Ex Parte Krause et al

Patent Trial and Appeal Board

Oct 31, 2017

14850404 (P.T.A.B. Oct. 31, 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.
14/850,404 09/10/2015 Bernd Krause 3724361-00190 9621
29178 7590
K&L Gates LLP-Gambro
P.O.BOX 1135
CHICAGO, IL 60690-1135
EXAMINER
MELLON, DAVID C
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
11/02/2017 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BERND KRAUSE, HERMANN GOHL,
MARKUS HORNUNG, and CARINA ZWEIGART
Applicant-Appellant'. GAMBRO LUNDIA AB.1
Appeal 2016-007892
Application 14/850,404
Technology Center 1700
Before CHUNG K. PAK, CHRISTOPHER L. OGDEN, and
CHRISTOPHER C. KENNEDY, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a)2 from the Examiner’s
decision rejecting claims 1—7 in the above-identified application.3 We have
jurisdiction pursuant to 35 U.S.C. § 6(b).
We AFFIRM.
1 The Appeal Brief identifies Appellant Gambro Lundia AB as the real party
in interest. See Appeal Br. 2, May 17, 2016.
2 Appeal Br.; Reply Br., Aug 16, 2016.
3 Final Office Action, February 23, 2016 [hereinafter Final Action];
Examiner’s Answer, July 15, 2016 [hereinafter Answer],
Appeal 2016-007892
Application 14/850,404
BACKGROUND
Appellant’s invention “concerns a semi-permeable hollow fiber
membrane having an outer wall surface, an inner wall surface and an interior
lumen extending along the length thereof,” and in particular, “a membrane
having [a] selective layer on the outer wall surface.” Spec.412.
Claim 1, the sole independent claim, is representative:
1. A microdialysis device comprising:
a sensor membrane for direct blood applications, the sensor
membrane being a semipermeable hollow fiber membrane
comprising an outer wall surface being smooth, continuous, and
homogeneous in a nanoscopic scale, an inner wall surface, and
an interior lumen extending along the length of the
semipermeable hollow fiber membrane, the semipermeable
hollow fiber membrane having a selective layer on the outer
wall surface, the outer wall surface having a smallest pore size
and being virtually devoid of roughness with roughness
parameters Ra and Rq of not more than 10 nm, roughness being
measured with an atomic force microscope (AFM), and the
roughness parameters Ra and Rq being calculated using the
following equations:
with N being the total number of data points and Zi being
the height of a data point above an average picture level.
Appeal Br. 11.
4 Specification, Oct. 15, 2015 (hereinafter Spec.).
2
Appeal 2016-007892
Application 14/850,404
The Examiner maintains the following grounds of rejection:5
1. Claims 1—3 and 5—7 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Gorsuch6 in view of Kurth7 and in view of
Kissinger.8 See Final Action 3—6.
2. Claim 4 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Gorsuch in view of Kurth and Kissinger, and further in
view of Kozawa,9 in light of additional evidence provided by Hajikano.10
See Final Action 6—7.
In the Appeal Brief, Appellant argues claims 1,3, and 5—7 as a group,
and provides a separate argument for dependent claim 2. See Appeal Br. 5—
9. Appellant provides no distinct argument with regard to dependent claim
4. See id. at 9. Therefore, consistent with 37 C.F.R. § 41.37(c)(l)(iv), we
limit our discussion to claims 1 and 2. Claims 3—7 stand or fall with claim 1.
DISCUSSION
Claim 1
The Examiner finds that Gorsuch discloses a semipermeable hollow
fiber membrane, used in one embodiment for dialysis processes, comprising
every limitation of claim 1 except that Gorsuch does not specifically disclose
(1) that the recited roughness parameters Ra and Rq are not more than 10 nm,
5 In the Answer, the Examiner withdrew two nonstatutory double patenting
rejections. See Answer 6.
