Ex Parte Ullestad et al

Board of Patent Appeals and Interferences

Feb 13, 2012

10836589 (B.P.A.I. Feb. 13, 2012)

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.
10/836,589 04/30/2004 David C. Ullestad 151P09592US01 8747
54228 7590 02/13/2012
IPLM GROUP, P.A.
POST OFFICE BOX 18455
MINNEAPOLIS, MN 55418
EXAMINER
EISENBERG, REBECCA E
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
02/13/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID C. ULLESTAD and MARK J. BINA
__________

Appeal 2010-008840
Application 10/836,589
Technology Center 3700
__________

Before DONALD E. ADAMS, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) from the
rejection of claims directed to an implantable medical device. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
An implanted medical device delivering either electrical stimulation
or a drug to a patient will eventually exhaust its power or its drug supply.
According to the Specification, timing power or drug supply replenishment
in such devices has been based on assumptions. (Spec. 2-3.) A problem
with the prior assumptions is said to be that “all of these assumptions taken
together may also dictate a replenishment time which is substantially earlier
than may be actually required.” (Id. at 3, [9].) “The present invention
solves these problems by providing an implantable medical device that can
determine with greater accuracy than was previously possible the time at
which the implantable medical device should be replenished.” (Id., [12].)
Claims 1-54 are on appeal. Claim 1 is illustrative and reads as
follows:
1. An implantable medical device for producing a variable therapeutic
output to a patient into which said implantable medical device is adapted to
be implanted, comprising:
a therapeutic output delivery module adapted to be coupled to said
patient and to deliver said variable therapeutic output to patient, said
therapeutic output delivery module requiring replenishment following
delivery of a predetermined amount of said therapeutic output;
a measure representative of an amount of said therapeutic output
actually delivered to said patient; and
a calculator responsive to said measure for determining a parameter
representative of a time in the future at which said therapeutic output
delivery module of said implantable medical device should be replenished
with said therapeutic substance based at least in part upon said amount
obtained from said measure. (Emphasis added.)

In an Examiner’s Answer entered March 25, 2010, the Examiner
rejected the claims as follows:
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 claims 1-3, 5-9, 14, 15, 17-21, 24-26, 28-31, 36, 41, 42, 44-47, and 52
under 35 U.S.C. § 102(e) as anticipated by Hansen;1
 claims 4, 16, 27, and 43 under 35 U.S.C. § 103(a) as unpatentable over
Hansen and Ullestad;2
 claims 10-13, 22, 23, 37-40, 53, and 54 under 35 U.S.C. § 103(a) as
unpatentable over Hansen and Hartlaub;3
 claims 32-35 and 48-51 under 35 U.S.C. § 103(a) as unpatentable over
Hansen;
 claims 1-3, 5-9, 14, 15, 17-21, 24-26, 28-31, 36, 41, 42, 44-47, and 52
under 35 U.S.C. § 103(a) as unpatentable over Hansen and Dingler;4
 claims 4, 16, 27, and 43 under 35 U.S.C. § 103(a) as unpatentable over
Hansen, Dingler and Ullestad;
 claims 10-13, 22, 23, 37-40, 53, and 54 under 35 U.S.C. § 103(a) as
unpatentable over Hansen, Dingler, and Hartlaub.

1 Steffen Hansen et al., WO 2004/028596 A1, published April 8, 2004.
2 David C. Ullestad et al., US 2003/0204274 A1, published Oct. 30, 2003.
3 Jerome T. Hartlaub, US 2002/0087113 A1, published July 4, 2002.
4 Geoffrey L. Dingler et al., US 7,231,928 B2, filed May 20, 2003.
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Appellants’ Reply Brief states that the Patent Examiner took
inconsistent positions in Office actions, an earlier Examiner’s Answer
mailed Jan. 8, 2010, and the Examiner’s Answer entered March 25, 2010.
(Reply Br. 8-10.) This Decision reviews the rejections presented in the
Examiner’s Answer entered March 25, 2010, and the arguments presented in
Appellants’ responsive Reply Brief filed May 25, 2010, and Appellants’
Appeal Brief filed Nov. 12, 2009.
ANTICIPATION
The Issues
Appellants contend that
Hansen et al ‘596 does not show, disclose or suggest a
calculator, responsive to an amount of therapeutic output or substance
actually delivered to the patient, for determining a parameter
representative of a time in the future at which the [device] should be
replenished (claim 1, lines 8 - 13; claim 14, lines 7 - 12; claim 24,
lines 8 - 21; claim 41, lines 7 - 18). While Hansen et al ‘596 discloses
that “the pump may be of the metering type ... the infusion unit may
be provided with detecting means for determining the amount of drug
actually infused”, (page 9, lines 15 - 18), Hansen et al ‘596 does not
then disclose any structure which provides an ability to identify an
amount of drug “actually infused.” Instead, Hansen et al ‘596
proceeds to disclose only tracking the remaining amount of drug in
the pump reservoir based on a current rate of delivery and tracking
when boluses are triggered (page 11, lines 29 - 30). . . . Thus, while
Hansen et al '596 uses the words “means for determining the amount
of drug actually infused”, the only disclosed embodiments do less and
only estimate the amount of drug infused using programmed
parameters and, hence, Hansen et al '596 does not provide an enabling
disclosure of a monitor for measuring the amount of drug actually
infused . . . .

(App. Br. 13-14.)
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Findings of Fact
1. The Examiner’s findings concerning the Hansen disclosure may be
found at Answer 3-12.
2. Hansen’s disclosure
relates to an indicating device for conveniently providing a user of a
portable drug delivery device with information in respect of the
delivery process, as well as a system comprising a drug delivery
system in combination with an indicating device.

(Hansen 1, ll. 5-7.)
3. Hansen disclosed
a drug delivery system (here: infusion system) 100 comprises an
infusion device 101 and an indicating device 102. The infusion device
comprises an infusion unit 111 having a drug reservoir and a pump
adapted for infusing a drug into a body of a user in accordance with
instructions received from a first processor 121. The pump may be of
the metering type, i.e. the amount of drug infused corresponds to the
controlling signals received from the processor or the infusion unit
may be provided with detecting means for determining the amount of
drug actually infused. The first processor is associated with a
transmitter 131 for transmitting data information (in the following
also just data) to the indicating device. The data comprises
information as to initial amount of drug in the reservoir, the current
amount of drug in the reservoir, the infusion rate and ID information
identifying the given infusion device. An energy source 141 is
provided in the form of a battery.
The indicating device comprises a second processor 122 associated
with a receiver 132 for receiving data from the first processor, as well
as a timer means 123 and memory means 124 for storing the received
data. The second processor is adapted for calculating an estimated
time-dependent value based upon the received data and time
information, and is associated with display means 112 for indicating a
calculated value.

(Id. at 9, ll. 12-28, emphasis added.)

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3. Ordinary meanings for the adjective “representative” include:
1. serving to represent; symbolic
2. a. exemplifying a class or kind; typical a representative
example of the species
b. containing or including examples of all the interests, types, etc.,
in a group a representative collection
3. acting as deputy or proxy for another or others

(Collins English Dictionary – Complete and Unabridged ©
HarperCollins Publishers 2003.)5
Principles of Law
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). The test under § 102 is
“whether one skilled in the art to which the invention pertains could take the
description of the invention in the printed publication and combine it with
his own knowledge of the particular art and from this combination be put in
possession of the invention on which a patent is sought.” In re LeGrice, 301
F.2d 929, 939 (CCPA 1962); see also In re Elsner, 381 F.3d 1125, 1128
(2004) (“In particular, one must be able to make the claimed invention
without undue experimentation.”).
Analysis
Appellants argue claims 1, 14, 24, and 41 separately.
A. Claim 1
Appellants focus their arguments on whether Hansen’s device
comprised the claimed “measure representative of an amount of said

