`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-00135
`Patent RE 45,776
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`DECLARATION OF PETER T. KEITH
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`Page 1
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`I, Peter Keith, hereby declare and state as follows:
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`1.
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`I have been retained by the owner of U.S. Patent No. RE45,776 (“the
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`’776 patent”), whom I will refer to in this declaration as “Teleflex,” to provide my
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`independent expert opinions in this matter. I understand that petitions for inter
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`partes review have been filed against certain claims of the ’776 patent. The
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`following provides my opinions in support of Teleflex’s Patent Owner Preliminary
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`Response in this matter.
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`I.
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`PERSONAL BACKGROUND
`2.
`I summarize my educational background and career history in the
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`following paragraphs. My complete qualifications are provided in my curriculum
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`vitae, which is attached to this declaration as Appendix A.
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`3.
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`I received a Bachelor of Science degree in mechanical engineering
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`with High Distinction from the University of Minnesota in 1987. During my
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`undergraduate training, I began working as an engineering intern in the research
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`and development (R&D) department at SCIMED, which was later acquired by
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`Boston Scientific Corporation. I joined SCIMED full-time after graduation, and I
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`remained with the company until 1996. During this time I rose from engineering
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`intern to full-time R&D engineer to Director of R&D. Throughout my various
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`roles at SCIMED, the focus of my work was on medical devices in the field of
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`interventional cardiology, particularly catheter design.
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`4.
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`Since 1997, I have served as an independent consultant for early stage
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`medical device companies in the areas of product design and intellectual property
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`development. Several of my consulting clients have developed successful products
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`that are on the market and in hospitals today. A number of the products have been
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`in the field of interventional cardiology, particularly catheters.
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`5.
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`In addition to my work as an independent consultant, since 2000 I
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`have engaged in a number of entrepreneurial ventures in the field of medical
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`devices. In many of these ventures, I held chief responsibility for product design
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`and development. Several of these products have been in the area of interventional
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`cardiology. I have also done considerable work outside the area of interventional
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`cardiology, including in treatments for orthopedics for extremities such as feet and
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`ankles and treatment of spinal disorders. In 2006, I co-founded Entellus Medical, a
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`company focused on catheter based treatments for chronic sinusitis. As Chief
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`Technology Officer, I led the product development and research teams. Entellus
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`went public in 2015, and was acquired by Stryker in 2018.
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`6.
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`Between my work at SCIMED, my independent consulting, and my
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`entrepreneurial ventures, I have been named as an inventor on over 140 issued U.S.
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`patents, as well as many corresponding patents in foreign countries. Numerous
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`patent applications on which I am a named inventor are still pending.
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`7.
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`I have prior experience with patent litigation involving the technology
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`at issue and the patent families at issue in this case. Among other things, I
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`provided expert infringement and validity opinions on behalf of Teleflex in the
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`case of QXMédical, LLC v. Vascular Solutions LLC, et al., No. 0:17-cv-01969 (D.
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`Minn.) (the QXM case). In the QXM case, among the patents asserted were four
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`of the five patents at issue in these IPRs: U.S. Patent Nos. 8,048,032; RE45,380;
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`RE45,760; and RE45,776. U.S. Patent No. RE47,379 had not yet issued when the
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`QXM case was filed, but it is in the same family as the other four patents listed
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`above that were asserted in the QXM case.
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`8.
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`I have also provided expert opinions concerning all five patents at
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`issue in these proceedings on behalf of Teleflex in the case of Vascular Solutions
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`LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.). Those opinions
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`were provided in connection with Teleflex’s Motion for Preliminary Injunction.
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`9.
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`In writing this declaration, I have considered my own knowledge and
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`experience, including my work experience in designing interventional cardiology
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`devices and my experience in working with others involved in the field of
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`interventional cardiology devices, including medical doctors working as
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`interventional cardiologists. I have also considered the information that a POSITA
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`would have been aware of in May 2006, including the documents I discuss in this
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`declaration.
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`10.
