Ex Parte Wu et al

Patent Trial and Appeal Board

Oct 18, 2017

13974464 (P.T.A.B. Oct. 18, 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.
13/974,464 08/23/2013 Yongjian Wu A13P3011 1309
24473 7590
Theresa Raymer
Pacesetter, Inc.
3200 Lakeside Drive
Bldg. B, 3rd Floor, M/S 314
Santa Clara, CA 95054
EXAMINER
PORTER, JR, GARY A
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
10/20/2017 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):
tray mer @ sj m. com
jnewell@sjm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YONGIJAN WU, ERIC HUSKY, DAVID DOUDNA,
CHAO-WEN YOUNG, MIN YANG, ROBERT ROMANO,
TOMMY AKKILA, GORAN, BUDGIFVARS,
and EDUARDO SERRANO
Appeal 2016-006693
Application 13/974,4641
Technology Center 3700
Before TAWEN CHANG, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to an
implantable medical device (IMD) and a method of operating an IMD,
which have been rejected as anticipated or obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellant is the Applicant, Pacesetter, Inc., which, according to the Brief,
is the Real Party in Interest. (Br. 3.)
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Application 13/974,464
STATEMENT OF THE CASE
Various IMDs are known that “are programmed and monitored by an
external programmer or external home-based patient care system.” (Spec.
13.) “For example, a patient may have an IMD that communicates with a
base station within the patient’s home or a programmer that is used by
physicians to change settings within the IMD and/or retrieve data from the
IMD.” (Id.) “Conventional external programmers and base stations employ
inductive communication techniques that facilitate communication between
the IMD and a telemetry wand that is operatively connected to the base
station.” (Id. 14.)
Appellant’s invention is directed to IMDs that communicate with an
external device through radio frequency (RF) signals. (Spec. 11.)
Claims 1—24 are on appeal. Claim 1 is representative and reads as
follows:
1. An implantable medical device (IMD) configured to be
implanted within a patient and communicate with an external
device remote from the patient, the IMD comprising:
a communication module configured to wirelessly
communicate over an RF link with the external device;
a therapy control module configured to deliver therapy to
the patient, the therapy control module including a
reprogrammable therapy
logic circuit configured to operate the therapy control
module in a reprogrammable mode of operation, and a base-
therapy state machine (BTSM) logic circuit configured to
operate the therapy control module in a base therapy mode of
operation;
a firmware control module including a central processing
unit (CPU) and a memory; and
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a service application stored in the memory, the firmware
control module configured to launch the service application
during which the BTSM logic circuit provides a base level of
sensing and pacing therapy while the communications module
in parallel maintains the RF link with the external device.
(Appeal Br. 27—28.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1—10, 12—15, and 17—24 under 35 U.S.C. § 102(b) as
anticipated by Petersen.2
Claim 11 under 35 U.S.C. § 103 as unpatentable over Petersen and
Masoud.3
Claim 16 under 35 U.S.C. § 103 as unpatentable over Petersen and
Rueter.4
DISCUSSION
Anticipation
The Examiner finds Petersen discloses an IMD that includes a
communication module that initiates a programming session, a therapy
control module, and a processor that is programmed to operate the therapy
control module in fail-safe mode when a programming or operational error is
detected. (Final Action 6; Ans. 3.) The Examiner further finds that Petersen
discloses IMD operation during fail-safe mode in which an RF link is
maintained in parallel with the pre-programmed therapy instructions (i.e.,
2 Petersen et al., US 2005/0049656 Al, published Mar. 3, 2005.
3 Masoud et al., US 2007/0239229 Al, published Oct. 11, 2007.
4 Rueter et al., US 2005/0021095 Al, published Jan. 27, 2005.
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default therapy and sensing parameters stored in memory) being executed.
(Final Action 6; Ans. 3 and 8—9.) According to the Examiner, Petersen
teaches this link is maintained to enable (1) user notification by an external
programmer, (2) receiving new programming instruction, and (3) fixing of
the programming and/or operational error. (Id.)
The Examiner explains that Petersen indicates that “the notification
device 22 can be located in the IMD 12 or the [external] programmer 14
(par. [0034]).” (Ans. 11.) Thus, the Examiner concludes that, as to
paragraph 37 of Petersen, when “the notification device 22 is indicated as
capable of communicating via a wireless network, it is understood that
device 22 is capable of the type of communication regardless of whether it is
associated with [external] programmer 14 or IMD 12.” (Id. at 12.)
