Ex Parte Taepke et al

Patent Trial and Appeal Board

Sep 5, 2018

13586572 (P.T.A.B. Sep. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/586,572 08/15/2012
80584 7590
Medtronic, Inc.
710 Medtronic Parkway
MS: LC340
Minneapolis, MN 55432
09/07/2018
FIRST NAMED INVENTOR
Robert T. Taepke II
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.
P0040489.USU2/ll ll-377 6379
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
09/07/2018 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT T. TAEPKE II, YA GUO, and JOSEPH D. BERGLUND
Appeal2017-008285 1
Application 13/586,572
Technology Center 3700
Before RICHARD M. LEBOVITZ, 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 devices and
methods for securing an implantable medical device within a blood vessel.
The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We affirm in part.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
claims 1---6, 8-13, 15, 21-26, 28-33, 35, and 40-43 under 35 U.S.C.
1 Appellants state that the real party in interest is "Medtronic, Inc. of
Minneapolis, Minnesota, the assignee of record, and Medtronic plc of
Dublin, Ireland, the ultimate parent entity of Medtronic, Inc." Appeal Br. 3.
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§ I03(a) for obviousness over Porat2 and Stinson. 3 Ans. 2-12. 4
Claims 1, 21, and 40 are the independent claims on appeal, and read
as follows:
Claim 1: An assembly comprising:
an implantable medical device (IMD) comprising a
housing containing electronics; and
a fixation device for the IMD, the fixation device
compnsmg:
a temporary fixation mechanism connected to the
IMD, wherein the temporary fixation mechanism comprises a
biodegradable material and is configured to anchor the IMD
within a blood vessel of a patient after implantation until the
temporary fixation mechanism biodegrades; and
a chronic fixation mechanism overlaying a first
side of the IMD housing, wherein the chronic fixation
mechanism is configured to promote tissue growth along the
first side of the IMD housing that anchors the IMD within the
blood vessel before the temporary fixation mechanism
biodegrades such that the chronic fixation mechanism is
configured to more permanently anchor the IMD to the blood
vessel than the temporary fixation mechanism,
wherein the temporary fixation mechanism is
configured to anchor the IMD within the blood vessel such that
the first side of the IMD housing, including the chronic fixation
mechanism, is arranged against endothelium of the blood
vessel.
2 US 6,277,078 Bl (issued Aug. 21, 2001).
3 EP O 923 912 A2 (published June 23, 1999).
4 The Examiner lists claim 7 among the rejected claims. Ans. 2. However,
the Final Action from which this appeal was taken indicates that claim 7 has
been withdrawn from consideration. Final Act. 1 ( entered July 14, 2016).
Also, claim 7 is not addressed in the body of the rejection. See Ans. 2-12.
Accordingly, we do not consider claim 7 as part of the appealed rejection.
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Claim 21: An implantable medical device (IMD) comprising:
a body containing electronics;
a fixation device connected to the body of the device,
wherein the fixation device comprises:
a temporary fixation mechanism comprising a
biodegradable material and configured to anchor the IMD
within a blood vessel of a patient after implantation until the
temporary fixation mechanism biodegrades; and
a chronic fixation mechanism overlaying a first
side of the body and configured to promote tissue growth along
the first side of the body that anchors the IMD within the blood
vessel of the patient before the temporary fixation mechanism
biodegrades such that the chronic fixation mechanism is
configured to more permanently anchor the IMD to the blood
vessel than the temporary fixation mechanism,
wherein the temporary fixation mechanism is
configured to anchor the IMD within the blood vessel such that
the first side of the body including the chronic fixation
mechanism is arranged against endothelium of the blood vessel.
Claim 40: A method of securing an implantable medical
device (IMD) within the body of a patient, the method
compnsmg:
arranging the IMD at a target location within a blood
vessel of the patient, wherein the IMD comprises a housing
containing electronics;
temporarily anchoring the IMD within the blood vessel
with a temporary fixation mechanism comprising a
biodegradable material, wherein the temporary fixation
mechanism is configured to secure the IMD within the blood
vessel after implantation until the temporary fixation
mechanism biodegrades; and
chronically anchoring the IMD within the blood vessel
with a chronic fixation mechanism overlaying a first side of the
IMD housing and configured to promote tissue growth along
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the first side of the IMD housing that secures the IMD within
the blood vessel before the temporary fixation mechanism
biodegrades, wherein the chronic fixation mechanism is
configured to more permanently anchor the IMD to the blood
vessel than the temporary fixation mechanism,
wherein the temporary fixation mechanism is configured
to anchor the IMD within the blood vessel such that the first
side of the IMD housing including the chronic fixation
mechanism is arranged against endothelium of the blood vessel.
