Ex Parte Kruecker et al

Patent Trial and Appeal Board

Feb 11, 2019

13885714 (P.T.A.B. Feb. 11, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/885,714 11/08/2013 Jochen Kruecker
24737 7590 02/13/2019
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.
201 OP00578WOUS 1676
EXAMINER
ZINK, AMANDA L
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
02/13/2019 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 JOCHEN KRUECKER, SANDEEP DALAL,
BRADFORD JOHNS WOOD, and SHENG XU
Appeal2018-001248
Application 13/885,714
Technology Center 3700
Before JAMES P. CALVE, WILLIAM A. CAPP, and LEE L. STEPINA,
Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge CAPP
Opinion dissenting filed by Administrative Patent Judge STEPINA
CAPP, Administrative Patent Judge
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the final
rejection of claims 18-31 under 35 U.S.C. § 102(b) as anticipated by
Kruecker (WO 2010/064154 Al, pub. June 10, 2010), and a provisional
double patenting rejection over co-pending Application No. 14/235,140. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
Appeal2018-001248
Application 13/885,714
THE INVENTION
Appellants' invention relates to RF ablation medical procedures.
Spec. 1. Claim 18, reproduced below, is illustrative of the subject matter on
appeal.
18. A workstation, comprising:
a processor; and
a memory coupled to the processor,
the memory storing a probability estimation module and a
planning tool,
the probability estimation module is configured to define
shapes and sizes of ablation volumes in accordance with a
treatment probability distribution, determines a joint probability
distribution for at least two planned ablations in a target
volume, and computes a metric using a spatial representation of
a joint probability map and the target volume;
the planning tool is configured to permit assigning of the
ablation volumes to discrete volumes of a target volume in
accordance with a plan by determining a number and location
of planned ablations within the target volume using the one or
more ablation volumes, and optimizes the metric to produce a
final configuration of ablation volumes with an associated
treatment probability distribution, wherein the treatment
probability distribution represents a likelihood of treatment
within the ablation volumes.
OPINION
Anticipation by Kruecker
Claims 18 and 26 are the only independent claims. Claims App.
Appellants argue claim 18, but do not argue for the separate patentability of
claim 26 or any of the dependent claims. Appeal Br. 6-13. We select
claim 18 as representative, with all remaining pending claims standing or
falling with claim 18. See 37 C.F.R. § 4I.37(c)(l)(iv).
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Application 13/885,714
The Examiner finds that Kruecker discloses all of the limitations of
claim 1. Final Action 2-3. In particular, the Examiner finds that Kruecker
discloses a memory that stores a probability estimation module and planning
tool as claimed. Id. at 2.
Appellants argue that Kruecker does not disclose a probability module
as claimed. Appeal Br. 7. According to Appellants:
[C]laim 18 recites, inter alia, a workstation comprising a
"probability estimation module [that] is configured to define
shapes and sizes of ablation volumes in accordance with a
treatment probability distribution, determines a joint probability
distribution for at least two planned ablations in a target
volume, and computes a metric using a spatial representation of
a joint probability map and the target volume." Kruecker et al.
does not disclose at least a probability estimation module
including any of these features, inherently or otherwise.
Id. at 7-8 ("Kruecker et al. simply does not disclose incorporating a
probabilistic approach to determining ablation shapes and sizes").
In response, the Examiner states that Kruecker discloses a planning
component that calculates a three-dimensional treatment plan including a
plurality of desired ablation probe placement positions and orientations and
a plurality of estimated ablation volumes to achieve a desired composite
ablation volume that will treat the entire planned target volume (PTV).
Ans. 4. The Examiner further states that Kruecker treats tissue with RF
ablation in accordance with a three-dimensional treatment plan. Id. The
Examiner further states that Kruecker determines actual probe position and
orientation and actual ablation volume based on treatment images. Id.
According to the Examiner, a treatment iteration is calculated based on the
treatment plan, the actual probe position/orientation, and actual ablation
volume. Id.
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Application 13/885,714
Explaining further, the Examiner states that the treatment iteration
results in a desired next probe position or desired next ablation volume.
Ans. 4. The Examiner then explains that Kruecker provides revised
treatment instructions to the operator based on the treatment iteration and
then continues such iterative treatment until the treatment is completed in
accordance with a desired planned target volume. Id.
The Examiner concludes that a planning tool that allows computation
of a composite ablation consisting of a plurality of individual ablation
positions and orientations based on the planned target volume that is
estimated or known, necessarily uses some variation of a probability. Id.
at 5. The Examiner finds that the foregoing is properly considered to be a
probability estimation module. Id.
In reaching the foregoing findings and conclusions, the Examiner
notes that Appellants' disclosure provides no special definition of
"probability distribution." Id. Thus, "the [E]xaminer takes the position that
the estimation ablation volumes are interpreted as a type of probability
distribution which also represent a likelihood of treatment within ablation
volumes." Id.
In reply, Appellants reiterate that Kruecker does not disclose a
probability estimation module as claimed. Reply Br. 5. Appellants reassert
that Kruecker does not inherently require probabilities, probability
distributions, or joint probability maps as recited in claim 18. Id.
In evaluating the competing positions of Appellants and the Examiner,
we note, at the outset, that there is commonality in the named inventorship
between Kruecker and the instant invention. Next, we note that the subject
matter of both Kruecker and the instant invention is directed to planning and
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Application 13/885,714
navigational guidance for RF ablation therapy procedures. Kruecker,
Abstract, 1-2. Third, we note that both Kruecker and the instant invention
disclose functions that may be implemented in computer software. Kruecker
,r 36; 1 Spec. 5, 11. 7-9. 2 Thus, Appellants' arguments are properly
understood as a team of inventors attempting to patentably distinguish an
alleged improvement over their own prior work.
Appellants make much of the fact that their instant disclosure makes
copious use of the word "probability" and variations thereof, but Kruecker
does not. See e.g., Appeal Br. 8 (Asserting that Kruecker "does not mention
probabilities in any context."). However, the fact that Kruecker does not use
the word "probability" does not mean that it does not anticipate claim 18.
See In re Bode, 550 F.2d 656, 660 (CCPA 1977) (explaining that, while
anticipation requires disclosure of each and every element of the claim at
issue in a single prior art reference, the disclosure need not be in haec
verba); see also In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009) (a
reference need not satisfy an ipsissimis verb is test).
Kruecker discloses a planning and navigation system for ablation
treatment that includes: (1) a planning component; (2) a navigation
component; (3) a feedback subsystem; (4) an imaging system; (5) a tracking
system; ( 6) an ablation probe; and (7) a graphical user interface. Kruecker
,r 19, Fig. 1. Kruecker teaches that:
1 "The invention, including the steps of the methodologies described above,
can be realized in hardware, software, or a combination of hardware and
software." Kruecker ,r 36.
2 The elements depicted in the FIGS. may be implemented in various
combinations of hardware and software and provide functions which
may be combined in a single element or multiple elements. Spec. 5, 11. 7-9.
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Application 13/885,714
The planning system component ( 1) can allow computation of a
composite ablation consisting of a plurality of optimal
individual ablation positions/orientations based on input of a
desired planned target volume (PTV) to be covered, and
estimated or known individual ablation sizes. The desired
composite ablation volume is comprised of a plurality of
ablations that together will treat the entire PTV. The planning
system component ( 1) utilizes image data acquired from the
imaging component (4) of the system. Inputs to the planning
component (1) can include a baseline image of the tissue to be
treated from the imaging component ( 4 ), PTV segmentation,
desired individual ablation shape and size, and desired skin
entry point(s) selected by the treating physician. The planning
system component (1) can calculate an initial plan for
treatment, which is a 3-D mapping of the optimal number of
ablations that will cover the PTV. The planning system
component also has the capability to use feedback about the
actual ablation positions or sizes, or actual tumor location
relative to the ablation probe, to update or refine the plan
iteratively. A plan includes the optimal number of ablations
that will completely treat/ablate the PTV, the 3D location of
each of those individual ablations, and the orientation of each of
those individual ablations.
Id. ,r 20. As explained in the above quoted passage, the planning system
calculates a treatment plan in the form of 3-D mapping of the optimal
number of ablations to be used in the treatment. Id. In view of the
foregoing disclosure, the Examiner's finding that Kruecker's system would
necessarily use "some variation of a probability" to achieve such
functionality has substantial merit. Ans. 5.
In their Appeal Brief, Appellants recite a passage from In re
Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) for the proposition that
inherency requires a showing that missing descriptive matter is necessarily
present in a reference and may not be established by probabilities or
possibilities. Appeal Br. 10. Appellants then assert that "the Examiner
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Application 13/885,714
bears the burden of proving inherency, which has not been done in the
Office Action." Id. Appellants' former assertion is a correct statement of
law. Appellants' latter statement is not entirely accurate.
In the instant case, the Examiner has set forth a reasonable basis for
believing that Kruecker inherently discloses probability analysis in
connection with its treatment planning function. Final Action 2-3;
Ans. 3-5. This is sufficient to shift the burden of proof to Appellants to
demonstrate otherwise. See In re Best, 562 F.2d 1252, 1255 (CCP A 1977)
( explaining that where the claimed and prior art products are identical or
substantially identical, 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); In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)
("[W]hen the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.").
