Ex Parte Byrum et al

Patent Trial and Appeal Board

Oct 26, 2016

12557836 (P.T.A.B. Oct. 26, 2016)

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.
12/557,836 09/11/2009 Randal T. Byrum END-6479 5204
21884 7590 10/26/2016
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
MATTHEWS, CHRISTINE HOPKINS
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
10/26/2016 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
__________

Ex parte RANDAL T. BYRUM, SEAN P. CONLON,
ALEC J. GINGGEN, BRET W. SMITH,
DEAN L. GARNER, and DANIEL F. DLUGOS JR.
__________

Appeal 2015-001376
Application 12/557,836
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL1
This Appeal under 35 U.S.C. § 134 involves claims 1, 10, and 11
(App. Br. 3). Examiner entered rejections under 35 U.S.C. §102(b) and 35
U.S.C. §103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 Appellants identify the Real Party in Interest as Ethicon Endo-Surgery, Inc.
(App. Br. 1).
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Application 12/557,836

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STATEMENT OF THE CASE
Appellants’ “invention relates to laparoscopic implants designed to be
implanted in the body of a patient around a biological organ having a pouch
or duct to regulate functioning of the organ or duct” (Spec. 1:6–8). More
particularly, Appellants’ invention “is directed to an implantable
telemetrically-powered and controlled ring having a detachable antenna
suitable for use as a gastric band to treat obesity or as an artificial sphincter”
(id. at 1:8–10). Independent claim 1 is representative and reproduced in
Appellants’ Appeal Brief.

1. Apparatus for regulating the functioning of a patient's
organ or duct, comprising:
an elongated member having first end and second ends;
a fastener disposed on the first end of the elongated
member, the fastener configured to engage the second end of the
elongated member so that the elongated member forms a ring
around the organ or duct;
a tension element disposed for movement within the
elongated member;
a drive element associated with and engaging the tension
element for causing the tension element to control the tension
applied by the elongated member against a patient's body organ
or duct; and
an antenna/controller pod releasably coupled to the
elongated member for control of the drive element, wherein an
antenna cable connects the antenna/controller pod to the
elongated member, the antenna cable including a proximal end
which is selectively secured to a distal end of the
antenna/controller pod by threads or a bayonet style connection
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in a manner maintaining electrical connections between the
antenna/controller pod and the antenna cable.
(Claims App’x, 19.)

Claim 11 stands rejected under 35 U.S.C. § 102(b) as being
anticipated by Bachmann.2
Claims 1 and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Paganon3 and Pool.4

Anticipation:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
Examiner’s finding that Bachmann teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Bachmann teaches that “[f]or treatment of urinary incontinence, the
ring may be further modified to minimize the volume of the ring
surrounding the urethra by moving the actuator motor to a location
elsewhere in the lower abdomen or pelvis, and coupling the actuator to the
motor via a transmission cable” (Bachman ¶ 141; see also Ans. 4–5).
ANALYSIS
Appellants’ independent claim 11 is for a method and requires, inter
alia, (a) “inserting an antenna/controller pod into the patient through a first
body opening remote from the patient’s organ or duct to be regulated;”

2 Bachmann et al., US 2005/0143765 A1, published June 30, 2005.
3 Paganon, US 2007/0213836 A1, published Sept. 13, 2007.
4 Pool et al., US 2009/0062825 A1, published Mar. 5, 2009.
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(b) “inserting through a second body opening spaced from the first body
opening an elongated restrictive device”, and (c) “connecting in situ the
antenna/controller pod via a cable to the drive element of the elongated
restrictive device in order to control movement of the tension element” (see
Claims App’x, 20–21).
Examiner finds that
Bachmann discloses that a controller (actuator) is coupled to the
drive element (motor) via a transmission cable. This takes place
in situ as Bachmann teaches moving the motor to a location
elsewhere in the lower abdomen or pelvis and then coupling the
controller (actuator) to the drive element (motor) via a
transmission cable [0141]. Since the controller (actuator) is
already located in the lower abdomen or pelvis, coupling the
controller (actuator) to the motor via a transmission cable must
occur in situ.
(Ans. 4–5.) We are not persuaded.
Instead, we agree with Appellants that:
the fact the actuator is connected to a motor via a transmission
cable and the motor may be positioned at locations within the
abdomen or pelvis, does not lead to the conclusion of an in situ
connection, either explicitly or inherently as required by the
pending claim at issue. Bachmann’s statement merely indicates
a connection, and does not disclose, either explicitly or
inherently, the step of “connecting in situ”[] as required by claim
11.
(Br. 9–10; see also FF 1; Reply Br. 2–3.) “Inherency . . . may not be
established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient.”
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MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 3–4), and provide the following findings for emphasis.
FF 2. Appellants’ Figure 9 is reproduced below:

Figure 9 shows “the antenna/controller pod 23 encloses a printed circuit
board 76 that carries the antenna 83 and microcontroller circuitry of the
gastric band 21” (Spec. 17:4–6).

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FF 3. Paganon’s Figure 2 is reproduced below:

Figure 2 shows
An implantable surgical ring (1, 10) for surrounding one or more
organs having a pouch or a duct, in order to modify the section
of the passage in the organ(s), the ring (1, 10) being in the form
of a flexible strap (2, 20) extending between first and second ends
(3, 4, 40, 400), the flexible strap (2, 20) being provided towards
its first and second ends (3, 4, 40, 400) with respective male and
female closure elements (5, 50; 6, 60, 600) arranged to co-
operate in such a manner that the flexible strap (2, 20) forms a
closed loop, the female closure element (6, 60, 600) permanently
forming a closed collar.
(Paganon Abstract; see also Ans. 3–4.)

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FF 4. Paganon’s Figure 9 is reproduced below:

Figure 9 shows that “[t]he electric motor 15, 150, which does not have any
internal power supply, is functionally connected via an electrical connection
17A to the circuit of the receiver antenna 16” (Paganon ¶ 73; see also Ans.
3–4).
FF 5. Paganon suggests that “the actuator-forming electric motor 15, 150 is
advantageously connected to a subcutaneous receiver circuit provided with a
receiver antenna 16 . . . for receiving a radiofrequency (RF) control and
power signal, the assembly being designed to be implanted in the body of
the patient” (Paganon ¶ 72; see also Ans. 3–4).
FF 6. Pool suggests “[a] system [that] includes an adjustable implant
configured for implantation internally within a subject, . . . a drive
transmission configured to alter a dimension of the adjustable implant” (Pool
Abstract; see also Ans. 4).

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FF 7. Pool’s Figure 68 is reproduced below:

Figure 68 shows that
the proximal end of the drive cable sheath 1026 . . . may have a
quick disconnect feature so that the drive cable 1050 and/or
implantable interface 1010 may be rapidly changed. In one
aspect, the proximal end of the drive cable sheath 1026 includes
a flanged end portion 1027 that is dimensioned to abut a sheath
retaining nut 1046 that engages with mating threads 1048 located
at one end of the housing 1062.
(Pool ¶ 231; see also Ans. 4.)
ANALYSIS
Appellants’ independent claim 1 requires, inter alia, “an
antenna/controller pod releasably coupled to the elongated member for
control” (see Appellants’ claim 1).
Examiner finds that “Paganon discloses an apparatus for regulating
the functioning of a patient’s organ or duct, comprising: an elongated
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member 2 having first end 3 and second ends 4 . . .” (Ans. 3). Examiner
acknowledges that “Paganon fails to disclose explicitly the connection
between the antenna/controller pod 16 and the antenna cable and the pod 16
and the retaining base” (id. at 3–4). Examiner turns to Pool and finds that
Pool suggests “that the proximal end of the drive cable sheath may have a
quick disconnect feature so that the drive cable 1050 and the implantable
interface (‘controller pod’) 1010 may be rapidly changed” (id. at 4).
Examiner concludes that it would have been obvious to “have incorporated a
threaded connection as taught by Pool, in a releasable coupling between a
controller and cable or controller and retaining base of a gastric banding
system as suggested by Paganon, as such a coupling allows a quick
disconnect feature to the system ([0231] of Pool)” (id.).
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 3–6; FF 3–7), and agree that the claims would have been
obvious over Paganon and Pool. We address Appellants’ arguments below.
As an initial matter, Examiner asserts that “claim 1 does not require
that the ‘antenna/controller pod’ receive wireless signals. Moreover, the
terms ‘antenna’ and ‘cable’ are presented in the alternative with the
inclusion of the slash in between the terms. Thus presently, the claim is
interpreted as a ‘controller pod’” (Ans. 5).
We are not persuaded and agree with Appellants that
[w]hile use of a “/” may indicate “or,” this is not the sole meaning
as it may be used to identify a clear connection between words.
The use of the “/” in the present application identifies a clear

