Ex Parte Mayou et al

Patent Trial and Appeal Board

Mar 29, 2018

13566874 (P.T.A.B. Mar. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/566,874 08/03/2012
68851 7590 04/02/2018
KNOBBE, MARTENS, OLSON & BEAR, LLP
DEXCOM, INC.
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Phil Mayou
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.
DEXCOM. l 97C 1 6241
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
04/02/2018 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHIL MA YOU, HARI HAMP APURAM, DAVID PRICE,
KERI WEINDEL, KOSTY ANTYN SNISARENKO,
MICHAEL ROBERT MENSINGER, LEIF N. BOWMAN,
ROBERT J. BOOCK, APURV ULLAS KAMATH, ELI REIHMAN, and
PETER C. SIMPSON
Appeal2017-006314 1
Application 13/566,8742
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 1-12 and 31, which are all pending claims. 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.
18, 2016) and Reply Brief ("Reply Br.," filed Mar. 7, 2017), and the
Examiner's Final Office Action ("Final Act.," mailed Feb. 11, 2016) and
Answer ("Ans.," mailed Jan. 9, 2017).
2 According to Appellants, the real party in interest is DexCom, Inc. Appeal
Br. 3.
Appeal2017-006314
Application 13/566,874
Statement of the Case
Background
Appellants' application relates to "systems and methods for analyzing
and detecting patterns in data received from an analyte sensor, such as a
glucose sensor." Spec. i-f 2. One embodiment allows the identification of a
hypoglycemic event, and the detection of patterns based on events. Id.
i-fi-1222, 224. "As a result, the user may alter their behavior based on the
indicated pattern information." Id. i-f 283. In one embodiment, the outputted
information is processed further to form or modify a medication
administration routine. Id. i-f 3 8.
In some implementations, a user can use the user interface to tum
on or off a hypoglycemia reoccurrence risk alert that, when
turned on, triggers an alert if it is determined that there is a risk
of the host reoccurring into hypoglycemia within a
predetermined time of having already detected a hypoglycemia
event or episode.
Id. i-f 297.
The Claims
Claim 1, reproduced below, is the sole independent claim on appeal
and is representative of the subject matter on appeal:
1. An analyte monitoring system configured to measure an
analyte concentration of a host, the system comprising:
a sensor configured to generate sensor data indicative of
a concentration of an analyte in a host over time;
a memory configured to store the sensor data;
one or more processors configured to (i) receive the
sensor data from the memory, (ii) detect a pattern in the data,
the detecting comprising identifying a plurality of events based
on the sensor data, associating at least some of the plurality of
events based on a criterion to from a set of events, and
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qualifying the set of events as the detected pattern, and (ii) form
or modify a medicament administration routine based on the
detected pattern; and
a medicament administration device configured to
administer a medicament to the host according to the
medicament administration routine.
Appeal Br. 28 (Claims App.).
The Issues
A. The Examiner claims 1-12 and 31under35 U.S.C. § 103(a) as
being unpatentable over Bocker3, Bortz4, and Cohen5.
B. The Examiner rejected 1-12 and 31under35 U.S.C. § 101 as
lacking patentable subject matter.
