Ex Parte ARENA et al

Patent Trial and Appeal Board

Jan 25, 2019

13332133 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/332, 133 12/20/2011
95450 7590 01/29/2019
NEW RIVER VALLEY INTELLECTUAL
PROPERTY LAW, PC
1750 Kraft Drive
Suite 2200
BLACKSBURG, VA 24060
FIRST NAMED INVENTOR
Christopher B. ARENA
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.
VTIP-47 A-11064-US 2040
EXAMINER
FOWLER, DANIEL WAYNE
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
01/29/2019 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):
MICHELE.MA YBERRY@NRVIPLA W.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER B. ARENA, RAFAEL V. DAVALOS,
and MICHAEL B. SANO
Appeal2018-001806
Application 13/332,133
Technology Center 3700
Before LISA M. GUIJT, LEE L. STEPINA, and BRENT M. DOUGAL,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeals under 35 U.S.C. § 134(a) from the Examiner's
rejection2 of claims 44--64 and 81-102. We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as Virginia Tech Intellectual
Properties, Inc. Br. 3.
2 Appeal is taken from the Final Office Action dated March 15, 2017.
Appeal2018-001806
Application 13/332, 133
STATEMENT OF THE CASE
Claims 44, 62, 91, and 94 are the independent claims on appeal.
Claim 44, reproduced below with disputed limitations italicized for
emphasis, is exemplary of the subject matter on appeal.
1. A medical device for ablating tissue cells by non-
thermal irreversible electroporation comprising:
one or more electrodes adapted to be positioned near a
target area containing target tissue cells to be ablated;
a power supply adapted to generate and deliver electrical
pulses to the electrodes; and
a controller in operable connection with and
programmable to control the power supply to output one or more
bursts of the electrical pulses, wherein said pulses have
predetermined pulse parameters with each burst containing
multiple electrical pulses at a frequency rate of 50 kHz or higher
and being sufficient to subject that target tissue cells to non-
thermal irreversible electroporation, each electrical pulse having
a pulse width of 10 microseconds or less so as to ablate the target
tissue cells by non-thermal irreversible electroporation;
wherein the controller is programmable to allow for
independent selection of width and amplitude of positive and
negative pulses within one or more of the bursts and to allow for
a delay between each burst of pulses; and
wherein the controller is programmable to control the
power supply to output the negative pulses with an amplitude of
between 500-4,000 V/cm.
THE REJECTIONS
I. Claims 44---64, 81-83, and 94--102 stand rejected under 35
U.S.C. § I03(a) as unpatentable over Deem '672 (US 2005/0261672 Al;
published Nov. 24, 2005), Francischelli (US 2010/0023004 Al; published
Jan. 28, 2010), and Chang (US 4,822,470; issued Apr. 18, 1989).
2
Appeal2018-001806
Application 13/332, 133
II. Claims 84--88 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Deem '672, Francischelli, Chang, Nanda (US 6,150,148;
issued Nov. 21, 2000), Zhang (US 6,972,013 Bl; issued Dec. 6, 2005),
Dzekunov (US 2003/0059945 Al; published Mar. 27, 2003), and Herbst
(US 6,029,090; issued Feb. 22, 2000).
III. Claim 91 stands rejected under 35 U.S.C. § I03(a) as
unpatentable over Deem '672, Francischelli, Chang, Nanda, and Zhang.
IV. Claims 89 and 90 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Deem '672, Francischelli, Chang, and Demarais (US
2007/0129760 Al; published June 7, 2007).
V. Claims 92 and 93 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Deem '672, Francischelli, Chang, Nanda, Zhang, and
Deem '989 (US 2007 /0060989 Al; published Mar. 15, 2007).
ANALYSIS
Rejection I
Appellants argue claims 44--64, 81-83, and 94--102 as a group. We
select independent claim 44 as representative, with claims 45---64, 81-83,
and 94--102 standing or falling with claim 44. See 37 C.F.R. §
4I.37(c)(l)(iv).
Regarding independent claim 44, the Examiner finds that Deem '672
discloses a medical device for ablating tissue cells by irreversible
electroporation (IRE) including one or more electrodes 126, 127, a power
supply, and a controller to output electrical pulses. Final Act. 2 ( citing
Deem '672 ,r,r 58, 64, 69, Fig. 8). The Examiner determines that Deem '672
does not disclose, inter alia, bursts containing multiple electrical pulses at a
3
Appeal2018-001806
Application 13/332, 133
frequency rate of 50 kHz or higher, although the Examiner finds that Deem
'672 teaches that "the disclosed device could be modified to include the
ability to output any pulse parameters that are known to produce
electroporation." Id. at 4.
