Ex Parte Park et al

Patent Trial and Appeal Board

May 24, 2016

12902006 (P.T.A.B. May. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/902,006 10/11/2010
21569 7590 05/26/2016
Caliper Life Sciences, Inc.
C/O CARDINAL LAW GROUP, LTD
1603 ORRINTON AVE STE 2000
EVANSTON, IL 60201-5543
FIRST NAMED INVENTOR
Charles Park
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.
100/19106 (4020.290DIV) 1282
EXAMINER
DAM, DUSTIN Q
ART UNIT PAPER NUMBER
1758
NOTIFICATION DATE DELIVERY MODE
05/26/2016 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):
caliperdocket@cardinallaw group .com
clg_ docketing@cardinal-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES PARK, PERSEFONI KECHAGIA,
MICHAEL SPAID, MORTEN JENSEN, IRINA G.
KAZAKOV A, and JOSH MOLH0 1
Appeal2014-008097
Application 12/902,006
Technology Center 1700
Before TERRY J. OWENS, CHRISTOPHER C. KENNEDY, and DEBRA
L. DENNETT, Administrative Patent Judges.
DENNETT, Administrative Patent Judge.
DECISION ON APPEAL 2
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
21. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the real party in interest as Caliper Life Sciences, Inc.
2 In our opinion below, we refer to the Final Action mailed October 25, 2013
("Final Act."), the Appeal Brief filed March 24, 2014 ("App. Br."), and the
Examiner's Answer mailed May 5, 2014 ("Ans.").
Appeal2014-008097
Application 12/902,006
The Invention
The claims are directed to a method of separating an analyte of
interest from one or more sample constituents not of interest. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A method of separating an analyte of interest from one or
more sample constituents not of interest, the method
compnsmg:
stacking the analyte of interest between a first end and a
second end of a first channel by isotachophoresis, the first
channel further comprising a skewing channel segment between
the first end and the second end;
skewing the analyte and the one or more sample
constituents not of interest by flowing the analyte and the one
or more sample constituents not of interest through the skewing
channel segment toward the second end;
stacking the skewed analyte one or both of while within
and after exiting the skewing channel segment to form a
focused analyte band; and
producing and maintaining axial diffi.1sion of the ske\~1ed
one or more sample constituents not of interest.
Ramsey
Nordman
Griffiths et al.,
hereinafter Griffiths
Williams et al.,
hereinafter Williams
The References
us 5,858,195
US 6,176,991 Bl
US 6,270,641 Bl
US 2002/0008029 Al
2
Jan. 12, 1999
Jan.23,2001
Aug. 7, 2001
Jan.24,2002
Appeal2014-008097
Application 12/902,006
The Rejections
Claims 1--4 and 7 stand rejected under 35 U.S.C. § 102(b) over
Williams with evidence from Griffiths.
The claims stand rejected under 35 U.S.C. § 103(a) as follows: claims
5, 6, 8, and 9 over Williams in view of Griffiths and Nordman; claims 10-15
over Williams in view of Griffiths; claims 16-20 over Williams with
evidence from Griffiths in view of Ramsey; claims 1-5, 7, 14, and 16-21
over Ramsey in view of Nordman; and claims 6, 8-13, and 15 over Ramsey
in view of Nordman and in further view of Griffiths.
OPINION
Claim 1 and its dependent claims require "skewing the analyte and the
one or more sample constituents not of interest by flowing the analyte and
the one or more sample constituents not of interest through the skewing
channel segment toward the second end." Independent claim 21 requires
"skewing the compact analyte band to form a skewed analyte band and
skewing the compact constituents not of interest band to form a skewed
constitutes not of interest band." Our decision in this case turns on whether
the prior art cited by the Examiner teaches skewing. As elaborated below,
we find that, to the extent any of the references discloses skewing, it would
discourage one of ordinary skill from including skewing in an analyte
separation method. See Galderma Labs., L.P., v. Tolmar, Inc., 737 F.3d 731,
738 (Fed. Cir. 2013)(a reference teaches away when "a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
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Application 12/902,006
the path that was taken by the applicant"). We consequently reverse the
Examiner's rejections.
Rejection of claims 1--4 and 7 under 35 U.S. C. § 102(b) over Williams
with evidence from Griffiths
Appellants define a "skewing channel" as "a channel segment that
causes skewing of sample constituents flowing in the channels, such as an
internal surface topography causing bands to have an oblique orientation
when passing through the channel." Spec. i-f 52. The Examiner interprets
the T-shaped intersections of Williams to read on a "skewing channel" due
to the alleged skewing of a sample flowing through the straight walled and
constant cross section channels during 90 degree turns, and directs us to
Figures 6A---6C of Williams. Ans. 3. Figures 6A---6C show an
isotachophoretic separation device; Figure 6A of Williams is pictured below:
Williams, Figure 6A
Although Williams neither discusses nor pictures such skewing, the
Examiner employs Griffiths for evidence that skewing occurs when a sample
makes a 90 degree tum. Id. (citing Griffiths at 14:39---60 as describing
varying the channel walls to control skewing).
Appellants question the use of a second reference in a 35 U.S.C.
§ 102(b) rejection and argues that Griffiths teaches away from the claimed
invention. App. Br. 11. However, the Examiner sufficiently explains that
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Application 12/902,006
Griffiths is cited to show skewing is an inherent characteristic of an analyte
flowing through non-linear channels (Ans. 25), and such use of a second
reference is allowed under this limited circumstance. MPEP 2131. 01 (III).
Moreover, teaching away is irrelevant to an anticipation analysis. Celeritas
Tech., Ltd. V. Rockwell Int'! Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)
("A reference is no less anticipatory if, after disclosing the invention, the
reference then disparages it."). Here the Examiner is not using Griffiths as
the anticipatory reference, thus whether it teaches away is of no moment to
this rejection.
To anticipate claims 1--4 and 7, Williams must teach "skewing the
analyte and the one or more sample constituents not of interest by flowing
the analyte and the one or more sample constituents not of interest through
the skewing channel segment toward the second end." The Examiner argues
that Williams, in Figure 6A---6C depicts that the analyte of interest and
sample constituents flow and are present in sample volume 102 and are
skewed as they pass the cited skewing channel segment towards the cited
second end, right most end of channel 14. Ans. 4. We disagree.
Viewing the three figures in sequence, in view of their description at
Williams i-fi-1 63---64, one understands that initially, as a result of application
of a voltage potential across a first channel 28 (from reservoir 38) and a
second intermediate channel 26 (from reservoir 40), sample (which would
including analyte and sample constituents) flows into the electrolyte channel
(the linear space between reservoirs 20 and 24). Williams i163. At the
same time, leading ion Lis supplied from third channel 30 to intermediate
second channel 26, by application of a voltage potential with the same
polarity.
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Appeal2014-008097
Application 12/902,006
As explained by Williams, Figure 6A
shows this sample injection produces a
sample volume element 102 in the
electrolyte channel between the first and
second channel ports, and a plug 104 of
leading ion immediately downstream of the
sample volume, and separated therefrom by
a sharp boundary. "Thus, proceeding in an
upstream-to-downstream direction, the
electrolyte channel includes a solution
containing the trailing ion supplied from
reservoir 20, a sample volume from
reservoir 40, a plug of solution containing
the leading ion supplied from reservoir 42,
and the solution containing the trailing ion."
Then, as shown in Figure 6B, a
voltage potential is applied across reservoirs
Williams, Figures 6A-6C
20 and 24 (at the left and right ends of the electrolyte channel). Id. at i-f 64.
"Since the sample volume is confined between plugs of leading and
terminating ions, the sample components in the sample volume will initially
stack by ITP, as above, forming a sample plug 102A having stacked bands
such as bands 104, 106, where the fastest moving bands stack initially
against the leading ion. This effect is transient only, because the sample
ions, having higher mobilities than the trailing ion T, will eventually
overtake these ions and the system transitions from ITP to capillary
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Appeal2014-008097
Application 12/902,006
electrophoresis (CE), where the sample ions are separated by their relative
mobilities, as above." Id.
Reading Williams i-fi-1 63---64 in view of Figures 6A---6B, one of skill in
the art understands that the analyte (sample) flows in a straight (linear) path
past the right angle bend at channel 30 because there is no voltage potential
drawing the sample toward reservoir 42. Trailing ions subsequently flow
into channels 26, 28, and 30, but they do not contain the analyte. The
analyte is not skewed in the electrolyte channel.
