Ex Parte Smith

Patent Trial and Appeal Board

Apr 18, 2018

13648987 (P.T.A.B. Apr. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/648,987 10/10/2012
121974 7590 04/20/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
SCOTT R. SMITH
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.
8150BSC0157 7704
EXAMINER
KIM, EUN HWA
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
04/20/2018 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
ndeane@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT R. SMITH
(APPLICANT: BOSTON SCIENTIFIC SCIMED, INC)
Appeal2017-002821
Application 13/648,987 1
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 19-38 (Ans. 2).
Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
Appellant discloses "method and apparatuses for modulation of nerves
through the walls of blood vessels. Such modulation may include ablation
1 Appellant identifies the real party in interest as "Boston Scientific Scimed,
Inc." (App. Br. 3.)
Appeal2017-002821
Application 13/648,987
of nerve tissue or other modulation technique" (Spec. 1 ). Claims 19 and 22
are representative and reproduced below:
19. A system for nerve modulation through a wall of a blood
vessel, comprising:
an elongate member extending along a central elongate
axis and having a proximal end and a distal end, the elongate
member having a radially expandable member disposed
proximate the distal end; and
a tubular sheath cooperatively engaged with the
expandable member such that the expandable member is not
expanded when in the tubular sheath and can expand when
moved out of the tubular sheath,
the expandable member comprising a plurality of
electrodes on an expandable frame wherein each of the plurality
of electrodes has a first surface that is entirely electrically
insulated and faces radially outwards relative to the expandable
member and a second surface that is electrically conductive and
faces radially inwards towards a central longitudinal axis of the
expandable member.
22. The system of claim 19, wherein at least some of the
plurality of electrodes and the expandable frame are formed
from the same material.
(App. Br. 16.)
The claims stand rejected as follows:
Claims 19--21, 23-29, and 31-38 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination ofRezai, 2 Parmer, 3 and
Stem. 4
2 Rezai et al., US 2009/0024195 Al, published Jan. 22, 2009.
3 Parmer et al., US 2011/0178584 Al, published July 21, 2011.
4 Stem, US 6,413,255 Bl, issued July 2, 2002.
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Application 13/648,987
Claims 22 and 30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Rezai, Parmer, and Fellows. 5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Rezai discloses "methods and apparatus for achieving renal
neuromodulation via an implantable device capable of delivering an electric
current to a desired intravascular location" (Rezai i-f 2; Final Act. 6 3).
FF 2. Rezai discloses that"[ e ]lectrical energy can be delivered to []
electrodes [] to decrease or inhibit nerve conduction from the superior
mesenteric ganglion [] to selected efferent nerve fibers" (Rezai i-f 93; id.
i-f 63 (the electrical energy may be RF energy); see also id. i-f 89).
FF 3. Rezai discloses that "the entire surface area of the electrodes [] may
be conductive or, alternatively, only a portion of the surface area of the
electrodes may be conductive" (Rezai i-f 62; see Final Act. 4).
FF 4. Rezai discloses
placing [an] apparatus in a blood vessel adjacent a desired
location, detecting a bodily activity associated with a renal
disease, and then activating the apparatus to apply electric
current to the desired location in response to the detected bodily
activity. Such bodily activity can include any characteristic or
function of the body, such as ... nerve action potential.
(Rezai i-f 73; see id. i-f 89 ("As electrical energy is delivered to [Rezai's]
apparatus [],the electrodes [] conduct the electrical energy to the vascular
5 Fellows et al., US 2003/0018362 Al, published Jan. 23, 2003.
6 Office Action mailed November 10, 2015.
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Application 13/648,987
wall at the desired locations and thereby cause nerves associated with the
desired locations to fire action potentials").)
FF 5. Examiner finds that Rezai teaches Appellants' claimed invention, but
for disclosing an: (a) electrode that has a "first surface [that] is entirely
electrically insulated" (Final Act. 4); (b) a
plurality of electrodes [that] are non-contact electrodes, wherein
each of the plurality of non-contact electrodes has a single
electrically conductive surface, wherein the expandable
member is configured such that when the expandable frame is
expanded and in contact with a blood vessel wall, the
electrically conductive surface of each of the plurality of non-
contact electrodes does not contact the blood vessel wall and
faces radially inward towards a central longitudinal axis of the
expandable member.
