Ex Parte Beaty

Patent Trial and Appeal Board

Sep 10, 2018

12867980 (P.T.A.B. Sep. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/867,980 10/19/2010 Patrick Shawn Beaty
147462 7590 09/12/2018
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 3.3-177 5036
EXAMINER
LIN,JERRY
New Providence, NJ 07974 ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
09/12/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PA TRICK SHAWN BEATY1
Appeal2017-005963
Application 12/867,980
Technology Center 1600
Before ERIC B. GRIMES, RY AN H. FLAX, and DAVID COTT A,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
and apparatus for determining the amount of blood in a blood culture, which
have been rejected as being directed to patent-ineligible subject matter. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
"Rapid and reliable detection of microorganisms in the blood is
among the most important functions of the clinical microbiology laboratory.
1 Appellant identifies the Real Party in Interest as Becton, Dickinson and
Company. Appeal Br. 1.
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Application 12/867,980
Several different blood culture systems and approaches are available to
laboratories." Spec. 1:11-13.
Optimal performance of a blood culture system ... is
dependent on collecting the correct amount of blood per
sample. Culture of a sample below the optimal level can affect
organism recovery based on a decreased probability of
obtaining viable organisms from the limited blood volume.
Culture of a sample above the optimum level can reduce the
recovery of viable organisms by failing to properly dilute or
remove inhibitors in the sample or by creating an unfavorable
competitive situation with blood competing with any microbes
present in the specimen for nutrients such as oxygen or sugar.
Id. at 1 :23-30.
The Specification discloses
[ d]ata transformation methods ... that provide an estimate of
the rate of metabolism and the change in rate of metabolism
with time that allows an estimate of the initial rates of
metabolic activity in the blood culture vessel that can be
standardized to the amount of blood present and allow an
estimate of the amount of blood in the blood culture.
Id. at 2:12-16.
Claims 1-32, 35, 36, and 38---64 are on appeal. Claim 1 is illustrative
and reads as follows:
1. A method of determining an amount of blood in a blood
culture in a vessel, the method comprising:
1) obtaining a blood sample;
2) combining the blood sample in a vessel with a blood culture
media;
3) monitoring changes in the biological state of the sample over
time using a sensor, wherein the biological state is one of CO2
concentration, 02 concentration, pH, a rate of change in CO2
concentration, a rate of change in 02 concentration, or a rate of
change in pH;
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Application 12/867,980
wherein the amount of blood in the sample is determined by:
(A) calculating a normalization relative value for each
respective measurement in a plurality of measurements of the
biological state of the blood culture in the vessel, each
measurement in the plurality of measurements taken at a
different time point between a first time point and a second time
point, between (i) the respective measurement and (ii) an initial
biological state of the blood culture measured at an initial time
point, thereby forming a plurality of normalization relative
values for 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; and
(D) determining the amount of blood in the blood culture in the
vessel based on a measure of central tendency of the plurality of
average relative transformation values.
Claims 3 1 and 3 5 are also independent. Claim 31 is directed to a
blood amount determination apparatus comprising a sensor and memory
having instructions for carrying out the steps recited in claim 1. Claim 35 is
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directed to a method like that of claim 1, but also requires "outputting the
amount of blood ... or displaying the amount of blood" in the culture.
DISCUSSION
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 101 as being directed to patent-ineligible subject matter. Ans. 2. The
Examiner finds that the claims are directed to an abstract idea-specifically,
mathematical processes-and that the physical steps of the claimed process
"are well-known, conventional and routine data-gathering steps." Id. at 2-3
( citing Bemdt2).
We agree with the Examiner that claim 1 is directed to a patent-
ineligible method. The Supreme Court has
set forth a framework for distinguishing patents that claim laws
of nature, natural phenomena, and abstract ideas from those that
claim patent-eligible applications of those concepts. First, we
determine whether the claims at issue are directed to one of
those patent-ineligible concepts. If so, we then ask, "[ w ]hat
else is there in the claims before us?" To answer that question,
we 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.
Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct. 2347, 2355 (2014)
( citations omitted).
