Ex Parte Austin et al

Patent Trial and Appeal Board

Oct 16, 2017

13567630 (P.T.A.B. Oct. 16, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/567,630 08/06/2012 Paul R. Austin 20120131-US-NP/XERP152US 6604
86185 7590 10/18/2017
Simpson & Simpson, PLLC
5555 Main Street
Williamsville, NY 14221-5406
EXAMINER
TOWNSEND, GUY K
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
10/18/2017 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):
patentEFS @ idealawyers.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL R. AUSTIN,
WENDELL LEWIS KIBLER, and
CLAUDE S. FILLION
Appeal 2016-001553
Application 13/567,630
Technology Center 3700
Before LINDA E. HORNER, MICHAEL L. HOELTER, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1—7, 9-25, and 27—32. Br. 1. Claims 8 and 26 have been
canceled. See Final Act. 2. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2016-001553
Application 13/567,630
THE CLAIMED SUBJECT MATTER
The disclosed subject matter “relates to a computer-based system and
method including a medication package and computer-based unit for
monitoring when spaces in the package containing medication are accessed.”
Spec. 11. Claims 1, 16, 31, and 32 are independent. Claim 1, illustrative of
the claims on appeal, is reproduced below (re-formatted for clarity).
1. A computer-based system for implementing and
monitoring a medication regimen, comprising:
a medication package including:
a base including a plurality of spaces for receiving
at least one medication;
a sheet of material including respective portions
sealing the plurality of spaces with respect to the base;
and,
a respective electrical circuit associated with each
respective portion; and,
a computer-based unit including:
a memory element configured to store first
computer readable instructions and a medication
regimen, formulated by a medical practitioner or
pharmacist, for the at least one medication;
a processor;
a user interface; and,
a wireless transmitter, wherein:
the computer-based unit is attachable to the
medication package or can wirelessly
communicate with the medication package; and,
the processor is configured to execute the
first computer readable instmctions to:
monitor the respective electrical
circuits to detect when the respective
portions are ruptured;
wirelessly transmit, using the wireless
transmitter, a compliance message for
receipt by at least one computer, the
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Application 13/567,630
compliance message indicating whether a
respective portion has been ruptured;
provide, using the user interface, a
first option to request assistance, or a second
option informing the medical practitioner or
pharmacist of a lack of desire or inability to
take the at least one first medication;
receive, using the user interface,
election of the first or second option; and,
transmit, using the wireless
transmitter, a message, including the first or
second selected option, to the at least first
one computer.
REFERENCE RELIED ON BY THE EXAMINER
Niemiec US 6,961,285 B2 Nov. 1,2005
THE REJECTION ON APPEAL
Claims 1—7, 9-25, and 27—32 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Niemiec.
ANALYSIS
Appellants address each independent claim 1, 16, 31, and 32
separately. Br. 10-29. We also address each such claim separately with the
remaining dependent claims standing or falling with their respective parent
claim. See 37 C.F.R. § 41.37(c)(l)(iv).
Claim 1
Appellants initially address the limitation “provide, using the user
interface, a first option to request assistance” contending that Niemiec does
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not teach or disclose, “providing the first option of claim l.”1 Br. 10.
Appellants’ Specification states that this first option “to request assistance”
(i.e., “option 60”) can reflect “a patient’s medical condition, environment,
preferences, or schedules.'’'’ Spec. 128 (emphasis added). This paragraph
continues, stating that this option “can include a plurality of requests for
example, requests for: information regarding dosage or schedule for MED
[i.e., medication], or information regarding side effects.” Hence, as
expressed, a request for assistance in accordance with the recited “first
option” includes a patient’s request for information relating to a dosage
schedule.
Appellants understand (as do we) that the Examiner correlates the
above referenced “computer-based unit” to Niemiec’s medication monitor
104. See Final Act. 6; Niemiec Figs. 1, 2; Br. 10. The Examiner also
identifies where Niemiec teaches that a patient can access monitor 104 for “a
dosing schedule” to be displayed thereon. Final Act. 6—7 (referencing
Niemiec 4:47—58). Hence, the Examiner concludes that Niemiec teaches
this “first option” because a patient is able to “request assistance” of
Niemiec’s monitor 104. Final Act. 6—7; see also Ans. 18.
On this point, Appellants contend, “Niemiec is silent regarding]
providing an interactive option for the patient.” Br. 11. Appellants’
argument is not persuasive because Niemiec states that the medication
monitor (104) may be implemented by “a personal digital assistant (PDA)”
1 To be clear, the “user interface” referenced in claim 1 is associated with a
“computer-based unit.” See Br. 31, Claims Appendix. Further, an example
of the invention describes providing the first option to a patient taking
medication. See Spec. 127.
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having “display and interface capabilities.”2 Niemiec 6:48—54; see also
Ans. 17.
Appellants acknowledge that in Niemiec, “[t]he user can determine if
a dose has been taken in compliance with a schedule, but there is no teaching
regarding an option, presented on monitor 104, to request help or contact a
pharmacist or medical practitioner.”3 Br. 11, emphasis omitted. However,
claim 1 does not require any “help or contact” with a pharmacist or medical
practitioner since the recitation of “request assistance” encompasses a
request for “information regarding dosage or schedule for MED.” Spec.
128. Appellants do not explain how Niemiec’s display of “a dosing
schedule” upon request by the patient fails to satisfy the recited limitation.
Niemiec 4:52—57.
Appellants also contend, “[i]t is only through the application of
impermissible hindsight that Niemiec can be modified to satisfy the claim 1
limitation in question.” Br. 12. First, Appellants do not indicate where the
Examiner relies on teachings that are gleaned only from Appellants’
Specification rather than from the express teachings of Niemiec. Second,
the Examiner is not relying on a modification of Niemiec to reach this “first
option to request assistance” claim language.
Accordingly, we are not persuaded that the Examiner erred in relying
on Niemiec or, that Niemiec fails to teach or suggest “the first option of
claim 1” as Appellants assert. Br. 10.
2 Appellants also state that the communications device can be a “PDA.”
Spec. 117.
3 Appellants contend, “viewing a schedule is not the same as an option to
request help or contact a pharmacist or medical practitioner.” Br. 11.
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Appellants also address the limitation “receive, using the user
interface, election of the first or second option.” Br. 12. The recited “user
interface” is understood to refer to the interface of the recited “computer-
based unit” (corresponding to Niemiec’s monitor 104) that receives the
election of an option. Final Act. 7; see also Ans. 18. Appellants argue that
because “Niemiec does not teach, suggest, or motivate providing the first
option, Niemiec cannot teach receiving an election of the option.'1'’ Br. 12
(emphasis added). Appellants’ arguments are not persuasive because
Niemiec teaches a monitor/PDA 104 (having “display and interface
capabilities”) that receives user input when a patient elects to display “a
dosing schedule” thereon. Niemiec 6:48—54; 4:47—58; see also Ans. 18—19.
Appellants further contend, ‘Tflhe claim 1 limitation in question is not
inherent in Niemiec” (Br. 13), but Appellants do not identify where the
Examiner is relying on inherency in finding that the above limitation is
taught by Niemiec (see Final Act. 7), and we fail to locate any such
application thereof. Further, Appellants’ argument that the Examiner relies
on ‘Tilmpermissible hindsight” (Br. 14—15) is likewise not persuasive for
reasons similar to those already expressed.
Appellants further address the limitation “transmit, using the wireless
transmitter, a message, including the first or second selected option, to the at
least first one computer.” Br. 15. The Examiner correlates this “at least first
one computer” to Niemiec’s “third party computer or computer network” to
which Niemiec’s monitor 104 can transmit. Final Act. 6—7; see also
Niemiec Fig. 2 (illustrating multiple computers that can receive wireless
transmissions from monitor 104); Ans. 19—20. Niemiec further expressly
states that monitor 104 may forward information it receives “to a remote
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computer via a network connection.” Niemiec 3:45—48; see also Niemiec
11:1—5. As above, such monitor information includes “a dosing schedule”
as well as patient compliance with such schedule. Niemiec 4:52—57
(“whether a dose was accessed at the requisite time”). In view of Niemiec’s
teaching regarding communication between the monitor and a remote
computer (see, e.g., Niemiec 9:3—5), the Examiner concludes that it would
have been obvious “to select the option as the message . . . and wirelessly
transmit the message of the selected option.” Ans. 20. In other words, the
Examiner concludes that it would have been obvious “to transmit data of an
election of an option to display information on medication compliance” to a
third party computer. Ans. 20. Since Niemiec readily discloses
transmissions from the monitor to remote computers, Appellants’ argument
about Niemiec’s silence “regarding transmission of a selection of an option
as recited in claim 1” is not persuasive that it would not have been obvious
to do so. See Br. 15—16.
Appellants also refer to a different data transfer (i.e., between
Niemiec’s instrumented medication package 102 and medication monitor
104) and repeat the argument that this transfer “is not a selection of a request
for help or to contact a pharmacist or medical practitioner.” Br. 16.
Appellants’ contention is not persuasive because it addresses a different
communication and because the selection of the first option does not require,
as discussed above, “a request for help or to contact a pharmacist or medical
practitioner.” See also Br. 17 (addressing the correct communication with
the same help/contact argument). Furthermore, Appellants’ subsequent
allegation of ‘Tilmnermissible hindsight” (Br. 17) is likewise not persuasive.
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In summation, and based on the record presented, we are not
persuaded the Examiner erred in relying on Niemiec for concluding that
claim 1, and dependent claims 2—7 and 9—15, are obvious.
Claim 16
Independent claim 16 includes the limitation, “modify the instructions
according to the transmission.” Br. 38. The Examiner references Niemiec
19:1—14 as teaching this limitation. Ans. 8: see also id. at 21—22. This
passage in Niemiec states, “[t]he monitoring schedule may be dependent
upon factors associated with the particular medication” (Niemiec 19:1—5)
and thereafter discusses such factors. Niemiec further states, “[instructions
could also be transmitted 662 from the central computer to the medication
monitor. Such instructions could alter the intake schedule, the monitoring
schedule, or provide information for a patient associated with the medication
monitor.” Niemiec 19:63—67. Hence, Niemiec teaches the transmission by
a remote computer to a monitor of an alteration to a variety of
schedules/information. Appellants’ argument to the contrary, focusing on
“the package,” or distinctions between “scheduling information,”
“monitoring schedule” or “medication regimen” (Br. 18—20), is not
persuasive that Niemiec fails to teach the limitation directed to a monitor
receiving a transmission from a remote computer that modifies the monitor’s
instructions. See Ans. 21—22.
In summation, and based on the record presented, we are not
persuaded the Examiner erred in relying on Niemiec for concluding that
claim 16, and dependent claims 17—25 and 27—30, are obvious.
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Claim 31
Independent claim 31 includes the limitation of an RFID “tag
including a medication regimen.” Appellants do not dispute Niemiec’s
disclosure of an RFID tag (see Niemiec 4:58 to 5:6), but instead dispute a
teaching “regarding a medication regimen stored on the tag.” Br. 21.
Niemiec is directed to “monitoring medication intake” and
accomplishes this task by “identifying the condition of severable
connectors” on the medication package. Niemiec 3:37-45; see also Ans. 23.
Niemiec teaches, “[t]he use of severable conductors 118 in association with
medication containments 120 [on package 102 (Fig. 2)] allows the detection
of when a patient accesses medication.” Niemiec 4:44-46. Thus, as per
Niemiec, “a patient unsure of whether they took required medication on time
would be able to review the times at which medication containments 120
were accessed, and compare this information with an intake schedule
identifying when a dose was supposed to have been taken.” Niemiec 4:47—
52. More specifically, Niemiec teaches the use of an RFID tag to transmit
data from the package to the monitor “such as times at which severable
conductors 118 were severed.” Niemiec 5:1—6; see also Niemiec 4:62—67.
Niemiec also teaches a pharmacist that may “associate 638 the specific
instrumented medication package with the prescription prior to dispensing
640 the medication.” Niemiec 18:29—31. In view of such teachings
(including Niemiec’s teaching that the RFID can store and transmit data
(Niemiec 5:1—6)), the Examiner concludes that it would have been obvious
“to provide the RFID tag for data transmission including a medication
regimen including a dosing schedule, as disclosed in different
embodiments.” Ans. 23—24. Appellants’arguments about Niemiec’s
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silence “regarding a medication regimen stored on the tag” is not persuasive
that this limitation would not have been obvious in view of Niemiec’s
teachings. See Br. 20-26. Appellants’ additional assertion regarding the
Examiner’s reliance on inherency (Br. 23) is equally not persuasive of
Examiner error.
In summation, and based on the record presented, we are not
persuaded the Examiner erred in relying on Niemiec for concluding that
claim 31 was obvious.
Claim 32
Claim 32 includes the limitation, “storing, in a second memory
element for at least one computer, second computer readable instructions”
(emphasis added by Appellants, Br. 26). Appellants contend that the
Examiner did not address this italicized portion but assumes “the Examiner
is referring to computer 200 as the at least one computer.” Br. 27. We agree
with Appellants’ understanding of the Examiner’s rejection (see Final Act.
10 referencing Niemiec 9:4—12) and further note that Niemiec teaches,
“remote computer 200 may be a single computer or one of several
computers in a network.” Niemiec 8:17—18.
Appellants thereafter address the limitation “modify the instructions
according to the transmission” and refer to “arguments for claim 16”
regarding this limitation. Br. 27. As indicated above, such arguments were
not deemed persuasive of Examiner error. See also Ans. 25—26.
Appellants further reference another limitation of claim 32 directed to
the transmission of “a second message, regarding the non-compliance with
respect to the medication regimen.” Br. 28. Appellants contend that this
limitation directed to a second non-compliance message is lacking. Br. 28.
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However, Appellants do not dispute that Niemiec addresses non-compliant
situations such as when a patient is not taking medication on time, or is
abusing the medication. Niemiec 4:52—57; 9:20-25; see also Ans. 26—27.
Niemiec also discloses a physician using the system to ascertain “the status
of a patient in completing a course of medication.” Niemiec 8:40-41. The
Examiner concludes that in view of such teachings (and others), it would
have been obvious “to transmit a second non-compliance message in
response to a first message regarding monitoring medication dosing, as
disclosed in different embodiments.” Ans. 27; see also Ans. 26.
Appellants’ argument about Niemiec’s silence “regarding transmitting a
second message, regarding non-compliance, to a communications device” is
not persuasive because it does not address the Examiner’s determination that
such a non-compliance message would have been obvious in light of
Niemiec’s teachings. See Br. 28.
Appellants also present the general allegation that “Niemiec does not
teach any device analogous to the communications device of claim 32” (Br.
29), but fail to further elaborate as to why Niemiec’s monitor 104 is not
analogous to Appellants’ communication device since both are “accessible
by a patient for whom the at least one medication has been prescribed” as
claimed.
Accordingly, in summation and based on the record presented, we are
not persuaded the Examiner erred in relying on Niemiec for concluding that
claim 32 was obvious.
DECISION
The Examiner’s rejection of claims 1—7, 9—25, and 27—32 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).
AFFIRMED
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