The Examiner asserts that the last claim limitation
does not [require] that a notification is provided at the same
time that the IMD provides a base level of sensing and pacing
therapy as presently claimed (emphasis added). Maintaining in
parallel, as required by the claim, only requires that the RF link
be usable while the IMD is operating according [to] base
programming parameters.
(Ans. 10; see also id. at 13.) The Examiner contends that this limitation is
met because
Petersen discloses changing therapy parameters in addition to
sending out notifications via an RF link (par. [0040, 0043]).
Petersen further discloses that the IMD can be further
monitored once the new parameters are established (par. [0068],
wherein the ways in which the IMD is monitored via RF
telemetry are highlighted in par. [0037, 0050, 0053]. One
example of note is found in par. [0050] in which IMD notes in a
failure log an occurrence of a failure and then sends the log to a
remote programmer, which can only be achieved via an RF
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telemetry link since there is no direct connection between a
device in the body and an external device outside of the body.
(Ans. 10.; see also id. at 9 (noting Petersen teaches (a) the IMD can send
electronic messages over a wireless network after a programming error
(citing Petersen || 36, 37), (b) “in addition to sending Tsuchl a notification,”
the IMD is instructed after the programming failure by a local programmer
“to revert to a set of default parameters” (citing Petersen 140), and (c) the
IMD “may be monitored again to detect an adverse event” (citing Petersen
1 68) (emphasis in the original)).
Regarding the claimed logic circuits, the Examiner states that “one
would understand that the processor 36 of Petersen, by virtue of the
functions it performs according [to] the instructions stored therein,
necessarily has the claimed hardware ‘circuits’, i.e. the control module, the
reprogrammable logic circuit, the BTSM logic circuit and the service
application.” (Final Action 3.) The Examiner explains further that “a
processor is not a single circuit but a combination of circuits,” and that the
“various substructures of a processor combine to execute instructions stored
in memory, and in particular separate memory locations.” (Ans. at 13—14.)
The Examiner finds that Petersen discloses that the IMD is reprogrammable
with default and new value parameters and can operate in a default sensing
and therapy mode, which functions are implemented via the processor. {Id.;
see also Final Action 6 (“since the processor is programmed with
instructions to perform the claimed functions, the processor necessarily has
the hardware circuits for storing and implementing said instructions.”).)
According to the Examiner, “[t]he combination of components in Fig. 3 of
Petersen are tangible circuits that perform the claimed functions and
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therefore anticipate the claimed invention.” (Ans. at 14.) In particular, the
Examiner explains that
In the Petersen reference, the execution of default program
parameters stored in location 50 require separate circuit
pathways than those required to execute new parameters in
location 48 (Fig. 3). Therefore, location 50 can be considered
part of the BTSM logic circuit since it contains the
configuration to operate the IMD 12 in a default, i.e. base,
therapy mode of operation as required by the claim. Likewise,
location 48 can be considered part of the reprogrammable
therapy logic circuit since it is a circuit component configured
to operate the IMD in a reprogrammable mode of operation.
{Id. at 14.)
We agree with the Examiner’s factual findings and determination that
claim 1 is anticipated.
a) an IMD that provides a base level of sensing and pacing therapy
while a communications module in parallel maintains an RF link
In its Appeal Brief, Appellant acknowledges that “Peterson discloses
that, in response to a programming session failure, a notification may be sent
to an external device and the processor may load default programming
parameters.” (Br. 17; see also Br. 19.) However, Appellant contends that
the Examiner’s rejection is in error because the portions of Petersen relied
upon by the Examiner do not disclose that “the notification is provided at
the same time that the IMD provides a base level of sensing and pacing
therapy.” {Id. at 17 (emphasis in the original).) According to Appellant,
paragraphs 35—37 of Petersen “merely state that notification is provided in
response to a programming failure. Such notification may be at a time
before the IMD switches programming parameters.” {Id.; see also Br. 20
(“the notification may be provided and then the IMD may revert to default
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parameters.”).) In other words, “the cited paragraphs do not teach or suggest
an implantable medical device (IMD) that provides a base level of sensing
and pacing therapy while a communications module of the IMD in parallel
maintains the RF link with the external device.” (Id. at 19 (emphasis in the
original).)
Appellant argues that paragraphs 40 and 44 also fail to teach the
foregoing. (Id. at 20-21.) Regarding paragraph 40, Appellant contends that
Petersen does not state when IMD 12 actually reverts to a set of
default parameters. Local programmer/monitor 14 may
communicate instructions to IMD 12 to revert to a set of default
parameters and a notification signal may be sent prior to IMD
12 reverting to a set of default parameters. Thus paragraph
[0040] does not inherently or otherwise teach the claim
limitations.
(Id. at 21.) Regarding paragraph 44, Appellant agrees that “Petersen teaches
. . . that local programmer/monitor 14 may be configured to deliver a therapy
in response to an adverse event associated with remote programming and
that delivering therapy to a patient may include therapy delivered via an
IMD 12.” (Id.) However, Appellant contends
Petersen does not disclose in paragraph [0044] that the therapy
“provides a base level of sensing and pacing therapy.” Petersen
teaches, for example, that local programmer/monitor 14 may
provide defibrillation therapy via other devices—which is clearly
not a base level of sensing and pacing therapy. Moreover,
paragraph [0044] of Petersen does not disclose maintaining an
RF link between the local programmer/monitor 14 and IMD 12
to deliver therapy—as opposed [to] an inductive link or other
form of communication. Indeed, local programmer/monitor 14
may be communicating with IMD 12 through inductive
telemetry, through a wand, and not an RF link.
(Id. at 21—22 (emphasis in the original).) Moreover, argues Appellant,
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paragraph [0044] of Petersen does not disclose that
programmer/monitor 14 interrogates IMD 12, using an RF link
or otherwise. Instead, paragraph [0044] teaches monitoring
patient data, such as the patient’s electrocardiogram (ECG),
using an automated external defibrillator (AED) 24 to
determine whether IMD 12 is providing adequate therapy. Thus
Petersen discloses that programmer/monitor 14 uses the
patient’s ECG collected by the AED 24 to determine whether
IMD 12 is working properly, and if not using the AED 24 to
deliver the therapy.
{Id. at 22.)
Regarding paragraphs 50, 53, and 57, Appellant agrees that
“Petersen states that default programming parameters are loaded if
failure of the remote programming session is detected, and that
notification of the programming failure may be sent,” and “failure log
logs information concerning detection of adverse events associated
with remote programming sessions.” {Id. at 18—19.) However,
Appellant argues that Petersen “does not disclose or suggest a BTSM
logic circuit that provides a base level of sensing and pacing therapy
while the communications module in parallel maintains the RF link
with the external device” because Petersen does not state that
(1) “notification is provided at the same time that the IMD
provides a base level of sensing and pacing therapy;” or
(2) “the failure log is sent at a time when the IMD is providing
a base level of sensing and pacing therapy.”
{Id. (emphasis in the original).) Regarding the latter point, Appellant notes
that “the failure log may be sent after, for example, inductive telemetry is
used to reactivate communication, and the processor of the IMD is reset.”
{Id. at 19.) Thus, Appellant contends that Peterson does not disclose that the
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firmware control module is configured to launch the service application
during the time the base-therapy state machine logic circuit of the therapy
control module provides a base level of sensing and pacing therapy while the
communications module in parallel maintains the RF link with the external
device, as required by claim 1.
We do not find Appellant’s arguments persuasive. We agree with the
Examiner (Ans. 8—9) that Petersen discloses (1) at least through paragraphs
36 and 37, that IMD 12 contains a notification device 22 and that the
notification device is able to send electronic messages via RF
communication over a wireless network to external programmer 14 after a
programming error; (2) that the RF telemetry link is maintained in parallel
after the programming failure in light of Petersen’s teaching at paragraph 40
that, “in addition to” notification process, the local programmer 14 instructs
the IMD 12 programming to revert to default parameters; and, (3) Petersen
discloses at paragraph 68 that “monitoring the IMD for programming errors
is an iterative process. . .,” which when read in conjunction with paragraph
40, provides that “the telemetry link used by the external programmer 14 is
established with IMD 12 while IMD 12 is programmed with and operating
according to stored program parameters” (Ans. 9).
We also agree with the Examiner (Ans. 10) that “[mjaintaining in
parallel, as required by the claim, only requires that the RF link be usable
while the IMD is operating according to base programming parameters.”
Thus, we also agree with the Examiner (Ans. 13) that “the determination of
exactly when an active communication is sent in relation to the delivery of
therapy is moot as the claims do not require such a feature. One can
‘maintain’ an RF link without actively communicating on said link.”
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As the Examiner notes, Petersen highlights in paragraphs 37, 50 and
53, ways in which IMD is monitored via RF telemetry. The Examiner points
out (Ans. 10-11), and we agree, Petersen does not disclose a “direct
connection between a device in the body and an external device outside of
the body,” but discloses that the “IMD notes in a failure log an occurrence of
a failure and then sends the log to a remote programmer.” Accordingly, a
skilled artisan would understand that the noting and sending process
discussed above is achieved via an RF telemetry link.
Appellant did not respond to the foregoing findings by the Examiner;
that is, Appellant did not address the Examiner’s identification as to the
interplay of paragraph 68 and the occurrence of base level sensing and
pacing being carried on while the RF link is maintained and capable of being
used for communication during that base level sensing and pacing.
We agree with Appellant that anticipation requires the reference to
disclose the claimed limitations as arranged in the claim. (Br. 10 (citing Net
MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)).)
However, in light of the unrebutted finding by the Examiner as to the
interplay of the teaching of paragraph 68 of Petersen being an iterative
process, and thus, the RF telemetry link being established while IMD 12 is
programmed with and operating according to stored programming
parameters, e.g., a base level, we find the Examiner has established Petersen
teaches the requirement of claim 1 that an IMD includes a firmware control
module configured to launch a service application stored in the memory
during which the BTSM logic circuit provides a base level of sensing and
pacing therapy “while a communications module of the IMD in parallel
[with that activity] maintains the RF link with the external device.”
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b) reprogrammable therapy logic and the base-therapy state machine
logic circuit
Appellant argues that “[t]he disclosure of processor 36 plus software
would not be understood by a person of skill in the art to be ‘a
reprogrammable logic circuit’ and a ‘base-therapy state machine logic
circuit’ even if their functions could be integrated in a single module and
combined in a single device, such as a single integrated circuit chip (as
argued by the Examiner at pars. 8 and 9 of the final Office Action, dated
March 24, 2015).” (Br. 24—25.) The Examiner, however, addresses
Appellant’s argument finding that “when specification instructions are
performed by the processor, a different combination of circuit components
within said processor are used to implement the instruction, beginning with
the unique memory location, which is made of a memory circuit called a
register.” (Ans. 14.) The Examiner also notes “Appellant has not defined
any specific or particular components that compose the claimed circuits and
instead only describes them functionally. Therefore, the prior art need only
disclose some form of circuit that performs the claimed function.” (Id.) The
Examiner finds “[t]he combination of components in Fig. 3 of Petersen are
tangible circuits that perform the claimed functions and therefore anticipate
the claimed invention.” (Id.) In particular, the Examiner points out
the execution of default program parameters stored in location
50 require separate circuit pathways than those required to
execute new parameters in location 48 (Fig. 3). Therefore,
location 50 can be considered part of the BTSM logic circuit
since it contains the configuration to operate the IMD 12 in a
default, i.e. base, therapy mode of operation as required by the
claim. Likewise, location 48 can be considered part of the
reprogrammable therapy logic circuit since it is a circuit
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component configured to operate the IMD in a reprogrammable
mode of operation.
(Id. ) Appellant did not provide persuasive argument or evidence to the
contrary. We accordingly agree with the Examiner’s finding that Petersen
teaches the claimed circuitry.
Thus, for the foregoing reasons, we affirm the Examiner’s rejection of
claim 1 as being anticipated by Petersen.
The Appellant’s arguments as to Examiner error with respect to claim
17 are the same as those for claim 1. (See, e.g., Br. 14 (“Petersen does not
disclose an IMP that provides a base level of sensing and pacing therapy
while a communications module in parallel maintains an RE link recited in
claims 1 and 17”).) For the reasons discussed, we also affirm the
Examiner’s rejection of claim 17 as being anticipated by Petersen.
Claims 2—10, 12—15, and 18—24 have not been argued separately and
therefore fall with claims 1 and 17. 37 C.F.R. § 41.37(c)(l)(iv).
Obviousness
The Examiner relies on Masoud for the limitations found in dependent
claim 11 and Rueter for the limitations found in dependent claim 16. (Final
Action 10—11.) Appellant does not dispute the Examiner’s findings with
regard to Masoud or Rueter or the Examiner’s rationale for finding claim 11
obvious in light of the teachings of Petersen and Masoud and claim 16
obvious in light of the teachings of Petersen and Rueter. Rather, Appellant
contends “[i[t is believed that the addition of Masoud and Rueter does not
remedy the deficiency of rejection of independent claim 1.” (Br. 25.)
Because we do not agree with Appellant that the Examiner’s anticipation
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rejection is deficient, we also affirm the Examiner’s obviousness rejections
of claims 11 and 16.
SUMMARY
We affirm the Examiner’s rejection of claims 1—10, 12—15, and 17—24
under 35 U.S.C. § 102(b) as anticipated by Petersen.
We affirm the Examiner’s rejection of claim 11 under 35 U.S.C. § 103
as unpatentable over Petersen and Masoud.
We affirm the Examiner’s rejection of claim 16 under 35 U.S.C. § 103
as unpatentable over Petersen and Rueter.
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
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