Ex Parte Piskun

Patent Trial and Appeal Board

Jul 25, 2017

12547258 (P.T.A.B. Jul. 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.
12/547,258 08/25/2009 Gregory Piskun H-ET-01US3(10276CIPCON) 4931
50855 7590 07/27/2017
Covidien LP
60 Middletown Avenue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
EXAMINER
NEAL, TIMOTHY JAY
ART UNIT PAPER NUMBER
3779
NOTIFICATION DATE DELIVERY MODE
07/27/2017 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GREGORY PISKUN1
Appeal 2016-004263
Application 12/547,258
Technology Center 3700
Before ERIC B. GRIMES, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for treating hemorrhoids, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification’s disclosure relates “to a hemorrhoid treatment
method wherein the base of a hemorrhoid is compressed by jaws of a
clamping instrument, and then the vascular supply of the hemorrhoid is
1 Appellant identifies the Real Party in Interest as Covidien LP. (Appeal Br.
1.)
Appeal 2016-004263
Application 12/547,258
occluded by application of an impact or energy. Th[e] invention also relates
to an instrument assembly designed to accomplish this task.” (Spec. 1:11—
14.) The tissue occlusion component of the instrument “may be a stapling
mechanism, an injection mechanism connectable to a reservoir of a
sclerosing composition, or optical fibers connectable to a source of laser
radiation.” (Id. at 23:6—8.)
Claims 67—77 and 79—86 are on appeal. Claim 67 is illustrative and
reads as follows (emphasis added):
67. An anoscope for treating a hemorrhoid in a patient comprising:
a hollow member defining a channel and having an open proximal end
and a closed distal end configured for insertion into a patient, the body
defining a window and having a first clamping surface positioned along an
edge of the window;
a closure member movably connected to the hollow member, the
closure member being movable between a first position uncovering the
window and a second position at least partially covering the window, the
closure member having a second clamping surface opposing the first
clamping surface such that the closure member is movable from the first
position towards the second position to grip tissue protruding through the
window between the first and second clamping surfaces; and
a tissue occlusion component mounted to at least one of the hollow
member and the closure member, the tissue occlusion component being
configured to act on tissue protruding through the window and gripped
between the first and second clamping surfaces to occlude the tissue without
cutting through the tissue;
wherein the hollow member includes a handle having a first handgrip
and the closure member includes a second handgrip, the first handgrip
being movable in relation to the second handgrip to move the closure
member between the first and second positions.
Claim 82, the only other independent claim, defines an anoscope
similar to that of claim 67, and similarly requires a “body including a
proximal handle including a first handgrip” and a “closure member
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Application 12/547,258
including a second handgrip extending parallel to the first handgrip, the
second handgrip being movable in relation to the first handgrip to move the
closure member between the first and second positions.”
The independent claims and some of the dependent claims stand
rejected under 35 U.S.C. § 103(a) as follows:
Claims 67—69, 73—77, and 79—83 based on McAlister,2 Avni,3 and
Green4 (Ans. 2);
Claims 67—69, 73—77, and 79—83 based on McAlister, Avni, and
McCall5 (Ans. 8); and
Claims 67—69, 73—77, and 79—83 based on McCall and McAlister
(Ans. 20).
The rest of the dependent claims stand rejected under 35 U.S.C.
§ 103(a) based on the combinations above and an additional reference, as
follows:
Claims 70 and 84 based on McAlister, Avni, Green, and Kaji6 (Ans.
14, 15);
Claims 71, 72, 85, and 86 based on McAlister, Avni, Green, and Tu7
(Ans. 14, 16);
Claims 70 and 84 based on McAlister, Avni, McCall, and Kaji (Ans.
17, 18);
2 McAlister et al., US 6,398,795 Bl, issued June 4, 2002.
3 Avni et al., US 6,447,444 Bl, issued Sept. 10, 2002.
4 Green et al., US 5,579,978, issued Dec. 3, 1996.
5 McCall, US 357,216, issued Feb. 8, 1887.
6 Kaji, US 6,142,931, issued Nov. 7, 2000.
7 Tu et al., US 6,346,105 Bl, issued Feb. 12, 2002.
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Application 12/547,258
Claims 71, 72, 85, and 86 based on McAlister, Avni, McCall, and Tu
(Ans. 17, 19);
Claims 70 and 84 based on McCall, McAlister, and Kaji (Ans. 25,
26); and
Claims 71, 72, 85, and 86 based on McCall, McAlister, and Tu (Ans.
25, 27).
