IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In Re the Application of:
`
`Inventors:
`
`Benjamin McCloskey etal.
`
`Confirmation No:
`
`Serial No.:
`
`14/523,104
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`Group Art Unit:
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`3190
`
`2855
`
`Filed:
`
`24 October 2014
`
`Examiner:
`
`Philip L. Cotey
`
`Title:
`
`FATIGUE TESTING SYSTEM
`FOR PROSTHETIC DEVICES
`
`
`DocketNo.:
`
`P201384.US.05
`
`AMENDMENTB AND RESPONSE TO OFFICE ACTION
`
`MAIL STOP AMENDMENT
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`In responseto the Office Action dated 20 March 2015, please amend the above-
`
`identified application as follows:
`
`Claim Amendments begin on page 2 of this paper.
`
`Remarks/Arguments begin on page 5 of this paper.
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`4822-5681 -6933
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`PAGE 1 OF 12
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`{
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`WATERS TECHNOLOGIES CORPORATION
`
`EXHIBIT 1007
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`WATERS TECHNOLOGIES CORPORATION
`EXHIBIT 1007
`
`PAGE 1 OF 12
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`

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`Docket No. P201384.US.05
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`CLAIM AMENDMENTS
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`The following listing of claims replacesall prior versions andlistings of claims in this
`
`application. Additional terms are presented in underline text and deleted terms areindicated in
`
`strikethreugh text or are enclosedin [[double brackets]].
`
`1.
`
`(Currently Amended) A method for operating an accelerated cyclic test system for
`
`evaluating a valved prosthetic device comprising
`
`driving a test system fluid cyclically above a normal physiological rate, at an accelerated
`
`pulsed rate of greater than 200 beats per minute within the test system:
`
`storing a volume of test system fluid in an excess volume area during a system driving
`
`stroke that opens the valved prosthetic device; and
`
`releasing the stored volume of test system fluid during a return stroke that closes the
`
`valved prosthetic device.
`
`2.
`
`(Original) The method of claim 1, wherein the excess volume area enlargesin
`
`response to a pressureon the test system fluid during the driving stroke and decreases during
`
`the return stroke.
`
`3.
`
`(Previously Presented) The method of claim 2, wherein the excess volume area
`
`provides a spring force counter to and in responseto the pressure on the test system fluid.
`
`4.
`
`(Original) The methodof claim 3 further comprising altering a spring factor of the
`
`spring force provided by the excess volume area through selection of a material forming at least
`
`a portion of a boundary of the excess volume area.
`
`5.
`
`(Original) The method of claim 4, wherein the material is an elastomeric material
`
`that expands and contracts in response to the pressure on the test system.
`
`6.
`
`(Previously Presented) The method of claim 1, further comprising compressing a
`
`volume of a compressible gas with the volume of test system fluid to provide a spring force
`
`counter to and in response to a pressureon the test system fluid when the volume oftest
`
`system fluid is stored in the excess volume area.
`
`7.
`
`(Original) The methodof claim 6 further comprising altering a spring factor of the
`
`spring force provided by the excess volume area by adjusting the volume of the compressible
`
`gas.
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`PAGE 2 OF 12
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`PAGE 2 OF 12
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`

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`Docket No. P201384.US.05
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`8.
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`(Withdrawn) A device for accelerated cyclic testing of a valved prosthetic device
`
`comprising
`
`a pressurizable test chamberfor containing test system fluid and further comprising
`
`a fluid distribution chamberpositioned on a first side of the valved prosthetic
`
`device and in fluid communication with a pressure source;
`
`a fluid return chamber positioned on a second side of the valved prosthetic
`
`device;
`
`a fluid return conduit both structurally and fluidily connecting the fluid distribution
`
`chamberto the fluid return chamber; and
`
`an excess volume areain fluid communication with the fluid return chamber
`
`providing a volume for storing a volume of a test system fluid when the test system fluid is under
`
`compression.
`
`9.
`
`(Withdrawn) The device in claim 8 further comprising
`
`a drive motor; and
`
`a fluid displacement member connected with and driven by the drive motor to provide
`
`the pressure source that increases and decreases a pressure on the test system fluid in the test
`
`chamber.
`
`10.|(Withdrawn) The device of claim 8, wherein the excess volume area enlargesin
`
`response to compression of the test system fluid and decreases during depressurization of the
`
`test system fluid.
