FRESENIUS MEDICAL CARE HOLDINGS, INC.

Patent Trials and Appeals Board

May 28, 2020

2019004490 (P.T.A.B. May. 28, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
14/958,335 12/03/2015 Palmer David UPDYKE 3192-035-01 3557
86723 7590 05/28/2020
Kilyk & Bowersox, P.L.L.C.
400 holiday Court, Suite 102
Warrenton, VA 20186
EXAMINER
PEO, JONATHAN M
ART UNIT PAPER NUMBER
1779
NOTIFICATION DATE DELIVERY MODE
05/28/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@kbpatentlaw.com
lkilyk@kbpatentlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PALMER DAVID UPDYKE, BARRY FULKERSON,
AMAURY DE LEON DE LEON, and MICHELLE BAYLY
____________

Appeal 2019-004490
Application 14/958,335
Technology Center 1700
____________

Before KAREN M. HASTINGS, MICHAEL P. COLAIANNI, and
DEBRA L. DENNETT, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

Appellant appeals under 35 U.S.C. § 134(a) the final rejection of
claims 1, 3–5, 7, and 11–28.1 Claims 2, 6, and 8–10 are canceled. We have
jurisdiction over the appeal. 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Fresenius Medical Care Holdings, Inc. as
the real party in interest (Appeal Br. 3).
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STATEMENT OF THE CASE
Appellant’s invention is directed to machines for performing
hemodiafiltration (HDF), as well as hemodialysis (HD), hemofiltration (HF),
and peritoneal dialysis (Spec. ¶¶ 2, 3, 5). HDF, which results in fluid loss
during ultrafiltration of a patient’s blood, requires the use of replacement
fluid (id. ¶ 4). This fluid must be ultrapure because it is replaced directly
into a patient’s blood stream (id.). The Specification describes that
performing HDF using purified dialysate avoids the use of dedicated,
ultrapure replacement fluid, or reliance on additional, cumbersome water
purification systems (id. ¶ 6).
Claims 1 and 15 are representative of the subject matter on appeal
(emphasis added):
1. A manifold kit comprising:
a manifold body comprising a first dialysate conduit, a
dialysate circuit pump header in fluid communication with the
first dialysate conduit, a blood circuit pump header, a first
external port in fluid communication with the first dialysate
conduit, a second external port in fluid communication with the
blood circuit pump header, and a plurality of pressure sensor
chambers, each pressure sensor chamber being independently
covered by a flexible sheet and configured to be aligned with a
pressure sensor on a dialysis machine housing to allow for
pressure measurements of a fluid;
a patient arterial tube that is external to the manifold
body, has a free end for connecting to a patient’s artery, and has
a manifold end connected to the second external port;
a dialyzer comprising a dialysate inlet, a dialysate outlet,
a blood inlet, and a blood outlet; and
an external tube connected at a first end thereof to the
manifold body at the first external port and comprising an
external main segment, a first external branch segment
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comprising a first flow restrictor, and a second external branch
segment comprising a second flow restrictor, the first external
branch segment having a first end and a second end, the first
external branch segment being connected at the first end
thereof to the external main segment and being connected at the
second end thereof to the dialysate inlet of the dialyzer, the
second external branch segment having a first end and a second
end, the second external branch segment being connected at the
first end thereof to the external main segment and being
connected at the second end thereof to the patient arterial tube,
wherein the second external branch segment is connected
to the patient arterial tube upstream of the blood circuit pump
header, wherein the manifold body, the patient arterial tube,
the dialyzer, and the external tube are preassembled such that
they are connected together, and wherein the entire manifold kit
comprises disposable components.
