Ex Parte Lee et al

Board of Patent Appeals and Interferences

Jul 29, 2012

10167681 (B.P.A.I. Jul. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte FRED T. LEE, DIETER HAEMMERICH, JOHN G. WEBSTER,
ANDREW S. WRIGHT, CHRIS D. JOHNSON, and DAVID M. MAHVI
____________

Appeal 2009-014945
Application 10/167,681
Technology Center 3700
____________

Before STEFAN STAICOVICI, GAY ANN SPAHN, and
EDWARD A. BROWN, Administrative Patent Judges.

SPAHN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Fred T. Lee et al. (Appellants) seek our review under 35 U.S.C. § 134
of the Examiner’s rejection of claims 30, 31, 33-39, and 41-45. Appellants
cancelled claims 1-29, 32, and 40. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
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The Claimed Subject Matter
The claimed subject matter relates, in general, to “radio-frequency
ablation of tumors” and more particularly, “to a device allowing for the
simultaneous use of multiple ablation electrodes,” for “treatment of the
tumor volume with more uniform lesion size by eliminating shielding effects
caused by simultaneous operation of two adjacent [electrodes].” Spec. 2,
para. [0003] and Spec. 5, para. [0015]. Claims 30 and 38 are independent,
and claim 30 reproduced below, with emphasis added, is illustrative of the
subject matter on appeal.
30. A method of non-microwave ablation of
a tumor having a volume, the method reducing
electrical shielding caused by simultaneous
activation of electrodes and comprising the steps
of:
(a) separately placing at least two physically
independent electrodes at edges of the tumor;
(b) connecting a source of radiofrequency
power having a frequency to a first electrode to
provide resistive heating of tissue at the first
electrode;
(c) after a first time, disconnecting the
source of radiofrequency power from the first
electrode to define a first duty cycle at the first
electrode;
(d) after step (c) connecting the source of
radiofrequency power to a second electrode to
provide resistive heating of tissue at the second
electrode;
(e) after a second time, disconnecting the
source of radiofrequency power from the second
electrode to define a second duty cycle at the
second electrode;
(f) repeating steps (b) through (e) while
varying the first and second duty cycles to deliver
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different levels of power to the first and second
electrodes dependent on a sensed condition of the
tissue while also energizing the first and second
electrodes at different, substantially non-
overlapping times independent of the sensed
condition.

The Rejections
The following Examiner’s rejections are before us for review.
(1). Claims 30, 31, and 33-37 are rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement.
(2). Claims 30, 31, and 33-37 are rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which Appellants regard as the invention.
(3). Claims 30, 31, 33-39, and 41-45 are rejected under 35 U.S.C. §
103(a) as being unpatentable over Gough (US 6,080,150, issued Jun. 27,
2000) and Edwards (US 5,968,041, issued Oct. 19, 1999).

