Ex Parte Hartlaub

Board of Patent Appeals and Interferences

Jun 8, 2012

10000701 (B.P.A.I. Jun. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
___________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
___________

Ex parte JEROME T. HARTLAUB
___________

Appeal 2010-010639
Application 10/000,701
Technology Center 3600
___________

Before ANTON W. FETTING, JOSEPH A. FISCHETTI, and
BIBHU R. MOHANTY, Administrative Patent Judges.
FETTING, Administrative Patent Judge.
DECISION ON APPEAL

1
Appeal 2010-010639
Application 10/000,701

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STATEMENT OF THE CASE 1
Jerome T. Hartlaub (Appellant) seeks review under 35 U.S.C. § 134 2
(2002) of a final rejection of claims 1, 3-6, 8-10 and 43-51, the only claims 3
pending in the application on appeal. We have jurisdiction over the appeal 4
pursuant to 35 U.S.C. § 6(b) (2002). 5
The Appellant invented automated drug management systems and 6
methods for implantable drug delivery devices. (Specification ¶ 04). 7
An understanding of the invention can be derived from a reading of 8
exemplary claim 1, which is reproduced below [bracketed matter and some 9
paragraphing added]. 10
1. A computing device 11
in communication with an implantable drug delivery 12
device 13
for delivering at least one drug to a patient, 14
the computing device comprising in combination: 15
(a) a drug management module 16
configured to determine whether a drug in a reservoir of 17
the implantable drug delivery device should be 18
replenished 19
based upon at least one drug usage parameter 20
received via telemetry from a drug monitor module 21
of the implantable drug delivery device, 22
the at least one drug usage parameter associated 23
with the drug in the reservoir of the implantable 24
drug delivery device, 25
wherein the at least one drug usage parameter 26
comprises 27
the amount of at least one drug remaining in 28
the implantable drug delivery device; 29
(b) a scheduling module 30
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for scheduling an appointment 1
to refill the implantable drug delivery device; 2
( c ) a memory 3
for storing therein 4
the drug management module, 5
the scheduling module, 6
and 7
at least one drug treatment parameter, 8
the drug treatment parameter stored in the memory 9
comprising drug management instructions 10
providing refill instruction specific to the drug In 11
the reservoir 12
and wherein 13
the determination by the drug management module is 14
also based upon 15
drug management instructions, 16
the drug management instructions 17
comprising order replacement drug a 18
predetermined number of days before an 19
estimated drug exhaustion date; 20
and 21
(d) a telemetry module 22
configured to provide bi-directional communication 23
between 24
the computing device 25
and 26
the implantable drug delivery device. 27
28
Appeal 2010-010639
Application 10/000,701

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The Examiner relies upon the following prior art: 1
Pilarczyk US 4,766,542 Aug. 23, 1988
Townsend US 5,810,198 Sep. 22, 1998
Gibbs US 5,871,526 Feb. 16, 1999
Lebel US 2002/0016568 A1 Feb. 7, 2002
Brown US 2004/0015132 A1 Jan. 22, 2004
Peterson US 2004/0064097 A1 Apr. 1, 2004
Claims 1 and 43-51 stand rejected under 35 U.S.C. § 103(a) as 2
unpatentable over Lebel, Pilarczyk, Peterson, and Townsend.1 3
Claim 4 stands rejected under 35 U.S.C. § 103(a) as unpatentable over 4
Lebel, Pilarczyk, Peterson, Townsend, and Gibbs. 5
Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable over 6
Lebel, Pilarczyk, Peterson, Townsend, Gibbs, and Official Notice. 7
Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over 8
Lebel, Pilarczyk, Peterson, Townsend, Brown, and Gibbs. 9
Claims 3, and 8-10 stand rejected under 35 U.S.C. § 103(a) as 10
unpatentable over Lebel, Pilarczyk, Peterson, Townsend, and Brown. 11
ISSUES 12
The issues of obviousness turn primarily on whether it was predictable 13
to use a scheduling module and number of days lead time for a drug refill 14
with Lebel, and whether instructions using such number of days could 15
distinguish the claims over the art. 16

1 The Examiner withdrew an objection to claims 1, 3-6, 8-10 and 49-51.
Ans. 13.
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FACTS PERTINENT TO THE ISSUES 1
The following enumerated Findings of Fact (FF) are believed to be 2
supported by a preponderance of the evidence. 3
Facts Related to the Prior Art 4
Lebel 5
01. Lebel is directed to ambulatory medical systems that include a 6
microprocessor controlled ambulatory medical device and a separate control 7
device that communicates via telemetry where the medical device has 8
enhanced functionality, safety features, failure detection, and/or alarming 9
capabilities. Preferred embodiments relate to implantable infusion pumps 10
and external devices for communicating therewith. Lebel para. [0002]. 11
02. Lebel describes an implantable infusion pump for selectively 12
dispensing a drug having a battery in the first housing and a reservoir for the 13
drug within the second housing, with a connection lead. The processor and 14
telemetry system are also located within the first housing and a pumping 15
mechanism is located within the second housing. Lebel para. [0060]. 16
03. Lebel has a memory for storing information related to the 17
amount of drug dispensed with each unit of activation of the pumping 18
mechanism and uses this information in calculating delivery amounts to 19
program into the medical device. Lebel para. [0076]. 20
04. An external communication device is capable of displaying an 21
estimate of the amount of medication remaining in the insulin reservoir and 22
is programmed to alarm when the medication remaining becomes less than a 23
predefined low-reservoir threshold. Low-reservoir threshold alarms are 24
reasserted after clearing if appropriate actions have not been taken to resolve 25
the condition that gave rise to the error or event (e.g. refilling of the 26
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reservoir has not been completed). Once the low-reservoir alarm is cleared, 1
and a predetermined period of time has lapsed and the system determines 2
that the reservoir has not yet been refilled, the alarm will be reasserted so as 3
to provide the user with a reminder to have the reservoir refilled. Lebel 4
para. [0179]. 5
05. The implantable device and external communication device 6
retain clinical history information as records of various events that the 7
system tracks. For example, events that stop the delivery of insulin such as 8
alarms are recorded in the clinical history. User-initiated events such as 9
suspend mode that stop the delivery of insulin are also recorded. Refills are 10
also recorded. The system also contains logs for system diagnostics such as 11
implantable device battery levels. Through menu options, the user may view 12
these various history logs. Lebel para. [0180]. 13
06. The implantable device includes a reservoir for holding a 14
desired quantity of the drug. The drug is added to the reservoir by means of 15
a transcutaneous needle that is passed from a position exterior to the body 16
into a self-sealing refill port. Lebel para. [0206]. 17
18
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Pilarczyk 1
07. Pilarczyk is directed to automated prescription drug refill 2
systems used in a pharmacy to automatically contact customers whose 3
prescriptions need to be refilled. Pilarczyk 1:7-11. 4
08. Pilarczyk contacts patients whose prescriptions are due to be 5
refilled by automatically telephoning each customer whose prescription 6
needs refilling. The contact is made with a computer driven voice 7
synthesizer which delivers a personalized message identifying the customer, 8
the drug in question and the prescription number. Pilarczyk 1:52-61. 9
09. The telephone dialer and voice synthesizer read data from a 10
schedule file. The schedule file lists all prescriptions issued by the 11
pharmacy according to the date when the customer (patient) should require 12
more medication. The schedule file is updated regularly based on 13
prescription refill activity at the pharmacy. The system takes as input 14
customer identification information, the drug prescribed, the dose 15
prescribed, and the number of doses given to the customer. From this 16
information, it calculates the day the customer's supply of the prescribed 17
drug should run out. This date is the date entered in the schedule file. 18
Pilarczyk 1:62 – 2:5. 19
10. The pharmacist may periodically review the contents of the 20
schedule file to note those customers whom he does not want to contact 21
concerning refills. The pharmacist may choose not to contact a customer 22
because the customer is clearly a transient, or for some other reason. All 23
other customers on the schedule file are identified as ones to be called. 24
Pilarczyk 2:6-12. 25
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11. After those customers whom the pharmacist wishes to contact 1
have been flagged on the schedule file, the pharmacist selects that group of 2
customers from the schedule file whose prescriptions have certain refill 3
dates. For example, the pharmacist may choose to contact all customers 4
whose prescriptions will expire during the next two weeks. Alternatively, he 5
may choose to contact all patients whose prescriptions expired in the 6
previous two weeks and who have not refilled their prescriptions. After this 7
choice has been made, the automatic customer contacting system takes over. 8
The device automatically dials each customer's designated phone number, 9
identifies the person whose prescription needs refilling, the prescription to 10
be filled and its refill date. The system then asks the customer to confirm 11
that the message has been received. This process is repeated by the 12
automatic telephoning equipment until each person on the schedule file has 13
either been reached, or the system has made a number, e.g., at least four, 14
unsuccessful attempts to contact the customer. Pilarczyk 2:13-34. 15
12. A schedule file is created by operating on the refill notification 16
records. The actual refill notification records in the schedule file are 17
provided to detect from the refill notification records when it is appropriate 18
to communicate refill information to a patient. Pilarczyk 5:50-61. 19
13. An ongoing review of prescription activity is carried out prior 20
to sending the information to the schedule file. All prescriptions without 21
refills which were part of the pharmacy's daily activity are filtered so that 22
data concerning them is not sent to the schedule file. The data base includes 23
additional information beyond that in the schedule file on the number of 24
refills, the date of last refill, the prescribing doctor and his D.E.A. number, 25
etc. Pilarczyk 6:15-28. 26
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14. The ongoing review of prescription activity is initiated by the 1
pharmacist. The data reflecting the daily (or some other time period) 2
prescription activity are then culled and the more limited data required by 3
the schedule file are forwarded to the schedule file. In this way the schedule 4
file is kept current. Pilarczyk 6:29-45. 5
15. Pilarczyk calculates the refill due date based on the daily 6
prescription activity. From the number of refills prescribed, the date of the 7
last refill dispensed, the days’ supply dispensed at that time, the number of 8
refills remaining and an internal calendar, a refill due date is calculated. All 9
records are stored in the schedule file based on this calculated refill due date. 10
When the records indicate that there are no refills remaining, the prescription 11
record is automatically culled and not forwarded to the schedule file 46. 12
Pilarczyk 6:46-55. 13
Peterson 14
16. Peterson is directed to administration of a medicinal fluid to a 15
patient with low-cost, easy-to-use infusion systems for the intravenous 16
dispensing of a fluid prescription. Peterson para. [0002]. 17
17. A chip in Peterson’s system contains electronically readable 18
information relating to the name of an active ingredient in the prescription; 19
the chemical name of a prescription carrier; additives in the prescription; 20
volume of the prescription; expiration date; name of a prescribing doctor; 21
name of a private loader; name of a local supplier/manufacturer of 22
ingredients of the prescription; source of at least some materials in the 23
prescription; a name of a therapy bag manufacturer; a name of a pharmacist; 24
a patient name; patient information relating to at least one of age, allergies, 25
address, frequency of prescription refill, weight, chemical intolerances, 26
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instructions for a flow control module with respect to desired flow rates; 1
intervals for delivery; rate and volume of delivery; and drip rate. Peterson 2
para. [0013]. 3
Townsend 4
18. Townsend is directed to a tablet dispenser for dispensing tablets 5
by activation of a pushbutton actuator. The tablet dispenser has a jam-proof 6
tablet dispensing mechanism; reminds the user to take tablets in a timely 7
manner and reminds the user when the supply of tablets is low, so that a 8
prescription may be timely refilled; has an enclosure having a surface area of 9
sufficient area to adequately label the medicine contained, even if large type 10
is used; and is electronically programmable, either by the user or the 11
manufacturer, to indicate that it is time to take a tablet, to prevent the user 12
from taking a tablet until it is time. Townsend 2:19-32. 13
ANALYSIS 14
We are not persuaded by the Appellant’s argument that none of the 15
references describe scheduling an appointment to refill the implantable drug 16
delivery device. Appeal Br. 13-15. 17
First, as the Examiner found at Answer 6, Pilarczyk uses a schedule 18
file that results in a medical practitioner (pharmacist) performing appointed 19
tasks required for refills. FF 07-15. Second, Lebel uses an implantable 20
device with a reservoir that must be refilled with a needle. FF 01- 06. 21
Appellant contends that Lebel states a concern for greater user 22
involvement, but provides no citation to support this contention, and a word 23
search of Lebel fails to show such a description in Lebel. We find 24
Appellant’s hypothesis that such a desire for greater user involvement would 25
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suggest the patient performing this refill procedure himself (Appeal Br. 15), 1
particularly injecting large quantities of highly medically problematic drugs 2
such as insulin, to be improbable, except for some rare circumstances with 3
highly trained patients. One of ordinary skill would have found it far more 4
predictable that someone other than the patient would perform the refill 5
operation given such conditions. 6
Third, both Lebel and Pilarczyk describe determining when a 7
prescription will run out, and Pilarczyk in particular describes scheduling 8
someone to perform the refill. These facts combine to show it was at least 9
predictable that Lebel would have scheduled an appointment to refill the 10
drug. 11
We are not persuaded by the Appellant’s argument that Townsend 12
fails to describe drug management instructions to order a replacement drug a 13
predetermined number of days before an estimated drug exhaustion date. 14
Appeal Br. 15-16. As the Examiner found, Townsend sends a signal when 15
the drug level is low so it may be timely refilled. Clearly such timing refers 16
to the refill lead time. In any event, we further find that using lead time in 17
the inventory management arts is notoriously well known, taught in entry 18
level inventory management courses, and the claimed instructions as to 19
number of days are aspirational and accordingly non-functional and so 20
cannot distinguish the claims over the art. 21
CONCLUSIONS OF LAW 22
The rejection of claims 1 and 43-51 under 35 U.S.C. § 103(a) as 23
unpatentable over Lebel, Pilarczyk, Peterson, and Townsend is proper. 24
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The rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable 1
over Lebel, Pilarczyk, Peterson, Townsend, and Gibbs is proper. 2
The rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable 3
over Lebel, Pilarczyk, Peterson, Townsend, Gibbs, and Official Notice is 4
proper. 5
The rejection of claim 6 under 35 U.S.C. § 103(a) as unpatentable 6
over Lebel, Pilarczyk, Peterson, Townsend, Brown, and Gibbs is proper. 7
The rejection of claims 3, and 8-10 under 35 U.S.C. § 103(a) as 8
unpatentable over Lebel, Pilarczyk, Peterson, Townsend, and Brown is 9
proper. 10
DECISION 11
The rejection of claims 1, 3-6, 8-10 and 43-51 is affirmed. 12
No time period for taking any subsequent action in connection with 13
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 14
§ 1.136(a)(1)(iv) (2007). 15
16
AFFIRMED 17
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Klh 22