15. A manifold comprising:
a manifold body comprising
a first transom comprising a first edge, and second
and third edges substantially parallel to the first edge,
a trunk substantially perpendicular to and adjacent
the first transom,
a second transom comprising a fourth edge, and
fifth and sixth edges substantially parallel to the first, second,
and third edges, the second transom being substantially
perpendicular to and adjacent the trunk and substantially
parallel to the first transom;
a first external port and a second external port
located on the fourth edge,
a first intra-manifold port located on the second
edge,
a second intra-manifold port located on the second
edge,
a third intra-manifold port located on the fifth
edge, and
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a fourth intra-manifold port located on the fifth
edge;
a first conduit in the second transom and in fluid
communication with the second external port and the third
intra-manifold port;
a second conduit in the manifold body and in fluid
communication with both the second intra-manifold port and
the first external port;
a first pump tube connected to and in fluid
communication with the first and third intra-manifold ports;
a second pump tube connected to and in fluid
communication with the second and fourth intra-manifold ports;
a first external tube connected to and in fluid
communication with the first external port and comprising an
external main segment, a first external branch segment, and a
second external branch segment; and
an external blood tube in fluid communication with and
extending from the second external port,
wherein the external main segment is connected to the
first external port, the first external branch segment is
connected to the external main segment and is configured to be
connected to a dialyzer, the second external branch is
connected to the external main segment and is in fluid
communication with the external blood tube upstream of the
first pump tube, and the entire manifold comprises disposable
components.
Appeal Br. 41–42, 44–46 (Claims App.).
The Examiner maintains the following rejections:
1. Claims 1, 4, 5, 7, 15–19, 21–24, and 27 are rejected under 35
U.S.C. § 103(a) as unpatentable over Fulkerson et al. (US
2011/0315611 A1; published Dec. 29, 2011, “Fulkerson”), in view of
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Kelly et al. (US 2005/0131331 A1; published June 16, 2005, “Kelly”)
(Final Act. 8–25).
2. Claims 11, 12, 14, 20, 25, and 262 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Fulkerson, in view of Kelly, and further
in view of Collins et al. (US 6,303,036 B1; issued Oct. 16, 2001,
“Collins”) (Final Act. 25–38).
3. Claim 3 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Fulkerson, in view of Kelly, and further in view of Falkvall et al.
(US 5,730,712; issued Mar. 24, 1998, “Falkvall”) (Final Act. 38–39).
4. Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Fulkerson, in view of Kelly, Collins, and further in view of
Falkvall (Final Act. 39–40).
5. Claim 28 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Fulkerson, in view of Kelly, Collins, and further in view of
Cicchello et al. (US 2009/0008306 A1; published Jan. 8, 2009,
“Cicchello”) (Final Act. 40–44).
Appellant offers separate arguments in support of independent claims
1, 11, and 15; and dependent claims 3, 13, and 28 (Appeal Br. 5, 15). Each
of these claims will be discussed separately.

2 Although the Examiner listed claim 28 in the Final Office Action’s
statement of this rejection, grounds for rejecting this claim are omitted (Final
Act. 25–38). The Examiner included grounds for specifically rejecting
claim 28 in a separate rejection (id. at 40–44). Accordingly, we view the
Examiner’s listing of claim 28 along with rejected claims 11, 12, 14, 20, 25,
and 26 as a clerical error.
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FINDINGS OF FACT & ANALYSIS
After review of the respective positions provided by Appellant and the
Examiner, we affirm the Examiner’s prior art rejections under 35 U.S.C.
§ 103(a) for the reasons presented by the Examiner and add the following for
emphasis.
A. Rejection of claims 1, 4, 5, 7, 15–19, 21–24, and 27 as unpatentable
over the combination of Fulkerson and Kelly.
1. Claim 1
With respect to claim 1, the Examiner’s findings and conclusions
regarding Fulkerson and Kelly are located on pages 8–15 of the Final Office
Action.
The Examiner finds that Fulkerson’s portable dialysis machine would
have rendered obvious each limitation of the manifold kit recited in
independent claim 1, except that Fulkerson does not disclose the external
tube’s features (Final Act. 8–13).
The Examiner finds Kelly discloses that, inter alia, manifold body 56
is connected to an external tube at a first port (id. at 13). The Examiner
finds that Kelly’s external tube discloses or suggests the claimed tube’s
segments and limitations missing from Fulkerson (id.). According to the
Examiner, Kelly’s Figure 1 depicts an external tube comprising: (i) an
external main segment, as represented by “[l]ines 60/88 and [p]ort 86
connected to [m]anifold 56,” (ii) the first external branch segment
comprising a first flow restrictor, as represented by “[l]ine 60 leading from
[b]ranch at [p]ort 86 that has [v]alve 58,” and (iii) the second external
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branch segment comprising a second flow resistor, as represented by “[l]ine
88, [v]alve 116/77” (id. at 13–14).
