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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. 11,844,921
`
`
`
`
`
`
`
`
`
`
`
`
`DECLARATION OF TROY L. THORNTON
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 11,844,921
`
`
`
`
`
`
`
`
`Imperative Care v. Inari Medical
`US Patent 11,844,921
`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 ’921 PATENT .................................................................................... 12
`
`A.
`
`B.
`
`C.
`
`Summary of the ’921 Patent ......................................................... 12
`
`The Challenged Claims ................................................................ 18
`
`Prosecution History ...................................................................... 19
`
`IV. CLAIM CONSTRUCTION........................................................................ 19
`
`A.
`
`B.
`
`The Board’s Institution Decision from the ’011 Patent IPR ........ 20
`
`Construction of “Filament” .......................................................... 23
`
`V. SUMMARY OF IPR GROUNDS ............................................................... 26
`
`- i -
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`VI. GROUNDS 1-4: CLAIMS 1-7, 9-10, 15-18, 20-24 ANTICIPATED
`BY SCHAFFER OR OBVIOUS OVER SCHAFFER ALONE OR
`IN COMBINATION WITH HARTLEY OR ELLER ........................... 26
`
`A.
`
`Claim 1 ......................................................................................... 31
`
`1.
`
`2.
`
`3.
`
`4.
`
`Preamble ............................................................................. 31
`
`Elongate Member ............................................................... 32
`
`Tensioning Mechanism ...................................................... 33
`
`Biasing Member ................................................................. 70
`
`Claim 2 ......................................................................................... 72
`
`Claim 3 ......................................................................................... 72
`
`1.
`
`2.
`
`3.
`
`Schaffer .............................................................................. 72
`
`Hartley ................................................................................ 74
`
`Eller .................................................................................... 76
`
`Claim 4 ......................................................................................... 77
`
`Claim 5 ......................................................................................... 80
`
`1.
`
`2.
`
`3.
`
`Schaffer .............................................................................. 81
`
`Hartley ................................................................................ 87
`
`Eller .................................................................................... 88
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Claim 6 ......................................................................................... 91
`
`- ii -
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`G.
`
`H.
`
`I.
`
`J.
`
`K.
`
`L.
`
`Claim 7 ......................................................................................... 97
`
`Claim 9 ......................................................................................... 98
`
`Claim 10 ....................................................................................... 99
`
`1.
`
`2.
`
`3.
`
`Schaffer ............................................................................ 100
`
`Hartley .............................................................................. 101
`
`Eller .................................................................................. 105
`
`Claim 15 ..................................................................................... 107
`
`Claim 16 ..................................................................................... 108
`
`Claim 17 ..................................................................................... 109
`
`M. Claim 18 ..................................................................................... 109
`
`N.
`
`O.
`
`P.
`
`Q.
`
`R.
`
`Claim 20 ..................................................................................... 109
`
`Claim 21 ..................................................................................... 110
`
`Claim 22 ..................................................................................... 111
`
`Claim 23 ..................................................................................... 111
`
`Claim 24 ..................................................................................... 111
`
`VII. GROUND 5-7: CLAIMS 1-3, 5-6, 9, 15-18, AND 21-24 OBVIOUS
`OVER HARTLEY IN COMBINATION WITH ELLER .................... 113
`
`A.
`
`Claim 1 ....................................................................................... 114
`
`1.
`
`Preamble ........................................................................... 114
`
`- iii -
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2.
`
`3.
`
`4.
`
`Elongate Member ............................................................. 114
`
`Tensioning Mechanism .................................................... 115
`
`Biasing Member ............................................................... 120
`
`Claim 2 ....................................................................................... 127
`
`Claim 3 ....................................................................................... 127
`
`Claim 5 ....................................................................................... 128
`
`Claim 6 ....................................................................................... 130
`
`Claim 9 ....................................................................................... 134
`
`Claim 15 ..................................................................................... 135
`
`Claim 16 ..................................................................................... 136
`
`Claim 17 ..................................................................................... 137
`
`Claim 18 ..................................................................................... 137
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`Claim 21 ..................................................................................... 137
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`Claim 22 ..................................................................................... 138
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`J.
`
`K.
`
`L.
`
`M. Claim 23 ..................................................................................... 138
`
`N.
`
`Claim 24 ..................................................................................... 139
`
`VIII. SECONDARY CONSIDERATIONS ................................................... 139
`
`IX. CONCLUSION ......................................................................................... 140
`
`- iv -
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`
`
`
`
`Exhibit
`No.
`
`TABLE OF EXHIBITS
`
`Description
`
`1001
`
`U.S. Patent No. 11,844,921 (“the ’921 patent”)
`
`1002
`
`Excerpts from the prosecution history of the ’921 patent
`
`1003
`
`Expert Declaration of Troy Thornton
`
`1004
`
`Resume of Troy Thornton
`
`1005
`
`1006
`
`U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al.
`(“Schaffer”)
`
`U.S. Patent Publication No. 2003/0116731 A1 to Hartley
`(“Hartley”)
`
`1007
`
`U.S. Patent No. 9,980,813 B1 to Eller (“Eller”)
`
`1008
`
`Certified File History of U.S. Patent Application 10/371,190
`(Schaffer File History)
`
`1009
`
`U.S. Patent No. 5,429,616 to Schaffer (“Schaffer ’616”)
`
`1010
`
`U.S. Patent No. 3,438,607 to Williams et al.
`
`1011
`
`U.S. Patent Publication No. 2015/0173782 A1 to Garrison et al.
`(“Garrison”)
`
`1012
`
`U.S. Patent No. 11,697,011 (“the ’011 patent”)
`
`1013
`
`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).
`
`1014
`
`Google Dictionary Definition of “String”
`
`1015
`
`Cambridge Dictionary Definition of “String”
`
`1016
`
`U.S. Patent No. 12,109,384 B2 to Merritt et al.
`
`Table of Exhibits 1
`
`
`
`
`
`Exhibit
`No.
`
`1017
`
`Description
`
`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)
`
`1018
`
`PCT Patent Publication WO 2018/019829 A1 to Brady et al.
`
`1019
`
`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)
`
`1020
`
`U.S. Patent No. 6,776,770 B2 to Treretola
`
`1021
`
`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)
`
`Table of Exhibits 2
`
`
`
`
`
`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 1-7, 9-10, 15-
`
`18, and 20-24 of U.S. Patent No. 11,844,921 (“the ’921 patent”). For the reasons
`
`discussed herein, I have concluded that Claims 1-7, 9-10, 15-18, and 20-24 of the
`
`’921 patent are unpatentable because the prior art references anticipate the claims
`
`or render them obvious.
`
`2.
`
`I understand that this Declaration supports Imperative Care’s Petition
`
`for the above-captioned inter partes review (“IPR”) of the ’921 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 ’921 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
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`product received FDA approval in 2013 and is currently available in over 30
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`countries.
`
`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 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
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`- 3 -
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`
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`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 ’921 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 ’921 patent;
`
` The level of ordinary skill in the art pertaining to the ’921 patent;
`
` The teachings of the prior art; and
`
` Whether Claims 1-7, 9-10, 15-18, and 20-24 of the ’921 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 ’921 patent.
`
`II. APPLICABLE LEGAL STANDARDS
`I am a biomedical engineer by training and profession. The opinions
`
`18.
`
`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 ’921 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
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`- 5 -
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`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, September 6, 2017).
`
`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
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`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.
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`- 7 -
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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 ’921 patent, e.g., hemostasis valves for use during intravascular
`
`procedures. The references are also pertinent to the problem the inventor was
`
`focused on, e.g., sealing a catheter during intravascular procedures to minimize
`
`blood leaks.
`
`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.
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`- 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
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`- 9 -
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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 1-7, 9-10, 15-18, and 20-24 of the ’921 patent
`
`- 10 -
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`
`
`would have been non-obvious, as further explained in Section § VIII (Heading:
`
`“Secondary Considerations”) below.
`
`D.
`
`Person of Ordinary Skill in the Art
`
`32.
`
`It is my understanding that when interpreting the claims of the
`
`’921 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 ’921 patent is September 6,
`
`2017. I 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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`35. Based on my review of the specification and claims of the ’921 patent,
`
`it is my opinion that a person of ordinary skill in the art would have had an
`
`undergraduate degree in mechanical engineering or a related engineering discipline
`
`and 2-4 years of product design or engineering experience.
`
`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 hemostasis valves or incorporate them into catheter-based projects. For such
`
`projects, I would assign an engineer with the experience described above.
`
`III. THE ’921 PATENT
`Summary of the ’921 Patent
`
`A.
`
`37. The ’921 patent describes embodiments of a hemostasis valve (also
`
`referred to in the ’921 patent as a “garrote” valve) for use with a catheter during
`
`minimally invasive intravascular procedures. Ex. 1001 (’921 patent) at 5:49-67.
`
`The valve creates a seal that prevents blood from passing through the valve,
`
`including when a tool is passed through the valve. Id. at 5:50-52. The valve
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`prevents blood from leaking through the catheter during the intravascular
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`procedure, and also prevents air or other contaminants from entering the patient’s
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`vasculature. Id. at 1:35-38.
`
`38. As illustrated in Figure 2 of the ’921 patent below, the valve described
`
`in the ’921 patent includes a “housing 128” that defines a “interior channel 130,”
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`and a collapsible “elongate member 132” that extends through the housing:
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`- 12 -
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`
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`Id. at 6:49-7:24, Fig. 2. The elongate member 132 has a “thin-walled compliant
`
`tubular structure,” which helps facilitate “the uniform collapse of the elongate
`
`member 132 and the sealing of the elongate member 132.” (Id. at 7:10-16.)
`
`39. The ’921 patent describes that the sealing of the elongate member is
`
`accomplished by a “constricting mechanism,” which can “collapse and seal the
`
`elongate member 132 via compression and/or constriction, and specifically via
`
`constriction with at least one filament 150.” (Id., 8:1-4.)
