Ex Parte Gerber

Patent Trial and Appeal Board

Mar 12, 2018

13852818 (P.T.A.B. Mar. 12, 2018)

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.
13/852,818 03/28/2013 Elliot M. Gerber 098331.000001 7155
23377 7590 03/14/2018
BAKER & HOSTETLER LLP
CIRA CENTRE 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
EXAMINER
JAMIALAHMADI, MAJID
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/14/2018 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):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELLIOT M. GERBER1
Appeal 2017-005068
Application 13/852,818
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for inflating the balloon of a balloon stent catheter, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that “[a]s a result of movement of the
coronary arteries during cardiac motion, it is difficult to accurately and
precisely place and deploy a coronary stent in the location of a stenosis
1 Appellant identifies the Real Party in Interest as Elliot M. Gerber. (Appeal
Br. 1.)
Appeal 2017-005068
Application 13/852,818
without compromising a branch vessel.” Spec. ^ 3. The Specification
discloses “a system for precise stent deployment in synchronization with the
cardiac cycle.” Id. ^\ 4.
“The disclosed system and method allow[] deployment of the balloon
stent within about 1 mm of the desired location by automatedly inflating the
balloon during diastole, when the coronary vessel is experiencing minimal
movement from cardiac motion.” Id.*\| 8. “This occurs by timing the stent
deployment with the transduced intracoronary arterial pressure curve. Using
intracoronary pressure is valuable to the proper intracoronary placement of
th[e] stent as there is an approximate 50 millisecond delay between coronary
pressure and peripheral arterial pressure (blood pressure).” Id. 24.
Claims 12-23 are on appeal. Claim 12 is the only independent claim
and reads as follows (emphasis added):
12. A system for inflating a balloon in a balloon stent catheter
comprising:
i) a cable set in communication with a source of intracoronary
arterial pressure waveform data that is indicative of the status of the cardiac
cycle, and with a central processor programmed to convert the intracoronary
arterial pressure waveform data into a control signal for controlling inflation
of the balloon such that the balloon is inflated in diastole, corresponding to
about 55% to about 85% of a single R-R interval of the cardiac cycle, by an
amount sufficient to achieve fixation of the stent at a target site in a coronary
artery; and,
ii) an inflation pump in fluid communication with the balloon for
inflating the balloon based on the control signal.
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Application 13/852,818
The claims stand rejected as follows:
Claims 12-15, 17, 20, and 23 under 35 U.S.C. § 103(a) based on
Camus2 and Nigroni3 (Non-Final Action4 2);
Claim 16 under 35 U.S.C. § 103(a) based on Camus, Nigroni, and
Wu5 (Non-Final Action 5);
Claims 18, 19, and 21 under 35 U.S.C. § 103(a) based on Camus,
Nigroni, and Durcan6 (Non-Final Action 6); and
Claim 22 under 35 U.S.C. § 103(a) based on Camus, Nigroni, and
Khosravi7 (Non-Final Action 8).
DISCUSSION
All of the rejections on appeal are based on the combination of Camus
and Nigroni. The same issue is dispositive with respect to all of the
rejections.
The Examiner finds that Camus discloses most of the limitations of
claim 12, but relies on ECG waveform data to indicate the status of the
cardiac cycle, and therefore “fails to disclose the cable set being in
communication with a source of intracoronary arterial pressure waveform
data . . . and the central processor being programmed to convert the
intracoronary arterial pressure waveform data into a control signal.” Non-
Final Action 2-3.
2 Camus et al., US 2010/0114289 Al, published May 6, 2010.
3 Nigroni et al., US 7,250,025 B2, issued July 31, 2007.
4 Office Action mailed Feb. 11, 2016.
5 Wu, US 2008/0015684 Al, published Jan. 17, 2008.
6 Durcan, US 2011/0022150 Al, published Jan. 27, 2011.
7 Khosravi et al., US 2012/0130468 Al, published May 24, 2012.
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Appeal 2017-005068
Application 13/852,818
The Examiner finds that Nigroni discloses
an intra-aortic balloon pump that is in communication with a
source of arterial pressure waveform data of the descending
aorta that is indicative of the status of the cardiac cycle and
programmed to convert the arterial pressure waveform data of
the descending aorta into a control signal for controlling
inflation of the balloon such that the balloon is inflated in
diastole.
Id. at 3.
The Examiner concludes that it would have been obvious to modify
Camus’ system to rely on “arterial pressure waveform data instead of an
ECG waveform data ... in order to provide the system with a more direct
and accurate measurement of the diastolic phase of the heart for precise
placement of the stent in the vessel.” Id. The Examiner also concludes that
“modifying Camus with Nigroni will result in the device of Camus, which is
placed in the coronary vessel, to take measurements of the pressure in the
coronary vessel therefore resulting in Camus to be in communication with a
source of intracoronary arterial pressure waveform data.” Id. at 3—4
(emphasis omitted).
Appellant argues that “[t]he Examiner has . . . improperly over­
generalized the references, and then used those over-generalizations as a
justification for combining them.” Appeal Br. 9. Appellant also argues that
[t]he Examiner has otherwise given no reason why one skilled
in the art would apply the heart pump teachings of Nigroni
(which is used to treat heart failure and cardiogenic shock) to
the balloon stent inflation teachings of Camus. . . . [0]ne skilled
in the art would not look to Nigroni to modify Camus in the
manner suggested by the Examiner.
Id.
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Appeal 2017-005068
