Ex Parte Elisabettini et al

Board of Patent Appeals and Interferences

Sep 22, 2010

11531121 (B.P.A.I. Sep. 22, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAOLA ELISABETTINI, JEAN-PAUL MENNEGUERRE,
JEROME COLAS, CHRISTIAN RENAUX, JOSE DIVINO, DIRK FAICT,
and ISABELLE WILMET
__________

Appeal 2010-005514
Application 11/531,121
Technology Center 1600
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims related to
dialysis methods and products. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
The Specification discloses a two part dialysis solution that includes
“a bicarbonate concentrate and an electrolyte concentrate which can be
readily and sterilely mixed to form a ready-to-use formulation for patient
administration” (Spec. 3, ¶¶ 0012). The Specification discloses that the
components can be stored “in separate and hydraulically connected
chambers of a multichamber container, until mixed together to form a mixed
solution” (id. at ¶ 0015). The Specification discloses that the container can
be configured so that one “component cannot be placed in direct fluid
communication with the patient prior to mixing” so that a component with
“an undesirable concentration of constituents, such as potassium,” would not
be administered unmixed to the patient (id. at 3-4, ¶ 0016).
Claims 6, 8-10, 16-17, 19-21, and 34 are on appeal. Claims 6, 16, and
34 are representative and read as follows:
6. A dialysis solution comprising:
a first part including a bicarbonate concentrate at least including
potassium from about 0.1 mmol/L to about 5 mmol/L; and
a second part including an electrolyte concentrate at least including
potassium at about 11 mmol/L or less,
wherein the mixed solution comprises about 100 mmol/L to about 173
mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about
0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45
mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride,
about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45
mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and
about 0 g/L to about 1.1 g/L of hydrous dextrose.

16. A method of providing dialysis comprising:
providing a dialysis solution including a bicarbonate concentrate in a
first chamber, the first chamber adapted to attach to a patient’s
administration line, and an electrolyte concentrate in a second chamber,
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wherein the bicarbonate concentrate does not include potassium and
the electrolyte concentrate at least includes potassium;
mixing the bicarbonate concentrate and the electrolyte concentrate to
form a mixed solution including about 5 mmol/L or less of potassium; and
administering the mixed solution through the administration line
during dialysis.

34. A multi-chambered dialysis container comprising:
a first chamber containing a bicarbonate concentrate substantially free
of potassium, the first chamber being in fluid communication with a
patient’s administration line; and
a second chamber containing an electrolyte concentrate at least
including about 11 mmol/L or less of potassium.

Issue
The Examiner has rejected claims 6, 8-10, 16, 17, 19-21, and 34 under
35 U.S.C. § 103(a) based on Gullberg,2 Feriani,3 and van Bommel4 (Answer
7) or based on Gullberg, Feriani, van Bommel, and Watanabe5 (Answer 3).
For each of the rejections, the claims have been argued in three groups:
claims 8-10 stand or fall with claim 6; claims 17 and 19-21 stand or fall with
claim 16; claim 34 was argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Gullberg discloses a “concentrate for dialysis
solutions which is divided into two containers, one (A) containing
bicarbonate in an aqueous solutions [sic] and the other (B) contains
physiologically compatible sodium and calcium salts” (Answer 5). The
Examiner also finds that Gullberg discloses that the solutions can also