I
The Examiner has rejected claims 67—69, 73—77, and 79—83 as
obvious based on McAlister, Avni, and Green. The Examiner has rejected
claims 70-72 and 84—86 as obvious based on McAlister, Avni, Green, and
either Kaji or Tu. The same issue is dispositive for all of these rejections.
The Examiner finds that McAlister discloses a device meeting most of
the limitations of claims 67 and 82, including “a handle (28) with two grips,”
but “[t]he details of the handle are not provided so McAlister does not
necessarily disclose” a handle meeting the limitations of the claims. (Ans.
3.) The Examiner finds that “Green shows the details of a similar handle [in
which] . . . [hjandgrips 12 and 14 move relative to each other with handgrip
14 being connected to the stapling member.” (Id. at 3—4.)
The Examiner concludes that it would have been obvious “to have
McAlister’s two grips move relative to each other so that the closure
device/stapler will function as designed. Green is used to show how pistol
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grips work and provides details that are lacking in McAlister’s disclosure.”
{Id. at 4.)8
Appellant argues that there is no reason based on the cited references
to modify McAlister’s device to include a handle like that of Green because
“Green’s fastening instrument 10 is a rigid device for open surgical
procedures. The mechanisms described in Green would not be suitable for
use in endoscopic devices such as those adapted to be advanced along an
endoscope as disclosed by McAlister.” (Appeal Br. 9.)
We agree with Appellant that the Examiner has not provided a sound
basis for concluding that modifying McAlister’s device to include the handle
recited in claims 67 and 82 would have been obvious to a person of ordinary
skill in the art based on the cited references.
McAlister discloses “a stapling unit for use with an endoscopic
stapling system comprising a first casing adapted to be advanced along an
endoscope . . ., the first casing having a distal end, a proximal end and a
stapling device mounted thereto adjacent to a first window extending
through a periphery of the first casing.” (McAlister 1:26—32.) McAlister’s
Figure 1A is reproduced below:
8 The Examiner cites Avni only as providing a reason to modify McAlister’s
distal end to be closed, to the extent that it is not already. (Ans. 3.) This
issue is not in dispute. (See Appeal Br. 9—10.)
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Figure 1A shows an embodiment of McAlister’s device. (Id. at 1:35—
36.) The device includes “stapling unit 1 [which] can be operated remotely
via a control unit 8 located outside the body during use.” (Id. at 2:49—51.)
“A stapling device [] is mounted to the unit 1 adjacent to the window.” (Id.
at 2:58-59.)
McAlister’s Figure 2A is reproduced below:
20-. 54 52 10
/ / \
12
FIG. 2A
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Figure 2 A shows “[t]he orientation and movement of the components
in the [Fig. 1A] embodiment.” {Id. at 3:6—7.) “One edge [] of the window
20 may form an anvil 12. The stapling device 50 may have a movable staple
head 52, forming a staple firing edge 54, which, when the stapling device 50
is mounted in the first casing 10, faces the anvil 12.” {Id. at 3:1—5.)
McAlister states that
[t]he stapling head 52 may be rotatably mounted within the first
casing 10 so that, in a first position, the staple firing edge 54 is
adjacent to the anvil 12. The stapling unit 1 may rotate, for
example, about an axis substantially parallel to a longitudinal
axis 14 of the first casing 10. Then, the staple head 52 is rotated
relative to the first casing 10, to a second position.
{Id. at 3:7-13.)
McAlister states that “[t]he stapling device 50 may optionally have a
position adjusting mechanism 27 (shown in FIG. 1A), operated using the
control unit 8, to adjust this predetermined stapling distance 63 before firing
staples.” {Id. at 3:47—50.) McAlister also states that “[t]he stapling unit 1
can have a stapling actuating mechanism 28 (shown in FIG. IB [sic, 1 A]),
also operated using the control unit 8 and coupled between the stapling
device 50 and a proximal end 19 of the unit 1 to activate the staple head 52
to fire staples.” {Id. at 3:52—56.)
The Examiner finds that McAlister’s staple actuating mechanism 28 is
a handle with two grips, but McAlister does not disclose that it functions as
recited in claims 67 and 82. (Ans. 3.) To fill this gap, the Examiner cites
Green. {Id. at 3^4: “Green shows the details of a similar handle (see Fig. 2).
. . . Green is used to show how pistol grips work and provides details that
are lacking in McAlister’s disclosure.”)
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Green discloses “instruments for applying surgical fasteners or staples
to body tissue.” (Green 1:16—17.) Green’s Figure 2 is reproduced below:
Figure 2 shows a “cross-sectional plan view of a surgical fastening
instrument employing the adjustable closure mechanism of [Green’s]
invention in which the instrument is in an at rest condition.” (Id. at 5:1—4.)
