Ex Parte Smith et al

Patent Trial and Appeal Board

Jul 31, 2018

11541105 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/541, 105 09/29/2006
27316 7590 08/01/2018
MA YBACK & HOFFMAN, P.A.
5846 S. FLAMINGO ROAD #232
FORT LAUDERDALE, FL 33330
FIRST NAMED INVENTOR
Kevin W. Smith
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
EES/Endostapler DIV2 2398
EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
08/01/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte KEVIN W. SMITH, MATTHEW A. PALMER,
KOREY ROBERT KLINE, and DEREK DEE DEVILLE
Appeal 2016-006645
Application 11/541, 105
Technology Center 3700
Before STEVEN D.A. McCARTHY, JILL D. HILL, and
NATHAN A. ENGELS, Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Kevin W. Smith et al. ("Appellants") 1 appeal under 35 U.S.C.
§ 134(a) from the Examiner's final decision rejecting claims 1-16. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Ethicon Endo-Surgery,
LLC. Appeal Br. 2.
Appeal2016-006645
Application 11/541,105
BACKGROUND
Independent claims 1, 6, and 11 are pending and not withdrawn.
Independent claim 1, reproduced below, represents the claimed invention,
with certain terms italicized.
1. A method for operating a surgical end effector of a
medical device, which comprises:
providing a surgical stapling end effector with an
articulation lock, the surgical stapling end effector housing at
least one surgical staple;
providing a control handle with an articulation joint
actuator;
connecting the end effector to the control handle at a
passive articulating joint to permit articulation of the end
effector at the passive articulating joint with respect to the
control handle and about an articulation axis;
positioning the articulation joint actuator to selectively
connect with and separate from the articulation lock of the end
effector such that:
in an unactuated state of the articulation joint
actuator, the articulation joint actuator automatically connects
with the articulation lock to lock the passive articulating joint
by temporarily preventing further articulating motion of the end
effector at the passive articulating joint; and
in an actuated state of the articulation joint
actuator, the articulation joint actuator is removed from the
articulation lock to unlock the passive articulating joint by
permitting articulating motion of the end effector at the passive
articulating joint dependent upon external forces acting upon
the end effector;
actuating the articulation joint actuator to unlock the
passive articulating joint;
contacting the end effector with the environment at a
surgical site that is internal to the body of a patient to cause the
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end effector to articulate at the passive articulating joint into a
desired articulated position; and
removing actuation of the articulation joint actuator to
lock the passive articulating joint and retain the end effector in
the desired articulated position.
REJECTION
I. Claims 1-16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Green (US 4,566,620, issued Jan. 28, 1986), Weller (US
7,097,650 B2, issued Aug. 29, 2006), and Fox (US 5,984,864, issued Nov.
16, 1999). Final Act. 2.
ANALYSIS
Independent method claim 1 recites connecting the end effector to the
control handle "at a passive articulating joint" and "contacting the end
effector with the environment at a surgical site ... to cause the end effector
to articulate at the passive articulating joint into a desired articulated
position."
Regarding claim 1, the Examiner finds that Green discloses, inter alia,
"connecting the end effector to the control handle at a passive articulating
joint (150) to permit articulation of the end effector ... about an articulating
axis (figure 1 col. 411. 4-15)." Final Act. 3. The Examiner acknowledges
that Green is silent regarding, inter alia, passive articulation by contact with
an environment at a surgical site, but the Examiner finds that Weller
discloses "a similar method and passively moving the end effector into a
desired articulation position by contacting the environment at a surgical site"
as an alternative to active manipulation. Id. ( citing Weller 16:25-31 ). The
Examiner concludes that it would have been obvious to one skilled in the art
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to provide Weller's passive articulation to the method of Green because
Weller recognizes that active and passive manipulation are acceptable
alternatives to "flex" an end effector. Id. In an Advisory Action dated
September 22, 2015, the Examiner explained that "the specific joint of
Weller is not being combined with Green, just the principle of using the
environment as an alternative means for adjusting a joint."
