Ex Parte Cohen et al

Patent Trial and Appeal Board

Aug 15, 2016

12630718 (P.T.A.B. Aug. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/630,718 12/03/2009
7590
Cambridge Heart, Inc.
46 Jonspin Road
Wilmington, MA 01887
08/15/2016
FIRST NAMED INVENTOR
Richard J. Cohen
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.
06541-0035001 1277
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3762
MAILDATE DELIVERY MODE
08/15/2016 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 RICHARD J. COHEN and ALI HAGHIGHI-MOOD
Appeal2013-005949
Application 12/630,718
Technology Center 3700
Before ANTON W. PETTING, CYNTHIA L. MURPHY, and
KENNETH G. SCHOPPER, Administrative Patent Judges.
MURPHY, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants 1 appeal under 35 U.S.C. § 134 from the Examiner's
rejection of claims 1--41. We have jurisdiction over this appeal under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appellants identify "Cambridge Heart, Inc." as the real party in
interest. (Appeal Br. 1.)
Appeal2013-005949
Application 12/630,718
STATEMENT OF THE CASE
The Appellants' invention "is directed to the measurement of
altemans and the use of pharmacological agents." (Spec. 1, 11. 7-8.)
Illustrative Claim2
1. A method comprising:
receiving first cardiac signal data generated from
measured heart beats of a subject;
determining, using at least one processor, characteristics
of altemans occurring in the received first cardiac signal data;
receiving second cardiac signal data generated from
measured heart beats of the subject after a change relating to an
administration of a pharmacological agent to the subject;
determining characteristics of altemans occurring in the
received second cardiac signal data; and
comparing the characteristics of altemans occurring in
the received first cardiac signal data with the characteristics of
altemans occurring in the received second cardiac signal data to
assess an effect of the pharmacological agent on the subject.
Haller
Zhou
Armoundas
References
US 2002/0052539 Al
US 2006/0116596 Al
US 2007/0191890 Al
Rejections
May 2, 2002
June 1, 2006
Aug. 16, 2007
I. The Examiner rejects claims 1, 4-14, 16-25, 28-33, and 35--41
under 35 U.S.C. § 102(b) as anticipated by Zhou. (Final Action 4.)
II. The Examiner rejects claims 2, 3, 26, 27, and 34 under
35 U.S.C. § 103(a) as unpatentable over Zhou and Haller. (Id. at 23.)
III. The Examiner rejects claim 15 under 3 5 U.S. C. § 10 3 (a) as
unpatentable over Zhou and Armoundas. (Id. at 24.)
2 This illustrative claim is quoted from the Claims Appendix ("Claims
App.") set forth on pages 9-19 of the Appeal Brief.
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Application 12/630,718
ANALYSIS
Independent Claim 1
Independent claim 1 is directed to a method comprising the steps of
"receiving first cardiac signal data generated from measured heart beats of a
subject," and "receiving second cardiac signal data generated from measured
heart beats of the subject after a change relating to an administration of a
pharmacological agent to the subject." (Claims App.) The Examiner finds
that Zhou discloses such receiving steps. (See Final Action 4--5.)
The Appellants argue that Zhou does not disclose "[a] second set of
cardiac signal data [that] is measured after a change relating to administration
of the pharmacological agent." (Appeal Br. 4.) We are not persuaded by this
argument because the Examiner establishes that Zhou discloses a method 250
wherein a second set of post-therapy cardiac signal data is obtained. (See
Answer 3.)
In Zhou's method 250, "current TWA measurements are compared to
a predefined cardiac event prediction threshold or other prediction criteria
based on TWA assessment." (Zhou i-f 81.) Zhou discloses that "[i]f a
cardiac event is predicted, a response to the prediction is provided," and this
response may include "delivering a therapy." (Id. i-f 83.) Zhou further
discloses that "[a]fter providing [this] prediction response," TWA
assessment "continues on a scheduled and/or triggered basis." (Id. i-f 86.)
The Examiner explains that "[t]his means that the system has delivered
therapy based on the prediction and runs through the TWA measurement a
second time" and "[t]his time the collected TWA measurement is measured
after a change relating to an administration of therapy (a pharmacological
drug)." (Answer 2-3.) In other words, Zhou discloses receiving a first set
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of pre-therapy cardiac signal data (that instigates delivery of the therapy) and
then receiving a second set of post-therapy cardiac signal data when TWA
assessment continues thereafter.
