Ex Parte Hauck et al

Patent Trial and Appeal Board

Jun 29, 2018

11647296 (P.T.A.B. Jun. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/647,296 12/29/2006
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
07/03/2018
FIRST NAMED INVENTOR
John A. Hauck
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.
OG-040407US I
82410-0138
CONFIRMATION NO.
1659
EXAMINER
NGANGA, BONIFACE N
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
07 /03/2018 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):
ptodocket@wileyrein.com
ASJM_Patents@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN A. HAUCK, JEFFREY A. SCHWEITZER, KEDAR
RA VIND RA BELHE, and JEFF L. BURRELL 1
Appeal2017-006483
Application 11/647,2962
Technology Center 1600
Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a robotic system for tissue
ablation. The Examiner rejected the claims as indefinite under 35 U.S.C.
§ 112 and as obvious under 35 U.S.C. § 103. Appellants appeal the
rejections pursuant to 35 U.S.C. § 134. We have jurisdiction under 35
U.S.C. § 6(b). We affirm the obviousness rejections and reverse the
indefiniteness rejection.
1 The Appeal Brief ("Br.") 2 lists St. Jude Medical, Atrial Fibrillation
Division, Inc., the assignee of record, as the real-party-in-interest.
2 The application is referred to as "the '296 Specification."
Appeal2017-006483
Application 11/647,296
STATEMENT OF THE CASE
Claims 6-17, 19, and 21-36 stand rejected by the Examiner as follows:
1. Claims 6-12 as indefinite under pre-AIA 35 U.S.C. § 112, second
paragraph or 35 U.S.C. § l 12(b ). Ans. 2.
2. Claims 6-11, 13-17, 19, 21-25, and 33-36 underpre-AIA 35
U.S.C. § 103 as obvious in view of U.S. Patent Application Publication No.
2006/0095022 Al (pub. date May 4, 2006) ("Moll") and International
Published Application No. WO 2007 /023407 Al (pub. date Mar. 1, 2007)
("Eck"). Ans. 3.
3. Claim 12 under pre-AIA 35 U.S.C. § 103 as obvious in view of
Moll, Eck, and U.S. Patent Application Publication No. 2006/0149139 Al
(pub. date July 6, 2006) ("Bonmassar"). Ans. 14.
4. Claims 26 and 27 under pre-AIA 35 U.S.C. § 103 as obvious in
view of Moll, Eck, and U.S. Patent Application Publication No.
2006/0116575 Al (pub. date June 1, 2006) ("Willis"). Ans. 14.
5. Claims 28 and 30-32 under pre-AIA 35 U.S.C. § 103 as obvious in
view of Moll, Eck, Willis, and U.S. Patent No. 5,673,704 (issued Oct. 7,
1997) ("Marchlinski"). Ans. 18.
6. Claim 29 under pre-AIA 35 U.S.C. § as obvious in view of Moll,
Eck, Willis, Marchlinski, and Bonmassar. Ans. 19.
Independent claim 33, which is representative of the rejected claims,
is reproduced below:
33. A robotic system for tissue ablation, comprising:
an electrophysiology processor configured to analyze
measured electrophysiology information from a cardiac surface
and to identify, from the measured electrophysiology
information, a first ablated area on the cardiac surface and a
second ablated area on the cardiac surface, wherein the first
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Application 11/647,296
ablated area and the second ablated area are separated by an
unablated gap; and
a robotic controller for moving a catheter within a
patient's body, wherein the robotic controller automatically:
advances the catheter to an initial waypoint within
the first ablated area; and
maintains contact between the catheter and the
cardiac surface while moving the catheter to a final
waypoint within the second ablated area along a lesion
pathway that crosses the unablated gap.
REJECTION BASED ON SECTION 112
The Examiner rejected claims 6-12 under pre-AIA 35 U.S.C. § 112,
second paragraph, or 35 U.S.C. § 112(b) "as being incomplete for omitting
essential elements." Final Act. 3. The Examiner asserts that the omitted
element is the "catheter that is detected by the contact sensor" and "the
claims require detection of a catheter by the contact sensor." Id. at 3--4.