Green states that “[fastening instrument 10 is provided with a stationary
handle 12 and an actuating handle 14 which together comprise the trigger
mechanism of instrument 10.” (Id. at 6:2—5.)
Thus, McAlister states that the stapling actuating mechanism of its
device functions to activate a staple head to fire staples. (McAlister 3:52—
56.) And Green describes the handles of its device as the trigger mechanism
for a surgical fastening instrument, meaning its handles also function to fire
staples. (Green 6:2—5.)
But claim 67 requires a “hollow member [that] includes a handle
having a first handgrip and the closure member [that] includes a second
handgrip, the first handgrip being movable in relation to the second handgrip
to move the closure member between the first and second positions.'1'’ (Claim
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67, emphasis added.) Claim 82 similarly requires “the second handgrip [to
be] movable in relation to the first handgrip to move the closure member
between the first and second positions.'1'’ (Claim 82, emphasis added.)
The Examiner has not pointed to any disclosure in the references that
would have provided a reason for a skilled worker to modify McAlister’s
device to include a handle having the function of moving its closure member
between first and second positions; i.e., rotating the stapling head of its
device within the window. McAlister, in fact, states that its staple actuating
member functions to fire staples and a separate position adjusting
mechanism 27 has the function of “adjusting] th[e] predetermined stapling
distance 63 before firing staples.” (McAlister 3:49—50.)
Thus, while it might have been obvious to modify McAlister’s staple
actuating member to move like the handles of Green’s device—in order to
activate the staple head to fire staples—the Examiner has not provided a
reasoned basis for concluding that it would have been obvious to modify the
staple actuating member to have the function of moving the closure member
of McAlister’s device between first (e.g., open) and second (e.g., closed)
positions. We therefore reverse the rejection of claims 67 and 82, and
dependent claims 68, 69, 73—77, 79—81, and 83 under 35 U.S.C. § 103(a)
based on McAlister, Avni, and Green.
The Examiner also rejected claims 70-72 and 84—86 as obvious based
on McAlister, Avni, Green, and either Kaji or Tu. (Ans. 14—17.) These
rejections, however, rely on the Examiner’s conclusion that the independent
claims would have been obvious based on McAlister, Avni, and Green.
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They therefore suffer from the same deficiency discussed above, and we
reverse them for the same reason.
II
The Examiner has rejected claims 67—69, 73—77, and 79—83 as
obvious based on McAlister, Avni, and McCall. The Examiner has rejected
claims 70-72 and 84—86 as obvious based on McAlister, Avni, McCall, and
either Kaji or Tu. The same issue is dispositive for all of these rejections.
The Examiner finds that, “[regarding Claim 67, McAlister and Avni
disclose the invention substantially as claimed as stated above.” (Ans. 8.)
The Examiner similarly finds that McAlister and Avni disclose most of the
limitations of claim 82. (Id. at 12—13.) The Examiner finds that McAlister
does not describe its handle as having the function recited in claims 67 and
82, but “McCall teaches using the claimed multi-handle configuration with
main parts (C and unlettered main body of the anoscope A) and handgrips (E
and F) for inserting the device into the patient and then closing the window.”
(Id. at 9, 13.) The Examiner concludes that “it would have been obvious to a
person having ordinary skill in the art at the time the invention was made to
modify McAlister’s handle to include McCall’s configuration.” (Id. at 9,
13.)
Appellant argues that “the modification of McAlister’s endoscopic
stapling system 200 in view of McCall’s speculum as proposed by the
Examiner would render the McAlister’s endoscopic stapling system 200
unsatisfactory for its intended purpose.” (Appeal Br. 12.) That is, “[t]he
incorporation of first and second handles on the first casing 10 and the
movable stapling head 52, respectively, of McAlister’s endoscopic system,
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such as taught by McCall, would prevent movement of the stapling unit
about an endoscope within a body lumen.” {Id.)
We agree with Appellant that the Examiner has not provided a sound
basis for concluding that modifying McAlister’s device to include the handle
recited in claims 67 and 82 would have been obvious to a person of ordinary
skill in the art based on the cited references. McAlister has been discussed
above. McCall discloses a “Recto-Vaginal Speculum . . . formed with a slot
in the side extending the length of the tube and provided with a slide fitted to
the slot.” (McCall 1:6—11.) McCall’s Figure 1 is reproduced below:
Figure 1 shows “a perspective view of the complete instrument with
the slide [C] partially withdrawn and the mirror [B] . . . in the end of the
tube.” {Id. at 1:22—24.) McCall states that “[t]o the slide is secured a
handle, e, and to the body of the instrument is fixed another one,/” (Id. at
1:75-77.)
