Zachary L. Helgeson et al.

Patent Trials and Appeals Board

Apr 1, 2020

15116785 - (D) (P.T.A.B. Apr. 1, 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.
15/116,785 08/04/2016 Zachary L. Helgeson CD-854USO1/065513-001507 8723
67337 7590 04/01/2020
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
NGO, LIEN M
ART UNIT PAPER NUMBER
3754
NOTIFICATION DATE DELIVERY MODE
04/01/2020 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):
ASJM_Patents@abbott.com
MN-IPMail@dykema.com
Patents@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZACHARY L. HELGESON, ALEXANDER C. HOUCK,
JOHN HER, SALOME A. GONZALEZ, SOMALLY MOM,
BRIAN M. MONAHAN, NEIL D. HAWKINSON, JAMES R. NIGG,
JAMES C. MARRS, XUAN YE KHIEU, TROY T. TEGG,
JILL A. LAFAVOR, and ISRAEL A. BYRD
Appeal 2019-002693
Application 15/116,785
Technology Center 3700
Before JENNIFER D. BAHR, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
BAHR, 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 1–4, 6–9, 11–18, and 20. 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 St. Jude
Medical, Cardiology Division, Inc. Appeal Br. 1.
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Application 15/116,785

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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to “elongate medical devices,
including the configuration of the shaft body and of electrodes disposed in or
on the shaft body.” Spec. ¶ 1. Claims 1, 8, and 13 are independent.
Claim 1, reproduced below, is illustrative of the claimed subject matter.
1. An elongate medical device assembly comprising:
an elongate shaft body; and
an annular electrode disposed on said elongate body, the
annular electrode defining a longitudinal axis and having an
outer diameter, wherein said outer diameter is greater at an axial
center of said electrode than at an axial end of said electrode;
wherein said elongate body has an outer diameter, wherein
said axial end of said electrode is radially within said outer
diameter of said elongate body.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Stevens-Wright US 5,715,817 Feb. 10, 1998
Engelson US 6,030,369 Feb. 29, 2000
Ponzi US 2003/0045831 A1 Mar. 6, 2003
Hastings US 2008/0161774 A1 July 3, 2008

REJECTIONS
I. Claims 1–4, 6, and 7 stand rejected under 35 U.S.C. § 102(a)(1) as
anticipated by Stevens-Wright.
II. Claims 8 and 9 stand rejected under 35 U.S.C. § 102(a)(1) as
anticipated by Engelson.2

