Ex Parte 5,836,908 et al

Board of Patent Appeals and Interferences

Nov 19, 2010

90010241 (B.P.A.I. Nov. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte Fresenius Medical Care Deutschland GMBH,
Patent Owner and Appellant
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Appeal 2010-009546
Reexamination Control 90/010,241
Patent 5,836,908
Technology Center 3900
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Before RICHARD E. SCHAFER, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL1

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”
shown on the PTOL-90A cover letter attached to this decision.
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Patent 5,836,908

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Fresenius Medical Care Deutschland GMBH (hereinafter
“Appellant”), the owner of the patent under reexamination (hereinafter the
“‘908 Patent”), appeals under 35 U.S.C. §§ 134(b) and 306 from a final
rejection of claims 1-18 and 21-37 (Appeal Brief filed March 4, 2010,
hereinafter “App. Br.,” at 5; Final Office Action mailed October 1, 2009).2
We have jurisdiction under 35 U.S.C. §§ 134(b) and 306.
We AFFIRM.

STATEMENT OF THE CASE
This reexamination proceeding arose from a third-party request for ex
parte reexamination filed by Alpa V. Patel of Hiscock and Barclay, LLP
(Request for Ex Parte Reexamination filed November 13, 2008).
We heard Patent Owner’s oral arguments on October 20, 2010, a
written transcript of which will be entered into the record in due course.
The ‘908 Patent describes a disposable balancing unit for balancing
fluids for a medical treatment device. (Col. 1, ll. 8-11.)
Claims 1, 6, 25, and 27 on appeal read as follows (underlining
indicates added subject matter relative to the original claims of the ‘908
Patent):

2 See Patent Assignment Abstract of Title, Reel 008435, Frame 0986, which
was entered into the record of this proceeding as “Title Report” on August
13, 2008, as well as assignments Reel 023292, Frame 0487 and Reel
023364, Frame 0800 (App. Br. 2). Claims 39-43 have been canceled, claims
19 and 20 have been confirmed, and claims 38 has been indicated as
allowable (App. Br. 4).
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1. A disposable balancing unit for balancing fluids for a
medical treatment device comprising: first and second
superposed plastic sheets, which are joined together in a
pressure-resistant manner, forming
a balancing chamber in the unit that is divided by a
flexible wall into a first and a second chamber half, said flexible
wall of said balancing chamber being formed by an
intermediate sheet, which is inserted between the first and
second sheet in the area of the balancing volume and is so
joined to the first and second sheets, forming the two chamber
halves so that said first chamber half is separated in a pressure-
tight manner from said second chamber half;
a first equalization chamber in the unit, which is in fluid
communication with the first chamber half via a first inlet
channel and, which is able to be clamped off in a pressure-tight
manner;
a second equalization chamber in the unit, which is in
fluid communication with the second chamber half via a second
inlet channel, which is able to be clamped off in a pressure-
tight manner; and
a first outlet channel, which is able to be clamped off in a
pressure-tight manner and is in fluid communication with said
first chamber half, and a second outlet channel, which is able to
be clamped off in a pressure-tight manner and is in fluid
communication with said second chamber half.
2. The disposable balancing unit as defined by claim 1,
wherein the inlet and outlet channels are formed at least in the
area of the clamping spots by flexible plastic hoses, which are
arranged between the first and second sheets and are joined in a
pressure-tight manner to the first and second sheets.
6. The disposable balancing unit as defined by claim 1,
wherein the first and second sheets are joined together in a
pressure-tight manner and form a serpentine channel which
leads into the second equalization chamber.
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25. The disposable balancing unit as defined by claim 1,
wherein the first outlet channel is located opposite from the
second inlet channel.
27. The disposable balancing unit as defined by claim 2,
wherein the first inlet channel and the first outlet channel are
heat-sealed to the intermediate sheet and are situated below the
intermediate sheet.

(Claims App’x, App. Br. 18-19.)

The Examiner relied upon the following publications as evidence of
unpatentability (Examiner’s Answer mailed March 18, 2010, hereinafter
“Ans.,” 4):
DeVries US 3,709,222 Jan. 9, 1973
Lichtenstein US 3,774,762 Nov. 27, 1973
Granzow, Jr. US 4,167,663 Sep. 11, 1979
Beden DE 41 16 178 C 1 Nov. 12, 1992

The Examiner rejected claims 1-18 and 21-37 as follows:
I. Claims 1-5, 10-12, 14-18, 21, 22, and 25-37 under 35 U.S.C. §
103(a) as unpatentable over Beden in view of DeVries and
Lichtenstein (Ans. 6-13); and
II. Claims 6-9, 13, 23, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Beden in view of DeVries and Lichtenstein,
further in view of Granzow, Jr. (Ans. 13-15).

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ISSUES
The Examiner found that Beden discloses a disposable balancing unit
having the features recited in claim 1, but that Beden does not disclose two
superposed plastic sheets forming the elements recited in the claim. (Ans. 6-
7.) The Examiner relied on DeVries and Lichtenstein to show that it was
known in the art to form balancing units having chambers and tubes from
two superposed plastic sheets in predetermined patterns. (Ans. 7.) The
Examiner concluded that it would have been obvious to form Beden’s
balancing chamber, compensation chambers (corresponding to the recited
equalization chambers), and channels from two superposed plastic sheets to
simplify the device, allow for easier installation and disposal of elements of
the device, and greatly decrease the possibility of contamination and
infection. (Ans. 7-8.)
Regarding claim 6, the Examiner found that Beden, DeVries, and
Lichtenstein do not disclose a serpentine channel leading into the second
equalization chamber as recited in the claim. (Ans. 13.) However, the
Examiner found that Granzow, Jr. discloses a serpentine conduit for heating
blood and other parental fluids prior to infusion into a patient. (Ans. 13.)
The Examiner concluded that it would have been obvious to substitute
Granzow, Jr.’s serpentine conduit for Beden’s heating system in order to
facilitate heating Beden’s fluid, because Granzow, Jr.’s heating design is a
known heating alternative and would produce the predictable result of more
accurately maintaining the output temperature of the fluid. (Ans. 13-14 and
26.)
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Appellant contends that Beden, DeVries, and Lichtenstein fail to
disclose the recited arrangement of chamber and channels out of two
superposed sheets. (App. Br. 10-12.) Appellant argues that it would not
have been obvious to modify Beden’s balancing unit in the manner
suggested by the Examiner because such a modification would have required
substantial redesign of Beden’s apparatus, particularly the compression units
located on the outer periphery of Beden’s compensation chambers. (App.
Br. 10; Reply Brief filed May 18, 2010 (hereinafter “Reply Br.”) 6-7.)
Appellant also argues that there is no reason to combine Beden with DeVries
and Lichtenstein because Beden already discloses compensation chambers
made from plastic pouches, which are easily installed and disposed. (App.
Br. 10-11; Reply Br. 7.)
Appellant further argues that Beden does not disclose that the
compensation chambers (the “equalization chamber” in claim 1) are in fluid
communication with the balancing chamber, because the claims require that
the inlet and outlet channels are directly connected to the balancing
chamber. (App Br. 12; Reply Br. 8-9.) Appellant contends that Beden does
not disclose the inlet/outlet configuration recited in the claims, because only
one channel is connected to the balancing chambers in Beden, which both
receives and expels the fluid. (App. Br. 12-14.) Appellant also argues that
with respect to claims 25 and 26, the inlet/outlet lines of Beden are not
located opposite one another as claimed. (App. Br. 14-15.) Regarding
claims 27 and 28, Appellant further contends that the prior art combination
fails to disclose inlet and outlet channels below or above the intermediate
sheet of Beden. (App. Br. 15-16.)
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Regarding claim 6, Appellant argues that one of ordinary skill in the
art would not have combined Beden with Granzow, Jr., because Beden
already discloses heating the fluid. (App. Br. 16-17.) Appellant further
contends that there would be no reason to used Granzow, Jr.’s flow path in
Beden because the problem solved in Granzow, Jr. is automatically
controlling the operation of heating elements to more accurately maintain
the output temperature of blood, and such a substitution would require
substantial redesign. (App. Br. 17.)
Thus, the dispositive issues in this appeal are:
1. Did the Examiner err in determining that it would have been
obvious to form Beden’s balancing chamber, compensation chambers, and
inlet and outlet channels as one unit from two superposed sheets in view of
DeVries and Lichtenstein?
2. Would the equalization chambers, balancing chamber halves, and
inlet and outlet channels in the configuration as recited in claims 1, 25, and
27, have been obvious over Beden in view of DeVries and Lichtenstein?
3. Did the Examiner err in determining that it would have been
obvious to one of ordinary skill in the art to incorporate the serpentine
channel disclosed in Granzow, Jr. into Beden’s balancing unit to arrive at the
disposable balancing unit containing a serpentine channel as recited in claim
6?

