GAMBRO LUNDIA AB

Patent Trials and Appeals Board

Feb 3, 2021

2019006178 (P.T.A.B. Feb. 3, 2021)

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.
14/364,755 06/12/2014 Ralf Flieg 52759-230287 2954
23643 7590 02/03/2021
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
EXAMINER
PEO, JONATHAN M
ART UNIT PAPER NUMBER
1779
NOTIFICATION DATE DELIVERY MODE
02/03/2021 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RALF FLIEG,
MARKUS STORR, BERND KRAUSE,
MARKUS HORNUNG, and KARL HEINZ KLOTZ
____________

Appeal 2019-006178
Application 14/364,755
Technology Center 1700
____________
Before MICHAEL P. COLAIANNI, GEORGE C. BEST, and
DEBRA L. DENNETT, Administrative Patent Judges.
BEST, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–7, 10–14, and 16–21 of Application
14/364,755. Final Act. 1 (Dec. 20, 2018). We have jurisdiction under
35 U.S.C. § 6.
For the reasons set forth below, we affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Gambro Lundia AB as the real party in
interest. Appeal Br. 2.
Appeal 2019-006178
Application 14/364,755

2
I. BACKGROUND
The ’755 Application describes a synthetic membrane for the removal,
isolation, or purification of substances from a liquid. Spec. 1:10–12. The
’755 Application describes that the synthetic membrane includes entrapped
hydrophobic and hydrophilic particles. Id. at 1:15. The synthetic membrane
is said to be: (i) mechanically stable and (ii) effective for adsorbing,
isolating, and/or removing nucleic acids, toxins, unconjugated bilirubin,
diazepam, and problematic endogenous substances from liquids. Id. at 3:24;
3:34–35; 4:1–3.
Claims 1 and 13 are representative of the ’755 Application’s claims
and are reproduced below from the Appeal Brief’s Claims Appendix.
1. A hollow fiber or flat sheet, the membrane comprising at
least one hydrophobic polymer selected from the group
consisting of polysulfones, polyethersulfones,
polyarylethersulfones, polyamides and polyacrylonitriles and at
least one hydrophilic polymer,
wherein the hollow fiber or flat sheet membrane
comprises 5–40 wt.-% of at least one of hydrophilic particles
and hydrophobic particles,
wherein the hydrophilic particles, when present, and the
hydrophobic particles, when present, have an average diameter
of between 0.1 μm and 15 μm, and
wherein the hollow fiber or flat sheet membrane has a
wall thickness below 150 μm and an inner diameter of less than
400 μm.
13. A method for preparing a flat sheet membrane
comprising at least one hydrophobic polymer selected from the
group consisting of polysulfones, polyethersulfones,
polyarylethersulfones, polyamides and polyacrylonitriles and at
least one hydrophilic polymer, the membrane comprising 5–40
wt.-% of at least one of hydrophilic particles and hydrophobic
particles,
Appeal 2019-006178
Application 14/364,755

3
wherein the hydrophilic particles, when present, and
hydrophobic particles, when present, have an average diameter
of between 0.1 μm and 15 μm, and
wherein the flat sheet membrane has a wall thickness
below 150 μm, the method comprising the steps of
(a) grinding the hydrophilic particles, when present, and
the hydrophobic particles, when present, to an average diameter
of at most 15 μm in an aqueous solution to form a particle
suspension;
(b) combining the at least one hydrophilic and the at least
one hydrophobic polymer with the particle suspension of (a) to
form a polymer particle suspension;
(c) stirring the polymer particle suspension to obtain a
homogeneous polymer solution wherein the hydrophilic
particles, when present, and the hydrophobic particles, when
present, are suspended;
(d) degassing the polymer particle suspension;
(e) casting the polymer particle suspension as a uniform
film onto a smooth surface to form the flat sheet membrane;
(f) washing the flat sheet membrane.
Appeal Br. (Claims App.) 34, 36 (emphasis added).
II. REJECTIONS
On appeal, the Examiner maintains the following rejections:
1. Claims 1–5, 10, 11, and 16–21 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Koops.2 Final Act. 43–56.

