UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`ACTA Medical L.L.C,
`Petitioners,
`v.
`
`CURLIN MEDICAL INC.,
`Patent Owner.
`________________
`
`U.S. Patent No. 6,164,921
`Issue Date: December 26, 2000
`Title of Patent: Curvilinear Peristaltic Pump Assembly Having Insertable Tubing
`Assembly
`________________
`
`Case No.: T.B.D.
`________________
`
`DECLARATION OF CARL MEINHART, Ph.D.
`
`
`
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`ACTA Ex. 1002-001
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`I, Carl Meinhart, Ph.D, declare and state as follows:
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`1.
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`I have been engaged by counsel for Defendant ACTA Medical, LLC
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`to examine certain facts concerning U.S. Patent No. 6,164,921 ("The ‘921 patent")
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`and, in particular, issued claims 15-34, and to provide my opinions as to whether
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`claims 15-34 are valid.
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`I.
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`QUALIFICATIONS
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`2.
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`The opinions and conclusions I express in this declaration are based
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`on my education, my extensive experience in mechanical engineering, fluid
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`mechanics, fluid-structure interaction, and medical devices, and my review of
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`materials related to this matter.
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`3.
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`I am currently Professor of Mechanical Engineering at the University
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`of California, Santa Barbara.
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`4.
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`I received a Bachelor of Science in Mechanical Engineering degree
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`from the University of Illinois in 1989 and a Doctor of Philosophy Degree from the
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`University of Illinois in 1994.
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`5.
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`I joined the faculty of the Department of Mechanical Engineering at
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`the University of California, Santa Barbara in 1996. I am a member of the UCSB
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`Institute for Collaborative Biophysics and the Principal Investigator at the UCSB
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`Microfluidics Lab. In 2011, I was named a Fellow of the American Physical
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`Society.
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`
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`2
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`ACTA Ex. 1002-002
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`6.
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`I have published over 55 articles in peer-reviewed journals and am the
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`named inventor or co-inventor on at least eleven (11) issued United States Letters
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`Patents.
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`7.
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`I have no financial interest in the outcome of this proceeding. I am
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`being compensated at my standard hourly consulting rate for my time spent
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`working on this matter, and my compensation is in no way contingent on the
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`conclusions I reach herein, the specifics of my testimony, or the outcome of this
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`proceeding.
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`8.
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`A more detailed account of my work experience, professional
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`services, publications, and other qualifications is listed in my Curriculum Vitae,
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`which is attached here to as Appendix A.
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`II. MATERIALS REVIEWED
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`9.
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`In forming my opinions, I have reviewed, among other things, the
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`’921 patent and papers filed in the U.S. Patent and Trademark Office (“PTO”) in
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`connection with prosecution of the application that led to the ‘921 patent, which I
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`understand constitute the prosecution history of the ’921 patent. A full list of
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`materials I have considered can be found in Appendix B.
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`
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`3
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`ACTA Ex. 1002-003
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`III. TECHNICAL BACKGROUND
`
`
`
`A. Development of peristaltic infusion pumps
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`10. Peristaltic infusion pumps were in use in industry at least as far back
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`as the 1940s. A benefit of peristaltic pumping mechanism is that the pumping
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`action can be applied externally of the tube carrying the fluid therein. This
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`maintains the sterile condition of the fluid while imparting propulsion on the fluid.
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`11.
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`In the medical setting, the ability to propel fluids in a sterile condition
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`is particularly advantageous. However, a further advantage is that the pumps are
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`capable of infusing low volumes of fluid (less than 1000 ml) to a patient over the
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`course of one or more hours, frequently in precise volumes. Accordingly, the
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`ability to infuse sterile fluids in a predictable manner gained traction in the medical
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`field.
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`12. Early peristaltic pumps utilized rotary peristaltic pumping features.
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`This utilized a set of rollers that compress a tube in order to press forward a known
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`amount of fluid. A driving motor is connected to an armature to at least one roller,
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`where the driving motor imparts a circular rotation on the armature to actuate the
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`roller member. A pressure plate is provided with tubing being present between the
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`pressure plate and the roller member. As the roller member rotates, it imparts
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`pressure on the tube and propels fluid in the tube in the direction of the rotation.
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`(See Classey Ex. 1015).
