Epicardial Frontiers, LLC

Patent Trials and Appeals Board

Apr 20, 2021

2020004563 (P.T.A.B. Apr. 20, 2021)

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.
14/645,809 03/12/2015 Brian Fill Epicardial-1401 1051
36787 7590 04/20/2021
BLYNN L. SHIDELER
THE BLK LAW GROUP
3000 Village Run Road
Suite 103-251
WEXFORD, PA 15090
EXAMINER
FERNANDEZ, KATHERINE L
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
04/20/2021 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):
blynn@BLKLawGroup.com
cbelleci@BLKLawGroup.com
patents@BLKLawGroup.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRIAN FILL and MARK J. GARTNER

Appeal 2020-004563
Application 14/645,809
Technology Center 3700
____________

Before STEFAN STAICOVICI, MICHAEL J. FITZPATRICK, and
LEE L. STEPINA, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant, Epicardial Frontiers, LLC,1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 8–16 and 20.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies itself as the sole real party in interest. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification
Appellant’s disclosure “to technologies to facilitate access to the
pericardial space and to perform procedures on the heart from the pericardial
space, more specifically the present invention relates to pericardial space
access tools that minimize potential myocardial damage via cardiac
perforation or coronary laceration.” Spec. ¶3.

The Claims
Claims 8–16 and 20 are rejected. Final Act. 1. Claims 1–4 and 7
have been withdrawn from consideration, and no other claims are pending.
Id. Claim 8 is illustrative of the claims on appeal and reproduced below.
8. An image guided pericardial procedure system for
performing percutaneous image guided pericardial procedures
comprising:
a) a tool tracking system having a display for
visualization of virtual representations of tracked tools
which is configured to have a field of operation
encompassing percutaneous pericardial space access and
procedures;
b) a patient specific three dimensional model of
the patient for use in percutaneous pericardial space
procedures that is registered with the tool tracking system
for simultaneous display of the patient specific three
dimensional model and at least one of the virtual
representations of the tracked tools on the tool tracking
system display; and
c) at least one percutaneously inserted tracked tool
for the tool tracking system into the pericardial space,
wherein the tool tracking system is configured to
simultaneously visualize a virtual representation of the
tracked tool as one of the virtual representations of
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tracked tools of the tool tracking system and the patient
specific three dimensional model on the tool tracking
system display at least through a portion of a pericardial
procedure.
Appeal Br. 16.
The Examiner’s Rejections
The following rejections are before us:
(1) claims 8, 9, and 14 under 35 U.S.C. § 102(a)(1)/(a)(2) as
anticipated by Zentgraf (US 2013/0150710 A1, published June 13, 2013);
and
(2) claims 10–13, 15, 16, and 20 under 35 U.S.C. § 103 as being
unpatentable over Zentgraf and Michels (US 2004/0087831 A1, published
May 6, 2004).

DISCUSSION
Rejection 1—Anticipation
The Examiner found that Zentgraf discloses all of the limitations of
claims 8, 9, and 14. Final Act. 3–4 (citing Zentgraf ¶¶9–10, 37, 41–42, 44,
49–52, 54, and 58–59, Figs. 1, 2, and 11). Because Appellant argues the
patentability of these claims under separate headings, we review the
rejection of each claim separately. 37 C.F.R. § 41.37(c)(1)(iv).

Claim 8
Appellant argues that “there is no teaching or suggestion in [Zentgraf]
of registering an alleged 3d patient model with a tool tracking system as
set forth in the claim[].” Appeal Br. 10. The limitation to which Appellant’s
argument refers recites as follows:
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b) a patient specific three dimensional model of the patient for
use in percutaneous pericardial space procedures that is
registered with the tool tracking system for simultaneous display
of the patient specific three dimensional model and at least one
of the virtual representations of the tracked tools on the tool
tracking system display;
Id. at 16. Appellant argues that, in Zentgraf, “virtual representations of
select tools are superimposed upon the ultrasound image data.” Id. at
10; see also id. at 12 (Zentgraf “is an augmented reality system in which the
tool representation are overlayed with the sensor imaging results.”).
Appellant further argues that such superimposing/overlaying is not
registering. Id. The Examiner responds “that, as is known in the art,
‘registering’ two sets of data comprises of transforming different sets of data
into one coordinate system (i.e. a common coordinate system),” as is done in
Zentgraf. Ans. 3–4. Further, the Examiner points out that, per Appellant,
“registration of the tool tracking system 300 with the model 330 . . . can also
be called integration of the model 330 into the tool tracking system display
310.” Id. at 4.2 And, as the Examiner points out, the Specification
repeatedly refers to “integrat[ion]” of two sets of data when describing the
claimed invention. Id. at 4 (quoting Spec. ¶¶49, 51). Appellant did not file a
reply brief and fails to apprise us of error in either the Examiner’s
construction of “registering” or the Examiner’s finding that it encompasses