Taking into consideration the commonality of named inventorship
between Kruecker and the application on appeal, Appellants are in a better
position than the Examiner to demonstrate whether or not Kruecker's
planning component uses mathematical probability techniques in calculating
a plan for treatment that includes 3-D mapping of the optimal number of
ablations to use during treatment. In our opinion, the Examiner has made
sufficient findings to shift the burden of proof on the "probability" issue to
Appellants under Best and Spada, supra.
Appellants' challenge to the Examiner's findings is, for the most part,
mere attorney argument. See generally Appeal Br.; and Reply Br. In our
opinion, Appellants have failed to carry their burden of proving that the
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Application 13/885,714
probability estimation features of claim 18 are not inherently present in
Kruecker.
Otherwise, the Examiner's findings of fact are supported by a
preponderance of the evidence, such that we sustain the Examiner's
anticipation rejection of claims 18-31.
Double Patenting
We do not reach the Examiner's provisional rejection of claims 18-31
on the ground of non-statutory obviousness-type double-patenting. See Ex
parte Moncla, 95 U.S.P.Q.2d 1884 (BPAI 2010) (precedential).
DECISION
The decision of the Examiner to reject claims 18-31 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOCHEN KRUECKER, SANDEEP DALAL,
BRADFORD JOHNS WOOD, and SHENG XU
Appeal2018-001248
Application 13/885,714
Technology Center 3700
Before JAMES P. CALVE, WILLIAM A. CAPP, and LEE L. STEPINA,
Administrative Patent Judges.
STEPINA, Administrative Patent Judge, dissenting.
I respectfully dissent.
As discussed above, the disputed issue in this case is whether
Kruecker discloses a probability estimation module and its associated
characteristics as recited in claim 18. See Appeal Br. 7-12; Reply Br. 4--8.
(a)
In determining that Kruecker discloses all the elements required by
claim 18, the Examiner states, "Kruecker discloses a system, comprising: a
workstation including a processor and a memory coupled to the processor
(inherent in planning system component 1 ), the memory storing a
probability estimation module and a planning tool (in planning system
component 1 ). " Final Act. 2 ( emphasis added). The Examiner next states
"the probability estimation module is configured to define shapes and sizes
of ablation volumes in accordance with a treatment probability distribution,
Appeal2018-001248
Application 13/885,714
determines a joint probability distribution for at least two planned ablations
in a target volume, and computes a metric using a spatial representation of a
joint probability map and the target volume." Id. at 2-3. As support for
these assertions, the Examiner explains that we should "see entire document
[(the entire disclosure of Kruecker)] for this and all other citations, including
0002, 0004 and 0016--0037." Id. at 3. Thus, as set forth in the Final Action,
the Examiner relies on inherent disclosure to meet only the requirements in
claim 18 for a workstation including a processor and a memory coupled to
the processor. In other words, the Examiner finds that some portion of
Kruecker' s "entire document" implicitly or expressly teaches a
probability estimation module . . . configured to define shapes
and sizes of ablation volumes in accordance with a treatment
probability distribution, determine[] a joint probability
distribution for at least two planned ablations in a target volume,
and computes a metric using a spatial representation of a joint
probability map and the target volume;
wherein the treatment probability distribution represents a
likelihood of treatment within the ablation volumes.
Appeal Br. 16 (Claims App.).
In the Advisory Action (dated June 1, 2017, herein Advisory Act.),
the Examiner clarifies where the above-noted probability estimation module
is to be found in Kruecker. Specifically, the Examiner states,
As disclosed by the prior art Kreucker, there is disclosed a
plurality of estimated ablation volumes to achieve a desired
composite ablation [Para 0013---0015]. When utilizing these
estimations there is an assumption that the clinician is using
probability to create an overall composite. Although the
language is not identical, probability estimation module, the
system of Kreucker is also configured to define shapes and sizes
of ablation volumes in accordance with a treatment distribution
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Application 13/885,714
by mapping it with a plurality of estimated ablation volumes and
creating a 3-D treatment plan which is based on any of the
physicians experience, simulation or experimentation.
Adv. Act. 2 (emphases added). Thus, the Examiner relies on Kruecker's
disclosure of "estimated ablation volumes" as a disclosure of "using
probability to create an overall composite."
