Ex Parte Zhang et al

Patent Trial and Appeal Board

Sep 19, 2017

13367924 (P.T.A.B. Sep. 19, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/367,924 02/07/2012 Yunlong Zhang 279.K60US2 6955
45458 7590 09/21/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 TOTH, KAREN E
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
09/21/2017 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):
uspto@slwip.com
SLW @blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUNLONG ZHANG and MARK SCHWARTZ
Appeal 2016-004989
Application 13/3 67,9241
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and TAWEN CHANG,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1—8, 11, 13—17,
19, 21, and 22 (May 26, 2015 Notice of Appeal). Examiner entered
rejections under 35 U.S.C. § 112, second paragraph, the enablement
provision of 35 U.S.C. § 112, first paragraph, and 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the real party in interest as “Cardiac Pacemakers, Inc.”
(App. Br. 2).
Appeal 2016-004989
Application 13/367,924
STATEMENT OF THE CASE
Appellants’ disclosure “relates generally to medical devices, and more
particularly to detecting autonomic activities with implantable medical
devices” (Spec. 12). Claim 1 is representative and reproduced below:
1. A method, comprising:
detecting a change in posture of a patient’s body using a
posture sensor;
determining autonomic imbalance of the patient using an
implantable medical device, wherein determining the
autonomic imbalance of the patient includes performing a
baroreflex sensitivity analysis (BSA) based on blood pressure
and cardiac signals measured during a time period
corresponding to the change in posture, and performing the
BSA includes measuring intervals between heartbeats at least
during the time period corresponding to the change in posture
and determining a rate of change of systolic blood pressure
relative to the intervals during the time period corresponding to
the change in posture;
delivering therapeutic electrical stimulation from the
implantable medical device to the heart of the patient; and
modifying the therapeutic electrical stimulation using an
outcome of the BSA.
(App. Br. 21.)
The claims stand rejected as follows:
Claims 1—8, 11, 13—17, 19, 21, and 22 stand rejected under 35 U.S.C.
§112, second paragraph.
Claims 1—8, 11, 13—17, 19, 21, and 22 stand rejected under the
enablement provision of 35 U.S.C. § 112, first paragraph.
2
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Claims 1—3, 7, 8, 13, 16, 17, 19, 21, and222 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination of Virag,3 Ogoh,4
and Baumann.5
Claims 4—6 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Virag, Ogoh, Baumann, and Aboul-Hosn.6
Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Virag, Ogoh, Baumann, and Robbe.7
Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Virag, Ogoh, Baumann, and Fukui.8
Definiteness'.
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellants claims are indefinite?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose
detecting the change in posture via the implantable device
involves detecting the change in posture via at least one of a
2 We recognize that Examiner included canceled claim 23 in the statement of
rejection (see Final Act. 5; Ans. 5; cfi Appellants’ Oct. 14, 2014 Amendment
and Response under 37 C.F.R. § 1.111 6 (canceling claim 23)). We did not
include canceled claim 23 in our deliberations.
3 Virag et al., US 2004/0215263 Al, published Oct. 28, 2004.
4 S. Ogoh et al., Haemodynamic changes during neck pressure and suction
in seated and supine positions, 540.2 J. Physiol. 707—716 (2002).
5 Baumann et al., US 2002/0058877 Al, published May 16, 2002.
6 Aboul-Hosn et al., US 6,935,344 Bl, issued Aug. 30, 2005.
7 H.W. Robbe et al., Assessment of baroreceptor reflex sensitivity by means
of spectral analysis, 10 Hypertension 538—543 (1987).
8Fukui, US 2007/0185536 Al, published Aug. 9, 2007.