A. 35 USC§ 103 over Bocker, Bortz, and Cohen
The Examiner finds that Bocker teaches a system for monitoring
patient blood concentration of a substance, e.g., glucose. Final Act. 7 (citing
Bocker, Abstract, 5: 17--45, 6:45--49, Figs. 1, 2). The Examiner finds that
Bortz teaches monitoring glucose patterns at the same time over a plurality
of days. Id. (citing Bortz, Abstract, i-fi-f 18, 20-22, 25-27, Figs.). The
Examiner finds that Bortz and Bocker do not teach, form, or modify a
medicament administration routine based on a detected pattern, but that
Cohen teaches determining a pattern and forming or modifying a
medicament administration routine based on a detected pattern and an
infusion pump configured to administer a medicament according to the
3 Bocker, US 5,507 ,288, iss. Apr. 16, 1996.
4 Bortz, US 2003/0216628 Al, pub. Nov. 20, 2003.
5 Cohen, US 2010/0160740 Al, pub. June 24, 2010.
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administration routine. Id. at 7-8 (citing Cohen i-fi-15-6, 63, 84, 88, 101,
Figs.). The Examiner determines that a person of ordinary skill would have
recognized the combination of teachings as predictable, i.e., following
Cohen's teaching to utilize patterns in blood glucose to adapt therapy
delivered to a patient. See Final Act. 8 (citing Cohen, Abstract, i-fi-1 5---6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Bocker, Bortz, and Cohen
render claims 1-12 and 31 obvious?
Appellants argue that Bocker fails to disclose identifying events and
detecting a pattern as recited in independent claim 1, i.e., "(ii) detect a
pattern in the data, the detecting comprising identifying a plurality of events
based on the sensor data, associating at least some of the plurality of events
based on a criterion to from a set of events, and qualifying the set of events
as the detected pattern." Appeal Br. 21. Appellants argue that even ifthe
Examiner is correct that Bocker discloses providing warnings of
hypoglycemia, that the providing of warnings does not constitute identifying
a plurality of events and qualifying the set of events as a pattern. Id. at 21-
22. Appellants also assert that Bortz discloses selecting a pattern based on
calculations, but fails to disclose identifying events and qualifying the events
as a pattern. Id. at 22.
However, as above, the Examiner instead relies on Cohen for the
teaching of determining a pattern in the data based on identified events.
Final Act. 8 (citing Cohen i-fi-184, 88, Figs.). Indeed, paragraphs 84 and 88 of
Cohen disclose analyzing sensor reading data in a report and determining a
pattern of an anomalous line based on a set of events. In this connection,
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paragraph 87 of Cohen discloses that an event, such as lunch, can be
identified by user input or by inferring user action.
Appellants argue that Cohen fails to suggest "forming or modifying
medicament administration as recited in independent claim 1, i.e., (ii) form
or modify a medicament administration routine based on the detected
pattern." Appeal Br. 23. Appellants assert that Cohen "suggests that the
user modifies the insulin delivery patterns." Id. The Examiner relies, inter
alia, on paragraph 101 of Cohen. Final Act. 8. Although Cohen describes
an embodiment in which the user may be instructed to increase the basal rate
of insulin in response to a glucose pattern level showing a rise, Cohen
immediately thereafter describes that, "if so configured, to automatically
increase the insulin delivery rate (basal or temporary) or administer a bolus."
Cohen i-f 101.
As such, we sustain the Examiner's rejection under 35 U.S.C. § 103 of
independent claim 1.
Although Appellants list the recitations of other claims in arguing
their patentability, Appellants do not provide specific arguments with
respect thereto aside from quoting the claim language of these claims. As
such, the arguments with respect to these claims are waived. 37 C.F.R.
§ 41.37 ("A statement which merely points out what a claim recites will not
be considered an argument for separate patentability of the claim.") We,
therefore, sustain the Examiner's rejection under 35 U.S.C. § 103 of claims
2-12 and 31, for similar reasons as for independent claim 1.
B. 35 USC§ 101
The Examiner determines that the claims are directed to an abstract
idea of an idea of itself of associating events with a pattern. Final Act. 2-
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3. The Examiner further determines that the claims are "directed to a
process implemented on a computer system or embedded on a computer
readable medium comprising instructions for carrying out the method." See
id. at 3--4. The Examiner determines that "[t]he method steps themselves are
considered to be an abstract idea because they do not purport to improve the
functioning of the computer itself, there is no specific or limitation recitation
of improved computer technology, nor do they effect an improvement in any
other technology or technical field." Id. at 4. The Examiner states that the
independent claims recite the elements of "sensor," "memory," "one or more
processors" and a "medicament administration device." Ans. 5. The
Examiner determines that "[ t ]he generic recitation of a medicament
administration device configured to administer a medicament are general,
well-known, routine and conventional in the art." Final Act. 4. The
Examiner further determines that "[ w ]ithout additional limitations, a process
that employs mathematical algorithms to manipulate existing information to
generate additional information is not patent eligible." Id.
