UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATERS TECHNOLOGIES CORPORATION
`Petitioner
`
`v.
`
`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES
`Patent Owner
`____________
`
`US Patent 9,186,224
`Inter Partes Review No.: ______________
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`____________
`
`DECLARATION BY KRISTEN BILLIAR, PH.D.
`UNDER 37 CFR § 1.132
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`!
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`3B6707@!&% % (!
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`IPR2018-00498
`
`
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATERS TECHNOLOGIES CORPORATION
`Petitioner
`
`v.
`
`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES
`Patent Owner
`____________
`
`US Patent 9,186,224
`Inter Partes Review No.: ______________
`
`____________
`
`DECLARATION BY KRISTEN BILLIAR, PH.D.
`UNDER 37 CFR § 1.132
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`41522130v2!
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`IPR2018-00498
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`TABLE OF CONTENTS
`QUALIFICATIONS, EXPERIENCE AND PUBLICATIONS......................3
`I.
`COMPENSATION..........................................................................................6
`II.
`LEGAL PRINCIPLES.....................................................................................6
`III.
`IV. MATERIALS CONSIDERED........................................................................8
`V.
`OPINIONS.....................................................................................................10
`A.
`RELEVANT FIELD, TIME AND PERSON OF
`ORDINARY SKILL IN THE ART ....................................................10
`NB? w//1 J;N?HN ;H> THE FILE HISTORY ..............................12
`CLAIM CONSTRUCTION ................................................................15
`CARDIOVASCULAR DEVICE DESIGN PRINCIPLES
`AND RELATED TESTING CONSIDERATIONS AT THE
`TIME OF THE INVENTION .............................................................17
`THE USE OF COMPLIANCE CHAMBERS IN
`ACCELERATED TEST SYSTEMS WAS NOT NEW.....................18
`GROUND 1A: CLAIMS 1-7 ARE OBVIOUS IN VIEW OF
`PICKARD AND WOODWARD........................................................19
`GROUND 1B: CLAIMS 1-7 ARE RENDERED OBVIOUS
`BY PICKARD IN LIGHT WOODWARD AND ST. JUDE .............28
`GROUND 2A: CLAIMS 1-4 ARE ANTICIPATED BY ST.
`JUDE ...................................................................................................31
`GROUND 2B: CLAIMS 3-7 ARE RENDERED OBVIOUS
`BY ST. JUDE IN LIGHT OF PICKARD...........................................42
`GROUND 2C: CLAIMS 6 AND 7 ARE OBVIOUS IN
`VIEW OF ST. JUDE AND IWASAKI...............................................49
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`B.
`C.
`D.
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`E.
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`F.
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`G.
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`H.
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`I.
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`J.
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`I, Kristen Billiar, Ph.D., do hereby make the following declaration:
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`I.
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`QUALIFICATIONS, EXPERIENCE AND PUBLICATIONS
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`1.
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`I am currently the Department Head of the Biomedical Engineering
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`Department and Professor in the Biomedical Engineering and Mechanical
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`Engineering Departments at Worcester Polytechnic Institute. I submit this
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`Declaration in support of Waters N[Y^debe]_[i =ehfehWj_edxi J[j_j_ed \eh W Inter
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`Partes Review of U.S. Patent No. 9,186,224 (the '224 Patent). In particular, I
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`submit this Declaration to provide relevant background information regarding the
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`technology at issue in the '224 Patent, and to set forth my opinions about the
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`lWb_Z_jo e\ j^[ YbW_ci e\ j^[ w//1 JWj[dj from the perspective of a person of
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`ordinary skill in the pertinent field.
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`2.
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`The following is a brief summary of my background and
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`qualifications. My background and qualifications are more fully set out in my
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`curriculum vitae (CV), attached as Exhibit 1004.
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`3.
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`I have at least 22 years' experience in the biomedical engineering and
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`medical device fields. I am currently a professor and department head of the
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`Biomedical Engineering Department, and an affiliated professor in the Department
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`of Mechanical Engineering at Worcester Polytechnic Institute (WPI), where my
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`responsibilities include developing and teaching courses for both the Biomedical
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`and Mechanical Engineering Departments. Additionally, I am an adjunct professor
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`in the Department of Surgery at the University of Massachusetts Medical School,
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`Worcester, MA.
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`4.
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`Prior to my current position, I was a staff engineer at Organogenesis,
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`Inc., from 1998 to 2002, where my responsibilities included designing and testing
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`blood vessel substitutes and testing systems.
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`5.
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`I obtained a Ph.D. in Bioengineering from the University of
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`Pennsylvania in 1998, where my dissertation investigated the effects of
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`glutaraldehyde treatment and mechanical fatigue on bioprosthetic aortic valves. I
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`also obtained a Master of Science in Bioengineering from the University of
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`Pennsylvania in 1992. Additionally, I obtained a Bachelor of Science in
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`Mechanical Engineering from Cornell University in 1991.
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`6.
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`I currently teach undergraduate and graduate courses concerning
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`mathematical modeling of physiologic materials and mechanisms, including
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`biomechanics, biofluids, and I also teach courses on medical device development,
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`including biomedical engineering design. In addition, I oversee a laboratory at
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`WPI that performs predominantly grant-funded research concerning tissue
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`mechanics and mechanobiology. The laboratory includes graduate, Ph.D., and
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`post-doctorate level researchers. Also, I supervise teams of undergraduate and
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`graduate students with research projects, including implantable medical prosthetic
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`and medical device development and testing.
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`7.
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`As shown in my CV, I have authored or coauthored over 70
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`publications, including publications concerning mechanical evaluation of
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`implantable cardiovascular devices subjected to mechanical and material testing. I
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`also serve as a peer reviewer for scholarly publications and journals, including the
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`Cardiovascular Engineering and Technology journal and the Journal of
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`Biomechanical Engineering for the American Society of Mechanical Engineers.
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`8.
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`I was also elected as a Fellow of the American Society of Mechanical
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`Engineers (ASME) in 2013, where I have served on the executive board of the
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`bioengineering division for 5 years. Also, I was elected as a Fellow of the
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`American Institute for Medical and Biological Engineering (AIMBE) in 2016.
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`Further, I serve as chair of a review committee for grants in biomedical
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`engineering for the American Heart Association.
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`9.
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`I have received $10.75 million worth of grant funding from various
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`organizations, including the American Heart Association, National Institutes of
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`Health, National Science Foundation, and Whitaker Foundation, for my
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`investigations into technology at the forefront of the bioengineering field.
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`10.
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`I am an inventor on eight patents in the bioengineering field.
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`II.
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`COMPENSATION
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`11.
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`I am being compensated for my time spent on this matter at the rate of
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`$450 per hour spent testifying in deposition, and at the rate of $250 per hour for all
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`other services performed in connection with this matter, plus reasonable expenses.
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`My compensation is not related to the outcome of this action and I have no
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`financial interest in this case.
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`III. LEGAL PRINCIPLES
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`12.
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`I have been informed that, in inter partes review, a claim is given its
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`broadest reasonable construction in light of the specification of the patent in which
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`it appears, and that the broadest reasonable construction is the broadest reasonable
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`interpretation of the claim language. I further understand that under this legal
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`standard, the claim language is read in light of the specification, as it would be
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`interpreted by the person of ordinary skill in the art (defined below). I also
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`understand that the words in a claim are generally given their ordinary and
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`accustomed meaning, unless the inventor has provided a specific definition in the
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`specification or the file history of the patent.
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`13.
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`I have been informed that anticipation of a claim requires that every
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`element of a claim is disclosed expressly or inherently in a single prior art
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`reference, arranged as in the claim. To anticipate the claim, the prior art does not
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`have to use the same words, but all of the requirements of the claim must have
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`been disclosed, either stated expressly or implied to a person of ordinary skill in
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`the art in the technology of the invention, so that looking at that one reference, that
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`person could make and use the claimed invention.
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`14.
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`I have been informed that in order to assess whether a claim is
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`obvious in light of the prior art, I must analyze the claims from the perspective of a
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`^ofej^[j_YWb uf[hied e\ ehZ_dWho ia_bb _d j^[ Whjv m^[d j^[ _dl[dj_ed mWi kdademd
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`and just before it was made.
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`I understand that this analysis considers: (1) the level
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`of ordinary skill in the art that someone would have had at the pertinent time; (2)
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`the scope and content of the prior art; (3) and any differences between the prior art
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`and the claimed invention.
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`15.
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`I have also been informed that when considering the obviousness of
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`a patent claim, one may consider whether there existed at the relevant time a
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`teaching, suggestion, or motivation that would have led one of ordinary skill in the
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`art to modify the prior art or to combine prior art teachings to arrive at the claimed
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`invention. I understand that other rationales that may support a conclusion of
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`obviousness include, but are not limited to: combining prior art elements according
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`to known methods to yield predictable results; the simple substitution of one
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`known element for another to obtain predictable results; the use of a known
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`technique to improve similar devices or products in the same way; the application
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`of a known technique to improve a known device or product ready for
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`improvement to yield predictable results; choosing from a finite number of
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`identified, predictable solutions, with a reasonable expectation of success; and
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`variations of known work based on design incentives or other market forces where
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`the variations are predictable to one skilled in the art. I have been informed that
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`the prior art must provide a reasonable expectation of success in order to find an
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`invention obvious. I have been informed that hindsight is impermissible and that
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`the obviousness or non-obviousness of a claim must be determined on the basis of
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`the facts gleaned from the prior art and the knowledge of a person of ordinary skill
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`at the relevant time. I have been informed that I must, in view of all of the factual
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`_d\ehcWj_ed) Z[j[hc_d[ m^[j^[h j^[ YbW_c[Z _dl[dj_ed uWi W m^eb[v mekbZ ^Wl[
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`been obvious at the relevant time to the hypothetical person of ordinary skill in the
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`art. I have been informed that in an inter partes review, a prior art reference must
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`be construed in its entirety, including portions that would teach away from the
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`claimed invention.
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`IV. MATERIALS CONSIDERED
`16.
`In preparing this declaration, I have considered the '224 Patent
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`(Ex.1001), its prosecution history including a copy of the originally-filed
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`application (Ex.1002), an Office Action mailed on March 20, 2015 (Ex.1005), an
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`Interview Summary mailed on May 14, 2015 (Ex.1006), an Amendment &
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`Response mailed June 17, 2015 (Ex.1007), an Inventor Declaration dated May 10,
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`2013 (Ex.1009), and Notice of Allowance mailed September 17, 2015 (Ex.1008);
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`the 2005 edition of ISO 5840 (Ex.1015); U.S. Patent No. 4,682,491 to Pickard
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`’uJ_YaWhZv( (Ex.1010); U.S. Patent No. 3,208,448 to Woodward ’uQeeZmWhZv(
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`(Ex.1012); U.S. Patent No. 5,916,800 to Elizondo et al. and assigned to St. June
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`Medical, Inc.1
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`’uMj+ DkZ[v( (Ex.1011); Iwasaki et al., Implications for the
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`Establishment of Accelerated Fatigue Test Protocols for Prosthetic Heart Valves,
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`Artificial Organs Vol. 26 No. 5:420-429 (May 2002)’uCmWiWa_v((Ex.1013); Reul et
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`al., Durability/Wear Testing of Heart Valve Substitutes, J Heart Valve Dis Vol. 7,
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`No. 2:151-157 (March 1998)’uLk[bv((Ex.1014); and Declaration of Michael
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`Girard in the Support of Motion for Preliminary Injunction dated November 22,
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`2017 and submitted in Case 0:17-cv-03403 in the United States District Court,
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`District of Minnesota (Ex.1017).2 I also relied upon my years of experience in the
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`field, though the testimony I offer is from the person of ordinary skill as I have
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`defined it below.
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`1 I believe that St. June Medical is a typographical error, and that the correct name
`of the owner is St. Jude Medical.
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`2 I understand that the materials I reviewed and refer to herein are being submitted
`as exhibits attached to the petition for Inter Partes Review of j^[ w//1 JWj[dj+
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`17.
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`I have been asked to provide my opinions regarding (a) the relevant
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`Whj \eh w/11 JWj[dj WdZ jhe person of ordinary skill in the art, (b) the state of the art
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`Wi e\ j^[ _Z[dj_\_[Z fh_eh_jo ZWj[ e\ j^[ w/11 JWj[dj) ’Y( j^[ c[Wd_d] e\ j^[ j[hci
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`uWYY[b[hWj[Zv WdZ u[nY[ii lebkc[ Wh[Wv Wi ki[Z _d j^[ YbW_ci e\ j^[ w/11 JWj[dj)
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`(d) whether claims 1-7 are obvious in view of Pickard and Woodward (Ground
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`1a), (e) whether claims 1-7 are obvious in view of Pickard, Woodward, and St.
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`Jude (Ground 1b), (f) whether claims 1 and 2 are anticipated by St. Jude (Ground
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`2a), (g) whether claims 3-7 are obvious in view of St. Jude and Pickard (Ground
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`2b), and (h) whether claims 6 and 7 are obvious in view of St. Jude and Iwasaki
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`(Ground 2c).
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`V.
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`OPINIONS
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`$#
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`18.
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`Relevant Field, Time and Person of Ordinary Skill in the Art
`N^[ w224 Patent claims priority to U.S. Provisional Application No.
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`61/158,185 filed on March 6, 2009. N^[ w//1 JWj[dj _i entitled "Fatigue Testing
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`System for Prosthetic Devices," and names Benjamin McCloskey, Craig Weinberg,
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`and Stel[ Q[_dX[h] Wi _dl[djehi+ N^[ w224 Patent generally relates to cyclic
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`testing of cardiovascular devices such as a valved prosthetic device.
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`19. BWl_d] h[l_[m[Z j^[ w224 Patent and its prosecution history, in my
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`opinion, the relevant field is testing of cardiovascular devices.
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`20.
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`In my opinion, the person of ordinary skill in the art (POSITA) would
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`^Wl[ Wj b[Wij ’W( W XWY^[behxi Z[]h[[ _d X_ec[Z_YWb [d]_d[[h_d]) eh W h[bWj[Z \_[bZ)
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`such as mechanical engineering or biomechanical engineering, who also has at
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`least 3-5 years of experience with cardiovascular devices; or (b) an advanced
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`degree in the same areas of academic study with at least 1-2 years of corresponding
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`experience.
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`21.
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`I have been informed that the relevant time period for my analysis in
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`forming my opinions is prior to the earliest identified priority date, March 6, 2009.
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`I believe that I understand what the person of ordinary skill in the art would have
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`known as of March 6, 2009, based upon my experience, which includes my
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`doctoral thesis research defended in 1998, and my years of research and teaching
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`biomechanics.
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`22. Unless otherwise stated, my statements below refer to knowledge,
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`beliefs, and abilities of a person of ordinary skill in the art at the time of the earliest
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`fh_eh_jo ZWj[ e\ j^[ x//1 JWj[dj+ @eh [nWcfb[) m^[d C ijWj[ j^Wj iec[j^_d] mekbZ
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`have been understood, I am referring to that it would have been understood by a
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`person of ordinary skill in the art Wj j^[ j_c[ e\ j^[ x//1 JWj[djxi fh_eh_jo ZWj[+
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`23. =bW_c . e\ j^[ w//1 Jatent is quoted below:
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`Claim 1. A method for operating an accelerated cyclic test system for
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`evaluating a valved prosthetic device comprising
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`driving a test system fluid cyclically above a normal physiological rate, at an
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`accelerated pulsed rate of greater than 200 beats per minute within the
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`test system;
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`storing a volume of test system fluid in an excess volume area during a
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`system driving stroke that opens the valved prosthetic device; and
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`releasing the stored volume of test system fluid during a return stroke that
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`closes the valved prosthetic device.
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`%#
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`24.
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`BOL _((* >HYLTY HTK YOL 3PRL History
`I have reviewed the patent anZ j^[ \_b[ ^_ijeho e\ j^[ w//1 Jatent.
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`25. Durid] j^[ fhei[Ykj_ed e\ j^[ w//1 Jatent, the Patent Office concluded
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`that Pickard uj[WY^[i W c[j^eZ \eh ef[hWj_d] Wd WYY[b[hWj[Z YoYb_Y j[ij ioij[c \eh
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`[lWbkWj_d] W lWbl[Z fheij^[j_Y Z[l_Y[+v (Ex.1005 at 3.). The Patent Office
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`YedYbkZ[Z j^Wj uJ_YaWhZ j[WY^[i s ijeh_d] lebkc[ e\ j[ij ioij[c \bk_Z _d Wd [nY[ii
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`lebkc[ Wh[W+v (Id.) N^[ JWj[dj I\\_Y[ \khj^[h YedYbkZ[Z j^Wj uJ_YaWhZ j[WY^[i s
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`releasing the stored volume of test system fluid during a return stroke that closes
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`j^[ lWbl[Z fheij^[j_Y Z[l_Y[+v (Id.) In other words, the Patent Office concluded
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`that Pickard disclosed the method of claim 1 as it was originally presented to the
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`JWj[dj I\\_Y[+ ?nY[fj m_j^ h[if[Yj je j^[ j[hc uWYY[b[hWj[Z)v Patent Owner does
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`dej Wff[Wh je ^Wl[ Y^Wbb[d][Z Wdo e\ j^ei[ JWj[dj I\\_Y[xi YedYbki_edi+ C W]h[[
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`m_j^ j^[ JWj[dj I\\_Y[xi YedYbki_ed j^Wj J_YaWhZ Z_iYbei[i W c[j^eZ \eh ef[hWj_d] W
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`cyclic test system for evaluating a valved prosthetic device, as stated in claim 1 of
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`j^[ w//1 Jatent. And I also agree that Pickard discloses a system that features the
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`storing and releasin] ij[fi e\ YbW_c . e\ j^[ w//1 Jatent.
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`26. Durid] j^[ fhei[Ykj_ed e\ j^[ w//1 Jatent, the Patent Office concluded
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`j^Wj uJ_YaWhZ j[WY^[i Yecfh[ii_d] a volume of compressible gas with the volume
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`of test system fluid to provide a spring force counter to and in response to a
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`pressure on the test system fluid when the volume of test system fluid is stored in
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`j^[ [nY[ii lebkc[ Wh[W+v (Ex.1005 at 4.) I agr[[ m_j^ j^[ JWj[dj I\\_Y[xi
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`conclusion that PickahZ j[WY^[i YbW_c 3 e\ j^[ w//1 Jatent.
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`27.
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`Patent Owner sought to distinguish Pickard on the basis that claim 1
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`mWi Z_h[Yj[Z je W c[j^eZ \eh ef[hWj_d] Wd uWYY[b[hWj[Zv j[ij ioij[c+ (See Ex.1006
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`at Substance of Interview.) But Patent Owner was unable to convince the Patent
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`I\\_Y[ j^Wj j^[ _dYbki_ed e\ j^[ mehZ uWYY[b[hWj[Zv _d j^[ fh[WcXb[ e\ h[‘[Yj[Z
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`claim 1 distinguished Pickard. (See id.)
`
`28.
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`So in response to the Patent Office rejection, Patent Owner amended
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`YbW_c . je h[gk_h[ uZh_l_d] W j[ij ioij[c \bk_Z s Wj Wd WYY[b[hWj[Z fkbi[Z hWj[ e\
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`]h[Wj[h j^Wd /-- X[Wji f[h c_dkj[+v (Ex.1007 at 2.) In the same document, Patent
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`Owner argued that the amended claim distinguished Pickard. (Id. at 6-9.)
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`29. Before Patent Owner amended claim 1, the application \eh j^[ w//1
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`Patent did not disclose any particular number of beats per minute for testing. (See
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`Ex.1002.)
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`30. Based on Patent Ownerxi Wc[dZc[dj WdZ _ji Wh]kc[dj) j^[ JWj[dj
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`Office Wbbem[Z j^[ YbW_ci e\ j^[ w//1 Jatent. The Patent Office stated that it
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`Wbbem[Z j^[ YbW_ci X[YWki[ J_YaWhZ \W_b[Z je if[Y_\_YWbbo j[WY^ uWd WYY[b[hWj[Z
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`cyclic test system for evaluating a valved prosthetic device with a pulsed rate of
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`greater than 200 beats per minute in independent claim 1 when combined with the
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`limitations of an excess volume area (which is a tehc e\ Whj s( WdZ _ji beYWj_ed sv
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`(Ex.1008 at 3.)
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`31.
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`Patent Owner sought to distinguish its claims from Pickard, which
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`Z_iYbei[i W wh[Wb-j_c[x j[ij ioij[c WYYehZ_d] je Patent Owner, on the basis that it
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`YbW_c[Z W c[j^eZ \eh ef[hWj_d] Wd uWYY[b[hWj[Zv j[ij ioij[c+ (See Ex.1007 at 5,
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`8.)
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`32.
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`CMI 251- Ze[i dej Z[\_d[ uWYY[b[hWj[Zv j[ij_d] Wi j[ij_d] Wj ]h[Wj[h
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`than 200 beats per minute.
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`33. According to Table 1 of ISO 5840, a heart valve substitute operational
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`environment includes a heart rate up to 200 beats per minute. (Ex.1015 at 12.)
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`Patent Owner used that information in ISO 5840 to persuade the Patent Office that
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`uWYY[b[hWj[Zv c[Wdi Wj ]h[Wj[h j^Wd /-- X[Wji f[h c_dkj[+ (See Ex.1007 at 6-7 and
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`Ex.1008 at 3-4.)
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`&#
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`34.
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`Claim Construction
`I have been asked to provide my opinion as to the meaning of the term
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`uWYY[b[hWj[Zv Wi ki[Z _d j^[ YbW_ci e\ j^[ w//1 Jatent. This word is used to
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`characterize the cyclic test system and the pulsed rate in the claims. I understand
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`from counsel that a patent applicant can define its terms in the specification, but I
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`found no such definition in the specification. I also understand that Patent Owner
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`is bound by their statements made during prosecution, especially if they are relied
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`upon to overcome prior art.
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`35. During prosecution, it is apparent that there was some disagreement
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`Zkh_d] [nWc_dWj_ed WXekj j^[ c[Wd_d] e\ j^[ j[hc uWYY[b[hWj[Z+v Nhe examiner
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`was unconvinced that the term had any special meaning. According to the Patent
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`Imd[hxi l[hi_ed e\ j^[ _dj[hl_[m) u;ffb_YWdj dej[Z j^Wjsj^[ _dZkijho ’_+[+) W
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`f[hied e\ ehZ_dWho ia_bb _d j^[ Whj( h[Ye]d_p[i Wd uWYY[b[hWj[Zv lWbl[ j[ij ioij[c je
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`mean a system that cycles faster thad W dehcWb f^oi_ebe]_YWb hWj[+v (Ex.1007 at 6.)
`
`Then, the u?nWc_d[h W]h[[Z j^Wj W b_c_jWj_ed Z[iYh_X_d] j^[ ioij[c [dl_hedc[dj Wi
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`being greater than 200 beats per minute would be sufficient to address this concern
`
`m_j^ j^[ YbW_c+v (Id.) The Patent Owner then amended the claims and they were
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`allowed.
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`36. ;i ikY^) _j _i co ef_d_ed j^Wj j^[ j[hc uWYY[b[hWj[Zv mWi Z[\_d[Z Xo
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`Patent owner to refer to ucycling above 200 beats per minute.v They did so in
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`agreement with the Examiner in order to obtain allowance. And they represented
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`to the Patent Office that a person of ordinary skill in the art would recognize the
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`j[hc uWYY[b[hWj[Zv je ^Wl[ j^_i c[Wd_d]+ (See Ex.1007 at 6.)
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`37.
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`I have been asked to provide my opinion as to the meaning of the term
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`u[nY[ii lebkc[ Wh[Wv Wi used in the claims of the w//1 Jatent. I understand from
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`counsel that a patent applicant can define its terms in the specification, but I found
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`no such definition in the specification. The Examiner seemed to be under the
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`impression that it was a term of art, but did not provide any special definition. The
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`?nWc_d[h Y_j[Z JWj[dj Imd[hxi h[ifedi[) Xkj C mWi kdWXb[ je \_dZ Wdo Z[\_d_j_ed eh
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`discern any special meaning ascribed to this term. (See Ex.1008 at 3.)
`
`38.
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`C Wc kdWmWh[ e\ Wdo if[Y_Wb c[Wd_d] e\ j^[ j[hc u[nY[ii lebkc[
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`Wh[W+v And in the if[Y_\_YWj_ed e\ j^[ w//1 Jatent, it appears to have its ordinary
`
`meaning. For [nWcfb[) j^[ w//1 Patent states:
`
`The compliance chambers 135 provide excess volume area for
`fluid to move into when the piston 114 performs a compression
`stroke. As the pressure of the gas in the compliance chamber
`135 increases, the volume occupied by the gas decreases to
`provide additional volume for displacement of
`the liquid
`working fluid within the test chamber 106.
`(Ex.1001 at 12:10-15 (emphasis added).)
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`39.
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`Accordingly, ij _i co ef_d_ed j^Wj u[nY[ii lebkc[ Wh[Wv ^Wi _ji
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`ordinary and plain meaning in that it generally indicates a location or a space
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`where fluid displaced by a pulsatile pump can flow into. Any location or a space
`
`where fluid displaced by a pulsatile pump can flow into is an excess volume area.
`
`This includes, but is not limited to compliance chambers.
`
`’#
`
`40.
`
`Cardiovascular device design principles and related testing
`considerations at the time of the invention
`Prior to use in a human body, cardiovascular devices are tested in
`
`environments that simulate a circulatory system. That is, cardiovascular devices
`
`are tested in environments that attempt to replicate the pulsatile flow conditions.
`
`(See Ex.1010 at 1:6-14.)
`
`41.
`
`Testing systems for cardiovascular devices, such as valved prosthetic
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`devices, were known prior to March 6, 2009, the earliest claimed priority date. I
`
`know that these testing systems were known as early as March 2009, as I reported
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`on bioprosthetic heart valve durability using such testing systems in my doctoral
`
`j^[i_i _d .665 [dj_jb[Z u; ijhkYjkhWbbo ]k_Z[Z Yedij_jkj_l[ ceZ[b \eh Wehj_Y lWbl[
`
`X_efheij^[i[i7 ?\\[Yji e\ ]bkjWhWbZ[^oZ[ jh[Wjc[dj WdZ c[Y^Wd_YWb \Wj_]k[+v
`
`42. One of the ways these testing systems attempt to simulate the
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`circulatory system is by using a liquid test fluid, such as water or phosphate
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`
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`buffered saline (PBS) solution, as a blood substitute in a flow circuit. Like blood,
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`the liquid test fluid is considered an incompressible fluid.
`
`43.
`
`Some test systems involve a closed flow circuit (i.e., not open to
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`atmosphere). In order for a pump to displace a volume of incompressible test fluid
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`in a closed flow circuit, the flow circuit must include an excess volume area where
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`the displaced fluid can be received or stored since, by definition, an incompressible
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`fluid cannot be compressed without generating (theoretically) infinite pressure.
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`44. While ISO 5840 imposes design specifications and minimum
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`performance specifications for heart valve prostheses, ISO 5840 does not provide a
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`definition of uWYY[b[hWj[Zv YoYb_Y testing as testing at a rate of greater than 200
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`beats per minute.
`
`(#
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`45.
`
`The use of compliance chambers in accelerated test systems was
`not new
`The use compliance chambers in accelerated test systems was not new
`
`in 2009 and would have been well known to a person of skill in the art at the
`
`relevant time period. For example, Iwasaki published on the combination of an
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`accelerated cyclic test system and excess volume area in 2002. Iwasaki states that
`
`its accelerated testing device was modified to include a compliance chamber.
`
`(Ex.1013 at 422.) Similarly, in 1998, Reul reports on the use of air compliance in
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`accelerated cyclic test systems. L[kb ki[i uWd WZ‘kijWXb[ Yecfb_WdY[ Y^WcX[h s
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`
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`for additional cedjheb e\ beWZ_d] \ehY[i+v ’?n+.-.1 at 153.) Reul can adjust peak
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`loading forces in its accelerated cyclic test system operating at 1000 bpm by, for
`
`example, adjusting air compliance. (Id. at 154.)
`
`46. Compliance chambers were known to provide excess volume area to
`
`avoid pressure spikes. For example, in 1998, Reul reports on an accelerated valve
`
`j[ij ioij[c Z[i_]d[Z WdZ cWdk\WYjkh[Z fh_eh je GWhY^ .665 j^Wj _dYehfehWj[i uWd
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`WZ‘kijWXb[ Yecfb_WdY[ Y^WcX[h s \eh WZZ_j_edWb Yedjheb e\ beWZ_d] \ehY[i+v (Ex.
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`1014 at 153.)
`
`47.
`
`It is my opinion that: Patent Owner obtained allowance based on the
`
`incorrect assertion that the use compliance chambers in accelerated test systems
`
`mWi d[m+ N^[ JWj[dj I\\_Y[ cWo dej ^Wl[ Wbbem[Z j^[ w//1 JWj[dj _\ _j ^WZ X[[d
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`told that compliance chambers having excess volume areas had been used in
`
`accelerated heart valve durability testing.
`
`)#
`
`48.
`
`Ground 1a: Claims 1-7 are Obvious in view of Pickard and
`Woodward
`I agree with the Patent Office that Pickard discloses the entirety of
`
`claim 1 as it was originally presented to the Patent Office.
`
`49.
`
`@eh [nWcfb[) J_YaWhZxi WXijhWYj Z[cedijhWj[i j^Wj J_YaWhZ j[WY^[i uW
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`method for operating an accelerated cyclic test system for evaluating a valved
`
`fheij^[j_Y Z[l_Y[+v And the passage spanning from column 13, line 52 to column
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`
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`14, line 15 demonstrates uijeh_d] W lebkc[ e\ j[ij ioij[c \bk_Z _d Wd [nY[ii lebkc[
`
`area during a system driving stroke that opens the valved prosthetic device; and
`
`releasing the stored volume of test system fluid during a return stroke that closes
`
`j^[ lWbl[Z fheij^[j_Y Z[l_Y[+v This passage of Pickard when read together with
`
`Figure 3 illustrates that test fluid travels in a flow circuit 18, and when oriented to
`
`provide flow in a counter-clockwise direction, fluid from the pump flows through
`
`valve 200 toward a first compensation/compliance module 136, as shown in
`
`annotated form X[bem+ uM_dY[ h[ijh_Yj_ed [b[c[dj .0/ Ze[i dej Wbbem j^[ fWiiW][
`
`of fluid as rapidly as it is driven by the power stroke of pump 46, excess fluid is
`
`received in first compensation module 136 under compliance pressure from
`
`diaphra[g]m 518 that is controlled by air pressure through hose 528. During the
`
`recovery strokes, the excess fluid in first compensation chamber 136 passes
`
`through resistance element 132, through second compensation chamber 142 so it
`
`may pass through the heart valve in second test chamber 128 and be returned into
`
`_djWa[ Y^WcX[h ./- WdZ fkcf 13 j^hek]^ _djWa[ eh_\_Y[ ./1+v (Ex.1010 at 13:67-
`
`14:10.) In other words, compliance or first compensation chamber 1363 is located
`
`on the outflow side of valve 200 and stores a volume of test fluid during a system
`
`3
`C dej[ j^Wj J_YaWhZ ki[i j^[ j[hci uYecfb_WdY[ ceZkb[v) uYecf[diWj_ed ceZkb[v)
`WdZ uYecf[diWj_ed Y^WcX[hv _dj[hY^Wd][WXb[ j^hek]^ekj ^_i fWj[dj+ ’See, e.g.,
`Ex.1010 at 8:27-33 and 14:1-10.)
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`
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`driving stroke. During a recovery or return stroke the volume of test fluid is
`
`released from chamber 136.
