St. Jude Medical, Cardiology Division, Inc.

Patent Trials and Appeals Board

Dec 23, 2020

2020003208 (P.T.A.B. Dec. 23, 2020)

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.
15/187,286 06/20/2016 Yuriy Malinin CD-911USO2/065513-001422 1087
67337 7590 12/23/2020
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/23/2020 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):
ASJM_Patents@abbott.com
MN-IPMail@dykema.com
Patents@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte YURIY MALININ, ANTHONY D. HILL,
CABLE P. THOMPSON, and LINDA RUETZ
____________

Appeal 2020-003208
Application 15/187,286
Technology Center 3700
____________

Before JOHN C. KERINS, MICHAEL J. FITZPATRICK, and
MICHELLE R. OSINSKI, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 14–21 under 35 U.S.C. § 102(a)(1) as anticipated
by Olson (US 2012/0265054 A1; pub. Oct. 18, 2012).2 We have jurisdiction
over the appeal under 35 U.S.C. § 6(b).

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as St. Jude Medical,
Cardiology Division, Inc. Appeal Br. 1.
2 A rejection of claims 18–21 under 35 U.S.C. §112(a) as failing to comply
with the written description requirement (Final Act. 2–3) has been
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We AFFIRM.
THE CLAIMED SUBJECT MATTER
Claims 14 and 18 are independent and are reproduced below.
14. A non-transitory computer-readable medium storing
instructions to generate a registration between impedance and
magnetic based coordinate systems, executable by a processing
resource to:
compute a location of a number of fiducial points,
wherein the number of fiducial points include impedance
locations of an electrode disposed on a catheter in an impedance
based coordinate system and magnetic locations of a magnetic
position sensor disposed on the catheter in a magnetic based
coordinate system;
compute a global electromagnetic transformation based
on the location of the number of fiducial points to transform the
impedance location of the electrode in the impedance based
coordinate system into a transformed impedance location of the
electrode in the magnetic based coordinate system;
determine a magnetic location of the electrode in the
magnetic based coordinate system;
determine whether an impedance shift exists between the
transformed impedance location of the electrode in the
magnetic based system and the magnetic location of the
electrode in the magnetic based system;
generate an electromagnetic dynamic registration
between the impedance based coordinate system and the
magnetic based coordinate system based on the impedance
shift; and
determine a shift corrected location of an electrode on an
impedance based medical device using the electromagnetic
dynamic registration.

18. A system for generating a registration between impedance
and magnetic based coordinate systems, comprising:

withdrawn (Ans. 3) and is not before us on appeal.
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a first catheter that includes a first electrode and a
magnetic position sensor;
a second catheter that includes a second electrode;
a processor and memory storing non-transitory computer-
readable instructions, executable by the processor to:
compute a location of a number of fiducial points,
wherein the fiducial points include impedance locations
of the first electrode in an impedance based coordinate
system and magnetic locations of the magnetic position
sensor in a magnetic based coordinate system;
compute a global electromagnetic transformation
based on the location of the number of fiducial points to
transform the impedance location of the first electrode in
the impedance based coordinate system into a
transformed impedance location of the first electrode in
the magnetic based coordinate system;
determine a magnetic location of the first electrode
in the magnetic based coordinate system;
determine whether an impedance shift exists
between the transformed impedance location of the first
electrode in the magnetic based system and the magnetic
location of the first electrode in the magnetic based
system;
generate an electromagnetic dynamic registration
between the impedance based coordinate system and the
magnetic based coordinate system based on the
impedance shift; and
determine a shift corrected location of the second
electrode by applying the electromagnetic dynamic
registration to the impedance locations of the second
electrode.

