Ex Parte Ashton

Board of Patent Appeals and Interferences

Oct 13, 2009

10901160 (B.P.A.I. Oct. 13, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte EDWARD ASHTON
__________

Appeal 2009-004293
Application 10/901,160
Technology Center 3700
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Decided: October 14, 2009
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Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for measuring parameters relating to vascularity of a tumor. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
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Statement of the Case
Background
“Dynamic contrast enhanced Magnetic Resonance Imaging (dceMRI)
has demonstrated considerable utility in both diagnosing and evaluating the
progression and response to treatment of malignant tumors” (Spec. 1, ll. 8-
10). The Specification teaches that “it is critical to be able to accurately
measure the change in these parameters over time due to disease progression
or response to therapy” (Spec. 1, ll. 14-15). According to the Specification
“[m]easurement reproducibility must therefore be of primary concern when
designing a system for perfusion assessment in clinical trials” (Spec. 1, ll.
15-17).
The Claims
Claims 1-18 are on appeal. We will focus on claims 1, 7, and 10-13,
which are representative and read as follows:

1. A method for providing reproducible measurements
of parameters relating to vascularity of a tumor in a patient
during a clinical trial and for reducing or eliminating effects
of noise on the measurements of the parameters, the method
comprising:
(a) developing a standard imaging protocol for use at
a plurality of sites, each of the plurality of sites having at
least one scanner on which the imaging protocol is to be
implemented;
(b) ensuring that each of the plurality of sites complies
with the standard imaging protocol;
(c) ensuring that the at least one scanner at each of the
plurality of sites is operating correctly;
(d) developing an automated process for analyzing
image data taken from the tumor to provide the reproducible
measurements;
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(e) taking the image data from the tumor using a
scanner at one of the plurality of sites; and
(f) determining the reproducible measurements from
the image data in step (e), using the automated process of
step (d).

7. The method of [claim 1 wherein step (e) is performed
through dynamic contrast enhanced magnetic resonance
imaging and] wherein step (c) comprises:
(i) providing at least one phantom;
(ii) imaging the at least one phantom in the at least
one scanner at each of the plurality of sites;
(iii) determining, from step (c)(ii), whether each
scanner is functioning correctly; and
(iv) performing maintenance on any scanner which is
determined in step (c)(iii) not to be functioning correctly.

10. The method of [claim 1 wherein step (e) is performed
through dynamic contrast enhanced magnetic resonance
imaging and] wherein step (d) comprises developing
software for analyzing the image data.

11. The method of claim 10, wherein the software comprises
software for performing a script-driven analysis.

12. The method of claim 11, wherein the script-driven
analysis comprises volumetric analysis and perfusion
analysis.

13. The method of claim 12, wherein the software further
comprises software for performing automated warp-based
registration to align time points in the image data and for
performing semi-automated tumor margin identification
through geometrically constrained region growth.

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The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Chaney et al. US 5,926,568 Jul. 20, 1999
Uber, III et al. US 6,385,483 B1 May 7, 2002
Bozdagi et al. US 6,594,403 B1 Jul. 15, 2003
Degani et al. US 2003/0211036 A1 Nov. 13, 2003
Declerck et al. US 2004/0071325 A1 Apr. 15, 2004
Hu et al. US 7,039,723 B2 May 2, 2006

The issues
A. The Examiner rejected claims 1-6, 10-12, and 14-18 under 35 U.S.C.
§ 103(a) as being obvious over Degani, Uber, and Hu (Ans. 3-5).
B. The Examiner rejected claims 7-9 under 35 U.S.C. § 103(a) as being
obvious over Degani, Uber, Hu, and Declerck (Ans. 5-6).
C. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as being
obvious over Degani, Uber, Hu, Chaney and Bozdagi (Ans. 6-7).
A. 35 U.S.C. § 103(a) over Degani, Uber and Hu
The Examiner rejected claims 1-6, 10-12, and 14-18 under 35 U.S.C.
§ 103(a) as being obvious over Degani, Uber and Hu (Ans. 3-5).
The Examiner finds that:
Degani discloses a method for measuring parameters using
dynamic contrast enhanced MRI (claim 14) relating to the
vascularity of a tumor (page 1, paragraph 0007, lines 1-4;
page 3, paragraph 0029) using the arterial input function
(page 2, paragraph 0014), for reducing the effect of noise
(page 1, paragraph 12, line 9 - page 2, paragraph 12, line 4),
ensuring that the scanner is operating correctly (page 8,
paragraph 0071, lines 11-15), and having an automated
script-driven process for analyzing image data using a
scanner at one of a plurality of sites
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(Ans. 3). The Examiner finds that “Degani does not disclose use of a
standard imaging protocol or specifying a dose and rate of contrast injection
into the patient (Ans. 4). The Examiner finds that “Uber, III discloses use of
a standard imaging protocol in MR imaging and specifies a dose and rate of
contrast injection into the patient” (Ans. 4). The Examiner finds that “Hu et
al. disclose a method of manipulating image data where a standard imaging
protocol is applied across a plurality of sites” (Ans. 4).
Appellant argues that the “Final Rejection acknowledges that Degani
and Uber III do not teach using the imaging protocol at a plurality of sites,
but instead cites Hu for that teaching. However, the Appellant respectfully
submits that Hu does not overcome that deficiency of the other applied
references” (App. Br. 4). Appellant argues that Hu “actually teaches a
standard trial protocol, rather than the standard imaging protocol called for
in the present claims” (App. Br. 4-5). Appellant also argues that the
Hu patent refers specifically to a PACS system feature
allowing multiple groups to work collaboratively on the
image analysis of a single data set. In particular, the patent
revolves around the ability to maintain and update image
analysis state variables on multiple networked PACS
workstations simultaneously. That has nothing to do with the
present claimed invention, which involves developing a
standard imaging protocol for use at a plurality of sites

(App. Br. 5).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Has Appellant demonstrated that the Examiner erred in finding it
obvious to modify the method of Degani and Uber to develop “a standard
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imaging protocol for use at a plurality of sites” based on the disclosure of
Hu?
Findings of Fact (FF)
1. Degani teaches “a method for monitoring tissue perfusion . . .
monitoring the tracer concentration in the tissue before enrichment, during
enrichment and post enrichment by an imaging technique, which can be
selected from one of MRI” (Degani 3 ¶ 0029).
2. Degani teaches “operating the apparatus in a manner such that
the spatial resolution is substantially increase[d] and the signal-to-noise
(SNR) of the dynamic 2H MR-images and processing the acquired data with
the same resolution as it was acquired” (Degani 1-2 ¶ 0012).
3. Degani teaches that the “computer is connected or coupled to a
scanner that generates images, a standard known machine in the art, to
receive the data generated by the scanner in the normal course of its
operation and functioning” (Degani 8 ¶ 0071).
4. Degani teaches that “[a]nalysis was performed utilizing a
nonlinear least-square fitting algorithm . . . at a voxel resolution” (Degani 6
¶ 0057).
5. Degani teaches an “automated program averaged the intensities
in adjacent pixels in the original MR images to create lower-resolution
images . . . The spatially degraded images (by a factor of 8) were processed
as described above, according to the model-based algorithm” (Degani 6
¶ 0058).
6. Uber teaches that the “imaging procedure standard protocol is
selected at first operative step 11 . . . If the patient’s weight is within the
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broad range of weights acceptable for the particular contrast media and set
of injection parameters, the standard protocol is determined to be appropriate
at stage 14” (Uber, col. 4, ll. 57-65).
7. Uber teaches that “information relating to image quality or
sensed concentration of contrast media is received to allow for automatic
adjustment of the system” (Uber, col. 6, ll. 27-30).
8. The Examiner finds that “Uber, III discloses embodiments as
being described with varying degrees of operator control, operator
verification and automatic operation (col 7, line 64 - col 8, line 6), and
therefore makes it obvious to also provide an electronic audit trail wherein
data consolidation can be tracked” (Ans. 4).
9. Hu teaches “an optimized method for multi-center trial
management using the teleradiology conferencing technology. This method
is designed to optimize the workflow and management of various tasks, such
as protocol selection, training/education, trial monitoring, and data
management for expert reading” (Hu, col. 6, ll. 21-26).
10. Hu teaches that “all remote conference participants may have
already had the copy of the same data set on each of their local disk . . . the
conferencing software . . . will generate the new image using the local copy
of the data and local computing resources and will synchronize the image
display” (Hu, col. 5, ll. 36-45).
11. Hu teaches “[u]sing the teleradiology conferencing techniques
described herein to choose a trial protocol” (Hu, col. 6, ll. 29-30).
12. Hu further teaches “to conduct interactive conferences between
the trial monitor and individual participating sites to review images, in order
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to assure quality and compliance during the trial process” (Hu, col. 6, ll. 38-
41).
13. The Examiner finds that “[i]t would have therefore been
obvious to one of ordinary skill in the art to use the teaching by Hu et al. to
modify the teaching by Degani and Uber III for the purpose of enabling a
standard protocol to be accessible across various sites (col. 5 lines 36-41)”
(Ans. 4-5).
14. Declerck teaches that “FIG. 3 illustrates an emission image of a
uniform cylindrical phantom before correction . . . FIG. 4 illustrates such an
image corrected by means of a transmission image. The uniformity is
restored” (Declerck 1 ¶ 0004).
15. Bozdagi teaches that it is known for “a subimage to be warped
based on the image affine parameters for the other subimage, so that the
subimage to be warped now has image affine parameters that will warp it
into registration with the base subimage” (Bozdagi, col. 8, ll. 49-52).
16. Bozdagi teaches that this image registration is used in
“registering together adjacent tomographic brain images” (Bozdagi, col. 3, l.
55).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
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need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 416. “If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” Id. at 417.
Moreover, an “[e]xpress suggestion to substitute one equivalent for
another need not be present to render such substitution obvious.” In re Fout,
675 F.2d 297, 301 (CCPA 1982). As noted by the Court in KSR, “[a] person
of ordinary skill is also a person of ordinary creativity, not an automaton.”
550 U.S. at 421.
Analysis
There is no dispute that Degani and Uber teach reproducibly
measuring parameters relating to vascularity of a tumor (FF 1), and reducing
noise on those measurements by using standard protocols (FF 2, 6, 7).
Further Degani and Uber teach ensuring that the scanner operates correctly
(FF 3), developing automated processes for analyzing image, taking image
data from a tumor, and determining reproducible measurements (FF 4, 5, 8).
The Examiner recognizes that Degani and Uber do not teach
standardizing the protocol at a plurality of clinical trial sites (Ans. 4) and
relies upon Hu to teach the claimed requirement of “(a) developing a
standard imaging protocol for use at a plurality of sites” (claim 1).
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Hu teaches multicenter trials with shared data (FF 9-10). Hu
specifically teaches “[u]sing the teleradiology conferencing techniques
described herein to choose a trial protocol” (Hu, col. 6, ll. 29-30; FF 11). Hu
further teaches “to conduct interactive conferences between the trial monitor
and individual participating sites to review images, in order to assure quality
and compliance during the trial process” (Hu, col. 6, ll. 38-41; FF 12).
We agree with the Examiner that the person of ordinary skill and
ordinary creativity in the field of “multi-center trial management” (Hu, col.
6, l. 27) would have had reason to develop a standard protocol for analysis
of vascularity of tumors at a plurality of sites as taught by Hu for the reasons
stated by the Examiner (FF 9-13). We further agree with the Examiner that
“in order to assure quality and compliance during the trial process” (Hu, col.
6, ll. 39-41; FF 12), the person of ordinary skill and creativity would have
ensured that the scanners at each site were operating correctly and would
have applied the automated analysis methods of Degani and Uber (FF 4, 5,
8).
We are not persuaded by Appellant’s argument that “Hu is applied for
teaching a standard imaging protocol. However, the cited portion of the
reference actually teaches a standard trial protocol” (App. Br. 4). When Hu
teaches using a standard trial protocol, Hu expressly teaches “to conduct
interactive conferences between the trial monitor and individual
participating sites to review images, in order to assure quality and
compliance during the trial process” (Hu, col. 6, ll. 38-41; FF 12). The
ordinary artisan would have found it obvious to use a standard imaging
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protocol to satisfy the teaching of Hu regarding reviewing images to assure
quality and compliance.
We are not persuaded by Appellant’s argument that the
Hu patent refers specifically to a PACS system feature
allowing multiple groups to work collaboratively on the
image analysis of a single data set. In particular, the patent
revolves around the ability to maintain and update image
analysis state variables on multiple networked PACS
workstations simultaneously. That has nothing to do with the
present claimed invention, which involves developing a
standard imaging protocol for use at a plurality of sites

(App. Br. 5). Hu directly suggests using standard trial protocols, of which
imaging protocols would have been a subset, such as any of the protocols
described in Degani and/or Uber. Given Hu’s teaching to standardize trial
protocols, we agree with the Examiner that implementing a standard trial
protocol at a multiple sites reasonably suggests in order to be able to
compare the results coming out of the trial (Ans. 8).
Conclusion of Law
Appellant has not demonstrated that the Examiner erred in finding it
obvious to modify the method of Degani and Uber to develop “a standard
imaging protocol for use at a plurality of sites” based on the disclosure of
Hu.

B. 35 U.S.C. § 103(a) over Degani, Uber, Hu and Declerck
We are not persuaded by Appellant’s argument that Declerck “fails to
teach or suggest using at least one phantom to determine whether multiple
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scanners are functioning correctly in the context of providing reproducible
measurements at a plurality of sites” (App. Br. 6).
We agree with the Examiner that the ordinary person of skill in the
art, performing a multi-center trial as taught by Hu of vascularity as taught
by Degani and Uber, would have had reason to ensure that the scanners used
for measurement were properly calibrated and would have reasonably
applied the “phantom” method of Declerck to ensure accuracy of the
scanners (FF 14). Such a combination is merely a “predictable use of prior
art elements according to their established functions.” KSR, 550 U.S. at 417.
C. 35 U.S.C. § 103(a) over Degani, Uber, Hu and Bozdagi
We are not persuaded by Appellant’s argument that “[s]ince the issue
of registering partial image portions scanned from a scanner does not arise in
the other applied references, a person having ordinary skill in the art . . .
would have regarded the combination of Bozdagi et al with the other applied
references as pointless and therefore non-obvious” (App. Br. 6). However,
“[i]f a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability.” KSR. at 417. The use of the Bozdagi technique
to standardize and overlap images, suggested by Bozdagi for use in brain
tomographic studies (FF 15-16), would have been obvious to the ordinary
artisan in order to align the images disclosed by Hu (FF 10, 12). We agree
with the Examiner that “warp-based registration and semi-automated margin
identification were part of the method for the purpose of being able to align
different images of tumors from different clinical trials for the purpose of
comparison using accepted image comparison techniques” (Ans. 9).
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Degani, Uber and Hu. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2-6, 10-12,
and 14-18 as these claims were not argued separately.
We affirm the rejection of claims 7-9 under 35 U.S.C. § 103(a) as
obvious over Degani, Uber, Hu, and Declerck.
We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as
obvious over Degani, Uber, Hu, Chaney, and Bozdagi.
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)(2006).
AFFIRMED

lp

STEPHEN B. SALAI, ESQ.
HARTER SECREST & EMERY LLP
1600 BAUSCH & LOMB PLACE
ROCHESTER NY 14604-2711