Ex Parte Bernini et al

Patent Trial and Appeal Board

Mar 20, 2018

13593575 (P.T.A.B. Mar. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/593,575 08/24/2012
98067 7590 03/22/2018
Harness Dickey & Pierce (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
FIRST NAMED INVENTOR
Nicole Bernini
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.
31016 US2 7038
( 15878A-00079)
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/22/2018 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):
rmills@hdp.com
pair_roche@firsttofile.com
troymailroom@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NICOLE BERNINI, PAUL J. GALLEY, STEP AN LIND EGGER,
JOHN F. PRICE, RETO SIGRIST, ROBINS. WAGNER,
and RICHARD W. WILSON
Appeal2017-006308 1
Application 13/593,5752
Technology Center 1600
Before JEFFREY N. FREDMAN, JAMES A. WORTH, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
WORTH, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
Final Rejection of claims 1-17, which constitute all the claims pending in
this application. We have jurisdiction under 35 U.S.C. §§ 134 and 6(b).
We affirm.
1 Our Decision refers to Appellants' Appeal Brief ("Appeal Br.," filed Aug.
19, 2016) and Reply Brief ("Reply Br.," filed Mar. 29, 2017), and the
Examiner's Final Office Action ("Final Act.," mailed Apr. 5, 2016) and
Answer ("Ans.," mailed Jan. 9, 2017).
2 According to Appellants, the real party in interest is Roche Diabetes Care,
Inc. (Appeal Br. 3).
Appeal2017-006308
Application 13/593,575
Statement of the Case
Background
Appellants' application relates "to an insulin pump and methods for
operating the insulin pump, namely methods for generating insulin delivery
records and methods for determining an amount of insulin to deliver in a
multiwave bolus." Spec. i-f 1. In one embodiment, the insulin pump includes
a controller configured to instruct the insulin delivery mechanism to begin
delivery of the insulin to the patient, monitor the delivery of the insulin to
determine whether the insulin pump is able to deliver the entire amount of
insulin, maintain a timer until the insulin pump recommences the delivery of
the insulin when the insulin pump is unable to deliver the entire amount of
insulin, and compare an amount of time indicated by the timer to a time
threshold when the insulin pump recommences the delivery of the insulin.
Id. i-f 20.
The Claims
Claims 1 and 11 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal:
1. A method for delivering insulin to a patient using an
insulin pump having one or more processors, the insulin pump
being configured to operate in a pause mode, the method
compnsmg:
receiving, at the insulin pump, an amount of insulin to
deliver to a patient from a remote device;
beginning, at the insulin pump, delivery of the insulin to
the patient;
monitoring, at the insulin pump, the delivery of the insulin
to determine whether the insulin pump is able to deliver the entire
amount of insulin;
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Application 13/593,575
maintaining, at the insulin pump, a timer until the insulin
pump recommences the delivery of the insulin when the insulin
pump is unable to deliver the entire amount of insulin,
when the insulin pump recommences the delivery of the
insulin, comparing an amount of time indicated by the timer to a
pause threshold;
when the amount of time indicated by the timer is less than
the pause threshold, generating a first insulin delivery record
indicating that a first amount of insulin was delivered to the
patient, the first amount being the entire amount of insulin, and
storing the first record on a computer readable medium of the
insulin pump; and
when the amount of time indicated by the timer is greater
than the pause threshold, generating a second insulin record
indicating that a second amount of insulin was delivered to the
patient and storing the second record on the computer readable
medium, the second amount being less than the entire amount of
insulin that was to be delivered to the patient.
(Appeal Br., Claims App.)
The Issue
The Examiner rejected claims 1-17 under 35 U.S.C. § 101 as
lacking patentable subject matter.
The Examiner determines that the claims are directed to an abstract
idea of mathematical relationships, i.e., comparing an amount of time to a
threshold. Final Act. 2-3. The Examiner further determines that the method
steps themselves do not purport to improve the functioning of the computer
itself nor do they effect an improvement in any other technology or technical
field. Id. at 4. The Examiner determines that receiving data is an
insignificant extra-solution activity, that calculating is non-statutory subject
matter, and that the computer and/or program/product amount to mere
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instruction to implement an abstract idea. Id. at 4; Ans. 3 (citing Electric
Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016);
FairWarning IP LLC v. Iatric Sys., Inc., 839 F.3d 1089 (Fed Cir. 2016)).
Appellants assert that claim 1 recites delivering insulin to the patient
by an insulin pump, monitoring the delivery of insulin by the insulin pump
and accurately recording the amount of insulin delivered to a patient by the
insulin pump. Appeal Br. 11. Appellants argue that the Examiner
characterized the invention too broadly and that the claimed steps are not
abstract because they involve more than merely comparing an amount of
time to a threshold, and that delivery of insulin is not "insignificant extra-
solution activity." Appeal Br. 11; Reply Br. 3. Appellants argue that the
Examiner inappropriately required Appellants to submit evidence to support
the assertion that the claims provide a technological solution. Appeal Br.
13-14.
To determine whether a claim is invalid under§ 101, we employ the
two-step Alice framework. In step one, we ask whether the claims are
directed to a patent ineligible concept, such as an abstract idea or law of
nature. Alice Corp. Pty. Ltd. v CLS Bank Intl, 134 S. Ct. 2347, 2355 (2014);
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012);
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 a patent ineligible concept. Ariosa, 788 F.3d at 1376.
Alice Step One
We have reviewed the Examiner's determinations, and we agree that
claim 1 is directed to the abstract idea of data processing according to a rule
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based system. The Examiner's determinations are adequately supported by
the intrinsic evidence. Neither the claims nor the Specification provide any
technological improvements to the mechanics of insulin delivery or
monitoring. Rather, as the Examiner found, the claims are directed to
