Audigier, Chloe et al.

Patent Trials and Appeals Board

Sep 26, 2019

14769844 - (D) (P.T.A.B. Sep. 26, 2019)

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.
14/769,844 08/24/2015 Chloe Audigier 2013P03921WOUS 3084
28524 7590 09/26/2019
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
3501 Quadrangle Blvd Ste 230
Orlando, FL 32817
EXAMINER
SKIBINSKY, ANNA
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
09/26/2019 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CHLOE AUDIGIER, TOMMASO MANSI, VIOREL MIHALEF,
ALI KAMEN, DORIN COMANICIU, PUNEET SHARMA, and
SAIKIRAN RAPAKA1
__________

Appeal 2019-003371
Application 14/769,844
Technology Center 1600
__________

Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, 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 simulation of liver tumor ablation, which have been rejected as being
directed to patent-ineligible subject matter. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the Real Party in Interest as Siemens Healthcare
GmbH. Appeal Br. 1.
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STATEMENT OF THE CASE
“[I]ncreasing interest has been focused on ablative approaches for the
treatment of unresectable liver tumors. Rather than extirpation, this
technique uses complete local in situ tumor destruction. . . . Radiofrequency
ablation (RFA) is the most commonly used” method. Spec. ¶ 3. “The RFA
procedure is performed by placing a probe within the target area, the tumor.
. . . [T]he success of the procedure depends on the optimal placement of the
probe and heat delivery.” Id. ¶¶ 4–5. The Specification discloses “a method
and system for interactive patient-specific simulation of tumor ablation.” Id.
¶ 6.
Claims 1–57 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A method for interactive patient-specific simulation of liver tumor
ablation, comprising:
estimating, from medical image data of a patient, a patient-specific
anatomical model of a liver of the patient and a venous system of the liver;
generating a computational domain from the patient-specific
anatomical model of the liver;
simulating blood flow in the liver and the circulatory system of the
liver based on the patient-specific anatomical model;
simulating heat diffusion due to ablation based on a virtual ablation
probe position corresponding to a possible ablation probe position for an
ablation procedure for the patient and the simulated blood flow in the liver
and the circulatory system of the liver by solving a bio-heat equation at each
of a plurality of nodes of the computational domain; and
computing cellular necrosis in the liver based on the simulated heat
diffusion and updating tissue parameters based on a computed cellular state
to provide a predicted necrotic extent resulting from the ablation procedure
for the patient with the possible ablation probe position.