As discussed above, McAlister describes the function of the stapling
actuating mechanism of its device as being to activate a staple head to fire
staples. (McAlister 3:52—56.) McCall does not describe the function of its
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handles, although the Examiner finds that the handles are “for inserting the
device into the patient and then closing the window.” (Ans. 9.)
This finding is consistent with McCall’s disclosure that the slide can
be withdrawn, and that the purpose of the mirror is to enable the operator to
see tissue presented in the slot of the instrument. (McCall 1:52—59, 70.)
Thus, movable handle e can move relative to stationary handle/to move
slide C, to which it is attached, forward and backward to close or open the
window.
However, McAlister’s device is an endoscope that is advanced to a
desired location in a body lumen. (McAlister 1:28—29.) The Examiner has
not provided a reasoned basis for concluding that it would have been
obvious to modify McAlister’s endoscope, in which the handle has the
function of firing staples, to include a handle like that of McCall’s speculum,
so that the handle is physically part of the closure member (stapling head 52
in McAlister) that is advanced within a body lumen to a desired location and
can be manually used to open and close the window of McAlister’s device.
We therefore reverse the rejection of claims 67 and 82, and dependent
claims 68, 69, 73—77, 79—81, and 83 under 35 U.S.C. § 103(a) based on
McAlister, Avni, and McCall.
The Examiner also rejected claims 70-72 and 84—86 as obvious based
on McAlister, Avni, McCall, and either Kaji or Tu. (Ans. 17—19.) These
rejections, however, rely on the Examiner’s conclusion that the independent
claims would have been obvious based on McAlister, Avni, and Green.
They therefore suffer from the same deficiency discussed above, and we
reverse them for the same reason.
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III
The Examiner has rejected claims 67—69, 73—77, and 79—83 as
obvious based on McCall and McAlister. The Examiner has rejected claims
70-72 and 84—86 as obvious based on McCall and McAlister, and either
Kaji or Tu. The same issue is dispositive for all of these rejections.
The Examiner finds that McCall’s speculum includes all of the
limitations of claim 67 except for a tissue occlusion component. (Ans. 20—
21.) The Examiner finds that “McAlister teaches using a tissue occlusion
component (stapling portion of 52')” and concludes that it would have been
obvious “to modify McCall’s anoscope to include McAlister’s tissue
occlusion component. Such a modification would give the user the ability to
staple tissue within the anoscope.” {Id. at 21.)
Appellant argues:
It is unclear from both McCall and McAlister how or why one of
ordinary skill in the art could or would modify the speculum of
McCall in view of McAlister’s stapling system. More
specifically, it is unclear how or why one having ordinary skill
in the art would or could incorporate the stapling unit and the
undisclosed actuating mechanism of McAlister into the
speculum of McCall.
(Appeal Br. 18—19.)
We agree with Appellant that the Examiner has not provided a sound
basis for concluding that modifying McCall’s device to include the tissue
occlusion component recited in claims 67 and 82 would have been obvious
to a person of ordinary skill in the art based on the cited references. Both
McCall and McAlister have been discussed above.
McCall states that its device allows the user to “more readily see,
examine, and treat the posterior aspect or surface of any tumor, enlargement,
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fistula, ulceration, polypus, or any other diseased tissue presented in the slot
of the instrument.” (McCall 1:55—59.) McCall does not indicate any need
or use for a component that staples tissue that protrudes through the window
of its device.
McAlister’s device is an endoscope that is advanced to a desired
location in a body lumen. (McAlister 1:28—29.) McAlister’s device
includes a stapling unit that can be operated remotely {id. at 2:49—51), in
contrast to McCall’s device in which a location of interest is directly
observed through its window, as reflected in its mirror (McCall 1:52—59,
70).
Based on the very different structures and intended applications of the
devices disclosed by McCall and McAlister, we agree with Appellant that
the Examiner’s conclusion that it would have been obvious to include
McAlister’s stapling unit in McCall’s speculum to “give the user the ability
to staple tissue within the anoscope” (Ans. 21) is not supported by a
preponderance of the evidence. We therefore reverse the rejection of claims
67 and 82, and dependent claims 68, 69, 73—77, 79—81, and 83 under
35 U.S.C. § 103(a) based on McCall and McAlister.
The Examiner also rejected claims 70-72 and 84—86 as obvious based
on McCall and McAlister, and either Kaji or Tu. (Ans. 25—27.) These
rejections, however, rely on the Examiner’s conclusion that the independent
claims would have been obvious based on McCall and McAlister. They
therefore suffer from the same deficiency discussed above, and we reverse
them for the same reason.
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SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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