Independent claim 1 additionally requires the step of "comparing the
characteristics of altemans occurring in the received first cardiac signal data
with the characteristics of altemans occurring in the received second cardiac
signal data." (Claims App.) The Examiner finds that Zhou discloses such a
comparing step. (See Final Action 4--5.)
The Appellants argue that the prior art does not show or suggest the
comparing step required by independent claim 1. (See Appeal Br. 3-6.)
According to the Appellants, Zhou teaches comparing data sets to a
threshold but not to each other. (See id.) We are persuaded by this
argument because the Examiner does not establish that Zhou shows or
suggests a comparison between its first set of pre-therapy cardiac signal data
and its second set of post-therapy cardiac signal data. 3 Zhou instead teaches
comparing such data sets to "a predefined cardiac event prediction threshold
or other prediction criteria." (Zhou i-f 81.)
Thus, we do not sustain the Examiner's rejection of independent
claim 1 under 35 U.S.C. § 102(b) as anticipated by Zhou (Rejection I).
3 The Examiner's findings regarding the comparison of data relate to Zhou's
"[ d]ata matrix formation" which includes "assigning every other T-wave an
'A' label and intervening T-waves a 'B' label." (Zhou i-f 55). Zhou does
disclose a "comparative analysis" wherein "the difference between 'A'
labeled T-wave measurements and 'B' labeled T-wave measurements" are
determined. (Id. i-f 57.) However, we agree with the Appellants (see Reply
Br. 1) that the Examiner's finding that "A is the time period before the
administration of therapy and B is after administration of therapy"
(Answer 3) is not supported by Zhou's disclosure.
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Application 12/630,718
Dependent Claims 2-19
Claims 2-19 depend directly or indirectly from independent claim 1.
(See Claims App.) The Examiner's further findings with respect to these
dependent claims (see Final Action 6-10, 23-25) do not compensate for the
above-discussed shortcoming in the rejection of independent claim 1. Thus,
we do not sustain the Examiner's rejection of dependent claims 4--14
and 16-19 under 35 U.S.C. § 102(b) as anticipated by Zhou (Rejection I);
we do not sustain the Examiner's rejection of claims 2 and 3 under
35 U.S.C. § 103(a) as unpatentable over Zhou and Haller (Rejection II); and
we do not sustain the Examiner's rejection of claim 15 under 35 U.S.C.
§ 103(a) as unpatentable over Zhou and Armoundas (Rejection III).
Independent Claim 20
Independent claim 20 is directed to a system comprising a user input
control configured "to enable a user to indicate a change relating to an
administration of a pharmacological agent" and a processor configured to
"generate second cardiac signal data when the user input control is used to
indicate the change relating to the administration of the pharmacological
agent, wherein the second cardiac signal data is associated with an indication
of the occurrence of the change relating to the administration of the
pharmacological agent." (Claims App.) The Examiner finds that Zhou
discloses such a user input control and such a processor. (See Final
Action 11.)
The Appellants argue that Zhou's user input control (i.e., patient
activator 16) is only adapted to allow a patient or other caregiver to initiate a
TWA assessment. (See Appeal Br. 7; Reply Br. 2.) We are not persuaded
by this argument because the Examiner explains that such a TWA-
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Application 12/630,718
assessment initiation "means that a change has occurred and the patient or
caregiver wants to assess the changes that occurred" such as "dynamic
changes in TWA for use in managing therapies (pharmacological agents)."
(Final Action 3.) The Appellants do not adequately address why Zhou's
post-therapy initiation of a TWA assessment (by patient activator 16) would
not indicate a change relating to a pharmacological agent. And the
Appellants also do not adequately address why the data generated as a result
of this initiation would not correspond to the second cardiac signal data
recited in independent claim 20 and/or why Zhou's processor would not be
configured to generate this data.
Independent claim 20 also requires the processor to be configured to
"generate first cardiac signal data when the user input control is not used to
indicate the change relating to the administration of the pharmacological
agent." (Claims App.) The Examiner finds that Zhou's processor is
configured to generate such first cardiac signal data. (See Final Action 11.)