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`
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`4
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`ACTA Ex. 1002-004
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
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`13. Another type of peristaltic pump is a linear peristaltic pump, which
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`utilizes a driving motor connected to an array of cams angularly spaced from one
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`another. As the motor rotates, the cams drive corresponding pressure fingers,
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`which thus raise and fall in a wave like motion. A pressure plate is juxtaposed to
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`and spaced apart from the fingers to allow for a tube to reside between. As the
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`pressure fingers contact the tube in a wave like motion, fluid in the tube is
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`propelled in the direction of the wave. (See Classey, Ex. 1015).
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`14. Curvilinear peristaltic pumps are very similar to linear peristaltic
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`pumps, but change the pumping section to be curved instead of linear. Yet this
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`style of pump maintains the wave like function of the fingers compressing tubing
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`to push liquids forward. (See Jester, Ex. 1013).
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`IV. U.S. PATENT NO. 6,164,921
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`A. The ‘921 patent
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`15.
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`I have reviewed the ‘921 patent. In general, the ‘921 patent discloses
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`a curvilinear peristaltic pump, IV tubing sets compatible with such pumps, and
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`pinch clips for use with the pumps and IV tubing sets.
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`16.
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`I have reviewed the claims of the ‘921 patent, which can generally be
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`stated to fall in three different sets. Claims 1-14 particularly relate to the pumps
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`themselves. Claims 15-20 and 22-33 are related to IV tubing sets or systems to be
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`
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`5
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`ACTA Ex. 1002-005
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`used in conjunction with a curvilinear peristaltic pump. Finally, claims 21 and 34
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`are related to a shut-off valve comprising a pinch clip.
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`17. Claim 15, for example reads in relevant part:
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`A tubing assembly for use in a peristaltic pump having a housing
`defining a support member which includes first and second
`recesses disposed therein, a platen member attached to the housing,
`a rotatable cam disposed within the housing, and a plurality of
`pump fingers movably attached to the housing and cooperatively
`engaged to the cam such that the rotation of the cam sequentially
`moves the pump fingers outwardly toward and inwardly away
`from the platen member, the tubing assembly comprising:
`a length of resilient tubing;
`a tubing locator pin attached to the tubing and removably insertable
`into the first recess; and
`a shut-off valve attached to the tubing and removably insertable into
`the second recess, the shut-off valve being operable to selectively
`obstruct the flow of liquid through the tubing;
`wherein the tubing locator pin and the shut-off valve are attached to
`the tubing at locations whereat a portion of the tubing is extended
`over the pump fingers when the tubing locator pin and the shut-off
`valve are removably inserted into respective ones of the first and
`second recesses within the support member of the housing.
`
`
`18. Claims 16-20 all depend, directly or indirectly, from claim 15.
`
`19. Claim 21 of the '921 patent reads as follows:
`
`A shut-off valve for use in a tubing assembly comprising a length of
`resilient tubing, the shut-off valve comprising:
`a valve body having an opening therein for permitting the passage of
`the tubing therethrough;
`a single pinch arm movably attached to the valve body and engagable
`to the tubing passing through the opening, the shut-off valve being
`configured such that the tubing resides within the pinch arm and
`the valve body when advanced through the opening; and
`a spring which extends between the valve body and the pinch arm;
`
`
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`6
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`ACTA Ex. 1002-006
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`the pinch arm being movable between an open position whereat the
`tubing passing through the valve body is not compressed by the
`pinch arm, and a closed position whereat the tubing passing
`through the valve body is collapsed by the compression thereof
`between the pinch arm and the valve body, the spring normally
`biasing the pinch arm to the closed position.
`
`
`20. Claim 22 of the '921 patent reads as follows:
`
`An administration set for use with a curvilinear peristaltic pump
`having a housing which includes at least one recess disposed
`therein, a plurality of pump fingers movably attached to the
`housing, a drive unit disposed within the housing for sequentially
`moving the pump fingers, and a sensor disposed within the housing
`for detecting the presence of the administration set, the
`administration set comprising:
`a length of straight line, resilient tubing; and
`at least one locating member positionable upon the tubing at a
`location whereat the locating member is removably insertable into
`the recess and operative to trip the sensor when a portion of the
`tubing is extended over the pump fingers;
`the tripping of the sensor being required to facilitate the activation of
`the drive unit.
