Ex Parte Goldman

Patent Trial and Appeal Board

Jun 5, 2017

12538402 (P.T.A.B. Jun. 5, 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.
12/538,402 08/10/2009 Ian Lee Goldman 103171.00015 7311
23619 7590 06/07/2017
Squire Patton Boggs (US) LLP
PHX-IP&T-S PB
8000 Towers Crescent Drive
14 th Floor
Tysons Corner, VA 22182
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
06/07/2017 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):
PHXIPDOCKET @ SquirePB .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IAN LEE GOLDMAN
Appeal 2015-007457
Application 12/538,402
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to systems and methods for providing medical treatment.
Claims 1—24 are on appeal as rejected under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discusses the medical issue of stress urinary
incontinence (SUI), which is treated by surgically providing a sling of
material under the urethra to replace deficient pelvic floor muscles and
provide structural support to the urethra. Spec. Tflf 5—8. The Specification
explains that, on occasion, such slings must be removed or re-positioned and
Appeal 2015-007457
Application 12/538,402
“a need exists for systems and methods for providing medical treatment
including means for attaching a structure to a patient and removing the
structure without damage, either to the structure or the patient.” Id. ]Hf 11—
15.
Claims 1 and 20—22 are independent claims; claim 1 is representative
and is reproduced below:
1. A system for providing medical treatment, the system
comprising:
a structure for attachment to a patient, the structure having a first
end and a second end;
a first fastener including at least one retractable barb, said first
fastener coupled to the first end of the structure for attachment
and being configured for selective removal from the patient; and
a second fastener including at least one retractable barb, said
second fastener coupled to the second end of the structure for
attachment and being configured for selective removal from the
patient,
wherein at least one of the first fastener and the second fastener
comprises a tip in a distal direction wherein the at least one
retractable barb is disposed proximally apart from the tip when
the retractable barb is in an unretracted position.
App. Br. 29 (Claims App.).
The following rejections are on appeal:
Claims 1—6 and 20—23 stand rejected under 35 U.S.C. § 103(a) over
Nowlin1 and Lizardi.2 Final Action 2.
1 U.S. Patent App. Pub. No. US 2007/0021649 A1 (pub. Jan. 25, 2007)
(“Nowlin”).
2 U.S. Patent App. Pub. No. US 2004/0002735 A1 (pub. Jan 1, 2004)
(“Lizardi”).
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Claims 7—11, 18, and 19 stand rejected under 35 U.S.C. § 103(a) over
Nowlin, Lizardi, and Trott.3 Id. at 10.
Claims 12 and 13 stand rejected under 35 U.S.C. § 103(a) over
Nowlin, Lizardi, and Hirotsuka.4 Id. at 12.
Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) over
Nowlin, Lizardi, and Gellman.5 Id. at 14.
Claim 16 stands rejected under 35 U.S.C. § 103(a) over Nowlin,
Lizardi, and Lamoureux.6 Id. at 15.
Claiml7 stands rejected under 35 U.S.C. § 103(a) over Nowlin,
Lizardi, and Skiba.7 Id. at 15.
Claims 1 and 24 stand rejected under 35 U.S.C. § 103(a) over Nowlin
and Hirotsuka. Id. at 16.
FINDINGS OF FACT
Except as otherwise indicated herein, we adopt the Examiner’s
findings of fact, reasoning on scope and content of the prior art, and
conclusions set out in the Final Action and Answer. The findings of fact set
forth below highlight certain evidence.
FF1. Nowlin discloses “adjustable length implantable sling
assemblies for providing support to anatomical locations,” useful in
3 U.S. Patent No. 5,501,683 (issued Mar. 26, 1996) (“Trott”).
4 U.S. Patent App. Pub. No. US 2008/0058584 A1 (pub. Mar. 6, 2008)
(“Hirotsuka”).
5 U.S. Patent App. Pub. No. US 2003/0023137 A1 (pub. Jan. 30, 2003)
(“Gellman”).
6 U.S. Patent App. Pub. No. US 2007/0021642 A1 (pub. Jan. 25, 2007)
(“Lamoureux”).
