Ex Parte Haider

Patent Trial and Appeal Board

Sep 1, 2016

11486680 (P.T.A.B. Sep. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111486,680 07/14/2006
26574 7590 09/06/2016
SCHIFF HARDIN, LLP
PA TENT DEPARTMENT
233 S. Wacker Drive-Suite 6600
CHICAGO, IL 60606-6473
FIRST NAMED INVENTOR
Sultan Haider
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.
P06,0225 4252
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
09/06/2016 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-CH@schiffhardin.com
jbombien@schifthardin.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SULT AN HAIDER
Appeal2014-008863
Application 11/486,680
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
r-T"I.. • • .. • • .. 1 .. ,..... ,_ T T r'1 I'\ l\ -1 ,..... Al r'" , "1 ims 1s a aec1s10n on appear unaer j) u.~.L. s lj4 rrom me
Examiner's rejection of claims 1--4 and 6-26. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses a method and apparatus for "representing
an examination region of an examination subject, to whom an agent has been
administered .... wherein, a time-related determination of ... the
intracorporeal influence of the agent in the examination region is made and
1 Appellant identifies the Real Party in Interest as Siemens
Aktiengesellschaft. App. Br. 1.
Appeal2014-008863
Application 11/486,680
the information is mapped to the examination region in [a] whole-body
overview image." Spec. 2-3. "[T]he whole-body overview image can be
generated by an imaging medical examination apparatus and/ or at least one
camera and/or an anatomical atlas and/or a computer program." Spec. 5.
Suitable imaging medical examination apparatuses for generating the whole-
body overview include "[a] magnetic resonance apparatus, a computed
tomography apparatus, a conventional x-ray apparatus or even an ultrasound
apparatus, a positron emission tomography (PET) apparatus and the like."
Id.
Claim 1 is representative of the claims on appeal and reads as follows:
1. A method for representation of a plurality of
examination regions of an examination subject, together with
information relating to an intracorporeal influence in the
respective regions of at least one agent administered to the
examination subject, said information being retained for a
subsequent evaluation, comprising the steps of:
generating a whole-body overview image of an examination
subject depicting internal anatomy of the subject, said overview image
encompassing a plurality of examination regions of the internal
anatomy of the subject that respectively contain different parts of said
internal anatomy of the subject;
with at least one medical imaging apparatus, acquiring a
respective dataset from each of said examination regions of the
examination subject, each data representing the part of said internal
anatomy in the respective examination region from which the data
was acquired, and automatically electronically mapping, using the
respective datasets, the examination regions on the whole-body
overview image;
determining time-dependent information describing a change
over time, within a time period, of an intracorporeal influence of an
agent in each examination region, that has been administered to the
examination subject, and, for each examination region, generating a
respective graphical representation of a changing spatial extent of said
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Application 11/486,680
agent in the respective examination region from said time-dependent
information describing changing of said intracorporeal spatially-
extending influence of said agent in the respective examination region
in said time period, and automatically electronically mapping the
respective graphical representations to the respective examination
regions in the whole-body overview image to show the changing
spatial extent of said agent relative to the internal anatomy of the
subject in said overview image that is contained in all of said
examination regions, thereby obtaining a supplemented whole-body
overview image; and
visually representing the supplemented whole-body overview
image at an image reproduction device.
The Examiner has rejected claims 1, 3, 6-12, 20-22, and 23-26 under
35 U.S.C. § 103(a) as obvious in view of Sjogren,2 Dumoulin,3 and Degani.4
Ans. 2, Final Rejection5 (hereinafter Fin. Rej.) 2-7. The Examiner has also
rejected claims 2, 4, and 13-19 under 35 U.S.C. § 103(a) as obvious in view
of Sjogren, Dumoulin, and Degani, and further in view of Harvey6 (claims 2,
4, and 13-16), Eisenberg7 (claim 17), or Tong8 (claims 18 and 19). Ans. 2,
Fin. Rej. 7-11.