(Final Act. 7); or ( c) "wherein each of the plurality of widened regions has a
first completely electrically insulated surface that faces radially outwards
relative to the expandable member and a second electrically conductive
surface that faces radially inwards towards a central longitudinal axis of the
expandable member" (Final Act. 10; see also Ans. 3, 5, and 7).
FF 6. Examiner relies on Parmer to support a conclusion that "RF
electrodes can be substituted by capacitive electrodes" (Final Act. 4 (citing
Parmer i-f 71))
FF 7. Parmer "relates generally to apparatus and methods for tightening
tissue of the female genitalia by heating targeted connective tissue with
radiant energy, while cooling the mucosal epithelial surface over the target
tissue to protect it from the heat" (Parmer, Abstract).
FF 8. Parmer discloses that
[ t ]he energy delivery element ... may be any of an RF
electrode, a microwave emitter, or an ultrasound emitter. ...
The RF electrode, in some embodiments, is a capacitive
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Application 13/648,987
electrode, which capacitively couples to the mucosal
epithelium. The RF electrode[] ... may have a thickness in the
range of about 0.01 to about 1.0 mm.
(Parmer i-f 71; see also id. i-f 14 ("energy delivery element may ... include
capacitively coupled RF electrodes")).
FF 9. Parmer's "method include[s] heating the target zone with radiant
energy, typically radiofrequency (RF) energy," wherein "[t]he RF energy
penetrates through the cooled epithelium and into the underlying target
tissue, and heats the tissue" (Parmer i-f 23).
FF 10. Examiner relies on Stem to support a conclusion that a "capacitive
electrode allows uniform delivery of thermal energy" (Final Act. 5 (citing
Stem 3: 13-26)).
FF 11. Stem discloses that
There are a number of dermatological procedures that lend
themselves to treatments which delivery thermal energy to the
skin and underlying tissue to cause a contraction of collagen,
and/or initiate a would [sic] healing response. Such procedures
include skin remodeling/resurfacing, wrinkle removal, and
treatment of the sebaceous glands, hair follicles adipose tissue
and spider veins. Currently available technologies that deliver
thermal energy to the skin and underlying tissue include Radio
Frequency (RF), optical (laser) and other forms of electro-
magnetic energy.
(Stem 2: 40-50.)
FF 12. Stem discloses that
when RF energy is being applied or delivered to tissue through
an electrode which is in contact with that tissue, the current
patterns concentrate around the edges of the electrode, sharp
edges in particular. This effect is generally known as the edge
effect. In the case of a circular disc electrode, the effect
manifests as a higher current density around the perimeter of
that circular disc and a relatively low current density in the
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Application 13/648,987
center. For a square shaped electrode there is a high current
density around the entire perimeter, and an even higher current
density at the comers where there is a sharp edge.
Edge effects cause problems in treating the skin for
several reasons. First they result in a nonuniform thermal effect
over the electrode surface. In various treatments of the skin, it is
important to have a uniform thermal effect over a relatively
large surface area, particularly for dermatologic treatments.
Large in this case being on the order of several square
millimeters or even a square centimeter. In electrosurgical
applications for cutting tissue, there typically is a point type
applicator designed with the goal of getting a hot spot at that
point for cutting or even coagulating tissue. However, this
point design is undesirable for creating a reasonably gentle
thermal effect over a large surface area.
(Stem 3: 1-23; see Final Act. 5.)
FF 13. Examiner finds that the combination of Rezai and Parmer "is silent
as to wherein at least some of the electrodes and the frame are formed from
[the] same material" and relies on Fellows to make up for this deficiency in
the combination of Rezai and Parmer (Final Act. 12).
