Ex Parte Ionescu-Zanetti et al

Patent Trial and Appeal Board

Oct 15, 2018

13183271 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/183,271 07/14/2011
27076 7590 10/17/2018
DORSEY & WHITNEY LLP - Seattle
INTELLECTUAL PROPERTY DEPARTMENT
Columbia Center
701 Fifth Avenue, Suite 6100
SEATTLE, WA 98104-7043
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Cristian Ionescu-Zanetti
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.
P219468.US.Ol 7975
EXAMINER
CROW, ROBERT THOMAS
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
10/17/2018 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):
ipdocket-se@dorsey.com
seattle.ip@dorsey.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CRISTIAN IONESCU-ZANETTI,
JOSHUA TANNER NEVILL, MICHAEL SCHWARTZ,
CAROLYN G. CONANT, and ROGER RUDOFF
Appeal2017-007274
Application 13/183,271
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
TA WEN CHANG, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method for separation of particles having magnetic labels from a fluid. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as Fluxion Biosciences, Inc.
(App. Br. 3).
2 We have considered and herein refer to the Specification of July 14, 2011
("Spec."); Final Office Action of Aug. 3, 2015 ("Final Act."); Appeal Brief
of Aug. 25, 2016 ("App. Br."); and Examiner's Answer of Dec. 9, 2016
("Ans.").
Appeal2017-007274
Application 13/183,271
Statement of the Case
Background
"The separation of particles from a fluid may have applications in
both the clinical diagnostic and the basic research fields. For a number of
applications, separation is performed by applying differential forces to the
positive fraction ( e.g. cells of interest) and the negative fraction ( e.g.
background cells)" (Spec. ,r 3). An "approach taken has been to selectively
bind beads of a paramagnetic material to the cells of interest, typically via a
surface marker present at the cell membrane. The positive fraction is then
separated using a magnetic field gradient" (Spec. ,r 4).
The Claims
Claims 1-13 and 46-56 are on appeal. Claim 1 is the sole
independent claim, is representative and reads as follows:
1. A method comprising:
providing a fluid containing a plurality of particles
having magnetic labels in a microfluidic device, wherein the
microfluidic device includes:
a first substrate at least partially defining a fluidic feature
having an opening;
a second substrate reversibly forming a portion of the
fluidic feature by covering the opening;
separating the plurality of particles having magnetic
labels from the fluid during flow of the fluid in the microfluidic
device at least in part by generating a magnetic field across the
microfluidic device such that the plurality of particles having
magnetic labels are transferred to the second substrate; and
removing the second substrate including the plurality of
particles having magnetic labels from the opening.
2
Appeal2017-007274
Application 13/183,271
The Rejections
A. The Examiner rejected claims 1, 2, 4, 10-13, and 46-54 under 35
U.S.C. I03(a) as being obvious over Su, 3 Farber, 4 and Davis5 (Final Act. 3-
9).
B. The Examiner rejected claim 3 under 35 U.S.C. I03(a) as being
obvious over Su, Farber, Davis, and Zobel6 (Final Act. 10-11).
C. The Examiner rejected claims 4---6 under 35 U.S.C. I03(a) as being
obvious over Su, Farber, Davis, and Bor Fuh7 (Final Act. 11-13).
D. The Examiner rejected claim 7 under 35 U.S.C. I03(a) as being
obvious over Su, Farber, Davis, and Lim8 (Final Act. 13-14).
E. The Examiner rejected claim 8 under 35 U.S.C. I03(a) as being
obvious over Su, Farber, Davis, and Chou9 (Final Act. 14--15).
F. The Examiner rejected claim 9 under 35 U.S.C. I03(a) as being
obvious over Su, Farber, Davis, and Stone 10 (Final Act. 16-17).
G. The Examiner rejected claims 55 and 56 under 35 U.S.C. I03(a) as
being obvious over Su, Farber, Davis, and Fritchie 11 (Final Act. 17-18).
3 Su et al., US 2008/0160634 Al, published July 3, 2008.
4 Farber, US 5,602,042, issued Feb. 11, 1997.
5 Davis et al., US 2009/0220979 Al, published Sept. 3, 2009.
6 Zobel et al., US 2009/0297327 Al, published Dec. 3, 2009.
7 Bor Fuh et al., Magnetic split-flow thin fractionation: new technique for
separation of magnetically susceptible particles, 813 J. CHROMATOGRAPHY
A 313-24 (1998).
8 Lim et al., US 2009/0264298 Al, published Oct. 22, 2009.
9 Chou et al., US 2004/0072278 Al, published Apr. 15, 2004.
10 Stone et al., WO 2010/117458 Al, published Oct. 14, 2010.
11 Fritchie et al., US 2009/0117004 Al, published May 7, 2009.
3
Appeal2017-007274
Application 13/183,271
A. 35 USC 103(a) over Su, Farber, and Davis
The issue with respect to obviousness is: Does a preponderance of the
evidence of record support the Examiner's finding that Su, Farber, and Davis
render obvious "a second substrate reversibly forming a portion of the
fluidic feature by covering the opening" "during flow of the fluid in the
microfluidic device" as required by claim 1?