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1--4 and 6-26 as obvious over the cited art. App. Br. 5-14,
2 Bo Sjogren et al., US 2004/0002641 Al, published Jan. 1, 2004.
3 Charles Lucian Dumoulin et al., US 6,584,337 B2, issued Jun. 24, 2003.
4 Hadassa Degani et al., US 2003/0105605 Al, issued Jun. 5, 2003.
5 Office Action mailed Nov. 5, 2013.
6 Paul Royston Harvey, US 2007/0276220 Al, published Nov. 29, 2007.
7 Harvey C. Eisenberg et al., US 2003/0128801 Al, published July 10, 2003.
8 Xin Tong et al., US 2004/0179651 Al, published Sept. 16, 2004.
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Application 11/486,680
Reply Br. 2--4. Because the same issues are dispositive for all rejections on
appeal we will consider them together. We disagree with Appellant's
contentions and adopt the Examiner's conclusions and findings concerning
the scope and content of the prior art set forth in the Examiner's Answer and
Final Rejection. For emphasis, we highlight and address the following:
FFI Sjogren discloses that "[d]iagnostic machines or imaging
machines are used to obtain anatomical information of a patient, including
localization of tumors." Sjogren, i-f 37. The imaging techniques include
"computed tomography (CT) ... and other diagnostic X-ray techniques,
positron emission computed tomography (PET), single photon emission
computed tomography (SPECT), combined PET and CT (PET /CT),
ultrasound, magnetic resonance (MR) techniques, e.g. magnetic resonance
imaging (MRI) and magnetic resonance spectroscopy (MRS)," among
others. Sjogren, i-f 37.
FF2 Sjogren discloses that the concept of the invention "is to
determine, in connection with each of a number of medical machines,
including diagnostic and radiation therapy machines, a 2- or 3-dimensional
representation of at least a portion of a patient in relation to an overall
common coordinate system associated with the patient." Sjogren, i-f 39. In
particular, "[A ]natomical patient information may be related between the
different medical machines ... [based on] the 2- or 3-dimensional
representations [] used as common reference between the machines ....
[This] make[s] it possible to integrate and depict anatomical information
obtained with different imaging techniques into the common coordinate
system." Id.; see Abstract. Thus "anatomical information ... from the
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Application 11/486,680
different diagnostic machines is coordinated and integrated, e.g. in order to
be displayed together in a common picture." Id. i-f 84.
FF3 Sjogren discloses that, in one embodiment, "the 2- or 3-
dimensional representation is a surface representation of the patient, e.g. a
surface representation of the skin of the patient." Id. i-f 55. "[T]o get a more
accurate representation ... the whole body surface or a suitable selected
portion thereof is measured to provide the 3-dimensional representation,
where a larger surface often implies a more accurate representation." Id.
FF4 Sjogren also recommends "a 2- or 3-dimensional representation
of at least a portion of the patient's skeleton," as an alternative to using a
surface representation of the patient. Id. i-f 56. "As for the surface
representations ... , "the skeleton representation may be measured on any
suitable portion of the patient's body," including "skeleton portions adjacent
to the tumor tissue." Id. "If a more complete representation is preferred the
representation may include the whole or a major portion of the patient's
skeleton." Id.
FF5 Figure 5 of Sjogren is shown below:
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Application 11/486,680
Figure 5 shows "a schematic block diagram of a system for relating
anatomical patient information between different medical machines."
Sjogren, i-f 33. "Measured imaging data 210 from a 2- or 3-dimensional
representation measuring system associated with a first medical machine is
input to a processing means 110 in the system 100." Sjogren, i-f 72. "The
processing means determines the 2- or 3-dimensional patient representation
expressed in the common overall coordinate system." Id. "A corresponding
processing means 120 receives diagnostic data 220 and processes it to
generate anatomical data of the tumor and relevant tissues and organs." Id.
The "anatomical data is forwarded together with the 2- or 3-dimensional
representation recorded in connection with the diagnostic data in the first
medical machine to matching means 130 that matches the representation
wit[h] the anatomical data." Id.
FF6 Sjogren discloses that, as a "complement to the anatomical data
from diagnostic machines, anatomical information from a body or organ
atlas may optionally be used in the treatment planning. This atlas is a
database or data bank comprising anatomical information of the human body
or a portion of it." Id. i-f 89. "[T]he atlas is typically a representation of an
average human, preferably containing all major organs and tissues, skeleton
and nervous system." Id. "In order to integrate anatomical data relating to
an individual patient, measured by a diagnostic machine ... with
information from the atlas, the associated 2- or 3-dimensional representation
of the patient is matched with a corresponding representation in the 'atlas
human'." Id. "In some cases, since the atlas is an average human, the atlas
has to be deformed or conformed to correspond to the actual representation
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of the patient ... Once the scale of the atlas corresponds to the scale of the
measured 2- or 3-dimensional representation, the two are merged or tied so
that certain points on the patient representation coincides with corresponding
points on the atlas." Id. "The measured anatomical information with the
tumor may now be displayed together with the organs, tissues and bones of
the atlas." Id.
