Gunnar Glad et al.

Patent Trials and Appeals Board

Aug 29, 2019

14008001 - (D) (P.T.A.B. Aug. 29, 2019)

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.
14/008,001 09/27/2013 Gunnar Glad 251525 (34428-0026) 6954
29052 7590 08/29/2019
Eversheds Sutherland (US) LLP
999 PEACHTREE STREET, N.E.
Suite 2300
ATLANTA, GA 30309
EXAMINER
NORRIS, CLAIRE A
ART UNIT PAPER NUMBER
1778
NOTIFICATION DATE DELIVERY MODE
08/29/2019 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):
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PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GUNNAR GLAD, BO-LENNART JOHANSSON, and
JEAN-LUC MALOISEL
____________

Appeal 2018-009020
Application 14/008,001
Technology Center 1700
____________

Before ROMULO H. DELMENDO, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.

DELMENDO, Administrative Patent Judge.

DECISION ON APPEAL
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The Applicant1 (“Appellant”) appeals under 35 U.S.C. § 134(a) from
the Primary Examiner’s final decision to reject claims 1–10, 12–14, and
18.2, 3 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
I. BACKGROUND
The subject matter on appeal “relates to a method for depletion of
undesired molecules and/or enrichment of desired molecules from samples,
for example[,] depletion of high abundant large proteins from low abundant
smaller proteins/peptides, such as biomarkers” (Specification filed
September 27, 2013 (“Spec.”), 1, ll. 3–6). Representative claim 1 is
reproduced from the Claims Appendix to the Appeal Brief, as follows:
1. A method for enriching low abundancy, low molecular
weight desired molecules from a sample comprising high
abundancy, high molecular weight molecules and low
abundancy, low molecular weight molecules, comprising
the following steps:
a) providing a separation material comprising a solid
phase of beads comprising an inner porous core
material comprising magnetic particles and an outer

1 The Applicant is “GE HEALTHCARE BIO-BIOSCIENCES AB”
(Application Data Sheet filed September 27, 2013, 4–5), which is also
identified as the real party in interest (Appeal Brief filed April 19, 2018
(“Appeal Br.”), 2). We note, however, that the Bibliographic Data Sheet
lists the Inventors as the Applicants. We presume that the Applicant
information indicated in the Application Data Sheet is correct.
2 Appeal Br. 4–13; Reply Brief filed September 19, 2018 (“Reply Br.”), 3–
13; Final Office Action entered November 20, 2017 (“Final Act.”), 3–15;
Examiner’s Answer entered July 27, 2018 (“Ans.”), 4–18.
3 Claims 15–17, which remain withdrawn pursuant to a restriction
requirement (Final Act. 2), were erroneously included in the Claims
Appendix to the Appeal Brief (Appeal Br. 17).
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porous shell with a porosity equal or greater than
that of the core;
b) adding the sample to the separation material;
c) adsorbing a first fraction of molecules with a
molecular weight of 500-50,000 Da in the core and
simultaneously excluding a second fraction of
molecules from binding to the core and the shell,
wherein the molecular weight of the second
fraction of molecules is at least 5 times higher than
the molecular weight of the first fraction of
molecules; and
d) eluting the low abundancy, low molecular weight
desired molecules from the separation material
while having an oscillating power/field applied
over the separation material, wherein the high
abundancy, high molecular weight molecules are
serum albumin, IgG, fibrinogen, transferrin, IgA,
IgM, haptoglobin, apo A-I, apo A-II, a1-
antitrypsin, a1-acid glycoprotein, and a2-
macroglobulin.
(Appeal Br. 15 (emphases added)).
II. REJECTIONS ON APPEAL
The claims on appeal stand rejected as follows:
A. Claims 1–10, 12–14, and 18 under pre-AIA 35 U.S.C. § 112, ¶ 2,
as indefinite;
B. Claims 1, 2, 4–10, 12, and 18 under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Cheng et al.4 (“Cheng”), Liburdy,5 and
Luchini et al.6 (“Luchini”);