"monitoring" and "receiving" data, running a timer, and "comparing" the
elapsed time to a threshold. See claim 1. We agree with the Examiner that
this type of data processing is abstract, both as a matter of mathematical
relationships (comparing the time to a threshold) and data processing. See
SmartGene, Inc. v. Advanced Biological Laboratories, SA, 555 Fed. Appx.
950, 955 (Fed. Cir. 2014) (claim directed to "the mental steps of comparing
new and stored information and using rules to identify medical options" was
held to be unpatentable subject matter); Electric Power Group, 830 F.3d at
1353-54 (presenting the results of the collection and analysis, without more,
are patent ineligible abstract concepts). Comparing time to a threshold is the
type of rule-based comparison that was held abstract in SmartGene, and the
receiving and processing of data is the type of routine data processing held
abstract in Electric Power Group.
Appellants state that the claims do not recite a basic concept that is
similar to any abstract idea previously identified by the courts and that the
Examiner failed to point to any controlling case law with analogous claims
which were held to be ineligible. Appeal Br. 11-12. However, the
Examiner's Answer provided citations to case law. See Ans. 3.
Appellants assert that by accurately recording the amount of insulin,
the pending claims improves upon the computer-related aspect of an insulin
pump. Id. at 12 (citing Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed.
Cir. 2016); Reply Br. 4 (citing McRO, Inc. v. Bandai Namco Games America
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Inc., 837 F.3d 1299 (Fed. Cir. 2016)). The cited cases dealt respectively
with inventions directed to an improvement in database structure (a self-
referential table) and a specific asserted improvement in computer animation
driven by subjective determinations. Enfish, 822 F.3d at 1335; McRO, 837
F.3d at 1315. However, the Examiner correctly finds that the claims do not
provide an improvement in computer technology. Final Act. 4. Indeed, the
Specification provides only generic and routine computer structures, such as
a touchscreen display (i-f 54); a database (i-f 55); a processing subsystem
(i-f 56); memory such as RAM (id.); a calculator (see i-f 125); and a datastore
(i-f 129). Neither the claims nor the Specification attempt to provide an
improvement in the mechanical handling of insulin. Rather the claims are
directed to associated data processing.
Appellants argue that information recorded by the claimed invention
can be used by a health care provider to determine whether the
recommended amount of insulin was actually delivered, and whether there
was a pause in the delivery, in order to improve patient care. See Reply Br.
3. However, this is an argument that goes to utility rather than abstractness
and does not make the claimed invention less abstract as in Mayo, where
information for optimizing therapeutic efficiency of 6-thioguanine was also
designed to improve patient care, but was found unpatentable. Mayo, 566
U.S. at 71.
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 naturally occurring phenomena into a patent-eligible application.
Mayo, 566 U.S. at 71-72 (quoting Alice, 134 S. Ct. at 2355). We must
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consider the elements of the claims both individually and as an ordered
combination to determine whether additional elements transform the nature
of the claims into a patent-eligible concept. Ariosa, 788 F.3d at 1375.
Appellants argue that, by effecting an improvement in the area of
insulin delivery in the particular way according to the steps recited in the
pending claims, the claims provide a solution to an identified problem and as
such are transformed into patent eligible subject matter. Appeal Br. 13;
Reply Br. 2. Appellants maintain that the Examiner erred in stating that
"patenting abstract ideas cannot be circumvented by attempting to limit the
use [the idea] to a particular technological environment" in view of Alice
and Diamond v. Diehr, 450 U.S. 175 (1981). Appeal Br. 13. We are
unpersuaded. In Diehr, the claim at issue was directed to significantly more
than a mathematical formula because it was "drawn to an industrial process
for the molding of rubber products." 450 U.S. at 192-93. We agree with the
Examiner that the claims do not provide significantly more than the
mathematical relationship of comparing the time to a threshold, and the
additional limitations make use of routine data processing, i.e., receiving
data. Nor is there an improvement in the composition or the handling of
insulin itself.
Appellants argue that the Examiner's rejection appears to only
consider the steps individually rather than as an ordered combination.
Appeal Br. 14. To the extent that Appellants contend 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
SmartGene, where the comparison of received data according to a rule was
held to be abstract.
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Appellants state without detailed argument with respect to the claims
at issue that "if claims are directed to a solution to a technical problem and
do not impose a disproportionate preemption of the use of an underlying
concept to solve other problems or solve the same problem in a different
way, then the claims are indeed directed to a patent-eligible subject matter."
Appeal Br. 12-13. However, a showing of pre-emption is not required for a
determination that an idea is directed to non-patentable subject
matter. Ariosa, 788 F.3d at 1379 ("Where 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."). This is a situation where the issue of pre-emption is adequately
addressed by the underlying issues set forth above. As such, we sustain the
Examiner's rejection under§ 101 of claim 1.
We have reviewed the additional limitations of claims 2-10 and
determine that they are directed to the same abstract idea of monitoring,
receiving, and comparing data, and sustain the Examiner's rejection under
§ 101 of claims 2-10 for similar reasons as independent claim 1.
Although claims 11-17 recite an insulin pump, we determine that the
claimed invention is similarly directed to rules-based data processing and
does not purport to provide an improvement in the mechanics of insulin
delivery nor in computer technology. As such, we sustain the Examiner's
rejection under§ 101 of claims 11-17 for similar reasons as independent
claim 1.
DECISION
The Examiner's decision to reject claims 1-17 under 35 U.S.C. § 101
is affirmed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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