7 U.S. Patent No. US 6,908,473 B2 (issued June 21, 2005) (“Skiba”).
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Application 12/538,402
“the treatment of stress urinary incontinence.” Nowlin Abstract, 17;
see also Final Action 2—20, and Ans. 2-4, 6—9 (discussing Nowlin).
FF2. Nowlin illustrates such a sling at Figures 1A and IB,
reproduced below:
12
10-X
XX 14b
X.
• 16a
Figure IB
Figures 1A and IB disclose “a sling assembly 10 according to an
illustrative embodiment of the invention. The sling assembly 10
includes a mesh sling 12, first 14a and second 146 dilator/anchors,
and first 16a and second 166 elastic members.” Nowlin 146; see also
Final Action 2—20, and Ans. 2-4, 6—9 (discussing Nowlin). “As
shown most clearly in the enlarged view of FIG. IB, the tissue
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Application 12/538,402
anchor/dilator 14a includes a proximal end 20 and a distal tip 22.”
Nowlin | 69; see also Final Action 2—20, and Ans. 2—4, 6—9
(discussing Nowlin). Further, “[t]he reduced diameter section 29
creates a shoulder 31 that can engage with the patient’s tissues and
resist removal of the anchor/dilator 14a subsequent to implantation.
In other illustrative embodiments, the anchor/dilator 14a includes one
or more radially extending barbs or other projections for resisting
removal.” Nowlin 170; see also Final Action 2—20, and Ans. 2-4, 6—
9 (discussing Nowlin).
FF3. Nowlin further discloses that “the dilator/anchors 14a
and 146 may be implanted into any suitable patient tissues,” including
soft tissues and bone. Nowlin | 84; see also Final Action 2—20, and
Ans. 2-4, 6—9 (discussing Nowlin).
FF4. Lizardi discloses:
A suture anchor for affixing soft tissue to bone. The anchor has
a hollow outer member, and an actuation member slidably
mounted within the outer member. The actuation member has at
least two engagement members that are pivotally mounted to the
actuation member. Proximal movement of the actuation member
with respect to the outer member causes the engagement
members to move outward to a deployed position, wherein the
engagement members are deployed in bone.
Lizardi Abstract; see also Final Action 2, 4—10, 12, 14, 15, 18—21, and
Ans. 2-4, 6—9 (discussing Lizardi).
FF5. Lizardi illustrates such a device at Figures 1 and 2,
reproduced below:
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Application 12/538,402
FIG. 1 rm
IBB
FIG, 2
Figures 1 and 2 depict the same device, a suture anchor 10, having
engagement members 150 in either retracted or extended positions.
Lizardi Tflf 44-47; see also Final Action 2, 4—10, 12, 14, 15, 18—21,
and Ans. 2—4, 6—9 (discussing Lizardi). The suture anchor has an
outer member (20) that is a “hollow elongated member having a
proximal end 25 and a distal end 28” and “[extending distally from
the distal end 28 is the nose member 30 having a substantially conical
configuration.” Lizardi 144; see also Final Action 2, 4—10, 12, 14,
15, 18—21, and Ans. 2-4, 6—9 (discussing Lizardi).
FF6. Lizardi discloses “[i]n order to deploy the anchor 10, and
cause the engagement members 150 to be deployed into surrounding
bone, a proximal force is exerted upon the actuation member 70,
preferably by pulling proximally on a suture mounted to the actuation
member 70 such as suture 180.” Lizardi 149; see also Final Action 2,
4—10, 12, 14, 15, 18—21, and Ans. 2-4, 6—9 (discussing Lizardi).
FF7. Lizardi discloses:
If desired, the anchor 10 may be removed from bore hole 310
after deployment of the engagement members 150. The distal
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Application 12/538,402
end of the insertion device 200 is inserted into the bore hole 310
so that the key members engage the openings 31. Then, actuation
member 70 is displaced distally by moving the instrument 200
distally to retrieve the engagement members 150 by causing the
distal movement actuation member 70, causing the members 150
to disengage [from] the bone 305 and displace inwardly into slots
50 of outer member 20 and cavity 90 of actuation member 70.
At this point the anchor device is not engaged with the
surrounding material. The anchor 10 is withdrawn from the bone
hole.
