Ex Parte Graumann et al

Patent Trial and Appeal Board

Feb 21, 2019

14112951 (P.T.A.B. Feb. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/112,951 10/21/2013
27350 7590 02/25/2019
LERNER GREENBERG STEMER LLP
Box SA
P.O. BOX 2480
HOLLYWOOD, FL 33022-2480
FIRST NAMED INVENTOR
Rainer Graumann
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.
2010P26547 1930
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
02/25/2019 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):
boxsa@patentusa.com
docket@patentusa.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAINER GRAUMANN, GERHARD KLEINSZIG, and
MARTIN RINGHOLZ
Appeal 2018-003770
Application 14/112,951 1
Technology Center 3700
Before EDWARD A. BROWN, RICHARD H. MARSCHALL, and
PAUL J. KORNICZKY, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Rainer Gramnann et al. (Appellants) seek review under 35 U.S.C.
§ 134(a) of the Examiner's decision rejecting claims 7-11. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Siemens Aktiengesellschaft is identified as the real party in interest.
Appeal Br. 1.
Appeal2018-003770
Application 14/112,951
CLAIMED SUBJECT MATTER
Representative claim 7 reads as follows:
7. A method for determining a location of a target position
for an invasive medical procedure on a patient in a coordinate
system, the method comprising:
recording radioscopy image data of the patient in order to
define the target position and an entry position for the procedure,
wherein the entry position is on a surface of the patient;
after recording the radioscopy image data of the patient,
affixing an entry mark to the patient defining the coordinate
system and indicating the entry position for the procedure;
after recording the radioscopy image data of the patient,
fixing a site marker to be identified in a radioscopy image in a
known relative position in the coordinate system;
after affixing the entry mark to the patient and after fixing
the site marker, recording at least two 2D radioscopy images of
the patient from mutually different recording directions, each
image capturing the site marker and the target position, wherein
the different recording directions are substantially orthogonal to
each other; and
determining the location of the target position in the
coordinate system from a representation of the target position
and a representation of the site marker in the 2D radioscopy
images and the relative position of the site marker in the
coordinate system.
Appeal Br. 11 (Claims App.).
REJECTION
Claims 7-11 stand rejected under 35 U.S.C. § I03(a) as unpatentable
over Gilboa (US 7,876,942 B2, issued Jan. 25, 2011), Battle (US
2008/0125846 Al, published May 29, 2008), and Glossop (US 6,317,616
Bl, issued Nov. 13, 2001).
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Application 14/112,951
ANALYSIS
As for claim 7, the Examiner finds that Gilboa discloses recording at
least two, two-dimensional radioscopy images of a patient from mutually
different recording directions, where each image captures the site marker
and the target position (Final Act. 3 (citing Gilboa, col. 9, 11. 55-67
("fluoroscopic images")), but finds that Gilboa does not disclose that "the
different recording directions are substantially orthogonal to each other" (id.
at 4 ). The Examiner relies on Battle for disclosing a method for stent
placement, comprising pre-acquiring a first image at a first orientation and a
second image at a second orientation substantially orthogonal to the first
orientation. Id. (citing Battle ,r,r 28, 29, 34). The Examiner concludes that it
would have been obvious to one of ordinary skill in the art to modify
Gilboa's method to acquire images in substantially orthogonal directions, as
taught by Battle, "as these images substantially orthogonal to one another
are typically acquired and will give a more complete picture of the patient's
anatomy." Id. at 4--5.
Appellants contend that Gilboa discloses that the images are taken for
the purpose of determining the relative position of the fiducial points and the
target, and obtaining a more complete picture of a patient's anatomy would
not be needed for achieving that purpose. Appeal Br. 5---6 ( citing Gilboa,
col. 9, 11. 55-57). Therefore, Appellants contend, a person of ordinary skill
in the art would not have modified Gilboa for the reason stated by the
Examiner. Id.
Appellants' contentions are not persuasive. Figure 3A of Gilboa
illustrates the relative positions of target 302 and a patch including markers
312, 313. Gilboa discloses, in a non-limiting example, "[using] two non-
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Application 14/112,951
parallel views derived from a fluoroscope (itself a two-dimensional imaging
device) to determine the relative positions of the target and markers in the
patch." See Gilboa, col. 9, 11. 57---61 (emphasis added). Although Gilboa
does not expressly describe using orthogonal views, Gilboa does not appear
to limit the angle defined between the "non-parallel views," or otherwise
teach or suggest that using orthogonal views would be undesirable.
Moreover, the Examiner, relying on Battle for support, finds that "images
substantially orthogonal to one another are typically acquired." Final Act 5.
Appellants do not apprise us of error in those findings. Nor do Appellants
take the position that the claimed substantially orthogonal recording
directions are critical. In that regard, we note Appellants' Specification
describes, "[ r ]adioscopy images are ideally recorded for instance from
projection directions which are orthogonal to one another." See Spec. 5, 11.
4---6. This description appears to imply that radioscopy images could be
recorded from other projection directions not orthogonal to each other.
Additionally for claim 7, the Examiner finds that Gilboa discloses
"affixing an entry mark to the patient defining the coordinate system and
indicating an entry position for the procedure" (Final Act. 3 ( citing Gilboa,
col. 10, 11. 1-28)), but that Gilboa does not disclose "recording radioscopy
images to define the target position and entry position" before affixing the
entry mark (id. at 4). The Examiner relies on Glossop for disclosing a
method to facilitate image guided surgery, which comprises obtaining pre-
acquired images and marking the position and orientation of an entry point
and the internal features of the patient in the images. Id. ( citing Glossop,
col. 6, 11. 47-55). The Examiner acknowledges that Gilboa does not disclose
how the entry point and target are initially located, but determines that it
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Application 14/112,951
would have been obvious to one of ordinary skill in the art to modify
Gilboa/Battle to use pre-acquired images to define the target position and
entry position, as taught by Glossop, before affixing the entry mark and
fixing the site marker, as using the pre-acquired images "allows one to more
accurately locate the appropriate area in which to place the entry mark and
site marker (patch) in order to guide the tool in a predetermined manner,
from a desired entry point to the target." Id. at 5.
Appellants challenge this proposed modification of Gilboa/Battle in
view of Glossop, contending there would have been no suggestion for
"affixing an entry mark and fixing a site marker after recording radioscopy
image data of the patient in order to define the target position and an entry
position for the procedure." Appeal Br. 7. Appellants contend that Gilboa's
method is based on determining a spatial relation between the target and
optically identifiable fiducial reference points defined on the external surface
of the body, and deriving a current tip projection from the positions of the
fiducial points in camera images. Id. at 6 (citing Gilboa, col. 3, 11. 16-35).
The fiducial points are provided on a patch that is placed on the surface of
the body. Id. at 7 (citing Gilboa, col. 8, 11. 61---63). Appellants contend that
placing the patch with fiducial points at a predetermined position would not
affect the accuracy of Gilboa's method, because the important aspect-i.e.,
determining a spatial relation between the target and the fiducial points in
the patch-is performed after placing the patch on the body. Id. Appellants
contend that Gilboa discloses "that once the location of the markers within
the patch are registered relative to the target, the position of the insertion
point is immediately known." Id. at 8 (citing Gilboa, col. 10, 11. 15-18).
Appellants contend that the patch is not used to set a predetermined
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Application 14/112,951
penetration point in Gilboa; "rather the patch is used so that as the tip of the
tool penetrates the patch, the insertion point can be determined due to the
known relationship between the location of the markers in the patch and the
location of the target." Id. at 8-9. Appellants submit that Glossop would
not have motivated one of ordinary skill in the art to modify Gilboa to
predefine the entry point, or to more accurately locate an area in which to
place the entry mark. Id. at 9.
As noted by both Appellants and the Examiner, Gilboa discloses:
One parameter employed in calculations of the tool tip
location and direction is the point of penetration of the tool into
the body. In principle, the point of penetration could be chosen
by the user in an arbitrary location on the swface of the body
within the camera field of view and this location could be
determined by image processing from the images from camera
115.
Gilboa, col. 10, 11. 1-7 (emphasis added); Appeal Br. 8; Ans. 3. This
description teaches or suggests that the chosen point of penetration is, in
principle, unimportant.
Gilboa also describes using a patch to determine the location of the
insertion point, as follows:
In practice, it is typically preferred to take advantage of the
presence of the patch to determine the penetration point more
easily and/or with higher accuracy than would otherwise be
possible. Thus, insertion of the tool into the body is preferably
performed through the patch. In one particularly preferred
implementation, the patch itself is configured to delineate a point
of penetration of the distal end of the tool into the body. This
may be achieved by providing a preformed aperture through
which the tool is to be inserted. In this manner, once the location
of the markers within the patch are registered relative to the
target, the position of the insertion point is immediately known.
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Application 14/112,951
See Gilboa, col. 10, 11. 7-18 (emphasis added). In these preferred
implementations, the tool is inserted through the patch to thereby determine
the penetration point with higher accuracy. Accordingly, the patch is
applied to a patient's skin before the penetration point is formed to achieve
the desired higher accuracy. Gilboa also describes "alternative
implementations" in which the tip of a tool is brought into contact with a
patch. See id. at col. 10, 11. 18-28. That is, the patch is applied to a patient's
skin before the penetration point is formed. As explained by Appellants,
"the point of penetration of the tool is not known at the instant of time that
the patch is applied to the surface of the body because the registration
process has not yet been performed." Reply Br. 6. Consistent with these
preferred and alternative implementations in Gilboa, we agree with
Appellants that "Gilboa does not teach that it is important to predefine the
entry point of the tool in the body as the Examiner has alleged." Id. We
also agree with Appellants that Gilboa teaches that wherever the patch is
placed on the body, the penetration point of the tool can be more accurately
and easily determined due to the registration of the fiducial markers of the
patch relative to the target, which registration is performed after applying the
patch to the surface of the body. Id.; see also Appeal Br. 9.
The Examiner also takes the position that it is known to determine the
target location before surgery, and thus, understand where to place the patch.
Ans. 3--4. As noted above, the Examiner relies on Glossop for teaching
determining the target location before the procedure. However, Gilboa
discloses using a patch that is applied to a patient before determining the
target location. See, e.g., Gilboa, col. 9, 11. 55-67, col. 10, 11. 29-37.
Considering this use of the patch in determining the target location, the
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Examiner does not explain adequately why one of ordinary skill in the art
would, nonetheless, have modified Gilboa to instead determine the target
location before surgery, and thus understand where to subsequently place the
patch.
For these reasons, we do not sustain the rejection of claim 7, or of
dependent claims 8-11, as unpatentable over Gilboa, Battle, and Glossop.
DECISION
The rejection of claims 7-11 is reversed.
REVERSED
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