Ex Parte White

Board of Patent Appeals and Interferences

Jun 22, 2010

11231401 (B.P.A.I. Jun. 22, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CARDIAC PACEMAKERS, INC.
____________________

Appeal 2009-009514
Application 11/231,401
Technology Center 3700
____________________

Decided: 22 June 2010
____________________

Before SALLY GARDNER LANE, JAMESON LEE, and RICHARD
TORCZON, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL

A. STATEMENT OF THE CASE
This is a decision on appeal by the real party in interest, Cardiac
Pacemakers, Inc. (“Cardiac Pacemakers”) under 35 U.S.C. § 134(a) from a
Appeal 2009-009514
Application 11/231,401

2
final rejection of claims 1-24. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

References Relied on by the Examiner
Markowitz 4,343,311 Aug. 10, 1982
Mann et al. (“Mann”) 5,470,342 Nov. 28, 1995
Williams et al. (“Williams”) US 6,324,422 B1 Nov. 27, 2001

The Rejections on Appeal
The Examiner rejected claims 1, 3-10, 14, and 18-23 under 35 U.S.C.
§ 103(a) as unpatentable over Mann and Williams.
The Examiner rejected claims 2, 11-13, 15-17, and 24 under 35
U.S.C. § 103(a) as unpatentable over Mann, Williams, and Markowitz.

The Invention
The invention relates to the management of cardiac rhythm through
control of refractory periods during cardiac pacing. (Spec. 1:8-10.) A
refractory period is a period of time following the detection of a cardiac
event during which a pacing device does not sense further cardiac events.
(Id. at 3:18-23.) In describing the purpose of the refractory periods, Cardiac
Pacemakers’ specification states (id. at 7:9-14):
Refractory periods are typically implemented after pacing to
prevent unwanted sensing of signals related to the pace, e.g., the
pacing output, pacing artifact, and/or crosstalk noise related to pacing.
It is desirable to control the duration of the refractory periods to
prevent misinterpretation of signals related to the pace, while allowing
detection of other signals, such as intrinsic depolarizations of a
tachyarrhythmic episode.

Appeal 2009-009514
Application 11/231,401

3
Claim 1 is reproduced below (App. Br. 19 Claims App’x.)
1. A method for managing refractory periods implemented during
a cardiac cycle, comprising:

pacing a heart;

detecting an evoked response of the heart; and

adapting at least one refractory period based on the detected
evoked response.
B. ISSUE
Has Cardiac Pacemakers shown that the Examiner erred in
determining that the teachings of Mann and Williams account for the feature
of its claims directed to adapting a refractory period based on a detected
evoked response?
C. FINDINGS OF FACT
1. Cardiac Pacemakers’ specification discloses that “adapting” a
refractory period includes, among other things, initiating or beginning the
refractory period. (Spec. 4:7-10.)
2. Mann discloses an implantable cardioverter defibrillator (ICD)
that operates to begin and adaptively adjust its refractory periods based on a
sensed depolarization signal for the purpose of detecting certain cardiac
events. (Mann Abstract; 2:18-24.)
3. A “depolarization signal” is a small electrical impulse generated
by muscle tissue, e.g., heart muscle tissue, as the tissue contracts. (Id. at
1:14-16; 4:48-50.)
Appeal 2009-009514
Application 11/231,401

4
4. Mann describes that an aspect of its invention is to allow its
ICD to adjust the refractory periods based on different types of
depolarization signals. (Id. at 3:18-35.)
5. Mann describes that refractory periods follow either a natural or
a “paced” depolarization. (Id. at 1:55-58.)
6. Mann also describes that the delivery of a pacing electrical
simulation pulse to a heart is used to “force a depolarization.” (Id. at 4:51-
54.)
7. Mann discloses that depolarization produces a depolarization
signal that may be sensed. (Id. at 4:46-51.)
8. Williams demonstrates that one of ordinary skill in the art
would have known that either a natural depolarization or an “induced
depolarization” causes an ICD to employ or begin a refractory period. (Id. at
2:14-28.)
D. PRINCIPLES OF LAW
A prior art reference must be considered for everything it teaches by
way of technology and is not limited to the particular invention it is
describing and attempting to protect. EWP Corp. v. Reliance Universal Inc.,
755 F.2d 898, 907 (Fed. Cir. 1985).
E. ANALYSIS
Claims 1, 14, and 22 are independent claims. Claims 2-13, 15-21, 23,
and 24 are ultimately dependent on, and argued collectively with, one of
those independent claims. We focus on the contested limitations. Each of
the independent claims includes a feature directed to the adaptation of a
refractory period based on a detected “evoked response.” An “evoked
Appeal 2009-009514
Application 11/231,401

