Ex Parte Kilcoyne et al

Patent Trial and Appeal Board

Nov 10, 2014

10687336 (P.T.A.B. Nov. 10, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

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

Appeal 2012-009003
Application 10/687,336
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a system
for measuring physiological parameters in the body of a patient indicative of
gastroesophageal reflux. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Given Imaging,
Ltd. (See App. Br. 1.)
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Statement of the Case
Background
“Gastroesophageal reflux is a condition in which gastric acid refluxes,
or flows in the direction opposite to the normal flow, from the stomach into
the esophagus . . . reflux episodes may result in a potentially severe problem
known as gastroesophageal reflux disease (GERD)” (Spec. 1, ll. 12–15).
The Specification teaches that the “primary and most reliable method of
objectively diagnosing GERD, however, is 24-hour measurement of pH
within the lower esophagus” (Spec. 2, ll. 28–29).
The Claims
Claims 50–60 are on appeal. Independent claim 50 is representative
and reads as follows:
50. A system for measuring physiological parameters in the
body of a patient indicative of gastroesophageal reflux, the
system comprising:
a monitoring device, said monitoring device comprising a
housing adapted to be implanted in the body of a patient by
attachment to tissue inside the body and a plurality of sensors
included in said housing, wherein each of the plurality of
sensors is capable of independently measuring a different
respective physiological parameter indicative of
gastroesophageal reflux and wherein said monitoring device
periodically transmits a signal indicative of the value of the
respective physiological parameter measured by each of the
plurality of sensors; and
a receiver that receives the signals from the monitoring
device, said signals representing measurements made by the
respective plurality of sensors, monitors the physiological
parameters indicative of gastroesophageal reflux based on the
received signals, and determines at least the presence of
gastroesophageal reflux based on each of said plurality of
signals received from said plurality of sensors.
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The issues
A. The Examiner rejected claims 50, 51, and 58–60 under 35 U.S.C.
§ 103(a) as being obvious over Anggiansah2 and Johnsson3 (Ans. 4–7).
B. The Examiner rejected claims 52–55 under 35 U.S.C. § 103(a) as
being obvious over Anggiansah, Johnsson, and Brune4 (Ans. 7–9).
C. The Examiner rejected claims 56 and 57 under 35 U.S.C. § 103(a) as
being obvious over Anggiansah, Johnsson, Brune, and Kumar5 (Ans. 9–10).
A. 35 U.S.C. § 103(a) over Anggiansah and Johnsson
The Examiner finds that “Anggiansah et al disclose a system for
measuring physiological parameters in the body of a patient indicative of
gastroesophageal reflux” but finds that “Anggiansah et al do not expressly
disclose that the determination of gastroesophageal reflux is based upon both
the pH and pressure signals” (Ans. 5). The Examiner finds that “Johnsson et
al teach that pressure data is highly valuable in gastroesophageal reflux
determination and is the single variable that correlates most strongly to the
amount of reflux determined using at least pH monitoring” (Ans. 5–6).
The Examiner finds it obvious to “have the determination of
gastroesophageal reflux performed by Anggiansah et al be made with both
pH and pressure signals . . . to more accurately determine the presence and

2 Anggiansah et al., Primary peristalsis is the major acid clearance
mechanism in reflux patients, 35 GUT 1536–1542 (1994).
3 Johnsson et al., Determinants of gastro-oesophageal reflux and
their inter-relationships, 76 BR. J. SURGERY 241–244 (1989).
4 Brune, S.A., US 5,984,875, issued Nov. 16, 1999.
5 Kumar et al., US 6,416,471 B1, issued July 9, 2002.
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amount of gastroesophageal reflux in the patient due to a known correlation
between pressure, pH, and reflux” (Ans. 6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Anggiansah and Johnsson render the
claims obvious?
Findings of Fact
1. Anggiansah teaches that “pH monitoring (Synectics Medical,
Sweden) was performed using an antimony pH sensor . . . . The pH catheter
was inserted transnasally until the sensor registered a low pH . . . . The pH
sensor was positioned 5 cm above the manometrically defined upper margin
of the lower oesophageal sphincter” (Anggiansah 1537, col. 1).
2. Anggiansah teaches that “[b]oth the pH and reference catheters
were secured to the patient with micropore tape (3M, St Paul, USA) and
connected to a digitrapper” (Anggiansah 1537, col. 1).
3. Anggiansah teaches that “[o]esophageal manometry was
performed using a catheter with six, surface mounted miniature pressure
transducers . . . . The mean lower oesophageal sphincter tonic pressure
above intragastric pressure was recorded in mm Hg” (Anggiansah 1537, col.
1).
4. Anggiansah teaches:
A catheter consisting of a dual channel antimony pH
electrode (Synectics Medical, Sweden) positioned 15 cm
apart was used to measure both intraoesophageal and
intragastric pH. This separate catheter was bonded to the
pressure sensing catheter so that the proximal pH sensor was
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at 5 cm above the lower oesophageal sphincter and the
distal pH sensor 15 cm below it.

(Anggiansah 1537, col. 2.)
5. Anggiansah teaches that “pressure and pH measurements were
monitored simultaneously at 8 samples/s (minimum sampling rate for
oesophageal peristaltic activity was 6 samples/s) on the seven channel, 24
hour ambulatory recording device . . . . This device used an internal
computer to record the data in a compression form” (Anggiansah 1537, col.
2).
6. Anggiansah teaches that “the ambulatory pH data showed that
all the patients studied had pathological gastro-oesophageal reflux”
(Anggiansah 1539, col. 1).
7. Johnsson teaches that “[w]e have shown that the pressure in the
distal oesophageal high pressure zone was the single factor that best
correlated to the amount of reflux in our patients” (Johnsson 242, col. 2).
8. Johnsson teaches that “Table 1 shows that the pressure in the
distal oesophageal high pressure zone is the single factor that best
determines gastro-oesophageal competence and that it explains c. 17 percent
of the variability in acid reflux” (Johnsson 243, col. 2).
Principles of Law
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the [S]pecification.” In re Hyatt,
211 F.3d 1367, 1372 (Fed. Cir. 2000)
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
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KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
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 over the phrase “adapted to be implanted in the body of a
patient by attachment to tissue inside the body” in claim 50.
We first turn to the Specification to determine whether this phrase has
any specific definition. The Specification does not define the phrase
“adapted to be implanted in the body of a patient by attachment to tissue
inside the body” of claim 50. The Specification does provide a specific
example of such an attachment, where a “pin is advanced through the tissue
to retain the device at the attachment site” (Spec. 5, ll. 1–2). However, none
of the claims are limited to this exemplary mode of attachment. Further, the
Specification does not identify any specific structural limitations required by
this phrase. See In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299
(Fed. Cir. 2007) (“[I]t is improper to ‘confin[e] the claims to th[e]
embodiments’ found in the specification.”)
Appellants contend that “an object that is inserted into the body and
taped externally to the skin is not implanted inside the body, but rather has a
portion attached outside the body and a different portion inserted inside the
body, and cannot be said to be attached to a tissue inside the body” (App. Br.
5). Appellants contend that “[a]ttachment of a device to a tissue outside the
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body, as disclosed in Anggiansah, is not equivalent to attachment of a device
to a tissue inside the body” (App. Br. 6).
We are not persuaded because the phrase “adapted to be implanted in
the body of a patient by attachment to tissue inside the body” imposes no
specific structural requirements on the device regarding the mode of
attachment. We interpret the phrase as an “intended use” recitation because
the claim is not a method which requires “attaching” the device, but rather is
a product claim which simply requires a device “adapted” for attachment,
with no specific device structural requirements identified for the attachment
process. The Examiner reasonably finds that the prior art Anggiansah
device “is fully capable of ‘attachment’ to tissue inside the body, i.e. in the
throat or even into an incision/cavity of the patient, due to the lack of a
positive recitation of the attachment structure” (Ans. 11). See In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the
recitation of a new intended use for an old product does not make a claim to
that old product patentable.”)
Appellants contend that “according to Johnsson, by measuring the
pressure level in the distal oesophageal high pressure zone one can estimate
the amount of gastro-oesophageal reflux in the monitored esophagus.
However, Johnsson does not detect and does not enable detection of gastro-
oesophageal reflux itself by measuring pressure level” (App. Br. 4).
We are not persuaded. None of the claims require that pressure
detection alone must function to detect reflux, nor do these device claims
require anything more than the combination of a pH sensor and pressure
sensor. Anggiansah teaches the combination of a pH sensor and pressure
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sensor in reflux patients (FF 1–6), while Johnsson provides further reasons
for including a pressure sensor because “pressure in the distal oesophageal
high pressure zone was the single factor that best correlated to the amount of
reflux in our patients” (Johnsson 242, col. 2; FF 7).
Appellants contend that
Two catheters bonded together is not equivalent to the
sensors being housed together. Therefore, Anggiansah does
not teach or suggest at least “a plurality of sensors included
in said housing, wherein each of the plurality of sensors is
capable of independently measuring a different respective
physiological parameter indicative of gastroesophageal
reflux”, as recited in claim 50

