Werner Mohl

Patent Trials and Appeals Board

Aug 1, 2019

12786785 - (D) (P.T.A.B. Aug. 1, 2019)

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.
12/786,785 05/25/2010 Werner Mohl 25955-0011001 / PICSO 11 3252
26191 7590 08/01/2019
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
08/01/2019 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):
PATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte WERNER MOHL
____________________

Appeal 2018-008912
Application 12/786,7851
Technology Center 3700
____________________

Before JENNIFER D. BAHR, WILLIAM A. CAPP, and LEE L. STEPINA,
Administrative Patent Judges.

STEPINA, Administrative Patent Judge.

DECISION ON APPEAL2

STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the Examiner’s Final
decision to reject claims 4 and 24–34. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

1 According to the Appeal Brief, Miracor Medical Systems GmbH is the real
party in interest. See Appeal Br. 1.
2 The Appeal Brief (filed March 19, 2018) indicates that this case is related
to appeals before the Board in two other applications, the serial numbers of
which are 13/549,585 and 13/925,107. Appeal Br. 1. These appeals were
decided on December 26, 2018. See Ex parte Mohl, Appeal No. 2018-
000308) and Ex. parte Mohl, Appeal No. 2018-000232, 2018 WL 7081163
(PTAB Dec. 21, 2018).
Appeal 2018-008912
Application 12/786,785

2
CLAIMED SUBJECT MATTER
The claims are directed to methods of treating heart tissue via the use
of intermittent occlusion of the coronary sinus. Claims 4 and 30 are
independent, and claim 4, reproduced below, is illustrative of the claimed
subject matter:
4. A method of treating heart tissue, comprising:
detecting a blockage in a coronary artery of the heart;
prior to intervening on the blockage in the coronary artery,
advancing a distal tip portion of a coronary sinus occlusion
catheter through a guide sheath in a right atrium and into the
coronary sinus, the coronary sinus occlusion catheter comprising
an inflatable balloon device configured to occlude the coronary
sinus when inflated;
intermittently occluding the coronary sinus using the
inflatable balloon device of the coronary sinus occlusion catheter
to redistribute venous blood flow into heart muscle tissue
affected by the blockage,
wherein the coronary sinus is intermittently occluded for
periods of time determined by a control system coupled to a
proximal portion of the coronary sinus occlusion catheter,
wherein the control system provides automated control of
the inflatable balloon device of the coronary sinus occlusion
catheter for providing pressure-controlled intermittent coronary
sinus occlusion treatment to the heart, the control system
comprising a display device that shows heart sensor data during
the intermittent occlusion of the coronary sinus,
wherein during an initial phase the control system
determines the time period for occluding the coronary sinus
based on a predetermined pattern of predetermined occlusion
times independent of coronary sinus pressure sensor data;
wherein during a second phase the control system
determines the time period for occluding the coronary sinus
based on sensor data received by the control system, the sensor
data comprising coronary sinus pressure and electrocardiogram
(ECG) information,
Appeal 2018-008912
Application 12/786,785

3
wherein the control system uses the received ECG
information to properly time a start time of inflation of the
inflatable balloon device, and wherein the control system uses
both the received ECG information and the received coronary
sinus pressure information to properly time a start time of
deflation of the inflatable balloon device during the intermittent
occlusion of the coronary sinus, and wherein the control system
starts the deflation of the inflatable balloon device after an
occlusion period that includes multiple heart beats; and
after intermittently occluding the coronary sinus,
delivering a coronary intervention tool via a body artery and to
the blockage in the coronary artery of the heart to perform a
coronary intervention procedure; and
after performing the coronary intervention procedure,
removing the coronary sinus occlusion catheter through the
guide sheath.
Appeal Br. 17–18 (Claims App.).

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Mohl
Lundquist
Peters
O’Neill
Mjachold
Makower
US 4,887,608
US 5,011,468
US 5,024,668
US 5,324,260
US 5,458,574
US 7,159,592 B1
Dec. 19, 1989
Apr. 30, 1991
June 18, 1991
June 28, 1994
Oct. 17, 1995
Jan. 9, 2007
Doty US 2007/0060883 A1 Mar. 15, 2007
Jose L. Navia et al., In Vitro Performance of the Novel
Coronary Sinus AutoRetroPerfusion Cannula, ASAIO Journal
51.6 (2005) (hereinafter “Navia”).
Appeal 2018-008912
Application 12/786,785

4
EVIDENCE RELIED UPON BY APPELLANT
Declaration under 37 C.F.R. § 1.132, executed by Dr. Levente
Molnar (hereinafter, the “Molnar Declaration”).