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`- 13 -
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`
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`Id. at Figs. 1-2. The constricting mechanism includes “an actuator 142 which can
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`be a manual actuator such as one or several buttons 144; and the at least one filament
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`150 that can extend at least partially around the elongate member 132.” Id. at 8:1-
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`5. The “filament 150 can be coupled to the actuator 142 such that the filament 150
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`- 14 -
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`
`
`
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`selectively constricts, collapses, and/or seals the elongate member 132 … based on
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`the movement and/or position of the actuator 142.” Id. at 9:18-22.
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`40. The valve also includes a “bias feature,” such a spring (148-A and 148-
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`B), which biases the actuator toward the open or closed configuration.to. Id. at
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`8:32-51. Figure 4 shows the valve biased toward a first, closed position:
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`
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`Id. at 8:32-51, Fig. 2.
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`41. Depressing the actuator buttons releases tension on the filament,
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`“thereby allowing the expansion of the elongate member 132 and the unsealing of
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`the central lumen 138 of the elongate member 132”:
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`- 15 -
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`
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`Id. at 9:48-56, Fig. 3.
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`42. The filament 150 can constrict the elongate member around a tool 400
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`inserted through the central lumen of the elongate member, “create[ing] a seal
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`between the elongate member 132 and the tool,” as illustrated in Figure 4:
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`Id. at 11:64-12:8, Fig. 4.
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`- 16 -
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`43. The “filament 150 can be arranged in a variety of configurations”
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`including a “single loop 604 that can extend around the elongate member 132” as
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`shown in Figure 6, multiple loops as shown in Figure 7, or a “U-shaped section
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`between the two ends of the filament 150” as shown in Figures 8-9:
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`
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`Id. at 13:10-14:27, Figs. 6-9.
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`44. The patent also discloses that “[t]he filament can be made from a
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`variety of materials including, for example, a polymer, a synthetic, and/or a metal.”
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`Id. at 9:13-15. The filament may also “comprise multiple filaments,” such as in
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`- 17 -
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`
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`
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`Figures 7-9, where “each of the multiple filaments can have a first end 700 and a
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`second end 702”:
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`
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`Id. at 13:1-9, Fig. 8.
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`B.
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`The Challenged Claims
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`45. The challenged claims include Claims 1-7, 9-10, 15-18, and 20-24 of
`
`the ’921 patent. Claims 1, 15, and 21 are independent claims.
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`46. Claim 1 is illustrative (but not representative) of some of the
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`limitations in the challenged claims. Claim 1 states:
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`1. A valve, comprising:
`an elongate member defining a lumen;
`an active tensioning mechanism including an actuator coupled to
`the elongate member via a filament extending at least partially
`around the elongate member, wherein the actuator is
`moveable between (a) a first position wherein the lumen is
`constricted and sealed and (b) a second position wherein the
`lumen is at least partially open; and;
`a biasing member configured to bias the actuator to the first
`position.
`
`
`
`- 18 -
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`
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`
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`Ex. 1001 (’921 patent) at Claim 1.
`
`C.
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`Prosecution History
`
`47.
`
`I have reviewed the ’921 patent’s prosecution history. I see that the
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`Patent Examiner did not offer any rejections of the claims in an Office Action. Ex.
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`1002 (’921 patent prosecution history excerpt). I see from the front of the patent
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`that the examiner did not have Schaffer (Ex. 1005) during prosecution, and
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`therefore did not consider the unpatentability arguments presented in this
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`Declaration based on Schaffer. I also do not see that the examiner ever mentioned
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`Eller (Ex. 1007) during prosecution.
`
`48. The Examiner issued a Notice of Allowance. Ex. 1002 at 21-30. In
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`the Notice of Allowance, the Examiner stated that Hartley (Ex. 1006) and Williams
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`(Ex. 1010) were the “closest prior art of record.” Ex. 1002 at 25. The Examiner
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`found that Hartley disclosed every limitation of several claims, including current
`
`claim 1 (claim 52 during prosecution), except “a biasing member configured to bias
`
`the actuator to the first position.” Id. While the Examiner found that Williams
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`disclosed a biasing member, the Examiner also found that Williams failed to
`
`disclose “a filament extending around the elongate member.” Id. at 26. The
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`Examiner did not address the combination of any references.
`
`IV. CLAIM CONSTRUCTION
`Independent claims 1, 10, 15, and 21 require a “filament.” I have
`
`49.
`
`offered a construction for “filament” in previous IPRs involving related patents,
`
`- 19 -
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`
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`including IPRs for U.S. Patent Nos. 11,691,011 and 11,697,012. I understand that
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`the ’011 and ’012 patents have the same specification as the ’921 patent (the subject
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`of this IPR). Consistent with my previous analysis, it is my opinion that a person
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`of ordinary skill in the art in September 2017 would have understood the term
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`“filament” in the claims of the ’921 patent to mean at least: “one or more threads,
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`lines, cords, ropes, ribbons, flat wires, sheets, or tapes.”
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`A. The Board’s Institution Decision from the ’011 Patent IPR
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`50.
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`I have reviewed
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