Appeal Br. 30, 33, 37.
STANDARD OF REVIEW
As stated inJn 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.
DISCUSSION
The Examiner's Prima Facie Case
The Examiner found that Porat describes an implantable device for
deployment in a blood vessel, the device having almost all of the features
and steps recited in the rejected claims, including the use of a stent as a
fixation mechanism for the implanted device. See Ans. 2-12.
The Examiner found, however, that Porat differs from claims 1, 21,
and 40, in that Porat "is silent with regards to the detail of the stent." Id. at 3
( discussing Porat in relation to claim 1 ); see also id. at 9 (same finding as to
claim 21 ); id. at 11 (same finding as to claim 40).
As evidence that, despite that difference, the devices of claims 1 and
21, and the process of claim 40, would have been obvious to an ordinary
artisan, the Examiner cited Stinson as describing a stent composed of
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temporary and chronic fixation mechanisms encompassed by claims 1, 21,
and 40. Id. at 3, 9, 11-12.
Based on the references' combined teachings, the Examiner reasoned
that an ordinary artisan would have considered it obvious "to modify the
assembly of Porat so that the stent comprises any composition of a stent
known in the art, including that of Stinson's stent (with both a chronic and a
temporary fixation mechanism)." Id. at 3--4 ( discussing claim 1 ); see also
id. at 10 (same rationale as to claim 21); id. at 12 (adopting same rationale as
to claim 40).
As to the requirement in claims 1, 21, and 40 for the chronic fixation
mechanism to overlay a first side of the device housing and promote tissue
growth on that side, the Examiner determined that the chronic fixation
mechanism "would be obviously located along the endothelial, outer side of
the sensor housing: if located on the inner, luminal side of the sensor
housing the chronic fixation mechanism would interfere with the function of
the sensor which is designed to measure the flow of blood through the artery
lumen[]." Id. at 4 ( discussing claim 1 ); see also id. at 10 ( same rationale as
to claim 21); id. at 12 (same rationale as to claim 40).
The Examiner found that the device suggested by the combination of
Porat and Stinson also differed from the rejected claims in that, as to claims
12 and 13, the references are "silent with regards to the sheet being a
rectangle with the sheet having four edges." Id. at 7; see also id. at 10
(adopting same rationale as to claims 32 and 33).
The Examiner reasoned that an ordinary artisan would have
considered it obvious to modify the shape of Stinson's chronic fixation
mechanism "to include a sheet of rectangular material ( e.g. there may be
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more than one rectangular sheet to comprise the entire chronic fixation
mechanism and cover the entirety of the temporary fixation mechanism as is
shown by Stinson; the material may be separated into different
pieces/shapes) .... " Id. at 8.
Id.
Further, the Examiner contended,
it has been held by the courts that a change in shape or
configuration, without any criticality in operation of the device,
is nothing more than one of numerous shapes that one of
ordinary skill in the art will find obvious to provide based on
the suitability for the intended final application. See In re
Dailey, 149 USPQ 47 (CCPA 1976). It appears that the
disclosed device would perform equally well shaped as
disclosed by Stinson.
Analysis
Claims 1, 21, and 40
Having carefully considered all of 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 claims 1, 21, and 40. In particular,
Appellants do not persuade us (see Appeal Br. 7-9, 13-16; Reply Br. 5---6)
that the cited references fail to provide a sufficient reason for using Stinson's
stent device as the fixation mechanism for Porat's implantable device.
Porat discloses an "intrabody implantable system for long-term, real
time monitoring of at least one parameter associated with heart
performance." Porat, abstract.
Porat's system includes a sensor "implantable in a blood vessel
supporting blood flow into or out of the heart ... [which] serves for
collecting information pertaining to a pressure and a flow within that
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[ vessel]. According to a preferred embodiment of the present invention,
sensor 106 is implanted in the pulmonary artery." Id. at 10:44--50.