2 Appellant canceled claim 10 subsequent to the Final Action. See
Amendment (June 29, 2018); Advisory Act. (July 18, 2018).
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III. Claims 11 and 12 stand rejected under 35 U.S.C. § 103 as
unpatentable over Engelson and Stevens-Wright.
IV. Claims 13–16 and 18 stand rejected under 35 U.S.C. § 103 as
unpatentable over Hastings and Stevens-Wright.
V. Claims 13, 14, 17, 18, and 20 stand rejected under 35 U.S.C. § 103
as unpatentable over Ponzi and Stevens-Wright.
OPINION
Rejection I—Anticipation by Stevens-Wright
The issue raised by Appellant in contesting the rejection of claim 1 is
whether Stevens-Wright discloses an elongate medical device assembly
comprising an elongate shaft body and an annular electrode, wherein “said
outer diameter [of said electrode] is greater at an axial center of said
electrode than at an axial end of said electrode; wherein said elongate body
has an outer diameter, wherein said axial end of said electrode is radially
within said outer diameter of said elongate body.” See Appeal Br. 8–12.
Consistent with the disclosure in paragraph 45 of Appellant’s Specification,
an axial end of the electrode is “radially within said outer diameter of said
elongate body” if at least the inner diameter of either axial end of the
electrode is within the outer diameter of the elongate body at the location of
the axial end.
The Examiner finds that Stevens-Wright discloses an electrode (ring
electrode 48) satisfying the aforementioned limitations of claim 1. Ans. 3
(citing Stevens-Wright, Figs. 2b, 3); id. at 7–8 (additionally citing Stevens-
Wright 5:62–6:4).
Appellant contends that “[t]he Examiner appears to pick and choose
from various embodiments of Stevens-Wright, shown in Figs. 2a, 2b, and 3
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. . . to disclose the above-quoted limitation of claim 1.” Appeal Br. 9.
Appellant submits that Figure 2b of Stevens-Wright shows convex-shaped
electrodes, which thus have an outer diameter that is greater at an axial
center than at the axial ends, but that Figure 2b does “not show the electrode
being radially within the outer diameter of the elongate body, as required by
claim 1.” Id. at 10. Appellant asserts that the Examiner turns to a different
embodiment, illustrated in Stevens-Wright’s Figure 3, “apparently showing
the electrode (48) being flush with the tubular section (60), to allegedly
disclose the axial end of the electrode being radially within the outer
diameter of the elongate body.” Id. Appellant asserts, however, that
Figure 3 of Stevens-Wright “fails to disclose the outer diameter of the
electrode being greater at an axial center than at an axial end, as required by
claim 1.” Id. at 10–11.
Appellant argues that the Examiner improperly relies on “multiple
different embodiments” of Stevens-Wright in rejecting claim 1 as anticipated
by Stevens-Wright. Appeal Br. 11. In particular, Appellant asserts that the
embodiment of Figure 3 appears to be different from the ones shown in
Figures 2a and 2b because “the electrodes (48) shown in Figs. 2a and 2b are
clearly not radially within the outer diameter of the elongate body (26).” Id.
We disagree with Appellant’s assertion that electrodes 48 shown in
Figures 2a and 2b of Stevens-Wright are clearly not radially within the outer
diameter of the elongate body (flexible tip assembly 26). Figures 2a and 2b
clearly show the outer diameters of electrodes 48 being radially outside the
outer diameter of flexible tip assembly 26, but Figures 2a and 2b show only
the outer surfaces of the electrodes and flexible tip assembly. Figures 2a
and 2b, unlike Figures 3 and 14, are not sectional views and reveal nothing
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about whether the inner diameter of ring electrodes 48 is within the outer
diameter of flexible tip assembly 26. Stevens-Wright uses Figures 2a and 2b
not to show the inner diameter of the electrodes, but to show the electrodes
raised above the outer surface of flexible tip assembly 26 to enhance contact
with the electrodes. See Stevens-Wright 5:66–6:2.
More specifically, Stevens-Wright discloses that Figure 1 is a
perspective view of a catheter; Figure 2 is a perspective view of a tip
assembly of the catheter (i.e., the catheter of Figure 1); Figure 2a “illustrates
the electrodes raised above the outer surface of the flexible tip assembly of”
Figure 2 (and, thus, of Figure 1); Figure 2b illustrates electrodes of Figure 2a
“being of a convex shape”; Figure 3 is a longitudinal section of Figure 1;
and Figure 14 is a longitudinal section of Figure 1. Stevens-Wright 1:26–37,
40–41. Stevens-Wright further discloses that Figures 3 and 14 show tip
assembly 26 comprising three ring electrodes 48 and that, “[p]referably, the
ring electrodes 48 are raised above the outer surface of the flexible tip
assembly 26,” as shown in Figure 2a, which can be a convex shape, as
shown in Figure 2b, “to enhance the contact with the electrodes 48.” Id.
5:63–6:3. In other words, Figure 2b illustrates a raised, convex outer shape
of electrodes 48 of Figures 3 and 14. To the extent that Figure 2b represents
a different embodiment than that of Figures 3 and 14, one of ordinary skill in