`
`11.|(Withdrawn) The device of claim 8 further comprising an elastomeric material
`
`that forms at least a portion of a boundary of the excess volume area and that expands and
`
`contracts in response to changesin pressure on the test system fluid within the test chamber.
`
`12.
`
`(Withdrawn) The device of claim 8, wherein the excess volume area further
`
`contains a volume of a compressible gas that is compressed by the volume of the test system
`
`fluid to provide a spring force when the volume of the test system fluid is stored in the excess
`
`volume area.
`
`13.|(Withdrawn) The device of claim 8, wherein the excess volume area comprises a
`
`compliance chamber defining a cavity within the fluid return chamber.
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`PAGE 3 OF 12
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`PAGE 3 OF 12
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`

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`14.
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`(Withdrawn) The device of claim 13 further comprising an elastomeric
`
`membrane separating at least a portion of the compliance chamberfrom fluid in the fluid return
`
`chamber.
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`Docket No. P201384.US.05
`
`15.|(Withdrawn) The device of claim 13 further comprising a porous material at least
`
`partially filling the compliance chamber.
`
`16.
`
`(Withdrawn) The device of claim 13, wherein the compliance chamber provides
`
`a volume for holding a gas or elastomeric material that compresses under a pressure placed
`
`upon the test system fluid in the test chamber and allows the test system fluid in the test
`
`chamberto occupy a portion of the volume in the compliance chamber.
`
`17.|(Withdrawn) The device of claim 8, wherein
`
`the test chamberdefinesa first port on a first side of the valved prosthetic device anda
`
`second port on a second side of the valved prosthetic device; and
`
`the first port and the second port are configured to receive one or more sensor devices.
`
`18.|(Withdrawn) The device of claim 9, wherein the drive motor is configured to
`
`operate cyclically, acyclically, or a combination of both, to provide cyclic and acyclic fluid
`
`pressures within the test chamber.
`
`19.|(Withdrawn) The device of claim 9, wherein the drive motor comprisesa linear
`
`motor.
`
`20.
`
`(Withdrawn) The device of claim 9, wherein the fluid displacement member
`
`further comprisesa flexible rolling bellows connected to a shaft of the drive motor.
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`4822-5681 -6933
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`PAGE 4 OF 12
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`

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`Docket No. P201384.US.05
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`REMARKS
`
`This Responseis consideredfully responsive to the Office Action mailed 20 March 2015.
`
`Claims 1-20 are pending in the application. Claims 8-20 are withdrawn. Claims 1-7 stand
`
`rejected.
`
`In this Response, claim 1
`
`is amended. Reexamination and reconsideration are
`
`requested.
`
`Interview Summary
`
`Applicant thanks the Examiner and Supervisory Examiner Lisa Caputofor their time on 7
`
`May 2015 and participation in a telephone interview with the undersigned and Craig Weinberg,
`
`Ph.D., one of the inventors.
`
`Dr. Weinberg discussedthe differences between the invention claimed in claims 1-77
`
`and the prior art references of record, namely, Pickard and Lundell et al. Dr. Weinberg noted
`
`that Pickard discloses a “real-time” test system (e.g., operating at physiologic rates on the order
`
`of 72 beats per minute, or 1.2 Hz) for hydrodynamic performancetesting of heart valves to
`
`characterize and define their anticipated fluid mechanical performance post implantation Dr.
`
`Weinberg noted that Pickard’s disclosure is thus not an accelerated durability testing system
`
`(e.g., operating at rates 2 3.5 Hz or 200 beats/cycles per minute) like the presently claimed
`
`invention and trying to cycle the Pickard system faster would frustrate the purpose of the testit
`
`is trying to perform (i.e., characterizing valve performance in a simulated circulatory system
`
`under whichthe valve is to be used) while not being able to perform the accelerated durability
`
`weartesting of the claimed invention. Dr. Weinberg also discussed the different purpose of
`
`system compliance betweenthe claimed durability test system and the hydrodynamic
`
`performance system of Pickard. Dr. Weinberg noted that in the Pickard system, complianceis
`
`used to shape the systemic pressure waveform and modify the systemic pressures to mimic the
`
`responseofthe circulatory system distensiblity (e.g., arterial vascular compliance) and create a
`
`physiological relevant environmentto characterize the prosthetic heart valve performance.
`
`In
`
`contrast, Dr. Weinberg noted the purposeof the excess volume area as claimed in the method
`
`of independent claim 1
`
`is to prevent or minimize the kinetic energy of fluid flow generated by the
`
`system driver from translating into high static fluid pressure in the test system during the
`
`accelerated frequencytesting.
`
`The Examiner expressed concern that the term “accelerated” in the preamble of claim 1
`
`wasinsufficient to differentiate the types of test systems disclosedin the cited prior art from the
`
`test system in which the claimed method operates. While Applicant disagreed with this
`
`analysis, the Applicant and Examiner discussed possible amendmentsto provide the clarity
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`4822-5681 -6933
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`PAGE 5 OF 12
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`Docket No. P201384.US.05
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`sought by the Examiner. Applicant noted that the ISO 5840 Standard provides guidelines for
`
`the accelerated durability testing of heart valves and that the industry(i.e., a person of ordinary
`
`skill in the art) recognizes an “accelerated” valve test system to mean a system that cycles
`
`faster than a normal physiological rate.
`
`It was discussed that the typical upper end of a normal
`
`physiological rate is above 200 beats per minute. The Examiner agreedthat a limitation
`
`describing the system environment as being greater than 200 beats per minute would be
`
`sufficient to address this concern with the claim.
`
`Continuation Application
`
`Applicant asserts that no argumentsor disclaimers made in the parent application no.
`
`12/718,316 apply to this continuation/divisional application and, consequently, it is asked that
`
`the Examiner review the present set of claims in view of all of the prior art of record and any
`
`search that he deems appropriate. Applicant presumes the Examiner has consideredthe file
`
`history in parent application no. 12/718,316 and has determined anyrejections therein not
`
`expressly madein the prosecution of the present application to be immaterial to the present
`
`application.
`
`Rejections Under 35 U.S.C. §102
`
`The Examiner has rejected claims 1-3 and 6-7 under 35 U.S.C. §102(b) as being
`
`anticipated by Pickard (U.S. Patent No. 4,682,491). Applicant respectfully traversesthis
`
`rejection for at least the following reasons.
`
`Pickard discloses a system and methodfor testing heart valves “prior to implant in the
`
`human body” as a “mockcirculatory loop.” (See Pickard, Abstract.) Pickard states that “the
`
`presentinvention is particularly useful for mimicking the humancirculatory system so that a
`
`heart valve may be placed therein, tested and observed for determining the suitability of the
`
`valve for actual implantation.” (See, Pickard, 1:9-14.) Pickard “seeks to provide a mechanical
`
`analog for the humancirculatory system, including the heart, arteries, veins and capillaries so
`
`that a prosthetic valve may be tested and observedprior to use in the human body.” (Pickard
`
`7:8-13; see also 3:9-57.) Thus, Pickard discloses a system and related methodologiesfor real-
`
`time testing of cardiac valves to examine fluid mechanical performancein a facsimile circulatory
`
`system, not a method in an accelerated system as claimed for the purposes of evaluating leaflet
`
`wear and implant durability over hundredsof millions of cycles in the expectedlifetime of a
`
`valve.
`
`As is well knownto persons of ordinary skill in the art of cardiac valve testing, real-time
`
`and accelerated testing have completely different requirements and use completely different
`
`4822-5681 -6933
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`PAGE6 OF 12
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`Docket No. P201384.US.05
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`methodologies for testing. For example, in Section 6.2.1 of the ISO 5840 Standard, Table 1
`
`specifies the “physiological parameters of the intended patient population” including the “Heart
`
`Rate: 30 beats/min to 200 beats/min.” These parameters define the physiological conditions of
`
`operation of heart valve devicesfor the intended patient population.
`
`6.2.4 Operational specifications
`
`
`
`
`& of operation,
`
`5 iteris
`:
`
`far heert
`
`Table i—Heart vaive substitute operational environment
`
`
`Parameter Description
`
`Sunraunding Medan:
`
`Temperature:
`
`Heari rate:
`30 berts/irun to SOO beatsATin
`
`Canes autogt 3 Yimin io $5 rain
`
`Strake volume:
`
` AartAgs
`mm Ha
`
`ram Ho
`Normofansive
`780 fo f36
`8S te 8S
`gh
`TES
`
`
`Hypoternsive
`
`ao
`
`40
`
`50
`
`8a
`
`
`340 to $58
`30 to 88
`Y23
`
`
`
`
`
`
`
`
`
`
`400 fa FOS
`
`#38
`
`VEOfa
`{55
`as
`
`Stage 4 ivery severe:
`~ BT8
`S320
`BS
`2
`TAXHTUN
`380
`60
`2a
`3a0
`Extreme
`pressure
`2 cyele}
`
`
`ANSI/AMMI/ISO 5840, “Cardiovascular Implants—Cardiac valve prostheses,” American National
`
`StandardsInstitute, Inc. (2005).
`
`Section 7.2.4.2 of ISO 5840 specifically discusses the numberof anticipated test cycles
`
`i.e., at least 400 million cycles for stiff or artificial valve leaflets or at least 200 million cycles for
`
`tissue valve leaflets, for durability testing. An excerpt is presented below.
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`4822-5681 -6933
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`Docket No. P201384.US.05
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`7.242 Bevice durability assessment
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`An assessment of the durability of tha fwert valve subsituiets) shall be pariarmmed in amer to ASSESS enminuead
`
`funclon over a reasonable ifiefime. Unless the labeding for a particular devine includes an exidicd siatemant
`about
`anicigated ay vivo device hfetime, festing shall be performed te demonstrate reasanahle assurance that ng
`2g
`yalve substitutes will remain functional far 400 milfion cycles and that flexible heart valve subsittules wil remam
`
`functional for 200 onion cyches. i te iabeding for a particular device inchudasan explicit stakement about anticipeted
`a2 wo devine Hetioe, lasting shall be gperormed fo supoor the tabeling claim.
`
`
`Testing shall be performed on at least three eachof the largest, medium, and smadiest sizes of each type (acrtic and
`mitral) of heayi valve subsiffule. One squivalant size reference valve shall be tested under identical conditions for
`euch valve sine iasied.
`
`Tests shall be paromedat a defined diflerantial pressure consistant with normotensive conditions specified in: Table
`Yt. Dunng the “durability testing,
`the definad target peak dlfereniial pressure across the closed valve shall be
`
`
`mantianied far 95 % of more of all ihe bast cycles.
`Each fest valve shai excerence a differanial pressure equal tou
`
`
`
`greater ihan the defined cifferential pressure
`o OF ye of ihe curation of each cyck:. Hf seric and mitral heart
`Vvahe suoshtiv]es ara identical
`
`for the sewing cuff, festing need onfy be performed under ths
`in design exeoapt
`differential pressure comaitions defined for the mitral valve.
`‘
`iyche rates used for accelerated and quasi-rest time Bunabilly testing should be jusifned fram the resulis of the ask
`
`analysis. Morsidaration should be given to the behaviar of time-dependentmateviais when selecting and justifying
`apprognate cycle rates.
`
`Id.
`
`If such cycle testing for durability were performed at normal heart rates, the testing would
`
`take between 6 and 12 years. Moreover,the third paragraph demonstrates there are no
`
`requirements on the pressure waveform shapeduring testing, to wit: “Each test valve shall
`
`experience a differential pressure equal to or greater than the defined differential pressure for
`
`5% or more duration of the cycle.” Therefore the waveform shapeis not intended to be
`
`physiological, rather it simply has to meetthis requirement for differential pressure loading and
`
`thus is not designed to mimic the circulatory system asis the goal in Pickard. The 4th
`
`paragraph of this section demonstrates that the term ‘accelerated’ is common vernacularto
`
`those versed in the art of heart valve development and testing and, sinceit will need to be
`
`‘justified,’ it assumesthat it is within a condition that is not standard physiological conditions.
`
`Additionally, ISO 5840, Annex L, describes the requirements for real-time test systems
`
`(e.g., the Pickard system) and defines that testing should be conductedin a “pulse duplicator
`
`that produces pressures and flow waveforms that approximate physiological conditions....” Id.
`
`Notably, this is not a requirement for durability testing as set forth in ISO 5840, Annex M. Id.
`
`Thus, while the conceptof using a compliance chamberto store excess volume oftest
`
`fluid in a real-time, physiologically accurate, cardiac valve test system is well knownfor the
`
`purpose of substituting for the arteries of the humancirculatory system (in fact, complianceis
`
`required by ISO 5840 in Annex L and detailed guidelines for compliant chambers are provided
`
`in Annex F), a method in an accelerated cyclic test system that uses an excess volume area is
`
`entirely new. As described in the specification of this application, “the compliance chambers
`
`135 assist in minimizing the effects of large and quickly changing pressure gradients(i.e.,
`
`pressure loading or pressure spikes) across test samples 130 placed within the test chamber
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`Docket No. P201384.US.05
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`106.” (See, § 0061.)
`
`In methodologies of prior commercial accelerated test systems, there were
`
`no specific design elements or system features to address this phenomenon of pressurespikes,
`
`which weretherefore viewed as an accepted drawbackassociated with testing at accelerated
`
`rates. As described in the present application, the compliance chamber may also be usedto
`
`fine-tune the pressure gradient across the valve sample being tested. The prior art of record
`
`fails to teach the claimed methodin the context of an accelerated cyclic test system. None of
`
`these concerns, goals, or solutions addressed and achievedby the claimed method are
`
`contemplated or recognized in the prior art of record. Thus, Pickard cannot be held to anticipate
`
`the invention of claim 1 because a method performed within an accelerated cyclic test system
`
`was not even a consideration in the context of the disclosure of Pickard.
`
`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., ~1.2 Hz) valve performancetest
`
`system. However, it has significant drawbacksin the context of an accelerated test system
`
`such as claimed in claim 1. For example, recall the ISO 5840 standard requirement that the
`
`valved prostheses be loaded through 200,000,000test cycles for biologic prosthesesor
`
`400,000,000 test cycles for synthetic prostheses. This extremely high cycle requirement
`
`prohibits the use of a standard 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. (See
`
`Declaration of Craig Weinberg, Ph.D., 4 10.)
`
`(Note: This declaration was submitted during the
`
`prosecution of the parent application to this continuation application.) Further, the friction
`
`caused bythe interference between the piston, seal, and chamber generate heat within the test
`
`system and additional wear on the components anddriver (Id.).
`
`Dependentclaims 2, 3, 6, and 7 depend upon and contain all the limitations of
`
`independent claim 1. For at least the reasons discussed abovein connection with independent
`
`claim 1, the Applicant respectfully submits that dependentclaims 2, 3, 6, and 7 are allowable.
`
`The Applicant makes this statement without waiving any independent basesfor patentability in
`
`claims 2, 3, 6, and 7. The Applicant reserves the right to separately argue the patentability of
`
`dependent claims 2, 3, 6, and 7 in a subsequently filed response, if necessary.
`
`The Applicant therefore requests reconsideration and withdrawalof the rejection of
`
`claims 1-3, 6, and 7 under 35 U.S.C. § 102.
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`Docket No. P201384.US.05
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`Rejections Under 35 U.S.C. §103
`
`The Examiner has rejected claims 4 and 5 under 35 U.S.C. §103(a) as being
`
`unpatentable over Pickard, in view of Lundell et al. (U.S. Publication No. 2002/0116054 A1).
`
`Applicant respectfully traverses the rejection.
`
`Initially, Applicant asserts that dependentclaims 4 and 5 depend upon and contain all
`
`the limitations of independent claim 1. For at least the reasons discussed abovein connection
`
`with independent claim 1, the Applicant respectfully submits that dependentclaims 4 and 5 are
`
`allowable. The Applicant makes this statement without waiving any independent basesfor
`
`patentability in claims 4 and 5.
`
`As noted, the deficiencies of Pickard with respect to claim 1 are equally applicable to
`
`claims 4 and 5 which depend therefrom. Lundell et al. fails to remedy the deficiencies of
`
`Pickard. Lundell et al. also discloses a real time system (e.g., 50 to 120 bom; see Lundell et al.,
`
`{ 0109) for testing medical devices “to more closely approximate natural biological conditions in
`
`which pulsedflow circulatesfluid... without use of a pump that directly applies pulsatile forces to
`
`the fluid.” (Lundell et al., § 0044.) “Conditions in the flow system can be adjusted to mimic the
`
`conditions in a patient’s cardiovascular system... [and] can also be usedto test and evaluate
`
`cell attachment andproliferation in association with a prosthesis or cell culture support matrix.”
`
`(See Lundell et al., ¢ 0047; see also J 0052 (“pulsed flow similar to in vivo conditions”).) Lundell
`
`et al. is thus not an accelerated testing system (e.g., cycles >= 2.5 Hz)like the presently claimed
`
`invention. Cycling the Lundell et al. system faster would frustrate the purposeofthe testit is
`
`trying to perform (i.e., “circulating blood, cell culture medium or otherfluids containing viable
`
`cells...for seeding biocompatible materials with viable cells...to produce prostheses with
`
`associated cells”; see Lundell et al., § 0046) while not being able to perform the accelerated
`
`durability wear testing of the claimed invention.
`
`The design shownin Figs. 12 and 13 of Lundell et al. depicts a test system using a
`
`shakertable to provide translational motion of fluid (110) across the valves (264, 266) in tubes
`
`(252, 254). The ends of the tubes are connectedto reservoirs (256, 258), which, in one
`
`embodiment, may expand and contract to accommodate changing fluid volume asthe fluid
`
`movesfrom one side of the valves to the other.
`
`In this embodiment, the reservoirs must be able
`
`to accommodatethis excess volume because one of the valves will be closed depending upon
`
`direction of the movementof the system and the fluid will back up behind it.
`
`The device of Lundell et al. cannot have a “driving stroke”or “return stroke” as required
`
`by claim 1 because Lundell et al. expressly disavowsuse of a pulsatile pump after describing
`
`problems with such a pump for its real-time physiologic testing purposes. (See Lundell et al.,
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`Docket No. P201384.US.05
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`{ 0044 (“standard pulsed pumpstend to damage cells”).) The embodimentidentified by the
`
`examiner uses, as noted, a shaker table to mechanically translate fluid flow from one side of the
`
`device to the other.
`
`In general, Lundell et al. states that it causes flow by moving the test
`
`system with respectto the fluid within the system (i.e., it uses a “swashplate” or a “shakertable”)
`
`or it uses a constant flow pump.
`
`In contrast, the claimed method expressly operates by driving
`
`a pulsed flow with a driving stroke and a return stroke.
`
`Further, the combination of Lundell with Pickard et al. is improper and the purported
`
`motivation to combine is fallacious. Pickard expressly requires a pulsatile pump. Lundell et al.
`
`expressly disavowsthe use of a pulsatile pump. Thus, there would be no motivation
`
`whatsoever to attempt to achieve “laminar flow” in Pickard as argued by the Examiner. Laminar
`
`flow would only be achievable by using the swash plate or shaker table of Lundell et al.
`
`The purposeof the excess volume areas(i.e., compliance chamber(s)) as claimed in the
`
`method of independentclaim 1
`
`is “to act as a resilient spring force to dampen the effects of
`
`large, quickly changing pressure gradients within the test chamber”in the test system during the
`
`accelerated frequency testing. (See Specification, 0046.) As with Pickard, this is not an issue
`
`considered by Lundell et al. nor do the reservoirs (256, 258) provide such a function. The
`
`reservoirs merely allow fluid to continue to flow across the open test valve whenthe fluid head
`
`encounters the closed opposing test closed test valve in the system. There is no teaching in
`
`Lundell et al. of using the reservoirs to alter a spring factor of the spring force provided by the
`
`compliance chamber asrecited in claim 4.
`
`The Applicant therefore requests reconsideration and withdrawal of the rejection of
`
`claims # under 35 U.S.C. § 103.
`
`Conclusion
`
`Claims 1-20 are currently pending in the application; claims 8-20 are presently
`
`withdrawn. Applicant has fully responded to each and every objection and rejection in the Office
`
`action dated 20 March 2015, and believes that claims 1-7 are in condition for allowance.
`
`Applicant therefore requests that a timely Notice of Allowance beissued in this case.
`
`The Applicant believes no otherfees or petitions are due with this filing. However,
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`should any suchfeesor petitions be required, please consider this a request therefor and
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`authorization to charge Deposit Account No. 04-1415 as necessary.
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`If the Examiner believes any issues could be resolved via a telephone interview, the
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`Examiner is invited to contact the undersigned at the telephone numberlisted below.
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`4822-5681-6933
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`Respectfully submitted this 17th day of June 2015 by
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`Docket No. P201384.US.05
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`
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`USPTO Customer No. 20686
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`Dorsey & Whitney LLP
`1400 Wewatta St., Suite 400
`Denver, Colorado 80202
`Tel: 303-629-3400
`Fax: 303-629-3450
`
`4822-5681 -6933
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