Ex Parte Trotter et al

Patent Trial and Appeal Board

Jun 6, 2018

14170409 (P.T.A.B. Jun. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/170,409 0113112014
95896 7590 06/08/2018
Knobbe, Martens, Olson & Bear, LLP
2040 Main Street
14th Floor
Irvine, CA 92614
FIRST NAMED INVENTOR
Joseph Trotter
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.
BDPHA.OlOA 8897
EXAMINER
DEJONG, ERIC S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
06/08/2018 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):
efiling@knobbe.com
j ayna.cartee@knobbe.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH TROTTER and SUJATA IYER 1
Appeal2017-006627
Application 14/170,409
Technology Center 1600
Before ERIC B. GRIMES, CHRISTOPHER G. PAULRAJ, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for controlling flow of a flow cytometer sample.
Claims 1-3, 10, and 12-14 are on appeal as rejected under 35 U.S.C. § 101
and§ 112, second paragraph. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states:
Particle analyzers, such as flow and scanning cytometers,
are analytical tools that enable the characterization of particles
on the basis of optical parameters such as light scatter and
1 Appellants identify the Real Party in Interest as "BECTON DICKINSON
AND COMPANY." App. Br. 4.
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Application 14/170,409
fluorescence. In a flow cytometer, for example, particles, such
as molecules, analyte-bound beads, or individual cells, in a fluid
suspension are passed by a detection region in which the particles
are exposed to an excitation light, typically from one or more
lasers, and the light scattering and fluorescence properties of the
particles are measured.
Spec. i-f 3. The Specification further states:
Occasionally multiple particles pass the detection station
612 in close proximity (e.g., clumping). As discussed, entrained
events produce signals that may not be distinguishable by the
flow system. Such coincident events are generally undesirable
and can lead to rejection of the droplet containing the particle of
interest. Such rejection can impact the yield of the sort (e.g.,
number of cells positively identified as a cell of interest).
Spec. i-f 94. To overcome this identified "clumping" issue, the Specification
describes "calculating the ratio of observed events [e.g., passing cells] to
expected frequency of events for this or any other time interval" so as to
"obtain an 'entrainment factor.' This value identifies a measure of the
dumpiness of the sample and the deviation from Poisson [distribution]. The
greater level of dumpiness indicated by the entrainment factor, the worse
the sample behavior in flow." Spec. i-f 50.
Independent claim 1, reproduced below, is representative:
1. A method for controlling flow of a flow cytometer sample,
the method comprising:
flowing the sample comprising a series of particles
through the flow cytometer wherein each particle is associated
with a signal;
detecting a series of events with a detection system in a
first time interval from a stream formed from the flow cytometer;
calculating an expected frequency of events in the first
time interval based on a characterizing distribution;
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Application 14/170,409
measuring, via the flow cytometer, an observed frequency
of events within a second time interval, wherein the second time
interval is within the first time interval;
while particles for the sample are flowing through the flow
cytometer, generating an entrainment factor based at least in part
on a comparison of the observed frequency to the expected
frequency;
determining the entrainment factor indicates a level of
sample clumping below a threshold; and
controlling the detection system or the stream formed from
the flow cytometer based on the determined entrainment factor
while particles for the sample are flowing through the flow
cytometer.
Appeal Br. 26 (Claims App'x).
The following rejections are appealed:
Claims 1-3, 10, and 12-14 stand rejected under 35 U.S.C. § 101 as
directed to patent-ineligible subject matter. Final Action 3.
Claims 1-3, 10, and 12-14 stand rejected under 35 U.S.C. § 112,
second paragraph, as indefinite. Id. at 6.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prim a facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
(emphasis added).
Patent-Eligibility
"Phenomena of nature, though just discovered, mental processes, and
abstract intellectual concepts are not patentable, as they are the basic tools of
scientific and technological work." Mayo Collaborative Servs. v.
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Prometheus Labs, Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalkv.
Benson, 409 U.S. 63, 67 (1972)). Claims directed to nothing more than
abstract ideas (such as mathematical algorithms), natural phenomena, and
laws of nature are not eligible for patent protection. Diamond v. Diehr, 450
U.S. 175, 185 (1981); accord MPEP § 2106 (II) (discussing Diehr); see also
Parker v. Flook, 437 U.S. 584, 592-94 (1978) (if, once the mathematical
algorithm is removed from consideration, nothing patentable remains, the
claims are not patent-eligible).
In analyzing patent-eligibility questions under 35 U.S.C. § 101, the
Supreme Court instructs us to "first determine whether the claims at issue
are directed to a patent-ineligible concept." Alice Corp. Pty. Ltd. v. CLS
Bankint'l, 134 S. Ct. 2347, 2355 (2014). If they are, we then move to a
second step and "consider the elements of each claim both individually and
'as an ordered combination' to determine whether the additional elements
'transform the nature of the claim' into a patent-eligible application." Id.
(quoting Mayo, 566 U.S. at 79, 78).
Here, although Alice was not specifically cited by the Examiner,
consistent with Alice's step one the Examiner determined that "[t]he claimed
invention expressly recites a series of abstract data processing steps." Final
Action 3. "Further, [the Examiner determined,] these mathematical
computations are all based on a natural phenomenon, namely that
distribution of particles observed in a flow cytometer naturally distribute
themselves into a Poisson distribution." Id. Under what could be equated to
Alice's step two, the Examiner determined that "[t]he instant claims do recite
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Application 14/170,409
additional steps in addition to the computational 'calculating' and
'generating' steps." Id. at 4. The Examiner determined:
Upon review, none of the above recited additional steps involves
anything beyond what is routine and conventional in the art.
Conventional flow cytometry data comes from performing
routine experiment on a sample using generic flow cytometry
protocols. The instant claims do not modify or require any
changes to generic and conventional flow cytometry protocols.
Further, the instant claims do not specify anything beyond
routine labeling already known and employed in conventional
flow cytometry practice, thus a sample containing particles that
are associated with a signal encompasses nothing new or out of
the ordinary in this field.
Id. Regarding the claimed "controlling" step, the Examiner determined it
"does not specify anything more than a calculation can be made to determine
an entrainment factor and thus pre-empts any and all practical application of
this abstract idea" and, further, "[t]he amended 'controlling' step still fails to
delineate anything other than consider a calculated entrainment factor before
making any adjustment to the flow cytometer." Id. at 4--5. The Examiner
concluded "[t]aking the claims as a whole, the method produces a purely
computational result of data collected by steps encompassing the basic and
routine operations of flow cytometry." Id. at 5.
Appellants argue "[ c ]laim 1 recites tangible features for controlling a
flow cytometer while a sample is flowing through the cytometer. This
provides a non-limiting advantage of more efficient collection of particles
from a sample." Appeal Br. 9. As such, Appellants argue the claims, while
involving math, are not directed to such calculations (as abstract ideas) or to
a substance's natural particle distribution upon flowing (a natural
phenomenon), but are directed to "tangible improvements to the way a flow
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cytometer operates." Id. at 11-13 (citing Enfzsh, LLC v. Microsoft Corp.,
822 F.3d 1327 (Fed. Cir. 2016) and Rapid Litigation Management Ltd. v.
CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016)).
Appellants also argue, when considered as a whole and as an ordered
combination, claim 1 recites significantly more than the alleged abstract
idea. Appeal Br. 15 (citingDiamondv. Diehr, 450 U.S. 175 (1981)).
Appellants argue:
[a]s in Diehr, the present claims provide an improved process in
the field of flow cytometry. The claims, as amended are directed
to novel methods and systems for identifying information for
generating entrainment factors for controlling flow cytometers
while a sample is flowing through the flow cytometer. This is
similar to the improvements in Diehr which resulted in "more
efficient employment of the mold and operator."
Id. at 15-16. Appellants argue, "[c]laim 1 does not merely recite the
calculating and generating in isolation, but integrates these ideas into the
process of controlling flow of a flow cytometer sample." Id. at 16.
It is without question that "[t]he line between a patentable 'process'
and an unpatentable 'principle' is not always clear." Flook, 437 U.S. at 589;
see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150
(Fed. Cir. 2016) ("defining the precise abstract idea of patent claims in many
cases is far from a 'straightforward' exercise") (quoting DDR Holdings, LLC
v. Hotels.com, L.P., 773 F.3d 1245, 1257 (Fed. Cir. 2014)). While this is a
close case, we conclude based on the facts before us that the claimed
invention is directed to a patent-eligible process.
We find the facts here analogous to those of Diehr, 450 U.S. 175, and
the Supreme Court has made clear that "an invention is not rendered
ineligible for patent simply because it involves an abstract concept." Alice,
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134 S. Ct. at 2354 (citing Diehr, 450 U.S. at 187). In Diehr, a computer-
implemented process for curing rubber was held to be patent-eligible, even
though it involved/required a computer and employed a well-known
mathematical equation, because it used that equation in a process designed
to solve a specific technological problem in a conventional industry practice.
Diehr, 450 U.S. at 177, 178. The method of Diehr resulted in a better rubber
mold or molding process. The method of claim 1, here, results in a better
use of a flow cytometer.
"[I]t is not enough to merely identify a patent-ineligible concept
underlying the claim; we must determine whether that patent-ineligible
concept is what the claim is 'directed to.'" CellzDirect, 827 F.3d at 1050
(emphasis added). In CellzDirect, the Federal Circuit concluded that "[t]he
end result of the ... claims [was] not simply an observation or detection of
the ability of hepatocytes to survive multiple freeze-thaw cycles [i.e., a
natural phenomenon and patent-ineligible concept critical to the invention].
Rather, the claims [were] directed to a new and useful method of preserving
hepatocyte cells [using that patent-ineligible concept]." Id. at 1048. We are
presented with a similar scenario here, where the claimed method
indisputably requires mathematics and calculations; however, it also uses
mathematics and calculations to better operate a machine. We conclude the
claims here are directed to a method of better operating a flow cytometer,
not to mere abstract calculations or the natural way something flows.
Because we find that claim 1 is not directed to patent-ineligible
subject matter, we do not reach Alice step two. Enfish, 822 F.3d at 1339.
We reverse this rejection.
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Indefiniteness
"'A claim is indefinite when it contains words or phrases whose
meaning is unclear,'" i.e., "ambiguous, vague, incoherent, opaque, or
otherwise unclear in describing and defining the claimed invention." In re
Packard, 751F.3d1307, 1310-13 (Fed. Cir. 2014); see also MPEP
§ 2173.02(!) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection
for indefiniteness is appropriate "after applying the broadest reasonable
interpretation to the claim, if the metes and bounds of the claimed invention
are not clear"). In resolving an indefiniteness issue, we ask whether one of
ordinary skill in the art would understand what is claimed when the claim is
read in light of the Specification. Power-One, Inc. v. Artesyn Techs., Inc.,
599 F.3d 1343, 1350 (Fed. Cir. 2010).
The Examiner determined:
Independent claim 1, from which all claims depend, now
recite[ s] the limitation of "determining the entrainment factor
indicates a level of sample clumping below a threshold" and
"controlling the detection system or the stream ... based at least
in part on the determined entrainment factor".
These limitation cause the metes and bounds of the instant
claims to be indefinite. The "entrainment factor" is defined in
the instant claims only by the information it is expected to
convey. In this case, the "entrainment factor" is the magic term
that, when calculated, will enable an artisan on the fly to
determine whether or not to increase or decrease a sample flow
rate. This decision is made "based on the entrainment factor".
Final Action 6.
Appellants argue "that the recited 'entrainment factor' provides the
requisite degree of certainty when properly considered as a whole, in the
context of the features recited in [ c ]laim 1, as well as in light of the
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application, the prior art, and the understanding of one of ordinary skill in
the relevant arts." Appeal Br. 23.
The question here is whether the claim language "entrainment factor"
has a definite meaning.
The Patent Office applies the broadest reasonable construction
standard in prosecution proceedings. Cuozzo Speed Tech., LLC v. Lee, 136
S. Ct. 2131, 2145 (2016). "[W]hile it is true that claims are to be interpreted
in light of the specification ... , it does not follow that limitations from the
specification may be read into the claims . . . . [T]he claims define the
invention." Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988).
However, "[t]he specification acts as a dictionary when it expressly defines
terms used in the claims or when it defines terms by implication." Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
The meaning of the term "entrainment factor" is not apparent from the
context of the claims. Appellants do not argue that the term "entrainment
factor" has a special meaning in the art that would be readily understood by
the skilled artisan. Turning to the Specification, we find that it states:
By calculating the ratio of observed events to expected frequency
of events for this or any other time interval we may obtain an
"entrainment factor." This value identifies a measure of the
dumpiness of the sample and the deviation from Poisson. The
greater level of dumpiness indicated by the entrainment factor,
the worse the sample behavior in flow.
Spec. i-f 50. This statement is followed by a description of how such a ratio
can be used as an entrainment factor to compare observed sample events to
expected sample events based on probability and, thus, determine if
excessive dumpiness is occurring so that some intervention may be
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necessary. Id. i-fi-155-56. Therefore, in view of the Specification, we
conclude the broadest reasonable interpretation of the term "entrainment
factor" is a value identifying a measure of the dumpiness of a sample based
at least in part on a ratio of observed events relative to the expected
probability of those events.
Because the broadest reasonable interpretation of the term
"entrainment factor" is ascertainable in view of the Specification, as set forth
above, the ambiguity upon which the rejection was based is resolved. For
this reason, we reverse the indefiniteness rejection.
SUMMARY
The rejection of the claims as directed to patent-ineligible subject
matter is reversed.
The rejection of the claims as indefinite is reversed.
REVERSED
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