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`I am being compensated at $525 per hour for my time, my standard
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`rate for this type of consulting activity. My compensation is not contingent on the
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`results of these or any other legal proceedings.
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`II. LEGAL STANDARDS
`11.
`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the legal standards below.
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`A. Claim Construction
`12.
`I understand that patent claims are to be interpreted in view of a
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`patent’s specification and prosecution history. I understand that claim construction
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`starts with the plain language of the claims as understood by a person having
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`ordinary skill in the art at the time the patent was filed.
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`13.
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`I understand that the parties agreed to constructions for certain claim
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`terms in the QXM case. I understand that those constructions are provided in the
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`document filed by the Petitioner in this inter partes review as Exhibit 1012. Other
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`than as specifically discussed in this declaration, I do not at this time offer any
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`opinions regarding those constructions. Rather, I apply them for the purpose of
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`this declaration.
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`14.
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`I understand that a patent may be its own lexicographer, so long as the
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`definition of a specific term is clearly set forth in the specification and it is clear
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`the inventor intended to define the term.
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`15. For any claim terms not explicitly noted as construed, I have applied
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`the plain and ordinary meanings as would be understood by a person of ordinary
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`skill in the art in 2006.
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`B. Anticipation
`16.
`I understand that a claim is invalid as anticipated if a single prior art
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`reference discloses each and every limitation of the claimed invention.
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`17.
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`I understand that a reference may be anticipatory regardless of
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`whether the prior art and the claimed invention are directed to achieving the same
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`purpose, if it contains the claim elements in the same order as claimed and would
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`inherently provide any claimed function.
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`18.
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`I understand that a prior art reference may anticipate a claim without
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`expressly disclosing a feature of the claimed invention if that missing feature is
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`necessarily present, or inherent, in the single anticipating reference.
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`19.
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`I understand that inherency requires more than a probability or
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`possibility that a claimed feature is present in the prior art, but rather that the
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`feature or characteristic is a necessary part of the prior art. I also understand that a
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`POSITA does not necessarily need to recognize the inherency at the time of
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`purported invention.
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`C. Obviousness
`20.
`I understand that obviousness is determined based on (1) the scope
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`and content of the prior art; (2) the differences between the claims and the prior art;
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`(3) the level of ordinary skill in the art; and (4) objective indicia of
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`nonobviousness.
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`21.
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`I understand that there must be a reason to modify a single prior art
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`reference, or to combine multiple references, to achieve the claimed invention. I
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`understand that this motivation may come from a teaching, suggestion, or
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`motivation to combine. I also understand that a specific teaching, suggestion, or
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`motivation is not required.
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`22.
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`I also understand that “objective indicia of nonobviousness” must be
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`considered, such as commercial success of the claimed invention, whether others
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`copied the invention, and whether others in the field praised the invention.
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`23.
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`I understand that after consideration of all of these factors, a patent is
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`not obvious unless the difference between the subject matter sought to be patented
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`and the prior art are such that the subject matter as a whole would have been
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`obvious at the time the invention was made to a person having ordinary skill in the
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`art to which said subject matter pertains.
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`III. SCOPE OF OPINIONS
`24.
`I have been asked only to provide my independent opinions and
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`analysis of the issues I specifically discuss in this declaration. I note that the
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`Petition (and the evidence it cites) appears to raise many other issues, but I have
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`not been asked to provide my opinions as to any of those other issues.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
`25.
`I understand that the Petitioner and Dr. Brecker have proposed a
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`definition of a person of ordinary skill: “a person of ordinary skill in the art
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`(“POSITA”) at the time of the alleged invention would have had (a) a medical
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`degree; (b) completed a coronary intervention training program, and (c)
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`experience working as an interventional cardiologist. Alternatively, a POSITA
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`would have had (a) an undergraduate degree in engineering, such as mechanical
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`or biomedical engineering; and (b) three years of experience designing medical
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`devices, including catheters or catheter-deployable devices. [. . .] Extensive
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`experience and technical training might substitute for education, and advanced
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`degrees might substitute for experience. Additionally, a POSITA with a medical
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`degree may have access to a POSITA with an engineering degree, and one with an
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`engineering degree might have access to one with a medical degree.” E.g. Ex.
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`1005, ¶31. While I do not necessarily agree with this proposed definition, my
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`opinions below are provided with respect to this definition of a POSITA.
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`26.
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`I have an undergraduate degree in mechanical engineering and more
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`than three years designing medical devices, including catheters or catheter-
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`deployable devices. Therefore I meet the definition provided by the Petitioner and
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`Dr. Brecker of a POSITA.
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`V. THE ’776 PATENT
`27.
`I have reviewed the claims and specification of the ’776 Patent. I have
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`also reviewed the prosecution history of the ’776 patent.
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`28. The ’776 Patent includes three independent claims—claims 25, 52,
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`and 53.
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`29. Claim 25 of the ‘776 patent recites:
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`A guide extension catheter for use with a guide catheter, comprising:
`a substantially rigid segment;
`a tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
`a segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and a
`proximal end of the tubular structure, the segment defining the
`partially cylindrical opening having an angled proximal end,
`formed from a material more rigid than a material or material
`combination forming the tubular structure, and configured to
`receive one or more interventional cardiology devices there-
`through when positioned within the guide catheter,
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`wherein a cross-section of the guide extension catheter at the
`proximal end of the tubular structure defines a single lumen.
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`30. Claim 52 is similar to claim 25, but additionally requires that the
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`segment defining the angled proximal end of the partially cylindrical opening
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`includes at least two inclined regions. Claim 53 is similar to claim 52, except that
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`(1) it additionally requires the tubular structure to have a lumen having a uniform
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`cross-sectional inner diameter that is not more than one French size smaller than
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`the cross-sectional inner diameter of the lumen of the guide catheter; and (2) does
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`not require that the segment defining a partially cylindrical opening to be formed
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`from a material having a greater flexural modulus than a flexural modulus of the
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`tubular structure.
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`VI. MEDTRONIC’S REFERENCES
`A.
`Itou (Ex. 1007)
`31. The Itou reference discloses an intravascular suction catheter that
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`includes a distal tubular portion attached to a wire-like portion for sucking out
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`foreign matter such as a thrombus located within a blood vessel:
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`Ex. 1007, 1:53-65.
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`32. The distal tubular portion 24 comprises three parts: tubular body
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`portion 21 (green) joined to a distal tip 22 (blue) at the distal end of the tubular
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`body portion, and joined to a proximal tip 23 (yellow) at the proximal end of the
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`tubular body portion.
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`
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`Id., at 3:50-58; Fig. 3 (color added). The proximal tip 23 is formed by “obliquely
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`cutting one end of a metal pipe” and then coating the inner and outer faces of the
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`pipe with a “resin.” Id., 4:25-42. The proximal tip is welded to the distal end of a
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`push wire 25. Id.
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`33.
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`Itou also discloses a “protective catheter 5” that is pre-loaded into the
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`suction catheter (i.e., inserted outside of the body) prior to delivery:
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` Ex. 1007, 4:44 and Fig. 1E. Itou explains this pre-loading process: it explains
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`that using the suction catheter involves first putting a guide catheter in place in a
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`coronary artery, then inserting a “combination” of the suction catheter and the
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`protective catheter “into the guiding catheter” to the target location, then pulling
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`the protective catheter out, and finally suctioning out the foreign matter. Id., 7:4-
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`26.
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`B. Kataishi (Ex. 1025)
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`Ex. 1025, Fig. 1. The distal end opening 12 has a “cut surface 16” with a concave
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`portion 161.
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`35. The distal portion of Kataishi’s suction catheter is a multi-lumen tube
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`containing at least two lumens. In addition to an evacuation lumen 11 that extends
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`the entire length of the catheter, a guidewire lumen 15 extends from insertion point
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`13 shown above in Figure 1 all the way to the distal end of the catheter. Id.,
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`[0029]. Figure 2 provides a cutaway view of the distal end of the suction catheter
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`device showing both lumens:
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`Ex. 1025, Fig. 2. The evacuation lumen 11 of Kataishi is not circular in cross-
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`section anywhere along its length, including at the distal end shown above in
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`Figure 2. See Figs. 4-5.
