Ex parte BENE

Board of Patent Appeals and Interferences

Aug 26, 1997

07942460 (B.P.A.I. Aug. 26, 1997)

Application for patent filed September 9, 1992.1
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THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1)
was not written for publication in a law journal and (2) is not
binding precedent of the Board.
Paper No. 20
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte BERNARD BENE
____________
Appeal No. 95-3830
Application 07/942,4601
____________
ON BRIEF
____________
Before KRASS, JERRY SMITH and LEE, Administrative Patent Judges.
LEE, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
examiner's final rejection of claims 12, 15-17, 20-22, 25 and 26
under 35 U.S.C. § 103 as being unpatentable over prior art.
Claims 1-11 have been canceled. Dependent claims 13, 14, 18, 19,
23 and 24 have been indicated as being allowable if presented in
proper form.
References Relied on by the Examiner
Appeal No. 95-3830
Application No. 07/942,460
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Shouldice et al. U.S. Patent No. 4,897,184 Jan. 30, 1990
Lipps et al. U.S. Patent No. 4,209,391 June 24, 1980
Veech U.S. Patent No. 5,091,094 Feb. 25, 1992
Polaschegg U.S. Patent No. 4,683,053 July 28, 1987
(Polaschegg '053)
Polaschegg U.S. Patent No. 5,100,554 March 31, 1992
(Polaschegg '554)
The Rejections on Appeal
In the final Office action, claims 12-26 were rejected under
35 U.S.C. § 103 as being unpatentable over Shouldice et al., or
Polaschegg '554, in view of Lipps et al., Veech, and Polaschegg
'053. In the examiner's answer, the examiner withdrew the
rejection of all claims over the combination of Polaschegg '554,
Lipps et al., Veech and Polaschegg '053. Also in the examiner's
answer, the examiner indicated that dependent claims 13, 14, 18,
19, 23 and 24 were allowable if rewritten in proper form.
Thus, before us in this appeal are only claims 12, 15-17,
20-22, 25 and 26. These claims stand rejected under 35 U.S.C.
§ 103 as being unpatentable over Shouldice et al., Lipps et al.,
Veech and Polaschegg '053.
The Invention
The invention is directed to an artificial kidney. The
device measures a physicochemical characteristic of the fresh and
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Application No. 07/942,460
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used dialysis liquid, computes a clearance value for a type of
impurity based on the measured data, compares the calculated
clearance with a predetermined clearance, and performs various
control functions based on the results of the comparison.
Claim 12 concerns controlling a flow rate through the
extracorporeal blood circuit. Claim 17 concerns controlling a
flow rate through the dialysis liquid circuit. Claim 22 concerns
controlling a blood filtrate exacting means on the basis of a
duration of treatment calculated on the basis of the results of
the comparison.
Representative claim 12 is reproduced below:
12. An artificial kidney comprising:
an exchanger having two compartments separated by
a semipermeable membrane, a first compartment being
connected to a circuit for extracorporeal circulation
of blood having a circulating pump disposed therein, a
second compartment being connected to a dialysis liquid
circuit;
measurement means for measuring data corresponding
to at least one physicochemical characteristic of a
fresh dialysis liquid and at least one physicochemical
characteristic of a used liquid;
computation means responsive to data received from
the measurement means for calculating an actual
clearance of the artificial kidney for a type of
impurity; and
control means for controlling a flow rate through
the extracorporeal blood circuit as a function of a
comparison between the calculated clearance and a
Appeal No. 95-3830
Application No. 07/942,460
The appellant’s supplemental reply brief (Paper No. 18)2
filed March 31, 1995, was not entered or considered by the
examiner. Accordingly, we have not considered the supplemental
reply brief.
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predetermined clearance.
