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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`
`IMPERATIVE CARE, INC.,
`Petitioner,
`
`v.
`
`INARI MEDICAL, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`Patent No. 11,969,333
`
`
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`
`
`DECLARATION OF TROY L. THORNTON
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,969,333
`
`
`
`
`Imperative Care v. Inari Medical
`US Patent 11,969,333
`Imperative Care Ex. 1003
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I. INTRODUCTION ........................................................................................... 1
`
`A.
`
`B.
`
`C.
`
`Engagement .................................................................................... 1
`
`Experience and Qualifications ........................................................ 2
`
`Topics of Opinions.......................................................................... 4
`
`D. Materials Considered ...................................................................... 5
`
`II. APPLICABLE LEGAL STANDARDS ......................................................... 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`Claim Construction ......................................................................... 6
`
`Anticipation .................................................................................... 7
`
`Obviousness .................................................................................... 7
`
`Person of Ordinary Skill in the Art ............................................... 11
`
`III. THE ’333 PATENT..................................................................................... 12
`
`A.
`
`B.
`
`C.
`
`Summary of the ’333 Patent ......................................................... 12
`
`The Challenged Claims ................................................................. 21
`
`Prosecution History....................................................................... 22
`
`IV. CLAIM CONSTRUCTION ........................................................................ 24
`
`A.
`
`The Board’s Institution Decisions from the ’011 and ’012
`Patent IPRs .................................................................................... 26
`
`1.
`
`2.
`
`The ’011 Patent IPR ........................................................... 26
`
`The ’012 Patent IPR ........................................................... 27
`
`- i -
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`B.
`
`C.
`
`Construction of “Filament” ........................................................... 29
`
`The Claims of the ’333 Patent Are Not Limited to
`“Flexible” Filaments ..................................................................... 32
`
`V. SUMMARY OF IPR GROUNDS ................................................................ 35
`
`VI. GROUNDS 1A, 2A, 3A, 4A – LAUB, AKLOG, AND GARRISON ........ 37
`
`A.
`
`Claim 1 .......................................................................................... 37
`
`1.
`
`2.
`
`3.
`
`Preamble ............................................................................. 37
`
`Advancing Aspiration Catheter .......................................... 53
`
`Generating Vacuum Pressure With Valve In First
`Position ............................................................................... 59
`
`4. Moving The Valve From First Position To Second
`Position ............................................................................... 67
`
`5.
`
`Filter ................................................................................... 68
`
`B.
`
`Claim 2 .......................................................................................... 72
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................... 72
`
`Aklog .................................................................................. 72
`
`Garrison and Laub or Aklog ............................................... 74
`
`C.
`
`Claim 3 .......................................................................................... 75
`
`1.
`
`2.
`
`Laub .................................................................................... 75
`
`Aklog .................................................................................. 75
`
`- ii -
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D.
`
`E.
`
`F.
`
`G.
`
`3.
`
`Garrison and Laub or Aklog ............................................... 77
`
`Claim 4 .......................................................................................... 77
`
`Claim 5 .......................................................................................... 78
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................... 78
`
`Aklog .................................................................................. 80
`
`Garrison .............................................................................. 80
`
`Claim 9 .......................................................................................... 81
`
`Claim 10 ........................................................................................ 83
`
`1.
`
`2.
`
`3.
`
`Garrison .............................................................................. 83
`
`Laub and Garrison .............................................................. 85
`
`Aklog and Garrison ............................................................ 87
`
`H.
`
`Claim 14 ........................................................................................ 88
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................... 88
`
`Aklog .................................................................................. 89
`
`Garrison .............................................................................. 90
`
`I.
`
`Claim 15 ........................................................................................ 90
`
`1.
`
`2.
`
`Laub .................................................................................... 91
`
`Aklog .................................................................................. 91
`
`- iii -
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`3.
`
`Garrison .............................................................................. 92
`
`J.
`
`Claim 16 ........................................................................................ 93
`
`1.
`
`2.
`
`Garrison .............................................................................. 93
`
`Laub and Aklog .................................................................. 95
`
`K.
`
`Claim 18 ........................................................................................ 97
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................... 98
`
`Aklog .................................................................................. 99
`
`Garrison ............................................................................ 100
`
`L.
`
`Claim 19 ...................................................................................... 101
`
`M. Claims 20-24, 28-29, 33-35, 37-38 ............................................. 102
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................. 103
`
`Aklog ................................................................................ 103
`
`Garrison and Laub or Aklog ............................................. 104
`
`VII. GROUNDS 1B, 2B, 3B, 4B – LAUB, AKLOG, AND GARRISON
`WITH GOFF ......................................................................................... 104
`
`A.