The Examiner proposes to modify Green to also add an articulation
lock 101 as disclosed for Fox's ball joint 109, so that an actuator of Green's
passively-articulated device can selectively (1) lock the ball joint to
preventing further articulating motion of the end effector, and (2) unlock the
ball joint to permitting articulating motion of the end effector dependent
upon external forces acting upon the end effector. Final Act. 4 ( citing Fox
7:62-8: 19). The Examiner concludes that it would have been obvious to one
skilled in the art to add Fox's lock 101 to allow locking and unlocking of the
passively-articulated ball joint of Green and Weller "to be able to lock and
unlock the joint while not obstructing the view or contact[ing] the organ
being operating on." Id. at 5.
Green discloses that, in surgical staplers, it is desirable to provide a
non-rigid connection between the fastener and the actuator of a surgical
fastener device, making the device "transversely flexible." Green 1 :52-59.
Green also appreciates, however, that excessive flexibility of a connection
between the fastener and the actuator makes the device undesirably
uncontrollable. Id. 1 :68-2:3. Green achieves a desirable amount of
transverse flexibility, between rigid and uncontrollably flexible, by
connecting the fastener to the actuator with an "articulation or joint such as a
ball rotatably mounted in a complementary socket." Id. 2:23-29; see also
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3 :44--49. Green's joint can be made stiff enough to permit transverse
flexibility, but for the fastener and actuator to "retain their relative rotational
orientation except when the configuration of the instrument is deliberately
altered by the user." Id. 2:33-38. Green discloses that the joint 150 is
"preferably tight enough so that during subsequent operation of the
apparatus, [the fastener and the actuator] maintain whatever relative angular
orientation they are placed in." Id. 4:11-16. Similarly, Green discloses that
socket surfaces 166, 172 "preferably engage ball 152 with sufficient force to
frictionally maintain whatever relative angular orientation [ of the fastener
and the actuator] is established by the user." Id. 6:48-52; see also Fig. 9.
Green thus discloses an articulation joint that permits articulation of an end
effector with respect to a handle, but is silent regarding whether the
articulation is passive as claimed.
Appellants argue claims 1-16 as a group. Appeal Br. 18-27. We
select claim 1 as representative. Claims 2-16 stand or fall with claim 1.
Appellants argue that Weller discloses flexing, rather than
articulation, and that one skilled in the art would understand the term
"flexing" to signify a more limited degree of movement than "articulating."
Appeal Br. 21. Appellants contend that "[t]his distinction is clearly
illustrated in Figs. 15A and 15B of Weller ... , in which the yoke assembly
(280) has a number of hinges within its length that 'flex' such that the yoke
assembly has a slight bend radius." Id.
Weller discloses a tissue fixation device having an end effector (e.g.,
16) that, in one embodiment, is attached to a working body 28 of an actuator
36 via a yoke/hinge assembly 280 that can flex via one or several additional
members 286,286', 290, 290' with pivots 284,284', 288, 288' along its
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length that form elongated arms. See Weller Figs. 1, 15A-15C, 16:4--15.
The elongated arms formed by the additional members can be "flexed to
have a bend radius, as shown in the example of FIG. 15B, to allow access to
various regions within [a] hollow body organ as well as to affix various
configurations of tissue." Id. 16:22-26. The elongated arms can be flexed
either by active manipulation by a user, or "may also be passively flexed by
contact against tissue." Id. 16:21-28.
The ordinary meaning of the verb "articulate" is "to unite by or as if
by means of a joint." https://www.merriam-
webster.com/dictionary/articulate (last visited July 25, 2018). This meaning
is consistent with use of the term in Appellants' Specification, and we do not
discern any different, or more specific, definition set forth by Appellants'
Specification. Appellants have provided no evidentiary support for their
proposition that "flexing" conventionally signifies a more limited degree of
movement than "articulating." We are not persuaded that Weller's
"flexing," which occurs due to pivoting of Weller's members 286, 286', 290,
290' fails to meet the definition of the verb "articulating," because the
proximal and distal ends of Weller's device, employing the embodiment of
its yoke illustrated in Figs. 15A---C, includes proximal and distal ends united
by a joint.
Appellants also argue that the hinges in Weller's yoke assembly 280
"do not constitute major structural joints of the device," such that although
Weller's flexing might be passive, it is "only relatively a slight movement of
a minimal joint," such that one skilled in the art would not have "the
requisite motivation or suggestion to configure joint (150) in Green to
passively articulate with any reasonable expectation of success." Appeal Br.
