Ex Parte Butler et al

Patent Trial and Appeal Board

Jul 7, 2016

13073026 (P.T.A.B. Jul. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/073,026 03/28/2011
34082 7590 07111/2016
ZARLEY LAW FIRM P.L.C.
CAPITAL SQUARE
400 LOCUST, SUITE 200
DES MOINES, IA 50309-2350
FIRST NAMED INVENTOR
Judd G. Butler
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.
P07422US1 7222
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
07/11/2016 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):
swood@zarleylaw.com
kconrad@zarleylaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUDD G. BUTLER and PAMELA J. FLECKENSTEIN
Appeal2016-006025
Application 13/073,0261
Technology Center 1600
Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a glucose management device and managing patient data.
Claims 1, 2, 6---9, 12, 13, 15, 16, 18-20, and 22-24 are on appeal as rejected
under 35 U.S.C. §§ 101 and 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
1 No Real Party in Interest different than the named inventors is identified by
Appellants. App. Br. i.
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Application 13/073,026
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 1, 9, and 19 are the independent claims. Claim 1
reads as follows:
1. A glucose management device comprising:
a housing have [sic] an input device that receives an in vitro test
element;
glucose measurement circuitry electrically connected to the in
vitro test element;
a processor in communication with the glucose measurement
circuitry to receive glucose level data provided by the in vitro
test element;
a first database to store user information and glucose level data;
a first outlet port in communication with the first database to
download only user information and glucose level data on the
first database;
a second database to store glucose level data only;
a second outlet port in communication with the second database
to download only glucose level data on the second database; and
wherein the processor prompts a user to input user infonnation
into the input device after the processor receives the glucose level
data provided by the in vitro test element and the user has the
option to accept, deny, or delay a prompt for information.
App. Br. 9 (Claims Appendix). Claim 9 reads as follows:
9. A method of managing glucose steps comprising:
determining a glucose level of a user with an in vitro test element;
communicating the glucose level of the user to a processor;
recording the glucose level of the user in a first database;
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prompting the user with the processor to input user information
into an input device;
prompting the user to accept, deny, or delay the prompt for
information;
inputting user information into the input device;
recording the user information in the first database of the
processor;
requesting a glucose level report by the user;
creating the glucose level report; and
storing the glucose level report in the second database.
Id. 9-10. Claim 19 reads as follows:
19. A method of managing glucose steps comprising:
determining a glucose level of a user with an in vitro test element;
communicating the glucose level of the user to a processor;
recording the glucose level in a first database of the processor;
requesting a report of glucose measurements; and
generating the report of glucose measurements with the
processor;
and storing the report in a second database.
Id. at 10.
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The following rejections are on appeal: 2
A. Claims 1, 2, 6-9, 12, 13, 15, 16, 18-20, and 22-24 under
35 U.S.C. § 101 as directed to patent ineligible subject matter. Final
Action 2.
B. Claims 1, 2, 7-9, 12, 13, 15, 16, and 18-20, and 22-24 under 35
U.S.C. § 103(a) over Galley,3 Soni,4 and Sabo.5 Final Action 7.
C. Claim 6 under 35 U.S.C. § 103(a) over Galley, Soni, Sabo, and
Brister. 6 Final Action 9.
DISCUSSION
A. The rejection of claims 1, 2, 6--9, 12, 13, 15, 16, 18-20, and 22-24
under 35 U.S.C. § 101.
The Examiner determined that all pending/appealed claims are
directed to the abstract idea of manipulating data, e.g., requesting, recording,
and creating data, and fail to recite significantly more so as to make the
claims patent-eligible. Final Action 2--4. We agree with respect to claims 9
and 19, and disagree with respect to claim 1.
2 Claims 3-5, 10, 11, 14, 17, and 21 were cancelled by Appellants during
prosecution. See Office Action Response dated Mar. 27, 2015. Therefore,
regardless of the listings in the Examiner's rejection or Appellants' briefing,
we omit these cancelled claims from our listings here.
3 U.S. Patent US 8,118,770 B2 to Galley et al. (issued Feb. 21, 2012)
(hereinafter "Galley").
4 U.S. Patent Application Pub. No. US 2010/0218132 Al (published Aug.
26, 2010) (hereinafter "Soni").
5 U.S. Patent Application Pub. No. US 2012/0095314 Al (published Apr.
19, 2012) (hereinafter "Sabo").
6 U.S. Patent US 7,857,760 B2 to Brister et al. (issued Dec. 28, 2010)
(hereinafter "Brister").
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The Supreme Court instructs us to "first determine whether the claims
at issue are directed to a patent-ineligible concept." Alice Corp. Pty Ltd. v.
CLS Bank Int'!, 134 S. Ct. 2347, 2355 (2014). If this threshold is met, we
move to the second step of the inquiry and "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." Id. (quoting Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 132 S. Ct. 1289, 1298, 1297 (2012)).
Taking up the first step of the patent-eligibility analysis, we find
claim 1 is not necessarily directed to an abstract idea because it recites a
glucose management device having two outlet ports and dedicates one of the
ports to glucose level data. Looking to the Specification to enlighten us as to
the claimed invention here, as did the Federal Circuit in Enfish, LLC v.
Microsoft Corp., --- F.3d --- , 2016 WL 2756255 (Fed. Cir. May 12, 2016),
we find it explains as follows:
Medicare requires pharmacies to retrieve a log from users each
time the strips are refilled. Because only a log of use of test strips
is needed, and considering HIPP A regulations, the user could
request a report be generated by the processor of only glucose
measurements. Alternatively, this information could be saved in
a separate database that is accessed through the output port 18 or
a second output port 30 if needed. The report would be
downloaded to the pharmacy's database and supplied to
Medicare on request to show compliance with regulations and
reduce or eliminate fraud.
Spec. 4, 11. 12-22. The Specification informs us that the inclusion of a
separate data output port dedicated to glucose measurements is a professed
improvement in glucose management device technology because it allows
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the device to communicate with, e.g., pharmacies or Medicare, to supply
information showing Medicare regulatory compliance in relation to using the
device for blood glucose measurement while withholding private and
irrelevant patient information. According to the Specification, this
information exchange goes hand-in-hand with patients' use of glucose meter
devices. Id. Therefore, as in Enfzsh, here the focus of claim 1 is on an
improvement to a device's functionality (or usefulness) itself and not on
other tasks for which the device is invoked merely as a tool or platform.
Enfzsh, 2016 WL 2756255 at *5.
For the above reasons, we find claim 1 is not directed to abstract,
patent-ineligible subject matter and the respective rejection should be
reversed.
Turning to claims 9 and 19, which are method claims, under the first
Alice step we find they are directed to the abstract idea of information
management. Similar to the facts of In re TL! Comm. LLC, --- F.3d ---, 2016
WL 2865693 *3-5 (Fed. Cir. May 17, 2016), the methods of these claims
are not directed to an improvement in computer or glucose meter device
technology, but simply to recording, requesting, and reporting information,
i.e., organizing data, using the tangible components of such technologies
only in their generic ways. Other than determining a glucose level and
implicating a computer processor, which the Specification indicates were
well known, the recited steps could be performed in the mind of a person or
on paper. See Spec. 1, 11. 14--20; see also CyberSource Corp. v. Retail
Decisions, Inc., 654 F.3d 1366 (Fed. Cir. 2011) ("method steps [that] can be
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performed in the human mind, or by a human using a pen and paper" are
abstract and unpatentable ).
Turning to the second step under Alice, the implication of any
technology in claims 9 and 19 is only in line with the well-known, routine
functionality of the technology, e.g., processors function to process data,
input devices function to enable users to interface with the device, databases
file information, and communication ports connect devices; nothing
significantly more is added. Thus, as did the Federal Circuit in In re TL!
Comm. LLC, we find that the steps recited by these claims, individually and
as a combined whole, cannot confer patent eligibility. In re TL! Comm.
LLC, 2016 WL 2865693 *7; see also SmartGene, Inc. v. Advanced Bio. Labs
SA, 555 Fed. App'x 950, 955-56 (Fed. Cir. 2014) (claims drawn to
organizing patient information and analyzing it as a doctor would were
directed to an abstract idea and requiring a computer to do this was not
enough to convey patent eligibility).
For the above reasons, we find that claims 9 and 19 are directed to
abstract, patent-ineligible subject matter without significantly more to bring
the abstract idea into the realm of patent-eligibility and the respective
rejection must be affirmed.
B. The rejection of claims 1, 2, 7-9, 12, 13, 15, 16, 18-20, and 22-24
under 35 U.S.C. § 103(a) over Galley, Soni, and Sabo.
With regard to the obviousness rejection(s), we adopt the Examiner's
findings of fact and reasoning regarding the scope and content of the prior
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art (see Final Action 7-9; Ans. 7-9, 13-15) and rely thereon in affirming the
final rejection. For emphasis only, we highlight the following:
FINDINGS OF FACT
FPL Galley disclosed "[a]n electronic device may be configured to
prompt a user via an on-board display to measure user glucose via an on-
board glucose meter ... and prompt the user via the display to enter
carbohydrate information into the device." Galley Abstract; see also Final
Action 7 (discussing Galley).
FF2. Galley disclosed:
The electronic device 12 further includes a carrier port 20 that
extends into the housing from an opening defined therein. The
carrier port 20 is sized to receive therein a sample carrier or
strip 22 upon which a liquid sample containing an analyte has
been or will be deposited. The electronic device 12 includes
electrical circuitry that analyzes the liquid sample deposited on
the sample carrier 22, when the sample carrier 22 is received
within the carrier port 20, to determine a concentration of the
analyte contained in the liquid sample. In one embodiment, the
liquid sample is blood and the analyte is glucose. In this
embodiment, the sample carrier 22 may [sic] is illustratively
provided in the form of a glucose test strip, and the electrical
circuitry of the electronic device 12 includes conventional
circuitry that measures the concentration of glucose in a blood
sample deposited on the test strip 22.
Galley col. 5, 1. 61 to col. 6, 1. 8; see also Final Action 7 (discussing Galley).
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FF3. Galley disclosed Fig. 1, reproduced below:
r--~-~~~~;~~;~--~~~;;~~----·····
c::::::J--·•f _:: :_~_:JA!> ,-12
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21.1 ! I
l ll!Sf'lAY !
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c--·---~}- : : : : ~-- _>m
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4 FIG. 1 lli
Galley Fig. 1. "FIG. 1 shows a block diagram of ... a wireless
communication system including a medical device and a remote electronic
device that are both configured to wirelessly communicate with each other."
Galley col. 3, 11. 53-55; see also Final Action 7 (discussing Galley Fig. 1).
Galley Fig. 1 shows the glucose-measuring medical device includes a
"display" labeled "34" and "user keys" labeled "32." Galley Fig. 1; see also
Final Action 7 (discussing Galley Fig. 1 ). Galley Fig. 1 shows a "wireless
communication module" (or circuit) labeled "30," which communicates data
(labeled "40") between the glucose-measuring medical device and remote
devices. Galley Fig. 1; col. 7, 11. 4--8; see also Final Action 7 (discussing
Galley Fig. 1 ).
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FF4. Galley disclosed Fig. 2, reproduced below:
FIG. 2
Galley Fig. 2. "FIG. 2 shows a block diagram schematic of ... an electronic
circuit that is carried by, and that controls, the remote electronic device of
FIG. 1." Galley col. 3, 11. 56-58; see also Final Action 7 (discussing Galley
Fig. 2). Galley Fig. 2 shows a "comm[unication] module" (or circuit)
labeled "52" connected to the device "memory subsystem" labeled "54" and
thereby to a "UI processor" labeled "50" and an "ME processor" labeled
"56" and thereby to an "electrical interface" labeled "76," which is
associated with the blood glucose strip insert element, labeled "20." Galley
Fig. 2; see also Final Action 7 (discussing Galley).
FF5. With regard to Fig. 2, Galley explained:
the wireless communication circuit 52 is provided in the form of
a conventional BlueTooth® telemetry module that includes a
conventional processor and a memory unit 70, and that further
includes conventional wireless communication hardware such as
a suitable antenna. The memory unit 70 illustratively has stored
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therein instructions that are executable by the processor of the
wireless communication circuit 52 to exclusively control of all
wireless communications with external devices ....
Galley col. 8, 11. 38--47; see also Final Action 7 (discussing Galley Fig. 2).
FF6. Galley disclosed Fig. 1 OB, reproduced below:
Galley Fig. lOB. "FIGS. lOA-lOC show a flowchart of ... a bolus advice
process carried by the remote electronic device." Galley col. 4, 11. 19-21;
see also Final Action 7 (discussing Galley Fig. 1 OB). Galley Fig. 1 OB
shows a process, which may begin by a user inserting a glucose blood test
strip into the device, and may be followed by the entering of other user
information, such as health events, into the system. Galley col. 28, 11. 13-
46; see also Final Action 7 (discussing Galley Fig. 1 OB). Galley Fig. 1 OB
shows that prompts for inputting information regarding, e.g., carb values or
user heath events, can be accepted or rejected ("YES" and "NO"). Galley
Fig. 1 OB; see also Final Action 7-8 (discussing Galley Fig. 1 OB).
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FF7. Galley disclosed:
The "my data" process 306 illustratively provides for the
viewing and editing of diary records, e.g., specific BG [blood
glucose] test records and pump history records, and also for the
analysis of the records over daily and/or weekly time periods ....
The diary records may also be downloaded to a PC or other
computer, and using compatible software all records may be
viewed and/or analyzed. Each diary record may contain date and
time, BG test result, meal time events, carbohydrate value, health
event, bolus type, bolus amount and duration. The UI processor
can filter and/ or sort data from these data records.
The "my data" process also provides for the analysis of the data
records in the form of daily and weekly averages, and standard
deviations, defined by time slot, and for trend analysis of any of
the collected data. Standard day and standard week tables or
graphs may be generated to view averages and/or trends.
Various charting and table options are also available for
presenting data in desired formats.
Galley col. 28; 11. 34--53; see also Final Action 7-8 (discussing Galley).
FF8. Galley disclosed:
The medical device 14 includes a conventional processor 28 that
is electrically connected to a wireless communication circuit 30.
The processor 28 includes a conventional memory unit 25 which
has stored therein a number of processes in the form of
instructions that are executable by the processor 28 to control
operation of the medical device 14 and to wirelessly
communicate with the electronic device 12. In the illustrated
embodiment, the medical device 14 further includes
conventional non-volatile memory units 27 and 29.
Galley col. 6, 11. 45-53; see also Final Action 7 (discussing Galley).
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FF9. Galley taught transferring data from a glucose-measuring
device to multiple databases of a remote device as follows:
the UI processor 50 is operable to transfer operating data, e.g.,
event history information, from the medical device 14 to the
remote electronic device 12 via the wireless communication link.
In one embodiment, the remote electronic device 12 includes
four separate databases that hold history information for
computing boluses and for reviewing and/or further analyzing.
Referring to FIG. 6, a diagram is shown of one illustrative
embodiment of four such databases that are included in the
remote electronic device 12, and that are illustratively located in
the memory device 66. The four databases include a BG/Diary
database 65, a pump records (PR) database 67, a meal correction
(MC) database 69 and a correction records (CR) database 71.
Galley col. 19, 1. 62 to col. 20, 1. 15.
FFlO. Galley disclosed Fig. 13, as follows:
/301
./ ;s·
Galley Fig. 13. Galley disclosed "FIG. 13 shows a graphic representation of
... a bolus advice display screen produced by the process of FIGS. 10A-
19C." Galley col. 4, 11. 26-28; see also Final Action 8 (discussing Galley
Fig. 13). Galley Fig. 13 shows a display of a blood glucose level and other
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patient information. Galley Fig. 13; see also Final Action 8 (discussing
Galley Fig. 13).
FF 11. Galley disclosed:
Illustratively, the "my data" feature corresponds to a data
viewing, editing and reporting feature via which a user may view
current, historical and trend data relating to operation of the on-
board glucose meter and/or the medical device 14. In any case,
the "NO" branch at step 132 loops back to the beginning of
step 132, and the "YES" branch advances to step 134 where the
UI processor 50 is operable to establish wireless connection with
the medical device 14 as described above.
Galley col. 19, 11. 19-27; see also Final Action 8 (discussing Galley).
FF12. Soni disclosed "a system and method managing the
implementation, execution, data collection, and data analysis of a structured
collection procedure running on a portable, hand-held collection device,"
where the device can be a blood glucose measurement device. Soni
Abstract, 11 8; see also Final Action 8 (discussing Soni).
FF 13. Soni disclosed blood glucose meter data collection prompts,
acceptance, denial, and snooze, as follows:
[G]uidance 230 provided in the form of a question "Are you
willing to conduct a test over 3 consecutive days?" is not
affirmed by the patient 12 e.g., via a "No" selection provided on
the collection device 24. In this illustrated example, the "Affirms
guidance" may be a drop down selection provided in a combo
box for customizing the adherence criterion 224 of the associated
collection event 237, which when selected causes the processor
102 to wait for the accepted/not accepted input (e.g., via buttons
147, 149) before executing the remaining logic ("if not add 1 day
to timing") of the adherence criterion 224.
Soni i-f 146; see also Final Action 8 (discussing Soni).
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FF14. Soni disclosed blood glucose meter data collection prompts,
acceptance, denial, and snooze, as follows:
the processor 102 prompts via a request 240 for the patient 12 to
take a reading around a lunch event as mandated by the collection
procedure 70. For example, the prompting of the request 240
may be an alarm provided by the processor 102 via indicator 148
that goes off, whereby the patient 12 is asked also on the
display 108 by the processor 102 to take a reading. In one
embodiment, the snooze feature as well as the skip reading
feature are provided by the software 34, where the patient 12 can
use the user interface 146 to enable a delay or to skip the data
collection.
Soni i-f 190; see also Final Action 8 (discussing Soni).
FF15. Soni disclosed:
The self-monitored data may include, but not [sic] limited
thereto, the glucose values of a patient 12, the insulin dose
values, the insulin types, and the parameter values used by
processor 102 to calculate future glucose values, supplemental
insulin doses, and carbohydrate supplement amounts as well as
such values, doses, and amounts.
Soni i-f 66; see also Final Action 8 (discussing Soni).
FF 16. Soni disclosed:
The collection device 24 can further provide a user interface 146,
such as buttons, keys, a trackball, touchpad, touch screen, etc. for
data entry, program control and navigation of selections, choices
and data, making information requests, and the likes. . . . In one
embodiment, the user can use one or more of buttons 147, 149 to
enter (document) contextualizing information, such as data
related to the everyday lifestyle of the patient 12 and to
acknowledge that prescribed tasks are completed. Such lifestyle
data may relate to food intake, medication use, energy levels,
exercise, sleep, general health conditions and overall well-being
sense of the patient 12 (e.g., happy, sad, rested, stressed, tired,
etc.). Such lifestyle data can be recorded into memory 110
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and/or 112 of the collection device 24 as part of the self-
monitored data via navigating through a selection menu
displayed on display 108 using buttons 147, 149 and/or via a
touch screen user interface provided by the display 108. It is to
be appreciated that the user interface 146 can also be used to
display on the display 108 the self monitored data or portions
thereof, such as used by the processor 102 to display measured
glucose levels as well as any entered data.
Soni i-f 67; see also Final Action 8 (discussing Soni).
FF 17. Soni disclosed:
The collection device 24 m one embodiment can include a
communication module 124. The communication module 124
allows software (e.g., the software 34, the collection procedures
70a, 70b, 70c, and 70d) and data (e.g., data resulting from
completed collections performed according to one or more of the
collection procedures 70a, 70b, 70c, and 70d) to be transferred
between the collection device 24 and an external device(s) 126.
Examples of communication module 124 may include one or
more of a modem, a network interface (such as an Ethernet card),
a communications port (e.g., USB, firewire, serial, parallel, etc.),
a PC or PCMCIA slot and card, a wireless transceiver, and
combinations thereof. The external device( s) 126 can be the
patient computer 18, the clinician computer 25, the handheld
computing devices 36, such as a laptop computer, a personal
digital assistance (PDA), a mobile (cellular) phone, and/or a
dongle, a docking station, or device reader 22 .... Software and
data transferred via communication module 124 can be in the
form of wired or wireless signals 128 . . . . Specific techniques
for connecting electronic devices through wired and/ or wireless
connections (e.g. USB and Bluetooth, respectively) are well
known in the art.
Soni i-f 63; see also Final Action 8 (discussing Soni).
FF18. Soni disclosed:
The software 34 residing on the client computer 25 serves as the
interface between the server 52 and the meter 24. The
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software 34 also interfaces with a database that includes relevant
patient data that is arranged by an individual patient ID, such as
used by and provided in the healthcare record system 27. The
software interface also allows the clinician 14 to access the
patient 12 details using the patient identifier. In this manner the
software 34 provides the clinician 14 with information about the
collection procedure(s) 70 that the patient 12 has already
completed (i.e., those with a completed set for the completion
flag 257), the associated results, and also the collection
procedure( s) 70 that the patient 12 is currently performing. All
of the data residing on the client computer 25 is secure and
access-controlled. The server 52 has no means to access the data.
. . . In addition, an individual patient 12 can access his data, such
as from a server of the clinicians, using his patient identifier in a
secure web-based format. This data is downloaded to the
database on computer 25 from the meter 24 and associated to the
patient 12 using the patient identifier.
Soni i-f 207; see also Final Action 8 (discussing Soni).
FF 19. Soni disclosed:
the collection device 24 can include the software and hardware
necessary to process, analyze and interpret the self monitored
data in accordance with predefined flow sequences (as described
below in detail) and generate an appropriate data interpretation
output. In one embodiment, the results of the data analysis and
interpretation performed upon the stored patient data by the
collection device 24 can be displayed in the form of a report ....
Soni i-f 74; see also Final Action 8 (discussing Soni).
FF20. Sabo disclosed:
A handheld diabetes management device having a database
management system is disclosed. The device comprises a
plurality of input modules, including a blood glucose reader, a
user interface, a communications interface, and a continuous
blood glucose input module. The input modules output data used
to generate data records of different record types. The device
further comprises N databases, each database having a different
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frequency range associated thereto, wherein the new record is
stored in a particular database of the N databases based on the
frequency range of the particular database and the frequency of
the particular record type ....
Sabo Abstract; see also Final Action 9 (discussing Sabo).
FF21. Sabo disclosed accumulating and segregating data, as follows:
In a first aspect of the disclosure, a handheld diabetes
management device having a database management system is
disclosed. The diabetes management device includes a blood
glucose reader that receives a fluid sample from a patient and that
outputs a blood glucose measurement that is used to generate a
first record having a first record type, a user interface that
receives input from a patient via an input device associated with
the handheld diabetes management device and that outputs
patient data that is used to generate a second record having a
second record type, and a communication interface that receives
data from an external device and that outputs device data that is
used to generate a third record having a third record type. The
first record type, the second record type, and the third record type
are of a plurality of different record types, wherein each record
type of the plurality of different record types has a corresponding
frequency, wherein the frequency of a record type indicates an
average amount of records having the record type received
during a predetermined period of time. The handheld diabetes
management device further comprises N databases, each
database having a different frequency range associated thereto,
wherein a new record of a particular record type based on data
received from one of the blood glucose reader, the user interface,
and the communication interface is stored in a particular database
of the N databases based on the frequency range of the particular
database and the frequency of the particular record type ....
Sabo i-f 11; see also Final Action 9 (discussing Sabo).
FF22. Sabo disclosed accumulating and segregating data, as follows:
a blood glucose reader that receives a fluid sample from a patient
and that outputs a blood glucose measurement that is used to
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generate a first record having a first record type, ii) a user
interface that receives input from a patient via an input device
associated with the handheld diabetes management device and
that outputs patient data that is used to generate a second record
having a second record type based, iii) a communication
interface that receives data from an external device and that
outputs device data that is used to generate a third record having
a third record type, and iv) a continuous blood glucose input
module that receives a blood glucose reading from a continuous
blood glucose meter and that outputs a continuous blood glucose
measurements used to generate a fourth record of a fourth record
type. The first record type, the second record type, the third
record type, and the fourth record type are of a plurality of
different record types, wherein each record type of the plurality
of different record types has a corresponding frequency, and
wherein the frequency of a record type indicates an average
amount of records having the record type received during a
predetermined period of time. The handheld diabetes
management device further comprises a record generation
module that receives data from one or more of the input modules
and generates a new record of a particular record type based on
the received data. The handheld diabetes management device
also includes N databases, each database having a different
frequency range associated thereto, wherein the new record is
stored in a particular database of the N databases based on the
frequency range of the particular database and the frequency of
the particular record type ....
Sabo i-f 12; see also Final Action 9 (discussing Sabo).
FF23. Sabo disclosed:
In another feature, the database integrity module further includes
a continuous blood glucose input module that receives a blood
glucose reading from a continuous blood glucose meter and
outputs a continuous blood glucose measurement used to
generate a fourth record of a fourth record type. The fourth
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record is stored in a different database of the N databases than a
database storing the first records.
Sabo i-f 64; see also Final Action 12 ("Sabo et al. teaches dedicating and
storing specific data to a specific database.").
ANALYSIS
The Examiner, discussing all pending claims together, determined
Galley taught a glucose measuring device, with circuitry to receive data
from a test element, and an associated processor. FF 1-FF 11. The Examiner
determined Galley taught providing prompts to a user to measure glucose
followed by prompts to the user to input user information. FFl, FF3, FF6,
FF 10, FF 11. The Examiner also determined Galley taught displaying blood
glucose level, historical glucose data and statistical analysis, suggesting a
log of glucose measurements. FF7, FFlO, FFl 1.
The Examiner indicated Galley did not teach a first database to store
user information and glucose data and a second database dedicated to storing
glucose data only. Final Action 8. Also, the Examiner indicated Galley did
not teach user options to accept, deny, or delay prompts for information. Id.
The Examiner combined Soni, also directed to a blood glucose
measurement device (see, e.g., FF12, FF15, FF16), with Galley for its
teaching of accept, deny, and snooze features with respect to data collection.
FF13, FF14. The Examiner also combined Soni's teaching of
communication ports, downloading patient data from a database, displaying
blood glucose measurements and historical trends (i.e., stored
measurements) upon user request, and storing user information in a
database. FF 16-FF 19.
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The Examiner indicated the Galley-Soni combination did not teach a
second database dedicated to glucose data only. For this, the Examiner
combined Sabo, which also disclosed a handheld blood glucose
measurement device. FF21. The Examiner determined Sabo taught
collecting data for diabetes management, including blood glucose
measurements, assigning a record type to respective types of data (e.g.,
blood glucose measurements), and storing each record type to a respective
database. FF21, FF22. In this way, the Examiner determined Sabo taught a
dedicated database for blood glucose measurement data.
We find the Examiner established a prima facie case for the
obviousness of claims 1, 9, and 19. Appellants dispute this. Appellants
argue only over claims 1, 9, and 19, therefore, all claims fall with these
claims. We address Appellants' arguments below.
Regarding claim 1, Appellants contend the Galley-Soni-Sabo
combination does not teach a first outlet port in communication with a first
database to download only user information and glucose level data and a
second outlet port in communication with a second database to download
only glucose level data. App. Br. 5---6. We do not find the balance of
evidence supports Appellants' argument.
A patent claim clause (e.g., a "whereby," "wherein," or "to [result]"
clause) that merely states the result of the limitations in the claim adds
nothing to the patentability or substance of the claim. Lockheed Martin
Corp. v. Space Systems/Loral, Inc., 324 F.3d 1308, 1319 (Fed. Cir. 2003)
(holding a clause of a satellite-control-system claim directed to a result of
rotating a structure "adds nothing to the substance of the claim"); Texas
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Application 13/073,026
Instr. Inc. v. U.S. Int'! Trade Comm'n, 988F.2d1165, 1171-72 (Fed. Cir.
1993) (holding claim language "merely describe[ing] the result of arranging
the components of the claims" "adds nothing to the patentability or
substance of the claim."). Here, beyond the recited first and second outlet
ports, the remainder of the respective claim clauses (i.e., what data is
communicated via respective ports) are merely directed to results of having
the ports communicate with the databases (which, in any event, would be
software-controlled, as was known according to the prior art of record).
"[A]pparatus claims cover what a device is, not what a device does."
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990). Both the Examiner and the Board may interpret the "result"
language as not imposing any structural limitations on the apparatus of claim
1, and as determined by the Examiner, Soni teaches a plurality of outlet
ports, which may be wired or wireless connections, as was well known in the
art. FFl 7; see also FF18 (software serves as the interface between the
device and external devices).
Even, assuming arguendo, the "result" clauses of the claims should be
interpreted as structural in determining patentability, the prior art
combination discloses blood glucose meters with communication circuits
that communicate blood glucose and user information from a database
(Galley), segregating data and communicating only blood glucose
measurement data from a designated database (Sabo), and providing a
plurality of communication outlet ports connected to a plurality of external
devices to distribute this data (Soni) so as to render the entirety of the claims
obvious. FF3, FF4, FFl 7, FF22; cf Reply 3 (contending lack of inherency).
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The Examiner determined that it would have been obvious to a person of
ordinary skill in the art to make the prior art combination because the
combined references are each directed to the same technology and one of
ordinary skill in the art would have recognized the results of such a
combination to have been predictable. Final Action 9. "The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007).
For the above reasons, we find that the evidence of record supports
the Examiner's determination that claim 1 would have been obvious over
Galley, Soni, and Sabo.
Regarding claims 9 and 19, Appellants contend that the Galley-Soni-
Sabo combination fails to teach "requesting a glucose level report by a user"
and "a report of glucose report measurements." App. Br. 6. We do not find
the balance of evidence supports Appellants' argument.
As the Examiner determined, Soni disclosed providing a user interface
for "making information requests" (FF 16) and software/hardware to process
data and generate an appropriate data interpretation output as a report
(FF19). As determined by the Examiner, Sabo disclosed segregating data,
such as blood glucose measurements, in respective databases. FF22, FF23.
For the above reasons, we find that the evidence of record supports
the Examiner's determination that claims 9 and 19 would have been obvious
over Galley, Soni, and Sabo.
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C. The rejection of claim 6 under 35U.S.C.§103(a) over Galley,
Soni, Sabo, and Brister.
Appellants have not contested the Examiner's prima facie case on the
obviousness of claim 6, therefore, we summarily sustain this rejection. See
MPEP § 1205.02, 8th ed., Rev. 9, Aug. 2012 ("If a ground of rejection stated
by the examiner is not addressed in the appellant's brief, that ground of
rejection will be summarily sustained by the Board.").
SUMMARY
The rejection of claims 1, 2, 6-9, 12, 13, 15, 16, 18-20, and22-24
under 35 U.S.C. § 101 is reversed with respect to claim 1 and affirmed with
respect to claims 9 and 19. Claims 12, 13, 15, 16, 18, 20, and 22-24 fall
with claims 9 and 19 as not argued separately. 37 C.F.R. § 41.37(c)(l)(iv).
The rejection of claims 1, 2, 7-9, 12, 13, 15, 16, 18-20, and22-24
under 35 U.S.C. § 103(a) over Galley, Soni, and Sabo is affirmed. Final
Action 7. Claims 2 and 7-8 fall with claim 1 and claims 12, 13, 15, 16, 18,
20, and 22-24 fall with claims 9 and 19 as not argued separately. 37 C.F.R.
§ 41.37(c)(l)(iv).
The rejection of claim 6 under 35 U.S.C. § 103(a) over Galley, Soni,
Sabo, and Brister is affirmed.
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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