Porat discloses the importance of securely anchoring the sensors to the
desired location within the blood vessel:
It will be appreciated that sensors 102 and 106 must be
securely anchored to the tissue into which they are implanted
since unwanted dislodgment and separation from the tissue can
lead to blood vessel blockage and/or damage which can pose a
serious health hazard to the individual. As such, sensors 102
and 106 are preferably provided with various anchoring
mechanisms including, but not limited to, various stud and
screw configurations, such that when implanted within the
tissue, no accidental dislodgment of these sensors occurs.
Id. at 10:58---67.
As the Examiner found, Porat discloses that a stent also may be used
as the implanted sensor's anchoring mechanism:
According to another preferred embodiment of the
present invention and as is specifically shown in FIGS. 11-13
sensors 106 are integrally formed with or attached to a stent
105. Stent 105 is configured so as to be positionable within
artery 108, using conventional stent deployment techniques. It
will be appreciated that any assembly which can be used to
position sensors 106 within an artery can be utilized by the
present invention.
Id. at 11 :27-34.
Porat does not disclose that its stent includes both a temporary
fixation mechanism and a chronic fixation mechanism, as required by
Appellants' claims 1, 21, and 40.
As the Examiner found, however, Stinson discloses a "a stent-graft
( 100) with a bioabsorbab le structure ( 110) and a permanent graft
(120) for luminal support and treatment of arterial fistulas, occlusive disease,
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and aneurysms." Stinson, abstract.
Stinson explains that its "stent-graft" is a generally tubular structure
that incorporates both bioabsorbable and permanent elements. Id. ,r 14
("[T]he invention relates to a stent-graft including a bioabsorbable structural
support including a tubular body having open ends, a sidewall structure
having openings therein, and an inside and an outside surface and a
permanent graft having an inside and outside surface.").
Stinson discloses that its device is useful for implantation in an artery
to address a number of disorders or defects. Id. ,r 20 ("The body vessel may
be an artery. The permanent graft portion may be replaced over time by a
composite wall including natural tissue and the permanent graft portion.
The defect may be at least one of an aneurysm, fistula, occlusive disease, or
recurrent occlusive disease.").
Stinson explains that the "stent" portion of its "stent-graft" is a
temporary bioabsorbable support structure that provides initial bracing to
keep the body lumen open, whereas the "graft" portion of the stent-graft is
intended to remain permanently in the patient, promoting tissue ingrowth, as
required by Appellants' claims 1, 21, and 40:
The support function of the bioabsorbable stent 110
portion of the stent-graft 100 is temporary while the function of
the graft 120 is generally permanent. For example, after
bracing the lumen open for a period of time necessary for tissue
formation on and within the stent-graft 100, the stent 110 is
gradually absorbed and vessel compliance and functional
stresses are generally transferred to the new tissue. After
implantation, the bioabsorbable stent 110 bioabsorbs over time
and the generally compliant graft 120 and natural tissue remain
in the vessel at the treatment site and form a composite vessel
wall.
Id. ,r 25; see also id. ,r 5 ("The graft is designed to remain permanently
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implanted in the body, however, small amounts of degradation may occur to
the graft over time in the body environment.").
Stinson explains that the temporary bioabsorbable stent portion of its
stent-graft, as well as the permanent graft portion of its stent-graft, may be
formed of filaments, fibers, or strands of a variety of materials, and that the
permanent graft portion may be either outside, inside, or interwoven with,
the temporary bioabsorbable stent portion of the device. Id. ,r,r 26-28.
Thus, to summarize, as discussed above Porat discloses a stent as a
preferred mechanism for anchoring its blood pressure/flow sensor within an
artery (Porat, 11 :27-34), and emphasizes the importance of permanently
anchoring its sensor within the artery (see id. at 10:58---67). As also
discussed above, Stinson discloses a stent-type device suitable for
implantation in an artery (Stinson ,r 20), the device having a functional
portion (i.e., a graft) being repeatedly described as permanently maintaining
its implanted location (see, e.g., id. ,r,r 5, 14, 20, 25), which is precisely the
attribute Porat emphasizes as being crucial to securely maintaining its
sensors in the blood vessel.
Accordingly, viewing the references in combination, Stinson
describes precisely the type of device taught by Porat as a preferred
anchoring mechanism for its sensor-a stent-and Stinson's stent possesses
the precise property desired by Porat for its anchoring stent mechanism-the
capacity to deliver a functional object to remain permanently at its implanted
location within an artery. Appellants, therefore, do not persuade us that the
Examiner erred in finding that an ordinary artisan had a good reason for, and
a reasonable expectation of success in, using Stinson's device as the
anchoring mechanism for Porat's sensor.
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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 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 elements
recited in claims 1, 21, and 40.
We acknowledge, as Appellants contend (Appeal Br. 8-9), that
Stinson uses its device to treat arterial disorders or defects, rather than
permanently anchoring other implantable devices within the artery. As
noted above, however, Stinson repeatedly describes its device as
permanently maintaining its implanted location (Stinson ,r,r 5, 14, 20, 25),
which is precisely the attribute Porat emphasizes as being crucial to its
anchoring device.
Appellants do not persuade us, therefore, that Stinson's device lacks
the permanence desired by Porat. Moreover, when Stinson is properly
viewed in combination with Porat's teachings regarding the importance of
secure and permanent implantation, we are persuaded that an ordinary
artisan had a good reason for, and a reasonable expectation of success in,
using Stinson's device as Porat's anchoring and delivery mechanism.
Further, because the methods of both Porat and Stinson involve the
implantation of stents in arteries, Appellants do not persuade us that the two
references are "directed to entirely different fields of endeavor." Appeal Br.
8.
Because the purpose of Porat's sensor is to measure blood flow and
pressure (Porat 10:46-48), we also discern no error in the Examiner's
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determination (Ans. 4, 10, 12) that an ordinary artisan would have placed
Porat's sensor on the inner luminal surface of Stinson's stent-graft, so as to
expose the sensor directly to the blood flowing through the artery. Because
this placement results in the permanent portion of Stinson's stent-graft
overlaying the side of the sensor that faces the blood vessel wall, Appellants
also do not persuade us (see Appeal Br. 9--10; Reply Br. 9--10) that the
Examiner erred in finding that using Stinson's stent-graft would result in the
configuration required by claims 1, 21, and 40, in which the chronic fixation
mechanism overlays a side of the implanted device, and arranges that side of
the implanted device, and overlaying chronic fixation mechanism, against
the endothelium of the blood vessel.
We acknowledge, but are unpersuaded by, Appellants' contention
(Appeal Br. 10-11) that placing Porat's sensor on the inner luminal surface
of Stinson's stent-graft would compromise the compressibility of the stent-
graft, to the extent that an ordinary artisan would have been dissuaded from
placing the sensor on the inner luminal surface. Appellants identify no
specific evidence or teaching in either reference suggesting that placing the
anchor/sensor combination in a pulmonary artery as directed by Porat (Porat
10:46-48) requires navigating the device through vessels of a size
sufficiently small to encumber the deployment of the posited stent-sensor
combination. To the contrary, Porat's express teaching of deploying a stent
and attached sensor (id. at 11 :27-34 and Fig. 13) supports the Examiner's
determination that the posited combination of Porat's sensor and Stinson's
stent-graft would be suitable for implantation in an artery in the manner
taught by Porat.
In sum, for the reasons discussed, Appellants do not persuade us that
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the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to claims 1, 21, and 40. Accordingly, we
affirm the Examiner's rejection of those claims over Porat and Stinson.
Because they were argued in the same groupings as claims 1, 21, and 40,
claims 3---6, 8, 21, 23-26, 28, and 41--43 fall with claims 1, 21, and 40.
Claims 2 and 22
Claim 2 reads as follows
Claim 2: The assembly of claim 1, wherein the temporary
fixation mechanism comprises a biodegradable stent configured
to be connected to at least one of the first side or a second side
of the IMD housing such that the stent is configured to push the
first side of the IMD housing, including the chronic fixation
mechanism, against the endothelium of the blood vessel.
Appeal Br. 30.
Claim 22 reads as follows:
Claim 22: The IMD of claim 21, wherein the temporary
fixation mechanism comprises a biodegradable stent configured
to be connected to at least one of a first side or a second side of
the body of the IMD generally opposite the first side such that
the stent is configured to push the first side of the body of the
IMD including the chronic fixation mechanism against the
endothelium of the blood vessel.
Id. at 34.
As noted above, Stinson discloses that the temporary bioabsorbable
stent component of its stent-graft initially urges the permanent graft portion
against the wall of the vessel in which the device is implanted, allowing
tissue ingrowth into the permanent graft portion of the device:
[ A ]fter bracing the lumen open for a period of time necessary
for tissue formation on and within the stent-graft 100, the stent
110 is gradually absorbed and vessel compliance and functional
stresses are generally transferred to the new tissue. After
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implantation, the bioabsorbable stent 110 bioabsorbs over time
and the generally compliant graft 120 and natural tissue remain
in the vessel at the treatment site and form a composite vessel
wall.
Stinson ,r 25; see also id. ,r 20 ("The bioabsorbable structure portion
provides temporary force to the body vessel and the permanent graft portion
provides a permanent synthetic wall at the area of the defect in the body
vessel and is receptive to growth of the natural tissue therein and thereabout
.... ").
Given these disclosures, we agree with the Examiner that, when
attached to Porat's sensor as suggested by the cited references' combined
teachings discussed above, it would have been obvious that the temporary
stent portion of Stinson's stent-graft would push the permanent graft portion
of the device against the wall of the artery into which the device was
implanted, and the attached sensor when Stinson's device is used as the
delivery mechanism, , thus meeting the requirements of claims 2 and 22.
We are not persuaded by Appellants' contentions (Appeal Br. 17-19,
24; Reply Br. 10-11) that because the Examiner's posited position of the
sensor is within the central lumen of Stinson's stent-graft, the sensor would
be pulled against the vessel wall, rather than pushed, as claims 2 and 22
require. Neither claim 2 nor 22 recites a specific structural configuration
that excludes the Examiner's posited positioning of the sensor within the
central lumen of Stinson's stent-graft.
Moreover, in using the term "push" in relation to the general action of
urging the sensor and overlayed chronic fixation mechanism against the
vessel wall, Appellants' Specification describes the same general outward
biasing taught in Stinson. See Spec. ,r 65 ("[T]he biasing of temporary
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fixation mechanism may function to push sensor 3 8 and chronic fixation
mechanism 103 against the endothelium of pulmonary artery 39 ( or another
vessel in which the sensor 38 is placed) when in an expanded state.").
Because Appellants' arguments, for the reasons discussed, do not
persuade us that the preponderance of the evidence fails to support
Examiner's conclusion of obviousness as to claims 2 and 22, we affirm the
Examiner's rejection of those claims over Porat and Stinson.
Claims 9, 10, 15, 29, 30, and 35
Claim 9 reads as follows:
Claim 9: The assembly of claim 1, wherein the chronic
fixation mechanism comprises a sheet of tissue growth
promoting material configured to be connected to the IMD
housing and configured to promote tissue growth into the
material to secure the IMD within the blood vessel of the
patient before the temporary fixation mechanism biodegrades.
Appeal Br. 32.
Claim 29 reads as follows:
Claim 29: The IMD of claim 21, wherein the chronic fixation
mechanism comprises a sheet of tissue growth promoting
material configured to be connected to the body of the IMD and
configured to promote tissue growth into the material to secure
the IMD within the blood vessel of the patient before the
temporary fixation mechanism biodegrades.
Id. at 35.
As the Examiner found, Stinson discloses that the permanent graft
portion of its stent-graft, which as discussed above "is receptive to growth of
the natural tissue therein" (Stinson ,r 20), "may be a film, sheet, or tube" (id.
,r 14 ). Appellants, therefore, do not persuade us that the Examiner erred in
finding that Stinson would have suggested using a sheet as the permanent
graft portion of its stent-graft, to which Porat's sensor would be attached.
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Appellants' Specification, moreover, teaches that a sheet may be a
curved structure. See Spec. ,r 67 ("In the example of FIG. 6A, the two edges
of chronic fixation mechanism 103 are attached to the body of sensor 3 8
such that the rectangular sheet is pulled taut to lay on the outer surface of
the sensor.") (emphasis added); see also Fig. 6A (showing curved sheet of
chronic fixation mechanism 103 pulled taut to lay on curved outer surface of
sensor 38). Appellants, therefore, do not persuade us (see Appeal Br. 19--20,
25; Reply Br. 12, 17) that the term "sheet" in claims 9 and 29 excludes the
curved sheets of material used in Stinson's stent-graft.
Because Appellants' arguments, for the reasons discussed, do not
persuade us that the preponderance of the evidence fails to support
Examiner's conclusion of obviousness as to claims 9 and 29, we affirm the
Examiner's rejection of those claims over Porat and Stinson. Because they
were argued in the same groupings as claims 9 and 29, claims 10, 15, 30,
and 35 fall with claims 9 and 29.
