Ex Parte Kim et al

Board of Patent Appeals and Interferences

Jun 26, 2012

10735519 (B.P.A.I. Jun. 26, 2012)

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.
10/735,519 12/12/2003 Jaeho Kim GUID.160PA 1580
11050 7590 06/26/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
HOLMES, REX R
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
06/26/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAEHO KIM, JOSEPH BOCEK, SCOTT A. MEYER,
PAUL A. HAEFNER, and HARIS J. SIH
__________

Appeal 2011-001867
Application 10/735,519
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method for determining a cardiac response to a pacing pulse. The Examiner
has rejected the claims for failing to comply with the written description
requirement. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
As noted in the Specification, medical devices such as implantable
pacemakers and cardiac defibrillators are used to treat patients with heart
conditions, such as arrhythmias. (Spec. 1.) Such devices comprise circuitry
that senses electrical signals from the heart, as well as a pulse generator that
delivers electrical stimulation pulses (pacing pulses) to the heart. (Id.) After
a pacing pulse produces a heart contraction, an electrical cardiac signal
occurs, which is denoted the captured response. The “captured response
may include an electrical signal, denoted the evoked response signal,
associated with the heart contraction, along with a superimposed signal
associated with residual post pace polarization at the electrode-tissue
interface.” (Id. at 2.)
The Specification further teaches that “a pacing pulse may merge with
an intrinsic beat, producing a fusion beat.” (Id. at 3.) In addition,
“[p]seudofusion occurs when a pacer output pulse is superimposed upon a
spontaneous P wave during atrial pacing or upon a spontaneous QRS
complex during ventricular pacing.” (Id.) “Capture may be verified by
detecting if a cardiac signal following a pace pulse indicates a captured
response.” (Id.) Capture detection allows the device to adjust the energy of
pacing pulses so that the device reliably produces contractions. (Id. at 2.)
That said, “the captured response must be discerned from other responses,
including the superimposed residual post pace polarization without capture,
intrinsic beats, and fusion/pseudofusion beats.” (Id. at 3.) Thus, the
invention relates to a method comprising classifying a cardiac response “as
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one of a captured response, a non-captured response, and a
fusion/pseudofusion beat using the sensed cardiac signal.” (Id. at 4.)
Claims 1-23, 35-48, 50-60, 62, and 63 are on appeal, with claims 1,
15, 35, 39, 52, 57, 59, and 62 being independent. Claim 1 is representative
(emphasis added):
1. A method of determining a cardiac response to a pacing pulse,
comprising:
providing a plurality of electrodes electrically coupled to a heart;
delivering the pacing pulse to the heart using a first electrode
combination;
sensing a single cardiac signal for cardiac response classification
following the pacing pulse using a second electrode combination; and
classifying the cardiac response to the pacing pulse as one of a
captured response, a non-captured response, and a fusion/
pseudofusion response by distinguishing between each of the
captured, non-captured, and fusion/pseudofusion responses using the
single cardiac signal without using any other cardiac signal sensed
following the pacing pulse.
Other independent claims similarly recite a classifying or detecting step, or a
component of a medical device configured to classify or detect a cardiac
response or fusion/pseudofusion beat, “using the single [or sensed] cardiac
signal without using any other cardiac signal sensed following the pacing
pulse.”
Pending claims stand rejected under 35 U.S.C. § 112, first paragraph,
for failing to comply with the written description requirement.

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Issue
Does the Examiner establish that the pending claims, and specifically
independent claims reciting “using the single [or sensed] cardiac signal
without using any other cardiac signal sensed following the pacing pulse,”
lack written description support?
Principles of Law
The “written description” requirement of 35 U.S.C. § 112, first
paragraph, requires a patent specification to “describe the invention
sufficiently to convey to a person of skill in the art that the patentee had
possession of the claimed invention at the time of the application, i.e., that
the patentee invented what is claimed.” LizardTech, Inc. v. Earth Res.
Mapping, Inc., 424 F.3d 1336, 1344-45 (Fed. Cir. 2005). When evaluating
claims for written description, the patent specification must be viewed from
the perspective of a person of skill in the art, who is deemed to “come[] to
the patent with the knowledge of what has come before.” Id. at 1345. Thus,
a patent specification need not spell out every detail of the invention in the
specification, but “enough must be included to convince a person of skill in
the art that the inventor possessed the invention” at the time the patent
application was filed. Id.
As explained by our colleagues in Ex parte Grasselli, negative
limitations recited in claims, which do not appear in the Specification as
filed, violate the written description requirement if the limitations “introduce
new concepts.” Ex parte Grasselli, 231 USPQ 393, 394 (Bd. App. 1983),
aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). As also stated in Ex parte Parks,
however, adequate written description “does not require literal support for
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the claimed invention.” Ex parte Parks, 30 USPQ2d 1234, 1236 (BPAI
1993). As such, “a lack of literal support does not, in and of itself, establish
a prima facie case for lack of adequate descriptive support ….” Id. “Rather,
it is sufficient if the originally-filed disclosure would have conveyed to one
having ordinary skill in the art that an appellant had possession of the
concept of what is claimed.” Id.
Analysis
The Examiner finds that the claim phrase “using the single [or sensed]
cardiac signal without using any other cardiac signal sensed following the
pacing pulse” corresponds to a negative element not set forth in the
Specification, and therefore fails to comply with the written description
requirement. (Ans. 3.) Specifically, according to the Examiner, because the
Specification “is silent as to the system using or not using any other signal
following the pacing pulse,” it follows that “there is no support for including
or excluding that limitation in the claims.” (Id. at 4, 5.)
We disagree that the Specification does not describe classifying a
cardiac response, or detecting a fusion/pseudofusion beat, using a single
cardiac signal without using any other cardiac signal sensed following the
pacing pulse. The Specification repeatedly refers to a cardiac signal in a
singular form in relevant contexts, and distinguishes between a “cardiac
signal” and “cardiac signals.” For example, the Specification states that:
A cardiac signal following the pacing stimulation is sensed. One or
more characteristics of the cardiac signal, for example, a peak, slope,
curvature, sequence of feature points, or other characteristic of the
cardiac signal is detected in one of the classification windows.
(Spec. 11, ll. 21-24.)
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An example of such a signal is shown in Figure 5.

As noted in the Specification, “Figure 5 is a graph illustrating a propagation
delay of a cardiac signal sensed on a shock channel following a pacing pulse
delivered on a rate channel.” (Spec. 7, ll. 19-20.) Cardiac signal 520 is
“sensed on a right ventricular (RV) shock channel vector following a pacing
pulse 510 delivered on a rate channel.” (Id. at 29.) “The cardiac signal 520
exhibits a propagation delay 530 … between the pacing pulse 510 and the
portion of the cardiac signal indicating a captured response 540.” (Id.)
Thus, Figure 5 shows a single cardiac signal, where one can measure
characteristics such as a “peak, slope, curvature, sequence of feature points”
as discussed above. (Id. at 11.) Thus, it is clear from the Specification that
one can classify a cardiac response (or detect a fusion/pseudofusion beat) by
looking at different characteristics of a single cardiac signal, even without
considering subsequent cardiac signals.
Likewise, Figure 9 shows a single cardiac signal:
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Figure 9 is a diagram illustrating a cardiac signal sensed within multiple
classification windows established following a pacing pulse. (Id. at 8.) As
further explained in the Specification:
A cardiac signal 940 following the pacing pulse is illustrated with
respect to three established classification windows 950, 960, 970. A
first characteristic 980, in this example, a positive peak, is detected in
the first classification window 960. A second characteristic, e.g.,
negative peak 990 is detected in the second classification window
950. The first and the second characteristics 980, 990 may be
compared to references and the cardiac response classified as
described in connection with the flowchart of Figure 8A.
(Id. at 40.) Such disclosures in the Specification, again, indicate that one can
classify a cardiac response (or detect a fusion/pseudofusion beat) by looking
at characteristics, e.g., three “classification windows,” of a single cardiac
signal, even without considering subsequent cardiac signals. (See also
Figures 14A-B (each showing peak width of a single cardiac signal); Spec.
45, ll. 15-21.)
To be sure, the Specification does not preclude the possibility of also
considering characteristics of other cardiac signals. The Specification refers
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to “cardiac signals” in numerous places. (See, e.g., id. at 14, ll. 12-14; 19, ll.
10-12, 18-20; 19, l. 28 – 20, l. 2, 22, ll. 7-9, 25, ll. 6-9 (stating that a “second
device may be employed to detect and classify cardiac responses to pacing
based on signals sensed using subcutaneous electrode arrays”); 31, ll. 23-29
(stating that “[c]ardiac signals representing one of more captured cardiac
beats may be used to form the CR template.”); 50, ll. 17-18 (stating that in a
two channel approach for template generation, “[a]dditional cardiac signals,
including rate channel signals and shock channel signals are sensed.”)
For instance, one box in a flowchart depicted in Figure 16 refers to
“Sense Cardiac Signals within the Classification Windows.” (Figure 16
(emphasis added); see also, id. at 48, ll. 8-9 (stating that “[c]ardiac signals
following the pacing pulses are sensed 1630 within the classification
windows.”) Notably, however, Figure 16 contrasts with Figures 6A and 12,
two figures noted by Appellants (App. Br. 6, 19). Figure 6A includes a box
in the depicted flowchart that refers to “Sense Cardiac Signal Following
Pacing Pulse Using a Second Electrode Combination.” (Figure 6A
(emphasis added).) Figure 12 similarly includes a box in the depicted
flowchart that refers to “Sense Cardiac Signal and Detect Peak.” (Figure 12
(emphasis added).)
As noted by Appellants, the Specification explains that the “flowchart
of Figure 12 illustrates a method of classifying a cardiac response using the
classification windows described in Figure 11,” where the “peak of a
cardiac signal sensed following the pacing stimulation is detected 1225 in
one of the classification windows.” (Id. at 42, ll. 19-20, 25-27 (emphasis
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added).) In relation to this single cardiac signal, the Specification also
teaches:
If the cardiac signal is determined to be noisy 1226, then
cardiac response classification is not performed for the pacing
stimulation and the process continues. …. If noise is not detected
1226, and if the amplitude of the detected peak is less than 1230 a
reference value, then the cardiac response is classified 1235 as a non-
captured response.
(Id. at 43, ll. 1-8.)
In concluding that the claim phrase “using the single [or sensed]
cardiac signal without using any other cardiac signal sensed following the
pacing pulse” lacks written description support, the Examiner relies on Ex
parte Grasselli, discussed in the section above. We disagree that Grasselli
dictates the Examiner’s conclusion.
In contrast to Grasselli, the claim phrases at issue here do not
“introduce new concepts” that the Specification otherwise fails to convey.
Ex parte Grasselli, 231 USPQ at 394. Based on clear disclosures in the
Specification, such as those discussed above, the Specification conveyed to a
skilled artisan that Appellants had “possession of the concept” of classifying
a cardiac response, or detecting a fusion/pseudofusion beat, using a single
cardiac signal “without using any other cardiac signal sensed following the
pacing pulse” as recited in independent claims. Ex parte Parks, 30 USPQ2d
at 1236. The Examiner has not persuaded us that a skilled artisan would not
have recognized that Appellants possessed the concept of assessing or
measuring certain characteristic(s) of a single cardiac signal “without using
any other cardiac signal sensed” as a way to classify a cardiac response or
detect a fusion/pseudofusion beat.
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Conclusion of Law
We conclude that the Examiner fails to establish that pending claims,
and specifically independent claims reciting “using the single [or sensed]
cardiac signal without using any other cardiac signal sensed following the
pacing pulse,” lack written description support.
SUMMARY
We reverse the rejection claims 1-23, 35-48, 50-60, 62, and 63 under
35 U.S.C. § 112, first paragraph, for failing to comply with the written
description requirement.

REVERSED

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