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Appeal 2016-004989
Application 13/367,924
piezoelectric sensor and a mechanical sensor. Determining the
autonomic imbalance of the patient may involve performing a
baroreflex sensitivity analysis (BSA) based on blood pressure
and cardiac signals measured during a time period
corresponding to the posture change. Performing the BSA may
involve measuring intervals between heartbeats at least during
the time period corresponding to the posture change and/or
performing a power spectral analysis on the intervals between
the heartbeats (e.g., R-R intervals). In other variations,
performing the BSA involves determining a rate of change of
systolic blood pressure relative to the intervals during the time
period corresponding to the posture change. The method may
also involve determining the patient’s susceptibility to heart
disease, arrhythmia, and/or sudden cardiac death based on the
autonomic tone.
(Spec. 19 (emphasis added).)
FF 2. Appellants disclose that when “systolic blood pressure is plotted
against the subsequent R-R interval during the period over which posture
change is detected[,] [t]he slope [] of this relationship is calculated and used
to analyze baroreflex sensitivity” {id. 1 63).
FF 3. Appellants disclose that when a “patient’s R-R interval is plotted as a
function of time[ and] [pjosture change is a trigger of the baroreflex[;] []
baroreflex sensitivity is determined as the slope [] of this plot in a time
period roughly corresponding to [the] change in posture” {id. 1 64).
ANALYSIS
Examiner recognizes that “[c]laim 1 calls for performing a baroreflex
sensitivity analysis during a time period corresponding to [a] change in
posture,” but, nevertheless, finds that “[i]t is not clear what time period is
being analyzed, or how one determines the exact metes and bounds of such a
period” (Ans. 3—4, citing Spec. ^fl[ 63 and 64; see also Ans. 12 (“As
[Appellants’] claim language uses both ‘during’ and ‘corresponding to’ to
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Appeal 2016-004989
Application 13/367,924
describe the relationship of the data to the posture change, it is not clear
which set of data is to be collected . . We are not persuaded.
As Appellants explain, notwithstanding Examiner’s assertion to the
contrary, Appellants’:
claim 1 recites “performing a baroreflex sensitivity analysis
(BSA) based on blood pressure and cardiac signals measured
during a time period corresponding to the change in posture”,
rather than “performing a baroreflex sensitivity analysis (BSA)
during a time period corresponding to the change in posture”
(as alleged by the Examiner and quoted above). In other words,
claim 1 recites signals measured during the time period rather
than [a] BSA performed during the time period.
(App. Br. 10; see FF 1—3.) Further, we agree with Appellants’ contention
that Examiner improperly based the rejection on a reading of “selected
portions of [Appellants’] [Specification,” which are taken out of the context
of Appellants’ full disclosure (see Reply Br. 5).
We are not persuaded by Examiner’s assertion that because
Appellants’ “[cjlaim 1 [] calls for determining a rate of change of systolic
blood pressure relative to intervals;” and Appellants’
disclosure . . . calls for determining a slope of blood pressures
plotted against subsequent intervals[,] [i]t is not clear what
values are used and how they relate to each other in the BSA
(matching or “subsequent” timepoints); further, it is not clear
how the relationship of “subsequent” data would be determined
and plotted.
(Ans. 4; see id. at 12—13.) Examiner’s assertion appears to improperly read
selected portions of Appellants’ Specification out of the context of
Appellants’ full disclosure (see Ans. 4 and 12—13; cf., e.g., FF 1—3; see
generally App. Br. 11—12).
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Application 13/367,924
Examiner finds that Appellants’ “claim 1 refers to measured blood
pressure signals, but performs a calculation using systolic blood pressure”
(Ans. 4). In this regard, Examiner finds that
systolic blood pressure has not been measured, nor is it clear
how the systolic blood pressure is related to the measured blood
pressure, whether it is derived from the general blood pressure
measurement, or a separate measurement is somehow
performed and the other general blood pressure measurement is
performed but not used.
{Id. 4; see id. at 12.) We are not persuaded.
Claims are in compliance with 35 U.S.C. § 112, second paragraph, if
“the claims, read in light of the specification, reasonably apprise those
skilled in the art and are as precise as the subject matter permits.”
Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385 (Fed.
Cir. 1986). As Appellants state, “the relationship between ‘blood pressure’
and ‘systolic blood pressure’ is within the knowledge of one of skill in the
art and allows one of skill in the art to determine systolic blood pressure, for
example, using the measured blood pressure” (App. Br. 11).
CONCLUSION OF LAW
The preponderance of evidence fails to support Examiner’s conclusion
that Appellants’ claims are indefinite. The rejection of claims 1—8, 11, 13—
17, 19, 21, and 22 under 35 U.S.C. § 112, second paragraph is reversed.
Enablement.
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention?
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Application 13/367,924
ANALYSIS
The enablement test determines “whether one reasonably skilled in
the art could make or use the invention from the disclosures in the patent
[application] coupled with information known in the art without undue
experimentation.” United States v. Telectronics, Inc., 857 F.2d 778, 785
(Fed. Cir. 1988). Appellants’ Specification “need not teach, and preferably
omits what is well known in the art.” Hybritech, 802 F.2d at 1384. On this
record, Examiner asserts that Appellants’ Specification fails to provide an
enabling disclosure of Appellants’ claimed invention for two reasons.
First, Examiner finds that although Appellants’ Specification discloses
measuring blood pressure, Appellants’ Specification fails to enable the
determination of a systolic blood pressure “from overall blood pressure
measurements” (Ans. 2—3). We are not persuaded. As Appellants explain,
“‘[b]lood pressure’ and ‘systolic blood pressure’ are both terms of the art,
and it is known in the art that systolic blood pressure is the blood pressure
when the heart contacts (systole), and measured as the peak in the blood
pressure signal” and “one reasonably skilled in the art could obtain the
‘systolic blood pressure relative to the intervals during the time period
corresponding to the change in posture’ with information known in the art
without undue experimentation” (App. Br. 8). While there may be, as
Examiner asserts, “a number of [] techniques for blood pressure
measurement that do not provide obvious routes to identification of systolic
pressure,” Examiner fails to explain why a person of ordinary skill in this art
would have considered any of these techniques to obtain a blood pressure
measurement that required the identification of systolic pressure (see Ans.
10).
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Second, Examiner finds that Appellants’ “disclosure merely generally
calls for performing [a rate of change of blood pressure relative to R-R
intervals] calculation, without providing any instructions or steps for doing
so, even though the numerous methods of determining rate of change of a set
of data points would provide drastically different results” (Ans. 3; see also
id. at 11). We are not persuaded. Examiner bears the initial burden of
providing reasons why a supporting disclosure does not enable a claim. In
re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). As Appellants explain,
Examiner
did not show any basis supporting the allegation that (1) “the
numerous methods of determining rate of change of a set of
data points would provide drastically different results”, and (2)
whether or how the alleged “drastically different results” would
prevent those skilled in the art from making and using the
invention.
(App. Br. 9.)
CONCLUSION OF LAW
The evidence of record fails to support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention.
The rejection of claims 1—3, 7, 8, 13, 16, 17, 19, 21, and 22 under the
enablement provision of 35 U.S.C. § 112, first paragraph is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
8
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Application 13/367,924
FACTUAL FINDINGS (FF)
FF 4. Examiner finds that the combination of Virag and Ogoh discloses
Appellants’ claimed invention, including “forming a baseline data set from
long-term measurements of posture changes and baroreflex responses,” but
fails to suggest the performance of BSA “based on blood pressure and
cardiac signals measured during a time period corresponding to the posture
change” and relies on Baumann to make up for this deficiency in the
combination of Virag and Ogoh (Ans. 6; see also id. at 5).
FF 5. Baumann “relates generally to a method and apparatus for assessing
baroreflex sensitivity . . (Baumann 12).
FF 6. Baumann’s Figure 2A is reproduced below:
............./W ...A .........<&......... V 0 ^
0 v
<>
' 0 0
0
0
BRS=0,S3
A PP {mroHg}
FIG. 2A
Baumann’s FIG. 2A “is a graph showing a line whose slope is indicative of
the BRS of a chronic heart failure patient” (Baumann 114).
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Appeal 2016-004989
Application 13/367,924
FF 7. Baumann’s Figure 2B is reproduced below:
s> JkA
0, wk■
$ $
A►
> BKi
______J
f3.7B
• 6 -3 0 3 6
a pp immHg}
FIG. 2B
Baumann’s FIG. 2B “is a graph showing a line whose slope is indicative of
the BRS of a patient having better health than the patient of FIG. 2 A”
(Baumann^ 15).
FF 8. Baumann discloses:
To establish a line having a slope representative of BRS, a
plurality of points are plotted from the transient change in cycle
length [(A CL (ms))] versus a transient change in pulse pressure
[(A PP (mmHg))] resulting from a pacing stimulus . . . using
linear regression. The slope of the regression line is equal to
the BRS of the particular patient.
(Baumann 120; see id. ! 22; see Ans. 6 (“cycle length is the interval
between heartbeats”).)
FF 9. Baumann discloses:
[P]ulse pressure is any measure of the patient’s blood pressure.
For purposes of [Baumann’s disclosure], pulse pressure may
include any measure indicative of blood pressure, including
direct measurements and methods which correlate other
measured parameters to blood pressure. Blood pressure, for
purposes of the present invention, includes systolic pressure,
diastolic pressure, pulse pressure, and mean pressure. Systolic
pressure includes maximum systolic pressure and end-systolic
pressure. Diastolic pressure includes minimum diastolic
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Appeal 2016-004989
Application 13/367,924
pressure and end-diastolic pressure. Pulse pressure includes
systolic pressure minus diastolic pressure. The pulse pressure
is typically measured with an implanted or an external pressure
sensor . . ., [wherein] the sensor can utilize a variety of methods
to measure blood pressure, including methods that correlate
other measured parameters to blood pressure.
(Baumann 123.)
FF 10. Examiner finds that the combination of Virag, Ogoh, and Baumann
fails to disclose “measuring [] blood pressure comprising measuring via a
force transducer sensitive to blood vessel displacement in the form of a
stent-like element capable of implantation” and relies on Aboul-Hosn to
make up for this deficiency in the combination of Virag, Ogoh, and
Baumann (Ans. 8).
FF 11. Examiner finds that the combination of Virag, Ogoh, and Baumann
fails to disclose the performance of “a power spectral analysis on the
intervals between [] heartbeats” and relies on Robbe to make up for this
deficiency in the combination of Virag, Ogoh, and Baumann (Ans. 9).
FF 12. Examiner finds that the combination of Virag, Ogoh, and Baumann
fails to disclose the determination of “the patient’s susceptibility to heart
disease comprising determining the patient’s susceptibility to arrhythmia or
sudden cardiac death based on the [patient’s] autonomic imbalance” and
relies on Fukui to make up for this deficiency in the combination of Virag,
Ogoh, and Baumann (Ans. 9).
ANALYSIS
The combination of Virag, Ogoh, and Baumann'.
Appellants’ claim 1 is reproduced above.
Based on the combination of Virag, Ogoh, and Baumann, Examiner
concludes that, at the time Appellants’ invention was made, it would have
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Application 13/367,924
been prima facie obvious to base the baroreflex sensitivity analysis
suggested by the combination of Virag and Ogoh “on the relationship
between blood pressure and heartbeat intervals measured during a time
period corresponding to [] posture change, as taught by Baumann, in order to
obtain further information about [a] patient” (Ans. 6; see FF 4—9). In this
regard, Examiner finds that
Baumann teaches using baroreceptor responses including blood
pressure and cardiac signals to perform a baroreflex sensitivity
analysis . . . including measuring intervals between heartbeats
(the parameter ACL, which is a measure of change of cycle
length; cycle length is the interval between heartbeats) and
determining a rate of change of blood pressure relative to the
intervals during the posture change period ([Baumann’s] figures
2A and 2B, [] show the relationship between blood pressure and
intervals . . .).
(Ans. 6; cf FF 4—9.) We note, however, that in order for Examiner to have
drawn Baumann’s disclosure within the scope of Appellants’ claimed
invention, Examiner interpreted Baumann’s: (a) change in pulse pressure or
blood pressure to read on the systolic blood pressure element of Appellants’
claimed invention and (b) change in cycle length to read on the intervals
between heartbeats element of Appellants’ claimed invention (see Ans. 6; cf.
App. Br. 21).
As Appellants explain, however, “Baumann’s transient change in
pulse pressure ... is not equivalent to [] systolic blood pressure ...” (App.
Br. 14; see Reply Br. 6; see generally FF 6—9). In this regard, Appellants
contend that “Baumann’s statement that ‘[b]lood pressure, for purposes of
the present invention, includes systolic pressure, diastolic pressure, pulse
pressure, and mean pressure’, as quoted by the Examiner, is not a teaching
or suggestion that systolic pressure is equivalent to pulse pressure” (App. Br.
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Application 13/367,924
16 (alteration original); see Reply Br. 6; see generally Ans. 11 and 13; see
also FF 9 (stating that “[pjulse pressure includes systolic pressure minus
diastolic pressure” (emphasis added)); App. Br. 14).
In addition, Appellants contend that “regardless of [the] difference
between pulse pressure and systolic blood pressure, [Appellants’] claim 1
recites ‘systolic blood pressure’ rather than [a] change in pressure” as
disclosed by Baumann (Reply Br. 6; see also App. Br. 14). Similarly,
“Baumann’s transient change in cycle length is not equivalent to the
intervals between heart beats as recited in [Appellants’] claim 1 . . .” (App.
Br. 16; see Reply Br. 7; FF 5—8).
Examiner, however, dismisses Appellants’ contentions asserting that
Baumann discloses that “pressure” may be “any measure of blood pressure
including systolic pressure” (Ans. 11; see FF 9). In this regard, Examiner
asserts that Appellants have “not shown any criticality to the usage of
systolic pressure relative to any other pressure, even if Baumann had not
already taught its usage” (Ans. 13).
In addition, Examiner asserts that although Baumann discloses the use
of, inter alia, a change in pulse pressure as opposed to systolic blood
pressure itself; “changes in pressure are still pressures” (Ans. 14 (emphasis
added)). Thus, Examiner concludes that “Baumann teaches that one would
look to th[e] relationship between the measured parameters of blood
pressure (such as a systolic pressure) and a cycle length when analyzing
baroreflex sensitivity” (Ans. 14). Appellants make clear, however, that
Examiner’s conclusion misses the mark, because Appellants’ claimed
invention requires “‘a rate of change of systolic blood pressure relative to
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Application 13/367,924
the intervals’ rather than merely [a] ‘relationship between the pressures and
the cycle lengths’” (Reply Br. 7).
In sum, Examiner established an evidentiary basis to support a
conclusion that a baroreflex sensitivity analysis may account for a
relationship between a: (a) change in pulse pressure, which may include
systolic pressure, and (b) change in the intervals between heartbeats (see FF
4— 9). From this evidence Examiner seemingly infers that a baroreflex
sensitivity analysis may include determining a rate of change of systolic
blood pressure (as opposed to a change in pressure) relative to the intervals
between heartbeats (as opposed to a change in heartbeat interval) (see Ans.
5— 6 and 13-14; see generally FF 2 (when “systolic blood pressure is plotted
against the [intervals between heartbeats] during the period over which
posture change is detected[,] [t]he slope [] of this relationship is calculated
and used to analyze baroreflex sensitivity”)).
Examiner, however, failed to adequately explain the evidentiary
foundation for Examiner’s inferences, which, as discussed above, were
expressly challenged by Appellants. See In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006) (“rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.”). In this regard, we note that it is Examiner’s “initial burden,
on review of the prior art. . ., [to] present[] a prima facie case of
unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Further, although this
Board has subject matter expertise, [] the Board cannot accept
general conclusions about what is “basic knowledge” or
“common sense” as a replacement for documentary evidence
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Application 13/367,924
for core factual findings in a determination of patentability. . . .
To hold otherwise would be to embark down a slippery slope
which would permit the examining process to deviate from the
well-established and time-honored requirement that rejections
be supported by evidence. It would also ultimately “render the
process of appellate review for substantial evidence on the
record a meaningless exercise.”
K/SHimpp v. Hear-Wear Technologies, LLC, 751 F.3d 1362, 1366 (Fed.
Cir. 2014), quoting In re Zurko, 258 F.3d 1379, 1385—86 (Fed. Cir. 2001);
see generally Manual of Patent Examining Procedure § 2144.03(C) (“If
applicant adequately traverses the examiner’s assertion of official notice, the
examiner must provide documentary evidence in the next Office action if the
rejection is to be maintained”).
Therefore, because Examiner failed to explain how the evidence relied
upon unambiguously relates to each element of Appellants’ claimed
invention we are compelled to reverse the rejection over the combination of
Virag, Ogoh, and Baumann.
The combination of Virag, Ogoh, Baumann, and Aboul-Hosn:
Based on the combination of Virag, Ogoh, Baumann, and Aboul-
Hosn, Examiner concludes that, at the time Appellants’ invention was made,
it would have been prima facie obvious to modify the method suggested by
the combination of Virag, Ogoh, and Baumann to “perform[] the blood
pressure measurement with a pressure sensor comprising a force transducer
in the form of a stent-like element, as taught by Aboul-Hosn, in order to
obtain measurements with minimal blood flow interference . . .” (Ans. 8).
We are not persuaded.
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As Appellants’ explain, Examiner failed to establish that Aboul-Hosn
makes up for the deficiencies in the combination of Virag, Ogoh, and
Baumann discussed above (see App. Br. 18).
The combination of Virag, Ogoh, Baumann, and Robbe:
Appellants’ claim 11 depends from and further limits Appellants’
“claim 1, wherein performing the BSA comprises performing a power
spectral analysis on the intervals between the heartbeats” (App. Br. 22).
Based on the combination of Virag, Ogoh, Baumann, and Robbe,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie obvious to modify the method suggested by the
combination of Virag, Ogoh, and Baumann to perform “a power spectral
analysis on the intervals between the heartbeats, as taught by Robbe, in order
to obtain the BSA results” (Ans. 9). We are not persuaded.
As Appellants’ explain, Examiner failed to establish that Robbe
makes up for the deficiencies in the combination of Virag, Ogoh, and
Baumann discussed above (see App. Br. 19).
The combination of Virag, Ogoh, Baumann, andFukui:
Appellants’ claims 14 and 15 both depends ultimately from and
further limit Appellants’ claim 1, to require “wherein determining the
patient’s susceptibility to heart disease comprises determining the patient’s
susceptibility to arrhythmia [(claim 14) or sudden cardiac death (claim 15)]
based on the autonomic imbalance” (App. Br. 22).
Based on the combination of Virag, Ogoh, Baumann, and Fukui,
Examiner concludes that, at the time Appellants’ invention was made, it
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would have been prima facie obvious to modify the method suggested by the
combination of Virag, Ogoh, and Baumann to “determine^ [a] patient’s
susceptibility to arrhythmia or sudden cardiac death based on [a patient’s]
autonomic imbalance, as taught by Fukui, in order to prevent the patient’s
death” (Ans. 9). We are not persuaded.
As Appellants’ explain, Examiner failed to establish that Fukui makes
up for the deficiencies in the combination of Virag, Ogoh, and Baumann
discussed above (see App. Br. 19).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1—3, 7, 8, 13, 16, 17, 19, 21, and 22 under
35 U.S.C. § 103(a) as unpatentable over the combination of Virag, Ogoh,
and Baumann is reversed.
The rejection of claims 4—6 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Virag, Ogoh, Baumann, and Aboul-Hosn is
reversed.
The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Virag, Ogoh, Baumann, and Robbe is reversed.
The rejection of claims 14 and 15 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Virag, Ogoh, Baumann, and Fukui is
reversed.
REVERSED
17