Ex Parte Say et al

Patent Trial and Appeal Board

Dec 23, 2016

12718891 (P.T.A.B. Dec. 23, 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.
12/718,891 03/05/2010 James L. Say 11554.0006USC2 5874
23552 7590 12/28/2016
MERCHANT & GOULD P.C.
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903
EXAMINER
MESSERSMITH, ERIC J
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
12/28/2016 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):
US PT023552@ merchantgould .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES L. SAY, HENNING SAKSLUND, and
MICHAEL F. TOMASCO
Appeal 2015-004670
Application 12/718,891
Technology Center 3700
Before MICHAEL L. HOELTER, JEFFREY A. STEPHENS, and
NATHAN A. ENGELS, Administrative Patent Judges.
ENGELS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
26, 28—32, and 34. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2015-004670
Application 12/718,891
ILLUSTRATIVE CLAIM
Claim 26, reproduced below, is illustrative of the claimed subject
matter:
26. An on-line lactate monitoring system comprising:
a catheter including a catheter sheath and a catheter hub;
an adapter that connects to the catheter hub;
a lactate sensor including an electrically conductive
portion that extends through the catheter sheath and includes a
sensing end positioned adjacent to a distal tip of the catheter
sheath, the lactate sensor including a sensing material
positioned at the sensing end of the lactate sensor, the sensing
material including a redox compound;
a reference electrode carried with the catheter, wherein a
potential is applied between the lactate sensor and the reference
electrode;
a source of sensor calibration fluid including a calibrant;
a calibration fluid flow line providing fluid
communication between the source of sensor calibration fluid
and the sensing end of the lactate sensor, the calibration fluid
flow line extending through the adapter, the catheter hub, and
the catheter sheath; and
a pump including a piston that is reciprocally mounted
within a cylinder, wherein the piston is configured to cause a
blood sample to be drawn from a patient and conveyed into the
catheter sheath to bathe the sensing end of the lactate sensor
with the blood sample, and wherein the piston[]is configured to
cause the sensor calibration fluid to flow through the calibration
fluid flow line from the source of sensor calibration fluid to the
sensing end of the lactate sensor.
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Application 12/718,891
THE REJECTION
Claims 26, 28—32, and 34 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable in view of the combination of Miyasaka et al. (US
4,813,423; Mar. 21, 1989) and Lim (US 4,830,011 May 16, 1989).
ANALYSIS
The Examiner finds Miyasaka teaches each limitation of claim 26
except those directly related to sensing lactate and cites Lim as evidence that
lactate sensors were well known in the art. Ans. 2—3; Final Act. 3^1.
Specifically, the Examiner states “[t]he only difference between the prior art
and the claimed invention is that Miyasaka is not configured to sense
lactate” (Ans. 3), and lactate sensors where known in the art, citing Lim as
an exemplary teaching of a lactate sensor having a reference electrode co­
located with a sensor (Ans. 3-4 (citing Lim, Fig. 1, col. 3,11. 60-67), 6-8
(citing Miyasaka, col. 2,1. 60 (disclosing sensors for measuring lactic acid)).
Appellants cite differences in the sensors disclosed in Miyasaka and
Lim to argue the references do not teach or suggest the sensor and reference
electrode as claimed. Br. 6-9. Specifically, Appellants argue “Miyasaka
discloses an external reference electrode in the form of an
electrocardiographic electrode at the abdomen of a dog” and “[n]o reason is
provided in Miyasaka to modify the catheter 2 to add the reference
electrode.” Br. 8. Further, Appellants argue the reference electrode
disclosed in Lim functions differently than, and cannot be combined with,
the catheter and sensor of Miyasaka because Lim’s electrode “would cover
the entrance to the catheter/indwelling needle . .. thereby preventing a blood
sample from reaching the sensor 3 within the catheter 2.” Br. 9. Finally,
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Application 12/718,891
Appellants argue modifying the catheter and sensor of Miyasaka to function
with the reference electrode ofLim would not result in the claimed invention
because “if Miyasaka is modified to move the sensor 3 to an exterior of the
catheter 2, then neither reference would include an electrically conductive
portion that extends through a catheter sheath as recited in claim 26.” Br. 9.
We disagree with Appellants. While Appellants correctly state that