Application 13/852,818
We agree with Appellant that the Examiner has not provided a
persuasive reason for concluding that it would have been obvious to a person
of ordinary skill in the art to modify Camus’ system as recited in claim 12,
based on Nigroni. Camus discloses a system for deploying a stent in a blood
vessel. Camus ^ 2. Like the claims on appeal here, Camus’ goal is to place
a stent very precisely and to avoid movement of the catheter “through the
deformation of the heart vessels which occurs when the heart moves, with
the speed of movement depending on the heart phase.” Id. 6-7.
Camus states that “the stent can be automatically deployed as a
function of an electrical signal derived from at least one electrocardiogram
and/or for an electrical signal derived from at least one impedance
cardiogram and/or from an electrical signal of a stimulator for an external
pacing of the heart cycle.” Id. ^ 19. “For example on the basis of the ECG
(Electrocardiogram) it is possible to detect that a period is currently
underway in which there is minimal heart activity, meaning that especially
[the] heart cycle is in the diastole, at which point the stent is expanded in
precisely the right location.” Id. ^ 20. Camus does not disclose using the
intracoronary arterial pressure to determine when the heart cycle is in
diastole.
Nigroni states that “[i]ntra-aortic balloon pump (IABP) therapy is a
form of temporary cardiac assist which is frequently prescribed for patients
who have suffered a heart attack or some other form of heart failure.”
Nigroni 1:20-23. In IABP therapy, a balloon is inserted into the patient’s
descending aorta and “connected through a series of thin tubes to a control
apparatus which causes the balloon to inflate and deflate in time with the
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Appeal 2017-005068
Application 13/852,818
patient’s heartbeat.” Id. at 1:25—27. The therapy “supports the left ventricle
of the heart by increasing perfusion of the coronary arteries and by reducing
left ventricular work.” Id. at 1:28-30.
An IABP system includes a balloon having a fluid-filled lumen that
establishes a continuous fluid column from the tip of the balloon to a
pressure transducer. Id. at 1:53-57. “As a result, the blood pressure in the
descending aorta is transmitted by hydraulic coupling through the fluid
column to pressure transducer 46 where it can be measured.” Id. at 1:57-60.
“In order to achieve optimal therapeutic benefits from the use of an
IABP system,. . . the balloon 10 must be inflated and deflated within the
diastolic interval.” Id. at 2:7-11. “The diastolic interval is determined based
on the pressure waveform in the descending aorta, as transmitted from the
tip of the balloon ... to pressure transducer 46. The dicrotic notch on the
waveform indicates the start of the diastolic interval. . . and the onset of
systole defines the end of the diastolic interval.” Id. at 2:12-19. Nigroni
discloses that “the balloon inflation cycle is preferably initiated so that
augmentation of the aortic pressure begins at the start of the diastolic
interval, i.e., at the dicrotic notch. Similarly, the balloon deflation cycle is
preferably initiated so that full deflation is reached at the end of the diastolic
interval.” Id. at 3:7-12.
We agree with Appellant that the Examiner has not shown that a
person of ordinary skill in the art would have considered it obvious to
modify Camus’ stent-placement system based on Nigroni’s method of
determining the diastolic phase of the heart cycle based on arterial pressure.
Nigroni’s method is intended to support the heart of a patient in heart failure,
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Application 13/852,818
by repeatedly inflating and deflating a balloon during diastole. Nigroni
states that balloon inflation is preferably begun at the start of diastole and
deflation ends at the end of diastole; i.e., the balloon is preferably inflated
for the duration of diastole.
Camus’ method, by contrast, is intended to allow very precise
placement of a stent by timing the inflation of the stent-expanding balloon to
take place during diastole, when there is minimal heart activity and therefore
little movement of the blood vessels. Camus’ method depends on automatic
deployment of the stent based on an electrical signal from an ECG,
impedance cardiogram, or pacing device that indicates that the heart is in
diastole.
In view of the different purposes of the balloons in Nigroni and
Camus—assisting left ventricle function and expanding a stent, respectively—
as well as the one-time inflation of Camus’ balloon and the repeated inflation
and deflation of Nigroni’s balloon, and the precise timing of balloon inflation
desired by Camus compared to Nigroni’s inflation lasting the duration of
diastole, we agree with Appellant that Nigroni’s disclosure does not support
the Examiner’s rationale that the proposed combination would have been
obvious “in order to provide [Camus’] system with a more direct and accurate
measurement of the diastolic phase of the heart for precise placement of the
stent in the vessel.” Non-Final Action 3.
Because the teachings of Camus and Nigroni do not support a prima
facie case of obviousness, we reverse the rejection of claim 12 and
dependent claims 13-15, 17, 20, and 23. We also reverse the rejection of
claim 16 based on Camus, Nigroni, and Wu; the rejection of claims 18, 19,
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Application 13/852,818
and 21 based on Camus, Nigroni, and Durcan; and the rejection of claim 22
based on Camus, Nigroni, and Khosravi, because the Examiner has not
pointed to any teachings in Wu, Durcan, or Khosravi that make up for the
deficiency of Camus and Nigroni discussed above.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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