Lizardi 1 55; see also Final Action 2, 4—10, 12, 14, 15, 18—21, and
Ans. 2-4, 6—9 (discussing Lizardi).
FF8. Hirotsuka is directed to an implant for anchoring into the
tissue of the tongue and discloses a
distal anchor [having] a first configuration with a reduced cross-
sectional profile to facilitate implantation of the distal anchor
within the tongue, and a second configuration with an expanded
cross-sectional profile to engage the surrounding tissue and/or
resist migration of the anchor within or out of the tongue. In
further embodiments of the invention, the distal anchor may have
a third configuration to facilitate removal of the distal anchor
from the tongue.
Hirotsuka 1161; see also Final Action 12—13, 16—18, 21, and Ans. 6—
7, 9-10 (discussing Hirotsuka).
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FF9. Hirotsuka illustrates such an anchor at Figures 78A and
78B, reproduced below:
f/G, 78,4
f/G./SB
Regarding Figures 78A and 78B, Hirotsuka explains:
FIGS. 78A-D depict schematic diagrams of an embodiment of a
tether 2150 that comprises a plurality of barbs 2152. An anchor
2154 is also shown distal to the tether 2150. The plurality of
barbs 2152 (which may be as previously described elsewhere in
the application) may be connected together by an internal wire
2156. In other embodiments, the tether 2150 may also include
an external sheath for housing the barbs 2152 and protecting
native tissues during deployment and removal of the entire
system. A method of deploying the barbed tether embodiment is
also disclosed. First, the distal anchor 2154 is deployed in the
tongue 9. The tether 2150 is shown prior to activation of the
barbs 2152 in FIG. 78A. Next, the barbed wire 2156 is pushed
forward to expose the barbs 2152 for engaging the tongue tissue.
The activated barbs 2152 are shown in FIG. 78B. Next, the
tongue tissue 9 (shown schematically as the two undulating lines
in step 3) is compressed over the barbed wire 2156 from the
proximal to the distal end to achieve advancement and
compression of the tongue tissue 9 in a distal direction (as
indicated by the arrows shown), as in FIG. 78C. Optionally, as
shown in step 4, the barbed wire 2156 may be retracted to
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Application 12/538,402
disengage the tongue tissue 9 and either adjust tension or
facilitate removal of the device, as in FIG. 78D.
Hirotsuka 1281; see also Final Action 12—13, 16—18, 21, and Ans. 6—
7, 9-10 (discussing Hirotsuka).
FF10. Gellman discloses “[a] medical sling is made from
material that is in a shape suitable for use in a medical application.”
Gellman Abstract; see also Final Action 14, and Ans. 7—8 (discussing
Gellman).
FF11. Gellman illustrates such a sling at Figure 7A, reproduced
below:
£ 7
A
FIG. 7A
“FIG. 7A illustrates a plan view of another embodiment of a sling
including elongated end members extending from a central portion of
the sling in accordance with the invention.” Gellman 142; see also
Final Action 14, and Ans. 7—8 (discussing Gellman).
FF12. Gellman discloses:
The sling of the invention may be made of a sheet that is in a
shape suitable for a medical application. Suitable shapes may
include rectangular and substantially rectangular. The sling may
be octagonal, hexagonal, trapezoidal, elliptical, or some other
shape that is suitable to the slings intended placement location
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Application 12/538,402
within the body. In some embodiments, the sheet has elongated
members.
Gellman || 20, 89; see also Final Action 14, and Ans. 7—8 (discussing
Gellman).
FF13. Lamoureux discloses:
An anchor mechanism includes a sleeve to fit around a structure
such as a radioactive source, a thermal ablation implant, a spacer,
a strand or a radiopaque marker. . . . One or more protrusion[s]
extend [] from an outer surface of the sleeve to engage
surrounding patient tissue after implantation of the structure into
a patient, to thereby reduce a tendency for the structure to migrate
and rotate after implantation.
Lamoureux Abstract; see also Final Action 15, and Ans. 8 (discussing
Lamoureux).