5
response” is described in Cardiac Pacemakers’ specification as being an
electrical cardiac signal that is produced from the contraction of heart tissue
due to a pace pulse supplied to the heart. (Spec. 2:13-15.)
Claim 1 is a method claim and includes the limitation “adapting at
least one refractory period based on the detected evoked response.” (App.
Br. 19 Claims App’x.)
Claim 14 is drawn to a medical device and includes a component that
is “configured to adapt at least one refractory period based on a detected
evoked response.” (Id. at 21.)
Claim 22 is also drawn to a medical device and includes “means for
adapting at least one refractory period based on a detected evoked response.”
(Id. at 22.)
Claim Construction
Each of Cardiac’s claims 1, 14, and 22 use some form of the term
“adapt” in the context of an action on a refractory period. Claim 1, for
instance, states “adapting at least one refractory period.” An applicant’s
specification is the single best guide in determining the meaning of a claim
term. Phillips v. AWH Corp., 415 F.3d at 1315. Thus, we look to Cardiac
Pacemaker’s specification for the meaning of “adapt” or “adapting” in
connection with a refractory period. The specification states (Spec. 4:7-10):
Adapting the refractory period may involve, for example, initiating
the refractory period, terminating the refractory period, extending the
refractory period or modifying one or more parameters of the
refractory period.

Thus, “adapting” a refractory period includes, among other things,
simply initiating or beginning the refractory period. Accordingly, the scope
Appeal 2009-009514
Application 11/231,401

6
of claims 1, 14, and 22 includes initiating a refractory period in response to a
detected evoked response.
The Prior Art Rejections
The Examiner relied on the teachings of Mann and Williams in
accounting for the above-noted feature in claims 1, 14, and 22.
Mann discloses an implantable cardioverter defibrillator (ICD) that
operates to start and adaptively adjust its refractory periods based on a
sensed depolarization signal for the purpose of detecting cardiac events.
(Mann Abstract 2:18-24.) A “depolarization signal” is a small electrical
impulse generated by muscle tissue, e.g., heart muscle tissue, as the tissue
contracts. (Id. at 1:14-16; 4:48-50.) Mann describes that a refractory period
defines a period of time following a natural or a “paced” depolarization.
(Mann 1:55-58.) More specifically, Mann discloses that the delivery of a
pacing electrical simulation pulse to a heart is used to “force a
depolarization” and that the signals generated by depolarization are sensed
by the ICD. (Id. at 4:40-54.)
Williams also demonstrates that one of ordinary skill in the art would
have known that detection of either a natural depolarization or an “induced
depolarization” causes an ICD to employ or begin refractory periods.
(Williams 2:14-28.) The Examiner found, and Cardiac Pacemakers does not
dispute, that an “induced depolarization” is an evoked response. (Ans. 3:16-
17.) Thus, a signal that is generated by an “induced polarization” is an
evoked response. The references reflect recognition in the art that upon
detection of the signal that occurs upon either a natural depolarization or an
induced depolarization, i.e., an evoked response, an ICD begins a refractory
period.
Appeal 2009-009514
Application 11/231,401