(App. Br. 7).
We are not persuaded because neither the Specification nor claim 50
specifically require a “single” housing, but simply require “a housing.” “As
a general rule, the words ‘a’ or ‘an’ in a patent claim carry the meaning of
‘one or more.’ . . . . That is particularly true when those words are used in
combination with the open-ended antecedent ‘comprising.’” TiVo, Inc. v.
EchoStar Communications Corp., 516 F.3d 1290, 1303 (Fed. Cir.
2008)(internal citations omitted). In the instant case, the phrase “a housing”
is used in combination with “the system comprising,” and neither the claim
nor the Specification clearly require a “single” housing, rather than “one or
more” housings.
Even if we interpret the claim to require a “single” housing and we
interpret Anggiansah’s device as not composed of a single housing, the
instant rejection is for obviousness, not anticipation. The ordinary artisan
would have found it obvious to integrate two components taught by the prior
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art as bonded together (FF 4) into a single housing. See In re Larson, 340
F.2d 965, 968 (CCPA 1965) (making elements of a device integral or
separable is considered an obvious design choice and does not render an
invention patentable); see also KSR, 550 U.S. at 416 (“[W]hen a patent
‘simply arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
such an arrangement, the combination is obvious.”).
Appellants contend that “the correlation between distal esophageal
pressure and amount of reflux in Johnsson is sufficiently different from
Anggiansah’s measurement of pressure throughout the esophagus, such that
a person of skill in the art would not combine the two” (App. Br. 8).
We are not persuaded because Johnsson provides additional reasons
for Anggiansah to continue using the disclosed combination of a pH sensor
and pressure sensor because both sensors function to determine
gastrointestinal reflux (FF 6, 7). Appellants provide no evidence supporting
their conclusion that the ordinary artisan would not combine these teachings,
instead relying upon attorney argument. See In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of
evidence”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Anggiansah and Johnsson render the claims obvious.
B. 35 U.S.C. § 103(a) rejections
Appellants do not argue separately the claims in these obviousness
rejections (see App. Br. 9–10). Having affirmed the obviousness rejection
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over Anggiansah and Johnsson for the reasons given above, we also find that
the further obvious combinations with Brune and Kumar render the
remaining claims obvious for the reasons given by the Examiner (see Ans.
7–10).
SUMMARY
In summary, we affirm the rejection of claim 50 under 35 U.S.C.
§ 103(a) as being obvious over Anggiansah and Johnsson. Pursuant to
37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 51, and 58–60
as these claims were not argued separately.
We affirm the rejection of claims 52–55 under 35 U.S.C. § 103(a) as
being obvious over Anggiansah, Johnsson, and Brune.
We affirm the rejection of claims 56 and 57 under 35 U.S.C. § 103(a)
as being obvious over Anggiansah, Johnsson, Brune, and Kumar.

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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