Katscher, Ulrich et al.

Patent Trials and Appeals Board

Mar 24, 2020

13521228 - (D) (P.T.A.B. Mar. 24, 2020)

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.
13/521,228 07/10/2012 Ulrich Katscher 2010P00111WOUS 9934
24737 7590 03/24/2020
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
THOMSON, WILLIAM D
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
03/24/2020 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):
katelyn.mulroy@philips.com
marianne.fox@philips.com
patti.demichele@Philips.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ULRICH KATSCHER, OLIVER LIPS,
CHRISTIAN FINDEKLEE, CHRISTOPH LEUSSLER,
KAY NEHRKE, DANIEL WIRTZ,
and JOHANNES ADRIANUS OVERWEG
__________

Appeal 2019-001667
Application 13/521,228
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
therapeutic apparatus. The Examiner rejected the claims as failing to
comply with the written description requirement and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm the obviousness rejections,
but designate our affirmance as a new ground of rejection.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Koninklijke
Philips N.V. (see App. Br. 1).
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Statement of the Case
Background
“In radiation therapy, ionizing radiation is used to selectively destroy
regions of tissues within the body of a subject. Radiation therapy is typically
used to kill cancerous tumors” (Spec. 1:6–8). “A difficulty with radiation
therapy is that the ionizing radiation may cause damage to healthy tissue that
lies along the path of the ionizing radiation” (Spec. 1:9–10).
Appellant’s “invention relates to a radiation therapy system . . . with
magnetic resonance guiding” (Spec. 1:2–3). “Controlling the heating of
tissue using the tissue heating system with the magnetic resonance
thermometry data allows more accurate heating of tissue and reduces the
likelihood of damaging healthy tissue” (Spec. 4:11–13).
The Claims
Claims 1, 23–34 and 36–41 are on appeal. Claim 1 is reproduced
below, reformatted with bracketed letters to aid in identifying elements
during the discussion below:
1. A therapeutic apparatus comprising:
[a] a magnetic resonance imaging system configured to
repeatedly acquire magnetic resonance thermometry data and
image data from nuclei of a subject located within an imaging
volume;
[b] a tissue heating system configured to heat a heated
volume, the heated volume being within and smaller than the
imaging volume;
[c] a radiation therapy system configured to irradiate a
selected irradiation volume of the subject, the irradiation
volume being within and smaller than the heated volume; and
[d] a controller configured to control the magnetic
resonance imaging system, the tissue heating system and the
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radiation therapy system according to a control plan, wherein
the controller is configured to:
[d][i] receive a treatment plan,
[d][ii] reconstruct the acquired magnetic
resonance image data into images of a portion of a
subject in the imaging volume,
[d][iii] register at least one of the magnetic
resonance images with the treatment plan,
[d][iv] control the tissue heating system to heat
the heating volume,
[d][v] acquire magnetic resonance thermometry
data repeatedly during the heating of the heated volume
and processing the magnetic resonance thermometry
data into magnetic resonance thermal maps,
[d][vi] in response to the thermal maps indicating
that the heated volume exceeds a first temperature,
controlling the radiation therapy system to irradiate the
irradiation volume,
[d][vii] during the irradiating, control the
magnetic resonance image system to repeatedly
acquire the magnetic resonance thermometry data and
the magnetic resonance image data,
[d][viii] during the irradiating, repeatedly process
the magnetic resonance thermometry data into the
thermometry maps and the magnetic resonance image
data into the images,
[d][ix] in response to the images showing motion
of the subject, control the radiation therapy system to
shift the irradiating zone to compensate for the motion
of the subject such that the selected irradiation volume
continues to be irradiated as the subject moves,
[d][x] in response to a region of the subject
outside of the heated volume and within the imaging
volume exceeding a second temperature which second
temperature is a temperature difference below the first
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temperature, controlling the irradiation system to stop
irradiating the irradiation volume and the tissue heating
system to stop heating the heating region.
The Issues2
A. The Examiner rejected claims 1, 23–34 and 36–41 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement (Final Act. 2).
B. The Examiner rejected claims 1, 23–25, 30, 32–34, 36, and 40 under
35 U.S.C. § 103(a) as obvious over Myhr3 and Röll4 (Final Act. 3–5).
C. The Examiner rejected claims 26 and 37 under 35 U.S.C. § 103(a) as
obvious over Myhr, Röll, Zhu, and Govind5 (Final Act. 5).
D. The Examiner rejected claims 31 and 41 under 35 U.S.C. § 103(a) as
obvious over Myhr, Röll, and Avinash6 (Final Act. 5–6).
E. The Examiner rejected claim 27 under 35 U.S.C. § 103(a) as obvious
over Myhr, Röll, and Maki7 (Final Act. 6).
F. The Examiner rejected claims 28, 29, 38, and 39 under 35 U.S.C.
§ 103(a) as obvious over Myhr, Röll, Maki, and Skliar8 (Final Act. 6–79).