Here, claim 1 is directed to the abstract idea of determining the
amount of blood in a culture vessel using a series of calculations that are
2 Berndt et al., WO 2006/023470 Al, March 2, 2006.
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based on changes in CO2 concentration, 02 concentration, or pH. So the
next question is, what else is there in the claims before us?
Berndt states that, in "the field of growth-based detection of
microorganisms in sealable containers, such as blood culture bottles,"
[u]sually, the presence of biologically active agents such
as bacteria or mycobacteria in a patient's body fluid is
determined using culture vials. A small quantity of body fluid
is injected through the enclosing rubber septum into the sterile
vial containing a culture medium. The vial is incubated at 37°C
and monitored for bacterial growth. . . . Changes in the carbon
dioxide [CO2] concentration are usually monitored using
chemical sensors disposed on the inner walls of the culture
bottles.
Berndt 1: 13-20. Thus, Berndt provides evidence that it was routine and
conventional to obtain a blood sample, combine the sample with a blood
culture medium, and monitor changes in the CO2 level in order to determine
bacterial growth in a blood culture.
Claim 1 on appeal recites the same conventional data-gathering steps
but analyzes the data in a new way. However, a method of analyzing data in
a different way is still nothing more than data analysis. "Information as such
is an intangible. Accordingly, ... collecting information, including when
limited to particular content ( which does not change its character as
information), [is] within the realm of abstract ideas." Electric Power Group,
LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (citations
omitted). "In a similar vein, ... analyzing information by steps people go
through in their minds, or by mathematical algorithms, without more, [is]
essentially mental processes within the abstract-idea category." Id. at 1354.
And "merely presenting the results of abstract processes of collecting and
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analyzing information, without more ( such as identifying a particular tool for
presentation), is abstract as an ancillary part of such collection and analysis."
Id.
Electric Power Group is directly applicable here: "The advance [the
claims] 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. They are
therefore directed to an abstract idea." Id.
Appellants argue that the claimed method is patent eligible under the
standard of Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016)
and McRo, Inc. v. Bandai Namco Games Am., Inc., 837 F.3d 1299 (Fed. Cir.
2016). Appeal Br. 6-8.
We do not find Appellants' argument persuasive. The Federal Circuit
has made clear that the claims at issue in both McRo and Enfish were held to
be patent-eligible because they were directed to improvements in computer
functionality. See SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161,
1167 (Fed. Cir. 2018):
The claims in McRO were directed to the creation of something
physical-namely, the display of "lip synchronization and
facial expressions" of animated characters on screens for
viewing by human eyes. [McRo, 837 F.3d] at 1313. The
claimed improvement was to how the physical display operated
( to produce better quality images), unlike ( what is present here)
a claimed improvement in a mathematical technique with no
improved display mechanism.
See also id. at 1168 (The claims in Enfzsh "were patent-eligible because they
were directed to improvements in the way computers and networks carry out
their basic functions. Enfzsh, 822 F.3d at 1335-36.").
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The claims of the instant application, by contrast, are not directed to
"an improvement to computer functionality itself." Enfish, 822 F.3d at
1336. In fact, the method of claim 1 does not even require using a computer:
all of the "calculating," "determining," and "computing" steps can be done
by a person using a pencil and paper or even in the human mind. To the
extent that a computer would be used in the claimed method, it is used only
in its conventional role of carrying out calculations; "the focus of the claims
is not any improved computer or network, but the improved mathematical
analysis." SAP America, 898 F.3d at 1168. McRo and Enfish therefore do
not support the patent-eligibility of claim 1.
Appellants also argue that the "claims do not 'tie up' the use of
normalization relative values, rate transformation values, or average relative
transformation values. Instead, Applicant's claims use these computational
techniques as steps in a way to determine 'an amount of blood (e.g., a
volume of blood) in a blood culture vessel."' Appeal Br. 8-9 ( quoting Spec.
2: 11). Appellants' arguments on this point focus on claim 31, which (as
noted previously) is directed to a blood amount determination apparatus
comprising a sensor and memory having instructions for carrying out the
steps recited in claim 1. Id. at 10-12.
Appellants' argument regarding preemption does not persuade us that
the apparatus of claim 31 or the method of claim 1 are eligible for patenting.
