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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.
`
`
`
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`
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`
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`Patent No. 11,697,012
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`DECLARATION OF TROY L. THORNTON
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,697,012
`
`
`
`
`IMPERATIVE Ex. 1003
`IPR Petition - US 11,697,012
`
`
`
`TABLE OF CONTENTS
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`Page No.
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`I. INTRODUCTION ........................................................................................... 1
`
`A.
`
`B.
`
`C.
`
`Engagement .................................................................................... 1
`
`Experience and Qualifications ....................................................... 2
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`Topics of Opinions ......................................................................... 4
`
`D. Materials Considered ...................................................................... 5
`
`II. APPLICABLE LEGAL STANDARDS ........................................................ 5
`
`A.
`
`B.
`
`C.
`
`D.
`
`Claim Construction......................................................................... 6
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`Anticipation .................................................................................... 7
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`Obviousness .................................................................................... 7
`
`Person of Ordinary Skill in the Art .............................................. 11
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`III. THE ’012 PATENT .................................................................................... 12
`
`A.
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`B.
`
`C.
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`Summary of the ’012 Patent ......................................................... 12
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`The Challenged Claims ................................................................ 20
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`Prosecution History ...................................................................... 21
`
`IV. CLAIM CONSTRUCTION........................................................................ 22
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`A.
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`B.
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`Filament ........................................................................................ 22
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`The “Aspiration Catheter” in the Preamble ................................. 29
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`V. SUMMARY OF IPR GROUNDS ............................................................... 30
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`- i -
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`TABLE OF CONTENTS
`(cont’d)
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`Page No.
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`VI. GROUNDS 1-4: CLAIMS 1-9 ANTICIPATED BY SCHAFFER OR
`OBVIOUS OVER SCHAFFER ALONE OR IN COMBINATION
`WITH HARTLEY OR ELLER .............................................................. 30
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`A.
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`Claim 1 ......................................................................................... 36
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`1.
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`2.
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`3.
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`4.
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`5.
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`Preamble ............................................................................. 36
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`Tubular Body ..................................................................... 42
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`Hemostasis Valve ............................................................... 45
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`Collapsible Tubular Sidewall ............................................. 49
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`Constricting Mechanism .................................................... 51
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`B.
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`Claim 2 ......................................................................................... 96
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`C.
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`D.
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`E.
`
`1.
`
`2.
`
`3.
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`Tubular Member ................................................................ 97
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`Constricting Mechanism .................................................... 98
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`Filament ............................................................................. 99
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`Claim 3 ....................................................................................... 110
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`Claim 4 ....................................................................................... 111
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`Claim 5 ....................................................................................... 113
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`1.
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`2.
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`3.
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`Schaffer ............................................................................ 114
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`Hartley .............................................................................. 120
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`Eller .................................................................................. 121
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`- ii -
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`TABLE OF CONTENTS
`(cont’d)
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`Page No.
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`F.
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`G.
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`H.
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`I.
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`Claim 6 ....................................................................................... 124
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`Claim 7 ....................................................................................... 130
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`Claim 8 ....................................................................................... 131
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`Claim 9 ....................................................................................... 132
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`VII. GROUNDS 5-7: CLAIMS 1-9 OBVIOUS OVER SCHAFFER IN
`COMBINATION WITH GARRISON AND OPTIONALLY
`HARTLEY OR ELLER ........................................................................ 134
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`A.
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`Claim 1 ....................................................................................... 136
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`1.
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`2.
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`3.
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`4.
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`Preamble ........................................................................... 136
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`Tubular Body ................................................................... 139
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`Hemostasis Valve ............................................................. 145
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`Remaining Limitations In Claim 1 .................................. 154
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`B.
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`Claims 2-9 .................................................................................. 154
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`VIII. SECONDARY CONSIDERATIONS ................................................... 155
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`IX. CONCLUSION ......................................................................................... 156
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`- iii -
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`Exhibit
`No.