`
`Claim 6 ........................................................................................ 104
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................. 104
`
`Aklog ................................................................................ 106
`
`Garrison ............................................................................ 107
`
`- iv -
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`B.
`
`C.
`
`4.
`
`Goff................................................................................... 108
`
`Claim 7 ........................................................................................ 112
`
`Claim 8 ........................................................................................ 113
`
`1.
`
`2.
`
`3.
`
`Laub .................................................................................. 114
`
`Aklog ................................................................................ 115
`
`Garrison ............................................................................ 116
`
`D.
`
`Claim 17 ...................................................................................... 117
`
`1.
`
`2.
`
`Garrison ............................................................................ 117
`
`Goff................................................................................... 117
`
`E.
`
`Claims 25-27 and 36 ................................................................... 118
`
`VIII. GROUNDS 1C-1D, 2C-2D, 3C-3D, 4C-4D – LAUB, AKLOG,
`AND GARRISON WITH SCHAFFER AND OPTIONALLY
`HARTLEY ............................................................................................ 119
`
`A.
`
`Claim 11 ...................................................................................... 119
`
`1.
`
`2.
`
`Schaffer............................................................................. 120
`
`Schaffer and Hartley ......................................................... 131
`
`Claim 12 ...................................................................................... 145
`
`Claims 30-31 ............................................................................... 146
`
`B.
`
`C.
`
`IX. SECONDARY CONSIDERATIONS ....................................................... 147
`
`- v -
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`X. CONCLUSION .......................................................................................... 147
`
`
`
`
`
`- vi -
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`
`
`
`
`Exhibit
`No.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`TABLE OF EXHIBITS
`
`Description
`
` 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
`
`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. 2014/0276868 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”)
`
`Table of Exhibits 1
`
`
`
`
`
`Exhibit
`No.
`
`Description
`
`1019
`
`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”)
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`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)
`
`1030
`
`Save, Jeffrey L., Time is Brain – Quantified, American Heart
`Association Journals, available at http://www.stokeaha.org (2005).
`
`Table of Exhibits 2
`
`
`
`
`
`Exhibit
`No.
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`Description
`
`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)
`
`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)
`
`Table of Exhibits 3
`
`
`
`
`
`Exhibit
`No.
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`Description
`
`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)
`
`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)
`
`Table of Exhibits 4
`
`
`
`
`
`I, Troy L. Thornton, do hereby declare:
`
`I. INTRODUCTION
`
`A. Engagement
`
`1.
`
`I have been retained on behalf of Imperative Care, Inc. (“Imperative
`
`Care”) to provide my opinion regarding the patentability of Claims 1-12, 14-31, and
`
`33-38 of U.S. Patent No. 11,969,333 (“the ’333 patent”). For the reasons discussed
`
`herein, I have concluded that Claims 1-12, 14-31, and 33-38 of the ’333 patent are
`
`unpatentable because the prior art references render them obvious.
`
`2.
`
`I understand that this Declaration supports Imperative Care’s Petition
`
`for the above-captioned inter partes review (“IPR”) of the ’333 patent.
`
`3.
`
`I reserve the right to supplement, change, clarify, or modify my
`
`opinions should additional information and/or documentation become available to
`
`me. I also reserve the right to submit a rebuttal declaration in response to any expert
`
`declaration(s) submitted on behalf of the owner of the ’333 patent, Inari Medical,
`
`Inc. (“Inari” or “Patent Owner”).
`
`4.
`
`I am being compensated at my customary hourly rate for my work in
`
`this matter and I am being reimbursed at cost for my expenses. My compensation
`
`in no way depends upon the substance of my opinions or the outcome of this
`
`proceeding. I have no financial interest in any of the parties to this proceeding.
`
`-1-
`
`
`
`
`
`B.
`
`Experience and Qualifications
`
`5. My experience and qualifications are summarized in my resume, a
`
`copy of which is included as Exhibit 1004.
`
`6.
`
`I received a Bachelor of Science degree in Engineering Science, with
`
`Biomedical Engineering emphasis, in 1985 from Iowa State University. Since then,
`
`I have worked as an engineer, executive, and consultant in the medical device
`
`industry, particularly in the cardiovascular field. My work has included designing
`
`and developing numerous medical devices in the cardiovascular field, including
`
`catheters, percutaneous heart valve repair systems, stent grafts, and blood pumps.