Regarding claim 31, Appellants do not argue that the recited sensor is not
routine and conventional. Rather, Appellants argue that the claimed
"apparatus explicitly includes a few essential structural components and sets
of electronically encoded instructions that utilize sensor data, normalization
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relative values, rate transformation values, and average relative
transformation values in a very specific way to determine the amount of
blood in a vessel." Appeal Br. 11. Appellants thus rely on the same relevant
limitations with respect to claim 31 as are recited in the method of claim 1.
However, "[w]here a patent's claims are deemed only to disclose
patent ineligible subject matter under the Mayo framework, as they are in
this case, preemption concerns are fully addressed and made moot." Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015).
Appellants' argument based on lack of preemption is therefore unpersuasive.
Appellants argue that-in DDR Holdings, LLC v. Hotels.com, L.P.,
773 F.3d 1245 (Fed. Cir. 2014); SiRF Technology, Inc. v. ITC, 601 F.3d
1319 (Fed. Cir. 2010); and Research Corp. Technologies, Inc. v. Microsoft
Corp., 627 F.3d 859 (Fed. Cir. 2010}-the claims "were directed to
improved processes for analyzing data and the Federal Circuit held that all
of these inventions were directed to eligible subject matter under 35 U.S.C.
§ 101." Appeal Br. 12. See also id. at 19-21 (discussing SiRF
Technology). 3
This argument is not persuasive. SiRF Technology and Research
Corp. Technologies were both decided in 2010, before the Supreme Court
prescribed the Mayo/Alice two-step framework for determining patent-
3 In the Reply Brief, Appellants present an argument based on Trading
Techs. Int'!, Inc. v. CQG, Inc., 675 F. App'x 1001 (Fed. Cir. 2017). Reply
Br. 5-6. The cited case, however, is nonprecedential and therefore does not
control over precedential cases of the Federal Circuit.
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eligibility. SiRF Technology and Research Corp. Technologies therefore did
not apply the currently controlling standard for patent-eligibility.
The DDR Holdings court applied the Mayo/Alice test for patent
eligibility. See DDR Holdings, 773 F.3d at 1255. We conclude, however,
that the outcome of DDR Holdings does not control here because the facts of
the instant appeal distinguish it from that case.
In DDR Holdings, the claims were
directed to systems and methods of generating a composite web
page that combines certain visual elements of a "host" website
with content of a third-party merchant. For example, the
generated composite web page may combine the logo,
background color, and fonts of the host website with product
information from the merchant.
773 F.3d at 1248. The point of the claimed invention was to allow a host
website to "display a third-party merchant's products, but retain its visitor
traffic," id. at 1249, rather than having visitors taken away from the host
website when they clicked on the merchant's advertisement on the host site,
id. at 1248.
The DDR Holdings court noted that the claims at issue were similar to
some earlier cases "in the sense that the claims involve both a computer and
the Internet." Id. at 1257. The court held, however, that
these claims stand apart because they do not merely recite the
performance of some business practice known from the pre-
Internet world along with the requirement to perform it on the
Internet. Instead, the claimed solution is necessarily rooted in
computer technology in order to overcome a problem
specifically arising in the realm of computer networks.
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Id. The court concluded that "the claimed solution amounts to an inventive
concept for resolving [a] particular Internet-centric problem, rendering the
claims patent-eligible." Id. at 1259.
Importantly with respect to the instant appeal, the DDR Holdings
court noted that, "after Alice, there can remain no doubt: recitation of
generic computer limitations does not make an otherwise ineligible claim
patent-eligible" and that "[ w ]e know that mathematical algorithms, including
those executed on a generic computer, are abstract ideas." Id. at 1256.
DDR Holdings does not support the patent-eligibility of the instant
claims because, as discussed above, claim 1 does not even require the use of
a computer and, to the extent that a computer would be used, it would do
nothing more than carry out calculations in the conventional manner of using
computers. See id. ("[I]n Bancorp Servs., L.L. C. v. Sun Life Assur. Co. of
Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012), the claims recited no
more than the use of a computer 'employed only for its most basic function,
the performance of repetitive calculations,' to implement [an] abstract idea.
