ANDERSON, JAMES

Patent Trials and Appeals Board

Dec 27, 2019

15058016 - (D) (P.T.A.B. Dec. 27, 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.
15/058,016 03/01/2016 JAMES ANDERSON 1001.2801102 1051
11050 7590 12/27/2019
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
KNAUSS, CHRISTIAN D
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/27/2019 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES ANDERSON
__________

Appeal 2019-003324
Application 15/058,016
Technology Center 3700
__________

Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
LISA M. GUIJT, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1–3, 5, 6, and 8–22. Final Act. 1. 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 the real party in interest as Boston
Scientific SciMed, Inc. Appeal Br. 4.
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STATEMENT OF THE CASE
Claims 1, 14, and 21 are the independent claims on appeal. Claims 1
and 14, reproduced below with disputed limitations italicized for emphasis,
are exemplary of the subject matter on appeal.
1. A method of recanalizing a blood vessel by establishing a
subintimal pathway around an occlusion, the method
comprising:
creating a subintimal pathway between a proximal
opening into a vessel wall proximal of an occlusion and a distal
opening into the vessel wall distal of the occlusion, the vessel
wall including an intima layer, a media layer, and an adventitia
layer, the subintimal pathway exposing a surface of the media
layer of the vessel wall;
positioning an expandable stent in the subintimal pathway;
expanding the expandable stent in the subintimal pathway
against the surface of the media layer; and
promoting native tissue regrowth around the stent to
create a superficial intimal layer within the vessel wall along the
subintimal pathway, the superficial intimal layer being
juxtaposed with and extending along the surface of the media
layer.

14. A method of recanalizing a blood vessel by establishing a
subintimal pathway around an occlusion, the method
comprising:
creating a subintimal pathway between a proximal
opening into a vessel wall proximal of an occlusion and a distal
opening into the vessel wall distal of the occlusion;
positioning an expandable stent surrounding a body
portion of an inflatable balloon structure in the subintimal
pathway with a distal anchoring portion of the inflatable balloon
structure positioned in a true lumen portion of the blood vessel
distal of the occlusion, the distal anchoring portion being
disposed distal of a distal end of the expandable stent;
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inflating the distal anchoring portion of the inflatable
balloon structure in the true lumen portion distal of the occlusion
to an inflated configuration; and
inflating the body portion of the inflatable balloon
structure to expand the expandable stent in the subintimal
pathway to an expanded configuration;
wherein the inflated distal anchoring portion anchors the
inflatable balloon structure from unintentional proximal
movement while the expandable stent is expanded in the
subintimal pathway to maintain proper placement of the
expandable stent in the subintimal pathway;
wherein an outermost diameter of the distal anchoring
portion in the inflated configuration is greater than an outermost
diameter of the expandable stent in the expanded configuration.

THE REJECTIONS
I. Claims 1 and 13 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Makower (US 6,709,444 B1; issued Mar. 23, 2004) and
Mandrusov (US 2006/0265043 A1; published Nov. 23, 2006).
II. Claims 2, 3, 5, 6, and 9–11 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Makower, Mandrusov, and Heuser (US 7,300,459
B2; issued Nov. 27, 2007).
III. Claims 8 and 12 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Makower, Mandrusov, Heuser, and Gerrans (US
2012/0259401 A1; published Oct. 11, 2012).
IV. Claims 14–20 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Makower and Heuser.
V. Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Makower, Mandrusov, and Heuser.