4 EP 1 764 152 A1, published March 21, 2007.
5 US 4,411,789, issued October 25, 1983.
6 US 2009/0087346 A1, published April 2, 2009.
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C. Claims 1 and 3 under 35 U.S.C. § 103(a) as unpatentable over
Cheng, Inomata et al.7 (“Inomata”), and Luchini; and
D. Claims 13 and 14 under 35 U.S.C. § 103(a) as unpatentable over
Cheng, Liburdy, Luchini, and Inana.8
(Ans. 4–18; Final Act. 3–15).
III. DISCUSSION
Rejection A (Indefiniteness). The Examiner’s position is that “[i]t is
not clear if the first fraction is [intended] to be the low abundancy molecules
and the second fraction the high abundancy molecules, or if the first and
second fraction can be in any relative abundancy” (Final Act. 4; Ans. 4–5).
The Appellant argues that when claim 1’s language is read in proper
context, the limitations at issue are definite to a person having ordinary skill
in the art (Appeal Br. 5–6). Specifically, the Appellant argues that “the first
fraction contains molecules of lower abundance than the molecules
contained in the second fraction” (id. at 6).
The Examiner responds that the Appellant’s argument is not
persuasive because:
the claims do not make it clear if the first fraction contains only
the low molecular weight molecules (50,000 Da would not be
considered a low molecular weight), all of the low molecular
weight molecules, a portion of the low molecular weight
molecules, or if the first and second fractions of molecules are
present in the sample in addition to the high and low molecular
weight molecules.
(Ans. 16).

