(cid:40)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87)(cid:3)2007(cid:3)
`A™ 2AR007B
`
`

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`Waters Techs. Corp. v. Biomedical Device Consultants & Labs
`IPR2018-00498
`Ex. 2007
`
`Page 1 of 15
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`

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`P201384.US.02
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`CLAIMS
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`This listing of claims replacesall prior versions andlistings of claims in this application.
`
`New terms are presented in underline text and deleted terms are indicated in st#kethrough text
`
`or are enclosedin [[double brackets]].
`
`Whatis claimedis:
`
`1.
`
`(Currently Amended) A device for simultaneous accelerated cyclic testing of a
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`plurality of valved prosthetic devices comprising
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`a pressurizable test chamberfurther comprising
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`a fluid distribution chamber having a first manifold definingafirst plurality of ports
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`configured to receive andfluidicly couple with a first end of each of a respective plurality of
`
`sample holders and defining an aperture in a lowerfacein fluid communication with a pressure
`
`source;
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`a fluid return chamber having a second manifold disposed opposite and spaced
`
`apart from the first manifold of the fluid distribution chamberand defining a second plurality of
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`ports configured to receive and fluidicly couple with a second end of each of the respective
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`plurality of sample holders;
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`a fluid return conduit both structurally and fluidily connecting the fluid distribution
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`chamberto the fluid return chamber; and
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`a compliance chamberproviding a volume for holding a gas or elastomeric
`
`material that compresses under a pressure placed upon fluid in the test chamber and-ard;
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`allowsfluid in the test chamberto occupy a portion of the volume,;
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`a drive motor configured to operate cyclically, acyclically, or a combination of both; and
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`a fluid displacement memberconnected with and driven by the drive motor to provide
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`the pressure source that increases and decreases a pressure on fluid in the test chamber;
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`wherebycyclic and acyclic fluid pressures are maintained throughout the test chamber.
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`2.
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`(Original) The device of claim 1 further comprising a plurality of sample holders,
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`each configured to hold a respective prosthetic device, mounted between the first manifold of
`
`the fluid distribution chamber and second manifold of the fluid return chamber, and mounted
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`within a respective pair of the first plurality of ports and the secondplurality of ports, whereby
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`the prosthetic device is placed in fluid communication with the distribution fluid chamber and the
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`return fluid chamber.
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`Page 2 of 15
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`P201384.US.02
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`3.
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`(Original) The device of claim 1, wherein
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`the compliance chamber comprises a plurality of compliance chambers formed as
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`cavities within the fluid return chamber; and
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`a respective one of the plurality of compliance chambersis positioned substantially
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`above eachof the secondplurality of ports and between each of the second plurality of ports
`
`and the fluid return conduit.
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`4.
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`(Original) The device of claim 1, wherein each of the sample holders defines a
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`first port on a first side of a test sample position and a second port on a second side ofthe test
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`sample position; wherein the first port and the secondport are configured to receive one or
`
`more sensor devices.
`
`5.
`
`(Original) The device of claim 4 further comprising a pressure transducerin fluid
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`communication with the first port and the second port in one of the sample holders configured to
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`measurea pressure gradient across a test sample positioned within the one of the sample
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`holders.
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`6.
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`(Original) The device of claim 1 further comprising a one-way valve positioned
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`within the fluid return conduit that prevents fluid flow through the fluid return conduit when the
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`fluid displacement member increases pressureon fluid in the test chamber.
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`7.
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`(Original) The device of claim 1, wherein the fluid return conduit is positioned
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`along an axial center of the test chamber.
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`8.
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`(Original) The device of claim 1, wherein the fluid return conduit further
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`comprises
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`an inner conduit wall having an outer diameter and attachedto one ofthe fluid
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`distribution chamberor the fluid return chamber;
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`an outer conduit wall having an inner diameterlarger than the outer diameterof the inner
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`conduit and attachedto the otherof the fluid distribution chamberor the fluid return chamber,
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`wherein the inner conduit call is received within the outer conduit wall; and
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`a seal memberpositioned between the inner conduit wall and the outer conduit wall to
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`create a fluid-tight seal therebetwen; wherein
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`the fluid return conduit is configured to telescopically lengthen or shorten.
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`Page 3 of 15
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`Page 3 of 15
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`P201384.US.02
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`9.
