Ex Parte Gronau et al

Patent Trial and Appeal Board

Jan 3, 2017

12766424 (P.T.A.B. Jan. 3, 2017)

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.
12/766,424 04/23/2010 Soeren GRONAU 2565/224 1402
26216 7590 01/05/2017
FISH & RICHARDSON P.C. (FRESENIUS)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
TOWNSEND, GUY K
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
01/05/2017 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):
PATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SOEREN GRONAU, GOETZ GUENTHER,
JUERGEN HAECKER, MARTIN LAUER,
JOACHIM MANKE, DEJAN NIKOLIC, and MANFRED WEIS
Appeal 2015-003199
Application 12/766,424
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims 1—15,
17—30, 32, 35—54, and 64 (App. Br. 1). Examiner entered rejections under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify “[t]he real party in interest [as] FRESENIUS
MEDICAL CARE DEUTSCHLAND GMBH” (App. Br. 1).
Appeal 2015-003199
Application 12/766,424
STATEMENT OF THE CASE
Appellants’ “invention relates to an external functional means. It
further relates to a blood treatment apparatus, as well as methods” (Spec.
1:10—11). More particularly, “[t]he external functional means comprises at
least one housing body, at least one chamber integrated into the housing
body for receiving medical fluids, at least one passage integrated into the
housing body for receiving and/or conducting a medical fluid, and at least
one valve means” {id. at 1:30-2:1). Independent claim 1 is representative
and reproduced in the Claims Appendix of Appellants’ Appeal Brief.
Claims 1—15, 17, 18, 22—25, 27, 30, 32-41, 48—52, and 64 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Beden.2
Claims 19-21 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Beden and Delnevo.3
Claims 42-47 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Beden and Stanus.4
Claims 26, 53, and 54 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Beden and Plahey.5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
2 Beden et al., US 2005/0230292 Al, published Oct. 20, 2005.
3 Delnevo et al., US 2006/0289360 Al, published Dec. 28, 2006
4 Stanus et al., US 2005/0283132 Al, published Dec. 22, 2005.
5 Plahey et al., US 7,935,074 B2, issued May 3, 2011.
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Application 12/766,424
FACTUAL FINDINGS (FF)
FF 1. Beden suggests “an apparatus for the treatment of a medical liquid
comprising a liquid treatment machine and a cassette insertable therein
substantially made of a rigid base body of the cassette with fitted chambers
and passages and a foil covering them” (Beden Abstract; see also Ans. 3—5).
FF 2. Figure 1 of Beden is reproduced below:
Figure 1 shows “a cassette 10” (Spec. 126) having “[pjassages 28,” “valves
30” (id. at 127), “a venous port [48]” (id. at 130), “pump chambers 50” (id.
at 131), “a venting chamber 56,” (id. at 132), an “arterial injection septum
16,” and a “venous injection septum 20” (id. at 136; see also Ans. 3—5).
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Application 12/766,424
ANALYSIS
Bedew.
Appellants’ independent claim 1 requires, inter alia,
the single-needle chamber is disposed on a venous blood side of
the medical device and above the venous blood chamber relative
to an orientation of the medical device during its use, the single­
needle chamber being in fluid communication with the at least
one passage integrated into the housing body for at least one of
receiving and conducting a medical fluid only via the venous
blood chamber.
(Appellants’ claim 1).
Examiner finds that Beden suggests “a medical device Fig. 1,
comprising: ... at least one venous blood chamber (50B) Fig.l; [0031]
Fig. 12” and a “single needle port (48) being in fluid communication with the
at least one passage (28B) [0030JF11—13 integrated into the housing body
(10) Fig. 1 for at least one of receiving and conducting a medical fluid only
via the venous blood port (48) [0030JF11—13” (Ans. 5 (emphasis omitted)).
Examiner acknowledges that “Beden does not teach that a single
needle chamber is disposed on the venous side of the device and in fluid
communication with the passage for receiving or conducting a medical fluid,
but Beden instead teaches the use of a port (48) Fig. 1” {id. at 6 (emphasis
omitted).
Examiner concludes that it would have been obvious to
provide the claimed access chamber as a substitute element of
access port of Beden,... in order to provide addition of medical
fluids through a port attached to passage (28) [0038JF25—27 and
to not interrupt blood flow [0030]F 1 ,[]6—8; as taught by Beden,
and to provide a fluid treatment apparatus comprising an
insertable cassette for a large flexibility of different applications
while maintaining fast and simple exchangeability [0006JF2—5;
as taught by Beden; and since it has been held that an express
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Application 12/766,424
suggestion to substitute one equivalent component or process for