2 We appreciate that the Examiner withdrew the obviousness rejections in
the Advisory action and then reinstated them as a new ground in the
Examiner’s Answer without the required signature of a TC Director (see
MPEP § 1207.03(I)). Because our reasoning differs from that of the
Examiner, we will designate our affirmance as a New Ground.
3 Myhr, WO 2008/152411 A1, published Dec. 18, 2008.
4 Röll et al., DE 102007060189 A1, published Feb. 19, 2009.
5 Govind et al., US 5,690,109, issued Nov. 25, 1997.
6 Avinash et al., US 2005/0113673 A1, published May 26, 2005.
7 Maki et al., US 2005/0070961 A1, published Mar. 31, 2005.
8 Skliar et al., US 2011/0137147 A1, published June 9, 2011.
9 Although the Examiner rejected claim 29 separately from claims 28, 38,
and 39 both rejections relied on the same set of references. Therefore, we
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A. 35 U.S.C. § 112, first paragraph
The Examiner asserts that “[i]t is unclear as to what values are used
for the first and second temperatures or how they are determined. The
specification merely discloses a temperature difference between the first
temperature and the second temperature. Applicant fails to provide any
guidance used by one skilled in the art to make such determinations” (Final
Act. 2).
Appellant responds:
One of skill in the art of radiation therapy understands typical
temperatures that are used in radiation therapy to kill tumor cells
without harming surrounding healthy cells. All the claims require
is that the second temperature (i.e., at which irradiation is
stopped) is below the first temperature (i.e., at which irradiation
is started). In addition, threshold values, for example temperature
values, are known in the art.
(App. Br. 8).
We are not persuaded by the Examiner’s position. We first note that
the issue addressed by the Examiner appears to be enablement, not written
description. There is express support for the language added to claim 1 in
the Specification (see Spec. 6, second paragraph). The Examiner provides
no evidence or persuasive reasoning that Appellant was not in possession of
the temperature limitations recited in claim 1. Moreover, the Examiner does
not establish that claim 1 is not enabled by the Specification.
[T]he question of undue experimentation is a matter of
degree. The fact that some experimentation is necessary

address the Examiner’s rejection of claims 28, 29, 28, and 39 as a single
rejection.
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does not preclude enablement: what is required is that the
amount of experimentation “must not be unduly extensive.”
PPG Indus. Inc. v. Guardian Indus. Corp, 75 F.3d 1558, 1564 (Fed. Cir.
1996). The Examiner cites no evidence that selection of temperatures would
have been unpredictable in any way or that anything other than routine
experimentation would have been required to use the recited temperatures.
Accordingly, we reverse the rejection under 35 U.S.C. § 112, first
paragraph.

B. 35 U.S.C. § 103(a) over Myhr and Röll
The Examiner finds that “Myhr discloses a therapy apparatus as
described above but fails to disclose the operation of the radiation therapy
system as set forth” in claim 1 (Ans. 4). The Examiner finds Röll teaches “a
therapy apparatus that combines MRI, a tissue heating system and a
radiation therapy system” (id.). The Examiner finds Röll teaches
“controlling the irradiation of the target volume in accordance with the
control of temperature and expansion of areas with increased temperature”
and “that the aim is to avoid an increase of the temperature outside the target
volume” (id.).
The Examiner finds it obvious “to have modified Myhr such that the
irradiation is controlled based on the temperatures detected in both the
imaging region and the irradiation volume in order to achieve the desired
effect without harming healthy tissue” (Ans. 4).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Myhr and
Röll render the claims obvious?
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Findings of Fact
1. Myhr teaches, regarding element (a) of claim 1, that “[u]sing an
MRI machine for monitoring enables spatial monitoring and mapping of the
region of interest, i.e. providing maps or gradients of pO2, temperature, pH
and/or CO2 in a region of interest. The MRI machine can also monitor as a
function of time by taking repeated measurements” (Myhr 7).
2. Myhr teaches, regarding element (b), that “[a]n electromagnetic
energy source may be a standalone component of the system” (Myhr 8) and
that mapping “data can be used to either correct the focus of the energy
source which is applying the hyperthermia” (Myhr 7).
3. Myhr teaches, regarding element (c), “other applied treatment
modalities such as radiotherapy. . . . The direction and focus of the
radiotherapy and/or chemotherapy can then be altered so as to target those
areas where the treatment will be effective, without applying the toxic
treatments to regions which will not benefit from that treatment” (Myhr 14–
15).
4. Myr teaches, regarding element (d), that:
the computation unit is connected to the energy source or
further treatment modality so as to be able to control the
energy source or further treatment modality. By using the
calculated data as a feedback mechanism connected to the
energy source or treatment modality, better control of the
treatment can be carried out. For example, the focus of the
energy source can be monitored by spatially detecting
temperature increases. If the spatially detected increases are
not sufficiently coincident with the region of interest, the
direction of the energy source can be corrected. Similarly, if
the temperature increases are not high enough or are too high,
the focus and/or intensity of the energy source can be adjusted
to increase or decrease the hyperthermia. The direction
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and/or focus of a further treatment modality can also be
adjusted or corrected in a similar manner.
(Myhr 9).
5. Myhr teaches, regarding elements (d)(i) and (d)(ii),
that:
[b]y modelling [sic]the region of interest (e.g. a tumor) before
treatment, i.e. spatially [sic] mapping tissue in the region of
interest (which can be done via a variety of techniques
including MRI and CT scans) and mapping the location of the
region of interest with respect to reference points on the
subject, it is possible to determine the levels of hyperthermia
and pO2, pH, and/or CO2 in relation to the position of the
region of interest, i.e. the position within the body. This data
can be used to either correct the focus of the energy source
which is applying the hyperthermia (e.g. to maintain accurate
targeting of the region of interest) and/or control the
directionality of the further treatment modality (e.g. to control
the direction and/or focus of applied radiation and/or applied
ultrasound) to maximise [sic] the treatment effectiveness.
Other factors, such as timing, intensity, fractionation and
overall treatment time, i.e. total energy applied, can also be
calculated more accurately using modelling of the region of
interest.
Further, by mapping and modelling [sic] the region
surrounding the region of interest, the direction and focus of
the energy source and/or the other treatment modalities can
be selected so as to avoid obstacles such as bones and air
pockets which could otherwise attenuate the energy and
reduce treatment effectiveness. Navigation, guiding and
tracking of the energy source and treatment modalities can be
effected throughout the duration of the treatment.
(Myhr 7).
6. Myhr teaches, regarding element (d)(iv), that
[t]he computer can determine if the applied hypothermia is
sufficiently coincident with the region of interest and it can
evaluate how long it takes for the hyperthermia to reach a
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desired level. The computer can use this analysis for feedback
and control of the energy source to correct the focus, direction
and/or intensity of the applied hyperthermia.
(Myhr 14).
7. Myhr teaches, regarding elements (d)(v), (d)(vii), and (d)(viii),
that the “MRI machine can also monitor as a function of time by taking
repeated measurements” and function in “providing maps or gradients of . . .
temperature . . . in a region of interest” (Myhr 7, cf. FF 1).
8. Myhr teaches, regarding element (d)(vi), that the “direction and
focus of the radiotherapy and/or chemotherapy can then be altered so as to
target those areas where the treatment will be effective, without applying the
toxic treatments to regions which will not benefit from that treatment”
(Myhr 15).
9. Röll teaches, regarding elements (a) and (c), “combined
radiation and magnetic devices conceivable to combine an open C-shaped
magnet having an irradiation device and generate a therapy beam only on the
inside of a magnet of the magnetic resonance apparatus” (Röll ¶ 5).
10. Röll teaches, regarding element (b), the “target volume [is]
simultaneously heated by means of the HIFU device and irradiated by the
irradiation apparatus, wherein both operations can be monitored by the
imaging device. Thus, a radiation effect of the irradiation device is limited
to the target volume and thus optimally protected surrounding healthy tissue
controls” (Röll ¶ 16).
11. Röll teaches, regarding element (d), a “control unit 9 is
connected to the image forming apparatus 1, the irradiation device 3 and the
HIFU Vorrichutng 5 and receives from the image forming apparatus 1 to
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obtain position and saturated the target volume and on the temperature in
and around the target volume” (Röll ¶ 35).
12. Röll teaches, regarding element (d)(i), a “treatment plan” (Röll
31–32).
13. Röll teaches, regarding elements (d)(ii) and (d)(iv),
a medical imaging device for determining and / or monitoring of
the position and size of a target volume, and temperatures in the
target volume, and an irradiation device to irradiate the target
volume with the treatment radiation, and HIFU device (HIFU:
“High Intensity Focused Ultrasound”) for irradiating the target
volume with ultrasound to increase the temperature in the target
volume.
(Röll ¶ 15).
14. Röll teaches, regarding elements (d)(iii), to register the image
with the treatment plan, specifically teaching “[c]ontrol of the position and
size of a target volume of the object in the radiation therapy apparatus by
means of the medical imaging device” (Röll ¶ 19).
15. Röll teaches, regarding element (d)(ix), that:
Upon irradiation often results in the problem that the
objective of the irradiation in the body is movable.
So, for example, moves a tumor in the abdominal area
during the respiratory process. . . .
Therefore, it has been proposed to control the position of
the irradiation target in the body during irradiation by imaging,
in order to control the beam in accordance with or, where
appropriate, to stop the irradiation, and thus increase the success
of the therapy.