The Examiner's contention that Williams, Figure 6A---6C depicts "the
analyte of interest and sample constituents flow and are present in sample
volume 102 and are skewed as they pass the cited skewing channel segment
[30] towards the cited second end, right most end of channel 14" is not
supported by the teachings of Williams, and no axial diffusion of skewed
sample constituents is produced or maintained. See Ans. 4.
Because the Examiner fails to show that Williams teaches "skewing
the analyte and the one or more sample constituents not of interest by
flowing the analyte and the one or more sample constituents not of interest
through the skewing channel segment toward the second end," the Examiner
does not establish that Williams anticipates claims 1--4 and 7. Gechter v.
Davidson, 116 F.3d 1454, 1460 (Fed. Cir. 1997) ("[T]o hold that a prior art
reference anticipates a claim, the Board must expressly find that every
limitation in the claim was identically shown in the single reference.").
Rejection of claims 5, 6, 8, and 9 under 35 U.S.C. § 103(a) over
Williams in view of Griffiths and Nordman
Claims 5, 6, 8, and 9 are rejected as obvious over Williams in view of
Griffiths and Nordman. Ans. 6. These claims depend from claim 1 and
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Application 12/902,006
require a skewing channel segment that comprises a serpentine curve (claim
5), a helix (claim 6), a coil (claim 8), or a spiral (claim 9). As in the
anticipation rejection, Williams is cited as teaching skewing. Id. Griffiths is
relied on for disclosing that "optimizing geometric parameters of skewing
channel segments can lead to dramatic improvements in miniaturizing
microfluidic separation devices via dispersion optimization." Id. (citing
Griffiths Abstract). Nordman is said to disclose a method of stacking
analytes and a skewing channel segment that comprises a curved shape
interpreted to read on a serpentine curve, a helix, a coil, and a spiral. Id.
Because we find that Williams does not teach "skewing the analyte
and the one or more sample constituents not of interest" and neither of the
other references remedy this deficiency, the Examiner has not set forth a
factual basis which is sufficient to support a prima facie case of obviousness
of the Appellants' claimed invention. See In re Warner, 379 F.2d 1011,
1017 (CCPA 1967). Accordingly, we reverse the rejections.
Rejection of claims 10--15 under 35 U.S. C. § 103 (a) over Williams in
view of Griffiths
Claims 10-15 are rejected as obvious over Williams in view of
Griffiths. Ans. 7. Williams is relied on for the same teachings as in the
anticipation rejection of claims 1--4 and 7. Id. Griffiths is said to teach the
optimizing the geometric parameters of the skewing channel segments can
lead to improvements in miniaturizing microfluidic separation devices via
dispersion optimization. Id. (citing Griffiths Abstract).
For the reasons previously given, we find Williams does not disclose
the required skewing. In addition, we find that, while Griffiths discloses
skewing, it teaches away from employing skewing in microchannel devices.
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Application 12/902,006
Griffiths teaches methods to avoid skewing a sample in order to reduce
dispersion, which is directly opposite the requirements of the claims. See In
re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) ("A reference may be said to
teach away when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant. The degree of teaching away will of course depend on the
particular facts; in general, a reference will teach away if it suggests that the
line of development flowing from the reference's disclosure is unlikely to be
productive of the result sought by the applicant.").
The Examiner has not made a prima facie case of obviousness of
claims 1 0-15. We reverse.
Rejection of claims 16--20 under 35 U.S.C. § 103(a) over Williams
with evidence from Griffiths in view of Ramsey
Claims 16-20 are rejected as obvious over \X/illiams "\~\rith evidence
from Griffiths" in view of Ramsey. Final Act. 8, Ans. 8. The Examiner
makes no argument regarding teachings of Griffiths in this rejection and
does not rely upon Ramsey to remedy Williams' deficiency in teaching
"skewing the analyte and the one or more sample constituents not of
interest." Therefore, the Examiner has not set forth a factual basis which is
sufficient to support a prima facie case of obviousness of the Appellants'
claimed invention. See In re Warner, 379 F.2d at 1017. Accordingly, we
reverse the rejections.
