Ex Parte Kuhn et al

Patent Trial and Appeal Board

Sep 25, 2017

13955393 (P.T.A.B. Sep. 25, 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.
13/955,393 07/31/2013 Jonathan I. Kuhn C00002846.USU 1 6905
27581 7590 09/27/2017
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/27/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHAN I. KUHN, MICHAEL P. CAMPBELL,
VLADIMIR GRUBAC, KENNETH D. RYS,
RICHARD W. SWENSON, and CHARLES L. WILSON1
Appeal 2016-003464
Application 13/955,393
Technology Center 3700
Before RICHARD J. SMITH, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
implantable medical device, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM, but designate the affirmance as a new ground of
rejection.
1 Appellants identify the Real Party in Interest as Medtronic, Inc. (Appeal
Br. 2.)
Appeal 2016-003464
Application 13/955,393
STATEMENT OF THE CASE
The Specification states that “[a]n implantable medical device . . .
may include at least one tissue-penetrating fixation component configured to
hold the device at an implant location,” where such tissue-penetration
fixation component may be formed by a plurality of tine portions. (Spec.
1:17-19, 23-25.)
For purposes of illustration, Figure 3D from the Specification is
reproduced below:
FX§. 3D
Figure 3D of the Specification illustrates the delivery of an implantable
medical device 200 to the implant location via a delivery catheter 300,
wherein the tine portions 230 of a tissue-penetration fixation component
have pierced tissue T and achieved full penetration for purposes of holding
the device at the implant location. (Id. at 2:8—9, 3:4—6, 9-13.) The
Specification explains that tine portion 230 is elastic such that the “hook”
segment of the tine “relax[es] back toward [a] pre-set curvature” once
deployed within the tissue. (Id. at 3:6—8.)
With respect to the tissue-penetration fixation component, the
Specification states that “there is still a need for new configurations of tine
portions for implantable devices . . . that may further enhance fixation.” (Id.
at 4:1—2.) According to the Specification, embodiments of the invention
include
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Application 13/955,393
one or more tine portions configured for increased strain relief during
the flexing thereof, either at initial implant (particularly in cases
where the retraction of penetrated tines is necessary for repositioning
the device), or when subject to cyclic loading during a chronic implant
of the fixated device, for example, within a beating heart. These tine
portions are, preferably, also configured to reduce the risk of tissue
trauma during the retraction thereof from the tissue, for example, for
repositioning.
(Id. at 4:6—14.) In particular, the Specification describes fixation devices
having tines with the relative dimensions depicted in Figure 6D, reproduced
below:
\
% shn.nz
Fie. 6D
Figure 6D of the Specification is a plan view of one of the tine portions
according to the invention, before the tine adopts its preset curvature. (Id. at
12:15—16.) The Specification states that the tapering along hook segment
631 shown in Figure 6D provides strain relief. (Id. at 12:15—22.) With
further reference to Figure 6D, the Specification states that “distal segment
632 of the tine portion 630 is terminated by a tissue-piercing tip 622 that has
a width W3, which is greater than second width W2 . . ., in order to be
atraumatic to tissue.” (Id. at 12:22—28.)
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Appeal 2016-003464
Application 13/955,393
Claims 16, 17, and 19-25 are on appeal. Claim 16 is illustrative and
reproduced below:
16. An implantable medical device comprising a
hermetically sealed housing and a tissue-penetrating fixation
component, the housing containing control electronics and a
power source of the device and defining a longitudinal axis of
the device, and the fixation component comprising a base
portion fixedly attached to the housing and at least one tine
portion extending therefrom, the at least one tine portion
comprising a hook segment and a distal segment terminated by
a tissue-piercing tip, the hook segment being pre-set to extend
along a curvature that encloses an angle of between 135 degrees
and 270 degrees, from a proximal end thereof, in proximity to
the base portion, to a distal end thereof, the distal segment
being pre-set to extend along a straight line that is tangent to the
distal end of the hook segment, from the distal end of the hook
segment to the tip, and the hook segment being elastically
deformable from the pre-set curvature to an open position; and
wherein:
the hook segment of the at least one tine portion tapers from
a first width thereof, in proximity to the proximal end
thereof, to a second width thereof, in proximity to the
distal end thereof, the second width being less than the
first width; and
the tissue-piercing terminal tip of the at least one tine
portion has a width that is greater than the second width
of the hook segment.