6 Gorsuch et al., US 6,802,820 B1 (issued Oct. 12, 2004).
7 Kurth et al., US 2003/0141242 Al (published July 31, 2003).
8 Kissinger, US 5,706,806 (issued Jan. 13, 1998).
9 Kozawa et al., US 6,355,730 B1 (issued Mar. 12, 2002).
10 Hajikano et al., US 6,284,137 B1 (issued Sept. 4, 2001).
3
Appeal 2016-007892
Application 14/850,404
or (2) use of the hollow fiber membrane in a microdialysis device. See Final
Action 3—5. However, the Examiner finds that Kurth teaches that surface
roughness is a factor that influences fouling propensity, and provides an
example surface roughness of 3.25 nm for an ultrafiltration membrane. Id.
at 4 (citing Kurth H 81, 165). The Examiner determines that a person of
ordinary skill in the art, in light of these teachings, would have had reason to
optimize the surface roughness in Gorsuch’s hollow fiber device in order to
minimize fouling. Id. at 4—5.
The Examiner also finds that Kissinger describes a microdialysis
probe using a hollow fiber membrane made of polysulfone. Id. at 5 (citing
Kissinger 3:25—40, claims 7, 8). (We note that Gorsuch teaches polysulfone
as the preferred membrane material, see Gorsuch 4:62, and Appellant’s
claim 3 recites polysulfone as a polymer composition for the membrane, see
Appeal Br. 11.) Thus, the Examiner concludes,
It would have been obvious to the ordinary artisan at the time of
the invention to have adapted the Gorsuch hollow fiber mem­
brane for use in a microdialysis application as taught by Kissin­
ger for the purpose of providing for a suitable hollow fiber mem­
brane used in its intended purpose and to allow for surgical im­
plantation and treatment of a patient using the membrane.
Answer 5.
Appellant argues that the Gorsuch hollow fiber membrane relies, for
its principle of operation, on the use of four different radial zones around the
axis of the fiber, each zone having different properties including pore size.
See Appeal Br. 7. According to Appellant, Kurth relates instead to
nanofiltration (NF) or reverse (RO) membranes, which according to Kurth,
“are most often regarded as not containing recognizable pores.” Id. (quoting
Kurth 14). Appellant argues that “[o]ne of ordinary skill in the art would
4
Appeal 2016-007892
Application 14/850,404
not have been motivated to modify Gorsuch s membrane with features that
would have resulted in non-recognizable pore sizes.” Id. Thus, according to
Appellant, the pores in Kurth’s membrane “would be too small for dialysis
applications,” and Kurth’s membrane “would not have been appropriate for
Gorsuch s purpose of in-vivo dialysis.” Id.', see also Reply Br. 2.
These arguments do not persuade us of reversible error in the
Examiner’s rejection. As the Examiner notes in the Answer, the rejection
cites Kurth solely for its surface roughness teaching. See Answer 7. The
issue is what Kurth, in combination with Gorsuch, would have suggested to
a person of ordinary skill in the art, not whether Kurth’s structure may be
bodily combined with the structure disclosed in Gorsuch. See In re Keller,
642 F.2d 413, 425 (CCPA 1981). Kurth teaches that surface roughness
affects the fouling propensity of the membrane surface. See Kurth 181.
Surface roughness, therefore, was known to be a result effective variable at
the time Appellant’s application was filed. See In re Applied Materials, Inc.,
692 F.3d 1289, 1297 (Fed. Cir. 2012) (“A recognition in the prior art that a
property is affected by the variable is sufficient to find the variable result-
effective.”) Therefore, a person of ordinary skill in the art would have had
reason to optimize the surface roughness parameters such that they are
within the range recited in claim 1.
On this record, we find no evidence that optimizing the surface
roughness parameters would have required more than ordinary skill in the art
at the time Appellant filed the application. See In re Boesch, 617 F.2d, 272,
276 (CCPA 1980) (“[Djiscovery of an optimum value of a result effective
variable ... is ordinarily within the skill of the art.”). Contrary to
Appellant’s arguments, Kurth’s teachings are not limited to membranes for
5
Appeal 2016-007892
Application 14/850,404
nanofiltration or reverse osmosis. Kurth states that “the polymer molecules
constituting the matrix may be formed into microporous or ultraporous
coatings that may function as microfiltration or ultrafiltration membranes.”
Kurth 173. Kurth also teaches an ultrafiltration membrane with a surface
roughness of 3.25 nm. See Kurth 1165. For the above reasons, we find no
reversible error in the Examiner’s conclusion that it would have been an
obvious variation over the prior art to select the surface roughness
parameters as recited in claim 1.
Appellant also argues that a skilled artisan would not have used
Gorsuch’s ultrafiltration membrane in a microdialysis device, as
microdialysis relies on diffusive transport of analytes across the membrane,
whereas ultrafiltration relies on convective transport of a liquid. See Appeal
Br. 8; see also Reply Br. 2—3. Thus, according to Appellant, using Gorsuch’s
ultrafiltration membrane for microdialysis would change the principle of
operation of the prior art device, and make it unsuitable for its intended
purpose. See id.
We find these arguments unpersuasive of reversible error because, as
the Examiner notes in the Answer, Gorsuch teaches that a person may use
the disclosed hollow fiber membrane for dialysis, which—like
microdialysis—involves diffusive transport. See Answer 8 (citing Gorsuch
5:55—6:10). Therefore, the preponderance of the evidence on this record
supports the Examiner’s conclusion that it would have been obvious to use
the hollow fiber membrane of Gorsuch, as modified by Kurth, in a
microdialysis device as taught by Kissinger. For the above reasons, we
affirm the Examiner’s rejections of claims 1 and 3—7.
6
Appeal 2016-007892
Application 14/850,404
Claim 2
Claim 2 depends from claim 1, adding the limitation that “the
semipermeable hollow fiber membrane has a hydraulic permeability within
the range of 1*10-4 to 100* 10”4 [cm3/cm2xbarxs].” Appeal Br. 11
(bracketed material in original). The Examiner determines that “the
membrane of Gorsuch as modified [by Kurth and Kissinger] will inherently
provide a hydraulic permeability within the claimed range. In the
alternative, it would have been obvious to modify and optimize the hydraulic
permeability to improve membrane performance without compromising
durability.” Final Action 5. According to Examiner, optimizing for this
permeability range would have been within the skill in the art, and Appellant
has not established that this range would provide an unexpected result. See
id.
Appellant argues that
the specification demonstrates attendant advantages of the spe­
cifically claimed hydraulic permeability. In this regard, the spec­
ification teaches that, with the claimed hydraulic permeability,
the convective transport through the membrane wall is mini­
mized at the same time having high diffusive transport in a broad
range with respect to the molecular size (up to 100,000 Dalton
depending on the fluid and measurement condition) or shape of
the molecule. The attendant advantage of the specifically
claimed hydraulic permeability is not even suggested by Gor­
such, Kurth, and Kissinger.'1'’
Appeal Br. 8—9.
Appellant has the burden to establish unexpected results. See In re
Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997). However, Appellant has
only provided the general description of an advantage, without showing (1)
that the evidence of the advantage is reasonably commensurate with the
7
Appeal 2016-007892
Application 14/850,404
scope of the claim, see In re Harris, 409 F.3d 1339, 1343 (Fed. Cir. 2005);
(2) that the closest prior art does not exhibit the advantage, see In re Baxter
TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991); or (3) that the advantage
was unexpected at the time of Appellant’s filing, see In re Klosak, 455 F.2d
1077, 1080 (CCPA 1972). Thus, on this record, Appellant has not shown
persuasive evidence of unexpected results, and has not shown reversible
error in the Examiner’s rejection of claim 2. Therefore, we affirm the
Examiner’s rejection of claim 2.
DECISION
The Examiner’s decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended. See 37 C.F.R. § 1.136(a)(l)(iv) (2016).
AFFIRMED
8