Ex Parte Kerkhoffs et al

Patent Trial and Appeal Board

Feb 25, 2019

14017505 (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/017,505 09/04/2013 Wolfgang Kerkhoffs
89554 7590 02/27/2019
Christopher & Weisberg, P.A.
1232 N. University Drive
Plantation, FL 33322
UNITED ST A TES OF AMERICA
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
21819J-2040U-C00016893.US 2103
EXAMINER
LEE, ERICA SHENG KAI
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
02/27/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ptomail@cwiplaw.com
rs.patents.five@medtronic.com
cwdocketing@cardinal-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WOLFGANG KERKHOFFS, OLIVER MARSEILLE,
MICHAEL MARTIN, ROBERT C. FARNAN,
JOHN P. BUDRIS, and J. CHRISTOPHER FLAHERTY
(APPLICANT: CircuLite, Inc.)
Appeal2017-009461
Application 14/017 ,505 1
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 30, 34, 36, 38-
46, and 49-53 (Br. 3). Examiner entered rejections under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify "Medtronic plc. CircuLite, Inc." as the real party in
interest (Appellants' January 3, 2017 Appeal Brief("Br.") 1).
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Application 14/017,505
STATEMENT OF THE CASE
Appellants' disclosure relates "to device and methods for assisting in
the conduction of bodily fluids such as blood" (Spec. ,r 3). Appellants'
independent claims 30, 36, 38, 42, 46, and 50 are representative and
reproduced below:
30. A blood flow system for a patient comprising:
a fluid drive module comprising:
a housing defining a chamber;
an inlet port, the inlet port being adapted to be in
fluid communication with the chamber;
an outlet port, the outlet port being adapted to be in
fluid communication with the chamber;
a rotatable fluid drive element within the chamber,
the fluid drive element configured to move the fluid; and
a motor connected to the fluid drive element, the
motor being configured to rotate the fluid drive element;
and
a control module operably coupled to the motor, the
control module configured to operate the fluid drive module by
controlling a rotational speed of the fluid drive element;
wherein the control module operates the fluid drive
element in a continuous series of changing speeds, the
continuous series of changing speeds including a first speed for
a first time period, the first speed generating a first speed flow
pattern comprising one or more first speed flow parameters, a
second speed for a second time period, the second speed being
constructed and arranged to modify one or more of the first
speed flow parameters, and a third speed for a third time period,
the third speed being constructed and arranged to modify one or
more of the first speed flow parameters; and
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wherein the control module is configured to analyze the
one or more first speed flow parameters and determine whether
to modify the speed of the fluid drive element.
(Br. 24--25.)
36. A blood flow system for a patient comprising:
a fluid drive module comprising:
a housing defining a chamber;
an inlet port, the inlet port being adapted to be in fluid
communication with the chamber;
an outlet port, the outlet port being adapted to be in fluid
communication with the chamber;
a rotatable fluid drive element within the chamber, the
fluid drive element configured to move the fluid; and
a motor connected to the fluid drive element, the motor
being configured to rotate the fluid drive element;
a control module operably coupled to the motor, the
control module configured to operate the fluid drive module by
controlling a rotational speed of the fluid drive element; and
one or more sensors connected to the control module, the
sensors configured to measure a flow parameter;
wherein the control module is configured to:
analyze any previously recorded undesired flow
conditions;
if a previous undesired flow condition has not been
detected, modify the speed of the fluid drive element to a first
speed profile; and
if a previous undesired flow condition has been detected,
modify the speed of the fluid drive element to a second speed
profile, wherein the second speed profile is different than the
first speed profile.
(Id. at 25-26.)
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38. A blood flow system for a patient comprising:
a fluid drive module comprising:
a housing defining a chamber;
an inlet port, the inlet port being adapted to be in fluid
communication with the chamber;
an outlet port, the outlet port being adapted to be in fluid
communication with the chamber;
a rotatable fluid drive element within the chamber, the
fluid drive element configured to move the fluid; and
a motor connected to the fluid drive element, the motor
being configured to rotate the fluid drive element;
a control module operably coupled to the motor, the
control module configured to operate the fluid drive module by
controlling a rotational speed of the fluid drive element and to
collect quantitative and/or qualitative flow data when the fluid
drive element is being operated; and
wherein the control module is configured to average the
data over a first time interval and a second time interval,
compare the averaged data from the first and second time
intervals to produce a result, compare the result to a threshold,
and, if the comparison of the result to the threshold is
unacceptable, perform a modification of the speed of the fluid
drive element.