5 Available at www.thefreedictionary.com/representative, accessed Jan. 25,
2012.
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therapeutic output actually delivered to said patient” and “calculator
responsive to said measure.” The arguments are unpersuasive.
Contrary to Appellants’ contentions, claim 1 does not require a
measure of the actual amount of therapy delivered to a patient, nor does it
require a calculator responsive to the actual amount. Claim 1 defines an
implantable medical device comprising, among other elements, “a measure
representative of an amount of said therapeutic output actually delivered to
said patient,” and a calculator responsive to the representative measure.
Ordinary meanings for the adjective “representative” include “symbolic” or
“acting as proxy for.” (FF 3.) Thus claim 1 requires a measure symbolic of,
or proxy for, the amount of output actually delivered, and a calculator
responsive to the symbolic or proxy measure for determining another
parameter representative of, symbolic of, or proxy for, the future
replenishment time. The claim does not require any degree of accuracy in
the representative measure or the representative parameter. To read the
claims as Appellants wish would effectively read the term “representative”
out of the claim. The term “representative” cannot be ignored, and
Appellants provide no basis for reading the claim narrowly enough to vitiate
the meaning of representative. Appellants also contend that Hansen’s
teaching to use a monitor with detecting means for determining the amount
of drug actually infused was not enabled. As claim 1 is not limited to a
measure of drug actually infused, we need not address the enablement
argument. Instead, we agree with the Examiner that Hansen anticipated
claim 1, even if Hansen enabled using only estimated, i.e., representative,
symbolic, or proxy, amounts of drug delivered.
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Claims 2, 3, and 5-9 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
B. Claims 14, 24 and 41
Claim 14 defines an implantable drug pump comprising, among other
elements, “a measure determining an amount based at least in part on an
amount of said therapeutic substance actually delivered to said patient,” and
a calculator responsive to the measure. Claim 24 defines an implantable
medical device comprising, among other elements, “a measure determining
an amount of said therapeutic output actually delivered to said patient,” and
“a comparator.” Claim 41 defines an implantable drug pump comprising,
among other elements, “a measure determining an amount based at least in
part on a quantity of said therapeutic substance actually delivered to said
patient” and “a comparator.”
Appellants contend that Hansen does not show, disclose or suggest the
measure based at least in part on the amount actually delivered, nor a
calculator or comparator responsive to such a measure. (App. Br. 16-17.)
Appellants acknowledge that Hansen explicitly mentioned using a
monitor with detecting means for determining the amount of drug actually
infused, but argue that Hansen did not provide an enabling disclosure of that
monitor, and therefore did not enable the claimed measure. (App. Br. 14.)
Hansen stated that “the infusion unit may be provided with detecting means
for determining the amount of drug actually infused.” (FF 3.) In their brief,
Appellants provide an explanation showing that Hansen described other
embodiments of its invention, but not a monitor and means for detecting
actual amounts of drug infused. In response, the Examiner does not point to
a further description of such means in Hansen’s disclosure, by which Hansen
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may have enabled a measure of drug actually delivered. The Examiner
argues instead that Hansen’s calculator had the capability of calculating how
much drug had actually been delivered. (Ans. 42-43, citing Hansen 5, ll. 11-
30, and 6, ll. 8-15.) This argument is unpersuasive for two reasons. First,
the cited Hansen passages describe estimating drug amounts, not measuring
actual amounts delivered. Second, this argument puts the cart before the
horse. As Appellants point out, the calculator defined in Claim 14, like the
comparator in claims 24 and 41, is responsive to the measure, it does not
calculate the measure. Thus, even if Hansen described a calculator having
the capability to produce a measure of drug actually infused, that capability
would not account for the calculator or comparator defined in Appellants
claims, which operates on the measure rather than producing the measure.
To find anticipation, the prior art elements themselves must be “arranged as
in the claim,” which means that claims cannot be “treated ... as mere
catalogs of separate parts, in disregard of the part-to-part relationships set
forth in the claims and that give the claims their meaning.” Lindemann
Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1458-
59 (Fed. Cir. 1984).
On these facts, the rejection presented a prima facie case for
anticipation by citing Hansen’s explicit disclosure that the infusion unit may
be provided with detecting means for determining the amount of drug
actually infused. Appellants challenged the prima facie case by reasonably
questioning whether Hansen’s mention of such means was enabling.
Appellants’ explanation, showing that the components Hansen did describe
in detail were incapable of providing the measure, was effective to shift the
burden back to the Examiner to produce evidence or reasoning showing that
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Hansen provided an enabling description of the means, or that the necessary
description was part of the knowledge in the art, or that the means was
enabled in some other way. See LeGrice, 301 F.2d at 939; Elsner, 381 F.3d
at 1128. The Examiner’s responsive argument did not produce the necessary
evidence or reasoning. Therefore, we reverse the anticipation rejection of
claims 14, 24, and 41, and their dependent claims because, on this record,
Hansen did not enable its teaching of a means for determining the amount of
drug actually infused.

OBVIOUSNESS
A. The rejection of claims 4, 16, 27, and 43 over Hansen and Ullestad;
the rejection of claims 10-13, 22, 23, 37-40, 53, and 54 over Hansen
and Hartlaub; and
the rejection of claims 32-35 and 48-51 over Hansen.

The claims rejected are all dependent on one of independent claims 1,
14, 24, and 41, respectively. The Examiner entered these obviousness
rejections based on an underlying finding that Hansen disclosed the
“measure” defined in the independent claims, as discussed in the
“Anticipation” section above. Thus, the Examiner directed these
obviousness rejections to additional features added in these particular
dependent claims.
Regardless of the specific features addressed in each obviousness
rejection, and the additional evidence upon which each rejection is based,
Appellants present the same argument against every obviousness rejection:
neither Hansen nor Ullestad nor Hartlaub described the “measure” and the
calculator or comparator defined in the claims, and together they do not
suggest them. (App. Br. 18-27.) We found, however, that Hansen did
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describe the measure and calculator recited in claim 1 and did anticipate
claim 1. We therefore affirm the obviousness rejections of the claims
dependent from claim 1: claims 4 and 10-13.
As to the claims dependent on claims 14, 24, and 41, we agree with
Appellants that the obviousness rejections did not account for the evidence
deficiency as to the measure and the calculator or comparator. (See
Anticipation section above.) We therefore reverse the obviousness
rejections of the claims dependent from claims 14, 24, and 41: claims 16,
22, 23, 27, 32-35, 37-40, 43, 48-51, 53, and 54.

B. The rejection of claims 1-3, 5-9, 14, 15, 17-21, 24-26, 28-31, 36, 41,
42, 44-47, and 52 over Hansen and Dingler;
the rejection of claims 4, 16, 27, and 43 over Hansen, Dingler and
Ullestad; and
the rejection of claims 10-13, 22, 23, 37-40, 53, and 54 over Hansen,
Dingler, and Hartlaub.

These rejections were new grounds of rejection added in the Answer.
The Examiner explains:
To the extent that appellant has argued that Hansen does not teach that
the calculator is for determining a parameter representative of a time
in the future at which said therapeutic output delivery module of said
implantable medical device should be replenished, Dingler teaches
that it is known to use an estimator to determine a time when the
pump will be empty and discloses the pump to be controlled by a
controller (Col. 7 In. 49-57).
It would have been obvious to one of ordinary skill in the art at the
time of the invention to add the time estimator of Dingler in order to
be aware of how long the user has to change the reservoir before the
fluid runs out.

(Ans. 22.) The rejections address the claims in turn. (Ans. 22-42.)
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Appellants reiterate their argument that
[w]hile Hansen et al '596 discloses that “the pump may be of the
metering type ... the infusion unit may be provided with detecting
means for determining the amount of drug actually infused”, (page 9,
lines 15 - 18), Hansen et al '596 does not then disclose any structure
which provides an ability to identify an amount of drug “actually
infused.”

