Ex Parte Daw et al

Patent Trial and Appeal Board

Aug 2, 2018

13362773 (P.T.A.B. Aug. 2, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/362,773 01/31/2012
96000 7590 08/06/2018
C. R. Bard, Inc./BBS
Intellectual Property Department
1415 W. 3rd St.
Tempe, AZ 85281
FIRST NAMED INVENTOR
Derek Daw
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. CONFIRMATION NO.
297-PDD-10-114 US CON 2774
EXAMINER
DELLA,JAYMIE
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/06/2018 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):
raust@austiplaw.com
BBSIP.Docket@crbard.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEREK DAW and JAMES HUNTINGTON DABNEY
Appeal 2017-002281 1
Application 13/3 62,773
Technology Center 3700
Before ANTON W. PETTING, PHILIP J. HOFFMANN, and
AMEE A. SHAH, Administrative Patent Judges.
SHAH, Administrative Patent Judge.
DECISION ON APPEAL 2
The Appellants3 appeal under 35 U.S.C. § 134(a) from the Examiner's
final decision rejecting claims 6-9, 33-37, 48-50, and 52-54. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 This appeal is related to Appeal 2014-003326, Application 12/229,794,
decided May, 23, 2016, and Appeal 2015-003617, Application 11/703,861,
decided April 18, 2017.
2 Throughout this Decision, we refer to the Appellants' Appeal Brief
("Appeal Br.," filed July 20, 2016), Reply Brief ("Reply Br.," filed Dec. 5,
2016), and Specification ("Spec.," filed Jan. 31, 2012, as amended Mar. 16,
2012), and to the Examiner's Answer ("Ans.," mailed Oct. 5, 2016) and
Final Office Action ("Final Act.," mailed Dec. 22, 2015).
3 According to the Appellants, the real party in interest is SenoRx, Inc.
Appeal Br. 3.
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Application 13/362,773
STATEMENT OF THE CASE
The Appellants' invention "relates to an electrosurgical method and
system including an electrosurgical generator and an electrosurgical
electrode." Spec. ,r 2.
Claims 6, 33, and 48 are the independent claims on appeal. Claim 6
(Appeal Br. 65 (Claims App.)) is exemplary of the subject matter on appeal
and is reproduced below (with added bracketing for reference):
6. A method for controlling an electrosurgical tissue
cutting electrode of a medical device comprising:
[ (a)] providing the electrosurgical tissue cutting electrode
having an arcuate electrode portion;
[ (b)] delivering energy from an RF generator to the
electrosurgical tissue cutting electrode, the radiofrequency (RF)
generator including an RF amplifier;
[ ( c)] monitoring an electrical characteristic associated
with the electrosurgical tissue cutting electrode; and
[(d)] establishing a desired RF power output and a
desired RF duty cycle at the RF generator by adjusting DC
input voltage applied to an output stage of the RF amplifier
based on the monitoring to effect tissue cutting by the arcuate
electrode portion.
REJECTIONS
I. Claims 6, 7, and 9 stand rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Bowers (US 2003/0181898 Al, pub.
Sept. 25, 2003) and Albrecht et al. (US 2003/0229341 Al, pub. Dec. 11,
2003) (hereafter "Albrecht").
II. Claims 6-8 stand rejected under pre-AIA 35 U.S.C. § I03(a) as
being unpatentable over Hagen (US 5,133,711, iss. July 28, 1992), Albrecht,
and Rexroth (US 4,473,075, iss. Sept. 25, 1984).
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Application 13/362,773
III. Claims 33-37 stand rejected under pre-AIA 35 U.S.C. § I03(a)
as being unpatentable over Hagen, Albrecht, and Rexroth.
IV. Claims 48-50, 52, and 53 stand rejected under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Hagen, Albrecht, Rexroth,
and Palanker et al. (US 6,780,178 B2, iss. Aug. 24, 2004) (hereafter
"Palanker").
V. Claim 54 stands rejected under pre-AIA 35 U.S.C. § I03(a) as
being unpatentable over Hagen, Albrecht, Rexroth, Palanker, and Hung et al.
