Ex Parte Sullivan

Patent Trial and Appeal Board

Oct 31, 2012

11734048 (P.T.A.B. Oct. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/734,048 04/11/2007 Roy Sullivan 10121/00902 9262
30636 7590 10/31/2012
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
EXAMINER
KISH, JAMES M
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
10/31/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

PATENT TRIALS AND APPEAL BOARD
__________

Ex parte ROY SULLIVAN
__________

Appeal 2011-008909
Application 11/734,048
Technology Center 3700
__________

Before DONALD ADAMS, JACQUELINE WRIGHT BONILLA, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims directed to a method and a system of imaging
lesions in a patient. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
The invention is directed to “identifying target tissue margins and for
guiding a tissue resection device to the target tissue in a tissue resection
procedure.” (Spec. 1.)
Claims 18-50 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief (App. Br. 12-17). Claims 18, 33, 43, 49, and 50 are
independent claims. Claim 18 is representative of the claims on appeal, and
reads as follows:
18. A method for performing a medical procedure, comprising the
steps of:
creating an image of a lesion within a patient's body on an
imaging device;
processing data representative of the lesion image by a video
processor from said imaging device;
defining tissue margins around the lesion by a processor based
on said processed data representative of the lesion image; and
operating a resection device during a resection procedure within
the patient's body based upon said defined tissue margins, wherein the
determining of the tissue margins is performed exclusively by the
processor.

The following grounds of rejection are before us for review:
1. The Examiner has rejected claims 18, 22, 31-34, 36, 41, 42, and 49
under 35 U.S.C. § 103(a) as unpatentable over Kreizman
1
in view
of Arnold.
2

1
Kreizman et al., US 6,214,018 B1, issued Apr. 10, 2001.
2
Arnold et al., US 4,922,915, issued May 8, 1990.
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2. The Examiner has rejected claims 19-21, 27-29, 35, 43, 44, 47-50
under 35 U.S.C. § 103(a) as unpatentable over Kreizman in view
of Arnold and further in view of Salb.
3

3. The Examiner has rejected claims 30 and 40 under 35 U.S.C. §
103(a) as unpatentable over Kreizman in view of Arnold and
further in view of Gilhuijs.
4

4. The Examiner has rejected claims 23 and 37 under 35 U.S.C. §
103(a) as unpatentable over Kreizman in view of Arnold and
further in view of Kadziauskas.
5

5. The Examiner has rejected claims 24-26, 38, and 39 under 35
U.S.C. § 103(a) as unpatentable over Kreizman in view of Arnold
and further in view of Gronningsaeter.
6

6. The Examiner has rejected claim 45 under 35 U.S.C. § 103(a) as
unpatentable over Kreizman in view of Arnold and Salb and
further in view of Kadziauskas.
7. The Examiner has rejected claim 46 under 35 U.S.C. § 103(a) as
unpatentable over Kreizman in view of Arnold and Salb and
further in view of Gronningsaeter.

ISSUE
The Examiner takes the position that “Kreizman discloses methods
and apparatus for removing tissue from a region of interest (ROI) using

3
Salb, US 2001/0001011 A1, published May 10, 2001.
4
Gilhuijs et al., WO 99/04690, published Feb. 4, 1999.
5
Kadziauskas et al., US 6,083,193, issued Jul. 4, 2000.
6
Gronningsaeter et al., US 6,019,724, issued Feb. 1, 2000.
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stereotactic radiographic guidance.” (Ans. 3.) The Examiner acknowledges
that in Kreizman “the tissue margins require a manual input from the user.”
(Ans. 4.) The Examiner finds that Arnold teaches an automated image
localization system to identify tumor tissues using a histogram analysis
where the “histogram calculations [are] performed automatically.” (Ans. 4.)
Appellant‟s arguments are that “Kreizman requires manual inputs
from the user” (App. Br. 5) and “Arnold does not disclose or suggest any
method for identifying or defining a margin of tissue surrounding a lesion.”
(App. Br. 6.)
Does the evidence of record support the Examiner‟s conclusion that
the combination Kreizman and Arnold renders obvious methods and
apparatus directed to an automated tissue lesion detection and resection
system?

FINDINGS OF FACT
FF1. Kreizman disclosed a method and apparatus for removing tissue from
a region of interest. Kreizman Fig. 6 is depicted below:
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Fig. 6 shows a flow diagram of the method disclosed by Kreizman. The
method is directed to finding and removing regions of interest (ROI) which
include “suspicious lesion[s]” (Kreizman col. 3, ll. 37-38) and/or cancerous
tissues (id. at col. 4, ll. 56-57; Ans. 3.) The method begins with
immobilizing the body part containing the region of interest (step 102) (id. at
col. 6, ll. 23-25), obtaining an image of the body part (step 104) (id. at col. 6,
ll. 26-32; Ans. 3-4) and displaying image on a monitor (step 106) (id. at col.
6,.ll. 26-32; Ans. 4), marking the boundaries of the region of interest (step
108) using a user interface (id. at col. 6, ll. 33-41; Ans. 4), having a
controller to calculate the size and location of the tissue removal volume
(step 110) (id. at col. 6, ll. 36-38 and col. 7, ll. 5; Ans. 4 and 11-12), moving
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the tip of tissue removal tool into the tissue removal volume (step 112) (id.
at col. 7, ll. 6-8; Ans. 4), and removing tissue while monitoring the removal
process (step 114) (id. at col. 7, ll. 10-16).
FF2. The apparatus can include a video display to display the stereotactic
images. (Kreizman col. 3, ll. 61-67; Ans. 4.) “The apparatus is further
provided with a user interface 26 that is adapted to enable a user to
interactively provide a visible boundary around the region of interest in the
body part 14 displayed in each stereotactic image.” (Id. at col. 4, ll. 1-4.)
FF3. As described in Kreizman:
[V]ia the user interface, a boundary 62a, 62b is interactively placed
(step 108) around the region of interest 15 appearing in each displayed
stereotactic image 64a, 64b. Referring to FIGS. 6, 8 and 9, the
controller 20 calculates the size and three dimensional location of a
tissue removal volume 66 surrounding the region of interest 15
relative to the predetermined point of reference based upon the
location, relative geometry and dimensions of the boundaries 62a,
62b.
(Kreizman col. 6, ll. 33-41.)
FF4. Kreizman disclosed that “[i]t is known to use certain radioactive
isotopes to mark cancerous tissue because such isotopes tend to concentrate
around such tissue.” (Kreizman col. 4, ll. 53-56.)
FF5. Arnold disclosed “[a]n automated image detail localization system for
digital image systems such as CT, MRI, [and] digital radiograph[s].”
(Arnold abstract; Ans. 4.)
FF6. Arnold disclosed that “[t]he histogram calculations are performed
automatically. After the region of interest [] is defined by positioning an
elliptical search ROI or other ROI, as discussed above, an algorithm
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systematically evaluates each pixel within the defined region of interest.”
(Arnold col. 29, ll. 23-27; Ans. 4.)
FF7. As stated in Arnold:
[O]nly those pixels corresponding to the tumor image 1100 are
included in the calculation of the average density or size. Therefore,
the histogram provides an accurate calculation of the density of the
tissue within the irregularly-shaped tumor without requiring laborious
manual placement of a corresponding irregularly- shaped region of
interest or complex computations to provide computer generated
boundaries or regions of interest.
(Arnold col. 30, l. 64 to col. 31, l. 4; Ans. 5.)

FF8. Arnold disclosed that “[t]he coordinates of the tumors can be saved
and compared with images of the same patient taken at different times to
determine whether the tumors are increasing or decreasing in size following
therapy and whether additional tumors are appearing.” (Arnold col. 30, ll.
20-24; Ans. 5.)
FF9. Salb disclosed “detection and localization of abnormal or diseased
tissue, such as malignant tissue, using radiography.” (Salb ¶0042; Ans. 7.)
“[T]he imaging agent accumulates in malignant tissue at a different rate than
in nonmalignant tissue.” (Salb ¶0057; Ans. 6.)
FF10. Salb disclosed that “[b]ecause the imaging agent is radio-opaque, its
differential accumulation causes corresponding differences in the absorption
of the illuminating X-ray beam, which are manifested as differing levels of
radiographic density on the radiograph.” (Salb ¶0071; Ans. 6.)

PRINCIPLES OF LAW
“[I]t it is well settled that it is not „invention‟ to broadly provide a
mechanical or automatic means to replace manual activity which has
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accomplished the same result.” In re Venner, 262 F.2d 91, 95 (1958).
Furthermore, it is obvious to adapt a known product “using modern
electronic components in order to gain the commonly understood benefits of
such adaptation, such as decreased size, increased reliability, simplified
operation, and reduced cost.” Leapfrog Enterprises, Inc. v. Fisher-Price,
Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007).
If the Examiner presents a prima facie case of unpatentability,
Appellant has the burden on appeal to the Board to demonstrate error in the
Examiner's position. See In re Kahn, 441 F.3d 977, 985-86 (Fed. Cir. 2006)
(“On appeal to the Board, an applicant can overcome a rejection [under §
103] by showing insufficient evidence of prima facie obviousness or by
rebutting the prima facie case with evidence of secondary indicia of
nonobviousness.”) (quoting In re Rouffet, 149 F.3d 1350, 1355 (Fed. Cir.
1998)).
ANALYSIS
Ground 1: Obviousness over Kreizman in view of Arnold
The Examiner takes the position that “Kreizman discloses methods
and apparatus for removing tissue from a region of interest (ROI) using
stereotactic radiographic guidance.” (Ans. 3.) The Examiner acknowledges
that Kreizman “require[s] a manual input from the user” to locate tissue
margins. (Ans. 4; FF2.) The Examiner combined Kreizman with Arnold
because this reference “teaches that a histogram calculation is performed
automatically (column 29, lines 23-46). . . . This technique may be used to
„evaluate irregularly-shaped images of soft tissue regions or masses such as
are obtained by CT or magnetic resonance imaging (MRI) of a patient's lung
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or brain.‟” (Ans. 4; FF5.) The Examiner concludes that it would have been
obvious to “automate the localization of the ROI, since it has been held that
broadly providing a mechanical or automatic means to replace manual
activity which has accomplished the same result involves only routine skill
in the art.” (Ans. 4.)
Appellant contends that “Kreizman requires manual inputs from the
user” (App. Br. 5). Appellant also contends that “Arnold does not disclose
or suggest any method for identifying or defining a margin of tissue
surrounding a lesion” (App. Br. 6) and “at no time does Arnold locate a
tumor in space or define any tissue margin around a tumor.” (App. Br. 7.)
We are not persuaded by Appellant‟s arguments. We agree with the
Examiner‟s findings that Kreizman disclosed all the method steps recited in
claim 18, but for the automated localization of the lesion. (Ans. 3-4; FF 1-
3.) The Examiner combines Kreizman with Arnold, a reference that
disclosed an automated lesion localization method employing CT, MRI or
digital radiography. (FF5.) Arnold disclosed a method of automating tumor
localization within a patient by using histogram analysis that compares
pixels in a CT scan slice with a phantom or reference sample. (FFs 5-8.)
Arnold also disclosed determining the size and density of the tumor based
pixel analysis (FF7). We are not persuaded by Appellant‟s arguments that
Arnold does not “locate a tumor in space or define any tissue margin around
a tumor” (App. Br. 7). Arnold disclosed saving the coordinates of the tumor
for later comparison (FF8). Additionally, the process of calculating the
tumor size requires that the tumor boundaries (or margins) must be
established in order to perform a size calculation (FF7). We agree with the
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Examiner, that automating the process of locating a tumor within a CT scan
replaces the laborious manual activity of drawing the tumor boundaries by
the operator. In re Venner, 262 F.2d 91, 95 (1958). We also agree with the
Examiner, as automating tumor localization increases reliability by reducing
operator error. Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d
1157, 1162 (Fed. Cir. 2007).
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that the combination of Kreizman and
Arnold renders obvious the method of imaging a tumor, automatically
defining the margins using a processor, and operating a resection device of
claim 18. We thus affirm the rejection of claim 18 under 35 U.S.C. § 103(a)
as being obvious. As claims 22, 31-34, 36, 41, 42, and 49 have not been
argued separately, they fall with claim 18 as acknowledged by Appellants
(App. Br. 8). 37 C.F.R. § 41.37(c)(vii).