`
`
`21. Claims 23-25 of the '921 patent depend, directly or indirectly, from
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`claim 22.
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`22. Claim 26 of the '921 patent reads as follows:
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`An administration set for use with a curvilinear peristaltic pump
`having a housing which includes at least one recess disposed
`therein and a sensor disposed within the housing for detecting the
`presence of the administration set, the administration set
`comprising:
`a length of straight line, resilient tubing; and
`at least one locating member positionable upon the tubing at a
`location whereat the locating member is removably insertable into
`
`
`
`7
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`ACTA Ex. 1002-007
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`the recess and operative to trip the sensor when a portion of the
`tubing is cooperatively engaged to the pump;
`the tripping of the sensor being required to facilitate the operation of
`the pump.
`
`
`23. Claims 27-29 of the '921 patent depend, directly or indirectly, from
`
`claim 26.
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`24.
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` Claim 30 of the '921 patent reads as follows:
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`An administration set for use with a curvilinear peristaltic pump
`having a housing which includes a plurality of pump fingers
`movably attached thereto, the administration set comprising:
`a length of straight line, resilient tubing; and
`at least one locating member removably insertable into the housing
`and positionable upon the tubing at a location whereat the insertion
`of the locating member into the housing will cause at least a
`portion of the tubing to be in contact with the pump fingers.
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`25. Claims 31-33 of the '921 patent depend, directly or indirectly, from
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`claim 30.
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`26. Claim 34 of the '921 patent reads follows:
`
`A shut-off valve for use in a tubing assembly comprising a length of
`resilient tubing, the shut-off valve comprising:
`a valve body having an opening therein for permitting the passage of
`the tubing therethrough;
`a single pinch arm movably attached to the valve body and engagable
`to the tubing passing through the opening, the shut-off valve being
`configured such that the tubing extends between the pinch arm and
`the valve body when advanced through the opening; and
`a biasing member cooperatively engaged to the pinch arm;
`the pinch arm being movable between an open position whereat the
`tubing passing through the valve body is not compressed by the
`pinch arm, and a closed position whereat the tubing passing
`through the valve body is collapsed by the compression thereof
`
`
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`8
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`ACTA Ex. 1002-008
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`between the pinch arm and the valve body, the pinch arm normally
`being biased to the closed position by the biasing member and
`including a breakable detent tab formed thereon which maintains
`the pinch arm in the open position, with the removal of the detent
`tab from the pinch arm resulting in the movement of the pinch arm
`to the closed position.
`
`
`B.
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`The PTO’s Reasons Why Claims 15-34 of the ’921 Patent Were
`Allowed to Issue
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`27.
`
`I have reviewed portions of the prosecution history of the ’921 patent
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`relevant to the entry, review, and allowance of the challenged claims. Issued
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`claims 15-34 of the ’921 patent correspond to claims 31-42, 49-65, many of which
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`were amended during prosecution.
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`28. For example, claim 31, related to the administration sets and issued as
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`claim 15, was rejected under Sancoff (Ex. 1023). Sancoff discloses a length of
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`resilient tubing, a tubing locator pin, and a shutoff valve according to the PTO.
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`(Ex. 1004 at pg. 6). Applicant amended claim 31 in a response dated February 10,
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`2000. (Ex. 1005 at pg. 6-7).
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`29. Applicant specifically amended claim 31 to add in language in the
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`preamble “defining a support member which includes first and second recesses
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`disposed therein,” as well as that the tubing locator pin is “removably insertable
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`into the first recess” and the shut-off valve “removably insertable into the second
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`recess.” A final amendment included a wherein clause of “wherein the tubing
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`locator pin and the shut-off valve are attached to the tubing at locations whereat a
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`
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`9
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`ACTA Ex. 1002-009
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`portion of the tubing is extended over the pump fingers when the tubing locator pin
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`and shut-off valve are removably insertable into respective ones of the first and
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`second recesses within the support member of the housing.”
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`30. Applicant argued that the Sancoff references “does not teach, suggest
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`or show the flow restrictor clamp 23 as being removably insertable into a
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`complimentary recess within a support member of the housing of the pump 30 for
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`purposes of causing the tubing to assume a particular orientation relative thereto.”
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`(Ex. 1005 at pg. 19).