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22. According to Appellants, it is insufficient to find that Weller discloses a
general concept of passive movement if Weller does not provide a
"motivation or suggestion to apply that concept to a significant structural
joint that is responsible for connecting an entire surgical stapling end
effector to an instrument shaft or a control apparatus of a device." Id.
We are not persuaded that the Examiner's findings and conclusions
contain error. Even if Appellants are correct that one skilled in the art would
not apply Weller's passive articulation teaching to a major structural joint,
claim 1 recites a "passive articulation joint," rather than a "major structural
joint." Further, Appellants' Specification does not define "passive
articulation joint" as limited to a major structural joint or explain any
difference between major and minor structural joints, or differing
manipulations thereof.
Further, regarding motivation to combine Green and Weller, it is
obvious to substitute one known element or method for another to obtain
predictable results. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Weller establishes that active and passive manipulation of a joint are known
alternatives. See Weller 16:21-28. Appellants have not provided evidence
that, or a persuasive explanation regarding why, the results of passively
manipulating Green's joint 150 would be unpredictable. We are not
persuaded that the Examiner's reason for combining Green and Weller lacks
a rational basis.
Appellants similarly argue that where the principle of passive
operation in Weller is "only imparted to a reader ... in connection with a
series of hinged joints incorporated into the length of a yoke assembly ... to
provide only a minimal degree of flex (by providing just a slight bend
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radius) in an otherwise linear yoke assembly," one skilled in the art would
not consider it obvious to apply Weller's principle of passive operation "to a
vastly different type of joint that is intended to have a much greater radius of
articulating movement and is responsible for the major structural function of
connecting the entire body of a load-bearing end effector to the remainder of
a surgical instrument." Appeal Br. 25-26.
Lacking evidentiary support, we are not persuaded by that one skilled
in the art would consider Weller's disclosure of alternative active and
passive joint manipulation of an end effector to be inapplicable to Green's
ball joint 150 just because Green's ball joint 150 has a much greater radius
of articulating movement.
Appellants further argue that configuring Green's joint 150 to
articulate passively upon contact with the environment would destroy the
principle of operation of Green. According to Appellants, Green requires
that joint 150 "have an inherent structural tightness (i.e., not caused by an
additional mechanism such as a lock) that is sufficient to prevent [its end
effector] from 'passively' (i.e., freely) changing position [via] mere contact
with the surrounding environment ( e.g., surrounding tissue at the surgical
site)" during use, and, Appellants argue, modifying Green's joint 150 to
articulate passively, would "require ridding joint (150) of its tightness,
which would result in the inability of the [ end effector] to maintain any
angular orientation during its use and it would flail about, thereby destroying
its function." Appeal Br. 22-24.
The Examiner responds that passively moving Green's device "would
not destroy the joint of Green, or change the principle of Green," because
Green's joint 150 "would work with a passive movement" that is selectively
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prohibited by Fox's joint 109 that can lock as needed to "sustain and/or
control the 'tightness' of the joint of Green." Ans. 4--5. According to the
Examiner, Fox's lock allows the user to lock and unlock the joint and can be
combined with the device of Green, as modified to be passively actuated, to
control the tightness of the joint. Id. at 5.
Appellants' arguments do not persuade us that the Examiner erred.
Initially, Appellants have defined neither the "principle of operation" of
Green that is alleged to be changed by passive articulation, nor the intended
use of Green's device. Further, Appellants' arguments fail to take into
account that the Examiner is also modifying Green to have selective locking
as disclosed by Fox, which selective locking would be employed to prevent
any undesired "flailing about."
Appellants lastly argue that the rejections are a product of
impermissible hindsight and, therefore, constitute clear error. Appeal Br. 27.
Because the Examiner provides a reasoning with a rational basis for
combining Green with Weller and Fox, we are not persuaded that the
rejection is based on impermissible hindsight. See In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971) ("[a]ny judgment on obviousness is in a
sense necessarily a reconstruction based on hindsight reasoning, but so long
as it takes into account only knowledge which was within the level of
ordinary skill in the art at the time the claimed invention was made and does
not include knowledge gleaned only from applicant's disclosure, such a
reconstruction is proper.").
For the reasons set forth above, we are not persuaded that the
Examiner's findings or conclusions are in error. We sustain the rejection of
claim 1. Claims 2-16 fall with claim 1.
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DECISION
We AFFIRM the rejection of claims 1-16 as unpatentable over Green,
Weller, and Fox.
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
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