Ex Parte Steckner et al

Patent Trial and Appeal Board

Dec 10, 2018

10573727 (P.T.A.B. Dec. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/573,727 03/07/2007 Michael C. Steckner
38107 7590 12/12/2018
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2003P02531WOUS 2265
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/12/2018 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):
patti.demichele@philips.com
marianne.fox@philips.com
katelyn.mulroy@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL C. STECKNER, PETER BOERNERT, and
KAYNEHRKE 1
Appeal2017-010863
Application 10/573,727
Technology Center 3700
Before TONI R. SCHEINER, ERIC B. GRIMES, and
ERICA A. FRANKLIN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims relating
to a method for tracking the location of a moving target region during
therapy, which have been rejected as indefinite and obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the real party in interest as Koninklijke Philips
Electronics N. V. Appeal Br. 2.
Appeal2017-010863
Application 10/573,727
STATEMENT OF THE CASE
"Tumor motion, along with size and location of the tumor, can also be
a factor in planning oncological procedures when it comes to accurately
aligning an interventional tool with an internal tumor." Spec. 2:5-7. The
Specification states that one known method of tracking the movement of a
target is to place internal markers on or near the target organ. Id. at 2:25-30.
"A drawback to this method of tumor tracking, however, is that it involves
the invasive procedure of implanting the internal markers." Id. at 3:1-2. The
Specification discloses noninvasive methods of tumor tracking. Id. at 3:9-30.
In one embodiment, "rather than using external markers ... , the
position of the region of interest 130 can be predicted non-invasively using
MR navigators." Id. at 10: 13-15. "In a preparation phase, the MRI apparatus
100 generates images of the subject which include the subject's diaphragm
170 and the target tissue 130. Various points, or contours, on the diaphragm
170 and target tissue are then identified on the MRI localizer 150." Id. at
11: 1--4. "[A] model is generated which relates the position of the target as a
function of the position of the diaphragm." Id. at 11 : 10-12.
"[D]uring treatment, the MRI apparatus generates navigator scan data
for the navigator points localized during the preparation phase" and "[t]he
treatment controller ... controls the interventional device 400 as desired."
Id. at 11:15-23. For example, "a focused ultrasound ablator 400' is
controlled to treat the tumor 130 while it moves during normal subject
movement, such as breathing." Id. at 11 :23-25.
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Application 10/573,727
Claims 1, 6, 23-27, 31-36, and 40 are on appeal. Claim 1 is
illustrative and reads as follows (emphasis added):
1. A targeted treatment apparatus, the apparatus comprising:
a magnetic resonance imaging apparatus that non-
invasively obtains image data and reference data of a subject
disposed within an examination region during a pretreatment
sess10n;
a magnetic resonance imaging localizer that receives the
image data and localizes a target region to provide a sequence
of target locations associated with one or more target points in
the target region;
a reference marker localizer that receives the reference
data and provides therefrom a sequence of reference locations
of one or more reference points on an internal anatomic
structure of the subject, the internal anatomic structure being
remote from the target region;
a tracking processor that receives the sequence of target
locations and the sequence of reference locations and creates a
tracking model that defines a mapping between the reference
locations and the target locations;
an intervention tool that directs a treatment to the target
area; and
a treatment controller that controls the intervention tool;
wherein, in a subsequent treatment session:
the magnetic resonance imaging apparatus provides
subsequent reference data;
the reference marker localizer receives the subsequent
reference data and provides therefrom one or more subsequent
reference locations of the one or more reference points on the
internal anatomic structure, and
the treatment controller receives the one or more
subsequent reference locations and uses the tracking model to
determine corresponding subsequent target locations, and uses
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Application 10/573,727
the subsequent target locations to direct the intervention tool to
the target area.
Claims 6 and 23 are the other independent claims. Claim 6 is directed
to a method and claim 23 is directed to a computer-readable medium that
includes a program. Claims 6 and 23 both include the limitation emphasized
above in claim 1.
The claims stand rejected as follows:
Claims 31 and 40 under 35 U.S.C. § 112, second paragraph, as
indefinite (Ans. 2) and
Claims 1, 6, 23-27, 31-36, and 40 under 35 U.S.C. § I03(a) as
obvious based on Schweikard '815 2 and Schweikard '981 3 (Ans. 3).
that
I
The Examiner has rejected claims 31 and 40 as indefinite, on the basis
[t]he term "substantially" in claims 31 and 40 is a relative term
which renders the claim indefinite. The term "substantially" is
not defined by the claim, the Specification does not provide a
standard for ascertaining the requisite degree, and one of
ordinary skill in the art would not be reasonably apprised of the
scope of the invention. The term "substantially" does not define
a boundary.
Ans. 3.
Appellants argue that
one of skill in the art would interpret a "substantially
continuous treatment" as an approximation of a purely
2 Schweikard et al. US 2004/0092815 Al May 13, 2004.
3 Schweikard et al. US 6,501,981 Bl Dec. 31, 2002.
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Application 10/573,727
continuous treatment with perhaps a few gaps, as distinguished
from a discontinuous treatment, wherein for example, the
treatment is paused between image gathering operations.
The courts have consistently held that the use of words of
approximation, such as "substantially", "generally", etc. do not,
per se, render claims indefinite.
Appeal Br. 7.
We agree with Appellants that the recitation of "a substantially
continuous treatment" in claims 31 and 40 does not make them indefinite.
"A claim is indefinite if, when read in light of the specification and
prosecution history, it fails to inform those skilled in the art about the scope
of the invention with reasonable certainty." Exmark Mfg. Co. Inc. v. Briggs
& Stratton Power Prods. Group, LLC, 879 F.3d 1332, 1344--45 (Fed. Cir.
2018). Addressing the definiteness of a claim limitation reciting a
"substantially straight baffle section," the Exmark court stated that
[ t ]hough Briggs seeks to impose a strict requirement of how
straight the baffle portions must be, no such numerical
precision is required when using such terms of degree. See
Sonix Tech. Co. v. Publ'ns Int'!, Ltd., 844 F.3d 1370, 1377
(Fed. Cir. 2017) ("[W]e have rejected the proposition that
claims involving terms of degree are inherently indefinite.
Thus, 'a patentee need not define his invention with
mathematical precision in order to comply with the definiteness
requirement."' ( quoting Invitrogen Corp. v. Biocrest Mfg., L.P.,
424 F.3d 1374, 1384 (Fed. Cir. 2005))).
Id. at 1346.
Here, the Specification states that tumor motion caused by, for
example, respiration can make it difficult to accurately align an
interventional tool with a tumor. Spec. 2:5-8. The Specification states that
one solution known in the art was "[g]ating the intervention .... In the case
of radiation and ultrasound therapy, the delivery of treatment is gated, or
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Application 10/573,727
selectively turned on or off in response to a gating trigger." Id. at 2: 13-16.
That is, "the treatment beam is shut off during stages outside the desired
portion of the breathing cycle. Unfortunately, gating prolongs the time
required for each treatment session since the treatment is not delivered
continuously." Id. at 2: 19-22 ( emphasis added).
Read in light of the Specification, therefore, the limitation of claims
3 1 and 40 requiring "a substantially continuous treatment" would be
understood by those skilled in the art to mean that the treatment is
administered continuously or with only brief interruptions, as contrasted
with a treatment that is interrupted for a portion of every breathing cycle of
the patient. We therefore conclude that the claim language informs those
skilled in the art of the scope of the invention with reasonable certainty. The
rejection of claims 31 and 40 under 35 U.S.C. § 112, second paragraph, is
reversed.
II
The Examiner has rejected all of the claims on appeal as obvious
based on Schweikard '815 and Schweikard '981. The Examiner finds that
Schweikard '815 discloses most of the limitations of claim 1, including a
reference marker localizer that provides
a sequence of reference locations of one or more reference
points on an internal anatomic structure of the subject, the
internal anatomic structure being remote from the target region
(see [0029-37] and Figs. 1, 3, 9-10, elements 42, elements 42
are sensor on the chest wall that define a plurality of points on
the diaphragm (internal anatomic structure) of the subject;
mapping/correlate real-time sensor with the target in correlation
model; the sensors are remote from the target).
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Ans. 4. The Examiner finds that Schweikard '981 discloses the remaining
limitations of claim 1 (id. at 5) and concludes that it would have been
obvious to combine the teachings of the two Schweikard references "since
Schweikard (' 815) makes the suggestion that its non-invasive system
teachings can be applied universally in different modalities including MRI
(see [0037])." Id. at 6.
Appellants argue that "Schweikard '981 discloses the use of internal
markers, such as metal inserts, that are surgically attached to the target
region. Schweikard '815 ... discloses the use of markers attached to an
external body part of the patient." Appeal Br. 8. Appellants argue that they
"claim mapping the locations of the reference points on the internal
structure to the target points on the target structure." Id. at 9.
Appellants argue that "Schweikard '815 defines a mapping between
the location of external sensors and the location of the target, and does not
define a mapping between reference points on an internal structure of a
patient and the location of the target, as specifically taught and claimed." Id.
at 10. See also id. at 11: "The combination of Schweikard '815 and '981
does not disclose using the locations of one or more reference points on an
internal anatomic structure of the patient to create a mapping between these
reference points and target locations."
We agree with Appellants that the rejection is not supported by a
preponderance of the evidence. Schweikard '815 discloses an "apparatus for
locating an internal target region during treatment without using implanted
fiducials." Schweikard '815 ,r 8. The apparatus may include
a real-time sensing system for monitoring an external
movement of the patient 14. The real-time sensing system
includes one or more real-time sensors 42 that are coupled to
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Application 10/573,727
an external body part of the patient 14 and a sensor reader 44
that takes a reading from the real-time sensors 42 periodically.
Readings of the real-time sensors 42 indicate the movement of
an external body part of the patient 14. This real time sensing
system may be any system that can be used for correlating the
real-time sensors 42 to respiration pattern.
Schweikard '815 ,r 29 (emphasis added).
The claimed invention, however, requires "a sequence of reference
locations of one or more reference points on an internal anatomic structure
of the subject." Appeal Br. 13 (Claims Appendix, emphasis added). Contrary
to the Examiner's finding, Schweikard '815 discloses sensors coupled to an
external body part, not "reference points on an internal anatomic structure of
the subject," as required by the claims. We therefore reverse the rejection
under 35 U.S.C. § 103(a) based on Schweikard '815 and Schweikard '981.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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