Ex Parte Gordon et al

Board of Patent Appeals and Interferences

Jan 11, 2012

10945855 (B.P.A.I. Jan. 11, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LUCAS S. GORDON, MARK L. MATHIS,
GREGORY NIEMINEN, LEONARD KOWALSKY,
RYAN BRAXTAN, and BRIAN J. DOLL
__________

Appeal 2010-007423
Application 10/945,855
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-3, 5, 6, 9-22, 24-26, 28-53, and 59-62. We
have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claims 1, 3, 12, 22, and 47 are representative of the claims on appeal,
and read as follows:
1. A method of delivering and deploying a tissue shaping device in a
coronary sinus within a patient, the tissue shaping device comprising an
anchor, the method comprising:
inserting a delivery catheter into the coronary sinus;
percutaneously delivering the device to a target site within the
coronary sinus through the delivery catheter;
operating an actuator in a first direction to allow the anchor to self-
expand outside of the delivery catheter; and
operating the actuator in a second direction to lock the anchor,
wherein operating the actuator to lock the anchor occurs after
operating the actuator to allow the anchor to self-expand outside of the
delivery catheter, and
wherein the second direction is opposite the first direction.

3. A method of delivering and deploying a tissue shaping device in a
coronary sinus within a patient, the tissue shaping device comprising an
anchor, the method comprising:
inserting a delivery catheter into the coronary sinus;
percutaneously delivering the device to a target site within the
coronary sinus through the delivery catheter;
operating an actuator to move the delivery catheter proximally to
expose the anchor; and
operating the actuator to move the delivery catheter distally to lock
the anchor.

12. A method of delivering and deploying a tissue shaping device in a
lumen within a patient, the tissue shaping device comprising an anchor, the
method comprising:
inserting a delivery catheter into the lumen;
percutaneously delivering the device to a target site within the lumen
through the delivery catheter;
operating a first actuator to expose the anchor; and
operating the first actuator to lock the anchor,
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wherein the anchor is a first anchor, the tissue shaping device further
comprising a second anchor disposed proximally to the first anchor, the
method further comprising operating the first actuator to expose the second
anchor; and
operating a second actuator to expand and lock the second anchor.

22. A method of delivering and deploying a tissue shaping device in a
lumen of a patient, the tissue shaping device comprising an anchor, the
method comprising:
inserting a delivery catheter into the lumen;
moving the device from a cartridge into the delivery catheter;
delivering the device to a target site within the lumen;
engaging a handle with the cartridge;
operating an actuator to move the delivery catheter with respect to the
anchor to expose the anchor; and
expanding the anchor.

47. A method of delivering and deploying a tissue shaping device in a
lumen of a patient, the tissue shaping device comprising a distal anchor and
a proximal anchor, the method comprising:
inserting a delivery catheter into the lumen;
moving the device from a cartridge into the delivery catheter;
delivering the device to a target site within the lumen;
operating a first actuator to move the delivery catheter with respect to
the distal anchor to expose the distal anchor;
expanding the distal anchor;
operating the first actuator to move the delivery catheter proximally to
expose the proximal anchor;
expanding the proximal anchor; and
locking the proximal anchor in the expanded configuration, wherein
locking the proximal anchor comprises applying an external actuation force
on the proximal anchor, and wherein
the step of applying an external actuation force on the proximal
anchor comprises operating a second actuator to move a proximal anchor
locking device distally.

The following grounds of rejection are before us for review:
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I. Claims 1-3, 5, 6, 9-11, and 14 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Shaw,
1

Huebsch,
2
and Sterman.
3

II. Claim 13 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Shaw, Huebsch, and
Sterman, as further combined with Snyders.
4

III. Claim 18 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Shaw, Huebsch, and
Sterman, as further combined with Simon.
5

IV. Claims 19-21 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Shaw, Huebsch, and
Sterman, as further combined with Leschinsky.
6

V. Claims 15 and 16 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Shaw and Huebsch.
VI. Claim 47 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Shaw, Huebsch, and
Leschinsky.
VII. Claims 12, 15-17, and 59-62 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Sideris
7

and Huebsch.

1
Shaw et al., US 6,080,182, issued Jun. 27, 2000.
2
Huebsch et al., US 6,312,446 B1, issued Nov. 6, 2001.
3
Sterman et al., US 5,961,481, issued Oct. 5, 1999.
4
Snyders, US 2002/0123802 A1, published Sep. 5, 2002.
5
Simon, US 5,741,297, issued Apr. 21, 1998.
6
Leschinsky et al., US 5,871,501, issued Feb. 16, 1999.
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VIII. Claim 3 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Sideris, Huebsch, and Sterman.
IX. Claims 22, 24-26, 28-32, 34-46, and 48-53 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of
Sideris, Huebsch, and Leschinsky.
X. Claim 33 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Sideris, Huebsch, and
Leschinsky, as further combined with Shaw.

We reverse.
ISSUE (Rejections I-V)
Does the preponderance of the evidence of record support the
Examiner‟s conclusion that the combination of Shaw and Huebsch teach a
step of operating the actuator to lock an anchor, as required by the claimed
methods?

FINDINGS OF FACT
FF1. The Examiner‟s statement of the Rejections may be found at pages 3-
8 of the Answer.
FF2. Specifically, according to the Examiner:
[I]n the configuration shown in figure 22D, the anchor can be
considered locked since it is being actively held by the catheter
against the tissue and is not free to move away from the tissue.
This occurs as the result of the catheter moving in the claimed
second direction. There is no language in the claim that gives a

7
Sideris, US 5,433,727, issued Jul. 18, 1995.
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specific structure to the locked state of the anchor and therefore,
when the anchor is held tightly against the wall by the catheter,
it can be considered locked to the tissue.

(Ans. 13.)
FF3. In the alternative, the Examiner notes:
[I]f the position of the anchor shown in figure 22D of Shaw is
not considered to be locked, it is also the examiner‟s position
that, in order for the anchor to reach the configuration shown in
figure 22G of Shaw, this distal movement of the catheter must
take place. The method of Shaw in view of Huebsch meets the
step of “operating the actuator in a second direction to lock the
anchor” because moving the catheter in a distal direction to
push the anchor against the tissue so that it is tightly fit within
the tissue defect is part of the locking process. The step of
moving the catheter in a distal direction is imperative to the
locking step because the two halves of the anchor must be close
enough that the proximal end of the latch (150) is proximal of
portion (140) of the anchor in order to hold sections (138) and
(140) of the anchor together and against the tissue wall. In
other words, although other steps are involved in the locking
process of Shaw such as withdrawing the pusher member (156)
to free the end of latch (150) after the catheter has been moved
distally to hold the anchor against the tissue, the catheter is
moved distally as part of this locking process and can therefore
be said to move distally to lock the anchor. It is noted that the
claim includes the transitional phrase “comprising”, which
allows for additional method steps.

(Id. at 13-14.)

ANALYSIS
Appellants argue that “[u]nder the Examiner‟s interpretation of the
claimed term „lock‟, any catheter, sheath, or other delivery instrument that
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simply engages a portion of an implantable device and maintains its position
adjacent tissue would be considered to „lock‟ the implantable device,”
which, Appellants assert is an unreasonable interpretation of the term “lock”
(Reply Br. 2).
We agree with Appellants. We recognize that during prosecution
before the Office, claims are to be given their broadest reasonable
interpretation consistent with the Specification as it would be interpreted by
one of ordinary skill in the art. In re American Academy Of Science Tech
Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). Claim language, however,
“should not [be] treated as meaningless.” Bicon, Inc. v. Straumann Co., 441
F.3d 945, 951 (Fed. Cir. 2006). Moreover, “the claims themselves provide
substantial guidance as to the meaning of particular claim terms.” Philips v.
AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc).
The Examiner‟s interpretation, however, as pointed out by Appellants,
is not a reasonable interpretation of the term “lock,” as the ordinary artisan
would not interpret pushing a portion of an implantable device against
adjacent tissue through use of a portion of the delivery instrument, such as a
catheter, as “locking an anchor” in deployment of a tissue shaping device.
Nor does the Examiner‟s interpretation find any support in the Specification.
As to the Examiner‟s alternative interpretation, Appellants assert that
claim 1 “requires operating the actuator in a second direction opposite the
first direction to lock the anchor” (Reply Br. 3). Appellants argue “that
distal movement of catheter 80 in Shaw does not cause device 32 to assume
the configuration shown in Figure 22G. Moving catheter 80 distally can not
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[sic] simply be part of an overall process to reconfigure device 32 to the
configuration shown in Figure 22G” (id.).
Again we agree with Appellants. Claim 1, for example, requires the
step of “operating the actuator in a second direction to lock the anchor.” We
interpret that as requiring a causal relationship between operating the
actuator and locking the anchor. The Examiner‟s alternative interpretation
does not require that causal relationship. That is, under the interpretation of
the Examiner, because the actuator is operated in a second direction at some
point in the process leading up to the locking of the anchor, which process
may include additional steps, such as operating the actuator in a different
direction, it meets that step of the claim. The Examiner‟s interpretation thus
essentially reads the step of “operating the actuator in a second direction to
lock the anchor” out of the claim, which we decline to do.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record does
not support the Examiner‟s conclusion that the combination of Shaw and
Huebsch teach a step of operating the actuator to lock an anchor, as required
by the claimed methods. We also conclude that the additional references
relied upon by the Examiner in setting forth Rejections I-V do not remedy
the deficiencies of the combination of Shaw and Huebsch. We are thus
compelled to reverse Rejections I-V.

