Ex Parte Hartman et al

Patent Trials and Appeals Board

Apr 19, 2019

14040479 - (D) (P.T.A.B. Apr. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/040,479 09/27/2013
75557 7590 04/23/2019
Kilpatrick Townsend & Stockton LLP (Varian)
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
FIRST NAMED INVENTOR
J oona Hartman
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.
88389-003000US-87 l 725 7385
EXAMINER
NGUYEN, TRAN N
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
04/23/2019 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):
ipefiling@kilpatricktownsend.com
ipdocket@varian.com
KTSDocketing2@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOONA HARTMAN, MARIA ISABEL CORDERO MARCOS,
ESA KUUSELA, JARKKO YRJANA PEL TOLA,
and JANNE ILMARI NORD
Appeal2018-001446 1
Application 14/040,4792
Technology Center 3600
Before HUBERT C. LORIN, NINA L. MEDLOCK, and
BRADLEY B. BAY AT, Administrative Patent Judges.
MEDLOCK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1, 4, 5, 7-11, and 13-22. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
1 Our decision references Appellants' Appeal Brief ("App. Br.," filed
May 23, 2017) and Reply Brief ("Reply Br.," filed November 22, 2017), and
the Examiner's Answer ("Ans.," mailed September 26, 2017) and Final
Office Action ("Final Act.," mailed December 23, 2016).
2 Appellants identify Varian Medical Systems, International AG as the real
party in interest. App. Br. 3.
Appeal 2018-001446
Application 14/040,479
CLAIMED INVENTION
Appellants' disclosure "relates generally to treatment planning for
treating a tumor" and, more particularly, to "choosing a treatment plan based
on estimation models for different treatments" (Spec. ,r 2).
Claims 1, 15, and 2 0 are the independent claims on appeal. Claims 1
and 20, reproduced below, are illustrative of the claimed subject matter:
1. A method of selecting among a plurality of treatment plan
types for treating a tumor of a first patient, the method
compnsmg:
for each of the plurality of treatment plan types:
creating, by a computer system, an estimation
function associated with the treatment plan type by:
receiving previous outcome values of one or
more types of outcome values for previous patients
treated using the treatment plan type,
receiving previous input values of input
variables for the previous patients,
for each of the one or more types of outcome
values:
using the previous input values and the
previous outcome values corresponding to
the type of outcome value to determine an
estimation subfunction of the estimation
function;
receiving, by the computer system, information about the
first patient;
analyzing, by the computer system, the information to
determine a set of input values, the input values including
characteristics of the tumor;
for each of the plurality of treatment plan types:
identifying an estimation function associated with
the treatment plan type, and
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predicting a quality of the treatment plan type by
using the set of input values with the identified estimation
function to calculate, by the computer system, one or more
outcome values, and determining a quality score based on
the one or more outcome values;
identifying, by the computer system, a first treatment plan
type having an optimal quality score to a user of the computer
system, the first treatment plan type including providing
radiation to the first patient;
generating, by the computer system, a first treatment plan
of the first treatment plan type based on the set of input values
and the plurality of outcome values, the first treatment plan
including instructions for controlling a treatment head in order to
treat the tumor of the first patient; and
providing, by the treatment head coupled with a radiation
source, radiation at predefined angles and pre-defined doses to
specific portions of a treatment area of the first patient according
to the first treatment plan, wherein the treatment head is
controlled by a control unit according to the instructions in the
first treatment plan.