OPINION
Claims 14, 15, and 17–21
The Examiner finds that Olson discloses all of the limitations of
independent claims 14 and 18. Final Act. 4–5. In particular, the Examiner
finds that Olson discloses, among other things:
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[a] non-transitory computer-readable medium and system
for generating a registration between impedance and magnetic
based coordinate systems ([0021], fig. 1), comprising: a first
catheter that includes a first electrode and a magnetic position
sensor (catheter 13 of hybrid localization system; [0027],
[0037], [0041]); a second catheter that includes a second
electrode (fixed reference electrode 31 carried on second
catheter; [0029]); a processor and memory storing non-
transitory computer readable instruction, executable by the
processor to: . . . determine a shift corrected location of the
second electrode by applying the electromagnetic dynamic
registration to the impedance locations of the second electrode
([0060]).
Id.
Olson describes “a system and method for registering the coordinate
frames of multiple [localization] systems [used in cardiac diagnostic and
therapeutic procedures] (e.g., a magnetic-based system and an impedance-
based system) to common coordinate frames.” Olson ¶ 3. Olson further
describes a “mapping function f [that] is defined so as to transform the
coordinates of a location, measured with the impedance-based localization
system, into the common coordinate frame.” Id. ¶ 39. Olson additionally
describes that its system can “monitor for and signal various abnormalities,
such as dislodgement or drift in one or more of the magnetic- and/or
impedance-based localization systems,” or in other words, “can keep track
of whether the mapping function f remains valid, and, if appropriate, correct
for any anomalies or compute a new mapping function f.” Id. ¶ 57. Olson
also describes that if there is “divergence exceed[ing] a divergence
threshold” between (i) the coordinate frame of the magnetic-based
localization system and (ii) the mapping function to transform the
coordinates of a location measured with the impedance-based localization
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system into the coordinate frame of the magnetic-based localization system,
this can be an indication of an anomaly such as “drift in the impedance-
based localization system and/or dislodgement of one or more of the fixed
reference localization elements.” Id. ¶ 60. A “fixed reference” localization
element is a term used to describe “fixed reference electrode 31. . . carried
on a second catheter 29.” Id. ¶ 29. Olson further describes that “where the
anomaly is a dislodgement of one or more fixed reference localization
elements, an offset vector may be calculated to account for the
dislodgement.” Id. ¶ 60.
Appellant argues that “[a]lthough paragraph 0060 discusses ‘fixed
reference localization elements,’ no mention is made of the ‘fixed reference
localization elements,’ being on the second catheter.” Reply Br. 4. In our
view, when reading paragraph 60’s reference to “dislodgement of one or
more of the fixed reference localization elements” in the context of the
entirety of Olson’s disclosure,3 it is clear that the fixed reference localization
element referenced in paragraph 60 of Olson encompasses a fixed reference
electrode carried on a catheter. Olson ¶¶ 29, 60.
Appellant also argues that “the Olson reference does not disclose
applying the offset vector to the impedance based medical device, which is
different from the catheter for correcting its location.” Appeal Br. 10. To
the extent Appellant is arguing that Olson does not disclose applying the
offset vector to an “impedance based medical device” or to “a second