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`31. Claim 31 was allowed in view of these amendments in the next
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`rejection (Ex. 1006) and thus it is my understanding that a reference needs to show
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`two recesses in a pump housing and to orient the tubing in a manner to place the
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`tubing over the pump features.
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`32. Claim 38, ultimately issued as claim 21. Claim 38 was rejected first
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`over a reference to
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`33. Claim 38 was then rejected over a reference to Redmer (UK 1205947)
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`(Ex. 1026). Redmer was cited for disclosing a shut-off valve having an opening
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`for tubing, a single pinch arm that collapses the tubing therein, and a biasing
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`member (Ex. 1006 at pg. 3). Claims 40 and 41, depending from claim 38 were
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`objected to based upon dependency to a rejected base claim. These limitations
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`10
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`ACTA Ex. 1002-010
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`were then added to base claim 38 in the following amendment (Ex. 1007 at pg. 1-
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`2).
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`34. Claim 40 included the limitation that the biasing member was spring
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`extending between the valve body and a spring arm. Claim 41 included a
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`breakable detent tab biasing the pinch arm in an open position.
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`35. Accordingly, it is my understanding that claim 38, corresponding to
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`allowed claim 21 was allowed based on a biasing member extending between the
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`valve body and a spring arm and the presence of a detent tab.
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`36. Claim 22 corresponds to claim 49, which was first added in a
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`supplemental preliminary amendment, dated June 14, 1999. (Ex. 1003). Claim 49
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`was rejected under 35 U.S.C. § 103(a) as unpatentable over Jester (Ex. 1013) in
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`view of Natwick (Ex. 1025, at pg. 27). The PTO argued that Jester taught claim 49
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`except for the sensor and a locating member operative to trip the sensor, but such
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`language was taught by Natwick.
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`37. Claim 49 was amended to recite that the housing contained “at least
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`one recess” and that the locating member was “removably insertable into the
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`recess.” (Ex. 1005 at pg. 9).
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`38. Claim 49 was allowed in the Final Rejection, dated March 29, 2000
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`(Ex. 1006). Accordingly, it is my opinion that claim 49 was allowed based upon
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`
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`11
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`ACTA Ex. 1002-011
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`the claim including the limitation of at least one recess in the housing and having
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`the locating member insertable into the recess.
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`39. Claim 26 issued from claim 53, which was added by preliminary
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`amendment. (Ex. 1003). Claim 53 was amended in response to the first office
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`action, to include the same limitations as claim 49, e.g. the housing having “at least
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`one recess disposed therein” and a locating member “removably insertable into the
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`recess.”
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`40. Claim 53, like claim 49 was allowed in the Final rejection. (See Ex.
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`1006 at pg. 1). Accordingly, it is my opinion that claim 53, which ultimately
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`issued as claim 26 was allowed based upon insertion of the above identified
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`limitations.
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`41. Claim 30 issued from claim 57 that was added by preliminary
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`amendment, dated June 14, 1999. (Ex. 1003 at pg. 3). Claim 57 was rejected in
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`the first office action only under a 35 USC 112 rejection (Ex. 1004, at pg. 4).
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`42. Claim 57 was amended on February 10, 2000 to claim that insertion
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`of the locating member into the hosing “will cause at least” a portion of the tubing
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`“to be” in contact with the pump fingers.
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`43. Claim 57 was allowed in the Final Rejection (Ex. 1006 at pg. 1).
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`Accordingly, it is my understanding that the claim was allowed over the art based
`
`upon a person inserting a locating member into the housing to cause at least a
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`
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`12
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`ACTA Ex. 1002-012
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`portion of the tubing to be in contact with the pump fingers. The pump being the
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`curvilinear peristaltic pump identified in the preamble of the claim.
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`44. Claim 34 was added as a new claim 65 in the response to the final
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`rejection, dated July 6, 2000. (Ex. 1007 at pg. 2). Applicant argued that claim 65
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`represented a “combination of the limitations set for in independent Claim 38 and
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`cancelled Claims 39 and 41.” (Ex. 1007 at pg. 3).
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`45. Claim 65 was ultimately allowed in the notice of allowance. (Ex.
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`1008). Accordingly, it is my understanding that claim 65 was allowed based upon
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`the presence of a biasing member extending between the valve body and a pinch
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`arm and the presence of a detent tab.
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`V. LEGAL STANDARDS
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`46.
