Dmitri Menn et al.

Patent Trials and Appeals Board

Jul 30, 2019

14159993 - (D) (P.T.A.B. Jul. 30, 2019)

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.
14/159,993 01/21/2014 Dmitri MENN 10121/08312(05-00225US3) 3894
104919 7590 07/30/2019
Fay Kaplun & Marcin, LLP -- BSC
150 Broadway, suite 702
New York, NY 10038
EXAMINER
HIGHLAND, RACHEL S
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
07/30/2019 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):
fkmiplaw@yahoo.com
okaplun@fkmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DMITRI MENN, RUSSELL F. DURGIN,
BRIAN KEITH WELLS, LANCE ALAN WOLF,
GREGORY R. FURNISH, VASILIY P. ABRAMOV,
and WILLIAM C. MERS KELLY1
____________

Appeal 2017-011463
Application 14/159,993
Technology Center 3700
____________

Before RICHARD M. LEBOVITZ, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The claims in this appeal are directed to a tissue clipping device. The
Examiner rejected the claims under 35 U.S.C. § 103 as obvious. Pursuant to
35 U.S.C. § 134, Appellants appeal the Examiner’s determination that the
claims are unpatentable. We have jurisdiction for the appeal under
35 U.S.C. § 6(b). The Examiner’s decision is reversed.

1 The Appeal Brief (“Appeal Br.” entered May 23, 2017) lists Boston
Scientific Scimed, Inc., as the Real Party in Interest. Appeal Br. 1.
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Application 14/159,993

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STATEMENT OF THE CASE
Claims 20–39 stand finally rejected by the Examiner as follows:
1. Claims 20–28, 30–37, and 39 under pre-AIA 35 U.S.C. § 102(b) as
anticipated by Kogiso et al. (EP 1 829 489 A1, published Sept. 5, 2007)
(“Kogiso”). Ans. 2.
2. Claims 29 and 38 under pre-AIA 35 U.S.C. § 103(a) as obvious in
view of Kogiso and Komiya (U.S. Pat. No. 3,958,576, issued May 25,
1976). Ans. 9.
Independent claim 20, which is representative of the claimed subject
matter, is reproduced below:
20. A tissue clipping device, comprising:
a flexible insertion member extending from a proximal
end which, during use remains outside a body accessible to a
user to a distal end which is inserted into the body through a
naturally occurring body lumen;
a clip including first and second clip arms;
a capsule housing a portion of the clip therein;
a control wire extending through the flexible insertion
member from a proximal end to a distal end removably coupled
to the clip by a joint at a proximal end of the clip,
the control wire being reversibly operable to move the
first and second clip arms between an open configuration in
which distal ends of the first and second clip arms are separated
from one another and a closed configuration in which the distal
ends of the first and second clip arms are drawn together to grip
tissue located therebetween; and
an actuator coupled to the control wire and configured to
move the first and second clip arms between the open and
closed configurations, application of a predetermined force to
the actuator applying a force to the control wire freeing the
proximal end of the clip to move radially outward to engage an
increased diameter portion of the capsule and disengage the
control wire from the clip.