We agree with Appellants that the claimed robotic system does not
require a catheter, and the claim is not indefinite under 35 U.S.C. § 112 for
failure to recite the catheter. The claim requires a "robotic controller for
moving the catheter" (claim 33) and "a contact sensor to detect when a distal
end of the catheter is in contact with the cardiac surface" (recited in claim 6
which depends from claim 33). Both of these limitations clearly identify the
function of the controller and sensor with respect to the catheter.
The Examiner did not adequately explain why the absence of a
catheter from the robotic system makes the contact sensor indefinite. To the
extent that the Examiner's rejection is based on a finding that the contact
sensor must be present on the catheter and the fact that a catheter is not
required by the claim makes the claim indefinite, we make the following
observations. First, the claim does not require the contact sensor to be on
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Application 11/647,296
the catheter. Second, and consistently, the '296 Specification discloses: "[i]t
should be understood that, though described herein as separate components,
one or more of sensor 84, electrode 88, and electrode 154 may optionally be
combined into a single component carried on probe 12." '296 Spec. i-f 97;
see also id. i-f 39 (the term "probe" is used "interchangeably" with
"catheter"). Thus, the Specification does not require the sensor to be present
on the catheter.
The Examiner asserts that detection of the distal end of the catheter is
"impossible in absence of [the] catheter." Ans. 21. However, claim 6 is
directed to a robotic system and not a method of use. Detection of the distal
end of the catheter is not required by claim.
The Examiner also stated that claims were incomplete in failing to
claim "the structural relationship between the electrophysiological
processor, robotic controller and the sensor." Final Act. 4.
We are not persuaded that the claim violates the requirement of
Section 112 of "particularly pointing out and distinctly claiming the subject
matter which" the regard as the invention." The claims define the function
of each of the processor, controller, and sensor which are a part of the
claimed robotic system. The Examiner did not identify what structural
relationship between these components is missing from the clairn.
For the foregoing reasons, the rejection of claims 6-12 as indefinite
under 35 U.S.C. § 112 is reversed.
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Application 11/647,296
REJECTIONS BASED ON MOLL AND ECK
Appellants identified claim 33 as representative of the appealed
independent claims. Appeal Br. 10. Thus, all of the obviousness rejections
are decided with respect to this claim.
The principal dispute with respect to this claim is whether the cited
Moll and Eck publications describe or suggest the recited limitation of "an
electrophysiology processor configured to analyze measured
electrophysiology information from a cardiac surface and to identify, from
the measured electrophysiology information."
To meet this limitation, the Examiner cited the Eck publication. The
Examiner found:
Eck discloses a mapping system that includes a catheter 30 and
electrophysiological processor (ECG recording and monitoring
system 34 and computer 50) wherein measured
electrophysiological information is used to identify a first
ablated area and a second ablated area separated by a gap along
an ablation line ....
Final Act. 6.
The Examiner referred to the teaching in Eck of determining whether
"electrical current is above the threshold current value indicative of a gap in
an ablation line or ring" as the electrophysiological information. Final Act.
6 (citing the Abstract of Eck).
The Examiner cited the following disclosure from Eck to support the
obviousness finding:
[U]ser 22 advances catheter 30 to the area of the surface of the
cardiac chamber on which ablation is to be performed at block
202. As ablation energy is applied to the cardiac surface,
ablation power generator 38 measures, preferably continuously,
the amount of electrical current that is needed to maintain the
tip at a constant temperature at block 204, as described above.
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Application 11/647,296
Current ablation catheters are controlled to keep a constant
temperature at their tip of about 50°C to about 65°C. The
ablation power generator 3 8 senses the amount of current that is
required to heat the catheter tip. A simple threshold decision or
other means of signal classification applied to this feedback
information at block 206 then allows distinguishing between
contact of the catheter tip with cardiac tissue (e.g., low current
required) and the catheter tip that is only in contact with the
blood flow (e.g., high current required). If the measured
feedback signal is classified as "not in contact" with the heart
tissue, then block 202. If the measured current is greater than
the threshold current value indicative of a lack of tip contact
with the heart tissue, then block 208.