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`36.
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` The interaction of Kataishi’s distal end with the thrombus is shown
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`in Figure 10, below.
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`Id., Fig. 10. The distal end opening of Kataishi’s suction catheter is designed to be
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`“flexible,” in order to increase its ability to absorb/suction the thrombus. Id. at
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`[0027] and Fig. 10 (“The concave portion 161 is a means for improving flexibility
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`of the catheter distal end and enabling the cut surface 16 to adsorb an expanded
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`atheroma AT by suction, when the atheroma AT as shown in FIG. 10 is covered
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`with the distal end opening 12”). Kataishi’s flexible, angled distal end allows a
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`coronary lesion to be enveloped by the opening and suctioned through the side of
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`the catheter. Id. at [0010], [0027], Fig. 10. Both the flat portion 162 and the
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`concave portion 161 are intended to improve the flexibility of the catheter’s distal
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`end and thereby improve its ability to envelop and absorb/suction the thrombus.
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`Id. at [0027]-[0028].
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`C. Ressemann (Ex. 1008)
`37. U.S. Patent No. 7,604,612 (“Ressemann”), Ex. 1008, discloses an
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`evacuation sheath assembly used to treat occluded vessels, which reduces the risk
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`of distal embolization during vascular interventions. Ex. 1008, Abstract. The
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`multi-lumen tube contains multiple offset lumens. E.g., Ex. 1008, 6:35-36, Figs.
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`1A, 1B, 16D, and 16E. These multiple lumens result in the evacuation (suction)
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`lumen being axially offset from the guide catheter lumen. Therefore the
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`evacuation lumen is not coaxial with the guide catheter lumen. Figures 1A and 1B
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`show an embodiment of Ressemann’s evacuation sheath assembly:
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`
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`The cross-sectional view of Figure 1B shows both the evacuation lumen 140 and
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`the inflation lumen 142, each of which is offset from the longitudinal axis of the
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`guide catheter. See id., 6:35-65.
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`38. Figures 16A-16J show “another aspect of the present invention,” and
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`“many of the elements present in previous embodiments are also shown in Figs.
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`16A-16J.” Ex. 1008, 22:29-37. This embodiment includes a metal support collar
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`shown in isolation in Figure 16J:
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`39.
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`In the assembled product, the collar 2141 (red) is not exposed as
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`shown in this Figure, but rather is embedded within the polymer material, with the
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`tab portion 2141b located underneath the lumen containing core wire 2135:
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`Collar 2141
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`Ex. 1008, Fig. 16D (color added).1 Figure 16D also shows encapsulation material
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`2133 (blue circle), which covers the support collar 2141, located below the core
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`wire lumen (containing core wire 2135), and therefore below (i.e. outside of) the
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`multi-lumen tube. See Ex. 1008 at Fig. 16D, 16E.
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`40. At the proximal end of Ressemann’s evacuation head, the full
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`cylindrical portion of Ressemann’s support collar 2141 is embedded in
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`encapsulation layer 2133, which is outside the multi-lumen tube 2138 (which
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`includes evacuation lumen 2140, inflation lumen 2142 and core wire lumen 2142).
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`This is plain from Figure 16D above. Encapsulation material 2133 covers and
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`adheres to the “windows” of support collar 2141. Ex. 1008, 25:4-6. In the cross
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`section below2, the encapsulation material 2133 is visible on the outside of the
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`multilumen tube. The annotated figure below illustrates where the support collar,
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`covered by and embedded in the encapsulation material, is located:
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`1 All figures from Ressemann reproduced herein are from the original drawings
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`submitted with U.S. Patent. App. 10/214,712 (Ex. 2052), which are of higher
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`resolution than the figures in Ex. 1008.
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`2 While this section is taken at the distal occlusion balloon, the shaft structure of
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`the distal tubular shaft is the same near the proximal end, where the fully
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`circumferential portion of the collar is positioned.
