Ex Parte Katscher et al

Patent Trial and Appeal Board

May 8, 2017

13521228 (P.T.A.B. May. 8, 2017)

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 05/10/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue SMITH, RUTH S
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
05/10/2017 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):
marianne. fox @ philips, com
debbie.henn @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 2015-007360
Application 13/521,228
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
therapeutic apparatus. The Examiner rejected the claims on the grounds of
failing to comply with the enablement requirement, indefiniteness,
anticipation, and obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Koninklijke Philips N.V.
(see App. Br. 1).
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Application 13/521,228
Statement of the Case
Background
Appellants’ “invention relates to a radiation therapy system . . . with
magnetic resonance guiding” (Spec. 1:2—3).
The Claims
Claims 1—14 and 17—22 are on appeal. Independent claim 1 is
representative and reads as follows (emphasis added):
1. A therapeutic apparatus, comprising:
a tissue heating system;
a magnetic resonance imaging system for acquiring
magnetic resonance thermometry data from nuclei of a
subject located within an imaging volume;
a radiation therapy system for irradiating an
irradiation volume of the subject, wherein the irradiation
volume is within the imaging volume; and
a controller configured to control the therapeutic
apparatus according to a control plan, wherein the controller
is configured to control the therapeutic apparatus to:
acquire magnetic resonance thermometry data
repeatedly using the magnetic resonance imaging
system,
heat at least the irradiation volume according to
the control plan using the tissue heating system,
wherein the heating is controlled using the magnetic
resonance thermometry data,
irradiate the irradiation volume according to the
control plan using the radiation therapy system
update the magnetic resonance image data
repeatedly during execution of the control plan, and
wherein the controller is further configured to modify
the control plan repeatedly during execution of the control
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plan using the updated magnetic resonance image data to
compensate for motion of the subject.
The Issues
A. The Examiner rejected claim 7 under 35U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement (Ans. 2).
B. The Examiner rejected claim 2, 3, and 7 under 35U.S.C. § 112,
second paragraph, as being indefinite (Ans. 2).
C. The Examiner rejected claims 1, 2, 4, 5, 14, 17, 18, 20, and 21 under
35 U.S.C. § 102(b) as being anticipated by Myhr2 (Ans. 2—5).
D. The Examiner rejected claim 3 under 35 U.S.C. § 103(a) as obvious
over Myhr and Roll3 (Ans. 5).
E. The Examiner rejected claims 6 and 7 under 35 U.S.C. § 103(a) as
obvious over Myhr and Straube4 (Ans. 5—6).
F. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as obvious
over Myhr and Kruip5 (Ans. 6).
G. The Examiner rejected claims 9, 11, and 12 under 35 U.S.C. § 103(a)
as obvious over Myhr and Maki6 (Ans. 6).
H. The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as obvious
over Myhr, Maki, and Turner7 (Ans. 6—7).
2 Myhr, WO 2008/152411 Al, published Dec. 18, 2008.
3 Roll et al., DE 102007060189 Al, published Feb. 19, 2009.
4 Straube et al., Dosimetry and techniques for simultaneous hyperthermia
and external beam radiation therapy, 17 International Journal of
Hyperthermia 1:48-62 (2001).
5 Kruip, US 2009/0234219 Al, published Sept. 17, 2009.
6 Maki et al., US 2005/0070961 Al, published Mar. 31, 2005.
7 Turner, US 4,633,875, issued Jan. 6, 1987.
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I. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious
over Myhr and McKinnon8 (Ans. 7).
J. The Examiner rejected claims 19 and 22 under 35 U.S.C. § 103(a) as
obvious over Myhr and Avinash9 (Ans. 7—8).
A. 35 U.S.C. § 112, first paragraph
The Examiner asserts that “[i]t is unclear as to how the photon system
could include more than one of the systems [as] set forth. Appellant has
failed to provide any showing as to how the systems could be jointly used
and controlled to achieve the desired effect” (Ans. 2).