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`I am not an attorney, and counsel for Petitioners informed of the
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`following legal standards that are relevant to my opinions.
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`47.
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`I understand that an issued patent is presumed to be valid, and that the
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`burden of establishing invalidity as to any claim of a patent rests upon the party
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`asserting invalidity, here Petitioners.
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`A. Anticipation
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`48.
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`I understand that a prior art reference “anticipates” a claim, and thus
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`renders the claim unpatentable, if all elements of the claim are disclosed in that
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`single prior art reference, either expressly or inherently.
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`
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`13
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`ACTA Ex. 1002-013
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`49. Thus, I also understand that a prior art reference having an identical
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`disclosure to that of the challenged claims would anticipate those claims to the
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`extent that the claims are enabled and described.
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`50.
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`I also understand that a reference may anticipate a claim when the
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`reference discloses the feature of the underlying claim, even if the reference and
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`the claim use different terms to disclose otherwise identical features.
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`B. Obviousness
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`51.
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`I understand that an obviousness inquiry requires consideration of the
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`following factors: (1) the scope and content of the prior art; (2) the differences
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`between the claims and the prior art; (3) the level of ordinary skill in the pertinent
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`art; and (4) any objective indicia of non-obviousness, such as commercial success,
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`long-felt but unresolved need, failure of others, industry recognition, copying, and
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`unexpected results.
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`52.
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`I further understand that a claim is invalid as obvious if the
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`differences between the subject matter as claimed and the prior art would have
`
`been obvious to a person having ordinary skill in the art.
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`53.
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`It is my understanding that the analysis of all prior art references are
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`to be looked at from the viewpoint of a person of ordinary skill in the art at the
`
`time the invention was made. Thus, the use of hindsight is not permitted.
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`
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`14
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`ACTA Ex. 1002-014
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
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`54.
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`It is my understanding that differences between the claimed invention
`
`and the prior art can be deemed obviousness if the difference is simply within the
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`common knowledge of a person of ordinary skill in the art.
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`55.
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`I also understand that obviousness may be based on a combination of
`
`references according to known methods to yield predictable results. I further
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`understand that obviousness based on a combination of references does not require
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`an explicit suggestion in any of the references to combine them, if, as a matter of
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`skill or practice in the field it would be known to do so.
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`56.
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`I also understand that in other circumstances, a claimed invention is
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`obvious if it simply substitutes one known element for another to obtain
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`predictable results.
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`57.
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`I also understand that obviousness may be based on the use of known
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`techniques to improve similar devices in the same way; the application of known
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`techniques to known devices ready for improvement to yield predictable results;
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`because it was obvious to try; and/or when an element is known to work in one
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`field of endeavor prompting variations for use in the same field based on design
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`incentives or other market forces, since the variations are predictable to one of
`
`ordinary skill in the art.
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`
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`15
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`ACTA Ex. 1002-015
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
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`C. The Field of the Invention and the Level of Ordinary Skill in
`the Art
`
`58.
`
`I was asked to consider the technical field(s) relevant to the subject
`
`matter of the ’921 patent, as well as the level of skill that an ordinary person
`
`working in that technical field would have had as of November 9, 1998 (the
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`earliest priority date of the ’921 patent). In my opinion, the technical field(s)
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`relevant to the subject matter of the ’921 patent concern fluid dynamics, fluid-
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`structure interactions, and mechanical devices for moving small volumes of fluid
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`under sterile conditions, namely IV pumps and tube sets.
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`59.
`
`I understand that factors such as the education level of those working
`
`in the field, the sophistication of the technology, the types of problems encountered
`
`in the art, the prior art solutions to those problems, and the speed at which
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`innovations are made may help establish the level of ordinary skill in the art. I
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`understand that a person of ordinary skill has the ability to understand the
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`technology and make modest adaptions or advances, and that a person of ordinary
`
`skill in the art is also a person of ordinary creativity, not an automaton.
`
`60.
`
`In my opinion, a person of ordinary skill in the art relevant to the ’921
`
`patent would have a bachelor’s degree in mechanical engineering and at least some
`
`experience related to fluid dynamics, fluid-structure interactions, and mechanical
`
`devices for moving small volumes of fluids.