Eck 7: 4--17.
Thus, Eck teaches that the current sensed at the tip of the catheter
provides feedback to determine when the tip is in contact with the heart
tissue.
Appellants argue:
... the electrical current necessary to maintain the tip of Eck's
catheter at a constant temperature is in no way
"electrophysiology information." "Electrophysiology" is "the
branch of physiology dealing with the electric phenomena
associated with the body and its functions."
Appeal Br. 11.
Appellants also contend that the information the Examiner
characterizes as "electrophysiological information" is not measured "from a
cardiac surface" as required by claim 33, but is "instead, a measurement
wholly internal to the Eck catheter." Appeal Br. 12.
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Application 11/647,296
DISCUSSION
At issue in this rejection is whether the current sensed at the catheter
tip, as described in Eck, meets the recited limitation of "measured
electrophysiology information."
It is true, as Appellants argue, that the Eck teaches that the power
generator senses current at the tip of catheter. Eck 7: 10-11 (see passage
reproduced above). However, the current necessary to heat the catheter tip
is directly based on "contact of the catheter tip with cardiac tissue (e.g., low
current required) and the catheter tip that is only in contact with the blood
flow (e.g., high current required)." Id. at 7: 13-14 (see passage reproduced
above). Thus, as explained by the Examiner, the current at the catheter tip is
a "measure of impedance changes ... based on either cardiac tissue or blood
in contact with the tip electrode." Ans. 24. The '296 Specification discloses
that "[t]ypical electrophysiology information includes, without limitation . .
. changes in impedance .... " '296 Spec. i-f 132 (emphasis added). In other
words, when the catheter tip contacts the heart/cardiac tissue, as taught by
Eck, the current needed to heat the tip is based on the electrical impedance
of the tissue, which is an electrophysiological property. Sensing a low
current indicates that tissue is heart tissue because that tissue's impedance
requires a lower current to achieve the desired heat. Eck 7: 4--17. On the
other hand, a higher current indicates that the tissue is blood because blood
requires a higher current to achieve the same temperature. Id. The tissue
impedance is thus sensed by the power generator using the current needed to
heat the catheter tip. Appellants did not identify a defect in the Examiner's
findings or reasoning, and we find the Examiner's determination to be
without error.
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Application 11/647,296
Appellants argue that certain parameters, such as lesion quality,
diameter, and depth, are not electrophysiological information. Reply Br. 5.
However, as discussed above, the Examiner found that Eck's teaching
regarding current sensing at the catheter tip is a measure of tissue impedance
and electrophysiological information. Ans. 24.
Appellants also argue that "electrophysiological information" is not
measured "from a cardiac surface" as required by claim 33, but is "instead, a
measurement wholly internal to the Eck catheter." Appeal Br. 12.
Appellants contend:
An accurate characterization of Eck would be that this value is
measured with the catheter on a cardiac surface or with the
catheter at a cardiac surface, neither of which is the same things
as measuring a value "from a cardiac surface" as claimed.
Reply Br. 5.
Appellants' argument is not persuasive. The sensed "current" may be
with respect to the tip of the catheter, but the current constitutes "measured
electrophysiological information from a cardiac surface" as recited in claim
33 because the catheter is in contact with the cardiac surface and the
measured current is a function of, and based on, the cardiac tissue
impedance and what is happening at the cardiac tissue surface, which is
electrophysiological information and a property of the cardiac tissue.
Summary
For the foregoing reasons, we affirm the rejection of claim 33 as
obvious in view of Moll and Eck. Separate arguments for claims 6-17, 19,
21-32, and 34-36 were not made by Appellants (Rejections 2---6). Appeal
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Application 11/647,296
Br. 12-13. These claims therefore fall with claim 33. 37 C.F.R.
§ 37.41(c)(l)(iv).
Obviousness rejections 1---6 are affirmed.
TIME PERIOD
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
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