20. A radiation therapy system comprising:
a radiation therapy device including:
a rotatable gantry including a treatment head and a
multileaf collimator, wherein the multileaf collimator is
configured to shape a radiation beam emitted from the
treatment head; and
a control unit configured to:
control the rotation of the rotatable gantry,
control emission of the radiation beam from
the treatment head, and
control the shape of the radiation beam via
the multileaf collimator;
wherein the radiation therapy device is configured to:
receive a first treatment plan of a first treatment plan
type; and
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provide the radiation beam at pre-defined angles
and pre-defined doses to specific portions of a treatment
area of a first patient according to instructions in the first
treatment plan;
one or more processors; and
a non-transitory computer readable medium for
controlling the one or more processors, the computer
readable medium storing a plurality of instructions that
when executed control the one or more processors to select
among a plurality of treatment plan types for treating a
tumor of the first patient, the instructions comprising:
receiving information about the first patient;
analyzing the information to determine a set of input
values, the input values including characteristics of the
tumor;
predicting, using a dose prediction model, a dose
distribution of radiation to be provided to the tumor based
on the characteristics of the tumor, the dose distribution
specifying a variation of radiation dose within the tumor;
determining one or more dose input values from the
predicted dose distribution;
for each of the plurality of treatment plan types:
identifying an estimation function associated
with the treatment plan type, the estimation function
generated based on outcomes of other patients using
the treatment plan type, and
predicting a quality of the treatment plan type
by using the set of input values with the identified
estimation function to calculate, by the computer
system, a plurality of outcome values and
determining a quality score based on the plurality of
outcome values, the set of input values including the
one or more dose input values;
identifying the first treatment plan type having an
optimal quality score, the first treatment plan type
including providing radiation to the first patient;
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generating the first treatment plan of the first
treatment plan type based on the set of input values and
the plurality of outcome values, the first treatment plan
including instructions for controlling the rotation of the
rotatable gantry, the emission of the radiation beam from
the treatment head, and the shape of the radiation beam via
the multileaf collimator in order to treat the tumor of the
first patient according to the predicted dose distribution;
and
providing the first treatment plan from the one or
more processors to the control unit of the radiation therapy
device.
REJECTION
Claims 1, 4, 5, 7-11, and 13-22 are rejected under 35 U.S.C. § 101 as
directed to a judicial exception without significantly more.
PRINCIPLES OF LAW
Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a
"new and useful process, machine, manufacture, or composition of matter."
35 U.S.C. § 101. The Supreme Court, however, has long interpreted§ 101
to include an implicit exception: "[l]aws of nature, natural phenomena, and
abstract ideas" are not patentable. Alice Corp. v. CLS Bank Int 'l, 573 U.S.
208,216 (2014).
The Supreme Court, in Alice, reiterated the two-step framework
previously set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), "for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts." Alice Corp., 573 U.S. at 217.
The first step in that analysis is to "determine whether the claims at issue are
directed to one of those patent-ineligible concepts." Id. If the claims are not
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directed to a patent-ineligible concept, e.g., an abstract idea, the inquiry
ends. Otherwise, the inquiry proceeds to the second step where the elements
of the claims are considered "individually and 'as an ordered combination"'
to determine whether there are additional elements that "'transform the
nature of the claim' into a patent-eligible application." Id. (quoting Mayo,
566 U.S. at 79, 78).
The Court acknowledged in Mayo, that "all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural phenomena,
or abstract ideas." Mayo, 566 U.S. at 71. Therefore, the Federal Circuit has
instructed that claims are to be considered in their entirety to determine
"whether their character as a whole is directed to excluded subject matter."
McRO, Inc. v. Bandai Namco Games Am., Inc., 837 F.3d 1299, 1312
(Fed. Cir. 2016) (quoting Internet Patents Corp. v. Active Network, Inc.,
790 F.3d 1343, 1346 (Fed. Cir. 2015)).
US PTO SECTION 101 GUIDANCE
The U.S. Patent and Trademark Office (the "USPTO") published
revised guidance on January 7, 2019 for use by USPTO personnel in
evaluating subject matter eligibility under 35 U.S.C. § 101; that guidance
"extracts and synthesizes key concepts identified by the courts as abstract
ideas to explain that the abstract idea exception includes" the following three
groupings: (1) mathematical concepts; (2) certain methods of organizing
human activity, e.g., fundamental economic principles or practices,
commercial or legal interactions; and (3) mental processes. 2019 REVISED
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PATENT SUBJECT MATTER ELIGIBILITY GUIDANCE, 84 Fed. Reg. 50, 52
(Jan. 7, 2019) (the "2019 Revised Guidance"). 3
Under the 2019 Revised Guidance, in determining whether a claim
is patent-eligible, we first look to whether the claim recites a judicial
exception, including one of the enumerated groupings of abstract ideas
("Step 2A, Prong One"). Id. at 54. If so, we next consider whether the
claim includes additional elements, beyond the judicial exception, "that
integrate the Uudicial] exception into a practical application," i.e., that apply,
rely on, or use the judicial exception in a manner that imposes a meaningful
limit on the judicial exception, such that the clam is more than a drafting
effort designed to monopolize the judicial exception. ("Step 2A, Prong
Two"). Id. at 54--55.
