Assaf Govari et al.

Patent Trials and Appeals Board

Aug 7, 2019

13326456 - (D) (P.T.A.B. Aug. 7, 2019)

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.
13/326,456 12/15/2011 Assaf Govari BIO5284USNP 9860
27777 7590 08/07/2019
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
PIATESKI, ERIN M
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
08/07/2019 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ASSAF GOVARI, ANDRES CLAUDIO ALTMAN,
and YARON EPHRATH
____________________

Appeal 2019-001203
Application 13/326,456
Technology Center 3700
____________________

Before JOHN C. KERINS, STEFAN STAICOVICI, and
WILLIAM A. CAPP, Administrative Patent Judges.

KERINS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants1 seek our review under 35 U.S.C. § 134(a) from the
Examiner’s Final Office Action dated August 2, 2017 (“Final Act.”),
rejecting claims 8–16. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellants identify Biosense Webster (Israel) Ltd as the real party in
interest. Appeal Br. 1.
Appeal 2019-001203
Application 13/326,456

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THE INVENTION
Appellants’ invention relates to a medical apparatus including a
bipolar ablation element and a dedicated sensing electrode. Claim 8 is
independent, is reproduced below, and is illustrative of the claimed subject
matter.
8. A medical apparatus, comprising:

a probe defining a longitudinal axis and having a bipolar ablation
element disposed on a distal portion of the probe, the bipolar
ablation element consisting of first and second ablation
electrodes concentrically disposed on the distal portion of the
probe relative to the longitudinal axis and a dedicated sensing
electrode concentrically disposed on the distal portion of the
probe relative to the longitudinal axis and between the first and
second ablation electrodes, the first and second ablation
electrodes being configured to operate as a bipolar pair in a
bipolar mode to deliver RF energy to ablate tissue and form a
lesion that extends between the first and second ablation
electrodes, the dedicated sensing electrode being separate and
distinct from the first and second ablation electrode and
configured to sense local electrical activity in the heart when the
ablation electrodes are delivering RF energy;

an ablation energy generator connected to the first and second
ablation electrodes; and

a monitor connected to the sensing electrode and operative to
detect cardiac electrical activity via the sensing electrode when
the probe is brought into contact with a target tissue in a heart of
a subject, the monitor comprising monitoring circuitry
configured to track the progress of lesion formation by detecting
a drop in the electrical amplitude of the electrical activity and a
graphical display operative for displaying a map of a portion of
the heart that includes the target tissue and a progression of
energy application along an ablation path.

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THE REJECTIONS
The Examiner rejects:
(i) claims 8 and 14–16 under 35 U.S.C. § 103(a) as being unpatentable
over Ben-Haim (US 5,954,665, issued Sep. 21, 1999) in view of
Francischelli (US 6,663,627 B2, issued Dec. 16, 2003), Deno (US
2011/0125150 A1, published May 26, 2011), Goldreyer (US 5,579,764,
issued Dec. 3, 1996) and Winkler (US 2010/0305562 A1, published Dec. 2,
2010);
(ii) claims 9 and 13 under 35 U.S.C. § 103(a) as being unpatentable
over Ben-Haim in view of Francischelli, Deno, Goldreyer, Winkler, and
Goldin (US 2002/0151807 A1, published Oct. 17, 2002);
(iii) claim 10 under 35 U.S.C. § 103(a) as being unpatentable over
Ben-Haim in view of Francischelli, Deno, Goldreyer, Winkler, Goldin, and
Bevelacqua (("Field Regions", http://www.antennatheory.
com/basics/fieldRegions.php, dated April 28, 2010, last accessed June 10,
2015); and
(iv) claims 11 and 12 under 35 U.S.C. § 103(a) as being unpatentable
over Ben-Haim in view of Francischelli, Deno, Goldreyer, Winkler and
Klimovitch (US 2010/0274238 A1, published Oct. 28, 2010).