Findings of Fact
1. Su teaches "methods that combine fluidic networks and
magnetic microarrays with an integrated circuitry element that perform
versatile and/or convenient analysis of an analyte with design flexibility"
(Su ,r 2).
2. Su teaches:
A microcoil array is "functionally coupled" with the fluidic
device when one or more microcoils are so situated that they
will achieve the desired effect of generating an magnetic field
within at least a portion of a fluidic zone of the device. Such
coupling can be permanent, where the microcoil array is
integrated into the fluidic device, or temporary, where the
microcoil array is adjacent or in proximity to the device but is
not integrated into the device.
(Su ,r 52).
3. Su teaches a "detection element can be fabricated into the
substrate, or can be fabricated separately and removably coupled to the
device when in use. Preferably the detection element is an optical detection
element or an electrical detection element" (Su ,r 168).
4. Su teaches "an open microchannel can be fabricated on a silicon
substrate by etching methods known to those skilled in the art. Closed
channels can be formed by sealing the open channels at top using methods
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Appeal2017-007274
Application 13/183,271
such as anodic bonding of glass plates onto the open channels on the silicon
substrate" (Su ,r 183).
5. Figure 3 of Su is reproduced below:
FIG. 3
C~1Ss section view
MagneM anay (lntf:gta!E..>d
or in separate devke}
' ............................................... ;~a~net(. ~r~.~.ti~a~1~~rt ........ _ ... -------------- ___________________________________ I
On off
"FIG. 3 illustrates a top-down view and cross-section view of the fluidic
network. The cross-section view illustrates the functionally coupled
magnetic microcoil array" (Su ,r 130).
6. Farber teaches "methods that couple magnetic beads to particles
for magnetically separating the particles out of the mixture in a controlled
manner" (Farber 1:10-12).
7. Farber teaches "the plate 16 can span substantially the
entire width of the container 22 to effectively prevent cells 24 from
collecting against the walls 20 of the housing when the magnet 12 is
activated" (Farber 7: 17-20).
5
Appeal2017-007274
Application 13/183,271
8. Figure 2 of Farber is reproduced below:
I I!
I
i I
I'
l i
't
11
11
11
20
SYST[JI
·----RAtllfl CCJtTR/l!
/"'l8
;~ THAHSfEH S,..,.,,lSMT[,-){---===,;::.Ji-----j-'g ___ ____,
t LJ
·44
I
FIG.2
Figure 2 illustrates:
The transfer system 18 is configured to lilt [sic] the housing 20,
magnet 12 and plate 16 out of the fluid sample 26 while
maintaining the magnetic field generated by magnet 12. The
mechanical linkage arm 34 can be operated by the transfer
system 18 to extract the housing 20, magnet 12 and plate 16
from contact with the fluid sample 26. In a preferred
embodiment of the invention, the housing 20 and plate 16 form
a collection assembly that can removably and replaceably
connect into the system 18 and fit around the magnet 12 to
fluidicly [sic] isolate the magnet 12 from the fluid sample 26.
(Farber 7:54--64).
6
Appeal2017-007274
Application 13/183,271
9. Farber teaches:
The collection assembly is extracted from the fluid sample 26
and pivoted into the high position by the motor 27. The plate
16, with the collected particles 24, faces the optical element 36.
The optical element 36 couples to the transfer magnet 48, and
the magnet 48 is in electrical circuit with the magnet control
system 14. The magnet control system 14 is in electrical circuit
with the magnet 12. In the depicted embodiment, the magnet 12
and the magnet 48 are electro-magnets operated under the
control of system 14 . ... Responsive to the position signal, the
magnet control system 14 deactivates the magnet 12 and
activates the transfer magnet 48. Typically, the transfer system
18 transfers the particles in response to a position signal
indicating that the arm 34 is in the high position and thus
adjacent to the receiver 36.
(Farber 8:59 to 9:9).
10. Farber teaches that "transfer can be accomplished by activating
the transfer magnet 48, by pressing the surface 42 against the surface of the
receiver 36 or by a combination of pressing and magnetic action performed
under the control of the control unit 31 within the transfer system 18"
(Farber 9: 15-19).
11. Davis teaches a robotic device for cell isolation that:
uses powerful magnetic rods covered in removable plastic
sleeves. These rods sweep through blood samples, capturing,
e.g., cancer cells labeled with antibodies linked to magnetically
responsive particles such as superparamagnetic beads. Upon
completion of the capturing protocol, the magnetic rods
undergo several rounds of washing, thereby removing all
contaminating blood cells. The captured target cells are released
into a final capture solution by removing the magnetic rods
from the sleeves.
(Davis, abstract).
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Appeal2017-007274
Application 13/183,271
12. Figures lA-D of Davis is reproduced below:
f T"""""T'"'"""""'""="-_''.""'"11
1 ___ . --- --·- ·-· -·--· •. - ·- - .-_)- --·----?
·:.()_} .. -~··
FIG. 1A FIG. 18
{'"~
:! ~
i(:·e\ r ............. L ........ ' .. ~ ........ 1 ............ 1
~ .
i ! I l
'"I I I I 10(,~--- . , ,. l ~(
c ....................................................................................... 1
,
-~;:_:(:.-.. ~/
FIG. 1C
Figure lA-D illustrate the device where "lA shows sweeping to pick up
cells; lB shows lifting of attached cells from the medium; 1 C shows
deposition of removed cells from lB into a different medium, and lD shows
separation of the cells from the wires" (Davis ,r 57).
Principles of Law
A prima facie case for obviousness requires "reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
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Appeal2017-007274
Application 13/183,271
Analysis
Appellants contend "Su does not teach 'a second substrate reversibly
forming a portion of the fluidic feature by covering the opening,' as recited
in claim 1" (App. Br. 4). Appellants contend "with respect to the
microfluidic device disclosed by Su, the coupling of components may be
either permanent or temporary. Objects integrated into the device are
permanently coupled with the device, and objects positioned adjacent or in
proximity to the device are temporarily coupled with the device" (id. at 5).
Appellants further contend "the system disclosed by Farber does not
teach or suggest 'a second substrate reversibly forming a portion of the
fluidic feature by covering the opening,' as recited in claim 1" (App. Br. 5).
Appellants contend "the optical element 36 disclosed by Farber does not
form a portion of the fluidic feature whatsoever, and is instead merely a
feature of a collection vessel that is lowered into and removed from the
fluidic feature comprised of a container 22 holding a fluid sample" (id.).
Appellants contend "Davis does not remedy this deficiency and is not relied
upon to do so" (id. at 6).
The Examiner responds that Su teaches "the channel in the
microfluidic device is open and unsealed (paragraph O 183), and thus
comprises an opening which would allow the magnetic particle to be
removed from the channel" (Ans. 18). The Examiner further contends Su
teaches "reversible coupling (paragraph 0052), and that the detection
element is reversibly coupled to the microfluidic device" (id.). The
Examiner then contends Farber "does teach a fluidic feature (i.e., the tube)
made up of the first substrate, and the magnetic second substrate (i.e., the
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Appeal2017-007274
Application 13/183,271
plate), which reversibly seals the opening (i.e., the top of the tube) to form
the fluidic feature (i.e., the sealed tube)" (id. at 20).
We find the evidence better supports Appellants' position. While Su
teaches open and closed microchannels (FF 4) and a detachably coupled
detection element (FF 3), Su never suggests that the detection element
should form a portion of an open microchannel (i.e. a fluidic feature of a
microfluidic device) for removal of magnetic particles "during flow of the
fluid in the microfluidic device" as required by claim 1. And while Farber
teaches a magnetic collection assembly for extraction of particles in a fluid
medium (FF 6), Farber also does not suggest that the magnetic collection
assembly form a portion of an open fluidic feature in a microfluidic device
while there is "flow of the fluid in the microfluidic device" as required by
claim 1. At best, Farber teaches that a plate may be lowered into, and lifted
from, a static tube for binding and removal of magnetic particles (FF 7-9).
Thus neither Su nor Farber suggest the use of a "second substrate
reversibly forming a portion of the fluidic feature by covering the opening"
that occurs "during flow of the fluid in the microfluidic device" as required
by claim 1.
We also are not persuaded by the Examiner's reasons for combining
Su and Farber. The Examiner finds an "added advantage of allowing
retention of the particles on the second substrate with a substantially
identical spatial resolution as the first substrate as explicitly taught by
Farber" (Final Act. 5). The Examiner also finds the combination obvious
because "the known techniques of Farber could have been applied to the
method of Su et al [] with predictable results because the known techniques
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Appeal2017-007274
Application 13/183,271
of Farber predictably results in a useful step and arrangement for transferring
magnetic particles" (id.).
However, while spatial resolution may be an advantage in the static
system of Farber, the Examiner does not provide a reason why such spatial
resolution would be desirable in Su's system in which the fluid is flowing
through a microfluidic device and no specific prior spatial resolution in the
fluid exists. Also, while the techniques of Farber and Su were known, "it
can be important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does." KSR, 550 U.S. at 418. Here, we are not
persuaded that the Examiner has established a reason to predictably modify
the device of Su to form a "second substrate reversibly forming a portion of
the fluidic feature by covering the opening" that functions "during flow of
the fluid in the microfluidic device" as required by claim 1.
As noted by both parties, Davis is not relied upon for these limitations
(see App. Br. 6; Ans. 21 ).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner's finding that Su, Farber, and Davis render obvious "a second
substrate reversibly forming a portion of the fluidic feature by covering the
opening" "during flow of the fluid in the microfluidic device" as required by
claim 1.
B.-G. 35 USC§ 103(a)
The Examiner relies upon Su and Farber for each of these rejections to
render obvious "a second substrate reversibly forming a portion of the
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Appeal2017-007274
Application 13/183,271
fluidic feature by covering the opening" "during flow of the fluid in the
microfluidic device" as required by claim 1 (see Final Act. 10-18). Having
reversed the obviousness rejection of claim 1 over Su, Farber, and Davis for
the reasons given above, we also find that the further combinations do not
render the rejected claims obvious for the same reason.
SUMMARY
In summary, we reverse the obviousness rejections.
REVERSED
12