FF7 Figures 7a-7d of Sjogren are shown below:
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Sjogren discloses that Figures 7 A-7D "illustrate the process of integrating
and coordinating anatomical information." Sjogren, i-f 35. Figure 7 A shows
"a schematic illustration of anatomical information 54, 55 from a first
diagnostic machine displayed in the common coordinate system together
with an associated 3-dimensional surface representation 60-1." Id.
,-r 84. Figure 7B shows "anatomical information 55, 56 from a second
diagnostic machine with an associated surface representation 60-2."
Sjogren, ,-r 85. Figure 7C shows "a simple rescale" of the image of Figure
7 A. Id. ,-r 86. "Once the patient representations 60-1, 60-2 have been
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Application 11/486,680
matched ... the corresponding anatomical information 54, 55, 56 may be
integrated and displayed together in the common overall coordinate system,"
as shown in Figure 7D. Id. i-f 87. "[A]natomical information 54, 56
obtainable only from specific diagnostic machines may be combined to give
... more detailed and comprehensive information of the tumor with adjacent
tissues and organs." Id.
FF8 Dumoulin discloses an "MRI system that may be employed as a
whole body screening tool for metastatic cancer and other diseases."
Dumoulin, col. 7, 11. 26-28. Dumoulin discloses that certain "clinical
situations require ... a head-to-toe scan of a patient ... For example,
metastatic cancer can occur anywhere in the body and patients at risk for
metastatic disease need to be evaluated regularly." Id. col. 1, 11. 11-14.
"Currently head-to-toe or ... extended volume imaging is generally
performed with whole body positron emission tomography (PET) systems or
nuclear studies in which small amounts of radioactive substances are given
to the patient and allowed to collect in regions of rapid tumor growth."
Dumoulin, col. 1, 11. 14--19. "The imaging sensitivity and specificity of
magnetic resonance (MR), however, makes MR a more desirable choice for
diagnosis[,] particularly when Gadolinium (Gd) contrast agents are
employed." Id. at col. 1, 11. 19-23. "Gd contrast agents ... tend to collect in
regions of angiogenesis associated with active tumors. Unfortunately, MR
scanners have limited sensitive volumes and whole body scanning requires
that a series of images be made at different stations." Id. at col. 1, 11. 23-28.
"Patient motion and table registration can make the joining of these separate
images a challenge." Id. at col. 1, 11. 28-31.
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Application 11/486,680
FF9 Dumoulin discloses that multiple "MR sub-images of portions
of the subject are made while the subject is moved through the imaging
portion of the MR imaging magnet." Id. at col. 4, 11. 52-54. "At the
completion of subject's 200 movement through magnet assembly 141 (FIG.
1) the sub-images are processed by image processor 106 (FIG. 1) and
combined to form a composite image of the entire subject." Id. at col. 4, 11.
63-67.
FF 10 Degani discloses "a unique MRI machine for diagnosing a
condition of a prostate, especially cancer" and "an apparatus for monitoring
a system with time in space .... [that] can be used for processing time
dependent data of radiologic examinations such as MRI, ultrasonography, X-
ray tomography or conventional X-ray, or nuclear medicine for obtaining
diagnosis, prognosis and therapy follow up of tumors or any other
pathological disorders." Degani, i-fi-12, 19
FF 11 Degani discloses that "MRI machines are used today to create
images with or without administration of a tracer-contrast agent.
Customarily, the machine is controlled to take a series of images at discrete
time intervals and the images are then dynamically analyzed to obtain an
output result." Id. i13. "[D]ynamic studies of contrast enhancement in
breast tumors have demonstrated that the rate of change in signal intensity is
an important parameter for the distinction of breast masses." Id. " [A] s a
result of tumor heterogeneity, there are significant local variations in the
time evolution of contrast enhancement, and, therefore, maintaining high
spatial resolution in both the recording and analysis steps is very important."