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Claims 20 and 39 are also independent and are directed to an
apparatus and a computer readable medium, respectively, for carrying out
the method of claim 1.
DISCUSSION
The Examiner has rejected claims 1–57 under 35 U.S.C. § 101
“because the claimed invention is directed to a judicial exception (i.e. a law
of nature, a natural phenomenon or an abstract idea) without significantly
more.” Ans. 3. Specifically, the claimed method “models heat diffusion
based on simulated stimuli, i.e. a virtual ablation probe[,] by solving a
biologically adapted heat equation. The claimed method relies on
calculations of fluid dynamics to model three dimensional blood flow as a
function of time.” Id. The Examiner finds that “[t]he claims as a whole are
directed to solving dynamics equations which model system behavior as a
function of time. Mathematical calculations are drawn to an abstract idea.”
Id. at 4.
The Examiner finds that additional elements in the claims are routine,
conventional, and well understood and “do not provide meaningful
limitation(s) to transform the abstract idea into a patent eligible application
of the abstract idea such that the claim(s) amounts to significantly more than
the abstract idea itself.” Id. at 4–5.
Appellant argues that “claim 1 involves computer-based simulations
of blood flow, heat diffusion, and cellular necrosis. Accordingly, one skilled
in the art would understand that method of independent claim 1 clearly
relates to the computer-related technology computer-based simulation of
liver-tumor ablation.” Appeal Br. 5.
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Specifically, “[t]he method recited in independent claim 1 simulates
heat diffusion for a possible ablation probe position for an actual ablation
procedure for the patient and computes the cellular necrosis to provide a
predicted necrotic extent resulting from the ablation procedure with the
possible ablation probe location.” Id. at 6. Appellant argues that the claimed
method allows
evaluat[ing] whether the possible probe position will result in a
successful ablation procedure for the patient. Therefore, the
method of independent claim 1 clearly provides a technological
improvement to conventional techniques for planning of liver
tumor ablations and selection of the ablation probe location for
liver tumor ablations.
Id. “A prediction of whether an ablation procedure with a certain ablation
probe position will be successful clearly improves the actual ablation
procedure, as it reduces the chances of ablation being performed with the
ablation probe at a sub-optimal position.” Id. at 10.
We agree with Appellant that the claims are not directed to a patent-
ineligible abstract idea. An invention is patent-eligible if it claims a “new
and useful process, machine, manufacture, or composition of matter.” 35
U.S.C. § 101. However, the Supreme Court has concluded that “[l]aws of
nature, natural phenomena, and abstract ideas” are not patentable under 35
U.S.C. § 101. See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216
(2014).
To determine if a claim falls into an excluded category, we apply a
two-step framework, described in Mayo and Alice. Id. at 217–18 (citing
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75–77
(2012)). We first determine what the claim is “directed to.” See Alice, 573
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U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging.”).
Patent-ineligible abstract ideas include certain methods of organizing
human activity, such as fundamental economic practices (Alice, 573 U.S. at
219–20; Bilski, 561 U.S. at 611), mathematical formulas (Parker v. Flook,
437 U.S. 584, 594–95 (1978)), and mental processes (Gottschalk v. Benson,
409 U.S. 63, 69 (1972)). In contrast, patent-eligible inventions include
physical and chemical processes, such as “molding rubber products”
(Diamond v. Diehr, 450 U.S. 175, 192 (1981)); “tanning, dyeing, making
water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7
(quoting Corning v. Burden, 56 U.S. 252, 267–68 (1854))); and
manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94
U.S. 780, 785 (1876))).
In Diehr, the claimed method employed a mathematical formula, but
the Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 176; see also id. at 192 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). The
Supreme Court noted, however, that a claim “seeking patent protection for
that formula in the abstract . . . is not accorded the protection of our patent
laws, . . . and this principle cannot be circumvented by attempting to limit
the use of the formula to a particular technological environment.” Id. (citing
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Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an
application of a law of nature or mathematical formula to a known structure
or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, and “examine the elements of the
claim to determine whether it contains an ‘inventive concept’ sufficient to
‘transform’ the claimed abstract idea into a patent-eligible application.”
Alice, 573 U.S. at 221 (quotation marks omitted). “A claim that recites an
abstract idea must include ‘additional features’ to ensure ‘that the [claim] is
more than a drafting effort designed to monopolize the [abstract idea].’” Id.
(quoting Mayo, 566 U.S. at 77 (alterations in original)). “[M]erely
requir[ing] generic computer implementation[] fail[s] to transform that
abstract idea into a patent-eligible invention.” Id.
The PTO recently published revised guidance on the application of
§ 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019) (“Revised Guidance”). Under that guidance, we first
determine whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts; certain methods of organizing
human activity such as a fundamental economic practice; or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
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See 84 Fed. Reg. at 54–55. Only if a claim (1) recites a judicial exception and
(2) does not integrate that exception into a practical application, do we then
determine whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
a “well-understood, routine, conventional activity” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See 84 Fed. Reg. at 56.
Guidance Step 2(a), Prong 1
Claim 1 recites “simulating heat diffusion . . . by solving a bio-heat
equation at each of a plurality of nodes of [a] computational domain.”
