Ex Parte Gerber

Patent Trial and Appeal Board

Sep 18, 2017

11591294 (P.T.A.B. Sep. 18, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/591,294 10/31/2006 Martin T. Gerber 1023-596US01/P0027183.00 7139
71996 7590 09/20/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/20/2017 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):
pairdocketing @ ssiplaw.com
medtronic_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN T. GERBER
Appeal 2016-004521
Application 11/591,294
Technology Center 3700
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
implantable medical elongated member. The Examiner rejected the claims
as anticipated and as obvious.1 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
Statement of the Case
Background
“Electrical stimulation systems may be used to deliver electrical
stimulation therapy to patients to treat a variety of symptoms or conditions
. . . An electrical stimulation system typically includes one or more
implantable medical leads coupled to an external or implantable electrical
1 Appellant identifies the Real Parties in Interest as Medtronic, Inc. and
Medtronic pic (see App. Br. 3).
Appeal 2016-004521
Application 11/591,294
stimulator” (Spec. 12). “In many electrical stimulation applications, it is
desirable for a stimulation lead to resist migration following implantation . . .
. . Securing the implantable medical lead at the target stimulation site may
minimize lead migration” (Spec. 16).
The Claims
Claims 1, 3—26, and 28—31 are on appeal. Independent claim 1 is
representative and reads as follows:
1. An implantable medical elongated member configured
to deliver a therapy from a medical device to a target therapy
delivery site in a patient, the implantable elongated member
comprising:
an elongated body extending between a proximal end
configured to couple to the medical device and a distal end;
a vacuum cavity defined by the elongated body and
configured to receive vacuum pressure from a vacuum
source to draw tissue of the patient into the vacuum cavity,
wherein the vacuum cavity defines at least a first opening
and a second opening;
a positive pressure line disposed within the elongated
body and connected to the vacuum cavity via the first
opening;
a fixation element disposed within the positive
pressure line, wherein the fixation element is configured to
enter the vacuum cavity from the positive pressure line
through the first opening when a positive pressure is exerted
on the fixation element via the positive pressure line; and
a vacuum channel disposed within the elongated body
to couple the vacuum cavity to the vacuum source, wherein
the vacuum channel is connected to the vacuum cavity via
the second opening.
2
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The Issues
A. The Examiner rejected claims 1,3, 6—15, 17—22, 25, 26, and 28—31
under 35 U.S.C. § 102(b) as anticipated by Colliou2 (Final Act. 2-4).
B. The Examiner rejected claims 4, 5, 16, 23, and 24 under 35 U.S.C.
§ 103(a) as obvious over Colliou (Final Act. 4—5).
A. 35 U.S.C. § 102(b) over Colliou
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Colliou anticipates the
claims?
Findings of Fact
1. Figure 1 of Colliou is reproduced below:
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3
Appeal 2016-004521
Application 11/591,294
Figure 1 depicts “a functional device 520 comprising a gastric stimulator []
attached to the stomach wall 104” (Colliou 193).
2. Colliou teaches:
The housing 521 includes an open chamber 522 for receiving a
portion of the stomach wall 104 for attachment. The chamber
522 includes an opening 527 coupled to a vacuum pipe 528
external to the chamber 522 of the housing. The vacuum pipe
528 has an open proximal end 529 for coupling through an
elongate tube to a vacuum source.
(Colliou 194).
3. Colliou teaches a “sliding needle 524 with a sharp tip 525
extends from a first proximal side of the device 520, distally through the
chamber 522 piercing the stomach wall 104, to an opposite distal side of the
device 520” (Colliou 195). Colliou teaches the “housing . . . includes a . . .
needle guide hole, and one or more anchor needles” (Colliou 122).
4. Colliou teaches that the “electrodes 531, 532 are located around
the circumference of the needle 524. The electrodes 531, 532 are
electrically isolated from each other and are electrically coupled to contacts
535, 536 through connectors 533, 534 extending from the electrodes 531,
532 through the needle 524 to the contacts 535, 536” (Colliou 195).