ANALYSIS
The rejection over the combination of Rezai, Parmer, and Stern:
Based on the combination of Rezai, Parmer, and Stem, Examiner
concludes that, at the time Appellant's invention was made, it would have
been prima facie obvious to substitute Parmer's capacitive electrodes for the
RF electrodes ofRezai's device, because of "the equivalence of RF
electrode and capacitive electrode for their use in the electrosurgical art and
the selection of any one of these known equivalents to delivery energy to
target tissue" (Final Act. 4--5; see also id. at 7 and 10; Ans. 3--4, 5, and 7).
We are not persuaded.
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Application 13/648,987
As Appellant explains, "Parmer cannot be fairly said to teach that
capacitively coupled and non-capacitively coupled electrodes are 'known
equivalents to delivery energy to target tissue' as urged in the [Final] Office
Action" (App. Br. 8; cf FF 6 and 8). In this regard, we note that Parmer and
Stem relate to devices that generate heat, through the use of RF energy, to
facilitate the remodeling of tissue (see FF 7, 9, 11, and 12). Examiner did
not identify, and we do not find, a disclosure in Rezai that relates to the use
of heat to stimulate a nerve. To the contrary, Rezai discloses an apparatus
that "appl[ies] electric current to the desired location in response to [a]
detected bodily activity" to "cause nerves associated with the desired
locations to fire action potentials" (see FF 4 ). As Appellant explains, "one
of ordinary skill in the art would have had no motivation to use a capacitive
electrode from a vaginal remodeling device such as that of Parmer in a
vascular neuromodulation device like that of Rezai" and Stem does not
support a contrary conclusion (App. Br. 8; see also id. at 12-13; Reply Br.
11-12).
As Appellant further explains, "the fact that Parmer and Rezai are
both medical devices with electrodes that are configured to deliver RF
energy through the electrode to a target tissue site, does not mean that they
are analogous" (Reply Br. 10). We agree. On this record, Examiner has, at
best, identified prior art that discloses different types of RF electrodes and
concluded, without a sufficient evidentiary basis, the a person of ordinary
skill in this art would have found that these different types of RF electrodes
are interchangeable among devices having different utilities (cf Ans. 9 ("all
the structures of a system for nerve modulation is disclosed by Rezai and
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Application 13/648,987
Parmer is relied upon ... to substitute contact electrode of Rezai with
capacitive electrode of Parmer")). We are not persuaded.
[I]dentification in the prior art of each individual part claimed is
insufficient to defeat patentability of the whole claimed
invention. . . . Rather, to establish obviousness based on a
combination of the elements disclosed in the prior art, there
must be some motivation, suggestion or teaching of the
desirability of making the specific combination that was made
by the applicant.
In re Kotzab, 217 F.3d 1365, 1369-70 (Fed. Cir. 2000) (citations omitted);
see also Ecolochem Inc. v. Southern California Edison, 227, F.3d 1361,
1375 (Fed. Cir. 2000) ("[A] rejection cannot be predicated on the mere
identification ... of individual components of claimed limitations. Rather
particular findings must be made as to the reason the skilled artisan, with no
knowledge of the claimed invention, would have selected these components
for combination in the manner claimed." (citations omitted)).
Further, "rejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness." In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006).
For the foregoing reasons, we are not persuaded by Examiner's
conclusion that a person of ordinary skill in this art would have found it
prima facie obvious to modify Rezai's device by substituting Parmer's RF
electrodes for the RF electrodes disclosed by Rezai (see Final Act. 4--5; see
also id. at 7 and 10).
The rejection over the combination of Rezai, Parmer, and Fellows:
Based on the combination of Rezai, Parmer, and Fellows, Examiner
concludes that, at the time Appellant's invention was made, it would have
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been prima facie obvious "to have modified the expandable frame [of the
apparatus suggested by the combination of Rezai and Parmer] so that it is
formed from platinum as taught by Fellows" (Final Act. 12). We are not
persuaded.
Examiner failed to establish that Fellows makes up for the foregoing
deficiency in the combination of Rezai and Parmer (see App. Br. 14; Reply
Br. 13; cf FF 13).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 19-21, 23-29, and 31-38 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Rezai, Parmer, and Stem is
reversed.
The rejection of claims 22 and 30 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Rezai, Parmer, and Fellows is
reversed.
REVERSED
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