(Röll ¶ 2).
16. The Examiner also finds, regarding element (d)(ix), that “use of
feedback to control the treatment will inherently compensate for changes to
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the region of interest including those caused by motion (breathing) of the
subject” (Final Act. 4).
17. Röll teaches, regarding element (d)(x), that “the aim of the
regulation of the HIFU device from it, to avoid an increase of the
temperature outside the target volume” (Röll ¶ 29).
18. Röll teaches, regarding temperature differences in claims 23
and 24, that “[f]or radiotherapy of people is therefore proposed that the
target temperature to be chosen such that approximately 39 deg. C does not
fall below about 43 deg C. are not exceeded” (Röll ¶ 30).
19. Avinash teaches that:
[t]he motion of the lungs or other respiratory organs of
interest, such as the diaphragm, may be measured in a variety
of ways. As one of ordinary skill in the art will readily
apprehend, the type of data gating desired, i.e., prospective or
retrospective, may determine the type of motion data
acquired. In some cases, the motion data of interest may be
derived using the image scanner . . . itself. For example, pre-
acquisition imaging techniques, such as navigator pulses in
MR systems, scout images in CT systems or fluoroscopic
images in other generalized X-ray applications, may be
employed to determine the motion of the lungs, diaphragm,
chest wall, and so forth, as indicators of respiration. Pre-
acquisition motion detection and measurement typically
involves determining the position of the organ or organs of
interest by a pre-acquisition measurement using the imaging
system . . . . Subsequent image acquisition can then occur
during similar states of organ motion or subsequently
acquired image data may be selected for processing and
reconstruction based upon a similar state of organ motion.
(Avinash ¶ 22).