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`Encapsulation material
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`Collar Position
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`Id., Fig. 16E (color added). This confirms that in the assembled device, the tab
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`portion 2141b of Ressemann’s collar is located outside of the multi-lumen tube
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`2138 and below where the core wire lumen and inflation lumen attach to the shaft
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`2120.
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`41. Ressemann explains that the support collar 2141 “serves to reinforce
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`the proximal opening of the evacuation lumen 2140 in the presence of deforming
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`forces, particularly torsional stresses,” and the tab portion “provides a flexibility
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`transition.” Id., 24:47-67.
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`D. Enger (Ex. 1050)
`42. Enger discloses a balloon catheter for use in the coronary arteries. Ex.
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`1050 at Abstract. Figure 1 shows the general structure of the balloon catheter,
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`which includes, in proximal to distal direction, a long, relatively stiff segment
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`defining an inflation lumen 36, a shorter, flexible plastic segment 30 having two
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`lumens, and a single lumen segment on which a balloon is mounted. Id.; see also
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`id. 4:67-5:13.
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`
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`43. Enger’s balloon catheter structure includes an inflation lumen 36 and
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`a separate guidewire lumen, terminating at proximal opening 46. Enger also
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`discloses a metal tube 28 containing the inflation lumen 36, that is mated to the
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`intermediate segment 30 at a location spaced apart proximally from the guidewire
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`lumen opening 46. Ex. 1050, 7:1-5, Fig. 7. As shown in Figure 7, below, a “neck”
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`is formed where the metal tube 28 is inserted into the proximal end of the
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`intermediate segment 30.
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`“Neck” located at
`point where the metal
`tube 28 mates
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`
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`Ex. 1050, Fig. 7 (arrow and annotation added). Enger does not describe what
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`shape the outer surface of the proximal end portion of intermediate segment 30
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`has, although it is evident from Figure 7 that it is not concave on the surface
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`between the “neck” and the guidewire lumen opening 46. Given that the purpose
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`of that proximal portion is solely to engage the metal tube 28, one would expect
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`the proximal end portion of the intermediate segment to be generally circular in
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`cross-section.
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`44. Enger’s opening 46 would be considered to be a partially cylindrical
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`opening. However, the segment defining an angled proximal end of this partially
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`cylindrical opening does not have at least two inclined regions. The partially
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`cylindrical opening in Enger is defined by the portion of intermediate segment 30
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`immediately surrounding the side opening 46. The neck where metal tube 28
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`mates with the proximal end of intermediate segment is a completely separate
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`portion of the device that plays no role in defining the side opening. It would not
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`be considered part of a “segment defining the angled proximal end of the partially
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`cylindrical opening.”
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`45. To operate Enger’s balloon catheter, guidewire 12 is first inserted into
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`the body and advanced through the stenosis to be treated. Id. at 6:54-57. Then,
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`“the balloon catheter 26 of the present invention is advanced over the guidewire 12
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`and within the guide catheter 14.” Id. This means that during operation, the
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`guidewire 12 is introduced to the distal end of the balloon catheter lumen,
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`indicating that the guidewire 12 passes through the proximal opening 46 in a distal-
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`to-proximal direction. The red arrow below indicates the motion of the guidewire
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`12 relative to the advancing balloon catheter lumen 46:
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`VII. ITOU’S SUCTION CATHETER IS NOT A GUIDE EXTENSION
`CATHETER
`46. Guide catheters were well known at the time the original priority
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`application for the ’776 patent was filed in 2006. They are used in interventional
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`cardiology procedures to guide a variety of interventional cardiology devices,
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`including stent and balloon catheters, from a location outside the body to the heart
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`or other location deep inside the vasculature.
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`47. As the name indicates, a “guide extension catheter” extends the
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`effective length of a guide catheter while still maintaining the guiding functionality
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`of receiving interventional cardiology devices and guiding them to a desired
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`location inside the vasculature. This is consistent with the structure and function
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`of all embodiments of the guide extension catheters disclosed in the ’776 patent.
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`48.
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`Itou’s suction catheter is not a guide extension catheter. Itou does not
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`disclose that its suction catheter guides any interventional cardiology devices.
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`Medtronic cites two references, Ressemann (Ex. 1008) and U.S. Patent No.
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`6,398,773 (“Bagaoisan”) (Ex. 1019), as teaching that suction catheters may
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`function as guide extension catheters through which interventional cardiology
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`devices may be inserted. See Paper 1 at 18. Medtronic characterizes the aspiration
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`catheters in these references as “similar to” Itou’s aspiration catheter. Id. This is
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`an oversimplification. Not all suction catheters are structurally equivalent, and not
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`all suction catheters necessarily are configured such that balloon catheters, stents,
`
`and stent catheters are insertable therethrough. In addition, a person of skill in the
`
`art would appreciate that the suction catheters disclosed in Ressemann and
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`Bagaoisan are structurally different from Itou’s suction catheter, and these
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`references would not lead him/her to believe that Itou’s suction catheter was
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`necessarily capable of functioning as a guide extension catheter by passing balloon
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`catheters, stents, and stent catheters.
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`VIII. ITOU’S SUCTION CATHETER DOES NOT HAVE A SEGMENT
`CONFIGURED TO RECEIVE ONE OR MORE INTERVENTIONAL
`CARDIOLOGY DEVICES THERETHROUGH WHEN POSITIONED
`WITHIN THE GUIDE CATHETER
`49.
`Independent claims 25, 52 and 53 of the ’776 patent all require a
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`segment defining a partially cylindrical opening that, inter alia, is “configured to
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`receive one or more interventional cardiology devices therethrough when
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`positioned within the guide catheter.” Itou’s suction catheter does not have such a
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`segment.
`
`50. The sole basis identified in the Petition for why this limitation is
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`allegedly met is Itou’s disclosure that the tubular portion of suction catheter 2 is
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`“large enough” to receive the distal end protective catheter 5. Petition at 24-25.
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`As previously discussed, however, Itou only discloses pre-loading the protective
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`catheter into the suction catheter outside the body. See ¶ 33 above. Thus, Itou’s
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`disclosure regarding the protective catheter does not meet the claim language.
`
`51. Pre-loading the protective catheter outside the body is not the same as
`
`advancing an interventional cardiology device into a partially cylindrical opening
`
`that is positioned within a guide catheter. Loading the protective catheter into the
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`suction catheter outside the body allows the loading to occur when the suction
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`catheter is in a straight position, and with direct manually controllable insertion
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`under direct vision from the operator. When the suction catheter is inside the body
`
`at the distal end of a guide catheter, it will always be in a curved position, and at a
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`remote position deep distally in the guide catheter, with no direct manual control of
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`entry, which negatively affects the ease and feasibility of passing stents and
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`balloon catheters therethrough
`
`IX. A POSITA WOULD NOT COMBINE THE DISTAL END OF
`KATAISHI’S THROMBUS SUCTION CATHETER WITH THE
`PROXIMAL TIP OF ITOU’S SUCTION CATHETER (PETITION
`GROUND 3)
`52. The portion of Kataishi’s thrombus suction catheter relied on in the
`
`Petition is located at the distal tip of the catheter. As taught by Kataishi, the multi-
`
`lumen distal tip portion is flexible, and is designed to envelop a thrombus attached
`
`to the vessel wall and suck it through the side of the catheter in a distal-to-proximal
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`direction. Ex. 1025 at [0027] and Fig. 10 (“The concave portion 161 is a means for
`
`improving flexibility of the catheter distal end and enabling the cut surface 16 to
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`adsorb an expanded atheroma AT by suction, when the atheroma AT as shown in
`
`FIG. 10 is covered with the distal end opening 12”). The Petition relies on Figure
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`10, below, which shows how Kataishi’s distal tip conforms to the thrombus in
`
`preparation for sucking it through the side of the catheter.