the art would understand from the description of Figures 1, 2, 2a, 2b, 3, and
14 discussed above that Figure 2b differs from Figure 3 only in illustrating a
convex-shaped outer surface raised above (i.e., radially beyond) the outer
surface of flexible tip assembly 26. Figures 3 and 14 are instructive as to the
inner diameter of electrodes 48 relative to flexible tip assembly 26, and they
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clearly show the axial ends of electrodes 48 radially within the outer
diameter of flexible tip assembly 26.
For the above reasons, the Examiner properly relies on Figure 2b and
Figure 3 together, along with Stevens-Wright’s description of these
drawings, to support the finding that Stevens-Wright discloses an
embodiment of an elongate medical device assembly in which: (a) the outer
diameter of electrode 48 is greater at an axial center of the electrode than at
an axial end of the electrode and (b) the axial end of electrode 48 is radially
within the outer diameter of the elongate body (flexible tip assembly 26).
The Examiner is not improperly picking and choosing features from various
different embodiments to establish anticipation.
Thus, Appellant does not apprise us of error in the rejection of claim 1
as anticipated by Stevens-Wright. Accordingly, we sustain the rejection of
claim 1, as well as claims 2–4, 6, and 7, for which Appellant does not
present any separate arguments (see Appeal Br. 8–12), as anticipated by
Stevens-Wright.
Rejection II—Anticipation Based on Engelson
The issue raised by Appellant in contesting the rejection of claim 8 as
anticipated by Engelson is whether it is reasonable for the Examiner to read
the “elongate body” of claim 8 on just inner layer 114 of Engelson’s two-
layer catheter body 103, rather than on the entirety of catheter body 103,
which has two layers, inner layer 114 and outer layer 116. See Appeal
Br. 13–14; Ans. 3–4 (referencing an annotated version of Engelson’s Figure
5 indicating the sections of Engelson’s inner layer 114 that the Examiner
finds correspond to the first, second, and third longitudinal sections,
respectively, of claim 1). Appellant argues that, “[c]onsidered in its entirety,
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Engelson discloses a catheter body with first, second, and third longitudinal
sections having first, second, and third outer diameters, respectively defined
by the outer diameter of the outer layer 116 of the catheter body . . . .”
Appeal Br. 14. Appellant concludes, with reference to the Examiner’s
annotated version of Engelson’s Figure 5, that,”[c]onsequently, Engelson
discloses that the second outer diameter is larger than the third outer
diameter, thereby failing to disclose ‘wherein said second outer diameter is
smaller than said first outer diameter and smaller than said third outer
diameter,’ as recited in independent claim 8.” Id. Resolution of this issue
turns on the proper construction of “elongate body” in claim 8.
The Federal Circuit has described the correct inquiry for determining
the broadest reasonable construction as follows:
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 Int’l, Inc., 871 F.3d 1375, 1382–83 (Fed. Cir. 2017) (holding that
the Board’s construction of the claim term “body” as including components
consistently identified and described in the appellant’s patent application
specification separately from the “body” was “unreasonable” because it gave
“the term ‘body’ . . . a strained breadth in the face of the otherwise different
description in the specification”).
In describing the disputed feature of Appellant’s invention recited in
claim 8, Appellant’s Specification discloses:
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An embodiment of an elongate medical device assembly
may comprise an elongate shaft body defining a longitudinal
axis. The elongate body may comprise a first longitudinal
section defining a first wall thickness, a second longitudinal
section defining a second wall thickness, and a third
longitudinal section defining a third wall thickness. The second
longitudinal section may be distal of the first longitudinal
section and the third longitudinal section may be distal of the
second longitudinal section. The second wall thickness may be
less than the first wall thickness and less than the third wall
thickness. The first wall thickness may be greater than the third
wall thickness.
Spec. ¶ 8. In describing such an embodiment in further detail, the
Specification discloses:
Figure 9 is a diagrammatic view of a cross-sectional
profile of an exemplary portion of an elongate medical device
shaft 100 such as, for example, a deflectable portion 102. For
example, the deflectable shaft portion 102 may be included in
the catheter 10 of Figure 1, the basket catheter 30 of Figure 2,
the introducer 38 of Figure 3, or any other elongate medical
device. The deflectable shaft portion 102 may define a
longitudinal axis E and may have a plurality of axial portions.
For example, the deflectable shaft portion may include three
axial portions 104, 106, 108. A first axial shaft portion 104
may have a first thickness tS1 and a first outer diameter ODS1, a
