Ex Parte Trayanova et al

Patent Trials and Appeals Board

Apr 2, 2019

13984741 - (D) (P.T.A.B. Apr. 2, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/984,741 11/20/2013
101887 7590 04/04/2019
The Johns Hopkins University
C/0 Venable LLP
P. 0. Box 34385
Washington, DC 20043-9998
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Natalia A. Trayanova
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.
02240-354323 2406
EXAMINER
BORIN, MICHAEL L
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
04/04/2019 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):
hjdaley@venable.com
PTOMAIL@VENABLE.COM
khauser@VENABLE.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
ExparteNATALIAA. TRAYANOVA, HENRY R. HALPERIN,
HERMENEGILD AREVALO, and JASON CONSTANTINO
Appeal2018-003128
Application 13/984,741 1
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal2 under 35 U.S.C. § 134(a) involves claims 1, 3, 6-10, 15,
17, 20-24, 29, 31, 34--38, and 43---63 (Final Act. 3 2). Examiner entered
rejections under 35 U.S.C. § 101, 35 U.S.C. § 103(a), and provisionally
under the judicially created doctrine of obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify "The Johns Hopkins University" as the real party in
interest (Appellants' August 10, 2017 Appeal Brief (Br.) 4).
2 This Appeal is related to Appeal 2018-002939 (Application 13/694,120).
3 Examiner's October 5, 2016 Final Office Action.
Appeal2018-003128
Application 13/984,741
STATEMENT OF THE CASE
Appellants' disclosure "relates to systems and methods for planning
patient-specific cardiac procedures" (Spec. 4 ,r 3). Appellants' independent
claims 1, 15, and 29 are representative and reproduced below:
1. A computer-implemented method of planning a patient
specific cardiac ablation procedure, comprising:
receiving contrast-enhanced three-dimensional MRI or
CT data that includes a living patient's heart;
segmenting said contrast-enhanced three-dimensional
MRI or CT data to obtain three-dimensional heart image data;
segmenting said three-dimensional heart image data into
a plurality of different tissue types of said heart based on said
contrast-enhanced three-dimensional MRI or CT data, said
plurality of different tissue types including a normal tissue
region, a scar tissue region and a transition zone region, said
transition zone region including an infarct border zone tissue
reg10n;
constructing a model of at least a portion of said living
patient's heart, said constructing said model comprising:
creating a finite element mesh using the segmented
three-dimensional data, to provide a geometrical representation
of said patient's heart, the finite element mesh comprising a
plurality of volume elements;
determining a fiber orientation in each of the
volume elements based on calculations executed on a patient-
specific geometry of the patient's heart; and
assigning electrophysiological parameters to each
of the volume elements taking into account the determined fiber
orientations and the type of tissue where the corresponding
volume element is located;
simulating, using a computer, at least one of
electrophysiological or electromechanical activity of at least a
4 Appellants' August 9, 2013 Specification.
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portion of said living patient's heart using said model, said
simulating inducing an arrhythmia in said model of said living
patient's heart; and
determining a patient-specific ablation target that
eliminates the arrhythmia with a minimal ablation lesion size;
and
providing said patient-specific ablation target to a user.
(Br. 26-27.)
15. A non-transitory computer-readable medium comprising
computer-executable code for planning a patient-specific
cardiac ablation procedure, said computer-executable code
comprising instructions that, when executed by said computer,
causes said computer to:
receive contrast-enhanced three-dimensional MRI or CT
imaging data of a living patient's heart, said living patient's
heart comprising normal tissue regions and remodeled tissue
reg10ns;
segment said contrast-enhanced three-dimensional MRI
or CT data to obtain three-dimensional heart image data;
segment said three-dimensional heart image data into a
plurality of different tissue types of said heart based on said
contrast-enhanced three-dimensional MRI or CT data, said
plurality of different tissue types including a normal tissue
region, a scar tissue region and a transition zone region, said
transition zone region including an infarct border zone tissue
reg10n;
construct a model of at least a portion of said living
patient's heart, said constructing said model comprising:
creating a finite element mesh using the segmented
three-dimensional data, to provide a geometrical representation
of said patient's heart, the finite element mesh comprising a
plurality of volume elements;
determining a fiber orientation in each of the
volume elements based on calculations executed on a patient-
specific geometry of the patient's heart; and
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assigning electrophysiological parameters to each
of the volume elements taking into account the determined fiber
orientations and the type of tissue where the corresponding
volume element is located;
simulate at least one of electrophysiological or
electromechanical activity of at least a portion of said living
patient's heart using said model, said simulating inducing an
arrhythmia in said model of said living patient's heart; and
determine a patient-specific ablation target that
eliminates the arrhythmia with a minimal ablation lesion size;
and
provide said patient-specific ablation target to a user.
(Br. 29-31.)
29. A system for planning a patient-specific cardiac ablation
procedure comprising a data processor configured with
computer-executable code, said computer-executable code
comprising instructions that, when executed by said data
processor, causes said data processor to:
receive contrast-enhanced magnetic resonance or CT
three-dimensional imaging data of a living patient's heart, said
patient's heart comprising normal tissue regions and remodeled
tissue regions;
segment said contrast-enhanced magnetic resonance or
CT three-dimensional imaging data to obtain three-dimensional
heart image data;
segment said three-dimensional heart image data into a
plurality of different tissue types of said heart based on said
contrast-enhanced magnetic resonance or CT three-dimensional
imaging data, said plurality of different tissue types including a
normal tissue region, a scar tissue region and a transition zone
region, said transition zone region including an infarct border
zone tissue region;
construct a model of at least a portion of said living
patient's heart, said constructing said model comprising:
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creating a finite element mesh using the segmented
three-dimensional data, to provide a geometrical representation
of said patient's heart, the finite element mesh comprising a
plurality of volume elements;
determining a fiber orientation in each of the
volume elements based on calculations executed on a patient-
specific geometry of the patient's heart; and
assigning electrophysiological parameters to each
of the volume elements taking into account the determined fiber
orientations and the type of tissue where the corresponding
volume element is located;
simulate at least one of electrophysiological or
electromechanical activity of at least a portion of said living
patient's heart using said model, said simulating inducing an
arrhythmia in said model of said living patient's heart; and
determine a patient-specific ablation target that
eliminates the arrhythmia with a minimal ablation lesion size;
and
provide said patient-specific ablation target to a user.
(Br. 33-35.)
Grounds of rejection before this Panel for review:
I. Claims 1, 3, 6-10, 15, 17, 20-24, 29, 31, and34-38 stand
provisionally rejected under the judicially created doctrine of obviousness-
type double patenting as being unpatentable over the claims of co-pending
Application 13/694, 120. 5
II. Claims 1, 3, 6-10, 15, 17, 20-24, 29, 31, 34--38, and 43-63 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of
5 See Examiner's July 14, 2015 Office Action 13-14.
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Trayanova 6 and any one of Constantini des, 7 Korn, 8 or Nathan, 9 in
combination with Frangi 10 and any one of Revishvili, 11 Chen, 12 or
Linenbank. 13
III. Claims 1, 3, 6-10, 15, 17, 20-24, 29, 31, 34--38, and43---63 stand
rejected under 35 U.S.C. § 101.
Re} ection I:
ISSUE
Should the provisional obviousness-type double patenting rejection on
this record be summarily affirmed?
ANALYSIS
Examiner provisionally rejected Appellants' claims 1, 3, 6-10, 15, 17,
20-24, 29, 31, and 34--38 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over the claims of
co-pending Application 13/694,120 (Examiner's July 14, 2015 Office
6 Natalia A Trayanova, PhD, FHA, FHRS, Whole Heart Modeling:
Applications to Cardiac Electrophysiology and Electromechanics, 108 CIRC
RES. 113-128 (2011) (citation is made to the NIH-Public Access CIR RES.
Author Manuscript 1-30; available in PMC 2012 January 7).