ISSUE (Rejection VI)
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Does the preponderance of the evidence of record support the
Examiner‟s conclusion that the combination of Shaw, Huebsch, and
Leschinsky teach a step of locking the proximal anchor which comprises
applying an external actuation force on the proximal anchor, and wherein the
step of applying an external actuation force on the proximal anchor
comprises operating a second actuator to move a proximal anchor locking
device distally, as required by the claimed method?

FINDINGS OF FACT
FF4. The Examiner‟s statement of the Rejection may be found at pages 7-8
of the Answer.
FF5. According to the Examiner:
Shaw discloses a method of delivery and deploying a tissue
shaping device, the device comprising distal and proximal
anchors (138, 140), the method comprising inserting a delivery
catheter (80) into the lumen, delivering the device to a target
site within the lumen (fig. 22a), moving the delivery catheter
with respect to the distal anchor (138) to expose the distal
anchor expanding the anchor, moving the delivery catheter
proximally to expose the proximal anchor (140) (fig. 22B to
22C; col. 12, ll. 3-8), expanding the anchor and locking the
proximal anchor in place by operating a second actuator
(proximal end of pusher 156) to move a proximal anchor
locking device (pusher 156) distally (col. 12, ll. 12-16; fig. 22C
to 22D).

(Ans. 7.)
FF6. Specifically, Shaw teaches that a catheter is withdrawn from the
helical closure device, which allows the latch to spring open to its memory
induced shape (Shaw, col. 12, ll. 30-33). The latch the “provides a means to
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secure the distal side membrane . . . to the proximal side membrane . . . of
the helical closure device . . . and also provide a sealing member securing
means” (id. at col. 12, ll. 34-37).
FF7. Shaw also teaches that alternate methods of deploying the latch
include withdrawing the inner tube and catheter, or the inner tube, catheter,
and pusher tube simultaneously away from the closure device (id. at col. 12,
ll. 37-42).

ANALYSIS
Appellants argue:
Shaw does not teach or suggest the step of locking the proximal
anchor which comprises applying an external actuation force on
the proximal anchor, and wherein the step of applying an
external actuation force on the proximal anchor comprises
operating a second actuator to move a proximal anchor locking
device distally. To the contrary, Shaw teaches retraction of
catheter 80 to fully release latch 150, which springs open to its
memory induced shape, securing the device 132 (Col. 12, lines
30-37; Figure 22G).

(App. Br. 13.)
We agree with Appellants. Specifically, the Examiner has not
explained how withdrawing the catheter, or how withdrawing the inner tube
and catheter, or the inner tube, catheter, and pusher tube simultaneously
away from the closure device, reads on the steps of locking the proximal
anchor in the expanded configuration, wherein locking the proximal anchor
comprises applying an external actuation force on the proximal anchor,
wherein the step of applying an external actuation force on the proximal
anchor comprises operating a second actuator to move a proximal anchor
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locking device distally. The Examiner‟s reliance on Figures 22C and 22D
seem to indicate that the Examiner is relying on a definition of “locking”
wherein the anchor is considered locked since it is being actively held by the
catheter against the tissue. We do not adopt that interpretation for the
reasons set forth above with respect to Rejections I-V.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record does
support the Examiner‟s conclusion that the combination of Shaw, Huebsch,
and Leschinsky teach a step of locking the proximal anchor which comprises
applying an external actuation force on the proximal anchor, and wherein the
step of applying an external actuation force on the proximal anchor
comprises operating a second actuator to move a proximal anchor locking
device distally, as required by the claimed method. We are thus compelled
to reverse Rejection VI.

ISSUE (Rejections VII and VIII)
Does the preponderance of the evidence of record support the
Examiner‟s conclusion that the combination of Sideris and Huebsch teach
the steps of operating an actuator to expose the anchor and operating the
actuator to lock the anchor, as required by the claimed methods?

