Ex Parte Zong

Patent Trial and Appeal Board

Jul 11, 2017

12919819 (P.T.A.B. Jul. 11, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/919,819 08/27/2010 Wei Zong 2008P00147WOUS 8668
24737 7590 07/13/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue TRAN, THO Q
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
07/13/2017 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):
marianne. fox @ philips, com
debbie.henn @philips .com
patti. demichele @ Philips, com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WEI ZONG
Appeal 2016-004910
Application 12/919,8191
Technology Center 3700
Before DONALD E. ADAMS, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1, 3—7, 9, 10,
12, 14—16, 18—21, and 23 (Final Act.2 2). Examiner entered rejections under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellant discloses a: “hemodynamic monitoring instrument” or
device, “monitoring method,” and non-transitory “computer medium []
storing instructions executable to control a computer and display to perform
1 Appellant identifies the real party in interest as “Koninklijke Philips
Electronics N.V.” (App. Br. 1.)
2 Examiner’s April 2, 2015 Office Action.
Appeal 2016-004910
Application 12/919,819
[Appellant’s] method [and] device” (Spec. 2). Claims 1 and 12 are
representative and reproduced below:
1. A hemodynamic monitoring instrument comprising:
a multi-functional patient monitor including:
one or more medical monitoring devices configured to
measure
physiological parameters including at least a measured
physiological parameter indicative of heart rate and a measured
physiological parameter indicative of arterial blood pressure;
a processor arranged to receive the physiological
parameter indicative of heart rate and the physiological
parameter indicative of arterial blood pressure and configured
to compute a vasopressor advisability index (VPAI) correlating
with systemic vascular resistance (SVR) using measured
physiological parameters consisting only of the measured
physiological parameter indicative of heart rate and the
measured physiological parameter indicative of arterial blood
pressure and not using any other measured physiological
parameter, the VPAI quantifying the heuristic “ABP is low
AND HR is slightly high or high” OR “ABP is very low” where
ABP denotes an arterial blood pressure indicated by the
physiological parameter indicative of arterial blood pressure
and HR denotes a heart rate indicated by the physiological
parameter indicative of heart rate;
a display configured to simultaneously display as a
function of time the computed VPAI, the physiological
parameter indicative of heart rate, and the physiological
parameter indicative of arterial blood pressure; and
an alarm configured to generate a perceptible signal
indicating advisability of vasopressor intervention responsive to
the computed VPAI satisfying an alarm criterion.
(App. Br. 15—16.)
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Application 12/919,819
12. A hemodynamic monitoring method comprising:
using one or more medical monitoring devices,
measuring a quantitative heart rate (HR) measure and a
quantitative arterial blood pressure (ABP) measure for a patient;
using a processor, computing a vasopressor advisability
index (VPAI) that (i) is computed using quantitative patient
measures consisting only of the quantitative HR measure and
the quantitative ABP measure, and (ii) correlates with the ratio
ABP/HR where ABP is the quantitative ABP measure and HR
is the quantitative HR measure;
displaying the VPAI;
generating a perceptible signal indicative of an abnormal
hemodynamic condition treatable by administration of a
vasoconstriction medication conditional upon the VPAI
satisfying an alarm criterion.
(Id. at 18.)
The claims stand rejected as follows:
I. Claims 1, 3—5, 9, 21, and 23 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Nielsen,3 Ardagh,4
Ceneviva,5 and Loria.6
II. Claims 12, 14, and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ardagh, and Ceneviva.
3 Nielsen et al., WO 2007/060559 A2, published May 31, 2007.
4 Michael W Ardagh et al., Pulse rate over pressure evaluation (ROPE) is
useful in the assessment of compensated haemorrhagic shock, 13 Emergency
Medicine 43^46 (2001).
5 Gary Ceneviva et al., Hemodynamic Support in Fluid-refractory Pediatric
Septic Shock, 102 PEDIATRICS 1-6 (1998).
6Loria, US 2006/0281724 Al, published Dec. 14, 2006.
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Application 12/919,819
III. Claims 6 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ceneviva, Ardagh, Loria,
Becker,7 and Lynn.8
IV. Claim 10 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ceneviva, Ardagh, Loria, and
Banet.9
V. Claims 15 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ceneviva, Ardagh, Becker,
and Lynn.
VI. Claim 19 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ceneviva, Ardagh, and Banet.
VII. Claim 20 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nielsen, Ceneviva, Ardagh, Becker,
Lynn, Suizdak,10 and Griffin.* 11
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Nielsen discloses “a medical monitoring system [that] includes a
monitoring station [] operatively connected with a modular biometric
monitor rack [that] includes an example heart rate (HR) monitor module []
7 Kurt Becker et al., Fuzzy Logic Approaches to Intelligent Alarms, IEEE
ENGINEERING ON MEDICINE AND BIOLOGY 710-16 (1994).
8 Lynn et al., US 2007/0191697 Al, published Aug. 16, 2007.
9Banet et al., US 2008/0312542 Al, published Dec. 18, 2008.
10 Siuzdak et al., US 2009/0104605 Al, published Apr. 23, 2009.
11 Griffin et al., US 2005/0137484 Al, published June 23, 2005.
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Application 12/919,819
configured to monitor patient heart rate [and] an example blood pressure
monitor module [] configured to monitor patient blood pressure []” (Nielsen
4: 4—8; see also id. at 1: 22—24 (“some medical monitoring systems include
derived parameters. For example, various blood pressure parameters such as
arterial blood pressure [] can be derived from a continuous blood pressure
monitor”); see Final Act. 3^4 (Nielsen discloses “a hemodynamic
monitoring instrument comprising . . . one or more medical monitoring
devices configured to measure physiological parameters including at least a
measured physiological parameter indicative of heart rate and a measured
physiological parameter indicative of arterial blood pressure []”)).
FF 2. Examiner finds that Nielsen’s monitoring system comprises, inter
alia, “a processor arranged to receive the physiological parameter indicative
of heart rate and the physiological parameter indicative of arterial blood
pressure” (Final Act. 4; see generally Nielsen 5: 1—6: 24).
FF 3. Examiner finds that Nielsen’s processor is “configured to compute
an index correlating with systemic vascular resistance (SVR) based on the
received physiological parameter indicative of heart rate and the received
physiological parameter indicative of arterial blood pressure,” wherein
“SVR is estimated using heart rate and arterial blood pressure; see
[Nielsen’s] equation U2 which estimates SVR; because the device estimates
SVR, the estimate is considered correlated to SVR[]” (Final Act. 4, citing
Nielsen 10: 1—15).
FF 4. Nielsen discloses that “an estimate of the SVR to the user-defined
biometric parameter U2” is defined by the equation:
“U2=(MABP - CVP)/((Kl/MABP) x (ABPsys-ABPdia) x HR),”
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“where ‘MAPBP’ represents the mean arterial blood pressure library
function selected from the library functions list[ ], ‘CVP’ represents the
central venous pressure library function selected from the library functions
list [],” “‘HR’ represents the heart rate monitored biometric parameter
selected from the monitored biometric parameters list[], ‘K1 ’ can be a
constant factor that is a function of age or disease state,” “‘ABPsys’
represents the systolic arterial blood pressure library function selected from
the library functions list [], [and] ‘ABPdia’ represents the diastolic arterial
blood pressure library function selected from the library functions list
(Nielsen 10: 5—12 (emphasis added) and 9: 15—21).
FF 5. Nielsen’s “library” includes “pre-defmed functions,” which “may
include general mathematical, statistical, or calculus functions such as
logarithm, integral ‘Int()’, or average ‘Avg()’,” and “may additionally or
alternatively include pre-defmed biometric parameters such as systolic
arterial blood pressure (ABPsys) or diastolic arterial blood pressure
(ABPdia),” wherein a user of Nielsen’s device may “select from a list [] of
the functions stored in the library []” (Nielsen 7:6—11).
FF 6. Examiner recognizes that Nielsen does not disclose a SVR
determination that uses measured physiological parameters consisting only
of the measured physiological parameter indicative of heart rate and the
measured physiological parameter indicative of arterial blood pressure and
not using any other measured physiological parameter (Ans. 3; see FF 3—5;
cf. App. Br. 15—16).
FF 7. Ardagh discloses:
The pulse rate over pressure evaluation (ROPE) places
the pulse rate (the numerator) over the pulse pressure (systolic
blood pressure minus diastolic blood pressure, the
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denominator). This emphasizes the physiological changes of
increased heart rate and increased peripheral vascular resistance
that occur during compensation [in a patient who is losing
blood volume through hemorrhage], and a high ROPE may
indicate approaching decompensation. If ROPE proves to be
predictive of decompensation, its ease and rapidity of
application would make it a useful clinical tool.
(Ardagh 43; id. (“ROPE is an easily applied and useful clinical tool [] being
predictive of the patient developing decompensated shock”); see Ans. 3
(“arterial blood pressure can be described [as] pulse pressure”); Ans. 5
(“Ardagh was used to teach a SVR measurement that uses heart rate and
arterial blood pressure as claimed”); Final Act. 6.)
FF 8. Examiner finds that Nielsen fails to disclose a processor configured
to compute a vasopressor advisability index (VPAI) correlating with
systemic vascular resistance (SVR), as is required by Appellant’s claimed
invention (Ans. 4; cf App. Br. 15—16).