(Appeal Br. 13 (Claims App.).)
The Examiner rejects claims 16, 17, and 19—25 under 35 U.S.C. § 103
as obvious over Griswold2 and Osypka3 or Flach.4 (Ans. 2.)
2 Griswold, US 2011/0251660 Al, published Oct. 13, 2011.
3 Osypka, U.S. Patent No. 6,684,109 Bl, issued Jan. 27, 2004.
4 Flach et al., U.S. Patent No. 8,452,420 B2, issued May 28, 2013.
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Application 13/955,393
DISCUSSION
Issue
The Examiner finds that Griswold teaches substantially all of the
limitations of claim 16, including a “tine portion . . . comprising a hook
segment [that tapers from a first width to a second width] and a distal
segment terminated by a tissue piercing tip,” except that “Griswold does not
specifically disclose that the tissue piercing terminal tip of the tine has a
width that is greater than the second width of the hook.” (Final Act. 5—6.)
The Examiner finds that Osypka “teaches ... a similar device [having]
electrode portions [that] form tines . . ., [where] the tine/electrode arm[]
tapers and then has an increased diameter at the distal end” so that “they can
easily fit into the collapsed configuration into a catheter.” (Id. at 6.) The
Examiner further finds that Flach similarly teaches tines having an increased
diameter at the distal end. (Id. at 6—7.)
The Examiner concludes that a skilled artisan would have found it
obvious “to modify Griswold to include tines that have an increased
diameter at the distal most end,” as taught by Osypka and Flach, in order “to
have tines that can fit into a collapsed configuration prior to implant” and/or
“to utilize a fixation structure that causes as little trauma as possible.” (Id.)
Appellants argue that a skilled artisan would not modify Griswold in
the manner suggested by the Examiner, because the tines in Griswold are
intended to penetrate the tissue, and, “in order to facilitate entry into the
tissue,” the width of such tines would not increase at the tip. (Appeal Br. 5—
6.) Appellants argue that “the structures in Flach and Osypka are not
intended to penetrate tissue, and their design reflects this fact.” (Id. at 7.)
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Application 13/955,393
Appellants do not separately argue the claims. We therefore limit our
analysis to claim 16 as representative. 37 C.F.R. § 41.37(c)(l)(iv). The
issue with respect to this rejection is whether a preponderance of the
evidence of record supports the Examiner’s conclusion that claim 16 is
obvious over the combination of Griswold, Flach, and Osypka.
Findings of Fact
1. Griswold relates to “a fixation device for securing a medical
implant to tissue of the heart.” (Griswold 11.)
2. Figures 1 and 2 of Griswold are reproduced below:
FIG. 1
FIG. 2
Figures 1 and 2 of Griswold depict “side views in partial section of an
implant delivery system 100 for delivering and implanting implant 102.”
{Id. 116.)
3. Referring to Figures 1 and 2, Griswold teaches that “implant
102 includes ... a generally cylindrical. . . housing 108 that hermetically
encloses the pacing system’s electrical components, including a wireless
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Application 13/955,393
communication system and an internal power source.” (Id.) Griswold
further teaches that “[ijmplant 102 is retained in heart tissue via a fixation
device 110, which is shown in a delivery configuration in FIG. 1 and an
expanded, deployed configuration in FIG. 2,” where “implant 102 is
securely retained at the implantation site due to tines 114 of fixation device
110 being secured to the heart tissue 150.” (Id. at || 17, 23; see also id. at |
4 (the tines penetrate “or otherwise engage” body tissue once they are
released from the constraint of the outer sheath of the delivery device.)
Griswold teaches that, “[although implant 102 is illustrated in FIG. 2 as
being deployed generally perpendicular to the heart wall, the disclosure is
not so limited.” (Id. 123.) As shown in Figure 5 of Griswold, reproduced
below, variations in the angle of deployment could affect whether particular
portions of the device contacts heart tissue:
FIG. 5
Figure 5 of Griswold depicts a fixation device 410 in accordance of another
embodiment of Griswold’s invention.
4. Figure 3 of Griswold is reproduced below:
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Appeal 2016-003464
Application 13/955,393
110
i 11a
' n /'
'!