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Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 3–5; FF 1–18), and agree with the Examiner that the
claims are obvious over Myhr and Röll. We address below Appellant’s
arguments.
As already noted above, because our reasoning and evidentiary basis
differs somewhat from that of the Examiner, we designate our affirmance of
the obviousness rejections as new grounds of rejection to ensure procedural
due process for Appellant.
Claim 1
Appellant contends “Röll discloses that the irradiation start
temperature is lower than the irradiation stop temperature. . . . the
temperature inside the target volume is the determining factor in Röll of
whether or not to stop irradiation, not the temperature outside of the target
volume” (Reply Br. 5). Appellant contends “claim 1 calls for stopping the
irradiation based on temperature outside of the target volume and Röll stops
irradiation based on temperature in the target volume” (id.). Appellant also
contends that “if the heating is occurring at area close to a periphery of the
heating volume, then the temperature outside the heating volume adjacent
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periphery may be higher than a temperature at a portion of the heating
volume that is spaced from the periphery” (id. at 6).
We find these arguments unpersuasive because Röll teaches “to avoid
an increase of the temperature outside the target volume” (FF 17). Thus,
Röll recognizes the same concern as that recited in element (d)(x) of claim 1
of “in response to a region of the subject outside of the heated volume . . .
exceeding a second temperature . . . controlling the irradiation system to stop
irradiating the irradiation volume and tissue heating system.” Indeed, Röll
teaches “a radiation effect of the irradiation device is limited to the target
volume and thus optimally protected surrounding healthy tissue controls”
(FF 10). Röll teaches to achieve this goal by, “where appropriate, to stop the
irradiation, and thus increase the success of the therapy” (FF 15).
Moreover, Myhr also teaches “to target those areas where the
treatment will be effective, without applying the toxic treatments to regions
which will not benefit from that treatment” (FF 3, 8). Myhr further teaches
“[i]f the spatially detected increases are not sufficiently coincident with the
region of interest, the direction of the energy source can be corrected” (FF
4). Thus, we conclude that the ordinary artisan would have found that Myhr
and Röll reasonably suggested modification of the irradiation temperature to
a lower temperature when the healthy tissue volume outside the treated
volume is exceeding a desired temperature.
Claims 32 and 33
Appellant contends “claims 32 and 33 also recite controlling the
irradiation system to stop irradiating the irradiation volume and the tissue
heating system to stop heating the heating volume in response to temperature
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in a region outside of the heated volume” (Reply Br. 6). We find this
argument unpersuasive for the same reasons as claim 1 discussed above.
Claims 23, 24 and 33
Appellant contends that “Röll discloses a temperature range of 4° C.
Dependent claim 24 and independent claim 33, for example, recite that
temperature difference is at least 5° C.” (Reply Br. 7). Appellant contends
“the Examiner alleges that this temperature selection recited in claims 23, 24
and 33 would be obvious one of skill in the art to achieve optimum results
without undue experimentation. However, the Examiner provides no
evidence to support this position” (id.).
We are not persuaded. As Appellant acknowledges, “Röll discloses a
temperature range of 4° C.” (Reply Br. 7; cf. FF 18 “the target temperature
to be chosen such that approximately 39 deg. C does not fall below about 43
deg C.”). Röll’s use of the words “approximately” and “about” reasonably
suggests that the temperatures are, within at least degree, results effective
variables, and therefore encompass ranges from 38 to 44 degrees C. or a 6
degree range, encompassing the recitations in claims 23, 24, and 33. See In
re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions
of a claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation.”). Appellant
provides no evidence that the temperature range recited in claims 23, 24, or
33 are anything other than optimized ranges identified by routine
experimentation. Appellant also does not rebut the Examiner’s finding that
the ordinary artisan, interested in minimizing tissue damage caused by
excessive temperature as taught by both Myhr and Röll, would have
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recognized temperature of tissue as an optimizable variable, particularly as
Myhr and Röll teach measurement of such temperatures (FF 1, 5, 8, 10, 18)
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Myhr and Röll render the claims obvious.

C–F. 35 U.S.C. § 103(a)
Appellant does not separately argue these rejections (see Reply Br. 4–
7). As set forth above, we found no deficiency in the Examiner’s rejection
as it relates to claims 1, 32, and 33. Thus, Appellant fails to establish error
in the Examiner’s prima facie case as it relates to the rejection of the
remaining claims.
DECISION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 23–34, 36–
41
112 ¶ 1 Written Description 1, 23–34,
36–41
1, 23–25, 30,
32–34, 36, 40
103(a) Myhr, Röll 1, 23–25,
30, 32–34,
36, 40

26, 37 103(a) Myhr, Röll, Zhu,
Govind
26, 37
31, 41 103(a) Myhr, Röll,
Avinash
31, 41
27 103(a) Myhr, Röll, Maki 27
28, 29, 38, 39 103(a) Myhr, Röll, Maki,
Skliar
28, 29, 38,
39

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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
Overall
Outcome
1, 23–34,
36–41

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