Ex Parte Stone et al

Patent Trial and Appeal Board

Aug 21, 2018

13385540 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/385,540 02/24/2012
121974 7590 08/23/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Corbett W. Stone
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.
8150BSC0254C3 9469
EXAMINER
GOOD, SAMANTHA M
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/23/2018 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CORBETT W. STONE, MICHAEL F. HOEY,
ROLFE TYSON GUSTUS, MIKE PERRY, ARTHUR G. BLANCK, and
LINAS R. KUNSTMANAS
Appeal2017-008049 1
Application 13/385,540
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN G. NEW, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a system for
remodeling tissue about a blood vessel. The Examiner rejected the claims
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
STATEMENT OF THE CASE
Appellants' invention relates, in certain embodiments, to an
angioplasty balloon capable of applying tissue-ablating radiofrequency (RF)
energy to diseased tissue within a blood vessel. See Spec. ,r,r 85-90.
1 The Real Party in Interest is Vessix Vascular, Inc. Appeal Br. 4.
Appeal2017-008049
Application 13/385,540
The Specification discloses that "[b ]y applying energy at the specific
frequency or range of frequencies that the tissue is more conductive, energy
penetrates the tissue more readily. In general, it has been shown that
samples of diseased tissue exhibit higher impedance characteristics than
samples of healthy tissue." Id. ,r 91.
The Specification explains:
Frequency targeting seeks to deliver more energy to the
diseased tissue by determining the frequency or range of
frequencies at which the impedance of the diseased tissue is
equal to or greater than that of the healthy tissue, such as by
operation at or below a threshold frequency. Energy delivered
at the specified frequency or range of frequencies will cause
more heat to be dissipated in the diseased tissue than energy
delivered outside of those specific frequencies.
Id. ,I 92.
Claim 1 illustrates the appealed subject matter and read as follows:
1. A system for remodeling tissue disposed about a blood
vessel, the system comprising:
an endovascular catheter having an energy delivery
portion adapted to be coupled with a target tissue, wherein the
catheter includes a balloon, wherein the energy delivery portion
comprises a plurality of electrodes disposed about the balloon
of the catheter so as to define a plurality of remodeling zones in
the target tissue when the balloon is in contact with a blood
vessel wall disposed adjacent to the target tissue; and
an energy source coupleable with the catheter, the energy
source being configured to deliver a controlled quantity of
energy to each of the plurality of electrodes in response to an
input such that the controlled quantity of energy heats at least
some of the plurality of remodeling zones of the target tissue so
as to remodel the target tissue and inhibit thermal damage of
collateral healthy tissues;
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Application 13/385,540
wherein the plurality of remodeling zones includes a first
remodeling zone and a second remodeling zone disposed
adjacent to the first remodeling zone and wherein the plurality
of electrodes comprise a plurality of bipolar electrode pairs
spaced around an axis of the balloon so that the plurality of
remodeling zones defined by the bipolar electrode pairs are
laterally separated from each other so as to form gaps between
the first remodeling zone and the second remodeling zone;
wherein the energy source includes a processor,
wherein the processor is designed to determine a frequency or
range of frequencies at which a first impedance of the target
tissue is equal to or greater than a second impedance of the
collateral healthy tissue; and
wherein the processor is configured to deliver the
controlled quantity of energy delivered to the plurality of
electrodes at the frequency or range of frequencies.
Appeal Br. 16-1 7 ( emphasis added to show claim limitation at issue).
The following rejections are before us for review:
(1) Claims 1--4, 6, 8, 9, 12, 14, 15, and 18, under 35 U.S.C.
§ 103 (a) as being unpatentable over Steinke,2 Wood, 3 and W oloszko 4
(Final Act. 5-9);
(2) Claims 10 and 11, under 35 U.S.C. § I03(a) as being
unpatentable over Steinke, Wood, and Carmel 5 (Final Act. 1 O); and
(3) Claim 13, under 35 U.S.C. § I03(a) as being unpatentable
over Steinke, Wood, and Winston 6 (Final Act. 11 ).
2 US 2005/0096647 Al (published May 5, 2005).
3 US 2004/0122421 Al (published June 24, 2004).
4 US 2003/0014051 Al (published Jan. 16, 2003).
5 US 2006/0089638 Al (published Apr. 27, 2006).
6 US 2005/0010208 Al (published Jan. 13, 2005).
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Application 13/385,540
DISCUSSION
The Examiner's Prima Facie Case
In rejecting claim 1 for obviousness over Steinke, Wood, and
Woloszko, the Examiner cited Steinke as describing a tissue remodeling
system having nearly all of the features recited in the claim, and which
included a temperature sensor coupled to the energy source, but conceded
that Steinke' s system did not include claim 1 's processor designed to
determine a frequency or range of frequencies at which a first impedance of
the target tissue is equal to or greater than a second impedance of the
collateral healthy tissue. Final Act. 6-7.
As evidence that an ordinary artisan would nonetheless have
considered the system of Appellants' claim 1 obvious, the Examiner cited
Wood as disclosing an analogous system that included "an energy source
(34) including a processor (46) designed to determine a frequency or range
of frequencies based on tissue impedance (paragraphs 0045 and 0054-
0057)." Id. at 7.
Based on the combined teachings of Steinke and Wood, the Examiner
reasoned that an ordinary artisan would have considered it obvious to
modify Steinke' s system for remodeling tissue "to be configured to
determine an optimum frequency or range of frequencies based on tissue
impedance, as taught by Wood, in order to properly select the treatment
frequency, time of energy delivery and total energy delivered (paragraphs
0054-0055)." Id.
The Examiner found, however, that the system suggested by Steinke
and Wood also differed from the system recited in Appellants' claim 1 in
that the references' combined teachings did not teach claim 1 's processor
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"designed to determine a frequency or range of frequencies at which a first
impedance of the target tissue is equal to or greater than a second impedance
of the collateral healthy tissue." Id.
As evidence that the system of Appellants' claim 1 would nonetheless
have been obvious, the Examiner found that "Woloszko teaches an
analogous system for treating tissue wherein the processor is designed to
determine a range of frequencies at which a first impedance of the target
tissue is equal to or greater than a second impedance of the collateral healthy
tissue (paragraph 0209)." Id. at 7-8.
Based on the references' combined teachings, the Examiner reasoned
that an ordinary artisan would have considered it obvious to modify the
processor suggested by the combination of Steinke and Wood, "to be
designed to determine a range of frequencies at which a first impedance of
the target tissue is equal to or greater than a second impedance of the
collateral healthy tissue, as taught by Woloszko, in order to control the depth
of penetration (paragraph 0209)." Id. at 8.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present appeal, Appellants persuade us that the preponderance
of the evidence does not support the Examiner's conclusion of obviousness.
In particular, Appellants persuade us (see Appeal Br. 11-13) that the
Examiner has not explained with sufficient particularity how or why the
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cited combination of references teaches or suggests a tissue remodeling
system with the processor required by Appellants' claims.
As noted above, Appellants' claim 1 recites a tissue remodeling
system that includes a processor which is "designed to," that is, configured
to or programmed to, "determine a frequency or range of frequencies at
which a first impedance of the target tissue is equal to or greater than a
second impedance of the collateral healthy tissue." Appeal Br. 17 (claim 1).
Appellants' claim 18, the other independent claim on appeal, recites a tissue
remodeling system similar to that recited in claim 1, which includes a
processor having the same features. See id. at 20 ( claim 18).
W oloszko, which the Examiner relies upon as to the claimed
processor, discloses an electrosurgical probe useful for ablating tissue within
a spinal disc. See W oloszko ,r 207.
Paragraph 209 of Woloszko, cited by the Examiner as disclosing the
processor required by Appellants' claims (see Final Act. 7-8; Ans. 4), reads
as follows:
In an alternative embodiment, the active electrode(s) 104
are brought into contact with, or close proximity to, the target
tissue so that the electric current passes directly into the tissue
to a selected depth. In this embodiment, the return electrode
draws the electric current away from the tissue site to limit its
depth of penetration into the tissue. Applicant has discovered
that the depth of current penetration also can be varied with
the electrosurgical system of the present invention by
changing the frequency of the voltage applied to the active
electrode and the return electrode. This is because the
electrical impedance of tissue is known to decrease with
increasing frequency due to the electrical properties of cell
membranes which surround electrically conductive cellular
fluid. At lower frequencies (e.g., less-than 350 kHz), the
higher tissue impedance, the presence of the return electrode
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Application 13/385,540
and the active electrode configuration of the present invention
(discussed in detail below) cause the current flux lines to
penetrate less deeply resulting in a smaller depth of tissue
heating. In an exemplary embodiment, an operating frequency
of about 100 kHz to 200 kHz is applied to the active
electrode(s) to obtain shallow depths of collagen shrinkage
(e.g., usually less than 1.5 mm and preferably less than 0.5
mm).