OPINION
Rejection (1) – Lack of Written Description
The Examiner determines that independent claim 30’s terminology of
“physically independent electrodes” is not supported by the originally filed
disclosure. Ans. 3. Appellants contend that “[t]wo umbrella-type
‘trifurcated electrodes’ 22a and 22b are shown in Fig. 1 of the application . .
. each on different electrode assemblies 16a and 16b,” and “[s]upport for the
physical independence of these electrodes is found, for example, at
paragraph [0039] . . . noting that the shafts 18a and 18b while shown as
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axially parallel, may be placed in other orientations.” App. Br. 8.
Appellants also rely for support on “[p]aragraph [0051] describ[ing] the
difficulty of positioning separate electrode[] assemblies 16a and 16b per Fig.
1 and constrast[ing] this to an embodiment using a unitary (physically
interdependent) electrode 40.” Id.
We agree with Appellants that Figure 1 provides support for the claim
terminology of “physically independent electrodes.” Figure 1 shows two
separate electrode assemblies 16a and 16b oriented parallel with respect to
each other and having their shaft tips 20a and 20b positioned at opposite
ends of an oval shaped tumor 12. The Examiner’s position is that “with
regard to the electrode assemblies of Figure 1, in addition to requiring a
connection to a controller . . . in order to provide the method claimed within
the scope of the originally filed disclosure, these assemblies conduct
electricity between one another,” and “the electrical coupling of these
electrodes constitutes a physical connection within the broadest reasonable
interpretation of this term, which lacks positive antecedent basis in the
originally filed disclosure.” Ans. 5. However, the scope of claims in patent
applications is determined by giving claims “their broadest reasonable
interpretation consistent with the specification” and “in light of the
specification as it would be interpreted by one of ordinary skill in the art.”
In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Emphasis Added. In this case, because we agree with Appellants that
“[e]lectrode[] assemblies of th[e] type [shown in Figure 1] are used
commonly in the medical profession and are recognized by those of ordinary
skill in the art to be physically independent and thus separately positionable
about a tumor” (App. Br. 8), we find the Examiner’s interpretation to be
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unreasonable. Thus, because we agree with Appellants that one of ordinary
skill in the art would understand the electrode assemblies 16a and 16b of
Figure 1 to be physically independent, regardless of their common
connection to a controller and electrical coupling, we conclude that
Appellants’ Specification reasonably conveys to those skilled in the art that
Appellants had possession of the subject matter of claims 30, 31, and 33-37
as of the filing date of the present application.
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 30, and claims 31 and 33-17 dependent thereon, under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Rejection (2) – Indefiniteness
The Examiner determines that independent claim 30’s terminology of
“physically independent electrodes” is indefinite because “the exact meaning
of the term . . . is unclear.” Ans. 3. Appellants contend that “the phrase
‘physically independent’ in the context of the claims’ limitation describing
separately placing the electrodes at edges of the tumor, is both reasonably
clear and precise, denoting electrodes that are free to be independently
positioned about a tumor.” App. Br. 9.
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations
omitted). The second paragraph of 35 U.S.C. § 112 requires claims to set
out and circumscribe a particular area with a reasonable degree of precision
and particularity. In re Johnson, 558 F.2d 1008, 1015 (CCPA 1977). In
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determining whether this standard is met, the definiteness of the language
employed in the claim must be analyzed, not in a vacuum, but always in
light of the teachings of the prior art and of the particular application
disclosure as it would be interpreted by one possessing the ordinary level of
skill in the pertinent art. Id. Therefore, reading claim 30 in light of
Appellants’ disclosure, as we must, we find that the claim term “physically
independent electrodes” would be understood by one of ordinary skill in the
art to mean electrodes that may be separately placed at the edges of a tumor
as suggested by Appellants.
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 30, and claims 31 and 33-37 dependent thereon, under 35
U.S.C. § 112, second paragraph, as being indefinite for failing to particularly
point out and distinctly claim the subject matter which Appellants regard as
the invention.
Rejection (3) – Obviousness based on Gough and Edwards
Independent claim 30 and dependent claims 31 and 33-37
The Examiner finds that Gough substantially discloses the claimed
subject matter of independent claim 30, except that Gough “does not teach
non-overlapping energy application.” Ans. 3-4. To cure the deficiency of
Gough, the Examiner turns to Edwards to teach “a radio frequency tumor
ablation device and method.” Ans. 4. The Examiner finds that in Edwards’s
method, “multiple antennae are introduced in a surrounding relation to
another electrode,” and both impedance and temperature measurements are
taken “at the electrodes to control the energy.” Id. The Examiner also finds
that Edwards’s method “controls the electrodes independently,” “controls
the duty cycle of the RF energy application,” and places the electrodes “at
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the edges of the tumor” and inserts the electrode tips having a temperature
sensor percutaneously. Id. The Examiner concludes that it would have been
obvious to one of ordinary skill in the art
to employ . . . the electrode placement device and method of
Gough . . . in the device and method of Edwards . . ., or to
employ the relative electrode placement of Edwards . . . in the
device and method of Gough . . . , since this creates a
predictable necrosis volume, as taught by Edwards . . . , and in
either case to provide the duty cycle envelope to be
substantially larger than the period of the radio frequency
power, since this is not critical; is well within the skill of one
having ordinary skill in the art; provides no unexpected result;
and would yield more efficient heating, since this would assure
that the duty cycle on time did not occur during the zero
crossing point in the radio frequency wave form; providing the
arrangement with a temperature sensor in the center of the
heated volume would inherently produce substantially non
overlapping energy application, since, according to
applicant[s’] originally filed disclosure, the central portion of
the tissue mass to be heated would only heat minimally and
would be relatively unresponsive to power level changes if
there was substantial overlap of the duty cycles’ on time, and
further substantial non-overlap would be provided by the
waveforms being out of phase, as they must be in any real
system, thus producing a device and method such as claimed.

