Access Flow Systems, LLC

Patent Trials and Appeals Board

Oct 5, 2020

2019006938 (P.T.A.B. Oct. 5, 2020)

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.
15/088,447 04/01/2016 L. Van Thomas Crisco 34457-0005 2982
29052 7590 10/05/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
OU, JING RUI
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
10/05/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte L. VAN THOMAS CRISCO
____________

Appeal 2019-006938
Application 15/088,447
Technology Center 3700
____________

Before STEFAN STAICOVICI, LEE L. STEPINA, and
ERIC C. JESCHKE, Administrative Patent Judges.

JESCHKE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks review, under 35 U.S.C. § 134(a), of the Examiner’s
decision, as set forth in the Final Office Action dated October 30, 2018,
rejecting claims 1–20. The record includes a transcript of the remote oral
hearing held on September 1, 2020 (“Tr.”). We have jurisdiction under
35 U.S.C. § 6(b).
We affirm in part.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Access Flow Systems, LLC as the
real party in interest. Appeal Br. 2.
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BACKGROUND
The disclosed subject matter relates to “percutaneous methods for
performing a coronary artery bypass graft (CABG) procedure on a patient.”
Spec. ¶ 2. Claims 1 and 10 are independent. Claim 1 is reproduced below.
1. A system for performing a percutaneous
vascular or cardiac procedure, the system
comprising:
a percutaneous catheter having a distal end
for insertion into a vein or artery of a patient;
a sealing portion at the distal end which is
configured to releasably form a hemostatic
connection between the catheter and an inner wall
of the vein or artery to form an interface between
the sealing portion and the inner wall of the vein or
artery, wherein the sealing portion is configured to
form the hemostatic connection around a portion of
the inner wall of the vein or artery, the hemostatic
connection substantially preventing blood from
flowing through the interface;
a balloon configured to releasably secure the
sealing portion against the inner wall to form the
hemostatic connection, wherein the balloon
surrounds the catheter; and
a penetration device configured to pass
through the catheter and form an aperture through
the vein or artery while maintaining the hemostatic
connection between the catheter and the inner wall,
the aperture being bounded by the hemostatic
connection.

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REJECTIONS
1. Claims 1–202 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
2. Claims 1–3, 5–9, and 15–20 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Goldsteen (US 2004/0116946 A1, published
June 17, 2004), LaFontaine ’526 (US 6,092,526, issued July 25, 2000), and
Schweich (US 5,716,340, issued Feb. 10, 1998).
3. Claim 4 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Goldsteen, LaFontaine ’526, Schweich, and Ressemann
(US 6,155,264, issued Dec. 5, 2000).
4. Claims 10–14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Goldsteen, Khitin (US 2007/0185566 A1, published Aug.
9, 2007), LaFontaine ’526, and Schweich.
5. Claims 1, 5, 7–11, 13–15, and 17–20 stand rejected under
35 U.S.C. § 103(a) as unpatentable over LaFontaine ’985 (US 2001/0003985
A1, published June 21, 2001) and Valley (US 2001/0001812 A1, published
May 24, 2001).
6. Claims 2 and 3 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over LaFontaine ’985, Valley, and LaFontaine ’526.
7. Claim 4 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over LaFontaine ’985, Valley, and Ressemann.

2 The Examiner discusses claims 1, 6, 10, and 12 in the body of the
Rejection in the Office Action and in the Answer (Final Act. 2–4; Ans. 4–7),
but only lists claims 6 and 12 in the lead paragraph to this Rejection (Final
Act. 2). Because claims 2–9 and 15–20 depend from claim 1 and claims 11–
14 depend from claim 10, we consider claims 1–20 as rejected on this basis.
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8. Claims 6 and 12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over LaFontaine ’985, Valley, and Termin (US 5,071,407,
issued Dec. 10, 1991).
9. Claim 16 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over LaFontaine ’985, Valley, and Goldsteen.

DISCUSSION
Rejection 1 – The rejection of claims 1–20 under
35 U.S.C. § 112, first paragraph
A. Claims 6 and 12
Claim 6 depends from claim 1 and recites: “The system of claim 1,
further comprising a counter-support extending from the catheter in a
direction opposite the sealing portion.” Appeal Br. 21 (Claims App.)
(emphasis added). The Examiner stated that “claim 6 in view of the
limitations of claim 1 does not have sufficient support in the original
disclosure and is considered as new matter.” Final Act. 3. According to the
Examiner, “[c]laim 1 recites the balloon which is shown in the embodiment
shown in Figure 5” whereas “[t]he counter-support(s) 119 is/are shown in a
different/alternative embodiment as shown in Figure 6.” Id. The Examiner
stated that “[t]he original disclosure does not disclose a single embodiment
that has both the balloon and the counter-support.” Id.
Claim 12 depends from claim 10 and recites: “The method of claim
10, wherein releasably forming the hemostatic connection between the
catheter and the inner wall comprises extending a counter-support from the
catheter in a direction opposite the sealing portion.” Appeal Br. 23 (Claims
App.). The Examiner stated that “claim 12 in view of the limitations of
claim 10 does not have sufficient support in the original disclosure and is
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considered as new matter” for the same reasons discussed above as to claim
6. Final Act. 3–4.
Appellant asserts that paragraph 29 of the Specification supports the
“counter-support” of claims 6 and 12 being used in combination with the
“balloon” of their respective independent claims. See Appeal Br. 7.
Specifically, Appellant highlights the statement in paragraph 29 that “[t]he
hemostatic connection between the catheter and the inner aortic wall may be
made using any suitable technique,” and then Appellant quotes the rest of
that paragraph, which, according to Appellant, “describes certain
techniques.” Id. Appellant also quotes the disclosures in paragraph 29 that
(1) “the hemostatic connection 112 may be created by forming sutures 116
through the catheter wall 110 to the inner aortic wall 18” and (2) “[t]he
hemostatic connection 112 also may be created by inflating a non-occluding
balloon 117 within the aorta 16.” Id. (quoting Spec. ¶ 29, with emphasis
added by Appellant). According to Appellant, “[i]n a similar manner, one
skilled in the art would understand that use of the described non-occluding
balloon and one or more counter-supports also may be combined to provide
a suitable hemostatic connection.” Id.
The test for compliance with the written description requirement is
“whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Appellant has not shown
error in the Examiner’s finding that the Specification does not reasonably
convey to one of ordinary skill in the art that the inventor had possession of
the “counter-support” of claims 6 and 12 being used in combination with the
“balloon” of the independent claims. Although the term “also” is included
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in the disclosure of the use of non-occluding balloon 117 to create the
hemostatic connection, that term need not mean that balloon 117 is used in
combination with another of the disclosed “technique[s]” to create the
hemostatic connection. Instead, we view the use of the term “also”—as does
the Examiner—as indicating an alternative technique to creating the
hemostatic connection. See Spec. ¶ 29; Final Act. 3 (“The original
disclosure does not disclose a single embodiment that has both the balloon
and the counter-support.”); see also Appeal Br. 7 (acknowledging that “[t]he
described use of sutures, a non-occluding balloon, and one or more counter-
supports are illustrated separately in Figures 3A, 5, and 6, respectively”
(emphasis added)).
Here, Appellant has not identified record evidence (such as, for
example, a declaration) supporting the assertions as to the understanding of
one of ordinary skill in the art. See In re Pearson, 494 F.2d 1399, 1405
(CCPA 1974) (“Attorney’s argument in a brief cannot take the place of
evidence.”); Appeal Br. 7 (arguing that “one skilled in the art would
appreciate from the corresponding description [of Figure 3A, 5, and 6],
when viewed as a whole, that such techniques also may be used in
combination as a ‘suitable technique’ contemplated by the inventor” and that
“one skilled in the art would understand that use of the described non-
occluding balloon and one or more counter-supports also may be combined
to provide a suitable hemostatic connection”). For these reasons, we sustain
the rejection of claims 6 and 12 under 35 U.S.C. § 112, first paragraph.
B. Claims 1–5, 7–11, and 13–20
The Examiner rejected independent claims 1 and 10, finding that the
phrases “the balloon surrounds the catheter” in claim 1 and “the balloon
surrounds the at least one catheter” in claim 10 lack adequate written
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description support and are new matter. See Final Act. 2–3. The Examiner
made the same findings for both claims. See id. Specifically, the Examiner
stated that the Specification “is silent on whether the balloon surrounds
(encloses on all sides) the catheter.” Id. at 2, 3. The Examiner stated,
“Figure 5 is the only figure that shows that balloon 117. However, part of
the balloon [1]17 is not shown as it’s blocked by the distal end of the
catheter and the flange 114 in Figure 5.” Id. at 2–3. According to the
Examiner, “[t]he balloon may not have the structure that covers or encloses
the part of the catheter on the left side of the catheter as shown in Figure 5.”
Id. at 3. Claims 2–9 and 11–20 are rejected on the same basis due to their
dependence from either claim 1 or claim 10. See supra note 2.
Appellant argues claims 1 and 10 together, highlighting paragraphs 28
and 29 as well as Figures 2 and 5 as allegedly supporting the limitations at
issue. See Appeal Br. 5. We reproduce Appellant’s Figures 2 and 5 below.

Spec., Figs. 2, 5. Figure 2 “illustrates a view of the heart of F[igure] 1 with
a hemostatic connection between the catheter and aorta” and Figure 5
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“illustrates a device and method for forming a hemostatic connection
between the catheter and aorta.” Spec. ¶¶ 9, 13. As to Figure 2, Appellant
highlights two disclosures in paragraph 28: (1) “In one embodiment, the
catheter 110 is used to form a hemostatic connection 112 with the inner
aortic wall 18 in an anterolateral, or otherwise preferred, projection” and (2)
“In one embodiment, the catheter 110 includes a flange 114.” Appeal Br. 5
(quoting Spec. ¶ 28). According to Appellant, “Figure 2 shows the
hemostatic connection 112 formed by the flange 114 positioned at a distal
end of the catheter 110.” Id.
As to Figure 5, Appellant highlights two disclosures in paragraph 29:
(1) “The hemostatic connection 112 also may be created by inflating a non-
occluding balloon 117 within the aorta 16 (F[igure] 5)” and (2) “The non-
occluding balloon should be inflated in such a way that it provides a
sufficient amount of pressure against the flange 114, thereby forming a
hemostatic connection between the flange and the inner aortic wall 18.”
Appeal Br. 5 (quoting Spec. ¶ 29). According to Appellant, “Figure 5 shows
the hemostatic connection 112 formed by the flange 114.” Id. Appellant
argues that, in view of these disclosures, “one skilled in the art would
appreciate that the ‘left side’ of the illustrated system, where the flange 114
forms the hemostatic connection 112, is the distal end of the system” and
would also “understand that the balloon 117, as shown in Figure 5,
surrounds the catheter 110 to provide the described pressure against the
flange 114, while leaving the sealing face of the flange 114 (at the distal end
of the system) exposed to form the hemostatic connection 112.” Id. at 6.
For the reasons stated by Appellant as summarized above, we agree
that paragraphs 28 and 29, as well as Figures 2 and 5, support the limitations
at issue. In light of these disclosures, we understand “surrounds” in the
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limitations at issue as requiring the balloon to fully encircle the catheter
about at least some of the catheter’s longitudinal axis, but not necessarily
requiring the balloon to cover the ends of the catheter. See Tr. 8:19–23.
Indeed, if “surrounds” meant “encloses on all sides”—as asserted by the
Examiner (Final Act. 2, 3 (emphasis added))—flange 114 would not be able
to exit catheter 110 and then form a hemostatic connection after receiving “a
sufficient amount of pressure” from balloon 117, as disclosed in paragraph
29. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir.
1996) (stating that a construction that excludes a preferred embodiment “is
rarely, if ever, correct and would require highly persuasive evidentiary
support”). Further, our construction of “surrounds” is supported by extrinsic
evidence identified by the Examiner. See App. A (Merriam-Webster,
www.merriam-webster.com/dictionary/surround (last visited September 23,
2020) (Definition 1(d): “to extend around the margin or edge of:
ENCIRCLE // a wall surrounds the old city”), discussed at Ans. 8–9, 10–11.
In the Answer, the Examiner questions the specific location where
Figure 5 is “taken.” Ans. 4; see also Ans. 6 (providing an annotated version
of a portion of Figure 3B, with “B” and “C1” added as potential locations for
Figure 5). We need not resolve that issue, however, to answer the question
at hand. As argued by Appellant, regardless of the specific viewpoint,
Figure 5 shows balloon 117 surrounding catheter 110—as well as all but one
surface of flange 114, which is part of catheter 110 (Spec. ¶ 28)—as the term
“surrounds” is defined above. See Reply Br. 3–4. Although the left surface
of flange 114 is not covered by balloon 117, under the construction above, it
need not be. The Examiner also questions whether balloon 117 in this
embodiment is “fully circular or substantially C-shaped.” Ans. 5. Based on
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the aspects of the Specification discussed above, we agree with Appellant
that balloon 117 is disclosed as circular. See Reply Br. 3–4.
For these reasons, we do not sustain the rejection of independent
claims 1 and 10, and also do not sustain this rejection of claims 2–9, and 15–
20 (which depend from claim 1) and claims 11–14 (which depend from
claim 10) under 35 U.S.C. § 112, first paragraph.3
Rejection 2 – The rejection of claims 1–3, 5–9, and 15–20
based on Goldsteen, LaFontaine ’526, and Schweich
Independent claim 1 recites, among other limitations, that “the balloon
surrounds the catheter.” Appeal Br. 21 (Claims App.). For this limitation,
the Examiner relied on Schweich, stating, “a balloon (10 or alternatively the
combination of 10, 12, 14, 16, and 24, Figs. 1–2b) surround a catheter (30,
Fig. 1).” Final Act. 7. Figures 1, 2a, and 2b in Schweich are reproduced
below.

3 As discussed above (see supra Rejection 1 § A), we sustain the
rejection of claims 6 and 12 under 35 U.S.C. § 112, first paragraph, on a
different basis.
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Schweich, Figs. 1, 2a, 2b. Figure 1 depicts an embodiment of a drug
delivery catheter, and Figures 2a and 2b depict cross-sectional views at the
locations indicated in Figure 1. See id. at 5:13–18.
Appellant argues that “Schweich does not actually teach or suggest a
balloon as recited in claim 1.” Appeal Br. 9. According to Appellant,
“[n]othing in Schweich indicates or suggests that any of the balloons 10, 12,
14, 16 surrounds the tubular shaft 30,” and instead, “Figures 1–2b clearly
indicate that the balloons 10, 12, 14, 16 do not pass around the lower region
of the tubular shaft 30 that contacts the vessel wall 20.” Id. at 10.
The Examiner responds by referencing the proposed definition of
“surround” discussed in the context of the written description rejection—
“encloses on all sides of”—and then proposes an alternative definition—“to
extend around the margin or edge of.” Ans. 8 (citing www.merriam-
webster.com). According to the Examiner, “Schweich. Jr.’s balloon 10
surrounds (extends around the margin or edge of) the catheter 30 (Figs. 1
and 2a).” Id. at 9.
The record supports Appellant’s position. As discussed above, we
construe “surrounds” in the limitation at issue in line with the Examiner’s
alternative construction. In the Reply Brief, Appellant argues that, in the
context of that proposed construction, “the term ‘surrounds’ means ‘to
extend around the margin or edge of’ the entire object.” Reply Br. 5
(emphasis added). The record supports Appellant’s understanding. After
providing that definition, the relevant entry in Merriam-Webster’s online
dictionary states: “ENCIRCLE” and then provide the exemplary phrase “a
wall surrounds the old city.” See App. A (Definition 1(d)). Applying this
understanding of the Examiner’s second proposed construction, for the
reason argued by Appellant, Schweich does not disclose the limitation at
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issue because the identified balloon does not fully encircle the catheter about
at least some of the catheter’s longitudinal axis. See Appeal Br. 10;
Schweich, Fig. 2a. Thus, we do not sustain this rejection of claim 1, or this
rejection of claims 2, 3, 5–9, and 15–20, which depend from claim 1, under
35 U.S.C. § 103(a).
Rejection 3 – The rejection of claim 4 based on Goldsteen,
LaFontaine ’526, Schweich, and Ressemann
Claim 4 depends from claim 1. Appeal Br. 21 (Claims App.). The
Examiner’s added reliance on Ressemann does not remedy the deficiencies
in the rejection based on Goldsteen, LaFontaine ’526, and Schweich,
regarding claim 1 (see supra Rejection 2). Thus, for the same reasons
discussed above, we do not sustain the rejection of claim 4 under 35 U.S.C.
§ 103(a).
Rejection 4 – The rejection of claims 10–14 based on
Goldsteen, Khitin, LaFontaine ’526, and Schweich
Independent claim 10 recites, among other limitations, that “a balloon
surrounds the at least one catheter.” Appeal Br. 22 (Claims App.). For this
limitation, the Examiner relied on Schweich in the same manner as in the
context of Rejection 2, stating: “a balloon (10 or alternatively the
combination of 10, 12, 14, 16, and 24, Figs. 1–2b) surround a catheter (30,
Fig. 1).” Final Act. 12–13; see also Final Act. 7 (same finding in the context
of Rejection 2).
Appellant argues that, “for reasons similar to those presented above
with respect to claim 1 [(i.e., Rejection 2)], Schweich does not actually teach
or suggest a balloon as recited in claim 10 because the balloons 10, 12, 14,
16 do not surround the tubular shaft 30.” Appeal Br. 13 (citing Appeal Br.
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9–10). The Examiner repeats the same arguments as in Rejection 2.
Compare Ans. 10–11 (Rejection 4), with id. at 8–9 (Rejection 2).
For the same reasons discussed above in the context of Rejection 2,
Schweich does not disclose the limitation at issue under the proper
construction of the term “surrounds,” as understood by a skilled artisan in
light of Appellant’s Specification. Thus, we do not sustain this rejection of
claim 10, or this rejection of claims 11–14, which depend from claim 10,
under 35 U.S.C. § 103(a).
Rejection 5 – The rejection of claims 1, 5, 7–11, 13–15,
and 17–20 based on LaFontaine ’985 and Valley
A. Claims 1, 5, 7–9, and 15
Independent claim 1 recites, among other limitations, “a balloon
configured to releasably secure the sealing portion against the inner wall to
form the hemostatic connection.” Appeal Br. 21 (Claims App.). For this
limitation, the Examiner relied on Valley, identifying “(710, Fig. 14, 722,
Fig. 15, or 780, Fig. 20B)” as the recited “balloon” and stating, “wherein the
balloon is configured or fully capable to releasably secure the opening at
distal end of the catheter against the inner wall to form the hemostatic
connection (Figs. 14, 15, and 20B).” Final Act. 14–15. Relied-upon Figures
14, 15, and 20B in Valley are reproduced below:
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Valley, Figs. 14, 15, 20B. Figure 14 shows “a front view of
an . . . endoaortic partitioning catheter having an eccentric aortic occlusion
balloon.” Valley ¶ 70. Figure 15 is “a schematic partly cut-away
representation of a patient’s aortic arch with an endoaortic partitioning
catheter having a concentric occlusion balloon positioned in the ascending
aorta.” Id. ¶ 71. Figure 20B is an end view of the endoaortic partitioning
catheter shown in Figure 20A. Id. ¶¶ 80–81.
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Appellant contends that “Valley describes an endoaortic partitioning
catheter to facilitate distribution of cardioplegic fluid to coronary arteries of
a patient.” Appeal Br. 15 (citing Valley ¶¶ 164–173, Figs. 14–20D). As to
the relied-upon Figures 14 and 20B, Appellant argues that “nothing in
Schweich [sic – Valley] indicates or suggests that the balloons 710, 780 are
configured to releasably secure the distal tips of the catheter shafts 702, 786
against the wall of the aorta to form a hemostatic connection” as required by
the limitation at issue. Appeal Br. 16 (emphasis added). According to
Appellant, Valley discloses that “balloons 710, 780 are configured to help
center the distal tips of the catheter shafts 702, 786 within the ascending
aorta to facilitate uniform distribution of cardioplegic fluid injected through
the infusion lumen and introduction of instruments through the infusion
lumen.” Id. (citing Valley ¶ 173). And as to the relied-upon Figure 15,
Appellant argues that, although that Figure shows
distal tip 728 contacting the wall of the aorta when the concentric
aortic occlusion balloon 722 is inflated, Valley indicates that the
illustrated positioning of the distal tip 728 is the problem that is
solved by the eccentric aortic occlusion balloons of the
embodiments shown in Figures 14 and 16–20.
Appeal Br. 16 (citing Valley ¶¶ 166, 173).
The Examiner responds that balloons 710, 722, 780 in Valley are “not
only for centering a distal tip of a catheter” but “also for stabilizing/
anchoring the catheter at the desire[d] location within the blood vessel in
addition to directing/positioning the catheter inside the blood vessel.”
Ans. 13 (citing Valley ¶ 166, Fig. 20B). According to the Examiner, “[o]nce
the eccentric balloon is inflated toward one side of the vessel wall, the
balloon would be capable of exerting the force on the catheter to be against
the other side of the vessel wall.” Id.
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As to Figure 15, we agree with Appellant that paragraph 166 of
Valley describes that system as an example of the “problem that is solved”
by the embodiments in Figures 14 and 16–20. Appeal Br. 16. Although a
prior art reference is generally “relevant for all that it teaches to those of
ordinary skill in the art” (In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir.
1992)), in the context of the invention described in Valley as seeking to
“center the distal tip of the aortic partitioning catheter” (¶ 173), one of
ordinary skill in the art would not have sought to employ the system in
Figure 15, which does not center the distal tip. See Valley ¶ 166 (discussing
Figure 15 and stating that “distal end 728 of the catheter is not centered in
the aortic lumen despite the concentricity of the balloon 722 because of the
mismatch between the catheter curve and the curve of the ascending aorta B”
(emphasis added), cited at Appeal Br. 16); see also In re Gurley, 27 F.3d
551, 553 (Fed. Cir. 1994) (“A reference may be said to teach away when a
person of ordinary skill, upon reading the reference, would be discouraged
from following the path set out in the reference . . . .”).
We turn now to Figures 14 and 20B. The Examiner acknowledges
that, as argued by Appellant, balloons 710 and 780 are disclosed as
centering the distal tip of the catheter. Ans. 13; Appeal Br. 16; Valley ¶ 173
(“The eccentrically shaped occlusion balloons of FIGS. 14 and 16–20 serve
to help center the distal tip of the aortic partitioning catheter within the
ascending aorta for uniform distribution of cardioplegic fluid injected
through the infusion lumen and for aligning the tip of the catheter with the
center of the aortic valve when other instruments are introduced through the
infusion lumen.”). Further, the record does not support the Examiner’s
apparent reliance on using those embodiments in a manner not actually
disclosed in Valley—i.e., to push the catheter against the vessel wall. See
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Ans. 13; Reply Br. 6 (arguing that “nothing in Valley indicates or suggests
that the balloons 710, 780 are configured to releasably secure the distal tips
of the catheter shafts 702, 786 against the wall of the aorta to form a
hemostatic connection”).
In the Answer, the Examiner states that Figure 25B in Valley “also
shows a similar scenario of directing and stabilizing the catheter tip toward
the vessel wall.” Ans. 13. Figure 25B of Valley is reproduced below:

Valley, Fig. 25B. Figure 25B depicts “endoaortic partitioning catheter for
de-airing the heart and ascending aorta.” Valley ¶ 90. Appellant responds
that claim 1 does not recite “directing and stabilizing a catheter tip towards a
vessel wall” but rather “a balloon configured to releasably secure the
sealing portion against the inner wall to form the hemostatic connection,
wherein the balloon surrounds the catheter.” Reply Br. 6 (quoting, with
emphasis added, claim 1). We are persuaded by Appellant’s position. On
the current record, the Examiner has not adequately explained why the
Figure 25 embodiment in Valley discloses the limitation at issue in claim 1.
For these reasons, we do not sustain this rejection of claim 1, or this
rejection of claims 5, 7–9, and 15, which depend from claim 1, under
35 U.S.C. § 103(a).
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B. Claim 10, 11, 13, and 14
Independent claim 10 recites, among other limitations, that the
“balloon . . . is configured to releasably secure the sealing portion against an
inner wall of the aorta.” Appeal Br. 22 (Claims App.). For this limitation,
the Examiner relied on Valley in the same manner as in the context of claim
1, stating, “a balloon (710, Fig. 14, 722, Fig. 15, or 780, Fig. 20B) . . .
wherein the connection between the catheter and the inner wall of the artery
was formed with the aid of a balloon pressing the catheter against the inner
wall of the artery (Figs. 14, 15, and 20B).” Final Act. 17; see also id.at 14–
15 (similar findings regarding claim 1).
Appellant argues that, “for reasons similar to those presented above
with respect to claim 1, Valley does not actually teach or suggest a balloon
as recited in claim 10 because the aortic occlusion balloons of Valley are
configured to help center the distal tips of the catheter shafts within the
ascending aorta.” Appeal Br. 19 (citing Appeal Br. 15–16). The Examiner
repeats the same arguments as provided in the context of claim 1. Compare
Ans. 14–16 (addressing claim 10), with id. at 12–14 (addressing claim 1).
For the same reasons discussed above in the context of claim 1,
Valley does not disclose the limitation at issue. Thus, we do not sustain this
rejection of claim 10, or this rejection of claims 11, 13, and 14, which
depend from claim 10, under 35 U.S.C. § 103(a).
Rejections 6–9 – The rejection of claims 2–4, 6, 12, and 16 based on
LaFontaine ’985, Valley, and other prior art
Claims 2–4, 6, and 16 depend from claim 1, and claim 12 depends
from claim 10. Appeal Br. 21–23 (Claims App.). The Examiner’s added
reliance on LaFontaine ’526 (regarding Rejection 6), Ressemann (regarding
Rejection 7), Termin (regarding Rejection 8), and Goldsteen (regarding
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19
Rejection 9) does not remedy the deficiencies in the rejection based on
LaFontaine ’985 and Valley, regarding claims 1 and 10 (see supra Rejection
5). Thus, for the same reasons discussed above, we do not sustain these
rejections of claims 2–4, 6, 12, and 16 under 35 U.S.C. § 103(a).

CONCLUSION
We affirm in part the Examiner’s rejection of claims 1–20.
More specifically, we (1) affirm the decision to reject claims 6 and 12
under 35 U.S.C. § 112, first paragraph, (2) reverse the decision to reject
claims 1–5, 7–11, and 13–20 under 35 U.S.C. § 112, first paragraph, and (3)
reverse the decision to reject claims 1–20 under 35 U.S.C. § 103(a).

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–20 112 ¶ 1 Written Description 6, 12 1–5, 7–11,
13–20
1–3, 5–9,
15–20
103(a) Goldsteen,
LaFontaine ’526,
Schweich
1–3, 5–9,
15–20
4 103(a) Goldsteen,
LaFontaine ’526,
Schweich,
Ressemann
4
10–14 103(a) Goldsteen, Khitin,
LaFontaine ’526,
Schweich
10–14
1, 5, 7–11,
13–15, 17–
20
103(a) LaFontaine
’985,Valley
1, 5, 7–11,
13–15, 17–
20
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20
2, 3 103(a) LaFontaine ’985,
Valley, LaFontaine
’526
2, 3
4 103(a) LaFontaine ’985,
Valley, Ressemann
4
6, 12 103(a) LaFontaine ’985,
Valley, Termin
6, 12
16 103(a) LaFontaine ’985,
Valley, Goldsteen
16
Overall
Outcome
6, 12 1–5, 7–11,
13–20

TIME PERIOD FOR RESPONSE
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 IN PART