Ex Parte Sharp et al

Patent Trial and Appeal Board

Mar 14, 2018

13028810 (P.T.A.B. Mar. 14, 2018)

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.
13/028,810 02/16/2011 Robert M. Sharp H-EB-00023 (203-7390) 9485
90039 7590
Covidien LP
Attn: IP Legal
5920 Longbow Drive
Mail Stop A36
Boulder, CO 80301-3299
03/16/2018 EXAMINER
VAHDAT, KHADIJEH A
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
03/16/2018 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):
mail @ cdfslaw. com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT M. SHARP, WILLIAM H. NAU JR.,
GLENN A. HORNER, DUANE E. KERR and
KRISTEL L. AMBROSIUS
Appeal 2017-001683
Application 13/028,810
Technology Center 3700
Before JEFFREY N. FREDMAN, ELIZABETH A. LaVIER, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to surgical
instrument. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“Instruments such as electrosurgical forceps are commonly used in
open and endoscopic surgical procedures to coagulate, cauterize and seal
tissue. Such forceps typically include a pair of jaws that can be controlled
1 Appellants identify the real party in interest as Covidien LP (see App. Br.
2).
Appeal 2017-001683
Application 13/028,810
by a surgeon to grasp targeted tissue, such as, e.g., a blood vessel” (Spec.,
1:8—102). “The combination of the mechanical clamping force and the
electro surgical energy has been demonstrated to join adjacent layers of
tissue captured between the jaws” (Spec., 1:13—14). “[T]he complexity of
an electrosurgical forceps tends to result in fairly labor intensive cleaning
procedures to prepare the forceps for subsequent use. Improper cleaning
may result in dangerous contamination being introduced surgical site” (Spec.
2:8-10).
The Claims
Claims 8, 12—16, and 21—23 are on appeal.3 Claims 8 and 16 are
representative and read as follows:
8. A surgical instrument comprising:
an elongated shaft extending distally from a handle;
an end effector extending distally from the elongated
shaft, the end effector including an active contact surface
thereon disposed to contact tissue in use, the end effector
including a pair of opposing jaw members, at least one of the
jaw members movable relative to the other to move the end
effector between an open configuration wherein the opposing
jaw members are substantially spaced for receiving tissue and a
closed configuration wherein the opposing jaw members are
closer together for clamping the tissue therebetween;
2 We herein refer to the Specification filed Feb. 16, 2011 (“Spec.”); Appeal
Brief, filed May 13, 2016 (“App. Br.”); and the Examiner’s Answer, mailed
Sept. 14, 2016 (“Ans.”). It is noted that a Reply Brief was filed on Nov. 10,
2016.
3 Claims 19, 20, 24, and 25 were cancelled in an Amendment filed May 12,
2016 that was entered in the Advisory Action mailed May 27, 2016.
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a replacement contact surface disposed relative to the
active contact surface such that presence of the active contact
surface prohibits the replacement contact surface from
contacting the tissue in use, and wherein the active contact
surface defines an active knife tip at a distal end of a
reciprocating knife distally movable through the end effector to
cut the tissue, and wherein the active contact surface is
removable from the end effector to permit the replacement
contact surface to contact the tissue in use, and wherein the
replacement contact surface defines a replacement knife tip, the
replacement knife tip being disposed proximally with respect to
the active knife tip on the reciprocating knife; and
an actuator disposed on the handle, the actuator pivotable
with respect to the elongated shaft for translating the
reciprocating knife, the actuator including a pawl configured to
contact an active drive notch of the reciprocating knife.
16. A surgical instrument comprising:
an elongated shaft extending distally from a handle;
an end effector extending distally from the elongated
shaft, the end effector including a pair of opposing jaw
members, at least one of the jaw members movable relative to
the other to move the end effector between an open
configuration wherein the opposing jaw members are
substantially spaced for receiving tissue and a closed
configuration wherein the opposing jaw members are closer
together for clamping the tissue therebetween;
a plurality of electrodes restrained within an internal
cavity defined in the elongated shaft;
an electrode receiving cavity defined in at least one of the
pair of opposing jaw members, the electrode receiving cavity
being configured for releasably receiving at least one of the
plurality of electrodes and for establishing an electrical
connection between the at least one of the plurality of
electrodes and a source of electrosurgical energy; and
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Application 13/028,810
a dispensing mechanism configured to selectively permit
and restrict passage of one of the at least one of the plurality of
electrodes from the internal cavity of the elongated shaft into
the electrode receiving cavity, wherein the plurality of
electrodes are configured as clips, each of the clips including an
upper electrode, a lower electrode and an electrically insulative
material disposed therebetween, wherein movement of the end
effector to the closed configuration induces plastic deformation
of the clips, and wherein the dispensing mechanism includes at
least one hook configured to selectively engage a distal portion
of one of the at least one of the plurality of electrodes, the at
least one hook being movable between a laterally inward
position where the hook restricts passage of one of the at least
one of the plurality of electrodes from the internal cavity of the
elongated shaft into the electrode receiving cavity, and a
laterally outward position where the hook permits passage of
one of the at least one of the plurality of electrodes from the
internal cavity of the elongated shaft into the electrode
receiving cavity.