second axial shaft portion 106 may have a second thickness tS2
and a second outer diameter ODS2, and a third axial shaft
portion 108 may have a third thickness tS3 and a third outer
diameter ODS3. In an embodiment, the first axial portion 104
may have the largest outer diameter ODS1 and thickness tS1 of
the three axial portions 104, 106, 108, the second axial portion
106 may have the smallest outer diameter ODS2 and thickness
tS2 of the three axial portions 104, 106, 108, and the third axial
portion 108 may have an outer diameter ODS3 and thickness tS3
that are between the first and second in size (i.e., in an
embodiment, tS1> tS3 > tS2 and ODS1 > ODS3 > ODS2). In an
embodiment, the first axial portion 104 may be the most
proximal of the three axial portions 104, 106, 108, the third
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axial portion 108 may be the most distal of the three axial
portions 104, 106, 108, and the second axial portion 106 may
be axially between the first and third axial portions 104, 108.
Spec. ¶ 50.
The different outer diameters ODS1, ODS2, ODS3 of the
three axial portions 104, 106, 108 may be created by using
different thicknesses of polymer in a layer of the shaft 100, in
an embodiment. For example, in the outermost polymer layer
of the shaft 100, a thickest outer polymer layer of the three axial
portions 104, 106, 108 may be used in the first axial portion
104, a thinnest outer polymer layer of the three axial portions
104, 106, 108 may be used in the second axial portion 106, and
an intermediate outer polymer layer may be used in the third
axial portion 108.
Spec. ¶ 52. The Specification also discloses that “[t]he three axial portions
104, 106, 108 of the deflectable portion 102 of the shaft 100 may include
structural features including one or more polymer layers . . . .” Id. ¶ 54.
As evidenced by the passages quoted above, Appellant’s Specification
uses the term “elongate body” to denote the “elongate shaft body” and
describes the “elongate body” or “elongate shaft body” as a discrete elongate
object that may be made up of multiple polymer layers, and not as a layer or
portion of a discrete elongate object. Thus, the Examiner’s attempt to read
the “elongate body” of claim 8 on only a single layer (inner layer 114) of
Engelson’s two-layer catheter body 103 is not consistent with the way
Appellant’s Specification describes an “elongate body.” Moreover,
Engelson uses the term “catheter body” in a similar manner to the way
Appellant uses the term “elongate body,” as denoting the entire catheter
structure, including all layers of a multi-layer structure (i.e., inner layer 114
and outer layer 116). Engelson 4:16–17 (referring to “catheter body (103)
[having] two layers, an inner layer (114) and an outer layer (116)”).
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In light of the above, the Examiner errs in reading the “elongate body”
of claim 8 on just inner layer 114 of Engelson’s catheter body 103. As
Appellant points out, when Engelson’s catheter body 103 is considered in its
entirety, the body has an outer diameter corresponding to that of outer layer
116. Appeal Br. 14. Thus, the longitudinal section the Examiner labels “2”
in the annotated version of Figure 5 on page 4 of the Answer has a second
outer diameter that is smaller than the first outer diameter of the longitudinal
section the Examiner labels “1,” but larger, not smaller, than the third
diameter of the longitudinal section the Examiner labels “3.” Therefore, the
Examiner errs in finding that Engelson anticipates the subject matter of
claim 8.
Accordingly, we do not sustain the rejection of independent claim 8,
or claim 9, which depends from claim 8, as anticipated by Engelson.
Rejection III—Obviousness Based on Engelson and Stevens-Wright
The aforementioned deficiency in the rejection of claim 8 also
pervades the rejection of claims 11 and 12, which depend from claim 8. See
Ans. 5. The Examiner’s application of Stevens-Wright does not cure this
deficiency. See id. Accordingly, we do not sustain the rejection of claims
11 and 12 as unpatentable over Engelson and Stevens-Wright.
Rejections IV and V—Obviousness Based on Hastings or Ponzi in
view of Stevens-Wright
Appellant relies on the arguments presented for claim 1 in contesting
the rejections of claims 13–18 and 20. Appeal Br. 15. For the reasons set
forth above, these arguments do not apprise us of error in the rejection of
claim 1 and, likewise, fail to apprise us of error in the rejections of claims
13–18 and 20. Accordingly, we sustain the rejection of claims 13–16 and 18
as unpatentable over Hastings and Stevens-Wright and the rejection of
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claims 13, 14, 17, 18, and 20 as unpatentable over Ponzi and Stevens-
Wright.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 6, 7 102(a)(1) Stevens-Wright 1–4, 6, 7
8, 9 102(a)(1) Engelson 8, 9
11, 12 103 Engelson, Stevens-
Wright
11, 12
13–16, 18 103 Hastings, Stevens-
Wright
13–16, 18
13, 14, 17,
18, 20
103 Ponzi, Stevens-
Wright
13, 14, 17,
18, 20

Overall
Outcome
1–4, 6, 7,
13–18, 20
8, 9, 11, 12

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