DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a cardiac chamber data acquisition module, a potential relationship establishing module, an endocardial potential solution module, a charge density determining module, all in claim 10
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
These structures appear to be the algorithmic steps disclosed (claimed in claim 1, for example) and performed by a computer processor, such as disclosed by ¶¶[0042-0043] the Specification dated 7/9/2024, see also Figs. 3-6.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see this section of the MPEP for additional information.
Claims 1 and 8-10 are directed to a method, system, computer readable medium, and computer product.
Step 1 of the analysis is the question: “Is the claim to a process, machine, manufacture, or composition of matter?” and the answer is determined to be yes, as the claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-evident. The answer is determined to be no, as the claim is not immediately self-evident as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 as a representative example recites the following limitations:
a. performing boundary element discretization processing of the endocardium using a normal vector in the geometric vector data, the position data and a preset electrostatic relationship of an intracardiac potential to determine a numerical relationship equation of electrostatics between the endocardial potential and the electrode potential after boundary element discretization
b. solving an endocardial potential by inverse operation based on the numerical relationship equation, the position data and the electrode potential data, so as to determine data of the endocardial potentials three-dimensionally distributed on the endocardium
c. determining an endocardial charge density on the endocardium at the current moment according to the endocardial potential data and a preset charge density algorithm
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP § 2106.04(a)(2) III B. this language is similar to concepts relating to organizing or analyzing information in a way that can be performed mentally or are analogous to human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods of logic circuit design, comprising converting a functional description of a level sensitive latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be used in conjunction with computer-based design tools, the claims did not include any limitations requiring computer implementation of the methods and thus do not involve the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The court therefore concluded that the claims “read on an individual performing the claimed steps mentally or with pencil and paper,” and were directed to a mental process of “translating a functional description of a logic circuit into a hardware component description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the language reads on an individual performing the computations mentally, or with the aid of a pencil and paper. They do not require any computer implementation that relies specifically upon computer technology and therefore are directed to a mental process of computing a charge density map from obtained electrical data.
Furthermore, the claim limitations are identified as directed to an explicit description of a mathematical concept. The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Supreme Court has identified a number of concepts falling within this grouping as abstract ideas including: a procedure for converting binary-coded decimal numerals into pure binary form, Gottschalk v. Benson, 409 U.S. 63, 65, 175 USPQ2d 673, 674 (1972); a mathematical formula for calculating an alarm limit, Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ2d 193, 195 (1978); the Arrhenius equation, Diamond v. Diehr, 450 U.S. 175, 191, 209 USPQ 1, 15 (1981); and a mathematical formula for hedging, Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ 2d 1001, 1004 (2010).
In the instant case, the identified mathematical concepts are organizing information and manipulating information through mathematical correlations, Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). The patentee in Digitech claimed methods of generating first and second data by taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form. The court explained that such claims were directed to an abstract idea because they described a process of organizing information through mathematical correlations, like Flook's method of calculating using a mathematical formula. 758 F.3d at 1350, 111 USPQ2d at 1721.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claims 1-10: workstation, catheter mapping system, tracking, display, etc.
The catheter mapping system is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed catheter mapping system amounts to mere data gathering and considered an insignificant extra-solution activity.
The display and workstation appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the above section under Step 2A Prong Two.
The catheter mapping system is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed catheter mapping system amounts to mere data gathering and considered an insignificant extra-solution activity.
The display and workstation appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Claims 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims, under the broadest reasonable interpretation of “computer readable medium” and “computer product” comprise signal and software per se, respectively. Applicant is suggested to amend the claims to include “non-transitory computer readable medium”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (U.S. Patent Application Publication No. 2020/0146575) hereinafter referred to as Stewart; in view of Welsh et al. (U.S. Patent Application Publication No. 2019/0200886) hereinafter referred to as Welsh; in view of Harlev et al. (U.S. Patent Application Publication No. 2016/0331259) hereinafter referred to as Harlev.