We are not persuaded by the Examiner that claim 7 is not enabled by
the Specification.
[T]he question of undue experimentation is a matter of
degree. The fact that some experimentation is necessary
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) (citation omitted). The Examiner fails to provide persuasive evidence
or reasoning explaining why more than one system as set forth in claim 7
would have been unpredictable in any way or that anything other than
combining the systems or routine experimentation would have been required
to obtain an apparatus having more than one of the recited therapy systems.
We therefore agree with Appellants that
[t]he Examiner fails to explain why it would be difficult for
anyone — and especially one skilled in the art — to provide a
photon radiation therapy system which includes both a linear
8 McKinnon, US 6,591,127 Bl, issued July 8, 2003.
9 Avinash et al., US 2005/0113673 Al, published May 26, 2005.
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accelerator gamma radiation therapy system and an X-ray
radiation therapy system. In particular, the Examiner fails to
identify anything in a linear accelerator gamma radiation
therapy system which would preclude its inclusion in a
photon radiation therapy system together with an X-ray
radiation therapy system, or vice versa.
(App. Br. 17.)
Accordingly, we reverse the enablement rejection.
B. 35 U.S.C. § 112, second paragraph
When the USPTO has initially issued a well-grounded
rejection that identifies ways in which language in a claim is
ambiguous, vague, incoherent, opaque, or otherwise unclear in
describing and defining the claimed invention, and thereafter
the applicant fails to provide a satisfactory response, the
USPTO can properly reject the claim as failing to meet the
statutory requirements of § 112(b).
In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).
The Examiner asserts that “[cjlaim 2 is vague and indefinite in that it
is unclear as to how the steps set forth relate to the functions of the controller
set forth in claim 1” (Ans. 2). We do not find this statement persuasive
because it does not identity how the language of claim 2 is ambiguous. We
note that breadth is not indefmiteness.
Moreover, Appellants provide a satisfactory response, explaining, “the
functions of the controller recited in claim 1 are to: (1) control the
therapeutic apparatus; and (2) modify the control plan repeatedly during
execution of the control plan using the updated magnetic resonance image
data to compensate for motion of the subject” (App. Br. 16; cf. claim 1). We
thus agree with Appellants that “it is apparent that all of the steps recited in
claim 2 cause the controller to [perform functions] (1). . . and (2)” (id.).
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Thus, claims 2 and 3 are not ambiguous nor has the Examiner explained how
the claims would have been susceptible to multiple interpretations.
The Examiner asserts that “[cjlaim 7 is vague and indefinite in that it
is unclear as to how the photon system could include more than one of the
systems set forth” (Ans. 2). Thus, it appears that the Examiner’s rejection
here is based on the same reason for the rejection of claim 7 for not being
enabled by the Specification. The Examiner does not explain how the
language of claim 7 is indefinite, only broad. Accordingly, we are not
persuaded for the reasons discussed above.
We thus reverse the indefmiteness rejection.
C. 35 U.S.C. § 102(b) over My hr
The Examiner finds that
Myhr discloses a therapeutic apparatus comprising: ... a
controller for controlling the therapeutic apparatus according
to a control plan (control of the treatment parameters in
order to achieve the desired treatment plan for the subject
being treated), . . . wherein the method further comprises:
updating the magnetic resonance image data repeatedly
during execution of the control plan; and modifying the
control plan repeatedly during execution of the control plan
using the updated magnetic resonance image data (page 5,
paragraph 2, page 6, paragraph 1, page 7, paragraph 1—page
9, paragraph 5. Page 13, paragraph 2—page 16, paragraph 5).
The Examiner notes that use of feedback to control the
treatment will inherently compensate for changes to the
region of interest including those caused by motion
(breathing) of the subject. Such feedback would inherently
take into consideration environmental conditions including
motion of the subject. If the patient moves and the treatment
is no longer focused on the desired treatment region the
feedback will cause the control plan to be modified.
(Ans. 2-3.)
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Myhr anticipates the claims?