Independent claims 20 and 39 include the same claim language.
Regarding this step, the Specification states that “[a] bio-heat equation
is . . . solved on an isotropic Cartesian grid using the Lattice Boltzmann
method.” Spec. ¶ 18. “Two main simplifications for solving the coupled bio-
heat equations are the Pennes model and the Wulff-Klinger (WK) model.”
Id. ¶ 31. “The Pennes model may be expressed as:
.” Id. ¶ 32. “The Wulff-Klinger
model can be expressed as: .” Id.
¶ 33. The variables in the above equations are defined in the Specification’s
¶ 34. “[E]mbodiments of the present invention solve the bio-heat equation
by combining the Pennes and Wulff-Klinger models.” Id. ¶ 36.
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Thus, although claim 1 does not recite any specific mathematical
equations or formulas, the limitation of “solving a bio-heat equation at each
of a plurality of nodes” is a recitation of a mathematical concept. Therefore,
claim 1 recites an abstract idea.
Guidance Step 2(a), Prong 2
Even though claim 1 recites a mathematical concept, it may still be
patent-eligible if “the claim as a whole integrates the recited judicial
exception into a practical application of the exception”; i.e., whether the
claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that
imposes a meaningful limit on the judicial exception.” 84 Fed. Reg. at 54.
This analysis includes “[i]dentifying whether there are any additional
elements recited in the claim beyond the judicial exception(s)” and
“evaluating those additional elements individually and in combination to
determine whether they integrate the exception into a practical application.”
Id. at 54–55.
Here, claim 1 as a whole integrates the recited mathematical concept
into a practical application. In addition to mathematical calculations, claim 1
includes using medical image data from a specific patient to “estimat[e] . . .
a patient-specific anatomical model of a liver of the patient and a venous
system of the liver,” which is then used to generate a computational domain
for simulating blood flow and heat diffusion, in order to compute cellular
necrosis “to provide a predicted necrotic extent resulting from the ablation
procedure for the patient with the possible ablation probe position.” Claim 1.
Appellant’s Specification states that “the success of the procedure
depends on the optimal placement of the probe and heat delivery with
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respect to the circulation system and tissue properties of the liver and
tumors. Different placements may have different results.” Spec. ¶ 5.
Conventionally, “[t]o place the probe at the target location, the physician
relies on intra-operative imaging techniques, such as ultrasound.” Id.
The Specification states that the claimed method “provides . . . for
interactive patient-specific simulation of tumor ablation.” Id. ¶ 6. The
Specification states that the method allows “fast patient-specific simulation
of liver tumor ablation that can be utilized with near real time interaction in
a clinical setting.” Id. ¶ 19. The Specification also states that the Lattice
Boltzmann method (LBM) implementation “can be implemented on a
massively parallel architecture” so that “liver tumor ablation simulations can
be performed efficiently in response to user interactions, which allows a user
to interactively plan liver tumor ablation therapy using the simulations in a
clinical setting.” Id.
Thus, as described in the Specification, the claimed method includes
the use of medical image data from a specific patient, which allows a
clinician to predict the effect of a tumor ablation procedure, in that patient,
with an ablation probe in different positions. We agree with Appellant that
“[a] prediction of whether an ablation procedure with a certain ablation
probe position will be successful” represents an improvement in the
technical field of liver tumor ablation, because “it reduces the chances of
ablation being performed with the ablation probe at a sub-optimal position.”
Appeal Br. 10.
We therefore conclude that, even though claim 1 recites a
mathematical concept, as a whole it integrates that concept into a practical
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application; specifically, calculating a particular set of recited parameters to
simulate a liver tumor ablation procedure in a specific patient, thereby
increasing the likelihood that the procedure will be successful. Therefore,
the claimed method, as a whole, is not “directed to . . . [a] patent-ineligible
concept.” Alice, 573 U.S. at 217. The same analysis applies to independent
claims 20 and 39. Cf. id. at 226 (“[T]he system claims are no different from
the method claims in substance.”).
The Examiner reasons that “planning a procedure and selection per se
are abstract ideas that can be performed as a mental process. Appellants have
not provided evidence that the information derived from their model is
practically applied such that an improvement is realized in the ‘real world.’”
Ans. 6.
We do not agree with this position. Claim 1 is directed to a “method
for interactive patient-specific simulation of liver tumor ablation” that
includes “estimating, from medical image data of a patient, a patient-specific
anatomical model of a liver of the patient.” Claim 1 (emphasis added). Thus,
the claim language makes clear that the method is directed to simulating the
effect of a liver tumor ablation procedure, not as an abstraction, but in a
specific patient.
As discussed above, the Specification states that the claimed method
“allows a user to interactively plan liver tumor ablation therapy using the
simulations in a clinical setting.” Spec. ¶ 19. Simulating the effect obtained
with an ablation probe in different positions is helpful because “the success
of the procedure depends on the optimal placement of the probe and heat
delivery. . . . Different placements may have different results.” Id. at ¶ 5.
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Thus, the evidence supports Appellant’s position that the claimed method
provides a real-world technological improvement to the process of ablating a
liver tumor in a patient.
In summary, we reverse the rejection of independent claims 1, 20, and
39 under 35 U.S.C. § 101. Claims 2–19, 21–38, and 40–57 depend from one
of claims 1, 20, or 39 and we therefore reverse the rejection of these claims
as well, for the reasons discussed above.

CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1–57 § 101 1–57

REVERSED