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`TABLE OF EXHIBITS
`
`Description
`
`1001
`
`U.S. Patent No. 11,697,012 (“the ’012 patent”)
`
`1002
`
`’012 Patent Prosecution History Excerpt
`
`1003
`
`Expert Declaration of Troy Thornton
`
`1004
`
`Resume of Troy Thornton
`
`1005
`
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`
`1006
`
`U.S. Patent Publication US 2003/0116731 A1 to Hartley (“Hartley”)
`
`1007
`
`U.S. Patent No. 9,980,813 B1 to Eller (“Eller”)
`
`1008
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`Drawings Submitted During Prosecution of U.S. Patent Application
`No. 10/371,190 dated June 18, 2003
`
`1009
`
`U.S. Patent No. 5,429,616 to Schaffer (“Schaffer ’616”)
`
`1010
`
`1011
`
`U.S. Patent Publication US 2011/0144592 A1 to Wong et al.
`(“Wong”)
`
`U.S. Patent Publication US 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`1012
`
`U.S. Patent No. 9,216,277 to Myers (“Myers”)
`
`1013
`
`Dorland Dictionary Definition of “Catheter”
`
`1014
`
`U.S. Patent No. 4,723,550 to Bales et al.
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`1015
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`U.S. Patent No. 5,895,376 to Schwartz et al.
`
`1016
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`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`Table of Exhibits 1
`
`
`
`
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`I, Troy L. Thornton, do hereby declare:
`
`I. INTRODUCTION
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`A. Engagement
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`1.
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`I have been retained on behalf of Imperative Care, Inc. (“Imperative
`
`Care”) to provide my opinion regarding the patentability of Claims 1-9 of U.S.
`
`Patent No. 11,697,012 (“the ’012 patent”). For the reasons discussed herein, I
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`have concluded that Claims 1-9 of the ’012 patent are unpatentable because the
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`prior art references anticipate the claims or render them obvious.
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`2.
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`I understand that this Declaration supports Imperative Care’s Petition
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`for the above-captioned inter partes review (“IPR”) of the ’012 patent.
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`3.
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`I reserve the right to supplement, change, clarify, or modify my
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`opinions should additional information and/or documentation become available to
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`me. I also reserve the right to submit a rebuttal declaration in response to any
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`expert declaration(s) submitted on behalf of the owner of the ’012 patent, Inari
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`Medical, Inc. (“Inari” or “Patent Owner”).
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`4.
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`I am being compensated at my customary hourly rate for my work in
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`this matter and I am being reimbursed at cost for my expenses. My compensation
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`in no way depends upon the substance of my opinions or the outcome of this
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`proceeding. I have no financial interest in any of the parties to this proceeding.
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`-1-
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`B.
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`Experience and Qualifications
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`5. My experience and qualifications are summarized in my resume, a
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`copy of which is included as Exhibit 1004.
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`6.
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`I received a Bachelor of Science degree in Engineering Science, with
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`Biomedical Engineering emphasis, in 1985 from Iowa State University. Since
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`then, I have worked as an engineer, executive, and consultant in the medical
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`device industry, particularly in the cardiovascular field. My work has included
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`designing and developing numerous medical devices in the cardiovascular field,
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`including catheters, percutaneous heart valve repair systems, stent grafts, and
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`blood pumps.
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`7.
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`Since 2015 I have worked as a consultant for various medical device
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`companies, assisting the companies with early design, development, problem-
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`solving, and intellectual property related matters.
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`8.
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`Before my current consulting business, I was a Program Director for
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`Abbott Ventures from June 2012 through December 2014. My work at Abbott
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`Ventures focused on technical assessment and analysis of potential investments in
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`both cardiovascular and non-cardiovascular medical device technologies.
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`9.
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`In June 2000, I assumed the position of Director of Research and
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`Development at Evalve, Inc., and in 2001 was promoted to Vice President of
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`Research & Development. I served in that position until June 2012. While at
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`- 2 -
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`Evalve, I was responsible for managing all aspects of research and development
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`for a percutaneous mitral valve repair system known as the MitraClip. The
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`MitraClip system included three complex catheters and a permanent mechanical
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`implant, and I led the research and development for all aspects of the product.
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`The MitraClip product received FDA approval in 2013 and is currently available
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`in over 30 countries.
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`10. From June 1995 through May 2000, I was a Project Manager at
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`Prograft Medical Inc. While at Prograft, I was responsible for the development
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`and commercial launch of a bifurcated, modular stent-graft used in the treatment
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`of abdominal aortic aneurysms known as Excluder. I managed the overall project
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`from its inception through initial commercialization, which involved designing
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`and building initial protypes, developing physician training materials, assisting
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`with regulatory filings, providing physician training, and supporting physicians
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`during five live case transmissions endovascular symposia.
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`11. From August 1989 through May 1995, I worked as a Project Group
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`Leader and Senior Engineer for Advanced Cardiovascular Systems at Guidant.
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`My work at Guidant focused on the design and development of percutaneous
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`transluminal coronary angioplasty (PTCA) and perfusion catheters. I was
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`responsible for catheter design, material selection, process development,
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`performance testing, physician evaluation, and animal studies for an elliptical
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`- 3 -
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`coronary PTCA catheter that ultimately became the top-selling PTCA in the
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`United States.
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`12.
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` From 1987 to 1989, I worked as a Manufacturing Engineer at
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`Symbion, Inc. My work at Symbion included developing and improving
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`manufacturing processes for class III medical devices, including a centrifugal
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`blood pump.
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`13. From 1985 to 1987 I worked as a Process Engineer at Becton-
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`Dickenson, Inc. My work at Becton-Dickenson included validating and
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`implementing manufacturing processes for a
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`thermodilution catheter and
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`conducting cost saving and process improvements for central venous catheter
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`products.
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`14.
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`In summary, I have more than 35 years of experience in the
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`cardiovascular medical device field, including significant experience designing,
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`developing, testing, and manufacturing catheters and catheter systems for
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`minimally invasive cardiovascular procedures. I am therefore very familiar with
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`the concepts of catheters, catheter systems, and hemostasis valves, and I believe I
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`am well placed to comment on the understanding of a person of ordinary skill in
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`the art in the context of the ’012 patent.
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`C. Topics of Opinions
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`15.
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`I offer opinions in this Declaration on the following general topics:
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`• The subject matter described and claimed in the ’012 patent;
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`• The level of ordinary skill in the art pertaining to the ’012 patent;
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`• The teachings of the prior art; and
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`• Whether Claims 1-9 of the ’012 patent would have been obvious
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`to a person of ordinary skill in the art at the time of the alleged
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`invention, in view of the prior art.
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`D. Materials Considered
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`16.
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`In preparing this Declaration, I have considered the materials
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`referenced in this Declaration and identified in the attached list of exhibits.
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`17.
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`I have also relied on my education, training, and experience, and my
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`knowledge of pertinent literature in the field of the ’012 patent.
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`II. APPLICABLE LEGAL STANDARDS
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`18.
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`I am a biomedical engineer by training and profession. The opinions
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`I am expressing in this Declaration involve the application of my education,
`
`training, and technical knowledge and experience to the evaluation of certain prior
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`art with respect to the ’012 patent.
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`19. Although I have had some prior exposure to patent matters, I am not
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`an expert in patent law. Therefore, I have been advised of certain principles of
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`patent law applicable in this matter, which I have used in arriving at my
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`determinations and opinions. The paragraphs below express my understanding of
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`how I must apply these principles in forming my opinions.
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`A. Claim Construction
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`20.
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`I understand that the first step in assessing the patentability of a
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`patent claim is to understand the meaning of the words used in the claims. I
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`understand this process of defining, or construing, the claim terms is generally
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`referred to as claim construction. Generally speaking, I understand that I am to
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`apply the ordinary and customary (i.e., plain and ordinary) meaning of each claim
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`term as would have been understood by a person of ordinary skill in the art at the
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`time of the invention, consistent with the specification and prosecution history.
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`21.
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`I also understand that the patentee may act as its own lexicographer
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`such that they may redefine a claim term to have a meaning that is different from
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`the plain and ordinary meaning. I understand that when a patentee has acted as its
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`own lexicographer, the patentee’s definition should be applied instead of the plain
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`and ordinary meaning that the term would have absent the redefinition. I
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`understand that the patentee can redefine a claim term in either the specification or
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`in statements made to the Patent Office during prosecution of the patent. I
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`understand that the patentee’s redefinition of a term does not need to be provided
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`in express definitional format, but rather that the redefinition can be implied
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`- 6 -
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`through the disclosure of the specification or the patentee’s statements during
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`prosecution.
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`B. Anticipation
`
`22.
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`I understand that a patent claim is unpatentable if it is “anticipated”
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`by a piece of prior art. I have been instructed that a claim is “anticipated” if a
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`prior art reference describes, either expressly or inherently, each limitation of the
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`claim. I understand that this description must be recognizable to a person of
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`ordinary skill in the art at the time of the alleged invention (in this case,
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`September 2017).
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`23.
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`I understand that an element is “inherent in,” and therefore taught by,
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`the prior art, if it necessarily flows from the explicit disclosure of the prior art.
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`The fact that a certain result or characteristic may be present in the prior art is not
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`sufficient to establish inherency. However, if the result or characteristic is
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`necessarily present based upon the explicit disclosure in the prior art, it is inherent
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`in the prior art and is therefore disclosed.
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`C. Obviousness
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`24.
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`I understand that a patent claim may also be unpatentable if it is
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`rendered “obvious” by the prior art. I have been instructed that a claim is
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`“obvious” if the claimed subject matter as a whole would have been obvious to a
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`person of ordinary skill in the art at the time of the alleged invention. I understand
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`that in considering obviousness I must consider the scope and content of the prior
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`art, the differences between the claimed subject matter and the prior art, and the
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`level of ordinary skill in the art at the time of the invention.
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`25.
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`In determining the scope and content of the prior art, I understand
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`that a reference is considered analogous (i.e., appropriate) prior art if it falls within
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`the field of the inventor’s endeavor. In addition, a reference is analogous prior art
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`if it is reasonably pertinent to the particular problem with which the inventor was
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`involved. A reference is reasonably pertinent if it logically would have
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`commended itself to an inventor’s attention in considering the problem. If a
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`reference relates to the same problem as the claimed invention, that supports use
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`of the reference as prior art in an obviousness analysis.
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`26. The prior art references applied in this Declaration are analogous art
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`that is usable in an obviousness combination. The references are from the same
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`field as the ’012 patent, e.g., hemostasis valves for use during intravascular
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`procedures. The references are also pertinent to the problem the inventor was
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`focused on, e.g., sealing a catheter during intravascular procedures to minimize
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`blood leaks.
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`27. To assess the differences between prior art and the claimed subject
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`matter, I have been instructed that the law requires the claimed invention to be
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`considered as a whole. This “as a whole” assessment requires showing that one of
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`ordinary skill in the art at the time of invention, confronted by the same problems
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`as the inventor and with no knowledge of the claimed invention, would have
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`selected the elements from the prior art and combined them in the claimed
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`manner.
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`28.
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`I am also informed that the law recognizes several rationales for
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`combining references or modifying a reference to show obviousness of claimed
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`subject matter. Some of these rationales include:
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`• combining prior art elements according to known methods to
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`yield predictable results;
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`• simple substitution of one known element for another to obtain
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`predictable results;
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`• a predictable use of prior art elements according to their
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`established functions;
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`• applying a known technique to a known device (method or
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`product) ready for improvement to yield predictable results;
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`• choosing from a finite number of identified, predictable solutions,
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`with a reasonable expectation of success; and
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`• some teaching, suggestion, or motivation in the prior art that
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`would have led one of ordinary skill to modify the prior art
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`- 9 -
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`reference or to combine prior art reference teachings to arrive at
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`the claimed invention.
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`29. A prior art reference may also suggest a limitation of the claims. In
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`that case, even if the prior art reference does not explicitly or inherently disclose
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`the limitation, the motivation to modify the prior art reference to include the
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`limitation may exist within the prior art reference itself. Thus, the limitation
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`would have been obvious over that prior art reference alone. This is the case if a
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`person of ordinary skill in the art would have had a simple design choice or a
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`finite number of identified, predictable solutions, for example, and if the
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`modification furthers the goals of the prior art reference.
