Ex Parte Mohl

Patent Trial and Appeal Board

Dec 21, 2018

13549585 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/549,585 07/16/2012
26191 7590 12/26/2018
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Werner Mohl
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.
25955-0011002 5196
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/26/2018 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):
P ATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WERNER MOHL
Appeal2018-000308
Application 13/549,585 1
Technology Center 3700
Before JENNIFER D. BAHR, WILLIAM A. CAPP, and LEE L. STEPINA,
Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL 2
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 the Examiner's decision
rejecting claims 1---6 and 10-13. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 According to Appellant, the real party in interest is Miracor Medical
Systems GMBH. Appeal Br. 1.
2 The Appeal Brief indicates that this case is related to a proceeding in
another application (US Serial Number 13/925, 107). Appeal Br. 1. The
currently pending appeal in that application is Appeal No. 2018000232. The
Examiner makes similar findings of fact in these cases.
Appeal2018-000308
Application 13/549,585
CLAIMED SUBJECT MATTER
The claims are directed to a system for treating heart tissue using
coronary sinus occlusion. We reproduce claim 1 below, with emphasis
added.
1. A system for treating heart muscle tissue, comprising:
a coronary sinus occlusion catheter including a distal tip
portion, a proximal hub portion, a pressure sensor lumen, and a
balloon fluid lumen, the distal tip portion of the coronary sinus
occlusion catheter comprising an inflatable balloon device
configured to occlude a coronary sinus when inflated with fluid
via the balloon fluid lumen; and
a control system to control the inflation and deflation of
the inflatable balloon device for pressure-controlled intermittent
coronary sinus occlusion, the control system comprising a
display device, a pressure signal input that receives a pressure
signal indicative of coronary sinus pressure, an
electrocardiogram (ECG) signal input, and a control circuit that
activates a pneumatic subsystem to inflate or deflate the
inflatable balloon device of the coronary sinus occlusion catheter
for a selected period of time based at least in part on the pressure
signal indicative of the coronary sinus pressure,
wherein the control system, during an initial period of
operation, activates the inflatable balloon device of the coronary
sinus occlusion catheter to intermittently occlude the coronary
sinus in an automated, predetermined pattern of occlusion
periods and release periods that is stored by control system and
that is independent of the pressure signal indicative of the
coronary sinus pressure, and during a second period of
operation, activates the inflatable balloon device of the coronary
occlusion catheter to intermittently occlude the coronary sinus
in a pattern that is dependent in part on the pressure signal
indicative of the coronary sinus pressure.
Appeal Br. 14 (Claims App.).
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Application 13/549,585
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Mohl '608
Lundquist
Peters
us 4,887,608
us 5,011,468
us 5,024,668
Dec. 19, 1989
Apr. 30, 1991
June 18, 1991
Jose L. Navia et al., In Vitro Peiformance of the Novel
Coronary Sinus AutoRetroPerfusion Cannula, ASAIO Journal
51.6 (2005) (hereinafter "Navia").
REJECTION
Claims 1-6 and 10-13 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Mohl '608, Peters, Navia, and Lundquist.
OPINION
Claim 1
The Examiner finds Mohl '608 discloses many of the elements
required by claim 1, including "a control circuit that activates a pneumatic
subsystem to inflate or deflate the inflatable balloon device of the coronary
sinus occlusion catheter for a selected period of time based at least in part on
the pressure signal indicative of the coronary sinus pressure." Final Act. 3
(citing Mohl '608, 3:1-14, 4:52-59, 6:5-32, 6:67-7:4). The Examiner finds
that Mohl '608 "fails to explicitly disclose that the initial period of operation
includes a pattern of occlusion periods and release periods independent of
the pressure signal." Id. The Examiner relies primarily on either of two
different disclosures in Peters to teach that "initial timing of
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Application 13/549,585
occlusion/release periods [ can be] independent of [ coronary sinus] pressure."
Final Act. 3--4, 12-14. 3
First, the Examiner refers to the portion of Peters that establishes a
"baseline" in which Peters' controller "inflate[s] and deflate[s] the occlusion
catheter to gather basic characteristics of the region and expected
characteristics of the system, including pressure values which can be
graphed." Final Act. 3. The Examiner finds that Peters' "control system can
base the occlusion periods and release periods on maximum and minimum
inflation times or the control system can base the occlusion and release
periods on maximum and minimum coronary sinus pressures." Id. at 4
( emphasis added). Thus, the Examiner finds that Peters teaches controlling
these occlusion and release periods independently of a signal indicative of
coronary sinus pressure. See id.
Second, the Examiner refers to Peters' "priming" process, which is
performed intermittently to extract all the fluid from the balloon and then
supply a metered amount of fluid to backfill the balloon. See Final Act. 13-
14 (citing Peters 4:66-5:14, 15:1-14, 33---65, 16:1--44, 23:62-24:14). With
respect to Peters' priming process, the Examiner states:
Since the initial inflation/deflation/priming of the system is
controlled by control signals that are sent after a preselected
3 For this element of the claim, the Examiner does not apply the disclosure in
Mohl '608 related to control of inflation/ deflation of a balloon intended to
occlude a coronary sinus independently of coronary sinus pressure. See
Mohl '608 1:42--46 ("The other end of the catheter is supplied with gas or
liquid by a pump which can be controlled to cause the balloon to inflate and
deflate cyclically,/or example at a rate synchronized with the heart pulse
rate, or on the basis of pressure.") (emphasis added), see also id. 2:28-35
("[T]he controller is arranged to trigger the initiation of the next occlusion at
a time determined by the flow signals ... the flow signals represent velocity
of flow, or fluid pressure as a function of time.") ( emphasis added).
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Application 13/549,585
vacuum pressure or a preselected period of time and are not
based on the coronary sinus pressure and since Peters discloses
that the control system includes programmed logic, the initial
period of inflation and deflation can be interpreted as a
predetermined pattern of occlusion and release periods that is
stored by the control system and is independent of the coronary
pressure signal.
Final Act. 13-14. Thus, the Examiner finds that the priming process inflates
and deflates the balloon independently of a pressure signal indicative of the
coronary smus pressure.
Baseline Process in Peters
Appellant argues that the Examiner erred in finding that the baseline
determination in Peters is performed independently of the coronary sinus
pressure. Appeal Br. 5-7. Rather, Appellant contends, in Peters, the
baseline determination is a manual process in which a user manipulates
control 543 based on a coronary sinus pressure displayed by indicator 350.
Id. Appellant refers to a declaration (herein the "Molnar Declaration")
submitted under 37 C.F.R. § 1.132, executed by Dr. Levente Molnar, in
support of this argument. Id. at 6-7.
For the reasons discussed below, Appellant fails to apprise us of error
in the Examiner's finding that Peters' priming process is controlled to
occlude the coronary sinus independently of the coronary sinus pressure.
Accordingly, we need not decide whether the Examiner erred in finding that
Peters' baseline process does so.
Priming Process in Peters
The sole argument in the Appeal Brief regarding Peters' priming
process is that it does not occlude the coronary sinus independently of the
coronary sinus pressure. Appeal Br. 7. First, Appellant contends that the
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Application 13/549,585
priming process in Peters applies a vacuum to the balloon, which would
deflate rather than inflate the balloon. Id. This argument is unavailing
inasmuch as deflation is only one of multiple steps in Peters' priming
process. Peters states, "[ t ]he priming system intermittently or selectively
operates first to extract substantially all fluid from the balloon and the fluid
pump and in sequence to supply a metered amount of selected fluid thereto."
Peters 4:67-5:3. In particular, Peters backfills the balloon after deflating it.
See Peters 16:2-5 ("[A] balloon, such as balloon 72 (FIG. 2), and all the
interconnecting tubing including channel 64 is baclifilled with a preselected
amount of helium.") (bolding omitted, emphasis added). Thus, not only
does Peters deflate its balloon, Peters backfills it.
Regarding the backfill step in Peter's priming process, Appellant
contends that Peters teaches that a specific metered amount of helium is fed
to the balloon, and this amount of helium may not be enough to cause the
balloon to occlude the coronary sinus. Appeal Br. 7 ("[N]owhere does
Peters describe that the amount of helium metered to the balloon by the
priming system would be sufficient to 'occlude the coronary sinus,' or that
occlusion during the priming operation would even be desirable.") (citing
Peters 4:66-5: 14; 15: 1---65; 16: 1--44; 23:62-24: 14); see also Reply Br. 5-6.
We disagree with Appellant's argument on this point. As discussed
above, Peters backfills the balloon. We understand this process to fill the
balloon. In particular, when referring to the backfill operation, Peters
describes this process as a matter of filling the balloon. For example, when
forced to re-perform the priming process, Peters explains, "the
retroperfusion therapy is interrupted and the priming cycle reinitiated so that
the balloon system is evacuated and refilled with helium." Peters 27:47--49;
see also id. 35:10-14 (claim 43) ("said balloon operation means includes
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Application 13/549,585
priming means connected by means to said second channel and operable to
remove fluid from said second channel and balloon, and to sequentially fill
said second channel and said balloon with a fluid."). Appellant does not
explain how filling a balloon positioned the way Peters' balloon is
positioned would fail to occlude the coronary sinus.
To the extent Appellant contends that Peters' priming process is not
performed independently of the coronary sinus pressure, we disagree.
Describing the sequence of events in the priming process, Peters states
"[a]fter a preselected period of time or upon attaining a preselected pressure
as determined by the pressure transducer 322, a signal reflective thereof is
supplied to the control means 280 via conductor 324 to in tum cause the
solenoid valve 260 to return to its normal closed position." Peters 16:5-11
(bolding omitted, emphasis added). Thus, Peters discloses performing this
process based on a preselected amount of timed. 4
Although Peters teaches that the priming system operates
intermittently, 5 Appellant contends, for the first time in the Reply Brief, that
Peters' priming process provides "at most, a single deflation and inflation to
prime the system for use," and, therefore, Peters does not disclose that this
process is performed with a predetermined pattern of occlusion periods and
release periods that is previously stored. Reply Br. 6. This argument is
untimely, and Appellant does not present any evidence or explanation to
4 We further note that the pressure measured by pressure transducer 322
measures the pressure inside tubing 310, not the coronary sinus pressure.
Peters 15 :24--29.
5 Additionally, the Examiner's uncontested finding that Mohl '608 teaches
"the balloon can be inflated/ deflated cyclically at a rate synchronized with
the heart pulse rate, or on the basis of pressure)" (Final Act. 3) is supported
by a preponderance of the evidence. See Mohl '608 1 :42--46, 2:34--36.
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Application 13/549,585
show good cause why it should be considered by the Board at this time. See
3 7 C.F .R. § 41.41 (b )(2) ("Any argument raised in the reply brief which was
not raised in the appeal brief, or is not responsive to an argument raised in
the examiner's answer ... will not be considered by the Board for purposes
of the present appeal, unless good cause is shown."). 6
We have considered all of Appellant's timely arguments in support of
the patentability of claim 1, but find them unavailing. Accordingly, we
sustain the rejection of claim 1.
Claim 5
Claim 5 recites, in part:
the display device of the control system shows a first time value
indicative of a period of occlusion of the coronary sinus and a
second time value indicative of a period of non-occlusion of the
coronary sinus, the first and second time values being displayed
contemporaneously with the graph of the pressure signal
indicative of the coronary sinus pressure.
Appeal Br. 16 (Claims App.).
The Examiner finds that Mohl '608 discloses the limitations added by
claim 5. Final Act. 7-8. Specifically, the Examiner finds that, in Figure 7 of
Mohl '608, to-tr represents a time value of occlusion, and Ref tr represents a
time value of non-occlusion. 7 The Examiner finds that Mohl '608 explicitly
6 Although Appellant asserts that the Examiner presents a new interpretation
of the term "occlude" in claim 1, Appellant's argument alleging the failure
of Peters to disclose a predetermined pattern of occlusion periods is not
dependent upon the Examiner's interpretation of the term "occlude." In
other words, whether the term "occlude" requires a complete blockage as
asserted by Appellant (see Reply Br. 5-6) or requires only a reduction in the
size of the flow path as asserted by the Examiner (see Ans. 5---6) is not
relevant to Appellant's new argument that the inflation/deflation occurs only
a single time.
7 Apparently, the beginning of the time period of non-occlusion.
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teaches displaying the "coronary sinus pressure over time" and that what is
depicted in Figures 4 and 7 of Mohl '608 corresponds to a depiction of
coronary sinus pressure over time. Id. at 15.
Aside from the arguments discussed above with respect to claim 1,
Appellant argues that "nothing in the Mohl '608 patent discloses that FIG. 7
is literally displayed." Appeal Br. 12. Rather, Appellant contends, Figure 7
of Mohl '608 merely depicts a representational graph for the purposes of
explaining the mathematical formulas used by the process discussed in
column 6 of Mohl '608. Id.
The Examiner responds that the time values recited in claim 5 are not
required to be equal to the entire time of occlusion or non-occlusion.
Ans. 9--10. Additionally, the Examiner finds that
Mohl states that the coronary sinus pressure can be plotted
against time and analyzed; wherein the pressure maxima and
minima can be determined and fit to curves; where the timing of
the next occlusions can be based on parameters derived from the
pressure maxima and minima; where the diastolic valleys on the
graphs can represent the pressure minima.
Id. at 9 (citing Mohl '608 2:3-24, 48---68, 3: 1-24, 6:67-7:24, 8:20-30).
Appellant does not further discuss this rejection in the Reply Brief.
See Reply Br. 1-6.
The Examiner has the better position on this issue. Mohl '608 states
that Figures 4 and 7 depict "a representational graph of changes of
coronary sinus pressure with time." Mohl '608 3:42--43. Mohl '608 further
states, "[r]eferring to FIG. 7, a typical plot of coronary sinus pressure against
time, beginning at the onset of occlusion ( ta), exhibits a series of systolic
pressure peaks 11 O." Mohl '608 6: 17-19 (bolding omitted, emphasis
added). Mohl '608 also states, "T P represents the period between the
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termination of occlusion and the peak reactive hyperemia." Id. 6:30-31. As
is depicted in Figure 7, the time period T P begins at time tr. Accordingly, the
Examiner's finding that the recited time periods are depicted in Figure 7 is
supported by a preponderance of the evidence.
Appellant does not dispute that Mohl '608 discloses displaying
information to a user. As for whether the content of Figure 7 is provided in
such a display, a preponderance of the evidence supports the Examiner's
finding on this point. As noted above, Figures 4 and 7 are representational
graphs of changes in coronary sinus pressure over time. See Mohl '608
3:42--43. Mohl '608 states "[p]rocessor 56 is also connected to real time
display 83 for displaying the [coronary] sinus pressure over time for
observation of the successive local pressure maxima as an indication of the
state of health of the heart tissue, e.g., its contractility." Id. 4:45--49 (bolding
omitted, emphasis added). Thus, Mohl '608 says that what is shown in
Figures 4 and 7 is coronary sinus pressure over time. Then Mohl '608 states
that coronary sinus pressure over time is displayed. Accordingly, the
Examiner's findings of fact are supported by a preponderance of the
evidence, and we sustain the rejection of claim 5.
Appellant makes no additional arguments for the patentability of
claims 2--4, 6, and 10-13. See Appeal Br. 4--13. Accordingly, these claims
fall with claim 1.
DECISION
The Examiner's decision to reject claims 1-6 and 10-13 is affirmed.
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
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