CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 1 of 17
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Biomedical Device Consultants &
`Laboratories of Colorado, LLC,
`
`Plaintiff,
`
`v.
`
`TA Instruments - Waters, LLC,
`
`Defendants.
`
`Civil File No. 0:17-cv-03403
`
`DECLARATION OF MICHAEL
`GIRARD IN SUPPORT OF MOTION
`FOR PRELIMINARY INJUNCTION
`
`I, Michael J. Girard, hereby declare and state as follows:
`
`1.
`
`I have been retained by Plaintiff Biomedical Device Consultants &
`
`Laboratories of Colorado, LLC ("BDC") to offer technical analysis and opinions
`
`regarding various issues relevant to this action, including infringement and validity of the
`
`Patents-in-Suit, U.S. Patent Nos. 8,584,538 ("the '538 Patent"), 8,627,708 ("the '708
`
`Patent"), 9,186,224 ("the '224 Patent"), 9,237,935 ("the '935 Patent") (collectively, the
`
`"Patents-in-Suit"). I have personal knowledge of the facts herein, and if called as a
`
`witness, I could and would testify competently thereto.
`
`2. My education includes a Bachelor of Science in Civil (Structural)
`
`Engineering from the University of Illinois, and a Master of Business Administration
`
`from the University of St. Thomas.
`
`3.
`
`I am currently the President ofmy own consulting firm, Girard Technical
`
`Services, Inc. My firm provides research and development, engineering, and technical
`
`management consulting services in the medical device industry.
`
`4816-6498-1075\5
`
`WATERS TECHNOLOGIES CORPORATION
`EXHIBIT 1017
`
`PAGE 1 OF 17
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Biomedical Device Consultants &
`Laboratories of Colorado, LLC,
`
`Plaintiff,
`
`v.
`
`TA Instruments - Waters, LLC,
`
`Defendants.
`
`Civil File No. 0:17-cv-03403
`
`DECLARATION OF MICHAEL
`GIRARD IN SUPPORT OF MOTION
`FOR PRELIMINARY INJUNCTION
`
`I, Michael J. Girard, hereby declare and state as follows:
`
`1.
`
`I have been retained by Plaintiff Biomedical Device Consultants &
`
`Laboratories of Colorado, LLC ("BDC") to offer technical analysis and opinions
`
`regarding various issues relevant to this action, including infringement and validity of the
`
`Patents-in-Suit, U.S. Patent Nos. 8,584,538 ("the '538 Patent"), 8,627,708 ("the '708
`
`Patent"), 9,186,224 ("the '224 Patent"), 9,237,935 ("the '935 Patent") (collectively, the
`
`"Patents-in-Suit"). I have personal knowledge of the facts herein, and if called as a
`
`witness, I could and would testify competently thereto.
`
`2. My education includes a Bachelor of Science in Civil (Structural)
`
`Engineering from the University of Illinois, and a Master of Business Administration
`
`from the University of St. Thomas.
`
`3.
`
`I am currently the President ofmy own consulting firm, Girard Technical
`
`Services, Inc. My firm provides research and development, engineering, and technical
`
`management consulting services in the medical device industry.
`
`4816-6498-1075\5
`
`WATERS TECHNOLOGIES CORPORATION
`EXHIBIT 1017
`
`PAGE 1 OF 17
`
`
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 2 of 17
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`4.
`
`I have thirty-seven years of experience in engineering, twenty-seven of
`
`which are in the medical device industry. I am a named inventor on 38 issued U.S.
`
`Patents with additional applications pending.
`
`5. My experience includes work with many cardiovascular devices and
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`specifically includes 19 years of heart valve experience. I've worked for several medical
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`device companies in the role of development and testing of both surgical and
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`transcatheter delivered prosthetic heart valves. Testing of heart valves usually includes
`
`durability testing at accelerated rates with equipment like the systems produced by BDC
`
`and TA Instruments. Therefore, I am very familiar with durability test equipment and the
`
`requirements of such testing. My curriculum vitae is attached hereto as Exhibit A.
`
`A. Technology Overview
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`6.
`
`This case concerns equipment used for durability or high cycle fatigue
`
`testing of heart valves. Before any medical device, such as a heart valve, is marketed it
`
`must meet certain regulatory standards. International bodies, such as the International
`
`Organization for Standardization ("ISO"), set certain standards, such as those for testing
`
`the durability of medical devices, including heart valves. The specific standards for heart
`
`valves are defined in ISO 5840.
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`7.
`
`Prosthetic heart valves must be tested to ensure that they will function for
`
`the anticipated life of the patient by opening and closing the valve leaflets under flows
`
`and pressures that are present within the human vascular system. The normal human
`
`heart beats about 40 million times each year. The test requirements for evaluating
`
`prosthetic heart valves according to the standards require that the valves be able to
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`2
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`PAGE 2 OF 17
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 3 of 17
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`survive and function for hundreds of millions of cycles ( e.g., at least 5 years or 200
`
`million cycles). The valves must also be able operate over a specific range of opening
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`and closing pressures that simulate physiological conditions, and therefore testing
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`standards require that a specific pressure differential be generated across the valve when
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`closed.
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`8.
`
`Testing systems use a test fluid to mimic blood and pressurize the fluid to
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`mimic the blood pressure in the human body. Testing requires fluid flow through the
`
`valve and creating a pressure differential across the test valve when closed at a certain
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`minimum pressure for a certain length of the cycle. A "drive mechanism" such as a
`
`pump drives the test fluid into the test chamber in order to create the fluid flow and
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`desired pressure conditions. In order to complete hundreds of millions of cycles in a
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`commercially viable timeframe, durability testing is done on an "accelerated" basis. In
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`other words, the speed of the cycles is faster than a normal human heartbeat ( a normal
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`beat rate is 70 beats per minute - bpm). Using current technology at accelerated cycling
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`of 800 bpm, testing takes approximately six months to simulate 200 million cycles.
`
`B. Problems in Prior Art Technology
`
`9.
`
`The Patents-in-Suit identify several problems with the prior art.
`
`10.
`
`Driving mechanisms in the prior art had limited control over closing rates
`
`and would often produce "pressure spikes" when the systems maintain pressure above the
`
`testing threshold for the amount of time required by testing standards. These pressure
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`spikes are undesirable because they wear out valves during testing faster than they would
`
`be worn out in the human body, causing false test failures.
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`3
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`PAGE 3 OF 17
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 4 of 17
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`11.
`
`According to the Patents-in-Suit, prior art valve testing devices also
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`experienced operational problem. For example, one prior art device used a flexible
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`metallic bellows to pressurize. '538 Patent col.111.34-36. However, a higher load is
`
`required to drive the metallic bellows and can thus, impact the reliability of the test
`
`system and increase maintenance requirements which increases the already lengthy
`
`durability testing process.
`
`C. Overview of the Patents-in-Suit
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`12.
`
`The Patents-in-Suit propose to solve these problems in the prior art.
`
`13.
`
`For example, the '935 Patent covers a device for accelerated testing of
`
`valved prosthetics with several components including a test chamber and an "excess
`
`volume area" that is connected to a return chamber. The excess volume area and return
`
`chamber within the test chamber are shown below:
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`4
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`PAGE 4 OF 17
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 5 of 17
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`Fluid return chamber
`
`~---_;Holder for test sample of
`prosthetic valve
`
`126
`
`120
`
`111
`
`Fluid
`return
`conduit
`
`Pressure source
`
`14.
`
`Another patent, the '224 Patent, covers a method for operating a test system
`
`with an excess volume area. The '224 Patent describes a method that includes storing a
`
`volume of the test fluid (which approximates blood) in an "excess volume area" when the
`
`system is in a "drive" stroke of the system that opens the prosthetic valve and releases the
`
`fluid from the area during the "return" stroke of the system.
`
`15.
`
`The excess volume area improves the testing environment by minimizing
`
`unnatural and undesirable pressure spikes and provides advantages of speed and
`
`longevity in the drive system. When the system is driving test fluid through the
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`5
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`PAGE 5 OF 17
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`- ·-.~.· .. ,
`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 6 of 17
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`prosthetic valve, the excess volume area is able to store the excess volume downstream of
`
`the prosthetic test valve. Tbis can alleviate some of the system pressure during the drive
`
`stroke. The excess volume area also provides compliance that controls the resistance and
`
`the forward flow pressure gradients across the valve, and minimizes unnatural and
`
`undesirable pressure noise or spikes. During the reverse stroke of the motor when the
`
`valve is closing, the excess volume area and compliance helps to build back pressure on
`
`the valve, return the downstream volume to the pump and minimize unnatural and
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`undesirable valve closing pressure spikes, i.e., recoil, that can negatively impact the
`
`durability of the prosthetic test valve.
