Ex Parte Wash

Board of Patent Appeals and Interferences

Aug 23, 2010

11179376 (B.P.A.I. Aug. 23, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte LORI L. WASH
____________

Appeal 2009-009050
Application 11/179,376
Technology Center 1700
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Before CHUNG K. PAK, TERRY J. OWENS, and
KAREN M. HASTINGS, Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL1
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1 through 5, which are all of the claims pending in the

1The 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.

Appeal 2009-009050
Application 11/179,376

above-identified application.2 We have jurisdiction under 35 U.S.C. §§ 6
and 134.
STATEMENT OF THE CASE
The subject matter on appeal is directed to “the packaging of a
dialysis bicarbonate solution containing ferric pyrophosphate” (Spec. 1,
para. 0001). According to pages 7 and 9 of the Specification, Appellant has
surprisingly or unexpectedly discovered that the use of a high density
polyethylene container allowed packaging of a dialysis bicarbonate solution
containing ferric pyrophosphate without causing any changes in a ferric
pyrophosphate concentration in the bicarbonate solution for a period of at
least 48 hours. In contrast, a convention glass container showed a
significant decrease in the pyrophosphate concentration, i.e., about 50% of
its original concentration after 48 hours (Spec. 9). Appellant also has
observed no iron precipitation in the dialysis bicarbonate solution containing
ferric pyrophosphate in the high density polyethylene container (id). Prior to
this discovery, the bicarbonate solution and ferric pyrophosphate were not
packaged together, but were mixed just before the administration of the
mixture to prevent the stability and/or precipitation problems associated with
the mixture (Spec. 5, para. 0018). Details of the appealed subject matter are
recited in claims 1 and 3 reproduced from the Claims Appendix to the
Appeal Brief as shown below:
1. A packaged bicarbonate solution for use in dialysis treatment,
comprising:
a bicarbonate solution into which ferric pyrophosphate is
dissolved in an amount sufficient to provide a therapeutic effect for

2 See page 2 of the Second Appeal Brief (“App Br.”) filed June 25, 2008.
and page 2 of Reply Brief (“Reply Br.”) filed November 13, 2008.
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Application 11/179,376

the treatment of anemia, iron deficiency or to reduce the dose of
recombinant erythropoietin needed to treat anemia when the
bicarbonate solution is combined with other dialysis components to
form a dialysate used for dialysis treatment of a patient; and
a polyolefin container or a container having a polyolefin liner,
in which the bicarbonate solution is contained, the packaged
bicarbonate solution being sufficiently stable to provide a ferric
pyrophosphate concentration that remains unchanged for at least 48
hours after preparation.
3. A process for treating anemia, iron deficiency, or for reducing
the dose of recombinant erythropoietin needed to treat anemia, during
a dialysis treatment, comprising:
preparing a bicarbonate solution suitable for dialysis treatment;
dissolving ferric pyrophosphate in the bicarbonate solution in
an amount sufficient to provide a therapeutic effect for the treatment
of anemia, iron deficiency, or to reduce the dose of recombinant
erythropoietin needed to treat anemia, when the bicarbonate solution
is combined with other dialysis components to form a dialysate used
for dialysis treatment of a patient;
storing the bicarbonate solution containing the ferric
pyrophosphate in a polyolefin container or in a container having a
polyolefin liner, the stored bicarbonate solution being sufficiently
stable to provide a ferric pyrophosphate concentration that remains
unchanged for at least 48 hours after preparation;
combining the bicarbonate solution containing ferric
pyrophosphate with a predetermined amount of water and
predetermined dialysis concentrate to form a dialysate;
and
dialyzing the patient with the dialysate.

As evidence of unpatentability of the claimed subject matter, the
Examiner relies upon the following evidence3:
Amand US 3,537,498 Nov. 3, 1970
Field US 4,636,412 Jan. 13, 1987
Gupta US 6,689,275 B1 Feb. 10, 2004

3 See page 2 of the Answer (“Ans.”) dated September 15, 2008
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Appeal 2009-009050
Application 11/179,376

Appellant seeks review of the following grounds of rejection set forth
at pages 3 through 5 of the Answer:
1. Claims 1, 3, and 5 under 35 U.S.C. § 103(a) as unpatentable
over Gupta in view of Amand; and
2. Claims 2 and 4 under 35 U.S.C. § 103(a) as unpatentable over
Gupta in view of Amand and Field.
ISSUE AND CONCLUSION
The dispositive question is: Has the Examiner erred in determining
that one of ordinary skill in the art would have been led to package a mixture
of bicarbonate solution and ferric pyrophosphate in a particular polyolefin
container capable of retaining a ferric pyrophosphate concentration in the
bicarbonate solution constant or unchanged for a period of at least 48 hours
and/or that a showing of unexpected results is not commensurate in scope
with the claims on appeal? On this record, we answer this question in the
affirmative.

