Ex Parte Addison et al

Patent Trial and Appeal Board

Dec 28, 2015

12487470 (P.T.A.B. Dec. 28, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/487,470
80883 7590
Covidien LP
ATTN: IP Legal
FILING DATE
06/18/2009
12/30/2015
6135 Gunbarrel Avenue
Boulder, CO 80301
FIRST NAMED INVENTOR
Paul Stanley Addison
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.
H-RM-01505/COV-59 7248
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
12/30/2015 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):
ip.legal@covidien.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL STANLEY ADDISON
and JAMES NICHOLAS WATSON
Appeal2013-008873
Application 12/487,470
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
method, a system, and a non-transitory computer-readable medium for
communicating a disease state of a patient. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as N ellcor Puritan Bennett
Ireland (see App. Br. 3).
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Application 12/487,470
Statement of the Case
Background
Appellants' invention "relates to patient monitoring, and more
particularly, relates to determining a patient's health status or susceptibility
to a disease state" (Spec. ,-r 1 ).
The Claims
Claims 1, 2, 5-11, and 15-20 are on appeal. 2 Independent claim 1 is
representative and reads as follows (emphasis added):
1. A method for communicating a disease state of a patient,
the method comprising:
obtaining a signal from a patient sensor, wherein the
signal changes in response to inducing a load on a vascular
system of the patient;
analyzing the signal at a first point before or while the
load is induced to determine a first baseline value of the signal
and a first amplitude value of the signal and at a second point
after the load is induced to determine a second baseline value
of the signal and a second amplitude value, wherein the signal
is analyzed by a processor coupled to the patient sensor;
calculating a baseline difference between the first
baseline value and the second baseline value and an amplitude
difference between the first amplitude value and the second
amplitude value;
determining the disease state based at least in part on the
baseline difference and on the amplitude difference; and
communicating the disease state to an output device.
2 Claims 3, 4, and 12-14 were cancelled (see App. Br. 17-19).
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The Issues
A. The Examiner rejected claims 1, 2, 5, 8, 11, 15, 18, and 20 under
35 U.S.C. § 103(a) as obvious over Mills3 and Chan4 (Final Act. 5-8).
B. The Examiner rejected claims 6, 9, 16, and 19 under 35 U.S.C.
§ 103(a) as obvious over Mills, Chan, and Chellappan5 (Final Act. 9-10).
C. The Examiner rejected claims 7, 10, and 17 under 35 U.S.C. § 103(a)
as obvious over Mills, Chan, and Addison6 (Final Act. 11-12).
Because the same issue is dispositive for all three rejections, and
Appellants do not separately argue rejections B. and C., we will consider all
of the rejections together.
The Examiner finds that Mills teaches "a method/system for
communicating a disease state of a patient" comprising "obtaining a signal
from a patient sensor/input signal generator," "analyzing the signal at a first
point before or while the load is induced to determine a first baseline value
of the signal and a first amplitude value of the signal [] and at a second point
after the load is induced to determine a second baseline value of the signal
and a second amplitude value[], wherein the signal is analyzed by a
processor coupled to the patient sensor" (Final Act. 5---6; citing Mills, Fig. 2,
Fig. 11, i-fi-f 105, 123, 153, 194). The Examiner finds that Mills teaches
"calculating a baseline difference between the first baseline value and the
second baseline value and an amplitude difference between the first
3 Mills, US 2005/0177046 Al, published Aug. 11, 2005.
4 Chan et al., US 2005/0256386 Al, published Nov. 17, 2005.
5 Chellappan et al., Effects of Physical Exercise on the Photoplethysmogram
Waveform, THE 5th STUDENT CONFERENCE ON RESEARCH AND
DEVELOPMENT, 1-5 (2007).
6 Addison et al., US 2006/0258921 Al, published Nov. 16, 2006.
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amplitude value and the second amplitude value" (Final Act. 6; citing Mills
ii 194).
The Examiner acknowledges that Mills does not teach "determining a
disease state based at least in part on the baseline difference and on the
amplitude difference" (Final Act. 6).
The Examiner finds that "Chan teaches a system and method for
venous pulse oximetry comprising determining disease state based at least in
part on venous saturation([] where elevated Sv02 measures at rest may
indicate reduced tissue perfusion due to impaired blood flow and depressed
Sv02 measures may suggest tissue dysfunction;[] where Sv02 measurement
will enhance the monitoring of hypoxia in a range of conditions), which
Mills [] discloses can be calculated from the baseline difference and on the
amplitude difference" (id.; citing Chan i-fi-1 101, 102).
