BIOSENSE WEBSTER (ISRAEL), LTD.

Patent Trials and Appeals Board

Jul 1, 2020

13648449 - (D) (P.T.A.B. Jul. 1, 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.
13/648,449 10/10/2012 Assaf Govari 178090 (BIO5347USNP) 1200
128032 7590 07/01/2020
Lewis Roca Rothgerber Christie LLP
P.O. Box 29001
Glendale, CA 91209-9001
EXAMINER
DELLA, JAYMI E
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
07/01/2020 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):
pair_cph@firsttofile.com
pto@lrrc.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ASSAF GOVARI and ATHANASSIOS PAPAIOANNOU

Appeal 2020-000232
Application 13/648,449
Technology Center 3700
____________

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

KERINS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, and 6–9, all of the claims pending
in the application. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 The term “Appellant” is used herein to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Biosense Webster (Israel) Ltd., as the
real party in interest. Appeal Br. 1.
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Application 13/648,449

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THE CLAIMED SUBJECT MATTER
Appellant’s invention relates to a method and apparatus for ablation of
tissue. Claims 1 and 6 are illustrative, and are reproduced below:
1. A method of ablation, comprising the steps of:

inserting a probe into a body of a living subject, the probe having
an ablation electrode;

prior to ablation and prior to the probe being put into a contacting
relationship with tissue:

selecting a contact force between the ablation electrode
and a target tissue, a power level and a time interval;

calculating a predicted lesion size that would result from
placing the ablation electrode in the contacting
relationship with the target tissue at the contact force while
applying energy at the power level via the ablation
electrode to the target tissue for ablation thereof for the
time interval by modeling the lesion size as a nonlinear
function of the contact force, the power level and the time
interval;

iterating the step of calculating a predicted lesion size by
increasing the contact force while keeping the power level
and the time interval constant until a saturation point,
wherein the saturation point is determined to be when a
further increase in the contact force fails to result in an
increase of the lesion size, wherein each iterative lesion
size has a corresponding known contact force, power level
and time interval;

establishing that one of the calculated predicted lesion
sizes corresponding to an iteration is suitable for ablation;

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urging the ablation electrode into the contacting relationship with
the target tissue; and

ablating the target tissue using the corresponding known contact
force, power level and time interval of the one of the iterative
lesion sizes established to be suitable for ablation.

6. An ablation apparatus, comprising:

a flexible catheter adapted for insertion into a heart of a living
subject and having a distally disposed ablation electrode to be
brought into contact with a target tissue in the heart;

an ablator, operative to apply a dosage of energy to the target
tissue at a power level so as to ablate the target tissue;

an impedance measuring system, comprising a body surface
electrode to be attached to the living subject, having circuitry for
passing an electrical current between the body surface electrode
and the distally disposed ablation electrode;

a processor for predicting a lesion size prior to contact between
the distally disposed ablation electrode and the target tissue that
would result according to a relationship between a chosen
contact force between the ablation electrode and the target tissue,
the power level of the energy to be delivered by the ablator and
a time interval during which the dosage of energy at the power
level is passed through the ablation electrode, wherein the
processor is operative to execute iterations of predicting the
lesion size that would result as a non-linear function of a
parameter selected from the chosen contact force, power level
and time interval until a saturation point is found, wherein an
increase of the parameter fails to result in an increased predicted
lesion size;

control circuitry for operating the ablator, at values of the chosen
contact force, the power level and the time interval in a selected
iteration of the iterations of the step of predicting the lesion size;
and
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a monitor linked to the processor, which is operative to display a
visual indication of the predicted lesion size.

THE REJECTIONS
The Examiner rejects:
(i) claims 1 and 2 under 35 U.S.C. § 103(a) as being unpatentable
over Govari (US 2011/0152856 A1, published June 23, 2011) in view of
Kruecker (US 2011/0251607 A1, published Oct. 13, 2011) and Lambert
(WO 2012/092275 A1, published July 5, 2012); and
(ii) claims 6–9 under 35 U.S.C. § 103(a) as being unpatentable over
Govari in view of Keidar (US 2004/0147920 A1, published July 29, 2004)
and Lambert.

ANALYSIS
Claims 1 and 2--Unpatentability over Govari, Kruecker, and Lambert
The Examiner finds that Govari discloses a method that includes most
of the steps of claim 1, with the exceptions that: Govari does not disclose
that the “selecting, calculating, iterating, and establish[ing]” steps occur
prior to the ablation probe being put into contact with tissue; and Govari
fails to disclose calculating a predicted lesion size by modeling the
saturation point at which an increase in contact force of the probe does not
result in an increased predicted lesion size, as a non-linear function of
contact force, and iterating the calculation until the saturation point is
determined. Final Act. 5, 7.
The Examiner relies on Kruecker as disclosing ablation planning steps
that are conducted either prior to or after the probe is placed into contact
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with tissue to be ablated, including iterative steps to calculate a predicted
lesion size. Id. at 5. The Examiner concludes that it would have been
obvious to modify the Govari method to perform its ablation planning steps
prior to contacting the probe to tissue, since Kruecker identifies that iterative
ablation planning steps can be performed either prior to or after the probe is
inserted and put into contact with tissue. Id. at 5–6.
The Examiner relies on Lambert as disclosing the modeling of the
saturation point that Govari lacks, taking the position that Lambert includes
a processor that predicts a lesion size as a non-linear function of one of
contact force, power level, and time interval, until a saturation point is
found. Id. at 7–8. The Examiner concludes that it would have been obvious
to modify the Govari process to involve saturation point information to
“provide the benefit of taking into account the asymptotic nature of lesion
formation as taught by Lambert.” Id. at 8. The Examiner further explains in
the Answer that:
Lambert is relied upon to teach the relationship between an
acceptable lesion size and saturation point as Lambert teaches
predicting lesion size as a function of the contact force, power
level, or time interval parameter until a saturation point is found,
where the saturation point is when an increase of the chosen
parameter fails to result in an increased predicted lesion size.
and
Lambert is only used to teach the relationship of ablation size and
a saturation point with the respective parameters of power, time
and force, and is not relied upon for the teaching of performing
the iterations before ablation or contact of a probe with the tissue
that are taught by Govari in view of Kruecker.
Ans. 5, 7 (emphasis added). Because the former statement alludes to
Lambert being relied on as teaching finding a saturation point via predicting
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lesion size(s) until that point is ascertained, we understand the latter
statement to mean that Lambert is not relied on in any manner for the timing
of performing iterative steps, namely for performing such iterative steps
prior to ablation or contact of a probe with tissue to be ablated.
Appellant challenges the rejection, in part, on the Examiner’s reliance
on the disclosure of Lambert relating to how Lambert addresses the
recognition that an ablation process of this type is subject to saturation
effects.2 In particular, Appellant argues that:
Lambert does not disclose iterating the step of making a
prediction by increasing one of the contact force, the power level
and the time interval until a saturation point is found, wherein a
further increase fails to result in an increased predicted lesion
size, and establishing that one of the iterations of the step of
making a prediction predicts a desired lesion size. Instead
Lambert only states each of the F (force), E (energization
parameter - power, voltage, current) and t (duration time)
parameters is taken into account through an exponential term that
models saturation effects. It does not iterate until the saturation
point is found.
Appeal Br. 7–8 (emphasis omitted).
Appellant’s characterization of the teachings of Lambert is largely on
point, and undermines the Examiner’s finding and interpretations as to what
Lambert teaches. Like Appellant, we see no indication that Lambert

2 Although Lambert does not describe the existence of a particular saturation
“point,” both Appellant and Lambert are consistent in describing that the
saturation phenomenon involves a recognition that for the set of
parameters/variables, time, power, and probe contact force, there is a
nonlinear relationship between an increase in the value of one of the
parameters selected to be variable, and increase in lesion size, and that, at
some point, increasing the value results in effectively no increase in lesion
size. See, e.g., Spec. ¶ 39; Lambert, p. 4, ll. 8–29 and p. 15, l. 21–p. 16, l.
21.
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performs iterative steps or other procedure to find what Lambert might
determine to be a saturation “point.” Rather, saturation effects are modeled
in an exponential term that is used in an equation to “predict,” in a lesion
size index (LSI) model, the size of a lesion, given values of probe contact
force, current (related to power), and duration time. Lambert, p. 15, l. 28–p.
16, l. 21.
With respect to Lambert’s use of the term “predict,” in discussing
lesion size, we note, as does Appellant, that it is not used in the sense of
performing pre-procedure iterations of varying contact force to obtain
successively increasing predicted lesion sizes with the goal of determining a
saturation point. Rather, Lambert “predict(s)” (p. 3, ll. 22–24), or perhaps
more aptly, “evaluate(s)” (p. 4, ll. 3–4) a size of a lesion created in an
ablation process, in the sense that, after a lesion is created, the LSI equation
is used to advise medical personnel of the approximate size of the lesion
(generally plural lesions) without having to perform, for example, post-
ablation electrical continuity measurements to assess the likelihood that the
procedure was successful. See generally, Lambert, p. 2, l. 20–p. 3, l. 14.
Finally, we further fail to see where Lambert discusses any particular
“relationship between an acceptable lesion size and saturation point,” as
asserted by the Examiner in the above quote.
In view of the above, the Examiner’s proposed modification to the
Govari process in view of Lambert to include a non-linear modeling of a
saturation point, falls short of rendering obvious a step of iteratively
calculating predicted lesion sizes by increasing contact force values until a
saturation point is determined, and the Examiner’s position that Lambert
actually determines a saturation point, whether by iterative calculations or
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some other manner, is not supported by rational underpinnings. The
rejection of claim 1 as being unpatentable over Govari, Kruecker, and
Lambert is not sustained. As claim 2 depends from claim 1, the rejection is
not sustained as to claim 2, either.

