Ex Parte Vicalvi et al

Patent Trials and Appeals Board

Mar 22, 2019

13825829 - (D) (P.T.A.B. Mar. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/825,829 04/01/2013 John J. Vicalvi
123162 7590 03/26/2019
GE Healthcare - Grogan, Tuccillo & V anderleeden LL
1350 Main Street, 5th Floor
Springfield, MA 01103
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
266914-6 X 10128 US 9294
EXAMINER
ORME, PATRICK JAMES
ART UNIT PAPER NUMBER
1779
NOTIFICATION DATE DELIVERY MODE
03/26/2019 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):
docket@gtv-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN J. VI CAL VI, JOSEPH MAKO WIECK.I,
JOSEPH D. CROWELL, and PARRISH M. GALLIHER
Appeal2018-003984
Application 13/825,829
Technology Center 1700
Before ROMULO H. DELMENDO, CHRISTOPHER C. KENNEDY, and
DEBRA L. DENNETT, Administrative Patent Judges.
DELMENDO, Administrative Patent Judge.
DECISION ON APPEAL
The Applicant ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from
the Primary Examiner's final decision to reject claims 1-24. 2 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 The Appellant is the Applicant, GE Healthcare Bio-Sciences Corp.
(Application Data Sheet filed April 26, 2016, 5), which, according to the
Brief, is the real party in interest (Appeal Brief filed October 2, 2017
("Appeal Br."), 2).
2 See Appeal Br. 5-21; Reply Brief filed March 2, 2018 ("Reply Br."), 5-9;
see also Final Office Action entered February 2, 2017 ("Final Act."), 7-27;
and Examiner's Answer entered January 2, 2018 ("Ans."), 2-12.
Appeal2018-003984
Application 13/825,829
I. BACKGROUND
The subject matter on appeal relates to systems and methods for
chromatography (Specification filed March 25, 2013 ("Spec."), ,r 1;
Abstract). Figure 2 (Drawings filed March 25, 2013; some annotations
added) is reproduced, as follows:
SYSTEM
CWTROLLER
GAS OR VA.C:UUM .4-1'!--"'t"":'
SOURCE
ill
F!G. 2
Figure 2 above is a schematic view depicting a disposable chromatography
system 200 operating in a slurried bed mode according to the invention,
wherein the system 200 includes, inter alia, a flexible container 102, a
support structure 104, an inlet port 106, an outlet port 108, a separation
device in the form of a frit filter 110 containing a nozzle 206 for passing
"high velocity mobile phase" pumped by an external pump to fluidize the
slurried bed (packing material 202), and a rigid distributor plate 134 (Spec.
,r,r 14, 15, 24, and 28).
2
Appeal2018-003984
Application 13/825,829
Representative claim 1 is reproduced from the Claims Appendix to the
Appeal Brief, as follows:
1. A disposable particulate slurry chromatography system,
compnsmg:
a flexible container configured to fit within a support
structure and adapted to receive a particulate slurry filtration
medium, the flexible container comprising:
at least one inlet;
at least one outlet;
a separation barrier peripherally sealed within the
container to separate the container into a filtration portion and a
drainage portion, the separation barrier including a nozzle;
a rigid distributor plate that supports the separation barrier;
and
wherein the separation barrier retains the filtration
medium separately from the drainage portion during use while
allowing fluids to pass therethrough, and
the nozzle allows a high velocity mobile phase, pumped
via an external pump, to fluidize the filtration medium via
dislodging at least some of the filtration medium.
(Appeal Br. 22, Claims App. (emphasis added)). Claims 11, 19, and
24, the only other independent claims on appeal, also recite similar
nozzle limitations (id. at 24--27).
II. REJECTIONS ON APPEAL
On appeal, the Examiner maintains multiple rejections under various
pre-AIA statutory provisions, as follows:
A. Claims 1-24 under 35 U.S.C. § 112, ,r 2, as indefinite;
B. Claims 1, 6, 10, 11, 19, 23, and 24 under 35 U.S.C. § 103(a) as
3
Appeal2018-003984
Application 13/825,829
unpatentable over Allen et al. 3 ("Allen") in view of Gebauer; 4' 5
C. Claims 2-5, 7, and 9 under 35 U.S.C. § I03(a) as unpatentable
over Allen in view of Gebauer and further in view of Lihme et
al. 6 ("Lihme") and Fernando; 7
D. Claims 8 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Allen and Gebauer and further in view of Lihme;
E. Claim 12 under 35 U.S.C. § I03(a) as unpatentable over Allen
and Gebauer and further in view of Ralph L. Shriner et al.