3 Olson earlier describes two examples of fixed reference electrodes for
impedance-based localization systems, namely, “a ‘belly patch” and “a fixed
intracardiac electrode 31, which is shown in FIG. 1 as carried on a second
catheter 29, [that] can be attached to a wall of the heart 10 or anchored
within the coronary sinus.” Olson ¶ 29.
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electrode” on “a second catheter,” as claimed, Olson describes “[f]or
impedance-based location systems, a reference electrode 21 . . . can be used
as a reference and/or ground electrode” or “[a]lternatively, a fixed
intracardiac electrode 31 may be used as a reference electrode” and can be
“carried on a second catheter 29.” Appeal Br. 17–18 (emphasis added);
Olson ¶ 29 (emphasis added). Thus, when considering Olson’s further
disclosure that “an offset vector may be calculated to account for the
dislodgement” “of one or more of the fixed reference localization elements”
(id. ¶ 60), it is apparent that Olson is determining an offset vector for “an
impedance[-]based medical device” (claim 14) or a “second electrode
[included on a second catheter]” (claim 18), as claimed.
To the extent Appellant is arguing more specifically that Olson does
not disclose applying an offset vector to an impedance-based medical device
“which is different from the catheter for correcting its location” (Appeal Br.
10 (emphasis added)), we do not see where claim 14 or claim 18 requires
that the determination of a shift corrected location of an electrode be for an
electrode on a medical device that is different from that used in computing a
transformation to transform impedance locations in an impedance-based
coordinate system into transformed impedance locations in a magnetic-based
coordinate system. We, thus, agree with the Examiner that Appellant’s
argument is not commensurate with the scope of claim 14 or claim 18,
which does not require that the step of determining a shift corrected location
of an electrode on an impedance-based medical device (claim 14) or an
electrode on a second catheter (claim 18), by applying the electromagnetic
dynamic registration, be specifically for a medical device that “is different
from the catheter for correcting its location.” See Ans. 4 (“[A]ppellant
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attempts to frame the arguments in regards to language which is not present
in the claims.”); In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (noting that it
is well established that limitations not appearing in the claims cannot be
relied upon for patentability).
Moreover, we have further considered Appellant’s argument (i) that
the “two devices [i.e., (a) the catheter having an electrode and a magnetic
position sensor disposed thereon and (b) an impedance-based medical device
of claim 14] are different devices” and (ii) that “the first catheter and the
second catheter [of claim 18] are two different devices,” and in either case,
“Appellant is not required to explicitly state the devices are different.”
Reply Br. 3. We, however, are not persuaded of error by the Examiner
because Appellant has not explained adequately why Olson’s first catheter
13 and second catheter 29 cannot reasonably be considered to satisfy the
claim elements. Appellant’s argument is based on an implicit construction
of the claims that would preclude the claimed impedance-based medical
device or second catheter from (i) being part of a system used to generate an
electromagnetic dynamic registration between coordinate systems or
(ii) being related to the earlier recited catheter in some way, without
explaining adequately how such a construction is required by the claims as
currently drafted or how such a construction is the broadest reasonable
construction consistent with the Specification and in light of the
Specification as it would be interpreted by one or ordinary skill in the art.
That is, with respect to claim 14, Appellant has not explained
adequately why Olson’s second catheter 29 having reference electrode 31
fixed thereon cannot be considered the claimed “impedance[-]based medical
device” separate from the claimed “catheter” having “an electrode” and “a
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magnetic position sensor” disposed thereon, for which the Examiner instead
relied on Olson’s catheter 13 including a plurality of localization elements.
With respect to claim 18, Appellant has not explained adequately why
Olson’s second catheter 29 having reference electrode 31 fixed thereon
cannot be considered the claimed “second catheter that includes a second
electrode” separate from the claimed “first catheter that includes a first
electrode and a magnetic position sensor,” for which the Examiner instead
relied on Olson’s catheter 13 including a plurality of localization elements.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s findings that Olson discloses all of the limitations of
independent claims 14 and 18. Accordingly, we sustain the rejection of
claims 14 and 18, and of claims 15, 17, and 19–21 depending therefrom and
for which Appellant relies on the same arguments and reasoning, under
35 U.S.C. § 102(a)(1) as anticipated by Olson.
Claim 16
Dependent claim 16 recites that the non-transitory computer-readable
medium “further compris[e] instructions to register an impedance location of
the electrode on the impedance based medical device with the magnetic
based coordinate system based on [a] secondary electromagnetic dynamic
registration” that has been determined in response to a determination that
impedance shift exists. Appeal Br. 17 (Claims App.). The Examiner takes
the position that, in Olson, “the registration may be continually updated
throughout the procedure when it is determined that the fixed reference
electrode has shifted (in effect, when the reference electrode shifts, the
registration is no longer accurate).” Ans. 5. In other words, the use of “an
‘offset vector’ . . . refers to correcting the registration by applying the
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offset.” Id. The Examiner further explains that, “upon determining the shift
[of the fixed reference electrode], the registration is updated . . . , and thus a
new ‘secondary’ registration is necessarily determined” and “[a]lternatively,
the entire registration may be recomputed, and this can also be considered a
‘secondary’ registration.” Id. The Examiner further explains that:
[i]n regards to claim 16, as the registration is updated
continuously or recomputed throughout the procedure, the
impedance location of the electrode on the impedance based
medical device is continually registered with the magnetic
based coordinate system as well. That is, as the registration is
updated after the reference electrode has shifted, the newly
updated “secondary” registration is then utilized to determine
the corrected locations of the electrodes, as described in [0060].
Id. at 6. Appellant does not respond with sufficient particularity to the
specific findings made by the Examiner in the Answer so as to persuade us
of error in the Examiner’s rejection. See Appeal Br. 13–14 (asserting only
that the Final Action is deficient in its analysis and that Olson lacks the
limitation of “register[ing] an impedance location of the electrode on the
impedance based medical device with the magnetic based coordinate system
based on the secondary electromagnetic dynamic registration” without
detailed explanation).
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s findings that Olson discloses all of the limitations of
claim 16. Accordingly, we sustain the rejection of claim 16 under 35 U.S.C.
§ 102(a)(1) as anticipated by Olson.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
14–21 102(a)(1) Olson 14–21

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED