Ex Parte Kratoska et al

Patent Trial and Appeal Board

Mar 25, 2014

11799785 (P.T.A.B. Mar. 25, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PAUL S. KRATOSKA and
THOMAS R. SKWAREK
____________

Appeal 2012-002204
Application1 11/799,785
Technology Center 3700
____________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method, a system, and processor instructions of providing feedback with
regard to tissue ablation based on temperature differences between two
needle probes. The Examiner has rejected the claims as lacking written

1 Appellants identify Medtronic, Inc. of Minneapolis, Minnesota as the Real
Party in Interest (App. Br. 3).
Appeal 2012-002204
Application 11/799,785

2
descriptive support, indefiniteness, anticipation, and for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
The Specification provides that “[m]easuring one or more tissue
properties after the ablation procedure may allow the clinician to verify the
size of the lesion formed or other therapy results.” (Spec. 1, ¶ 0005.)
Claims 1-8, 11-22, and 25-32 are on appeal, and can be found in
Appendix A of the Appeal Brief. Claim 1 is illustrative of the claims on
appeal, and reads as follows (emphasis added):
1. A method for providing feedback regarding the results of
tissue ablation, the method comprising:
deploying one or more needles from a catheter into a
target tissue, wherein the one or more needles comprise a first
needle and a second needle;
delivering energy via at least one of the one or more
needles to ablate at least a portion of the target tissue to form a
lesion;
stopping energy delivery via the at least one of the one or
more needles; and
measuring a tissue property via at least one of the one or
more needles after the energy delivery has been stopped,
wherein the tissue property is a temperature difference between
the first needle and the second needle.

The Examiner has rejected the claims as follows:
I. claims 1-8, 11-22, and 25-32 under 35 U.S.C. § 112, first
paragraph;
II. claims 1-8, 11-22, and 25-32 under 35 U.S.C. § 112, second
paragraph;
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Appeal 2012-002204
Application 11/799,785

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Fig. 5D of the Specification, reproduced above, shows a needle 44
with a thermocouple 52 and a needle 48 with three thermocouples 50, 54,
and 56. (Spec. 13 ¶ 0059.) Needle 44 delivers energy to the target system
and 36 forms the tip of the catheter. (Spec. 11 ¶ 0052.)
FF 2. Fig. 5 of the Specification “shows thermocouple 50 at the distal
end of second needle 48 and thermocouple 52 located at the distal end of
first needle 44. Providing multiple thermocouples to obtain more than one
temperature reading may allow a temperature gradient to be monitored
between the sensors.” (Spec. 13 ¶ 0058.)
FF 3. The Specification provides
The clinician may desire more feedback to more accurately
determine the volume of the lesion produced or other therapy
results. In some embodiments, the temperature readings may
be compared to data stored in look-up tables to determine the
volume of the lesion produced. In other embodiments, the
volume of the lesion formed may be calculated based on the
measured temperature readings.
(Spec. 13 ¶ 005.)
FF 4. The originally filed claims of the Specification recite:
[Claim] 1. A method for providing feedback regarding
the results of tissue ablation, the method comprising: . . .
measuring a tissue property via at least one of the one or more
needles after the energy delivery has been stopped.
[Claim] 9. The method of claim 1, wherein the tissue
property is temperature.
[Claim] 10. The method of claim 9, wherein the one or
more needles comprise a first needle and a second needle,
further comprising measuring a temperature difference between
the first needle and the second needle.
(Spec. 19-20, see claims.)
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Application 11/799,785

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Analysis
Appellants contend that feedback and measuring temperature at two
locations are “elements [that] were described in the specification as
originally filed. As stated in the MPEP, originally filed claims are part of
the specification” (App. Br. 7; Reply Br. 6).
The disclosure as originally filed need not provide “in haec verba
support for the claimed subject matter at issue,” rather, the disclosure should
convey to one skilled in the art that the inventor was in possession of the
invention at the time of filing. Purdue Pharma L.P. v. Faulding Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (citations omitted).
With regard to the limitation directed to “measuring temperature at
two different locations” and using a difference in these temperatures as
feedback, we find that the Appellants have the better position. The law does
not require that Appellants claim the subject matter using only the words as
recited in the Specification. The Specification provides that each needle can
possess a thermocouple as well as be configured to deliver energy (FFs
1 & 2). The presence of multiple thermocouples allows for a temperature
gradient to be measured in the treated tissue (FF 2). The temperature
readings can be used to determine the volume of the lesion produced in the
procedure (FF 3). Here, the Specification as originally filed did provide for
the use of feedback to determine the progress of the ablation procedure by
measuring a tissue property, specifically, by “measuring a temperature
difference between the first needle and the second needle” (FF 4).
Accordingly, we find that the evidence supports Appellants’ position
that there is sufficient descriptive support for the claimed limitations. We
reverse the rejection based on 35 U.S.C. § 112, first paragraph.
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Application 11/799,785

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II. The Issue: Indefiniteness
The Examiner takes the position that the claim is unclear in the
recitation of
“[O]ne or more needles”, and then the subsequent recitation of
“wherein the one or more needles comprise a first needle and a
second needle”. The first recitation clearly allows for a single
needle to be included within the scope of the claims, but the
second recitation then contradicts this statement by requiring at
least 2 electrodes [sic, needles].
(Ans. 5.)
Does the preponderance of the evidence of record support the
Examiner’s conclusion that the claims are indefinite?
Appellants contend that:
The requirement of a first needle and a second needle is entirely
consistent with the “one or more needles” limitation.
Appellant[s] acknowledge[ ] that claim 1 thus requires a first
needle and a second needle. But, there is no contradiction
between any claim elements because the requirement of two
different needles satisfies the other requirement of one or more
needles.
(App. Br. 9; see also Reply Br. 9.)
With respect to the recitation of “one or more needles,” we find that
the Examiner has the better position. We agree with the Examiner’s position
that the claim recitation of “‘one or more needles’ . . . ‘wherein the one or
more needles comprise a first needle and a second needle’” could not be
achieved with the use of single needle (Ans. 5). In other words, deploying a
single needle from the catheter would not be sufficient to meet the remaining
claim limitation. The claims require a first and a second needle, thus,
minimally the claims require the use of two needles. Appellants have not
explained how the use of a single (one) needle would also meet the claim
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requirements. Accordingly, we affirm the rejection of the claims as being
indefinite under 35 U.S.C. § 112, second paragraph.
With respect to claim 11, the Examiner position is that the claim is
“unclear because it depends from canceled claim 9” (Ans. 5).
Appellants do not argue the merits of the rejection in their Appeal
Brief, however, in the Reply Brief they acknowledge “that claim 11 should
be dependent upon independent claim 1 instead of the currently recited claim
9. This minor inadvertent error can be corrected with an amendment prior to
issuance” (Reply Br. 9). Even though Appellants acknowledge this error,
because this error has not been rectified, we summarily affirm the rejection.
See MPEP 1205.02.

III.-IV. Rejections based on Johnson
The Examiner takes the position that Johnson disclosed the claimed
invention. Specifically, Johnson “teach[es] that the needles may be capable
of both measuring impedance and delivering RF energy, or that select
needles may be used solely for the measurement of impedance while other
needles are used to treat tissue.” (Ans. 6.) The Examiner concludes that
Johnson “disclose[d] the use of a temperature sensor on each electrode, and
the measurement of temperature at each location. The examiner maintains
that by measuring the temperature at each location, one inherently knows the
difference in temperature between those two locations.” (Ans. 7.)
Does the preponderance of the evidence of record support the
Examiner’s finding that Johnson anticipates the claims?

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Findings of Fact
FF 5. We adopt the Examiner’s findings and analysis concerning the
scope and content of the prior art. The following facts are repeated for
reference convenience.
FF 6. Johnson disclosed that “the apparatus can also be configured to
utilize one or more impedance measurements to monitor a target tissue site
and control the course of ablative therapy before during or after the delivery
of ablative energy or other treatment to the tissue site.” (Johnson 1 ¶ 0005;
Ans. 12.)
FF 7. Johnson disclosed that
The completion of lesion creation can be checked by advancing
energy delivery device 316 from distal end 16' of introducer 12
to a position corresponding to a desired lesion size and
monitoring the temperature at the periphery of the lesion such
that a temperature sufficient to produce a lesion is attained.
(Johnson 14 ¶ 0113; Ans. 12.)
FF 8. Johnson disclosed getting an image of the target tissue in order
to position the apparatus relative to the tumor and surrounding tissue, and
using software to calculate power frequency for the desired ablation volume
before sending the information to an output feed.
Another benefit of these and related embodiments is the ability
to produce an energy or thermal gradient within a target tissue
site. That is the ability to deliver more or less energy to
discrete sections of the target tissue volume in order to titrate
the delivery of energy to address the physical and thermal
conditions of a particular tumor mass and even subsections of
the tumor mass.
(Johnson 13 ¶ 0104; Ans. 11.)
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FF 9. Johnson disclosed that
[S]ensor 22 can be selected to measure temperature along with
impedance to compensate for any temperature related bias or
hysteresis in the impedance measurement. Accordingly, in an
embodiment a feedback signal from a temperature sensor or
temperature calculation device 342 can be inputted to the
impedance calculation device 334 described herein to
compensate for such variation. Temperature monitoring can
also be used to perform real time monitoring of ablative energy
delivery.
(Johnson 12 ¶ 0100; Ans. 7.)
FF 10. Johnson disclosed “[i]mpedance sensing members 22m, or
sensors 22 coupled to resilient members 18 can be deployed independently
or simultaneously to enable probing of target tissue 5’ in multiple locations
so as to measure impedance in multiple locations and/or through multiple
conductive pathways 22cp.” (Johnson 1 ¶ 0062; Ans. 6.)
FF 11. Johnson disclosed
In use, electrode 18e can be positioned to heat, necrose or
ablate any selected target tissue volume 5’. A radiopaque
marker 11 can be coated on electrodes 18e for visualization
purposes. Electrode 18e can be coupled to introducer 12 and or
an advancement member or device 15 or and advancement-
retraction member 34 . . . . Also, electrode 18e can include one
or more coupled sensors 22 to measure temperature and
impedance (both of the electrode and surrounding tissue),
voltage and current other physical properties of the electrode
and adjacent tissue. Sensors 22 can be at exterior surfaces of
electrodes 18e at their distal ends or intermediate sections.
(Johnson 11 ¶ 0092.)
FF 12. Johnson disclosed “[t]he temperature of the tissue, or of RF
electrodes 314 and 316 is monitored, and the output power of energy source
320 adjusted accordingly.”(Johnson 14 ¶ 0111.)
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Analysis
The Examiner takes the position that
Johnson goes on to disclose the closed loop system that is used
to control the delivery of energy to individual electrodes based
on feedback sensing of temperature. Hence, Johnson clearly
discloses the use of measuring temperature at two or more
different locations and using the various sensed temperatures to
control the delivery of RF energy to the individual electrodes.
(Final Rej. 6-7.)
Johnson uses temperature measurement to determine
completion of the lesion, which is that point at which a lesion of
a desired size/volume is created. Paragraph [0005] expressly
states that tumor volume and ablation volume is monitored
during the procedure, and paragraph [0113] expressly states the
use of temperature sensors for monitoring an ablation volume.
(Ans. 12.) “The examiner maintains that by measuring the temperature at
each location, one inherently knows the difference in temperature between
those two locations.” (Id. at 7.)
Appellants contend
As a threshold matter, claim 1 does not require that “one ...
knows the difference in temperature” or require “provid[ing] a
temperature difference to the user.” Instead, claim 1 recites
“measuring a tissue property ... wherein the tissue property is a
temperature difference between the first needle and the second
needle.”
(App. Br. 11.) Additionally, Appellants contend that “Johnson fails to
disclose measuring a tissue property via at least one of the one or more
needles after the energy delivery has been stopped” (Reply Br. 11).
We are not persuaded by Appellants’ contentions. We consider the
rejections based on the Johnson reference together because the same issue is
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Application 11/799,785

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dispositive for the anticipation as well as the obviousness rejection based on
Johnson (see App. Br. 13-15).
Johnson disclosed ablating tissue using multiple electrodes thereby
creating a temperature gradient within the tissue (FF 8). These electrodes
may also possess multiple sensors to measure impedance and temperature of
the electrode as well as that of the surrounding tissue (FFs 11 & 12). In
addition, Johnson acknowledges that temperature measurements are taken
along with impedance measurements because that combination allows for
adjustments in the impedance measurements due to temperature effects
(FF 9). Johnson also disclosed placing temperature probes at positions that
correspond to the appropriate lesion size and monitoring the temperature at
the lesion periphery (FF 7).
We agree with the Examiner that Johnson disclosed that impedance
measurements can be made before, during, and after therapy (FF 6).
According to Johnson the electrodes can not only provide the energy for
ablation therapy but the electrodes also contain sensors (FF 11) to measure
not only the temperature of the electrode itself but also the tissue
surrounding the electrode (FF 12). By taking impedance measurements
through multiple locations or pathways (FF 10) Johnson requires the use of
multiple (i.e. two or more) sensors to define these multiple impedance
pathways. Because the sensors can measure temperature along with
impedance (FF 9) we agree with the Examiner that the temperature is
measured at multiple locations. “[T]o the extent that the temperature at
different locations are known, the examiner has maintained that the
temperature difference is also inherently known.” (Ans. 10.) Additionally,
we also agree with the Examiner’s conclusion that a “temperature difference
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may be ascertained from a gradient, [because] a temperature gradient merely
shows the different temperatures at different locations. This is the exact
same modality by which the prior art Johnson et al reference operates (i.e.
using the temperature from a plurality of different locations as feedback).”
(Id. at 8.) “A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
We thus affirm the rejection of claim 1 under 35 U.S.C. § 102 as
anticipated. As claims 3-8, 11-14, 16-21, and 25-31 have not been argued
separately, they fall with claim 1 as acknowledged by the Appellants (App.
Br. 13-15). 37 C.F.R. § 41.37(c)(1).
With respect to claims 2, 22, and 32 Appellants contend that “Johnson
provides no suggestion regarding determining a volume of the lesion based
on temperature, let alone determining a volume of the lesion using the
measured temperature difference” (App. Br. 15).
We agree with the Examiner that “[p]aragraph [0005] expressly states
that tumor volume and ablation volume is monitored during the procedure,
and paragraph [0113] expressly states the use of temperature sensors for
monitoring an ablation volume.” (Ans. 12; FFs 6 & 7.) Johnson also
disclosed measuring impedance after the delivery of ablative energy has
ended (FF 6). To compensate for any temperature related bias in the
impedance measurement, temperature readings are taken at the same time as
impedance readings at the same locations (FF 9). The ablation volume can
be measured via impedance even after the application of ablative energy is
stopped (Johnson 1, ¶ 0005). Because temperature readings are taken
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13
alongside impedance to determine the ablative volume, we agree with the
Examiner’s finding “that by measuring the temperature at each location, one
inherently knows the difference in temperature between those two locations”
(Ans. 7.) In sum, the device of Johnson uses impedance and temperature
measurements to determine the volume of tissue ablation achieved. If a
prior art device, in its normal and usual operation, would necessarily
perform the method claimed, then the method claimed will be considered to
be anticipated by the prior art device. In re King, 801 F.2d 1324 (Fed. Cir.
1986).
With respect to claim 15, Appellants contend that the combination of
Johnson and McGaffigan are in error for the same reasons discussed for
claim 1 (App. Br. 15).
The Examiner found that Johnson disclosed the method of claim 1, as
discussed regarding the rejection of claim 1 (Ans. 6-7). The Examiner
added McGaffigan for the teaching of treating prostate tumors (id. at 7). As
we have found no error in the Examiner’s prima facie case of anticipation,
we affirm the rejection of claim 15 for the same reasons discussed above for
claim 1.

SUMMARY
We reverse the rejection of claims 1-8, 11-22, and 25-32 under
35 U.S.C. § 112, first paragraph.
We affirm the rejection of claims 1-8, 11-22, and 25-32 under
35 U.S.C. § 112, second paragraph.
We affirm the rejection of claims 1-8, 11-14, 16-22, and 25-32 under
35 U.S.C. § 102(b) as being anticipated by Johnson.
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We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as being
unpatentable over Johnson in view of McGaffigan.

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

AFFIRMED

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