2 Gullberg, EP 0 022 922 A1, Jan. 28, 1981
3 Feriani et al., US 4,630,727, Dec. 23, 1986
4 Eric F. H. van Bommel Continuous Renal Replacement Therapy for
Critically Ill Patients: An Update, 9 J. INTENSIVE CARE MEDICINE 265-280
(1994)
5 Watanabe et al., US 5,122,516, June 16, 1992
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contain potassium (id.). The Examiner finds that Feriani discloses a dialysis
solution “contained in a twin-chamber bag in which the first chamber is
filled with a bicarbonate-containing fluid and the second chamber is filled
with an acid fluid.… [P]otassium can be present in the bicarbonate-
containing solution.” (Id. at 4.) The Examiner also finds that Feriani
discloses putting “the bicarbonate in the compartment which has the
discharge duct to prevent the acid part from being administered to the patient
unmixed” (id. at 4-5).
The Examiner concludes that the claimed inventions would have been
obvious to one of ordinary skill in the art because “it would have been well
within the skill of one of ordinary skill in the art to prepare a two-part
composition in which potassium is contained in the bicarbonate part and/or
the acid/electrolyte part” (id. at 6) and that “one of ordinary skill in the art
would have been motivated to use a double chambered bag in which a first
component cannot be administered to a patient without mixing with the
second component for purposes of patient safety” (id.).
Appellants contend that the cited references do not disclose or suggest
the ranges of potassium specified in claim 6 (Appeal Br. 12) or a potassium-
limited bicarbonate concentrate in a chamber that is adapted to attach to or is
in fluid communication with a patient’s administration line, as specified in
claims 16 and 34 (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusions that the references would have
made obvious a two-part dialysis solution including the ranges of potassium
recited in claim 6, and a bicarbonate solution including little or no potassium
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in the chamber that is adapted to attach to or in fluid communication with a
patient’s administration line, as recited in claims 16 and 34?
Findings of Fact
1. Gullberg discloses that “[i]n order to obtain storable and
bacteriostatic concentrates for dialysis solutions …, the concentrates
according to the invention are divided to two containers” (Gullberg,
abstract).
2. Gullberg discloses that one container
contains an aqueous solution (A) of sodium carbonate or
bicarbonate and the other of which contains an aqueous solution
(B) of an acid forming physiologically compatible sodium and
calcium salts …, whereby both solutions (A) and (B) may
contain additionally sodium chloride and, if desired, potassium
cations.
(Id.)
3. Gullberg provides an example in which all of the potassium was in
the acid/electrolyte solution and not in the carbonate or bicarbonate solution
(id. at 8, ll. 1-18).
4. Feriani discloses a “container for preparing a bicarbonate
containing solution for dialysis” (Feriani, col. 1, ll. 5-8) that “may be used
[for] prolonged long-term storage of bicarbonate-containing solutions” (id.
at col. 2, ll. 24-26).
5. Feriani discloses that the container has “a first container part filled
with acid solution, and a second container part separated from the first one
by a flow blocking valve which is filled with a bicarbonate-containing
solution, one of said container parts having at least one discharge tube
having a removable closure” (id. at col. 1, ll. 8-13).
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6. Feriani discloses that it is
advantageous that, prior to mixing with the acid solution, the
basic bicarbonate-containing solution, is held in that
compartment which has the discharge duct or hose. This
arrangement is to be preferred for safety reasons.… A
bicarbonate-containing solution in the unmixed condition may
be tolerated by the patient without morbid symptoms,
something that is not true of the acid one.
(Id. at col. 7, ll. 3-14.)
7. Feriani discloses that its acidic solution contains Ca2+, Mg2+, Cl–,
and CH3COOH, and its bicarbonate-containing solution contains Na+, K+,
HCO3–, and Cl– (id. at col. 6, ll. 15-27).
Analysis
Claims 16 and 34
Claim 16 is directed to dialysis method that comprises mixing
separate bicarbonate and electrolyte concentrates and administering the
mixed solution during dialysis. Claim 34 is directed to a dialysis container
that comprises, among other things, bicarbonate concentrate and electrolyte
concentrate in separate chambers. Both claims also require that the
electrolyte concentrate includes potassium, but the bicarbonate concentrate
does not (claim 16) or is “substantially free of potassium” (claim 34).
Finally, both claims require that the bicarbonate concentrate chamber “is
adapted to attach to” (claim 16) or “is in fluid communication with” (claim
34) a patient’s administration line.
Feriani discloses a container for preparing a bicarbonate-containing
dialysis solution that includes a first part filled with an acid solution and a
second part filled with a bicarbonate-containing solution; the solutions in the
separate compartments are mixed prior to patient administration. Feriani
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also discloses that the bicarbonate-containing solution contains potassium.
Feriani discloses that it is advantageous to have the bicarbonate-containing
solution in the compartment which has the discharge duct or hose to prevent
the acid concentrate from passing into the patient unmixed.
Gullberg also discloses a two-part bicarbonate-based dialysis solution,
and discloses that potassium may be included with the bicarbonate
concentrate, the acid/electrolyte concentrate, or both. In view of these
disclosures, it would have been obvious to one of skill in the art to modify
the Feriani container so that the potassium was in the acid solution rather
than, or in addition to, the bicarbonate-containing solution because Gullberg
explicitly discloses that potassium may be included in either or both of the
concentrates.
The facts of the present case track those the Supreme Court addressed
in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007):
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
Here, Gullberg and Feriani demonstrate that there was a design need
or market pressure to solve the problem of providing bicarbonate-containing
dialysis solutions in storage-stable form by separating the acid component
from the bicarbonate component (FFs 1, 4, 5). Separating the components
requires choosing to put the potassium in either the bicarbonate-containing
solution, the acid-containing solution, or both. Gullberg and Feriani disclose
that each of these choices is valid: Gullberg teaches that potassium can be
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included in both solutions, and exemplifies including it in the acid solution
(FFs 2, 3), while Feriani exemplifies including potassium only in the
bicarbonate solution (FF 7). Therefore, any of the finite number of solutions
to the problem of where to put the potassium in the separated components of
a dialysis solution would have been obvious.
Appellants argue that the cited references do not disclose or suggest a
“bicarbonate concentrate that does not include potassium is in a first
chamber that is adapted to attach or is in fluid communication with a
patient’s administration line” (Appeal Br. 12). Appellants further argue that
Feriani teaches that the potassium is in the bicarbonate concentrate and thus
teaches away from the inventions of claims 16 and 34 (Appeal Br. 14).
These arguments are not persuasive. As discussed above, Gullberg
and Feriani teach that the potassium component of a dialysis solution can be
included in either or both of the separated acid- and bicarbonate-containing
solutions. Although Feriani exemplifies including potassium in the
bicarbonate concentrate (in the container part adapted to be connected to a
patient’s administration line), Appellants have not pointed to any teaching of
Feriani the potassium must be in that concentrate rather than the acid
concentrate. Thus, Feriani does not teach away from the inventions of
claims 16 and 34.
Appellants further argue that “Gullberg does not teach or suggest …
safe and effective uses for two-part bicarbonate-based solutions by avoiding
potassium overload during medical therapy in accordance with the present
claims” (Appeal Br. 15).
This argument is not persuasive. Although the cited references do not
suggest limiting the potassium to the acid/electrolyte concentrate in order to
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avoid overloading a patient with potassium, they make it obvious to do so
for other reasons. “In determining whether the subject matter of a patent
claim is obvious, neither the particular motivation nor the avowed purpose
of the patentee controls. . . . [A]ny need or problem known in the field of
endeavor at the time of invention and addressed by the patent can provide a
reason for combining the elements in the manner claimed.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 419-20 (2007).
Claim 6
Claim 6 is directed to a dialysis solution comprising a bicarbonate
concentrate including about 0.1 to 5 mmol/L potassium and an electrolyte
concentrate including about 11 mmol/L or less potassium.6
Appellants argue that the cited references do not disclose or suggest
“a two-part dialysis solution having the bicarbonate concentrate and the
electrolyte concentrate that include the specified ranges of potassium as
required by Claim 6” (Appeal Br. 12).
This argument is not persuasive. As discussed above, based on
Gullberg and Feriani, a skilled worker would have considered it obvious to
include potassium in either or both of the separated acid- and bicarbonate-
containing components of a two-part dialysis solution. Determining how
much potassium to put in each of the two components is simply routine
optimization of the invention suggested by the prior art. See In re Aller, 220
F.2d 454, 456 (CCPA 1955) (“[I]t is not inventive to discover the optimum

6 Claim 6 also specifies that the mixture of the bicarbonate and electrolyte
concentrates comprises sodium, bicarbonate, and chloride in specified
amounts, but Appellants do not dispute that the cited references suggest
those limitations.
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or workable ranges by routine experimentation.”); KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill is also a person
of ordinary creativity, not an automaton.”). Appellants have pointed to no
unexpected results arising from the particular ranges recited in claim 6.
Appellants also argue that Watanabe teaches away from the invention
of claim 6 by teaching potassium “only in the electrolyte concentrate”
(Appeal Br. 14, citing Watanabe at col. 2, ll. 52-65).
This argument is not persuasive. Although Watanabe discloses that
only its acid/electrolyte component contained potassium, Appellants have
not pointed to any teaching in Watanabe of any reason why potassium must
be included only in that component. Thus, Watanabe does not teach away
from including potassium in either or both of the components of a two-part
dialysis solution.
Conclusion of Law
The evidence of record supports the Examiner’s conclusions that the
references would have made obvious a two-part dialysis solution including
the ranges of potassium recited in claim 6, and a bicarbonate solution
including little or no potassium in the chamber that is adapted to attach to or
in fluid communication with a patient’s administration line, as recited in
claims 16 and 34.
SUMMARY
We affirm the rejection of claims 6, 8-10, 16-17, 19-21 and 34 under
35 U.S.C. § 103(a).
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Application 11/531,121

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TIME PERIOD FOR RESPONSE
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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