Ex Parte Vanderveen et al

Board of Patent Appeals and Interferences

May 9, 2011

10361704 (B.P.A.I. May. 9, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE 1
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3
BEFORE THE BOARD OF PATENT APPEALS 4
AND INTERFERENCES 5
___________ 6
7
Ex parte TIMOTHY W. VANDERVEEN and 8
RICHARD M. BATCH 9
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11
Appeal 2010-004477 12
Application 10/361,704 13
Technology Center 3600 14
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Before HUBERT C. LORIN, ANTON W. FETTING, and 17
BIBHU R. MOHANTY, Administrative Patent Judges. 18
FETTING, Administrative Patent Judge. 19
DECISION ON APPEAL 20
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STATEMENT OF THE CASE1 1

1 Our decision will make reference to the Appellants’ Appeal Brief (“App.
Br.,” filed May 22, 2009) and the Examiner’s Answer (“Ans.,” mailed
November 16, 2009).
Timothy W. Vanderveen and Richard M. Batch (Appellants) seek review 2
under 35 U.S.C. § 134 (2002) of a final rejection of claims 2-7, 9, and 10, 3
the only claims pending in the application on appeal. We have jurisdiction 4
over the appeal pursuant to 35 U.S.C. § 6(b) (2002). 5
The Appellants invented a way of managing information with respect to 6
medical care, medication delivery, asset identification, and verification of 7
drug delivery (Specification 1:5-8). 8
An understanding of the invention can be derived from a reading of 9
exemplary claim 2, which is reproduced below [bracketed matter and some 10
paragraphing added]. 11
2. A system for use with a medication administration device for 12
reducing the possibility of medication errors, the system 13
comprising: 14
[1] a first program configured 15
to accept user inputs 16
related to medication administration device 17
operating parameters limits and 18
to generate a data base from those user inputs; 19
[2] a second program 20
located in a medication administration device 21
configured 22
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to receive the medication administration device 1
parameter data base generated by the first program, 2
the second program also configured 3
to compare 4
medication administration device parameters 5
programmed into the medication 6
administration device by an operator with 7
a second data base of institutionally 8
accepted guidelines, 9
the second program also configured 10
to monitor the comparison and 11
if the comparison exceeds the limits 12
established in the second data base, 13
provide an indication to the 14
medication administration device 15
operator 16
that the programmed operating 17
parameter is outside the limits 18
in the second data base; and 19
[3] communication means for communicating 20
the indication that the programmed operating parameter 21
is outside the limits of the second database 22
to an event log database, 23
[4] wherein if the comparison exceeds a hard limit, 24
the second program is configured 25
to prevent the operator from initializing operation 26
of the medication administrative device. 27
The Examiner relies upon the following prior art: 28
Ford US 5,681,285 Oct. 28, 1997
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Claims 1-7, 9, and 10 stand rejected under 35 U.S.C. § 102(b) as 1
anticipated by Ford. 2
ISSUES 3
The issue of anticipation turns on whether Ford is configured to prevent 4
the operator from initializing operation of the medication administrative 5
device as recited in limitation [4]. 6
FACTS PERTINENT TO THE ISSUES 7
The following enumerated Findings of Fact (FF) are believed to be 8
supported by a preponderance of the evidence. 9
Facts Related to the Prior Art - Ford 10
01. Ford is directed to programmable drug infusion pumps. Ford 11
1:9-10. 12
02. Ford creates a customized drug library for an electronically 13
loadable drug infusion pump. Associated with each drug entry is 14
a set of associated drug delivery parameters and/or drug delivery 15
protocols for configuring the drug infusion pump. Ford lets one 16
select a set of drug entries, add the selected drug entries along 17
with the sets of drug delivery information to a customized library; 18
and load the customized library into the drug infusion pump. 19
Ford 2:66 – 3:9. 20
03. Each of the associated sets of drug delivery parameters includes 21
information selected from a group of parameters including drug 22
concentration, drug delivery rate, drug dose, and bolus size. The 23
group of parameters includes minimum, default and maximum 24
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drug delivery rate; minimum, default and maximum dose; 1
minimum, default and maximum bolus size; and maximum bolus 2
rate. Ford 3:13-19. 3
04. The set of features includes a volume limit detection flag, 4
wherein the volume limit flag either enables or disables, 5
depending upon the condition of the volume limit flag, a function 6
within the pump that enables the user to specify a volume limit for 7
a drug delivery configuration when the customized library is 8
loaded into the drug infusion pump. Ford 4:12-17. 9
05. Selecting is normally disabled and password protection serves 10
to enable the selection only if a system user supplies a preselected 11
password to the password protection logic. There are many access 12
levels, each of which corresponds to a different set of access 13
privileges in the system and a table associates each user with a 14
corresponding access level. Ford 4:20-30. 15
06. The pump includes a means for preventing the controller from 16
running the drive mechanism if the current date is later than the 17
expiration date. Ford 6:8-10. 18
07. Ford sets a minimum, default, and maximum dose and bolus 19
rate. The range from minimum dose to maximum dose defines the 20
therapeutic range of the drug, i.e., the dose range over which the 21
drug should generally be used to effectively achieve the intended 22
therapeutic effects. Ford 16:57-62. 23
08. For both dose and Bolus administration, Ford checks both 24
predefined limits for the pump itself and predefined limits for the 25
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administered drug. Any dosage or Bolus entry outside the pump 1
limit will simply cause the entry to be reset to the nearest pump 2
limit. For checking against predefined dosage and Bolus limits, 3
Ford first checks whether the current programmed entry is within 4
the predefined limits. If the current entry is not, Ford then checks 5
whether the previous programmed entry was also outside the 6
predefined limits, on the same side of the limits (i.e. below the 7
minimum or above the maximum). If both the current and 8
previous entries exceeded the predefined limits in the same 9
direction, then Ford’s pump will display "DOSE [or RATE or 10
BOLUS]>nnn" or if the previously programmed value was also 11
out of range for the drug, and in the same direction, it will display 12
"DOSE [or RATEor BOLUS]nnn" or "VERIFY to verify the 19
desired value, or use , or digit or arrow keys to change the 20
displayed value. Ford 23:53 – 24:67. 21
ANALYSIS 22
We are unpersuaded by the Appellants’ argument that Ford fails to 23
describe limitation [4] that if the comparison exceeds a hard limit, a second 24
program is configured to prevent the operator from initializing operation of 25
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the medication administrative device. Appeal Br. 14-16. Ford checks for 1
whether a programmed dosage level is outside the predefined limits. If it is 2
outside those limits, and is not simply a repeat of the earlier dosage also 3
outside those limits, Ford stops the dosage administration and requests 4
confirmation before allowing dose administration to proceed. FF 08. Thus, 5
Ford interrupts the dosage administration in such an event. 6
The Appellants contend this interruption does not prevent the operator 7
from initializing operation of the device. The Appellants found that the term 8
"prevent", is defined in Webster's 9th New Collegiate Dictionary, as: "to 9
keep from happening." We have verified this definition. We find that 10
interrupting the dose administration as in Ford keeps the operator from 11
initializing operation of the device, at least until the operator confirms the 12
value that is being programmed. 13
The Appellants contend that it remains possible for the operator to 14
override Ford’s interruption. We agree, but find this is irrelevant, as the 15
scope of the claim encompasses prevention that is subsequently overridden. 16
The claim is simply silent as to any response to the last limitation. 17
To the extent the Appellants contend that the verb “prevent” implies no 18
capacity for being overridden, the Appellants have provided no evidence of 19
this, and in fact, most if not all preventive mechanisms are capable of being 20
overridden in some manner. 21
The Appellants point to examples in the Specification in which 22
conventional programming would be thwarted following prevention, but 23
these are purely exemplary, as no definition or further claim limitation 24
narrows the scope of the claims to only those examples. 25
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CONCLUSIONS OF LAW 1
The rejection of claims 1-7, 9, and 10 under 35 U.S.C. § 102(b) as 2
anticipated by Ford is proper. 3
DECISION 4
The rejection of claims 1-7, 9, and 10 under 35 U.S.C. § 102(b) as 5
anticipated by Ford is sustained. 6
No time period for taking any subsequent action in connection with this 7
appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 8
§ 1.136(a)(1)(iv) (2007). 9
10
AFFIRMED 11
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mev 16
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