Folk, Christopher et al.

Patent Trials and Appeals Board

Dec 30, 2019

14758754 - (D) (P.T.A.B. Dec. 30, 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.
14/758,754 06/30/2015 Christopher Folk HKN-02738US01 6396
137834 7590 12/30/2019
MDT_RTGNV/Shumaker & Sieffert P.A.
Attn: IP Legal Department
826 Coal Creek Circle
Louisville, CO 80027
EXAMINER
WOLF, MEGAN YARNALL
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
12/30/2019 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):
pairdocketing@ssiplaw.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER FOLK and
JACOB KEARNS
Appeal 2019-003381
Application 14/758,754
Technology Center 3700

Before ANTON W. FETTING, PHILIP J. HOFFMANN, and
AMEE A. SHAH, Administrative Patent Judges.
HOFFMANN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 9–22 and 24–35. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
Appellant’s “disclosure generally relates to medical systems and
methods.” Spec. ¶ 1. Claims 9, 27, and 30 are the independent claims on
appeal. Below, we reproduce claim 9 as illustrative of the appealed claims:

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Ford
Global Technologies, LLC. Appeal Br. 2.
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9. A method for performing a diagnostic or therapeutic
procedure on an aneurysm, the method comprising:
introducing an intravascular device through a parent vessel
and adjacent an aneurysm or within the aneurysm to reduce blood
flow from the parent vessel into the aneurysm;
introducing a guide into the parent vessel and advancing
the guide through the parent vessel past a proximal neck of the
aneurysm, wherein a sensor is on the guide;
positioning the sensor one of upstream or downstream of
the aneurysm and measuring, with the sensor and while the
sensor is on the guide and within the parent vessel, at least one
of a first pressure, a first volume, or a first blood flow velocity;
and
after measuring the at least one of the first pressure, the
first volume, or the first blood flow velocity, positioning the
sensor the other one of upstream or downstream of the aneurysm
and measuring, with the sensor and while the sensor is on the
guide and within the parent vessel, at least one of a second
pressure, a second volume, or a second blood flow velocity to
determine the effectiveness of the intravascular device in
minimizing blood flow from the parent vessel into the aneurysm.
REJECTIONS AND PRIOR ART
The Examiner rejects the claims as follows:
I. Claim 21 under 35 U.S.C. § 112, second paragraph, as
indefinite;
II. Claims 9–12, 15, 18–22, 24, 30, and 32–34 under
35 U.S.C. § 103(a) as unpatentable over Evans et al.
(US 7,666,220 B2, iss. Feb. 23, 2010) (“Evans), Letort et al.
(US 2003/0199772 A1, pub. Oct. 23, 2003) (“Letort”), and
Hayashi et al. (US 2003/0229388 A1, pub. Dec. 11, 2003)
(“Hayashi”);
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III. Claims 27, 28, and 35 under 35 U.S.C. § 103(a) as unpatentable
over Evans, Letort, and Escamilla et al. (US 2004/0059407 A1,
pub. Mar. 25, 2004) (“Escamilla”);
IV. Claims 13, 14, 16, 17, 25–29, 31, and 35 under
35 U.S.C. § 103(a) as unpatentable over Evans, Letort, Hayashi,
and Escamilla.
ANALYSIS
Rejection I—Indefiniteness rejection
As set forth above, the Examiner rejects claim 21, which depends
from claim 9, as indefinite. Below, we reproduce relevant portions of
independent claim 9, and claim 21 in its entirety.
9. A method for performing a diagnostic or
therapeutic procedure on an aneurysm, the method comprising:
introducing an intravascular device through a parent
vessel and adjacent an aneurysm or within the aneurysm to
reduce blood flow from the parent vessel into the aneurysm;
introducing a guide into the parent vessel and advancing
the guide through the parent vessel past a proximal neck of the
aneurysm, wherein a sensor is on the guide; [and]
positioning the sensor one of upstream or downstream of
the aneurysm and measuring, with the sensor and while the
sensor is on the guide and within the parent vessel, at least one
of a first pressure, a first volume, or a first blood flow
velocity . . . .
21. The method according to claim 9, wherein
advancing the guide through the parent vessel past the
proximal neck of the aneurysm comprises advancing the guide
from a first position in which the sensor is upstream of the
aneurysm to a second position in which the sensor is
downstream of the aneurysm.
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Appeal Br., Claims App. (emphases added). According to the Examiner,
claim 21 is indefinite based on the following:
Claim 21 requires that advancing the guide comprises
advancing the guide from a first position in which the sensor is
upstream of the aneurysm to a second position in which the
sensor is downstream of the aneurysm. Claim 9, from which
[claim] 21 depends, requires both advancing the guide, as well
as positioning the sensor upstream/downstream and then
downstream/upstream. It is unclear if the advancing steps
required in claim 21 are the same as the positioning steps of 9
or are different from the positioning steps of claim 9.
Final Action 6–7 (emphases added). Based on our review of the record, we
disagree with the Examiner, and instead agree with Appellant that claim 21
is not indefinite. Appeal Br. 6–7. Claim 21 expressly recites that it is
claim 9’s step of “advancing the guide through the parent vessel past the
proximal neck of the aneurysm” that comprises advancing the guide from
the first to the second position, as claim 21 further recites.