7 Constantinides, US 2003/0120151 Al, published June 26, 2003.
8 Korn et al., US 2011/0087088 Al, published Apr. 14, 2011.
9 Nathan et al., US 2011/0087110 Al, published Apr. 14, 2011.
10 Alejandro F. Frangi et al., Three-Dimensional Modelingfor Functional
Analysis of Cardiac Images: A Review, 20 IEEE TRANSACTIONS ON
MEDICAL IMAGING 2-25 (2001 ).
11 Revishvili et al., US 2010/0191131 Al, published July 29, 2010.
12 Chen et al., US 2005/0018885 Al, published Jan. 27, 2005.
13 Linnenbank et al., US 2012/0002840 Al, published Jan. 5, 2012.
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Action 13-14; see also Final Act. 13 ("The double patenting rejection of
record is maintained for the reasons of record")).
Appellants' Brief does not address this provisional rejection. As
Examiner explains, Appellants "requested[] the rejection [be] held in
abeyance until allowable subject matter is identified" (Final Act. 13; see
Appellants' October 14, 2015 Amendment with Request for Continued
Examination 25-26).
If a ground of rejection stated by Examiner is not addressed in the
Appellants' Brief, Appellants waived any challenge to that ground of
rejection and that ground of rejection will be summarily sustained by the
Board. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or authorities not
included in the appeal brief will be refused consideration by the Board for
purposes of the present appeal").. Therefore, we summarily affirm the
provisional nonstatutory obviousness-type double patenting rejection on this
record.
CONCLUSION
The provisional obviousness-type double patenting rejection on this
record is summarily affirmed. The provisional rejection of claim 1 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims of co-pending Application No. 13/694, 120 is
summarily affirmed. Claims 3, 6-10, 15, 17, 20-24, 29, 31, and 34--38 are
not separately argued and fall with claim 1.
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REJECTION 11:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Trayanova's "article ... assess[es] the current state-of-the-art in
whole-heart modeling and the plethora of its applications in cardiac
research" (Trayanova 1 ).
FF 2. Examiner finds that Trayanova discloses, inter alia, a method of
"constructing a whole-heart geometric model for simulating at least one of
electrophysiological activity or electromechanical activity of [a] patient's
heart using imag[e] data" (Final Act. 9 (citing Trayanova §§ 2.1, 2.2, 3.2,
and Figures 1 and 3); see also Ans. 6 ( citing Trayanova § 2.2); Trayanova §
2.2 ("In cases where neither histological nor ... imaging information is
available, rule-based approaches have been used[] to assign fiber orientation
consistent with measurements")).
FF 3. Examiner finds that Trayanova discloses the planning of a patient-
specific cardiac procedure based on its simulations and "[i]n particular,
modelling arrhythmia in diseased heart [to] provide simulation guidance for
planning ablation" (Final Act. 10 ( citing Trayanova § 3 .3, last paragraph
("simulation results demonstrated that the organizing center of infarct-
related VT is located within the BZ, regardless of the pacing site from which
VT is induced. This result has important implications for ablation of infarct-
related VT" and "further simulation studies on the subject are expected to
provide simulation guidance of VT ablation in patients"))).
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FF 4. Examiner finds that although Trayanova relates to ex vivo
measurements, "obtaining three-dimensional imaging data of patient's heart
in vivo, from contrast-enhanced MRI imaging in particular, are known in the
art" as evidenced by any of Constantinides, Korn, or Nathan (see Final Act.
10 (citing Constantinides ,r,r 62, 63, and 66; Korn ,r,r 7, 24, 26, 39, and 70;
Nathan ,r,r 24, 26, 39, 69, and 70)).
FF 5. Examiner relies on Frangi to disclose "selecting edge features such
as position, length, etc." of a volume element (Final Act. 12 (citing Frangi
10: second paragraph); see generally Frangi 3: second column ("This paper
presents a comprehensive and critical review of the state-of-the art in
geometric modeling of the cardiac chambers, notably the [left ventricle
(L V)], and their potential for functional analysis")).