Findings of Fact
1. Myhr teaches
Using an MRI machine for monitoring enables spatial
monitoring and mapping of the region of interest, i.e.
providing maps or gradients of pCE, 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.
By modeling the region of interest (e.g. a tumor) before
treatment, i.e. spatially 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 pC>2, 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 either to 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 maximize 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 modeling 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.
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(Myhr 7:6—29; see also Ans. 2—3.)
2. Myhr teaches
More preferably, 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 and/or focus of a further
treatment modality can also be adjusted or corrected in a
similar manner.
(Myhr 9:12—22; see also Ans. 2—3.)
3. Myhr teaches that
[t]he computer can determine if the applied hyperthermia is
sufficiently coincident with the region of interest and it can
evaluate how long it takes for the hyperthermia to reach a
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 14:27—30; see also Ans. 2—3.)
Principles of Law
A prior art reference can only anticipate a claim if it discloses all the
claimed limitations “arranged or combined in the same way as in the claim.”
Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361
(Fed. Cir. 2012).
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Analysis
We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 2—10; FF 1—8), and agree with the Examiner that the
claims are anticipated by Myhr. We address below Appellants’ arguments.
Claims 1, 4, 5, 14, 17, 20, and 21
Appellants contend that “Myhr does not disclose modifying a control
plan repeatedly during execution of the control plan using updated magnetic
resonance image data to compensate for motion of the subject” (App. Br. 7;
see also Reply Br. 2—6). Appellants argue that in regard to Myhr’s use of
feedback, “as anyone skilled in the art knows, feedback can only take into
consideration changes to a signal which occur within the bandwidth of the
feedback loop,” and that “there is certainly no evidence that such feedback
would ‘inherently take into consideration all environmental conditions'1'’'’
(App. Br. 9).
We are not persuaded.
Myhr teaches that “[t]he MRI machine can also monitor as a function
of time by taking repeated measurements’ '’ (FF 1 (emphasis added)). Myhr
teaches
it is possible to determine the levels of hyperthermia and
pCF, 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 either to 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 maximize the treatment effectiveness.
(FF 1 (emphasis added).) Myhr also teaches that “by mapping and modeling
the region surrounding the region of interest, the direction and focus of the
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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” (FF 1 (emphasis
added)).
Myhr further teaches that “[b]y 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” (FF 2), that “[t]he direction
and/or focus of a further treatment modality can also be adjusted or
corrected in a similar manner” (FF 2), and that “[t]he 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” (FF 3).
Thus, because Myhr uses feedback that includes data from repeated
measurements from the MRI machine, monitors levels of hyperthermia in
relation to the position of the region of interest, i.e., the position within the
body, to correct the focus of the energy source and directionality of further
treatment modality to maintain accurate monitoring, while avoiding
obstacles such bones and air pockets in the body (FF 1—3), Myhr necessarily
uses a controller that is “configured to modify the control plan repeatedly
during execution of the control plan using the updated magnetic resonance
image data to compensate for motion of the subject” as claimed.
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
Whether the rejection is based on “inherency” under 35 U.S.C.
§ 102, on “prima facie obviousness” under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
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fairness is evidenced by the PTO’s inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citation and footnote
omitted). We thus agree with the Examiner that
the recitation of “to compensate for motion of the subject” is
considered to be an inherent result of using the
apparatus/computer readable medium or performing the
method. For example, if the patient moves and the treatment is
no longer focused on the desired treatment region due to such
movement the feedback will cause the control plan to be
modified.
(Ans. 8.) Absent persuasive arguments or evidence, we are not persuaded by
Appellants’ contention to the contrary.
Claim 2
We recognize, but are not persuaded by, Appellants’ contention that
Myhr does not mention any treatment plan or control plan, and
particularly does not teach acquiring magnetic resonance image
data using the magnetic resonance imaging system; registering
the magnetic resonance image data to the treatment plan; and
generating a control plan using the registration of the magnetic
resonance imaging data to the treatment plan.
(App. Br. 10.)
As noted above, Myhr teaches that “[t]he MRI machine can also
monitor as a function of time by taking repeated measurements’ '' (FF 1
(emphasis added)). Myhr also teaches that “by mapping and modeling 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” (FF 1 (emphases
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added)). Myhr also teaches that “[b]y 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” (FF 2), that “[t]he
direction and/or focus of a further treatment modality can also be adjusted or
corrected in a similar manner” (FF 2), and that “[t]he 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” (FF 3).
In using MRI imaging, Myhr necessarily carries out basic steps such
as acquiring the image and registration which Appellants argue Myhr does
not perform. Although Myhr does not use the term “plan” any medical
utilizing MRI imaging would inherently require one. We thus are not
persuaded by Appellants’ contention to the contrary (see also Ans. 8—9).
Identical language between the prior art and claims is not required to sustain
a prior-art rejection. In re Skoner, 517 F.2d 947, 950 (CCPA 1975) (“Any
other result would permit the allowance of claims drawn to unpatentable
subject matter merely through the employment of descriptive language not
chosen by the prior art.”).
Claim 18
Appellants contend that
[t]he Examiner does not explain how or why it is believed that
Myhr discloses an apparatus with a controller is configured to
modify the control plan repeatedly during execution of the
control plan using the updated magnetic resonance image data
to compensate for internal deformation in an anatomy of the
subject as the subject breathes.
(App. Br. 10; see also Reply Br. 6—7.)
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This argument is also unpersuasive. As discussed above, we agree
with the Examiner that Myhr inherently teaches compensating for motion of
the subject. As all living persons that undergo treatment must breathe, it
follows that Myhr’s compensation for motion includes motion by breathing.
We thus are not persuaded by Appellants’ contention to the contrary (see
also Ans. 9).
D. 35 U.S.C. § 103(a) over Myhr and Roll
In regard to claim 3, the Examiner acknowledges that Myhr “fails to
disclose the operation of the radiation therapy system as set forth” (Ans. 5).
The Examiner finds that Roll teaches
controlling the irradiation of the target volume in accordance
with the control of temperature and expansion of areas with
increased temperature [0019], [0029]—[0030]. Roll et al[.]
disclose that a desired target temperature (which can be a
temperature range) is chosen and the HIFU device is
controlled based on values determined for the target volume
and spread to an elevated temperature such that maximum
temperature is reached but not exceeded. Rolle et al[.]
further disclose that the aim is to avoid an increase of the
temperature outside the target volume.
(Id.)
The Examiner concludes that it would have been 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” (id.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Myhr and Roll render the claim
prima facie obvious?
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Findings of Fact
4. The Specification teaches
In another embodiment the irradiation volume is
irradiated only when the heated volume is above a first
predetermined temperature. The irradiation volume is
irradiated only when the region of the subject within the
imaging volume and not within the heated volume is below
a second predetermined temperature. This embodiment is
advantageous because only the heated volume is above a
first predetermined temperature. A temperature differential
between the first predetermined temperature and the second
predetermined temperature can be maintained so as to
reduce the likelihood of ionizing radiation damaging tissue
within the imaging volume and is not within the heated
volume.
(Spec. 6:20-27; see also App. Br. 4.)
5. Roll teaches
[a]n inventive method for controlling a radiotherapy
apparatus, comprising a medical imaging device, an
irradiation device and a HIFU device, comprising the steps
of, after an object to be examined is positioned in the
radiotherapy apparatus comprising: . . .
- Control of temperature and spreading of areas with
increased temperature in the object under examination by
the medical imaging device,
- Share of irradiation of the target volume with therapeutic
radiation irradiation device once a target temperature in the
target volume is reached,
- Controlling the heat generated by the HIFU device of the
target volume by controlling the HIFU device according to
results of the control of temperature and expansion of areas
of elevated temperature,
- Controlling the irradiation of the target volume with the
treatment beam by the control unit in accordance with
results of the control of the position of the target volume
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and/or in accordance with results of the control of
temperature and expansion of areas with increased
temperature [and]
- Cancel the irradiation, once a desired radiation dose was
administered from therapeutic radiation or a maximum
temperature is exceeded in the target volume.