FF 9. Examiner relies on Ceneviva to “teach[] that [v]asopressor therapy is
used to counter low SVR” (Ans. 4; Ceneviva 1 (“When decreased SVR
contributes to shock, vasopressor therapy is used to increase SVR”); see also
Final Act. 5 (Ceneviva discloses “that SVR is a parameter that can be used
to indicate the need for vasopressor therapy”)).
FF 10. Examiner finds that Nielsen’s device comprises “a display
configured to simultaneously display as a function of time the computed
index correlating with SVR, the physiological parameter indicative of heart
rate, and the physiological parameter indicative of arterial blood pressure”
(Final Act. 4, citing Nielsen 5: 13—25).
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FF 11. Nielsen’s device “[ojptionally [] includes an alarm, such as a visual
alarm light [], an audio alarm speaker [], or so forth” (Nielsen 6: 3^4; Final
Act. 5).
FF 12. Examiner finds that Nielsen “does not disclose that the vasopressor
advisability index can be used to quantify the heuristics ‘ABP is low and HR
is slightly high or high’ or ‘ABP is very low’” and relies on Loria to make
up for this deficiency in Nielsen (Final Act. 7).
ANALYSIS
Rejection /:
Based on the combination of Nielsen, Ardagh, Ceneviva, and Loria,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious “to modify Nielsen to use the index
correlating with SVR as a vasopressor advisability index based on
Ceneviva[’s] teachings that low SVR should be treated with vasopressors
because this index can be used to treat shock symptoms which can be life
threatening” (Final Act. 5—6). Because Appellant’s claimed invention uses
the open transitional phrase, comprising, Examiner reasons that it would
have been prima facie obvious at the time of Appellant’s claimed invention
to modify the system suggested by the combination of Nielsen and
Ceneviva:
to include a secondary measure of vascular resistance that
depends only on measurements of HR and BP, as taught by
Ardagh, for monitoring patients because Ardagh [] teach[es]
that ROPE can be used to conventional signs [sic] of a patient’s
volume status are unreliable until the patient has
decompensated, at which point it may be too late [].
(Final Act. 6 (emphasis added).) In this regard, Examiner reasons that
“[although Ardagh uses pulse pressure as opposed to the claimed arterial
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Application 12/919,819
blood pressure, it is notoriously known that arterial blood pressure can be
estimated closely using only diastolic and pulse pressure (i.e. a simple
substitution of known equivalent factors” (id. at 7). Taken together,
Examiner concludes that “Ceneviva in combination with Ardagh and
Nielsen teaches that a patient’s SVR level itself is an indicator of when to
administer vasopressor (e.g. Ceneviva demonstrates that a low SVR can be
countered using a vasoconstriction medication)” (Ans. 5).
Lastly, Examiner reasons that when “[t]he term heuristic [is]
interpreted as criteria” it would have been prima facie obvious at the time of
Appellant’s claimed invention “to use heuristics such as ‘ABP is low and
HR is slightly high or high’ or ‘ABP is very low’ in view of Loria’s teaching
of shock symptoms because such identified conditions require prompt
treatment” (id. at 7, citing Loria, Abstract and 115).
Claim 1:
Examiner relies on Ardagh to suggest a SVR using measured
physiological parameters consisting only of the measured physiological
parameter indicative of heart rate and the measured physiological parameter
indicative of arterial blood pressure and not using any other measured
physiological parameter as required by Appellant’s claimed invention (FF
7). In this regard, Ardagh discloses that the ease and rapidity of [the ROPE]
application [] make it a useful clinical tool (id.). Therefore, we find no error
in Examiner’s conclusion that it would have been prima facie obvious to
include a secondary measure of vascular resistance that depends only on
measurements of HR and BP, as taught by Ardagh, in Nielsen’s device (see
Final Act. 6—7; see also FF 7; c/ FF 3—6). In addition, Examiner relies on
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Ceneviva to suggest that SVR is correlative to VPAI, because SVR can be
used as an indicator to treat shock symptoms with vasopressors (see FF 9).
Therefore, we are not persuaded by Appellant’s contention that
“Ardagh [alone] does not fairly suggest calculating a vasopressor
advisability index which is used to indicate the advisability of vasopressor
intervention,” because that contention fails to account for Ceneviva’s
contribution to the combination of Nielsen, Ardagh, and Ceneviva (App. Br.
10; see Reply Br. 2—3 (“simply predicting decompensated shock does not
show when an advisability of vasopressor intervention is warranted. In other
words, Ardagh does not fairly suggest a vasopressor advisability index
which is used to indicate the advisability of vasopressor intervention”).)
Likewise, we are not persuaded by Appellant’s contention that, when viewed
in isolation, “Ceneviva is silent with respect to a[] SVR calculated using
only HR and ABP” and, thus, “does not add anything that would cure the
deficiencies of Nielsen [in combination with] Ardagh” (App. Br. 10; Reply
Br. 3). The references must not be read in isolation, but for what they fairly
teach together. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
We are not persuaded by Appellant’s contention that “Ardagh gives
two specific examples of where ROPE would be ineffective at determining
when a vasoconstriction medication should be administered” or that
Ceneviva alone “does not fairly suggest administering of vasopressor
intervention based on a calculation using only HR and ABP” (App. Br. 10,
citing Ardagh 46; see Reply Br. 3).
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Claim 3:
Appellant’s claim 3 depends from and further limits Appellant’s claim
1 to require “a memory for storing a patient age” and a “processor
configured to compute the VPAI further using the stored patient age” (App.
Br. 16). In this regard, we note that Appellant’s claimed invention is open to
include multiple SVR calculations, which correlate with VPAI, including an
SVR calculation that accounts for patient age such as disclosed by Nielsen
(see FF 4). Thus, the combination of Nielsen, Ardagh, Ceneviva, and Loria
makes obvious a device comprising memory for storing a patient’s age and a
processor configured to compute VPAI using the stored patient age.
Further, Appellant’s claim 3 does not require that the device or any of
a plurality of methods for calculating VPAI, used by the device’s processor,
to compute VPAI is effective for all age groups, but instead simply requires
that patient age be stored in the memory of the device and that the device’s
processor be configured to compute the VPAI using the stored patient age
(see App. Br. 16). Therefore, we are not persuaded by Appellant’s
contention that one method (ROPE), among a plurality (see Nielsen), of
computing VPAI “may not climb in elderly people prior to decompensation;
thus, ROPE is an ineffective predictor of decompensation for this group of
people” (App. Br. 12; see Reply Br. 4).
Claim 9:
Appellant’s claim 9 depends from and further limits Appellant’s claim
1 to require that “the processor is configured to increase HR by AFHr where
AFHr denotes a correction term based on patient age” (App. Br. 18).
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As discussed above the combination of Nielsen, Ardagh, Ceneviva,
and Loria makes obvious a devices comprising a processor configured to
compute VPAI using the stored patient age. In this regard, Nielsen discloses
a SVR calculation, which correlates with VPAI, that includes the variable
Kl, thereby, accounting for a patient’s age (FF 4).
Therefore, we are not persuaded by Appellant’s contention that the
combination of Nielsen, Ardagh, Ceneviva, and Loria fail to make obvious
Appellant’s claimed invention (App. Br. 12; see Reply Br. 4—5).
Rejection II:
Examiner relies on Nielsen, Ardagh, and Ceneviva as discussed above
(see Final Act. 12). Examiner recognizes, however, that the combination of
Nielsen, Ardagh, and Ceneviva suggests an SVR calculation, ROPE, that is
HR/ABP, which is the inverse of the calculation required by Appellant’s
claimed invention: ABP/HR (id.). Nevertheless, Examiner reasons that the
use of “an inverse of a known ratio fails to make the teachings unobvious to
one of ordinary skill in the art at the time of the invention” (id.).
Claim 12:
Appellant does not dispute Examiner’s rationale regarding the use of
an inverse relationship (see App. Br. 11). Rather, Appellant contends that
the combination of Nielsen, Ardagh, and Ceneviva fails to “‘comput[e] a
vasopressor advisability index (VPAI) that (i) is computed using quantitative
patient measures consisting only of the quantitative HR measure and the
quantitative ABP measure’ ... for similar reasons discussed above with
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respect to claim 1” (id.). Having found no error in Examiner’s rejection of
claim 1, we are not persuaded.
Claim 18:
Appellant’s claim 18 depends from and further limits the method of
Appellant’s claim 12 to require that the VPAI computation “further
comprises increasing the quantitative HR measure by AFHr where AFHr
denotes a correction term based on patient age” (App. Br. 20.)
Having found no deficiency in Examiner’s rejection of claim 9, we are
not persuaded by Appellant’s contention that “[cjlaim 18 is patentable over
the applied references for similar reasons discussed with respect to claim 9”
(App. Br. 13; see Reply Br. 5).
Rejections III— VII:
ANAFYSIS
If a ground of rejection stated by the examiner is not addressed in
Appellant’s Brief, that ground of rejection will be summarily sustained by
the Board. See Manual of Patent Examining Procedure § 1205.02.
Appellant does not address Rejections III—VII; therefore, they are summarily
affirmed.
CONCEUSION OF FAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
Rejection I: The rejection of claims 1, 3, and 9 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Nielsen, Ardagh,
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Ceneviva, and Loria is affirmed. Claims 4, 5, 21, and 23 are not separately
argued and fall with claim 1.
Rejection II: The rejection of claims 12 and 18 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Nielsen, Ardagh, and
Ceneviva is affirmed. Claim 14 is not separately argued and falls with claim
12.
Rejections III—VII are summarily affirmed.
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
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