Woloszko ,r 209 ( emphasis added).
As is evident, ,r 209 does not describe a processor, per se, as recited in
Appellants' claims. We nonetheless acknowledge, as the Examiner found,
that the cited portion of W o loszko teaches that, because the electrical
impedance of tissue decreases as the frequency of the applied ablative
energy is increased, the depth of tissue ablation can be varied by varying the
frequency of the ablation energy applied to the tissue.
As seen above, however, both independent claims on appeal require
the claimed system's process to make a specific determination-a
determination of a frequency or range of frequencies at which a first
impedance of the target tissue is equal to or greater than a second impedance
of the collateral healthy tissue. Appeal Br. 17 ( claim 1) and 20 ( claim 18).
That is, Appellants' claims require the processor to determine a frequency,
or range of frequencies, in relation to both (a) the impedance of the target
tissue, and (b) a second impedance of collateral healthy tissue.
The Examiner does not explain, with any degree of particularity, how
or why the cited teaching in Woloszko, that the depth of tissue ablation can
be varied by varying the frequency of the ablation energy applied to the
tissue, necessarily equates to a teaching, or even a suggestion, of a processor
that determines an ablative energy frequency, or range of frequencies, in
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relation to both (a) the impedance of the target tissue, and (b) a second
impedance of collateral healthy tissue.
To the contrary, in presenting the rejection, the Examiner simply
states, without explanation, that ,r 209 of W oloszko teaches a processor with
that functionality. See Final Act. 7-8 ("Woloszko teaches an analogous
system for treating tissue wherein the processor is designed to determine a
range of frequencies at which a first impedance of the target tissue is equal
to or greater than a second impedance of the collateral healthy tissue
(paragraph 0209).").
In responding to Appellants' arguments, the Examiner simply quotes a
portion of W oloszko' s ,r 209, without explaining why that disclosure equates
to a teaching, or even a suggestion, of a processor that makes the
determination required by Appellants' claims:
Woloszko specifically teaches in the embodiment
mentioned in paragraph 0209 that they "discovered that the
depth of current penetration also can be varied with the
electro surgical system of the present invention by changing the
frequency of the voltage applied to the active electrode and the
return electrode" in paragraph 0209, which is applicable to a
variety of electrosurgical applications.
Ans. 4.
As our reviewing court has explained, to support a conclusion of
obviousness, "[ w ]hether the Board relies on an express or an implicit
showing, it must provide particular findings related thereto. Broad
conclusory statements standing alone are not 'evidence."' In re Kotzab, 217
F.3d 1365, 1370 (Fed. Cir. 2000) (citation omitted).
In the present appeal, given the absence, on this record, of a specific
explanation, based on either evidence or sound scientific reasoning, as to
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Application 13/385,540
why the cited references, in particular the cited portion of Woloszko, would
have taught or suggested a tissue remodeling system with a processor having
the functionality required by Appellants' claims 1 and 18, we must reverse
the Examiner's rejection of those claims, and their dependent claims 2--4, 6,
8, 9, 12, 14, and 15, for obviousness over Steinke, Wood, and Woloszko.
In rejecting claims 10 and 11 over Steinke, Wood, and Carmel, and in
rejecting claim 13 over Steinke, Wood, and Winston, the Examiner cited
Carmel and Winston as evidence that the elements recited in those
dependent claims would have been obvious features of Steinke' s system.
See Final Act. 10-11. Because Carmel and Winston do not remedy the
deficiency discussed above as to independent claim 1, from which claims 10,
11, and 13 depend, we must reverse the Examiner's rejection of those claims
as well.
SUMMARY
For the reasons discussed, we reverse each of the Examiner's
obviousness rejections.
REVERSED
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