7
In challenging the Examiner’s rejection based on Mann and Williams,
Cardiac Pacemakers takes the position that no combination of Mann or
Williams can account for the feature of the claims directed to the adapting of
a refractory period based on the detection of an evoked response. Cardiac
Pacemakers bases that position on the theory that neither Mann nor Williams
contemplate an evoked response as being the basis for adapting a refractory
period, and thus a combination of their teachings must also be deficient with
respect to the feature. (See, e.g., App. Br. 9:20-22; Reply Br. 3:16-18.)
We are not persuaded by Cardiac Pacemakers’ argument. That
argument is based on an inaccurate assessment of the disclosure of Mann
and Williams. As noted above, those references convey that a person of
ordinary skill in the art would have known that upon detection of an evoked
response by an ICD a refractory period is initiated. That is sufficient to
account for the requirement of Cardiac Pacemakers’ claims directed to
adapting a refractory period based on a detected evoked response.
Moreover, even if the claims are construed as requiring an adjustment
of the refractory period, and not simply its initiation, based on a detected
evoked response, we agree with the Examiner’s determination (Ans. 3-4)
that that adjustment would also have been understood from the teachings of
Mann and Williams.
Cardiac Pacemaker’s challenges the Examiner’s determination on the
theory that Mann’s teachings are limited to adjusting refractory periods
solely based on natural depolarizations. Cardiac Pacemakers concludes that
there is nothing in either Mann or Williams indicating that the inventors in
those references considered that refractory periods based on evoked
responses would also be adjusted. (App. Br. 15-16.)
Appeal 2009-009514
Application 11/231,401

8
Mann describes that “different types of depolarization signals” may be
detected and serve as the basis for adjusting refractory periods. (Mann 3:28-
32) Mann provides examples of some depolarization signals that may be
detected, stating (id. at 3:33-35):
[E].g., the relatively high magnitude depolarization signals associated
with normal cardiac depolarizations and tachycardias, or the relatively
low magnitude depolarization signals associated with fibrillation.

The depolarization signals described in the above-quote are examples
of signals from natural depolarizations. However, Mann’s listing of some
examples of the types of depolarization signals which result in the
adjustment of a refractory period does not mean that Mann’s teachings apply
only to those examples. Mann’s invention may be primarily concerned with
those particular signals, but that does not mean it teaches that other signals
cannot be used for adjusting a refractory period. A prior art reference must
be considered for everything it teaches by way of technology and is not
limited to the particular invention it is describing and attempting to protect.
EWP Corp., 755 F.2d at 907.
As discussed above, Mann, as well as Williams, establishes that a
forced or an induced depolarization produces signals that may be detected by
an ICD, which detection starts a refractory period of the ICD. Mann
generally teaches that it is known to adjust the duration of the refractory
periods of an ICD based on different types of detected depolarization
signals. (Id. at 3:18-32; 9:4-62.) In light of the knowledge in the art that
depolarizations produce depolarization signals, and that evoked responses
are a known type of depolarization signal, a person of ordinary skill in the
art, who is also a person of ordinary creativity, KSR Int’l Co. v. Teleflex Inc.,
Appeal 2009-009514
Application 11/231,401

9
550 U.S. 398, 421 (2007), would have readily appreciated that the refractory
period may be adjusted based on detection of an evoked response. We reject
Cardiac Pacemakers’ argument to the contrary as it does not adequately
account for how a person of ordinary skill and creativity in the art would
have viewed the teachings of the references. For instance, it is unexplained
why one with ordinary skill in the art would think an evoked response
cannot be similarly used like other detected polarization signals.
For the foregoing reasons, Cardiac Pacemakers has not shown that the
Examiner erred in rejecting claims 1, 14, and 22. We sustain the rejection of
claims 1, 14, and 22 over Mann and Williams.
The patentability of dependent claims 2-13, 15-21, 23, and 24 is not
separately argued apart from the claims 1, 14, and 22. We also sustain the
rejection of claims 3-10, 18-21, and 23 over Mann and Williams and the
rejection of claims 2, 11-13, 15-17, and 24 over Mann, Williams, and
Markowitz.
F. CONCLUSION
Cardiac Pacemakers has not shown that the Examiner erred in
determining that the teachings of Mann and Williams account for the feature
of its claims directed to adapting a refractory period based on a detected
evoked response.
G. ORDER
The rejection of claims 1, 3-10, 14, and 18-23 under 35 U.S.C.
§ 103(a) as unpatentable over Mann and Williams is affirmed.
The rejection of claims 2, 11-13, 15-17, and 24 under 35 U.S.C.
§ 103(a) as unpatentable over Mann, Williams, and Markowitz is affirmed.
Appeal 2009-009514
Application 11/231,401

10
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

HOLLINGSWORTH & FUNK
8500 Normandale Lake Blvd
SUITE 320
MINNEAPOLIS MN 55437