Ex Parte Mohl

Patent Trial and Appeal Board

Dec 21, 2018

13925107 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/925, 107 06/24/2013
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.
25955-0011003 8278
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 1
Appeal2018-000232
Application 13/925, 107
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 1-17. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Miracor Medical Systems GmbH (Appellant) is the applicant as provided
in 37 C.F.R. § 1.46 and is identified as the real party in interest. Appeal Br.
1.
2 The Appeal Brief indicates that this case is related to a proceeding in
another application (US Serial Number 13/549,585). Appeal Br. 14. The
currently pending appeal in that application is Appeal No. 2018-000308.
Appeal2018-000232
Application 13/925,107
CLAIMED SUBJECT MATTER
The claims are directed to a system that treats heart tissue via
coronary sinus occlusion. We reproduce sole independent 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, 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 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 intermittently occluding the coronary
smus,
wherein the control system is programmed to activate the
inflatable balloon device of the coronary sinus occlusion
catheter to intermittently occlude the coronary sinus according
to an automated, predetermined pattern of occlusion periods and
release periods that is previously stored by the control system
and that is independent of the pressure signal indicative of the
coronary sinus pressure.
Appeal Br. 10 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Mohl '608
Lundquist
Peters
Frazier
Mohl '922
us 4,887,608
us 5,011,468
us 5,024,668
US 6,669,624 B2
US 7,331,922 B2
2
Dec. 19, 1989
Apr. 30, 1991
June 18, 1991
Dec. 30, 2003
Feb. 19,2008
Appeal2018-000232
Application 13/925,107
Jose L. Navia et al., In Vitro Peiformance of the Novel Coronary Sinus
AutoRetroPeifusion Cannula, ASAIO Journal 51.6 (2005) (hereinafter
"Navia").
D. H. Glogar et al., Pressure Controlled Intermittent Coronary Sinus
Occlusion Effects the Myocardium at Risk and Reduces Infarct Size, The
Coronary Sinus (1984) (hereinafter "Glogar").
REJECTIONS
(I) Claims 1, 3-8, and 12-14 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Mohl '608, Peters, Navia, and Lundquist.
(II) Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Mohl '608, Peters, Navia, Lundquist, and Glogar.
(III) Claims 9-11 and 15 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Mohl '608, Peters, Navia, Lundquist, and Mohl '922.
(IV) Claims 16 and 17 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Mohl '608, Peters, Navia, Lundquist, Mohl '922, and
Frazier.
OPINION
Rejection (I): claims 1, 3---8, and 12-14
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 intermittently occluding the coronary sinus."
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
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Application 13/925,107
periods independent of the pressure signal." The Examiner relies primarily
on either of two different disclosures in Peters to teach that "initial timing of
occlusion/release periods [ can be] independent of [ coronary sinus] pressure."
Final Act. 3, 12-13. 3
First, the Examiner refers to portions of columns 25-27 where Peters
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--4. 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.
( emphasis added). Thus, the Examiner finds that Peters' process for
establishing a baseline controls 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. 3--4;
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, for 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).
4
Appeal2018-000232
Application 13/925,107
see also 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
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. 12-13. 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 a coronary sinus
pressure signal. Appeal Br. 4---6. 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.
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 5---6. 4
4 The Molnar Declaration was filed on March 16, 2017 ( after the date of the
Final Office Action from which this Appeal is taken) and re-filed on May
17, 2017. The Examiner discusses and attempts to address the content of the
Molnar Declaration, but also indicates that the Molnar Declaration was not
entered. Ans. 4--5; see also Advisory Act. 2 (dated May 1, 2017). Appellant
argues that the Examiner made comments on the Molnar Declaration and it
should be entered by the Examiner. Appeal Br. 5-6; Reply Br. 3-5. As we
decide this Appeal based on the Examiner's findings regarding Peters'
priming process, we need not reach Appellant's arguments regarding the
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Application 13/925,107
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. 6. First, Appellant contends that the
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
baseline process ( or the Molnar Declaration, which is discussed in only these
arguments). Further, the procedural issue of whether the Examiner should
have entered the Molnar Declaration is a petitionable matter and is not for
the Board to decide. See In re Affidavit Filed After Final Rejection, 152
USPQ 292 (Comm'r Pat. & Trademarks) (1966) ("The consideration of an
affidavit filed after a final rejection would be subject to the same objections
as consideration of an amendment filed at that time."); see also MPEP
§ 1205.02 (stating "37 CPR 4I.37(c)(2) prohibits the inclusion in a brief of
any new or non-admitted amendment, affidavit or other evidence. If an
appellant wishes to seek review of an examiner's refusal to admit an
amendment, affidavit or evidence, such review is by petition to the Director
under 37 CPR 1.181.").
6
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Application 13/925,107
amount of helium.") (bolding omitted, emphasis added). Thus, not only
does Peters deflate its balloon, Peters backfills it.
Regarding the backfill step in Peters' 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. 6 ("[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. 6-7.
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
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 implies 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
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Application 13/925,107
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 time. 5
Although Peters teaches that the priming system operates
intermittently, 6 Appellant contends in the Reply Brief ( and for the first time
in this Appeal), 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. 7-8. This argument is untimely, and Appellant does not present any
evidence or explanation to 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."). 7
5 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.
6 Additionally, the Examiner's uncontested finding that Mohl '608 teaches
"a control circuit that activates a pneumatic subsystem to inflate or deflate
the inflatable balloon device of the coronary sinus occlusion catheter for
intermittently occluding the coronary sinus" (Final Act. 3) is supported by a
preponderance of the evidence. See Mohl '608 3:1-14, 6:5-32.
7 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
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Application 13/925,107
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 7
Claim 7 depends indirectly from claim 1 and 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. 11 (Claims App.).
The Examiner finds that Mohl '608 discloses the limitations added by
claim 7. Final Act. 6. 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. The Examiner finds that Mohl '608 explicitly
teaches displaying the "coronary sinus pressure over time," and what is
depicted in Figures 4 and 7 of Mohl '608 corresponds to a depiction of
coronary sinus pressure over time. Id. at 14.
Appellant argues that "nothing in the Mohl '608 patent discloses
that FIG. 7 is literally displayed." Appeal Br. 8. 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.
other words, whether the term "occlude" requires a complete blockage as
asserted by Appellant (see Reply Br. 6-7) or requires only a reduction in the
size of the flow path as asserted by the Examiner (see Ans. 8) is not relevant
to Appellant's new argument that the inflation/deflation occurs only a single
time.
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Application 13/925,107
The Examiner responds that the time values recited in claim 7 are not
required to be equal to the entire time of occlusion or non-occlusion.
Ans. 11. 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. (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. 1-8.
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 (to), 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
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 t1. Accordingly, the
Examiner's finding that the time periods recited in claim 7 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
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Application 13/925,107
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, a
preponderance of the evidence supports the Examiner's findings with respect
to claim 7, and we sustain this rejection.
Appellant makes no additional arguments for the patentability of
claims 3-6, 8, and 12-14. See Appeal Br. 3-9. Accordingly, these claims
fall with claim 1.
Rejections (11)-(IV): claims 2, 9-11, and 15-17
As Appellant makes no separate arguments traversing any of
Rejections (II}-(IV) (see Appeal Br. 3-9), we sustain these rejections for the
same reasons discussed above regarding the rejection of claim 1.
DECISION
The Examiner's decision to reject claims 1-17 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
11