Only if the claim ( 1) recites a judicial exception and (2) does not
integrate that exception into a practical application do we then look to
whether the claim "[a]dds a specific limitation or combination of
limitations" that is not "well-understood, routine, conventional activity in the
field" or simply "appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception" ("Step 2B"). Id. at 56.
With the legal principles outlined above, and the 2019 Revised
Guidance in mind, we tum to the § 101 rejection here at issue.
3 The Revised Guidance, by its terms, applies to all applications, and to all
patents resulting from applications, filed before, on, or after January 7, 2019.
84 Fed. Reg. 50.
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ANALYSIS
Patent-Ineligible Subject Matter
Independent Claim 1 and Dependent Claims 4, 5, 8-11, 13, 14, 17-19, 21
and 22
In rejecting independent claim 1 under 35 U.S.C. § 101, the Examiner
determined that the steps of claim 1 "describe the concept of receiving
patient outcome values (new information) and comparing with the current
patient (stored information) to determine a treatment plan (using rules to
identify options)," which the Examiner concluded is an abstract idea because
it "corresponds to the concepts identified as abstract ideas by the courts in
Alice, such as comparing new and stored information and using rules to
identify options in SmartGene" (Final Act. 4 ). 4 The Examiner also
determined that claim 1 does not include additional elements or a
combination of elements that is sufficient to ensure that the claim amounts to
significantly more than the judicial exception (id. at 2, 4--7) because the
additional limitations, i.e.,
"a computer system" and
"providing, by the treatment head coupled with a radiation
source, radiation at predefined angles and pre-defined doses to
specific portions of a treatment area of the first patient according
to the first treatment plan, wherein the treatment head is
controlled by a control unit according to the instructions in the
first treatment plan,"
"provide conventional functions that do not amount to an inventive concept
that would add meaningful limits to practicing the abstract idea" (id. at 2, 4).
4 SmartGene, Inc. v. Advanced Biological Labs, SA, 555 F. App'x 950
(Fed. Cir. 2014).
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More particularly, the Examiner found that the claimed "computer
system" encompasses "a generic/ general-purpose computer" (id. at 5 ( citing
Spec. ,r 101 ); and that "[ t ]he Specification discloses that radiation therapy
devices administering a treatment plan [are] well understood, routine, and
conventional in the pertinent art" (id. at 6 (citing Spec. ,r 31)). The
Examiner, thus, concluded that "[t]hese computer components and radiation
therapy equipment are recited [at] a high level of generality and ... as
performing generic computer functions routinely used in computer
applications," i.e., that these "[g]eneric computer components [are] recited
as performing generic computer functions that are well-understood, routine
and conventional activities [ and] amount to no more than implementing the
abstract idea with a computerized system" (id.).
Appellants argue that the Examiner erred in determining that the
claims are directed to an abstract idea, and that the claims instead "provide a
particular solution for how measured outcome values and measurements
about a current patient are to be used to provide a treatment" (App. Br. 13).
Appellants thus, maintain that the claims are "related to the technical field of
the medicine [sic], more specifically the technical field of generation and
evaluation of cancer treatment plans by computers" (id. at 16), and that,
similar to the claims at issue in McRO, the pending claims "improve
computer-related technology by allowing computer performance of a
function not previously performable by a computer" (id. at 17).
The Specification is entitled "DECISION SUPPORT TOOL FOR
CHOOSING TREATMENT PLANS," and states that the disclosure "relates
generally to treatment planning for treating a tumor," and, more particularly,
to "choosing a treatment plan based on estimation models for different
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treatments" (Spec. ,r 2). The Specification discloses, in the Background
section, that there are multiple techniques for treating a tumor, e.g., radiation
treatment, chemotherapy, and surgery, each of which may encompass
several additional techniques; radiation treatment, for example, "may be
photon or proton" (id. ,r 3). The Specification describes that producing a
treatment plan can be a time-consuming process and, according to the
Specification, "only after the plan has been produced may [the] physician
determine that the treatment is not suitable" (id.). Using optimization
algorithms, a physician may, thus, spend several hours creating a treatment
plan for a patient of a selected treatment type only to find, after the work is
done, that the treatment plan is insufficient (id. ,r 5). At that point, the
physician must decide whether to refine the treatment process for the current
treatment type or generate a treatment plan for a new treatment type (id.).