(US 2002/0133151 Al, pub. Sept. 19, 2002) (hereafter "Hung"). 4
ANALYSIS
Rejection I - Claims 6, 7, and 9 - Bowers and Albrecht
The Appellants contend that the Examiner's rejection of independent
claim 6 is in error because Bowers, upon which the Examiner relies, does
not teach limitations ( c) and ( d) of establishing a desired RF power output
and a desired RF duty cycle at the RF generator by adjusting DC input
voltage applied to an output stage of the RF amplifier based on the
monitoring of an electrical characteristics associated with the electrode to
effect tissue cutting by the arcuate electrode portion. Appeal Br. 19; see also
Reply Br. 8-9. Specifically, the Appellants argue, in relevant part, that
Contrary to claim 6, Bowers establishes a desired RF energy
output based on: ( 1) providing constant current when the output
impedance level is low, such as in cut and coagulation modes
(Bowers, ,r 0034; Fig. 19); (2) providing constant power when
the output impedance level is "within the medium range of
4 The Examiner withdraws the rejection of claims 6-8 under 35 U.S.C.
§ I03(a) as unpatentable over Rexroth, Albrecht, and Bowers, and all of the
rejections of claims 15-18. Ans. 3--4.
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Application 13/362,773
[output] impedances" (Bowers, ,r 0034; Fig. 19); and
(3) providing constant voltage when the output impedance level
is high, such as in the Spray or Fulguration mode (Bowers,
,r,r 0035, 0039; Fig. 19).
Appeal Br. 18-19.
The Examiner finds that Bowers teaches a method for controlling a
cutting electrode of a medical device and relies on Bowers, at paragraphs 3 7,
42, and 50, for teaching limitations ( c) and ( d). Final Act. 4. Specifically,
the Examiner finds that Bowers' sensing of the RF energy output by RF
sensing circuit 23 meets the monitoring step ( c) (id.), and that Bowers'
"microprocessor 28 determin[ing] the level of DC voltage required to
produce the given mode of operation, RF drive waveforms, and other
functions of the generator while sensing via RF sensing circuit 32" meets the
establishing step ( d) (id. at 4; see also Ans. 5).
However, the Examiner does not adequately explain how Bowers
teaches establishing an RF power output and RF duty cycle at the RF
generator by adjusting the DC voltage input based on the sensed RF energy
output. Bowers teaches producing different clinical effects by controlling
the RF energy and by applying a duty cycle to RF waveforms. Bowers ,r 37;
Ans. 5. As the Examiner states, "Bowers further teaches the operator
selecting the mode (i.e., cut), the microcontroller 28 receiving this input, and
outputting a level of DC voltage required to produce the given mode of
operation, where each mode is effected by applying duty cycles to
waveforms." Ans. 5; Bowers ,r,r 42, 44, 46, 50. But, this teaches that
adjusting the DC voltage is based on a user selecting a mode. We do not
see, and the Examiner does not explain, how the DC voltage is adjusted
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Application 13/362,773
based on the monitored/sensed RF energy output so as to establish a desired
or predetermined RF power output and duty cycle, as required by claim 6.
Thus, we are persuaded of error on the part of the Examiner, and we
do not sustain the Examiner's rejection of independent claim 6 as obvious
over Bowers and Albrecht. We also do not sustain the rejection of claims 7
and 9, each of which depends from independent claim 6. Cf In re Fritch,
972 F.2d. 1260, 1266 (Fed. Cir. 1992) ("dependent claims are nonobvious if
the independent claims from which they depend are nonobvious").
Rejection II - Claims 6-8 -Hagen, Albrecht, and Rexroth
The Appellants contend that the Examiner's rejection of independent
claim 6 is in error because Hagen, upon which the Examiner relies, does not
teach limitations ( c) and ( d) of establishing a desired RF power output and a
desired RF duty cycle at the RF generator by adjusting DC input voltage
applied to an output stage of the RF amplifier based on the monitoring of an
electrical characteristics associated with the electrode to effect tissue cutting
by the arcuate electrode portion. Appeal Br. 26; see also Reply Br. 9-10.
