Ex Parte Wist et al

Board of Patent Appeals and Interferences

May 27, 2009

10150877 (B.P.A.I. May. 27, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HENRIK WIST, ALF RITTER, MARIO ZEISS,
HANNA ROTERMUND-BUWEN, HELMAR WERNER LANG,
JORG PETER STROBEL, and KLAUS-PETER KREUZER
__________

Appeal 2009-0004201
Application 10/150,877
Technology Center 3700
__________

Decided:2 May 27, 2009
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 BrainLAB AG is the real party in interest (App. Br. 2).
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-000420
Application 10/150,877

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for assigning digital image information to navigational data of a medical
navigation system. The Examiner has rejected the claims as anticipated and
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“[I]n surgery on a patient’s spine, it is particularly important to
operate with great accuracy, and to assist the physician in this respect,
medical navigation systems are increasingly often used” (Spec. 1). For
example, “digital C-arc x-ray devices . . . provide digital image information,
within the framework of navigating with the aid of registered x-ray images”
(id. at 2).
However, a “certain period of time can pass before the navigation
system obtains a processed image and is then able to detect the
corresponding patient position in the navigation system. In this time,
however, the patient or the C-arc can have moved, even if this movement is
caused merely by breathing” (id.).
The Specification discloses “a method for assigning digital image
information to the navigational data of a medical navigation system, wherein
there is no danger of mis-registration due to time delays in transmitting the
image information” (id. at 2-3). Specifically, “a signal (telegram) [is
transmitted] from the image recording device to the navigation system while
producing the image. Delivering this signal[] informs the navigation system
that digital image information is being produced at a particular point in
time” (id. at 3). The information sent to the navigation system can include,
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for example, “an image number, time of image production and other
information about the properties of the image” (id. at 4).
Claims 1-11 and 13-18 are pending (see App. Br. 2). The Examiner
objected to claims 8 and 9 as being dependent on a rejected base claim, but
allowable if rewritten in independent form including all of the limitations of
the base claim and any intervening claims (Ans. 2).
Claims 1-7, 10, 11, and 13-18 stand finally rejected and are on appeal
(id.).
Claims 1, 11, and 13, the independent claims, illustrate the appealed
subject matter and read as follows:
1. A method for assigning digital image information
to navigational data of a medical navigation system,
comprising:
producing digital image information from a digital
image recording device for a patient being
monitored by said navigation system;

transmitting a signal from said image recording
device to said navigation system when an image is
produced, said signal including assignment
information for assigning said image information
to navigational data which apply to said image
information

transmitting said image information from said
image recording device to said navigation system;
and

assigning said image information and said
corresponding navigational data to each other
based on the signal such that the assigned image
information and captured navigational data relate
to substantially the same instant in time.

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11. A program embodied on a computer readable
medium for assigning digital image information to navigational
data of a medical navigation system, comprising:
code that produces digital image information from a
digital image recording device for a patient being monitored by
said navigation system;
code that transmits a signal from said image recording
device to said navigation system when an image is produced,
said signal including assignment information for assigning said
image information to navigational data which apply to said
image information;
code that transmits said image information from said
image recording device to said navigation system; and
code that assigns said image information and said
corresponding navigational data to each other based on the
signal such that the assigned image information and captured
navigational data relate to substantially the same instant in time.

13. An apparatus for assigning digital image
information to the navigational data of a medical navigation
system, comprising:
a digital image recording device that produces digital
image information for a patient being monitored by said
navigation system;
a signal transmission device that transmits a signal from
said image recording device to said navigation system when an
image is produced, said signal including assignment
information for assigning said image information to
navigational data which apply to said image information;
an image transmission device that transmits said image
information from said image recording device to said
navigation system; and
a data processing device that assigns said image
information and said corresponding navigation data to each
other based on the signal such that the assigned image
information and captured navigational data relate to
substantially the same instant in time.
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The Examiner cites the following document as evidence of
unpatentability:
Rahn et al. US 6,895,268 B1 May 17, 2005

The following rejections are before us for review:
Claims 1-5, 7, 10, 11, and 13-18 stand rejected under 35 U.S.C. §
102(e) as being anticipated by Rahn (Ans. 3-4).3
Claim 6 stands rejected under 35 U.S.C. § 103(a) as being obvious in
view of Rahn (Ans. 4).
ANTICIPATION
ISSUE
The Examiner cites Rahn as disclosing “a method, computer program
and system for assigning CT (digital) image information to navigational data
of a medical navigation system, including means and steps for producing the
image information from a C-arm x-ray device/digital image recording
device” (Ans. 3-4). The Examiner finds that Rahn discloses “transmitting
both the image information and emitter signals from the C-arm to the
navigation system, wherein the signal contains positional information used
to assign the image information and navigation information, and the image
information and signal are simultaneously transmitted from the C-arm” (id.
at 4 (citing Rahn, Figure 4, and col. 9, ll. 33-67)).

3 Page 3 of the Examiner’s Answer does not list claims 13-18 as being
subject to this ground of rejection. However, those claims were rejected as
anticipated by Rahn in the Final Rejection (Final Rejection 3 (mailed June
15, 2007)), and the Examiner includes claims 13-18 in the discussion of the
anticipation rejection (see Ans. 5-7). We therefore consider the Examiner’s
failure to mention claims 13-18 in the initial statement of the rejection to be
a typographical error.
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Appellants contend that “Rahn has not been shown to teach or fairly
suggest all the features of claim 1” (App. Br. 16). In particular, Appellants
argue that the portions of Rahn cited by the Examiner do not describe
transmitting a signal having assignment information “from the image
recording device to the navigation system when the image is produced, or
assigning the image information to corresponding navigational data based on
the signal such that the assigned image information and navigational data
relate to substantially the same instant in time, as recited in claim 1” (id. at
15).
The Examiner responds that Rahn’s system has reference elements
56-58 that send positional information to the navigation system (Ans. 5).
Therefore, the Examiner reasons:
[S]ince Rahn (‘268) is transmitting a signal from the reference
elements, which are attached to cameras and thus considered
part of the image recording system, to the navigation system
while images are being produced, it can be said that the
reference does indeed transmit a signal from the image
recording device to the navigation system when an image is
produced.

(Id.)
The Examiner further argues:
[S]ince Rahn (‘268) expressly discloses that the signals from
the reference elements are needed to derive the position of the
instrument and subject with respect to the reference coordinate
system (col. 9 line 37-44), and it is widely known in the art that
such reference coordinate systems are needed to correlate the
instrument position and orientation (“navigation data”) to
images of the subject (“image information”), it is quite
reasonable to conclude that the reference element signals
contain information “for assigning [the] image information to
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navigational data” as recited in claim 1. In other words, by
correlating both navigation and image data to a reference
coordinate system, the two sets of data are thereby being
assigned to each other. Moreover, it is well known in the art of
surgical navigation that navigation and image data must be
acquired such that they are time-correlated, as temporally
misregistered datasets provide no useful information to the
surgeon.

(Id. at 5-6.)
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
finding that Rahn meets all of the limitations recited in claims 1, 11, and 13,
including the limitation requiring transmitting a signal from the image
recording device to the navigation system when an image is produced, the
signal including assignment information for assigning image information to
navigational data which apply to the image information.
FINDINGS OF FACT (“FF”)
1. Claim 1 recites a method for assigning digital image information to
navigational data in a medical navigation system. The method includes a
step of producing digital image information from a digital image recording
device for a patient being monitored by the navigation system.
The method also requires a signal to be transmitted from the image
recording device to the navigation system when an image is produced. This
signal must include “assignment information” which will assign the image
information to navigational data that apply to the image information.
The method further requires the image information to be transmitted
from the image recording device to the navigation system. The transmitted
image information and corresponding navigational data are then assigned to
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each other based on the signal “such that the assigned image information and
captured navigational data relate to substantially the same instant in time.”
2. Claim 11 recites, essentially, a program on a readable medium with
code for executing the process of claim 1. Thus, the program includes “code
that transmits a signal from [an] image recording device to [a] navigation
system when an image is produced, said signal including assignment
information for assigning said image information to navigational data which
apply to said image information.”
3. Claim 13 recites, essentially, an apparatus configured to perform the
process of claim 1. Accordingly, the apparatus includes “a signal
transmission device that transmits a signal from [the] image recording
device to [the] navigation system when an image is produced, said signal
including assignment information for assigning said image information to
navigational data which apply to said image information.”
4. Rahn discloses methods and systems “of the type having an apparatus
for acquiring images of a first subject, an apparatus for determining the
position of a second subject, and the capability of mixing an image of the
second subject into an image of the first subject” (Rahn, col. 1, ll. 9-13).
5. Rahn discloses that such systems are used “in clinical application
fields, for example o[r]thopedics or traumatology, for supporting operative
(surgical) interventions at the patient, whereby images of instruments are
mixed into images of the interior of the body of the patient” (Rahn, col. 1, ll.
20-24). Thus, the “location coordinates, i.e. the position and orientation, of
the instrument in space or at an operation site are identified with a position
sensor of a navigation system, the sensor being arranged at the instrument,
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and the image thereof is mixed into an image of the patient acquired with the
image acquisition unit” (id. at col. 1, ll. 29-33).
6. Rahn discloses that, in a preferred embodiment, “the overall system
employs a navigation system that identifies the position of the [image] signal
acquisition unit as well as the position of the second subject [e.g., surgical
instrument] as well as the position of the second subject relative to the image
signal acquisition unit” (Rahn, col. 3, ll. 18-22).
7. Rahn discloses:
[T]he navigation system includes detectable marks and/or
position sensors that can be attached to a subject. Such marks
can, for example, be marks that are optically detectable with a
camera system. The position sensors can be fashioned as
transmitters whose signal[s] are received by a receiver of the
navigation system and all [sic, are?] correspondingly interpreted
for determining the respective positions of the position sensors.

(Rahn, col. 3, ll. 23-30.)
8. Rahn discloses:
As a result of the suitable attachment of such marks and/or
position sensors at the image signal acquisition unit at the
second subject, the respective positions of the image signal
acquisition unit and the second subject as well as their relative
position with respect to one another in the reference coordinate
system can be determined in a simple way with a signal
navigation system.

(Rahn, col. 3, ll. 35-41.)
9. Rahn discloses:
3D images of a body part or of an organ of a patient can be
intra-operatively produced with [an] image[] signal acquisition
unit so that the pre-conditions for an exact mixing of an image
of an instrument into one of the 3D images are created. The
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mixing thereby corresponds with high coincidence to the real
position and orientation of the instrument relative to the body of
the patient. The exact determination of the position and
orientation of the image signal acquisition unit and of the
instrument preferably ensues with the assistance of the
navigation system, and the corresponding mixing of the image
into a generated 3D image ensues with the assistance of the
mixing unit, which, for example, can be an image computer or
the navigation computer in practice. Due to the excellent
agreement with the real conditions prevailing at the operation
site, such mixing of an image of an instrument into a 3D image
showing the actual position and shape of a body part or organ
represents effective and dependable support for a surgeon in
operative interventions.

(Rahn, col. 3, l. 62, through col. 4, l. 15.)
10. Figure 4 of Rahn is reproduced below:

The Figure shows
[A] system . . . for medical navigation, having a C-arm X-ray
apparatus 41 with an apparatus cart 43 movable on wheels 42.
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The C-arm X-ray apparatus 41 has a lifting mechanism (only
schematically indicating in FIG. 4) with a column 45. A holder
46 is connected to a holding mechanism 47 for a C-arm 48
having an isocenter IZ. An X-ray emitter 49 and an X-ray
receiver 50 are arranged at the C-arm opposite one another.

(Rahn, col. 8, l. 61, through col. 9, l. 1.)
11. Figure 4 also shows:
The C-arm X-ray apparatus 41 shown in FIG. 4 allows a
3D image dataset of the body or of body parts of a patient P
borne on a vertically and horizontally adjustable patient support
52 to be produced therewith, with various 3D images of the
body of the patient being reconstructable therefrom. For 3D
imaging, an image computer 53 that is arranged in the apparatus
cart 43 of the C-arm X-ray apparatus 41, and that is connected
in a way not shown to the receiver 50 and the display 51 is
provided . . . .

(Rahn, col. 9, ll. 8-15.)
12. Regarding the system shown in Figure 4, Rahn discloses:
Using . . . an optical navigation system in the exemplary
embodiment, an image of an instrument employed by a surgeon
(not shown in FIG. 4) can be mixed into 3D images of the body
of the patient P produced during the operation. . . . [T]he
surgeon is provided with effective and dependable support in
the operative intervention. In order, however, to be able to
exactly position an instrument on the basis of the image
information, exact images of the real operation site that are
obtained by the acquisition of 3D images during the operation
are required.

(Rahn, col. 9, ll. 22-32.)
13. Regarding the system shown in Figure 4, Rahn further discloses:
[T]he navigation system has cameras 54, 55 and
reference elements 56 through 58 detectable with the cameras
54, 55 that are arranged at instruments or subjects to be
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identified as to their position and that are acquired by the
cameras 54, 55. A navigation computer 59 of the navigation
system interprets the pictures acquired with the cameras 54, 55
and can determine the positions, i.e. the attitudes and
orientations, of the reference elements 56 through 58, and thus
of the instruments or subjects, with respect to a reference
coordinate system K2 on the basis of the acquired reference
elements 56 through 58.

(Rahn, col. 9, ll. 33-44.)
14. Regarding the system shown in Figure 4, Rahn further discloses:
[R]eference element 56 is arranged at a surgical
instrument, the reference element 57 is arranged at the C-arm
48 of the C-arm X-ray apparatus 42 and the reference element
58 is arranged at the patient support 52. In this way, the
navigation computer 59 can respectively determine the current
positions of the C-arm 48 and thus of the isocenter IZ of the C-
arm 48, and the respective position of the instrument 60 and the
patient support 52 on the basis of the acquired camera pictures.
The navigation computer 59, which is connected to the image
computer 53 in a way that is not shown, makes the data about
the current positions of the isocenter IZ, the instrument 60 and
the patient support 52 available to the image computer 53. On
the basis of the position information, the image computer 53
can mix an image of the instrument 60 into a 3D image
acquired with the C-arm X-ray apparatus 41 during the
operation, whereby the attitudes and orientation of the
generated image dataset in the reference coordinate system K2
are known on the basis of the known position of the isocenter
IZ.

(Rahn, col. 9, ll. 45-64.)
PRINCIPLES OF LAW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
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After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

For a reference to anticipate a claim “[e]very element of the claimed
invention must be literally present, arranged as in the claim.” Richardson v.
Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236 (Fed. Cir. 1989) (emphasis
added).
ANALYSIS
We agree with Appellants that the Examiner has not made a prima
facie case of anticipation.
We note that Rahn’s device includes an X-ray apparatus that can be
considered “a digital image recording device” (see, e.g., FF 10, 11).
However, Rahn’s device is configured such that the positional data obtained
by the navigation system is transmitted from the navigational computer to
the imaging computer attached to the X-ray apparatus. (See Rahn, col. 9, ll.
53-59 (“The navigation computer 59, which is connected to the image
computer 53 . . ., makes the data about the current positions of the isocenter
IZ, the instrument 60 and the patient support 52 available to the image
computer 53”) (FF 14).)
That is, rather than transmitting a signal from the imaging device to
the navigation system, as required by claim 1, Rahn’s device transmits
information about the surgical instrument’s position from the navigation
system to the image recording device. Thus, while we agree with the
Examiner that the navigational and imaging data are co-presented in a
manner as close as possible to real time, thereby making the information
useful to a surgeon (see FF 9), Rahn’s device accomplishes the coordination
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by transmitting navigational data from the navigational device to the image
recording device (see FF 14) -- the opposite of the configuration required in
claims 1, 11, and 13 (see FF 1-3).
We therefore do not agree with the Examiner that Rahn’s device is
configured in a manner encompassed by those claims. Nor are we persuaded
by the Examiner’s argument (Ans. 5) that the reference elements 56-58 of
the optical navigational system shown in Figure 4 (see FF 10-14) meet the
limitation requiring a signal to be transmitted from the image recording
device to the navigation system when an image is produced.
We note that Rahn’s navigational reference elements 56-58 can
transmit signals to the navigational system during imaging (see, e.g., FF 7).
However, we do not agree with the Examiner that the elements themselves
can be considered digital image recording devices merely because they are
connected to a navigational system that also includes cameras.
Rather, the reference elements are either transmitters which are
detected by receivers in the navigational system (FF 7), or visual markers
detected optically by the navigational system’s cameras (FF 13). Because
the reference markers 56-58 and the cameras are disclosed as being separate
components of Rahn’s navigational system (see, e.g. FF 10), we do not agree
that the references markers are properly considered digital image recording
devices as the Examiner posits.
In sum, we do not agree with the Examiner that Rahn’s device meets
the limitation in claim 1 requiring a signal to be transmitted from the image
recording device to the navigation system, or the corresponding limitations
in claims 11 and 13 directed, respectively, to code and a device configured
for executing the step recited in claim 1. Because we do not agree with the
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Examiner that Rahn meets all of the limitations of those claims, we reverse
the Examiner’s anticipation rejection of those claims, and their dependent
claims 2-5, 7, 10, and 14-18.
OBVIOUSNESS
Claim 6 stands rejected under 35 U.S.C. § 103(a) as being obvious in
view of Rahn (Ans. 4).
Claim 6 recites “[t]he method as set forth in claim 1, wherein said
transmission of the image information is delayed with respect to said
transmission of the signal to said navigation system.”
The Examiner urges that it is well known that “image information
contains more data than the signal from an emitter such as that disclosed by
Rahn . . ., and therefore image information would necessarily take longer to
reach the navigational system than would the signal from the C-arm
emitters” (Ans. 4). Therefore, the Examiner concludes “one of ordinary skill
in the art at the time of invention would find it obvious that the claimed
delay is implicitly taught by . . . Rahn” (id.).
Claim 6 depends from claim 1 and incorporates all of claim 1’s
limitations. In rejecting claim 6, the Examiner has not explained how any
teachings or disclosures in Rahn overcome the deficiencies discussed above
with respect to claim 1. We therefore reverse this rejection also.

SUMMARY
We reverse the Examiner’s rejection of claims 1-5, 7, 10, 11, and 13-
18 under 35 U.S.C. § 102(e) as being anticipated by Rahn.
We also reverse the Examiner’s rejection of claim 6 under 35 U.S.C. §
103(a) as being obvious in view of Rahn.
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REVERSED

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