The Appellants argue that, in Zhou, "there would be no data
corresponding to the recited first cardiac signal data." (Appeal Br. 7.) We
are not persuaded by this argument because, as discussed above, Zhou's
"TWA assessment continues on a scheduled and/or triggered basis." (Zhou
i-f 86.) The Appellants do not adequately address why, for example, a
scheduled TWA assessment (or any assessment unassociated with therapy)
would not correspond to the first cardiac signal data recited in independent
claim 20 and/or why Zhou's processor would not be configured to generate
this data.
The Appellants further argue that "there also would be no comparison
of characteristics of altemans between the two sets of data." (Appeal Br. 7.)
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However, as pointed out by the Examiner (see Answer 3--4), independent
claim 20 does not require such a comparison.
Thus, we sustain the Examiner's rejection of independent claim 20
under 35 U.S.C. § 102(b) as anticipated by Zhou (Rejection I).
Dependent Claims 21-32
Claims 21-32 depend directly or indirectly from independent
claim 20. (See Claims App.) The Appellants do not argue these dependent
claims separately and/or further (see Appeal Br. 6-7), so they fall with
independent claim 20. Thus, we sustain the Examiner's rejection of
dependent claims 22-25 and 28-32 under 35 U.S.C. § 102(b) as anticipated
by Zhou (Rejection I); and we sustain the Examiner's rejection of claims 26
and 27 under 35 U.S.C. § 103(a) as unpatentable over Zhou and Haller
(Rejection II).
Independent Claim 33
Independent claim 3 3, like independent claim 1, recites "comparing
the characteristics of altemans occurring in the first cardiac signal data
segments with the characteristics of altemans occurring in the second
cardiac signal data segments to assess an effect of the pharmacological agent
on the subject." (Claims App.) As discussed above in connection with
independent claim 1, the Examiner does not sufficiently show that Zhou
discloses such a comparison. Thus, we do not sustain the Examiner's
rejection of independent claim 33 under 35 U.S.C. § 102(b) as anticipated by
Zhou (Rejection I).
Dependent Claims 34-40
Claims 34--40 depend directly or indirectly from independent
claim 33. The Examiner's further findings with respect to these claims do
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not compensate for the above-discussed shortcoming in the rejection of
independent claim 33. (See Final Action 19-24.) Thus, we do not sustain
the Examiner's rejection of dependent claims 35--40 under 35 U.S.C.
§ 102(b) as anticipated by Zhou (Rejection I); and we do not sustain the
Examiner's rejection of claim 34 under 35 U.S.C. § 103(a) as unpatentable
over Zhou and Haller (Rejection II).
Independent Claim 41
Independent claim 41 is directed to a method comprising the steps of
"receiving a cardiac signal data generated from measured heart beats of a
subject after a change relating to an administration of a pharmacological
agent" and "comparing the characteristics of altemans occurring in the
received cardiac signal data with the characteristics of altemans expected to
be present prior to administration of the pharmacological agent." (Claims
App.) The Examiner finds that Zhou discloses such receiving and
comparing steps. (See Final Action 22.)
The Appellants argue that independent claim 41 "recites features
similar to the noted features" of independent claim 1 and refers to the
"reasons discussed above" with respect to independent claim 1. (Appeal
Br. 7.) We are not persuaded by this argument because, as discussed above,
the Examiner establishes that Zhou discloses the step of receiving a set of
"post-therapy" cardiac signal data and comparing this data to a predefined
prediction threshold or other prediction criteria. (See Zhou i-fi-181, 83, 86.)
While independent claim 1 requires a comparison of this post-therapy
cardiac signal data with pre-therapy cardiac signal data, independent
claim 41 only requires a comparison of this post-therapy cardiac signal with
"expected" characteristics of the altemans. The Appellants do not
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Application 12/630,718
adequately address why Zhou's comparison criteria does not constitute "the
characteristics of altemans expected to be present prior to administration of
the pharmacological agent" required by independent claim 41.
Thus, we sustain the Examiner's rejection of independent claim 41 as
anticipated by Zhou (Rejection I).
DECISION
We AFFIRM the Examiner's rejections of claims 20-32 and 41.
We REVERSE the Examiner's rejections of claims 1-19 and 33--40.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED-IN-PART
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