Id. "In a standard clinical MRI of the breast, it is difficult to achieve high
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Application 11/486,680
spatial resolution and also maintain high temporal resolution." Id. "In most
dynamic studies performed previously, the emphasis was on high temporal
resolution (at the expense of spatial resolution) monitoring the equilibration
in the intravascular space and early diffusion into the extracellular space of
the tissue." Id.
FF12 Degani discloses that there are "numerous phenomena that
evolve over space with time in a way that can be treated ... by utilizing a
novel approach which is termed ... wash-in and wash-out behavior." Id.
i-f 20. "Specifically, flow of fluid in a system where the fluid or fluid
component dissipates or needs to be regenerated, is described as wash-in and
wash-out." Id.
FF13 Degani discloses the application of wash-in and wash-out "for
contrast-enhanced MRI data in order to obtain products that facilitate
specific diagnosis of cancer. The time of start of contrast administration is
time point tO and then two post contrast time points t 1 and t2 are utilized."
Id. i-f 23. Degani discloses that this method, designated "3TP," "can be
adapted to the diagnosis of a prostate condition." Id. i-f 24. Degani teaches
that "[b ]lood vessel density in prostate cancer is an independent indicator of
pathological state and prognosis. With the addition of [monitoring] vessel
permeability by the 3TP method, which reflects high angiogenic activity,
this parameter may be even more reliable as a prognostic factor." Id. i-f 25.
"The color distribution in the 3TP images also enables characterizing tumor
cellularity (the density of the cells in the tumor) and hence the differentiation
of the lesion with high cellularity." Id.
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We agree with the Examiner's reasoning that it would have been
obvious
to have modified the methods and systems for relating and
integrating anatomical patient information obtained by different
medical machines as described by Sjogren, particularly the
image dataset acquired by at least one of the diagnostic machines
to be registered to the whole body overview image, to include a
respective image dataset for each examination region (e.g. whole
body) which visually represents the changing spatial extent of a
contrast agent within the body as described by Dumoulin and
Degani in order to efficiently and accurately screen a subject for
diseases such as cancer and plan treatment accordingly.
Fin. Rej. 6.
Appellant argues that Sjogren does not disclose the claimed "whole-
body overview image" or "the use of an overview image for the purpose of
identifying respective regions thereof." App. Br. 5---6. Appellant further
argues that Sjogren provides "no teaching or suggestion ... to make use of
the skeletal image in the manner that the whole body image is used in the
claims of the present application ... other than (possibly) as one of the
images that is set into relation with the common coordinate system." Id. at
6-7.
Appellant's arguments are not persuasive. Sjogren discloses that that
the whole body surface of the patient may be measured to provide an
accurate three-dimensional representation of the patient. FF FF3. Sjogren
also teaches that other three-dimensional representations of the patient can
be used, such as "the whole or major portion of a patient's skeleton,"
emphasizing, in particular, "skeletal portions adjacent to the tumor tissue."
FF FF4. Sjogren further discloses that, as a complement to the anatomical
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data from diagnostic machines, anatomical information from a body atlas or
images provided by diagnostic machines may be integrated with the 2- or 3-
dimensional representation of a patient. FF 5, FF6. Dumoulin, likewise,
discloses the desirability of generating whole body images, such as for the
purpose of screening for metastatic cancer. FF 9-11. Accordingly, we agree
with the Examiner the combination of the cited references would have made
obvious the use of a whole body overview image in diagnostic or treatment
purposes.
Appellant argues that the Examiner acknowledged that Sjogren does
not disclose "mapping a respective data set for each examination region,
such that the aforementioned whole body image is completely mapped with
additional image data." App. Br. 6.
Appellant's argument is not persuasive. Claim 1 does not require that
the whole-body overview is completely mapped with additional image data,
but only requires that the "whole body overview image comprises a plurality
of examination regions of the internal anatomy of the subject" and that a
medical imaging apparatus acquires "a respective dataset from each of said
examination regions of the examination subject ... , and automatically
electronically mapping ... the examination regions on the whole-body
overview image."
Dumoulin discloses head-to-toe scans of a patient to screen for
metatstatic cancer and discloses that, with PET scans and radioactive
substances, radioactive substances collect in regions of rapid tumor growth.