FINDINGS OF FACT (“FF”)
1. Beden discloses a balancing chamber that has an interior space
separated into two halves by a flexible wall, where each
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balancing chamber half is alternatively fed by two
compensation chambers (equalization chambers) in the form of
flexible bags. (Page 2, second column, ll. 36-57.)
2. DeVries discloses an apparatus for dialysis including a plastic
container sheet, which “is intended to be disposable to avoid the
sterilization problems incident to the use of reusable
containers.” (Col. 1, ll. 4-41; col. 3, l. 66-col. 4, l. 1; Fig. 5,
conduit sheet 160.)
3. DeVries further discloses that the “sheet is made from a plastic
which is preferably transparent, or at least translucent, and heat
sealable. Chambers are formed, in the double or folded-over
sheet, by heat sealing the peripheries, and plastic tubes are heat
sealed into these chambers . . . to provide the necessary ingress
and egress.” (Col. 4, ll. 1-7.)
4. Lichtenstein discloses a hemodialysis system that includes a
flexible component made up of layers of transparent flexible
sheets. (Col. 4, ll. 19-20; col. 8, ll. 34-37.)
5. Lichtenstein discloses that the transparent flexible sheets “are
sealed to each other according to a predetermined pattern” and
that “[t]he pattern according to which these sheets are sealed to
each other will create fluid passages . . . and pockets . . . which
define flow paths and reservoirs, within the disposable
component for the fluid which is to be processed and to contain
necessary reagents or active principles of the process or
procedure.” (Col. 4, ll. 25-30.)
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6. Granzow, Jr. discloses an apparatus for heating parental fluids
such as blood prior to infusion in the body in “applications
where a highly accurate fluid output temperature must be
maintained over a wide range of flow rates.” (Col. 1, ll. 5-8 &
50-53; col. 11, ll. 10-17.)
7. Granzow, Jr. depicts a serpentine warming bag 26 for warming
parental fluids. (Col. 4, ll. 9-13; Fig. 2.)

PRINCIPLES OF LAW
“‘During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification.’” In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir.
2010) (quoting In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379
(Fed. Cir. 2007)). Although claims are interpreted in light of the
specification, limitations from the Specification are not read into the claims.
In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
In KSR, the Supreme Court explained, “[w]hen a work is available in
one field of endeavor, design incentives and other market forces can prompt
variations of it, either in the same field or a different one. If a person of
ordinary skill can implement a predictable variation, §103 likely bars its
patentability.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “A
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” Id. at 421.
“[T]he test for combining references is not what the individual
references themselves suggest but rather what the combination of disclosures
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taken as a whole would suggest to one of ordinary skill in the art.” In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).