2 US 2006/0099414 A1, published May 11, 2006.
Appeal 2019-006178
Application 14/364,755

4
2. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Koops and Hughes.3 Final Act. 56–57.
3. Claim 7 is rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Koops and Hodgdon.4 Final Act. 57–58.
4. Claims 12 and 14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Koops, Ekiner,5 Akçay,6 and
Mabuchi.7 Final Act. 58–65.
5. Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Koslow,8 Liu,9 Miller,10 Ekiner, Akçay, and
Mabuchi. Final Act. 65–70.
III. DISCUSSION
A. Rejection of Claims 1–5, 10, 11, and 16–21 under 35 U.S.C.
§ 103(a) as unpatentable over Koops
Appellant argues for the reversal of the rejection of claims 1–5, 11,
and 16–21 on the basis of limitations present in independent claim 1. Appeal
Br. 7–28. We select claim 1 as representative. 37 C.F.R. § 41.37(c)(1)(iv).

3 US 2003/0196960 A1, published Oct. 23, 2003.
4 US 4,851,100, issued July 25, 1989.
5 US 6,663,805 B1, issued Dec. 16, 2003.
6 Kani Akçay et al., Wet ball milling of zeolite HY, 142 Powder Technology
121–28 (2004) (hereinafter “Akçay”).
7 US 7,638,052 B2, issued Dec. 29, 2009.
8 US 6,630,016 B2, issued Oct. 7, 2003.
9 US 2010/0018926 A1, published Jan. 28, 2010.
10 US 2005/0139065 A1, published June 30, 2005.
Appeal 2019-006178
Application 14/364,755

5
Accordingly, claims 2–5, 11, and 16–21 will stand or fall with claim 1.
Appellant provides separate arguments for the reversal of the rejection of
claim 10. Appeal Br. 28. Claim 10 will be discussed separately.
a. Claim 1
In rejecting claim 1, the Examiner found that Koops describes a
polymeric matrix’s embodiment having each component of the claimed
membrane, except Koops’s embodiment is silent regarding the matrix
comprising 5–40 wt.-% particulate material. Final Act. 46. The Examiner,
however, found that Koops describes another embodiment in which the
polymeric matrix possesses particulate material in a range that overlaps the
claimed range. Id. (citing Koops ¶ 52).
The Examiner determined that it would have been obvious to a person
having ordinary skill in the art at the time of invention to have modified
Koops’s membrane by incorporating the membrane comprising 5–40 wt.-%
of the particles as in Koops’s second embodiment because Koops teaches,
inter alia, that “‘suitable adsorptive particles will be apparent to those
skilled in the art.’” Final Act. 46 (citing Koops ¶ 35).
Appellant argues that Koops merely discloses “broad ranges of
particulate content, particle size, and wall thickness” for preparing a
polymeric matrix having trapped particles. Appeal Br. 11. According to
Appellant, Koops’s broad ranges would not have motivated one of ordinary
skill in the art to arrive at the claimed subject matter. Id. at 10–11. For the
following reasons, we do not find Appellant’s arguments persuasive.
Koops explicitly discloses a polymeric matrix comprising “30–80%
by weight of particulate material,” which overlaps the claimed range of 5–40
wt.-%. Koops ¶ 52. Likewise, Koops discloses particle size and wall
Appeal 2019-006178
Application 14/364,755

6
thickness ranges that similarly overlap the claimed ranges for each of these
features. See Final Act. 45 (citing Koops ¶ 38 (describing that the average
particle size diameter “is preferably in the range of 0.1 to 30 μm,” which
overlaps the claimed range of between 0.1–15 μm)); see also Final Act. 45–
46 (citing Koops ¶ 60 (describing a hollow fiber diameter ranging between
10 and 300 μm, which necessarily overlaps the claimed wall thickness range
of below 150 μm)).11 Thus, the Examiner’s findings are sufficient to create a
prima facie case of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed.
Cir. 2003) (a prima facie case of obviousness typically exists when the
ranges of a claimed composition overlap the ranges disclosed in the prior
art).
The Examiner reasoned that the routineer would have been motivated
to arrive at the claimed invention because Koops teaches that the proportion
of particulate material “used has ‘a distinct influence on the ultimate pore
structure of the matrix,’ which may be selected for via ‘a balance between
particle load and accessibility, depending on a particular application of the
polymeric matrix.’” Final Act. 46 (citing Koops ¶¶ 49, 50) (internal citations
omitted). The Examiner determined that the ordinarily skilled artisan would
have selected the claimed wt.-% range of particulate material to produce a
polymeric matrix pore structure having “macrovoids, ‘which may be
beneficial in view of convective transport and diffusional resistance in the
polymeric matrix.’” Final Act. 47 (citing Koops ¶ 50).

