Ex Parte Boone et al

Patent Trials and Appeals Board

Jun 4, 2019

11913494 - (D) (P.T.A.B. Jun. 4, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/913,494 11/02/2007
20350 7590 06/06/2019
KILPATRICK TOWNSEND & STOCKTONLLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
John M. Boone
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.
081906-191910US-0755171 5573
EXAMINER
IP,JASONM
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
06/06/2019 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):
ipefiling@kilpatricktownsend.com
KTSDocketing2@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN M. BOONE and THOMAS R. NELSON 1
Appeal2018-005458
Application 11/913,494
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
and apparatus for generating a simulated mammogram based on x-ray
computed tomography data, which have been rejected as obvious and
lacking adequate written description. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
1 Appellants identify the Real Parties in Interest as Regents of the University
of California, Isotropic Imaging Corporation and Izotropic Corporation.
Appeal Br. 3.
Appeal2018-005458
Application 11/913,494
STATEMENT OF THE CASE
"X-ray computed tomography (CT) allows the internal structure of
tissue to be clearly imaged without the need to flatten or otherwise distort
the tissue as is done in mammography." Spec. ,r 9. "One drawback to ...
breast CT machines, in instances where a suspicious lesion is found and a
biopsy is required, is that compression of the breast in a standard
mammography fixture and possibly re-imaging of the breast may be required
to provide the necessary guidance for the biopsy procedure." Id. ,r 10.
The Specification states that, "in one aspect of the invention, a
simulated mammogram is created from CT data by employing an algorithm
for compressing the volume data of the breast and projecting it into a two-
dimensional image." Id. ,r 16.
Claims 1-5, 7, 8, 40-53, and 56-63 are on appeal. Claims 1 and 49
are the independent claims and read as follows (emphasis added):
1. A method for breast imaging, comprising the steps of:
generating, based on data produced by an x-ray computed tomography
(CT) scanner, a three-dimensional volume data set of at least a portion of a
breast, wherein a voxel in the three-dimensional volume data set is generated
based on x-ray attenuation of a plurality of breast tissue types corresponding
to the voxel;
generating a model of the breast using voxels of the three-dimensional
volume data set by assigning biomechanical properties to the plurality of
breast tissue types in each voxel of the three-dimensional volume data set;
generating a compressed volume data set by applying a compression
algorithm to the three-dimensional volume data set in a first direction to
simulate compression of the breast in the first direction; and
generating a simulated radiographic compression mammogram
projection image corresponding to the three-dimensional volume data set of
at least the portion of the breast using cone beam projection on the
compressed volume data set, wherein the simulated radiographic
compression mammogram projection image is two dimensional
2
Appeal2018-005458
Application 11/913,494
mammographic image of the compressed volume data set produced by the
compression algorithm based on the biomechanical properties of the
plurality of breast tissue types from the three dimensional volume data set
produced by the x-ray CT scanner, wherein the value of a pixel of the
simulated radiographic compression mammogram projection image is the
result of a summation along a projection path of a ray of the cone beam
projection passing through the voxels of the compressed volume data set,
wherein at least one value is associated with each voxel of the compressed
volume data set, the generating further including:
transforming contrast property of at least one voxel of the three-
dimensional volume data set of at least the portion of the breast to simulate
contrast properties of actual radiographic compression mammogram
projection images, wherein the contrast property of the at least one voxel is
transformed by using linear attenuation coefficients based on composition of
the at least one voxel in the three-dimensional volume data set.
49. An apparatus for generating imaging of a breast comprising:
a table supporting a patient in a prone position with the breast;
an x-ray computed tomography (CT) scanner comprising an x-ray
source and detector positioned to acquire a CT projection set about a
horizontal axis around the breast; and
a positron emission tomography (PET) detector positioned to acquire
PET data of the breast, and
a computer receiving data from the x-ray computed tomography (CT)
scanner and the PET detector programmed to:
generate, based on data produced by the x-ray computed
tomography (CT) scanner and the PET data acquired by the PET
detector, a three-dimensional volume data set of at least a portion of a
breast, wherein a voxel in the three-dimensional volume data set is
generated based on x-ray attenuation of a plurality of breast tissue
types corresponding to the voxel;
generate a model of the breast using voxels of the three-
dimensional volume data set by assigning biomechanical properties to
the plurality of breast tissue types in each voxel of the three-
dimensional volume data set;
3
Appeal2018-005458
Application 11/913,494
generate a compressed volume data set by applying a
compression algorithm to the three-dimensional volume data set in a
first direction to simulate compression of the breast in the first
direction; and
generate a simulated radiographic compression mammogram
projection image corresponding to the three-dimensional volume data
set of at least the portion of the breast using cone beam projection on
the compressed volume data set, wherein the simulated radiographic
compression mammogram projection image is two dimensional
mammographic image of the compressed volume data set produced by
the compression algorithm based on the biomechanical properties of
the plurality of breast tissue types from the three dimensional volume
data set produced by the x-ray CT scanner and the PET detector,
wherein the value of a pixel of the simulated radiographic
compression mammogram projection image is the result of a
summation along a projection path of a ray of the cone beam
projection passing through the voxels of the compressed volume data
set, wherein at least one value is associated with each voxel of the
compressed volume data set, the generating further including:
transforming contrast property of at least one voxel of the
three-dimensional volume data set of at least the portion of the
breast to simulate contrast properties of actual radiographic
compression mammogram projection images, wherein the
contrast property of the at least one voxel is transformed by
using linear attenuation coefficients based on composition of
the at least one voxel in the three-dimensional volume data set.
The claims stand rejected as follows:
Claims 1-5, 7, 8, 40-53, and 56-63 under 35 U.S.C. § 112, first
paragraph, for lack of adequate written description (Ans. 2);
4
Appeal2018-005458
Application 11/913,494
Claims 1-3 and 46 under 35 U.S.C. § I03(a) as obvious based on
Yin,2 Bakic, 3 and Tomai4 (Ans. 3--4);
Claims 4 and 42--44 under 35 U.S.C. § I03(a) as obvious based on
Yin, Bakic, Tomai, and Tanner5 (Ans. 7);
Claims 5, 40, and 41 under 35 U.S.C. § I03(a) as obvious based on
Yin, Bakic, Tomai, Tanner, and Berger6 (Ans. 8);
Claims 7 and 8 under 35 U.S.C. § I03(a) as obvious based on Yin,
Bakic, Tomai, and Amon7 (Ans. 8);
Claim 45 under 35 U.S.C. § I03(a) as obvious based on Yin, Bakic,
Tomai, Ning, 8 Beyer,9 and Bar-Shalom 1° (Ans. 9);
2 Yin et al., "ImageParser: a tool for finite element generation from three-
dimensional medical images," 3 (31) Bio Medical Engineering OnLine 1-9
(2004).
3 Bakic et al., "Mammogram synthesis using a 3D simulation. I. Breast
tissue model and image acquisition simulation," 29 Medical Physics. 2131-
2139 (2002).
4 Tomai et al., US 2002/0143249 Al, published October 3, 2002.
5 C. Tanner et al., "A Method for the Comparison of Biomechanical Breast
Models," IEEE Workshop 11-18 (2001). A copy of Tanner was made of
record on Dec. 4, 2014.
6 Berger et al., US 5,912,720, issued June 15, 1999.
7 Amon, US 7,292,719 B2, issued November 6, 2007.
8 Ning, US 6,480,565 Bl, issued November 12, 2002.
9 T. Beyer et al., "Acquisition Protocol Considerations for Combined
PET/CT Imaging," 45 Journal of Nuclear Medicine 25S-35S (2004).
10 R. Bar-Shalom et al., "Clinical Performance of PET/CT in Evaluation of
Cancer: Additional Value Diagnostic Imaging and Patient Management,"
44(8) Journal of Nuclear Medicine 1200-1209 (2003).
5
Appeal2018-005458
Application 11/913,494
Claim 63 11 under 35 U.S.C. § 103(a) as obvious based on Yin, Bakic,
Tomai, and Toth 12 (Ans. 10);
Claim 48 under 35 U.S.C. § I03(a) as obvious based on Yin, Bakic,
Tomai, and Heuscher13 (Ans. 11 );
Claims 49-53 and 56-61 14 under 35 U.S.C. § I03(a) as obvious based
on Yin, Bakic, Tomai, and Kennedy 15 (Ans. 11);
Claim 62 under 35 U.S.C. § I03(a) as obvious based on Yin, Bakic,
Tomai, Kennedy, and Heuscher (Ans. 15-16); and
Claim 63 under 35 U.S.C. § I03(a) as obvious based on Yin, Bakic,
Tomai, Kennedy, and Toth (Ans. 16).
I
The Examiner has rejected all of the claims on appeal on the basis that
certain limitations of the independent claims are not adequately described in
the Specification. Ans. 2-3. With respect to both claim 1 and claim 49, the
Examiner finds that "[t]he compression algorithm, which has been admitted
to be a proprietary algorithm, is not described in a reasonable way." Id. at 2,
3.
11 The statement of the rejection refers to claim 48 but the body of the
rejection addresses claim 63. Ans. 10. We understand the rejection to apply
to claim 63.
12 Toth et al., US 6,310,938 Bl, issued October 30, 2001.
13 Heuscher et al., US 2003/0007593 Al, published January 9, 2003.
14 The statement of the rejection includes claims 49-61 but the body of the
rejection only addresses claims 49-53 and 56-61. Ans. 11-15. Claims 54
and 55 were cancelled. Advisory Action mailed Aug. 16, 2017.
15 Kennedy, US 7,205,546 B 1, issued April 17, 2007.
6
Appeal2018-005458
Application 11/913,494
Appellants argue that the compression algorithm is described in
Figure 7 and paragraphs 40 and 85-93 of the Specification. Appeal Br. 9, 12.
See also Reply Brief 2-3:
[S]tep 6 of FIG. 7 refers to "finite element compression
algorithm" and is an element of Appellants' claimed
compression algorithm, which includes all 10 steps illustrated on
FIG. 7. One of ordinary skill in the art will be familiar with the
finite element compression algorithm without requiring further
description. In contrast, the overall steps of the claimed
compression algorithm are illustrated in FIG. 7 and described in
detail at paragraphs [0085] - [0093] of Appellants' specification.
The examiner
"bears the initial burden ... of presenting a prima facie case of
unpatentability." In re Oetiker, 977 F.2d 1443, 1445, 24
USPQ2d 1443, 1444 (Fed. Cir. 1992). Insofar as the written
description requirement is concerned, that burden is discharged
by "presenting evidence or reasons why persons skilled in the
art would not recognize in the disclosure a description of the
invention defined by the claims."
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
If "the specification contains a description of the claimed invention,
albeit not in ipsis verbis (in the identical words), then the examiner ... , in
order to meet the burden of proof, must provide reasons why one of ordinary
skill in the art would not consider the description sufficient." Id.
We conclude that the Examiner has not adequately explained why a
person of ordinary skill in the art would not recognize that Appellants were
in possession of the recited compression algorithm at the time the
application was filed. As Appellants point out, the Specification describes all
of the steps of the algorithm (Appeal Br. 9, 12), including the step in which
"a model of the breast is constructed, for example using finite element
7
Appeal2018-005458
Application 11/913,494
techniques." Spec. ,r 86. Appellants have argued that those skilled in the art
would be familiar with the finite element compression algorithm (Reply
Br. 2). The Examiner has not provided any basis for doubting Appellants'
position. See Ans. 18. We therefore reverse the rejection of claim 1, and this
basis for the rejection of claim 49, under 35 U.S.C. § 112, first paragraph.
With respect to claim 49, the Examiner finds that the claim recites
"[t]he acquisition and use of PET data in generating a model, but the
Specification fails to describe how this is done." Ans. 3.
Appellants argue that "i-f [O 167] of the publication of the present
application explains how PET data is used in generating a model." Appeal
Br. 12. "Appellants submit[] that the foregoing section of the specification
reasonably conveys to one skilled in the relevant art that the inventor( s ), at
the time the application was filed, had possession of the claimed invention."
Id.
The Examiner responds that "paragraph [0167] only speaks of
overlaying PET data onto CT images. There are no details on how PET data
is used in the actual creation of the model using image data." Ans. 20. The
Examiner does not, however, challenge Appellants' position that the
Specification's description would have conveyed, to those of skill in the art,
that Appellants were in possession of the disputed limitation at the time of
filing, or explain why the claim language requires anything more than
overlaying PET data onto a model made based on CT data. We therefore
reverse this basis for the rejection of claim 49.
Also with respect to claim 49, the Examiner finds that "[t]he exact
procedure for generating a model of the breast using voxel data from the CT
8
Appeal2018-005458
Application 11/913,494
is not described in a reasonable way." Ans. 3. Finally, with respect to claim
49, the Examiner finds that "[t]he process of simulating the compression by
way of summing along a projection path of a cone beam projection, is
merely stated, but not described in a reasonable way." Id.
Appellants argue that "i-f [0086] of the publication of the present
application describes in detail the model of the breast. Appellants submits
that the foregoing sections of the specification reasonably conveys to one
skilled in the relevant art that the inventor( s ), at the time the application was
filed, had possession of the claimed invention." Appeal Br. 12. Appellants
also argue that "i-f [0088] of the publication of the present application
describes in detail the summing along a projection path of a cone beam
projection." Id. at 13. Appellants argue that "the foregoing section of the
specification reasonably conveys to one skilled in the relevant art that the
inventor( s ), at the time the application was filed, had possession of the
claimed invention." Id.