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`Petition at 49 (citing Ex. 1025, Fig. 10). Kataishi never discloses any
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`interventional devices being passed through its thrombus suction catheter, let alone
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`any devices passing through the distal tip of the catheter in the distal-to-proximal
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`direction. Indeed, a thrombus suction catheter was designed to be used as an
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`alternative to stents catheters and balloon catheters, not in conjunction with such
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`devices. Id. at [0004]. Kataishi also does not disclose anything (thrombus or
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`otherwise) being advanced through its distal tip in an axial direction.
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`53. An opening designed to suction thrombus in through the side of the
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`distal end of a suction catheter is far different from a proximal opening designed to
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`facilitate insertion of balloon catheters, stents, and stent catheters into the proximal
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`end of a suction catheter. Given the distinct requirements of such openings, and
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`the different considerations implicated in designing a device to perform these
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`specific tasks, a person of ordinary skill in the art would not look to the distal end
`
`of Kataishi’s thrombus suction catheter when trying to modify the proximal end of
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`a suction catheter to enable insertion of interventional cardiology devices
`
`therethrough.
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`54.
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`I also disagree with the assertion that a person of ordinary skill in the
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`art would be motivated to incorporate Kataishi’s angled distal tip onto the proximal
`
`tip of Itou’s suction catheter to “minimize kinking during insertion.” Petition at
`
`50. First, Itou already contains a proximal tip having an angled opening and made
`
`of metal, which is rigid. A person of ordinary skill in the art would not believe that
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`Itou’s proximal tip portion would be prone to kinking. Second, the concave and
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`flat portions of Kataishi’s distal end opening are designed to increase flexibility.
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`E.g., Ex. 1025, Abstract and [0027] (“The concave portion 161 is a means for
`
`improving flexibility of the catheter distal end”). Increased flexibility would, if
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`anything, increase the risk of kinking. A person of ordinary skill in the art seeking
`
`to make Itou’s proximal opening less prone to kinking would not be motivated to
`
`adopt modifications that increased the risk of kinking.
`
`X.
`
`IT WOULD NOT HAVE BEEN OBVIOUS TO COMBINE
`RESSEMANN’S SUPPORT COLLAR WITH THE PROXIMAL TIP
`OF ITOU’S SUCTION CATHETER (PETITION GROUND 4)
`55. The Petition asserts that it would have been obvious to combine Itou
`
`and Ressemann in a very specific way that results in claim limitations of claims
`
`such as independent claims 52 and 53 and dependent claims 32 and 36-38 being
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`25
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`met. The Petition provides the following illustration of what the resulting structure
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`would allegedly look like:
`
`
`
`E.g. Petition at 74.
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`56. Even assuming that a person of ordinary skill in the art would be
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`motivated to modify Itou’s suction catheter to facilitate insertion of interventional
`
`cardiology devices through the proximal opening of Itou’s tubular portion (a
`
`premise I do not agree with), it would not have been obvious to combination Itou
`
`and Ressemann in the very specific way shown above in order to achieve this
`
`objective.
`
`57. As discussed above, Ressemann’s support collar, and in particular tab
`
`portion 2141b, is buried inside and under other components of Ressemann’s
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`suction catheter. See ¶¶ 38-40 above.
`
`58. The following illustration from Figure 16E of Ressemann shows
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`where the cylindrical part of the support collar is located:
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`Collar Position
`
`
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`Ex. 1008, Fig. 16E (red circle added to generally indicate positioning of support
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`collar 2141 adjacent to the exterior walls of the multi-lumen tube 2138).
`
`59. Ressemann expressly teaches to position the tab portion 2141b of the
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`collar “adjacent the exterior walls of the multi-lumen tube 2138,”—i.e., outside of
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`the walls of the tube containing the suction lumen. Ex. 1008, 24:62-64 (emphasis
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`added). Figure 16D shows the tab portion 2141b of the collar on the underside of
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`the junction where shaft 2120 connects to inflation lumen 2142 and core wire
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`lumen 2143:
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`Teleflex Ex. 2042
`Medtronic v. Te
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