Ex Parte Misener

Patent Trials and Appeals Board

Apr 10, 2019

14201300 - (D) (P.T.A.B. Apr. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/201,300 03/07/2014 Anthony K. Misener
158673 7590 04/12/2019
ED/Rutan & Tucker, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
101672.0074Pl6 6974
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
04/12/2019 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):
patents@rutan.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED ST ATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY K. MISENER 1
Appeal2018-006945
Application 14/201,300
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
AR THURM. PESLAK, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Final Office
Action rejecting claims 1-8, 17, 18,and22-26. AppealBr.3. Wehave
jurisdiction under35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND OF REJECTION
pursuantto ourauthorityunder37 C.F.R. § 4I.50(b).
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. AppealBr. 3.
Appeal 2018-006945
Application 14/201,300
CLAIMED SUBJECT MATTER
Claims 1 and 22 are independent. Claim 1 is reproduced below.
1. A system for guiding and placing a medical device
within a body of a patient, the system comprising:
one or more processors;
a display communicatively coupled to the one or
more processors, the display for depicting
information relating to the medical device
during insertion of the medical device into the
body;
a non-transitory storage device communicatively
coupled to the one or more processors, the non-
transitory storage device having stored thereon
logic, that when executed by the one or more
processors, causes performance of operations
including:
depicting an icon on the display, the icon
designed to indicate at least a four-
dimensional position of the medical device,
the icon including: (i) a position indicator
(ii) an orientation indicator, and (iii) at least
one additional indicator included with the
position indicator designed to be displayed
when the medical device is proximate to a
predetermined location;
receiving updated positioning information; and
depicting the icon in an updated state on the
display according to the received updated
positioning information.
REJECTION
Claims 1-8, 17, 18, and 22-26 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Cox (US 2011/0295108 Al, pub. Dec. 1, 2011 ), Kalpin
(US 2011/0237935 Al, pub. Sept. 29, 2011), and Gharib (US 2005/0182454
Al, pub. Aug. 18, 2005).
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Appeal 2018-006945
Application 14/201,300
ANALYSIS
The Examiner fmds that Cox teaches a system for guiding and placing
a medical device in the body of a patient, substantially as recited in claim 1,
including depicting an icon on the display to indicate a position in x and y
positions and an orientation of the device. Final Act. 5. The Examiner fmds
that Cox does not teach an icon that illustrates a third-dimensional position
for the z-axis or at least one additional indicator that is displayed when the
medical device is proximate to a specified location. Id. at 6.
The Examiner fmds that Kalpin teaches an icon that indicates a spatial
position of a medical device in three dimensions to make insertion easier by
improving identification of the location of the device in the patient during a
medical procedure. Id. The Examiner fmds that Gharib teaches an indicator
to display when a medical device is proximate to a specified location by
changing color to provide a relative indication of distance (proximity) from
the medical device to a specified location (tissue) to reduce the risk of harm
to the patient. Id.
The Examiner determines it would have been obvious to modify the
system of Cox to include these features to provide the predictable results of
improving insertion by making identification of the location of the device in
the patient better as taught by Kalp in and to provide a relative location of the
medical device to a specified location by changing color to reduce the risk of
harm to the patient as taught by Gharib. Id. at 6-7.
Appellant argues that Cox teaches a position indicator in three (x, y, z)
dimensions with the orientation (pitch and yaw) of a needle that is depicted.
Appeal Br. 10-11. Appellant argues that a skilled artisan would not look to
Kalp in for a z-axis indicator when Cox already teaches the feature. Id. at 11.
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Appeal 2018-006945
Application 14/201,300
Appellant also argues that Kalpin teaches not only the position and
orientation of a tracked instrument via guidance rings 5080 but also teaches
to display an additional ring 6008 to indicate the relative position of distal
tip 4059 of a selected needle 4058 relative to a selected target port 32 of an
implantable device 30. Id. at 12. Appellant argues that Kalpin "necessarily
teaches the position of the needle within the body, and therefore there is no
reason to look beyond Kalpin to Gharib." Id. ("even if [ a person of ordinary
skill in the art] looked to Kalp in, there is no motivation to further look to
Gharib to remedy a problem that doesn't exist in Kalpin"). Appellant further
argues that Cox and Kalpin fail to teach a position indicator designed to be
displayed when the medical device is proximate to a predetermined location.
Id.at 14.
We agree with Appellant that Cox teaches a system that depicts an
icon in at least four dimensions, i.e., X, Y, Z, and orientation as illustrated in
the embodiment of Figure 23B, which is reproduced below. Cox ,r 141.
FIG, 238
Fig. 23B depicts needle image 1234 (icon) in three dimensions with
the orientation (pitch, yaw) of the needle cannula depicted as well. Id.
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Appeal 2018-006945
Application 14/201,300
We appreciate the Examiner's findings that Cox teaches sensors that
continuously detect and update the position and orientation of needle 1200.
Ans. 4--5. However, Cox teaches that this information is used to depict the
advancement and movement of needle 1200 in real time with needle image
1234 on display 1130 and to update the position of needle image 1234 and
ultrasound image 1232 continuously in real time on display 1130 during a
placement procedure or other activity. Cox ,r,r 13 7-139. Cox discloses
needle image 1234 as being "displayed in a three dimensional aspect,"to
enable "the angle and orientation of the needle 1200, as depicted by the
needle image 1234, to be ascertained and compared with the intended target
imaged by the ultrasound image 1232." Id. ,r 141 ( discussing Fig. 23B).
Needle image 1234 corresponds to the claimed icon because it is an
indicator of the three-dimensional position and orientation of needle 1200,
which is a medical device as claimed. 2 See id. ,r,r 13 7-141.
The Examiner's articulated reasoning and factual underpinnings are
essential elements of a ground of rejection. See In re Biedermann, 733 F.3d
329,335 (Fed. Cir. 2013). Here the Examiner's reason for combining the
teaching ofKalpin with Cox is based on a faulty underpinning, namely, that
Cox does not display a three-dimensional position for a medical device, i.e.,
a position along X, Y, and Z axes. Final Act. 6. Because Cox displays
needle image 1234 in three dimensions, as discussed above, the rejection
lacks an underpinning to support the determination of obviousness.
2 The Specification uses the terms indicator and icon interchangeably, i.e.,
that an icon includes various indicators such as depth scale indicator 124 as
argued by Appellant (Appeal Br. 10). See Spec. ,r,r 105,180,210, 232-235
(icon 114 includes orientation indicator 1502 (elongate rod 1512), depth
indicator 1504 (circle array 1514)).
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Appeal 2018-006945
Application 14/201,300
Stated another way, the Examiner's fmdings regarding the scope and
content of the prior art are not supported by a preponderance of evidence.
The fmding that Cox only teaches a two-dimensional position of a medical
device using an icon, when in fact Cox teaches needle image 1234 in three
dimensions, undermines the Examiner's reason for combining the teachings
of Kalpin and Cox. Accordingly, we do not sustain the rejection of claim 1
and claims 2-8, 17, and 18, which depend therefrom.
Because the Examiner relies on the same fmdings regarding Cox as a
basis for combining the same teachings of Kalp in to render obvious claim 22
and its recital of "a position indicator designed to visually represent a three-
dimensional position relating to the catheter" (Final Act. 9-10), we do not
sustain the rejection of claim 22 or claims 23-26, which depend therefrom.
NEW GROUND OF REJECTION
Weenteranewgroundofrejectionforclaims 1-8, 17, 18, and22-26
under 35 U.S.C. § 103(a), as unpatentable over Cox, Kalpin, and Gharib.
We adopt all of the Examiner's fmdings regarding these references as to all
claims except where noted differently below.
Regarding independent claims 1 and 22, we fmd that Cox teaches a
system for guiding and placing a catheter within a patient with the claimed
processors, display, and non-transitory storage device ( claim 1 only) and an
icon (needle image 1234) that indicates at least a four-dimensional position
of a medical device (needle 1200, Fig. 22A) with sensors, and needle image
1234 provides a three-dimensional position of needle 1200 in X, Y, and Z
axes and depicts an orientation of needle 1200. Cox. ,r,r 136-141, Fig. 23B.
Appellant agrees that needle image 1234 displays three dimensions and pitch
and yaw orientation of a needle. Appeal Br. 10-11.
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Appeal 2018-006945
Application 14/201,300
Cox teaches a four-dimensional indicator as claimed, and as Appellant
admits, but does not teach an additional indicator "designed to be displayed
when the medical device is proximate to a predetermined [specific] location"
as claimed. However, Kalpin and Gharib both teach this feature.
Kalp in teaches a system for guiding a needle within a patient with an
icon (guidance rings 5092---6000) that provides a three-dimensional position
of the needle tip (ring 6008) and orientation of the needle itself. See Kalpin
,r,r 159-174, Figs. 20-23. These features allow a user to position and orient
a needle and distal tip proximate to target port 32, which is inside a human
body,andin alignment therewith. Id. ,r,r 168-172,Fig. 23. Oncetheneedle
is properly positioned in X, Y, and Z axis positions at target port 32 and is
aligned properly with target port 32, as indicated by the icon rings (Fig. 23),
an additional graphical indicator INSERT NEEDLE 6024 is displayed. Id.
,r 172, Fig. 23. This additional indicator signifies that the medical device is
proximate to a predetermined/specific location, i.e., target port 32. Id.
Furthermore, Kalpin teaches an additional graphical indicator as ring
6008, which denotes the distal tip of the needle and its distance from target
port 32, and also signifies when the needle tip reaches target port 32 inside a
patient "by having the same diameter in a concentric pattern of the rings" as
frrst ring 5092, which signifies the three-dimensional location of target port
32. Id. ,r,r 173-174. Indicator ring 6008 indicates when the needle tip is
proximate to a predetermined/specific location, i.e., target port 32. Br. 12.
Gharib teaches a system for guiding a medical device by displaying an
icon to indicate when the device is proximate to a nerve. Gharib ,r,r 53, 54,
71, Fig. 7. As the instrument nears a nerve, the color of the icon changes
from green to yellow to red. Id. ,r 71.
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Application 14/201,300
We determine it would have been obvious to modify Cox with these
teachings ofKalpin and Gharib to include an additional indicator such as
INSERT NEED LE ( or similar message relevant to the particular procedure)
on the display and/or to change the size, shape, or color of needle image
1234 to indicate when the needle tip is proximate to a predetermined/specific
location as claimed. See Kalpin ,r,r 150, 160 (teaching that the rings can be
different colors, shapes, or designs and change color as well as size). Such
indicators facilitate ease of insertion of a medical instrument to the precise,
desired location in a patient to promote the efficacy of the medical procedure
without injuring the patient. Kalpin ,r,r 7, 143, 144, 151, 160, 168, 169, 172;
Gharib ,r,r 53, 54, 71; see Final Act. 6-7 (Kalpin's icon would improve ease
of insertion and identification of location, and Gharib would reduce the risk
of harm to the patient); see also KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007) (holding that using a technique that has been used to improve
one device to improve similar devices in the same way is obvious unless its
actual application is beyond the level of ordinary skill in the art). For the
foregoing reasons, we enter a new ground of rejection of claims 1 and 22 as
unpatentable over Cox, Kalpin, and Gharib. We also adopt the Examiner's
fmdings and determinations of obviousness as to dependent claims 2-8, 17,
18, and 23-26.
DECISION
We reverse the rejection of claims 1-8, 17, 18, and 22-26.
Weenteranewgroundofrejectionofclaims 1-8, 17, 18, and22-26
as unpatentable over Cox, Kalpin, and Gharib.
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Appeal 2018-006945
Application 14/201,300
This decision contains a new ground of rejection entered pursuant to
37 C.F.R. § 4I.50(b ). Section4I.50(b) provides that "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 41. 5 O(b) also provides:
When the Board enters such a non-fmal decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41. 52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MANUAL OF PATENT EXAMINING PROCEDURE§ 1214.01 (9th
Ed., Rev. 08.2017, Jan. 2018).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
REVERSED; 37 C.F.R. §4I.50(b)
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