Ex Parte Kshirsagar

Patent Trial and Appeal Board

Mar 6, 2019

14254236 (P.T.A.B. Mar. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/254,236 04/16/2014
32692 7590 03/08/2019
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
FIRST NAMED INVENTOR
Manjiri T. Kshirsagar
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.
65742US010 3218
EXAMINER
ARIAN!, KADE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
03/08/2019 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MANJIRI T. KSHIRSAGAR 1
Appeal2018-005944
Application 14/254,236
Technology Center 1600
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 According to Appellant, the real party in interest is 3M Company (Appeal
Br. 2).
Appeal2018-005944
Application 14/254,236
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-14 and 16 as unpatentable under
35 U.S.C. § 103(a) as obvious over the combination ofN.Y. Lee et al.,
Microfluidic Immunoassay Plaiform Using Antibody-immobilized Glass
Beads and Its Application for Detection of Escherichia coli 0157:H7, 27
BULL. KOREAN CHEM. Soc. 479--483 (2006) ("Lee"); Plumb et al. (US
7,298,886 B2, November 20, 2007) ("Plumb"); and D.V. Volodkin et al.,
Protein Encapsulation via Porous CaC03 Microparticles Templating, 5
BIOMACROMOLECULES 1962-72 (2004) ("Volodkin"). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to a process for optically detecting
the presence of coliform strains in a sample by using a particulate
concentration agent to bind or capture a variety of coliform strains and
contacting the coliform-bound particulate concentration agent with a culture
medium in a culture device. Spec.; Abstr.
2 We note that the Examiner inadvertently erred in omitting Volodkin from
the statement of the obviousness rejection, but relies on Volodkin in the
body of the rejection. See Final Act. 7. Because the Examiner previously
cited Volodkin during prosecution and put the Appellant on notice of the
reference, we hold this error harmless.
2
Appeal2018-005944
Application 14/254,236
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A process comprising
(a) providing at least one sample suspected of comprising
at least one coliform strain;
(b) providing at least one culture device comprising at
least one culture medium that is hydrated or hydratable;
( c) providing at least one particulate concentration agent
that is substantially optically transparent when in contact with
said culture medium in said culture device when said culture
medium is hydrated, wherein each of said at least one
particulate concentration agent can concentrate a variety of
coliform strains, wherein said particulate concentration agent
comprises inorganic microparticles selected from metal
silicates; silica; metal carbonates; metal phosphates; metal
oxide-, gold-, or platinum-modified diatomaceous earth; and
combinations thereof;
( d) placing said particulate concentration agent in contact
with said sample such that at least a portion of said coliform
strain is bound to or captured by said particulate concentration
agent to form coliform-bound particulate concentration agent;
( e) placing said coliform-bound particulate concentration
agent in contact with said culture medium of said culture
device;
(f) incubating said culture device comprising said
coliform-bound particulate concentration agent in contact with
said culture medium, said culture medium being hydrated; and
(g) optically detecting the presence of said coliform
strain without separating said coliform strain from said
particulate concentration agent, wherein said optically detecting
is performed in the culture device.
App. Br. 24.
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Appeal2018-005944
Application 14/254,236
ISSUES AND ANALYSIS
We adopt the Examiner's findings, reasoning, and conclusion
establishing that Appellant's claims 1-14 and 16 are primafacie obvious
over the combined prior art. We address the arguments raised by Appellant
below.
Issue 1
Appellant argues that the Examiner erred because the cited prior art
does not disclose a microparticle that can concentrate a variety of coliform
strains. App. Br. 15.
Analysis
The Examiner finds that Lee teaches the simultaneous detection of
multiple bacterial pathogens by using glass beads attaching different
antibodies in a single microfluidic device. See Final Act. 6; see also Ans. 6-
7 (citing Lee 479,483). The Examiner finds Lee teaches a specific example
of a process of detecting the presence of at least one coliform strain (E. coli)
by: (1) providing a sample of E. coli in a hydrated growth medium,
providing at least one glass bead with surface antibodies specific to E. coli;
(2) contacting the E. coli and growth medium with the glass beads to bind
the E. coli in a microfluidic chamber; and (3) optically detecting the E. coli
without separating the E. coli from the glass bead. Final Act. 6 ( citing Lee
482--483).
The Examiner finds that Lee "do[ es] not teach the particulate
concentrating agent comprises metal carbonate microparticles." Final Act.
7. However, the Examiner finds Volodkin teaches metal carbonate
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Application 14/254,236
microparticles capable of absorbing macromolecules. Id. ( citing Volodkin
Abstr., 1963). The Examiner determines a person of ordinary skill in the art
would have combined Volodkin's metal carbonate microparticles with Lee's
detection process, in order to reduce non-specific binding with a reasonable
expectation of success in capturing coliform strains. See id.