(Roll 11910; see also Ans. 5.)
6. Roll teaches a
HIFU device is controlled on the basis of values determined
for the temperature in the target volume and spread to an
elevated temperature until the end of the total irradiation
such by the data regarding the temperature in the target
volume evaluating control unit such that a desired target
temperature is reached in the target volume, a maximum
temperature but is not exceeded ....
Likewise, the aim of the regulation of the HIFU device from
it, to avoid an increase of the temperature outside the target
volume........
If necessary, the ultrasonic irradiation can be temporarily
suspended at the HIFU device, if such [a]s the maximum
temperature has been exceeded.
(Roll 129; see also Ans. 5.)
7. Roll teaches that “[t]he desired target temperature may be a
temperature range” (Roll 130).
Principles of Law
“[CJlaims in an application are to be given their broadest reasonable
interpretation consistent with the specification and that claim language
should be read in light of the specification as it would be interpreted by one
of ordinary skill in the art.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir.
1983) (citation omitted).
10 The Examiner provides an English translation of Roll.
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Analysis
Claim 3 recites
wherein the control is further configured to control the
radiation therapy system to irradiate the irradiation volume
only when both: (1) a volume heated by the tissue heating
system is above a first predetermined temperature; and (2)
the region of the subject within the imaging volume and not
within the volume heated by the tissue heating system is
below a second predetermined temperature.
(See Appellants’ claim 3.)
Appellants contend that
the cited text [from Roll] teaches that, for example, heat
should be applied to the target volume to insure that the
temperature stays at a target temperature, or stays within a
defined target range (e.g., 42° C +/-0.50 C). This does not
teach irradiating the irradiation volume only when a volume
heated by the tissue heating system is above a first
predetermined temperature. Instead, this teaches
irradiation should be controlled to maintain the temperature
within a desired range. So if, for example the temperature
starts to fall below the target range, then the radiation is
maintained to bring the temperature back up to at least the
lowest temperature in the target range.
(App. Br. 13; see also Reply Br. 4—5.)
We do not find this argument persuasive. Appellants do not explain
why it is advantageous to irradiate only when the heated volume is above a
predetermined temperature (FF 4). Instead, the Specification teaches that
“[a] temperature differential between the first predetermined temperature
and the second predetermined temperature can be maintained so as to reduce
the likelihood of ionizing radiation damaging tissue within the imaging
volume and is not within the heated volume” (FF 4 (emphasis added)).
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Roll teaches
- Control of temperature and spreading of areas with
increased temperature in the object under examination by
the medical imaging device,
- Share of irradiation of the target volume with therapeutic
radiation irradiation device once a target temperature in the
target volume is reached,
- Controlling the heat generated by the HIFU device of the
target volume by controlling the HIFU device according to
results of the control of temperature and expansion of areas
of elevated temperature,
- Controlling the irradiation of the target volume with the
treatment beam by the control unit in accordance with
results of the control of the position of the target volume
and/or in accordance with results of the control of
temperature and expansion of areas with increased
temperature [and]
- Cancel the irradiation, once a desired radiation dose was
administered from therapeutic radiation or a maximum
temperature is exceeded in the target volume.
(FF 5.) Roll also reaches that a “HIFU device is controlled on the basis .. .
by the data regarding the temperature in the target volume evaluating
control unit such that a desired target temperature is reached in the target
volume, a maximum temperature but is not exceeded” (FF 6), that “the aim
of the regulation of the HIFU device from it, to avoid an increase of the
temperature outside the target volume” (FF 6), that “the ultrasonic
irradiation can be temporarily suspended at the HIFU device, if such [a]s the
maximum temperature has been exceeded” (FF 6), and that “[t]he desired
target temperature may be a temperature range” (FF 7).
Accordingly, because Roll uses a temperature range so that a target
temperature is reached in the target volume for effective therapy, Roll
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necessarily teaches irradiation up to a certain temperature and starting at a
certain temperature. Claim 3 does not specify a particular temperature.