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ANALYSIS
Rejection I
Claim 1:
Regarding independent claim 1, the Examiner finds, inter alia, that
Makower discloses a method of recanalizing a blood vessel by establishing a
subintimal pathway around an occlusion, the method comprising the step of
“creating a subintimal pathway between a proximal opening into a vessel
wall proximal of an occlusion and a distal opening into the vessel wall distal
of the occlusion (Figures 5A–5D, 7A, 7B),” in which “the vessel wall
includ[es] an intima layer (I), a media layer (M), and an adventitia layer
(A),” and “the subintimal pathway expos[es] a surface of the media layer of
the vessel wall (Figure 5D).” Final Act. 2–3.
The Examiner acknowledges that “Makower fails to explicitly
disclose promoting native tissue regrowth around [a] stent to create a
superficial intimal layer within the vessel wall along the subintimal pathway,
the superficial intimal layer being juxtaposed with and extending along the
surface of the media layer.” Id. at 3. The Examiner, however, finds that
Mandrusov discloses a stent (1340) that promotes native tissue regrowth
(i.e., plaque and fibrous cap 1320) around the stent upon delivery, creating a
superficial layer around the stent. Id. (citing Mandrusov Figs. 13A–13B).
The Examiner also finds that Mandrusov discloses that the stent has a
coating of a drug or a bioactive agent that controls the thickness of the tissue
that grows around the stent and that the superficial layer provides
stabilization of a lumen. Id. (citing Mandrusov ¶¶ 69–72). The Examiner
further finds that Mandrusov discloses that after the stent has been deployed
at a desired location, it may cause platelet deposition, fibrosis, and
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neointimal formation in the stented region, and that this fibromuscular
response may cause the original fibrous cap thickness to increase (i.e., “new
tissue is present that did not exist prior to insertion of the stent”). Id.; see
also Mandrusov ¶ 69 (“After stent 1340 has been deployed at a desired
location, it may cause platelet deposition, fibrosis and neointimal formation
in the stented region.” (emphasis added)).
The Examiner reasons that it would have been obvious to modify the
method of Makower to include a coating comprising a drug or a bioactive
agent to promote native tissue growth around a stent, as taught by
Mandrusov, to create a superficial intimal layer within the vessel wall along
the subintimal pathway, the superficial intimal layer being juxtaposed with
and extending along the surface of the media layer because the
“modification would provide stabilization of the stent and subintimal
pathway.” Final Act. 3–4.
Appellant contends that “[t]here is no rational reason for one of
ordinary skill in the art, upon reading Makower, directed to treating
complete occlusions, to look to Mandrusov, directed to treating vulnerable
plaques, for ways of modifying the technique of Makower.” Appeal Br. 10.
In support, Appellant argues that “Makower provides no teaching or
suggestion of a desire or need to have tissue growth within the vessel wall”
and that “[t]he only reasons for modifying Makower to have these elements
are found in Appellant’s specification, which is improper.” Id. Appellant
submits that although the Examiner concludes that it would have been
obvious to modify Makower’s method to “provide stabilization of the stent
and subintimal pathway,” Makower already accomplishes this in disclosing
inflation of the balloon “to radially expand the stent 208 such that the ends
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of the stent 208 firmly coapt with the intima I of the artery and the mid-
portion of the stent 208 provides a scaffold which maintains the sub-intimal
tract 205 in an open condition capable of carrying blood past the obstruction
O.” Id. (quoting Makower 11:41–46); see also Reply Br. 2–4, 6.
Appellant’s contentions are unpersuasive.
[E]vidence of a motivation to combine need not be found in the
prior art references themselves, but rather may be found in “the
knowledge of one of ordinary skill in the art, or, in some cases,
from the nature of the problem to be solved.” . . . When not from
the prior art references, the “evidence” of motive will likely
consist of an explanation of the well-known principle or
problem-solving strategy to be applied.
Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1366 (Fed. Cir. 2006) (emphases in original, quoting In re
Dembiczak, 175 F.3d 994, 999 (Fed. Cir. 1999)). Here, the Examiner
correctly responds that
[o]ne having ordinary skill in the art would recognize that if a
drug-eluting stent can provide the advantage of promoting native
tissue growth around the stent to stabilize a vulnerable plaque
positioned within a vessel wall and prevent rupture of the vessel
wall (and further problems as a result of the vessel wall
rupturing), promoting tissue growth around a stent in a pathway
within a vessel wall to stabilize the stent and pathway would also
be advantageous to prevent damage to the vessel and further
issues that could arise as a result.
Ans. 4–5 (emphasis added). The Examiner further explains that “[t]he
motivation to modify Makower in view of Mandrusov was derived from the
teachings of Mandrusov and the level of one having ordinary skill in the art”
and that “[w]hile Makower does disclose that that the method results in a
firm placement of the stent and an open subintimal tract, the modification
presented by the Examiner is an improvement in that it would result in
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further stabilization of the stent and the subintimal pathway while also
preventing damage to the vessel.” Id. at 5 (emphasis added).
Appellant contends that Mandrusov does not disclose that its “cited
configuration (FIGS. 13A–13B) of a coated stent promotes the creation of a
superficial intimal layer along a subintimal pathway, with the superficial
intimal layer being juxtaposed with and extending along the surface of the
media layer of a vessel wall.” Appeal Br. 11. Appellant also contends that
Mandrusov does not disclose “the creation of a new layer of tissue (e.g., an
intimal layer) juxtaposed with a distinctly different tissue layer (e.g., the
dissected media layer).” Id. at 11–12; see also Reply Br. 4–5. Appellant
further contends that “[t]he proposed modification would appear to merely
stimulate growth of the layer(s) (e.g., the media and/or the adventitia) that
the stent of Makower is in contact with along the subintimal pathway” and
“[t]here is no teaching that adding the coating of [Mandrusov] would
promote the creation of a (new) superficial intimal layer along the subintimal
pathway that is juxtaposed with and extending along a surface of the media
layer.” Id. at 12; see also Reply Br. 4–5.
Appellant’s contentions are unpersuasive in that they do not address
the Examiner’s rejection. “Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references []. [The reference] must be read,
not in isolation, but for what it fairly teaches in combination with the prior
art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
As the Examiner points out, Mandrusov discloses that its stent has a coating
of a drug or a bioactive agent and that after the stent “has been deployed at a
desired location, it may cause platelet deposition, fibrosis, and neointimal
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formation in the stented region.” Final Act. 3 (quoting Mandrusov ¶ 69 with
emphasis added); see also id. (explaining that “i.e.[,] new tissue is present
that did not exist prior to insertion of the stent.”). Put another way, the
Examiner finds that Mandrusov discloses promoting native tissue regrowth
around the stent to create a superficial intimal layer. The Examiner finds
that it is Makower that discloses using a stent to create a “subintimal
pathway [that] expos[es] a surface of the media layer of the vessel wall
(Figure 5D).” Final Act. 2–3. “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). Here, Makower provides a vessel wall having an intimal layer
adjacent to and extending along a media layer and a stent that creates a
subintimal pathway exposing a surface of the vessel wall’s media layer such
that coating the stent to promote neointimal (new intimal) formation, as
taught by Mandrusov, would yield predictable results of “a superficial
intimal layer within the vessel wall along the subintimal pathway, the
superficial intimal layer being juxtaposed with and extending along the
surface of the media layer,” as claimed.2,3

2 We note that the Specification does not disclose that coating the stent with
any particular agent would promote one type of cell growth, i.e., an intimal
layer, rather than another type of cell growth, i.e., a media layer or an
adventitia layer.
3 We agree with Appellant that a skilled artisan would recognize that the
claimed superficial intimal layer has a similar tissue configuration as the
claimed intima layer. See Reply Br. 5–6. However, as discussed above, the
Examiner’s proposed combination of Makower and Mandrusov would result
in the creation of a new layer of intima cells that has a similar tissue
configuration as the native intima cells and that is juxtaposed with and
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Accordingly, we sustain the Examiner’s rejection of claim 1 as being
obvious over Makower and Mandrusov.
Claim 13:
Claim 13 depends from claim 1. Appeal Br. 22 (Claims App.).
Appellant does not provide substantive arguments for this claim and appears
to rely on arguments made for claim 1. Id. at 15. As we do not find error in
the rejection of claim 1, the rejection of claim 13 is sustained for the same
reasons discussed above.

Rejection IV
Regarding independent claim 14, the Examiner finds, inter alia, that
Makower discloses a method of recanalizing a blood vessel by establishing a
subintimal pathway around an occlusion in which the method comprises the
step of positioning an expandable stent 208 surrounding a body portion of an
inflatable balloon structure in a subintimal pathway with a distal anchoring
portion of the inflatable balloon structure positioned in a true lumen portion
of a blood vessel distal of an occlusion. Final Act. 9–10 (citing Makower
Figs. 7D, 7E). The Examiner acknowledges that Makower does not disclose
that the distal anchoring portion of the inflatable balloon structure is
disposed distal of a distal end of the expandable stent and wherein an