(Reply Br. 12.) Thus, Appellants maintain their argument that “Hansen et al
'596 does not provide an enabling disclosure of a monitor for measuring the
amount of drug actually infused.” (Id.) Appellants present an analysis of
Dingler’s disclosure showing that Dingler measures the amount of time a
delivery nozzle is turned on (id. at 13), and contend that “because Dingler et
al '928 specifically discloses measuring an amount of time nozzle 50 is
activated, Dingler et al '928 is not only not sensitive to the amount of bulk
wash aid supply 48 actually delivered, Dingler et al '928 isn't even sensitive
to the amount of liquid actually delivered” (id. at 14). Appellants conclude:
Because neither Hansen et al '596 nor Dingler et al '928 show,
disclose or suggest determining an amount of therapeutic substance
actually delivered to the patient and a calculator for determining a
parameter representative of a time in the future at which
replenishment should occur, neither Hansen et al '596 nor Dingler et al
'928, alone or in combination, show, disclose or suggest at least one
essential element of claims 1, 14, 24 and 41, and as such the rejections
of claims 1, 14, 24 and 41 under 35 USC § 103(a) as being
unpatentable over Hansen et al '596 in view of Dingler et al '928 are
improper and should be reversed.

(Id.)
In the Anticipation section above, we found no deficiency in the
rejection of claim 1 and its dependent claims 2, 3, and 5-9 over Hansen. As
anticipation is the epitome of obviousness, we affirm the obviousness
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rejection of claims 1-3 and 5-9 over Hansen and the additional Dingler
reference. In the obviousness section above, we concluded that the
rejections had established a prima facie case of obviousness for claim 4 over
Hansen and Ullestad, and for claims 10-13 over Hansen and Hartlaub. We
therefore affirm the obviousness rejections of claims 4 and 10-13 over the
same references combined with the additional Dingler reference.
Concerning claims 14, 24, and 41, and their dependent claims,
Appellants’ analysis of Hansen continues to persuade, and their analysis of
the Dingler disclosure is likewise persuasive. The obviousness rejections of
claims 14-54 are reversed.

SUMMARY
We affirm:
the rejection of claims 1-3 and 5-9 under 35 U.S.C. § 102(e) as anticipated
by Hansen;
the rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable over
Hansen and Ullestad;
the rejection of claims 10-13 under 35 U.S.C. § 103(a) as unpatentable over
Hansen and Hartlaub;
the rejection of claims 1-3 and 5-9 under 35 U.S.C. § 103(a) as unpatentable
over Hansen and Dingler;
the rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable over
Hansen, Dingler and Ullestad; and
the rejection of claims 10-13 under 35 U.S.C. § 103(a) as unpatentable over
Hansen, Dingler, and Hartlaub.

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We reverse:
the rejection of claims 14, 15, 17-21, 24-26, 28-31, 36, 41, 42, 44-47, and 52
under 35 U.S.C. § 102(e) as anticipated by Hansen;
the rejection of claims 16, 27, and 43 under 35 U.S.C. § 103(a) as
unpatentable over Hansen and Ullestad;
the rejection of claims 22, 23, 37-40, 53, and 54 under 35 U.S.C. § 103(a) as
unpatentable over Hansen and Hartlaub;
the rejection of claims 32-35 and 48-51 under 35 U.S.C. § 103(a) as
unpatentable over Hansen;
the rejection of claims 14, 15, 17-21, 24-26, 28-31, 36, 41, 42, 44-47, and 52
under 35 U.S.C. § 103(a) as unpatentable over Hansen and Dingler;
the rejection of claims 16, 27, and 43 under 35 U.S.C. § 103(a) as
unpatentable over Hansen, Dingler and Ullestad; and
the rejection of claims 22, 23, 37-40, 53, and 54 under 35 U.S.C. § 103(a) as
unpatentable over Hansen, Dingler, and Hartlaub.

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-IN-PART

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