11 As the Examiner explained, Koops’s “wall thickness must be less than
half the diameter of the disclosed hollow fiber” because “a wall of a hollow
fiber is defined from the interior of the fiber to the exterior of the fiber.”
Final Act. 45.
Appeal 2019-006178
Application 14/364,755

7
Appellant, however, contends that Koops “teaches away from the
claimed invention.” Appeal Br. 7; see also id. at 26–28. In particular,
Appellant argues that “a person of ordinary skill in the art would not be
motivated to arrive at the claimed membrane based on the broad disclosure
of Koops due to the undesirable formation of macrovoids.” Id. at 10; see
also Reply Br. 2–4. According to Appellant, Koops’s Example 6 shows that
a membrane having 10% particulate content possesses undesirable
macrovoids, whereas a membrane having 75% particulate content desirably
contains no macrovoids. Appeal Br. 12 (citing Koops Fig. 7). Appellant
argues that Koops’s Example 6 demonstrates that Koops’s macrovoids, as
described in paragraph 50, are only formed in “membranes having a high
total load of particles (wt.-%) but with very large particles.” Appeal Br. 21.
We are not persuaded by Appellant’s characterization of Koops’s
teachings for the reasons expressed in the Examiner’s Answer. See Answer
41–43. Koops explicitly teaches that a polymeric matrix’s particle load may
be adjusted to provide macrovoids and their concomitant benefits, such as
convective transport and diffusional resistance. See Koops ¶ 50. Regarding
Koops’s Example 6, the Examiner has the better position that Koops
exemplifies a membrane formed from a 10 wt.-% particle load and particles
less than 20 µm to obtain a matrix with macrovoids. Answer 43; see also id.
at 35. Thus, we are not convinced that Koops’s macrovoids in paragraph 50
must only be formed using “a high total load of particles (wt.-%)” and “very
large particles.” See Appeal Br. 21.
Appellant, moreover, does not identify, nor do we discern, any
specific teaching in Koops indicating that it would have been undesirable to
modify the described polymeric matrix to have macrovoids. To the contrary,
Appeal 2019-006178
Application 14/364,755

8
viewing the teachings of Koops as a whole, and given the advantages taught,
we agree with the Examiner that a skilled artisan would have reasoned that it
would be desirable to combine one embodiment’s particulate load (see
Koops ¶ 52) into another. See Boston Scientific Scimed, Inc. v. Cordis Corp.,
554 F.3d 982, 991 (Fed. Cir. 2009) (“Combining two embodiments
disclosed adjacent to each other in a prior art patent does not require a leap
of inventiveness.”).
Appellant directs our attention to other evidence, not relied upon by
the Examiner, purported to show that macrovoids were commonly known to
have detrimental effects. Appeal Br. 12–18. Appellant argues that the
cumulative teachings of this evidence indicates “that a skilled artisan would
be led away from the elements of the claimed invention because . . . they
would undesirably result in macrovoids.” Reply Br. 5.
We, however, agree with the Examiner that neither Koops’s
subsequent WO 2006/019293, Mulder’s Basic Principles of Membrane
Technology textbook, or the declarations of Dr. Markus Storr, one of the
’755 Application’s co-inventors, show that the Examiner’s reliance on
Koops’s paragraph 50 was clearly erroneous. See Answer 36–41. As the
Examiner explained, the relied upon disclosure “poses two different routes
of adding particles to a composition for making a membrane, giving reasons
why one would pursue either route.” Id. at 36 (citing Koops ¶ 50). Even
assuming that macrovoids were commonly known to have detrimental
effects, Koops establishes that macrovoids promote beneficial convective
transport and diffusional resistance within the polymeric matrix.
A person of ordinary skill in the art would have understood and
weighed this tradeoff in benefits. Winner Int’l Royalty Corp. v. Wang, 202
Appeal 2019-006178
Application 14/364,755

9
F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit
comes at the expense of another benefit . . . should not nullify its use as a
basis to modify the disclosure of one reference with the teachings of another.
Instead, the benefits, both lost and gained, should be weighed against one
another.”); see Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed.
Cir. 2006) (“[A] given course of action often has simultaneous advantages
and disadvantages, and this does not necessarily obviate motivation to
combine”).
Appellant argues that Mylan Pharmaceuticals Inc. v. Research Corp.
Technologies, Inc., 914 F.3d 1366, 1369 (Fed. Cir. 2019) supports the
contention that a person of ordinary skill in the art would not have been
motivated to modify Koops’s teachings to arrive at the claimed invention.
Appeal Br. 24.
Mylan, however, is factually distinguishable from this case. In Mylan,
the Federal Circuit concluded that the pharmaceutical composition of
Research Corporation Technologies’ patent is nonobvious. Mylan, 914 F.3d
at 1376. The Federal Circuit’s conclusion was based upon the fact that the
Kohn 1991 reference, which disclosed compound 3l, described undesirable
“reductions in potency and the significant conformational changes that
would have been expected” from modifying 3l to arrive at the claimed
compound. Id. Our reviewing court agreed with the Board that Mylan’s
Appellants failed to provide substantial evidence that Kohn 1991 would
have motivated one of skill in the art to make their proposed modification of
compound 3l. Id. at 1374, 1376.
In this case, however, Koops is devoid of evidence that a person of
skill in the art would have been led away from modifying the proportion of
Appeal 2019-006178
Application 14/364,755

10
particulate material to provide a polymeric matrix with macrovoids. Rather,
Koops paragraph 52 explicitly discloses a particulate material wt.-% range,
which overlaps the claimed range of 5–40 wt.-%. See Peterson, 315 F.3d at
1329. We, furthermore, agree with the Examiner that Koops teaches that
“macrovoid formation may be advantageous and beneficial.” Answer 33
(citing Koops ¶ 50). Thus, Mylan is factually inapposite to this case.
In the absence of evidence of criticality or unexpected results,
Appellant has not rebutted the Examiner’s prima facie case of obviousness.
In re Urbanski, 809 F.3d. 1237, 1242–43 (Fed. Cir. 2016) (“There is no
evidence, and [Appellant] does not suggest, that the claimed ranges . . . are
‘critical’ or ‘produce a new and unexpected result’” or “that the ‘variables
interacted in an unpredictable or unexpected way,’ which could render the
claims nonobvious.”).
For the reasons set forth above and in the Answer, we determine that
the Examiner did not reversibly err in rejecting claim 1 as unpatentable over
Koops. Accordingly, we also affirm the rejection of claims 2–5, 11, and 16–
21, which depend from claim 11.
b. Claim 10
Claim 10 of the ’755 Application’s claims is reproduced below from
the Appeal Brief’s Claims Appendix.
10. The membrane according to claim 1 wherein the
hydrophilic particles, when present, and the hydrophobic
particles, when present, are in an amount of from 20 wt.-% to
35 wt.-% relative to the weight of the membrane.
Appeal Br. (Claims App.) 35 (emphasis added).
Appellant argues that the “narrower range of particle amount” recited
in claim 10 is not taught or suggested by Koops. Id. at 28. According to
Appeal 2019-006178
Application 14/364,755

11
Appellant, “given that the broad teachings of Koops does not render the 5-40
wt.-% range obvious, it follows that the narrower range from 20 wt.-% to 35
wt.-% is also not obvious.” Id.
We are not persuaded by these arguments. Koops’s paragraph 52
explicitly discloses a polymeric matrix comprising “30–80% by weight of
particulate material,” which overlaps the claimed range of 5–40 wt.-%. See
Peterson, 315 F.3d at 1329. We, therefore, affirm the rejection of claim 10
as unpatentable over Koops.
B. Rejection of Claim 6 under 35 U.S.C. § 103(a) as unpatentable
over Koops and Hughes
Appellant argues that the rejection of claims 6 as unpatentable over
the combination of Koops and Hughes should be reversed for the reasons set
forth in arguing for reversal of the rejection over Koops. See Appeal Br. 29
(“The addition of Hughes does not cure deficiencies noted above in regard to
claim 1.”).
For the reasons set forth above, we have affirmed the rejection of
independent claim 1 as unpatentable over Koops. We, therefore, also affirm
the rejection of claim 6 as unpatentable over the combination of Koops and
Hughes.
C. Rejection of Claim 7 under 35 U.S.C. § 103(a) as unpatentable
over Koops and Hodgdon
Appellant argues that the rejection of claim 7 as unpatentable over the
combination of Koops and Hodgdon should be reversed for the reasons set
forth in arguing for reversal of the rejection over Koops. Appeal Br. 29.
(“The addition of Hodgdon does not cure deficiencies noted above in regard
to claim 1.”).
Appeal 2019-006178
Application 14/364,755