Ground 2: Obviousness over Kreizman in view of Arnold in further
view of Salb
Based on the combination of Kreizman, Arnold and Salb, the
Examiner concludes that, at the time of Appellants‟ claimed invention, it
would have been obvious to use “imaging agents [in the combination
suggested by Kreizman and Arnold] to facilitate[] the precise location of
malignant tissue in relation to nearby anatomical landmarks.” (Ans. 6-7; FF
9-10.)
Appellant contends that Salb fails to make up for the deficiencies in
the combination of Kreizmann and Arnold (App. Br. 8). For the foregoing
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reasons, having found no deficiencies in the combination of Kreizmann and
Arnold, we are not persuaded by Appellant‟s contentions to the contrary.
Appellant further contends that independent claims 43 and 50 include
the additional limitation of “analyzing the image data to define a region of
tissue that includes the tissue to be resectioned and to locate the marker.”
(App. Br. 8.)
We are not persuaded by Appellant‟s arguments. Salb disclosed the
use of radiography to detect malignant tissue (FF9). The radio-opaque dye
accumulates in malignant tissue at a higher rate and therefore that tissue
shows up as having a higher density on a radiograph (FF10). The resection
method suggested by the combination of Kreizman and Arnold was directed
to detecting and removing tumor tissue based on the increased density of the
tumor tissue. (FFs 1-8.) The Examiner‟s concludes that adding “imaging
agents [that increase radiographic density] to facilitate[] the precise location
of malignant tissue” to methods that rely on differential density between
malignant and healthy tissue to locate the tumor (FF1), determine the
volume of the tumor tissue (FFs 1, 3, 7), and monitor the removal of the
tumor tissue (FF1) would have been obvious. (Ans. 6-7.) We agree with
the Examiner that it is obvious to combine familiar elements according to
known methods to yield a predictable result. See KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007).
We find that the preponderance of the evidence of record supports the
Examiner‟s conclusion that the combination of Kreizman in view of Arnold
in further view of Salb renders obvious the method and device of claims 43
and 50. We thus affirm the rejection of claims 43 and 50 under 35 U.S.C. §
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103(a) as being obvious. As claims 19-20, 27-29, 35, 44, and 47-50 have
not been argued separately, they fall with claims 43 and 50 as acknowledged
by the Appellants (App. Br. 8). 37 C.F.R. § 41.37(c)(vii).

Grounds 3-7: Remaining obviousness rejections
The remaining claims 23-26, 37-39, 40, and 45 stand rejected based
on the following combinations of Kreizman in view of Arnold and further in
view of Gilhuijs (Ans. 7), Kreizman in view of Arnold and further in view of
Kadziauskas (Ans. 8), Kreizman in view of Arnold and further in view of
Gronningsaeter (Ans. 8-9), Kreizman in view of Arnold and Salb and further
in view of Kadziauskas (Ans. 9), Kreizman in view of Arnold and Salb and
further in view of Gronningsaeter (Ans. 10).
Appellant contends that taken alone or in combination the above cited
references do not disclose or suggest the limitations of the independent
claims 18, 33, and 43. (App. Br. 8-10; Reply Br. 6-8) Because Appellant
does not separately argue the dependent claims 23-26, 37-39, 40, and 45,
these claims fall together with the independent claims 18, 33, and 43 as
acknowledged by Appellant (App. Br. 8-10; Reply Br. 6-8). 37 C.F.R. §
41.37 (c)(1)(vii).
The Examiner has rejected the independent claims based on the
combination of Kreizman in view of Arnold (Ans. 3) and Kreizman in view
of Arnold and further in view of Salb (Ans. 6). As discussed above we have
found no deficiency in the Examiner‟s prima facie case based on the
combination of Kreizman and Arnold with or without Salb. We conclude
that the preponderance of evidence of record supports the Examiner‟s
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conclusion that the combination of Kreizman in view of Arnold (Ans. 3) and
Kreizman in view of Arnold and further in view of Salb (Ans. 6) meet all the
limitations set out in the independent claims. We thus affirm the rejection of
claims 18, 33, and 43 under 35 U.S.C. § 103(a) as being obvious. As claims
23-26, 37-39, 40, and 45 have not been argued separately, they fall with
claims 18, 33, and 43 as acknowledged by the Appellants (App. Br. 8-10;
Reply Br. 6-8). 37 C.F.R. § 41.37(c)(vii).

SUMMARY
1. We affirm the rejection of claims 18, 22, 31-34, 36, 41, 42, and 49
under 35 U.S.C. § 103(a) as unpatentable over Kreizman in view
of Arnold.
2. We affirm the rejection of claims 19-21, 27-29, 35, 43, 44, 47-50
under 35 U.S.C. § 103(a) as unpatentable over Kreizman in view
of Arnold and further in view of Salb.
3. We affirm the rejection of claims 30 and 40 under 35 U.S.C. §
103(a) as unpatentable over Kreizman in view of Arnold and
further in view of Gilhuijs.
4. We affirm the rejection of claims 23 and 37 under 35 U.S.C. §
103(a) as unpatentable over Kreizman in view of Arnold and
further in view of Kadziauskas.
5. We affirm the rejection of claims 24-26 and 38-39 under 35 U.S.C.
§ 103(a) as unpatentable over Kreizman in view of Arnold and
further in view of Gronningsaeter.
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6. We affirm the rejection of claim 45 under 35 U.S.C. § 103(a) as
unpatentable over Kreizman in view of Arnold and Salb and
further in view of Kadziauskas.
7. We affirm the rejection of claim 46 under 35 U.S.C. § 103(a) as
unpatentable over Kreizman in view of Arnold and Salb and
further in view of Gronningsaeter.

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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