Ans. 4-5.
Appellants contend that both Gough and Edwards teach “switching
power to electrodes based on sensed conditions of the tissue such as
impedance or temperature measurement,” and neither Gough nor Edwards
teach “switching power to the electrodes independent of a sensed condition
of the tissue.” App. Br. 10. With respect to the Examiner’s statement that
“providing the arrangement with a temperature sensor in the center of the
heated volume would inherently produce substantially non overlapping
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energy application,” Appellants contend that: (1) the Examiner is
“assum[ing] . . . switching based on a sensed temperature of the tissue, and
thus . . . not satisfy[ing] the claim limitation of switching the electrodes
independent of a sensed tissue condition; and (2) “abnormally cool tissue
would not cause non-overlapping energizing of the electrodes at the tissue
temperature sensing system,” because in a temperature sensing system, “a
cold spot sensed by temperature sensors on the electrodes would drive the
control system toward increasing the on-time of the electrodes making it
more likely that they would be energized at the same time” thus
exacerbating the very shielding effect, i.e., preventing the area of the tumor
between the two electrodes from being ablated. App. Br. 10-11. With
respect to the Examiner’s statement that “substantial non-overlap would be
provided by the waveforms being out of phase,” Appellants contend that
“[t]wo signals that are slightly shifted in phase . . . are not energized at
‘substantially non-overlapping’ times but are still energized at substantially
overlapping times because the zero crossing point is a vanishingly small
percentage of the total cycle time,” and “a condition which might occur
under certain tissue loading characteristics is insufficient to establish
inherency which requires that the condition be ‘necessarily present.’” App.
Br. 12 (citing to In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993)).
It is undisputed that Gough’s tumor ablation method is dependent
upon sensed temperature and Gough does not disclose “energizing the first
and second electrodes at different, substantially non-overlapping times
independent of the sensed condition.” See Ans. 4 and App. Br. 10. Both
Gough and Edwards disclose a cell necrosis apparatus (12 in Gough, 10 in
Edwards) including an introducer (14 in Gough, 12 in Edwards) and one or
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more energy delivery devices or radio frequency (RF) electrodes (16 in
Gough, 16, 18 in Edwards). See Gough, col. 3, ll. 61-63, col. 5, ll. 21-22,
and Fig. 1; see also Edwards, col. 3, ll. 19-24 and Figs. 1 and 2. One or
more sensors (24 in Gough, 34 in Edwards) may be positioned on at least a
portion of interior or exterior surfaces of introducer (14 in Gough, 12 in
Edwards), energy delivery device or RF electrodes (16 in Gough, 16, 18 in
Edwards) or insulation sleeve (18 in Gough, 20 in Edwards) to permit
accurate measurement of temperature at a tissue site in order to determine
the extent and amount of cell necrosis and whether or not further cell
necrosis is needed. See Gough, col. 5, ll. 38-48; see also Edwards, col. 4, ll.
24-34. We note that Edwards discloses a very similar cell necrosis apparatus
10 to that of Gough’s cell necrosis apparatus 12, and it appears that
Edwards’s tumor ablation method, like Gough’s, is dependent upon sensed
temperature and does not disclose “energizing the first and second electrodes
at different, substantially non-overlapping times independent of the sensed
condition.”
Regardless, we are not persuaded by the Examiner’s statements that
“[s]ince the originally filed disclosure encompasses the use of phase
differences to provide the switching, and since the switching produces the
activation of the electrodes; the term ‘substantially non-overlapping’ must be
construed to encompass electrodes which have waveforms applied to them
that are out or phase” and “this substantially non-overlapping energizing of
the electrodes will occur strictly according to the phases of the waveforms
involved, irrespective of any sensed tissue conditions.” See Ans. 8. Even if
the Examiner’s statement with respect to out of phase waveforms is true, the
Examiner has not pointed to anything in either Gough or Edwards that
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shows the cell necrosis devices in those references are operating with out of
phase waveforms. Although the Examiner does allude to Gough’s Figure 8
as showing a “clear difference in electrode length both as extending out from
and along the length of the shaft of the applicator” (see Ans. 10), we do not
agree that this necessarily shows that Gough’s method of tissue ablation is
operating with an out of phase waveform.
In view of the foregoing, we do not sustain the Examiner’s rejection
of independent claim 30, and claims 31 and 33-37 dependent thereon, under
35 U.S.C. § 103(a) as unpatentable over Gough and Edwards.
Independent claim 38 and dependent claims 39 and 41-45
The Examiner makes the same findings and conclusions as discussed
supra with respect to independent claim 30 and Appellants make the same
contentions as discussed supra with respect to independent claim 30. See
Ans. 3-5 and App. Br. 10-13. For the same reasons as discussed supra with
respect to independent claim 30, we do not sustain the Examiner’s rejection
of independent claim 38, and claims 39 and 41-45 dependent thereon, under
35 U.S.C. § 103(a) as unpatentable over Gough and Edwards.

DECISION
We reverse the Examiner’s rejections of:
(1). claims 30, 31, and 33-37 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement;
(2). claims 30, 31, and 33-37 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which Appellants regard as the invention;
and
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(3). claims 30, 31, 33-39, and 41-45 are rejected under 35 U.S.C. §
103(a) as being unpatentable over Gough and Edwards.

REVERSED

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