The Examiner relies on Chang for disclosing "an electroporation
device capable of ablating via electroporation." Final Act 5 ( citing Chang
7:7-10 ("[t]he cell normally remains viable after such reversible
breakdown," however, "if the induced potential is much higher than Ve, the
membrane breakdown is irreversible"). The Examiner finds that Chang
discloses using "pulsed [radiofrequency (RF)] energy on the order of 50 kHz
to 500 MHz" for electroporation. Id. (citing Chang 3:30-39). The Examiner
reasons that it would have been obvious "to allow the system of [Deem '672,
as modified by Francischelli] to produce RF pulses as taught by Chang to
produce the predictable result of allowing an operator to program a
generator/controller to interact with tissue in a desired manner." Id.
Appellants argue that Chang discloses "a thermal ablation technique"
and "teaches away from[] non-thermal IRE." Br. 5; see also id. 10 ("RF
energy is a thermal ablation technique, which teaches away from
[Appellants'] non-thermal IRE technique"). Appellants submit that "[i]t is
well known in the medical device arts that RF energy produces thermal
effects, including radiant thermal heating in target and non-target tissue."
Id. at 12 (citing Francischelli ,r,r 7, 27). Appellants refer to dictionary
definitions of the term "radiofrequency ablation," for example, "'[a]
procedure that uses radio waves to heat and destroy abnormal cells"' and
"'[a] technique for removing a tumor by heating it with a radiofrequency
current."' Id. at 12. Appellants argue that "reliance on the quantitative
4
Appeal2018-001806
Application 13/332, 133
pulse parameter of Chang cannot be divorced from the type of energy
resulting from those parameters, RF energy, a thermal ablation technique."
Id. 10-11.
The Examiner responds that the Specification discloses that "it is
tissue ablation that is non-thermal, not the IRE process itself' (Ans. 5 (citing
Spec. ,r,r 15, 80, 85, 113)). The Examiner further finds that "the non-thermal
benefit is associated with minimizing Joule heating, not the utter absence of
any temperature increase." Id. at 5---6. The Examiner also determines that
neither Deem '672 nor Chang discloses, with respect to the IRE process, that
"thermal ablation is contemplated or required, or that Joule heating is the
primary mechanism of ablation." Id. at 6.
Appellants' argument does not provide sufficient explanation or
evidence for concluding that using a pulsed RF field across the electrodes to
porate the cells ( as taught in Chang) is inherently a thermal IRE process.
See Chang, Abstract ("The power function generator can apply ... a pulsed
radiofrequency electric field across the electrodes," wherein "[t]he pulsed
radiofrequency electrical field porates ... the cells."). Appellants argue that
cited prior art is limited to the use of heat in a conventional RF ablation
procedure, wherein radio waves heat and destroy cells. However, as
discussed infra, the prior art distinguishes between these two types of RF
procedures.
As determined by the Examiner, the Specification does not provide a
precise meaning for the claim term "non-thermal irreversible
electroporation," for example, as compared to "thermal irreversible
electroporation." See, e.g., Ans. 5---6; Spec. ,r 34 (distinguishing non-thermal
IRE by disclosing that "[ m ]ethods according to the invention can be
5
Appeal2018-001806
Application 13/332, 133
modified to provide for administering non-thermal IRE, IRE, and/or
reversible electroporation"). The Specification discloses that "[t]o maintain
its non-thermal benefits, the pulse parameters for IRE procedures are
restricted to those that minimize any associated Joule heating" (id. ,r 86) and
that "[h]igh-frequency electroporation ... reduces the potential for thermal
damage in low passive conductivity tissue" (id. ,r 101 ). The Specification
also discloses that, with respect to "high frequency IRE" (Example 7),
"[p ]ulse parameters were chosen based on the results from the analytical and
numerical models to ensure the greatest potential for non-thermal tissue
ablation." Spec. ,r,r 129, 132. Thus, on the record before us, we determine
that "non-thermal irreversible electroporation" means irreversible
electroporation (IRE) ablation performed without causing Joule heating in
the treated tissue that results in thermal damage, for example, by the
appropriate selection of pulse parameters. Non-thermal IRE, as determined
by the Examiner supra, does not use Joule heating as the mechanism to
destroy or ablate the treated tissue, and further, involves the selection of
pulse parameters to prevent thermal damage to the treated tissue.
