Anthony K. Misener

Patent Trials and Appeals Board

Jul 23, 2019

14201300 - (R) (P.T.A.B. Jul. 23, 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.
14/201,300 03/07/2014 Anthony K. Misener 101672.0074P16 6974
158673 7590 07/23/2019
BD/Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
07/23/2019 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):
ip.docket@bd.com
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ANTHONY K. MISENER1
__________________

Appeal 2018-006945
Application 14/201,300
Technology Center 3700
____________________

Before JAMES P. CALVE, GEORGE R. HOSKINS, and
ARTHUR M. PESLAK, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING

STATEMENT OF THE CASE
Appellant requests a rehearing of the Decision mailed April 12, 2019
(“Dec.”). Request for Rehearing (filed June 6, 2019) (“Req.”). Requests for
Rehearing are limited to points that are believed to have been overlooked or
misapprehended by the Board in rendering a decision. See 37 C.F.R.
§ 41.52(a)(1).

1 C. R. Bard, Inc. is identified as the real party in interest and also is the
applicant pursuant to 37 C.F.R. § 1.46. Appeal Br. 3.
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ANALYSIS
Appellant argues that the Decision misinterprets Kalpin and Gharib as
teaching the claimed “additional indicator . . . designed to be displayed when
the medical device is proximate to a predetermined location” as recited in
independent claims 1 and 22. Req. 4.
Appellant argues that our reliance on the INSERT NEEDLE 6024
icon of Kalpin as the claimed “additional indicator” (Dec. 7) misapprehends
Kalpin’s teaching that graphical indicator 6024 is displayed to instruct a user
to start inserting a tracked instrument instead of when the tracked instrument
is proximate to the target location as claimed. Req. 4–5. This argument
does not persuade us that we misapprehended any matter taught in Kalpin.
First, this argument amounts to an individual attack on the references.
Cox is relied on to teach a position and orientation indicator guide a catheter
within a patient’s vascular as claimed. Dec. 6; Cox. ¶¶ 2, 129–141. Kalpin
is relied on to teach an additional indicator to indicate in Cox when a needle
is proximate to a predetermined location in the vasculature. See Dec. 6–8.
Appellant does not dispute that INSERT NEEDLE indicator 6024 indicates
a needle location. See Req. 4–5. Rather, Appellant argues that this indicator
is not displayed “when the medical device is proximate to a predetermined
location” as claimed. Id. at 5. However, Cox teaches a four-dimensional
indicator to guide and accurately place a catheter within the vasculature of a
patient. Thus, the needle already is inserted into a patient’s vasculature in
Cox and guided to a particular place via needle image 1234. As modified
with Kalpin’s teachings (discussed further below), Cox’s device is provided
with an additional indicator to indicate that the needle tip is proximate to
some predetermined location in the patient’s vasculature. See Dec. 8.
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Application 14/201,300

3
Non-obviousness cannot be established by attacking references
individually when a rejection is based on their combined teachings. In re
Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Obviousness
considers “whether a person of ordinary skill in the art, having all the
teachings of the references before him, is able to produce the structure
defined by the claim.” Samsung Elecs. Co. Ltd. v. Elm 3DS Innovations,
LLC, 925 F.3d 1373, 1382 (Fed. Cir. 2019) (citation omitted) (noting that a
determination of obviousness based on teachings of multiple references does
not require an actual, physical substitution of elements).
Furthermore, independent claims 1 and 22 do not recite features of “a
predetermined/specified location” that distinguish over the predetermined
target port 32 location in Kalpin. The preambles of claims 1 and 22 recite
“[a] system for guiding and placing a medical device [or catheter] within a
body of a patient,” but the “predetermined location” is not claimed to be in
the body of a patient. Even so, Kalpin teaches an icon that indicates a four-
dimensional position of a needle 4058 to include position and orientation, as
claimed, and an additional indicator 6024 that is displayed when the needle
is proximate to a predetermined location inside a patient’s body, i.e., target
port 32. See Kalpin ¶¶ 111, 159–174, Figs. 13, 20–23.
The Specification provides some guidance as to what comprises a
“predetermined location” but no definition is identified by Appellant for this
term. Req. 4–5. The Specification discloses that once the catheter distal tip
arrives at a “suitable intended destination,” e.g., the lower 1/3rd portion of
the Superior Vena Cava, location indicator 1610 is displayed. Spec. ¶ 251,
Fig. 74. The catheter placement system, thus, facilitates the placement of
the distal tip of the catheter in a predetermined, desired position. Id. ¶ 118.
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Application 14/201,300