FF 6. Examiner finds, "with regard to defining volume elements of [a]
model, it is known that volume mesh elements in 3D heart models may take
the form of any closed polyhedron, and typically contain tetrahedral-shaped
volume elements" (Final Act. 12 (citing Revishvili ,r,r 75-80; Chen ,r 180;
Linenbank ,r,r 5, 8, and 82).
ANALYSIS
Based on Trayanova and any one of Constantinides, Korn, or Nathan,
in combination with Frangi and any one of Revishvili, Chen, or Linenbank,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima obvious "to use data of three-dimensional imaging
of a living patient's heart that are acquired in vivo, as it simplifies and
facilitates the imaging data acquisition and does not require invasive
procedures" (Final Act. 11 ). Examiner also concludes that it would have
been obvious to "combine the steps of simulating and ... planning based on
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said simulations because such a combination is merely a 'predictable use of
prior art elements according to their established functions'," and "if there are
any differences between [Appellants'] claimed method and that of the prior
art, the differences would ... appear minor in nature" and represent "either
additional features known per se from the prior art or being slight
constructional changes which come within the scope of the customary
practice followed by the persons skilled in the art" (id. atl 1-12). We are not
persuaded.
"[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting a prim a facie case of unpatentability." In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Further, "rejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).
Appellants' claimed method, non-transitory computer-readable
medium, and system each require, inter alia, the determination of "a patient-
specific ablation target that eliminates the arrhythmia with a minimal
ablation lesion size" (see Br. 26-27, 29-31, and 33-35). As Appellants
explain, "Trayanova fails to disclose determining a patient-specific ablation
target that eliminates the induced arrhythmia with a minimal ablation lesion
size" and none of "Constantinides, Korn, Nathan, Frangi, Revishvili, Chen,
[or] Linenbank ... make up for the deficiencies of Trayanova (Br. 24).
Examiner failed to establish an evidentiary basis on this record that
Trayanova and any one of Constantinides, Korn, or Nathan, in combination
with Frangi and any one of Revishvili, Chen, or Linenbank makes obvious
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Appellants' claimed invention, which comprises, inter alia, the
determination of "a patient-specific ablation target that eliminates the
arrhythmia with a minimal ablation lesion size" (see Br. 26-27, 29-31, and
33-35; cf Final Act. 8-13; Ans. 5---6). Examiner also fails to address
Appellants contention with respect to this feature of Appellants' claimed
invention (see Br. 24; cf Ans. 5---6). In this regard, we note, but are not
persuaded by Examiner's conclusory assertion that "any differences between
[Appellants'] claimed method and that of the prior art, the differences would
... appear minor in nature" and represent "either additional features known
per se from the prior art or being slight constructional changes which come
within the scope of the customary practice followed by the persons skilled in
the art" (Final Act. 12). See Kahn, 441 F.3d 988.
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1, 3, 6-10, 15,
17, 20-24, 29, 31, 34--38, and 43---63 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Trayanova and any one of
Constantinides, Korn, or Nathan, in combination with Frangi and any one of
Revishvili, Chen, or Linenbank is affirmed.
REJECTION 111:
ISSUE
Does the preponderance of evidence of record support Examiner's
finding that Appellants' claimed invention is directed to patent ineligible
subject matter?
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PRINCIPLES OF LAW
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 long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "'[l]aws of nature, natural phenomena, and abstract
ideas'" are not patentable. E.g., Alice Corp. v. CLS Bankint'l, 573 U.S.
208,216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's 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)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
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. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
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 (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 191
(1981) ); "tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
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252, 267---68 (1853))); and manufacturing flour (Gottschalk, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited 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 191 ("We
view respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated 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 Gottschalk and Parker); 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 tum to the second
step of the Alice and Mayo framework, where "we must 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).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
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The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (January 7, 2019) ("Revised Guidance"). Under that
guidance, we first look to 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)).
See 84 Fed. Reg. 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
look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
are not "well-understood, routine, conventional" 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. 51.
ANALYSIS
Applying the Revised Guidance to the facts on this record, we find
that Appellants' claims are directed to patent-ineligible subject matter. The
Revised Guidance instructs us first to determine whether any judicial
exception to patent eligibility is recited in the claim. The Revised Guidance
identifies three judicially-excepted groupings identified by the courts as
abstract ideas: ( 1) mathematical concepts, (2) certain methods of organizing
human behavior such as fundamental economic practices, and (3) mental
processes.
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Examiner finds that Appellants' "process is a computational method
of planning an ablation procedure" (Final Act. 2). In this regard, Examiner
finds that Appellants' method steps relate to organizing data/information,
categorizing data, mathematical calculations, and providing information,
(id.). We agree with Examiner that claim 1 recites patent ineligible subject
matter. More specifically, Appellants' claim 1, reproduced above, recites
the following limitations: (1) "segmenting ... [the] data ... to obtain three-
dimensional heart image data," (2) "segmenting [the] three-dimensional
heart image data into ... [additional] data," and (3) "determining a fiber
orientation in each of the volume elements based on calculations executed
on a patient-specific geometry of the patient's heart" (Br. 26-27). These
limitations simply require mathematical calculations, which, without more,
is an abstract idea. Intellectual Ventures I, 850 F.3d at 1340; see also
Digitech Image Techs., LLC. v. Elecs. For Imaging, Inc., 758 F.3d 1344,
13 51 (Fed. Cir. 2014) ("Without additional limitations, a process that
employs mathematical algorithms to manipulate existing information to
generate additional information is not patent eligible").
For the reasons discussed above, Appellants claimed invention is
directed to mathematical calculations, which are among the groupings
identified in the Revised Guidance, and thus an abstract idea (see Final Act.
4 (Examiner finds that Appellants' claims are "directed to an abstract idea
which is a judicial exception"); cf Br. 14--17).
Having determined that Appellants' claim 1 is directed to a judicial
exception, the Revised Guidance directs us to next consider whether the
claims integrate the judicial exception into a practical application. On this
record, Appellants' claim 1 comprises the additional steps of: (a) " [a]
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computer-implemented method of planning a patient-specific cardiac
ablation procedure," (b) "receiving ... data that includes [ data regarding] a
living patient's heart," ( c) "constructing a model of at least a portion of said
living patient's heart ... ," (d) simulating, using a computer, at least one of
electrophysiological or electromechanical activity of at least a portion of
said living patient's heart using said model ... ," (e) "determining a patient-
specific ablation target that eliminates the arrhythmia with a minimal
ablation lesion size" and (f) "providing said patient-specific ablation target
to a user" (Br. 26-27). We find, however, that analyzing information by
steps people go through in their minds, or by mathematical algorithms, and
outputting the results of such an analysis or calculation to a user, i.e. by a
display, do not amount to significantly more than the abstract idea because
they are insignificant post-solution activities. See Elec. Power Grp., 830
F.3d at 1353-54. Similarly, the receiving, or data collection, step of
Appellants' claim, does not amount to significantly more than the abstract
idea because it is an insignificant pre-solution activity. See Mayo 566 U.S.
at 79 (quoting Flook, 437 U.S. at 590) ("Purely 'conventional or obvious'
'[pre ]-solution activity' is normally not sufficient to transform an
unpatentable law of nature into a patent-eligible application of such a law").
In addition, the use of a generic computer to perform generic computer
functions that are "well-understood, routine, conventional activities"
previously known in the industry is not enough to transform the abstract idea
into a patent-eligible invention. See Alice, 573 U.S. at 225-26. In sum,
Appellants' claimed method directs a person of ordinary skill in this art to
create and manipulate data as part of a model of a living patient's heart in
order to simulate the induction of an arrhythmia in the model to determine a
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patient-specific ablation target that eliminates the arrhythmia with a minimal
ablation lesion size as distinguished from a technical improvement for
achieving or applying that result, i.e., the elimination of an arrhythmia with a
minimal ablation lesion size in a living patient's heart. Cf Diehr, 450 U.S.
at 179 n.5 (The claims in Diehr recited a method for operating a rubber-
molding press including the step of "opening the press automatically when a
said comparison [ of calculated cure time vs. elapsed time] indicates
equivalence." Thus, the recited mathematical equation had the practical
application of automatically operating a press). Therefore, on this record,
we conclude that the ineligible subject matter in Appellants' claim 1 is not
integrated into a practical application ( cf Br. 14--17; see also id. at 19
("[E]xaminer provided no analysis of these limitations")).