Regarding claim 1, Stewart teaches boundary element-based three-dimensional mapping method, wherein the method is applied to a boundary element-based three-dimensional mapping system (¶[0060]), the three-dimensional mapping system at least comprises
a three-dimensional cardiac imaging system, an interventional three-dimensional mapping catheter, a three-dimensional spatial positioning system, and a display system (Fig. 1, image acquisition and preparation, catheter, display tracking system);
the interventional three-dimensional mapping catheter comprises a multichannel electrode catheter, and a multichannel acquisition system, and a plurality of mapping electrodes arranged in a certain mode are arranged on the multichannel electrode catheter (¶¶[0060-0061] catheter with a plurality of electrodes acquiring a plurality of channel signals from the electrodes during a mapping operation), and the method comprises the following steps:
acquiring electrode potential data of the plurality of mapping electrodes collected by the multichannel acquisition system at a current moment (¶[0061] acquire signals resulting from the electrical activity in the heart), position data of the multichannel electrode catheter collected by the three-dimensional positioning system (¶[0064] location of the catheter…can be determined using a conventional sensing and tracking system), and a three-dimensional endocardium model modeled by the three-dimensional cardiac imaging system (¶[0070] mapped, using a mesh, to an electroanatomical shell surface), wherein the three-dimensional endocardium model (¶[0105]) at least comprises geometric vector data of each triangle in a triangular mesh model of the three-dimensional endocardium model (¶[0104] surface geometry represented as a mesh containing vertices and triangle connectivity between), the position data is used to reflect a spatial position of the multichannel electrode catheter in a cardiac chamber (¶[0060] multiple locations within the heart chamber), and the electrode potential data is used to reflect a blood flow potential at each position in the cardiac chamber corresponding to each mapping electrode (¶[0108] instantaneous potential, ¶[0111] corresponding set of 3-D position coordinates);
performing processing of the endocardium using a normal vector in the geometric vector data, the position data and a preset electrostatic relationship of an intracardiac potential to determine a numerical relationship equation of electrostatics between the endocardial potential and the electrode potential after boundary element discretization (¶[0124] influence force as a function of the electrical signal feature position);
Stewart does not teach boundary element discretization, or solving an endocardial potential by inverse operation based on the numerical relationship equation, the position data and the electrode potential data, so as to determine data of the endocardial potentials three-dimensionally distributed on the endocardium; and determining an endocardial charge density on the endocardium at the current moment according to the endocardial potential data and a preset charge density algorithm, outputting the endocardial charge density to the display system, thus displaying the endocardial charge density on the three-dimensional endocardium model in real time.
Attention is drawn to the Welsh reference, which teaches solving an endocardial potential by inverse operation based on the numerical relationship equation, the position data and the electrode potential data, so as to determine data of the endocardial potentials three-dimensionally distributed on the endocardium (¶[0113] surface charge density obtained by solving the inverse problem); and
determining an endocardial charge density on the endocardium at the current moment according to the endocardial potential data and a preset charge density algorithm, outputting the endocardial charge density to the display system (¶[0359] surface charge data), thus displaying the endocardial charge density on the three-dimensional endocardium model in real time (¶¶[0118-0119] continuously in real time).
It would have been obvious to one of ordinary skill in the art to modify the cardiac mapping of Stewart to include an inverse solution for obtaining charge density, as taught by Welsh, to avoid improper detection of cardiac activation, avoiding consquences such as imprecise ROI for therapy delivery and incomplete characterization of ablation efficiency (Welsh ¶[0014]).
Stewart as modified does not teach specifically, a boundary element discretization numerical method and the charge potential represents blood flow potential.
Attention is drawn to the Harlev reference, which teaches a boundary element discretization numerical method for determining an endocardial charge density on the endocardium at the current moment according to the endocardial potential data and a preset charge density algorithm (¶[0096], ¶¶[0103-0106]) and the charge potential represents blood flow potential (¶[0089]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cardiac mapping of Stewart as modified to incorporate boundary element methods, as taught by Harlev, because it relies upon a known physical relationship between current and potential, greatly improving accuracy (Harlev, ¶[0085]).
Regarding claim 2, Stewart as modified teaches the method according to claim 1.
Harlev further teaches wherein performing boundary element discretization processing of the endocardium using a normal vector in the geometric vector data, the position data and a preset electrostatic relationship of an intracardiac potential to determine a numerical relationship equation of electrostatics between the endocardial potential and the electrode potential after boundary element discretization (¶[0085], ¶¶[0104-0105]) comprises the following steps:
traversing the normal vectors in the geometric vector data to obtain a target normal vector with a positive direction being a direction outside the endocardium (¶[0109]);
when a vector product of a (k+1)-th normal vector and a k-th normal vector is less than 0, flipping a direction of the (k+1)-th normal vector, and enabling k=k+1, and returning to the step that the vector product of the (k+1)-th normal vector and the k-th normal vector is less than 0 until the normal vectors of all triangles are traversed, thus obtaining a target normal vector with a positive direction being a direction outside the endocardium, wherein an initial value of k is 1 (¶[0136]);
performing boundary element discretization processing based on an endocardial boundary and the position data of the multichannel electrode catheter to determine a transformation matrix between the endocardial potential and the electrode potential after boundary element discretization, wherein the transformation matrix is used to transform the endocardial potential to a multichannel electrode potential (¶[0042], ¶[0052], ¶[0175]); and
determining a numerical relationship equation between the endocardial potential and the electrode potential after boundary element discretization using the transformation matrix (¶¶[0171-0172], ¶[0175]).
Regarding claim 3, Stewart as modified teaches the method according to claim 1.
Harlev further teaches wherein the numerical relationship equation between endocardial potential and the electrode potential after boundary element discretization is as follows:
A
*
E
1
=
E
2
wherein
E
1
∈
R
M
is endocardial potential data, M represents the number of triangles in the triangular mesh model of the three-dimensional endocardium model,
E
2
∈
R
N
is the electrode potential data collected by the plurality of mapping electrodes, N represents the number of mapping electrodes,
A
∈
R
N
*
M
is the transformation matrix which is used to transform the endocardial potential to the multichannel electrode potential (¶¶[0125-0127]).
