Ex Parte Shennib

Patent Trial and Appeal Board

Jun 11, 2013

11131574 (P.T.A.B. Jun. 11, 2013)

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.
11/131,574 05/17/2005 Adnan Shennib 5669
7590 06/11/2013
ADNAN SHENNIB/CARDIOVU, INC.
4101-F #111 DUBLIN BLVD.
DUBLIN, CA 94568
EXAMINER
HELLER, TAMMIE K
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
06/11/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ADNAN SHENNIB
____________

Appeal 2011-001128
Application 11/131,574
Technology Center 3700
____________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1-8, 10-18, and 22-26
(App. Br. 4; Reply Br. 2; Ans. 2). Examiner entered rejections under 35
U.S.C. § 112, first paragraph, 35 U.S.C. § 102(b), and 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The claims are directed to a disposable programmable cardiac
test/monitor patch and method of non-invasive cardiac monitoring. Claims

1 The Real Party in Interest is Cardiovu, Inc. (App. Br. 2).
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1, 18, and 22 are representative and are reproduced in the Claims Appendix
of Appellant’s Brief.
Claims 1-8 and 10-12 stand rejected under the enablement provision
of 35 U.S.C. § 112, first paragraph.
Claims 22 and 23 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Thompson.2
Claims 1-6, 8, 10-17, and 24-26 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Thompson and Del Mar.3
Claims 1-8, 10-17, and 24-26 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Nissila4 and Del Mar.
Claims 1-8, 10-17, and 22-26 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Platt5 and Del Mar.
Claim 18 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Thompson, Nissila, or Platt.
Claims 22 and 23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Nissila and Platt.

Enablement:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention?

2 Thompson, US 2003/0083559 A1, published May 1, 2003.
3 Del Mar et al., US 5,205,295, issued April 27, 1993.
4 Nissila, US 2002/0082491 A1, published June 27, 2002.
5 Platt et al., US 5,634,468, issued June 3, 1977.
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FACTUAL FINDINGS (FF)
FF 1. Appellant’s Specification discloses that “the programmable sensor
patch … is programmed by an external handheld programmer,” wherein
“programming parameters are selected by keypad … and displayed on the
display unit … of the programmer” (Spec. 9: ¶ [0034]; see also id. at
¶ [0034] (In an alternative embodiment “the patch programmer … is a
personal computer (PC) communicating wirelessly via radio frequency (FR)
signals … to send programmable parameters to [the] programmable
patch”)).
FF 2. Appellant’s Specification discloses that “[t]he physician, clinician or
medical researcher selects monitoring and detection parameters, referred to
here generally as parameters, which are programmed into the patch
according to the individual being evaluated or the individual group being
studied” (id. at ¶ [0033]).
FF 3. Examiner finds that Appellant’s “originally-filed specification fails
to disclose a ‘means for customizing said at least one programmable
monitoring parameter to said person or to an individual group that is being
monitored’” and “it is not known … what structural element is required to
satisfy this claim limitation” (Ans. 4).
ANALYSIS
Examiner finds that “while the external handheld programmer is
originally disclosed to perform programming operations, the programmer is
not discussed as it relates to customizing at least one programmable
monitoring parameter” (Ans. 18; see also FF 3). We are not persuaded. As
Appellant explains, the user selects parameters that are “programmed into
the patch according to the specific individual or group being studied or
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evaluated” (FF 2 (emphasis added)). Stated differently, the patch’s
programming is customized relative to the specific individual or groups
being studied or evaluated. Notwithstanding Examiner’s confusion
regarding the structural element that performs this function; Appellant’s
Specification discloses that the patch is programmed by use of a handheld
programmer or personal computer (FF 1).
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 1-8 and 10-12 under the enablement provision of 35
U.S.C. § 112, first paragraph is reversed.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Thompson teaches Appellant’s claimed invention?
FACTUAL FINDINGS (FF)
FF 4. Appellant discloses that “the patch is formed of a flexible circuit
substrate … with trace extensions to the electrodes…. Conductive gel …
covers the electrodes to conduct surface ECG potentials from the skin to the
electrodes … or alternatively [the electrodes may be] made for dry metal
contact with electrodes directly contacting the skin” (Spec. 10: ¶ [0037]).
FF 5. Examiner finds that Appellant’s claim 23 does not “require direct
skin contact, but simply require[s] direct electrical contact between two or
more electrodes of the patch and a person’s skin surface” (Ans. 19).
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FF 6. Thompson’s figure 3 is reproduced below:

FIG. 3 is a cross-sectional perspective view of Thompson’s peripheral
monitor patch (Thompson 3: ¶ [0022]).
FF 7. Thompson teaches that sensors 112a and b may represent: (1)
electric field sensors as suggested by Brun del Re or (2) non-acoustic pulse-
echo radar monitors as suggested by McEwan (id. at 4: ¶ [0040]-[0044]).
FF 8. In the context of electric field sensors, Thompson teaches that the
sensors are capacitive pickup electrodes, which “may be positioned at a
‘stand off’ location, spaced from intimate contact with the surface of the
body” allowing “body-generated electrical signals … [to] be acquired
without use of conductive gels and suction-based electrodes, without direct
electrical contact to the body and even through layers of clothing” (id. at 4:
¶ [0042] (emphasis added); see also Thompson 6: Claim 1 (“at least one
electrode positioned at a location spaced from intimate contact with a
surface of the patient’s body”) (emphasis added)).
ANALYSIS
Appellant’s claim 22 is drawn to a method of non-invasive cardiac
monitoring of a person implanted with a cardiac control device, wherein the
method comprises, inter alia, applying a self-adhered cardiac patch
comprising two or more electrodes that directly electrically contact said
person’s skin surface (Appellant’s Claim 22). Appellant’s claim 23 depends
from claim 22.
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Examiner provides the following three alternative rationales to
support a finding of anticipation:
(1) Thompson is not limited to capacitively-coupled (i.e. stand-off)
electrodes and Thompson’s reference to stand-off electrodes is “one
particular embodiment of … Thompson”;
(2) since electrodes 112a and b are components on Thompson’s
substrate 102, “when substrate 102 is directly affixed to the skin surface,
electrodes 112a and 112b would likewise be directly affixed to the skin
surface; and
(3) “even if the electrodes of Thompson are assumed to be limited to
… [stand-off electrodes,] direct electrical contact is in fact present as current
will flow directly between the electrodes and the body” (Ans. 19-20). We
are not persuaded.
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). Examiner failed to establish an evidentiary basis
on this record to support a finding that Thompson teaches that sensors 112a
and b may represent something other than: (1) electric field sensors as
suggested by Brun del Re or (2) non-acoustic pulse-echo radar monitors as
suggested by McEwan (see FF 7; see App. Br. 16 (“Nowhere does
Thompson refer to the electrode element directly contacting the skin.”)).
Therefore we are not persuaded by Examiner’s first rationale relating to the
scope of Thompson’s disclosure.
Thompson’s device allows body-generated electrical signals to be
acquired without direct electrical contact to the body (FF 8). Therefore, we
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are not persuaded by Examiner’s second rationale, which is counter to
Thompson’s disclosure (see App. Br. 18 (“Thompson basically employs the
concept of moving ECG charge indirectly from the skin (an electrode) to
another electrode via a gap which may be made of a dielectric material or air
(also a dielectric)”); see generally App. Br. 15-21).
Thompson’s stand-off electrodes are “spaced from intimate contact
with the surface of the body” (FF 8). Thompson characterizes this
configuration as not in direct electrical contact with the body (id.).
Therefore, we are not persuaded by Examiner’s third rationale, which is
counter to Thompson’s disclosure.
We recognize Examiner’s reliance on Kaufman,6 to establish “that a
capacitively-coupled electrode [such as that taught by Thompson] may
function either by directly contacting the skin or communicating electrical
signal through a dielectric” (Ans. 21-22). However, as Appellant explains,
“[t]he issue is not whether electrodes that make electrical contact are known,
but whether Thompson teaches this” (App. Br. 22). For the reasons set for
above, Examiner failed to establish an evidentiary basis to support a
conclusion that Thompson teaches a method that comprises, inter alia, the
step of applying a cardiac patch that comprises two or more electrodes that
directly electrically contact a person’s skin surface as is required by
Appellant’s claim 22.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Thompson teaches Appellant’s claimed invention.

6 Kaufman et al., US 3,744,482, issued July 10, 1973.
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The rejection of claims 22 and 23 under 35 U.S.C. § 102(b) as being
anticipated by Thompson is reversed.

Obviousness:
The rejection over the combination of Thompson and Del Mar:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 9. Examiner relies on Thompson as discussed above (FF 6-8; see also
Ans. 6 (“when [Thompson’s] substrate 102 is in direct physical contact with
the skin, electrodes 112a,b are likewise in direct physical contact with the
skin” or in the alternative “[i]f electrodes 112a,b are considered to be
capacitively-coupled electrodes including an air gap between the electrodes
and the skin … the electrodes are in direct electrical contact with the skin as
current flows directly between the electrodes and the skin”)).
FF 10. Examiner finds that Thompson suggests encoding the patch with
device control parameters, which represent at least one programmable
monitoring parameter (Ans. 7 and 24; see also Thompson 1: ¶[001]
(Thompson’s device “is particularly well suited for long term monitoring of
body events like electrocardiograms … and in detecting/monitoring other
body physiologic events … which may include, for example, without
limitation, such parameters as arrhythmia detection, syncope, QT variability,
ischemia, and respiration relevant to normal and abnormal physiologic
function”); Cf. Spec. 7: ¶ [0024] (Appellant discloses that “[t]he
programmable parameters include heart rate limits, ST segment position and
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shift, QT and WRS intervals, and pacing. Risk patters generally relate to
arrhythmia, syncope, myocardial infarction and transient ischemic attack”)).
FF 11. Examiner finds that “Thompson fails to disclose that the processor
performs signal averaging of a periodic ECG segment” and relies on Del
Mar to make up for this deficiency in Thompson (Ans. 7).
ANALYSIS
Based on the combination of Thompson and Del Mar, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to program the processor of Thompson to perform
signal averaging of a period ECG segment, as taught by Del Mar, in order to
reduce the amount of noise present within the ECG signal” (Ans. 7).

Claims 1-6, 8, and 10-17:
Claims 1-6, 8, and 10-17 all require electrodes that directly
electrically contact a person’s skin (see e.g., independent claims 1 and 13).
As discussed above, Examiner failed to establish that Thompson suggests a
device comprising electrodes that directly electrically contact a person’s skin
(see App. Br. 13; Cf. FF 9). Examiner also failed to establish that Del Mar
makes up for this deficiency in Thompson.

Claim 24:
Claim 24 does not require electrodes that directly electrically contact a
person’s skin. Therefore we are not persuaded by Appellant’s contention
that Thompson fails to suggest such an electrode configuration (see App. Br.
24).
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Claim 24 does not require a processor programmed to detect the effect
of medication on a person’s heart. Therefore, we are not persuaded by
Appellant’s contention that the prior art relied upon by Examiner fails to
suggest a processor programmed to detect the effect of medication on a
person’s heart (see Reply Br. 15-16 (“Del Mar in attempting to detect
micropotential or late potential for Holter Monitoring has nothing to do with
detecting subtle changes in ECG signal patterns resulting from taking
cardioactive medication”); see generally App. Br. 27).
We find no error in Examiner’s finding that Thompson suggests
encoding the patch with at least one programmable monitoring parameter
(FF 10). In this regard, Thompson suggesting monitoring a parameter
related, inter alia, to syncope (id.). Accordingly, we are not persuaded by
Appellant’s contention “that Thompson does not teach the programming of
monitoring parameters claimed by Applicant” (App. Br. 25).
Arguments not made are waived.

