IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Application No.
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`:
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`12/718,316
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`Confirmation No.
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`: 4620
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`First Applicant
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`: Benjamin McCloskey
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`Art Unit
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`Filed
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`Title
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`:
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`5 March 2010
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`Examiner
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`: Fatigue testing system for prosthetic devices
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`:
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`:
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`4125
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`Jahangir, Naeem M.
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`Docket No.
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`: P201384.US.02
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`Customer No.
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`:
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`20686
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`DECLARATION OF CRAIG WEINBERG, Ph.D. UNDER 37 C.F.R. § 1.132
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`Mail Stop Amendment
`Commissioner for Patents
`US. Patent and Trademark Office
`PO. Box 1450
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`Alexandria, VA 22313-1450
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`I, CRAIG WEINBERG, having a residence at 4132 Decatur Street, Denver, Colorado
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`80211 and being a US. citizen, hereby declare as follows:
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`1.
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`I am a named inventor on the patent application captioned above and am an
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`owner and president of the assignee of the application, Biomedical Device Consultants and
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`Laboratories of Colorado, LLC.
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`l have held this position for over 7 years.
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`2.
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`l have a Ph.D. in Mechanical/Biomedical Engineering from the University of
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`Colorado — Boulder (2003).
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`3.
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`My primary expertise is with the cardiovascular system and my research
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`experience is focused on statistically based experimental design and analysis, cardiovascular
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`system experimental modeling, and control system algorithm development. My doctoral thesis
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`was in the area of ultrasound imaging, experimental fluid dynamics and flow visualization.
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`Additional research and development experience includes vascular implants (synthetic and
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`biologic), endovascular implants, radio-frequency tissue treatments (tissue fusion, division, and
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`coagulation), control system logic development, and management of acute and chronic
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`preclinical animal studies.
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`4.
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`I participated in the preparation of the subject patent application captioned above
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`and have also reviewed the pending claims in this application and the references cited by the
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`examiner in the Office action dated 3 January 2013,
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`5.
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`The examiner cites the Vilendrer reference in the Office action as disclosing a
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`similar system as the system of claim 25 of our application.
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`I would note particularly that the
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`Vilendrer system employs the use of two metal bellows on each end of the system to drive the
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`4843-6621 -9283\2
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`PAGE 1 OF 3
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`1
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`WATERS TECHNOLOGIES CORPORATION
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`EXHIBIT 1009
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`WATERS TECHNOLOGIES CORPORATION
`EXHIBIT 1009
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`PAGE 1 OF 3
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`

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`Serial No.: 12/718,316
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`Attorney Docket No. P201384.US.02
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`system. The use of metal bellows is something that we intentionally avoided in the design of the
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`system of claim 25.
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`6.
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`Metal bellows technology requires a substantially increasing force during
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`compression, once beyond the initial, relatively small displacement, to increase the bellows
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`compression. Therefore to achieve higher flow rates through larger displacements as required
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`for testing some larger sized valved prosthetic devices (such as tested by the claimed
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`invention) and to ensure full opening and closing performance of the test article, one must
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`provide a larger electromagnetic driver(s) for a metal bellows that can generate the necessary
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`higher forces during operation. Consequently, further challenges to the test equipment result
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`from this factor such as increased heat generation from the driver, increased operating stresses
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`on adjacent components, and increased physical size requirements for the driver and test
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`system.
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`7.
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`In addition, metal bellows possess their own spring constant and effective mass.
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`During cyclic, oscillatory motion the bellows therefore responds as a standard mass-spring
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`system with a respective vibrational natural frequency and subsequent harmonic response.
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`This characteristic can impact the operation of the test system by producing undesirable
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`excitation of the valved test prosthesis(es) under evaluation and/or impart artificial limitations in
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`the system operating frequency.
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`8.
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`By utilizing a flexible elastomeric rolling bellows diaphragm technology as
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`provided in claim 25, higher system flow generated by large displacements can be achieved
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`without any need for increased force requirements to the driver beyond the loading
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`requirements of the valved test prosthesis(es) under evaluation. No incremental load
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`considerations are necessary for the motion of the rolling bellows. Furthermore, a flexible rolling
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`bellows diaphragm does not possess an effective spring constant; therefore, the rolling bellows
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`does not respond as a mass-spring system nor possess its own natural frequency. These
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`points combine to an added benefit of requiring a smaller electromagnetic driver(s), fewer
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`system component stresses, and no operational or frequency restrictions stemming from the
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`prior art metal bellows component.
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`9.
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`The examiner secondarily identified the system in the Kruse et al. reference as
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`using a diaphragm to drive a prosthetic test system.. The system described in the Kruse et al. is
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`for evaluation and testing of heart valve frames (referred to in Kruse at al. as a “valve stent”)
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`and describes a preferred embodiment that has limited to no system flow through the test
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`article. Therefore, the Kruse et al. system does not require the large driver/ diaphragm
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`displacements since the opening and closing of the test article leaflets are not desired. The
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`Serial No.: 12/718,316
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`Attorney Docket No. P201384.US.02
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`diaphragm in the Kruse et al. system performs in a manner similar to a loudspeaker cone, with
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`the diaphragm merely flexing inward and outward with respect to a fixed circumferential
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`position. Such a diaphragm does not have a rolling interface along the diaphragm like a rolling
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`bellows and would not be applicable to the system of claim 25 in which much larger
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`displacements are achieved using the rolling bellows diaphragm. This allows the system of
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`claim 25 to test larger valved prosthetic devices that require larger fluid volume flows.
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`10.
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`Additionally, test requirements for valved endovascular prostheses, as outlined
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`by the United States Food & Drug Administration (FDA) and all worldwide regulatory agencies,
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`provide that the valved prosthesis(es) be loaded through 200,000,000 -— 600,000,000 cycles.
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`This extremely high cycle requirement prohibits the use of a standard piston with seal(s) as
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`used in the Pickard reference (which is a real-time, not accelerated system) to provide a driving
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`member, since seal technologies such as O—rings, cup seals, and others do not have an
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`anticipated life-duration equivalent to one test run. Moreover, standard seal technologies
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`function by interference between the seal and the piston cylinder. The amount of interference is
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`a delicate balance of providing adequate pressure on the seal—cylinder interface to prohibit the
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`leaking of working fluid while recognizing that the resulting pressure will create friction and
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`require additional input force to overcome and increase the wear of the seals during operation.
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`This friction can also generate heat in the test system and additional wear and stresses on the
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`components and driver.
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`11.
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`Since a rolling bellows diaphragm does not generate a fluid seal by an
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`interference fit and contact between a piston and piston cylinder as with classic seals, the
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`shortcomings of classic seals such as friction and inadequate life-span during a test run are
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`overcome. Thus, the rolling bellows overcomes the problems of prior driver technologies used
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`in these test systems requiring extremely high test cycles.
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`12.
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`I declare further that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and further that
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`these statements were made with the knowledge that the making of willful false statements and
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`the like are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the
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`United States Code and that such willful statements may jeopardized the validity of the
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`application or any patent issuing thereon.
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`Dated: 10 May 2013
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