`
`7.
`
`Since 2015 I have worked as a consultant for various medical device
`
`companies, assisting the companies with early design, development, problem-
`
`solving, and intellectual property related matters.
`
`8.
`
`Before my current consulting business, I was a Program Director for
`
`Abbott Ventures from June 2012 through December 2014. My work at Abbott
`
`Ventures focused on technical assessment and analysis of potential investments in
`
`both cardiovascular and non-cardiovascular medical device technologies.
`
`9.
`
`In June 2000, I assumed the position of Director of Research and
`
`Development at Evalve, Inc., and in 2001 was promoted to Vice President of
`
`Research & Development. I served in that position until June 2012. While at
`
`Evalve, I was responsible for managing all aspects of research and development for
`
`- 2 -
`
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`
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`a percutaneous mitral valve repair system known as the MitraClip. The MitraClip
`
`system included three complex catheters and a permanent mechanical implant, and
`
`I led the research and development for all aspects of the product. The MitraClip
`
`product received FDA approval in 2013 and is currently available in over 30
`
`countries.
`
`10. From June 1995 through May 2000, I was a Project Manager at
`
`Prograft Medical Inc. While at Prograft, I was responsible for the development and
`
`commercial launch of a bifurcated, modular stent-graft used in the treatment of
`
`abdominal aortic aneurysms known as Excluder. I managed the overall project from
`
`its inception through initial commercialization, which involved designing and
`
`building initial protypes, developing physician training materials, assisting with
`
`regulatory filings, providing physician training, and supporting physicians during
`
`five live case transmissions endovascular symposia.
`
`11. From August 1989 through May 1995, I worked as a Project Group
`
`Leader and Senior Engineer for Advanced Cardiovascular Systems at Guidant. My
`
`work at Guidant focused on the design and development of percutaneous
`
`transluminal coronary angioplasty (PTCA) and perfusion catheters. I was
`
`responsible for catheter design, material selection, process development,
`
`performance testing, physician evaluation, and animal studies for an elliptical
`
`- 3 -
`
`
`
`
`
`coronary PTCA catheter that ultimately became the top-selling PTCA in the United
`
`States.
`
`12.
`
` From 1987 to 1989, I worked as a Manufacturing Engineer at
`
`Symbion, Inc. My work at Symbion included developing and improving
`
`manufacturing processes for class III medical devices, including a centrifugal blood
`
`pump.
`
`13. From 1985 to 1987 I worked as a Process Engineer at Becton-
`
`Dickenson, Inc. My work at Becton-Dickenson included validating and
`
`implementing manufacturing processes for a
`
`thermodilution catheter and
`
`conducting cost saving and process improvements for central venous catheter
`
`products.
`
`14.
`
`In summary, I have more than 35 years of experience in the
`
`cardiovascular medical device field, including significant experience designing,
`
`developing, testing, and manufacturing catheters and catheter systems for
`
`minimally invasive cardiovascular procedures. I am therefore very familiar with
`
`the concepts of catheters, catheter systems, and hemostasis valves, and I believe I
`
`am well placed to comment on the understanding of a person of ordinary skill in the
`
`art in the context of the ’333 patent.
`
`C. Topics of Opinions
`
`15.
`
`I offer opinions in this Declaration on the following general topics:
`
`- 4 -
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`
`
`• The subject matter described and claimed in the ’333 patent;
`
`• The level of ordinary skill in the art pertaining to the ’333 patent;
`
`• The teachings of the prior art; and
`
`• Whether Claims 1-12, 14-31, and 33-38 of the ’333 patent would
`
`have been obvious to a person of ordinary skill in the art at the time
`
`of the alleged invention, in view of the prior art.
`
`D. Materials Considered
`
`16.
`
`In preparing this Declaration, I have considered the materials
`
`referenced in this Declaration and identified in the attached list of exhibits.
`
`17.
`
`I have also relied on my education, training, and experience, and my
`
`knowledge of pertinent literature in the field of the ’333 patent.
`
`II. APPLICABLE LEGAL STANDARDS
`
`18.
`
`I am a biomedical engineer by training and profession. The opinions
`
`I am expressing in this Declaration involve the application of my education,
`
`training, and technical knowledge and experience to the evaluation of certain prior
`
`art with respect to the ’333 patent.