ANALYSIS
Appellants have grouped certain claims subject to the first grounds of
rejection separately. However, Appellants rely on similar arguments for
some of the claim groupings. Accordingly, we confine our discussion to
appealed claims 1, 6, 25, and 27, which contain claim limitations
representative of the arguments made by Appellants, and address other
claims only to the extent that Appellants have argued them separately
pursuant to 37 C.F.R. § 41.37(c)(1)(vii).
Issue #1
Upon consideration of Appellant’s arguments, we discern no error on
the part of the Examiner in determining that modifying Beden’s balancing
unit to form the balancing chamber, compensation chambers, and inlets and
outlets out of superposed plastic sheets would have been obvious in view of
DeVries and Lichtenstein. We agree with the Examiner that Appellant’s
arguments unduly focus on the individual teachings of the prior art, rather
than what the prior art as a whole would disclose to one of ordinary skill in
the art. Specifically, both DeVries and Lichtenstein disclose that plastic
sheets may be used to form chambers and flow paths according to a desired
pattern. (FF 2-5.) Though Appellant argues that incorporating the concept
disclosed in DeVries and Lichtenstein into Beden’s balancing unit would
require substantial redesign of the balancing unit, Appellant provides no
persuasive evidence that the amount of redesign required would be beyond
the level of one of ordinary skill in this art. Appellant contends that the
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principle of operation is being changed because the compensation chambers
are not being provided as separate elements (Reply Br. 7). However, the
elements are not being eliminated, but simply are formed from the same
sheet as taught by the prior art.
Moreover, we are not persuaded by Appellant’s argument that the
only reason for making the required modifications given by the Examiner is
based on hindsight. The Examiner’s rationale appears to be based on the
reasonable position that by making the separate disposable components
disclosed in Beden integral by forming the required chambers and flow paths
out of superposed plastic sheets as suggested by DeVries and Lichtenstein,
one of ordinary skill in the art would obtain a predictable improvement in
simplicity of the device, and the ease of installation and disposal of the
portions of the device that contact fluid, which greatly decreases the
possibility of infection. (Ans. 7-8.)
Similarly, Appellant’s argument that forming the compensation
chambers disclosed in Beden from two superposed plastic sheets would
require substantial redesign of the compression units and dimensional
sensors is unavailing. Again, Appellant appears to be arguing the individual
teachings of each reference rather than what the references as a whole would
convey to one of ordinary skill in the art. Further, Appellant has not directed
us to any persuasive evidence that one of ordinary skill in the art would have
been incapable of adjusting the position of the compression units or
evaluating the dimensional displacement of the compensation chambers to
accommodate the modified design of Beden’s balancing unit.
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Issue #2
We are also unconvinced by Appellant’s arguments that Beden in
view of DeVries and Lichtenstein fails to disclose arrangement of balancing
and equalization chamber with the inlet and outlet channels recited in the
claims.
Initially, we agree with the Examiner, that the phrase “in fluid
communication” via first and second inlet channels as recited in claim 1
does not require that the recited inlet and outlet channels are directly
connected to the first and second chamber halves. The claim recites that the
chambers are in communication “via” inlet channels, but do not recite a
structure, path, or specific connection through which the fluid
communication is achieved. As stated by the Examiner, the inlet and outlet
channels of Beden must be “in fluid communication” with the respective
chamber halves in order for the fluid to flow into and exit the chamber
halves of Beden, meeting the corresponding claim limitation. (Ans. 23-24.)
Appellant has failed to direct our attention to a specific definition for “in
fluid communication” via inlet and outlet channels in the Specification,
which would exclude the inlet/outlet line configuration disclosed in Beden.
Though Figure 1 of the ‘908 Patent depicts an embodiment where the inlet
and outlet channels are directly connected to the first and second chamber
halves, we agree with the Examiner that interpreting the claims to require
such a direct connection would be tantamount to reading limitations from the
Specification into the claims. (Ans. 24.)
Similarly, Appellant’s argument that Beden’s T-connector
configuration fails to satisfy claim recitations of first and second inlet and
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outlet channels in fluid communication with the balancing chamber halves is
also unpersuasive. Appellant acknowledges that Beden discloses inlet and
outlet lines for each balancing chamber half, but argues that because each of
these lines is connected to a T-connector in Beden, the inlet and outlet lines
are not connected with Beden’s chambers. (App. Br .13-14.) Appellant
contends that Beden’s configuration cannot simultaneously provide and
remove substituent to and from the first and second chamber halves. (App.
Br. 13-14.) Consistent with the preceding discussion, because Beden
discloses a compensation (equalization) chamber in fluid communication
with each balancing chamber half via an inlet line, as well as outlet lines
which are in fluid communication with each balancing chamber half, Beden
discloses the required relationship between the balancing chambers,
equalization chambers, and inlet and outlet lines recited in the claims. As to
Appellant’s arguments that Beden’s configuration cannot simultaneously
provide fluids from each chamber half, we agree with the Examiner that
Appellant argues limitations that do not appear in the claims. (Ans. 24.)
The instant claims are directed to a disposable balancing unit or devices that
all include a disposable balancing unit. In other words, the present claims
are apparatus claims and not methods for using the apparatus. Here, the
relationships between the balancing chambers, equalization chambers, inlet
channels, and outlet channels recited in the claims would be satisfied by
modifying Beden’s apparatus in view of DeVries and Lichtenstein in the
manner suggested by the Examiner.
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Claims 25 and 26
Claims 25 and 26 recite the outlet channel “is located opposite” the
inlet channel. The Examiner found this limitation met by the structure
disclosed in Beden’s Figure 1, where the inlet and outlet pairs were located
on opposite sides of the balancing chamber (Ans. 25). Appellant contends
that the Examiner’s interpretation of “opposite” as including the “opposite
sides” of the balancing chamber is not reasonable in view of Figure 1 of the
Specification. (Reply Br. 9; Ans. 25.) However, Appellant has not set forth
a specific definition of the general term “opposite,” which would exclude the
Examiner’s interpretation. Although Appellant’s Figure 1 depicts one
embodiment of the balancing unit, we decline to read the arrangement of
Figure 1 into the claims. Therefore, we do not find the Examiner’s
interpretation of the term “opposite” in the claim to be unreasonable.
Accordingly, we agree with the Examiner, that in modifying the Beden in
view of DeVries and Lichtenstein, the first outlet channel would be located
opposite the second inlet channel.