The Specification describes that when the optimized treatment plan is below
expectations, further refinement may be chosen. "But, such a process does
not guide the physician's decision about whether to refine the treatment plan
for the current treatment type, or generate a treatment plan for a new
treatment type" (id. ,r 6). The Specification, thus, observes, that "it is
desirable to provide new tools that allow a physician to determine early what
type of treatment plan should be pursued" (id. ,r 7).
The claimed invention is intended to address this issue by providing
alternative treatment strategies to a user for evaluation (id. ,r 8). The
Specification, thus, describes that data regarding a particular patient are used
to determine input values to different estimation functions for different
treatment types (id. ,r 9; see also id. ,r 41 ("The patient information can
include diagnostic information (e.g., general tumor location or stage
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information) and geometric information (e.g., the spatial geometry of the
tumor and of other organs in the patient).")). These estimation functions are
each used to estimate one or more outcome values for the respective
treatment type, i.e., values that indicate the predicted quality of the treatment
e.g., the effect of the treatment on the patient (id. ,r 9; see also id. ,r 24). A
quality score is determined using the estimated outcome value( s ), and a first
treatment plan having an optimal quality score, i.e., a score that satisfies one
or more criteria or is better than another quality score, is identified (id. ,r 9;
see also id. ,r 24). In other words, the physician determines, based on the
quality scores, which of the treatment plan types is most suitable for the
particular patient (id. ,r 87).
Consistent with this discussion, claim 1 recites a method of selecting
among a plurality of treatment plan types for treating a tumor comprising:
( 1) "for each of the plurality of treatment plan types: creating ... an
estimation function associated with the treatment plan type"; (2) "receiving
... information about the first patient"; (3) "analyzing ... the [patient]
information to determine a set of input values ... including characteristics of
the tumor"; (3) "for each of the plurality of treatment plan types: ...
predicting a quality of the treatment plan type by using the set of input
values with the ... estimation function [ associated with the treatment plan
type] to calculate one or more output values, and determining a quality
score based on the one or more outcome values"; and (4) "identifying ... a
first treatment plan type having an optimal quality score." These limitations,
when given their broadest reasonable interpretation, recite mathematical
relationships between, e.g., input values, outcome values, estimation
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functions, and quality scores, 5 i.e., a mathematical concept, and, therefore,
an abstract idea. See 2019 Revised Guidance, 84 Fed. Reg. at 52. See also
RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1326 (Fed. Circ. 2017)
("[C]laim 1 is directed to the abstract idea of encoding and decoding image
data. It claims a method whereby a user displays images on a first display,
assigns image codes to the images ... using a mathematical formula, and
then reproduces the image based on the codes."); Digitech Image Techs.,
LLC v. Elecs. For Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014)
("Without additional limitations, a process that employs mathematical
algorithms to manipulate existing information to generate additional
information is not patent eligible.").
Having determined that claim 1 "recites" a judicial exception, i.e., a
mathematical concept, which is an abstract idea, we next consider whether
the claim recites "additional elements that integrate the judicial exception
into a practical application." See MANUAL OF PATENT EXAMINING
PROCEDURE ("MPEP") § 2106.05(a}-(c), (e}-(h).
Here, claim 1 recites additional limitations, which focus on treatment
of a specific tumor. These limitations (i.e., "generating ... a first treatment
5 See, e.g., Spec. ,r 24 ("A[ n] 'outcome value' refers to a value that indicates
a predicted quality of the treatment, such as an effect of the treatment on the
patient ( e.g., organ failure probability) and a property resulting from the
treatment (e.g., treatment time)."); id. ("A 'quality score' can correspond to
a particular outcome value were be a function of multiple outcome values.");
id. ,r 72 ("The input values can be mapped to output values, for example, by
using clustering, correlation, and functional fitting methods."); id. ,r 80 ("[A]
mapping (estimation) function between dose input value( s) and potentially
other input values to outcome values for the previous patients is
determined.").