another is not necessary to render such a substitution obvious.
(Ans. 6 (emphasis omitted).)
We are not persuaded. Beden suggests “a venous port [48]”
connected to “pump chambers 50” (FF 2). Fluid communication between
the venous port and the pump chambers is via “[pjassages 28,” “valves 30,”,
“a venting chamber 56,” an “arterial injection septum 16,” and a “venous
injection septum 20,” among other things (FF 2).
Examiner has not provided sufficient “articulated reasoning with some
rational underpinning” — based on Beden — why the skilled artisan would
make the changes necessary to arrive at a medical device with the claimed
features. KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting
In re Kahn, 441F.3d 977, 988 (Fed. Cir. 2006). Examiner identified Beden’s
“pump chambers 50” as being equivalent to the claimed venous blood
chamber (see Ans. 5). We observe that Examiner also referred to Beden’s
chamber 56 but did not clearly identify chamber 56 as equating to the
claimed venous blood chamber (see Ans. 4—6, 16). We also note Examiner’s
reference to Beden’s port 48 as a single needle port 48, but then identified
passage 28B for receiving and conducting fluid only via the venous port 48
(see id. at 16).
Even if the venous port is substituted with a chamber as Examiner
asserted, Beden does not suggest “the single-needle chamber being in fluid
communication with the at least one passage integrated into the housing
body for at least one of receiving and conducting a medical fluid only via the
venous blood chamber” as required by claim 1 (emphasis added; see also
App. Br. 4, Reply Br. 3). Examiner does not explain clearly where Beden
suggests this limitation, or why Beden’s passages, valves, venting chamber,
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Application 12/766,424
or septums would be eliminated “to not interrupt blood flow” (see Ans. 6).
“[Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
The preponderance of evidence on this record fails to support
Examiner’s conclusion that it would have been obvious to modify the
medical device of Beden such that “the single-needle chamber [is] in fluid
communication with the at least one passage integrated into the housing
body for at least one of receiving and conducting a medical fluid only via the
venous blood chamber” as claimed.
The combination of Beden and Delnevo:
Based on the combination of Beden and Delnevo, Examiner concludes
that it would have been obvious to “provide a the dialysis cassette pump of
Delnevo with the cassette of Beden, using the teaching of Delnevo and one
of skill would have been motivated to do so, in order to collect and return
blood to the patient, as taught by Delnevo [0023]L3^4” (Ans. 13 (emphasis
omitted)). Examiner, however, failed to establish that Delnevo makes up for
the deficiency of Beden as discussed above.
The combination of Beden and Stanus:
Based on the combination of Beden and Stanus, Examiner concludes
that it would have been obvious to
provide tamper or reuse protection via touch protection element,
as a the dialysis container access port/safety tab of Stanus, with
the cassette of Beden, using the teachings of Stanus, and one of
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skill would have been motivated to do so, in order to provide
protection for touch (contamination) or tampering (for safety) for
dialysis additive connections [0047JL3—1; [0053]L3—5, as taught
by Stanus.
{Id. at 14 (emphasis omitted).) Examiner, however, failed to establish that
Stanus makes up for the deficiency of Beden as discussed above.
The combination of Beden and Plahey:
Based on the combination of Beden and Plahey, Examiner concludes
that it would have been obvious to
provide the 11—15 or 8 degree inclination angle based on the
teaching of Plahey, and one would have been motivated to do so,
in order to provide a dialysis cassette apparatus provide openings
and a door that can be closed in parallel to connect and enclose
the cassette within the apparatus [0013JL1—17, as taught by
Plahey, and since such inclinations are known in the art; and
since optimizing such angles depending on their intended use is
within the skill of those skilled in the art.
{Id. at 14—15 (emphasis omitted).) Examiner, however, failed to establish
that Plahey makes up for the deficiency of Beden as discussed above.
CONCLUSION OF LAW
The preponderance of the evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1—15, 17, 18, 22—25, 27, 30, 32—41, 48—52,
and 64 under 35 U.S.C. § 103(a) as unpatentable over Beden is reversed.
The rejection of claims 19-21 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Beden and Delnevo is reversed.
The rejection of claims 42-47 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Beden and Stanus is reversed.
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The rejection of claims 26, 53, and 54 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Beden and Plahey is reversed.
REVERSED
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