Claims 11 and 31
Claim 11 recites "[t]he assembly of claim 9, wherein the sheet of
tissue growth promoting material comprises a sheet of flexible fabric."
Appeal Br. 32.
Claim 31 recites "[t]he IMD of claim 29, wherein the sheet of tissue
growth promoting material comprises a sheet of flexible fabric." Id. at 3 5.
As the Examiner found, Stinson discloses that the tissue ingrowth-
promoting permanent graft portion of its stent-graft may be formed from
"[ s ]trands [which] can be woven, braided, or knitted into a tubular fabric
shape." Stinson ,r 47; see also id. ,r 48 (describing graft portion as "film or
sheet preferably formed in the shape of a tubular graft"); id. ,r 49 ( describing
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"exterior layer of stent-graft 100 as a textile sheeting or graft 120, formed of
multiple textile strands 42 and interwoven with one another").
We note, moreover, that Stinson describes the overall structure of its
device as being flexible. Id. ,r 3 ("The flexible nature and reduced radius of
the compressed stent-graft enables it to be delivered through relatively small
and curved vessels.").
Given these disclosures, Appellants do not persuade us that the
Examiner erred in determining that the cited combination of references
would have suggested using a sheet of flexible fabric as the tissue growth
promoting material for anchoring Porat's device to the interior of an artery.
We acknowledge, as Appellants contend (Appeal Br. 20-21, 26;
Reply Br. 13-14), that Appellants' Specification includes a discussion of the
flexibility properties a chronic fixation mechanism may have. See Spec. 68
("In examples including a flexible fabric chronic fixation mechanism, such
mechanism may not conform to a particular shape, but may, instead, be
shaped based on external forces, e.g. gravity and/or tissue or fluids within
the body of the patient.").
We are not persuaded, however, that the Specification's disclosure of
the potential flexibility properties of a chronic fixation mechanism
constitutes a specific definition of the term "flexible" or "flexible fabric"
that excludes from claims 11 and 31 materials having the flexibility taught in
Stinson. See In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004) ("[A]bsent
claim language carrying a narrow meaning, the PTO should only limit the
claim based on the specification ... when [it] expressly disclaim[ s] the
broader definition.").
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In sum, because Appellants' arguments, for the reasons discussed, do
not persuade us that the preponderance of the evidence fails to support
Examiner's conclusion of obviousness as to claims 11 and 31, we affirm the
Examiner's rejection of those claims over Porat and Stinson.
Claims 12, 13, 32, and 33
Claim 12 reads as follows:
Claim 12: The assembly of claim 9, wherein the sheet of
tissue growth promoting material comprises a rectangular sheet
of tissue growth promoting material defined by four edges, and
wherein a first edge is attached to the outer surface of the IMD
housing and a second edge generally parallel to and offset from
the first edge is attached to the outer surface of the IMD
housing.
Appeal Br. 32.
Claim 32 reads as follows:
Claim 32: The IMD of claim 29, wherein the sheet of tissue
growth promoting material comprises a rectangular sheet
defined by four edges, and wherein a first edge is attached to
the outer surface of the body of the IMD and a second edge
generally parallel to and offset from the first edge is attached to
the outer surface of the body of the IMD.
Id. at 35.
In this instance, we find that the preponderance of the evidence does
not support the Examiner's conclusion of obviousness. We acknowledge, as
the Examiner contends, that Stinson discloses that the permanent graft
portion of its stent-graft "may be a film, sheet, or tube." Stinson ,r 14.
We are not persuaded, however, that Stinson's disclosure that its
tissue growth promoting material may be in the form of a sheet would have
suggested the specific configuration of features required by Appellants'
claims 12 and 32, in which parallel edges of a rectangular sheet of material
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are attached to the implanted device. Specifically, the Examiner has not
identified any specific teaching in either reference suggesting the specific
arrangement of features required by claims 12 and 3 2. We, therefore,
reverse the Examiner's rejection of claims 12 and 32, as well as the rejection
of claims 13 and 33, which depend from claims 12 and 32, respectively.
SUMMARY
For the reason discussed, we affirm the Examiner's rejection of 1---6,
8-11, 15, 21-26, 28-31, 35, and 40-43 under 35 U.S.C. § 103(a) for
obviousness over Porat and Stinson.
For the reasons discussed, however, we reverse the Examiner's
rejection of claims 12, 13, 32, and 33 over those references.
TIME PERIOD
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
18