(Id. at 26-27.)
42. A method for operating a blood flow system for a patient,
the system comprising a fluid drive module, the fluid drive
module comprising a housing defining a chamber, an inlet port,
an outlet port, a rotatable fluid drive element within the
chamber, and a motor connected to the fluid drive element, and
a control module configured to operate the fluid drive module,
the method comprising:
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operating the fluid drive element in a continuous series of
changing speeds, wherein the continuous series of changing
speeds includes repeated sets of speeds.
(Id. at 28 (emphasis added).)
46. A method for operating a blood flow system for a patient,
the system comprising a fluid drive module, the fluid drive
module comprising a housing defining a chamber, an inlet port,
an outlet port, a rotatable fluid drive element within the
chamber, and a motor connected to the fluid drive element, a
control module configured to operate the fluid drive module,
and one or more sensors in communication with the control
module, the sensors configured to measure a flow parameter,
the method comprising:
operating the fluid drive element at a first speed for a first
time period, the first speed generating a first speed flow pattern
comprising one or more first speed flow parameters;
performing an analysis of the one or more first speed
flow parameters measured by the one or more sensors;
recording any undesired flow conditions;
analyzing any previously recorded undesired flow
conditions; and
modifying the speed of the fluid drive element based on
the analysis,
wherein modifying the speed includes:
if there are previously recorded undesired flow
conditions, operating the fluid drive element based on a first
speed profile; and
if there are no previously recorded undesired flow
conditions, operating the fluid drive element based on a second
speed profile, wherein the second speed profile is different than
the first speed profile.
(Id. at 29-30.)
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50. A method for operating a blood flow system for a patient,
the system comprising a fluid drive module, the fluid drive
module comprising a housing defining a chamber, an inlet port,
an outlet port, a rotatable fluid drive element within the
chamber, and a motor connected to the fluid drive element, and
a control module configured to operate the fluid drive module,
the method comprising:
operating the fluid drive element at a first speed for a first
time period, the first speed generating a first speed flow pattern
comprising one or more first speed flow parameters;
collecting quantitative and/or qualitative flow data;
performing an analysis of the one or more first speed
flow parameters; and
modifying the speed of the fluid drive element based on
the analysis,
wherein modifying the speed includes:
averaging the data over a first time interval and a second
time interval;
comparing the averaged data from the first and second
time intervals to produce a result;
comparing the result to a threshold; and
if the comparison of the result to the threshold is
unacceptable, modifying the speed of the fluid drive element.
(Id. at 31.)
Grounds of rejection before this Panel for review:
Claims 30, 36, 42--44, 46, and 49 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over Reich. 2
2 Reich et al., US 2003/0045772 Al, published Mar. 6, 2003.
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Claims 38 3 and 50 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Reich and Hayama. 4
Claims 34 and 45 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Reich and Jarvik '001. 5
Claims 39, 41, 51, and 53 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Reich and Jarvik '089. 6
Claims 40 and 52 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Reich and Kung. 7
ISSUE
Does the preponderance of evidence, relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Reich "relates generally to heart assist pumps, and, more
specifically, to control thereof in cooperation with the natural heart" (Reich
3 Examiner notes a typographical error in Examiner's August 1, 2016 Final
Action ("Final Act."), wherein claim 36 was indicated as rejected, along
with claim 50, under "35 U.S.C. [§] I03(a) as being unpatentable over Reich
et al. (US PG Pub 2003/0045772) in view ofHayama et al. (US PG Pub
2008/0261597)" (Examiner's April 13, 2017 Answer ("Ans.") 9).
According to Examiner, the reference to claim 36 in the foregoing rejection
should have been to claim 3 8 (id.). As Examiner explains, Appellants'
"arguments directed toward claim 50 presented in the appeal brief and in the
previous Office action would therefore also apply to claim 3 8 given the
commonality of the two claims" (id.). We agree and find Examiner's
typographical error harmless on this record and address claim 3 8 as part of
this rejection.
4 Hayama et al., US 2008/0261597 Al, published Oct. 23, 2008.
5 J arvik, US 2005/0071001 A 1, published Mar. 31, 2005.
6 Jarvik et al., US 5,965,089, issued Oct. 12, 1999.
7 Kung et al., US 2007/0073393 Al, published Mar. 29, 2007.
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FF 2. Reich's
blood pump may have any conventional form, and in the
preferred embodiment is a rotary or centrifugal pump having a
suction inlet joined to the left ventricle and pressure outlet
joined to the aorta. Performance of the rotary pump is
conventionally rated by corresponding performance curves in
which the flowrate through the pump corresponds with the
differential pressure across the pump between the inlet and
outlet thereof, and varies as the speed of the rotary impeller
increases. Increasing impeller speed generally corresponds
with increasing differential pressure and increasing flowrate
through the pump.
(Reich ,r 17 .)
FF 3. Reich's Figure 2 is reproduced below:
FIG. 2
f'{~,
i~i
3i
PJ _J_ ---·~
Reich's "FIG. 2 is a schematic representation of the feed-back control for
[Reich's] blood pump" (id. ,r 14 (emphasis omitted)).
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As illustrated in [Reich's] FIG. 2, the controller 30 is suitably
configured for adjusting speed of the pump in an outer closed
loop control 46 using feedback of the measured outlet pressure
P2 for maintaining the outlet pressure in a second range
preselected by the physician. The outer loop 46 preferably
operates in conjunction with the inner loop 40, with feedback of
the measured inlet pressure P 1 being used for maintaining the
measured inlet pressure in the first preselected range.
(Reich ,r 44 ( emphasis omitted).)
FF 4. Reich's "control system illustrated in FIG. 2 includes a conventional
summing junction ... which provides means for comparing the measured
inlet pressure P 1 from the sensor ... with a desired or set value thereof to
determine a difference or error value there between" (id. ,r 27 ( emphasis
omitted)).
FF 5. Reich's
summing junction is operatively joined to the blood pump ...
by a speed controller 3 8 for the electrical motor thereof, which
controls motor operation by rotation of the impeller therein.
The rotary speed in revolutions per minute (RPM) of the pump
... is adjusted in an inner closed loop control 40 using
feedback of the measured inlet pressure P 1 to minimize the
pressure difference with the setpoint at the summing junction.
(id. ,r 28 (emphasis omitted).)
FF 6. Reich's
[ c ]losed loop feedback control is conventional, and is used in
accordance with ... [Reich's] invention for controlling rotary
speed of the blood pump based on the measured inlet pressure
P 1. In a fundamental or first level of pump control, the desired
level of the inlet pressure P 1 may be suitably set in the control
system, and the inner feedback loop 40 is used to control motor
speed until the difference or error signal between measured and
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set pressures is reduced to substantially zero, at which time the
measured inlet pressure P 1 matches the desired value therefor.
(Reich ,r 29.)
FF 7. Reich's Figure 1 is reproduced below:
FIG. 1
. Stl' IJl'[L 1 r:· SFf . . . . . LEVEL 2
I '" pi .
lliJ.·.n~.- t~P, 1{11 L.~f '~ .. %X @) HR o:n I Lill u : HfTillt I L~!'.JM~X s n
p; ·--:······--······w~~.-----,.· 1 lH:~T;SPUt;.R ·42
p ·····-·····.lP.tlaf rj I t VB [ill
I O··--······ . --~.1 lYA!)IT] [ill
I O ........ T!Mf. ... ....... 1 L -
Illustrated schematically in [Reich's] FIG. 1 is a living patient
10 having a dysfunctional heart 12 which lacks normal
capability for pumping blood 14 through the arterial branch for
all levels of activity from rest to strong exercise. In particular,
the left ventricle 16 of the heart lacks capability to properly
pump blood through the aorta 18 to feed the arterial system.
(Reich ,r 15 (emphasis omitted); id. ,r 13 (Reich's "FIG. 1 is a schematic
representation of an implanted blood pump and cooperating controller in
accordance with an exemplary embodiment of [Reich's] ... invention, with
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an external monitor for initializing the controller and monitoring
performance of operation" ( emphasis omitted)).)
FF 8. Reich discloses:
the control panel 42 illustrated in FIG. 1 permits the physician
to set the desired inlet pressure Pl for the pump, as well as the
corresponding first range for the measured inlet pressure P 1,
which is + 10 to -2 mm Hg, which corresponds with the full
range in Table 1, for example. The first level of feedback
control provided in the inner loop 40 may then be used to
control operation of the pump to achieve the desired setpoint
for the inlet pressure Pl, with the panel 42 illustrated in FIG. 1
showing the actual measured value of the inlet pressure P 1 in
the corresponding circular indicator. In contrast, the square
indicators are used for the various physician programmable
values in the control system.