extending along the surface of the media layer. Additionally, we note that
claim 1 recites “the superficial intimal layer being juxtaposed with and
extending along the surface of the media layer” and does not recite the
superficial intimal layer “covering the exposed” media layer. Appeal Br. 21
(Claims App.) (emphasis added); see also Reply Br. 6; In re Self, 671 F.2d
1344, 1348 (CCPA 1982) (limitations not appearing in the claims cannot be
relied upon for patentability).
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outermost diameter of the distal anchoring portion in the inflated
configuration is greater than an outermost diameter of the expandable stent
in the expanded configuration. Id. at 9. The Examiner, however, finds that
Heuser discloses inflating a distal anchoring portion (i.e., flexible membrane
20) of an inflatable balloon structure to an inflated configuration and into
contact with an intimal wall of a blood vessel. Id. at 10 (citing Heuser Fig.
3). The Examiner also finds that Heuser discloses that the distal anchoring
portion of the inflatable balloon structure has an outermost diameter in the
inflated configuration that is greater than an outermost diameter (at
intermediate portion 30c) of the expandable stent in the expanded
configuration. Id. (citing Heuser Fig. 4).
The Examiner reasons that it would have been obvious to modify the
method of Makower to have the inflatable balloon include a distal anchoring
portion that is positioned distal of a distal end of the expandable stent,
wherein the distal anchoring portion has an outermost diameter in the
inflated configuration greater than an outermost diameter of the expandable
stent in the expanded configuration, as taught by Heuser, to “provide[] a
distal anchoring portion that can be initially inflated independently of the
body portion of the balloon to ensure proper positioning of the stent within
the vessel” and to “provide[] a balloon with a body portion that allows the
proximal and distal ends of the stent to be expanded before fully expanding
the stent, ensuring proper placement before fully expanding the stent.” Id. at
10–11.
Appellant contends that an ordinary artisan “would not characterize
the partially expanded configuration shown in FIG. 4 [of Heuser] to properly
correspond to the claimed expanded configuration of the expandable stent in
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the expanded configuration” because an ordinary artisan “would clearly and
easily recognize FIG. 4 [of Heuser] as showing a partially expanded stent.”
Appeal Br. 17 (citing Heuser 2:31–34).
The Examiner responds that “[i]n Figure 4 of Heuser, the second end
30a (characterized by the Examiner as the distal anchoring portion in the
rejections) of the flexible membrane 30 is clearly in an expanded
configuration” such that an ordinary artisan “would recognize that the
flexible membrane 30 is in an uninflated configuration in Figure 3 [of
Heuser] and in an inflated configuration in Figure 4 [of Heuser]” and that
“[t]here is no language in claim 14 requiring the distal anchoring portion [to
be] in a fully inflated configuration.” Ans. 9.
Appellant’s contention is persuasive.
The correct inquiry in giving a claim term its broadest reasonable
interpretation in light of the specification is not whether the
specification proscribes or precludes some broad reading of the
claim term adopted by the examiner. And it is not simply an
interpretation that is not inconsistent with the specification. It is
an interpretation that corresponds with what and how the
inventor describes his invention in the specification, i.e., an
interpretation that is “consistent with the specification.”
In re Smith International, Inc., 871 F.3d 1375, 1382–83 (Fed. Cir. 2017)
(citing In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (citation and
internal quotation marks omitted); In re Suitco Surface, 603 F.3d 1255,
1259–60 (Fed. Cir. 2010)).
As an initial matter, we note that claim 14 recites “the expandable
stent in the expanded configuration” rather than a portion of the expanded
stent in the expanded configuration. Appeal Br. 23 (Claims App.) (emphasis
added). With respect to Figure 5, the Specification discloses that “[t]he
recanalization catheter 10 may be advanced through the subintimal space in
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a delivery configuration, such as with the balloon structure 20 in a deflated,
folded configuration with the stent 40 surrounding the folded balloon
structure 20.” Spec. 14:21–24 (emphasis added). Thus, Appellant discloses,
with respect to Figure 5, the entire stent 40 is in an unexpanded
configuration. The Specification further discloses that
[o]nce positioned through the subintimal pathway, the balloon
structure 20 may be inflated with an inflation medium directed
through an inflation lumen of the catheter shaft 12 to radially
expand the stent 40 in the subintimal pathway, and thus maintain
a pathway for subsequent blood flow around the occlusion 90.
As shown in FIG. 6, the distal anchoring portion 60 may be
inflated in the true lumen 88 distal of the occlusion 90 to anchor
the inflatable balloon structure 20, including the body portion 52
underlying the stent 40, from unintentional proximal movement
while the stent 40 is expanded in the subintimal pathway to
maintain proper placement of the stent 40 in the subintimal
pathway.
Id. at 15:3–11 (emphasis added). Thus, the Specification describes an
“expanded stent,” as shown in Figure 6, to be a stent in which its entire body
is in a fully expanded configuration, rather than one portion being expanded
and another portion being unexpanded or partially expanded. See Spec.,
passim. In other words, the Specification never discloses a partially
expanded configuration; rather, the Specification discloses a fully expanded
configuration when describing an “expanded stent.” We, thus, construe the
term “the expandable stent in the expanded configuration” as the entire stent
being in a fully expanded configuration.
In finding that Heuser discloses the limitation at issue, the Examiner
looks to Figure 4 which shows that the end portions of the stent, excluding
the middle portion of the stent, are in an expanded configuration. Thus, in
effect, the Examiner interprets the term “the expandable stent in the
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expanded configuration” to include a stent that has a portion that is
unexpanded or partially expanded––an interpretation that does not
correspond with what and how the inventor describes his invention in the
Specification, i.e., it is not an interpretation that is “consistent with the
specification.” It is Figure 5, not Figure 4, of Hueser that discloses an entire
stent that is in a fully expanded configuration, i.e., “an expandable stent in
the expanded configuration.” Here, comparing the outermost diameter of
flexible membrane 20 and the outermost diameter of stent 40, it cannot be
said that Heuser’s Figure 5 discloses “an outermost diameter of [a] distal
anchoring portion [of an inflatable balloon structure] in the inflated
configuration is greater than an outermost diameter of [an] expandable stent
in the expanded configuration,” as claimed because both diameters appear to
be the same size. As such, we agree with Appellant that the Examiner’s
interpretation of the term “expanded” and “inflated” to encompass “partially
expanded” and “partially inflated,” respectively, is unreasonable, and the
Examiner’s finding that Heuser discloses that a distal anchoring portion of
an inflatable balloon structure has an outermost diameter in the inflated
configuration that is greater than an outermost diameter of the expandable
stent in the expanded configuration, is in error.
Accordingly, we do not sustain the Examiner’s rejection of
independent claim 14, and claims 15–20 depending therefrom as being
obvious over Makower and Heuser.