The Examiner concludes that it would have been obvious "to modify
the method/ device of Mills [] with determining a disease state based at least
in part on Sv02 as taught by Chan in order to provide the predictable results
of examining the severity of injury and functional compromise resulting
from trauma to be examined more easily, and allowing judgments to be
made about the viability of tissue during trauma or disease" (Final Act. 7;
citing Chan ii 101 ).
The Examiner also finds that Mills teaches an output device where
results from a signal processor are sent to a display, and concludes that it
would have been obvious "to communicate the disease state to an output
device to provide the predictable results of providing an indication of a
patient's disease state to a medical professional so that medical assistance or
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intervention can be provided when necessary" (Final Act. 7; citing Mills,
Fig. 1, ii 153).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Mills and Chan render the
claims prima facie obvious?
Findings of Fact
1. Mills teaches
methods for noninvasively monitoring physiological
characteristics of a patient's blood. Determinations of blood
constituent concentrations may be made by comparing
absorbance of radiation at varying parameters, such as path
length and blood pressure. Preferably, changes in pressure are
effected by changing the height of the probes relative to the
patient's heart.
(Mills, Abstract; see also Final Act. 5---6.)
2. Mills teaches
providing a tissue probe having a radiation emitter with a
wavelength and a detector configured to receive the wavelength
after absorbance through a path length of the patient's blood;
measuring absorbance of the patient's blood by emitting and
detecting radiation after passage through the patient's blood;
varying the path length [] to provide multiples of path length;
measuring absorbance of the patient's blood at each multiple of
the path length; and determining the concentration of the blood
constituent based upon the changing absorbance.
(Mills ii 14; see also Final Act. 5---6.)
3. Mills teaches
[making] measurements of both total absorbance and pulsatile
absorbance. Raise the probe a known distance. Again measure
both total absorbance and pulsatile absorbance. Both will be
decreased. This is because the pulse amplitude is less because
the arterial blood pressure within the probe is less (due to
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decrease in hydrostatic pressure). However, the total
absorbance will also decrease, as the distending pressure in the
venous system is less, and hence the veins and venules are
smaller. All changes in absorbance can be assumed to be due to
changes in blood volume. Saturation is calculated using the
ratios of absorbance of distinct wavelengths.
(Mills i-f 194; see also Final Act. 5---6.)
4. Chan teaches that
[p ]ulse oximetry is one of the main applications of
photoplethysmography (PPG), and is widely used for the
measurement of arterial oxygen saturation, Sp02. The PPG
waveform contains two components, one which is attributable
to the pulsatile component in the vessels, i.e. the arterial pulse,
is caused by the heartbeat and gives a rapidly alternating signal
(AC component), and the other is due to the blood volume and
its change in the skin and gives a steady signal that only
changes slowly (DC component).
(Chan i-f 6.)
5. Chan teaches that
[t]he diagnosis and monitoring of vascular disease and
circulatory function will be enhanced by the availability of
Sv02 measurement. Elevated Sv02 measures at rest may
indicate reduced tissue perfusion due to impaired blood flow.
Monitoring venous oxygen saturation will therefore allow the
severity of injury and functional compromise resulting from
trauma to be examined more easily. Depressed Sv02 measures
may suggest tissue dysfunction and monitoring will allow
judgements to be made about the viability of tissue during
trauma or disease.
(Id. at i-f 101; see also Final Act. 6-7.)
6. Chan teaches that "Sv02 measurement will enhance the
monitoring of hypoxia in a range of conditions" (Chan i-f 102; see also Final
Act. 6).
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7. Figure 5 of the Specification is reproduced below:
PPG signal 500 may include a mean baseline value of Bl and
an amplitude of Al when the patient is stable or at rest (e.g.,
when the patient's finger is level with the patient's heart). Each
pulse of PPG signal 500 may correspond to one cardiac cycle
and may include a primary peak 510 and a dicrotic notch 520.
PPG signal 500 may change when a load is induced on the
patient's vascular system. For example, at time tl, the patient
may raise the hand to which sensor [] may be coupled, which
may change the baseline and the amplitude of PPG signal 500.
The baseline of PPG signal 500 may increase by an amount B
to a new baseline mean B2 as the venous blood drains from the
raised limb, including the finger to which sensor 12 may be
coupled. The amplitude of PPG signal 500 may be A2 after the
limb is elevated, where A2 may be greater than initial
amplitude Al, as the vessels in the elevated limb become more
free to expand because the elevated limb contains less blood at
lower pressure.
(Spec. Fig. 5, i-fi-163, 64; see also App. Br. 11-12.)
Principles of Law
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
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art in the light of the Specification. See Jn re Sneed, 710 F .2d 1544, 1548
(Fed. Cir. 1983).