(Reich ,r 3 8 ( emphasis omitted).)
FF 9. Reich discloses that its "control system ... preferably also includes a
second level of control typically associated with the patient undergoing
exercise and requiring additional blood flow. Level-2 control is indicated
schematically by the reference numeral 54 in FIG. 2 and is readily
incorporated into the control system using additional software" (id. ,r 56
( emphasis omitted)).
FF 10. Reich discloses that a
physician may specify a resting heart rate (HR) for the patient
in terms of beats per minute (BPM). And, as shown
schematically in FIG. 2, means 56 are provided for measuring
or determining the heart rate of the patient's heart which is used
for initiating the Level-2 control. When the measured heart rate
is greater than the specified resting heart rate, the second level
control 54 is effective for increasing speed of the blood pump to
correspondingly increase the outlet pressure P2, and thereby
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provide more blood flow for meeting the increased demand
therefor during exercise.
(Id. ,r 57 (emphasis omitted).)
FF 11. Reich discloses a
third level of control 58 [that] ... includes suitable means 60
for measuring rotary speed of the pump as expressed in RPM.
It is noted that the pump 20 is conventional and typically
includes an electrical outlet line that provides a speed signal for
the pump using suitable measuring means integrated in the
pump itself. Additional outputs for the pump may include the
voltage and electrical current for the motor thereof.
(Id. ,r 64 (emphasis omitted).)
FF 12. Reich discloses
that the three levels of pump control illustrated in FIG. 2 all
share the common summing junction 36 for adjusting
performance of the primary Level-I feedback control loop 40
for primarily controlling the inlet pressure Pl, and secondarily
controlling outlet pressure P2 during rest in Level-I and during
exercise in Level-2, and pump power or load sharing in Level-3
within the programmed limits of inlet and outlet pressures.
(Id. ,r 72 ( emphasis omitted).)
FF 13. Reich discloses:
The Level-2 and Level-3 control algorithms provide additional
outer feedback to modulate the Level-I primary loop feedback
control. The Level-2 control algorithm tries to increase the
arterial pressure by increasing pump speed based on increased
heart rate. Increased arterial pressure results in increase blood
flow to those muscle tissues with dilated arterioles, e.g., during
exercise. The increase in pump speed can only occur if the left
ventricle diastolic filling pressure is maintained within its
acceptable range.
(Id. ,r 92 ( emphasis omitted).)
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FF 14. Examiner finds that although Reich "discloses determining an
average of the data over a time interval to control the blood pump," Reich
does not expressly disclose wherein the control module is
configured to compare the averaged data from that time interval
with averaged data from a second time interval to produce a
result, and compare the result to a threshold to determine if it is
unacceptable and to perform a modification of the speed of the
fluid drive element if the result is unacceptable.
(Final Act. 10-11 (citing Reich ,r 53).)
FF 15. Hayama "relates to handoff techniques in wireless communication
systems and more particularly, to a handoff technique for performing
handoff processing operation between different wireless communication
systems in an area in which wireless systems based on a plurality of wireless
communication schemes are present" (Hayama ,r 2).
FF 16. Examiner finds that Hayama establishes that it was "well known in
the art to compare a current average value of a time interval with a previous
average value in another time interval to determine trend changes of the
value, and the result compared to a threshold to better determine the
changes" (Final Act. 11 ( citing Hayama ,r 54) ).
FF 17. Examiner finds that Reich
does not expressly disclose operating the fluid drive element in
a continuous series of changing speeds includes: operating the
fluid drive element at a first series of speeds changed at a first
frequency; and operating the fluid drive element at a second
series of speeds changed a second frequency, the first frequency
being different from the second frequency [and relies on Jarvik
'001 to teach] ... a representative speed cycle for the pulsatile
function of the controller where the pump is operated at a first
series of speeds changed at a first frequency ... and operating
the pump at a second series of speeds changed at a second
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frequency, the first frequency being different than the second
frequency.
(Id. at 11-12 (citing Jarvik '001, Fig. 7, ,r 37).)
FF 18. Examiner finds that Reich "does not disclose when the analysis of
the one or more flow parameters detects an undesired flow condition, the
system activates an alert mode" and relies on Jarvik '089 to "provid[ e] an
alarm for various undesirable detected conditions during the operation of a
blood pump, such as low blood flow rate or low inlet pressure" (Final Act.
12 (citing Jarvik '089, 15:23--45).
