Ex Parte Vertatschitsch et al

Patent Trial and Appeal Board

Jul 30, 2018

11165843 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/165,843 06/24/2005
69414 7590 08/01/2018
VARIAN I PERKINS COIE, LLP
P.O. BOX 1247
SEATTLE, WA 98111-1247
FIRST NAMED INVENTOR
Edward J. Vertatschitsch
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.
078751-8032.USOl 4646
EXAMINER
KISH, JAMES M
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
08/01/2018 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):
patentprocurement@perkinscoie.com
ipdocket@varian.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte EDWARD J. VERTATSCHITSCH,
STEVEN C. DIMMER, TIMOTHY P. MATE, ERIC MEIER,
KEITH SEILER, and J. NELSON WRIGHT
Appeal2017-007108
Application 11/165,843
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
of treating a target in a lung of a patient. The Examiner rejected the claims
under nonstatutory double patenting and as obvious under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as Varian Medical Systems,
Inc. (see App. Br. 2).
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Application 11/165,843
Statement of the Case
Background
"This invention relates generally to systems and methods for
accurately locating and tracking a target in a lung of patient" (Spec. ,r 2).
"[I]t is not only desirable to increase the radiation dose delivered to the
tumor, but it also desirable to mitigate the volume of healthy tissue subject
to radiation and the dose of radiation delivered to such healthy tissue" (Spec.
,r 6). "One difficulty of radiation therapy is compensating for movement of
the target within the patient either during or between radiation sessions"
(Spec. ,r 7). "Another challenge in radiation therapy is accurately aligning
the tumor with the isocenter of the radiation beam" (Spec. ,r 8).
[ A ]lthough the target ... may move within the patient because
of breathing, organ filling/ emptying, cardiac functions or other
internal movement as described above, the localization system
[ of this invention] ... accurately tracks the motion of the target
relative to an external reference outside of the patient to
accurately deliver radiation within a small margin around the
target.
(Spec. ,r 59.)
The Claims
Claims 1, 2, 6, 7, 9, 11-13, 15, 16, 19, 20, and 23 are on appeal.
Claim 1 is representative and reads as follows:
1. A method of treating a target in a lung of a patient,
compnsmg:
positioning a leadless marker in the lung of the patient
relative to the target;
collecting position data of the implanted marker with a
localization system using a non-ionizing energy to track the
implanted marker while the patient is in a treatment session;
determining the location of the implanted marker in an
external reference frame based on the collected position data;
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providing an objective output in the external reference
frame that is (a) directly responsive to movement of the
implanted marker and (b) provided at a periodicity that tracks
the location of the target;
wherein the position data is collected at a time tn, and
wherein providing the objective output responsive to the
location of the target comprises providing the objective output to
at least one of a user interface, a memory device, a computer and
a medical device within a latency period, wherein the position
data is collected by the localization system; and
wherein the latency period between the movement of the
implanted marker and the objective output of the collected
position data during application of therapeutic ionizing radiation
is not greater than approximately 2 seconds of time tn and the
objective output is provided at a periodicity not greater than
approximately 2 seconds during the application of the
therapeutic ionizing radiation.
The Rejections2
A. The Examiner rejected claim 1 on the grounds of nonstatutory double
patenting as being unpatentable over claim 2 of Wright et al., US 8,239,005
B2, issued Aug. 7, 2012 (Final Act. 5).
B. The Examiner rejected claims 1, 2, 6, 7, 11, 16, 19, and 20 under 35
U.S.C. § 103(a) as obvious over Mate3 and Sharp4 (Final Act. 6-9).
C. The Examiner rejected claim 9 under 35 U.S.C. § 103(a) as obvious
over Mate, Sharp, and Schweikard5 (Final Act. 10).
2 The double-patenting rejection over US 11/166,801 is moot in view of the
abandonment of that application on April 11, 2018.
3 Mate et al., US 2002/0193685 Al, published Dec. 19, 2002.
4 Sharp et al., Prediction of Respiratory Tumour Motion for Real-time
Image-guided Radiotherapy, 49 PHYS. MED. BIOL. 425--440 (2004).