Such claims are not patent-eligible.").
Appellants argue that the claimed invention amounts to significantly
more than a judicial exception because it "(1) offers an improvement to a
technical field and (2) includes unconventional steps that confine the claim
to a particular useful application." Appeal Br. 13-14. With regard to
improvement to a technical field, Appellants argue that patent-eligibility of
the instant claims is supported by Diamond v. Diehr, 450 U.S. 175 (1981), in
which the Court stated
that "when a claim containing a mathematical formula
implements or applies that formula in a structure or process
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which, when considered as a whole, is performing a function
which the patent laws were designed to protect ( e.g.,
transforming or reducing an article to a different state or thing),
then the claim satisfies the requirements of § 101."
Id. at 14 (quoting Diehr, 450 U.S. at 192).
We do not agree that Diehr supports patent-eligibility of the claims on
appeal. In Diehr, "[t]he claimed invention [was] a process for molding raw,
uncured synthetic rubber into cured precision products." Diehr, 450 U.S. at
177. The claimed process "us[ed] well-known time, temperature, and cure
relationships to calculate by means of the Arrhenius equation when to open
the press and remove the cured product." Id. at 177-78. The Court noted
that the "claims involve the transformation of an article, in this case raw,
uncured synthetic rubber, into a different state or thing." Id. at 184.
The method of claim 1, by contrast, does not result in transforming an
article into a different state or thing. Claim 1 recites conventional steps of
gathering data ( obtaining a blood sample, combining it with culture media,
and monitoring changes in, e.g., CO2 concentration), followed by
mathematical steps to transform those data into different data ( the amount of
blood in the culture vessel). Gathering data and transforming it to other data
does not amount to a patent-eligible method. See Electric Power Group,
830 F.3d at 1353, 1354 ("[C]ollecting information, including when limited
to particular content (which does not change its character as information),
[is] within the realm of abstract ideas" and "analyzing information by steps
people go through in their minds, or by mathematical algorithms, without
more, [is] essentially mental processes within the abstract-idea category.").
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Appellants also argue that the claimed method includes
unconventional steps. Appeal Br. 16. Appellants argue that 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 blood culture media and a sensor to determine the amount of blood in
the vessel." Id. at 1 7.
This argument is also unpersuasive. As discussed above, the physical
steps recited in claim 1 were routine and conventional, as evidenced by
Berndt. The only unconventional steps recited in the claimed method are the
mathematical steps used to transform routinely-gathered data into data
indicating the volume of blood in the culture vessel. But a mathematical
algorithm, even an innovative one, is not patent-eligible. See SAP America,
898 F .3d at 1163 ("[T]he advance lies entirely in the realm of abstract ideas,
with no plausibly alleged innovation in the non-abstract application realm.
An advance of that nature is ineligible for patenting."); Ass 'n for Molecular
Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 577 (2013)
("Groundbreaking, innovative, or even brilliant discovery does not by itself
satisfy the§ 101 inquiry."). The Federal Circuit has recognized that "a
claim for a new abstract idea is still an abstract idea." Synopsys, Inc. v.
Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016).
Finally, Appellants argue that "[t]he advantages of [the] invention
become readily apparent when the claims are viewed as a whole" because
the "invention as claimed provides a 'more efficient solution' to the '[r]apid
and reliable detection of microorganisms in the blood,' ... by 'determining
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an amount of blood (e.g., a volume of blood) in a blood culture vessel.'"
Appeal Br. 19. Appellants argue 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." Id.
We are not persuaded. As discussed above, claim 1 recites
conventional data-gathering steps, as evidenced by Berndt, followed by a
mathematical algorithm to transform the gathered data into different data
that indicate the volume of blood in a culture vessel. We therefore agree
with the Examiner that the claimed method is not eligible for patenting
under the controlling standard set out in Alice and Mayo.
We affirm the rejection of claims 1 and 31 under 35 U.S.C. § 101.
Claims 2-30, 32, 35, 36, and 38-64 were not argued separately and therefore
fall with claims 1 and 31. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection on appeal.
TIME PERIOD FOR RESPONSE
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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