Ex Parte Beaty

Patent Trial and Appeal Board

Mar 23, 2018

12918011 (P.T.A.B. Mar. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/918,0ll 05/11/2011 Patrick Shawn Beaty
147462 7590 03/27/2018
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 3.3-164 5249
EXAMINER
LIN, JERRY
New Providence, NJ 07974 ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/27/2018 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
Appeal2017-005815
Application 12/918,011
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for identifying microorganisms 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 a
culture, such as a blood culture, is among the most important
functions of the clinical microbiology laboratory. Currently, the
1 Appellant identifies the Real Party in Interest as Becton, Dickinson and
Company. Appeal Br. 1.
Appeal2017-005815
Application 12/918,001
presence of biologically active agents such as bacteria in a
patient's body fluid, and especially in blood, is determined
using culture vials. A small quantity of the patient's body fluid
is injected through an enclosing rubber septum into a sterile vial
containing a culture medium and the vial is then incubated and
monitored for microorganism growth.
Spec. 1. Culture system such as the BACTEC® systems are used to
grow and detect microorganisms using a fluorescent C02 sensor. Spec. 1-2.
The systems are programmed to detect growth using various computer
algorithms. Spec. 2. "A drawback with these microorganism detection
approaches is that they do not always detect microorganism type in such
cultures." Id.
The Specification describes systems, methods, and apparatus for
presumptive organism identification. Id.
Claims 1, 3-53, 55, and 56 are on appeal. Claim 1 is representative
and reads as follows:
1. A method of identifying a microorganism type in a culture in
a vessel, 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
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Application 12/918,001
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;
(D) determining a maximum metabolic rate and an extent of
growth from the plurality of normalization relative values and the
plurality of average relative transformation values;
(E) determining the microorganism type in the culture in the
vessel from the maximum metabolic rate and the extent of growth;
and
(F) outputting an identification of the microorganism type in the
culture in the vessel 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 an identification of the
microorganism type in the culture.
The claims have been rejected under 35 U.S.C. § 101 as being
directed to patent ineligible subject matter.
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Application 12/918,001
Issue
DISCUSSION
The issue with respect to this rejection is whether the Examiner
properly concluded that the claims are directed to subject which is not
eligible for patent protection.
The Examiner finds that the claims are directed to determining the
microorganism type using a mathematical process involving:
calculating a normalization relative value for a plurality of
measurements, determining a first derivative of the
normalization values to create a plurality of rate transformation
values, computing an average relative transformation value, and
determining a maximum metabolic rate and extent of growth,
and determining the microorganism type in the culture form the
maximum metabolic rate and extent of growth.
Final Act. 2-3. The Examiner finds that the mathematical process is an
abstract idea and is directed to a judicial exception. Id.
The Examiner also finds that the claims do not include additional
elements that amount to significantly more than the judicial exception. Id.
The Examiner finds that the additional elements of "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.
Appellant contends that a proper application of the Alice/Mayo test
demonstrates that the claims are directed to patentable subject matter.
Appeal Br. 8. With respect to the first step of the Alice/Mayo test, Appellant
contends that the claims are not directed to an abstract idea but are directed
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Application 12/918,001
to "a specific implementation of a solution to a problem in the field of
culture testing (i.e., automatically determining the type of microorganism in
a culture)." Appeal Br. 11. Appellant also contends that the claims do not
tie up "the use of normalization relative values, rate transformation values,
or average relative transformation values." Id.
With respect to the second part of the Alice/Mayo test, Appellant
contends that the claims recite elements that amount to significantly more
that the judicial exception. Appeal Br. 16. Appellant contends that the
invention offers an improvement to technical field of microorganism
identification. Appeal Br. 17-18. Appellant also argues that the additional
elements include unconventional steps that confine the claims to the
identification of microorganisms. Appeal Br. 18-20. Appellant argues that
the claims do not append well-understood routine and conventional activities
known in the industry. Appeal Br. 20-22. Finally, Appellant argues 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. Appeal Br. 22-23.
Analysis
Under § 101, "any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof' may be
eligible for a patent, subject to the conditions and requirements of the Patent
Act. 35 U.S.C. § 101. But, under Supreme Court precedent, "'[L]aws of
nature, natural phenomena, and abstract ideas' are not patentable." Mayo
Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293
(2012) (citation omitted). "Groundbreaking, innovative, or even brilliant
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Application 12/918,001
discovery does not by itself satisfy the § 101 inquiry." Ass 'n for Molecular
Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013).
The Supreme Court articulated a two-step test for patent eligibility
under § 101 that "distinguish[ es] patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-eligible
applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int 7,
134 S. Ct. 2347, 2355 (2014) (citing Mayo, 132 S. Ct. at 1296-97) ("the
Alice/Mayo test"). "First, we determine whether the claims at issue are
directed to one of those patent-ineligible concepts. If so, we then ask, what
else is there in the claims before us?" Id. (citation and quotations omitted).
Second, we "search for an inventive concept-i.e., an element or
combination of elements that is sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon the ineligible concept
itself." Id. (quotations and alterations omitted).
We agree with the Examiner that claim 1 is directed to ineligible
subject matter. The present claims are directed to mathematical
manipulation of data to determine if a naturally occurring feature of a
microorganism is present. As such the claims are directed to an abstract idea
and a natural phenomenon and are not eligible for patent protection.
Appellant contends that the claims are not directed to an abstract idea
in that the claims are directed to a specific implementation of a solution to a
problem in the field of microbiology. Appeal Br. 10-11. Appellant cites to
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) in