`
`19. Although I have had some prior exposure to patent matters, I am not
`
`an expert in patent law. Therefore, I have been advised of certain principles of
`
`patent law applicable in this matter, which I have used in arriving at my
`
`- 5 -
`
`
`
`
`
`determinations and opinions. The paragraphs below express my understanding of
`
`how I must apply these principles in forming my opinions.
`
`A. Claim Construction
`
`20.
`
`I understand that the first step in assessing the patentability of a patent
`
`claim is to understand the meaning of the words used in the claims. I understand
`
`this process of defining, or construing, the claim terms is generally referred to as
`
`claim construction. Generally speaking, I understand that I am to apply the ordinary
`
`and customary (i.e., plain and ordinary) meaning of each claim term as would have
`
`been understood by a person of ordinary skill in the art at the time of the invention,
`
`consistent with the specification and prosecution history.
`
`21.
`
`I also understand that the patentee may act as its own lexicographer
`
`such that they may redefine a claim term to have a meaning that is different from
`
`the plain and ordinary meaning. I understand that when a patentee has acted as its
`
`own lexicographer, the patentee’s definition should be applied instead of the plain
`
`and ordinary meaning that the term would have absent the redefinition. I understand
`
`that the patentee can redefine a claim term in either the specification or in statements
`
`made to the Patent Office during prosecution of the patent. I understand that the
`
`patentee’s redefinition of a term does not need to be provided in express definitional
`
`format, but rather that the redefinition can be implied through the disclosure of the
`
`specification or the patentee’s statements during prosecution.
`
`- 6 -
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`
`
`B. Anticipation
`
`22.
`
`I understand that a patent claim is unpatentable if it is “anticipated” by
`
`a piece of prior art. I have been instructed that a claim is “anticipated” if a prior art
`
`reference describes, either expressly or inherently, each limitation of the claim. I
`
`understand that this description must be recognizable to a person of ordinary skill
`
`in the art at the time of the alleged invention (in this case, August 2018).
`
`23.
`
`I understand that an element is “inherent in,” and therefore taught by,
`
`the prior art, if it necessarily flows from the explicit disclosure of the prior art. The
`
`fact that a certain result or characteristic may be present in the prior art is not
`
`sufficient to establish inherency. However, if the result or characteristic is
`
`necessarily present based upon the explicit disclosure in the prior art, it is inherent
`
`in the prior art and is therefore disclosed.
`
`C. Obviousness
`
`24.
`
`I understand that a patent claim may also be unpatentable if it is
`
`rendered “obvious” by the prior art. I have been instructed that a claim is “obvious”
`
`if the claimed subject matter as a whole would have been obvious to a person of
`
`ordinary skill in the art at the time of the alleged invention. I understand that in
`
`considering obviousness I must consider the scope and content of the prior art, the
`
`differences between the claimed subject matter and the prior art, and the level of
`
`ordinary skill in the art at the time of the invention.
`
`- 7 -
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`
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`25.
`
`In determining the scope and content of the prior art, I understand that
`
`a reference is considered analogous (i.e., appropriate) prior art if it falls within the
`
`field of the inventor’s endeavor. In addition, a reference is analogous prior art if it
`
`is reasonably pertinent to the particular problem with which the inventor was
`
`involved. A reference is reasonably pertinent if it logically would have commended
`
`itself to an inventor’s attention in considering the problem. If a reference relates to
`
`the same problem as the claimed invention, that supports use of the reference as
`
`prior art in an obviousness analysis.
`
`26. The prior art references applied in this Declaration are analogous art
`
`that is usable in an obviousness combination. The references are from the same
`
`field as the ’333 patent, e.g., devices for aspirating unwanted material from a
`
`patient. The references are also pertinent to the problem the inventor was focused
`
`on, e.g., removing clots, emboli, and thrombi from a patient’s blood vessel.
`
`27. To assess the differences between prior art and the claimed subject
`
`matter, I have been instructed that the law requires the claimed invention to be
`
`considered as a whole. This “as a whole” assessment requires showing that one of
`
`ordinary skill in the art at the time of invention, confronted by the same problems
`
`as the inventor and with no knowledge of the claimed invention, would have
`
`selected the elements from the prior art and combined them in the claimed manner.
`
`- 8 -
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`
`
`28.
`
`I am also informed that the law recognizes several rationales for
`
`combining references or modifying a reference to show obviousness of claimed
`
`subject matter. Some of these rationales include:
`
`• combining prior art elements according to known methods to yield
`
`predictable results;
`
`• simple substitution of one known element for another to obtain
`
`predictable results;
`
`• a predictable use of prior art elements according to their established
`
`functions;
`
`• applying a known technique to a known device (method or product)
`
`ready for improvement to yield predictable results;
`
`• choosing from a finite number of identified, predictable solutions,
`
`with a reasonable expectation of success; and
`
`• some teaching, suggestion, or motivation in the prior art that would
`
`have led one of ordinary skill to modify the prior art reference or to
`
`combine prior art reference teachings to arrive at the claimed
`
`invention.
`
`29. A prior art reference may also suggest a limitation of the claims. In
`
`that case, even if the prior art reference does not explicitly or inherently disclose
`
`the limitation, the motivation to modify the prior art reference to include the
`
`- 9 -
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`
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`
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`limitation may exist within the prior art reference itself. Thus, the limitation would
`
`have been obvious over that prior art reference alone. This is the case if a person
`
`of ordinary skill in the art would have had a simple design choice or a finite number
`
`of identified, predictable solutions, for example, and if the modification furthers the
`
`goals of the prior art reference.
`
`30.
`
`I have also been informed that the obviousness analysis must be
`
`performed from the perspective of a person of ordinary skill in the art at the time of
`
`the alleged invention. This is to avoid using impermissible hindsight in the analysis.
`
`The claims of the patent must not be used to provide a road map for obviousness;
`
`instead, the claims would have been obvious if a person of ordinary skill in the art
`
`would have been motivated to combine the teachings of the prior art to arrive at the
`
`claimed invention and had a reasonable expectation of success in doing so.
`
`31. An obviousness analysis also must consider whether there are
`
`additional factors that would indicate that the invention would not have been
`
`obvious. These factors include whether there was: (i) a long-felt need in the
`
`industry; (ii) any unexpected results; (iii) skepticism of the invention; (iv) a teaching
`
`away from the invention; (v) commercial success; (vi) praise by others for the
`
`invention; and (vii) copying by others. I am not aware of any evidence under these
`
`factors that would suggest that Claims 1-38 of the ’333 patent would have been non-
`
`- 10 -
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`
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`obvious, as
`
`further explained
`
`in Section § IX
`
`(Heading: “Secondary
`
`Considerations”) below.
`
`D.
`
`Person of Ordinary Skill in the Art
`
`32.
`
`It is my understanding that when interpreting the claims of the ’333
`
`patent, I must do so based on the perspective of a person of ordinary skill in the art
`
`at the relevant priority date. I have been instructed to assume for the purposes of
`
`my opinions that the relevant priority date of the ’333 patent is August 13, 2018. I
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`have been informed that all of the references relied upon in this Declaration qualify
`
`as prior art under that priority date.
`
`33.
`
`I am informed that the person of ordinary skill in the art is a
`
`hypothetical person who is presumed to have known the relevant art at the time of
`
`the invention. This is a person of ordinary creativity, not an automaton.
`
`34.
`
`I am informed that in determining the level of ordinary skill in the art,
`
`several factors are considered. Those factors may include: (i) the type of problems
`
`encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity
`
`with which innovations are made; (iv) the sophistication of the technology; and
`
`(v) the educational level of active workers in the field. A person of ordinary skill
`
`in the art must have the capability of understanding the scientific and engineering
`
`principles applicable to the pertinent art.
`
`- 11 -
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`
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`35. Based on my review of the specification and claims of the ’333 patent,
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`it is my opinion that a person of ordinary skill in the art would have had an
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`undergraduate degree in mechanical engineering or a related engineering discipline
`
`and 2-4 years of catheter design experience and, where necessary, would have
`
`consulted with a physician regarding the methods of treatment.
`
`36.
`
`I can make this assessment because during my career, I had experience
`
`assigning engineers to work on mechanical design projects, including projects to
`
`design catheters, sheaths, and related components such as hemostasis valves for use
`
`in cardiovascular procedures. For such projects, I would assign an engineer with
`
`the experience described above.
`
`A.
`
`Summary of the ’333 Patent
`
`III. THE ’333 PATENT
`
`37. The ’333 patent is titled “System for Treating Embolism and
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`Associated Devices and Methods” and describes an aspiration system for
`
`intravascular removal of clot material. Ex. 1001 (’333 patent) at 4:17-4:33. The
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`’333 patent explains that the system can treat various clots including pulmonary
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`embolisms (“PE”), cerebral embolism, and deep vein thrombosis (“DVT”). Id. at
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`4:51-4:58. The aspiration system includes an aspiration “assembly 10” having a
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`“catheter subsystem 100,” “pressure
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