Ex Parte Odom et al

Patent Trial and Appeal Board

Aug 14, 2018

11487297 (P.T.A.B. Aug. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/487,297
90039 7590
Covidien LP
Attn: IP Legal
5920 Longbow Drive
Mail Stop A36
07/14/2006
08/16/2018
Boulder, CO 80301-3299
FIRST NAMED INVENTOR
Darren Odom
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.
H-US-00473 (203-4967) 6470
EXAMINER
GOOD, SAMANTHA M
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/16/2018 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):
mail@cdfslaw.com
rs. patents. two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DARREN ODOM, CRAIG WEINBERG, and AMY DENHAM
Appeal2017-008045 1
Application 11/487,297
Technology Center 3700
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to an electrode
assembly for performing surgery. The Examiner rejected the claims for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We affirm.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1-3, 5, 8-10, 16, 17, and 19-23, under 35 U.S.C. § 103(a)
for obviousness over Sakurai2 and Wrublewski3 (Final Act. 2---6); and
1 Appellants state that the real party in interest is Covidien AG. Appeal Br.
1.
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Application 11/487,297
(2) Claim 7, under 35 U.S.C. § I03(a) for obviousness over Sakurai,
Wroblewski, and Goble4 (Ans. 14--16).
Claim 1 is representative and reads as follows:
1. An electrode assembly comprising:
two opposing jaw members at least one of which is
movable relative to the other from an open position wherein the
jaw members are disposed in spaced relation relative to one
another to a closed position;
each of the jaw members including at least one
electrically-conductive tissue sealing surface extending along a
length thereof, each of the tissue sealing surfaces adapted to
connect to an electrosurgical energy source and configured to
communicate electrosurgical energy between the tissue sealing
surfaces of the two opposing jaw members;
a first electrical connection adapted to permit electrical
connection between the at least one electrically-conductive
tissue sealing surface of each of the jaw members and the
electrosurgical energy source;
at least one heating element disposed within at least one
of the jaw members and adapted to pre-heat the at least one
electrically conductive tissue sealing surface of the at least one
of the jaw members before the at least one electrically-
conductive tissue sealing surface is activated with
electrosurgical energy;
a second electrical connection adapted to permit
electrical connection between the at least one heating element
and an alternate energy source; and
at least one electrically conductive cutting element
disposed upon a portion of the tissue sealing surf ace of at
least one of the jaw members.
2 US 2003/0073987 Al (published Apr. 17, 2003).
3 US 6,174,309 Bl (issued Jan. 16, 2001).
4 US 2003/0139741 Al (published Jul. 24, 2003).
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Application 11/487,297
Appeal Br. 11 ( emphasis added to show limitation at issue).
OBVIOUSNESS-
SAKURAI AND WRUBLEWSKI
The Examiner's Prima Facie Case
The Examiner found that Sakurai described a device having almost all
of the features recited in representative claim 1, but conceded that Sakurai
differs from claim 1 in that "Sakurai et al teaches cutting and sealing
however fails to teach a cutting element" as recited in claim 1. Final Act. 3.
As evidence that an ordinary artisan nonetheless would have
considered claim 1 's device obvious, the Examiner cited Wroblewski as
teaching an "analogous system comprising two opposing jaw members (101
and 102) each including a sealing surface (Col. 3, lines 18-23) comprising at
least one electrically conductive cutting element (105) disposed upon a
portion of the tissue sealing surface of at least one of the jaw members .... "
Id.
Based on the references' combined teachings, the Examiner reasoned
that an ordinary artisan would have considered it obvious to modify
Sakurai' s device to include Wroblewski' s electrically conductive cutting
element "in order to simultaneously cut and seal tissue (Col. 1, lines 54-56)."
Id. at 3--4.
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
primafacie case ofunpatentability ....
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.
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In the present case, having carefully considered the arguments and
evidence advanced by Appellants and the Examiner, Appellants do not
persuade us that the preponderance of the evidence fails to support the
Examiner's conclusion of obviousness as to claim 1.
In particular, Appellants do not persuade us (see Appeal Br. 6-7;
Reply Br. 3) that Sakurai teaches away from the Examiner's posited
incorporation of Wrublewski's electrically conductive cutting element into
Sakurai's device. Nor do Appellants persuade us (see Appeal Br. 7-8;
Reply Br. 2-3) that the fundamental operating principle of Sakurai's device
would be changed by incorporating Wrublewski's electrically conductive
cutting element into Sakurai' s device, or that the Examiner's posited
modification would render Sakurai's device unsuitable for its intended
purpose.
As the Examiner found, and Appellants do not dispute, Sakurai
discloses an electrode assembly having the movable jaw members, tissue
sealing surfaces connected to an energy source, and heating element also
connected to an energy source, recited in Appellants' claim 1. See, e.g.,
Sakurai Figs. 1, 2, 5; see also id. ,r,r 71-72 (discussing embodiments shown
in Figs. 1 and 2).
Sakurai discloses that, when operating the device, the heating element
(heating member 5) is initially used to coagulate tissue grasped by the jaw
members:
An operator manipulates the forceps body 1 by holding the
handle portions 21 and 22 and peels living-body tissue to be
coagulated/resected. Then, the living-body tissue is grasped and
held by using the jaws 31 and 32. After that, the operator steps
on the pedal 11 in the thermal surgical knife side of the foot
switch 10 to supply current from the generator 9 to the heating
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member 5 for the thermal surgical knife. Then, heat is generated
in the heating member 5, and the operator manipulates so as to
coagulate living-body tissue grasped by the jaws 31 and 32.
Id. ,I 90.
Sakurai discloses that, by continuously applying heat to the tissue for
a sufficient time, a separation, i.e., a cut or resection, is generated in the
tissue grasped by the jaw members:
In general, when heat is continuously given to the living-
body tissue, the temperature increases gradually to coagulate
the living-body tissue properly. The temperature at that time is
about 80° C. The temperature of the living-body tissue is
increased to about 150° C. by continuing to give heat thereto.
Thus, a separating action is caused in the living-body tissue,
and the forceps body 1 can resect the living-body tissue.
Id. f 91 ( emphasis added).
Sakurai discloses that, when excessive tissue or blood is present such
that heating member 5 cannot generate enough heat to coagulate or resect
the target tissue, the electrode portions 71 and 72 in the jaws 31 and 32 are
energized to supplement the heat provided by heating member, allowing the
grasped tissue to be coagulated:
[B]ipolar electric surgical knife current can be flown
[ sic, flowed] for a short period of time between the electrode
portions 71 and 72 provided at the sides of the jaws 31 and 32.
Then, the electrode portions 71 and 72 increase[] the
temperature of living-body tissue grasped by the jaws 31 and 32
quickly up to about 60° C. After that, the forceps body 1 and
the generator 9 can coagulate the living-body tissue by using
heat generated by the heating member 5 for the thermal surgical
knife.
Id. ,I 93.
Sakurai explains that the combination of the heating member 5 and
electrodes 71 and 72 in the jaws allows the distal portion of the device to be
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heated rapidly to perform tissue coagulation and resection under all surgical
conditions, without excessively increasing the size of the device:
[E]lectrode portions 71 and 72, which can supply high
frequency current to treat living-body tissue, are provided with
the jaws 31 and 32, respectively. Thus, the size of the distal
end treating portion 3 including the jaws 31 and 32 is not
increased. The features of the thermal surgical knife can be
used effectively, and, at the same time, the temperature of the
distal end treating portion 3 can be increased quickly up to
close to the target temperature even under a condition where the
temperature of the distal end treating part 3 is hard to increase.
Therefore, the forceps body 1 according to the first embodiment
has the distal end treating portion 3 including the pair of jaws
31 and 32, which is not so large. Thus, coagulation and
resection of living-body tissue can be performed by using the
distal end treating portion 3 in any operation cases.
Id. ,I 94.
As to the electrically conductive cutting element recited in
Appellants' claim 1, as the Examiner found, and Appellants do not dispute,
Wroblewski discloses a forceps-like device similar to Sakurai' s device that
grasps, cuts, and seals tissue, but which also includes a cutting member
encompassed by Appellants' claim:
An electrosurgical instrument has a handle and a body
which position and close a jaw about a tissue site for
simultaneously cutting and sealing relatively large tissue
structures. The jaw includes an electrosurgical cutting member,
which may be a blade or wire, against which tissue is biased
along a cut line, and a clamping assembly that clamps a region
adjacent to or surrounding the cut line. The clamping assembly
includes sealing electrodes for heating the region and welding
tissue along the side of the cut as the cutter parts the tissue.
Wroblewski, abstract; see also id. at Fig. 1 ( showing blade 105 disposed
between and within grasping jaws 101a and 102a).
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As the Examiner found (Final Act. 3--4; Ans. 2-3), Wroblewski
discloses that the configuration of its device is desirable in that it "may be
used to simultaneously cut and seal multiple vessels of the mesentery," and
also in that it "coagulates quickly while producing little heat in the body of
the instrument so that it may be used for prolonged periods in operation on
major tissue structures such as the colon, small bowel, lungs, stomach or
uterus, as well as smaller structures." Wroblewski 1:56-63.
Given Wroblewski' s teaching that its electro surgical cutting member
was a useful element for surgical devices, like Sakurai' s, that grasp, cut, and
seal tissue, and further given Wroblewski' s teachings regarding the
advantages of a device including such a cutting member, we agree with the
Examiner that an ordinary artisan had good reason for, and a reasonable
expectation of success in, modifying Sakurai' s device to include
Wrublewski's cutting member. Because the Examiner's conclusion of
obviousness is, thus, based on the teachings in the prior art, Appellants do
not persuade us that the Examiner's rejection of claim 1 relies on improper
hindsight.
To the contrary, as the Supreme Court has explained, "when a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result." KSR Int'! Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007). In the present case, Appellants identify no
specific unpredictable result stemming from the combination of known
elements recited in claim 1.
As to Appellants' teaching away argument, our reviewing court has
explained that a reference "does not teach away ... if it merely expresses a
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general preference for an alternative invention but does not criticize,
discredit, or otherwise discourage investigation into the invention claimed."
DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327
(Fed. Cir. 2009) (internal quotations omitted).
In the present case, we acknowledge Sakurai' s disclosure that, in its
tissue resecting process, "when heat is continuously given to the living-body
tissue, the temperature increases gradually to coagulate the living-body
tissue properly." Sakurai ,r 91.
We acknowledge also Wroblewski' s disclosure that one advantage of
its device is that it "coagulates quickly while producing little heat in the
body of the instrument so that it may be used for prolonged periods in
operation on major tissue structures such as the colon, small bowel, lungs,
stomach or uterus, as well as smaller structures." Wroblewski 1:59-63.
We are not persuaded, however, that Sakurai' s disclosure of a gradual
increase in tissue temperature when using its tissue-resecting device
sufficiently criticizes, discredits, or discourages investigation into alternative
techniques for resecting tissue, such that Sakurai teaches away from
deploying Wroblewski' s electrosurgical cutting member in Sakurai' s device.
To the contrary, rather than criticizing resecting devices, like Wrublewski's,
that function quickly, Sakurai discloses that the rapid function of its own
device is advantageous:
The features of the thermal surgical knife can be used
effectively, and, at the same time, the temperature of the distal
end treating portion 3 can be increased quickly up to close to
the target temperature even under a condition where the
temperature of the distal end treating part 3 is hard to increase.
Sakurai ,r 94 ( emphasis added).
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Moreover, because Sakurai discloses that the rapid function of its own
device is advantageous, Appellants do not persuade us that the fundamental
operating principle of Sakurai' s device would be changed by incorporating
Wroblewski' s electrically conductive cutting element into Sakurai' s device,
or that the Examiner's posited modification would render Sakurai' s device
unsuitable for its intended purpose.
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to claim 1. We, therefore, affirm the
Examiner's rejection of claim 1 over Sakurai and Wroblewski. Because
they were not argued separately, claims 2, 3, 5, 8-10, 16, 17, and 19-23, fall
with claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv).
OBVIOUSNESS-
SAKURAI, WRUBLEWSKI, AND GOBLE
The Examiner's Prima Facie Case
Claim 7 recites "[t]he electrode assembly according to claim 1,
wherein the at least one heating element is disposed within the electrically
conductive cutting element." Appeal Br. 12.
In rejecting claim 7 over Sakurai, Wroblewski, and Goble, the
Examiner relied on the teachings in Sakurai and Wroblewski, discussed
above, and cited Goble as evidence that it was known in the art to include a
heating element within an electrically conductive cutting element on surgical
scissors-type devices. Final Act. 6 (citing Goble ,r 125). Based on the
references' combined teachings the Examiner reasoned that it would have
been obvious to "modify the heating element, as taught by Sakurai et al[.], to
be disposed within the electrically conductive cutting element, as taught by
Goble, in order to allow for both cutting and coagulating tissue while
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reducing tissue build up and extending the operating life of the device
(paragraph 0125)." Id.
Analysis
Appellants do not persuade us that the preponderance of the evidence
fails to support the Examiner's conclusion of obviousness as to claim 7.
Appellants argue:
[I]n the cited portion of Goble, Goble disclosed cutting
blades including a PTC material coating applied to the blades to
prevent the adherence of tissue on the blades. (See Goble, ,r
[0125]). Accordingly, Goble has not been shown to have
disclosed or made obvious, "the at least one heating element is
disposed within the electrically conductive cutting element," as
recited in claim 7. (Emphasis added).
Appeal Br. 9; see also Reply Br. 5 ("[T]o the extent that the Examiner
contends that the PTC material coating of Goble is a heating element,
Appellant respectfully submits that the PTC material is a coating disposed
on the blades.").
We acknowledge Goble' s disclosure that its device includes a PTC
coating material that "provides improved temperature control preventing the
adherence of tissue to the blades" which is a "common problem" with
surgical scissors-type devices. Goble ,r 125.
Appellants fail to explain, however, how the presence of the PTC
coating demonstrates that the Examiner mischaracterized Goble as
disclosing that it was known in art to include a heating element within a
cutting element of devices such as those described in Sakurai, Wroblewski,
and Goble. To the contrary, Goble suggests that it was well known in the art
to include heating elements for coagulating tissue within cutting elements of
such devices. See id. (describing "bipolar scissors devices [that] can be used
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to both cut and coagulate tissue" as "entirely conventional apart from the
PTC material coating applied to the blades").
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to claim 7. We, therefore, affirm the
Examiner's rejection of claim 7 over Sakurai, Wroblewski, and Goble.
SUMMARY
For the reason discussed, we affirm both of the Examiner's
obviousness rejections.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.I36(a).
AFFIRMED
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