Analysis
Claims 1, 2, 5, 8, 11, 15, 18, and 20
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 5-12; FF 1---6) and agree that
the claims are obvious over Mills and Chan. We address Appellants'
arguments below.
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the requirement for "a first baseline value" and "a second baseline
value" in claim 1. Appellants contend that "the total absorbance discussed
in Mills is not the same as [Appellants'] claimed baseline values" because
Appellants' Figure 5 and Specification at page 23, lines 10-23 "make clear
to what baseline value refers" (App. Br. 11-12; see also Reply Br. 2-3; see
also FF 7). More particularly, Appellants contend that:
according to [A ]ppellants' disclosure, a baseline value (e.g., as
represented by Bland B2 in FIG. 5 of [A]ppellants' disclosure)
refers to that portion of the signal that does not include the
pulsatile (i.e., the AC) component (e.g., as represented by
amplitudes Al and A2 in FIG. 5 of [A]ppellants' disclosure).
(App. Br. 12; see also Reply Br. 2-3; see also FF 7.)
Appellants then contend that
even assuming, arguendo, that the term "baseline" must be
given its broadest reasonable interpretation consistent with the
specification, then such definition must be within the context of
signal processing of pulsatile signals. This is the fundamental
context of Appellants' disclosure and invention. In this context,
the term baseline still means that portion of a signal, which
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does not include the pulsatile component. See, e.g.,
Telecommunications: Glossary of Telecommunication Terms,
Federal Standard 1037C, Published August 7, 1996
(http://www.its.bldrdoc.gov/fs-1037 /fs-1037c.htm) (defining
the term "pulse" as "[a] rapid, transient change in the amplitude
of a signal from a baseline value to a higher or lower value,
followed by a rapid return to the baseline value" (emphasis
added)).
(Reply Br. 3.) Appellants next contend that the Examiner relies on an
incomplete dictionary definition of the term "baseline," and acknowledge
that there are other dictionary definitions of this term (id.).
The Examiner finds that Appellants' Specification "does not disclose
[that] the baseline refers to a 'DC' portion of the signal, or [to] the portion of
the signal that does not include the pulsatile component" (Ans. 4). More
particularly, the Examiner explains that
(Id.)
[Appellants disclose] measuring a first mean baseline value
(B 1) and amplitude (Al) of a PPG signal, inducing a load on
the vascular system; and measuring a second mean baseline
value (B2) and amplitude (A2) of the PPG signal. The pre-load
values (B 1 and Al) are compared to the post-load values (B2
and A2, respectively) to determine the extent to which the PPG
signal changes with the induced load (paragraphs [0063]-
[0065]). A "baseline" is broadly defined as "a set of critical
observations or data used for comparison or control" (Merriam-
Webster 's Collegiate Dictionary, 10th Edition, 1998), which is
consistent with [Appellants'] disclosure.
We find that the Examiner has the better position. "[D]uring patent
prosecution when claims can be amended, ambiguities should be recognized,
scope and breadth of language explored, and clarification imposed." In re
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Zietz, 893 F.2d 319, 321 (Fed. Cir. 1989). Here, the ambiguity at issue is
whether "baseline value" refers to that portion of the signal that does not
include the pulsatile/ AC/amplitude component. As the Examiner notes,
Appellants' Specification does not disclose that the baseline refers to a DC
portion of the signal or exclude the pulsatile component (Ans. 4). The
Examiner further notes that the Specification, in describing Figure 5, teaches
measuring mean baseline values and that "baseline" is broadly defined as "a
set of critical observations or data used for comparison or control" according
to Merriam- Webster's Collegiate Dictionary, 10th Edition (id.; see also FF
7).
Thus, at best, the baseline values B 1 and B2 as depicted in
Appellants' Figure 5 are mean baseline values, and the term "baseline value"
may be interpreted more broadly than a portion of the signal that does not
include the pulsatile/AC/amplitude component. See In re Morris, 127 F.3d
1048, 1054--56 (Fed. Cir. 1997) ("Absent an express definition in their
specification, the fact that appellants can point to definitions or usages that
conform to their interpretation does not make the PTO' s definition
unreasonable when the PTO can point to other sources that support its
interpretation.")
We, therefore, conclude that the broadest reasonable interpretation of
the term "baseline value," in light of the absence of any limiting definition in
the Specification and the multiple dictionary definitions, is a requirement for
a value that is based on "a set of critical observations or data used for
comparison or contro 1."
We next address Appellants' contention that "the total absorbance
discussed in Mills is not the same as [A ]ppellants' claimed baseline values"
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because of the Examiner's interpretation of "baseline value" (App. Br. 11-
12). Appellants contend that:
[t]he term "absorbance," as used by Mills, refers to radiation
absorbed by a path length of a patient's blood (see Mills,
paragraphs [0014], and [0015]). The term "total" means
"comprising or constituting a whole: entire" (Merriam-
Webster 's Collegiate Dictionary, 10th Edition, 2001).