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`
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`16
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`ACTA Ex. 1002-016
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`

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`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
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`61. As of the earliest priority date of the ’921 patent, I qualified as a
`
`person of ordinary skill in the art based upon my experience and education in the
`
`mechanical arts and fluid dynamics as related to the ‘921 patent. My opinions
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`provided herein are made through the lens of a person of ordinary skill in the art as
`
`of November 9, 1998.
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`D. Claim Construction
`
`62.
`
`I understand that in deciding whether to institute Petitioners’ request
`
`for Inter Partes Review, the first step in the PTO’s analysis will be to determine
`
`the scope of the claims of the ’921 patent. I understand that the PTO presumes that
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`the words of a patent claim have their ordinary and customary meaning based on
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`the broadest reasonable interpretation of the claim language.
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`63.
`
`I understand that the Patent owner has argued in a parallel proceeding
`
`that the claims are entitled to their ordinary and customary meaning. Accordingly,
`
`in analyzing the claims of the ‘921, I have used the plain and ordinary meaning of
`
`each and every term, so as to provide the broadest reasonable interpretation of the
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`claims. I expressly reserve the right, however, to supplement these opinions and/or
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`offer additional opinions after the Court provides its construction of the terms used
`
`in the asserted claims to the extent that construction may differ from its plain and
`
`ordinary meaning.
`
`
`
`17
`
`ACTA Ex. 1002-017
`
`

`
`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`E.
`
`Priority Date of the ’921 Patent
`
`64. The ‘921 patent was filed on November 9, 1998. No earlier priority
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`date is claimed by the ‘921 patent.
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`65.
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`I have been advised by counsel that:
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`– A document that was made publicly available before November 9, 1997 is
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`prior art to claims 15-34 of the ’921 patent under pre-AIA 35 U.S.C.
`
`§ 102(b); and
`
`– A patent filing made in the United States before November 9, 1998, and
`
`which became publicly available after November 9, 1998, is prior art to
`
`claims 15-34 of the ‘921 patent under pre-AIA 35 U.S.C. § 102(e).
`
`VI. DETAILED DESCRIPTION OF THE PRIOR ART
`66. As discussed below, the prior art discloses, teaches, or suggests every
`
`limitation of claims 15-34, including the subject matter the PTO found missing
`
`from the prior art in the Reason For Allowance.
`
`A. U.S. Patent No. 5,747,498 (Ex. 1009)
`67. U.S. Patent No. 4,689,043 (“Bisha” Ex. 1009) issued as a patent
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`August 25, 1987, which is more than one-year before the earliest priority date of
`
`the ‘921 patent. Accordingly, Bisha, is prior art as to claims 15-34 of the ‘921
`
`patent under 35 U.S.C. § 102(b) (Pre-AIA). Bisha was not before the PTO during
`
`the prosecution of the application leading to the ‘921 Patent.
`
`
`
`18
`
`ACTA Ex. 1002-018
`
`

`
`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`68. Bisha discloses “an IV tube activator for use with a peristaltic IV
`
`infusion pump comprises means that require the closure of a tube associated clamp
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`upon engagement of the IV tube with the pump…” (Ex. 1009 at Abstract).
`
`69. Bisha, for example, specifies in FIG. 2 that there is a pin (feature 22)
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`and a first recess (feature 26). (Ex. 1009 at FIG. 2). Further defined in FIG. 2 are
`
`a clamping device (feature 20) and a second recess, which is defined as a bracket
`
`(feature 24). (Ex. 1009 at FIG. 2). The specification defines these features “[a]s
`
`shown in FIG. 2, IV tube 12 and its associated pumping section 18 are mounted on
`
`the device 10 by the engagement of fitment 22 with upper bracket 26 and the
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`engagement of slide clamp fitment 20 with lower hinge bracket 24.” (Ex. 1009 at
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`col. 3, ll. 37-41). Accordingly, it is my understanding that by positioning fitment
`
`22 and fitment 20 into their corresponding brackets, the tubing is placed over the
`
`pumping mechanism. Indeed, this is confirmed by the statement from the
`
`specification “Thus, when IV tube 12 is engaged with device 10, pumping section
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`18 is positioned against the peristaltic pumping means 28.” (Ex. 1009 at col. 3, ll.
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`41-43).
`
`70.