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plan of the first treatment plan type ... including instructions for controlling
a treatment head in order to treat the tumor of the first patient"; and
"providing, by the treatment head coupled with a radiation source, radiation
at pre-defined angles and pre-defined doses to specific portions of a
treatment area of the first patient according to the first treatment plan"),
when considered individually and in combination, integrate the
mathematical concept into a practical application, i.e., these additional
elements apply the input values, outcome values, estimation functions, and
quality scores recited in the claim in a meaningful way, such that it is more
than a drafting effort designed to monopolize the judicial exception. In
particular, these limitations apply the recited mathematical relationships to
improve the selection of a treatment plan type that is optimal for treating a
particular patient's tumor based on specific characteristics of the tumor. See,
e.g., Spec. ,r,r 25-26. The claim limitations, thus, provide a technical
improvement in the evaluation of cancer treatment plans. See MPEP
§ 2106.05(a) ("Improvements to the Functioning of a Computer or To Any
Other Technology or Technical Field").
The claimed limitations also apply the judicial exception, i.e., the
mathematical concept, with a particular machine, i.e., "a treatment head ...
coupled with a radiation source and controlled by a control unit." See MPEP
§ 2106.05(b) ("Particular Machine"). As with the GPS receiver in SiRF, the
treatment head recited in claim 1 is a particular machine that "is integral
to ... the claim[ ] at issue." SiRF Tech., Inc. v. Int 'l Trade Comm 'n, 601
F.3d 1319, 1332 (2010). Claim 1, as described above, calls for generating a
treatment plan for a specific tumor, including "instructions for controlling a
treatment head in order to treat the tumor of the first patient" and "providing,
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by the treatment head coupled with a radiation source, radiation at
predefined angles and pre-defined doses to specific portions of a treatment
area of the first patient according to the first treatment plan." See SiRF, 601
F.3d at 1332 (concluding that the claim required "'pseudoranges' that
estimate the distance from 'the GPS receiver to a plurality of GPS
satellites"' and that pseudoranges "can exist only with respect to a particular
GPS receiver that receives the satellite signals"). Thus, as in SiRF, "the
method[ ] at issue could not be performed without the use of a [ treatment
head]." Id.; see also MPEP § 2106.05(b) ("When determining whether a
claim recites significantly more than a judicial exception, examiners should
consider whether the judicial exception is applied with, or by use of, a
particular machine.").
We conclude that claim 1 is not directed to an abstract idea.
Therefore, we do not sustain the Examiner's rejection of claim 1 under
35 U.S.C. § 101. For the same reasons, we also do not sustain the rejection
of dependent claims 4, 5, 7-11, 13, 14, 17-19, 21 and 22.
Independent Claim 15
Independent claim 15 includes language substantially similar to the
language of claim 1. Therefore, we do not sustain the rejection of claim 15
under 35 U.S.C. § 101 for the same reasons set forth above with respect to
claim 1.
Independent Claim 20
Independent claim 20 calls for a radiation therapy system, and
requires that the radiation therapy system comprise "a radiation therapy
device" including "a rotatable gantry including a treatment head and a
multileaf collimator" and "a control unit configured to control the rotation of
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the rotatable gantry." Although claim 20, like claim 1, recites a
mathematical concept, these structural limitations, along with the steps of
"generating the first treatment plan ... including instructions for controlling
the rotation of the rotatable gantry, the emission of the radiation beam from
the treatment head, and the shape of the radiation beam via the multileaf
collimator in order to treat the tumor" and "providing the first treatment plan
from the one or more processors to the control unit of the radiation therapy
device," are additional elements that integrate the mathematical concept into
a practical application for the same reasons set forth above with respect to
claim 1.
We are persuaded that the Examiner erred in rejecting claim 20 under
35 U.S.C. § 101. Therefore, we do not sustain the Examiner's rejection.
DECISION
The Examiner's rejection of claims 1, 4, 5, 7-11, and 13-22 under
35 U.S.C. § 101 is reversed.
REVERSED
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