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`30.
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`I have also been informed that the obviousness analysis must be
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`performed from the perspective of a person of ordinary skill in the art at the time
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`of the alleged invention. This is to avoid using impermissible hindsight in the
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`analysis. The claims of the patent must not be used to provide a road map for
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`obviousness; instead, the claims would have been obvious if a person of ordinary
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`skill in the art would have been motivated to combine the teachings of the prior art
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`to arrive at the claimed invention and had a reasonable expectation of success in
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`doing so.
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`31. An obviousness analysis also must consider whether there are
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`additional factors that would indicate that the invention would not have been
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`obvious. These factors include whether there was: (i) a long-felt need in the
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`industry; (ii) any unexpected results; (iii) skepticism of the invention; (iv) a
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`teaching away from the invention; (v) commercial success; (vi) praise by others
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`for the invention; and (vii) copying by others. I am not aware of any evidence
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`under these factors that would suggest that Claims 1-9 of the ’012 patent would
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`have been non-obvious, as further explained in Section § VIII (Heading:
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`“Secondary Considerations”) below.
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`D.
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`Person of Ordinary Skill in the Art
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`32.
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`It is my understanding that when interpreting the claims of the ’012
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`patent, I must do so based on the perspective of a person of ordinary skill in the art
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`at the relevant priority date. I have been instructed to assume for the purposes of
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`my opinions that the relevant priority date of the ’012 patent is September 6, 2017.
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`I have been informed that all of the references relied upon in this Declaration
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`qualify as prior art under that priority date.
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`33.
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`I am informed that the person of ordinary skill in the art is a
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`hypothetical person who is presumed to have known the relevant art at the time of
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`the invention. This is a person of ordinary creativity, not an automaton.
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`34.
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`I am informed that in determining the level of ordinary skill in the
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`art, several factors are considered. Those factors may include: (i) the type of
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`problems encountered in the art; (ii) prior art solutions to those problems; (iii) the
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`rapidity with which innovations are made; (iv) the sophistication of the
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`technology; and (v) the educational level of active workers in the field. A person
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`of ordinary skill in the art must have the capability of understanding the scientific
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`and engineering principles applicable to the pertinent art.
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`35. Based on my review of the specification and claims of the ’012
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`patent, 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
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`discipline and 2-4 years of product design or engineering experience.
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`36.
`
`I can make this assessment because during my career, I had
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`experience assigning engineers to work on mechanical design projects, including
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`projects to design hemostasis valves or incorporate them into catheter-based
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`projects. For such projects, I would assign an engineer with the experience
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`described above.
`
`A.
`
`Summary of the ’012 Patent
`
`III. THE ’012 PATENT
`
`37. The ’012 patent describes a delivery system that includes a catheter
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`and a hemostasis (or “garrote”) valve for use during minimally invasive
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`intravascular procedures, as illustrated below in Figure 1:
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`Ex. 1 (’012 patent) at 6:26-47, Fig. 1. The hemostasis valve is used with a
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`catheter that is inserted into the patient’s vasculature and prevents blood from
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`passing through the valve. In this way, the valve helps provide a seal to minimize
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`blood loss, prevent the introduction of air into the vasculature, and maintain
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`sterility during the procedure. Id. at 1:41-44. The ’012 patent states that the
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`hemostasis valve “can seal with or without a tool extending through the valve.”
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`Id. at 5:55-58.
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`38. As illustrated in Figure 2 of the ’012 patent below, the hemostasis
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`valve described in the ’012 patent includes a “housing 128” that defines a “interior
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`- 13 -
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`channel 130,” and a collapsible “elongate member 132” that extends through the
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`housing 128:
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`Id. at 7:1-31, Fig. 2. The ’012 patent explains that the elongate member 132 has a
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`“thin-walled compliant tubular structure,” which helps facilitate “the uniform
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`collapse of the elongate member 132 and the sealing of the elongate member
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`132.” Id. at 7:17-20.