Deem '672 discloses using "RF energy" to "ablate the site," wherein
"[ e ]lectrodes 44, 52 employ energy ( e.g., RF energy) for stimulating,
targeting, and/or ablating target tissue," which "may also be accomplished
using microwaves, cryothermia probes/balloons, alcohol injection, laser
light, magnetic stimulation, and/or ultrasound energy." Deem '672 ,r 44.
Deem '672 alternatively discloses that "it may be desirable ... [to use]
pulsed electric fields and/or electroporation," and describes, in relevant part,
"electroporation" as "encompass[ing] the use of pulsed electric fields," and
"'ablation' [as encompassing] the mechanism of electroporation leading to
6
Appeal2018-001806
Application 13/332, 133
denervation whether it be ... reversible or irreversible ... without
necessitating the presence of a thermal effect." Id. ,r 55 (emphasis added).
Deem '672 further teaches that "[ v ]arious waveforms or shapes of pulses
may be applied to achieve electroporation, including sinusoidal AC pulses,
DC pulses, square wave pulses, exponentially decaying waveforms or other
pulse shapes such as combined AC/DC pulses, or DC shifted RF signals."
Id. ,r 60. Therefore, Deem '672 recognizes a distinction between the
( conventional) use of RF energy to ablate tissue by heating the tissue with an
RF current ( a definition relied on by Appellants supra), as compared to the
use of pulsed electric fields for electroporation, including the use of RF
signals. Deem '760 further discloses that"[ w ]hen utilizing an electric field
to achieve desired neuromodulation [(by performing IRE)], parameters
[include] voltage, field strength, pulse width, pulse duration, the shape of the
pulse, the number of pulses (e.g., duty cycle), power, etc.," wherein
"[s]uitable shapes of the waveform include ... RF waveforms 3." Deem
'760 i125.
Chang discloses "an apparatus and a method for the poration ... of
cells using radiofreqency electrical pulses, ... wherein [t]he power generator
can apply a continuous AC electric field and/or a pulsed radiofrequency
electrical field across the electrodes." Chang, Abstract. Appellants'
argument does not provide sufficient evidence that the use of a pulsed RF
electric field for electroporation, when selected as a parameter for use in the
3 An ordinary definition of "wave form" is "the profile or shape of a wave,
especially the graphical representation of one of its characteristics, e.g.,
frequency or amplitude, relative to time." Waveform-Definition-Microsoft®
Encarta® College Dictionary, 1625 (2001 ).
7
Appeal2018-001806
Application 13/332, 133
device of Deem '672 as modified by Francischelli, as proposed by the
Examiner supra, necessarily causes Joule heating in the treated tissue which
results in tissue damage. Instead, Appellants' argument appears to address
the conventional use of thermally-induced ablation that uses RF energy to
destroy tissue by using heat. See Ans. 5 ("Chang is not [a conventional]
ablation device."). 4 As set forth supra, the Examiner relies on electrodes
126, 127 used for electroproration as disclosed in Deem '672 (not
conventional RF ablating electrodes 44, 52) in the rejection of the claims.
See, e.g., Deem '672 ("[ e ]lectroproration element 125 includes first
electrode 126 and second electrode 127 operatively coupled to pulse
generator 121 for delivering a desired number, duration, amplitude and
frequency of pulses to targeted cardiac tissue" which "parameters can be
modified ... whether a reversible or irreversible cell poration is desired").
Id. at i163.
Additionally, Appellants have not presented sufficient argument or
evidence that Chang teaches away from non-thermal IRE. Rather, Chang
recognizes that "[ e ]xcessive current is harmful to the cell because of the
resulting thermal effects." Chang 11: 1-2. As set forth supra Deem '672
describes electroporation ablation as a procedure without necessitating the
presence of a thermal effect. 5
4 The Examiner also responds that if the mere use of an electric field having
a radio frequency (i.e., "50 kHz or higher") results in thermal IRE, then the
medical device recited in claim 44 "would also necessarily produce a
thermal response." Ans. 5. Appellants neither address nor demonstrate
error in this finding by the Examiner.