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`(Original) The device of claim 8 further comprising a plurality of adjustment posts
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`positioned between the fluid distribution chamber and the fluid return chamber and operable to
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`adjust a separation distance betweenthe fluid distribution chamberandthe fluid return
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`chamber.
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`10.
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`(Original) The device of claim 1 further comprising a computer control system
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`connected with the drive motor and a sensor positioned within the test chamber, wherein the
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`computer control system is configured to operate one or moreof the following:
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`an alarm module for alerting a user or arresting operation of the device upon receipt of
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`data from the sensor that is outside a preset parameter; or
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`a closed loop feedback module for adjusting operation of the drive motor upon receipt of
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`data from the sensor to maintain a pressureprofile within the test chamber according to a preset
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`parameter.
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`11.
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`(Original) The device of claim 1 further comprising
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`a heater positioned in the test chamberfor heating fluid within the test chamber; and
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`a temperature sensor positioned within the test chamber to measure temperatureof fluid
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`within the test chamber.
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`12.
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`(Original) The device of claim 1, wherein the fluid displacement member
`
`comprisesaflexible diaphragm.
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`13.
`
`(Original) The device of claim 1, wherein the drive motor comprisesa linear
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`motor.
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`14.
`
`(Original) The device of claim 13 further comprising
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`a mounting structure connected to and supporting the linear motor in a vertically
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`mounted position; and
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`a spring supported by the mounting structure, and interfacing with an end of a shaft of
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`the linear motor extending from a lower end of the linear motor, wherein
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`the spring prevents the shaft from dropping downward from the linear motor when the
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`linear motor is in an unpoweredstate.
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`15.
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`(Original) The device of claim 1, wherein the fluid displacement memberfurther
`
`comprisesa flexible rolling bellows connected to a shaft of the linear motor.
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`Page 4 of 15
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`Page 4 of 15
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`P201384.US.02
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`16.
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`(Original) The device of claim 15 further comprising
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`a drive adapter coupledto the either directly or indirectly to the distribution chamber and
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`in fluid communication with the aperture in the lowerface of the fluid distribution chamber,
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`wherein
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`the drive adaptor defines an aperture with an upper diameter congruent with a diameter
`
`of the aperture in the lowerfaceof the fluid distribution chamber;
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`the rolling bellowsis further attached to a piston connected to the shaft of the linear
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`motor and the piston movesaxially within a cylinder;
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`the cylinder defines an opening of a diameterthat is substantially the same as a
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`diameter of an end wall of the rolling bellows;
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`the cylinder is coupled to the drive adapter and a circumferential flange of the rolling
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`bellowsis held therebetween; and
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`the aperture defined in the drive adaptor has a lower diameter congruentwith the
`
`diameter of the openingin the cylinder.
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`17.
`
`(Currently Amended) A test chamberfor accelerated cyclic testing of a valved
`
`prosthetic device in a variable pressurized environment comprising
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`a fluid distribution chamber havingafirst manifold definingafirst port configured to
`
`receive andfluidicly couple with a first end of a sample holder and a lower face defining an
`
`aperture for communicating with a fluid pressure source;
`
`a fluid return chamber having a second manifold disposed opposite and spaced apart
`
`from the first manifold of the fluid distribution chamber and defining a secondport configured to
`
`receive andfluidicly couple with a second end of the sample holder;
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`a fluid return conduit both structurally and fluidly connecting the fluid distribution
`
`chamberto the fluid return chamber; and
`
`a compliance chamberproviding a volume for holding a gas or elastomeric material that
`
`compresses undera pressure placed upon fluid in the test chamber-anrd; allowsfluid in the test
`
`chamberto occupy a portion of the volume.
`
`18.
`
`(Original) The test chamber of claim17, wherein the compliance chamberis
`
`defined as a cavity within the fluid return chamber.
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`19.
`
`(Original) The test chamber of claim 18, wherein the fluid return chamberdefines
`
`a port providing fluid communication between an outer surfaceof the fluid return chamber and
`
`the cavity forming the compliance chamber.
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`Page 5 of 15
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`P201384.US.02
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`20.
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`(Original) The test chamberof claim 17 further comprising a sample holder
`
`configured to hold a prosthetic device, mounted betweenthe first manifold of the fluid
`
`distribution chamber and second manifold of the fluid return chamber, and mounted within the
`
`first port and the second port, whereby the prosthetic device is placed in fluid communication
`
`with the distribution fluid chamber and the return fluid chamber.