5. Colliou teaches the “electrodes may be mounted directly on the
housing, the attachment device, or placed on a flexible tail or tether. The
electrodes are preferably coupled to the electronic circuitry through sealed
electrical contacts or through leads extending into the housing through
molded corrosion resistant materials” (Colliou 127).
6. The Specification teaches the “physician may apply the positive
pressure via positive pressure line 94 in a number of different manners”
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Application 11/591,294
(Spec. 171), specifically teaching: “In another example, a flexible, but
generally incompressible, wire may be placed within positive pressure line
94 and used as a push rod to force fixation element 92 through the captured
tissue 90 of target stimulation site 18” (Spec. 174).
7. Figures 2B and 2C of Colliou are reproduced below:
As illustrated in FIG. 2B, the chamber 522 of the device
520 is placed against the stomach wall 104 at the site 105. A
vacuum is applied through the tube 558, vacuum pipe 528 and
the opening 527 into the chamber 522. The vacuum draws a
portion of the stomach wall 104 into the chamber 522.
As illustrated in FIG. 2C, while the engaging tool 550
holds the device in place, the grasping instrument 556 is
advanced distally to move the needle 524 from an open position
to a closed position in which the needle 524 extends through the
chamber 522. As the needle 524 extends through the chamber
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Application 11/591,294
522, it pierces through the stomach wall from the inside of the
stomach wall to the outside through a fold in the stomach wall
104 and back through the stomach wall to the inside of the
stomach wall 104 where the needle tip 525 is placed within
recess 526 and the magnets 518, and 519 magnetically engage
to hold the needle 524 in its closed position.
(Colliou 1198-99).
8. Figure 11 of Colliou is reproduced below:
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FIG. 11
Figure 11 depicts an embodiment where “stimulator device further
comprises an elongate member 692 with bipolar ring electrode pairs . . . The
elongate member 692 is implanted in the stomach wall after the housing 691
has been attached to the stomach wall 104” (Colliou 1122).
9. Colliou teaches the “endoscope includes an
aspiration/instrument channel 112 and irrigation/air channel 113. The
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Appeal 2016-004521
Application 11/591,294
aspiration/instrument channel 112 may be used for instruments if not
otherwise required in a procedure” (Colliou 1 90). Colliou further teaches
“If desired, an overtube may be used to protect the esophagus .. . The
overtube may also include additional channels for inserting additional
instruments” (Colliou 191).
10. Colliou teaches “the housing may include radiopaque markers
located on the device so that the location and orientation of the device may
be identified, particularly after it has been placed” (Colliou 193).
11. Colliou teaches “stimulation electrodes provide stimulation
either by way of a preprogrammed pulse generator or one that is
programmed or revised when the device is implanted in the stomach”
(Colliou 116).
12. Colliou teaches:
Various sensors may be used, e.g., a pressure sensor, a strain
gauge, a temperature sensor, a pH monitor, a sensor for sensing
muscle contractions of the stomach, a sensor for sensing
electrical parameters of the stomach wall, a glucose monitoring,
or redox. The sensors may be used to sense electrical
parameters, pressure, movement, temperature.
(Colliou 114).
Principles of Law
A prior art reference can only anticipate a claim if it discloses all the
claimed limitations “arranged or combined in the same way as in the claim.”
Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361
(Fed. Cir. 2012).
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Application 11/591,294
Analysis
Our findings of fact set forth above (FF 1—12) are adopted from the
Examiner’s findings concerning the scope and content of the prior art. We
separately address whether the individual claims are anticipated by Colliou.
We address Appellants’ arguments below.
Claim 1
Appellants contend
Colliou does not disclose “a positive pressure line disposed
within the elongated body and connected to the vacuum cavity
via fa] first opening; and a fixation element disposed within the
positive pressure line, wherein the fixation element is
configured to enter the vacuum cavity from the positive
pressure line through the first opening when a positive pressure
is exerted on the fixation element via the positive pressure
line,” as recited in claim 1.
(App. Br. 7).
We do not find this argument persuasive. Colliou teaches, as shown
in figure 1, a medical device comprising an elongated body 520 with a
proximal and distal end (FF 1). Colliou teaches that the device comprises a
vacuum cavity 522 with a second opening 527 that is coupled to a vacuum
channel 528 that is connected to a vacuum source 529 (FF 2).
Colliou teaches, as shown in figures 2B and 2C, a needle 524 that
passes into the housing 521. We note that Colliou’s figure 1 depicts the
needle passing through the housing material into and through the vacuum
chamber and coming to rest within a wall of the housing opposite from its
entry point. Colliou teaches that the housing includes a needle guide hole.
(FF 3.) The Examiner considers this guide hole to be a “conduit.” (Final
Act. 3) Thus, while not explicitly described, we find that the housing
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Application 11/591,294
includes a guide hole/conduit through which the needle is passed prior to
entering the vacuum cavity. The position through which that needle passes
first to enter the vacuum cavity is through an opening, termed “first
opening” in claim 1, that is present in a proximal portion of elongated body
520, i.e., the needle guide hole, that functions as a “positive pressure line”
leading into vacuum cavity 522 (FF 7). Needle 524 is used as a fixation
element to fix tissue 104 when positive pressure is exerted via the positive
pressure line using grasping instrument 556 (FF 3,7). As the Examiner
noted, “the examiner considers the fixation element to be a single structure
extending from the distal tip of Fig. 2C, #524 to the proximal end of #556”
(Final Act. 3).
We recognize, but find unpersuasive, Appellants contention that
“Colliou fails to disclose that the ‘conduit’ in which the grasping element
556 is disposed (the ‘positive pressure line’ according to the Examiner)
connects to the portion of the housing 521 in which tissue 104 is ‘sucked
into the device’” (App. Br. 8).
We find this argument unpersuasive because it fails to properly
interpret the limitations of claim 1, as well as misconstrues the Examiner’s
reasonable interpretation of Colliou. Claim 1 simply requires a “positive
pressure line” that allows positive pressure to be exerted on the fixation
element. Moreover, there is no requirement in the claim that the positive
pressure element itself enters the positive pressure line.
The Examiner’s rejection does not rely on the element 556 being
disposed in the conduit. As the Examiner explains the fixation element
includes a proximal end 556 (the grasping element) and distal tip 524,
including needle point 525. As the fixation element passes through the
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Appeal 2016-004521
Application 11/591,294
guiding hole/conduit, 524 enters the vacuum cavity from the conduit when a
positive pressure is exerted on the fixation element (i.e., pushing on the
proximal end 556) while the fixation element (at least a portion of 524) is in
the conduit. (See Colliou Figure 2C (showing arrow in which element 556 is
being moved).)
This reading of claim 1 is consistent with the Specification, which
teaches that a wire may be “placed within positive pressure line 94 and used
as a push rod to force fixation element 92 through the captured tissue” (FF
6). Thus, the broadest reasonable interpretation consistent with the
Specification of the requirement in claim 1 for “positive pressure” that “is
exerted on the fixation element via the positive pressure line” encompasses a
portion of needle 524 serving as the push rod that forces the fixation
element, the needle point 525, through the captured tissue as disclosed by
Colliou (FF 7).
Appellants contend
It does not necessarily follow that the “conduit” in which the
grasping element 556 is disposed (the “positive pressure line”
according to the Examiner) is actually connected to a vacuum
cavity simply because the element 556 leaves the asserted
positive pressure line and is attached to an element 524 which
then enters the asserted vacuum cavity.
(App. Br. 9).
We also find this argument unpersuasive. The fixation element of
needle point 525 is connected via a wire composed of a portion of 524 to the
grasping element 556, and Figures 2B and 2C clearly shows movement of at
least a portion of 54 through the elongated body 520 into vacuum chamber
522 (FF 7). Thus, the conduit for the needle through the housing wall that
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Appeal 2016-004521
Application 11/591,294
opens out to the vacuum cavity 522 is reasonably interpreted as the “positive
pressure line.” As discussed, there is no requirement in the claim that the
positive pressure element itself enters the positive pressure line, so even if
we interpreted element 556 as providing positive pressure, that pressure is
still exerted through to the needle in the guiding hole/conduit in elongated
body 520, which is the “positive pressure line”.
Appellants contend:
The Office has not shown that one of ordinary skill in the art
would have understood Colliou’s endoscope 110, or engaging
tool 550, which is attached to the endoscope 110 by a band 549,
to have been an implantable elongated member configured to
deliver a therapy from a medical device to a target therapy
delivery site.
(App. Br. 9—10 (footnote omitted)).
We find this argument unpersuasive because the language “configured
to deliver a therapy” represents an intended use recitation that does not
structurally distinguish the device of Colliou. “[Apparatus claims cover
what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch
& Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990). Merely stating an
intended use for an apparatus is not sufficient to distinguish the apparatus
from the prior art. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997).
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Appeal 2016-004521
Application 11/591,294
Claim 6
Appellants contend “one of ordinary skill in the art would not have
understood the endoscope 110, alone or in combination with functional
device 520, to have been a lead” (App. Br. 11).
We do not find this argument persuasive. Colliou teaches the device
comprises electrodes around the needle (FF 4) and teaches “electrodes may
be mounted directly on the . . . the attachment device. . . . The electrodes are
preferably coupled to the electronic circuitry through . . . leads extending
into the housing” (FF 5). Thus, Colliou teaches the structure required by
claim 6, with distal electrodes coupled by leads to electronic circuitry 25 that
is located in the proximal end of the device (FF 1).
Claims 7 and 8
Appellants contend “as shown in FIG. 1 of Colliou, the ring electrodes
531 and 532 are located within the chamber 522, such that the chamber 522
is not a ‘vacuum cavity [] located between [] one or more electrodes and [a]
proximal end of [a] lead,’ as recited in claim 7.” (Reply Br. 8).
The Examiner responds
electrode 532 is considered the electrode meeting the claimed
“one or more electrodes[,]” the vacuum cavity still extends in
the proximal direction; therefore, it would be found between the
proximal end of the lead and electrode 532, because of its
positioning with respect to the distal and proximal end of the
device as a whole.
(Ans. 4).
We find the Examiner has the better position. Claim 7 does not
require that the entire vacuum cavity is located between the electrodes and
the proximal end of the lead, but rather that at least part of the vacuum
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Application 11/591,294
cavity is so positioned. As figure 1 shows, electrode 532 is near the distal
end so a significant portion of the vacuum chamber is located between that
electrode and the proximal end of the lead that terminates at electronic
circuitry 25 (FF 1). Thus, Colliou teaches that a vacuum cavity region is
located between an electrode and the proximal end of the lead as required by
claim 7.
Claim 9
Appellants contend “a person having ordinary skill in the art would
not have understood the chamber 522 to have been a ‘the vacuum cavity []
located between [] one or more electrodes and [a] distal end of [a] lead, ’ as
recited in claim 9” (App. Br. 13).
The Examiner responds that
electrode 531 is considered the electrode meeting the claimed
“one or more electrodes[,”] the vacuum cavity still extends in
the distal direction; therefore, it would be found between the
distal end of the lead and electrode 532, because of its
positioning with respect to the distal and distal end of the
device as a whole.
(Ans. 5).
We find the Examiner has the better position. As discussed above
regarding claim 7, claim 9 also does not require the entire vacuum cavity to
be located between an electrode and the distal end of the lead. As the
Examiner correctly notes, there is a region of vacuum cavity between
electrode 531 and the distal end of the lead that terminates in electrode 532
(FF 1).
Claim 11
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Application 11/591,294
Appellants contend “Colliou also fails to disclose or suggest the
system of claim 11, which depends from independent claim 1 and recites
that ‘the elongated member comprises a catheter’” (App. Br. 13).
The Examiner responds that in Figure 11, “the additional components
show that the device can be further used in a catheter fashion for implanting
a guidewire component” (Ans. 5).
We find that Appellants have the better position.3 Figure 11 depicts a
guidewire, but that guidewire is not implanted by using the device as a
catheter, rather the “elongate member 692 is implanted in the stomach wall
after the housing 691 has been attached to the stomach wall 104” (FF 8).
The Examiner provides no evidence demonstrating that the device
“comprises a catheter” as required by claim 11.
Claim 31
We recognize, but find unpersuasive, Appellants argument that
“Figure 2D of Colliou, reproduced below, illustrates that the proximal end of
the needle 524 (which the Examiner characterized as a ‘fixation element’) is
not within anything that could reasonably be considered a positive pressure
line” (App. Br. 14—15). As we have already discussed, the portion of needle
524 that passes through the opening in elongated body 520 proximal to the
vacuum chamber reasonably satisfies the requirement of a “positive pressure
line” (FF 7).
Claims 12, 13, and 17
3 We note that we agree with the Examiner (see Ans. 5) and disagree with
Appellants (see App. Br. 14) that reliance on Figure 11 as a further
description of Figure 1 is appropriate in this anticipation rejection, but we
disagree that Figure 11 anticipates claim 9.
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Application 11/591,294
Appellants rely upon overcoming claim 1 (see App. Br. 15). Because
we did not find these arguments persuasive for claim 1, we do not find them
persuasive for these claims.
Claim 14
Appellants contend
[cjlaim 14 recites both an elongated body and an introducer,
and both a vacuum channel and an introducer vacuum channel.
Accordingly, Colliou’s endoscope 110 cannot be used to
anticipate both the elongated body of claim 12 and the
introducer of claim 14, and Colliou’s elongate tube 558 cannot
be used to anticipate both the vacuum channel of claim 12 and
the introducer vacuum channel of claim 14.
(App. Br. 16).
The Examiner responds that “Colliou teaches the use of an introducer
channel #112 with respect to the implantation of the prior embodiments
when describing the handle design” and “the introducer as depicted in
Fig[ures] 18A/B would require some sort of vacuum channel/connection in
order to functionally equip the endoscope with a vacuum during insertion
and use” (Ans. 6—7).
We find the Examiner has the better position. Colliou teaches
“vacuum pipe 528 has an open proximal end 529 for coupling through an
elongate tube to a vacuum source” (FF 2). Colliou also teaches that the
endoscope that introduces the device “includes an aspiration/instrument
channel 112 [that] may be used for instruments if not otherwise required in a
procedure” (FF 9). Consequently, Colliou is reasonably understood as
teaching that the vacuum source required by the vacuum pipe in the elongate
body may be supplied by an aspiration channel within the introducer (FF 2,
9).
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Application 11/591,294
Claim 15
Appellants contend the “Examiner failed to address the limitations of
claim 15. There is no indication as to what the Examiner considers to be a
first marker or a second marker” (App. Br. 16).
The Examiner responds that “|[ ]93 of Colliou is clear in describing
markers located on the device to identify its location and orientation” (Ans.
7).
Appellants, in the Reply Brief, respond
even if the radiopaque material of Colliou may be characterized
as a marker of Appellant’s claim 15, [JColliou does not disclose
or suggest “a first marker on the elongated body and a second
marker on the introducer to align with the first marker on the
elongated body to align the vacuum inlet of the elongated body
with the introducer vacuum channel” as recited in Appellant’s
claim 15.
(Reply Br. 16).
We find that Appellants have the better position because claim 15
requires a specific relationship between the markers and Colliou only
teaches the general use of markers (FF 10). Because the instant rejection is
for anticipation, not obviousness, we simply note that the Examiner has not
established that Colliou teaches the specific locations of the markers on the
introducer to align with the elongated body, and do not address whether this
limitation would have been obvious.
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Claim 18
Appellants contend “nothing in Colliou discloses ‘an electrical
stimulator coupled to [a] proximal end of [a] lead and configured to deliver
electrical stimulation to [a] target therapy delivery site via [] at least one
electrode of the lead,’ as recited in claim 18” (App. Br. 17).
The Examiner responds that “Colliou teaches an external controller
providing external stimulation signals which would necessarily place it
proximal to the implanted device - i.e. H 16 and 19” (Ans. 7).
We find the Examiner has the better position. Colliou teaches
“stimulation electrodes provide stimulation either by way of a
preprogrammed pulse generator or one that is programmed or revised when
the device is implanted in the stomach” (FF 11). Colliou further teaches, as
already discussed, “leads extending into the housing” (FF 5) and a
“stimulator device” (FF 8). Therefore, Colliou reasonably teaches the
structural elements required by claim 18 of a lead, an electrode and an
electrical stimulator that delivers electrical stimulation (FF 5, 8, 11).
Claim 19
Appellants rely upon overcoming claims 9 and 11 (see App. Br. 17—
18). Because we did not find these arguments persuasive for claims 9 and
11 as discussed above, we do not find them persuasive for claim 19.
Claim 20
Appellants contend “Colliou also fails to disclose or suggest the
system of claim 20, which depends from independent claim 12 and recites
that ‘the medical device comprises at least one of a sensor to sense a
parameter of a patient, an electrical stimulator or a fluid delivery device’”
(App. Br. 18).
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We find this argument unpersuasive because Colliou is replete with
disclosures describing sensors for parameters of patients including teaching
that “[vjarious sensors may be used, e.g., a pressure sensor, a strain gauge, a
temperature sensor, a pH monitor, a sensor for sensing muscle contractions
of the stomach, a sensor for sensing electrical parameters of the stomach
wall, a glucose monitoring, or redox” (FF 12).
Claim 21
Appellants rely upon overcoming claim 1 (see App. Br. 18). Because
we did not find these arguments persuasive for claim 1 as discussed above,
we do not find them persuasive for claim 21.
Claim 22
Appellants rely upon overcoming claim 14 (see App. Br. 19).
Because we did not find these arguments persuasive for claim 14 as
discussed above, we do not find them persuasive for claim 22 (see FF 9,
citing Colliou’s discussion of both an endoscope that serves as an introducer
for the elongated member and overtube that serves as an introducer for the
endoscope).
Claims 25
Appellants contend “Colliou also fails to disclose or suggest the
method of claim 25, which depends from independent claim 21 and recites
‘coupling the implantable medical elongated member to a medical device,
the medical device delivering a therapy to the target therapy delivery site via
the implantable medical elongated member’” (App. Br. 19).
The Examiner responds “the elongated member of Colliou is coupled
to some sort of controller and electrical stimulator to deliver and control the
target stimulation and operation of the device” (Ans. 8).
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We find the Examiner has the better position. Colliou specifically
teaches “stimulation electrodes provide stimulation either by way of a
preprogrammed pulse generator or one that is programmed or revised when
the device is implanted in the stomach” (FF 11). Colliou’s teaching
reasonably satisfies the requirement for therapy, here by electrical
stimulation, where the pulse generator is delivered to the elongated member
located in the stomach (see FF 11).
Claim 26
Appellants rely upon overcoming claim 25 (see App. Br. 20).
Because we did not find these arguments persuasive for claim 25 as
discussed above, we do not find them persuasive for claim 26 because
Colliou teaches an electrical stimulator and electrical sensors (FF 11, 12).
Claim 28
Appellants rely upon overcoming claim 1 (see App. Br. 20). Because
we did not find these arguments persuasive for claim 1 as discussed above,
we do not find them persuasive for claim 28.
Claim 29
Appellants contend the “Examiner has acknowledged in the rejection
of claims 4, 5, and 16, discuss infra, that Colliou does not disclose first and
second vacuum cavities. Thus, the Examiner has not shown that Colliou
anticipates claim 29, which recites first and second vacuum cavities” (App.
Br. 20-21).
The Examiner responds “the vacuum cavities are not required to be
distinct or separate cavities, but rather can be met by simply labelling two
different portions of the cavity” (Ans. 9).
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We find Appellants have the better position. Claim 29 reasonably
requires “a first vacuum cavity” and “a second vacuum cavity” and we agree
that “[s]uch an interpretation is overly broad and inconsistent with
Appellant’s specification” (Reply Br. 18 (footnote omitted)). We therefore
agree with Appellants that claim 29 is reasonably interpreted as requiring ‘“a
first vacuum cavity [and] a second vacuum cavity, ’ not a first portion of a
vacuum cavity and a second portion of the vacuum cavity” (id.).
Conclusions
The evidence of record supports the Examiner’s conclusion that
Colliou anticipates claims 1, 6—9, 12—14, 17—22, 25, 26, 28, and 31.
The evidence of record does not support the Examiner’s conclusion
that Colliou anticipates claims 11, 15, and 29.
B. 35 U.S.C. § 103(a) oyer Colliou
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Colliou renders the rejected
claims obvious?
Claims 4 and 5
Appellants contend
the addition of a second vacuum cavity is not a mere
duplication of parts. For example, there are issues with whether
additional vacuum channels may be needed, whether, vacuum
pressure can be applied selectively or not, and with the fact that,
at least for claim 5, a single fixation element enters both
cavities.
(App. Br. 22).
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The Examiner responds “separating a single vacuum cavity into two
separate cavities while performing the same function as a single cavity
requires no additional components, nor would it require anything more than
a mere duplication of a basic cavity design well known and understood in
the art” (Ans. 9).
We find that the Examiner has the better position. “It is well settled
that the mere duplication of parts has no patentable significance unless a
new and unexpected result is produced.” In re Harza, 274 F.2d 669, 671
(CCPA 1960). Just as the use of additional ribs in the concrete divider of
Harza was an obvious duplication of parts without any evidence of a
secondary consideration {Harza, 274 F.2d at 671), we agree with the
Examiner that the use of two or more vacuum cavities for fixation of
multiple portions of the stomach in Colliou is also an obvious duplication of
parts which is “the predictable use of prior art elements according to their
established functions.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 417
(2007). Appellants provide no evidence of any secondary consideration
regarding the use of two vacuum cavities or a single fixation element that
enters both cavities.
Claim 16
Appellants rely upon overcoming claims 4 and 5 (see App. Br. 22).
Because we did not find these arguments persuasive for claim 4 and 5 as
discussed above, we do not find them persuasive for claim 16.
Claims 23 and 24
The Examiner finds “it would have been obvious to one of ordinary
skill in the art at the time the invention was made to modify the treatment
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location of Igo [sic ?]4 in order to treat a patient requiring therapy at a target
site other than the pericardial tissue” (Final Act. 5).
Appellants contend
Colliou has not been shown to have rendered obvious the
methods of claims 23 and 24, which recite “inserting the
introducer into the patient comprises subcutaneously
introducing the introducer proximate to a peripheral nerve of
the patient” (claim 23) and “inserting the introducer proximate
to the peripheral nerve comprises positioning the introducer
substantially transversely across an occipital nerve” (claim 24).
(App. Br. 23).
The Examiner responds “subcutaneously introducing requires that the
device is introduced under the skin of the patient. The examiner considers
anything internal to the patient, especially a device capable of reaching the
stomach of a patient, meeting the claimed limitation of being subcutaneously
introduced” (Ans. 10).
We find that Appellants have the better position. While Colliou
discusses “subcutaneous” implantation (see Colliou 1 8), the Examiner does
not identify a reason to implant the particular device of the claims proximate
to a peripheral nerve or transverse an occipital nerve. An invention
“composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” KSR, 550 U.S. at 418. Here, the Examiner has not established
any reason to implant the device in the location recited by claims 23 and 24
4 We note that the Examiner appears to refer to an additional reference “Igo”
but does not cite the reference in the statement of rejection or identity any
disclosure from the reference.
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Application 11/591,294
based on Colliou, such as a technology-independent reason, or even any
common sense reason.
Conclusions
The evidence of record supports the Examiner’s conclusion that
Colliou renders claims 4, 5, and 16 obvious.
The evidence of record does not support the Examiner’s conclusion
that Colliou renders claims 23 and 24 obvious.
SUMMARY
In summary, we affirm the rejection of claims 1, 6—9, 12—14, 17—22,
25, 26, 28, and 31 under 35 U.S.C. § 102(b) as anticipated by Colliou.
Claims 3, 10, and 30 fall with claim 1.
We reverse the rejection of claims 11, 15, and 29 under 35 U.S.C.
§ 102(b) as anticipated by Colliou.
We affirm the rejection of claims 4, 5, and 16 under 35 U.S.C.
§ 103(a) as obvious over Colliou.
We reverse the rejection of claims 23 and 24 under 35 U.S.C. § 103(a)
as obvious over Colliou.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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