The Issues
A. The Examiner rejected claims 8, 12, 13, and 21—23 under 35 U.S.C.
§ 103(a) as obvious over Dumbauld,4 Barker,5 and Gerhardt6 (Final Act. 3—
7).
B. The Examiner rejected claims 14 and 15 under 35 U.S.C. § 103(a) as
obvious over Dumbauld, Barker, Gerhardt, and Townsend7 (Final Act. 7—8).
C. The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as obvious
over McGarry8 and Nardella9 (Final Act. 8—10).
4 Dumbauld et al., US 7,481,810 B2, issued Jan. 27, 2009.
5 Barker, US 2007/0261174 Al, published Nov. 15, 2007.
6 Gerhardt, US 2011/0276049 Al, published Nov. 10, 2011.
7 Townsend, US 2009/0088744 Al, published Apr. 2, 2009.
8 McGarry et al., US 4,509,518, issued Apr. 9, 1985.
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A. 35 U.S.C. § 103(a) over Dumbauld, Barker, and Gerhardt
The Examiner finds Dumbauld teaches a surgical instrument as
required by claim 8 except “Dumbauld does not teach a practical
replacement contact surface as claimed” (Final Act. 3—4). The Examiner
finds Dumbauld does teach
the end effector assembly 100 may be selectively and releasably
engageable with the distal end 16 of the shaft 12 and/or the
proximal end 14 of shaft 12 may be selectively and releasably
engageable with the housing 20 and the handle assembly 30. In
either of these two instances, the forceps 10 would be
considered “partially disposable” or “reposable”, i.e., a new or
different end effector assembly 100 (or end effector assembly
100 and shaft 12) selectively replaces the old end effector
assembly 100 as needed.
(Final Act. 4). The Examiner finds that because “because the artisan “would
have recognized that one practical need of having to replace the end effector
would be due to the blade loosing sharpness and becoming dull... in order
to save time and money” it would have been obvious “to make use of
a snap-off blade such as that taught by Barker in order to simply snap-off the
dull blade for a sharp new blade to use” (Final Act. 4—5).
The Examiner also finds that “Dumbauld and Barker are silent in
teaching the details associated with the actuator having a pawl configured to
contact an active drive notch of the reciprocating knife” (Final Act. 5). The
Examiner finds “Gerhardt teaches a blade drive mechanism for use with a
forceps instrument having an actuator 38 disposed on the handle, the
9 Nardella, US 5,201,900, issued Apr. 13, 1993.
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actuator pivotable with respect to the elongate shaft for translating the
reciprocating knife, the actuator including a pawl” (id.). The Examiner finds
it obvious “to add a plurality of notches in the drive rod mechanism of
Dumbauld for a pawl or gear mechanism of the trigger or actuator for better
engagement and advancing the blade through the end effector” (Final Act.
6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Dumbauld, Barker, and Gerhardt
render the rejected claims obvious?
Findings of Fact
1. Figure 1A of Dumbauld is reproduced below:
“FIG. 1A is a side view of an endoscopic forceps showing a housing, a shaft,
an end effector assembly and a trigger assembly in a first position”
(Dumbauld 5:49-51). Figure 1A also shows “trigger assembly 70 mounts
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atop movable handle 40 and cooperates with the knife assembly 180 ... to
selectively translate knife 185 through a tissue seal” (Dumbauld 10:34—37).
2. Dumbauld teaches: “Forceps 10 generally includes a housing
20, a handle assembly 30, a rotating assembly 80, a trigger assembly 70 and
an end effector assembly 100 which mutually cooperate to grasp, treat and
divide tissue” (Dumbauld 6:58—61).
3. The Specification teaches the “active contact surface may be
configured as an active knife tip at a distal end of a reciprocating knife”
(Spec. 4:5-6).
4. Figures 5A-C are reproduced below:
As best illustrated in FIGS. 5A-5C, a knife channel 115a and
1156 runs through the center of the jaw members 110 and 120,
respectively, such that a blade 185 can cut tissue grasped
between the jaw members 110 and 120 when the jaw members
110 and 120 are in a closed position.