Figure 1 of Kelly, as annotated by the Examiner and reproduced
below, illustrates a system for providing HF/HDF clearance modes to a
patient:

Figure 10 of Kelly illustrates HF/HDF system 10, including manifold
56, port 86, HF line 88, predilution line 106, postdilution line 104, valve 77,
pinch clamp 116, blood circuit 70, arterial access 72, pump 82, dialyzer 44,
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dialysate line 60, bypass line 62, and bypass valve 58 (Kelly ¶¶ 51–54, 56–
57, 59).
The Examiner determines that it would have been obvious for one of
ordinary skill in the art at the time of the invention “to have modified the
manifold of Fulkerson by incorporating” Kelly’s hemofiltrating external
tube features (Final Act. 14). According to the Examiner, Kelly’s control
over the substitution fluid amounts used for predilution and postdilution
infusion would have provided Fulkerson’s modified manifold efficient use
of flow components (id. (citing Kelly ¶¶ 18, 20, 54)). The Examiner
concludes that the proposed modification would have improved Fulkerson’s
manifold’s clearance ability through postdilution therapy, while preventing
blood clotting and hypotension through predilution therapy (Final Act. 15
(citing ¶ 21)).
Appellant argues that Kelly does not teach or suggest that the first
external branch segment is “connected” to the external main segment, as
recited in claim 1 (Appeal Br. 17). In particular, Appellant argues that
Kelly’s line 60 terminates at one end with bypass valve 58, which prevents
any connection to the alleged main segment (id. at 19; Reply Br. 3–5). Even
assuming that Kelly’s line 60 extends through bypass valve 58 to provide the
requisite connection with a main segment, Appellant contends that Kelly
fails to teach or suggest that bypass valve 58 restricts fluid flow (Reply Br.
5–6).
We are not persuaded by these arguments.
The Examiner’s findings explicitly describe that “[o]ne end of [l]ine
60 is connected to the branch at [p]ort 86” (Final Act. 14 (citing Kelly Fig.
1; ¶ 51)). Although the line connecting port 86 to bypass valve 58 is not
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annotated as “line 60” in Kelly’s Figure 1, the Examiner explains that the
line that suggests the claimed first external branch segment “starts at the
junction point at substitution port 86” (Ans. 40–41; see supra Examiner’s
annotated Fig. 1). The Examiner, furthermore, reasonably interprets the
“flow restrictor” language recited in claim 1 as encompassing Kelly’s valve
58 (Final Act. 13 (citing Kelly Fig. 1)); see also Spec. ¶ 56 (explaining that a
“valve can act as a flow restrictor”). Therefore, we agree with the Examiner
that Kelly teaches or suggests that the first external branch segment line is
“connected” to the external main segment within the meaning of claim 1.
Appellant argues that Kelly fails to teach or suggest that the second
external branch segment is “connected” to the external main segment, as
recited in claim 1 (Appeal Br. 19–20). Specifically, Appellant contends that
Kelly’s port 86 is not a line and thus prevents any connection between line
88 and the alleged main segment line (id. at 20 (asserting that “line 88
connects to a port, not to a tube”; Reply Br. 6; see also Kelly Fig. 1)).
We are not persuaded by these arguments because Kelly’s port 86 is
an opening through which line 88 can directly attach or connect to the main
segment line (see Ans. 43). In our view, the ordinarily skilled artisan would
have viewed port 86 as amenable to providing a connection between
segments of a manifold’s external tube. Therefore, we agree with the
Examiner that Kelly teaches or suggests that the second external branch
segment line is “connected” to the external main segment within the
meaning of claim 1.