Rejection of claims 1-5, 7, 14, and 16--21under35U.S.C.§103(a)
over Ramsey in view of Nordman
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Appeal2014-008097
Application 12/902,006
Claims 1-5, 7, 14, and 16-21 stand rejected as obvious over Ramsey
in view of Nordman. Ans. 11. According to the Examiner, Ramsey
discloses a method of separating an analyte of interest from one or more
sample constituents not of interest, the method comprising stacking the
analyte of interest by selective isotachophoresis in a first channel. Ans. 11.
The Examiner acknowledges that, inter alia, "Ramsey does not appear to
explicitly disclose a method wherein the first channel comprising a first and
second end and a skewing channel segment between the first and second
end." Id. The Examiner relies on Nordman for "disclosing the channel
comprising a skewing channel segment between a first and second end"
wherein;
the serpentine channel of Nordman is interpreted to read on the
claimed "skewing channel segment" because FIG. 2 [of
Nordman] depicts the channel segment causes skewing of
sample 48 when flowing through the channel from a first right
end to a left second end) comprising an angle (as depicted in
FIG. 2) \'I/herein the ske\'l1ing channel segment is configured to
produce and maintain axial diffusion of the one or more sample
constituents not of interest.
Id. at 12.
We find that Appellants have the better position. Rather than teaching
a skewing channel segment that causes skewing of a sample to produce and
maintain axial diffusion of one or more sample constituents not of interest,
we find that Nordman teaches away from such a result.
Specifically, in reviewing the teachings of Nordman, including Figure
2 immediately below, we find that Nordman teaches skewing as a problem,
not a solution.
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Application 12/902,006
Fig .. 2
Nordman, Figure 2
According to Nordman, in order to create a separation column of
sufficient useful length in a microchip electrophoresis device, it is necessary
to form the separation column in the form of a serpentine pathway.
Nordman 1:33--44. The serpentine column, however, introduces a
potentially serious limitation in terms of column resolution, in that band
resolution is lost at each tum. Id. at 1 :45-55. Nordman teaches a second
curved portion of a channel to provide a correction on the opposite channel
side, for the band distortion produced in the first curved portion. Id. at 3:9-
11.; see also id. at 3:23-24, 4:35-37, 4:52-54, 59-11, 716-22. Thus,
Nordman teaches that skewing is a problem that must be resolved in order to
avoid band distortion.
"In determining whether obviousness is established by combining the
teachings of the prior art, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations
omitted). "[A] reference will teach away when it suggests that the
developments flowing from its disclosures are unlikely to produce the
objective of the applicant's invention." Syntex (U.S.A.) LLC v. Apotex, Inc.,
407 F.3d 1371, 1380 (Fed. Cir. 2005). Such is the case here. One of skill in
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Application 12/902,006
the art would not combine the disclosures of Ramsey with the teachings of
Nordman to achieve the claimed invention. Rather, upon reading Nordman,
one of skill in the art would be led in a direction divergent from the path that
was taken by Appellants. Galderma Labs., L.P., v. Tolmar, Inc., 737 F.3d
731, 738 (Fed. Cir. 2013)(a reference teaches away when "a person of
ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant").
The Examiner has not made a prima facie case of obviousness of any
claims over Ramey in view of Nordman. We reverse the rejections.
Rejection of claims 6, 8-13, and 15 under 35U.S.C.§103(a) over
Ramsey in view of Nordman and in further view of Griffiths
Claims 6, 8-13, and 15 are rejected as obvious over Ramsey in view
of Nordman and in further view of Griffiths. Ans. 19. Griffiths is employed
as disclosing optimizing the geometric parameters of the ske\~1ing channel
segments can lead to dramatic improvements in miniaturizing microfluidic
separation devices via dispersion optimization. Id. For the reason discussed
above, and because we find both Nordman and Griffiths teach away from the
claimed invention, we reverse the rejections of these claims.
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DECISION
For the reasons above, the Examiner has not set forth a factual basis
which is sufficient to support a prima facie case of obviousness of the
Appellants' claimed invention. See In re Warner, 379 F.2d 1011, 1017
(CCPA 1967). Accordingly, the Examiner's rejection of claims 1-21 is
REVERSED.
REVERSED
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