Claims 25-26:
The method of claims 25-26 does not require electrodes that directly
electrically contact a person’s skin. Claims 25-26 do, however, require,
inter alia, that one or more ECG monitoring parameters are stored in a
programmable patch memory, wherein the one or more parameters are
representative of a risk pattern in an ECG signal that is indicative of a
cardiac effect of a cardiac drug on the subject (see e.g., independent claim
25). Examiner made no findings relative to whether one or more parameters
programmed into the patch’s memory are representative of a risk pattern in
an ECG signal that is indicative of a cardiac effect of a cardiac drug on a
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subject as is required by Appellant’s claims 25 and 26 (see e.g., Ans. 7 and
24-25).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claim 24. The rejection of claim
24 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Thompson and Del Mar is affirmed.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to claims 1-6, 8, 10-17, 25,
and 26. The rejection of claims 1-6, 8, 10-17, 25, and 26 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Thompson and Del Mar is
reversed.

The rejection over the combination of Nissila and Del Mar:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 12. Nissila’s invention “relates to a heart rate measuring arrangement for
measuring the ECG signal on the skin of a person’s chest,” which
“comprises an electrode structure placed on a person’s chest and a wrist-
worn receiver unit” (Nissila 1: ¶ [0008]; see also id. at 4: ¶¶ [0041]-[0042];
Ans. 10-11).
FF 13. Nissila’s “electrode structure … compris[es] ECG processing means
communicating with the electrodes for measuring the potential difference
between the first and second electrodes caused by the ECG signal and for
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producing heart rate information on the basis of the measured potential
difference” (id.; Ans. 10-11).
FF 14. Nissila’s “electrode structure further comprises a transmitter for
transmitting the heart rate information to the wrist-worn receiver which
comprises a receiver for receiving the heart rate information transmitted
from the electrode structure” (id.; see also id. at 4: ¶¶ [0039], [0041], and
[0042]; Ans. 10-11 and 28).
FF 15. Nissila’s device comprises a means for entering “data, such as an
indication of the starting and ending moment of the heart rate measurement”
and “ROM memory intended for storing the necessary programs” (id. at 4: ¶
[0045]; Ans. 29).
FF 16. Examiner finds that Nissila fails “to disclose that the processor
performs signal averaging of a periodic ECG segment” and relies on Del
Mar to make up for this deficiency in Thompson (Ans. at 7).
ANALYSIS
Based on the combination of Nissila and Del Mar, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to program the processor of Nissila to perform
signal averaging of a period ECG segment, as taught by Del Mar, in order to
reduce the amount of noise present within the ECG signal” (Ans. 11).
Appellant’s claims require, inter alia: (1) a means for customizing at
least one programmable monitoring parameter of the patch (see e.g.,
independent claim 1); (2) wirelessly programming at least one
programmable monitoring parameter into the patch (see e.g., independent
claims 13, 18, 22, and 24); or (3) selecting one or more ECG monitoring
parameters … for programming into the programmable patch according to
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the monitoring need of the subject or group being monitored (see e.g.,
independent claim 25).
We have reviewed the teachings in the references cited by Examiner.
Notwithstanding Examiner’s assertions to the contrary, however, we are not
persuaded that the Examiner established an evidentiary basis to support a
conclusion that the combination of Nissila and Del Mar suggests: (1)
customizing at least one programmable monitoring parameter of the patch,
(2) wirelessly programming the patch, or (3) selecting one or more ECG
monitoring parameters … for programming into the programmable patch
according to the monitoring need of the subject or group being monitored
(see generally App. Br. 32-34; Cf. FF 12-16; Ans. 10-13 and 27-29).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-8, 10-17, and
24-26 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Nissila and Del Mar is reversed.