Appellant argues that there would have been no motivation to
combine Fulkerson’s teachings with Kelly’s because Fulkerson’s
requirement for recycling “the same small volume of dialysate” teaches
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away from the Examiner’s proposed combination (Appeal Br. 22 (citing
Fulkerson ¶ 262); Reply Br. 7). Appellant argues that the Examiner’s
proposed “modification would [have] reduce[d] the volume of dialysate
throughout diafiltration of Fulkerson, which is in violation of an explicit
requirement of the Fulkerson invention” (Appeal Br. 22).
Appellant’s arguments are unpersuasive.
We find that Fulkerson does not explicitly prohibit reducing dialysate
volume or modifying the dialysate circuit tubing such that branch segments
provide hemofiltration. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)
(“A reference may be said to teach away when a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant.”). As the Examiner finds, Fulkerson’s
Figure 33 depicts an inlet for fresh dialysate from a dialysate reservoir (Ans.
44 (citing Fulkerson ¶ 328)). We, furthermore, agree with the Examiner that
Fulkerson suggests that this dialysate reservoir is not limited to a small
volume, but can be replaced to accommodate a variety of uses or patients
(Ans. 44 (citing Fulkerson ¶ 187)).
Appellant argues that one of ordinary skill in the art would not have
combined the teachings of the Examiner’s applied prior art because
Fulkerson’s manifold is not analogous to Kelly’s manifold (Appeal Br. 23–
28). Specifically, Appellant directs our attention to differences between
Fulkerson’s and Kelly’s manifold portability, sensor type and placement,
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disposability, fluid type circulated therein, and utilization of pumps,
branches, cartridges, blood drip chambers, etc. (id.).
To the extent Appellant argues that the Examiner is combining non-
analogous art, each of the relied upon references are either in the field of
Appellant’s endeavor or are reasonably pertinent to the particular problem
with which the Appellant was concerned. See In re Kahn, 441 F.3d 977,
986‒87 (Fed. Cir. 2006); see also In re Oetiker, 977 F.2d 1443, 1447 (Fed.
Cir. 1992). The Examiner has made reasoned findings establishing that
Fulkerson and Kelly are each directed to hemodialysis systems, which
circulate dialysate using a manifold capable of evaluating circulation
characteristics therein (Ans. 45). For the reasons set forth in the Answer on
pages 45–47, 50–51, and 53, we are not persuaded by Appellant that any of
the allegedly non-analogous manifold features would have been viewed by
one of ordinary skill in the art as reasons not to combine Fulkerson’s and
Kelly’s teachings.
Furthermore, Appellant’s arguments lack persuasive merit because the
Examiner’s proposed modification does not replace Fulkerson’s manifold
3300 with Kelly’s manifold 56. Rather, the Examiner proposes
incorporating Kelly’s lines and conduits, which are connected to manifold
56, to Fulkerson’s manifold 3300 (Ans. 46).
Therefore, Appellant’s arguments are insufficient to convince us of
reversible error in the Examiner’s rejection of claim 1. Appellant argues
claims 1, 4, 5, 7, and 21–27 as a group (Appeal Br. 5).
On this record, we sustain the Examiner’s § 103(a) rejection as to
claims 1, 4, 5, 7, 21–24, and 27.
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2. Claim 15
With regard to claim 15, the Examiner’s findings and conclusions
regarding Fulkerson and Kelly are located on pages 18–23 of the Final
Office Action.
Appellant argues that Fulkerson’s and Kelly’s “combination does not
disclose or suggest the two ‘fluid communication’ limitations of separately
argued claim 15.” (Appeal Br. 30). Appellant contends that Kelly does not
disclose “that fluid is sent out of manifold 56 to by-pass valve 58 and
simultaneously is sent out substitution port 86” (id.).
Appellant’s arguments are not dispositive because the Examiner’s
findings with respect to claim 15 do not require fluid flowing from out of
manifold 56 to bypass valve 58 (Final Act. 22–23). Rather, the Examiner
finds that Kelly’s “[l]ine 88 leading from [p]ort 86 to Y-connector 102”
depicts the claimed external tube comprising an external main segment (id.
at 22; see Kelly Fig. 1).
The Examiner finds that Kelly’s external tube includes the claimed
first external branch segment: (i) comprising a first flow restrictor, as
represented by “[l]ine 104, [v]alve 114,” and (ii) connected to the external
main segment and configured to be connected to a dialyzer, as represented
by “[l]ine 106[] connected to [l]ine 88 via [c]onnector 102, and [l]ine 106[]
later connected to [d]ialyzer 44” (id. at 22–23).