FF14. Lamoureux discloses “an anchor mechanism 1400
includes a sleeve 1404 to which are attached, by living hinges 1406,
wings 1408. The wings 1408 are shown as being generally
rectangular, but can have other shapes.” Lamoureux | 88; see also
Final Action 15, and Ans. 8 (discussing Lamoureux). Lamoureux also
discloses, “[bjecause of the biasing of the living hinges 1406, once
implanted in the patient, the wings 1408 will tend to open or unfold
along the living hinges 1406, causing the wings 1408 to thereby
engage the surrounding patient tissue. This engagement will resist
migration.” Lamoureux | 88; see also Final Action 15, and Ans. 8
(discussing Lamoureux).
FF15. Skiba discloses “[a]n elastic suspension device is
disclosed. The elastic suspension device includes an element
including an elastic connector and at least one anchor at an end
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Application 12/538,402
portion of the connector, the at least one anchor is designed for
anchoring the elastic connector to a tissue.” Skiba Abstract; see also
Final Action 15—16, and Ans. 9 (discussing Skiba).
FF16. Skiba illustrates such an anchor at Figure 1, reproduced
below:
FIG. 1 illustrates a tissue anchoring device in accordance
with the teachings of the present invention, which is referred to
hereinbelow as anchoring device 10.
Device 10 includes an element 12 which includes a
connector 14 and at least one inflatable anchor 16 which is
attached to, or form a part of a distal portion 18 of connector 14.
. . . [the] anchoring device 10 is preferably utilized for
predetermined time periods following which removal thereof is
preferred.
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Skiba 7:5—24; see also Final Action 15—16, and Ans. 9 (discussing
Skiba).
FF17. The Specification describes “deploying the retractable
barb formed by the inflatable body 190,” and illustrates such
inflatable body at Figures 1 IB—1 ID, reproduced below:
FIG. 11D
Figures 1 IB—1 ID show “forcing] fluid into inflatable body 190,
causing deployment of the retractable barb” and “[o]nce inflation is
complete, the retractable barb is formed (or deployed) by inflatable
body 190, as shown in Figure 1 ID.” Spec. 1147.
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DISCUSSION
Only those arguments made by Appellant in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
The rejection of claims 1—6 and 20—23 over Nowlin and Lizardi
We find the Examiner has established that claim 1 would have been
obvious over the cited prior art. Further, we find there would have been
motivation to combine the cited prior art, at least because they are each
directed to anchoring medical devices in tissue (soft or bone), thus,
combining the various attributes of each reference’s disclosed subject matter
would have been obvious and reasonably expected to succeed. Appellant
has not produced evidence showing, or persuasively argued, that the
Examiner’s determination is incorrect. We address Appellant’s arguments
below.
Appellant argues that Nowlin fails to disclose the “first fastener . . .,”
“second fastener . . .,” and “tip . . . distal [and]. . . retractable barb is
disposed proximally” of claim 1. App. Br. 13. Appellant contends Nowlin’s
anchor “is not ‘configured for selective removal from the patient’ and does
not include a ‘retractable barb.’” Id. at 14. Appellant argues that Lizardi’s
anchor is used in a hole drilled in bone and is not useful for the system of
Nowlin, which is for anchoring in soft tissue. Id. at 15. Appellant argues
Nowlin teaches away from its combination with Lizardi to include
retractable barbs because Nowlin teaches its anchor resists removal from a
patient’s tissue. Id. at 15—16 (citing Nowlin || 14, 70).
To the extent Appellant argues over the prior art references
individually, such arguments are not persuasive. “Non-obviousness cannot
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be established by attacking references individually where the rejection is
based upon the teachings of a combination of references. . . . [The
reference] must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole.” In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986). Here, Nowlin teaches an incontinence treating
sling having a tissue anchor device at each end thereof and Lizardi teaches
anchor devices that include extendable and retractable barbs where the barbs
are proximally positioned relative to a distal tip (retracted or extended) and
where the anchors are configured for selective removal when the barbs are
retracted. FF1—FF7. There is no reason to expect the anchors of Lizardi,
which are extendable/retractable barbs, would be ineffective in any type of
tissue, hard or soft, or even that they would be less effective in soft tissue
than the shoulders of the anchors of Nowlin. In any event, Nowlin suggests
that its anchor can comprise “barbs.” FF2.