2 The Examiner quoted this statement from paragraph 90 of the published
version of the application, US 2015/0305770 A1. Ans. 4. However, it also
appears in the Specification as filed, albeit with a small typographical error.
See Spec. ¶95 (“registration of the tool tracking system 300 with the model
330 . . . can also be called integration of the model 330 into the tool tracking
system display310”).
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Zentgraf’s disclosure of superimposing/overlaying one set of image data
onto another.
Appellant also contests that what is registered in Zentgraf constitutes
“a patient specific three dimensional model of the patient,” as recited in
claim 8. Appeal Br. 12. More specifically, Appellant argues that Zentgraf’s
“anatomy 204” (which is discussed in paragraph 51 and shown in Figure 11)
refers to a “real time anatomy image” and “not a patient specific three
dimensional model as defined in the present invention.” Id.; see also id. at
12–13 (“This integration that is present in the applied art is teaching that the
virtual images of select tools are superimposed upon the ultrasound image
data. There is no PATIENT MODEL which is registered with the tool
tracking system as in the present claimed invention.” (italics added)). The
Examiner responds that “Zentgraf explicitly discloses ‘[u]sing the tracked
TEE image data, geometric models of pertinent anatomy . . . are added to
provide the surgeon with a significantly more intuitive environment for
performing the surgical procedure.’” Ans. 6 (quoting Zentgraf ¶49
(Examiner’s emphasis)).3 The Examiner further responds that Zentgraf also
“discloses ‘[t]he information is displayed on a user interface 200 . . .
showing the ultrasound image data with dynamic virtual geometric
representations of surgical tools 202 and anatomy 204.’” Id. (quoting
Zentgraf ¶51 (Examiner’s emphasis)). Appellant fails to apprise us of error
in the Examiner’s finding that Zentgraf discloses “a patient specific three
dimensional model of the patient,” as recited in claim 8.

3 “TEE” refers to trans-esophageal echocardiography. Zentgraf ¶5.
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Next, Appellant argues Zentgraf “is directed to tools for heart valve
repair, within the heart chamber itself” and not the pericardial space
surrounding the heart. Appeal Br. 13. Thus, according to Appellant,
Zentgraf does not disclose, for example, “a patient specific three
dimensional model of the patient for use in percutaneous pericardial space
procedures.” Id. (quoting claim 8). The Examiner responds that the
broadest reasonable construction of a “percutaneous pericardial space
procedure[],” as recited in claim 8, encompasses “any procedure wherein the
pericardial space is accessed or crossed.” Ans. 8. This construction is
reasonable in view of the Specification, which does not define “percutaneous
pericardial space procedure[].” In particular, we see no basis on which to
exclude from the scope of this term a procedure in which the pericardial
space is accessed or crossed. Additionally, the Examiner points out that
Appellant’s claims are apparatus claims that cover what the recited
apparatus is, not what the recited apparatus does. Ans. 9 (quoting Hewlett-
Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990)
as holding “[A]pparatus claims cover what a device is, not what a device
does.”). And the Examiner found:
The tool tracking system having the display and tracked tool of
Zentgraf would be capable of being used for any cardiac
procedure, including pericardial space procedures (i.e. the
display of Zentgraf is capable of providing visualization of any
cardiac procedure and the tracked tool, such as the needle and
jaws set forth in paragraph [0044] of Zentgraf[], are similar to
the tools described by Appellant[] for the pericardial space
procedures and therefore would be capable of being used for
pericardial space procedures).
Ans. 10. These findings are supported by substantial evidence and
unrebutted by Appellant.
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In sum, Appellant’s arguments do not apprise us of error in the
rejection of claim 8. Accordingly, we affirm the rejection of claim 8.

Claim 9
Claim 9 depends from claim 8 and recites “wherein the at least one
tracked tool includes at least one of a direct vision tool, an ablation tool, a
material delivery tool, a left atrial appendage closure tool, a material
grasping tool, a surgical fastener placement tool, and a lead placement tool.”
Appeal Br. 16. Appellant argues that Zentgraf’s “heart valve repair device
teaches a device for operation within the heart chamber itself and teaches
away from the series of pericardial space tools further defined in claim 9.”
Id. at 14. First, the concept of “teaching away” is inapposite here given that
the rejection of claim 9 is for anticipation. See Seachange Int’l, Inc. v. C-
COR, Inc., 413 F.3d 1361, 1380 (Fed. Cir. 2005) (“Teaching away is
irrelevant to anticipation.”). Second, as the Examiner points out (Ans. 11),
Zentgraf discloses that its heart valve repair device includes “a capture
assembly 142” that may include “clamping jaws” that “can be used to
capture tissue.” Zentgraf ¶44. The Examiner found that Zentgraf thus
discloses “a material grasping tool,” which is one of the options recited in
claim 9. Ans. 11. In light of these findings, which are fully supported by
paragraph 44 of Zentgraf, Appellant fails to apprise us of error in the
rejection of claim 9.
Accordingly, we affirm the rejection of claim 9.

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Claim 14
Claim 14 depends from claim 9 and recites that “the at least one
tracked tool includes a left atrial appendage closure tool.” Appeal Br. 17.
Appellant argues that Zentgraf’s heart valve repair tool could not “be used to
close the left atrial appendage and certainly not from the pericardial space.”
Id. at 14. The Examiner responds that claim 14, like claim 8 discussed
above, is an apparatus claim and Zentgraf discloses a tool capable of being
use to close a left atrial appendage. Ans. 12–13. In particular, the Examiner
found “Zentgraf discloses a tool for inserting a suture into tissue (paragraphs
[0044], [0062]), and therefore, the tool which can insert a suture into tissue
is viewed as a ‘left atrial appendage closure tool’ as it is a tool which can
provide a suture, which is well known in the art for the use of
stitching/closing of tissue.” Id. (citing Zentgraf ¶¶44, 62). We discern no
error in the Examiner rejection of claim 14.
Accordingly, we affirm the rejection of claim 14.

Rejection 2—Obviousness
The Examiner found that claims 10–13, 15, 16, and 20 would have
been obvious in view of Zentgraf and Michels. Final Act. 5–7. Appellant
argues against this rejection as follows:
The ’831 publication [(i.e., Michels)] teaches away from the
augmented reality process of the ’710 publication [(i.e.,
Zentgraf)]. The ’831 publication expressly teaches the use of a
thoracoscope 16 to be use[d] so the procedure is performed under
direct vision, thereby teaching away from the augmented reality
aspects of the primary reference. The secondary reference when
considered as a whole teaches away from the key claimed
features of the present claimed invention.
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Appeal Br. 15 (no citation provided). That Michels employs one alternative
(“direct vision”) does not by itself teach away from other alternatives. See
In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from any of these alternatives because such disclosure does not criticize,
discredit, or otherwise discourage the solution claimed.”). Moreover, the
Examiner’s rejection does not rely on Michel’s thorascope but rather on the
use of a direct vision tool in the form of Michel’s image capture device.
Ans. 13; see also Final Act. 6 (“[I]t would have been obvious . . . to
substitute [Zentgraf’s tool] with a tool for a minimially [sic] invasive
procedure which includes a direct vision tool providing an image guided
pericardioscopy procedure, a radio frequency ablation tool, a material
delivery tool and/or a lead placement tool, as taught by Michels.”).
Appellant fails to apprise us of error in the Examiner rejection of claims 10–
13, 15, 16, and 20.
Accordingly, we affirm the rejection of claims 10–13, 15, 16, and 20.

SUMMARY
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
8, 9, 14 102(a)(1)/
(a)(2)
Zentgraf 8, 9, 14
10–13,
15, 16,
20
103 Zentgraf, Michels 10–13, 15,
16, 20

Overall
outcome
8–16, 20

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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