Rejection II—Obviousness rejection of claims 9–12, 15, 18–22, 24,
30, and 32–34 based on Evans, Letort, and Hayashi
Independent claim 9, and its dependent claims 10–12, 15, 18–
22, 24, and 34
As set forth above, independent claim 9 recites the following:
9. A method for performing a diagnostic or
therapeutic procedure on an aneurysm, the method comprising:
introducing an intravascular device through a parent
vessel and adjacent an aneurysm or within the aneurysm to
reduce blood flow from the parent vessel into the aneurysm;
introducing a guide into the parent vessel and advancing
the guide through the parent vessel past a proximal neck of the
aneurysm, wherein a sensor is on the guide;
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positioning the sensor one of upstream or downstream of
the aneurysm and measuring, with the sensor and while the
sensor is on the guide and within the parent vessel, at least one
of a first pressure, a first volume, or a first blood flow velocity;
and
after measuring the at least one of the first pressure, the
first volume, or the first blood flow velocity, positioning the
sensor the other one of upstream or downstream of the
aneurysm and measuring, with the sensor and while the sensor
is on the guide and within the parent vessel, at least one of a
second pressure, a second volume, or a second blood flow
velocity to determine the effectiveness of the intravascular
device in minimizing blood flow from the parent vessel into the
aneurysm.
Appeal Br., Claims App. (emphases added). Restated, claim 9’s method
uses a sensor to measure either pressures, volumes, or blood-flow velocities
both upstream and downstream of an aneurysm. For the reasons set forth
below, the Examiner does not support adequately that the proposed
combination of Evans, Letort, and Hayashi would provide a method where
sensors measure properties both upstream and downstream of an aneurysm.
Thus, we do not sustain the Examiner’s obviousness rejection of
independent claim 9.
The Examiner’s rejection relies on Evans’s double-walled filling
structure 12 to disclose the claimed intravascular device. See, e.g., Final
Action 7. Consistent with Appellant’s argument (Appeal Br. 11), Hayashi
discloses measuring properties with sensors 18 that are disposed at ends of
graft 10 (see, e.g., Hayashi ¶ 20, Fig. 1). The Examiner proposes, in part, to
modify Evans, to “measure the upstream/downstream pressure” as “taught
by Hayashi.” Answer 8.
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We agree with Appellant, however, that “Hayashi does not describe
that pressure measurements should be taken upstream and downstream of an
aneurysm in order to detect endoleaks. Instead, Hayashi describes that the
positioning of sensors relative to the ends of . . . graft 10 enables detection of
endoleaks.” Appeal Br. 11 (citing Hayashi ¶ 23) (underlining omitted).
Thus, a modification of Evans based on Hayashi would result in an
arrangement in which sensors measure properties at the ends of Evans’s
double-walled filling structure 12. Appeal Br. 11–12.
If Evans’s double-walled filling structure 12 extends upstream and
downstream of the aneurysm, then measuring properties at the ends of
structure 12 would result in an arrangement where sensors measure
properties both upstream and downstream of an aneurysm, consistent with
claim 9’s recitations. The reason that we do not sustain the rejection,
however, is because the Examiner does not support adequately that Evans’s
structure 12 extends upstream or downstream of an aneurysm.
Evans describes that its
methods for treating an aneurysm comprise positioning at least
one double-walled filling structure across the aneurysm. By
“across” the aneurysms, it is meant generally that the filling
structure will extend axially from one anatomical location,
which has been identified by imaging or otherwise as the
beginning of the aneurysm, to a space-part location (or
locations in the case of bifurcated aneurysm) where it has been
established that the aneurysm ends.
Evans col 6, l. 61–col. 7, l. 2 (emphases added). This is consistent with the
arrangement shown in Evans’s Figure 5C, for example, in which structure 12
extends from a top-right end of aneurysm AAA to bottom-left and bottom
left end of the aneurysm. It is not clear to us that even measuring properties
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at structure 12’s top-left and bottom-left ends, for example, would be
measurements upstream and downstream of the aneurysm.
According to the Examiner, Evans’s “[Figure] 5C . . . shows ends of
the device extending slightly upstream and downstream of the aneurysm.”
Answer 6. This finding is not supported adequately in view of Evans’s
express description that its method uses structures that extend from the
beginning to the end of the aneurysm.
The rejection further references Evans’s Figure 5D, which, according
to the Examiner, “shows the device extending even further from the limits of
the aneurysm.” Answer 6–7 (citing Evans col. 18, ll. 10–13, Fig. 5D). To
the extent that it would have been obvious to measure properties at the end
of “seals, anchors, stents, or other additional prosthetic components” (Evans
col. 18, ll. 10–12) that are attached to Evans’s structure 12, rather than at the
ends of structure 12 itself, consistent with Appellant’s argument, Evans
discloses that such components are “position[ed] . . . at either . . . proximal
end 52 or distal end 50 of the graft” (id. at col. 18, ll.10–13 (emphases
added)). That is, this portion of Evans does not state that the components
are positioned at both ends of structure 12, so that measuring characteristics
at both ends of structure 12 with any additional component would result in a
method where sensors measure properties both upstream and downstream of
an aneurysm. This is consistent with Evans’s Figure 5D, which shows “a
stent-like structure . . . planted in . . . upper proximal opening 52 of the
tubular lumen of . . . filling structure 12”—i.e., in only one end of
structure 12. Id. at col. 18, ll. 13–15. No other figure appears to disclose
prosthetic components in one end (or more importantly both ends) of
structure 12.
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Thus, based on the foregoing, we do not sustain the Examiner’s
rejection of independent claim 9. Further, we do not sustain the Examiner’s
rejection of claims 10–12, 15, 18–22, 24, and 34 that depend from claim 9.

Independent claim 30, and its dependent claims 31–33
Independent claim 30 recites the following:
30. A method comprising:
delivering an intravascular device through a parent vessel
of a patient to a treatment site adjacent an aneurysm or within
the aneurysm to reduce blood flow from the parent vessel into
the aneurysm;
introducing a guide into the parent vessel and advancing
the guide within the parent vessel past a neck of the aneurysm
to position a sensor on the guide one of upstream or
downstream of the aneurysm;
measuring, with the sensor and while the sensor is on the
guide, at least one of a first pressure, a first volume, or a first
blood flow velocity within the parent vessel;
after measuring the at least one of the first pressure, the
first volume, or the first blood flow velocity, positioning the
sensor the other one of upstream or downstream of the
aneurysm and measuring, with the sensor and while the sensor
is on the guide, at least one of a second pressure, a second
volume or a second blood flow velocity within the parent vessel
to determine an effectiveness of the intravascular device in
minimizing blood flow from the parent vessel into the
aneurysm.
Appeal Br., Claims App. (emphases added). Thus, claim 30 includes
recitations similar to those discussed above with respect to independent
claim 9. Accordingly, we do not sustain claim 30’s obviousness rejection
for reasons similar to the reasons we do not sustain claim 9’s rejection.
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Further, we do not sustain the Examiner’s obviousness rejection of
claims 31–33 that depend from claim 30.

Rejection III—Obviousness rejection of claims 27, 28, and 35
Independent claim 27 recites the following:
27. A method comprising:
introducing an intravascular device through a parent
vessel and adjacent an aneurysm or within the aneurysm to
reduce blood flow from the parent vessel into the aneurysm,
wherein introducing the intravascular device comprises
delivering a stent adjacent the aneurysm such that the stent
assumes a deployed configuration in which the stent extends
from a position upstream of the aneurysm to a position
downstream of the aneurysm, or positioning a plurality of
microcoils within the aneurysm;
introducing a guide into the parent vessel and advancing
the guide within the parent vessel past a neck of the aneurysm
to position a sensor on the guide at least adjacent to the
aneurysm;
with the guide at least partially within the parent vessel
and the sensor on the guide, measuring at least one of pressure,
volume or blood flow velocity adjacent the aneurysm with the
sensor to determine an effectiveness of the intravascular device
in minimizing blood flow from the parent vessel into the
aneurysm; and
after measuring the at least one of pressure, volume or
blood flow velocity adjacent the aneurysm with the sensor,
moving the sensor within the patient by at least moving the
guide.
Appeal Br., Claims App. (emphases added). The Examiner’s proposed
combination of references includes Evans and Escamilla. As set forth
below, we agree with Appellant that the Examiner’s proposed modification
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changes Evans’s principle of operation, and, therefore, is improper. See
Appeal Br. 23–24; see also Answer 12–15.
Almost Evans’s entire disclosure is directed to describing a double-
walled filling structure that is positioned across an aneurysm, and then filled
with a filling medium so that the structure’s outer wall conforms to the
aneurysm and the inner wall forms a lumen through which blood may flow.
See, e.g., Evans Abstract, col. 2, ll. 52–56. The Examiner’s proposed
combination does not rely on Evans’s double-walled filling structure to fill
an aneurysm, but instead fills the aneurysm with Escamilla’s embolic
coils 60 from microcatheter 58. Final Action 14. Thus, as we state above,
we agree with Appellant that combining Evans with Escamilla, such that an
aneurysm is treated by filling the aneurysm with coils rather than
conforming a double-walled filling structure’s outer wall to the aneurysm
and then filling the double-walled structure, impermissibly changes Evan’s
principle of operation.
Therefore, based on the foregoing, we do not sustain the Examiner’s
obviousness rejection of independent claim 27. Further, we also do not
sustain the obviousness rejection of claims 28 and 35 that depend from
claim 27.

Rejection IV—Obviousness rejection of claims 13, 14, 16, 17, 25–29,
31, and 35
Each of claims 13, 14, 16, 17, 25–29, 31, and 35 depends from one of
independent claims 9, 27, and 30. In the dependent claims’ rejection, the
Examiner does not rely on any reference to disclose anything that would
remedy the above-discussed deficiencies in the independent claims’
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rejections. Thus, we do not sustain the Examiner’s obviousness rejection of
dependent claims 13, 14, 16, 17, 25–29, 31, and 35.

CONCLUSION
We REVERSE the Examiner’s indefiniteness and obviousness
rejections of claims 9–22 and 24–35.
In summary:
Claims
Rejected
35 U.S.C. § Basis/Reference(s)  Affirmed Reversed
21 112, second
paragraph
Indefiniteness 21
9–12, 15,
18–22, 24,
30, 32–34
103(a) Evans, Letort, Hayashi 9–12, 15,
18–22, 24,
30, 32–34
27, 28, 35

103(a) Evans, Letort,
Escamilla
27, 28, 35
13, 14, 16,
17, 25–29,
31, 35
103(a) Evans, Letort, Hayashi,
Escamilla
13, 14, 16,
17, 25–29,
31, 35
Overall Outcome: 9–22, 24–35
REVERSED