FF 8-9. Dumoulin also discloses that with, magnetic resonance (MR) and
Gadolinium (Gd), the Gd contrast agents "tend to collect in regions of
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angiogenesis associated with active tumors." FF 8. Sjogren discloses that
anatomical information from specific diagnostic machines may be combined
to a give more detailed information on areas of interest in the context of
adjacent tissues and organs. FF7. In view of Dumoulin and Sjogren, it
would have been obvious to one of skill in the art to incorporate more than
one region of interest from e.g., a PET scan or an MRI scan into the whole-
body overview image disclosed in Sjogren so that multiple areas of interest
could be analyzed simultaneously.
Appellant argues that the combination of Sjogren, Dumoulin, and
Degani would not have made obvious a method of mapping "graphical
representations of a changing spatial extent of an agent in a respective
examination region in an overview image ... in order to obtain a
supplemented whole-body overview image." App. Br. 9. Appellant argues
that, as acknowledged by the Examiner, Sjogren does not disclose the
graphical representation of time-dependent information related to the
incorporeal influence of an agent." Id. at 6.
Appellant argues further that although Dumoulin discloses that
radioactive substances and gadolinium contrast agent will collect in regions
of rapid tumor growth, imaging of these agents merely generates "a
'snapshot' of the region ... at a particular point in time." Id. at 7. Appellant
further argues that although the Examiner relied on Degani as teaching
"diagnostic imaging for detecting cancer wherein a series of images at
discreet [sic] time intervals is obtained, and the images ... analyzed by
assessing the rate of change in signal intensity," "[s]imply having
knowledge that images can be analyzed in the manner described in the
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Degani et al. reference ... does not 'complete' the teachings that are absent"
from the combination of Sjogren and Dumoulin. Id. at 8.
Appellant's argument is not persuasive. Under KS1?, a "combination
of familiar elernents according to known rnethods is likely to be obvious
when it does no rnore than yield predictable results." K5'R Int 'l Co. v.
Tele.flex Inc., 550 U.S. 398, 416 (2007). Both Sjogren and Dumoulin
disclose methods directed to imaging accurately tumors or suspected sites of
metastases. That is, Sjogren discloses that diagnostic images may be
combined in order to provide more accurate information on tumor location.
FF FF1-FF7.
Dumoulin discloses methods of screening for cancer metastases using
PET or MRI whole body scans that identify agent accumulation at tumor
sites. FF 9, 10. Degani discloses that dynamic studies of contrast
enhancement in breast tumors have demonstrated that the rate of change of
in signal intensity is useful for distinguishing breast masses. FF 10-13.
Degani also discloses that time-dependent contrast-enhanced MRI studies
are useful in diagnosing cancer, including tumor cell density. FF 10, 13.
Because Degani discloses that "determining time-dependent information ...
of an intracorporeal influence of an agent," as recited in claim 1, is useful for
imaging and diagnosing cancer, we agree with the Examiner that it would
have been obvious for one of ordinary skill in the art to incorporate this
feature in the method of Sjogren and Dumoulin in order to optimize a
method for imaging and diagnosis of cancer.
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Thus, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a).
Claims 3, 6-12, 20-22, and 23-26 have not been argued separately and,
therefore, fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner has also rejected claims 2, 4, and 13-19 under
35 U.S.C. § 103(a) as obvious in view of Sjogren, Dumoulin, and Degani,
and further in view of one of Harvey (claims 2, 4, and 13-16), Eisenberg
(claim 17), or Tong (claims 18 and 19). Ans. 2, Fin. Rej. 7-11. Appellant
does not provide arguments directed toward Harvey, Eisenberg, or Tong, but
argues that these references do not cure the deficiencies of the combination
of Sjogren, Dumoulin, and Degani, as discussed above (App. Br. 13-14).
Thus, we also affirm the rejection of claims 2, 4, and 13-19 under 35 U.S.C.
§ 103(a).
Conclusion of Law
A preponderance of the evidence supports the Examiner's conclusion
that the combination of Sjogren, Dumoulin, and Degani would have made
obvious the claim 1 "method for representation of a plurality of examination
regions of an examination subject, together with information relating to an
intracorporeal influence in the respective regions of at least one agent
administered to the examination subject."
SUMMARY
We affirm the rejection of claims 1--4 and 6-26 under 35 U.S.C.
§ 103(a).
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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