Ex Parte Moriarty et al

Patent Trial and Appeal Board

Jan 24, 2019

14200944 (P.T.A.B. Jan. 24, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/200,944 03/07/2014 Micheal Moriarty
28390 7590 01/28/2019
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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.
C00004174.USU1 8082
EXAMINER
BEHRINGER, LUTHER G
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
01/28/2019 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):
rs.vasciplegal@medtronic.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 MICHEAL MORIARTY and BRIAN KELLY
Appeal2018-000257 1
Application 14/200,944
Technology Center 3700
Before: JENNIFER D. BAHR, JEREMY M. PLENZLER, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1-
15. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 The Applicant is Medtronic Ardian Luxembourg S.a.r.l, which the Appeal
Brief indicates is the real party in interest. Appeal Br. 1.
Appeal2018-000257
Application 14/200,944
CLAIMED SUBJECT MATTER
The claims are directed to a method of performing cryotherapy with a
refrigerant-cooled cryotherapeutic element positioned in a patient's body.
Spec. ,r 1. Claim 1, reproduced below with emphasis added, is illustrative of
the claimed subject matter:
1. A method, comprising:
advancing an elongate shaft of a catheter toward a
treatment location within a body lumen of a human patient;
directing a flow of refrigerant toward a cryotherapeutic
element at a distal end portion of the shaft via a supply line
extending along at least a portion of a length of the shaft;
expanding the directed refrigerant to cause cooling within
a balloon of the cryotherapeutic element;
exhausting the expanded refrigerant via an exhaust line
extending along at least a portion of the length of the shaft;
measuring pressure within the cryotherapeutic element
and/or within a distal portion of the exhaust line via a monitoring
line extending along at least a portion of the length of the shaft;
calculating a rate of change of the measured pressure;
processing the rate of change of the measured pressure
using a first feedback loop during a first monitoring window of
a treatment cycle, the first feedback loop being configured to
cause the flow of refrigerant through the supply line to stop if the
rate of change of the measured pressure falls outside a range from
a first lower threshold to a first upper threshold;
switching from the first monitoring window to a second
monitoring window of the treatment cycle; and
processing the rate of change of the measured pressure
using a second feedback loop during the second monitoring
window, the second feedback loop being configured to cause the
flow of refrigerant through the supply line to stop if the rate of
change of the measured pressure falls outside a range from a
second lower threshold to a second upper threshold, wherein (a)
the first lower threshold is different than the second lower
threshold and/or (b) the first upper threshold is different than the
second upper threshold.
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Appeal2018-000257
Application 14/200,944
Appeal Br. 20-21 (Claims App.).
REFERENCES RELIED ON BY THE EXAMINER
Pang
Mandel
Watson
Gerber
US 6,477,658 Bl
US 2006/0235374 Al
US 8,187,261 B2
US 2012/0277823 Al
Nov. 5, 2002
Oct. 19, 2006
May 29, 2012
Nov. 1, 2012
THE REJECTIONS ON APPEAL
(I) Claim 14 is rejected under 35 U.S.C. § 112(a) as failing to comply
with the enablement requirement. 2
(II) Claims 1-11 are rejected under 35 U.S.C. § I02(a)(l) as
anticipated by Watson.
(III) Claim 12 is rejected under 35 U.S.C. § 103 as unpatentable over
Watson and Mandel.
(IV) Claims 13 and 14 are rejected under 35 U.S.C. § 103 as
unpatentable over Watson and Pang.
(V) Claim 15 is rejected under 35 U.S.C. § 103 as unpatentable over
Watson, Pang, and Gerber.
OPINION
Rejection (I)
2 The Final Office Action discusses this rejection on pages 2--4 (the
Response to Arguments) and formally lists the rejection on page 2 of the
Answer.
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Application 14/200,944
Dependent claim 13 depends from claim 1 and recites first and second
algorithms operating at first and second cycle speeds, respectively. Appeal
Br. 24 (Claims App.). Claim 14 depends from claim 13 and recites that the
first cycle speed is at least 10 times as fast as the second cycle speed. Id.
In rejecting claim 14 as not enabled, the Examiner determines (i) "[a]
generic recitation of an algorithm is clearly not enabling for all types of
algorithms, given the complexities associated with the differing types of
algorithms" (Final Act. 3), and (ii) Appellant's disclosure "does not enable
speeds that are, for example, 1000 times that of the second cycle speed or
hundreds of thousands of times that of the second cycle speed" (id. at 4). In
support of part (ii) of the rejection, the Examiner refers to MPEP 2164.06(a)
and MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d
1377, 103 USPQ2d 1769 (Fed. Cir. 2012). Final Act. 3.
Appellant contends "the specification provides numerous relevant
working embodiments described in conjunction with Figures 2-4 and
elsewhere," and the disclosure need not teach all possible algorithms usable
with the claimed method. Appeal Br. 10-11. Appellant also contends that
MagSil is inapposite because the limitation in claim 14 recites a relationship
between two variables that are capable of being specified by a user, whereas,
in MagSil, the variable was "a lower boundary for a single variable." Id. at
12. Appellant also analogizes the "at least 10 times" limitation in claim 14
to a theoretical claim reciting "a plurality of widgets," which, in theory,
encompasses an infinite number of widgets. Id.
In the Answer, the Examiner focuses on the holding in MagSil and
reiterates that Appellant's disclosure does not enable a first cycle speed that
is hundreds of thousands of times the second cycle speed. See Ans. 15.
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Appeal2018-000257
Application 14/200,944
Appellant has the better position. The facts of MagSil are
distinguishable inasmuch as the limitation at issue in that case involved a
physical property that, according to the record, the inventor had never been
able to increase by more than 11.8% and had a theoretical upper limit of a
100% increase. Magsil, 687 F.3d at 1381-1382. In contrast, it appears that
the ratio of the first and second cycle speeds in Appellant's method is not
physically limited, even if, for example, the second cycle speed at an
extremely low rate might be impractical. In other words, we agree with
Appellant's argument that, as the first and second cycle speeds are capable
of being specified by the user (Appeal Br. 12), the disclosure enables the "at
least 10 times" limitation in claim 14. Accordingly, we do not sustain the
rejection of claim 14 as failing to comply with the enablement requirement.
Re} ection (II)
The Examiner finds that Watson discloses all the elements recited in
claim 1, and, in particular, that Watson's disclosure of a differential pressure
measurement corresponds to the requirement to calculate a rate of change of
a measured pressure. Final Act. 7-8 (citing Watson, 7:38-57, 11:15-28,
Figs. 1A-2A, 3A--4).
Appellant contends that the Examiner erred on this point because
"[d]ifferential pressure, as disclosed in Watson, is merely pressure relative to
an ambient pressure at a given time[, and, i]n contrast, rate of change in
pressure, as recited in claim 1, is change in pressure divided by time."
Appeal Br. 14.
In response, the Examiner refers to a definition of the word
"differential" that uses the word "derivative." Ans. 16 (citing
www.thefreedictionary.com). The Examiner then refers to a definition of
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Application 14/200,944
the word "derivative" indicating that it means an instantaneous rate of
change and the slope of a tangent line to the graph of a function. Id. ( citing
www.thefreedictionary.com). The Examiner concludes, "[b ]ased on these
definitions, it is seen that a differential pressure measurement necessarily
constitutes a measurement of the rate of change of pressure." Id. at 17.
In reply, Appellant contends the Examiner errs in referring to
mathematical definitions of the words "differential" and "derivative"
because Watson uses the term "differential" with the word "pressure"
merely to refer to a pressure difference, not to refer to an instantaneous rate
of change in pressure. See Reply Br. 2-3.
Appellant's argument is persuasive. The Examiner refers to column
7, lines 38-57 of Watson as supporting the finding that Watson discloses
calculating a rate of change of measured pressure in a cryotherapeutic
element. Final Act. 8. Watson describes its pressure measurement process
as follows:
Individual pressure sensors can measure pressure in
different ways. In some implementations, each sensor measures
absolute pressure, for example, in pounds per square inch
absolute (PSIA). In such implementations, two pressure sensors
may typically be used to obtain a differential measurement that
inherently eliminates any effect of local atmospheric pressure
(e.g., ambient pressure). For example, if Pl and P2 are absolute
pressure sensors in the catheter 100, the controller 228 can
employ both P 1 and P2 to differentially determine a pressure in
the supply lumen 212.
Watson 7:37--47 (emphasis omitted). 3 Thus, we agree with Appellant's
assertion that the cited portion of Watson uses the term "differential" merely
3 Lines 48-57 of column 7 of Watson describe measuring pressure relative
to atmospheric pressure rather than measuring absolute pressure. This
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Application 14/200,944
to describe a difference between measurements taken by two different
pressure sensors in the system, not to describe a mathematical derivative
(slope). In other words, Watson describes finding a difference in pressures
at two different locations, i.e., a pressure differential. This, by itself, is not
the same as calculating a rate of change of pressure. Accordingly, the
Examiner's finding that Watson discloses calculating a rate of change of a
measured pressure within a cryotherapeutic element as recited in
independent claim 1 is not supported by a preponderance of the evidence,
and we do not sustain the rejection of claim 1, and claims 2-11 depending
therefrom, as anticipated by Watson.
Re} ections (111)-(V)
The Examiner does not rely on any of Mandel, Pang, or Gerber in any
manner that would remedy the deficiency discussed above regarding
Rejection (II). See Final Act. 13-17. Accordingly, we do not sustain
Rejections (III}-(V).
DECISION
The Examiner's decision to reject claims 1-15 is reversed
REVERSED
difference does not support the Examiner's finding that Watson discloses a
mathematical derivative any more than does Watson's disclosure regarding
the use of absolute pressure. The Examiner also refers to column 11, lines
15-28 (Final Act. 8), but this portion of Watson uses the term "differential"
in a manner consistent with its use in the cited portion of column 7.
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