The Examiner finds Lee does "not teach optically detecting a color
change in the presence of [a] gas bubble proximate to at least [an] E. coli
colony with the flat film." Final Act. 7. However, the Examiner finds that
Plumb teaches a flat film culture medium for optically detecting a color
change and the presence of a gas bubble proximate to an E. coli colony. See
id. at 7-8 (citing Plumb col. 1, 11. 52-56; col. 13, 11. 33-50). The Examiner
determines that a person of ordinary skill in the art would have been
motivated to combine the growth medium for optically detecting a color
change and the presence of a gas bubble from an E. coli colony in a culture
device with Lee to reduce errors as taught by Plumb. See id.
Appellant argues that "the silica microparticles of Lee are not
structurally the same as the inorganic microparticles disclosed in the present
application." App. Br. 15 ( emphasis in original). Specifically, Appellant
argues that application discloses amine-functionalized glass beads and
unmodified silica micro spheres, as opposed to Lee's glass beads, which are
surface modified with antibodies and L-lysine blocking the remaining
surface. See id. at 16-17. Appellant further argues that "surface
functionalization of the concentration agent is critical to its total structure,
because the surface functionalization affects the ability of the concentration
agent to selectively or non-selectively capture a material." Reply Br. 5.
Appellant argues that this limitation is recited in the claims as "wherein each
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Application 14/254,236
of said at least one particulate concentration agent can concentrate a variety
of coliform strains." See id.
Furthermore, Appellant argues that "Lee does not explicitly disclose
glass beads having more than one antibody attached such that each
microparticle could concentrate a variety of coliform strains." App. Br. 17
( emphasis in original). Rather, Appellant contends that Lee "discloses the
use of multiple different beads of different sizes having different attached
antibodies to detect multiple analytes in one device using discrete
microchambers for the different beads. Nowhere does Lee disclose that each
of the beads can concentrate a variety of coliform strains." Id. at 18.
We are not persuaded by Appellant's arguments. We begin with the
interpretation of the claims on appeal. We interpret the claims in light of
Appellant's Specification and with the knowledge of one of ordinary skill in
the art. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
1996). Appellant contends that "wherein each of said at least one particulate
concentration agent can concentrate a variety of coliform strains" requires a
specific surface functionalization of the concentration agent. See Reply Br.
4---6. However, the Specification states that "[ s ]uitable particulate
concentration agents include ... particles comprising biomolecules ... (for
example, beads with surface-bound antibodies)." Spec. 13. Absent an
express recitation of a specific surface functionalization, we conclude that
the broadest reasonable interpretation of the particulate concentration agent
includes beads with surface-bound antibodies, as taught by Lee.
We agree with Appellant that Lee does not expressly disclose beads
including more than one antibody immobilized on each bead. However,
"[i]n determining whether the subject matter of a patent claim is obvious,
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Application 14/254,236
neither the particular motivation nor the avowed purpose of the patentee
controls. What matters is the objective reach of the claim. If the claim
extends to what is obvious, it is invalid under§ 103." KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398,419 (2007). Here the claims recite "at least one
particulate concentration agent ... wherein each of said at least one
particulate concentration agent can concentrate a variety of coliform strains,
wherein said particulate concentration agent comprises inorganic
microparticles selected from ... silica." The Specification defines
"concentration agent" as "a material or composition that binds
microorganisms including coliforms ... ," which, as discussed above, may
comprise surface-bound antibodies. Spec. 7, 13. Therefore, we conclude
that the broadest reasonable interpretation of the claims includes at least one
particulate concentration agent being a material, e.g., silica microparticles,
wherein the each of the material (silica microparticles) can concentrate a
variety of coliform species.
Because Lee teaches glass beads attaching several different antibodies
for simultaneous binding and detection of multiple bacterial pathogens, we
agree with the Examiner that Lee teaches or suggests the recited limitation
that each of at least one particulate concentration agent can concentrate a
variety of coliform strains.
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Appeal2018-005944
Application 14/254,236
Issue 2
Appellant argues that the Examiner erred because the cited prior art
does not disclose a culture device comprising a culture medium and thus
does not teach or suggest the required steps of the claimed process. App. Br.
19-21.
Analysis
Appellant argues that Lee teaches a microfluidic device, not a culture
device with a culture medium or a flat film. App. Br. 20. Appellant argues
that Lee teaches adding E. coli and growth medium at the same time to a
microfluidic device packed with anti-body coated glass beads. See id. at 21.
Thus, Appellant argues that "Lee fails to disclose ... 'providing at least one
culture device comprising at least one culture medium that is hydrated or
hydratable' and 'placing said coliform-bound particulate concentration agent
in contact with said culture medium of said culture device."' Id. In other
words, Appellant argues that the prior art does not teach steps (b) and ( e) of
the claimed process. See Reply Br. 9.
Appellant further argues that Lee teaches optically detecting
microorganism strains using fluorescence, which does not require incubating
prior to optical detection. App. Br. 21. Thus, Appellant argues there would
have been no motivation to modify the microfluidic device of Lee with the
culture device of Plumb, "at least because incubation of microorganisms is
more time consuming than fluorescence detection and requires either
including a growth medium in the microfluidic device or transferring the
beads to a (e.g., flat film) culture device." Id.
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Appeal2018-005944
Application 14/254,236
We are not persuaded by Appellant's arguments. Again, we begin
with claim interpretation, where the Specification defines "culture device" as
"a device that can be used to propagate microorganisms including coliforms
under conditions that will permit at least one cell division to occur." Spec.
7. Applying the broadest reasonable interpretation, we conclude the
definition of culture device includes Lee's microfluidic device as well as
Plumb's flat film.
As to the steps of the process, we conclude that the broadest
reasonable interpretation of the claims allows for overlap between the steps.
The plain meaning of the claims does not preclude combining the
"providing" and "placing steps." Moreover, the Specification provides:
The sample contacting step of the process of the invention can be
carried out by any of various known or hereafter-developed
methods of providing contact between two materials. For
example, the particulate concentration agent can be added to the
sample, or the sample can be added to the particulate
concentration agent.
Spec. 24 ( emphasis added). The Specification also states: "the particulate
concentration agent and the sample are combined (using any order of
addition) in any of a variety of containers." Id. As to contacting with a
culture medium, the Specification provides:
A preferred contacting method includes both mixing . . . and
preliminarily incubating ... a microorganism-containing sample
(preferably, a fluid) with particulate concentration agent. If
desired, one or more additives (for example ... microbial growth
media . . . can be included in the combination of particulate
concentration agent and sample.
Id. at 25-26. Furthermore, the Specification states that "[h]ydration of the
culture medium ... can be effected either prior to or after ... the culture
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Application 14/254,236
medium and the coliform-bound particulate concentration agent are brought
into contact (or simultaneously therewith)." Spec. 27. In other words, the
Specification allows for simultaneously mixing of a sample and
concentration agent with a hydrated growth medium.
Because we determine that the broadest reasonable interpretation of
the claims allows for the overlap between process steps, we find Lee's
method of combining a glass bead (concentration agent), diluted growth
medium containing E. coli (hydrated culture medium and coliform sample),
and a microfluidic device ( culture device), teaches the limitations of steps
(b ),( d), and ( e) of the claimed process.
Moreover, as to the combination with Plumb for teaching incubating
an E. coli colony on a flat film culture medium for optical detection, we are
similarly not persuaded that the references cannot be combined. As
discussed above, Appellant argues the combination requires incorporating "a
growth medium in the microfluidic device" or "the beads to a ( e.g., flat film)
culture device." However, "[t]he test for obviousness is not whether the
features of a secondary reference may be bodily incorporated into the
structure of the primary reference.. . . Rather, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art." In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981). Instead, we
agree with the Examiner that the combined teaching suggests a process using
an optically transparent particulate concentration agent that can concentrate
a variety of coliform strains with a flat film culture medium for optically
detecting coliform foodbome pathogens.
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Application 14/254,236
Issue 3
Appellant argues the Examiner's proposed modification to the prior
art would render it inoperable for its intended purpose.
Analysis
Appellant contends the Examiner "proposed supplementing the glass
beads coated with antibody specific to one microorganism strain with metal
carbonate particles." App. Br. 22. Appellant argues that "to include a
concentration agent such as a metal carbonate as proposed by the Examiner,
would destroy the sensitivity ... of the method of Lee, rendering it
unsatisfactory for its intended purpose." Reply Br. 10.
We are not persuaded that the Examiner erred in determining that
there would be a reasonable expectation of success to employ metal
carbonate as a particulate concentrating agent to bond coliform strains. See
Ans. 12-13. Appellant adduces no evidence that modifying the
multiparticulate material in Lee would prevent "multiple-analyte detection
with a single operation" which is the end goal of the reference. See Lee 483.
Therefore, we conclude that it would have been obvious to a person of
ordinary skill in the art to modify the detection process of Lee with the metal
carbonate particles of Volodkin.
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Appeal2018-005944
Application 14/254,236
DECISION
The Examiner's rejection of claims 1-14 and 16 as unpatentable under
35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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