Therefore, "total absorbance" refers to the entire absorbance of
radiation by a path length of a patient's blood, including
absorbance by both arterial blood (i.e., associated with the
pulsatile component of the absorption signal) as well as venous
blood (i.e., associated with the non-pulsatile component of the
absorption signal).
(Id. at 13.) Appellants then contend that Mills does not refer to a non-
pulsatile absorbance but instead refers to all of the absorbance for its term
"total absorbance" because Mills uses "baseline" elsewhere in its disclosure
to refer to a non-pulsatile component, that Mills does not teach analyzing a
signal to determine a first baseline value at a point before or while a load is
induced and a second baseline value at a point after the load is induced, and
that even under the Examiner's definition of "baseline," Mills' "total
absorbance" is not used for comparison or control (id.; see also Reply Br. 3-
4)
This argument is not persuasive because it relies on Appellants' prior
contention that the Examiner improperly interpreted Appellants' term
"baseline value." As discussed above, we find that the broadest reasonable
interpretation of the term "baseline value" does not require that the
amplitude/ AC/pulsatile component be excluded. Further, we agree with the
Examiner that:
Mills discloses a determination of venous saturation and
pressure compnsmg, pnor to inducing a load, making
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measurements of both total absorbance (i.e., "baseline") and
pulsatile absorbance (i.e., "amplitude") of a PPG signal;
inducing a load by raising the probe a known distance; after
inducing the load, making a second measurement of both total
absorbance (baseline) and pulsatile absorbance (amplitude) of
the PPG signal; and calculating a difference between the first
and second total absorbance (baseline) values and a difference
between first and second pulsatile absorbance (amplitude)
values ([0194] where the changes in absorbance (i.e.,
differences) are assumed to be due to changes in blood volume
and utilized to calculate saturation). The total absorbance
values measured pre-load and post-load (i.e., before and after
raising the probe, respectively) by Mills are observations or
data used for comparison.
(Ans. 4--5; see also FF 3.) Therefore, we are not persuaded by Appellants'
contention that Mills does not teach Appellants' claimed baseline values
because its "total absorbance" does not refer to a non-pulsatile absorbance,
and that Mills does not teach analyzing a signal to determine a first baseline
value at a point before or while a load is induced and a second baseline value
at a point after the load is induced. Concerning Appellants' contention that
Mills does not meet the Examiner's own definition of a baseline, we are not
persuaded because as explained above, Mills teaches comparing a total
absorbance at one point in time to one at another point in time (Ans. 4--5; see
also FF 3). "[L ]imitations are not to be read into the claims from the
specification." In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). See
In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail
from the outset because ... they are not based on limitations appearing in the
claims.")
Appellants do not contend that the Examiner erred in combining the
teachings of Mills and Chan other than the reasons discussed above.
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Conclusion ofLaw
The evidence of record supports the Examiner's conclusion that Mills
and Chan render the claims 1, 11, and 20 prima facie obvious. Appellants
do not argue separately the claims for this obviousness rejection. Therefore,
claims 2, 5, and 8 fall with claim 1, and claims 15 and 18 fall with claim 11.
Claims 6, 9, 16, and 19
Appellants contend that "[t]he rejection of claims 6, 9, 16, and 19[],
which depend from claims 1 and 11 should be overturned for at least those
reasons the rejection of claims 1 and 11 should be overturned" (App. Br.
15). Having affirmed the obviousness rejections of claims 1 and 11, over
Mills and Chan for the reasons given above, we therefore, affirm the
rejection of claims 6, 9, 16, and 19.
Claims 7, 10, and 17
Appellants contend that "[t]he rejection of claims 7, 10, and 17, which
depend from claims 1 and 11 should be overturned for at least those reasons
the rejection of claims 1 and 11 should be overturned" (App. Br. 16).
Having affirmed the obviousness rejections of claims 1 and 11, over Mills
and Chan for the reasons given above, we therefore, affirm the rejection of
claims 7, 10, and 17.
SUMMARY
In summary, we affirm the rejection of claims 1, 2, 5, 8, 11, 15, 18,
and 20 under 35 U.S.C. § 103(a) as obvious over Mills and Chan.
We affirm the rejection of claims 6, 9, 16, and 19 under 35 U.S.C.
§ 103(a) as obvious over Mills, Chan, and Chellappan.
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We atlirm the rejection of claims 7, 10, and 17 under 35 U.S.C.
§ 103(a) as obvious over Mills, Chan, and Addison.
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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