5 Francischelli ,r 39 ( disclosing that "optimization of the electroporation
pulsed energy is, at least in part, a function of thickness and composition of
a tissue to be ablated [wherein] optimal energy parameters ( e.g., voltage,
8
Appeal2018-001806
Application 13/332, 133
Accordingly, we sustain the Examiner's rejection of independent
claim 44, and claims 45---64, 81-83, and 94--102 fall therewith.
Rejections II, III, and V
Regarding claims 84--88 and 91-93, the Examiner determines that
"[ t ]he claimed generator elements are commonly used in the electroporation
art." Final Act. 7, 9 ( citing Nanda 11 :23-29 ( for disclosing "a capacitor
bank"); Zhang 40:67 (for disclosing "a polarity switch"); Dzekunov ,r 153
(for disclosing "current limiting resistors"); Herbst 6:54 (for disclosing "an
arbitrary function generator") and 3:42--45 (for teaching that "the generator
can produce a wave of any arbitrary shape and allows individual adjustment
of electrical parameters")). The Examiner reasons that "the art discloses that
known elements ( the various circuit components) can be combined
according to known methods ( the methods that allow any of the prior art
references to be functional) to produce predictible results (electroporation)."
Id. 7-8, 9 (citingKS1~lnt'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007)
("[ t ]he combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.")).
The Examiner also determines that, with respect to the spacing of the
electrodes, "considering the device is used in the body, a distance on the
order of mm or cm would be expected and it is well within the purview of
one of ordinary skiU in the art to select an electrode gap that would produce
a desired result." Final Act. 11 (citing Deem '672, Fig. 6).
pulse duration, etc.) are characterized as those resulting in a narrow,
transmural lesion, with minimal damage to surrounding tissue and not
generating excessive heat").
9
Appeal2018-001806
Application 13/332, 133
Appellants argue that the Examiner has failed to show how the prior
art "teaches or suggest any of the specific claimed circuits." Br. 13. In
support, Appellants submit that "[t]he fact that known circuit components
such as resistors and capacitors exist does not render every circuit
configuration incorporating these components obvious," and that "[h Jere,
there are not a finite number of possibilities for the different components of
the claimed systems, nor a finite number of ways those components could be
arranged." Id. at 14. Appellants conclude that the Examiner "has not shown
that it would have been obvious to choose the particular components
claimed, let alone the particular arrangement of components claimed." Id. at
15 (emphasis added) (citing, for example, Bayer Schering Pharma AG v.
Barr Lab., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009) ("[A]n invention is
not obvious to try where vague prior art does not guide an inventor toward a
particular solution") ( emphasis added).
Claims 85-88 and 91-93 recite, in relevant part, a polarity switch
wherein an input of the polarity switch is in direct operable connection with
an output of [a] capacitor bank"; "current limiting resistors ... in direct
operable connection with an output of the power supply; "an input of the
current limiting resistors is in direct operable connection with an output of
the power supply"; "an arbitrary function generator, wherein an output of the
arbitrary function generator is in direct operable connection with an input of
the polarity switch"; "a positive and negative polarity switch in
communication with the power supply and a capacitor bank disposed
between the power supply and the positive and negative polarity switches";
and "wherein the electrodes are spaced at least 1 mm apart" or "up to 3 cm
apart or less." Br. 22-23 (Claims App.). The Specification discloses that
10
Appeal2018-001806
Application 13/332, 133
"[ t ]he system relies upon both commercially available components and
circuits built by the inventors," which "allows for a flexible treatment
program that may be tailored to meet a patient's individual needs." Spec. ,r
118. The Specification also acknowledges that "[ o ]ther systems are
available in the literature for generating bipolar pulses, and the invention
should not be limited to the system described [in Paragraph 118]." Id. ,r 119.
Appellants' argument that the Examiner has failed to demonstrate that
the claimed combinations of electrical components are obvious to try does
not address the Examiner's articulated reasoning that the claimed
combinations of electrical components constitute a combination of familiar
elements according to known methods. Thus, Appellants' argument does
not apprise us of error in the Examiner's findings or reasoning.
Accordingly, we sustain that Examiner's rejection of claims 84--88
and 91-93.
Re} ection IV
Appellants chose not to present separate arguments for the
patentability of claims 89 and 90, which depend from independent claim 44.
Therefore, for essentially the same reasons set forth supra, we also sustain
the Examiner's rejection of claims 89 and 90.
DECISION
The Examiner's decisions rejecting claims 44--64 and 81-102 are
AFFIRMED.
11
Appeal2018-001806
Application 13/332, 133
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
12