9 Y> „
§ r
/TV *
i! yJi v ^
112J
\ 116
FIG, 3
-114
Figure 3 of Griswold provides a perspective view of the fixation device of
FIG. 1 removed from the implant delivery system. (Id. 19.) With respect
to Figure 3, Griswold teaches that
fixation device 110 includes an annular collar 112 .. . and an
array of prongs or tines 114 that extend from an edge 118 of
collar 112. Fixation device 110 is formed of a shape memory
material and tines 114 are preset to splay outwardly from
implant 102 and to curve backwards toward collar 112. . . .
[The] tines 114 of fixation device 110 have a mechanical
memory to return to the expanded, deployed configuration
shown in FIGS. 2 and 3 from the straightened delivery
configuration shown in FIG. 1.
(Id. at 117.)
5. Griswold teaches that “[cjollar 112 [of the fixation device] is
prevented from sliding backward in a proximal direction due to the light
interference fit between collar 112 and housing 108.” (Id. 122.) Griswold
more generally teaches that “variations of stops, detents, tabs, snap fits,
notches and grooves” in collar 112 and/or housing 108 “may be used to
secure collar 112 against either distal or proximal movement along housing
108 once implant 102 is in its deployed configuration.” (Id.)
6. Flach relates to
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Application 13/955,393
[a]n implantable catheter lead or electrode lead [that] includes
an elongated flexible lead body with the fixation means
attached to the lead body, for the purpose of effecting fixation
of the catheter lead or electrode lead in a predetermined
position within a vessel or a bodily cavity of a patient.
(Flach Abstract.)
7. Figures 1 and 2 of Flach are reproduced below:
i
Fig. 1
i
Figures 1 and 2 of Flach depict views of an embodiment of Flach’s
stimulation electrode, with fixation means deactivated (Fig. 1) or activated
(Fig. 2). (Id. at 4:14—17.) Flach teaches that “[a] spreading element 17
composed of Nitinol is clamped onto lead body 7, which ... in the inactive
state shown in FIG. 1 is held by a tubular sleeve 19.” (Id. at 4:44^46.)
Flach further teaches that, “[i]n the state shown in FIG. 2,. . . tubular sleeve
19 . . . has been somewhat retracted, while spreading element 17 has
expanded and is now in the active state for fixation of electrode lead 1.” (Id.
at 4:52—55.) Flach teaches that in the embodiment shown in Figures 1 and 2,
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Application 13/955,393
“the ends of the arms 17b [are] designed in a widened spade-like shape to
reduce trauma to the bodily tissue contacted by them.” {Id. at 4:55—59.)
8. Figures 3a—3h of Flach are reproduced below:
Figures 3a—3h of Flach “illustrates various versions of spreading elements or
fixation means of a type shown for spreading element 17 of FIGS. 1 and 2.”
{Id. at 5:1—3.) With respect to these figures, Flach teaches that “[a]mong the
many commercially available designs, the operator can easily make a
selection that is optimally matched to a catheter lead or electrode lead to be
implanted in terms of a fixation that is reliable and at the same time causes
as little trauma as possible.” {Id. at 5:10-14.)
Analysis
Griswold teaches an implantable medical device (component 102 in
Fig. 2) comprising a hermetically sealed housing (component 108 in Fig. 2)
containing control electronics and a power source, where the housing defines
a longitudinal axis of the medical device. (FF1—FF3.) Griswold’s
implantable medical device contains a tissue-penetrating fixation component
(component 110 in Fig. 2), comprising a base portion (i.e., annular collar,
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Application 13/955,393
component 112 in Figs. 2 and 3) and at least one tine portion (component
114 in Figs. 2 and 3) extending from the base. (FF2—FF4.) Griswold
teaches securing the annular collar of the fixation device against either distal
or proximal movement along the housing once the implant is in its deployed
configuration. (FF5.)