`
`I understand that the brackets defined by features 26 and 24 to include
`
`a recess in the housing of the pump. For example, Bisha describes that “on lower
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`hinge bracket 24 is a recess 54 adapted for mating engagement…” (Ex. 1009 at
`
`col. 4, ll. 28-29). The fitment 22 is also described as engaging with the upper
`
`
`
`19
`
`ACTA Ex. 1002-019
`
`

`
`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`bracket 26 (Ex. 1009, FIG. 2). Accordingly, in my opinion, these features teach a
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`recess.
`
`71. Bisha further defines a slide clamp in FIGS. 4 and 5 that depict a
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`tubing passing through the body of the slide clamp. (Ex. 1009 at FIGS. 4, 5). The
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`slide clamp depicts a pinch arm that engages to the body of the clamp and slides.
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`By sliding the pinch arm, the tubing is pressed into a collapsed position, or one that
`
`is not compressed. (Ex. 1009 at FIGS. 4, 5).
`
`72. Bisha further defines a spring feature to correspond with the clamping
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`feature. For example, the specification defines that the “lockout spring 90 is
`
`positioned to prevent the movement of slide clamp 32 from the position as shown
`
`in FIG. 4 to a position as shown in FIG. 5.” (Ex. 1009 at col. 5, ll. 49-51. FIG. 4
`
`shows a closed position, wherein the tubing is collapsed, and FIG. 5 shows an open
`
`position where the tubing is not compressed by the pinch arm.
`
`B.
`Fields, U.S. Patent No. 5,437,635 (Ex. 1010)
`73. Fields U.S. Patent No. 5,437,635, issued on August 1, 1995, which is
`
`more than one-year before the earliest priority date of the ‘921 patent.
`
`Accordingly, Fields, is prior art as to claims 15-34 of the ‘921 patent under 35
`
`U.S.C. § 102(b) (Pre-AIA). Fields was not before the PTO during the prosecution
`
`of the application leading to the ‘921 Patent.
`
`
`
`20
`
`ACTA Ex. 1002-020
`
`

`
`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`74. Fields, like Bisha describes an IV pump and sensor in conjunction
`
`with a “flow limiter mechanism for use with an infusion pump of the type
`
`operating upon a disposable cassette held by the infusion pump and having a flow
`
`tube connected to the cassette.” (Ex. 1010 at abstract).
`
`75. The cassette pumping mechanism is a variation to the curvilinear
`
`peristaltic pumping mechanism that places a tube in a cassette over a rotating cam
`
`to press fluids forward. In many cassette type pumps, each cassette can be placed
`
`onto a separate rotating cam on the pump, to allow for multiple channels to dose
`
`fluids at different rates.
`
`76. Fields discloses a cassette and a flow limiter mechanism in FIGS. 1
`
`and 2. The cassette is received into a cassette receiving section. (Ex. 1010 at col.
`
`4, ll. 62-63). There is also a second recess for insertion of the flow clip. “The flow
`
`clip carrier 40 has a shape 44 for alignment with a corresponding receptacle 28
`
`which has a correspondingly shaped indentation 46 for alignment of the flow clip
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`carrier therein.” (Ex. 1010 at col. 5, ll. 16-19).
`
`77. Fields also discloses that there are sensors embedded into the pump.
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`These sensors are utilized to “detect the presence of a tubing 38 within a tubing
`
`channel 26.” (Ex. 1010 at col. 7, ll. 45-46).
`
`78. Schweitzer, U.S. Patent No. 5,584,671 (Ex. 1011)
`
`
`
`21
`
`ACTA Ex. 1002-021
`
`

`
`U.S. Patent No. 6,164,921—Petition for Inter Partes Review
`Declaration of Carl Meinhart, Ph.D.
`
`
`79. Schweitzer U.S. Patent No. 5,584,671, issued on December 17, 1996,
`
`which is more than one-year before the earliest priority date of the ‘921 patent.
`
`Accordingly, Schweitzer, is prior art as to claims 15-34 of the ‘921 patent under 35
`
`U.S.C. § 102(b) (Pre-AIA). Schweitzer was not before the PTO during the
`
`prosecution of the application leading to the ‘921 Patent.
`
`80. Schweitzer describes that it was known in the art to use a valve and a
`
`positioning member on an IV tubing set, which places the tubing against the
`
`peristaltic pumping means. Schweitzer describes a mounting member (24) having
`
`its own recess in the pump unit housing. (Ex. 101