Appellant’s argument that Nowlin teaches away from combination
with Lizardi because Nowlin teaches its anchors resist removal is not
persuasive. As determined by the Examiner, Lizardi’s anchors also resist
removal once implanted and may only be removed once the barbs are
retracted. Final Action 19; Ans. 3.
Appellant separates out each of claims 2, 3, 4, 5, 6, 20, 21, 22, and 23
as patentable over Nowlin and Lizardi, but does not provide any specific
argument or evidence in support of the patentability of these singled-out
claims. Statements in a brief that “merely mention [a] claim . . . and lack
any type of separate, substantive argument concerning the claim” are not
sufficient to constitute separate argument regarding that claim under 37
C.F.R. § 41.37(c)(l)(vii). In re Kao, 639 F.3d 1057, 1065 (Fed. Cir. 2011).
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“Since the claims are not separately argued, they all stand or fall together.”
In reKaslow, 707 F.2d 1366, 1376 (Fed. Cir. 1983).
For the reasons above, we affirm this rejection.
The rejection of claims 7—11, 18, and 19 over Nowlin, Lizardi, and
Trott
Here, the Examiner cites Trott for teaching a tissue (bone) anchor
made of a twisted wire. Final Action 10—11; see also Trott Abstract. Trott’s
anchor has barbed ends (points on the wire’s ends) that are initially provided
in what appears to be a retracted configuration in that they do not engage
tissue until acted upon by a user. See Trott FIG. 7. These barbs expand
outwardly of the anchor device to secure it into tissue (bone) when the user
exerts a pulling force on the wire so that its pointed ends are spread apart by
a shell enclosing the remainder of the wire. See id. FIG. 8. The Examiner
cites Trott as teaching the arms, and their configuration with one another,
and the retractable barb, as recited by claim 7.
Appellant argues that there is no evidence that the Trott wire anchor
would work in anything but bone. App. Br. 19. Appellant argues that if
Trott’s anchor were used in Nowlin’s system the device would lack the
“retractable barb is disposed proximally apart from the tip,” as recited by
claim 1, because Trott’s wire is the foremost part of the anchor. Id. at 19—20
(citing Trott Fig. 10). Appellant argues that Trott does not teach “a shaft
from which each retractable barb selectively protrudes” as recited by claim 6
from which claim 7 depends. Id. at 20. Further, Appellant argues that
Trott’s anchor’s two wire arms are not coupled at the twist 13 shown in the
figures of Trott, but are coupled at the bend 11 of the wire, which does not
form an acute angle between them.
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Analyzing the disclosure of Trott, we cannot find that in combining its
anchor device with the devices disclosed by Nowlin and Lizardi the result
would provide a “retractable barb,” as required by claim 1, from which
claim 7 depends. There is no disclosure in Trott that, once deployed, its
barbs can be retracted. It is also not apparent how one would combine the
wire of Trott, identified by the Examiner as the recited “arms,” with the
barbs of Lizardi. Therefore, for at least these reasons, we reverse this
rejection.
We note that Appellant separately argues the patentability of claims
10 and 11, contending that the cited prior art (Trott) does not teach “the
member is biased to push the first arm away from the second arm,” as
recited by claim 10, or “the member is biased to pull the first arm toward the
second arm,” as recited by claim 11. App. Br. 22. Regarding these
arguments, we are further persuaded by Appellant. There is no disclosure in
Trott that its wire anchor is biased in any direction; it appears to be a purely
static wire until acted upon by the user. For this additional reason we
reverse the rejection as to claims 10 and 11.
We note, further, that Appellant separately argues the patentability of
claim 18, contending that the prior art (Trott) does not teach “a guide ring
within the shaft for maintaining a desired alignment of the member,” and
that Trott’s “channels 67 and 69,” cited by the examiner for such a
disclosure, are not such a ring and not within a shaft. App. Br. 23.
Regarding this argument, we are again persuaded. Looking at the channels
identified as 67 and 69 in Trott, it is clear that these features are not a ring.
For this reason, also, we reverse the rejection as to claim 18.