The Examiner finds that Kelly’s external tube includes the claimed
second external branch segment: (i) comprising a second flow restrictor, as
represented by “[l]ine 106, [v]alve 116/77,” and (ii) connected to the
external main segment and in fluid communication with an external blood
tube upstream of a first pump tube, as represented by “[l]ine 106 connected
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to main [l]ine 88, and may connect to an external blood tube 70 via valve 77
which is upstream of [p]ump 82” (id. at 23).
The Examiner, however, fails to adequately explain how Kelly’s lines
correspond to each segment recited in claim 15.
We begin our analysis by construing “the first external branch
segment” and “the second external branch segment” in the context of the
Specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed.
Cir. 2004) (During examination of a patent application, pending claims are
given their broadest reasonable construction consistent with the
Specification.). On paragraph 55, the Specification describes that “[t]he
dialysate flow can originate from a main segment 714 and be split between a
first branch segment 716 and a second branch segment 718.” (emphasis
added). In Figure 7A of the Specification, Appellant depicts first branch
segment 716 and second branch segment 718 as distinct portions connected
to a terminal end of main segment 714.
Based upon these disclosures, we construe “the first external branch
segment” and “the second external branch segment” as distinct elements.
Where a claim lists elements separately, “the clear implication of the claim
language” is that those elements are “distinct component[s]” of the patented
invention. Becton, Dickinson and Co. v. Tyco Healthcare Group, LP, 616
F.3d 1249, 1254 (Fed. Cir. 2010) (citing Gaus v. Conair Corp., 363 F.3d
1284, 1288 (Fed. Cir. 2004); see also Engel Indus., Inc. v. Lockformer Co.,
96 F.3d 1398, 1404–05 (Fed. Cir. 1996) (concluding that where a claim
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provides for two separate elements, a “second portion” and a “return
portion,” these two elements “logically cannot be one and the same”).
In light of our proper claim construction, we find that Kelly’s line 104
and line 106 cannot be found to reasonably correspond to the claimed first
external branch segment (see id. at 22–23). We, furthermore, find that
Kelly’s line 106 cannot be found to reasonably correspond to both the
claimed first and second external branch segments (see id. at 23).
Because the Examiner has not adequately explained how Kelly’s lines
104 and 106 teach or suggest the claimed distinct external branch segments
required by the claims, the Examiner failed to establish a prima facie case of
obviousness regarding claim 15. Appellant argues claims 15–20 as a group
(Appeal Br. 5).
On this record, we do not sustain the Examiner’s § 103(a) rejection as
to claims 15–19.
B. Rejection of claims 11, 12, 14, 20, 25, and 26 as unpatentable over the
combination of Fulkerson, Kelly, and Collins.
1. Claim 11
With respect to claim 11, the Examiner’s findings and conclusions
regarding Fulkerson, Kelly, and Collins are located on pages 25–35 of the
Final Office Action.
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Claim 11 is set forth below (emphasis added):
11. A dialysis machine comprising:
a housing;
a manifold kit comprising a manifold body;
a receptacle mounted on the housing and configured to
accept the manifold body; and
at least one flow restrictor, wherein
the manifold body is operatively engaged with the
receptacle,
the manifold body comprises a first dialysate
conduit, a dialysate circuit pump header in fluid
communication with the first dialysate conduit, a blood circuit
pump header, a first external port in fluid communication with
the first dialysate conduit, a second external port in fluid
communication with the blood circuit pump header, and a
plurality of pressure sensor chambers, each pressure sensor
chamber being independently covered by a flexible sheet and
configured to be aligned with a pressure sensor on a dialysis
machine housing to allow for pressure measurements of a fluid,
the manifold kit further comprises
a patient arterial tube that is external to the
manifold body, has a free end for connecting to a patient's
artery, and has a manifold end connected to the second external
port,
a dialyzer comprising a dialysate inlet, a dialysate
outlet, a blood inlet, and a blood outlet, and
an external tube connected at a first end thereof to
the manifold body at the first external port and comprising an
external main segment, a first external branch segment, and a
second external branch segment comprising at least one
bacterial filter, the first external branch segment having a first
end and a second end, the first external branch segment being
connected at the first end thereof to the external main segment
and being connected at the second end thereof to the dialysate
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inlet of the dialyzer, the second external branch segment having
a first end and a second end, the second external branch
segment being connected at the first end thereof to the external
main segment and being connected at the second end thereof to
the patient arterial tube,
the at least one flow restrictor is mounted on the housing
and configured to accept at least one of the first external branch
segment and the second external branch segment,
the second external branch segment is connected to the
patient arterial tube upstream of the blood circuit pump header,
the manifold body, the patient arterial tube, the dialyzer,
and the external tube are preassembled such that they are
connected together, and
the entire manifold comprises disposable components.