`
`16.
`
`The Patents-in-Suit offer potential advantages for heart valve durability
`
`testing compared to the prior art. The use of the excess volume area and the avoidance of
`
`pressure spikes allows the system to better comply with the rigors of the durability testing
`
`standards without exposing the test valves to undesirable, excess, and clinically irrelevant
`
`pressures.
`
`D. Infringement Analysis of DuraPulse Test System
`
`17.
`
`I understand that the accused device in this case is the DuraPulse Heart
`
`Valve Test Instrument ("DuraPulse"). To understand the components of the DuraPulse
`
`and their operation, I have reviewed the following: the TA Instruments website offering
`
`the DuraPulse for sale, the sales brochure for the DuraPulse attached to the Complaint in
`
`this case, pictures of the DuraPulse included in BDC's motion for preliminary injunction,
`
`a video of the operation of the DuraPulse available at
`
`https://www.youtube.com/watch?v=KgmpQCRrYpQ, and U.S. Patent No. 9,662,210
`
`6
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`PAGE 6 OF 17
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 7 of 17
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`("the '210 Patent"), attached hereto as Exhibit B. The '210 Patent belongs to Defendant
`
`TA Instruments-Waters, LLC ("TA Instruments"). The '210 Patent is entitled "System
`
`for Testing Valves" and, based on the diagrams and description, appears to describe the
`
`DuraPulse. In addition, I understand that BDC's CEO Dr. Craig Weinberg has observed
`
`the DuraPulse and the '210 Patent describes that product.
`
`18.
`
`I understand that the patent infringement analysis involves two steps: ( 1)
`
`claim construction, and (2) comparison of the accused product to the construed claims. I
`
`understand that direct infringement of an apparatus claim requires that each and every
`
`limitation set forth in a claim appear in the accused products. I further understand that
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`direct infringement of a method claim requires all steps of the claimed method to be
`
`performed by or attributable to a single entity.
`
`i.
`
`Claim Construction
`
`19.
`
`I understand that claim terms are to be given the ordinary and customary
`
`meaning of the term as evaluated from the perspective of one of ordinary skill in the art at
`
`the time of the invention. I further understand that the claim term is to be read in context
`
`of the claim itself and in the context of the entire patent, including the specification, but
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`that limitations from the specification should not be read into the claims.
`
`20.
`
`Based on context, including both the claims and the specification, the
`
`person of ordinary skill would understand that the term "compliance chamber" to mean
`
`"a cavity or volume that functions to absorb some of the pressure in the system." This is
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`explained directly in the specification of the Patents-in-Suit. See, e.g., '538 Patent col.8
`
`11.59-62. The specification explains that the chamber or chambers absorb some of the
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`7
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`PAGE 7 OF 17
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 8 of 17
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`pressure placed upon the fluid in the t~st chamber and can also impact the recoil.
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`Likewise, the compliance chamber minimizes the effect of rapidly changing pressure
`
`gradients associated with accelerated testing. Finally, the compliance chamber is "a
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`cavity or volume" because the specification notes that it may be air or another gas and
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`may directly contact the fluid or may be separated from the fluid by a membrane.
`
`ii.
`
`Comparison of Claim Elements to DuraPulse
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`21.
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`It is my opinion that the DuraPulse infringes at least claims 1 and 9 of the
`
`'935 Patent. In addition, it is my opinion that use of the DuraPulse infringes at least
`
`claims 1 and 6 of the '224 Patent.
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`22.
`
`The DuraPulse includes all the elements of the Patents-in-Suit. For
`
`example, an image of the DuraPulse is shown below, as noted it has a test chamber with
`
`an excess volume area:
`
`Test chamber
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`23.
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`The DuraPulse also has a drive motor that operates the system at an
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