Ex Parte Ruchala et al

Patent Trial and Appeal Board

Sep 18, 2012

10506866 (P.T.A.B. Sep. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KENNETH J. RUCHALA, GUSTAVO H. OLIVERA,
JEFFREY M. KAPATOES, PAUL J. RECKWERDT, WEIGUO LU,
and JOHN H. HUGHES
____________

Appeal 2011-006005
Application 10/506,866
Technology Center 3700
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 27-57 (App. Br. 4;
Ans. 2). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method for achieving a desired dose
distribution (claims 27-43) and a method of delivering radiation therapy
(claims 44-57). Claim 27 is representative and is reproduced in the Claims
Appendix of Appellants‟ Brief.
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Claims 27-57 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Miller,
1
Frohlich,
2
and Robar.
3

We reverse.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Miller suggests a “system and procedure for repeatedly aligning a
tumor or other desired tissue area in a patient with a radiation beam of … [a]
radiation beam therapy system” (Miller, col. 1, ll. 5-8; see generally Ans. 4).
FF 2. According to Miller‟s process “CT scan data of the particular tissue
volume of interest, i.e., that region of the patient where the cancerous tumor
is located, is obtained … and used to prepare a treatment plan for the
patient” (id. at col. 2, ll. 53-59; see generally Ans. 4).
FF 3. Miller‟s “treatment plan[] includes … preparing digitally
reconstructed radiographs (DRR‟s) from the CT data for each beam angle”
(id. at ll. 59-63; see generally Ans. 4).
FF 4. “Once … [Miller‟s] treatment plan is finalized … [a] physical
simulation of the treatment plan is … carried out to verify that the selected
cancerous cells will be properly irradiated by the treatment plan” (id. at col.
2, l. 67 - col. 3, l. 4; see generally Ans. 4).
FF 5. Miller‟s

1
Miller et al., US 5,117,829, issued June 2, 1992.
2
Frohlich, US 2002/0080915 A1, published June 27, 2002.
3
Robar et al., US 2001/0033682 A1, published October 25, 2001.

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physical simulation is carried out … [w]ithin the X-ray system
so that the X-rays enter the tissue volume at the same angle as
specified for a particle radiation beam in accordance with the
treatment plan. The resulting physical simulation radiograph
(PSR) is compared to the appropriate DRR to verify that it is
essentially the same.

(id. at col. 3, l. 67 - col. 4, l. 6; see generally Ans. 4.)
FF 6. “If … [Miller‟s] physical simulation verifies that the treatment plan
will properly irradiate the cancerous cells without significantly irradiating
non-cancerous cells, the treatment plan is executed by irradiating the
cancerous cells with the proton beam in accordance with the plan” (id. at col.
3, ll. 4-9; see generally Ans. 4).
FF 7. Miller suggests, however, that “before actually irradiating the target
tissue with the radiation beam, a further X-ray exposure of the tissue volume
is made … which is compared with the appropriate DRR and/or the PSR to
verify that the correct entry angle for the beam and correct patient position
have been achieved” (id. at col. 4, ll. 10-21; see generally Ans. 4).
FF 8. Examiner finds that Miller does not suggest that the treatment plan
includes a dose distribution (Ans. 4).
FF 9. Frohlich suggests that a typical radiation treatment process involves
the steps of obtaining three dimensional images, by for example
conventional CT, to prescribe a treatment plan, verifying the treatment plan,
and operating the “apparatus … in accordance with the treatment plan to
deliver the prescribed radiation dosage to the patient” (Frohlich 2: ¶ [0025]).
FF 10. Examiner finds that “Frohlich „directly define[s] the desired dose
distribution instead of defining beam parameters … e.g. by drawing on the
two-dimensional (2D) CT slices …” (Ans. 5; Frohlich 1: ¶ [0006]).
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FF 11. Examiner finds that “Frohlich states that … dose distributions may
be displayed in 2D or 3D” (Ans. 10; see generally Frohlich 2: ¶ [0016]).
FF 12. Examiner finds that “neither Miller nor Frohlich teach that a three-
dimensional image is used for volumetric dose calculations and used to
compare with the treatment planning image” (id.at 5).
FF 13. Robar suggests “the creation of volumetric data sets from multiple
two-dimensional analog images” (Robar 1: ¶ [0002]; see generally Ans. 5-
6).
FF 14. Robar suggests arranging films “in stacks, separated by tissue
equivalent spacers, to provide a series of two-dimensional images showing
the dose distribution on a number of parallel planes in a dose distribution”,
in this regard, Robar suggests that the films “may be arranged within a
cassette inside a tissue-equivalent phantom” (id. at 3: ¶ [0030]-[0031]; see
generally Ans. 5-6).
ANALYSIS
Based on the combination of Miller, Frohlich, and Robar, Examiner
concludes that, at the time Appellants‟ invention was made, it would have
been prima facie obvious “to use the teachings of Robar to create a three-
dimensional image of dose distribution for comparison with the three-
dimensional images used in the treatment plan of Miller so that „[a]ny
deviations of the actual distribution from the intended dose distribution can
thereby be identified before a radiosurgery treatment is delivered to a
patient…‟” (Ans. 6). We are not persuaded.
Each of Appellants‟ independent claims require, inter alia, obtaining
at least two images of a patient (see Claims 27, 44, and 50). The first image
is used to create at least one treatment plan (id.). Miller and Frohlich
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suggest this element of Appellants‟ claimed invention (see FF 1, 2, and 9).
Appellants‟ independent claims, however, require the second image to be a
three-dimensional image from the patient in substantially a treatment
position (see Claims 27, 44, and 50). Miller, Frohlich, and Robar fail to
suggest this element of Appellants‟ claimed invention.
While Miller suggests obtaining a number of images in addition to the
image used to create a treatment plan, Examiner failed to identify a
suggestion in Miller that any of these additional images are three-
dimensional images of a patient in substantially a treatment position, as
required by Appellants‟ claimed invention (see FF 4-7; see generally App.
Br. 9-10, 13-14, and 16; Reply Br. 2-3 and 6-7).
Examiner‟s reliance on Frohlich relates to images used to develop a
treatment plan (see FF 9-11). Accordingly, Examiner failed to identify a
suggestion in Frohlich that any of the images, that may be three-dimensional
images of a patient in substantially a treatment position, are in addition to
the image(s) used to develop the treatment plan as required by Appellants‟
claimed invention, as it relates to the second image (see Claims 27, 44, and
50; see generally App. Br. 10-11, 14, and 16-17; Reply Br. 3-4 and 6-7).
Robar relates to the use of a phantom or more specifically, an image
that is not a three-dimensional image of a patient in substantially a treatment
position, as required by Appellants‟ claimed invention (FF 13-14; see
generally App. Br. 11-12, 14-15 and 17-18; Reply Br. 4-7).
In sum, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that the combination of Miller, Frohlich, and
Robar suggest both a first image that is used to develop a treatment plan and
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a second three-dimensional image from the patient in substantially a
treatment position as required by Appellants‟ claimed invention.

CONCLUSION OF LAW
The preponderance of evidence on this record fails to support a
conclusion of obviousness. The rejection of claims 27-57 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Miller, Frohlich, Robar is
reversed.
REVERSED

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