REJECTIONS
I. Claims 4, 24–26, and 30–34 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Mohl, Peters, Navia, Lundquist, Doty, and
Makower.
II. Claims 27 and 29 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Mohl, Peters, Navia, Lundquist, Doty, Makower, and
O’Neill.
III. Claim 28 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Mohl, Peters, Navia, Lundquist, Doty, Makower, O’Neill, and
Machold.

OPINION
Rejection I
Only those arguments actually made by the Appellant have been
considered in this decision. Arguments that the Appellant could have made
but chose not to make have not been considered and are deemed to be
waived. See 37 C.F.R. § 41.37(c)(1)(iv); In re Jung, 637 F.3d 1356, 1365–
66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075–76 (BPAI 2010
(precedential)).
Claims 4, 24–26, and 34
The Examiner finds that Mohl discloses, among other things, a
method of treating heart tissue that includes advancing a tip portion of an
Appeal 2018-008912
Application 12/786,785

5
occlusion catheter into a coronary sinus and intermittently occluding the
coronary sinus using an inflatable balloon device. Final Act. 3 (citing Mohl,
Fig. 1; 3:63–4:14, 4:52–59). However, the Examiner finds that Mohl fails to
disclose delivering a coronary intervention tool after intermittently
occluding the coronary sinus. Final Act. 8. Addressing this deficiency in
the teachings of Mohl, the Examiner finds Doty discloses “it is well known
in the art to treat heart tissue after myocardial infarction; where such
treatment helps salvage and/or rehabilitates the ischemic tissue and can
occur before (pretreatment), during and/or after an angioplasty procedure;
where parts of the system can be withdrawn after treatment.” Id. at 8 (citing
Doty ¶¶ 3, 21, 42.
Appellant argues that, “unlike the claimed method, Doty describes
only a single device in a single location for providing treatment.” Appeal
Br. 6 (emphasis omitted). Appellant further contends:
Doty not only fails to disclose the claimed method including
advancing a distal tip portion of a coronary sinus occlusion
catheter through a guide sheath “in a right atrium and into the
coronary sinus,” after intermittently occluding the coronary
sinus, delivering a coronary intervention tool via a body artery
and to the blockage “in the coronary artery of the heart” to
perform a coronary intervention procedure, and “after
performing the coronary intervention procedure, removing the
coronary sinus occlusion catheter through the guide sheath,” but
describes a configuration that prevents (and teaches away from)
the claimed method.
Id. at 6–7 (emphasis added).
In response, the Examiner asserts that, rather than address the
proposed combination of references in the rejection, Appellant’s argument
attacks Doty individually. See Ans. 3–4. The Examiner also finds that the
existence of a mere difference between the method disclosed by Doty and
Appeal 2018-008912
Application 12/786,785

6
the various steps of the method discussed by Appellant does not amount to
Doty’s teaching away from the claimed invention. See id.
We agree on both points. The Examiner relies on Doty to teach the
treatment of heart tissue after myocardial infarction, (i) where such treatment
helps rehabilitate ischemic tissue and can occur before angioplasty and (ii)
where parts of the system can be withdrawn after treatment. Final Act. 8.
Doty teaches the occlusion of a blood vessel in order to provide a therapeutic
agent. Doty, Abstract. Doty states “[t]he treatment may occur, for example,
before, during, and/or after a CABG[3] or PTCA[4] procedure in an effort to
salvage and/or rehabilitate myocardial tissue.” Doty ¶ 21. Thus, the
Examiner’s finding regarding Doty’s disclosure of treatment before
angioplasty is supported by a preponderance of the evidence. Doty further
explains that treatment is performed with elongate element 20 and that after
treatment is completed, “[e]longate element 20 may then be withdrawn from
the patient along with the guidewire 80.” Doty ¶ 42 (emphasis omitted).
Consequently, the Examiner’s finding regarding Doty’s disclosure of
withdrawal of parts of the system after treatment is also supported by a
preponderance of the evidence.
As for whether Doty teaches away from the claimed invention,
Appellant does not direct our attention to any portion of Doty that would
have led a person of ordinary skill in the art in a direction divergent from the
path that was taken by the Appellant. Rather, as stated by the Examiner,
Appellant merely alleges that there is at least one difference between the
system and method taught by Doty and the method recited in claim 4.

3 “Coronary Artery By-Pass Grafting”
4 “Percutaneous Transluminal Coronary Angioplasty”
Appeal 2018-008912
Application 12/786,785

7
Paragraph 42 of Doty makes clear that elongate member may be left in place
or withdrawn, and paragraph 21 makes clear that the treatment can occur
before, during, or after other treatment. Thus, it appears that the method
disclosed by Doty is relatively flexible as to when and how it is performed,
and Appellant does not indicate how Doty’s use of “only a single device in a
single location” would interfere or otherwise lead a person of ordinary skill
in the art in a direction divergent from the path that was taken by the
Appellant.
Appellant makes a general statement, without explanation or specific
reference to the Examiner’s reasoning, that the rejection is based on
impermissible hindsight. See Appeal Br. 7–8. Such a conclusory assertion
with no analysis to the underlying challenge is insufficient to apprise us of
Examiner error. Accordingly, Appellant’s arguments with respect to the
Examiner’s reliance on the teachings of Doty are unavailing.
Appellant then discusses Makower, making the same general attacks
on Makower as not disclosing extensive portions of claim 4 when the
rejection relies on Makower to teach much less. Appeal Br. 7; see also Final
Act. 9 (finding that Makower teaches delivery of an angioplasty catheter in a
coronary artery and removal of the catheter after completion of the
angioplasty). Specifically, Appellant states:
Makower does not cure these deficiencies in the proposed
rejection based on Doty. Makower describes “a flexible guide
catheter is percutaneously inserted into a peripheral artery ... and
... a balloon catheter is passed through the guide catheter and into
the obstructive lesion.” See, Makower, 1:57-63. Here again, like
Doty, the devices of Makower are in a single location. Thus,
Makower likewise not only fails to describe the combination of
“prior to intervening on the blockage in the coronary artery,
advancing a distal tip portion of a coronary sinus occlusion
Appeal 2018-008912
Application 12/786,785

8
catheter through a guide sheath in a right atrium and into the
coronary sinus,” and “after intermittently occluding the
coronary sinus, delivering a coronary intervention tool via a
body artery and to the blockage in the coronary artery of the
heart to perform a coronary intervention procedure,” as recited
in claim 4, but describes a different configuration that prevents
(and teaches away from) the claimed method.
Appeal Br. 7 (underlining added).
We agree with the Examiner’s assessment in the Answer that
Appellant’s contention merely attacks the teachings of Makower
individually rather than as applied in the proposed combination of teachings
made by the Examiner. See Ans. 4–5 (stating that Makower was found to
teach “performing an angioplasty includes delivering an angioplasty catheter
(i.e. coronary sinus intervention tool) to A BODY ARTERY and to the
blockage to perform the coronary artery procedure treatment (i.e.
angioplasty) and additionally teaches after performing the angioplasty
procedure, removing the system.”). Indeed, Appellant does not contest the
Examiner’s findings regarding Makower’s disclosure. See Appeal Br. 7.
Rather, Appellant asserts that other elements for which Makower is not
relied upon are missing from Makower.
Similar to Appellant’s discussion of Doty, Appellant’s contention that
Makower teaches away from the claimed invention is unpersuasive.
Appellant makes no explanation as to why any of the disclosure in Makower
would lead a person of ordinary skill in the art away from the invention
recited in claim 4. Thus, Appellant does not apprise us of Examiner error
with respect to the use of Makower in the rejection of claim 4.
Appeal 2018-008912
Application 12/786,785

9
Peters/Occlusion Process
Claim 4 requires, in part, that during an initial phase, the control
system determines the time period for occluding the coronary sinus based on
a predetermined pattern of predetermined occlusion times independent of
coronary sinus pressure sensor data.
In the statement of the rejection of claim 4, the Examiner finds that
Peters discloses an occlusion process, independent of coronary sinus
pressure, in columns 4, 5, 15, 16, 23, and 24. Final Act. 5–6 (citing
Peters 4:66–5:14, 15:1–14, 33–65, 16:1–44, 23:62–24:14).5 This disclosure
in Peters includes a “priming process.” With respect to this 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. 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 backfilled with a preselected
amount of helium.”) (bolding omitted, emphasis added).
In the Response to Arguments section of the Final Office Action, the
Examiner refers to the teachings in columns 25–26 of Peters as disclosing an

5 For this element of the claim, the Examiner does not apply the disclosure in
Mohl related to control of inflation/deflation of a balloon intended to
occlude a coronary sinus independently of coronary sinus pressure. See
Mohl 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.”), see also id. at 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.”).
Appeal 2018-008912
Application 12/786,785

10
occlusion process that is independent of the coronary sinus pressure. Final
Act. 13–14. This disclosure in Peters is different from the priming process.
Specifically, the process disclosed in Peters’ columns 25–26 is characterized
by Peters as the taking of a series of measurements in order to obtain a “base
line” (see Peters 25:15–20). The objective of the base line procedure is to
determine the expected level or degree of retrograde perfusion that will
occur upon the selection of certain operating parameters such as coronary
sinus pressures. Peters 25:31–38. This provides a way to determine what
may be viewed as the efficiency of the retroperfusion therapy. Id.
The Examiner relies on Navia to teach that performing intermittent
coronary sinus occlusion by connecting a proximal end of a balloon catheter
to a pneumatic pump that automatically inflates and deflates the balloon
according to a preset cycle of predetermined times. Final Act. 6.
Appellant argues “[a]s a separate and additional error in the Office
Action, the proposed combination, unlike independent claim 4, fails to
describe a control system that ‘determines the time period for occluding the
coronary sinus based on a predetermined pattern of predetermined occlusion
times independent of coronary sinus pressure sensor data.’” Appeal Br. 8
(emphasis omitted). Appellant next discusses (see Appeal Br. 8–10) the
base line process disclosed in Peters’ columns 25–26. Id. Appellant’s
assertion is that, contrary to the requirements of claim 4, this base line
process in Peters is performed manually, and includes implementing a user’s
input, which is, in turn, based on coronary sinus pressure readings. See
Appeal Br. 8–10; Reply Br. 2–4. Referring to the Molnar Declaration,
Appellant states,
Appeal 2018-008912
Application 12/786,785

11
the testimony evidence of Dr. Levente Molnár provided in the
Declaration dated April 7, 2015 shows that Peters teaches that
the user manually selected when to deflate the balloon (so as to
obtain base line measurements) and the “manual
inflation/deflation periods were plainly dependent on the
pressure readings (and each physician’s personal intuition based
on those pressure readings).”
Appeal Br. 9 (citing Molnar Declaration ¶ 7, Peters 25:47–26:17, Figs. 18,
21) (footnote omitted). The Molnar Declaration and Appeal Brief do not
address the priming process disclosed in Peters. In other words, the
Examiner relies on either of two different processes disclosed in Peters for
the occlusion process that is independent of coronary sinus pressure, and
Appellant addresses only one of these processes, namely, the base line
process. Consequently, we have before us no stated opposition to the
findings the Examiner made with respect to Peters’ priming process, and,
accordingly, Appellant has waived any such arguments for the purposes of
this appeal. See 37 C.F.R. § 41.37(c)(1)(iv); Jung, 637 F.3d at 1365–66;
Frye, 94 USPQ2d at 1075–76. Based on the discussion above, Appellant’s
contention regarding Peters does not apprise us of Examiner error.
Appellant next argues that Navia bases its control on coronary sinus
pressure, and, therefore, fails to remedy any deficiency in Peters. See
Appeal Br. 10–11.
The Examiner relies on Navia to teach “perform[ing] intermittent
coronary sinus occlusion by connecting a proximal end of a balloon catheter
to a pneumatic pump that automatically inflated and deflates the balloon
according to a preset cycle of predetermined times since timing of the
balloon inflation and deflation is critical.” Final Act. 6 (emphasis added).
The Examiner’s finding on this point is supported by Navia’s disclosure on
Appeal 2018-008912
Application 12/786,785

12
page 686, column 1 and page 690, column 1. The Examiner does not rely on
Navia to teach control that is independent of coronary sinus pressure. See id.
Thus, Appellant’s arguments attack Navia as failing to disclose an element
for which the Examiner relies on a different reference to teach.
We have considered all of Appellant’s arguments in support of the
patentability of claim 4, but the arguments asserted do not identify Examiner
error. Accordingly, we sustain the rejection of claim 4. As Appellant does
not make separate arguments for any of claims 24–26 and 34, these claims
fall with claim 4, from which they depend.
Claims 30–33
On pages 11–13 of the Appeal Brief, Appellant reiterates the same
arguments regarding Doty and Makower made on pages 6–8 of the Appeal
Brief. Similarly, on pages 13–15 of the Appeal Brief, Appellant reiterates
the arguments made on pages 8–11 of the Appeal Brief regarding Peters and
Navia. For the same reasons discussed above, these arguments do not
identify Examiner error, and we sustain the rejection of claim 30 and claims
31–33 depending therefrom.
Rejections II and III
Appellant does not make separate arguments for the patentability of
any of claims 27–29. See Appeal Br. 6–16. Accordingly, these claims fall
with claim 4, from which they depend.

DECISION
The Examiner’s rejection of claims 4 and 24–34 is affirmed.
Appeal 2018-008912
Application 12/786,785

13
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)(1)(iv).

AFFIRMED