(Dumbauld 8:63—67).
5. Dumbauld teaches:
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It is envisioned that the forceps 10 may be designed such that it
is fully or partially disposable depending upon a particular
purpose or to achieve a particular result. For example, end
effector assembly 100 may be selectively and releasably
engageable with the distal end 16 of the shaft 12 and/or the
proximal end 14 of shaft 12 may be selectively and releasably
engageable with the housing 20 and the handle assembly 30. In
either of these two instances, the forceps 10 would be
considered “partially disposable” or “reposable”, i.e., a new or
different end effector assembly 100 (or end effector assembly
100 and shaft 12) selectively replaces the old end effector
assembly 100 as needed.
(Dumbauld 17:54—65).
6. Figure 1 of Barker is reproduced below:
Figure 1 shows “device 101 comprises a cutter 110; a marker 120; a first
module 115 retaining the cutter 110, wherein first module 115 comprises at
least one first end (or blade end) 117 and at least one second end (or
connector end) 119” (Barker | 13).
7. Barker teaches the “cutter 110 may comprise a razor blade
112 that includes one or more snap-off razor blades 113. The cutter 110 may
include any type of snap-off razor blade 113” (Barker 117).
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8. Gerhardt teaches a
surgical instrument includes an end effector extending distally
from the elongate shaft. The end effector may include a pair of
jaw members . . . The reciprocating member may be coupled to
a knife adjacent a distal end of the reciprocating member, and
the knife may be selectively extendable through a knife channel
defined in the jaw members. The jaw members may include at
least one electrode connectable to a source of electrosurgical
energy.
(Gerhardt 19).
9. Figure 4 of Gerhardt is reproduced below:
FIG. 4
A “pinion drive mechanism 54a as depicted in FIG. 4 may offer a greater
knife stroke . . . Movement of the trigger 28a through the actuation stroke
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rotates a gear set 64a, which in turn drives the rack 70a in a longitudinal
direction” (Gerhardt 130).
Principles of Law
A tribunal “exercise[s] caution before holding a claimed invention
obvious when combining references would violate the principle of operation
of the modified reference.” Univ. of Md. Biotechnology Inst. v. Presens
Precision Sensing GmbH, 2017 WL 5041459, at *3 (Fed. Cir. Nov. 3, 2017)
(non-precedential). In considering potential modifications of what is
disclosed in the prior art, care should be taken to avoid hindsight. See In re
Ratti, 270 F.2d 810, 813 (CCPA 1959) (“Once appellant had taught how this
could be done, the redesign may, by hindsight, seem to be obvious to one
having ordinary skills in the [relevant] art. However, when viewed as of the
time appellant’s invention was made, and without the benefit of appellant’s
disclosure, we find nothing in the record which suggests appellant’s
[invention].”)
Analysis
Appellants contend
that by making the blade 185 of Dumbauld breakable, several
components of Dumbauld’s forceps would be required to be
reengineered to ensure such a shortened blade 185 is able to
completely traverse its knife channel, for example; the forceps
would not be safely usable if its blade 185 failed to extend
through the knife channel and fully cut tissue. Appellants]
discusse[s] these design challenges on pages 18-20 of its
specification.
(App. Br. 8). The Specification explains that after a knife tip is removed, to
“ensure the new knife tip 152b, e.g., traverses the entire knife channel 166,
an adjustment is made at the proximal end of knife 152. The pawl 160 may
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Application 13/028,810
be disengaged from the active drive notch 164a and may be moved to
engage a supplementary or replacement drive notch 164b” (Spec. 18:20 to
19:1).
The Examiner responds
one having ordinary skill in the art at the time of the invention
would have found it obvious to make at least a section of the
blade of Dumbauld that extends out of the end effector snap-off
in order to easily snap-off a used blade and make use of a sharp
clean blade. One having ordinary skill in the art at the time of
the invention would have found it beneficial to make use of this
configuration in order to save time and money by only snapping
off a small section of a used blade and reuse the instrument
rather than replacing the end effector.
(Ans. 5).
We find that Appellants have the better position. While we agree with
the Examiner that Dumbauld provides motivation for replaceable end
effector assemblies (FF 5), we agree with Appellants that the rejection needs
to address why it would have been obvious to use a snap-off blade in a
system where removal of the snapped-off portion of the blade would not
allow the blade to extend far enough to cut tissue. We note that, if
Dumbauld’s original blade was longer, it would extend too far and cut too
deeply into tissue.
The solution in the Specification, also found in claim 8, is the use of a
pawl in the active drive notch of the blade that moves to different notch
locations as the blade is shortened by removal of blade portions (see Spec.