7 US 2008/0248559 A1, published October 9, 2008.
8 US 2010/0035336 A1, published February 11, 2010.
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We agree with the Appellant on this issue. Claim 1, step c), recites:
“adsorbing a first fraction of molecules with a molecular weight of 500-
50,000 Da in the core and simultaneously excluding a second fraction of
molecules from binding to the core and the shell, wherein the molecular
weight of the second fraction of molecules is at least 5 times higher than the
molecular weight of the first fraction of molecules” (Appeal Br. 15). When
read in context with the claim in its entirety including the preamble and step
d), we agree with the Appellant that a person having ordinary skill in the art
would understand that “it is intended that the first fraction contains only and
all of the desired low abundancy, low molecular weight molecules from the
sample,” which in unseparated form includes both fractions (Reply Br. 5
(emphasis added)). To the extent that the claimed method reads on
situations in which only a portion of the “low abundancy, low molecular
weight desired molecules” is separated from the sample, the Examiner’s
criticism relates to breadth rather than indefiniteness. In re Johnson, 558
F.2d 1008, 1016 n.17 (CCPA 1977) (“[U]ndue breadth is not
indefiniteness.”).
For these reasons, we do not sustain Rejection A.
Rejections B–D (Obviousness). The Appellant’s arguments against
Rejection B focus only on claim 1 (Appeal Br. 6–12). Therefore, all claims
subject to Rejection B stand or fall with claim 1, which we select as
representative. 37 C.F.R. § 41.37(c)(1)(iv). As for Rejections C and D, the
Appellant relies on the same arguments offered against Rejection B, adding
only that Inomata (Rejection C) and Inana (Rejection D) do not cure the
alleged deficiencies in Cheng and Luchini (Rejection C) and Cheng,
Liburdy, and Luchini (Rejection D) (Appeal Br. 12–13).
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The Examiner finds that Cheng describes a method for enriching low
abundancy, low molecular weight desired molecules from a sample
comprising both low abundancy, low molecular weight desired molecules
and high abundancy, high molecular weight molecules (Ans. 6–7). The
Examiner finds that Cheng’s method includes substantially all the limitations
recited in claim 1 but acknowledges the differences between it and the
claimed subject matter as follows:
Cheng does not explicitly teach that the first fraction of
molecules have a molecular weight of 500-50,000 Da, the
molecular weight of the second fraction molecules is at least 5
times higher than the molecular weight of the first fraction and
wherein step d) is performed using an oscillating power/field
applied over the separation material or that the high abundancy,
high molecular weight molecules are serum albumin, lgG,
fibrinogen, transferrin, lgA, lgM, haptoglobin, apo A-I, apo A-
II, a1-antitrypsin, a1-acid glycoprotein, and a2-macroglobulin.
(Id. at 7). To resolve these differences, the Examiner relies on Liburdy,
which was found to teach the use an oscillating field (i.e., a magnetic field)
to elute a selected material from a separation material, and Luchini, which
was found to teach separating low abundancy, low molecular weight
molecules from high abundancy, high molecular weight molecules such as
serum albumin (id.). Based on these findings, the Examiner concludes that a
person having ordinary skill in the art would have been prompted to
combine the prior art teachings in the manner claimed by the Inventors (id.
at 7–8).
The Appellant contends that the rejection is based on an “obvious to
try” rationale, which is inappropriate because the Inventors “starting with
Cheng was not faced with limited choices for enriching low abundancy, low
molecular weight desired molecules” (Appeal Br. 8). The Appellant argues
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that “Cheng merely mentions that its core beads can be used in magnetic
chromatography, but does not impart any importance to the use of magnetic
beads,” which must be selected from any material suitable for
chromatography (id.). In addition, the Appellant argues that “Cheng does
not impart any importance to the actual or any specific pore size” and that
“[i]n fact Cheng discloses that the pore size is not particularly limited” (id. at
9). Thus, according to the Appellant, a person having ordinary skill in the
art would not have had no reason to arrive at a method including the
disputed limitations highlighted above in reproduced claim 1, steps c) and d)
(id.). In the Appellant’s words, “Cheng does not disclose or suggest the
general conditions of [the Inventors’] claims, does not limit the choices [the
Inventors] faced in order to derive the claimed invention and the advantages
obtained thereby, and does not render [the Inventors’] claims mere
optimization of a known result effective variable” (id.). Furthermore, the
Appellant argues that a person having ordinary skill in the art would not
have looked to Liburdy or Luchini “because Cheng provides no teaching or
motivation to do so” and “[t]here are countless of possible molecular
weights, countless pore sizes, and numerous methods for separation” (id.).
According to the Appellant, Liburdy and Luchini generally relate to
separation of molecules but are not analogous to Cheng because these
references do not relate to asymmetric magnetic beads (id. at 10). The
Appellant urges, therefore, that “the Examiner’s reliance on the secondary
references as providing the motivation for modifying Cheng evidences that
the Examiner has merely collected the elements of [the Inventors’] claimed
invention and improperly placed them in the template of Appellant’s patent
application” (id. at 11).
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The Appellant’s arguments fail to identify reversible error in the
Examiner’s rejection. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
As an initial matter, we emphasize that the Supreme Court of the
United States explained that “neither the particular motivation nor the
avowed purpose of the [applicant] controls.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 419 (2007). The Court stated that “[w]hat matters is the