12
As discussed above, we have affirmed the rejection of claim 1. We,
therefore, also affirm the rejection of claim 7.
D. Rejection of Claims 12 and 14 under 35 U.S.C. § 103(a) as
unpatentable over Koops, Ekiner, Akçay, and Mabuchi
Appellant argues that the rejection of claims 12 and 14 as
unpatentable over the combination of Koops, Ekiner, Akçay, and Mabuchi
should be reversed for the reasons set forth in arguing for reversal of the
rejection over Koops. Appeal Br. 29 (“The addition of Ekiner in further view
of Ak[ç]ay and in further view of Mabuchi does not cure deficiencies noted
above in regard to . . . claim 1.”).
As discussed above, we have affirmed the rejection of claim 1. We,
therefore, also affirm the rejection of claims 12 and 14.
E. Rejection of Claim 13 under 35 U.S.C. § 103(a) as unpatentable
over Koslow, Liu, Miller, Ekiner, Akçay, and Mabuchi
Appellant’s arguments focus on the Examiner’s findings with respect
to Koslow’s teachings. Appeal Br. 31–32.
Appellant argues that the rejection of claim 13 should be reversed
because Koslow’s flat-sheet composite is distinguished from the claimed
membrane, which is constructed from a homogenous material. Id. at 31.
Appellant contends that Koslow’s “skin in composite membranes is a
different material than the porous substructure onto which it is cast.” Id.
Appellant further distinguishes the claimed subject matter from the known
filter by noting that Koslow’s cationic particles are not placed into the
membrane in situ. Id. at 32.
We are not persuaded by these arguments because the limitations of
claim 13 are silent with respect to any requirements for: (1) a homogenous
Appeal 2019-006178
Application 14/364,755

13
membrane lacking composite construction or (ii) placement of cationic
particles. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“Many of
[Appellant’s] arguments fail from the outset because . . . they are not based
on limitations appearing in the claims.”). In other words, Appellant has not
persuasively distinguished Koslow’s porous substructure from the flat sheet
membrane subject matter of claim 13.
Appellant’s Appeal Brief states that the applied prior art would not
have suggested or motivated the method for preparing the flat sheet
membrane comprising the reproduced portions of the limitations in claim 13.
Appeal Br. 32. This is an insufficient basis for reversal. See 37 C.F.R.
§ 41.37(c)(1)(iv) (“A statement which merely points out what a claim recites
will not be considered an argument for patentability of the claim.”).
Appellant argues that “the addition of Liu in further view of Miller in
further view of Ekiner in further view of Ak[ç]ay and in further view of
Mabuchi does not cure deficiencies noted above in regard to Koslow.”
Appeal Br. 32.
For the reasons set forth above, Appellant has failed to identify any
deficiencies with regard to Koslow. We, therefore, affirm the rejection of
claim 13 as unpatentable over the combination of Koslow, Liu, Miller,
Ekiner, Akçay, and Mabuchi.
IV. CONCLUSION
In summary:
Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 10, 11, 16–21 103(a) Koops 1–5, 10, 11, 16–21
6 103(a) Koops, Hughes 6
7 103(a) Koops, Hodgdon 7
Appeal 2019-006178
Application 14/364,755

14
Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
12, 14 103(a) Koops, Ekiner, Akçay, Mabuchi 12, 14
13 103(a) Koslow, Liu, Miller, Ekiner, Akçay, Mabuchi 13
Overall Outcome 1–7, 10–14, 16–21
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