`
`21.
`
`(Original) The device of claim 20, wherein the sample holderdefinesa first port
`
`on a first side of a test sample position and a second port on a secondsideof the test sample
`
`position; wherein the first port and the second port are configured to receive one or more sensor
`
`devices.
`
`22.
`
`(Original) The device of claim 17, further comprising a porous material at least
`
`partially filling the compliance chamber.
`
`23.
`
`(Original) The device of claim 17, further comprising an elastomeric membrane
`
`separating at least a portion of the compliance chamber from fluid in the fluid return chamber.
`
`24.
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`(Original) The device of claim 17, wherein the compliance chamberis positioned
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`substantially above the second port and between the second port and the fluid return conduit.
`
`25.
`
`(Currently Amended) A pressurization system for a fluid test chamberfor
`
`accelerated cyclic pressure testing of a of a valved prosthetic device comprising
`
`a linear drive motor that displaces a shaft in an axial direction;
`
`a flexible elastomeric rolling bellows diaphragm connected with and driven axially by the
`
`shaft of the linear motor that cyclically increases and decreases a pressureon a fluid in the fluid
`
`test chamber; wherein active control of the linear drive motor provides an ability to create small
`
`and large fluid displacements with consequentvariable effect of a fluid pressure ofthe fluid in
`
`the fluid test chamber.
`
`26.
`
`27.
`
`(Canceled)
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`(Currently Amended) The system of claim 25, further comprising
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`a cylinder that defines an opening of a diameterthat is substantially the same as a
`
`diameter of an end wall of the rolling bellows diaphragm; and
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`a piston connectedto the shaft of the linear motor, wherein
`
`the end wall of the rolling bellows diaphragm is attached to the piston;
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`Page 6 of 15
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`Page 6 of 15
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`the piston and the end wall of the rolling bellows diaphragm moveaxially within the
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`cylinder to create the fluid displacements.
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`P201384.US.02
`
`28.
`
`29.
`
`30.
`
`31.
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`(Canceled)
`
`(Canceled)
`
`(Canceled)
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`(Canceled)
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`Page 7 of 15
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`P201384.US.02
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`REMARKS & ARGUMENTS
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`The Applicant provides the following remarks and argumentfor consideration in further
`
`examination of the present application and explanation of the amendments presentedherein.
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`Interview Summary
`
`Applicant thanks the Examiner and Supervisory Examiner John Fitzgerald for their time
`
`on 29 April 2013 and participation in a telephone interview with the undersigned and Craig
`
`Weinberg, Ph.D., one of the inventors.
`
`Initially the difference between the “compliance
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`transducer”(i.e., a laser micrometer used to measureradial dilation of stents and grafts)
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`disclosed in Vilrendrer and the Applicant's use of a “compliance chamber” was discussed. The
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`examiners agreed that the Vilrendrer structure is completely different and for a different purpose
`
`than the structure of Applicant’s claims 1 and 17 and, for at least this reason, the rejections of
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`claims with this feature in view of Vilrendrer would be withdrawn.
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`Dr. Weinberg further discussed the differences betweenthe invention claimed in claims
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`1 and 17 and the prior art references of record, namely, Vilrendrer, Pickard, and Kruseetal..
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`Dr. Weinberg notedthat the Vilredrer device is designedfor testing radial dilation of stents and
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`grafts, not cardiac, vascular, or other prosthetic biologic valves. Dr. Weinberg further noted the
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`Vilrendrer device would not workto test the wearof valve leaflets though opening andclosing of
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`the valve in view of the need to push fluid from both endsinto the tubes holding the prosthetic
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`stents or grafts.
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`Dr. Weinberg next discussed the difference between Pickard and the presentclaims.
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`Pickard discloses a real time system (e.g., 1 Hz) for testing heart valves immediately before
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`implantation. Pickard is thus not an accelerated testing system (e.g., 25 Hz) like the presently
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`claimed invention andtrying to cycle the Pickard system faster would frustrate the purposeof
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`the test it is trying to perform (i.e., characterizing valve performancein a simulated circulatory
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`system under which the valve is to be used) while not being able to perform the accelerated
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`weartesting of the claimed invention. Dr. Weinberg also discussed the different purpose of
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`compliance between the two systems.
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`In the Pickard system, compliance is used to shape the
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`systemic pressure waveform to mimic the circulatory system distensiblity (e.g., capillaries) and
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`characterize the prosthetic heart valve performance.
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`In contrast, the purpose of the compliance
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`chamber(s) as claimed in the devices of independent claims 1 and 17 is to prevent or minimize
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`the kinetic energy of fluid flow from translating into high static fluid pressure in the test system
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`during the accelerated frequencytesting.
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`Page 8 of 15
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`Page 8 of 15
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`P201384.US.02
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`Dr. Weinbergfinally discussed the differences between Kruseet al. and the claimed
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`invention. Kruse et al. discloses a testing system for evaluation of the valve prostheses frame.
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`The Kruse et al. device is not designed to test or determine leaflet wear(i.e., life-cycle wearof
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`the prosthesis leaflets resulting from the opening and closing of the leaflets during a cardiac
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`cycle). Notably, the system disclosed in Kruseetal. is not interestedin fluid flow through the
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`prostheses nor opening and closing of the leaflets. A closed membrane is placed acrossthe
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`frame to include the commissureposts in order to place significant fluid pressure on the frame
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`to test the fatigue resistance to deformation of the frame under back pressuresanticipated
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`during clinical use over time.
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`In the preferred embodimentin Kruseet al., the native prosthesis
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`leaflets are replaced with flexible membranesthat have significant differences from the native
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`prosthesis leaflets to limit or cease flow whenpositive pressure is applied. Thus, no fluid flow is
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`required through the membrane or valve componentin the Kruseet al. system.
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`In contrast, the
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`valve leaflets are the structures being tested by the claimed invention and thus the presenceof
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`fluid flow through the leaflets is necessary in order for the valve test article to open and close
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`functionally..
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`In view of these comments, the examiners stated that it waslikely that the references
`
`were improperly applied and that claims 1 and 17 arelikely allowable in view of the references.
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`Claim Amendments
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`Claims 1, 17, and 25 are amendedto clarify that the claimed systems and devices are
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`for the accelerated cyclic testing of valved prosthetic devices.
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`Claim 25 is further amendedto provide proper antecedent basis for claim 27 by
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`incorporating the subject matter of claim 26.
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`Claim 26 is canceled herein and the subject matter thereof is incorporated into claim 25.
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`Claims 28-31 are canceled herein without prejudice to or disclaimer of the subject matter
`
`presented therein.
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`Claim Rejections — 35 U.S.C. § 102
`
`Claims 1, 17, 25 and 28 are rejected in the Office action pursuant to 35 U.S.C. § 102 as
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`anticipated by Vilendrer (US Patent No. 5,670,708).
`
`It appears that the examiner may
`
`misunderstand claims 1 and 17, which require, inter alia, a compliance chamber. As shown and
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`described in the specification, a compliance chamber 135 is a cavity associated with a sample
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`holder that absorbs some of the pressure placed upon the fluid in the test chamber and help
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`control recoil to the original volume dimensions. (See 4 0046.) The compliance chamber assist
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`in minimizing the effects of large and quickly changing pressure gradients across test samples.
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`-9-
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`Page 9 of 15
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`P201384.US.02
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`(Id.) The examinerpoints to the compliance transducer(32) in Vilrendrer as a structure meeting
`
`this claim limitation. To the contrary, the compliance transducer(32) is a laser scanning
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`micrometer used to measure the diameterof the prosthetic tubes to determine the amount of
`
`dilation when the tubes being tested are placed undercyclic pressures. Thus, the compliance
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`transducers of Vilrendrer have absolutely no relevance to the structure or function of the
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`compliance chamber of independent claims 1 and 17. For at least this reason, Applicant
`
`requests that the rejection of claims 1 and 17 in view of Vilrendrer be withdrawn.
`
`With respect to claim 25, Applicant respectfully submits that the first paragraph of the
`
`examiner’s rejection has no relevanceto the claimed linear drive motor andaflexible
`
`diaphragm. Applicant is uncertain of the reason for the examiner's recitation of the quoted
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`passage from Vilrendrer(col. 2, Il. 52-57) to the claim.
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`[Applicant notes that the examiner
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`actually cited col. 4, ll. 52-57 for this passage in the Office action.]
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`With respect to the second paragraph of the rejection of claim 25, the examinerrecites a
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`passage from Vilrendrer regarding the drive system used in the system disclosed therein.
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`However, the examiner provides no explanation of how the drive system for a stent dilation test
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`system has any relationship to the pressurization system presentedin independentclaim 25.
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`Vilendrer discloses a prosthesis fatigue test system that, inter alia, employs the use of
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`two metal bellows, one on each end of the system to drive the system. Claim 25 specifically
`
`providesfor the useof a flexible rolling bellows diaphragm. As setforth in the Declaration of
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`Craig Weinberg Ph.D. filed in conjunction with this response, the problems with metal bellows
`
`technology as disclosed in Vilendrer are particularly avoided by the system of claim 25. He
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`states that metal bellows require large driving forces to achieve large fluid displacements during
`
`compression. (ld. at 4 6.) This in turn requires large electromagnetic driver(s) that impart
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`operating challenges such as increased heat generation from the driver, increased operating
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`stresses on adjacent components, and increased physical size requirements for the driver and
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`system. (Id.)
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`In addition, metal bellows possess their own spring constant and effective mass. (Id. at
`
`q 7.) During cyclic, oscillatory motion the metal bellows therefore responds as a standard mass-
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`spring system with a respective vibrational natural frequency and subsequent harmonic
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`response, producing undesirable excitation of the test prostheses underevaluation and/or
`
`limitations in the system operating frequency. (Id.)
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`In contrast, these problems are avoided through the useofa flexible rolling bellows
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`diaphragm asprovidedin claim 25. Larger displacements for generating higher system flow
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`rates can be achieved without any need for increased force requirements to the driver beyond
`
`-10-
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`Page 10 of 15
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`Page 10 of 15
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`P201384.US.02
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`the loading requirements of the test prostheses under evaluation. (Id. at § 8.) Additionally, a
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`rolling bellows diaphragm does not have aneffective spring constant and, therefore, does not
`
`respond as a mass-spring system nor possessa natural frequency. (Id.) Dr. Weinberg also
`
`notes further benefits of the rolling bellows diaphragm in view of other types of drive systems.
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`Further, in consideration of the incorporation of the elements of claim 26 into claim 25 by
`
`amendmentherein, and in view of the rejection of claim 26 in view of Pickard and Kruseet al.,
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`Applicant makesthe following additional observations. The system described in the Kruseetal.
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`is for evaluation and testing of heart valve frames(referred to in Kruseet al. as a “valve stent”)
`
`and describes a preferred embodiment that has limited or no system fluid flow through the test
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`article. (Weinberg Dec., ¢ 10.) This technology therefore does not require the larger driver /
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`diaphragm displacements. The Kruseet al. diaphragm merely flexes in and out and generates
`
`very small displacements. (Id.) Such a diaphragm doesnotoperatelike a rolling bellows
`
`diaphragm and would not be applicable to the system of claim 25 in which much larger
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`displacements are achieved. Use of a rolling bellows diaphragm allows the system of claim 25
`
`to test larger valved prostheses and achieve higher system flowto facilitate better opening of
`
`the test article. (Id.)
`
`Further, with respect to Pickard, a piston pump is disclosed to drive the disclosed
`
`system. A piston pump may be adequatefor a real-time (i.e., ~1 Hz) valve performancetest
`
`system. However, it has significant drawbacksin the context of an accelerated test system
`
`such as claimed in claim 25. For example, the United States Food & Drug Administration (FDA)
`
`and other regulatory agencies, require that the valved prostheses be loaded through
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`200,000,000 test cycles for biologic prostheses or 600,000,000 test cycles for synthetic
`
`prostheses. (Id. at 411.) This extremely high cycle requirement prohibits the use of a standard
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`piston with seal(s) as a driver since because O-rings, cup seals, and other standard seal
`
`structures wear out before the completion of a single test run. (Id.) Further, the friction caused
`
`by the interference between the piston, seal, and chamber generate heat within the test system
`
`and additional wear on the components and driver (Id.). A rolling bellows diaphragm avoids all
`
`of these inherent problems in other drive systems in the context of a prosthetic test environment
`
`requiring large displacement and extremely high test cycles. (Id.)