We also are not persuaded by Appellants' contentions regarding
McRO v. Bandai Namco Games America, Inc., 837 F.3d 1299 (Fed. Cir.
2016) (see generally Br. 15-18 and 21). In this regard, Appellants contend
that their claimed invention improves a computer-related technology14 in a
manner analogous to the claims found patent-eligible in McRO ( Br. 15).
Appellants do not, however, identify any specific rules in their claimed
invention that that enable the computer to function in a way analogous to the
specific rules enabled the computer in McRO to generate the computer-
animated characters. We also find no evidence of record here to support the
argument that the present situation is like the one in McRO where computers
were unable to make certain subjective determinations, i.e., regarding morph
14 See Br. 15 ("The fact that the current invention provides 'a computer-
implemented method of planning a patient-specific cardiac ablation
procedure' is a major improvement over current technology").
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weight and phoneme timings, which could only be made prior to the claimed
invention by human animators.
Having determined that the judicial exception is not integrated into a
practical application, the Revised Guidance requires us to evaluate the
additional elements individually and in combination to determine whether
they provide an inventive concept, such as a specific limitation beyond the
judicial exception that is not well-understood, routine, conventional 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. See 84 Fed. Reg. 51. In this regard, we note that
Appellants' method comprises the steps of: (i) "constructing a model of at
least a portion of [a] living patient's heart" and (ii) "simulating ... at least
one of electrophysiological or electromechanical activity of at least a portion
of [a] living patient's heart using [the] model, said simulating inducing an
arrhythmia in said model of said living patient's heart" (Br. 26-27). We
recognize that the model construction step of Appellants' claimed invention
comprising the additional steps of
creating a finite element mesh using the segmented three-
dimensional data, to provide a geometrical representation of
said patient's heart, the finite element mesh comprising a
plurality of volume elements;
determining a fiber orientation in each of the volume
elements based on calculations executed on a patient-specific
geometry of the patient's heart; and
assigning electrophysiological parameters to each of the
volume elements taking into account the determined fiber
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Appeal2018-003128
Application 13/984,741
orientations and the type of tissue where the corresponding
volume element is located.
(Br. 26-27.) As discussed above, with respect to the obviousness rejection,
however, the foregoing method steps were known, routine, conventional
activities previously known to the industry (see e.g. FF 1---6; Final Act. 8-13;
Ans. 5-6; cf Br. 17-22). Therefore, we conclude that Appellants' claim 1
does not include an inventive concept. For the reasons set forth above, we
are not persuaded by Appellants' contention that "'constructing a model of
at least a portion of [a] living patient's heart' is sufficient in itself to render
the claim patent eligible under the step 2B analysis" (Br. 20; see also id. at
21 (Appellants' claimed "combination provides a 'computer-implemented
method of planning a patient-specific cardiac ablation procedure"')).
Similarly, for the same reasons, we are not persuaded by Appellants'
contention that "the simulating step provides significantly more to render the
claim patent eligible under the step 2B analysis" (id. at 20). We are not
persuaded by Appellants' contentions regarding "fiber orientation" and
"electrophysiological parameters," which are well-known, convention, and
routine features incorporated into cardiac models, are not persuasive (see id.
at 20-21; cf FF 2).
CONCLUSION OF LAW
The preponderance of evidence of record supports Examiner's finding
that Appellants' claimed invention is directed to patent ineligible subject
matter. The rejection of claim 1 under 35 U.S.C. § 101 is affirmed. Claims
3, 6-10, 15, 17, 20-24, 29, 31, 34--38, and 43---63 are not separately argued
and fall with claim 1.
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Application 13/984,741
TIME PERIOD FOR RESPONSE
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
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