Ex Parte Banerjee et al

Patent Trial and Appeal Board

Jan 10, 2017

10032657 (P.T.A.B. Jan. 10, 2017)

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.
10/032,657 12/28/2001 Sukanta Banerjee 48544-526001US 6168
102694 7590
Mintz Levin/Bio Array
One Financial Center
Boston, MA 02111
EXAMINER
SHIBUYA, MARK LANCE
ART UNIT PAPER NUMBER
1677
NOTIFICATION DATE DELIVERY MODE
01/12/2017 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):
IPDocketingBOS @ mintz.com
IPFileroomBOS@mintz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUKANTA BANERJEE, and MICHAEL SEUL1
Appeal 2016-002955
Application 10/032,657
Technology Center 1600
Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and
RICHARD J. SMITH, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 18—22. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm but designate the affirmance as a new ground of rejection.
STATEMENT OF THE CASE
Appellants’ invention relates to multiplex analyte detection using
magnetic microparticles assembled as planar arrays. Spec. Abstract, 7:19—
8:2; 13:21-14.
1 Appellants identify the real party-in-interest as Bio Array Solutions, Ltd.,
App. Br. 2.
Appeal 2016-002955
Application 10/032,657
Independent claim 18 is illustrative (emphasis added):
18. A method of multiplex analysis of analytes in a solution,
comprising:
providing a plurality of magnetically polarizable
microparticles of two or more types wherein different
types bear an optically distinguishable signature, and the
different types display different capture moieties on their
surfaces capable of binding to different analytes;
suspending the microparticles in a first solution containing,
or suspected to contain, analytes of interest, under
conditions permitting the capture of analytes by the
capture moieties, and wherein an optical signal is
generated following such capture;
using a magnetic field to assemble the microparticles in a
planar array on a designated section of a substrate,
where said magnetic field is generated by coils or
magnets, and is uniformly distributed over the surface of
the substrate, and wherein the spacing between particles
within the array can be varied by varying the strength of
the magnetic field; and
imaging the optically distinguishable signatures associated
with the microparticles and the optical signals, and
correlating the optical signals with microparticles having
particular optically distinguishable signatures to
determine which analytes are bound by which capture
moieties.
Claims 18—22 stand rejected under 35 U.S.C. § 103(a) as obvious over
the combination of Walt,2 Wang,3 Farber,4 and McArdle.5
2 Walt et al., US 7,115,884 Bl, issued Oct. 3, 2006.
3 Wang et al., US 6,013,531, issued Jan. 11, 2000.
4 Farber, US 5,602,042, issued Feb. 11, 1997.
5 McArdle et al., US 6,402,876 Bl, issued June 11, 2002.
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Application 10/032,657
ANALYSIS
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claims 18—22 as unpatentable over the cited art. See App. Br. 5—
19; Reply Br. 1—5. Except as otherwise discussed below, we disagree with
Appellants contentions and adopt as our own the findings with respect to the
scope and content of the prior art set forth in the Examiner’s Answer.
Because our reasoning differs somewhat from that of the Examiner, we
designate our affirmance a new ground of rejection. For emphasis and
clarity, we highlight and address the following:
Findings of Fact
FF1. Walt discloses a method for multiplex analysis of analytes in solution
wherein optically distinguishable (e.g., fluorescently labeled) beads or
microspheres bound to capture moieties are assembled into an array and
exposed to a sample. Walt, 5:5—29, 11:7—32; 12:58—14:37. “[T]he
optical response of each element in the array can be compared to a library
of characteristic optical response signatures for its corresponding bead
subpopulation type, where the characteristic optical response signature to
various analytes has been previously measured and recorded, and [] the
identity of the unknown can be determined.” Id. at 5:20—26.
FF2. Wang teaches the use of magnetically-responsive fluorescent particles
coupled to “biological material such as antigens, antibodies, enzymes or
DNA/RNA and used as solid phase for various types of immunoassays,
DNA/RNA hybridization assays, affinity purification, cell separation,
phagocytosis, and other biomedical applications.” Wang, Abstract, 1:42—
2:25. In one embodiment, magnetic particles coated with an antigen are
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incubated with serum containing a corresponding antibody, magnetically
separated, washed, and fluorescently labeled. Id. at 15:8—16:8.
FF3. Farber discloses a method for collecting biological particles tagged
with superparamagnetic microbeads (Farber 2:46-48; 1:21—44),
involving
automated collection and transfer of particles from a liquid
suspension to a glass slide for visual examination. A magnet
is positioned adjacent to a solution which contains particles
tagged with magnetic beads, for example cells, so that the
magnetic particles flow toward the magnet and collect
against a collection surface positioned between the particles
and the magnet. A transfer mechanism applies a selected
pressure to a second side of the collection surface for
transferring collected cells to a viewing slide.