Specifically, the Appellants argue, in relevant part, that
In Hagen, the switching from the first set point to the second
setpoint is based on the achievement of the tuning of the control
circuit and is not based on the monitoring of an electrical
characteristic associated with the electrosurgical tissue cutting
electrode, whereas in claim 6, fourth clause, the establishing of
a desired RF power output and a desired RF duty cycle occurs
based on the monitoring of the electrical characteristics
associated with the electrosurgical tissue cutting electrode.
Appeal Br. 26-27 (emphasis omitted).
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Application 13/362,773
The Examiner finds that Hagen teaches a method for controlling a
cutting electrode of a medical device and relies on Hagen, at column 4,
line 53 through column 5, line 8, for teaching limitations ( c) and ( d). Final
Act. 5-6. Specifically, the Examiner finds that Hagen's measuring/
determining of the DC voltage representing an "unbalance of discharge
action between active electrode 16 and tissue 17 in contact with inactive
electrode 18" meets the monitoring step ( c) (id. at 5). The Examiner finds
that Hagen teaches establishing step ( d) in that
Hagen teaches two embodiments of adjusting the DC voltage:
( 1) monitoring of the magnitude of electric arc/voltage present
at the cutting electrode causes switch 22 to either increase or
reduce output power of the HF source 12 by adjusting DC
voltage to switch 22 (Col. 4-5, 11. 66-18); and (2) DC voltage
setpoint is chosen for first adjustment means, and upon
detection of tuning of the circuit, second adjustment means
reduces DC voltage by reduction percentage (Col. 5-6, 11. 48-2).
Ans. 10. The Examiner further finds that "Hagen discloses monitoring for
the electric arc, and then changing the output of the HF source 12 to control
the magnitude of the electric arc, and thus controlling, or 'effect[ing] tissue
cutting."' Id. at 11. The Examiner relies on Rexroth to "disclose the power
output to have a desired duty cycle." Final Act. 6.
However, the Examiner does not adequately explain how Hagen,
alone or in combination with Rexroth, teaches establishing an RF power
output and RF duty cycle at the RF generator by adjusting the DC voltage
input based on the monitored electric arc. Hagen teaches determining the
DC voltage based on the sensed unbalanced oscillations and using the DC
voltage "as the input for controlling the power of the [high-frequency]
source." Hagen, col. 4, 11. 58---65. The DC voltage is applied to a variable
threshold switch that, depending on its setting, determines the power control
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of the high frequency source. Id. at col. 4, 1. 66-col. 5, 1. 4. Depending on
the magnitude of the voltage present at the output of the circuit, the switch
either increases or reduces the output power at the high frequency source.
Id. at col. 5, 11. 4--8. In another embodiment, the microprocessor reduces the
setpoint for the DC voltage based on detected values from the discharge
detector circuit. Id. at col. 5, 11. 48-57. At best, this teaches adjusting the
DC voltage based on monitoring of the arc and/or voltage, and using the DC
voltage to increase or reduce the power output. But, we do not see, and the
Examiner does not explain, how this adjustment of the DC voltage
establishes a desired or predetermined RF power output and duty cycle, as
required by claim 6.
Even if we were to agree that Hagen teaches adjusting a DC voltage to
establish an RF power output, we do not see how Hagen, alone or in
combination with Rexroth, teaches establishing an RF duty cycle based on
the adjusted DC voltage. To the extent the Examiner relies on Rexroth for
this aspect of the limitation (see Ans. 11-12; Final Act. 6), the Examiner
states (Ans. 12), but does not adequately explain how, Rexroth's "start-up
period" and "steady state period" duty cycles are analogous to Hagen's
setpoints to meet the claimed establishing of an RF duty cycle based on the
adjusted DC voltage.
Thus, we are persuaded of error on the part of the Examiner, and we
do not sustain the Examiner's rejection of independent claim 6. We also do
not sustain the rejection of claims 7 and 8, each of which depends from
independent claim 6.