DISCUSSION
Claims 8 and 14–16--Ben-Haim/Francischelli/Deno/Goldreyer/Winkler
The Examiner finds that Ben-Haim discloses a bipolar element
disposed at a distal portion of a probe, with the bipolar element having first
and second bipolar electrodes in the form of dedicated sensing electrodes 28,
30, and that the probe also has a dedicated ablation electrode 26. Final
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Act. 4. Acknowledging that claim 8 instead requires a pair of bipolar
ablation electrodes with a sensing electrode disposed between the pair of
ablation electrodes, observing that “this arrangement is precisely the
opposite of the arrangement taught by Ben-Haim” (id. at 5), the Examiner
embarks on a convoluted path of citing to other teachings in Ben-Haim to
eventually reach the conclusion that the claimed configuration would have
been obvious to a skilled artisan, because it “is only a minor variant of the
embodiments already taught by Ben-Haim.” Id. at 6.
The Examiner’s specific rationale is to the effect that, because Ben-
Haim discloses, in one embodiment, that a dome-shaped ablation electrode
can also be used for sensing, the modification to place a sensing electrode
between two bipolar ablation electrodes would have been recognized by a
person of ordinary skill in the art as providing “an additional functional and
effective embodiment of the system.” Id. Appellants point out, however,
that the Ben-Haim system does not, in any of the disclosed embodiments,
employ bipolar ablation, thus begging the question as to why it would have
been obvious to modify Ben-Haim to have that capability. Appeal Br. 7.
Appellants explain that the disclosure in Ben-Haim directed to using an
ablation electrode in a bipolar pair with a sensing electrode is for the purpose
of bipolar sensing, and not ablation. Id.; See Ben-Haim 8:58–9:5.
Appellants note, in this respect, that Ben-Haim discloses disconnecting
ablation electrode 26 from sensing circuitry 36 when the electrode is to be
used for ablation, and nowhere is it disclosed or suggested that ablation
electrode 26 might be used with another electrode to effect bipolar ablation.
Appeal Br. 6.
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The Examiner additionally cites to Winkler as disclosing a
configuration in which two bipolar ablation electrodes are employed, with a
sensor placed between the ablation electrodes, and concludes that it would
have been obvious to include, presumably, although not stated, in the Ben-
Haim device, bipolar ablation forming a lesion, and a sensing electrode on
that lesion in order to assess the progression and quality of lesion formation.
Final Act. 6. Although Winker evidences that the technique of employing
bipolar ablation between electrodes with a sensor disposed between was
known in the art, that does not alone make the teachings obvious to combine
with the system in Ben-Haim. This purported reason to modify Ben-Haim
effectively disregards much, if not all, of the teachings of how the Ben-Haim
device is designed to be operated.
As part of the obviousness rejection, the Examiner finds that Ben-
Haim fails to teach the provision of monitoring circuitry configured to track
the progress of lesion formation by detecting a drop in the electrical
amplitude of the electrical activity. Final Act. 4. The Examiner relies on
Francischelli as disclosing a system that detects a drop in electrical
amplitude of electrical activity during ablation, and that a drop in the
electrical activity may indicate that ablation is proceeding too quickly or not
quickly enough, depending on the rate of the drop. Id. at 4–5. The
Examiner concludes that it would have been obvious to apply these
teachings of Francischelli to Ben-Haim “because this information may be
used to trigger changes to energy level at which ablation is applied, to allow
accurate and safe therapy.” Id. at 5.
Appellants maintain that the reason articulated by the Examiner for
the proposed modification of Ben-Haim to include the monitoring of the
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drop in electrical amplitude, i.e., to allow for changes to the applied energy
level for safe and accurate therapy, is improper and based on conjecture.
Appeal Br. 9. According to Appellants,
Ben-Heim does not even contemplate changing energy levels
during or after ablation. Ben-Haim simply teaches ablating, then
after ablation using the sensing electrodes to determine electrical
activity on either side of the lesion. If the lesion is deemed
unsatisfactory (i.e. electrically activity across the lesion), the
ablation is restarted. Further, there is no disclosure in either
reference that states a change [in] energy level is to allow
accurate and safe therapy.
Id.
The Examiner responds that “Francischelli was cited for the purpose
of showing the reasoning for using the drop in energy level as a metric to
guide ablation therapy.” Ans. 14. The Examiner further maintains that “the
applicability of Ben-Haim’s disclosure is not limited to possibilities
envisioned by Ben-Haim. The advantage gained by the incorporation of a
feature does not need to be the same advantage envisioned by the appellant.”
Id. at 16.
Appellants have the better position here. Although the general
statements made in the Examiner’s response are essentially accurate, they do
not compensate for the lack of rational underpinnings underlying the initial
articulated reason to modify Ben-Haim in view of Francischelli.
Francischelli’s monitoring of the rate of ablation via the rate of drop in the
amplitude of a depolarization signal in cardiac tissue to determine whether
the ablation might be proceeding too quickly or not quickly enough, has not
been shown by the Examiner to have any particular applicability to the
ablation process using the Ben-Haim ablation system. As noted by
Appellants, Ben-Haim does not contemplate changing the power of the
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applied energy, and does not appear to require sensing during ablation. In
other words, the reason proffered by the Examiner to modify the teachings
of Ben-Haim, i.e., “to allow accurate and safe therapy,” appears to already
be adequately performed by Ben-Haim when comparing electrical signals
before and after ablation to determine whether the ablation is effective, i.e.,
“accurate and safe.” See Ben-Haim, col. 3, ll. 1–11. Thus, the Examiner’s
rejection appears to be an exercise in hindsight reconstruction in view of
Appellants’ disclosure to conclude that the proposed modification would
have been obvious.
Accordingly, the rejection of claim 8, and of dependent claims 14–16,
is not sustained.

Claims 9 and 13--Ben-Haim/Francischelli/Deno/Goldreyer/Winkler/Goldin
The Examiner does not rely on Goldin in any manner that remedies
the deficiency, noted above, in the rejection of independent claim 8. The
rejection of claims 9 and 13 is thus not sustained, for the same reason.

Claim 10--Ben-Haim/Francischelli/Deno/Goldreyer/Winkler/
Goldin/Bevelacqua
The Examiner does not rely on Bevelacqua or Goldin in any manner
that remedies the deficiency, noted above, in the rejection of independent
claim 8. The rejection of claim 10 is thus not sustained, for the same reason.

Claims 11 and 12--Ben-Haim/Francischelli/Deno/Goldreyer/Winkler/
Klimovitch
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The Examiner does not rely on Klimovitch in any manner that
remedies the deficiency, noted above, in the rejection of independent claim
8. The rejection of claims 11 and 12 is thus not sustained, for the same
reason.

DECISION
The rejections of claims 8–16 under 35 U.S.C. § 103(a) are reversed.

REVERSED