Id., Abstract; see also 3:59-4:11. “[T]he magnet element can be
arranged with the plate element so that the generated magnetic
field is stronger at selected areas of the plate surface.” Id. at
3:61—63. In one embodiment, “a spatially-varying and time-
varying magnetic field” may be used to “cause[] the
magnetically-induced movement of the particles,” Id. at 11:21—
37. “In a preferred embodiment, the magnet element is
positioned vertically above the plate, and couples to the plate at
select locations for providing a stronger magnetic attraction at
these locations.” Id. at 3:67-4:3.
FF4. Farber Figure 1 is reproduced below:
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Application 10/032,657
Farber Figure 1 is “a block diagram illustration of an apparatus ... for
magnetically removing particles from a mixture.” Id. at 6:14—16. With
respect to Figure 1, Farber teaches that
plate 16 is disposed between the magnet 12 and the particles
24 with a geometry such that particles drawing toward the
magnet 12 collect on the surface of the plate 16 and
magnetically adhere to it. In one preferred practice, the
magnetic posts 30 are selectively activatable by the control
system 14. The magnet control system 14, selectively
activates the posts 30 and thus generates a spatially-varying
and time-varying magnetic field. The resultant varying
magnetic field causes the magnetically-induced movement of
the particles and the particles 28 are distributed across the
surface of plate 16 by the selectively activated posts 30. In
this way, a specific spatial distribution of particles 24 is
collected against a plate 16.
Id. at 11:20—32; see 7:20—50.
FF5. McArdle discloses a method of making ordered or random arrays of
electrically-conductive particles in a ferrofluid by applying a uniform
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magnetic field to assemble the particles to a substrate, which may be a
curable film. See generally, McArdle, Abstract. In one embodiment,
The method includes applying to one set of conductors a
layer of an adhesive composition of the composition so
described; bringing a second set of conductors against the
layer of adhesive composition; exposing the layer of
adhesive composition to a substantially uniform magnetic
field such that interaction between the ferrofluid and the
electrically-conductive particles causes the electrically-
conductive particles to form a regular pattern of particles
each in electrical contact with an adjacent particle and/or
with a conductor in one or both sets whereby conductive
pathways are provided from one set of conductors to the
other set, each pathway including one or more of the
electrically-conductive particles; and curing the composition
to maintain the pattern in position and to bond the
conductors.
Id. at 2:41-57.
With respect to particles in the resulting monolayer, McArdle
states:
Desirable concentrations of substantive particles depend
upon a number of factors that can be determined by those
person skilled in the art through routine experimentation
and/or mathematical calculations. U.S. Pat. No. 4,846,988
(Skjeltorp) notes that the concentration of magnetic holes in
ferrofluids polarized with a magnetic field, determines the
distance between them. Shiozawa . . . indicates that contact
resistance in traditional anisotropically conductive adhesives
decreases as particle count (per unit area) increases. An
increasing number of conductive particles increases the
current carrying capacity. The current carrying capabilities
are not only concentration dependent but also particle type
dependent...
Thus, the actual concentration of conductive particles
should depend on the particle type, density, diameter,
electrical pattern, minimum required contact resistance
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measurements, the spacing between opposing and adjacent
conductors, the surface area of the conductors and the like.
Li and Morris . . . describe[] computer programs which
calculate the minimum pad size for different loading
densities and the minimum pad space for different particle
sizes of conductive particles in conductive adhesives. In
ordering the array of particles, a magnetic field may be
applied by a permanent magnet or by electromagnetic means.
The magnetic field is described to be in the range of 10 mT
to 1000 mT, such as 10 mT to 100 mT, applied for a time in
the range to 10 minutes, such as 0.5 to 5 minutes. The
magnetization saturation of the ferrofluid composition should
influence the selection of the magnetic field strength.
Id. at 22:9-44.
Analysis
The Examiner finds that it would have been obvious to use the
magnetic beads as taught by Wang in the method of Walt “because the
magnetic fluorescent particle in Walt can be used as a separation means and
as a label at the same time and thus avoid the use of a second label.” Ans. 3.
The Examiner also finds that it would have been obvious “to apply various
magnetic field strengths to the magnetic particles to a substrate to control the
spatial distribution of the magnetic particles against the substrate according
to the method taught by Farber to assemble the magnetic particles into an
array for use in the combined method of Walt and Wang.” Id. at 5. The
Examiner further finds that it would have been obvious to use a uniform
magnetic field as taught by McArdle, “so that the magnetic particles can be
assembled into an array for analysis on a substrate such as a chip.” Id. at 7.
Appellants argue that the rejection is in error because the Examiner
fails to establish a reason to combine Farber with McArdle, or to modify
Farber to include a uniform magnetic field. App. Br. 8—15. With reference
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to Farber Figure 2, Appellants argue that the application of a non-uniform
(spatially varying) electric field at posts 30 results in a spatial distribution of
collected particles that may be transferred to an optical element as “clustered
groupings of particles.” Id. 11—12. According to Appellants, “[t]o eliminate
this spatial variance, which allows for clustered groupings would change the
principle of operation of the systems of the Farber reference.” Id. at 12.
We do not find Appellants’ argument persuasive. The Examiner
reasonably interprets both Farber and McArdle as directed to the use of a
magnetic field to hold magnetic particles against a substrate in an array.
Ans. 10, 13. The Examiner reasonably finds that “it is well known in the art
that a uniform magnetic field is used in order to produce an array of
magnetic particles on a substrate” {id. at 7), that the magnetic field near
Farber’s magnetic posts (e.g., posts 30) would be “stronger or at least
substantially uniform,” and that “a monolayer of magnetic particles could
form at the area of the magnetic post” {id. at 10; see also FF3 (“In a
preferred embodiment, the magnet element is positioned vertically above the
plate, and couples to the plate at select locations for providing a stronger
magnetic attraction at these locations.”).
The Examiner’s reasoning is underscored by the language of claim 18,
which recites the use of a magnetic field to assemble microparticles in a
planar array “on a designated section of a substrate.” Although the claim
further recites that the magnetic field is “uniformly distributed over the
surface of the substrate,” we interpret that phrase as referring to the
designated section of the substrate in which microparticles are assembled in
the planar array. Nevertheless, even if the claim were read to require a
uniformly distributed magnetic field over the entire surface of the substrate,
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the claim’s focus on assembling microparticles on a designated section of
the substrate is obvious in light of the “stronger, or at least substantially
uniform” magnetic field close to Farber’s magnetic posts, over which a
monolayer of beads is assembled. See Ans. 10. Accordingly, under either
interpretation, we agree with the Examiner that one of ordinary skill would
have reasonably looked to McArdle for teaching a uniform magnetic field to
generate a monolayer of magnetic beads as suggested by Farber. See id. at
9-10, 13.
Appellants further argue that the combination of Farber and McArdle
is in error because “[t]he Examiner has pointed to nothing to teach or
suggest that one of skill in the art would apply the teachings of this reference
more broadly to any liquid containing magnetic particles generally, much
less a liquid containing magnetic particles that are functionalized with
biomolecules.” App. Br. 15. We do not find Appellants’ argument
persuasive and agree with the Examiner that one of ordinary skill in the art
would have been motivated to combine Farber and McArdle for the reasons
discussed above and, further, that the use of magnetic fields to separate
magnetically-responsive, biologically-functionalized particles from solution
is well known in the art, as illustrated by Wang and Farber. See Ans. 13; FF
2,3.
Appellants also argue that “none of the references discloses or
suggests varying the spacing between particles within the array by ‘varying
the strength of the magnetic field,’ as recited in claim 18,” stating in
particular, that “[t]he teachings of the McArdle reference do not or suggest
any connection between particle spacing and magnetic field strength.” Id. at
16—18 (emphasis omitted). We do not find Appellants’ argument persuasive
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because the claim element in question, “wherein the spacing between
particles within the array can be varied by varying the strength of the
magnetic field,” recites an optional limitation that does not narrow the scope
of the claim. Claim 18 (emphasis added). Here, the plain language of claim
18 indicates that the spacing between particles within the array can, but need
not be, varied by varying the strength of the magnetic field. See In re
Johnston, 435 F.3d 1381, 1384 (Fed. Cir. 2006) (“As a matter of linguistic
precision, optional elements do not narrow the claim because they can
always be omitted.”). Accordingly, we need not find this element in
McArdle to sustain the Examiner’s rejection.6
For the reasons set forth above, the rejection is affirmed.
SUMMARY
I. We affirm the rejection of claims 18—22 under § 35 U.S.C.
103(a) as obvious over the combination of Walt, Wang, Farber, and
McArdle. We designate our affirmance a new ground of rejection
under 37 C.F.R. § 41.50(b).
6 We further note that Appellants object to the Examiner’s characterization
of the claims as “contradictorily” requiring a uniform magnetic field and
varying the magnetic field strength to vary spacing of the particles on the
substrate. See Reply Br. 5, referencing Ans. 6. We discern no such
contradiction under our construction.
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TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
AFFIRMED: 37 C.F.R, $ 41.50(b)
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