The rejection over the combination of Platt and Del Mar:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 17. Platt suggests a device comprising “circuitry for receiving signals
from … electrodes…, for conditioning the signals to provide a conditioned
signal and a short range radio transmitter to transmit the conditioned signal
to … [a] portable monitor unit” (Platt, col. 5, ll. 25-30; see also id. at ll. 16-
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19 (Platt’s “patch is provided with a number of electrodes …, which are
positioned on the gel … so as to contact the skin of the patient”)).
FF 18. Platt suggests a device “coupled to a controller of … [an] automatic
treatment device[, which can be an automatic drug delivery system, such as
an infusion pump, an external pacemaker device, or defibrillation device,] so
as to … control the automatic treatment device according to whether a
cardiac arrhythmia in the ECG data signal is detected” (Platt, col. 3, ll. 37-
47).
FF 19. Examiner finds that “Platt fails to disclose that the processor
performs signal averaging of a periodic ECG segment” and relies on Del
Mar to make up for this deficiency in Thompson (Ans. 15).
ANALYSIS
Based on the combination of Platt and Del Mar, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious “to program the processor of Platt to perform signal averaging
of a period ECG segment, as taught by Del Mar, in order to reduce the
amount of noise present within the ECG signal” (Ans. 15-16).
Appellant’s claims require, inter alia: (1) a means for customizing at
least one programmable monitoring parameter of the patch (see e.g.,
independent claim 1), (2) wirelessly programming at least one
programmable monitoring parameter into the patch, or a programmable
patch (see e.g., independent claims 13, 18, 22, 24, and 25).
Having reviewed the teachings in the references cited by Examiner,
and notwithstanding Examiner’s assertions to the contrary, we are not
persuaded Examiner established an evidentiary basis to support a conclusion
that the combination of Platt and Del Mar suggests: (1) customizing at least
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one programmable monitoring parameter of the patch, (2) wirelessly
programming the patch, or a programmable patch (see generally App. Br.
35; Reply Br. 17-18; Cf. FF 17-19; Ans. 14-17 and 30).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-8, 10-17, and
24-26 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Nissila and Del Mar is reversed.

The rejection of claim 18 over the Thompson, Nissila, or Platt:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Claim 18 is drawn to a disposable programmable cardiac test patch
comprising, inter alia, (a) at least two electrodes that directly electrically
contact a person’s skin and (b) a means to receive a wireless programming
signal (Claim 18).
For the reasons discussed above, Examiner failed to establish that (1)
Thompson suggests a device comprising at least two electrodes that directly
electrically contact a person’s skin and (2) Nissila or Platt suggest a means
to receive a wireless programming signal.
We recognize Examiner’s reference to a number of supplemental
documents supporting Examiner’s assertion “that it is well known in the art
to coat electrodes that are to be in contact with human tissue with an anti-
microbial agent” (Ans. 27; see generally Ans. 29 and 30). Examiner,
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however, failed to establish that these documents make up for the foregoing
deficiency in Thompson, Nissila, or Platt.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claim 18 under 35
U.S.C. § 103(a) as unpatentable over Thompson, Nissila, or Platt is reversed.

The rejection of claims 22 and 23 over the combination of Nissila and Platt:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Claim 22 is drawn to a method of non-invasive cardiac monitoring
comprising, inter alia, the step of: sending a wireless programming signal,
representing any of at least one monitoring parameter, from an external
programming device and the loading thereof into a cardiac patch’s memory.7
For the reasons discussed above, Examiner failed to establish that
Nissila or Platt alone or in combination suggest a method comprising the
step of sending a wireless programming signal representing any of at least
one monitoring parameter, from an external programming device and the
loading thereof into a cardiac patch’s memory.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 22 and 23

7 Claim 23 depends directly from claim 22.
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under 35 U.S.C. § 103(a) as unpatentable over the combination of Nissila
and Platt is reversed.

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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