) as being anticipated by Quick. (Ex. 1002,
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`1046-1047.) Rejected claim 32 was an apparatus claim having all the components
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`required by allowed claim 21. The Examiner also concluded that Quick’s device
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`was configured to perform the steps recited in allowed claim 21 but allowed claim
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`10
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`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
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`21 because Quick did not expressly disclose the steps. (Ex. 1002, 1043-1051.) PO
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`subsequently canceled claim 32 and the ’580 patent issued.
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`C. Earliest Possible Priority Date
`
`The ’580 patent claims priority to a provisional application 62/622,691, filed
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`January 26, 2018, which is the earliest possible priority date for the ’580 patent. (Ex.
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`1001.) Petitioner applies this earliest priority date in this Petition but reserves its
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`right to challenge the priority date in subsequent proceedings.
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`III. LEVEL OF ORDINARY SKILL
`
`A POSITA in January 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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`11
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`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`Claims 15-17 of the ’580 patent require a hemostasis valve having “a filament
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`coupled to the button and the tubular member[.]” The Board has preliminarily
`
`addressed the construction of “filament” in three prior IPRS. (See Exs. 1031-1033;
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`Ex. 1003, ¶¶53-59 (summarizing decisions).) The present claims reciting a
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`“filament” most closely resemble the claims of the ’011 Patent. In that IPR, the
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`Board preliminarily determined
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`that “filament” encompasses Petitioner’s
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`construction of at least “one or more threads, lines, cords, ropes, ribbons, flat wires,
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`sheets, or tapes.” (Ex. 1031, 13.) The Board also preliminarily rejected PO’s
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`argument that the Board should import the term “flexible” into “filament.” (Id., 15.)
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`The present claims are distinguishable from the claims in the ’012 patent,
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`which required the filament to form a “loop.” (Ex. 1032, 15.) The Board
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`preliminarily determined that the “loop” limitation required a “flexible” filament in
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`the ’012 patent claims. (Id.) The current claims do not require a loop but merely
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`require pressing a button on the hemostasis valve “to loosen the filament.” The term
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`“loosen” merely means “to release from restraint,” which may be accomplished with
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`rigid or flexible filaments. (Ex. 1003, ¶72.)
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`Thus, the claim language does not provide a POSITA with guidance on the
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`meaning of “filament.” (Id., ¶61.) Likewise, the ’580 specification does not provide
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`any further detail on the structure or materials of the “filament.” (Id., ¶62.)
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`However, the ’580 patent purports to incorporate by reference descriptions of
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`12
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`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`hemostasis valves having filaments from U.S. Provisional Patent Application No.
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`62/554,931.1 (Ex. 1001, 17:49-55; hereinafter, the “’931 application”, Ex. 1017.)
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`Like the ’011 and ’012 patents, the ’931 application states, “the filament 150
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`can comprise one or several threads, lines, cords, rope, ribbon, flat wire, sheet, or
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`tape.” (Ex. 1017, [0046].) The application also states, “the filament can be made
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`from a variety of materials including, for example, a polymer, a synthetic, and/or a
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`metal.” (Id.) The application further states, “the filament can comprise a single
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`strand such as, for example, a monofilament, [or] the filament can comprise a
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`plurality of strands that can be, for example, twisted, woven, grouped, and/or fused
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`to form the filament.” (Id.) Additionally, the ’931 application explains that “the
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`filament 150 can comprise multiple filaments, and specifically, as shown in FIGS. 7
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`through 9, the filament 150 can comprise a first filament 150-A and a second
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`filament 150-B.” (Id., [0064].) Given these descriptions, a POSITA would have
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`understood the claim term “filament” to mean at least “one or more threads, lines,
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`cords, ropes, ribbons, flat wires, sheets, or tapes.” (Ex. 1003, ¶¶60-66.)
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`Petitioner does not believe any other terms in the challenged claims require
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`construction to resolve the patentability issues herein.
`
`
`1 Petitioner reserves its right to challenge in future proceedings whether PO has
`effectively incorporated by reference.
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`13
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`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`
`V. STATEMENT OF RELIEF REQUESTED
`
`A.
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`IPR Grounds
`
`Petitioner asserts the following grounds of unpatentability:
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`Ground Reference(s)
`
`35 U.S.C.
`
`Challenged
`Claims
`
`Garrison
`
`Garrison
`
`Garrison and Schaffer
`
`Garrison and Hartley
`
`§102
`
`§103
`
`§103
`
`§103
`
`1, 5, 9, 11-14, 18, 21-22,
`24-28, 30, 33-34
`
`1, 5, 9, 11-14, 18, 21-22,
`24-28, 30, 33-34
`
`1, 5-6, 9, 11-18, 21-30, 33-
`34
`
`1, 5, 9, 11-14, 18, 21-22,
`24-28, 30, 33-34
`
`Garrison, Schaffer, and Hartley
`
`§103
`
`15-17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`Garrison and Goff
`
`Garrison, Schaffer, and Goff
`
`Garrison, Hartley, and Goff
`
`Garrison and Laub
`
`10 Garrison and Aklog
`
`11 Garrison, Laub, and Schaffer
`
`12 Garrison, Laub, and Hartley
`
`13 Garrison, Aklog, and Schaffer
`
`14 Garrison, Aklog, and Hartley
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`§103
`
`18-22, 24-28
`
`18-29
`
`18-22, 24-28
`
`10
`
`10
`
`10
`
`10
`
`10
`
`10
`
`
`The Petition is supported by the expert declaration of Troy Thornton.
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`(Ex. 1003.)
`
`B.
`
`The Asserted References Are Prior Art
`
`The following references are prior art under at least 35 U.S.C. §102(a)(1):
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`14
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`

`IPR Petition – Patent 12,016,580
`Imperative Care, Inc. v. Inari Medical Inc.
`
`(1) Goff (Ex. 1005) published November 23, 2006;
`
`(2) Garrison (Ex. 1006) published June 25, 2015;
`
`(3)
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`Schaffer (Ex. 1007) published December 4, 2003;
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`(4) Hartley (Ex. 1008) published June 26, 2003;
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`(5) Aklog (Ex. 1011) issued May 27, 2014; and
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`(6) Laub (Ex. 1012) published February 16, 2017.
`
`C. The Asserted References Are Analogous Art
`
`The asserted references are analogous art that is usable in an obviousness
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`combination. Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1000 (Fed. Cir.
`
`2016). The references are from the same field as the ’580 patent, e.g., devices for
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`aspirating unwanted material from a patient, and hemostasis valves for use during
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`intravascular procedures. (Ex. 1003, ¶26.) The references are also pertinent to the
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`problem the inventor was focused on, e.g., removing clots, emboli, and thrombi from
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`a patient’s