(eds.), The Systematic Identification of Organic Compounds: A
Laboratory Manual, 376, 379-80, 383,387, 6th ed. 1979
("Shiner");
F. Claims 13, 14, and 17 under 35 U.S.C. § I03(a) as unpatentable
over Allen, Gebauer, and Shriner and further in view of Lihme
and Fernando;
G. Claims 15 and 16 under 35 U.S.C. § I03(a) as unpatentable
over Allen, Gebauer, Shriner, Lihme, and Fernando, and further
3 US 2002/0166816 Al, published November 14, 2002.
4 US 2008/0217248 Al, published September 11, 2008.
5 In the Final Action (Final Act. 9-10), the Examiner also relies on
McDonald et al. ("McDonald"), US 4,250,035, issued February 10, 1981,
which Allen incorporates by reference for a disclosure on a pressurized fluid
providing radial compression to a flexible wall to close voids in and provide
uniform packing of resin beads in a chromatography column's stationary
phase (Allen ,r,r 3, 17).
6 US 6,620,326 B 1, issued September 16, 2003.
7 US 2010/0107752 Al, published May 6, 2010.
4
Appeal2018-003984
Application 13/825,829
in view of Lauer et al. 8 ("Lauer");
H. Claims 20 and 21 under 35 U.S.C. § 103(a) as unpatentable
over Allen and Gebauer and further in view of Lihme and
Fernando; and
I. Claim 22 under 35 U.S.C. § 103(a) as unpatentable over Allen
and Gebauer and further in view of Lihme.
(Ans. 2-12; Final Act. 3-27.)
III. DISCUSSION
Rejection A. Regarding the four independent claims on appeal
(namely, claims 1, 11, 19, and 24), the Examiner states that the term "high"
in the recitation "high velocity" is a relative term for which no standard for
ascertaining the requisite degree is provided in either the claims or the
accompanying description in the Specification (Final Act. 8). Regarding
claim 17, which depends on claim 11 through intervening claims 14, 13, and
12, the Examiner states that "the at least one probe" lacks sufficient
antecedent basis (id.).
The Appellant contends that the term "high" in claims 1, 11, 19, and
24 does not render the claims indefinite because the Specification and
Drawings reasonably apprise one skilled in the relevant art that the recitation
"high velocity" refers to a mobile phase velocity through the nozzle
sufficient to dislodge and fluidize the filtration medium (Appeal Br. 18).
Regarding the recitation "the at least one probe" in claim 17, the Appellant
does not offer any substantive argument but instead concedes that the claim
contains a typographical error in that the claim should have been drafted to
8 US 3,539,505, issued November 10, 1970.
5
Appeal2018-003984
Application 13/825,829
depend from claim 16--not claim 14 (id.). According to the Appellant, the
error "is readily addressable post-appeal via an Examiner's amendment or
Ex Parte Quayle Action" (id. at 19).
1. Claims 1, 11, 19, and 24
The test for indefiniteness is whether the claim, when read in light of
the specification, reasonably apprises one skilled in the art of its scope. In re
Warmerdam, 33 F.3d 1354, 1361 (Fed. Cir. 1994). "Claim language
employing terms of degree has long been found definite where it provided
enough certainty to one of skill in the art when read in the context of the
invention." Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed.
Cir. 2014).
We agree with the Appellant that the term "high," when read in the
context of the claims and the Specification, does not render the claims
indefinite. For example, claim 1 itself recites that "the nozzle allows a high
velocity mobile phase ... to fluidize the filtration medium via dislodging at
least some of the filtration medium" (Appeal Br. 22, Claims App.). One
skilled in the relevant art would understand from the claim itself and the
remainder of the Specification (e.g., Spec. ,r 24) that for a given nozzle size,
the velocity created by the external pump is sufficiently high such that at
least some of the filtration medium is dislodged to cause fluidization. Thus,
contrary to the Examiner's position, the Specification, which includes claim
1, reasonably apprises one skilled in the relevant art a standard for
determining whether a nozzle velocity is "high." Although the claim
language's scope is arguably broad as the filtration medium, the nozzle size,
and the pump capacity are not limited, "[b ]readth is not indefiniteness." In
re Gardner, 427 F.2d 786, 788 (CCPA 1970).
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Application 13/825,829
2. Claim 17
Because claim 17 has not been amended to correct the typographical
error or argued on the merits as to the indefiniteness issue, we summarily
affirm the rejection as maintained against this claim. Cf Hyatt v. Dudas,
551 F.3d 1307, 1314 (Fed. Cir. 2008) ("In the event of ... a waiver, the
[Board] may affirm the rejection ... without considering the merits.").
Rejections B--1. Regarding the independent claims on appeal (claims
1, 11, 19, and 24 ), the Examiner finds that Allen describes most of the
limitations recited in these claims but acknowledges that the reference does
not disclose a nozzle ( or use thereof) as specified in the claims (Final Act. 9-
10, 11-12, 13-14, and 15-16). The Examiner finds, however, that
"Gebauer ... discloses a nozzle ... and the nozzle allows a high velocity
mobile phase, pumped via an external pump, to fluidize the filtration
medium via dislodging at least some of the filtration medium" (id. at 10
(citing Gebauer, Fig. 2 and ,r 62); see also Final Act. 12, 14, and 16). The
Examiner concludes from these findings that "[i]t would have been obvious
to one of ordinary skill in the art ... to combine the system disclosed by
Allen with the nozzle disclosed by Gebauer because, according to Gebauer,
the nozzle facilitates distribution and even packing of the slurry with the bed
space" (Final Act. 11; see also id. 13, 14, and 16).
The Appellant contends that Allen does not disclose a flexible
container adapted to receive a particulate slurry filtration medium as recited
in, e.g., claim 1, but, instead, a solid monolithic filter (Appeal Br. 6-7). The
Appellant argues, inter alia, that because Allen teaches a solid monolith
filter, any nozzle placed on a separation barrier as required by the claims
would be incapable of fluidizing the solid monolith (id. at 10). Furthermore,
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Appeal2018-003984
Application 13/825,829
the Appellant argues that a person having ordinary skill in the art would not
have been prompted to include Gebauer's nozzle on Allen's outlet manifold,
which has been found to correspond to the "separation barrier" (e.g., a frit
filter (Spec. ,r 24)) recited in the claims, as the nozzle would be below the
solid monolith and, thus, incapable of fluidizing any particulates (Appeal Br.
10).
We concur with the Appellant because the rejection fails to articulate
a sufficient reason with some rational underpinning that would have
prompted a person having ordinary skill in the art to combine Allen and
Gebauer in the manner claimed by the Inventors. In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006), cited in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Allen's Figure 2 (annotated) is reproduced as follows:
cartridge
16
\
21 vessei (flexible waii)
::< ,-14 pressure chamber
FIG. 2
28bottom plate
24 oL,tlet manifo!d
8
Appeal2018-003984
Application 13/825,829
Allen's Figure 2 above depicts a sectional view showing a chromatography
apparatus for separating a chemical contained in a solution, wherein the
apparatus includes, inter alia: a cartridge 16 including a flexible-walled,
cylindrical vessel 21 that receives a plug-shaped monolith chromatography
stationary phase 20; an inflow line 32; an outlet line 34; an outlet manifold
24; and a bottom plate 28 (Allen ,r,r 16-17). Allen teaches that the monolith
stationary phase 20 may be "formed in place in flexible vessel 21" (id. ,r 18).
According to the Examiner, the outlet manifold 24 corresponds to the
"separation barrier peripherally sealed within the container to separate the
container into a filtration portion and a drainage portion" as recited in claim
1 (Final Act. 10). As the Examiner acknowledges, however, Allen's outlet
manifold does not include a nozzle, let alone a "nozzle [that] allows a high
velocity mobile phase, pumped via an external pump, to fluidize the
filtration medium via dislodging at least some of the filtration medium" (id.).
In discussing other prior art, Allen identifies McDonald as disclosing
that "[i]t is known to compress flexible-walled columns (also referred to as
cartridges) in order to close voids and provide uniform packing of the resin
beads of the stationary phase" (Allen ,r 3). Allen states that "[b]ecause [its]
stationary phase is provided as [a] unitary structure, it will not suffer from
the shifting of individual particles as can happen with the resin beads" used
in the prior art (id. ,r 4 ). Allen also incorporates by reference McDonald for
a teaching on using a pressurized liquid for radially compressing vessel 21 's
flexible wall (id. ,r 17; see also, e.g., McDonald col. 4, 11. 20-48).
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Appeal2018-003984
Application 13/825,829
Gebauer's Figure 2 (partially annotated) is reproduced as follows:
101-~
\
cof1...Hrin \•
i33
j'
'--140 r. .. :.-i ·34!] (