Opinion
We do not sustain the rejection of claims 12, 15-17, 20-22,
25 and 26. The teachings of Shouldice et al., Lipps et al.,
Veech and Polaschegg '053 would not have reasonably suggested the
appellant's claimed invention.2
In the examiner's answer, the examiner explained in a
meaningful manner, for the first time, his application of
Shouldice et al. to the rejected claims. He further indicated
(answer at 3 and at 4) that the secondary references Lipps et
al., Veech and Polaschegg are cumulative with respect to the
teachings of Shouldice et al.
In our view, there is error in the examiner's analysis. It
concerns the requirement in all three independent claims 12, 17,
and 22 for (1) a computation means responsive to data received
from the measurement means "for calculating an actual clearance
of the artificial kidney for a type of impurity," and for (2) a
control means which performs a certain control function based on
a comparison between the calculated clearance and a predetermined
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Application No. 07/942,460
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clearance.
The claimed invention requires a measurement means for
measuring data corresponding to at least one physicochemical
characteristic of a fresh dialysis liquid and at least one
physicochemical characteristic of a used liquid. In that
connection, the examiner found the following in Shouldice et al.
(answer at 3):
Sensor 94 measures pressure of inlet dialyzate which
corresponds to the physicochemical characteristic of
the fresh dialyzate. Sensor 96 measures pressure of
used liquid which corresponds to the physicochemical
characteristic of dialysis containing the impurity
"ultrafiltrate" from the blood. (Emphasis in
original.)
Because the appellant has not specifically challenged or disputed
the examiner's treating pressure as a physicochemical
characteristic of a liquid, we will regard the measuring means
feature as having been met by Shouldice et al.
What the appellant does argue is that the measured data on
the dialysis liquid pressure would not permit a computation means
to "calculate a clearance value for a type of impurity," and that
Shouldice et al. further does not disclose any controlling
function based on a comparison between the calculated clearance
and a predetermined clearance for an impurity. We agree with the
appellant.
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We can observe no basis for the examiner's finding (answer
at 3) that:
The ultrafiltrate monitor (Fig. 2) uses the data from
the [pressure] sensors to calculate the membrane
clearance for ultrafiltrate impurity. The UF control
124 controls the flow rate as claimed. The
ultrafiltrate rate is related to the transmembrane
pressure.
Figure 2 of Shouldice et al. merely shows that data from pressure
sensors 94 and 96 are inputted to the ultrafiltrate monitor 130.
We find no discussion anywhere in Shouldice et al. concerning
calculation of a clearance for "a type of impurity" based on the
data from pressure sensors 94 and 96, and the examiner has cited
none. The closest Shouldice et al. comes to that is the
following (column 5, lines 9-13):
A TMP (transmembrane pressure) that is too high
indicates that the operator is trying to pull too much
ultrafiltrate (in which event he can lower the
ultrafiltration rate) or that the membrane is clogged
(in which event use of the clogged dialyzer must be
discontinued).
Shouldice et al., in column 3, lines 13-14, defines the term
"ultrafiltrate" as that liquid passing through the membrane in
dialyzer 20 from blood to dialysate. Transmembrane pressure is
not the same as either the fresh dialysis liquid pressure or the
used dialysis liquid pressure as measured by pressure sensors 94
and 96. Even assuming that the transmembrane pressure can be
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Application No. 07/942,460
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deduced from the fresh and used liquid pressure measured by
sensors 94 and 96, the above-quoted text of Shouldice et al.
merely suggests calculating the actual transmembrane pressure and
then comparing it with a predetermined transmembrane pressure to
see if it is too high.
Based on the foregoing, we find that the examiner has
equated determining the general transmembrane pressure to
calculating an actual clearance of the artificial kidney for a
type of impurity. That is erroneous.
Consistent with the appellant's specification (see pages 14-
15), regarding artificial kidneys the "clearance" for a type of
impurity is based on the concentration of substances in the
blood, on the flow rates of blood and the dialysis liquid in the
exchanger, and on the membrane characteristics of the exchanger.
It concerns the efficiency for removing the type of impurity.
For instance, in the appellant’s preferred embodiment (pages 14-
15), conductivity of the dialysis liquid is measured, based on
which the concentration of ionized substances, predominantly
sodium, is calculated, and then through extrapolation and known
rules of correspondence the "clearance" of urea is determined
based in part on the characteristics of the exchanger and the
flow rates of the blood and dialysis liquid. Alternatively, the
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Application No. 07/942,460
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disclosed invention calculates the actual "clearance" for
creatinine (page 7).
In our view, it is unreasonable to regard transmembrane
pressure in the exchanger, or either the input or output dialysis
liquid pressure, as the claimed "clearance" for a type of
impurity. The appellant is also correct that the clearance for a
given type of impurity cannot be determined solely on the basis
of detecting the pressure of fresh and used dialysis liquid.
Pressure data alone, including the transmembrane pressure, cannot
reveal how efficient a given type of impurity is being removed.
The examiner has shown no evidentiary basis to find that
Shouldice et al. discloses or reasonably suggests calculating the
"clearance" for a type of impurity, and certainly not comparing
the calculated clearance with a predetermined clearance as the
basis for control. The statement in the examiner's answer that
the claimed computation and control means are inherent in
Shouldice et al. is without adequate support on this record.
Furthermore, it is also unreasonable, in the context of the
appellants' claimed invention, to regard the entirety of the
ultrafiltrate, i.e., that liquid passing in the exchanger from
blood to the dialysate, as the "a type of impurity" contemplated
by the claims. The ultrafiltrate contains all types of
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impurities as far as artificial kidneys are concerned and thus
cannot satisfy claim features directed to calculating or
performing something specific to "a type of impurity."
Alternatively, the examiner found (answer at 3) that "it
would have been obvious to one with ordinary skill in the art, at
the time the invention was made, to substitute conductivity
meters for the pressure sensors of Shouldice et al. We disagree.
The examiner has articulated no motivation for one with ordinary
skill in the art to replace Shouldice et al.'s pressure sensors
with conductivity meters. Conductivity meters do not measure
pressure. The examiner also has not pointed to any useful
purpose that would be recognized by one with ordinary skill in
the art for having conductivity meters positioned upstream and
downstream of the dialysis liquid in Shouldice et al. In any
event, merely having the conductivity meters do not equate to or
reasonably suggest calculating the actual "clearance for a type
of impurity," comparing the calculated clearance with a
predetermined clearance, and performing various control functions
based on the results of the comparison.
Finally, with regard to claim 22, the examiner has not
explained where in Shouldice et al. he finds that the duration of
treatment has been calculated. Simply terminating operations
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Application No. 07/942,460
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when preset alarm limits have been exceeded is not the same as
calculating a duration of treatment.
Lipps et al., Veech, and Polaschegg '053 do not, in any
combination, make up for the above-noted deficiencies of
Shouldice et al. The examiner is correct, insofar as the
appellants' claimed invention is concerned, that these secondary
references are merely cumulative to Shouldice et al. The
examiner has not relied on these references to show the features
of calculating an actual clearance for a type of impurity,
comparing the calculated actual clearance with a predetermined
clearance, and performing control functions based on the results
of the comparison. We also do not find in these references,
alone, or in combination, a reasonable suggestion for such
features. In the final Office action, the examiner stated merely
that Lipps et al. varies flow rates, Veech controls diffusion,
and Polaschegg '053 shows a well known 3-way valve (Paper No. 9).
For the foregoing reasons, the rejection of claims 12, 15-
17, 20-22, 25 and 26 over Shouldice et al., Lipps et al., Veech
and Polaschegg '053 cannot be sustained.
Conclusion
The rejection of claims 12, 15-17, 20-22, 25 and 26 under
35 U.S.C. § 103 as being unpatentable over Shouldice et al.,
Appeal No. 95-3830
Application No. 07/942,460
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Lipps et al., Veech and Polaschegg '053 is reversed.
REVERSED
ERROL A. KRASS )
Administrative Patent Judge )
)
)
)
JERRY SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
JAMESON LEE )
Administrative Patent Judge )
Appeal No. 95-3830
Application No. 07/942,460
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