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Rejection III- Claims 33-37
The Appellants contend that the Examiner's rejection of independent
claim 33 is in error because Hagen, upon which the Examiner relies, does
not teach the limitations of
determining when the electrosurgical tissue cutting
electrode has started cutting the tissue; and switching the
energy from a start mode that provides a first RF power
output and a first RF duty cycle, to a run mode having a
second RF duty cycle and a second RF power output lower
than the first RF power output and controlled by a control servo
system, responsive to the determining.
Appeal Br. 53; see also Reply Br. 13-14. Specifically, the Appellants argue
that, similar to related Appeal 2014-003326, "it is wholly unreasonable to
conclude that the tuning of the control circuit in Hagen is equivalent to the
determining clause of claim 33," and thus, Hagen does not discloses
switching the energy from a start mode to a run mode, as "expressly
define[ d]" in terms of RF duty cycle and power output, in response to the
determining. Appeal Br. 54.
The Examiner finds that Hagen teaches determining when the
electrode has started cutting tissue and switching modes responsive to the
determination at column 2, lines 42--49, column 4, line 41 through column 5,
line 19, and column 5, line 51 through column 6, line 2. Final Act. 12.
Specifically, the Examiner finds that Hagen's "monitoring tuning of the
control circuit first as a function of the input set point and then subsequently
as a function of a reduced set point," ensures an "optimum glow discharge
and an optimum start of cutting." Id. Regarding delivering energy from a
start mode with a high RF power output, the Examiner finds Hagen's
"means of adjustment 23' is used to choose a set point for the DC voltage
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between electrodes 16, 18 as detected by discharge detector circuit 20 and on
commencement of cutting tissue, the cutting procedure is monitored and
controlled according to the set point entered." Id. Regarding the run mode,
the Examiner finds "as soon as microprocessor 22' detects tuning of the
control circuit, it reduces the entered set point to a percentage of the value of
reduction to perform further control of the cutting procedure as a function of
the reduced set point." Id. The Examiner acknowledges that Hagen does
not teach "each mode having a first and second duty cycle" and relies on
Rexroth for curing this deficiency. Id. at 13.
However, the Examiner does not explain with particularity what, in
Hagen, the Examiner finds as the start mode and the run mode. To the
extent the Examiner finds that Hagen discloses a start mode of the chosen set
point voltage (see Final Act. 12), the microprocessor switching to a run
mode of the reduced entered set point as the microprocessor 22' detects the
tuning of the control circuit (see id.), and/or when optimum glow discharge
occurs (see Ans. 15), it appears the Examiner's finding is based on the
detecting of the control circuit being tuned for the first time being equivalent
to the determination that the electrode has started to cut the tissue. This
basis is not adequately supported; it is not clear that Hagen's tuning of the
circuit for the first time indicates a commencement of the cut such that the
microprocessor switches from the applied setpoint value ( start mode) to the
reduced or second setpoint value (run mode). To the extent the Examiner
finds that the detecting of the optimum glow discharge is equivalent to the
determination that the electrode has started to cut the tissue (see Final
Act. 12; Ans. 15), we do not see, and the Examiner has not adequately
explained, how Hagen's optimum glow discharge teaches determining a start
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of cutting. Hagen discloses "ensuring not only an optimum glow discharge
between the active electrode and the tissue but also an optimum start of
cutting to particular advantage" (Hagen, col. 2, 11. 46-49), and that "[ o ]n
commencement of cutting the tissue 17 by means of the active electrode 16
the cutting procedure is first monitored and controlled according to the
setpoint 60 entered by first adjustment means 23 "' (id. at col. 5, 11. 58---61 ).
But we do not see, and the Examiner has not adequately explained, how
Hagen determines when the electrode has started cutting and switching
modes based on this determination.
Thus, we are persuaded of error on the part of the Examiner, and we
do not sustain the Examiner's rejection of independent claim 33. We also do
not sustain the rejection of claims 34--37, each of which depends from
independent claim 33.