The Examiner does not respond to Appellants' arguments on either of
these points. See Ans. 18-20. Thus, the Examiner does not challenge
Appellants' position that the Specification's description would have
conveyed, to those of skill in the art, that Appellants were in possession of
the disputed limitations at the time of filing. We therefore reverse these
bases for the rejection of claim 49.
In summary, we reverse the rejection of claims 1-5, 7, 8, 40-53, and
56-63 under 35 U.S.C. § 112, first paragraph, for lack of adequate written
description.
9
Appeal2018-005458
Application 11/913,494
II
The Examiner has rejected claims 1-5, 7, 8, 40-46, 48-53, and 56-63
as obvious based on Yin, Bakic, and Tomai, by themselves or combined
with other references. The same issue is dispositive for all of the rejections.
The Examiner finds that Yin and Bakic teach certain limitations of
claim 1. Ans. 4--5. The Examiner finds that "[n]either Yin et al nor Bakic
explicitly disclose[ s] the use of a cone beam projection. However, Tomai et
al teach the use of a cone beam x-ray system ([0061])." Id. at 5. The
Examiner concludes that "it would have been obvious to one of ordinary
skill in the art to apply the cone beam system of Tomai et al to the system of
Yin et al and Bakic, as to provide a well-known projection scheme." Id.
Appellants argue, among other things, that "in the claimed invention,
the cone beam projection is used on the compressed volume data set, as
opposed to the actual breast. The claimed invention considers a ray of the
cone beam projection passing through the voxels of the compressed volume
data set, as opposed to the ray passing through the patient's breast." Appeal
Br. 17. Appellants argue that
Id.
the section of Tomai clearly recites that "in order to
accommodate the short focal length cone-beam x-ray system, as
well as help avoid physical interference with the torso, the PET
detectors may have different or variable RORs at different
projection viewing angles." See Tomai, ,r [0061]. Accordingly,
in Tomai, the cone beam x-ray system is used on the patient,
the rays passing through the patient's torso.
We agree with Appellants that the section of Tomai that the Examiner
cites as meeting the "cone beam projection" limitation of claim 1 discloses a
"cone-beam x-ray system" that is used on a patient, not on voxels of a
10
Appeal2018-005458
Application 11/913,494
compressed volume data set, as required by claim 1. Tomai states that its
Figures 12A and 13A show a gantry system that includes SPECT and PET
emission and x-ray transmission imaging systems. Tomai ,r 61. As relevant
to the rejection, Tomai states that "[t]he 'X' within the breast 414 designates
the axis-of-rotation; note that the central ray of the x-ray CT system 312,313
does not intersect the AOR [axis-of-rotation]." Id. Tomai also states that the
PET detectors are designed to accommodate the cone beam x-ray system and
to avoid physical interference with the torso of a patient. Id. Thus, Tomai's
cone beam x-ray system is used on a patient, not on voxels of a compressed
volume data set.
The Examiner responds that "Tomai's cone-beam configuration
would be easily simulated by one possessing ordinary skill in the art on a
model." Ans. 21. The Examiner cites no evidence to support this position but
even assuming that a skilled artisan could simulate Tomai's cone-beam x-
ray configuration on the voxels of a compressed volume data set, the
Examiner has not presented any reason why a skilled artisan would find it
obvious to do so.
"[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007)
(quoting In re Kahn, 441 F.3d 977,988 (Fed. Cir. 2006)).
Here, the Examiner has not articulated any reasoning with rational
underpinning to support a conclusion that the cited references would have
made obvious at least the "cone beam projection" limitation of claim 1. We
11
Appeal2018-005458
Application 11/913,494
therefore reverse the rejection of claim 1 under 35 U.S.C. § 103(a) based on
Yin, Bakic, and Tomai. The rejection of claim 49 under 35 U.S.C. § 103(a)
based on Yin, Bakic, Tomai, and Kennedy relies on the same disclosure in
Tomai with respect to the cone beam projection limitation. Ans. 11-13. We
therefore reverse the§ 103(a) rejection of claim 49 for the reason discussed
above. Claims 2-5, 7, 8, 40-46, 48, 50-53, and 56-63 depend from either
claim 1 or claim 49; the§ 103(a) rejections of these claims is therefore
reversed as well.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
12