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We also note, that Appellant separately argues the patentability of
claim 19, arguing the prior art (Trott) does not teach “a protrusion from the
member for contacting an internal wall of the shaft when a respective barb is
deployed,” and contending that elements 15 and 21 of Trott are not
protrusions from the wire. App. Br. 23. We are persuaded. Looking at the
wire anchor device of Trott, we find there are no protrusions of any sort
provided. For this reason, also, we reverse the rejection as to claim 19.
The rejection of claims 12 and 13 over Nowlin, Lizardi, and Hirotsuka
We find the Examiner has established that claims 12 and 13 would
have been obvious over the cited prior art. Further, we find there would
have been motivation to combine the cited prior art, at least because they are
each directed to anchoring medical devices in tissue (soft or bone), thus,
combining the various attributes of each reference’s disclosed subject matter
for the advantages describe in the reference would be obvious and
reasonably expected to succeed. Appellant has not produced evidence
showing, or persuasively argued, that the Examiner’s determination is
incorrect. We address Appellant’s arguments below.
Regarding claim 12, Appellant argues it would not be obvious to use
Hirotsuka’s mechanism for extending and retracting barbs with Lizardi’s
mechanism for retracting barbs because Lizardi requires one to push the
mechanism to retract the barbs. App. Br. 23—24.
Hirotsuka teaches tissue anchors (for the tongue), and discloses
deployable and retractable barbs on a wire, where the barbs are deployed by
pushing a wire and are retracted by pulling a wire, which facilitates removal
of the device. FF8—FF9. As determined by the Examiner, it would be
obvious to incorporate such a system of deployable barbs on a wire into
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either of the anchor devices of Nowlin (or, for that matter, of Lizardi). Final
Action 13; Ans. 7.
Appellant separates out claim 13, but does not provide any argument
or evidence to support its patentability. Thus, claim 13 falls with claim 12.
See In re Kao, 639 F.3d at 1065.
For the reasons above, we affirm this rejection.
The rejection of claims 14 and 15 over Nowlin, Lizardi, and Gellman
We find the Examiner has established that claims 14 and 15 would
have been obvious over the cited prior art. Further, we find there would
have been motivation to combine the cited prior art, at least because they are
each directed to anchoring medical devices (straps) in tissue (soft or bone),
thus, combining the various attributes of each reference’s disclosed subject
matter would have been obvious and reasonably expected to succeed.
Appellant has not produced evidence showing, or persuasively argued, that
the Examiner’s determination is incorrect. We address Appellant’s
arguments below.
The Examiner cites Gellman for, essentially, teaching a urinary
incontinence-treating strap with a wide waist, and that the strap can have an
elliptical shape. FF10—FF12.
Appellant argues claim 14 is patentable for the same reasons claim 2,
from which it depends, is patentable over this prior art combination. App.
Br. 24. However, as noted, supra, Appellant presents no specific argument
or evidence for the patentability of claim 2 different from that presented for
claim 1, which we have found to be not persuasive over the same prior art.
See id. at 17; see discussion, supra.
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Regarding claim 15, Appellant argues the prior art (Gellman at
Figures 7A and 7B) does not disclose “an elliptical shape” as recited by the
claim. App. Br. 25. Gellman expressly indicates that its strap can be
elliptically shaped, as an alternative to the hexagonal shape illustrated at
Gellaman’s FIG. 7A. See FF11, FF12. Thus, we do not find Appellant’s
argument persuasive.
For the reasons above, we affirm this rejection.
The rejection of claim 16 over Nowlin, Lizardi, and Lamoureux
We find the Examiner has established that claim 16 would have been
obvious over the cited prior art. Further, we find there would have been
motivation to combine the cited prior art, at least because they are each
directed to anchoring medical devices in tissue (soft or bone), thus,
combining the various attributes of each reference’s disclosed subject matter
would have been obvious and reasonably expected to succeed. Appellant
has not produced evidence showing, or persuasively argued, that the
Examiner’s determination is incorrect. We address Appellant’s arguments
below.
The Examiner finds that Lamoureux discloses a tissue anchor with
wings/fms/protrusions/barbs with living hinges, which deploy to secure the
device in tissue. FF13—FF14. Appellant argues that combining Lamoureux
with Nowlin effectively writes Lizardi out of the combination. App. Br. 25.