Rejection IV- Claims 48, 49, 52, and 53
The Appellants contend that the Examiner's rejection of independent
claim 48 is in error because the prior art "taken alone or in combination, do
not disclose or suggest a device that switches from a start mode wherein the
DC voltage is at a level to form plasma on the electrosurgical tissue cutting
electrode as recited in claim 48." Appeal Br. 58; see also id. at 59---60;
Reply Br. 14--17. Specifically, the Appellants argue that
Hagen's tuning of the circuit for the first time, which triggers
the switching from the applied setpoint value to the reduced or
second set point value, does not indicate and is not equivalent
to a monitored DV voltage that is detected to be at a level to
form plasma on the electrode, as required by claim 48.
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Appeal Br. 59. Rather, the Appellants argue, Hagen teaches switching the
setpoint "to a second DC setpoint when the control circuit is tuned, and not
based on a detected DC voltage." Id.
The Examiner finds that Hagen, at column 2, lines 42--49, and
column 5, line 51 through column 6, line 2, teaches switching modes when
the monitored DC voltage is detected to be at a level. Final Act. 15-16.
Specifically, the Examiner finds that Hagen discloses that "DC voltage is
detected to detect tuning of the control circuit at which point,
microprocessor 22 reduces the entered set point according to the value of
reduction to perform further control of the cutting procedure such that the
procedure is optimized." Id. "The Examiner also notes that Hagen discloses
in the first embodiment that the DC voltage at the electrode is monitored for
arc formation at which point the setpoint is adjusted ([ c ]ol. 4-5, 11. 66-8)."
Ans. 17. The Examiner acknowledges that Hagen does not teach "each
mode having a first and second duty cycle" and relies on Rexroth for curing
this deficiency. Final Act 16. The Examiner further acknowledges that
"Hagen fails to specifically disclose the level to be a level to form plasma on
the tissue cutting electrode." Id. at 17. The Examiner relies on Palanker for
curing this deficiency and determined that one of ordinary skill in the art
would
modify the invention of Hagen such that the level detected is a
level to form plasma on the cutting electrode in order to provide
the benefit minimizing the damage zone produced during the
cutting process and minimize heat losses into the material being
cut as well as the surroundings and hand pieces as taught by
Palanker.
Id. (citing Palanker, col. 3, 11. 45--49, col. 8, 11. 12-15).
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Even were we to agree with the Examiner that Hagen teaches
switching modes when the monitored DC voltage is detected to be at a
certain level, the Examiner has not adequately explained how the
combination of Hagen and Palanker teaches switching modes when the
detected DC voltage is at a level to form plasma on the cutting electrode.
Palanker discloses using plasma-assisted cutting (Palanker, col. 3, 11. 15-17),
and adjusting the modulation format of voltage pulses "so that plasma 28 is
maintained at the regime of streamer and spark discharges but the arc
discharges are prevented" (id. at col. 8, 11. 12-15; see also id. at col. 6,
11. 41--45, col. 7, 11. 1-5). The Examiner has not adequately explained how
Palanker teaches detecting a voltage level at which plasma is formed.
Further, the Examiner has not adequately explained how Palanker' s teaching
of modulating voltage pulses to maintain plasma would be combined with
Hagen's switching of modes when detecting DC voltage to teach switching
modes when detecting a DC voltage level at which plasma is formed.
Thus, we are persuaded of error on the part of the Examiner, and we
do not sustain the Examiner's rejection of independent claim 48. We also do
not sustain the rejection of claims 49, 50, 52, and 53, each of which
ultimately depends from independent claim 48.
Rejection V- Claim 54
The Examiner's rejection of dependent claim 54 under 35 U.S.C.
§ 103 as unpatentable over Hagen, Albrecht, Rexroth, Palanker, and Hung
relies on the same inadequately supported finding as discussed above with
respect to claim 48 and is not cured by additional findings and/or reasoning
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associated therewith. See Final Act. 18-19. Thus, for the same reasons as
discussed above, we do not sustain the rejection of dependent claim 54.
DECISION
The Examiner's rejections of claims 6-9, 33-37, 48-50, and 52-54
under 35 U.S.C. § 103(a) are REVERSED.
REVERSED
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