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connection between the words “antenna” and “controller” as it
indicates the dual functions of the pod.
(App. Br. 16; FF 2.) We are, however, not persuaded by Appellants’
contention that
while element 1010 of Pool is an implantable interface, the
implantable interface is not an antenna/controller pod as claimed
in accordance with the present invention. Rather, implantable
interface 1010 includes a magnetic element 1064 used to rotate
the drive cable so as to cause linear movement of an actuator. A
magnetic element used to rotate a drive cable so as to cause linear
movement of an actuator is very different from the claimed
antenna/controller pod receiving wireless signals for control
thereof. The considerations associated with the provision of a
quick release mechanism in conjunction with the mechanical
based implantable interface 1010 of Pool are very different from
those associated with an electrical based antenna/controller pod
as claimed in accordance with the present invention or the
receiver antenna 16 of Paganon.
(App. Br. 14–15; see also Reply Br. 3.)
Paganon suggests “[a]n implantable surgical ring (1, 10) for
surrounding one or more organs having a pouch or a duct, in order to modify
the section of the passage in the organ(s)” (FF 3). Paganon suggests that
“[t]he electric motor 15, 150, which does not have any internal power
supply, is functionally connected via an electrical connection 17A to the
circuit of the receiver antenna 16” (FF 4 (emphasis added)), and that “the
actuator-forming electric motor 15, 150 is advantageously connected to a
subcutaneous receiver circuit provided with a receiver antenna 16 . . . for
receiving a radiofrequency (RF) control and power signal, the assembly
being designed to be implanted in the body of the patient” (FF 5 (emphasis
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added)). Therefore, Paganon suggests an “antenna/controller pod” as
claimed.
Pool suggests “[a] system [that] includes an adjustable implant
configured for implantation internally within a subject, . . . a drive
transmission configured to alter a dimension of the adjustable implant” (FF
6). Pool evidences that “the proximal end of the drive cable sheath 1026
. . . may have a quick disconnect feature so that the drive cable 1050 and/or
implantable interface 1010 may be rapidly changed” (FF 7 (emphasis
added)).
We therefore agree with the Examiner that it would have been
obvious to provide the releasable coupling as taught by Pool to the
implantable device of Paganon (see Ans. 4). The combined teachings of
Pool and Paganon regarding a quick disconnect feature, would yield
predictable results of an implantable device having a controller/pod that can
be rapidly changed from the implantable device.
“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references []. [The reference] must be read, not in isolation,
but for what it fairly teaches in combination with the prior art as a whole.”
In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). See also In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[A]ttorney argument [is] not
the kind of factual evidence that is required to rebut a prima facie case of
obviousness”).
In regard to claim 10, Appellants contend that “this claim relate[s] to a
threaded attachment between the antenna cable and the antenna/controller
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pod. . . . Appellants find no disclosure, either explicitly or implicitly,
regarding a threaded attachment as claimed” (App. Br. 17).
We are not persuaded. Pool suggests that “the proximal end of the
drive cable sheath 1026 includes a flanged end portion 1027 that is
dimensioned to abut a sheath retaining nut 1046 that engages with mating
threads 1048 located at one end of the housing 1062” (FF 7 (emphasis
added)).
CONCLUSION OF LAW
The rejection of claim 11 under 35 U.S.C. § 102(b) as being
anticipated by Bachmann is reversed.
The rejection of claims 1 and 10 under 35 U.S.C. § 103(a) as
unpatentable over Paganon and Pool is affirmed.

TIME PERIOD FOR RESPONSE
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-IN-PART