`
`For these reasons, Applicant submits that Vilendrer (alone or in combination with
`
`Pickard and/or Kruseet al.) does not disclose the system of claim 25. Further, none of the
`
`benefits of the system of claim 25 can be achieved by such Vilrendrer. Applicant therefore
`
`requests that the rejection of claim 25 be withdrawn.
`
`Claim 28 is canceled herein. Therefore, the examiner’s rejection of the same is moot.
`
`-11-
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`P201384.US.02
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`The Applicant therefore requests reconsideration and withdrawalof the rejection of
`
`claims 1, 17, and 25 under 35 U.S.C. § 102.
`
`Claim Rejections — 35 U.S.C. § 103
`
`Claims 2-4, 6-8, 10-13 and 15 are rejected in the Office action pursuant to 35 U.S.C.
`
`§ 103 as obvious in view of Vilendrer (US Patent No. 5,670,708) in combination with Pickard
`
`(US Patent No. 4,682,491).
`
`Dependentclaims 2-4, 6-8, 10-13 and 15 depend upon and contain all the limitations of
`
`independent claims 1 or 17 as applicable. For at least the reasons discussed abovein
`
`connection with independent claims 1 and 17, the Applicant respectfully submits that dependent
`
`claims 2-4, 6-8, 10-13 and 15 are allowable. The Applicant makesthis statement without
`
`waiving any independent basesfor patentability in claims 2-4, 6-8, 10-13 and 15. The Applicant
`
`reservesthe right to separately argue the patentability of dependent claims 2-4, 6-8, 10-13 and
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`15 in a subsequently filed response, if necessary.
`
`With particular respect to claims 7 and 8, contrary to the examiner’s assertion, the
`
`claimed structures of a fluid return conduit that is axially oriented along a centerof the device
`
`and a return fluid conduit that telescopes are not disclosed in any of the cited references. For
`
`these additional reasons, Applicant submits that claims 7 and 8 are allowable.
`
`With respectto claim 15, contrary to the examiner’s assertion, none of the references
`
`disclose the claimed structure of a flexible rolling bellows. For this additional reason, Applicant
`
`submits that claim15 is allowable.
`
`Claims 18-23 are rejected under 35 USC § 103(a) as obvious in view of Vilendrerin
`
`combination with Pickard and Kruseetal. (U.S. Publication No. 2003/0235804).
`
`Dependentclaims 18-23 depend upon and contain all the limitations of independent
`
`claim 17 as applicable. For at least the reasons discussed abovein connection with
`
`independentclaim 17, the Applicant respectfully submits that dependent claims 18-23 are
`
`allowable. The Applicant makesthis statement without waiving any independentbasesfor
`
`patentability in claims 18-23. The Applicant reserves the right to separately argue the
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`patentability of dependent claims 18-23 in a subsequently filed response, if necessary.
`
`With particular respect to claim 18, Applicant notes the basis for rejection cited by the
`
`examinerhaslittle or no direct relationship to the claimed structure.
`
`In fact, the argument
`
`appears to be directed to the last clause of claim 17. However, the cited passage in Kruseet al.
`
`has nothing at all to do with the compliance chamberof claim 17, muchless the furtherlimitation
`
`on the compliance chamber in claim 18. Applicant therefore submits that the examinerfailed to
`
`makea prima facie case of obviousness with respectto claim 18.
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`-12-
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`P201384.US.02
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`With particular respect to claims 22 and 23, contrary to the examiner's assertion, the
`
`cited passage in Kruse hasnothing at all to do with the material or design of a compliance
`
`chamber. For this additional reason, Applicant submits that claims 22 and 23 are allowable.
`
`Claims 24, 26, 27 and 29-31 appearto be rejected under 35 USC § 103(a) as obvious in
`
`view of Pickard in combination with Kruse et al. However, the examiner doesnotexplicitly state
`
`this as groundsfor the rejection. Applicant assumesthat this is the case becausethe only
`
`references mentionedin the detailed statements of reasons for rejection are Pickard and Kruse
`
`et al.
`
`Claims 26 and 29-31 are canceled herein. Therefore, the examiner's rejection of the
`same is moot.
`
`Dependentclaims 24 and 27 depend upon and contain all the limitations of independent
`
`claims 17 or 25 as applicable. For at least the reasons discussed above in connection with
`
`independentclaims 17 and 25, the Applicant respectfully submits that dependent claims 24 and
`
`27 are allowable. The Applicant makesthis statement without waiving any independent bases
`
`for patentability in claims 24 and 27. The Applicant reservesthe right to separately argue the
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`patentability of dependent claims 24 and 27 in a subsequentlyfiled response, if necessary.