Claims 27 and 28
We agree with the Examiner that without a recited reference point, the
recited limitations “above” and “below” are indistinguishable from left and
right. (Ans. 25.) Appellant’s arguments that Beden’s chamber halves only
contain one line that acts as both an inlet and an outlet are unpersuasive for
the reasons previously discussed.
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Issue #3
We are unconvinced by Appellant’s argument that Granzow, Jr.
provides no reason to use a serpentine flow path in Beden’s device because
Granzow, Jr. is directed to “automatically controlling the operation of
heating elements to more accurately maintain the output temperature of the
blood.” (App. Br. 16.) Granzow, Jr. discloses that the blood warming
apparatus is merely an example, and that the invention may be used in other
applications where a highly accurate fluid output temperature is required.
(FF 6.) Thus, we agree with the Examiner that substitution of Granzow, Jr.’s
system for the heating means of Beden’s device would have been a “mere
substitution of one known prior element for another with perfectly
predictable results.” (Ans. 27.) Regarding Appellant’s argument that such a
substitution would require redesign of Beden’s device, we agree with the
Examiner that this does not constitute strong evidence of non-obviousness,
as at least some redesign is involved in most cases where elements or
systems are modified. In addition, Appellant has not presented any
persuasive evidence that any redesign required by virtue of incorporating
Granzow, Jr.’s heating system into Beden’s device would have been beyond
the level of ordinary skill in the art. (Ans. 27-28.)

CONCLUSION
On this record, we do not find error in the Examiner’s factual findings
and conclusions that:
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it would have been obvious to form Beden’s balancing chamber,
compensation chambers, and inlet and outlet channels as one unit from two
superposed sheets in view of DeVries and Lichtenstein;
the equalization chambers, balancing chamber halves, and inlet and
outlet channels in the configuration as claimed in claims 1, 25, and 27,
would have been obvious over Beden in view of DeVries and Lichtenstein;
and
it would have been obvious to one of ordinary skill in the art to
incorporate the serpentine channel disclosed in Granzow, Jr. into Beden’s
balancing unit to arrive at the disposable balancing unit containing a
serpentine channel as recited in claim 6.

DECISION
The Examiner’s decision to reject claims 1-18 and 21-37 under 35
U.S.C. § 103(a) is affirmed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

cu

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FOR PATENT OWNER:
KENYON & KENYON LLP
ONE BROADWAY
NEW YORK, NY 10004

FOR THIRD-PARTY REQUESTER:
HISCOCK & BARCLAY, LLP
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100 CHESNUT STREET
ROCHESTER, NY 14604-2404