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`39. The ’012 patent describes that the elongate member is sealed by a
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`“constricting mechanism,” which can “collapse and seal the elongate member 132
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`via compression and/or constriction, and specifically via constriction with at least
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`one filament 150.” Id. at 8:5-8. The ’012 patent explains that the filament “can
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`extend at least partially around the elongate member.” Id. at 8:11-12. The
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`- 14 -
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`constricting mechanism also includes an actuator, which the ’012 patent states
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`“can be a manual actuator such as one or several buttons 144”:
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`- 15 -
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`Id. at 8:8-10, Figs. 1-2. The filament is “coupled to the actuator 142 such that the
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`filament 150 selectively constricts, collapses, and/or seals the elongate member
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`132 … based on the movement and/or position of the actuator 142.” Id., at 9:24-
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`28.
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`40. The ’012 patent also explains that the valve can include a “bias
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`feature,” such as a spring, which biases the valve to either the closed (referred to
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`as first) or open (referred to as second) position when no outside forces are being
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`applied to the actuator button(s). Id. at 8:38-56. Figure 4 shows the valve biased
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`toward the first, closed position:
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`- 16 -
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`Id. at 8:38-56, Fig. 4. The ’012 patent explains that when the actuator buttons are
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`depressed by an outside force, the tension on the filament is loosened “thereby
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`allowing the expansion of the elongate member 132 and the unsealing of the
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`central lumen 138 of the elongate member 132.” Id. at 9:54-62. Figure 3 below
`
`depicts the valve in the second, opened position when the actuator buttons are
`
`depressed:
`
`
`
`Id. at 5:32-32, Fig. 3.
`
`41. The ’012 patent explains that its constricting mechanism, including
`
`the filament, can constrict the elongate member around a tool that is inserted
`
`through the central lumen of the elongate member to “seal the valve 104 around
`
`- 17 -
`
`
`
`
`
`the tool.” Id. at 11:64-12:15. Figure 4 below depicts the valve in the first, closed
`
`position, with a tool 400 inserted through the central lumen of the elongate
`
`member:
`
`
`
`Id. at 5:33-35, Fig. 4.
`
`42. The ’012 patent discloses that the “filament 150 can be arranged in a
`
`variety of configurations” including a single loop 604 that can extend around the
`
`elongate member 132 as shown in Figure 6, multiple loops that can extend around
`
`- 18 -
`
`
`
`
`
`the elongate member as shown in Figure 7, or a “U-shaped section between the
`
`two ends of the filament 150” (i.e., a bight) that can extend around the elongate
`
`member as shown in Figures 8 and 9:
`
`
`
`Id. at 13:17-14:34, Figs. 6-9. The ’012 patent also discloses that the filament can
`
`be formed from a range of materials “including, for example, a polymer, a
`
`synthetic, and/or a metal.” Id. at 9:13-15. The filament can also “comprise a
`
`single strand such as, for example, a monofilament” or it “can comprise a plurality
`
`of strands that can be, for example, twisted, woven, grouped, and/or fused to form
`
`the filament.” Id. at 9:16-20. Accordingly, “the filament 150 can comprise one or
`
`several threads, lines, cords, rope, ribbon, flat wire, sheet, or tape.” Id. at 9:21-23.
`
`- 19 -
`
`
`
`
`
`Additionally, “in some embodiments, each of the first end 700 and the second end
`
`702 of one or more of the multiple filaments 150 can be coupled to different
`
`buttons 144”:
`
`
`
`Id. at 13:8-11, Fig. 8.
`
`B.
`
`The Challenged Claims
`
`43. The challenged claims include Claims 1-9 of the ’012 patent. Claim
`
`1 is the only independent claim.
`
`44. Claim 1 is illustrative (but not representative) of some of the
`
`limitations in the challenged claims. Claim 1 states:
`
`1. An aspiration catheter, comprising:
`an elongate, flexible tubular body, having a proximal end, a
`distal end and a central lumen;
`a hemostasis valve on the proximal end of the catheter, the
`hemostasis valve comprising
`(a) a collapsible tubular sidewall defining a valve lumen in
`communication with the central lumen; and
`
`- 20 -
`
`
`
`
`
`(b) a constricting mechanism having at least a first actuator, a
`first filament formed into a loop around the collapsible tubular
`sidewall, the filament having at least a first end portion extending
`away from the loop and connected to the first actuator, and a first
`spring configured to move the first actuator in a direction that pulls
`the first end portion such that a diameter of the valve lumen decreases
`in response to reducing a diameter of the loop.