4
Kalpin also displays an additional indicator (INSERT NEEDLE 6024)
with a position indicator when needle tip is proximate to a predetermined
location, i.e., target port 32 of a refillable implanted device. Kalpin ¶ 172,
Fig. 23; Dec. 7 (citing id.). Target port 32 is a predetermined location inside
a patient’s body. Dec. 7; Kalpin ¶ 111, Fig. 13. Thus, it corresponds to the
“predetermined location” in claim 1 and “specified location” in claim 22.
Cox already uses a four-dimensional indicator (needle image 1234) to
guide a needle tip through a patient’s vasculature toward a target. Cox ¶¶ 2,
129–141. Kalpin uses a similar four-dimensional indicator (guidance rings
5092–6000, 6008) to guide a needle tip to a predetermined, desired location
and an additional indicator that is displayed when the needle tip is proximate
to the predetermined location, i.e., target port 32, which is located inside a
patient’s body. Kalpin ¶¶ 111, 159–174, Figs. 13, 20–23; Dec. 7.
A skilled artisan would have been motivated to improve Cox’s system
using the teachings of Kalpin to provide an additional indicator with a four-
dimensional indicator to improve Cox’s similar guidance system in the same
way, i.e., to provide a notification when the catheter/needle tip is proximate
to a desired, predetermined location. Dec. 8 (citing KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007)). As modified, Cox’s guidance system would
provide an additional notification when the catheter tip is proximate to a
predetermined location in a patient’s vasculature or heart. See Cox ¶¶ 3, 4.
Appellant also argues that the change in size of Kalpin’s icon does not
equate to a teaching of a presence/absence of an additional indicator that is
displayed when the medical device is proximate to a predetermined location.
Req. 5. Appellant argues that the first ring 5092 is displayed irrespective of
whether the tip is proximate to the predetermined location. Id.
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This argument is not persuasive for several reasons. First, it is not
commensurate with the scope of claims 1 and 22, which do not recite any
particular features of the “additional indicator.” The claims recite that the
additional indicator is “designed to be displayed when the medical device is
proximate to a predetermined location.”
When we consider the Specification, particularly the portions cited as
providing a written description of the “additional indicator” (Appeal Br. 4, 6
citing Spec. ¶¶ 235, 251, 252, 254), we learn that the additional indicator is
manifested in a number of different ways. First, a position indicator icon
114 can include a circle array 1514 of concentric circles. Spec. ¶ 235. As a
distal tip of the stylet moves proximate to a predetermined location (sensor
50), additional concentric circles are displayed to indicate this proximity. Id.
The additional indicator concentric circles, thus, change the size of the icon.
Therefore, the “additional indicator” according to Appellant’s contentions,
includes changes that appear with a position indicator and change the size of
the icon to indicate proximity to a desired location as claimed. Cf. Req. 5.
Second, the “additional indicator” may be a location indicator 1610,
which can be displayed superimposed over part of the position indicator icon
(rod 1512 and circle array 1514). Spec. ¶¶ 251, 252, Figs. 74, 75. Location
indicator can be displayed in different shapes, colors, and shading. Id.
The Decision pointed out that Kalpin discloses multiple embodiments
of an additional indicator similar to the multiple embodiments of Appellant’s
additional indicator described above. In addition to the INSERT NEEDLE
additional indicator discussed above, Kalpin’s guidance rings 5092–6000
and 6008 provide a four-dimensional position and an additional indicator
when the needle tip is proximate to target port 32. See Kalpin ¶¶ 159–174.
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In this regard, Kalpin’s guidance ring 5026 represents a selected target
port 32, 32’ graphically in a particular color and size to differentiate it from
other guidance rings. Kalpin ¶¶ 149, 150. Other guidance rings 5080, 5092,
5096, 6000, 6008 display the location and orientation of a tracked instrument
relative to target port 32 to include a distance of a distal tip 4059 of needle
4058 relative to target port 32. Id. ¶¶ 159–170. These guidance rings may
be displayed in different colors and shapes. Id. ¶ 160.
First ring 5092 indicates the needle tip is aligned with an entrance of
target port 32, and ring 6008 indicates the distance of needle tip from target
port 32. Kalpin ¶¶ 170–74, Figs. 20–23. Ring 6008 provides an “additional
indicator” when the needle tip is proximate to a predetermined location (i.e.,
target port 32 inside the patient). Its size/shape/diameter changes to be the
same size/shape/diameter as first ring 5092 to indicate the distal tip 4059 is
proximate to the entrance to target port 32, the predetermined location. Id.
¶ 174. As with Appellant’s alternative embodiment (Spec. ¶ 235), ring 6008
is superimposed on a position/orientation indicator icon to indicate, in
conjunction with first ring 5092, that the needle tip is proximate to target
port 32 when ring 6008 is the same size/shape/diameter as first ring 5092.
Appellant’s argument that this embodiment of Kalpin requires a user
to make a subjective assessment of proximity (Req. 5) is not commensurate
with the scope of the claims, which do not preclude such an assessment.
Indeed, Appellant’s Figure 65 discloses a similar additional indicator that
changes a size/diameter of circle array 1514 to indicate the proximity of a
needle tip to a predetermined location as discussed above. Spec. ¶ 235.
Furthermore, Kalpin’s embodiment requires ring 6008 to match first ring
5092 in size/diameter. Kalpin ¶ 174. No subjective assessment is required.
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This finding does not rely on ring 6008 for two separate elements as
Appellant alleges. Req. 6. Ring 6008 indicates needle tip location. It also,
in conjunction with first ring 5092, provides an additional indicator of when
the needle tip is proximate to target port 32. Appellant uses ring array 1514
to indicate depth and proximity to a predetermined location (e.g., sensor 50)
in a similar manner discussed above. Spec. ¶ 235 (cited in Appeal Br. 2, 4).
Appellant’s location indicator 1610 embodiment is a color and shape
that is superimposed on array 1514 position/orientation icon. Spec. ¶ 251
(cited in Appeal Br. 2, 4). Thus, location indicator 1610 effectively changes
the color/size of ring array 1514 by superimposing a colored shape over that
icon. Spec. ¶¶ 251, 252, Figs. 74, 75. Thus, a change in color or size can act
as an “additional indicator” contrary to Appellant’s arguments. Req. 6.
Similarly, Kalpin teaches target port ring 5026 and the guidance rings
(e.g., rings 5080, 5092, 5096, 6000, 6008) can be different colors, patterns,
and shapes. Kalpin ¶¶ 150, 160; Dec. 8 (citing id.). The Decision reasoned
that Kalpin teaches that ring 6008 can provide an additional indicator when
its size/shape/diameter is the same as first ring 5092, which occurs when the
needle tip is proximate to the target port 32 (ring 5026) as discussed above.
Dec. 7–8. This “additional indicator” function is provided by ring 6008 in
conjunction with first ring 5092. Kalpin ¶ 174. Because Kalpin teaches that
the shapes, patterns, sizes, and colors of these rings can change, the Decision
reasoned that it would have been obvious to change the size, shape, pattern,
and/or color of Cox’s needle image 1234 similarly to indicate when a needle
tip is proximate to a predetermined location within the patient’s vasculature.
Such a change provides a similar additional indicator that the needle/tip is
positioned proximate to a predetermined location, as claimed. See Dec. 8.
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The use of any of these indicators of Kalpin (INSERT NEEDLE 6024,
ring 6008 becoming the same size/diameter/shape as first ring 5092, and/or
guidance rings changing shape or color) to provide an “additional indicator”
of when a catheter distal tip in Cox is proximate to a predetermined location
within a patient’s vasculature would improve Cox similarly. See KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007); Dec. 8.
Appellant argues that Gharib’s teaching of an icon that changes color
from green to yellow to red as a medical instrument nears a nerve “does not
equate to a teaching of a presence/absence of an icon feature such that the
additional indicator is ‘to be displayed when the medical device is proximate
to a predetermined location.’” Req. 7. This argument is not persuasive for
the reasons discussed above, namely, that the Specification discloses that
location indicator 1610 changes the color of a position/orientation icon to
indicate proximity to a predetermined location. Spec. ¶¶ 251, 252; Appeal
Br. 2, 4 (citing id.). Gharib uses the presence or absence of an icon color,
i.e., when the icon changes from green to yellow to red, as an additional
indicator that an instrument is proximate to a predetermined location, i.e., to
a nerve.
For the foregoing reasons, Appellant does not persuade us that we
overlooked or misapprehended any of the matters asserted in the Request for
Rehearing. Accordingly, we deny the Request for Rehearing.
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)(1)(iv).
REHEARING DENIED