Ex Parte Bene et al

Patent Trial and Appeal Board

Feb 28, 2013

10503766 (P.T.A.B. Feb. 28, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/503,766 08/06/2004 Bernard Bene PN0057 US-WO 01
(405.0046
3807
26813 7590 02/28/2013
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
MENON, KRISHNAN S
ART UNIT PAPER NUMBER
1777
MAIL DATE DELIVERY MODE
02/28/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BERNARD BENE, NICHOLAS GOUX, PER HAQNSSON,
THOMAS HERTZ, OLOF JANSSON, ROLAND PERSSON,
JAN STERNBY, and PERRY ASBRINK
____________

Appeal 2011-009910
Application 10/503,766
Technology Center 1700
____________

Before TERRY J. OWENS, MICHAEL P. COLAIANNI, and
GEORGE C. BEST, Administrative Patent Judges.

BEST, Administrative Patent Judge.
DECISION ON APPEAL
On July 26, 2010, the Examiner finally rejected claims 148-178, 180,
183, 184, 186, and 187 of Application 10/503,766 under 35 U.S.C. § 102(e)
as anticipated, under 35 U.S.C. § 103(a) as obvious, and under the judicially-
created doctrine of obviousness-type double patenting, and also rejected
claim 187 under 35 U.S.C. § 112, ¶ 2 as indefinite. Appellants seek reversal
of these rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction
under 35 U.S.C. § 6(b).
For the reasons set forth below, we AFFIRM.
Appeal 2011-009910
Application 10/503,766
2
BACKGROUND
The ’766 application describes a method for determining the fluid
flow rate in a blood access structure, often called a fistula, used for extra-
corporeal treatment of blood, e.g., dialysis (Spec. 1). As described in the
’766 application, the fluid flow rate may be calculated based upon
conductivity measurements of the dialysis fluid and the blood treatment unit
effluent (id.). Maintenance of a high fluid flow rate in the fistula is important
so that the amount of blood that is recirculated through the dialysis machine
is minimized and treatment can be completed in an efficient and effective
manner (id. at 1-2).
Claim 184 is representative of the ’766 application’s claims and is
reproduced below:
184. A method for determining a fluid flow rate (Qa) in a
blood access having an upstream position and a downstream
position using a blood treatment apparatus, the blood treatment
apparatus including:
a blood treatment unit having a semi permeable membrane
delimiting a first chamber through which blood removed
from said blood access passes and a second chamber through
which dialysis liquid passes,
an arterial line connected to an inlet of the first chamber, and
a venous line connected to an outlet of the first chamber,
said arterial and venous lines being able to be configured
according to at least a normal configuration, in which said
arterial line carries blood from said upstream position of said
blood access, and said venous line carries blood towards
said downstream position of said blood access, and to at
least a reversed configuration, in which said arterial line
carries blood from said downstream position of said blood
Appeal 2011-009910
Application 10/503,766
3
access, and said venous line carries blood towards said
upstream portion of said blood access, said method
comprising the steps of:
passing a dialysis liquid through the second chamber of
said treatment unit, at least for a time interval (T) said
dialysis liquid upstream the treatment unit having a
concentration (Ci) of at least one substance being
different from the concentration of the same substance in
blood, wherein the step of passing a dialysis liquid
through the second chamber comprises the following
sub-steps:
passing a first dialysis liquid through the second
chamber of said treatment unit, said first dialysis
liquid presenting a first concentration for said
substance, then
increasing or decreasing, at a time Ti, the
concentration of the substance in the first dialysis
liquid for passing through the second chamber a
second dialysis liquid which, during the time interval
T after the increasing or decreasing sub-step, has a
concentration of at least said substance different from
the concentration of the same substance in blood and
different from the concentration of the same substance
in first dialysis liquid;
keeping substantially constant, during the time
interval T after the increasing or decreasing sub-step,
the concentration of said at least one substance in the
second dialysis liquid upstream of the treatment unit,
switching the venous and arterial lines, during said time
interval (T) after the increasing or decreasing sub-step,
between one of said normal and reversed configurations
to the other of said normal and reversed configuration;
obtaining, downstream of the treatment unit, a first post-
treatment unit conductivity of the second dialysis liquid
or a first post treatment unit concentration of said
Appeal 2011-009910
Application 10/503,766
4
substance in the second dialysis liquid, said first post
treatment conductivity or concentration referring to the
dialysis liquid before switching of the venous and arterial
lines during said time interval (T);
obtaining, downstream of the treatment unit, a second
post treatment unit conductivity of the second dialysis
liquid or post treatment unit concentration of said
substance in the dialysis liquid, said second post
treatment conductivity or concentration referring to the
dialysis liquid after switching of the venous and arterial
lines during said time interval (T);
calculating the fluid flow rate (Qa) in said blood access,
as a function of:
said first post treatment unit concentration or
conductivity; and of said second post treatment unit
concentration or conductivity.
(App. Br. 35-37 (Claims App’x)).
REJECTIONS
1. The Examiner finally rejected claim 187 under 35 U.S.C.
§ 112, ¶ 2 as indefinite (Final Rejection (“FR”) 4-5 (July 26,
2010); Ans. 4-5).
2. The Examiner finally rejected claims 148-178, 183, 184, 186, and
1871 on the ground of obviousness-type double patenting as being
unpatentable over claims 1-13 of U.S. Patent No. 6,726,647 B1
(“Sternby ’647,” issued April 27, 2004) in view of U.S. Patent No.
6,648,845 B1 (“Gotch,” issued Nov. 18, 2003) (FR 5-7; Ans. 6-8).

1 The Examiner also finally rejected claim 180 on this ground. Claim 180,
however, had been cancelled by Appellants before entry of the Final
Rejection (see Amendment (“Amdt.”) 22 (July 16, 2010)).
Appeal 2011-009910
Application 10/503,766
5
3. The Examiner finally rejected claims 148-178, 183, 184, 186, and
1872 under 35 U.S.C. § 103(a) as obvious over WO 00/244403
(“Sternby ’440,” published May 4, 2000) in view of Gotch (FR 7-
10; Ans. 8-11).
4. The Examiner finally rejected claims 148-178, 183, 184, 186, and
1874 under 35 U.S.C. § 102(e) as being anticipated by or in the
alternative under 35 U.S.C. § 103(a) as being obvious over Gotch
(FR 10-11; Ans. 12-15).
DISCUSSION
Rejection 1. The Examiner finally rejected claim 187 as indefinite.
The relevant portion of claim 187 is set forth below:
187. A method for determining a fluid flow rate (Qa) in a
blood access having an upstream position and a downstream
position . . .
said method comprising the steps of:
passing a first dialysis liquid through the second chamber
of said treatment unit, said first dialysis liquid presenting
a first conductivity;
generating a gradient between the conductivity of the
first dialysis liquid and a second dialysis liquid;

2 The Examiner also finally rejected claims 180 and 185 on this ground. As
discussed in n.1, supra, Appellants cancelled claim 180 prior to entry of the
Final Rejection. The same is true of claim 185 (see Amdt. 22).
3 We follow the Examiner, who, without objection, cited Sternby ’647 as the
U.S. equivalent to Sternby ’440.
4 See n.2, supra.
Appeal 2011-009910
Application 10/503,766
6
passing the second dialysis liquid through the second
chamber of said treatment unit, said second dialysis
liquid presenting a second conductivity, a conductivity
difference between the blood and the second dialysis
liquid being about from 1 to 2 mS/cm, . . . .
(App. Br. 40-42 (Claims App’x) (emphasis added)).
The Examiner argues that the phrase “generating a gradient between
the conductivity of the first dialysis liquid and a second dialysis liquid” is
indefinite because a person of ordinary skill in the art would be confused by
the use of the term gradient in claim 187 (Ans. 5). The Examiner asserts that,
as presently worded, the claim “gives the impression that the first and the
second dialysis liquids are applied simultaneously or together, which is
confusing. The term ‘gradient’ means gradually changing, whereas the
change in concentration from the first to the second dialysis liquid is
disclosed as abrupt” (id.). Appellants, on the other hand, argue that a person
of ordinary skill in the art would understand from the Specification that the
term “generating a gradient” means increasing or decreasing the
conductivity of the dialysis liquid (App. Br. 16-17).
We are not persuaded by either argument. As the Examiner correctly
concluded (Ans. 5), a person of ordinary skill in the art would normally
understand the term “generating a gradient” to require a gradual change in
the conductivity of the dialysis fluid. See also WEBSTER’S NINTH NEW
COLLEGIATE DICTIONARY 530 (1985) (“a rate of regular or graded ascent or
descent;” “a part sloping upward or downward”).
Appellants, on the other hand, argue that a person of ordinary skill in
the art would understand that the term “generating a gradient” means
increasing or decreasing the conductivity in any manner whatsoever, based
upon the disclosure provided in the Specification (App. Br. 17). Appellants
Appeal 2011-009910
Application 10/503,766
7
are attempting to redefine the phrase “generating a gradient” so that it is
broader than its ordinary meaning to a person of ordinary skill in the art.
While Appellants are free to redefine terms in their Specification, any such
novel definitions must be clearly indicated. Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Appellants’ Specification does not
clearly indicate that the term gradient is being used in a manner other than
its ordinary and customary meaning. Accordingly, a person of ordinary skill
in the art would give the phrase “generating a gradient” its ordinary and
customary meaning.
A person of ordinary skill in the art would have understood from
Appellants’ Specification that the conductivity measurements must be
performed when the conductivity of the dialysis fluid at the inlet is stable so
that an equilibrium value for the effluent conductivity can be measured (see
Figs. 5 & 6). Therefore, such a person would have understood that it is
immaterial to the claimed method whether the transition from the first
dialysis liquid to the second dialysis liquid is accomplished in a gradual or
abrupt manner. Accordingly, one of ordinary skill in the art, giving
Appellants’ claim term “generating a gradient” its broadest reasonable
interpretation consistent with the Specification, would have considered that
term to encompass an abrupt change.
Because the term “generating a gradient” is not insolubly ambiguous,
we reverse the Examiner’s rejection of claim 187 as indefinite.
Rejections 2 and 3. Appellants argue for reversal of these rejections
together on the basis of the limitations set forth in claim 184 (App. Br. 18-
22). Accordingly, all of the claims in the ’766 application stand or fall with
claim 184.
Appeal 2011-009910
Application 10/503,766
8
Appellants argue that the rejections of claim 184 as obvious over the
combination of either Sternby ’440 or Sternby ’647 (collectively, Sternby)
with Gotch should be reversed because Sternby and Gotch, either alone or in
combination, fail to describe or suggest several features recited in claim 184
(App. Br. 18).
First, Appellants argue that Sternby fails to teach changing the
concentration of a substance in the dialysis fluid upstream of the dialyzer
unit because Sternby is concerned with the measurement of urea in the
dialysis fluid downstream of the dialyzer unit (id.). The Examiner agrees that
Sternby does not describe these limitations and points to Gotch as providing
the necessary disclosure (Ans. 10, 16).
Appellants argue that Gotch fails to remedy the deficiencies in
Sternby’s disclosure because Gotch describes methods for determining
access flow rate by determining dialysance values rather than concentrations
or conductivities (App. Br. 20-21). However, as the Examiner explains (Ans.
16-18), while Gotch describes the calculation of the fluid flow rate in the
fistula from dialysance values (Gotch Eq. (17)), Gotch further describes the
determination of dialysance values by measurement of concentration or
conductivity values (id. at 2:64-3:20). Indeed, Gotch expressly states that “it
is possible to determine dialysance or clearance from conductivity
measurements alone” (id. at 12:66-67) and describes a preferred
embodiment which determines dialysance values via a series of conductivity
measurements of the dialysis fluid upstream and downstream of the dialysis
unit when dialysis fluids having differing initial sodium ion concentrations
are used (id. at 13:12-35).
Second, Appellants argue that using Gotch’s process to determine the
fluid flow rate in the fistula cannot be accomplished while meeting claim
Appeal 2011-009910
Application 10/503,766
9
184’s requirement that the concentration of the substance being measured be
kept constant at the dialysis unit inlet while the concentration of the
substance in the dialysis unit effluent is measured in the normal and reversed
flow conditions (App. Br. 21-22). The Examiner, however, demonstrates
that this argument is incorrect (Ans. 18-19). Furthermore, as the Examiner
points out (id. at 19), Appellants’ method for determining the fluid flow rate
in the fistula requires determination of the transport rate (Tr) of substances
over the semipermeable membrane in the dialyzer unit and the ultrafiltration
flow rate (Quf) in addition to the concentrations of the substance in the
dialyzer unit effluent (Spec. 4). Appellants’ Specification states that the
effective ionic dialysance can be used to determine the transport rate Tr (id.).
In view of the foregoing, we determine that the Examiner did not err
in concluding that the claims of the ’766 application would have been
obvious to a person of ordinary skill in the art in view of the combination of
Sternby and Gotch.
Rejection 4. Appellants’ arguments against the Examiner’s rejection
of the ’766 application’s claims as either anticipated by or obvious over
Gotch alone are the same as those asserted against the combination of
Sternby and Gotch (App. Br. 20-22). Therefore, we also affirm this
rejection.
CONCLUSION
As discussed above, we reverse the Examiner’s rejection of claim 187
as indefinite, but we affirm the rejections of all of the claims in the ’766
application as obvious over Gotch, whether alone or in combination with
either Sternby ’440 or Sternby ’647. Because we have affirmed rejections of
Appeal 2011-009910
Application 10/503,766
10
all of the claims in the ’766 application, we affirm the Examiner’s decision
not to allow any of the appealed claims.

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

bar