18:20 to 19:1). However, we agree with Appellants that “various other
components of Dumbauld’s device would also have to be substantially
redesigned to ensure that a shorted blade 185 can fully traverse its knife
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channel to reliably and effectively cut tissue” (App. Br. 8—9). The Examiner
provides no prior art teachings or scientific reasoning explaining why the
redesign of these other components of Dumbauld’s device would have been
obvious without hindsight.
Therefore, we conclude the Examiner has not satisfied the burden of
establishing a prima facie case of obviousness because if Dumbauld were
modified as proposed and a blade shortened, “it would be rendered
inoperable for its intended purpose.” In re Gordon, 733 F.2d 900, 902 (Fed.
Cir. 1984). The blade would not be able to cut tissue, the essential goal in
Dumbauld.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Dumbauld, Barker, and Gerhardt render the rejected claims obvious.
B. 35 U.S.C. § 103(a) over Dumbauld, Barker, Gerhardt, and Townsend
The Examiner relies upon Dumbauld, Barker, and Gerhardt to render
independent claim 8 obvious. Having reversed the obviousness rejection of
claim 8 over Dumbauld, Barker, and Gerhardt for the reasons given above,
we also find that the further combination with Townsend does not render the
rejected claims obvious for the same reason.
C. 35 U.S.C. § 103(a) rejection over McGarry andNardella
The Examiner finds McGarry teaches the device of claim 16 except
“McGarry does not teach each of the clips including an upper electrode, a
lower electrode and an electrically insulative material disposed therebetween
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and the jaws being configured for establishing an electrical connection
between the at least one of the plurality of clips and a source of
electro surgical energy” (Final Act. 9). The Examiner finds
Nardella teaches benefits of using a bipolar surgical clip
including an upper electrode, a lower electrode and an
electrically insulative material disposed therebetween and the
jaws being configured for establishing an electrical connection
between the at least one of the plurality of clips and a source of
electro surgical energy for better and safer fusion of the clip to
the adjacent tissue during use.
(id.). The Examiner finds it obvious “to make use of such bipolar clips in
surgical procedures that require permanent placement of clips in a patient's
body in order to better fuse the clip in place to reduce the risk of
displacement over time as Nardella teaches” (Final Act. 9-10).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that McGarry and Nardella render the
rejected claims obvious?
Findings of Fact
10. McGarry teaches “an improved one-handed surgical clip
applying instrument” that “provides a smaller, lighter, more versatile
instrument by providing apparatus which can automatically sequence clip
feeding and clip closure, and which can close the clip by movement of jaws
into a sleeve, rather than by the pivoting of levers” (McGarry 2:7—15).
11. Figure 7 of McGarry is reproduced below:
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Figure 7 shows “placement of a clip about the tissue to be clamped”
(McGarry 2:45—46).
12. Figures 13 and 14 of McGarry are reproduced below:
The motion of the forwardmost or clip stop tooth 24 is
similar to that of the other feed ratchet teeth 102 except that
rather than pushing its associated clip past the next forward
backstop tooth 104, tooth 24 pushes its clip into jaws 12. To
guide the forwardmost clip into jaws 12, the forward part of
clip carrier housing 78 includes ramps 108 . . . which bring the
clip arms into contact with jaw grooves 40. Clip carrier
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housing 78 also includes spring element 110 (FIG. 13) which
rides against the shank 112 of clip stop tooth 24 to cause that
tooth to follow the curve of sleeve 22 and jaw blade arms 52.
The spacing between clip stop tooth 24 and the tooth 102
just behind it is slightly greater than the pitch space distance p.
This allows clip stop tooth 24 to extend further into jaws 12 so
as to facilitate clip feeding.
(McGarry 8:55 to 9:2).
13. Nardella teaches
a surgical clip construction which enables the clip to be used as
a bipolar electrosurgical device. The clip comprises a pair of
opposed prong members which each have a contiguous
conductive surface over at least part of their outer periphery. A
bridge member constructed of a highly resistive material joins
the two prong members and serves to electrically isolate the
prong members from each other. The clip is bipolar in that one
of the prongs may communicate with an active electrode
through which current may be delivered to adjacent tissue while
the other prong serves as a ground electrode. Electrosurgical
application of such a clip results in fusing of the clip to the
adjacent tissue and also minimizes any potential risk to the
patient which may result from current traveling through the
body over relatively long distance from the active electrode to a
remote ground electrode.
(Nardella 1:58 to 2:6).