FF 19. Examiner finds that Reich "does not disclose analyzing a current
drawn by the motor; and estimating an actual rotational speed of the motor"
and relies on Kung to disclose "analyzing a current drawn by the motor and
estimating the actual rotational speed of the motor ... in order to determine
the flow values of the blood within the pump at high flow and low flow
areas" (id. at 13 (citing Kung ,r,r 58-59)).
ANALYSIS
The rejection over Reich:
Claim 30:
Appellants' product claim 30 is reproduced above.
Reich discloses a blood pump comprising a controller configured to
adjust the speed of the pump's fluid drive element (see FF 1-8). Reich's
blood pump is configured to operate at a number of different operational
levels (see FF 8-13). Reich discloses that the blood pump's controller
increases or decreases the speed of the blood pump's fluid drive element to
meet specific operational levels (see id.). For example, Reich discloses that
when a patient shifts from resting heart rate, or level 1, to an exercise, or
level 2, activity "the measured heart rate is greater than the specified resting
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heart rate ... [and, therefore, the controller increases the] speed of the blood
pump to correspondingly increase the outlet pressure P2, and thereby
provide more blood flow for meeting the increased demand ... during
exercise" (FF 10).
A person of ordinary skill in this art would have recognized from
Reich that during the blood pump's transition from a level 1 to a level 2
operation, a closed loop feedback control is used to control the speed of the
pump based on measured inlet pressure Pl (see generally FF 6). In this
regard, Reich discloses that a
desired level of the inlet pressure P 1 may be suitably set in the
control system, and the inner feedback loop 40 is used to
control motor speed until the difference or error signal between
measured and set pressures is reduced to substantially zero, at
which time the measured inlet pressure P 1 matches the desired
value.
(Reich ,r 29; see Ans. 10; see also FF 1-13; Final Act. 7-8.) Stated
differently, Reich suggests that the controller continuously and
incrementally changes the speed of the pump and tests inlet pressure P 1 until
such time that the measured inlet pressure Pl matches the desired value (see
Reich ,r 29). Thus, as Examiner explains:
In achieving [Reich's] substantially zero difference between the
measured inlet pressure P 1 and the desired set value, one of
ordinary skill in the art at the time the invention was made
would have thought it obvious if not inherent that several
different speeds must be achieved ... as the system checks for
the P 1 differences, each of these speeds thereby modifying the
one or more of the first speed flow parameters.
(Ans. 10 (emphasis added); see also Final Act. 3). We find no error in
Examiner's conclusion.
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Although Examiner recognizes that Reich's pump "would not
necessarily be operating at a first, second, and third speed if the measured
inlet pressure P 1 does not vary from the set point pressure," we note that
Appellants' claim 30 is not a method of operating a blood pump, but is
instead a product, i.e. an apparatus (see Br. 24--25). Thus, claim 30 simply
requires the blood pump to be capable of operating in the manner claimed
(id.; cf Br. 14 ("Reich does not disclose that the speed of [Reich's] pump 20
will necessarily change during operation" and "[ o ]ne of ordinary skill in the
art would not understand Reich's actual disclosure to mean that the pump
will necessarily be operated at a first, second, and third speed"); see id. at 14
("Reich fails to disclose operating the fluid drive element in a continuous
series of changing speeds that includes a first speed, a second speed, and a
third speed")).
For the foregoing reasons, we are not persuaded by Appellants'
contention that "Reich fails to disclose or suggest operating the fluid drive
element in a continuous series of changing speeds that includes a first speed,
a second speed, and a third speed" (Br. 13).
Claims 36 and 46:
Appellants' claims 36 and 46 are reproduced above.
As discussed above, Reich discloses a blood pump that comprises,
inter alia, a controller that facilitates a change in speed of the pump's fluid
drive element in response to different operational levels, i.e. needs of the
user (see FF 1-13). In this regard, Reich discloses that its device includes a
feedback system that monitors the performance of the pump relative to the
patient's needs, e.g., resting or exercising (see id.). Thus, in transitioning
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from a resting, or first operational level, to an exercise, or second operational
level, the feedback loop of Reich's device will detect an undesired flow
condition (i.e. flow at a first operational level flow rate when a second
operational level flow rate is required) and modify the speed of the pump's
fluid drive element in response to this undesired flow condition (id.; see
Final Act. 8-9). In contrast, if a patient maintains a resting operational level,
Reich's device will maintain the device's fluid drive element at a first speed
(see Final Act. 8-9).
Therefore, although Reich may use different words to express the
performance of its system, 8 Reich makes obvious the product of Appellants'
claim 36, wherein a
control module [is]. .. configured to:
analyze any previously recorded undesired flow
conditions;
if a previous undesired flow condition has not been
detected, modify the speed of the fluid drive element to a first
speed profile; and
if a previous undesired flow condition has been detected,
modify the speed of the fluid drive element to a second speed
profile, wherein the second speed profile is different than the
first speed profile.
(Br. 26) and the method of Appellant's claim 46, which comprises the
steps of
analyzing any previously recorded undesired flow
conditions; and
8 Identical language between the prior art and claims is not required to
sustain a prior-art rejection. In re Skoner, 517 F.2d 947, 950 (CCPA 1975)
("Any other result would permit the allowance of claims drawn to
unpatentable subject matter merely through the employment of descriptive
language not chosen by the prior art.")
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modifying the speed of the fluid drive element based on
the analysis,
wherein modifying the speed includes:
if there are previously recorded undesired flow
conditions, operating the fluid drive element based on a first
speed profile; and
if there are no previously recorded undesired flow
conditions, operating the fluid drive element based on a second
speed profile, wherein the second speed profile is different than
the first speed profile.
(Br. 30.)9 Thus, we find no error in Examiner's conclusion that Reich makes
obvious the subject matter of Appellants' claims 36 and 46.
For the foregoing reasons, we are not persuaded by Appellants'
contention that "Reich fails to mention undesired flow conditions, much less
disclose modifying the speed of the pump ... based on an analysis of any
previously recorded undesired flow conditions as required by [Appellants'
claims 36 and 46]" (Br. 17-18; see also id. at 16-19). Although Appellants
contend that Reich fails to teach the requirement of their claims 3 6 and 46,
Appellants' contention offers no explanation as to how Reich's pump
controller adjusts the pump's performance during the different operational
levels of the pump in a manner that is necessarily different than is required
by Appellants' claimed invention (see e.g., FF 9-13). Accordingly, we are
not persuaded by Appellants' contentions regarding Reich.
Claims 42-44:
9 Absent evidence to the contrary, we find that the first and second speed
profiles of Appellants' claim 46 reads on Reich when the first speed is the
speed necessary to maintain Reich's second operational level and the second
speed is the speed necessary to maintain Reich's first operational level.
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Appellants' method claim 42 is reproduced above. Appellants' claims
43 and 44 depend, directly or indirectly, from Appellants' claim 42.
Based on Reich, Examiner concludes that
[i]t would ... have been obvious if not inherent to one of
ordinary skill in the art at the time [Appellants'] invention was
made that over the duration of several processes of matching
the measured inlet pressure P 1 with the desired value, the
continuous series of changing speeds would include repeated
sets of speeds as required by [Appellants'] claim [42].
(Final Act. 4 (emphasis added).) Examiner, however, does not identify, and
we do not find, a disclosure in Reich of a method of operating a blood flow
system for a patient, which comprises operating a "fluid drive element in a
continuous series of changing speeds, wherein the continuous series of
changing speeds includes repeated sets of speeds," as required by
Appellants' claim 42 (Br. 28 (emphasis added)). As Appellants contend,
"Reich fails to disclose or suggest operating the fluid drive element in a
continuous series of changing speeds that includes repeated sets of speeds"
(Br. 15). Thus, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that Reich makes obvious the subject matter
of Appellants' claims 42--44.
To be complete, we recognize Examiner's intimation that Appellants'
claims 42--44 are indefinite, wherein Examiner asserts that Appellants have
"not provided further limitations with regard to 'continuous series of
changing speeds includes repeated sets of speeds', such as para. [ 007 4] or
[0079] of the instant application's specification" (Final Act. 4 (alteration
original)). We are not presented with an indefiniteness rejection on this
record, however.
The rejection over the combination of Reich and Hayama:
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Application 14/017,505
Appellants' claims 38 and 50 are reproduced above.
Examiner finds that Reich teaches the subject matter of Appellants'
claims 3 8 and 50, but for a
control module ... configured to compare the averaged data
from [ a first] time interval with averaged data from a second
time interval to produce a result, ... compare [this] result to a
threshold to determine if it is unacceptable and [then] perform a
modification of the speed of the fluid drive element if the result
is unacceptable
(Final Act. 10-11; see Ans. 5). To make up for this deficiency in Reich,
Examiner relies on Hayama to teach that "it is well known in the art to
compare a current average value of a time interval with a previous average
value in another time interval to determine trend changes of the value, and
[ compare that result] ... to a threshold [value]" (id. at 11 ( citing Hayama
,r 11); see Ans. 5-6; see also FF 1-16).
Based on the combination of Reich and Hayama, Examiner concludes
that, at the time Appellants' invention was made, it would have been prima
facie obvious to utilize a comparison technique, such as that suggested by
Hayama, to determine if the speed of Reich's fluid drive element should be
modified (Final Act. 11 ).
Appellants contend, however, that those of ordinary skill in the art of
blood pump methods and systems would not look to Hayama's "method of
performing a handoffbetween a plurality of wireless systems having
different service areas and a wireless communication terminal" (Hayama,
Abstract) "to apply modifications to the Reich blood pump system" (Br. 20).
In this regard, Appellants explain that Hayama, as relied upon by Examiner,
relates to
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a calculation of the speed of a "wireless terminal" and the
ability to "handoff' with the telecommunications system based
on the calculated moving speed of that wireless terminal.
Hayama states: "[t]o this end, the wireless terminal requires
moving speed information from the GPS receiver or speed
sensor built therein ... calculates an average moving speed
from the acquired information ... compares the calculated
average moving speed with the previous average moving speed
... determines whether the average moving speed is increased
or decreased ... compares the average moving speed with a
threshold held in the wireless terminal ... and determines
whether or not the average moving speed is changed across
values defined by the thresholds." This paragraph of Hayama
goes on to state that a wireless system is selected based on
whether the average moving speed is higher or lower than the
threshold.
(Br. 21 (citing Hayama ,r 54)). Appellants "fail[] to see," and contend that
Examiner failed to "explain how one of ordinary skill in the Appellants'
claimed art would specifically utilize the teachings of the Hayama wireless
telecommunication system and appropriate those teachings for use in the
Reich blood pump system" (id. at 20, 21 ). We agree with Appellants.
We recognize Examiner's assertion that "[ t ]he limitations taught by
Hayama ... are mathematical principles that can be applied to any invention
that comprises sets of data compiled over intervals of time" (Ans. 14).
Examiner may be correct in that the mathematical manipulation of averages
and comparison of a calculated value to a threshold value are generally
applicable mathematical principles (id.). As Appellants explain, however,
Hayama explains how these so called mathematical principles are applied in
the context of a wireless telecommunication system. What is missing on this
record is an explanation of how, or why absent improper hindsight
reasoning, a person of ordinary skill in this art would have applied these
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principles to Reich's specific method and system to perform a modification
of the speed of a fluid drive element as is required by Appellants' claims 38
and 50.
[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was,
independently, known in the prior art. Although common sense
directs one to look with care at a patent application that claims
as innovation the combination of two known devices according
to their established functions, it can be important to identify a
reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the
claimed new invention does.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007); see also In re
Kotzab, 217 F.3d 1365, 1371 (Fed. Cir. 2000) ("[A] rejection cannot be
predicated on the mere identification ... of individual components of
claimed limitations. Rather, particular findings must be made as to the
reason the skilled artisan, with no knowledge of the claimed invention,
would have selected these components for combination in the manner
claimed.").
The rejection over the combination of Reich and Jarvik '001:
Appellants' claim 34 is representative, and depends from and further
limits the system of Appellants' claim 30 to require that a "continuous series
of changing speeds includes a first series of speeds changed at a first
frequency and a second series of speeds changed at a second frequency, the
first frequency being different than the second frequency" (Br. 25).
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Examiner finds that Reich teaches the subject matter of Appellants'
claim 34 but for the operation of
the fluid drive element in a continuous series of changing
speeds includes: operating the fluid drive element at a first
series of speeds changed at a first frequency; and operating the
fluid drive element at a second series of speeds changed a
second frequency, the first frequency being different from the
second frequency.
(Final Act. 11; see Ans. 6.) Examiner, however, relies on Jarvik '001 to
make up for this deficiency in Reich, finding that Jarvik '001 teaches "a
representative speed cycle for the pulsatile function of the controller where
the pump is operated at a first series of speeds changed at a first
frequency ... and operating the pump at a second series of speeds changed
at a second frequency, the first frequency being different than the second
frequency" (Final Act. 11-12 (citing Jarvik '001, Figs. 6A, 6B, 7, ,r,r 35-37);
see Ans. 6; see also FF 1-13, 17).
Therefore, based the combination of Reich and Jarvik '001, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to modify Reich to include a first and second series
of speeds, which are changed at different frequencies, as taught by Jarvik
'001, in order to prevent negative effects such as thrombus formation while
providing speeds serving Reich's intended purpose (Final Act. 12 (citing
Jarvik '001 ,r,r 1, 35, 37); see Ans. 6-7).
Having found no deficiency in Examiner's rejection of Appellants'
claim 30 over Reich, we are not persuaded by Appellants' contention that
Jarvik '001 fails to make up for the deficiencies in Reich (see Br. 22).
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The rejection over the combination of Reich and Jarvik '089:
Appellants' claim 39 is representative and depends from and further
limits the system of Appellants' claim 30 to require that "when the analysis
of the one or more flow parameters detects an undesired flow condition, the
system activates an alert mode" (Br. 27).
Examiner finds that Reich teaches the subject matter of Appellants'
claims 39, 41, 51, and 53 but for the activation of an alert mode, by the
system, "when the analysis of the one or more flow parameters detects an
undesired flow condition" or a "motor [that] includes a position sensing
element configured to monitor the position of one or more components of
the motor" (Final Act. 12-13; see Ans. 7-8). Examiner, however, relies on
Jarvik '089 to make up for these deficiencies in Reich (Final Act. 12-13; see
Ans. 7-8).
Therefore, based the combination of Reich and Jarvik '089, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to modify Reich to include the "activation of an
alarm when the analysis of one ... or more flow parameters detects an
undesirable flow condition" and a "motor speed dial and digital output of the
dial position," as taught by Jarvik '089, "[i]n order to actively notify the
operator of the system when system parameter changes need to be modified"
and "better notify the operator of the exact speed parameter of the pump
motor" (Final Act. 12-13; see Ans. 7-8; see generally FF 1-13, 18).
Having found no deficiency in Examiner's rejection of Appellants'
claim 3 0 over Reich, we are not persuaded by Appellants' contention that
Jarvik '089 fails to make up for the deficiencies in Reich (see Br. 22).
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The rejection over the combination of Reich and Kung:
Appellants' claim 40 is representative and depends from and further
limits Appellants' claims 30 to require that "the fluid drive element
comprises a rotor and the control module is configured to analyze a current
drawn by the motor to estimate an actual rotational speed of the rotor" (Br.
28).
Examiner finds that Reich teaches the subject matter of Appellants'
claims 40 and 52 but for the analysis of a current drawn by the motor and
estimating an actual rotational speed of the motor (Final Act. 13; see Ans.
8). Examiner, however, relies on Kung to make up for this deficiency in
Reich, finding that Kung discloses the analysis of current drawn by a motor
and estimating the actual rotational speed of the motor in order to determine
the flow values of the blood within the pump during high and low flow (id.
(citing Kung ,r,r 58-59); see Ans. 8).
Based the combination of Reich and Kung, Examiner concludes that,
at the time Appellants' invention was made, it would have been prima facie
obvious to modify Reich, according to Kung, "to utilize the current drawn
by the motor and analyzing the parameter to estimate an actual rotational
speed of the motor in order to better determine the flow values of the blood
within the pump" (Final Act. 13 (citing Kung ,r,r 58-59); see Ans. 8; see also
FF 1-13, 19).
Having found no deficiency in Examiner's rejection of Appellants'
claim 3 0 over Reich, we are not persuaded by Appellants' contention that
Kung fails to make up for the deficiencies in Reich (see Br. 22).
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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to Appellants' claims 30, 34, 36, 39,
40, and 46.
The rejection of claims 30, 36, and 46 under 35 U.S.C. § 103(a) as
unpatentable over Reich is affirmed is affirmed. Claim 49 is not separately
argued and falls with claim 46.
The rejection of claim 34 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Reich and Jarvik '001 is affirmed. Claim 45 is not
separately argued and falls with claim 34.
The rejection of claim 39 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Reich and Jarvik '089 is affirmed. Claims 41, 51,
and 53 are not separately argued and fall with claim 39.
The rejection of claim 40 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Reich and Kung is affirmed. Claim 52 is not
separately argued and falls with claim 40.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to Appellants' claims 3 8,
42--44, and 50.
The rejection of claims 42--44 under 35 U.S.C. § 103(a) as
unpatentable over Reich is reversed.
The rejection of claims 38 and 50 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Reich and Hayama is reversed.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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