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Application 14/159,993

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ANTICIPATION REJECTION BASED ON KOGISO
The Examiner found Kogiso describes a tissue clipping device that
meets all the limitations of the claimed device. Final Act. 2. In response to
arguments made by Appellants in the Appeal Brief that Kogiso does not
describe “application of a predetermined force to the actuator applying a
force to the control wire freeing the proximal end of the clip to move
radially outward to engage an increased diameter portion of the capsule and
disengage the control wire from the clip” (Appeal Br. 8), the Examiner
further cited the embodiment in Kogiso illustrated in Figures 9–13 (Ans. 2).
The Examiner found that these figures and accompanying disclosure
described all the structural features of the claimed control wire and proximal
end of the clip, and are capable of performing the recited functions. Ans. 4,
6. In reaching this determination, the Examiner interpreted the claims to
require that the “application of a predetermined force to the actuator”
achieves two separate results which are products of separate forces. Ans. 13.
According to the Examiner, the first result is the radial expansion of the
proximal end of the clip into engagement with “an increased diameter
portion of the capsule” and the second result is to “disengage the control
wire from the clip.” Id. (Quoted portions correspond to the limitation in the
last clause of claim 20.) The Examiner stated that these two results are
“separate,” can occur in any order, and need not have a “causal
relationship.” Id.
Appellants challenge the Examiner’s interpretation of the claims.
Appellants contends that the two results are a product of one force.
Appellants argue that the claims require the application of the recited
predetermined force to the control wire to free the proximal end of the clip
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“to (1) move radially outwardly to engage the increased diameter portion of
the capsule and (2) disengage the control wire from the clip.” Reply Br. 4.
Thus, Appellants disagree with the Examiner’s determination that the two
results are separate and not causally related. Because the dispute between
the Examiner and Appellants turns on the issue of claim interpretation, we
begin our analysis by construing the claims.
During patent examination proceedings, claim terms are given “the
broadest reasonable meaning . . . in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in the applicant’s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
The disputed claim limitation reads as follows:
application of a predetermined force to the actuator applying a
force to the control wire freeing the proximal end of the clip to
move radially outward to engage an increased diameter portion
of the capsule and disengage the control wire from the clip.
The plain language of the claim requires a single force (“applying a
force”) to the control wire. This force frees the proximal end of the clip
allowing it “to move radially outward to engage an increased diameter
portion of the capsule and disengage the control wire from the clip.” The (1)
radial outward movement and (2) disengagement of the control wire from
the clip are therefore a result of the action of the force “freeing the proximal
end of the clip.”
This interpretation of the claim is consistent with the Specification. In
explaining how the predetermined force works, the Specification refers to
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Figure 10. Figure 10 is reproduced below (labels and colored shading have
been added for clarity):

Figure 10 shows the structural features of the claimed device,
including:
(1) “flexible insertion member” 330;
(2) “clip” having “first and second clip arms” 304;
(3) “capsule” 360 (the figure points to the entire structure, but from
the description, it appears to be the structure formed from 362 and 364
(numerals shaded red); and
(4) “control wire” 332 (cream-colored shading).
As shown in Figure 10 reproduced above, 362 and 364 form a shell or
capsule having cavities 307, 309 (green-colored shading) in which the ends
of the clip arms 304 (“tabs 305”) are constrained. Spec. ¶ 17 (“The cavities
307, 309 receive proximal ends of the arms 304 and constrain them to
remain therein against a bias which urges the proximal ends of the arms 304
and tabs 305 formed thereby radially outward.”). The Specification
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discloses that “the post 318 can bind the proximal and distal halves 362, 364
to one another.” Spec. ¶ 18.
The Specification discloses that the movement of the clip is controlled
by the control wire 332. Spec. ¶ 18. The Specification further discloses that
a “proximally directed force applied to the control wire 332 increases
tension on the control wire 332 and, consequently, on the post 318 until a
failure level of the post 318 is exceeded.” Spec. ¶ 19. The Specification,
with reference to Figure 10 reproduced above, explains what happens when
the post 318 fails:
When the post 318 fails, the proximal and distal halves 362,
364 can be separated from one another, and the tabs 305 which
are no longer constrained by the walls of the cavity 309 of the
proximal half 362 can spring outward and engage
corresponding features of the capsule 360 (e.g., windows 363)
to lock the clip closed and keep it in position within the capsule
360.
Spec. ¶ 19.
In other words, “applying a force to the control wire” breaks the post
318 which results in both claimed results of (1) “freeing the proximal end of
the clip to move radially outward to engage an increased diameter portion of
the capsule” and (2) “disengage the control wire from the clip.”
The Examiner’s interpretation of the claim to not require the results to
be causally related ignores the language in the claim that requires “applying
a force” which results in “freeing the proximal end of the clip to move
radially outward to engage an increased diameter portion of the capsule and
disengage the control wire from the clip.” While the claim does not exclude
the application of other forces, the same force must accomplish both results.