14. Nardella teaches a “surgical clip may be deployed to tissue by a
suitable electrosurgical clip applicating device” (Nardella 2:53—55) and
“connected (through a clip applicating device, not shown) to a source of
electrosurgical current such as electrosurgical generator 22. Conductive
electrode wire 24 communicates with prong 12, enabling prong 12 to deliver
current to adjacent tissue” (Nardella 2:44-49).
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Principles of Law
“The protocol of giving claims their broadest reasonable interpretation
during examination does not include giving claims a legally incorrect
interpretation. This protocol is solely an examination expedient, not a rule
of claim construction.” In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir.
2009).
Analysis
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. In this case, the
dispute centers on the phrase “hook being movable between a laterally
inward position . . . and a laterally outward position” in claim 16.
We first turn to the Specification to interpret this phrase. The
Specification teaches “dispensing mechanism 142 includes a pair of hooks
144 each extending toward a proximal end of the instrument 130. The hooks
144 may be actuated from a proximal end of the instrument 130 to shift in a
laterally outward direction to permit passage” (Spec. 17:7—9). Thus, the
Specification distinguishes between the proximal/distal direction and the
lateral direction, explaining that the hooks physically extend in a proximal
direction but move in a lateral direction (see, e.g., figure 7 of the
Specification, element 144; Spec. 17:7—9).
The dictionary definitions of the term “lateral” are “1: of or relating to
the side — a lateral view; 2: situated on, directed toward, or coming from the
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side — the lateral branches of a tree; 3: extending from side to side — the
lateral axis of an airplane.”10
Both the Specification and dictionary definition of the term “lateral”
distinguish between motion in a proximal/distal or forward/backward
direction and motion in a side to side direction.
We recognize the
examiner takes the position that since the distal tip of shaft 22 is
curved (as shown in Figs. 1 and 12-14 and explained in the
disclosure), by taking a longitudinal axis that passes through the
whole shaft, as the distal section 24 comprising a hook, moves
from the position shown in Fig. 13 to a position shown in Fig.
14, it is shown to be movable between “a laterally inward
position” (Fig. 14) where the hook restricts passage of one of
the at least one of the plurality of electrodes from the internal
cavity of the elongated shaft into the electrode receiving cavity,
and “a laterally outward position” (Fig. 13) where the hook
permits passage of one of the at least one of the plurality of
electrodes from the internal cavity of the elongated shaft into
the electrode receiving cavity.
(Ans. 7—8). The Examiner alternatively contends “in a different
interpretation, as the actuator moves . . . [the movement indirectly] causes
some sort of lateral movement of the tip section that is taken to be a laterally
inward” (Ans. 8).
We do not find either of the Examiner’s positions persuasive because
the Examiner’s interpretation of “lateral” as encompassing either any
possible direction of movement of the hook or “some sort of [undefined]
lateral movement” would effectively read the term “lateral” out of claim 8.
10 See https://www.merriam-webster.com/dictionary/lateral (accessed March
8, 2018).
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See Merck & Co., Inc. v. leva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed.
Cir. 2005) (“A claim construction that gives meaning to all the terms of the
claim is preferred over one that does not do so.”). Our reasoning is
consistent with NuVasive, where the Federal Circuit found “the proper scope
of ‘lateral’ is more restrictive than the Board’s interpretation, which covers
any approach ‘lateral, to any degree, as compared to an anterior puncture.’”
In re NuVasive, Inc., 693 F. App’x 893, 899 (Fed. Cir. 2017) (non-
precedential).
The motion of element 24 as shown in figures 13 and 14 of McGarry
is reasonably understood as being in a proximal/distal or forward/backward
direction, and not in a side to side or lateral direction (FF 12). This
interpretation is consistent with the text of McGarry which states that the
clip spacing “allows clip stop tooth 24 to extend further into jaws 12” (FF
12), also suggesting that element 24 is moving in a forward/backward
direction.
We therefore agree with Appellants that “the dispensing mechanism
24 appears to move proximally and distally” (App. Br. 17). The Examiner
does not identify a suggestion or reason to modify McGarry that would
result in lateral movement of element 24 and has therefore not met the
burden of establishing a prima facie case of obviousness.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that McGarry and Nardella render the rejected claims obvious.
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SUMMARY
In summary, we reverse the rejection of claims 8, 12, 13, and 21—23
under 35 U.S.C. § 103(a) as obvious over Dumbauld, Barker, and Gerhardt.
We reverse the rejection of claims 14 and 15 under 35 U.S.C. § 103(a)
as obvious over Dumbauld, Barker, Gerhardt, and Townsend.
We reverse the rejection of claim 16 under 35 U.S.C. § 103(a) as
obvious over McGarry and Nardella.
REVERSED
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