Further, a physician or an operator for an MRI machine would inherently
start irradiation at a temperature that is safe and appropriate for the patient.
We thus agree with the Examiner that Roll teaches irradiation when both
conditions as claimed are met (see Ans. 8—9) and that “[i]t would have been
obvious to one skilled in the art 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. 5).
E—I. 35 U.S. C. § 103(a) over Myhr and Straube; over Myhr and Kruip;
over Myhr and Maki; over Myhr, Maki, and Turner; and over Myhr
and McKinnon
Appellants contend that Straube, Kruip, Maki, Turner, and McKinnon
“do[] not remedy the deficiencies of Myhr as set forth above with respect to
claim 1” (see App. Br. 13—15). As set forth above, we found no deficiency
in the Examiner’s rejection as it relates to claim 1. Thus, Appellants fail to
establish error in the Examiner’s prima facie case as it relates to the rejection
of claims 6—13.
J. 35 U.S.C. § 103(a) over Myhr and Avinash
In regard to claims 19 and 22, the Examiner acknowledges that Myhr
“fails to disclose tracking a location of a diaphragm to compensate for
motion of a subject” (Ans. 7).
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The Examiner finds that Avinash teaches “using MR data in
determining motion of a diaphragm as indicator of respiration [0022] which
results in compensation for motion of the subject” (id.).
The Examiner concludes that it would have been obvious to “have
modified Myhr such that the diaphragm is tracked using MR data in order to
compensate for motion of the subject. Such a modification adding further
means for ensuring that treatment takes place in the desired region of interest
using a known motion compensation means” (id. at 7—8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Myhr and Avinash render the claims
prima facie obvious?
Findings of Fact
8. 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
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selected for processing and reconstruction based upon a
similar state of organ motion.
(Avinash 122; see also Ans. 7.)
Analysis
Claim 19 recites “the controller is further configured to track a
location of a diaphragm of the subject as the subject breathes to compensate
for internal deformation in an anatomy of the subject as the subject
breathes.” Claim 22 recites a similar limitation.
Appellants argue that “the cited text in Avinash teaches that the
imaging should simply be gated when patient movement exceeds some
threshold. It does not mention any sort of compensation” (App. Br. 15; see
also Reply Br. 7—8).
This argument is unpersuasive.
We note that claims 19 and 22 do not exclude data gating. Avinash
teaches that
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.
(FF 8 (emphases added).) Because Avinash teaches pre-acquisition imaging
and subsequent image acquisition to account for motion in the diaphragm,
Avinash teaches “to compensate for internal deformation in an anatomy of
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Application 13/521,228
the subject as the subject breathes” as claimed. See In re Skoner, 517 F.2d at
950.
SUMMARY
In summary, we reverse the rejection of claim 7 under 35 U.S.C.
§112, first paragraph, as failing to comply with the enablement requirement.
We reverse the rejection of claims 2, 3, and 7 under 35 U.S.C. § 112,
second paragraph, as being indefinite.
We affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as being
anticipated by Myhr. Claims 2, 4, 5, 14, 17, 18, 20, and 21 fall with claim 1.
We affirm the rejection of claim 3 under 35 U.S.C. § 103(a) as
obvious over Myhr and Roll.
We affirm the rejection of claims 6 and 7 under 35 U.S.C. § 103(a) as
obvious over Myhr and Straube.
We affirm the rejection of claim 8 under 35 U.S.C. § 103(a) as
obvious over Myhr and Kruip.
We affirm the rejection of claims 9, 11, and 12 under 35 U.S.C.
§ 103(a) as obvious over Myhr and Maki.
We affirm the rejection of claim 10 under 35 U.S.C. § 103(a) as
obvious over Myhr, Maki, and Turner.
We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as
obvious over Myhr and McKinnon.
We affirm the rejection of claims 19 and 22 under 35 U.S.C. § 103(a)
as obvious over Myhr and Avinash.
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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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