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Kogiso
In the Answer, the Examiner reproduced Figures 9–13 of Kogiso,
finding that these figures met the disputed “applying a force” of claim 20.
Specifically, the Examiner found the Kogiso describes:
application of a predetermined force to the actuator applying a
force to the control wire (when wire is pulled proximally as
seen starting in Fig. 11) freeing the proximal end of the clip to
move radially outward (note that as wire is moved proximally,
the portions 90 which are restrained in the smaller diameter
portion of the capsule in Fig. 10 are freed to expand in the
larger diameter section of the capsule (See Fig. 11) and
continued proximal force also causes the joint 44 to separate the
control wire from the clip (See Fig. 12).
Ans. 4.
The Examiner’s own explanation based on the disclosure of Kogiso is
that a force frees the end of the clip allowing it to move radially outward and
then a “continued proximal force” is applied to separate or disengage the
control wire from the clip.
Figure 11 of Kogiso, reproduced below, shows the clips after they
have moved radially outward (label and red-colored shading added for
clarity).
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Figure 11 shows a tissue clip which is grabbing tissue A by clip arms
42, 62. The clip element 90 was moved from the cavity in position 92 in
Fig. 10 (not shown) to where it is shown in Fig. 11 as located in the cavity of
pressing member 40. The Examiner found that operation wire 30 depicted in
the figure is a “control wire.” Ans. 3. In the figure, the proximal end of the
clip has been radially expanded “to engage an increased diameter portion of
the capsule,” accomplishing the first result of claim 20. For clarity, the
portion of the clip which engages the diameter of the cap has been marked
with red-colored shading. As shown in this figure, the clip is still engaged
with the control or operation wire 30.
Figure 12, reproduced below, shows the clip disengaged from the
control wire (30) (labels added for clarity), which is the second result of
claim:
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Figure 12 shows the operation wire 30, which serves as the claimed
control wire, separated from the clip by separating at breaking portion 74.
Kogiso 68. The force is not “a continued proximal force” as asserted by the
Examiner (Ans. 4), but is a second force accomplished after the clip has
been expanded radially outward. Kogiso discloses:
Referring to FIG. 12, in a state that the portion to be ligatured A
has been properly ligatured and the clip claw member 42 has
been sufficiently withdrawn into the pressing member 40, the
slider 36 is retreated relative to the control portion main body
34, the first breaking portion 74 of the connection member 44 is
broken, and the clip claw member 42 is separated from the
operation wire 30. After the first breaking portion 74 is broken,
the slider 36 is further retreated relative to the control portion
main body 34.
Kogiso ¶ 68.
Thus, after the clip has been radially expanded into the portion of the
device known as pressing member 40 (see Fig. 11 and corresponding
structure labeled 40) (which meets the claim limitation of “freeing the
proximal end of the clip to move radially outward to engage an increased
diameter portion of the capsule”), the connection member is broken by a
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separate second force and the wire and clip are disengaged as required by the
claim (“disengage the control wire from the clip”). The Examiner did not
establish that the same applied force could both expand the proximal end of
the clip and break the connection.
The Examiner further stated that “[a]s long as the prior art meets the
structural requirements and is capable of performing the functions, the prior
art meets the limitations.” Ans. 4. The Examiner concluded that “the device
of Kogiso meets all the structural requirements and is capable of performing
the intended function” (id.), but did not explain how the same force could be
used in Kogiso to accomplish both results. The Examiner has the burden of
providing a “sound basis” on which to believe that Kogiso device is the
same device as claimed. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Once this burden it met, the burden shifts to Appellants to prove otherwise.
Id. However, in this case, the Examiner simply made a conclusory statement
based on an unreasonably broad interpretation of the claim and an incorrect
finding that a “continued proximal force” separated the clip and
control/operation wire 30. Ans. 4. Because the Examiner did not meet the
burden of establishing a prima facie case, the anticipation rejection of claim
20 and dependent claims 21–28 are reversed.
Independent claim 30, and dependent claims 31–37 have substantially
the same “force” limitation as claim 20 and the rejection of these claims are
reversed for the same reasons.
Independent claim 39 uses different language from claim 20, but still
requires the same force to move the clip proximal end into an enlarged
diameter and disengage the control wire and clip (“separate a joint coupling
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the control wire to the clip”). Consequently, the anticipation rejection of
these claims are reversed, as well.

OBVIOUSNESS REJECTION
Claims 29 and 38 are further rejected as obvious based on Kogiso and
Komiya. The Examiner cited Komiya to reach additional limitations in
these claims. Ans. 8–9. Komiya is not cited by the Examiner to reach the
“force” limitation of the claims. The rejection based on these publications is
also reversed because the Examiner did not establish that Kogiso, alone or in
combination with Komiya, discloses or suggests “applying a force to the
control wire freeing the proximal end of the clip to move radially outward to
engage an increased diameter portion of the capsule and disengage the
control wire from the clip.”

REVERSED