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`Although claim 26 is canceled herein, because the elements thereof are incorporated
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`into claim 25 (addressed above), Applicant makesthe following further statements with respect
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`to Pickard and Kruseet al. which form the basis of the rejection. Applicant initially notes that
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`Pickard does notdisclose a flexible diaphragm as suggestedin the rejection. Pickard discloses
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`a pump (46)that is described as a piston pump. The differences and deficiencies of a piston
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`pump as comparedto the claimed rolling bellows diaphragm (now in claim 25) are discussed
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`above with respect to claim 25. The examinercites a passage in Kruseetal. that refers to
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`alternate types of pumpsthat could be used in the system, none of whicharerolling bellows.
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`Therefore, Applicant submits that since Pickard and Kruseetal. in combination fail to render
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`claim 26 obvious, for the same reasons the combination thereof would not render claim 25 as
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`amended obvious.
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`With respect to claim 27, Applicant submits that the argument presented by the
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`examiner based upon the cited passage in Pickard (i.e., a motor with a square shaft that rotates
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`a valve elementto provide flow restriction) has nothing atall to do with the design of the piston
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`and rolling bellows set forth in the claim. Further, as discussed abovewith respect to claim 25,
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`Kruseet al. does not disclose a rolling bellows, but instead discloses a metal bellows, which has
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`significant deficiencies in the context of providing clinically relevant test results as stated by Dr.
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`Weinberg in his declaration and as discussed above with respect to claim 25. Finally, the
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`P201384.US.02
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`combination of Kruse et al. with Pickard would defeat the purpose of Pickard. As noted byDr.
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`Weinbergin the interview, Pickard is a real-time valve function test system with a circulatory
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`loop while Kruseetal. is not interested in flow through the prosthetic device, but rather wants to
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`create a high static pressure on a single side of the valve frame for the purposeof frame
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`deformation. For these additional reasons, Applicant submits that claim 27 is allowable.
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`For these additional reasons, the Applicant requests reconsideration and withdrawalof
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`the rejection of claims 24 and 27 under 35 U.S.C. § 103.
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`Claims Not Addressed
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`Applicant notes that the examinerfails to address claims 5, 9, 14, and 16 in any wayin
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`the detailed action. However, the examiner indicates on the summary sheetthat each of these
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`claims is rejected.
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`In view of the examiner’s failure to provide a detailed rationale for the
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`rejection of these claims, Applicant submits that the examiner hasfailed to meet the burden for
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`making a prima facie case of either anticipation or obviousness with respect to any of these
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`claims. See M.P.E.P §§ 2121 & 2142. Withdrawal of the rejection for failure to meet this burden
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`is therefore requested.
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`Conclusion
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`Claims 1-25 and 27 are currently pending in the application. Applicant hasfully
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`responded to the objections and rejections in the Office action dated 3 January 2013 and
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`believes that claims 1-25 and 27 are in a condition for allowance. Applicant therefore requests
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`that a timely Notice of Allowance beissuedin this case.
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`This responseis submitted within the first month following the shortened statutory period
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`for response. Accordingly, please consider this document a petition for a one-month extension
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`of time. The appropriate fees are paid contemporaneously herewith. Applicant believes that no
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`additional fees or petitions beyond these noted are due withthis filing. However, should any
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`such fees or petitions be required, please considerthis a request therefor and authorization to
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`charge Deposit Account No. 04-1415 as necessary.
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`If the Examiner should require any additional information or amendment, please contact
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`the undersigned attorney.
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`If the Examiner believes any issues could be resolved via a
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`telephone interview, the Examineris invited to contact the undersigned at the telephone number
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`listed below.
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`P201384.US.02
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`Respectfully submitted this 10" day of May 2013
`28
`eS Ns
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` 3
`Brad J. Héftenbach, Esq.
`Registratién No. 42,642
`Customer No. 20686
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`.
`
`Ss
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`:
`=
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`SH"s
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`DORSEY & WHITNEY LLP
`1400 Wewatta Street
`Suite 400
`Denver, Colorado 80202
`303-269-3400 (TEL)
`303-269-3450 (FAX)
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