Appeal Br. 43–44 (Claims App.).
We note that the Examiner provides a substantially similar application
of Kelly’s teachings in separate rejections to render the external tube of
claims 1 and 11 obvious (compare Final Act. 13–15 with id. at 32–34).
Appellant argues that the Examiner has not established a prima facie
case of obviousness as “there is no disclosure or suggestion of connecting
the external tube apparently disclosed in Kelly to a manifold qualifying as a
claimed manifold” (id. at 32 (asserting that “the claimed manifold and the
Fulkerson manifold, are not the same thing as manifold 56 of Kelly”)).
In other words, Appellant proffers the same unpersuasive arguments
set forth above that Fulkerson’s manifold is not analogous to Kelly’s
manifold (compare Appeal Br. 23–28 with id. at 32, 34, 35). For the reasons
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set forth supra on pages 10 to 11, we are not convinced that Fulkerson’s and
Kelly’s known manifolds for circulating dialysate are non-analogous art.
Appellant argues that modifying Fulkerson’s manifold to include
Kelly’s external tube would have required “incorporating Kelly’s complex
system into the manifold of Fulkerson” (id. at 33). Appellant contends that
the Examiner’s proposed modification would have required including “what
Kelly calls ‘pre/postdilution manifold 100’ (paragraph [0055]), which itself
includes a large number of components, such as filter 90, substitution pump
94, cap 108, and union 109, among other elements” (Reply Br. 8–9; see also
Kelly Fig. 1).
We are unpersuaded by these arguments because claim 11 contains
the open transitional term “comprising,” which permits elements in addition
to those specified to be included in the composition of the claim. In re
Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004) or In re Baxter, 656 F.2d 679,
686 (CCPA 1981).
Appellant argues that Fulkerson neither discloses nor suggests how
dialysate could be diverted into a blood circuit (Appeal Br. 33–34).
Appellant contends that Kelly only uses fresh dialysate for predilution (id. at
34). Appellant asserts that there is no disclosure in either Fulkerson or Kelly
that shows diverting dialysate from Fulkerson’s manifold into a blood circuit
that leads back into the manifold (id.). Appellant argues that the proposed
modification would have required adding Kelly’s entire dialysate circuit
network to Fulkerson’s manifold kit and, thus, the dialysis machine “would
neither be preassembled nor disposable” (id. at 35). Appellant contends that
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Kelly fails to teach arranging line 88 such that one end returns to a manifold
(id.).
We, however, agree with the Examiner that these arguments attack
Fulkerson and Kelly individually instead of addressing what the combined
teachings of the applied prior art would have suggested to the ordinarily
skilled artisan. In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Figure 33 of Fulkerson, as annotated by the Examiner and reproduced
below, illustrates a manifold body for circulating dialysate and blood:

Figure 33 of Kelly illustrates manifold body 3300, including fresh
dialysate output reservoir line to port E 3319, fresh dialyzer inlet line from
port F 3320, and dialyzer 3330 (Fulkerson ¶¶ 319, 327–329).
As the Examiner explains, Fulkerson is provided a fresh dialysate
source and, thus, it would not have been necessary to include Kelly’s entire
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dialysate circuit network (Ans. 56 (citing Fulkerson Fig. 33); see also Ans.
58 (correctly reasoning that “[a]dding branch segments leading from the
external tube from” Fulkerson’s manifold, “like line 88 of Kelly[,] would not
[have] require[d] a whole new way to generate dialysate” in Fulkerson’s
system)). The Examiner’s proposed modification would have: (i) added
Kelly’s line 88 to Fulkerson’s external tube leading from the fresh dialyzer
inlet line of manifold 3300 (see Ans. 59) and (ii) connected the other end of
Kelly’s line 88, via line 106, to Fulkerson’s blood circuit, thereby returning
to a blood line upstream of a blood circuit pumping tube in the same
manifold body (id. at 60 (citing Fulkerson Fig. 33 (see “PATIENT OUT”
blood line, which leads to port C 3317); see also Final Act. 28)).
We, therefore, are persuaded by the Examiner that the proposed
modification would have diverted dialysate from Fulkerson’s manifold
having dialysate and blood circuit pump headers into Kelly’s blood circuit
leading back into the manifold (see Ans. 58).
Appellant’s arguments regarding claim 11 also rely on the same
unpersuasive arguments made regarding claim 1 (Appeal Br. 31).
Appellant’s arguments that Collins fails to teach the various features of the
independent claim 11 were also considered (id.). Because we found that
Fulkerson and Kelly were not deficient with regard to any of the features in
the independent claim 11, we determine that Appellant’s arguments
regarding Collins to be without persuasive merit. Therefore, Appellant’s
arguments are insufficient to convince us of reversible error in the
Examiner’s rejection of claim 11. Appellant argues claims 11, 12, and 14 as
a group (Appeal Br. 5).
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On this record, we sustain the Examiner’s § 103(a) rejection as to
claims 11, 12, and 14.
2. Claim 20
Appellant argues claims 15–20 as a group (Appeal Br. 5). For the
reasons set forth above, we have not sustained the Examiner’s rejection of
claims 15–19.
On this record, we likewise do not sustain the Examiner’s § 103(a)
rejection of claim 20.
3. Claims 25 and 26
Appellant argues claims 1, 4, 5, 7, and 21–27 as a group (Appeal Br.
5). For the reasons set forth above, we have sustained the Examiner’s
rejection of claim 1.
On this record, we likewise sustain the Examiner’s § 103(a) rejection
of claims 25 and 26.
C. Rejection of claim 3 as unpatentable over Fulkerson, Kelly, and
Falkvall.
With respect to claim 3, the Examiner’s findings and conclusions
regarding Fulkerson, Kelly, and Falkvall are located on pages 38–39 of the
Final Office Action.
Claim 3 is set forth below:
3. The manifold kit of claim 1, wherein at least one of the
first and second flow restrictors comprises a static flow
restrictor.
Appeal Br. 42 (Claims App.).
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The Examiner supports the rejection of these claims by finding that
“Falkvall discloses a dialysis system with a static flow restrictor,
(Constriction 12 . . . The restrictor is static in that it cannot change its
diameter or adjust its impediment of the flow of dialysate)” (Final Act. 38
(citing Falkvall 9:13–15; Fig. 3b)).
Appellant argues that Falkvall neither teaches nor suggests that
circumferential constriction 12 cannot change its diameter (Appeal Br. 37).
We begin our analysis by construing “a static flow constrictor” in the
absence of the claim term’s definition in the Specification. Appellant’s
briefs do not proffer a definition for the disputed claim term. The Examiner,
however, finds that a dictionary defines the word “static” to mean
“unchanging” or “constant” (Ans. 62 (citing
www.dictionary.com/browse/static)).
Based upon these definitions and our comparison of Falkvall’s
disclosure with claim 3, we find that the claim encompasses the prior art.
Appellant has not identified any disclosure showing that Falkvall’s
constriction 12 diameter can be adjusted. We, therefore, agree with the
Examiner that the term “a static flow restrictor” encompasses Falkvall’s
unchanging constricted diameter in a dialyzer (Ans. 62).
Appellant’s arguments regarding claim 3 also rely on the same
unpersuasive arguments made regarding claim 1 (Appeal Br. 36).
On this record, we sustain the Examiner’s § 103(a) rejection as to
claim 3.
