Ex Parte Kilcoyne et al

Board of Patent Appeals and Interferences

Mar 29, 2012

10896553 (B.P.A.I. Mar. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN T. KILCOYNE, ROSS TSUKASHIMA,
GEORGE M. JOHNSON, and CHRISTOPHER KLECHER
__________

Appeal 2011-000411
Application 10/896,553
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS and
DEMETRA J. MILLS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to a
medical sensor device for placement within a body lumen. The Examiner
has rejected the claims for anticipation, obviousness, and obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse
the anticipation and obviousness rejections but affirm the double patenting
rejection.
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STATEMENT OF THE CASE
The Specification discloses “a method and system for monitoring
physiological parameters within a body lumen (cavity)” (Spec. 8:13-14).
The Specification discloses an “implantable probe for monitoring one or
more parameters in the esophagus, such as pH, in connection with the
detection of gastroesophageal reflux disease” (id. at 1:8-10). Figure 4 of the
Specification is shown below:

Figure 4 is said to show a schematic illustration of physiological monitor 18
(id. at 12:22-23). The Specification discloses that “an outer shell 120
surrounds the monitor‟s 18 electronic components” (id. at 12:23-24). The
Specification discloses that “the monitor shell 120 has an eyelet attachment
122, which serves to hold a suture 30, string, staple, or other securing
structure, which can secure the monitor to the wall of the esophagus or other
body lumen wall” (id. at 13:32-14:2).
Claims 55-59, 62, 66-68, 75-81, 84, 88 and 95-97 are on appeal.
Claim 55 is representative and reads as follows:
55. A medical device for placement within a body lumen of a patient,
the device comprising:
a device shell sized for introduction into the body lumen;
a sensor, carried by the device shell, to sense at least one
physiological parameter within the body lumen; and
a securing structure mounted to the device shell to secure the device
shell relative to a surface within the body lumen, wherein the securing
structure is at least partially degradable,
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wherein said device shell and said sensor are to remain in the body
lumen at least until said securing structure is substantially downgraded.

The claims stand rejected as follows:
• claims 55, 56, 66, 68, 75-78, 88, and 95-96 under 35 U.S.C. §
102(b) in view of Miyawaki;
1

• claims 57-59, 79-81, and 97 under 35 U.S.C. § 103(a) in view of
Miyawaki and Mills;
2

• claim 67 under 35 U.S.C. § 103(a) in view of Miyawaki and
Wolinsky;
3

• claims 62 and 84 under 35 U.S.C. § 103(a) in view of Miyawaki
and Schneider;
4
and
• claims 75, 77, 79, and 81 for obviousness-type double patenting in
view of claim 24 of U.S. Patent 6,689,056.
5,6

Issue
The Examiner has rejected claims 55-56, 66, 68, 75-78, 88, and 95-96
under 35 U.S.C. § 102(b) as anticipated by Miyawaki. The Examiner has
also rejected, under 35 U.S.C. § 103(a), claims 57-59, 79-81, and 97 in view

1
Miyawaki et al., US 5,697,384, issued Dec. 16, 1997.
2
Mills et al., US 5,080,663, issued Jan. 14, 1992.
3
Wolinsky et al., US 6,699,186 B1, issued Mar. 2, 2004.
4
Schneider, US 3,636,956, issued Jan. 25, 1972
5
Kilcoyne et al., U.S. Patent 6,689,056 B1, issued Feb. 10, 2004.
6
With regard to the obviousness-type double patenting rejection, the Appeal
Brief states that “[a]pplicants have offered to provide a terminal disclaimer
upon indication of allowable claims” (Appeal Br. 21). Since Appellants
have not disputed the merits of the obviousness-type double patenting
rejection, we summarily affirm it.

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4
of Miyawaki and Mills, claim 67 in view of Miyawaki and Wolinsky, and
claims 62 and 84 in view of Miyawaki and Schneider. Since the same issue
is dispositive for all of these rejections, we will consider them together.
The Examiner finds that Miyawaki discloses
a medical device for placement within a body lumen of a
patient, the device comprising: a device shell 1 sized for
introduction into the body lumen…; a sensor 82, carried by the
device shell…; a securing structure 8, 9 mounted to the device
shell to secure the device shell relative to a surface within the
body lumen . . .

(Answer 3; citing Fig. 6a and 6b of Miyawaki). The Examiner finds that
Miyawaki discloses that “the securing structure is at least partially
degradable” (id.).
Appellants contend that Miyawaki does not disclose a device with “a
securing structure mounted to the device shell to secure the device shell
relative to a surface within the body lumen, wherein the securing structure is
at least partially degradable,” as required by claim 55, because the cited
Miyawaki degradable element is not a “securing structure” within the
meaning of claim 55 (Appeal 16). Appellants argue that the cited
degradable element “has no part in securing the device to the surface within
a body lumen” (id.).
The issue presented is: Does the evidence of record support the
Examiner‟s finding that Miyawaki discloses a securing structure that is at
least partially degradable?”
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Findings of Fact
1. The Specification discloses that the “monitor 18 can … be attached
to the esophagus 30 through the use of a clip …. This clip … can hold the
monitor in place by capturing, or „pinching,‟ the mucosa and submucosa of
the esophagus 30 between its arms or „jaws.‟” (Spec. 14:6-10.)
2. The Specification discloses that the clip can have “parts made of
… absorbable or dissolvable materials …. This dissolvable material can
facilitate the removal of the monitor 18 from the wall of the esophagus 30
after a given period of time. As materials in the clip dissolve … the clip will
break free of the esophagus 30” (id. at 14:10-15).
3. Miyawaki discloses “an internal identification apparatus to be
swallowed by a ruminant and that stays in the first or second stomach of the
ruminant” (Miyawaki, col. 1, ll. 5-8).
4. Miyawaki discloses that the “apparatus has a casing whose weight
and shape are designed to stay in the first or second stomach once it is
swallowed” (id. at col. 2, ll. 43-45).
5. Miyawaki discloses that the apparatus is “20 to 60 g in weight and
has hairs of 10 to 15 cm in diameter so that the apparatus … may stay in the
first stomach …. The hairs may be made from any material if it is not
digested …. It is preferable that the hairs are hard like straw” (id. at col. 4, ll.
41-45).
6. Miyawaki discloses that “[t]o keep the apparatus in the second
stomach …, the diameter D of the capsule 1 will be about 10 to 25 mm, and
the length L thereof will be about 40 to 150 mm. The weight of the
apparatus … will be about 50 to 150 g” (id. at col. 4, ll. 45-48).
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7. Figure 6(a) and 6(b) of Miyawaki are shown below:

Miyawaki discloses that “FIG. 6(a) is an outside view showing an internal
identification apparatus 13 … and FIG. 6(b) is a side view showing the
apparatus 13 before being applied to an animal” (id. at col. 6, ll. 7-10).
8. Miyawaki discloses that the “apparatus 13 has fins 8 that protrude
sidewards when the apparatus 13 enters the first or second stomach of a
ruminant, to surely keep the apparatus 13 in the stomach” (id. at col. 6, ll.
11-13).
9. Miyawaki discloses that as “shown in FIG. 6(b), the fins 8 are
closed with a band 9 before the apparatus 13 is applied to an animal. When
the band 9 melts in the first or second stomach of a ruminant, the fins 8
protrude sidewards as shown in FIG. 6(a)” (id. at col. 6, ll. 14-17).
Analysis
Claim 55 is directed to a medical device for placement within a
patient body lumen that comprises, among other things, a “securing structure
[that] is at least partially degradable.”
Miyawaki discloses a medical device for placement in the stomach of
animals via swallowing of the device, wherein the device is kept in the
stomach via a particular geometry of the device such as the size of the
device or projections from the device such as straws or fins. In one
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embodiment (i.e. Miyawaki Fig. 6a and 6b), Miyawaki discloses that fins
may be secured to the device with a band that melts in the stomach and
releases the fins (i.e. the securing structure). The Examiner asserts that the
combination of the fins and the band is the claimed securing structure that is
partially degradable.
Appellants argue that the degradable band of Miyawaki is not a
“securing structure” within the meaning of claim 55 (App. Br. 16).
Appellants argue that the cited degradable element “has no part in securing
the device to the surface within a body lumen” (id.). We agree.
Miyawaki‟s degradable band holds Miyawak‟s securing structure
(e.g., the fins) in a closed position before the apparatus is applied to an
animal (see FF 7; Fig. 6(b); see also Miyawaki, col. 6, ll. 13-15). When
Miyawaki‟s band melts, the securing structure protrudes sidewards and
secures the device in a body lumen (see FF 7; Fig. 6(a); see also Miyawaki,
col. 6, ll. 15-17). Accordingly, Miyawak‟s band is not a component of the
securing structure and plays no part in actually securing the device “relative
to a surface within the body lumen” as is required by Appellants‟ claimed
invention.
Thus, the evidence of record does not support the Examiner‟s finding
that Miyawaki discloses the medical device of claim 55 with a securing
structure that is as at least partially degradable. Thus, we reverse the
rejection of independent claim 55 and dependent claims 56, 66, and 68.
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Independent claim 95
7
is similar to claim 55 and requires “means,
mounted to the device shell, for securing the device shell relative to a
surface within the body lumen, wherein the securing means is at least
partially degradable.” As discussed above, the Examiner has not adequately
explained how Miyawaki discloses the required securing means. Thus, the
rejection of independent claim 95 and dependent claims 96 and 97 is also
reversed.
Independent claim 75
8
is directed to method for remotely monitoring a
physiological parameter in a body lumen that comprises introducing a
medical device into the body lumen and “securing the medical device
relative to a surface within the body lumen with a securing structure

7
Claim 95 is as follows: A medical device for placement within a body
lumen of a patient, the device comprising:
a device shell sized for introduction into the body lumen;
means, carried by the device shell, for sensing at least one
physiological parameter within the body lumen; and
means, mounted to the device shell, for securing the device shell
relative to a surface within the body lumen, wherein the securing means is at
least partially degradable, wherein said device shell and said sensor are to
remain in the body lumen at least until said securing structure is
substantially degraded.
8
Claim 75 is as follows: A method for remotely monitoring a physiological
parameter in a body lumen of a patient, the method comprising:
introducing into the body lumen a medical device comprising a device
shell and carrying a sensor to sense at least one physiological parameter
within the body lumen;
securing the medical device relative to a surface within the body
lumen with a securing structure mounted to the device shell that is at least
partially degradable,
wherein said device shell and said sensor are to remain in the body
lumen at least until said securing structure is substantially degraded.
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mounted to the device shell that is at least partially degradable.” Thus, claim
75 also requires a medical device with securing structure that is at least
partially degradable. Thus, we also reverse the rejection of independent
claim 75 and dependent claims 76-78 and 88.
With regard to the rejections under 35 U.S.C. § 103(a), the Examiner
relies on the same findings and reasoning with regard to Miyawaki, as
discussed above, and thus we also reverse these rejections.
SUMMARY
The rejection of claims 55-56, 66, 68, 75-78, 88, and 95-96 under 35
U.S.C. § 102(b) is reversed.
The rejection of claims 57-59, 62, 67, 79-81, 84 and 97 under 35
U.S.C. § 103(a) is reversed.
The rejection of claims 75, 77, 79, and 81 for obviousness-type double
patenting is summarily 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

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