Ex Parte Muller-Spath et al

Patent Trial and Appeal Board

Feb 23, 2018

14169320 (P.T.A.B. Feb. 23, 2018)

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.
14/169,320 01/31/2014 Thomas MULLER-SPATH Q209744 9268
23373 7590 02/27/2018
SUGHRUE MION, PLLC
2100 PENNSYLVANIA AVENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
EXAMINER
GRABER, KARA M
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
02/27/2018 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
USPTO@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS MULLER-SPATH, LARS AUMANN,
GUIDO STROHLEIN, MICHAEL BAVAND,
and NICOLE ULMER
Appeal 2018-000926
Application 14/169,320
Technology Center 1700
Before JAMES C. HOUSEL, JEFFREY R. SNAY, and
DEBRA L. DENNETT, Administrative Patent Judges.
DENNETT, Administrative Patent Judge.
DECISION ON APPEAL1
1 In our Opinion, we refer to the Specification filed January 31, 2014
(“Spec.”); the Final Action mailed December 23, 2016 (“Final Act.”); the
Advisory Action mailed April 6, 2017 (“Advis. Act.”); the Appeal Br. filed
June 16, 2017 (“Appeal Br.”); the Examiner’s Answer mailed September 22,
2017 (“Ans.”); and the Reply Brief filed November 6, 2017 (“Reply Br.”).
Appeal 2018-000926
Application 14/169,320
STATEMENT OF THE CASE
Appellant2 appeals under 35 U.S.C. § 134(a) from a rejection of
claims 1,3,4, 7—9, 19, 21—24, and 32. We have jurisdiction under 35 U.S.C.
§ 6(b). An oral hearing was held February 15, 2018, a transcript of which
will be entered into the record in due course.
We REVERSE.
The claims are directed to chromatographic purification methods.
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1. A chromatographic purification method for an isolation
of target molecules from a feed consisting of the target
molecules and impurities to be separated from the target
molecules, the target molecules being adsorbed on an affinity
chromatography material having immobilized ligands that bind
specifically to the target molecules while letting the impurities
pass by unaffected, the method using only two chromatographic
columns consisting of a first column and a second column, the
first column and the second column being loaded with the
affinity chromatography material, the first column having a first
column inlet and a first column outlet, the second column
having a second column inlet and a second column outlet, the
method comprising the following steps in order:
a start-up step, wherein
the second column outlet is connected to the first
column inlet and the feed is loaded into the second
column;
a first batch step, performed during a batch timespan,
wherein
the two chromatographic columns are
disconnected,
2 Appellant is applicant ChromaCon AG, identified as the real party in
interest. Appeal Br. 2.
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Application 14/169,320
the first column is loaded with the feed via the first
column inlet at a first flow rate and the first column
outlet is directed to a waste, and
from the second column, the target molecules are
recovered via the second column outlet based on the
second column being subjected to a regeneration process,
the regeneration process comprising the following steps
in order:
(i) washing with a washing-solvent and/or a
washing-buffer under a first condition that the target
molecules are not released from the affinity
chromatography material;
(ii) eluting with an eluting-solvent and/or an
eluting-buffer under a second condition that the target
molecules are released from the affinity
chromatography material; and
at least one of the following steps (iii) and (iv):
(iii) cleaning in place using a cleaning-solvent
and/or a cleaning-buffer to release everything from the
affinity chromatography material after the steps (i) and
(ii); and
(iv) equilibrating by using an equilibrating-solvent
and/or an equilibrating-buffer;
a first interconnected step, performed during an
interconnected timespan, wherein
the first column outlet is connected to the second
column inlet, the first column thus being a first upstream
column and the second column thus being a first
downstream column,
the first column has a dynamic breakthrough
capacity of the target molecules beyond which the target
molecules exit the first column via the first column
outlet,
the first column is loaded beyond the dynamic
breakthrough capacity with the feed via the first column
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Application 14/169,320
inlet at a second flow rate which is 1.5 to 4.0 times larger
than the first flow rate,
the second column outlet is directed to the waste,
and
wherein during a subsequent washing timespan,
the first column outlet remains connected to
the second column inlet,
the first column and the second column are
subjected to a subsequent washing process by
washing with a subsequent washing-solvent, which
is the same as or different from the washing-
solvent, and/or a subsequent-washing-buffer,
which is the same as or different from the
washing-buffer, and
an eluate exiting the second column outlet is
directed to the waste,
wherein the subsequent washing timespan,
which is denoted as twash,ic is determined according
to the following equation:
twash,IC — k • Vdead / Qwash,IC
wherein Vdead is a dead volume of a single column,
Qwashjc is a subsequent washing flow rate, and k is a
rational number equal to or larger than 1;
a second batch step, wherein the first column performs
all tasks of the second column in the first batch step, and the
second column performs all tasks of the first column in the first
batch step; and
a second interconnected step, wherein the second column
outlet is connected to the first column inlet, the first column
performs all tasks of the second column in the first
interconnected step and the second column performs all tasks of
the first column in the first interconnected step,
wherein at the first column outlet and the second
column outlet, a concentration of the target molecules
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Application 14/169,320
and/or a concentration of the impurities is detected using
a detector.
Appeal Br. 49-51 (Claims App’x).
REJECTIONS
The Examiner maintains the following rejections:
A. Claims 1, 3, 4, 7—9, 19, 21—24, and 32 under 35 U.S.C.
§ 112(b) as indefinite for failing to particularly point out and distinctly claim
the subject matter which the inventors regard as the invention; and
B. Claims 1, 3, 4, 7—9, 19, 21—24, and 32 under 35 U.S.C.
§ 103(a) as obvious over Jeon et al.3 (hereinafter “Jeon”) in view of NJIT4.
OPINION
Rejections under 35 U.S.C. § 112(b) as indefinite
The Examiner finds the following terms in claim 1, the sole
independent claim, to be indefinite: “a feed consisting of the target
molecules and impurities,” “everything,” and “a single column.” Final Act.
2—3. With respect to “a feed consisting of the target molecules and
impurities,” the Examiner finds “consists of’ limits “feed,” the composition
of “feed” is not clear, and “the target molecules and impurities” do not
exclude any element since they are not specific compositions. Id. The
Examiner also finds that the scope of “everything” is not clear. Id. at 3. The
Examiner finds that it is not clear whether “a single column” refers to “two
3 US 9,024,000 B2, published February 21, 2013 and November 3, 2011.
4 B.B. Kebbekus and S. Mitra, Chapter 4, Chromatographic Methods,
Environmental Chemical Analysis, 1998, Blackie, referred to by the
Examiner and Appellant as “NJIT”.
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Application 14/169,320
chromatographic columns consisting of a first column and a second column”
or a different column. Id.
The Examiner finds the term “respectively” renders claims 3 and 9
indefinite. Id.
Appellant argues that the terms are not indefinite. Appeal Br. 41—47.
During prosecution, a claim is indefinite “when it contains words or
phrases whose meaning is unclear.” In re Packard, 751 F.3d 1307, 1314
(Fed. Cir. 2014); see also Ex parte McAward, 2017 WF 3669566, at *5
(PTAB Aug. 25, 2017) (precedential).
We disagree with the Examiner’s findings regarding indefmiteness.
One of ordinary skill in the art at the time of the invention would have
understood the term “a feed consisting of the target molecules and
impurities” to mean that the composition of a “feed” is limited by the phrase
“consisting of’ to only “target molecules and impurities.” The target
molecules and impurities need not be identified as specific compositions.
The feed excludes a solvent phase. See Ans. 23.
While the scope of the term “everything” may frequently be unclear,
the term “release everything from the affinity chromatography material”
would have been understood in the context of claim 1 to mean “release the
target molecules and impurities still attached to the affinity chromatography
material from the affinity chromatography material.” The feed is limited to
target molecules and impurities, thus the term “everything” is sufficiently
clear in claim 1.
Claim 1 recites “two chromatographic columns consisting of a first
column and a second column” and subsequently “a single column.” The
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Application 14/169,320
term “a single column” would have been understood to refer to either the
first column or the second column.
Claim 3 recites “respectively” to refer to either the first interconnected
step or the second interconnected step. Appeal Br. 51—52 (Claims App’x).
Claim 9 recites “respectively” to refer to either the first batch step or the
second batch step. Id. at 52.
Rejection under 35 U.S.C. § 103(a) as obvious
The Examiner rejects all pending claims over Jeon in view of NJIT.
Final Act. 4. The Examiner finds, inter alia, that Jeon does not explicitly
teach that the first column and second column are subjected to a subsequent
washing timespan where the first column outlet is connected to the second
column inlet. Id. at 7. The Examiner finds that it would have been obvious
to incorporate the equation taught by NJIT into the method of Jeon in order
to determine a subsequent washing timespan in order to minimize additional
fluids in the system. Id. at 8.
Appellant argues that the Examiner acknowledges that Jeon does not
teach or suggest a subsequent washing process while the first column outlet
is connected to the second column inlet. Appeal Br. 22—23. Appellant
contends that NJIT does not remedy this deficiency in Jeon. Id. at 24.
Appellant states that the Examiner appears to assert that it would be inherent
or obvious from the equation to connect a first and second column as
claimed. Id.
Jeon discloses a two column chromatography apparatus wherein:
As the injection step, the filtered cell culture is injected at
a maximum biding capacity of the equilibrium state, and the
product discharged from the first column is continuously
injected to the second column.
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After the first column absorbs the product at a maximum
level, it is separated from the second column, and enters the
collection step.
Jeon col. 4,11. 30-36. Jeon also discloses that “the washing, elution and
regeneration are performed in each column.” Id. col. 3,11. 7—8. Jeon’s
Figure 6, reproduced below, further illustrates Jeon’s process:
FIG. 6 is a schematic diagram of the operation of the 2 column
chromatography apparatus. Id. col. 3,11. 36—37.
Jeon does not disclose connection of the first and second columns
during a washing timespan. Rather, Jeon discloses separation of the
columns during the washing and regeneration process. Id.
NJIT does not discuss connection of two or more chromatography
columns. The Examiner’s reference to NJIT as teaching the claimed
equation does not support a conclusion that NJIT would lead one of ordinary
skill in the art to connect two columns together during the washing and
regeneration process in light of Jeon’s disclosure.
For the above reasons, the Examiner does not show a prima facie case
of obviousness of the claims over Jeon in view of NJIT. We do not reach
Appellant’s additional arguments.
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DECISION
The rejection of claims 1, 3, 4, 7—9, 19, 21—24, and 32 is reversed.
REVERSED
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