Ex Parte Legay et al

Patent Trial and Appeal Board

Jan 26, 2018

13009629 (P.T.A.B. Jan. 26, 2018)

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.
13/009,629 01/19/2011 Thierry Legay 104292-0117 1065
22428 7590 01/30
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
KINNARD, LISA M
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
01/30/2018 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):
ipdocketing @ foley. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THIERRY LEGAY and DOMINIQUE DECOENE
Appeal 2017-002332
Application 13/009,6291
Technology Center 3700
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an active
implantable medical device for cardiac pacing, resynchronization and/or
defibrillation. The Examiner rejected the claims on appeal under 35 U.S.C.
§ 103(a) as obvious.
We reverse.
1 According to Appellants, the real party in interest is SOREST CRM S.A.S.
App. Br. 2.
Appeal 2017-002332
Application 13/009,629
STATEMENT OF THE CASE
The Specification discloses that “MRI examination has been
contraindicated for patients with an implanted cardiac pacemaker or
defibrillator type of generator.” Spec. 1 5. MRIs for patients with an
implanted device can cause “heating near the electrodes connecting the
generator to the patient’s heart” and the “high intensity static magnetic field
produced by the MRI equipment” may exert “forces and torques of
attraction” on the device. Id. In addition, the device may behave
unpredictably “due to the exposure to the strong magnetic field.” Id. The
Specification discloses that it is an objective of the claimed device to
“provide a solution to [these] problems, particularly to avoid malfunction or
unpredictable behavior of the device in a strong magnetic field.” Id. 1 6.
The device disclosed in Appellants’ Specification achieves this goal using a
switch that places the device in “protected MRI mode” when a magnetic
field sensor detects a magnetic field and returns the device to a standard
operating mode in the absence of the magnetic field. Id. 125—26.
Claims 1, 3—17, and 19—23 are on appeal. Claim 1 is illustrative and
reads as follows:
1. An active implantable medical device for cardiac pacing,
resynchronization and/or defibrillation, comprising:
an electronic circuit configured to provide electrical
stimulation signals at a stimulation frequency; and
a magnetic field sensor configured to detect the presence
of a predetermined permanent magnet, wherein the magnetic
field sensor is configured to detect the presence of the
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Application 13/009,629
permanent magnet by comparing a level of a first magnetic field
detected by the magnetic field sensor to a single preset
threshold magnetic field level set to a level equivalent to that
emitted by the predetermined permanent magnet, wherein the
first magnetic field is a static magnetic field that is weaker than
a second magnetic field emitted by the MRI equipment while
being operated during an MRI examination;
wherein the electronic circuit is configured to switch the
active implantable medical device between a standard operating
mode and a mode awaiting the MRI examination;
wherein the electronic circuit and magnetic field sensor
are configured to provide switching between at least four
different modes of operation of the active implantable medical
device using the detection of the permanent magnet, wherein
the electronic circuit is configured to determine a mode of
operation of the at least four different modes of operation to
which to switch based on a current mode of operation of the
active implantable medical device when the magnetic field
sensor detects the presence of the permanent magnet using the
single preset threshold magnetic field level;
wherein, when the active implantable medical device is
in the mode awaiting the MRI examination, the electronic
circuit is configured to switch the active implantable medical
device from the mode awaiting the MRI examination to a
protected operating mode in response to the magnetic field
sensor detecting the presence of the predetermined permanent
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Application 13/009,629
magnet, wherein the protected operating mode is configured to
protect the active implantable medical device from effects of
the stronger second magnetic field generated by the MRI
equipment during the MRI examination; and
wherein, when the active implantable medical device is
in the standard operating mode, the electronic circuit is
configured to switch the active implantable medical device
from the standard operating mode to a magnet mode in
response to the magnetic field sensor detecting the presence of
the predetermined permanent magnet, wherein, in the magnet
mode, the electronic circuit adjusts the stimulation frequency
based on a level of consumption of a power supply battery.
App Br. 30.
The claims stand rejected as follows:
Claims 1, 3—5, 10, 12, 13 and 20—22 were rejected under 35 U.S.C.
§ 103(a) over the combination of Linder,2 Terry,3 and Hareland.4
Claims 6 and 7 were rejected under 35 U.S.C. § 103(a) over the
combination of Linder, Terry, Hareland, and Armstrong.5
2 Linder et al., US Patent Publication No. 2009/0157146 Al, published June
18, 2009 (“Linder”).
3 Terry et al., US Patent No. 6,937,906 B2, issued Aug. 30, 2005 (“Terry”).
4 Hareland, US Patent Publication No. 2008/0147135 Al, issued June 19,
2008 (“Hareland”).
5 Armstrong, US Patent Publication No. 2007/0173890 Al, published July
26, 2007 (“Armstrong”).
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Application 13/009,629
Claim 8 was rejected under 35 U.S.C. § 103(a) over the combination
of Linder, Terry, Hareland, Armstrong, and Zeijlemaker.6
Claim 9 was rejected under 35 U.S.C. § 103(a) over the combination
of Linder, Terry, Hareland, and Zeijlemaker.
Claim 11 was rejected under 35 U.S.C. § 103(a) over the combination
of Linder, Terry, Hareland, and Funke.7
Claims 14 and 15 were rejected under 35 U.S.C. § 103(a) over the
combination of Linder, Terry, Hareland, and Cooke.8
Claims 16 and 23 were rejected under 35 U.S.C. § 103(a) over the
combination of Linder, Terry, Hareland, Cooke, and Zeijlemaker.
Claim 17 was rejected under 35 U.S.C. § 103(a) over the combination
of Linder, Terry, Hareland, and Stevenson.9
Claim 19 was rejected under 35 U.S.C. § 103(a) over the combination
of Linder, Terry, Hareland and Heifer.10
ANALYSIS
The same issue is dispositive with respect to all nine of the
Examiner’s rejections. Accordingly we address all of the pending rejections
together.
In rejecting the pending claims as obvious, the Examiner relies upon
Linder as disclosing “switching between at least four different modes of
6 Zeijlemaker, US Patent Publication No. 2006/0173295 Al, published Aug.
3, 2006 (“Zeijlemaker”).
7 Funke, US Patent No. 7,082,328 B2, issued July 25, 2006 (“Funke”).
8 Cooke et al., US Patent No. 7,561,915 Bl, issued July 14, 2009 (“Cooke”).
9 Stevenson, US Patent Publication No. 2009/0163980 Al, published June
25, 2009 (“Stevenson”).
10 Heifer et al., US Patent Publication No. 2002/0138124 Al, published
Sept. 26, 2002 (“Heifer”).
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Appeal 2017-002332
Application 13/009,629
operation” using a magnetic field sensor that uses a “single preset threshold
magnetic field level.” Final Act. 2—3.11 Appellants argue that Linder does
not disclose switching between multiple modes of operation based on a
single threshold magnetic field level. App. Br. 12—13. We find that
Appellants have the better position.
Linder discloses five different operational modes including: a “normal
ambulatory operating mode,... a battery status test mode, a mode
configured to abort therapy delivery, a mode to trigger storage of
electrograms ... a mode to trigger one or more research features, a mode to
increase or decrease therapy, [and] or one or more other operating modes.”
Linder 136. Linder also discloses switching between operational modes
“when the sensed [magnetic field] magnitude equals or exceeds the one or
more programmable thresholds.” Id. H 50-51. However, Linder does not
expressly discuss whether a single magnetic threshold can be used to switch
between all five of the disclosed modes. Moreover, the Examiner suggests
that it is “impossible for a system to determine amongst a plurality of modes
it should operate based upon a single threshold” because “[e]ach mode must
be distinguished with its own range of values.” Ans. 20.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
“[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability.” Here, it is not clear how the Examiner contends the
claim element requiring that the implantable device select among multiple
operational modes based on a “single preset threshold magnetic field level”
is disclosed or suggested by the cited art, while at the same time asserting
11 Office Action mailed October 28, 2015 (“Final Act.”).
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that this claim element is “impossible.”12 Accordingly, we reverse the
Examiner’s rejection of claims 1, 3—17, and 19-23.
SUMMARY
For the reasons set forth herein, we reverse the Examiner’s rejection
of claims 1, 3—17, and 19-23 under 35 U.S.C. § 103(a).
REVERSED
12 Appellants assert that “[t]he device of claim 1 is able to switch between
multiple modes of operation using a single preset threshold because the
mode of operation to which to switch is based on a current mode of
operation.” Reply Br. 4. The Examiner does not contend that Appellants
have failed to comply with the enablement requirement.
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