Miyasaka does not directly disclose a reference electrode carried with a
catheter (Br. 9), the Examiner’s rejection relies on the combined teachings of
the prior art, not Miyasaka alone (see Ans. 6-9). See In re Keller, 642 F.2d
413, 426 (CCPA 1981) (“[Ojne cannot show non-obviousness by attacking
references individually where, as here, the rejections are based on
combinations of references.”). Further, while Appellants cite differences
between Miyasaka and Fim, “[t]he test for obviousness is not whether the
features of a secondary reference may be bodily incorporated into the
structure of the primary reference; ... the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” See Keller, 642 F.2d at 425; see also In re Beattie, 91A F.2d
1309, 1312—13 (Fed. Cir. 1992) (concluding that showing there are
differences between two references is insufficient to establish one reference
teaches away from another).
The Examiner explains, and we agree, that “[pjersons having ordinary
skill in the art, as taught by both Miyasaka and Fim, [would have]
understood that a reference electrode is needed in order to complete the
circuit and produce a reading that is indicative of analyte concentration” and
that Fim evidences that it was known that a reference electrode may be co­
located with the working electrode of a catheter. Ans. 8—9. The Examiner’s
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Application 12/718,891
findings are consistent with the level of skill evidenced by Appellants’
Specification, which states that a person of ordinary skill would have
appreciated that various known configurations of reference electrodes could
have been used with Appellants’ invention. See Spec. 8:23—26. In fact, this
portion of Appellants’ Specification suggests a person of ordinary skill
would have understood a skin-mounted reference electrode to be an
alternative to the reference electrode depicted in Appellants’ Figure 6A,
which Appellants cite as a supporting disclosure for claim 26. Compare Br.
4 (citing Spec., Fig. 6A as a supporting disclosure for claim 26), with Spec.
8:23—26 (“While the reference electrode 48 is shown positioned within the
adapter 68, it will be appreciated that other configurations could also be
used. For example, the reference electrode 48 could comprise a skin
mounted electrode positioned on the patient’s skin adjacent to the catheter
sheath 64.”); see In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994)
(explaining that a Specification’s lack of detail evidences that a person of
ordinary skill would have been able to implement the claimed features with
a similar level of disclosure in the prior art).
Appellants have not rebutted the Examiner’s findings of fact that each
element of claim 26 was known in the art, and Appellants offer no evidence
to establish that the Examiner’s proffered combination of known elements
would have been “uniquely challenging or difficult for one of ordinary skill
in the art.” Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162
(Fed. Cir. 2007) (citing KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007)). To the contrary, and contrary to Appellants’ arguments, we agree
with the Examiner that the evidence of record establishes that a person of
ordinary skill would have recognized the claimed invention as a combination
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of known elements in known ways yielding predictable results. See Ans. 2—
9; Miyasaka, col. 2,1. 53—col. 3,1. 3 (stating that the disclosed invention
could be used with sensors for measuring lactic acid, that “[t]he detection
method adopted in the sensor is not particularly critical,” and that “any fine
linear sensor which can be inserted and kept in the blood vessel through an
indwelling needle or indwelling catheter can be used”); Spec. 8:23—26
(“While the reference electrode 48 is shown positioned within the adapter
68, it will be appreciated that other configurations could also be used. For
example, the reference electrode 48 could comprise a skin mounted
electrode positioned on the patient’s skin adjacent to the catheter sheath
64.”).
Having considered the Examiner’s rejection in view of each of
Appellants’ arguments and the evidence of record, we agree with the
Examiner and adopt as our own the Examiner’s findings, conclusions, and
reasons. We sustain the Examiner’s rejection of claim 26, as well as claims
28—32, and 34 which Appellants do not argue independently.
DECISION
For the above reasons, we affirm the Examiner’s rejection of claims
26, 28-32, and 34.
No time period for taking any subsequent action in connection with
this appeal may be extended. 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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