Claims 6–9--Unpatentability over Govari, Keidar, and Lambert
Independent claim 6 is directed to an ablation apparatus, whereas
independent claim 1 discussed above is directed to an ablation method.
The Examiner includes reference to, and relies on, Keidar as teaching
an impedance measuring system as recited in claim 6, a limitation not
present in claim 1. Final Act. 10. Appellant argues only that Keidar does
not mention use of an actual or estimated contact force to predict a lesion
size. Appeal Br. 9. Because the Examiner does not rely on Keidar as
providing that function or ability, the argument fails to apprise us of error in
the Examiner’s inclusion of Keidar in the rejection, which involves
modifying Govari in view of Keidar to provide the Govari system with the
claimed impedance measuring system.
The Examiner does not include Kruecker in this ground of rejection
because claim 6 does not recite the temporal aspect step present in claim 1 of
performing iterative calculations of lesion size prior to ablation and prior to
a probe being put into a contacting relationship with tissue. Instead, claim 6
requires only that a processor is “for” predicting a lesion size prior to contact
between an ablation electrode and target tissue. The Examiner finds that the
processor (console 24) in Govari is capable of so doing. Final Act. 9.
In a similar vein, the language in claim 6 reciting that the “processor
is operative to execute iterations of predicting the lesion size,” from a non-
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linear function of one of contact force, power level, and time interval, until a
saturation point is found, requires only that the processor be configured to
perform such iterations, and not that the system actually perform those steps.
The Examiner finds that Govari teaches a processor configured to
execute iterations of predicting lesion sizes based on varying one of contact
force, power level, and time interval. Final Act. 9, citing Govari ¶ 27. The
Examiner additionally finds that Lambert discloses an ablation apparatus
having a processor that predicts lesion sizes as a non-linear function of one
of contact force, power level, and time interval, and recognizes and factors
into the predictive model a saturation effect. Final Act. 10–11. The
Examiner concludes that it would have been obvious to employ the non-
linear function modeling of Lambert in the lesion size predictions performed
by the processor in Govari, in order to take advantage of the benefit of
Lambert’s teaching that lesion formation size has an asymptotic relationship
with the parameters of contact force, power, and time interval. Id. at 11.
Appellant leads with the argument that an important feature of the
invention that distinguishes over the cited references “is the fact that the
processor for predicting lesion size is configured to make such determination
prior to the catheter engaging tissue.” Appeal Br. 8. Appellant does not
adequately explain how Govari’s processor is not so configured. The
processor receives input values for contact force, power, and time duration.
See, e.g., Govari ¶ 58 (controller may report indication of expected ablation
volume at estimated ablation time, and energy dosage and mechanical
force). Although, in practice, as noted by Appellant (Appeal Br. 9), Govari
acquires and inputs an actual value of a measured contact force, the
processor is fully capable of computing a predicted lesion size with a contact
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force value selected by a user as an estimated or desired contact force value.
Cf., Govari ¶ 51 (“Similarly, by fixing the desired size of the ablation zone,
the required force can be computed at a given RF power and application
time or for a given total energy dosage at different combinations of
application time and RF power.”). Stated simply, it matters not to the
processor how and where the input value indicative of contact force was
generated.
Appellant’s arguments directed to Lambert, specifically, mainly focus
on the fact that the Lambert process for predicting lesion size takes place
during or just after the time that the lesion is formed, and “not prior to
ablation as claimed.” Appeal Br. 9–10 (emphasis omitted). Not only does
the Examiner not rely on Lambert as to the timing of when the lesion size is
predicted, but, unlike claim 1, there is no positive limitation in claim 6 that a
lesion size prediction step necessarily occurs prior to ablation. Rather, claim
6 only requires the capability of doing so.
Appellant again, as with claim 1, points out that “Lambert does not
disclose iterating the step of making a prediction” of lesion size, until a
saturation point is found. Appeal Br. 10 (emphasis omitted). As before, we
agree with Appellant, but, in the case of claim 6, that is not germane.
Claim 6 requires only that a processor be provided that is “operative to
execute iterations of predicting the lesion size,” the Govari processor being
operative to execute such iterations. As modified in accordance with the
non-linear modeling taught by Lambert, which takes into account saturation
effects, for predicting lesion size, Govari, too, is configured to operate to
execute iterations until a saturation point is found.
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Claim 6, unlike claim 1, includes no requirement that iterative steps to
find the saturation point actually be performed, which, in terms of the
rejections at hand, results in us sustaining the rejection of claim 6, while at
the same time not sustaining the rejection of claim 1.
Claims 7–9 depend from claim 6, and the same three references that
are applied in rejecting claim 6 are applied against claims 7–9. Appellant
argues that the rejection does not specifically state how or why claims 7–9
are rejected, but instead the rejection refers back to claims 3–5 and the
rationale applied against those claims. Appeal Br. 10. As pointed out by the
Examiner, detailed grounds specific to claims 7–9 appear at pages 11–16 of
the Final Action. Ans. 8. The Examiner is correct, and Appellant’s
argument is not supported in the record.
Appellant otherwise repeats and relies on arguments advanced for the
patentability of claim 6 as reasons why the rejection of claims 7–9 is in
error. Appeal Br. 10–11. As addressed above with respect to claim 6, the
arguments do not apprise us of error in the rejection. The rejection of claims
7–9 is therefore sustained.

DECISION
The rejection of claims 1 and 2 as being unpatentable over Govari,
Kruecker, and Lambert is reversed.
The rejection of claims 6–9 as being unpatentable over Govari,
Keidar, and Lambert is affirmed.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2 103(a) Govari, Kruecker,
Lambert
1, 2
6–9 103(a) Govari, Keidar,
Lambert
6–9
Overall
Outcome
6–9 1, 2

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

AFFIRMED IN PART