Rejection V
Independent claim 21 recites a similar limitation as that of claim 14,
namely, “wherein the distal anchoring portion of the inflatable balloon
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structure has an outermost diameter in the inflated configuration greater than
an outermost diameter of the expandable stent in the expanded
configuration.” Appeal Br. 24 (Claims App.). The Examiner relies on
Makower and Heuser for disclosing the limitations of claim 21, and uses the
same rationale for combining the teachings of these references in the same
manner as discussed above for claim 14. Final Act. 12–15. Thus, the
rejection is based on an incorrect finding with respect to the Heuser
reference as discussed above.
Accordingly, for reasons similar to those discussed above for claim
14, we do not sustain the rejection of independent claim 21, and claim 22
depending therefrom as being obvious over Makower, Mandrusov, and
Heuser.

Rejections II and III
Claim 2:
Claim 2 depends from claim 1. Appeal Br. 21 (Claims App.).
Appellant does not provide substantive arguments for this claim and appears
to rely on arguments made for claim 1. Id. at 15. Accordingly, for reasons
similar to those discussed above, we sustain the rejection of claim 2 over
Makower, Mandrusov, and Heuser.
Claims 3, 5, 6, and 8–12:
Claim 3 depends indirectly from claim 1 and recites a similar
limitation as that of claim 14, namely, “wherein the distal anchoring portion
of the inflatable balloon structure has an outermost diameter in the inflated
configuration greater than an outermost diameter of the expandable stent in
the expanded configuration.” Appeal Br. 21 (Claims App.). Claims 5, 6,
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and 8–12 depend either directly or indirectly from claim 3. Id. at 21–22
(Claims App.). Similar to the rejection of claim 14, the Examiner
incorrectly finds that Heuser discloses the limitation of claim 3. Final Act.
5. Accordingly, for reasons similar to those discussed above for claim 14,
we do not sustain the rejection of claims 3, 5, 6, and 8–12 over the various
combinations of cited prior art.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 13 103(a) Makower,
Mandrusov
1, 13
2, 3, 5, 6, 9–
11, 21, 22
103(a) Makower,
Mandrusov,
Heuser
2 3, 5, 6, 9–
11, 21, 22
8, 12 103(a) Makower,
Mandrusov,
Heuser, Gerrans
8, 12
14–20 103(a) Makower, Heuser 14–20
Overall
Outcome
1, 2, 13 3, 5, 6, 8–
12, 14–22

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED IN PART