5 Schweikard et al., US 2003/0125622 Al, published July 3, 2003.
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D. The Examiner rejected claims 11-13 and 15 under 35 U.S.C.
§ 103(a) as obvious over Mate, Sharp, and Gisselberg6 (Final Act. 10-11).
E. The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as obvious
over Mate, Sharp, and Shachar7 (Final Act. 11-12).
A. Double Patenting
Appellants do not dispute the obviousness-type double patenting
rejection on the merits (see App. Br. 9). We therefore summarily affirm the
obviousness-type double patenting rejection over U.S. Patent No. 8,239,005.
See Manual of Patent Examining Procedure§ 1205.02 ("If a ground of
rejection stated by the examiner is not addressed in the appellant's brief, that
ground of rejection will be summarily sustained by the Board.")
B. Obviousness
Because all of the obviousness rejections tum on the same issue, and
rely upon the basic combination of Mate and Sharp, we will consider them
together.
The Examiner finds that Mate teaches the limitations of claim 1, and
specifically finds "Mate teaches that the position of the marker is
substantially continuous and that real-time movement of the target-to-
machine isocenter is tracked" (Final Act. 6-7). The Examiner acknowledges
that "Mate fails to teach a specific latency period and a periodicity, as
claimed" (Final Act. 7).
6 Gisselberg et al., US 2003/0052785 Al, published Mar. 20, 2003.
7 Shachar, US 7,280,863 B2, published Oct. 9, 2007.
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The Examiner finds that "Sharp teaches predictions of respiratory
tumor motion for real-time image-guided radiotherapy", teaches that the
periodicity is "30 samples per second", and teaches "variable imaging rates
and system latencies of 33ms, 200ms and 1 second" (Final Act. 7-8).
The Examiner finds that:
one of ordinary skill in the art would understand that
determination of 3D positional information via an image takes
computational processing, in the same manner that
determination of 3D position information via multiple sensors
of a sensor array (as taught by Mate) also required
computational processing. With this in mind, one of ordinary
skill in the art would have found it obvious that the imaging
rates and system latencies illustrated in Figure 1 of Sharp may
be directly applied to the system and methods of Mate, where in
the Image Capture steps illustrated and discussed by Sharp
would instead be the detection of the marker via the sensor
array in the context of Mate. As such, it would have been
obvious to one of ordinary skill in the art at the time the
invention was made to consider the system latency issues
examined by the studies of Sharp within the system and
methods of Mate in order to determine whether a 1 s latency or
as little as a 33ms latency is sufficient for the particular
procedure. For example, in a location with little movement, a
latency of 1 s may be sufficient for safe radiation delivery, while
a location with greater movement may require the illustrated
RMS error generated by a latency of 33ms.
(Final Act. 8-9.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Mate and Sharp render claim
1 obvious?
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Findings of Fact
1. Mate teaches a method of treating a target in a lung of a patient
comprising positioning a leadless marker (small, self-contained, wireless
excitable markers) in the lung of the patient relative to the target (Mate,
Abstract, ,r,r 8, 41, 48, 55, 59).
2. Mate teaches determining the location of the implanted marker
in an external reference frame ( external reference frame or machine
isocenter) based on the collected position data (data from the sensor array;
target isocenter); and teaches providing an objective output (three-
dimensional coordinates created by the wireless markers) in the external
reference frame (reference frame) that is directly responsive to the
movement of the implanted marker (Mate, Abstract, ,r,r 9--10, 36, 43, 56-
57, 59).
3. Mate teaches "the actual position of the target isocenter 40 is
substantially continuously monitored and tracked relative to the machine
isocenter 22 during delivery of the radiation therapy" (Mate ,r 59).
4. Sharp teaches "[i]mage guidance in radiotherapy" and
"evaluates various predictive models for reducing tumour localization
errors when a realtime tumour-tracking system targets a moving tumour at a
slow imaging rate and with large system latencies" (Sharp, Abstract (425)).
5. Sharp teaches "prediction improves gated treatment accuracy
for systems that have latencies of 200 ms or greater, and for systems that
have imaging rates of 10 Hz or slower" (Sharp, Abstract (425)) and also
teaches systems using a 30 Hz periodicity and 33 ms, 200 ms, and 1 second
latencies (Sharp 432, 435).
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Principles of Law
A prima facie case for obviousness require "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
The claims recite a specific "latency period between the movement of
the implanted marker and the objective output of the collected position data
during application of therapeutic ionizing radiation" and a periodicity for the
objective output. As explained above, the Examiner found that Sharp
teaches latency and periodicity values, and found them obvious to use in
Mate's method.
Appellants contend,
Sharp's latency and periodicity are for an entirely different
modality (i.e., x-ray imaging) than the sensed non-ionizing
marker signals disclosed in Mate or the claimed invention. As
such, a person of ordinary skill in the art would not have even
looked to Sharp's disclosure when considering the rate at which
marker signals are received and processed.
(App. Br. 12.) Appellants contend the Examiner "erred by not articulating
an apparent rational reason or motivation to combine Mate and Sharp to
arrive at the features of claim 1" (App. Br. 16).
The Examiner responds,
Mate teaches real-time and/or continuous tracking but does not
provide the level of specificity that is found in the claim (i.e.,
less than 2 seconds of latency and periodicity). Continuous
tracking would imply to one of skill in the art that the
periodicity is effectively zero and the latency is effectively zero.
However, Sharp has been incorporated to provide explicit
teachings, rather than implications. Sharp is not being
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incorporated to replace the marker localization methods of
Mate, but to provide evidence to the question of "What does
real-time actually mean?" As described in the rejection, Sharp
investigates at least three different imaging rates and system
latencies of 33ms, 200ms and 1 second (see Figures 8 and 9).
Therefore, the Examiner has provided motivation to combine,
the motivation stems from the references and would be obvious
to one of ordinary skill in the art.
(Ans. 5---6.)
We agree with the Appellants. The Examiner does not identify any
persuasive motivation, advantage, or reason to incorporate either the latency
period or periodicity in Mate's method to have arrived at the limitations
recited in claim 1. In fact, because Sharp teaches that predictions only
improves systems with "latencies of 200 ms or greater, and for systems that
have imaging rates of 10 Hz or slower" (FF 5), Sharp provides no reason to
combine the latency and periodicity teachings with a system that is "real-
time" as in Mate that has shorter latency and faster imaging rates.
To the extent that the Examiner relies upon inherency to suggest that
Mate's real time periodicity and latency satisfy the latency and periodicity
recitations in claim 1, the Examiner has not established Mate necessarily
satisfies these requirements. "Inherency ... may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient." MEHL/Biophile Int 'l.
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
In addition, the Examiner has not established a prima facie case under
the burden shifting rationale of In re Best, 562 F.2d 1252, 1254--55 (CCPA
1977), because the Examiner does not specifically rely upon Mate to
inherently teach the latency and periodicity, instead finding that "Mate fails
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to teach a specific latency period and a periodicity, as claimed" (Final Act.
7).
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Mate and Sharp render claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 on the grounds of
nonstatutory double patenting as being unpatentable over claim 2 of Wright
et al., US 8,239,005 B2.
We reverse the rejection of claims 1, 2, 6, 7, 11, 16, 19, and 20 under
35 U.S.C. § 103(a) as obvious over Mate and Sharp.
We reverse the rejection of claim 9 under 35 U.S.C. § 103(a) as
obvious over Mate, Sharp, and Schweikard.
We reverse the rejection of claims 11-13 and 15 under 35 U.S.C.
§ 103(a) as obvious over Mate, Sharp, and Gisselberg.
We reverse the rejection of claim 23 under 35 U.S.C. § 103(a) as
obvious over Mate, Sharp, and Shachar.
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-IN-PART
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