The Examiner additionally reasons that the claimed invention is
abstract because it automates a function performed by a physician when it
receives data from a sensor, looks at the data for patterns, and defines or
modifies a therapy based on a pattern. See Ans. 3 (citing SmartGene, Inc. v.
Advanced Bio. Labs SA, 555 Fed. App'x 950, 955-56 (Fed. Cir. 2014)). The
Examiner also concludes that the claimed invention resembles the type of
abstract idea found unpatentable in the following cases: the collection,
analysis, and display of available information in a particular field, found
unpatentable in Electric Power Group, and the broad concept of monitoring
audit log data, found unpatentable in Fair Warning IP LLC. Ans. 4 (citing
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Elec. Power Grp., 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)).
The Appellants assert that claim 1 recites "a sensor configured to
generate sensor data indicative of a concentration of an analyte in a host over
time," "detect a pattern in the data, the detecting comprising identifying a
plurality of events based on the sensor data, associating at least some of the
plurality of events based on a criterion to from a set of events, and qualifying
the set of events as the detected pattern," "form or modify a medicament
administration routine based on the detected pattern," and "a medicament
administration device configured to administer a medicament to the host
according to the medicament administration routine." Appeal Br. 13.
Appellants argue that the Examiner characterized the invention too broadly,
that the claims are drawn to more than an idea of itself, that the
aforementioned limitations are not well-known and routine, and that
improvements need not be physical. Id. at 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 Bankint'l, 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.
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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
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 glucose
sensing. Rather, as the Examiner found, the claims are directed to a
"sensor," detecting a pattern, and forming or modifying a routine for
medicament administration. See claim 1. We agree with the Examiner that
this type of data processing is abstract, both as a matter of mathematical
relationships (pattern recognition and dosage modification based thereon)
and data processing itself. See SmartGene, Inc. v. Advanced Biological
Labs., SA, 555 Fed. App'x 950, 955 (Fed. Cir. 2014) (claim directed "the
mental steps of comparing new and stored information and using rules to
identify medical options" which was held to be unpatentable subject matter);
Elec. Power Grp., 830 F.3d at 1353-54 (presenting the results of the
collection and analysis without more are patent ineligible abstract concepts).
Comparing glucose readings and basing dosage modifications thereon is the
type of rule-based comparison with generation of options that was held
abstract in SmartGene. Appellants argue that the presence of a sensor
distinguishes the claimed invention from the database system of SmartGene.
Reply Br. 8. Nevertheless, the receiving and processing of data to detect
events, including data gathered from sources being monitored, is the type of
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routine data processing held abstract in Electric Power Group, 830 F .3d at
1355.
Appellants similarly argue that the claimed invention can improve
diabetes management. Appeal Br. 15. However, this is an argument that
goes to the issue of utility rather than whether the claimed invention is
directed to unpatentable subject matter, e.g., as abstract or claiming a law of
nature. Further, the claimed invention in Mayo sought to optimize the
therapeutic efficacy of 6-thioguanine but was still held to be unpatentable
subject matter. Mayo, 566 U.S. at 71.
Appellants assert that the rejection must rely on evidence, case law, or
intrinsic evidence, and address the limitations individually and as a whole,
and that the Examiner fails to do so. Appeal Br. 15-16. However, as above,
the Examiner's Answer provided citations to case law and in comparing the
combination of limitations to prior cases in which there was monitoring,
comparing data to a rule, and generation of options. See Ans. 3--4. Further,
the Examiner's finding that sensors and medicament administration devices
are well-understood, routine and conventional in diabetes management
technology (see id. at 5), is supported by the evidence of record, as discussed
above with respect to the rejection under§ 103. See also Spec. i-fi-14--5, 139,
153, 155, 163.
Appellants imply that the claimed invention is comparable to Enfzsh,
in which there was an improvement in logical structures and processes rather
than physical features because the claim here detects a pattern and modifies
medicament administration based thereon, the claimed invention. See
Appeal Br. 16; Reply Br. 10 (citing Enfzsh, LLC v. Microsoft Corp., 822
F.3d 1327 (Fed. Cir. 2016)). However, the claims in Enfish were directed to
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an improvement in database structure (a self-referential table). Enfish, 822
F.3d at 1335. Here, the Examiner correctly finds that the claims do not
provide an improvement in computer technology, nor do the claims provide
any improvement in insulin delivery. Final Act. 4. Indeed, the Specification
provides only generic and routine computer structures, such as a touchscreen
display devices (i-fi-f 148, 175); a personal computer (i-f 157); a sensor
electronics module (i-f 160); a graphical user interface (i-f 299); and a date
slider control (i-f 319). The Specification does not present any of these
features as more than standard components.
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.
Alice, 134 S. Ct. at 2355 (quoting Mayo, 566 U.S. at 71-72). We must
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 claimed invention is not a mathematical formula
in isolation because it recites medicament administration based on a detected
pattern similar to the rubber-molding press of Diehr responding to the
Arrhenius equation calculations. Appeal Br. 14 (citing Diamond v. Diehr,
450 U.S. 175 (1981)). Although the claimed invention at issue in Diehr was
based on mathematical principles, an invention directed to determining the
proper dosage of a medicament appears to be more similar to Mayo, in
which the Court held unpatentable an invention directed to optimizing
therapeutic efficacy of 6-thioguanine. Mayo, 566 U.S. at 71.
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Appellants argue that the Examiner's rejection appears to only
consider the steps individually rather than as an ordered combination.
Appeal Br. 15-16. 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 and
the generation of options was held to be abstract.
Appellants argue that the claimed invention, when considered as a
whole, amounts to significantly more than any potential exception because it
constitutes an improvement to a particular technology, i.e., healthcare
delivery using a device. Reply Br. 6. Appellants contend that the claimed
invention resembles an example in a US PTO' s guidance document on
subject matter eligibility, July 2015 Update: Subject Matter Eligibility
Appendix 1. Id. at 5---6. In particular, Appellants assert:
Similar to Example 26, in which "the rate of change of the engine
throttle position" is applied to the exhaust gas recirculation valve
to "change the position of the exhaust gas recirculation valve,"
the present [ c ]laim 1 recites "the detected pattern" that is used to
"form or modify [the] medicament administration routine,"
which is further used by "a medicament administration device
configured to administer a medicament to the host according to
the medicament administration routine."
Id. However, in the instant application, neither the claims nor the
Specification are directed to an improvement in the mechanical delivery of
insulin but are rather directed to an improvement in associated data
processing. As such, Appellants' invention is essentially computational and
is therefore unlike a valve in an engine that changes position, to which they
compare their invention. Further, as above, the Supreme Court has held the
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calculation of dosage to be unpatentable subject matter. Mayo, 566 U.S. at
71.
As such, we sustain the Examiner's rejection under§ 101 of claim 1.
Appellants make similar arguments with respect to the remaining
claims. We have reviewed the additional limitations of claims 2-12 and 31
and determine that they are directed to the same abstract idea of monitoring,
receiving, and comparing data. We, thus, sustain the Examiner's rejection
under§ 101 of claims 2-12 and 31 for similar reasons as independent claim
1.
DECISION
The Examiner's decision to reject claims 1-12 and 31 under 35 U.S.C.
§ 103 is affirmed.
The Examiner's decision to reject claims 1-12 and 31 under 35 U.S.C.
§ 101 is affirmed.
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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