support of his position.
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Appellant's argument is unpersuasive. In Enfish, the claims were
focused on an improvement to computer functionality itself. Enfzsh, 822
F.3d at 1336. Specifically the invention was directed to a novel computer
database which improved the way computers operate. Id. In contrast, the
present claims merely take data and apply well known mathematical
operations to determine if a natural characteristic is present. See, Digitech
Image Techs. v. Electronics for Imaging, Inc., 758 F.3d 1344, 1351 (Fed.
Cir. 2014). ("Without additional limitations, a process that employs
mathematical algorithms to manipulate existing information to generate
additional information is not patent eligible.")
Similarly, Appellant's reliance on McRO is also unpersuasive. In
McRO, the invention was directed to application of a specific set of rules to
improve lip-sync animation. McRO, 837 F.3d at 1314. Here the invention
uses known, general mathematic operations to manipulate data which is
obtained by conventional means.
Appellant next argues that the present claims do not tie up a judicial
exception. This argument is also unpersuasive. Our reviewing court has
expressly rejected similar contentions regarding preemption, stating that a
patentee's "attempt to limit the breadth of the claims by showing alternative
uses ... outside of the scope of the claims does not change the conclusion
that the claims are directed to patent ineligible subject matter." Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015).
The court explained that, "[ w ]hile preemption may signal patent ineligible
subject matter, the absence of complete preemption does not demonstrate
patent eligibility .... Where a patent's claims are deemed only to disclose
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patent ineligible subject matter under the Mayo framework ... preemption
concerns are fully addressed and made moot." Id.
We, therefore, agree with the Examiner that, as to part one of the
Supreme Court's test, Appellant's claims are expressly directed an abstract
idea.
As to part two of the test, the remaining elements are directed to
equipment and steps that are well known in the art. This is best
demonstrated by Appellant's own statement that by "using the novel
systems, methods, and apparatus of the present invention, an incubating
system, such as the BACTEC® blood culture system, can be programmed
to determine the microorganism type in a culture before manual tests, such
as a Gram stain or a subculture, are performed." Spec. 2 (emphasis added).
Thus the present invention involves programming for known blood culture
systems. The presence of a generic blood culture system, including all of its
elements, is not unlike using a generis computer to implement software and
does not constitute something significantly more than the judicial exception.
See, Alice, 134 S.Ct. at 2357.
Appellant contends that the claims recite an improvement to a
technical filed, specifically determination of a microorganism type. Appeal
Br. 17-18, Reply Br. 7-8. We are unpersauded. As the Examiner points
out, there is no evidence of record that shown that the claimed method offers
an improvement over the prior art. Ans. 4.
In support of his argument, Appellant argues that the present method
"may 'obviate any need to perform a Gram test or subculture in order to
identify the microorganism type that is infecting the culture."' Appeal Br.
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Application 12/918,001
18, Reply Br. 7. We find this unpersuasive. As stated in the background of
the invention, "A drawback with [prior art] microorganism detection
approaches is that they do not always detect microorganism type in such
cultures." Spec. 2. This does not appear to be any different from the
claimed system which may avoid the need for further procedures.
Moreover, all inventions can be said to be an improvement over what
was known before. However, not every improvement constitutes patentable
subject matter. See~ Intellectual Ventures I LLC v. Capital One Bank (USA),
792 F.3d 1363, 1367 (Fed. Cir. 2015) (claims to improved speed of
efficiency did not render claims patentable).
Appellant next argues that the invention includes unconventional steps
that confine the claim to a particular useful application. Appeal Br. 19.
Appellant point to the fact that the claims are directed to more than just
mathematical concepts but are tied to "a vessel with a culture disposed
therein to automatically determine the type of microorganism in the culture."
Id.
We find this argument unpersuasive. As noted above, lack of
preemption alone does not support a finding that the claims are directed to
patent eligible subject matter. In addition, the use of a vessel to grow the
microorganism as well as acquiring data as the microorganism grows, are
conventional steps. Only the application of various mathematical concepts
to that data is different.
Appellant argues that the "invention does not simply append well-
understood, routine and conventional activities known to the industry,
specified at a high level of generality to a judicial exception." (emphasis
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Application 12/918,001
and title caps omitted) Appeal Br. 20. We remain unpersuaded. The instant
invention is one that can be accomplished by programming the recited
mathematical concepts or steps into an existing blood culture machine.
Spec. 2, Appeal Br. 18, Reply Br. 6. Thus the invention appears to be
nothing more than using an existing blood culture machine to obtain data
about the culture and then using various mathematical concepts to
manipulate the data. This is an application of a judicial exception to a well-
known and conventional activity.
Finally, Appellant argues that the present claims are similar to those in
SiRF where our reviewing court found the claims to be patentable. Appeal
Br. 22. Appellant contends that like the system in SiRF, the claimed method
requires the use of specific components, namely a sensor that gathers
information about the conditions in the culture vessel over time or a culture
vessel. Appeal Br. 22-23.
We have considered Appellant's argument and are unpersuaded. As
our reviewing court noted in SiRF, "[i]n order for the addition of a machine
to impose a meaningful limit of the scope of a claim, it must play a
significant part in permitting the claimed method to be performed, rather
than function solely as an obvious mechanism for permitting a solution to be
achieved more quickly." SiRF, 601 F.3d at 1333. In SiRF, a GPS receiver
was found to be essential to performing the claimed method. Id at 1332. In
the present case, as the Examiner has found, the claimed sensor and culture
vessel are not essential to the performance of the claimed mathematical
calculations. Ans. 7.
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We, therefore, agree with the Examiner that, under the Supreme
Court's two-part test, claim 1 recites subject matter ineligible for patenting
under§ 101.
SUMMARY
We affirm the rejection of claims 1, 3-53, 55, and 56 under 35 U.S.C.
§ 101.
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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