FINDINGS OF FACT
Gupta teaches storing a bicarbonate concentrate useful for a
hemodialysis system in a plastic receptacle that is capped (col. 3, l. 55 to col.
4, l. 1). Gupta teaches that the concentrate is prepared within 24 hours of its
use (col. 4, ll. 1-2). Gupta teaches introducing ferric pyrophosphate into the
plastic receptacle containing the concentrate for the purpose of mixing the
concentrate with ferric pyrophosphate just prior to using the resulting
mixture for dialysis iron therapy (col. 4, ll. 1-35 and col. 4, l. 63 and col. 5, l.
25).
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Application 11/179,376

Amand teaches that the thicknesses and shape of thermoplastic bottles
for storing and dispensing sterile medical liquids can be particularly
designed to overcome the problem associated with the currently existing
polyolefin thermoplastic bottles (col. 1, ll. 3-59). Amand teaches (col. 1, ll.
63-72) that:
All of these bottles are of a thermoplastic that will withstand
steam sterilization of 220oF, to 260oF, and all are required to be
generally transparent so an operator can view the liquid
contents. Unfortunately, the thermoplastic materials which will
withstand the high sterilizing temperatures are polyolefins such
as polyethylene, polypropylene and copolymers of polyethylene
and polypropylene. These polyolefins are generally transparent
in only very thin wall sections and become increasingly cloudy
as the wall sections thicken.

Field teaches “a container useful for storage and administration of
medical compositions” such as those compositions that can be stored for
periods as long as 12 months in the package prior to use (col. 1, ll. 10-11
and ll. 58-60). Field teaches using a combination of an inner layer of linear
low density polyethylene, an intermediate layer of high density
polyethylene, and an outer layer of biaxially oriented nylon to construct the
wall of the container (col. 3, ll. 43-60); According to Field, “[t]he
intermediate layer is transparent and impermeable to water vapour” (col. 3,
ll. 59-60).

ANALYSIS AND PRINCIPLES OF LAW
The claimed subject matter requires packaging a mixture of a
bicarbonate solution and ferric pyrophosphate in a particular polyolefin
container or a container having a particular polyolefin liner for dialysis
treatment. The polyolefin container or liner employed is not any polyolefin
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Application 11/179,376

container or liner. Instead, the claimed particular polyolefin container or
liner must be capable of causing a ferric pyrophosphate concentration in the
bicarbonate solution to remain unchanged for a period of at least 48 hours.
As correctly acknowledged by the Examiner at page 6 of the Answer, such
polyolefin container or liner, according page 9 of the Specification, is made
of high density polyethylene (HDPE).
The Examiner has the initial burden of establishing a prima facie case
of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); In re
Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984). The “prima facie case”
serves as a procedural mechanism that shifts the burden of going forward to
Appellant to produce evidence and/or argument rebutting any inference of
unpatentability. Oetiker, 977 F.2d at 1445; Piasecki, 745 F.2d at 1472. The
Board reviews the obviousness rejection set forth by the Examiner for error
based on all the arguments and evidence relied upon by Appellants. See 37
C.F.R. § 41.37(c)(1)(vii); see also In re Baxter Travenol Labs., 952 F.2d
388, 391 (Fed. Cir. 1991) ("It is not the function of this court to examine
the claims in greater detail than argued by an appellant, looking for
nonobvious distinctions over the prior art.").
Here, the Examiner has shown that Gupta teaches that bicarbonate
solution and ferric pyrophosphate can be mixed in a thermoplastic container
prior to the administration of such mixture in a dialysis treatment. The
Examiner has also demonstrated that such thermoplastic container can be
made of a polyolefin material based on the teachings of Amand or a high
density polyolefin material based on the teachings of Field. However, as
correctly argued by Appellant at pages 5 and 6 of the Appeal Brief, the
Examiner has not demonstrated that the collective teachings of Gupta and
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Application 11/179,376

Amand or Gupta, Amand, and Field would have led one of ordinary skill in
the art to package a mixture of bicarbonate solution and ferric pyrophosphate
in a particular polyolefin container or a container having a particular
polyolefin liner capable of retaining a ferric pyrophosphate concentration in
the bicarbonate solution constant or unchanged for a period of at least 48
hours. In this regard, we note that the Examiner has not referred to any
teachings in the applied prior art references, which would have directed one
of ordinary skill in the art to store or package bicarbonate solution and ferric
pyrophosphate together.
In addition, as correctly argued by Appellant at pages 4 and 5 of the
Appeal Brief, the Examiner has not demonstrated that Gupta, Amand and
Field recognize the unexpected advantage of employing a high density
polyolefin container or liner in packaging a mixture of bicarbonate solution
and ferric pyrophosphate shown at page 9 of the Specification. Nor has the
Examiner demonstrated that such unexpected advantage is not
commensurate in scope with the claims on appeal since the claimed
particular polyolefin container or liner is limited to those having the
unexpected properties discussed at page 9 of the Specification.
Accordingly, on this record, we reverse the Examiner’s decision
rejecting claims 1 through 5 under 35 U.S.C. § 103.
ORDER
In view of the foregoing, the decision of the Examiner is reversed.

REVERSED

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Application 11/179,376

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