`
`
`Ex. 1001 (’012 patent) at Claim 1.
`
`C.
`
`Prosecution History
`
`45.
`
`I have reviewed the ’012 patent’s prosecution history. I see that the
`
`Patent Examiner issued a single non-final office action that did not include any
`
`prior-art based rejections. Ex. 1002 (’012 patent prosecution history excerpt) at
`
`81-87. I notice that the examiner did not have Schaffer during prosecution, and
`
`therefore did not consider the unpatentability arguments presented in this
`
`Declaration. I also do not see that the examiner ever mentioned Eller during
`
`prosecution.
`
`46.
`
`I see that in a notice of allowance issued on November 23, 2022, the
`
`Examiner stated the following regarding the Hartley prior art reference that I
`
`discuss herein:
`
`Hartley discloses a catheter is capable for aspiration therefore,
`it can be called as an aspiration catheter, comprising: an elongate,
`flexible tubular body 4, having a proximal end (adjacent to element
`7), a distal end (opposite end of the proximal end, the distal end being
`inserted into a patient) and a central lumen (catheter lumen); a
`hemostasis valve 8 on the proximal end of the catheter, the hemostasis
`valve 8 comprising - (a) a collapsible tubular sidewall 22 defining a
`valve lumen 3 in communication with the central lumen; and (b) a
`
`- 21 -
`
`
`
`
`
`constricting mechanism 12 & 20 having at least a first actuator 12, a
`first filament 14 formed into a loop around the collapsible tubular
`sidewall 8, see Figs. 3-4, the filament 14 having at least a first end
`portion 16 extending away from the loop and connected to the first
`actuator 12.
`
`
`Harley fails to disclose that and [sic] a first spring configured to
`move the first actuator in a direction that pulls the first end portion
`such that the diameter of the valve lumen decreases in response to
`reducing a diameter of the loop.
`
`
`Id. at 85. In other words, the Examiner found that Hartley disclosed every
`
`limitation in Claim 1 of the ’012 patent except for “a first spring configured to
`
`move the first actuator in a direction that pulls the first end portion such that the
`
`diameter of the valve lumen decreases in response to reducing a diameter of the
`
`loop.” Id.
`
`47.
`
`I see that the Examiner also concluded that two additional references,
`
`Wong (attached as Exhibit 1010) and Myers (attached as Exhibit 1012), described
`
`“a missing limitation of Hartley (i.e. a spring), however, the spring in Wong or
`
`Myers is inapplicable to add into the device of Hartley.” Id. at 85-86. The
`
`examiner did not provide further information regarding this conclusion.
`
`A.
`
`Filament
`
`IV. CLAIM CONSTRUCTION
`
`48. Claim 1 requires “a first filament formed into a loop around the
`
`collapsible tubular sidewall.” I have reviewed the claims, specification, and
`
`prosecution history of the ’012 patent, and in my opinion, a person of ordinary
`
`- 22 -
`
`
`
`
`
`skill in the art in September 2017 would have understood the term “filament” in
`
`the claims of the ’012 patent to mean at least: “one or more threads, lines, cords,
`
`ropes, ribbons, flat wires, sheets, or tapes.”
`
`49.
`
`I understand from counsel that the claim construction analysis should
`
`begin with the language of the claims. Here, the claims do not provide much
`
`information about the meaning of “filament.” Claim 1 of the ’012 patent says that
`
`the constricting mechanism includes “at least a first actuator [and] a first filament
`
`formed into a loop around the collapsible tubular sidewall.” Ex. 1001 (’012
`
`patent) at Claim 1. Claim 1 goes on to say that the “filament” has at least “a first
`
`end portion extending away from the loop and connected to the first actuator.” Id.
`
`Claim 2 says that the “filament” further comprises a second end portion extending
`
`away from the loop in a different direction than the first end portion and
`
`connected to the second actuator.” While this langua
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