FINDINGS OF FACT
FF8. The Examiner‟s statement of the Rejections may be found at pages 8-
9 of the Answer.
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FF9. Specifically, according to the Examiner:
Firstly, it is the examiner‟s position that, in the configuration
wherein the catheter (38) has been moved distally to push the
latex piece (28) near proximal half (14) of the anchor so that it
is touching the center of the wires (18) of the distal half (11) of
the anchor, the anchor can be considered locked since it is being
actively held by the catheter within the tissue defect and is not
free to move away from the defect because the catheter is
blocking proximal movement of the anchor. This occurs as the
result of the catheter moving in the claimed second direction.
There is no language in the claim that gives a specific structure
to the locked state of the anchor and therefore, when the anchor
is held to the tissue by the catheter so that proximal movement
is prevented, it can be considered locked to the tissue.

(Ans. 15.)
FF10. In the alternative, the Examiner notes
[I]n order to reach the final configuration of the anchor
disclosed by Sideris wherein the anchor is attached to the tissue,
this distal movement of the catheter must take place. The
method of Sideris in view of Huebsch meets the step of
“operating the actuator in a second direction to lock the anchor”
because moving the catheter in a distal direction to push the
anchor against the tissue so that it is maintained within the
tissue defect is part of the locking process. The step of moving
the catheter in a distal direction is imperative to the locking step
because the two halves of the anchor must be close enough that
the anchor cannot move within the defect. In other words,
although other steps are involved in the locking process of
Sideris such as spring wire (22) being freed after the catheter
has been moved distally to hold the anchor against the tissue,
the catheter is moved distally as part of this locking process and
can therefore be said to move distally to lock the anchor.

(Id. at 15-16.)
ANALYSIS
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Appellants argue that independent claims 12, 15, 16, and 59 require
the steps of operating an actuator to expose the anchor and operating the
actuator to lock the anchor (App. Br. 13). Thus, Appellants assert, there is a
direct causal relationship between operating an actuator to expose the anchor
and operating the actuator to lock the anchor (id. at 14).
We agree with Appellants for the reasons set forth in the Analysis
with respect to Rejections I-V.

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record does
not support the Examiner‟s conclusion that the combination of Sideris and
Huebsch teach the steps of operating an actuator to expose the anchor and
operating the actuator to lock the anchor, as required by the claimed
methods. We are thus compelled to reverse Rejections VII and VIII.

ISSUE (Rejections IX and X)
Does the preponderance of the evidence of record support the
Examiner‟s conclusion that the combination of Sideris, Huebsch, and
Leschinsky renders obvious the step of engaging a handle with the cartridge
as required by the claimed method?

FINDINGS OF FACT
FF11. The Examiner‟s statement of the Rejections may be found at pages 9-
12 of the Answer.
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FF12. According to the Examiner, “Sideris fails to disclose moving the
device from a cartridge into the delivery catheter or engaging a handle with
the cartridge” (Ans. 10).
FF13. The Examiner relies on Leschinsky for teaching “that it is old and
well known to provide a cartridge” (id.).
FF14. As to the handle, the Examiner finds:
Either the proximal end of the catheter may be considered a
handle as it is the portion of the device closest to the user and
available for grasping or it would have been obvious to
incorporate a handle onto the device of Sideris to facilitate
gripping of the device at its proximal end by the user.

(Id. at 16.)
FF15. The Examiner notes that the rejection is not based on the suggestion
of adding a handle onto the device of Leschinsky (id.).

ANALYSIS
Appellants argue that the Examiner has not established that “it would
have been obvious to engage a handle with the cartridge to facilitate
manipulation of the catheter by the user” (App. Br. 15).
We agree. First, as the Examiner‟s finding that the catheter may be
considered the handle that is not consistent with the claim language, which
requires “a delivery catheter,” a “cartridge” and a “handle.” The Examiner‟s
finding conflates the “delivery catheter” and the “handle,” and thus reads an
element out of the claim. Second, even if we agree that it would have been
obvious to add a handle to the catheter of Sideris, the Examiner has not
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explained how that would read on the step of “engaging a handle with the
cartridge.”

CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record does
not support the Examiner‟s conclusion that the combination of Sideris,
Huebsch, and Leschinsky renders obvious the step of engaging a handle with
the cartridge as required by the claimed method. We are thus compelled to
reverse Rejections IX and X.

REVERSED

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