Ex Parte Drew

Patent Trial and Appeal Board

Jul 30, 2018

13358140 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/358,140 01/25/2012
71996 7590 08/01/2018
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Touby A. Drew
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.
1123-005US01/P0033971.0l 2425
EXAMINER
LEE, WENG WAH
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/01/2018 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TOUBY A. DREW 1
Appeal2017-010494
Application 13/358,140
Technology Center 3700
Before JAMES P. CALVE, LEE L. STEPINA, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Final Office
Action finally rejecting claims 1-12, 15-26, 29, 30, and 34--41. See Notice
of Appeal, filed Oct. 17, 2016. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Medtronic, Inc. and its ultimate parent entity, Medtronic plc, is identified
as the real party in interest. Appeal Br. 3.
Appeal2017-010494
Application 13/358,140
CLAIMED SUBJECT MATTER
Claims 1, 15, 29, and 3 0 are independent. Claim 1 is illustrative and
is reproduced below.
1. A method comprising:
receiving a proposed therapy dosing program that defines a
fluid therapy for delivery to a patient via a medical fluid delivery
device for a first period of time;
determining, using one or more processors, a total dosage over
a second period of time based on the proposed therapy dosing
program, wherein the total dosage is determined prior to applying the
proposed therapy dosing program to control therapy delivery to the
patient, and wherein the second period of time only partially overlaps
the first period of time, and the first period of time only partially
overlaps the second period of time; and
comparing, prior to applying the proposed therapy dosing
program to control therapy delivery to the patient, the total dosage
over the second period of time to a reference dosage defined based on
a total duration of the second period of time.
Appeal Br. 18 (Claims App'x).
REJECTI0NS 2
Claims 1-3, 5, 7-12, 15-17, 19, 21-26, 29, 30, and 34--41 are rejected
under 35 U.S.C. § 102(b) as anticipated by Gorton (US 5,009,641, iss. Apr.
23, 1991 ). Final Act. 3-15.
Claims 4, 6, 18, and 20 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Gorton and Larson (US 5,609,575, iss. Mar. 11, 1997).
Final Act. 15-18.
2 The Examiner withdrew the rejection of claim 36 under 35 U.S.C. § 112,
second paragraph, for indefiniteness. See Ans. 2; Final Act. 2.
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Appeal2017-010494
Application 13/358,140
ANALYSIS
Claims 1-3, 5, 7-12, 15-17, 19, 21-26, 29, 30, and 34-41
Rejected As Anticipated by Gorton
Appellant argues each independent claim. See Appeal Br. 8-16.
Dependent claims stand or fall with their respective independent claim.
Claims 1-3, 5, 7-12, and 36-38
The Examiner finds that Gorton discloses the method of claim 1 of
receiving a proposed therapy dosing program that defines a fluid therapy for
delivery for a first period of time when a patient requests a bolus or demand
dose from medical fluid delivery device 20. Final Act. 3. The Examiner
also finds that "the first period of time begins at the time the patient request
is made, and includes delivery of the bolus or demand dose and the length of
the lockout period after the bolus or demand dose has been delivered." Ans.
3 ("the patient's request for a bolus or demand dose constitutes a proposed
therapy of an amount of medication set to be delivered and a lockout period
afterwards, since another bolus or demand dose cannot be delivered again
until at least the lockout period expires").
The Examiner finds that Gorton also determines a total dosage over a
second period of time by checking if the lockout period has ended and then
comparing the total dosage over the second period of time to a maximum
cumulative dosage that is a reference dosage. Final Act. 3--4; Ans. 3. The
Examiner finds that the program determines whether the lockout period of
the first period of time and the maximum cumulative dosage of a second
predetermined period of time would be exceeded. Ans. 4. The Examiner
reasons that the first period of time (lockout period) only partially overlaps
the second period of time (maximum dosage period). Id.; Final Act. 3.
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Appeal2017-010494
Application 13/358,140
Appellant argues Gorton does not receive a proposed dosing program
defining a fluid therapy for delivery to a patient via a medical fluid delivery
device for a first period of time. Appeal Br. 10. Appellant also argues that
Gorton appears to define a fluid therapy delivery program only for the time
period over which the bolus or demand dose actually is administered to the
patient for the device, whereas "for a first period of time" refers to the period
of time over which the fluid therapy of the proposed therapy dosing program
would be delivered to a patient. Id. at 10, 12-13. Appellant argues that "the
first period of time under such a characterization of the technique of Gorton
would not begin until the start of the bolus or demand dose actually being
administered." Reply Br. 6. Appellant further argues that this first period of
time would not satisfy the requirement that "the second period of time only
partially overlaps the first period of time, and the first period of time only
partially overlaps the second period of time," as recited in claim 1. Id.
The Examiner reasonably interprets claim 1 to read on Gorton's drug
delivery device in which a proposed therapy dosing program that defines a
drug therapy for a patient via the device "for a first period of time" allows a
patient to request a dosage (bolus) for a first period of time that includes a
lockout period. Gorton discloses such a program that sets a demand dose
(bolus) volume, a lockout interval (minimum time between administration of
doses), and a maximum dosage allowed over a given time period. Gorton,
2 :40-45. The Examiner correctly finds that a patient request for a proposed
bolus also initiates a first period that includes a proposed lockout period.
Ans. 2-3. Appellant discloses a similar therapy program that allows a
patient to request and adjust therapy parameters and set ranges that do not
violate lockout intervals and maximum dosage limits. Spec. ,r 42.
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Appeal2017-010494
Application 13/358,140
We agree with Appellant that claim 1 requires a proposed therapy
dosing program that defines a fluid therapy that would be delivered to a
patient for a first period of time. See Appeal Br. 13. We agree with the
Examiner that Gorton discloses receiving such a proposed therapy program
that defines delivery for a first period of time, and this first period of time
begins when a patient requests a dosage. Ans. 3--4. Gorton illustrates this
first period as receiving a bolus request in Figure 4. Appellant's argument
that the first period begins when a demand dose is administered (Appeal Br.
12-13; Reply Br. 3-5) is not commensurate with claim 1. Claim 1 requires
receiving a proposed therapy dosing program that defines a fluid therapy
''for delivery to a patient" ''for a first period of time." Appeal Br. 18.
We also agree with the Examiner that Gorton determines a total
dosage over a second period of time for the proposed therapy dosing as a
maximum dosage over a given time period. Final Act. 3; Ans. 4. We agree
with the Examiner that this second period of time does not begin until after
the processor checks the lockout interval and maximum cumulative dosage,
and then determines that the lockout interval has expired and the maximum
cumulative dosage would not be exceeded for a second period of time that
begins upon completion of this control routine being performed. Gorton,
7:7--41, Fig. 4. This second period of time only partially overlaps the first
period of time set when a patient requests a bolus, and this second period of
time is only partially overlapped by the first period of time, as recited in
claim 1, and as the Examiner illustrates in the Answer. 3 See Ans. 4.
3 In this regard, we note that the Specification discloses that "the second
period of time at least partially overlaps the first period of time." Spec.
,r,r 5-8, 62 ( emphasis added).
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Appeal2017-010494
Application 13/358,140
The Examiner finds that Gorton teaches a first period of a proposed
therapy program begins when a patient requests a bolus ( designated TR) and
includes a proposed lockout period. See Ans. 4. The Examiner finds that a
second time period begins after the processor checks the total dosage and a
patient receives a therapy demand dose (designated Tc). Id. The Examiner
reasonably finds that the first period differs from the actual lockout period
and the maximum cumulative dosage of the second period because both are
set after the bolus request is cleared by a processor. Id.; see Gorton, 7:7--41,
Fig. 4. Thus, the first period of time of a proposed therapy program has a
proposed lockout period that begins before, and overlaps, a second time
period that begins when a bolus request is authorized for delivery, and an
actual lockout period and maximum dosage period are set for that dosage.
Claim 1 requires "receiving a proposed therapy dosing program that
defines a fluid therapy for delivery to a patient .. . for a first period of time."
Appeal Br. 18 (Claims App'x) (emphasis added). There is no requirement
that a dose is delivered during the first period of time.
The Examiner's findings point out another issue, however. Gorton
teaches that the lockout and maximum dosage periods are not fixed relative
to one another. In other words, a lockout period may have expired within a
maximum cumulative dosage period that has not yet expired when a patient
bolus demand is made. Thus, when Gorton's device and its administrative
controller illustrated in Figure 4 clear a dosage request for administration, a
new lockout period begins at that time; however, the maximum cumulative
dosage period may still be running at that time. Thus, the spans of the new
lockout period and the existing maximum dosage period may only partially
overlap one another when a bolus is cleared for delivery and then delivered.
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Appeal2017-010494
Application 13/358,140
Stated another way, a patient may request a bolus after the lockout
period has expired from the previous dose and the requested bolus does not
exceed the maximum dosage for the current maximum dosage period. See
Gorton, 2:40-45, 7:7-34. However, the maximum dosage period may be
near expiration such that a new lockout period that begins with an approved
bolus request only partially overlaps the existing maximum cumulative
dosage period and extends beyond the existing maximum dosage period.
Therefore, the existing maximum cumulative dosage period only partially
overlaps the new lockout interval period and the new lockout period only
partially overlaps the existing maximum cumulative dosage period.
By way of example, Gorton teaches a maximum dosage period may
be four hours. Gorton, 7: 17-25. If a lockout period is one hour, a patient
request that is less than the maximum allowable dosage, but granted at the
3 .5 hour point of the current maximum dosage period, starts a new lockout
interval of one hour that extends beyond the current four-hour max dosage
period by thirty minutes as claimed. Thus, we sustain the rejection of claim
1 and its dependent claims 2, 3, 5, 7-12, and 36-38.
Claims 15-17, 19, 21-26, 29, 30, 34, 35, and 39-41
Independent claims 15, 29, and 30 recite systems and a computer-
readable medium that involve first and second periods of time as recited in
claim 1. See Appeal Br. 18, 21, 24, 25. Appellant argues that these claims
are patentable at least for the reasons provided for claim 1 including the non-
overlapping first and second time periods. Id. at 15-16. This argument is
not persuasive for the reasons discussed above for claim 1. Thus, we sustain
the rejection of claims 15, 29, and 30 and their respective dependent claims
16, 17, 19, 21-26, 34, 35, and 39--41.
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Appeal2017-010494
Application 13/358,140
Claims 4, 6, 18, and 20
Rejected As Unpatentable over Gorton and Larson
The Examiner relies on Larson to teach an indicator of whether a
selected infusion rate is valid or not. Final Act. 16. Appellant argues that
Larson does not overcome the deficiencies of Gorton as to independent
claims 1 and 15 from which claims 4, 6, 18, and 20 respectively depend.
Appeal Br. 17. Because we sustain the rejection of claims 1 and 15, this
argument is not persuasive and we also sustain the rejection of claims 4, 6,
18, and 20.
DECISION
We affirm the rejections of claims 1-12, 15-26, 29, 30, and 34--41.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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