`
`50. ;dej^[h [nWcfb[ e\ J_YaWhZxi Z_iYbeikh[ e\ j^[ ijeh_d] WdZ h[b[Wi_d]
`
`steps of the w//1 Patent can be found in claims 1 and 9 of Pickard. In particular,
`
`YbW_c . _dYbkZ[i W ufkcf_d] c[Wdi \eh YoYb_YWbbo fkcf_d] \bk_Z Wbj[hdWj[bo by a
`
`power stroke and a recovery stroke, said fluid being pumped during the power
`
`stroke through said fluid inlet towards said first and second test chambers whereby
`
`one of said first and second heart valves passes the fluid therethrough while the
`
`other one of said first and second heart valves resists fluid flow, fluid being
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`
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`pumped during the power stroke accumulating under pressure in said first and
`
`second compensation reservoirs, and during the recovery stroke whereby said one
`
`of the heart valves closes and the other one of the heart valves opens so that said
`
`first and second fluid pressure compliance means force fluid through the other one
`
`of heart valve back into said intake chamber, said restriction means being
`
`selectively adjustable to permit flow of a volume of fluid over a time period of one
`
`pump cycle which volume is equal to the volume of fluid displaced by the power
`
`stroke of the pump+v (Ex.1010, claim 1 at 17:29-48.) ;dZ YbW_c 6 _dYbkZ[i uW
`
`plurality of optical view ports positioned for viewing the opening and closing of
`
`said first and second heart valves in the test position during successive power and
`
`h[Yel[ho ijhea[i e\ iW_Z fkcf c[Wdi+v (Ex.1010, claim 9 at 18:27-31.)
`
`51.
`
`Patent Owner amended the claims after receiving the Office Action
`
`dated March 20, 2015, je h[Y_j[ uZh_l_d] W j[ij ioij[c \bk_Z YoYb_YWbbo WXel[ W
`
`normal physiological rate, at an accelerated pulsed rate of greater than 200 beats
`
`f[h c_dkj[ m_j^_d j^[ j[ij ioij[c+v (Ex.1007 at 2.) Pickard describes driving a
`
`test system fluid cyclically. (Ex.1010 at 7:42-10 ’u@bk_Z _i Zh_l[d j^hek]^
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`circulatory loop 18 in a pulsatile or cyclical manner by means of a piston pump
`
`13+v); see also, e.g., Ex.1010 at 15:23-28.)
`
`52.
`
`F_a[ j^[ w//1 Wffb_YWj_ed) Pickard did not disclose any particular
`
`number of beats per minute for testing. But Pickard teaches a heart valve testing
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`system operated under individualized test conditions. Pickard teaches that an
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`uobject of the present invention to provide a method and apparatus for testing of a
`
`prosthetic heart valve under individualized test conditions simulating a specific
`
`human circulatory environment into which the lWbl[ cWo X[ fbWY[Z+v (Ex.1010 at
`
`2:57-61, see also 4:62-5:5.)
`
`53.
`
`It is my opinion that Pickard is not limited to 72 bpm or any range
`
`including up to 200 bpm asserted by Patent Owner and the inventor Dr. Weinberg.
`
`Pickard discloses a system used to test and observe prosthetic devices before use in
`
`a human body. (See Ex.1010 at 7:4-13.) And teaches that an advantage of its
`
`c[j^eZi _i uYkijec_p_d] e\ j^[ j[ij_d] fheY[Zkh[ je Yehh[ifedZ je W if[Y_\_Y
`
`_dZ_l_ZkWbxi Y_hYkbWjeho ioij[c) s) _d W cWdd[h j^Wj i_cklates the circulatory
`
`environment of the specific patient w^e m_bb h[Y[_l[ j^[ lWbl[+v (Id. at 2:35-42.)
`
`As a patient/human does not have just a single heart rate, simulating the circulatory
`
`environment of a specific patient would include testing across the range that would
`
`be experienced by the valve.
`
`54.
`
`Pickard recognizes the advantage of customizing the testing procedure
`
`je Yehh[ifedZ je W if[Y_\_Y _dZ_l_ZkWbxi Y_hYkbWjeho ioij[c je ^[bf ]kWhZ W]W_dij
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`malpractice and product liability claims. (Ex.1010 at 2:27-45.) As Patent Owner
`
`WYademb[Z][Z j^Wj uj^[ jof_YWb kff[h [dZ e\ W dehcWb f^oi_ebe]_YWb hWj[ _i Wbove
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`/-- X[Wji f[h c_dkj[v ’?n+.--4 at 6), its narrow interpretation limiting Pickard to
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`
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`72 beats per minute is not justified. Moreover, this passage in Pickard provides
`
`explicit motivation to test the typical upper end of a normal physiological ratet
`
`which Patent Owner tells us is above 200 beats per minutetto ensure the device is
`
`safe for use in the patient.
`
`55.
`
`The Patent Office did not consider Woodward during prosecution of
`
`j^[ w//1 Jatent. Woodward teaches about an artificial heart pump circulation
`
`system. Woodward teaches that it was known in the art that a normal
`
`physiological heart rate for a normal young adult includes a range of from 60 bpm
`
`(resting) to 160-180 bpm (heavy exercise) to 240-270 bpm (short exhaustive
`
`work). (Ex.1012 at 13:38-49.) I
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