Griswold also discloses the tines of its fixation device comprising a
hook segment and a distal segment terminated by a tissue-piercing tip, where
the tines have a preset configuration exemplified in Fig. 3, showing the hook
segment having a curvature enclosing an angle between 135 and 270 degrees
and tapering from the proximal end (i.e., the end near the base portion) to the
distal end, as well as a distal segment extending along the tangent to the
distal end of the hook. (FF2, FF4.) Griswold teaches that the hook segment
of its tines are elastically deformable from the preset curvature to a
straightened delivery configuration. (FF2—FF4.) Accordingly, we agree
with the Examiner that Griswold discloses all of the limitations of claim 16
except that it does not specifically disclose that “the tissue piercing terminal
tip of the at least one tine portion has a width that is greater than the second
width of the hook segment.” (Appeal Br. 13, claim 16.)
Appellants do not appear to dispute that Griswold discloses the
limitations of claim 16 discussed above. However, Appellants contend that
there is no reason for a skilled artisan to modify the fixation component in
Griswold such that the terminal tip of the tine has a width greater than the
tapered end of the tine’s hook segment. (Appeal Br. 5—12; Reply Br. 2—10.)
We are not persuaded. Flach teaches a fixation means for effecting
fixation of the catheter or electrode lead, comprising a spreading element
clamped onto the lead body and having multiple “arms” radially extending
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Application 13/955,393
from a clamping ring. (FF6.) Flach teaches that, in certain embodiments,
the ends of the arms are “designed in a widened spade-like shape to reduce
trauma to the bodily tissue contacted by them.” (FF7.) We agree with the
Examiner that it would be obvious for a skilled artisan, in light of Flach, to
widen the terminal tip of Griswold’s tines in order to reduce trauma to the
bodily tissue contacted by the tines.
Appellants argue that a skilled artisan would not have reason to
modify Griswold according to the disclosure in Flach, because Griswold’s
tines effect fixation by penetrating the tissue while Flach’s device contact
(e.g., press against) but are not intended to penetrate tissue. (Appeal Br. 7—
12; Reply Br. 2, 7—10.) We are not persuaded. While Griswold certainly
discloses that its tines are capable of penetrating tissue, not all of the tines in
Griswold’s fixation devices penetrate and/or remain in the tissue upon
deployment and may, for instance, contact tissues adjacent to the
implantation site. (FF3 (Griswold describing tines of its fixation device as
“penetrating] or otherwise engaging body tissue” after release from the
outer sheath of the delivery device and further describing embodiments (e.g.,
Fig. 5) where only some of the tines of the fixation device penetrate tissue at
the implantation site) (emphasis added).) In light of Flach’s disclosure that
widened terminal tips may reduce trauma to bodily tissue contacted by these
tips, we find that a skilled artisan would have reason to modify Griswold’s
fixation device to include such terminal tips to reduce trauma that may result
from tissues contacting exposed tips, even assuming arguendo that a
broadened terminal tip may create somewhat more trauma during initial
penetration.
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Application 13/955,393
In its Reply Brief, Appellants appear to suggest that Flach teaches
away from the claimed invention. (Reply Br. 7.) We are not persuaded.
“[A] reference will teach away when it suggests that the developments
flowing from its disclosures are unlikely to produce the objective of the
applicant’s invention.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371,
1380 (Fed. Cir. 2005) (citation omitted). Appellants have cited no evidence,
whether in Flach or elsewhere, that a tine with the broadened terminal tip
described in Flach would not be capable of penetrating tissue.
For the reasons discussed above, we affirm the Examiner’s rejection
of claim 16 as obvious over at least Griswold and Flach. Thus, we do not
address Appellants’ argument with respect to Osypka. See generally In
re Bush, 296 F.2d 491, 496 (CCPA 1961) (Board may rely on less than all of
the references applied by the Examiner). Claims 17 and 19—25, which are
not separately argued, fall with claim 16. 37 C.F.R. § 41.37(c)(l)(iv).
Because our affirmance relies upon facts and arguments that differ slightly
from those used by the Examiner,5 we designate our affirmance as setting
forth a new ground of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
5 Although the Examiner and this panel both find that a skilled artisan would
have had reason to modify the tines of Griswold’s fixation device with
Flach’s widened tips in order to lessen tissue trauma, the Examiner’s
arguments appear to depend at least in part on the contention that the device
of either Flach and/or Osypka in fact penetrates tissue. (Ans. 3—5.) In
contrast, our affirmance does not depend on such a contention.
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Application 13/955,393
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§§ 41.50(f), 41.52(b).
AFFIRMED: 37 C.F.R, § 41.50(B)
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