Ex Parte Voto et al

Board of Patent Appeals and Interferences

Oct 30, 2009

11176746 (B.P.A.I. Oct. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ANDREW M. VOTO, RONALD K. SELBY,
KENNETH D. PERRY, DAVID A. ROSS and ALFRED V. DUMSA, JR.
____________

Appeal 2009-001947
Application 11/176,746
Technology Center 1700
____________

Decided: October 30, 2009
____________

Before JEFFREY T. SMITH, KAREN M. HASTINGS, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

SMITH, Administrative Patent Judge.

DECISION ON APPEAL

Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision finally rejecting claims 1-3 and 5-13 (Final Office Action, mailed
Appeal 2009-001947
Application 11/176,746

September 12, 2007), the only claims pending in the application. We have
jurisdiction under 35 U.S.C. § 6(b).1
We AFFIRM.
STATEMENT OF THE CASE
Claims 1 and 9 illustrative of the subject matter on appeal, and are
reproduced from the Claims Appendix to the Appeal Brief (“App. Br.”):
1. A hemodialysis system, comprising:

a blood circuit tube having an interior;

a dialyzer in fluid communication with the interior of the blood circuit
tube; and

not more than one substantially biochemically inert disposable sensor
unit including at least one disposable sensor device in fluid
communication with the interior of the blood circuit tube, wherein the
at least one disposable sensor device is configured to sense one or
more physical or chemical parameters of contents of the blood circuit
tube; wherein the not more than one substantial biochemically inert
disposable sensor unit is operatively placed one of: upstream of the
dialyzer; or within the dialyzer.

9. A dialyzer for renal dialysis, comprising a housing and at least one
dialysis membrane, wherein the housing has not more than one
substantially biochemically inert disposable sensor unit mounted one
of:

adjacent to and upstream from the housing; or

within the housing.

1 In rendering this decision we have considered Appellants’ Brief dated
September 6, 2006, and the Reply Brief dated August 7, 2008.
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Appeal 2009-001947
Application 11/176,746

Appellants request review of the following rejections (App. Br. 6):
claims 1-3, 8-9, and 11-13 under 35 U.S.C. § 103(a) as unpatentable over
Krivitski, Published U.S. Patent Application 2003/0111423 A1, dated June
19, 2003, Van Antwerp, Published U.S. Patent Application 2006/0052745,
dated March 9, 2006; claims 5 and 10 under 35 U.S.C. § 103(a) as
unpatentable over Krivitski, Van Antwerp, and Moscaritolo, U.S. Patent
6,936,160, issued August 30, 2005; claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Krivitski, Van Antwerp, and Utterberg US 6,755,801,
issued June 29, 2004; and claim 7 under 35 U.S.C. § 103(a) as unpatentable
over Krivitski, Van Antwerp, and Truitt U.S. Patent 5,910,252, issued June
8, 1999.
Appellants have not presented separate arguments for any claim on
appeal. (See App. Br. generally). We will limit our discussion to
independent claims 1 and 9.
ISSUE
The following issue is presented for our review:
Have Appellants shown reversible error in the Examiner’s
determination that it would have been obvious to form a hemodialysis
system comprising a substantially biochemically inert disposable sensor unit
as described by claim 1 and 9?
We answer this question in the negative
FINDINGS OF FACT (“FF”)
1. The Specification discloses “[m]edical equipment for dialysis is
typically made of partly disposable and partly reusable parts.” [Spec 0003].
2. The Specification discloses parameters which are known to be
monitored during dialysis include blood pressure, blood temperature, blood
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Appeal 2009-001947
Application 11/176,746

volume and flow rates, blood and activity and blood chemistry. [Spec
0004].
3. The Specification discloses the disposable sensors do not have
to be completely biochemically inert. Specifically the Specification states:
[T]he disposable sensors do not have to be completely biochemically
inert, in order to justify their contacting the circulating blood of the
patient as "virtually biochemically inert" components. Any xenogenic
chemical released by one or more of the disposable sensors and that is
permeable to the dialysis membrane can be removed by the dialysis
process and will not be returned to the patient, thus rendering the sensor
virtually biochemically inert. This ability to cleanse the blood of any
impurity introduced by the sensor is one reason why the preferred
location of the disposable sensor(s) is upstream of the dialyzer, or at
least in the upstream portion of the dialyzer. [Spec. 0019].

4. Krivitski discloses a hemodialysis system, comprising a blood
circuit tube including a sensor configured to measure a change in a blood
characteristic resulting from the introduction of an indicator to the blood
flowing in the dialysis shunt via a venous line of a dialysis system. [0027].
5. Krivitski discloses a variety of known sensors are suitable for
use in dialysis systems. [0027].
6. Van Antwerp describes sensors which are in direct contact with
blood in vivo for detecting analytes in the blood. [0005].
7. Van Antwerp discloses the sensors are suitable for use in
hemodialysis systems. [0006].
8. Van Antwerp discloses the sensors are biocompatible and
suitable for short or long term use. [0005].

PRINCIPLES OF LAW
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Appellants have the burden on appeal to the Board to demonstrate
error in the Examiner's position. See In re Kahn, 441 F.3d 977, 985-86 (Fed.
Cir. 2006) (“On appeal to the Board, an applicant can overcome a rejection
[under § 103] by showing insufficient evidence of prima facie obviousness
or by rebutting the prima facie case with evidence of secondary indicia of
nonobviousness.”) (quoting In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir.
1998)). Therefore, we look to Appellants’ Brief to show error in the
proffered prima facie case. See 37 C.F.R. § 41.37(c)(1)(vii) (2007).
A claimed invention is unpatentable if the differences between it and
the prior art “are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the art.” 35 U.S.C. § 103. “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). The question to be asked is “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” Id. at 417.
ANALYSIS
Appellants contend that the Examiner has not established a prima
facie case of obviousness because Krivitski teaches away from using a
sensor that contacts the blood because Krivitski only teaches a sensor
located outside of the dialysis tube. (App. Br. 10). Appellants contend that
if a skilled artisan were to substitute the sensor of Krivitski with the sensor
of Van Antwerp this substitution would destroy the stated purpose and
teaching of the Krivitski disclosure. (App. Br. 10-11).
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Appellants have not shown reversible error in the Examiner’s
proposed combinations of Krivitski and Van Antwerp. Krivitski and Van
Antwerp both disclose hemodialysis systems comprising sensors for
detecting various parameters. Van Antwerp describes sensors which are in
direct contact with blood in vivo for detecting analytes in the blood. These
sensors are biocompatible and suitable for short or long term use.
Appellants have not provided a technical reason why the biocompatible
sensors of Van Antwerp would have been unsuitable for use in a
hemodialysis system such as that of Krivitski. Appellants have not provided
a technical reason why the biocompatible sensors of Van Antwerp are not
biochemically inert within the meaning of the claimed invention. Appellants
have not explained why sensors suitable for short term use are not
disposable within the meaning of the claimed invention.
A person of ordinary skill in the art would have sufficient skill to
select the appropriate sensors for use in hemodialysis systems. A person of
ordinary skill in the art interested in measuring the blood flow in a
hemodialysis system or the analyte content in the blood would have looked
to the sensors of Krivitski and Van Antwerp. A person of ordinary skill in
the art interested in any of these parameters would have sufficient skill to
select the appropriate sensor to measure such a parameter. Moreover, the
claimed invention does not preclude the use of the sensors of Van Antwerp
in conjunction with those of Krivitski. The claim language “not more than
one substantially biochemically inert disposable sensor” does not exclude
the external sensors of Krivitski used in conjunction with the internal sensors
of Van Antwerp.
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Application 11/176,746

As set forth above, equipment for dialysis is known by persons of
ordinary skill in the art to be made of partly disposable and partly reusable
parts. Consequently a person of ordinary skill in the art would have
reasonably expected that disposable sensors would have been suitable for
use in dialysis equipment.
Appellants contend that the separate rejection of dependent claims 5,
6, 7, and 10 would not have been obvious over the cited references for the
reasons provided for independent claims 1 and 9. (App.Br. 13-15).
Appellants’ contentions are not persuasive because it does not identify an
error in the Examiner’s findings regarding the cited prior art and the
determination that it would have been obvious to a person of ordinary skill
in the art to combine the components as suggested by the Examiner.
Accordingly, we affirm the rejections of claims 1-3. 8-9 and 11-13
under 35 U.S.C. § 103(a) over Krivitski and Van Antwerp; claims 5 and 10
under 35 U.S.C. § 103(a) over Krivitski, Van Antwerp, and Moscaritolo;
claim 6 under 35 U.S.C. § 103(a) over Krivitski, Van Antwerp, and
Utterberg; and claim 7 under 35 U.S.C. § 103(a) over Krivitski, Van
Antwerp, and Truitt.
CONCLUSION
The decision of the Examiner rejecting claims 1-3 and 5-13 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

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tc

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