We do not find this argument persuasive because, as explained by the
Examiner, it would have been obvious to modify the barbs of Lizardi (and
Nowlin) by adding a living hinge to deploy or assist in deploying tissue
anchoring barbs. See Ans. 8.
For the reasons above, we affirm this rejection.
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The rejection of claim 17 over Nowlin, Lizardi, and Skiba
We first note that Appellant’s Specification clearly describes and
illustrates an “inflatable device to facilitate formation of at least one
retractable barb.” FF17. The Specification describes such an inflatable barb
as an inflatable bladder that can be filled with fluid so as to extend from the
end of the anchoring device so as to resist removal of the anchoring device
from tissue in which it is embedded. See Spec. Tflf 147—149. Thus, we find
claim 17 encompasses, inter alia, a device as illustrated in Figures 1 IB—1 ID
of the Specification.
We find the Examiner has established that claim 17 would have been
obvious over the cited prior art. Further, we find there would have been
motivation to combine the cited prior art, at least because they are each
directed to anchoring medical devices in tissue (soft or bone), thus,
combining the various attributes of each reference’s disclosed subject matter
for the advantages describe in the reference would be obvious and
reasonably expected to succeed. Appellant has not produced evidence
showing, or persuasively argued, that the Examiner’s determination is
incorrect. We address Appellant’s arguments below.
The Examiner cites Skiba as teaching an inflatable anchoring system,
as shown in Skiba Figure 1. FF15, FF16. Similar to the argument regarding
claim 16, Appellant argues that combining Skiba with Nowlin effectively
writes Lizardi out of the combination. App. Br. 25. Whether Lizardi is
considered or not, modifying Nowlin’s anchoring system with the inflatable
barb of Skiba would render claim 17 obvious.
For these reasons, we affirm this rejection.
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Appeal 2015-007457
Application 12/538,402
The rejection of claims 1 and 24 over Nowlin and Hirotsuka
We find the Examiner has established that claims 1 and 24 would
have been obvious over the cited prior art. Further, we find there would
have been motivation to combine the cited prior art, at least because they are
each directed to anchoring medical devices in tissue (soft or bone), thus,
combining the various attributes of each reference’s disclosed subject matter
would have been obvious and reasonably expected to succeed. Appellant
has not produced evidence showing, or persuasively argued, that the
Examiner’s determination is incorrect. We address Appellant’s arguments
below.
Appellant argues Hirotsuka does not disclose the spatial configuration
(distil and proximal) of the tip and retracted barb, as recited by claim 1.
Appellant contends Hirotsuka’s barbs extend out of a tip and retract into a
tip, as shown in the reference’s Figures 7G, 7H, 7J, 8A, and 8B. This
argument is not persuasive because Hirotsuka’s Figures 78A and 78B clearly
show retractable barbs proximal to a distal tip of an anchoring device. FF9.
Regarding claim 24, Appellant refers to the arguments for the
patentability of claim 1 and also argues that the cited prior art cannot
accommodate deployment using a threaded shaft, as recited by claim 24.
We do not find this argument persuasive, in part, because Hirotsuka
expressly discloses retractable barbs are deployed and retracted via a
threaded shaft, as explained by the Examiner. See Final Action 17
(discussing Hirotsuka Figs. 51 A—E).
For these reasons, we affirm this rejection.
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Appeal 2015-007457
Application 12/538,402
SUMMARY
The rejection of claims 1—6 and 20—23 over Nowlin and Lizardi is
affirmed.
The rejection of claims 7—11, 18, and 19 over Nowlin, Lizardi, and
Trott is reversed.
The rejection of claims 12 and 13 over Nowlin, Lizardi, and Hirotsuka
is affirmed.
The rejection of claims 14 and 15 over Nowlin, Lizardi, and Gellman
is affirmed.
The rejection of claim 16 over Nowlin, Lizardi, and Lamoureux is
affirmed.
The rejection of claim 17 over Nowlin, Lizardi, and Skiba is affirmed.
The rejection of claims 1 and 24 over Nowlin and Hirotsuka is
affirmed.
TIME PERIOD FOR RESPONSE
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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