Ex Parte Beaty

Patent Trial and Appeal Board

Sep 21, 2018

12918019 (P.T.A.B. Sep. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/918,019 10/19/2010 Patrick Shawn Beaty
147462 7590 09/25/2018
Botos Churchill IP Law LLP
430 Mountain A venue
Suite 401
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.
BECTON 3.3-163 (E)
(P-774
EXAMINER
LIN,JERRY
5304
New Providence, NJ 07974 ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
09/25/2018 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):
rbotos@bciplaw.com
ip.docket@bd.com
pto@bciplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PATRICK SHAWN BEATY
Appeal2017-007200
Application 12/918,019
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, 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 of determining whether a culture in a vessel contains a plurality of
microorganisms. The Examiner rejected the claims as directed to non-
statutory subject matter. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
1 Appellant identifies the Real Party in Interest as Becton, Dickinson and
Company (App. Br. 1 ).
2 We have considered and herein refer to the Specification of Aug. 17, 2010
("Spec."); Final Office Action of Mar. 23, 2016 ("Final Action"); Appeal
Brief of Sept. 14, 2016 ("App. Br."); Examiner's Answer of Dec. 2, 2016
("Ans.") and Reply Brief of Feb. 1, 2017 (Reply Br.).
Appeal2017-007200
Application 12/918,019
Statement of the Case
Background
"Rapid and reliable detection of microorganisms in a culture, such
as a blood culture, is among the most important functions of the clinical
microbiology laboratory" (Spec. 1: 10-11 ). The "present invention describes
a data transformation that can be applied to metabolic or cell growth data in
a way that provides confidence that a culture in a vessel is infected with a
microorganism (high confidence positive) and essentially eliminates the
potential for false negative determinations" (Spec. 2:20-23).
The Claims
Claims 1, 3-25, 27-31, 33, 38, 40-43, 46-49, and 53-55 are on
appeal. Claim 1 is representative and reads as follows:
1. A method of determining whether a culture in a vessel
contains a plurality of microorganisms, the method comprising:
i) providing a vessel with a culture disposed therein, the
vessel further comprising a sensor in communication with the
culture;
ii) obtaining a signal from the sensor, the signal being a
measure of an initial biological state of the culture;
iii) incubating the culture disposed in the vessel;
iv) obtaining signals from the sensor, the signal being a
measure of the biological state of the culture during incubation;
(A) calculating a normalization relative value for each
respective measurement in a plurality of measurements of a
biological state of the culture in the vessel, taken at different
time points between a first time point and a second time point,
between (i) the respective measurement and (ii) an initial
biological state of the culture taken at an initial time point,
thereby forming a plurality of normalization relative values for
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Application 12/918,019
each of a plurality of predetermined fixed interval of time
points;
(B) determining, for each respective predetermined fixed
interval of time points between the first time point and the
second time point, a first derivative of the normalization
relative values for measurements of the biological state in the
respective predetermined fixed interval of time points, thereby
forming a plurality of rate transformation values, wherein the
plurality of rate transformation values comprises a plurality of
sets of rate transformation values, wherein each respective set
of rate transformation values in the plurality of sets of rate
transformation values is for a different set of contiguous time
points between the first time point and the second time point;
(C) computing, for each respective set of rate
transformation values in the plurality of sets of rate
transformation values, an average relative transformation value
as a measure of central tendency of each of the rate
transformation values in the respective set of rate
transformation values, thereby computing a plurality of average
relative transformation values;
(D) obtaining (i) a first result based on a determination of
whether any average relative transformation value in the
plurality of average relative transformation values exceeds a
first threshold value or (ii) a second result based on a
determination of whether an extent of growth exhibited by the
culture exceeds a second threshold value;
(E) using the first result or the second result to determine
whether the culture in the vessel contains the plurality of
microorganisms; and
(F) outputting the first result, the second result, or a
determination of whether the culture in the vessel contains the
plurality of microorganisms to a user interface device, a
monitor, a computer-readable storage medium, a computer-
readable memory, or a local or remote computer system; or
displaying the first result, the second result, or the
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determination of whether the culture in the vessel contains the
plurality of microorganisms.
The Re} ection
The Examiner rejected claims 1, 3-25, 27-31, 33, 38, 40-43, 46-49,
and 53-55 under 35 U.S.C. § 101 as directed to non-statutory subject matter
(Final Act. 2--4).
The Examiner finds that the claims on appeal are directed to patent-
ineligible subject matter. Specifically, the Examiner finds that the claims are
directed to a "mathematical process of calculating a normalization relative
value for a plurality of measurements" and that "[ s ]uch a mathematical
process is an abstract idea" (Final Act. 2-3). The Examiner finds that the
"claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception" (id. 3).
The Examiner cites Pitner3 to establish that steps including "providing
a vessel with a culture and sensor, obtaining a signal from the sensor,
incubating the culture in the vessel, and obtaining signals from the sensor
as a measure of the biological state of the culture" "are well-known,
conventional and routine data-gathering steps" (id.).
The Examiner reached these conclusions by applying the test set out
in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S.
66 (2012) (Ans. 2--4) based on the two-step Alice framework. Alice Corp.
Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct. 2347, 2355 (2014).
Appellant contends that the claims are not directed to an abstract idea,
that Federal Circuit caselaw does not support the Examiner's position, that
the claims do not preempt all uses of the abstract idea, and that the claims
3 Pitner et al., US 2002/0155424 Al, published Oct. 24, 2002.
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include additional elements or something more that transforms the nature of
the claims into a patent-eligible application (App. Br. 8-22).
Analysis
To determine whether a claim is invalid under§ 101, we employ the
two-step Alice framework. In Alice step one, we ask whether the claims are
directed to a patent ineligible concept, such as an abstract idea or law of
nature. Alice, 134 S.Ct. at 2355; Mayo, 566 U.S. at 75-77; Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015).
While method claims are generally eligible subject matter, method claims
that are directed only to abstract ideas and/or natural phenomena are directed
to patent ineligible concepts. Ariosa, 788 F.3d at 1376. In Alice step two,
we examine the elements of the claims to determine whether they contain an
inventive concept sufficient to transform the claimed naturally occurring
phenomena into a patent-eligible application. Mayo, 566 U.S. at 71-72
( quoting Alice, 134 S.Ct. at 2355).
Alice Step One
Claim 1 is directed to an abstract idea. In particular, the recited steps
of "(A) calculating a normalization relative value for each respective
measurement"; "(B) determining ... a first derivative of the normalization
relative values . . . thereby forming a plurality of rate transformation
values"; "(C) computing, for each respective set of rate transformation
values ... an average relative transformation value"; and "(D) obtaining (i) a
first result based on a determination of whether any average relative
transformation value ... exceeds a first threshold value" all involve
categorizing and/or analyzing information.
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Information as such is an intangible .... Accordingly, we have
treated collecting information, including when limited to
particular content ( which does not change its character as
information), as within the realm of abstract ideas .... In a
similar vein, we have treated analyzing information by steps
people go through in their minds, or by mathematical
algorithms, without more, as essentially mental processes
within the abstract-idea category
Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed.
Cir. 2016) (internal citations omitted)) Additionally, the Federal Circuit in
Electric Power Group stated that the "advance they purport to make is a
process of gathering and analyzing information of a specified content, then
displaying the results, and not any particular assertedly inventive technology
for performing those functions" (id. at 1354).
Here, Appellant acknowledges the advancement is the process of
analyzing information; specifically, Appellant acknowledges "the present
invention describes a data transformation that can be applied to metabolic or
cell growth data in a way that provides confidence that a culture in a vessel
is infected" (Spec. 2:20-22). Also, the Specification teaches "[a]lgorithms
are then applied to the sequence of signal data that are designed to recognize
signal changes with time that are indicative of the presence of growing
microorganisms" (Spec. 11: 5-7).
In Digitech, the Federal Circuit stated that"[ w ]ithout additional
limitations, a process that employs mathematical algorithms to manipulate
existing information to generate additional information is not patent eligible.
'If a claim is directed essentially to a method of calculating, using a
mathematical formula, even if the solution is for a specific purpose, the
claimed method is nonstatutory'" Digitech Image Technologies, LLC v.
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Application 12/918,019
Electronics for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Here,
the process employs mathematical algorithms to manipulate existing
metabolic or cell growth data to generate additional information regarding
the presence of a microorganism and therefore is not patent eligible.
Moreover, the "calculating", "determining", "computing" and
"obtaining" steps are the type of work that can be performed mentally and
therefore are abstract ideas. As the Federal Circuit explained, "methods
which can be performed mentally, or which are the equivalent of human
mental work, are unpatentable abstract ideas-the 'basic tools of scientific
and technological work' that are open to all"' CyberSource Corp. v. Retail
Decisions, Inc., 654 F.3d 1366, 1371, (Fed. Cir. 2011) (citing Gottschalkv.
Benson, 409 U.S. 63 (1972)).
This case is distinguishable, for example, from cases like Diamond v.
Diehr, 450 U.S. 175 (1981), because in Diehr, an algorithm was used to
control the change in state of rubber in a curing process. In re Diehr, 602
F .2d 982, 983-84 (CCP A 1979). The algorithm calculated the Arrhenius
equation for the reaction time during the cure to determine when the
compound was cured and to automatically open the press when the cured
state was achieved. Id. In the rejected claims, the recited algorithm is not
used for a physical step that completes a product when a change of state is
complete as it was in Diehr. Rather, in the rejected claims, the algorithm is
utilized to analyze data obtained by measuring signals in culture vessels, but
no final physical step analogous to opening the press after curing is present.
Instead, the final "using" and "outputting" clause in the instant claims "tell
the relevant audience about the laws while trusting them to use those laws
appropriately where they are relevant to their decisionmaking." Mayo, 566
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U.S. at 78. Thus, the algorithm does not tell when the change of state is
complete and to perform a manipulative step based on it as in Diehr.
Because the claims are directed to an abstract idea, we tum to the
second step of the Alice framework.
Alice Step Two
In Alice step two, we examine the elements of the claims to determine
whether they contain an inventive concept sufficient to transform the
claimed abstract idea into a patent-eligible application. Mayo, 566 U.S. at
71-72 (quoting Alice, 134 S.Ct. at 2355). We must consider the elements of
the claims both individually and as an ordered combination to determine
whether the additional elements transform the nature of the claims into a
patent-eligible concept. Ariosa, 788 F.3d at 1375.
The Specification acknowledges that "several different culture
systems and approaches are available to laboratories. For example, the
BACTEC® radiometric and nonradiometric systems (Becton Dickenson
Diagnostic Instrument Systems, Sparks, Maryland) are often used for this
task" (Spec. 1 :31 to 2: 1 ). The Specification also acknowledges that
measurements of the samples are performed using known, prior art,
techniques such as colorimetric assays (see Spec. 19:10-16), fluorometric
assays (see Spec. 24--28), and infrared assays (see Spec. 20:5-9).
Thus, the Specification acknowledges that measuring bacterial culture
samples using a variety of analytical approaches is routine and conventional
and that "[c]urrently, the presence of biologically active agents ... is
determined using culture vials" that are "incubated and monitored for
microorganism growth" (Spec. 1: 12-16).
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The Examiner further cites Pitner as a prior art reference to evidence
that the structural elements aside from the mathematical steps in claim 1 "are
well-known, conventional and routine data-gathering steps" (Ans. 3).
Specifically, Pitner teaches "a quick, easy, and unambiguous method for the
measurement and/or detection of respiring aerobic microorganisms ... by
measurement or visual observation of luminescence" (Pitner ,r 51 ). Pitner
teaches step of (i) providing a vessel with a culture where "TSB broth ...
containing about 0.05 CPU/ml E. coli . .. was added to one of the flasks."
(Pitner ,r 105). Pitner then teaches the step of (ii) obtaining a signal from a
sensor where "fiber optic probe allowed the fluorescence from the flasks to
be measured" (Pitner ,r 105). Pitner next teaches the step of (iii) incubating
the culture where "the flasks were incubated at 37° C." (Pitner ,r 105).
Pitner teaches a next step of (iv) obtaining signals from the sensor where a
"strip chart was attached to the fluorometer and the fluorescence monitored
continuously for 16 hours" (Pitner ,r 105).
In addition, Pitner teaches comparing an initial reading with a later
reading, and performing an algorithmic normalization, specifically teaching
"[ n ]ormalized fluorescence data was generally obtained by dividing well
values at selected time points by the same well' s initial reading with only
media or buffer present prior to adding cells" (Pitner ,r 121). Pitner provides
an output showing fluorescent data regarding the growth of E. coli in Figure
6.
In sum, the evidence of record supports the Examiner's position that
the claims do not add something "significantly more" to the abstract idea.
Instead, the evidence shows that the additional elements in the claims are
conventional, routine, and well-known. We conclude that the method claim
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does not result in an inventive concept that transforms the abstract idea
described above into a patentable invention.
We address Appellant's arguments below.
Appellant contends that the "Examiner's conclusory application of the
first step of the Mayo/Alice framework is directly at odds with the Federal
Circuit's recent holdings in Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327
(Fed. Cir. 2016) andMcRo, Inc. v. Bandai Namco Games Am., [837 F.3d
1299 (Fed. Cir. 2016)]" (App. Br. 8). Appellant contends that, consistent
with the facts in Enfzsh and McRo, the "claims are directed to a specific
implementation of a solution to a problem in the field of culture testing (i.e.,
rapid, and reliable determination of the presence or absence of
microorganisms in a culture)" (App. Br. 10; cf Reply Br. 2). Appellant
therefore "respectfully submits that claims 1, 3-25, 27-31, 33, 38, 40-43,
46-49, and 53-55 are not even directed to an abstract idea" (App. Br. 10).
We find these arguments unpersuasive because the "calculating",
"determining", "computing" and "obtaining" steps are directed to an abstract
mathematical approach to data analysis that is applied to the particular
known test format of analytical biosensor systems, not to any improvement
in the analytical biosensor itself. "'If a claim is directed essentially to a
method of calculating, using a mathematical formula, even if the solution is
for a specific purpose, the claimed method is nonstatutory. "' Digitech
Image Technologies, LLC v. Electronics for Imaging, Inc., 758 F.3d 1344,
1351 (Fed. Cir. 2014).
Similar to the claims in Electric Power Group, these steps are directed
to data analysis and mathematical calculations, because they transform the
data to another form without applying the resulting data further to the
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method to alter anything other than data. That is, the analysis of biosensor
signals does not change anything about how the biosensor itself operates,
nor is anything physical in the biosensor altered by the claimed method.
Rather the instant claims focus on particular mathematical operations for
analysis of the biosensor data, whether "calculating a normalization relative
value" or determining "a first derivative of the normalization relative value"
as in Claim 1. In either case, the focus "is on selecting certain information,
analyzing it using mathematical techniques, and reporting or displaying the
results of the analysis. That is all abstract." SAP America, Inc. v. Investpic,
LLC, 898 F.3d 1161, 1167 (Fed. Cir. 2018).
We recognize, but find unpersuasive, Appellant's reliance on the Federal
Circuit decisions in Enfish and McRO. Enfish explains that "the first step in the
Alice inquiry in this case asks whether the focus of the claims is on the specific
asserted improvement in computer capabilities ... or, instead, on a process that
qualifies as an 'abstract idea' for which computers are invoked merely as a
tool." Enfish, 822 F.3d at 1335---6. Applied to claim 1, there can be no
reasonable doubt that the method does not teach any improvement in computer
capabilities, or indeed, any technical improvement in a biosensor apparatus, but
rather "describes a data transformation that can be applied to metabolic or cell
growth data" (Spec. 2:20-21).
The claims in McRO were drawn to automation of the operation of a
computer at a task of lip reading, where the method "uses a combined order
of specific rules that renders information into a specific format that is then
used and applied to create desired results: a sequence of synchronized,
animated character." See McRO, 837 F.3d at 1315. Again, Appellant has
not demonstrated an improvement in the operation of the computer itself,
nor does Appellant create any structure such as an animated character, but
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rather Appellant simply relies on signal analysis using a particular algorithm
to determine whether a culture contains a plurality of microorganism. The
algorithm is an abstract idea that involves data transformation. Thus,
claim 1 at best suggests an improvement where "inventive data
transformation can be applied to metabolic or cell growth data in a way that
provides confidence in the positive status of a vessel and essentially
eliminates the potential for false negative determinations" (Spec. 31 :30-32).
"[T]he focus of the claims is not a physical-realm improvement but an
improvement in wholly abstract ideas-the selection and mathematical
analysis of information, followed by reporting or display of the results."
SAP, 898 F.3d at 1168.
Appellant cites Example 2 from the 2014 Interim Guidance on Patent
Subject Matter Eligibility and Example 26 from the July 2015 Update on
Subject Matter Eligibility, contending that "[i]n both examples, the novel
aspect of the invention was the use of a mathematical principle to improve a
specific type of technology" (App. Br. 11-12; cf Reply Br. 6). Appellant
contends "claim 1 explicitly provides the types of feedback that laboratory
staff in a clinical laboratory can receive" (App. Br. 13).
We find this argument unpersuasive because in both the robotic
arm Example 2 and the internal combustion engine Example 26, the
mathematical principle impacts the device itself, as in Diehr, and does more
than analyze and output data. In the claim in Example 2, the device "uses
the movement information from the sensor to adjust the velocity of the end
effector in order to achieve a smooth motion along the predetermined motion
path" (App. Br. 10, citing Example 2 from the 2014 Interim Guidance on
Patent Subject Matter Eligibility). Similarly, in the claim in Example 26, the
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device functions to "calculate a position of the exhaust gas recirculation
valve based upon the rate of change of the engine throttle position and
change the position of the exhaust gas recirculation valve to the calculated
position" (App. Br. 11, citing Example 26 from the July 2015 Update on
Subject Matter Eligibility).
In both of these situations, the calculations directly impact the
physical operation of the device. Just as the mathematical method in Diehr
improved the rubber press itself, so too, the calculations in these examples
improve the physical operation of the robotic arm or combustion engine
devices themselves. That is unlike the current claim 1, where the
calculations result in "outputting the first result" or "displaying the first
result." There is no step in the current claim 1 where the calculation impacts
the incubation process for the microorganism or the way the sensors obtain
signals. "Here, the focus of the claims is not any improved computer or
[device], but the improved mathematical analysis; and indeed, the
specification makes clear that off-the-shelf ... technology is usable to carry
out the analysis." SAP, 898 F.3d at 1168.
Appellant contends the "invention as claimed provides functional and
palpable applications in the field of culture testing" (App. Br. 17). Appellant
further contends
the present claims utilize generic mathematical concepts ( e.g.,
normalization relative values, rate transformation values, and
average relative transformation values) in a very specific and
novel way to determine whether a culture in a vessel contains a
plurality of microorganisms. Thus, Applicant's claims utilize
generic mathematical concepts (i.e., field #1) to provide an
improvement in the field of culture testing (i.e., field #2).
(App. Br. 17; cf Reply Br. 5).
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We do not dispute that the use of mathematical operations,
acknowledged by Appellant as "generic" in this case, may be "a positive and
valuable contribution to science. But even such valuable contributions can
fall short of statutory patentable subject matter, as it does here." Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1380 (Fed. Cir. 2015).
We note that even the limitation to a particular field such as culture testing
information does not rescue the claim from being abstract because
"limitation of the claims to a particular field of information ... does not
move the claims out of the realm of abstract ideas." SAP, 898 F .3d at 1169.
Appellant contends the "claims describe in significant detail how
various mathematical concepts ( e.g., normalization relative values, rate
transformation values, and average relative transformation values) can be
used in combination with a vessel with a culture and a sensor to determine
whether the culture contains a plurality of microorganisms" (App. Br. 18).
Appellant further contends that "[b ]y focusing on the individual structural
elements of Applicant's claims and ignoring how the structural elements
work together, Examiner has failed to appreciate that the claims as a whole
do amount to significantly more than the judicial exception" (App. Br. 20;
cf Reply Br. 7-8).
We find these arguments unpersuasive because the asserted
"unconventional steps" are solely drawn to mathematical computations that
Appellant earlier in the Appeal Brief state "utilize generic mathematical
concepts" (App. Br. 17). As discussed in our analysis above, particularly citing
Pitner and the Specification, the evidence demonstrates that each of the
manipulative steps of the method were known and used in the prior art, and
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Appellant provides no evidence or persuasive argument that any of these
manipulative steps were unconventional and not used by others.
To the extent that Appellant contends that the claimed invention is
patentable based on an ordered combination of limitations, this type of ordered
combination has been found to be patent ineligible by SAP, where comparisons
of received data according to rules and the generation of outputted data was
held to be abstract. Smartgene similarly involves claims to an ordered
combination that involves performing data analysis and outputting a result that
was held abstract. SmartGene, Inc. v. Advanced Biological Labs., SA, 555 Fed.
Appx. 950, 952 (Fed.Cir. 2014). Appellant provides no persuasive evidence or
reasoning explaining why the combination of "generic mathematical concepts"
(App. Br. 17) with widely known biosensors as disclosed in the Specification
and Pitner represents something significantly more than the judicial exception.
Appellant contends that the instant claims are similar to those in SiRF
Technology, Inc. v. ITC, 601 F.3d 1319 (Fed Cir. 2010), where our reviewing
court found the claims to present patentable subject matter (See Appeal Br. 21-
23). Appellant specifically contends that "like the GPS receiver discussed in
SiRF, Applicant's claims require the use of particular components" and
"[t]herefore, the claimed sensor, like the GPS receiver in SiRF, places a
meaningful limit on the scope of Applicant's claims" (App. Br. 22).
We find Appellant's reliance on SiRF unpersuasive because SiRF was
decided before Mayo and Alice and thus did not have the guidance provided
by those cases. It is therefore not clear that SiRF was decided under the
proper test. See SiRF, 601 F.3d at 1332. Nonetheless, in SiRF, the GPS
receiver was considered to place a meaningful limitation on the claim
because "without a GPS receiver it would be impossible to generate
pseudoranges or to determine the position of the GPS receiver whose
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position is the precise goal of the claims." Id. The algorithm in SiRF was
used to determine the position of the GPS receiver. The claims in this case
are distinguishable because the algorithm, while receiving data from a
device, namely the sensor measuring the culture, has no application to the
operation of either the sensor or the culture vessel. Rather, the algorithm is
used to deduce information about microorganism growth and simply outputs
the data, whether as a printout or screen display.
We therefore conclude that all of the claims on appeal are directed to
patent-ineligible subject matter.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 101
as being directed to non-statutory subject matter. Pursuant to 37 C.F.R.
§ 4I.37(c)(l), we also affirm the rejection of claims 3-25, 27-31, 33, 38,
40-43, 46-49, and 53-55 as being directed to non-statutory subject matter as
these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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