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D. Rejection of claim 13 as unpatentable over Fulkerson, Kelly, Collins,
and Falkvall.
With regard to claim 13, the Examiner’s findings and conclusions
regarding Fulkerson, Kelly, and Falkvall are located on pages 39–40 of the
Final Office Action.
Claim 13 is set forth below:
13. The dialysis machine of claim 11, wherein at least one
flow restrictor comprises a static flow restrictor.
Appeal Br. 44 (Claims App.).
Appellant’s arguments regarding claim 13 also rely on the same
unpersuasive arguments made regarding claims 1 and 3 (Appeal Br. 38).
Appellant’s arguments that Falkvall fails to teach the various features of the
independent claim 11 were also considered (id.). Because we found that
Fulkerson and Kelly were not deficient with regard to any of the features in
the independent claim 11, we determine that Appellant’s arguments
regarding Falkvall to be without persuasive merit.
On this record, we sustain the Examiner’s § 103(a) rejection of claim
13.
E. Rejection of claim 28 as unpatentable over Fulkerson, Kelly, Collins,
and Cicchello.
With respect to claim 28, the Examiner’s findings and conclusions
regarding Fulkerson, Kelly, Collins, and Cicchello are located on pages 40–
44 of the Final Office Action.
Claim 28 requires, inter alia, that “the dialysis machine of claim 11 . .
. further comprises a second manifold kit that comprises a second manifold
body” (Appeal Br. 48 (Claims App.)) (emphasis added).
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Appellant distinguishes Fulkerson’s systems for conducting HD,
HDF, or HF with Cicchello’s system, which “has a ‘cassette 30a’ that is used
for peritoneal dialysis” (Appeal Br. 39–40),
The Examiner finds that Cicchello describes HD, HDF, or HF, and
peritoneal dialysis (Ans. 63 (citing Cicchello ¶¶ 4–7)). The Examiner finds
that Cicchello explicitly discloses that dialysis cassettes can be replaced or
exchanged to carry out either HD or peritoneal dialysis (Ans. 63–64 (citing
Cicchello ¶¶ 15, 16, 73 (teaching that “[c]assette 30b is configured for
HD”))).
Appellant responds by arguing that there would have been no reason
to modify Fulkerson’s complex system to include Cicchello’s cassettes
(Reply Br. 10).
The Examiner, however, determines that
[i]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to have modified the
dialysis machine of modified Fulkerson by incorporating the
dialysis machine[, which] further comprises a second manifold
kit that comprises a second manifold body, and the second
manifold kit is configured to carry out hemodialysis on the
dialysis machine . . . as in Cicchello in order to ‘provide an
opportunity to the patient to alternate between PD [peritoneal
dialysis], HD . . . and/or HDF.’
(Final Act. 43 (citing Cicchello ¶ 15)). The Examiner finds that one of
ordinary skill in the art at the time of the invention would have been
motivated to modify Fulkerson’s system to include Cicchello’s cassettes
because “alternating therapies provides two primary advantages, namely,
preserving maximum residual renal function in PD and obtaining maximum
urea clearance through HD and/or HDF” (Final Act. 43–44 (citing Cicchello
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¶ 15)). Therefore, Appellant’s arguments are insufficient to convince us of
reversible error in the Examiner’s rejection of claim 28.
Appellant’s arguments regarding claim 28 also rely on the same
unpersuasive arguments made regarding claim 1 (Appeal Br. 39).
On this record, we sustain the Examiner’s § 103(a) rejection as to
claim 28.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4, 5, 7,
15–19, 21–
24, 27
103(a) Fulkerson, Kelly 1, 4, 5, 7, 21–
24, 27
15–19
11, 12, 14,
20, 25, 26
103(a) Fulkerson, Kelly, Collins 11, 12, 14,
25, 26
20
3 103(a) Fulkerson, Kelly,
Falkvall
3
13 103(a) Fulkerson, Kelly,
Collins, Falkvall
13
28 103(a) Fulkerson, Kelly,
Collins, Cicchello
28
Overall
Outcome
1, 3–5, 7, 11–
14, 21–28
15–20
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED IN PART