GE HEALTHCARE BIO-SCIENCES AB

Patent Trials and Appeals Board

Dec 18, 2020

2020000584 (P.T.A.B. Dec. 18, 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.
14/201,175 03/07/2014 KLAUS GEBAUER 273134-US-1 7803
108433 7590 12/18/2020
Eversheds Sutherland (US) LLP GE HC Life Sciences
999 Peachtree Street, NE
Atlanta, GA 30309
EXAMINER
PEO, KARA M
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
12/18/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KLAUS GEBAUER
Appeal 2020-000584
Application 14/201,175
Technology Center 1700
Before BEVERLY A. FRANKLIN, BRIAN D. RANGE, and LILAN REN,
Administrative Patent Judges.
RANGE, Administrative Patent Judge.
DECISION ON APPEAL

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Application 14/201,175

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STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–3, 6–9, 12–19, and 21–23. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

CLAIMED SUBJECT MATTER2
Appellant describes the invention as relating to packed bed columns
useful for liquid chromatography separation of biomolecules. Spec. 1:10–13.
Claim 1 is illustrative:
1. A method for preparing a plurality of packed preparative
chromatography columns connected in parallel, comprising the steps
of:
a) obtaining dried chromatography medium particles from a
chromatography medium slurry and preparing a plurality of aliquots
of the dried chromatography medium particles, wherein the
chromatography medium is agarose based;
b) re-suspending each of the plurality of aliquots in a packing
liquid in a container to form a plurality of aliquot slurries;
c) providing a plurality of identical empty chromatography
columns and packing one of said aliquot slurries from its container
into each identical chromatography column to obtain a plurality of
packed chromatography columns that have same bed volume and bed
height; and

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as GE
HEALTHCARE BIO-SCIENCES AB. Appeal Br. 3.
2 In this Decision, we refer to the Non-Final Office Action dated November
21, 2018 (“Final Act.”), the Appeal Brief filed May 20, 2019 (“Appeal Br.”),
and the Examiner’s Answer dated August 8, 2019 (“Ans.”).
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d) fluidically connecting said plurality of packed
chromatography columns in parallel,
wherein the chromatography medium slurry comprises aqueous
solvent and chromatography medium particles and the dried
chromatography medium particles are obtained by filtering the
chromatography medium slurry to obtain chromatography medium
particles followed by washing the particles with an organic solvent
and vacuum dry the washed particles.

REFERENCES
The Examiner relies upon the prior art below in rejecting the claims
on appeal:
Name Reference Date
Soderman et al.
(“Soderman”)
US 2005/0035061 A1 Feb. 17, 2005
McNeff et al.
(“McNeff”)
US 2005/0118409 A1 June 2, 2005
Natarajan US 2009/0321338 A1 Dec. 31, 2009

REJECTIONS
The Examiner maintains (Ans. 3) the following rejections on appeal:
A. Claims 1–3, 6–9, 12–19, and 21–23 under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement. Non-Final
Act. 3; see also id. at 2 (indicating that examination is under the AIA).
B. Claims 1–3, 6–9, and 12–19 under 35 U.S.C. § 103 as obvious over
Soderman in view of Natarajan and McNeff. Id. at 6.
C. Claims 21–23 under 35 U.S.C. § 103 as obvious over Soderman in
view of Natarajan. Id. at 14.

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OPINION
We review the appealed rejections for error based upon the issues
identified by Appellant and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential),
cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t
has long been the Board’s practice to require an applicant to identify the
alleged error in the examiner’s rejections.”). After considering the evidence
presented in this Appeal and each of Appellant’s arguments, we are not
persuaded that Appellant identifies reversible error. Thus, we affirm the
Examiner’s rejections for the reasons expressed in the Final Office Action
and the Answer. We add the following primarily for emphasis.
Rejection A, written description. The Examiner rejects claims 1–3, 6–
9, 12–19, and 21–23 under 35 U.S.C. § 112(a) as failing to comply with the
written description requirement. Non-Final Act. 3. Pursuant to the written
description requirement of 35 U.S.C. § 112, a patent application’s disclosure
must “reasonably convey[] to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc). The written description inquiry is a question of fact. Id. The Examiner
provides three different bases for written description rejections, and we
address each basis below.
As a first basis, the Examiner determines that the independent claims’
recitation “obtaining dried chromatography medium particles from a
chromatography medium slurry and preparing a plurality of aliquots of the
dried chromatography medium particles” is new matter not supported by the
Specification. Ans. 3–4. In particular, the Examiner maintains that there is
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“no support for a chromatography medium slurry being dried and then used
to prepare a plurality of aliquots.” Id. at 4.
Appellant explains that the Specification teaches drying particles from
slurry and also teaches packing aliquots with dry chromatography medium
particles. Appeal Br. 11–12. The Specification supports Appellant’s
position. Spec. 12:20–25, 15:4–10, 23:9–11. Because the Specification
teaches drying particles from slurry and also teaches packing aliquots with
dried particles, we agree with Appellant that the cited passages reasonably
convey that Appellant possessed the general concept of the “obtaining …
particles” recitation.
In the Answer, the Examiner further determines that the Specification
does not provide support “for all types of particles, all solvents, and all
washing and drying techniques.” Ans. 17. Thus, the Examiner raises the
question of whether Appellant’s written description adequately conveys
possession of the claims’ recited method when the method is considered as a
genus of all methods within the claims’ scope. Our reviewing court has set
forth two ways disclosure to support a claim’s recited genus can meet the
written description requirement:
A genus can be described by disclosing: (1) a representative
number of species in that genus; or (2) its “relevant identifying
characteristics,” such as “complete or partial structure, other
physical and/or chemical properties, functional characteristics
when coupled with a known or disclosed correlation between
function and structure, or some combination of such
characteristics.”

In re Alonso, 545 F.3d 1015, 1019 (Fed. Cir. 2008) (quoting Enzo Biochem,
Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)).
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Here, Appellant provides examples of how its method is performed
(for example, “freeze drying, spray drying or vacuum drying”) and identifies
characteristics of the process (for example, drying and making use of the dry
particles). See, e.g., Spec. 12:20–25. The Examiner has not adequately
explained how the Appellant’s disclosure, as explained at pages 11–12 of the
Appeal Brief, does not provide a representative number of methods to
support the scope of Appellant’s claims and does not provide a sufficient
relevant identifying characteristics of Appellant’s recited method. As such,
we do not sustain the Examiner’s rejection to the extent the rejection relies
upon this first basis.
As a second basis for a written description rejection, the Examiner
determines that the claims’ recitations of “preparative chromatography” and
“preparatory chromatography” are not supported by the Specification. Ans.
4. Preparative chromatography contrasts from analytical chromatography
because the goal of preparative chromatography is to separate a large
quantity of sample rather than just provide analysis of a sample. Appeal Br.
14–15 (explaining preparative and analytical chromatography). Although
Appellant’s Specification does not use the precise words “preparative
chromatography,” Appellant’s Specification indicates that the apparatus and
method described are designed to separate a sample in large quantity and
thus indicates Appellant’s possession of “preparative chromatography” or
“preparatory chromatography.” Appeal Br. 12–13; see also, e.g., Spec. 17:7–
8 (“The connection to a single sample inlet allows scaling of a process
chromatography step through addition of further chromatography columns in
parallel.” (Emphasis added.)). We, thus, do not sustain the Examiner’s
rejection to the extent the rejection relies on this second basis.
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As a third basis, the Examiner determines that the claims’ recitation of
“wherein the chromography medium slurry comprises aqueous solvent and
the dried chromatography medium particles are obtained by filtering the
chromatography medium slurry to obtain chromatography medium particles
by washing the particles with an organic solvent and vacuum dry the washed
particles” is not supported by the Specification. Ans. 4; Non-Final Act. 5. In
the Answer, the Examiner clarifies this determination by acknowledging
support for washing with aqueous ethanol solution but not for the full scope
of “organic solvent.” Ans. 19.
Appellant responds to this determination by, in total, arguing that the
Specification supports the recitation at 12:20–25 and 23:9–11. Appeal Br.
13. These cited portions of the Specification, however, refer to aqueous
ethanol solution. Appellant does not explain why these recitations support
the claims’ broader recitation of organic solvent. Because Appellant’s
argument as to this third determination does not adequately identify error,
we sustain the Examiner’s rejection to the extent it relies upon this third
basis.
Rejections B and C, obviousness. The Examiner rejects claims 1–3,
6–9, and 12–19 under 35 U.S.C. § 103 as obvious over Soderman in view of
Natarajan and McNeff. Non-Final Act. 6. The Examiner also rejects claims
21–23 under 35 U.S.C. § 103 as obvious over Soderman in view of
Natarajan. Id. at 14. Appellant does not argue these rejections separately and
argues claims 1–3, 6–9, and 12–19 as a group. Therefore, consistent with the
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provisions of 37 C.F.R. § 41.37(c)(1)(iv) (2013), we limit our discussion to
claim 1, and all other claims on appeal stand or fall together with claim 1.
The Examiner finds that Soderman teaches, for example, preparing
aliquots from dried particles obtained from slurry. Ans. 5–7 (citing
Soderman). The Examiner finds that Natarajan teaches, for example, parallel
and substantially identical chromatography columns. Id. at 6–7 (citing
Natarajan). The Examiner determines that it would have been obvious to
combine the teachings of Soderman and Natarajan in order to, for example,
“provide scalability.” Id. at 6–7. The Examiner finds that McNeff teaches
vacuum drying washed particles. Id. at 7–8 (citing McNeff). The Examiner
determines that it would have been obvious to combine the teachings of
modified Soderman and McNeff as “a known way to dry particles to achieve
desired particle properties.” Id. at 8.
Appellant argues that Soderman does not teach drying particles from
slurry. Appellant also argues that Soderman’s particles “unlike agarose used
in the claimed invention” are not usable in a dry form. The preponderance of
the evidence, however, supports the Examiner’s position that Soderman
teaches drying particles from slurry. Ans. 5, 7, 20–21. In particular,
Soderman teaches, for example, that its particles are prepared by transferring
a suspension to a sintered-glass funnel where “the aqueous phase was
filtered from the polymer.” Soderman ¶¶ 70–75. Moreover, Soderman
suggests use of agarose as being “used for many chromatographic
applications” although acknowledging the particles are not as advantageous
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“where high pressures are used.” Id. ¶ 7. Soderman thus suggests drying
particles.
Appellant also argues that a person of skill in the art would not have
reason to modify “the analytical column aspect of [] Soderman” with
Natarajan’s teachings of parallel packing. Appeal Br. 14–15. The
preponderance of the evidence, however, supports the Examiner’s position
that Soderman’s teachings are not limited to analytical columns. Ans. 21–24.
While, as Appellant argues (Appeal Br. 14–15), Soderman describes one
example as making use of “analytical steel columns” (Soderman ¶¶ 80–82),
Soderman does not suggest that its particles are only useful for analytical
chromatography. See, e.g., Soderman Abstract (indicating that particles are
useful for chromatography generally), ¶ 69 (explaining that examples are
only illustrative and not limiting). Just to the contrary, Soderman is
interested in “recovery of liquids” (Soderman ¶ 4) thus suggesting
preparative chromatography. Soderman also describes “preparative ion
exchange chromatography matrices” as one example of the kind of particles
Soderman seeks to improve upon. Id. ¶ 9.
Finally, Appellant argues that McNeff only teaches washing and
drying of inorganic particles. Appeal Br. 153. The Examiner, however,
explains that McNeff teaches preparing packing mediums for
chromatography and finds that McNeff’s field of endeavor and problem to
solve are the same as those of Appellant. Ans. 24–25. The Examiner finds
that McNeff teaches vacuum drying of chromatography particles. Id. at 7–8.

3 This argument does not apply to the Examiner’s rejection of claims 21–23
because the Examiner does not rely on McNeff to reject those claims. Ans.
13.
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The Examiner also states a reason why a person of skill in the art would
have combined the teachings of McNeff and modified Soderman. Id. A
person of skill in the art would have recognized that vacuum drying can be
used to dry a variety of particles and is not limited in use to McNeff’s
particular particles. Appellant’s argument regarding McNeff is unpersuasive
because it does not squarely dispute the Examiner’s positions. Appellant
does not persuasively explain why McNeff’s teachings relating to vacuum
drying and packing columns having inorganic particles would be
inapplicable to Soderman.
Because Appellant’s arguments do not identify error, we sustain the
Examiner’s obviousness rejections.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 6–9, 12–
19, 21–23
112 written description 1–3, 6–9,
12–19, 21–
23

1–3, 6–9, 12–
19
103 Soderman,
Natarajan, McNeff
1–3, 6–9,
12–19

21–23 103 Soderman,
Natarajan
21–23
Overall
Outcome
1–3, 6–9,
12–19, 21–
23

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED