Ex Parte Ali et al

Patent Trial and Appeal Board

Jun 30, 2017

13097316 (P.T.A.B. Jun. 30, 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.
13/097,316 04/29/2011 Irfan Z. Ali 134.06150101 6276
64619 7590 07/05/2017
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
EXAMINER
STILES, AMBER R.
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
07/05/2017 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):
medtronic_neuro_docketing @ cardinal-ip.com
ptodocketing @ mrgs .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IRFAN Z. ALI and SCOTT L. KALPIN
Appeal 2016-003515
Application 13/097,316
Technology Center 3700
Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and
BRANDON J. WARNER, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Irfan Z. Ali and Scott L. Kalpin (“Appellants”)1 appeal under
35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1—21 and
24. See Appeal Br. 1. Claims 22 and 23 have been canceled. See id.,
Claims App. We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the real parties in interest are Medtronic,
Inc. of Minneapolis, Minnesota, the assignee of record, and Medtronic pic of
Dublin, Ireland, the ultimate parent entity of Medtronic, Inc. Appeal Br. 2.
Appeal 2016-003515
Application 13/097,316
CLAIMED SUBJECT MATTER
Appellants’ disclosed invention relates to “devices, systems[,] and
methods for limiting pressure in implanted catheters.” Spec. | 1. Claims 1
and 24, reproduced below with emphasis added, are illustrative of the
subject matter on appeal.
1. A method carried out by an implantable infusion device,
comprising:
receiving data regarding a catheter being used with the
infusion device, wherein the data comprises information
indicative of a burst pressure or a cutoff pressure of the
catheter, the catheter having a lumen operably coupled to a
reservoir of the infusion device and configured to deliver fluid
from the infusion device to a target location of a patient;
infusing fluid from the reservoir into the lumen of the
catheter at a first rate;
monitoring pressure via a pressure sensor in
communication with the lumen of the catheter, wherein
monitoring the pressure comprises acquiring pressure data from
the pressure sensor at a first frequency;
determining whether the monitored pressure exceeds a
first threshold, wherein the first threshold is based on the data
regarding the catheter; and
decreasing the rate at which the fluid is delivered from
the reservoir into the catheter if the monitored pressure is
determined to exceed the threshold.
24. A method carried out by an implantable infusion device
comprising:
infusing fluid from a reservoir into a lumen of a catheter
at a first rate;
monitoring pressure via a pressure sensor in
communication with the lumen of the catheter, wherein
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Application 13/097,316
monitoring the pressure comprises acquiring pressure data from
the pressure sensor at a first frequency;
monitoring a rate of infusion of fluid from the reservoir
into the lumen of the catheter;
determining whether the rate of infusion exceeds a
threshold rate of infusion; and
increasing the frequency of acquisition ofpressure data
from the pressure sensor if the monitored rate of infusion is
determined to exceed the threshold rate of infusion.
EVIDENCE
The Examiner relied on the following evidence
on appeal:
Thompson US 5,645,531
Morris US 2005/0090799 A1
Caso US 2010/0259406 A1
Injev US 2011/0295191 A1
REJECTIONS
The following rejections are before us for review:
I. Claims 1, 3, and 6—9 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Injev and Thompson. Final Act. 2—5.
II. Claims 2, 5, 10, 11, 13—16, 18—21, and 24 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Injev,
Thompson, and Caso. Id. at 5—16.
III. Claim 4 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Injev, Thompson, and Morris. Id. at 5.
in rejecting the claims
July 8, 1997
Apr. 28, 2005
Oct. 14, 2010
Dec. 1,2011
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Application 13/097,316
IV. Claims 12 and 17 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Injev, Thompson, Caso, and Morris.
Id. at 16—17.
ANALYSIS
Rejections I—IV— Claims 1—21 as unpatentable over Injev
and one or more of Thompson, Caso and Morris
Each of claims 1—21 requires, in relevant part, a step of “receiving
data regarding a catheter being used with the infusion device, wherein the
data comprises information indicative of a burst pressure or a cutoff pressure
of the catheter.” Appeal Br., Claims App. Appellants argue that Thompson,
as relied upon in the rejection, does not teach such a step. See id. at 10—19,
21—23; Reply Br. 2—7. We agree.
In rejecting the claims, the Examiner acknowledged that “Injev does
not explicitly disclose that the infusion system . . . includes a catheter,” or
that “the data comprises information indicative of a burst pressure or a cutoff
pressure of the catheter.” Final Act. 3, 8, 10, 12. However, the Examiner
found that Thompson teaches an infusion system in which “a user can
convey/input data/information indicative of a cutoff pressure of the catheter
(maximum safe patient delivery pressure) into the system (col. 18,
lines 1—19).” Id. at 3, 8, 11, 13. The Examiner explains that Thompson’s
“maximum safe patient [delivery] pressure is a cutoff pressure as required by
one alternative recited in the claim, at which the alarm state is activated.”
Ans. 3 (emphasis omitted). The Examiner also explains that Thompson
“teaches that key characteristics of parameters (such as patient delivery
pressure) of the system are measured at the catheter.” Id. at 5 (emphasis
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omitted) (citing Thompson, col. 16,11. 1—4). According to the Examiner, “a
cutoff pressure for the system is measured at the catheter, and thus is broadly
construed by the Examiner as a cutoff pressure of the catheter.” Id. at 6.
Appellants persuasively assert that “[t]he Examiner has applied an
unreasonably broad interpretation of the claim term, cutoff pressure,” when
read in view of the Specification. Reply Br. 2. In particular, the
Specification describes that the burst pressure of a catheter is “the maximum
pressure within a lumen of the catheter that the catheter can withstand
without bursting.” Spec. 140. The Specification also describes that “[t]he
cutoff pressure may be a pressure determined to reproducibly result in
maintained catheter integrity (i.e., no bursting).” Id.', see id. (describing a
direct correlation between the burst/maximum pressure and a cutoff pressure
as, “for example, a cut[]off pressure that is 90% of maximum pressure or
85%, 80%, 75% or the like of the maximum pressure of the catheter’'')
(emphasis added). In this regard, Appellants correctly note that the claimed
“burst pressure is a pressure at which the catheter may burst, while the cutoff
pressure is a function of the burst pressure (such as percentage of the burst
pressure).” Reply Br. 3 (citing Spec. Tflf 40-41); see also id. (explaining that
“[e]ach of the burst pressure and cutoff pressure are characteristics of the
catheter'”) (emphasis added).
Although we appreciate the Examiner’s finding that Thompson’s
patient delivery pressure is an infusion cutoff pressure measured at the
catheter (see Ans. 5 (citing Thompson, col. 16,11. 1—4)), we agree with
Appellants that such a cutoff pressure is not a characteristic “of the
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catheter,” as required by the claims.2 Namely, Thompson “does not describe
anything regarding a pressure at which a catheter may burst, and therefore,
cannot describe a cutoff pressure as recited in independent claim 1 (e.g.,
because the cutoffpressure is a function of the burst pressure).’ '’ Reply
Br. 3^4 (emphasis added; underlining omitted). In other words, to the extent
that Thompson’s patient delivery pressure represents a cutoff pressure for
infusing fluids through a catheter, this cutoff pressure is not a function of the
burst pressure of the catheter, and thus does not constitute a “cutoff pressure
of the catheter,” as called for in Appellants’ claims.
In short, the Examiner has not sufficiently established a finding
supported by a preponderance of the evidence that Thompson teaches the
disputed limitation as claimed. This unsupported finding from Thompson
pervades the rejections of claims 1—21. See Final Act. 3—14, 16—17. We
note that Caso and Morris were relied on by the Examiner for teaching
additional features, but not to cure the above-noted deficiency with respect
to Thompson. See id.
Accordingly, based on the record before us, the Examiner has not met
the burden of establishing a proper case of obviousness. On this basis, we
do not sustain the rejections of claims 1—21 under 35 U.S.C. § 103(a).
2 We note that the Examiner’s interpretation of “a cutoff pressure of the
catheter,” which essentially equates the “cutoff pressure of the catheter” with
any threshold pressure used in monitoring infusion pressure measured at a
catheter, is unreasonably broad and effectively reads out of the claim the
constraints mandated by “of the catheter,” such that any cutoff pressure used
in monitoring an infusion system having a catheter would be considered “of
the catheter.” See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362
(Fed. Cir. 2007) (denouncing claim constructions that render phrases in
claims superfluous).
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Rejection IV— Claim 24 as unpatentable over Injev, Thompson, and Caso
In rejecting claim 24, the Examiner relied on Caso for teaching, inter
alia, a step of “increasing the frequency of acquisition of pressure data upon
the detection of some perturbation within the system (paragraph 37; any
perturbation; paragraph 29), such as pressure fluctuations (paragraph 33 and
53) or flow fluctuations (paragraph 37) that exceed the first threshold.”
Final Act. 15 (emphasis omitted). The Examiner also found that Caso
teaches “increasing the rate of pressure sampling due to some perturbation of
the system, for example, a rapid decrease in flow (paragraph 37).” Id. The
Examiner explained that
the increase in pressure sampling could follow any perturbation
of the system (paragraph 29). It logically follows that if the
system taught by [Caso] can increase the rate of pressure
sampling in response to a perturbation like a decrease in flow rate
(i.e., infusion rate) (paragraph 37) or an increase in pressure
(paragraph 53), then it would be obvious to one having ordinary
skill in the art that the system could also increase the rate of
pressure sampling in response to an increase in flow rate (i.e.,
infusion rate).
Id. (emphasis omitted). The Examiner also found that Caso “teaches the use
of alarm states (i.e., thresholds) associated with perturbations when the
system triggers the increased frequency of sampling (paragraph 53),” such
that, “[w]hen a threshold is exceeded, the system of [Caso] triggers both an
increase in frequency of sampling, but also triggers an audible or visual
warning signal.” Id. at 16 (emphasis omitted). The Examiner concluded
that, given the teachings of the prior art, it would have been obvious
to have included the step of increasing the frequency of the
monitoring of pressure as disclosed in [Caso] in response to the
detection of some perturbation within the system, such as if the
monitored rate of infusion is determined to exceed the threshold
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Application 13/097,316
rate of infusion, as disclosed in Injev in order to provide an
indication that attention on the part of the controller needs to be
given to the system (paragraph 37 of [Caso]) and to provide a
unique power saving approach to the operation of the system
(paragraph 33 of [Caso]).
Id.
Appellants argue that Caso “does not teach or suggest increasing the
frequency of acquisition of pressure data from the pressure sensor if the
monitored rate of infusion is determined to exceed the threshold rate of
infusion.” Appeal Br. 21. In particular, Appellants assert that Caso “only
considers a rapid decrease in flow such that might be seen with an
obstruction,” and “does not teach or suggest that some perturbation of flow
rate includes an increase in flow rate.” Id. (emphasis omitted). Appellants
also assert that Caso “revolves around two circumstances in which an
increase in pressure sampling may occur: the increased proximity of a user
to the regulator and an obstructed line/tube as a result of a kink, block, or
debris.” Reply Br. 6 (citing Caso ^fl[ 29, 36—37, 53). According to
Appellants, “one of ordinary skill in the art would recognize that an
obstruction of the fluid flowing through the line/tube of [Caso] would not
result in an increase in flow rate.” Id. at 7 (emphasis omitted).
We are not persuaded by Appellants’ argument because it is not
responsive to the rejection articulated by the Examiner. Namely, the
Examiner did not find that Caso discloses a perturbation in the form of
increased flow rate. The Examiner also did not find that an obstruction of
fluid would result in an increase in flow rate. Rather, as discussed above,
the Examiner determined that, based on the teachings of Injev and Caso, it
would have been obvious to one of ordinary skill in the art to increase
pressure monitoring frequency in response to the infusion rate exceeding a
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threshold. See Final Act. 15—16; see also Ans. 9-11. In this regard,
Appellants do not allege, nor do we discern, any error with respect to the
Examiner’s findings or reasoning articulated in support of the conclusion of
obviousness.
Accordingly, we sustain the rejection of claim 24 under 35 U.S.C.
§ 103(a) as being unpatentable over Injev, Thompson, and Caso.
DECISION
We REVERSE the Examiner’s decision rejecting claims 1, 3, and 6—9
under 35 U.S.C. § 103(a) as being unpatentable over Injev and Thompson.
We REVERSE the Examiner’s decision rejecting claims 2, 5, 10, 11,
13—16, and 18—21 under 35 U.S.C. § 103(a) as being unpatentable over
Injev, Thompson, and Caso.
We REVERSE the Examiner’s decision rejecting claim 4 under
35 U.S.C. § 103(a) as being unpatentable over Injev, Thompson, and Morris.
We REVERSE the Examiner’s decision rejecting claims 12 and 17
under 35 U.S.C. § 103(a) as being unpatentable over Injev, Thompson, Caso,
and Morris.
We AFFIRM the Examiner’s decision rejecting claim 24 under
35 U.S.C. § 103(a) as being unpatentable over Injev, Thompson, and Caso.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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