Appellants and the Examiner agree that Kruecker creates a treatment
plan that uses an estimated shape and size of each individual ablation. See
Appeal Br. 7-8; Adv. Act. 2. However, as Appellants point out, Kruecker's
teaching to estimate a balloon volume of an individual ablation is not the
same as teaching to define ablation volumes in accordance with a treatment
probability distribution. The Examiner does not identify any disclosure in
Kruecker that explains how the above-noted estimate is related to a
probability distribution of any kind, much less a probability distribution that
represents a likelihood of treatment within the ablation volumes as required
by claim 18. Nor do I find such disclosure in Kruecker. Thus, a
preponderance of the evidence does not support the Examiner's finding that
Kruecker explicitly or implicitly teaches a probability estimation module as
recited in claim 18.
(b)
Absent sufficient explanation from the Examiner as to how disclosure
of "a plurality of estimated ablation volumes" qualifies as a teaching in
Kruecker that a "clinician is using probability to create an overall
composite" or how even this use of probability, per se, would qualify as a
teaching of the probability estimation module configured specifically as
recited in claim 18 (Advisory Act. 2), Appellants traverse what amounts to a
rejection based on inherency. Appeal Br. 9. In this regard, in an attempt to
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Application 13/885,714
rebut a finding of inherency, Appellants provide an example of how to
determine ablation volumes without doing so in accordance with a treatment
probability distribution. Id. In response, the Examiner does not address this
example directly, but states:
By having a planning tool that allows computation of a
composite ablation consisting of a plurality of individual ablation
positions and orientations based on the planned target volume
that is estimated or known, the user or system would
fundamentally use some variation of a probability. Which can
be considered to be a probability estimation module. By
combining and integrating the planning, visualizing and
navigating portions of the system, Kreucker discloses the
claimed method.
Ans. 5 (emphasis added). Thus, the Examiner finds that Kruecker's system
would fundamentally use some variation of a probability.
To the extent the Examiner's position relies on an inherent disclosure
of the above-noted features in Kruecker, I find Appellants' example to be
reasonable, and I find Appellants' argument persuasive. Some estimates are
not made in accordance with a treatment probability distribution ( or even in
accordance with any kind of probability distribution). 3 Further, even
assuming, for the purpose of argument, that an estimate always requires
reliance on a probability of some kind, the Examiner does not explain
sufficiently how using "some variation of probability" would meet,
specifically, the requirement in claim 18 for a treatment probability
3 Perhaps the Examiner correlates an "estimate" with defining shapes and
sizes of ablation volumes in accordance with a treatment probability
distribution in the sense that an estimate is not necessarily perfectly accurate,
i.e., it "might be" or is "nearly" or "probably" correct. Nonetheless, an
estimate that has some probability of being correct is not necessarily the
same as one that is made in accordance with a treatment probability
distribution.
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Application 13/885,714
distribution that represents a likelihood of treatment within the ablation
volumes.
(c)
As for whether the probability estimation module recited in claim 18
is met by Kruecker's disclosure of a planning system that calculates a
treatment plan in the form of 3-D mapping of the optimal number of
ablations to be used in the treatment (see Kruecker ,r 20), I see no reason that
planning, calculating, or 3-D mapping of the optimal number of ablations to
be used necessarily requires a system using "some variation of a
probability," much less one that satisfies the requirement in claim 18 that the
probability estimation module be configured to (i) "define shapes and sizes
of ablation volumes in accordance with a treatment probability distribution,"
(ii) determine "a joint probability distribution for at least two planned
ablations in a target volume," and (iii) compute "a metric using a spatial
representation of a joint probability map and the target volume" when the
treatment probability distribution represents a likelihood of treatment in the
ablation volumes. Although, planning, calculating, and 3-D mapping of the
optimal number of ablations to be used would appear to require the use of
mathematics in some manner, I see no reason that these steps would require
the use of a treatment probability distribution. Creating an initial plan, based
on estimated individual ablation sizes, need not be in accordance with any
probability distribution, even if the estimate of the individual ablation sizes
has less than a 100% probability of being accurate. Likewise, the fact that
the plan includes the optimal number of ablations (based on the estimate)
that will treat the target volume does not mean that the plan is made in
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Application 13/885,714
accordance with any probability distribution. 4 Nor does iteratively updating
and refining the plan based on feedback about the actual ablation positions
or sizes, or actual tumor location relative to the ablation probe necessarily
implicate the use of a probability distribution.
Appellants have apprised me of error in the Examiner's rejection of
claim 18. Accordingly, I would reverse the rejection of claim 18 as
anticipated by Kruecker.
4 If I estimate that my snow shovel is 2 feet wide and then use that estimate
to determine the optimum route for shoveling my driveway ( a route
minimizing the distance the shovel travels), I may do this intuitively,
iteratively with pen and paper, or via a mathematical algorithm, all without
the use of any probability distribution.
6