objective reach of the claim” and that “[i]f the claim extends to what is
obvious, it is [unpatentable] under § 103.” Id. Thus, the Appellant’s
argument based on what the Inventors or the Appellant faced (Appeal Br. 8)
—as distinguished from what a person having ordinary skill in the art would
have found and concluded from the prior art teachings—is not particularly
pertinent.
In addition, the Appellant’s argument that Cheng does not indicate
any “importance” in using magnetized beads is inapt. We have not been
directed to binding authority that requires a prior art reference to state an
“importance” as to a feature recited in a claim in order to form a proper
evidentiary basis in an obviousness rejection. “[C]ase law does not require
that a particular combination must be the preferred, or the most desirable,
combination described in the prior art in order to provide motivation for the
current invention.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
Turning to the prior art references, Cheng describes a separation
method (e.g., biomolecule separation) using an asymmetric chromatography
media, particularly as packed bed, fluidized bed, or magnetized bed
chromatography media (Cheng, ¶¶ 11, 14). Specifically, Cheng teaches that
the media comprises asymmetric particles, particularly beads, having at least
two distinct layers, each having distinct controlled pore size distributions (id.
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¶ 11). Cheng discloses that “the pore size in the internal region is smaller
than the pore size in the external region” but “[t]he size of the pores is not
particularly limited” and “the internal pore size can be small enough to
effectively only adsorb small biomolecules (e.g., less than 10 KD
[kilodaltons] molecular weight) or can be open enough for large
biomolecules” (id. ¶ 16 (emphasis added)). According to Cheng, “[t]he
internal and external pore sizes can extend over a range necessary to affect
[sic] an improved chromatographic separation” (id.).
Thus, Cheng discloses magnetized chromatography as one of only a
few disclosed options. In addition, Liburdy, which also relates to magnetic
resonance chromatography, teaches separating molecules such as cells and
proteins into different populations based on their interactions with a
magnetic field oscillating at radio frequencies (Liburdy, col. 1, ll. 10–15;
col. 2, ll. 3–17). Given these facts, we find no persuasive merit in the
Appellant’s arguments that the Examiner’s rejection is based on an improper
“obvious to try” rationale. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007) (approving an “obvious to try” standard where the prior art provides
a finite number of identified, predictable solutions within the technical grasp
of a person of ordinary skill); Wm. Wrigley Jr. Co. v. Cadbury Adams USA
LLC, 683 F.3d 1356, 1364–65 (Fed. Cir. 2012) (holding that a “strong case
of obviousness” exists where the combination of ingredients recited in the
claims were based on selections from a finite number of identified,
predictable solutions).
As for Liburdy, we also find no merit in the Appellant’s argument that
Liburdy is not “analogous” to Cheng. The Appellant’s skeletal argument
that Liburdy does not disclose asymmetric chromatography media is
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insufficient to establish that the references are not “analogous” and,
therefore, not combinable. Both references, although not coextensive, relate
to magnetic resonance chromatography and, therefore, a person having
ordinary skill in the art would have considered them together.
With respect to the molecular weight limitations in claim 1, step c),
we found above that Cheng discloses “the pore size in the internal region is
smaller than the pore size in the external region,” that “[t]he size of the pores
is not particularly limited,” and that “the internal pore size can be small
enough to effectively only adsorb small biomolecules (e.g., less than 10 KD
[kilodaltons] molecular weight) or can be open enough for large
biomolecules” (Cheng, ¶ 16 (emphasis added)). Additionally, we found that
Cheng teaches “[t]he internal and external pore sizes can extend over a range
necessary to affect an improved chromatographic separation” (id.). Under
these circumstances, we agree with the Examiner’s finding (Ans. 8) that the
appropriate media’s regional pore sizes needed to separate particular
biological components with different molecular weights, e.g., a components
that differ in molecular weight by a ratio of at least 5 with one component
having a molecular weight of 10 kDa as disclosed in Cheng, are result-
effective variables. Thus, when Cheng’s method is implemented to effect
separation of small molecules from serum or plasma, such as described in
Luchini (Luchini, ¶¶ 162–63), a person having ordinary skill in the art would
have arrived at suitable pore sizes to effect components separation in a
biological sample in which one component has a higher molecular weight
(e.g., five times greater) than another component by routine experimentation.
In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012)
(“‘[W]here the general conditions of a claim are disclosed in the prior art, it
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is not inventive to discover the optimum or workable ranges [of variables
known to be result-effective] by routine experimentation.’” (quoting In re
Aller, 220 F.2d 454, 456 (CCPA 1955)).
As we found for Liburdy, we are not persuaded by the Appellant’s
argument that Luchini is not “analogous” to Cheng. Luchini, like Cheng,
relates to capture particles using a magnetic field to effect separation of
biomarkers from a sample (Luchini, ¶ 21). The mere fact that Luchini does
not teach asymmetric chromatography particles does not negate its
combination with Cheng as references need not be coextensive to permit
their combination.
For these reasons and those given by the Examiner, we uphold
Rejections B through D.
IV. SUMMARY
Rejection A is not sustained.
Rejections B through D are sustained.
Therefore, the Examiner’s final decision to reject claims 1–10, 12–14,
and 18 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED