`
`In Re the Application of:
`
`Inventors:
`
`Benjamin McCloskey etal.
`
`Confirmation No:
`
`3190
`
`Serial No.:
`
`14/523,104
`
`Group Art Unit:
`
`2855
`
`Filed:
`
`24 October 2014
`
`Examiner:
`
`Philip L. Cotey
`
`Title:
`
`FATIGUE TESTING SYSTEM
`FOR PROSTHETIC DEVICES
`
`
`Docket No.:
`
`P201384.US.05
`
`AMENDMENT B AND RESPONSE TO OFFICE ACTION
`
`MAIL STOP AMENDMENT
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`In response to 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.
`
`4822-5681-6933
`
`1
`
`PAGE 1 OF 12
`
`WATERS TECHNOLOGIES CORPORATION
`
`EXHIBIT 1007
`
`WATERS TECHNOLOGIES CORPORATION
`EXHIBIT 1007
`
`PAGE 1 OF 12
`
`
`
`Docket No. P201384.US.05
`
`CLAIM AMENDMENTS
`
`The following listing of claims replaces all prior versions and listings of claims in this
`
`application. Additional terms are presented in underline text and deleted terms are indicated in
`
`strikethreugh text or are enclosed in [[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 enlarges in
`
`response to a pressure on 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 response to the pressure on the test system fluid.
`
`4.
`
`(Original) The method of 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 pressure on the test system fluid when the volume of test
`
`system fluid is stored in the excess volume area.
`
`7.
`
`(Original) The method of 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.
`
`4822-5681-6933
`
`PAGE 2 OF 12
`
`PAGE 2 OF 12
`
`
`
`Docket No. P201384.US.05
`
`8.
`
`(Withdrawn) A device for accelerated cyclic testing of a valved prosthetic device
`
`comprising
`
`a pressurizable test chamber for containing test system fluid and further comprising
`
`a fluid distribution chamber positioned 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
`
`chamber to the fluid return chamber; and
`
`an excess volume area in 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 enlarges in
`
`response to compression of the test system fluid and decreases during depressurization of the
`
`test system fluid.
`
`1 1.
`
`(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 changes in 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.
`
`4822-5681-6933
`
`PAGE 3 OF 12
`
`PAGE 3 OF 12
`
`
`
`Docket No. P201384.US.05
`
`14.
`
`(Withdrawn) The device of claim 13 further comprising an elastomeric
`
`membrane separating at least a portion of the compliance chamber from fluid in the fluid return
`
`chamber.
`
`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
`
`chamber to occupy a portion of the volume in the compliance chamber.
`
`17.
`
`(Withdrawn) The device of claim 8, wherein
`
`the test chamber defines a first port on a first side of the valved prosthetic device and a
`
`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 comprises a linear
`
`motor.
`
`20.
`
`(Withdrawn) The device of claim 9, wherein the fluid displacement member
`
`further comprises a flexible rolling bellows connected to a shaft of the drive motor.
`
`4822-5681-6933
`
`PAGE 4 OF 12
`
`PAGE 4 OF 12
`
`
`
`Docket No. P201384.US.05
`
`REMARKS
`
`This Response is considered fully 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 Caputo for 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 discussed the differences between the invention claimed in claims 1-77
`
`and the prior art references of record, namely, Pickard and Lundell et aI. 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 performance testing 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 test it
`
`is trying to perform (i.e., characterizing valve performance in a simulated circulatory system
`
`under which the valve is to be used) while not being able to perform the accelerated durability
`
`wear testing of the claimed invention. Dr. Weinberg also discussed the different purpose of
`
`system compliance between the claimed durability test system and the hydrodynamic
`
`performance system of Pickard. Dr. Weinberg noted that in the Pickard system, compliance is
`
`used to shape the systemic pressure waveform and modify the systemic pressures to mimic the
`
`response of the circulatory system distensiblity (e.g., arterial vascular compliance) and create a
`
`physiological relevant environment to characterize the prosthetic heart valve performance.
`
`In
`
`contrast, Dr. Weinberg noted the purpose of 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 frequency testing.
`
`The Examiner expressed concern that the term “accelerated” in the preamble of claim 1
`
`was insufficient to differentiate the types of test systems disclosed in 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 amendments to provide the clarity
`
`4822-5681-6933
`
`PAGE 5 OF 12
`
`PAGE 5 OF 12
`
`
`
`Docket No. P201384.US.05
`
`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 (Le, 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 agreed that 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 arguments or 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 considered the file
`
`history in parent application no. 12/718,316 and has determined any rejections therein not
`
`expressly made in 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 traverses this
`
`rejection for at least the following reasons.
`
`Pickard discloses a system and method for testing heart valves “prior to implant in the
`
`human body” as a “mock circulatory loop.” (See Pickard, Abstract.) Pickard states that “the
`
`present invention is particularly useful for mimicking the human circulatory 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 human circulatory system, including the heart, arteries, veins and capillaries so
`
`that a prosthetic valve may be tested and observed prior to use in the human body.” (Pickard
`
`7:8-13; see also 3:9-57.) Thus, Pickard discloses a system and related methodologies for real-
`
`time testing of cardiac valves to examine fluid mechanical performance in a facsimile circulatory
`
`system, not a method in an accelerated system as claimed for the purposes of evaluating leaflet
`
`wear and implant durability over hundreds of millions of cycles in the expected lifetime of a
`
`valve.
`
`As is well known to 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
`
`PAGE 6 OF 12
`
`PAGE 6 OF 12
`
`
`
`Docket No. P201384.US.05
`
`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 devices for the intended patient population.
`
`5.2.1 Operationalspecifications
`
`
`
`Table 1—Heart valve substitute operational environment
`
`Pa ra m eter Description
`
`
`1g the pri
`nment if? \v
`
`
`
`Surrounding medium:
`
`
`
`Temperature:
`
`Heart rate:
`38 Enema-him to 23$} Seatsvtmiri
`
`
`Ceres-ac eutput: 3 sfmiz‘i to {5 limit}
`
`Sistine L-‘alume:
`
`
`Differential pressur
`
`
`
`
`
`
`
`
`
`
`
`Aorta: 3,3,,
`mm Hg
`
`83
`
`'35
`
`{3:3
`
`3.0
`
`5i:
`
`CC:
`
`
`MB is: ti:
`5‘38 to 99
`323.
`
`
`
`‘lGGte list?
`
`338
`
`Extreme
`presmre
`
`'3 iii i=1
`
`>
`
`163
`
`3'35
`
`:03
`
`2:; ‘~
`
`35
`
`2":
`
`SJC
`
`ANSI/AMMl/ISO 5840, “Cardiovascular Implants—Cardiac valve prostheses,” American National
`
`Standards Institute, Inc. (2005).
`
`Section 7.2.4.2 of ISO 5840 specifically discusses the number of 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.
`
`4822-5681-6933
`
`PAGE 7 OF 12
`
`PAGE 7 OF 12
`
`
`
`Docket No. P201384.US.05
`
`TEA? Device durability assessment
`
`An 55855551551: oi“ the durability of the head wisesub:‘t’i‘iuteis‘ shaii be perftiimiad in 5839i :0 555555 minimum
`fusribiien 055'!” 5 reesonabie iifetime Unieszs the:5:351:85: for 5 {iaiiicu-rl.5: deal-rim isnciudas 5i? exrilib‘l‘1 state-nicer
`'
`'
`
`.
`anticipated ii:- Vii-'5 device iifetiiiie, testing: ghali be meriormed :5 denierstrata 55536:ebie assurance the: rig
`waive gubetitute5 wiii remain funrtonal f9: 43% miiiien (235355 and :he: tiexibie heed Vaisre substiiiiteg wisii remain
`
`f:initioriai f0? 2203 mi!iim cycles. itmeeiaiweii
`~' far a Liam-2:315 r device inciudee en explicit etaiemen: about flnfiClflatefi
`is.i‘in iiéiiii:25e‘liieti'me testing shat: be pars‘mn'ieij is flipper: tha- iateiiziig iiiaim.
`
`
`T55~mg shaiihe5 , perfmned m ail-5551:3555 555i": 5:»? the iaigesat medi um and 5n51i395:5i:5-=5f east.h:3~55 {afflict am
`mitral‘ 0: heart val 55 \bbk‘itituie One equiv:aient size r5ieiei1ce wise siiaii D5:esteiij(rider identical imediums far
`
`each ualv5size , ed.
`
`Tests; 5iiali be Qe-rs'nmiedi at a defined difierenhei priesisure corisisiieist with nermmensi‘oie conditieiss Specified iris Tabs-e
`i. Diiiim the duiabiiiisi ”53*:ng the defin5d tan 5: peak difierentiai {3:855:55 acmss :he dissed val-ire 5ha§l be
`
`
`maint-ais‘ied f5: 55 ‘tfn er more of aii :he test 0;
`'
`'
`ach :55: 555:9 shaii e erienm a d=iff5r5ntiei ’prezssui‘e equai to (is
`
`
`
`greater than the defined diffiei'ezntiai pressure
`3: er aware of the dun-3
`n at each cyci5 if mitts and ii "
`' heart
`Veiire stitisfimteis 555 ideizticei
`in d55§gn 5x55
`:5; it:5. 55iwii‘g cuff testing need minis-r be peifm‘nes'i under the
`
`differientiai pressure mnditima 555555 for the mitmi mice
`
`i.g:5 rates used for ac:eieiated a:d quasi res:it time 55:55: :esstizi1g Eéhtflilij be justified free~.~'i :he resuit: 5f :335 3133':
`
`anal:~y“1_ {_03:55:5er; Sammie be given :c- the b5haVi.r {if nmaieisondertiatiina.3 when Qalecrm andsizu.etif'gii1g
`aggirsoimate £15535 53:55
`
`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 shape during 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 shape is not intended to be
`
`physiological, rather it simply has to meet this requirement for differential pressure loading and
`
`thus is not designed to mimic the circulatory system as is the goal in Pickard. The 4th
`
`paragraph of this section demonstrates that the term ‘accelerated’ is common vernacular to
`
`those versed in the art of heart valve development and testing and, since it will need to be
`
`‘justified,’ it assumes that 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 conducted in 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 concept of using a compliance chamber to store excess volume of test
`
`fluid in a real-time, physiologically accurate, cardiac valve test system is well known for the
`
`purpose of substituting for the arteries of the human circulatory system (in fact, compliance is
`
`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
`
`4822-5681-6933
`
`PAGE 8 OF 12
`
`PAGE 8 OF 12
`
`
`
`Docket No. P201384.US.05
`
`106.” (See, 11 0061.)
`
`In methodologies of prior commercial accelerated test systems, there were
`
`no specific design elements or system features to address this phenomenon of pressure spikes,
`
`which were therefore viewed as an accepted drawback associated with testing at accelerated
`
`rates. As described in the present application, the compliance chamber may also be used to
`
`fine-tune the pressure gradient across the valve sample being tested. The prior art of record
`
`fails to teach the claimed method in the context of an accelerated cyclic test system. None of
`
`these concerns, goals, or solutions addressed and achieved by 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 adequate for a real-time (i.e., ~1.2 Hz) valve performance test
`
`system. However, it has significant drawbacks in 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 200,000,000 test cycles for biologic prostheses or
`
`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., 11 10.)
`
`(Note: This declaration was submitted during the
`
`prosecution of the parent application to this continuation application.) 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 (ld.).
`
`Dependent claims 2, 3, 6, and 7 depend upon and contain all the limitations of
`
`independent claim 1. For at least the reasons discussed above in connection with independent
`
`claim 1, the Applicant respectfully submits that dependent claims 2, 3, 6, and 7 are allowable.
`
`The Applicant makes this statement without waiving any independent bases for 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 withdrawal of the rejection of
`
`claims 1-3, 6, and 7 under 35 U.S.C. § 102.
`
`4822-5681-6933
`
`PAGE 9 OF 12
`
`PAGE 9 OF 12
`
`
`
`Docket No. P201384.US.05
`
`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 dependent claims 4 and 5 depend upon and contain all
`
`the limitations of independent claim 1. For at least the reasons discussed above in connection
`
`with independent claim 1, the Applicant respectfully submits that dependent claims 4 and 5 are
`
`allowable. The Applicant makes this statement without waiving any independent bases for
`
`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 bpm; see Lundell et al.,
`
`11 0109) for testing medical devices “to more closely approximate natural biological conditions in
`
`which pulsed flow circulates fluid... without use of a pump that directly applies pulsatile forces to
`
`the fluid.” (Lundell et al., 11 0044.) “Conditions in the flow system can be adjusted to mimic the
`
`conditions in a patient’s cardiovascular system... [and] can also be used to test and evaluate
`
`cell attachment and proliferation in association with a prosthesis or cell culture support matrix.”
`
`(See Lundell et al., 11 0047; see also 11 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 purpose of the test it is
`
`trying to perform (i.e., “circulating blood, cell culture medium or other fluids containing viable
`
`cells...for seeding biocompatible materials with viable cells...to produce prostheses with
`
`associated cells”; see Lundell et al., 11 0046) while not being able to perform the accelerated
`
`durability wear testing of the claimed invention.
`
`The design shown in Figs. 12 and 13 of Lundell et al. depicts a test system using a
`
`shaker table to provide translational motion of fluid (110) across the valves (264, 266) in tubes
`
`(252, 254). The ends of the tubes are connected to reservoirs (256, 258), which, in one
`
`embodiment, may expand and contract to accommodate changing fluid volume as the fluid
`
`moves from one side of the valves to the other.
`
`In this embodiment, the reservoirs must be able
`
`to accommodate this excess volume because one of the valves will be closed depending upon
`
`direction of the movement of 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 disavows use of a pulsatile pump after describing
`
`problems with such a pump for its real-time physiologic testing purposes. (See Lundell et al.,
`
`4822-5681-6933
`
`PAGE 10 OF 12
`
`1 0
`
`PAGE 10 OF 12
`
`
`
`Docket No. P201384.US.05
`
`11 0044 (“standard pulsed pumps tend to damage cells”).) The embodiment identified 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 aI. states that it causes flow by moving the test
`
`system with respect to the fluid within the system (i.e., it uses a “swashplate” or a “shaker table”)
`
`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 fa||acious. Pickard expressly requires a pulsatile pump. Lundell et aI.
`
`expressly disavows the 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 purpose of the excess volume areas (i.e., compliance chamber(s)) as claimed in the
`
`method of independent claim 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, 10046.) As with Pickard, this is not an issue
`
`considered by Lundell et aI. nor do the reservoirs (256, 258) provide such a function. The
`
`reservoirs merely allow fluid to continue to flow across the open test valve when the 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 as recited 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 be issued in this case.
`
`The Applicant believes no other fees or petitions are due with this filing. However,
`
`should any such fees or petitions be required, please consider this a request therefor and
`
`authorization to charge Deposit Account No. 04-1415 as necessary.
`
`If the Examiner believes any issues could be resolved via a telephone interview, the
`
`Examiner is invited to contact the undersigned at the telephone number listed below.
`
`4822-5681-6933
`
`PAGE 11 OF 12
`
`1 1
`
`PAGE 11 OF 12
`
`
`
`Respectfully submitted this 17th day of June 2015 by
`
`Docket No. P201384.US.05
`
`
`
`Brad' J. Hesttes'nhach
`Registratiér—‘i‘ No. 42,642
`USPTO Customer No. 20686
`
`Dorsey & Whitney LLP
`1400 Wewatta St., Suite 400
`Denver, Colorado 80202
`Tel: 303-629-3400
`Fax: 303-629-3450
`
`4822-5681-6933
`
`PAGE 12 OF 12
`
`1 2
`
`PAGE 12 OF 12
`
`