Regarding claim 7, Stewart teaches a boundary element-based three-dimensional mapping system, comprising
a three-dimensional cardiac imaging system (Fig. 1), an interventional three-dimensional mapping catheter (Fig. 1, CATHETER), a three-dimensional spatial positioning system (Fig. 1, IMAGE ACQUISITION & PREPARATION), an ECG (Electrocardiograph) acquisition system (Fig. 1, ELEC. MODULE, ¶[0062]), a display system (Fig. 1, DISPLAY), and a workstation (¶[0096]);
wherein the three-dimensional cardiac imaging system, the interventional three-dimensional mapping catheter, the three-dimensional spatial positioning system, the ECG acquisition system and the display system are in communication connection with the workstation, respectively (Fig. 1);
the three-dimensional cardiac imaging system is used to perform endocardial modeling by intracardiac echocardiography to obtain a three-dimensional endocardium model, and upload the three-dimensional endocardium model to the workstation (¶[0100] ultrasound),
wherein the three-dimensional endocardium model at least comprises geometric vector data of each triangle in a triangular mesh model of the three-dimensional endocardium model (¶[0104]);
the interventional three-dimensional mapping catheter comprises a multichannel electrode catheter, a multichannel acquisition system, and a control handle, wherein a plurality of mapping electrodes arranged in a certain mode are arranged on the multichannel electrode catheter, the mapping electrodes are arranged at a tip of the multichannel electrode catheter, and the control handle is arranged at a distal end of the multichannel electrode catheter far from the tip (¶¶[0060-0061], ¶[0110], and see additional disclosures incorporated by reference ¶[0095]);
the multichannel acquisition system comprises a plurality of data acquisition channels, the data acquisition channels correspond to the mapping electrodes one by one, and the data acquisition channels are used to collect electrode potentials of the mapping electrodes in parallel (¶[0064], ¶[0066] multiple electrodes tracked separately);
the plurality of mapping electrodes form an electrode probe, the electrode probe is inserted into a cardiac chamber in a first shape convenient for intervention, the control handle is used to control the electrode probe to be transformed from the first shape to a second shape convenient for mapping after the probe is inserted into the cardiac chamber, and the electrode probe is also used to map electrode potential data in the cardiac chamber in a non-contact manner using the plurality of mapping electrodes based on the second shape, and to upload the electrode potential data to the workstation (¶[0060], ¶[0100] deployment);
the electrode potential data is used to reflect blood flow potentials at all parts in the cardiac chamber, the first shape is a closed shape, and the second shape is a non-closed shape; the three-dimensional spatial positioning system is used to acquire position data of the multichannel electrode catheter and upload the position data to the workstation, wherein the position data is used to reflect a spatial position of the multichannel electrode catheter in the cardiac chamber (¶¶[0060-0061], ¶[0100] deployment, workstation in Fig. 1);
the ECG acquisition system is used to acquire ECG data on a body surface and upload the ECG data to the workstation, wherein the ECG data is used to reflect each heartbeat cycle (Fig. 4, ¶[0100]);
the workstation is used to receive model parameters, the electrode potential data, the position data and the ECG data, to count model parameters, electrode potential data and position data in a current heartbeat cycle based on the ECG data, and to execute the steps of the method according to claim 1 (see rejection above, Fig. 1, ¶[0100] and Fig. 4); and
the display system is used to display the three-dimensional endocardium model and an endocardial charge density on the three-dimensional endocardium model in real time on a preset display terminal (Fig. 1, ¶[0103]).
Regarding claims 8-10, the claims are directed to an apparatus, computer readable medium, and computer device comprising substantially the same subject matter as claim 1 and is rejected under substantially the same sections of Stewart, Welsh, and Harlev.
Allowable Subject Matter
Claims 4-6 comprise subject matter that is not rejected in view of prior art, but the claims are not allowable as they are rejected under 35 U.S.C. § 101.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record, Stewart, Welsh, and Harlev teach a variety of finite element and boundary element techniques for determining a charge density of an endocardium of a heart and creating a cardiac map from the derived information. However, none of the cited art appears to anticipate or make obvious the following calculations:
wherein the preset electrostatic relationship of the intracardiac potential is as follows:
λ
ε
,
η
,
ζ
E
ε
,
η
,
ζ
=
∑
k
=
1
k
=
M
E
¯
(
k
)
ε
,
η
,
ζ
D
2
(
k
)
ε
,
η
,
ζ
-
p
¯
(
k
)
D
1
(
k
)
ε
,
η
,
ζ
;
wherein
λ
is a target constant coefficient,
D
1
(
k
)
,
p
¯
(
k
)
, and
D
2
(
k
)
are variables geometrically related to a structure of the boundary,
E
ε
,
η
,
ζ
represents the endocardial potential and the electrode potential,
E
¯
(
k
)
ε
,
η
,
ζ
is an endocardial potential of a k-th triangle in the intracardiac potential,
k
∈
M
.
wherein an equation for solving the endocardial potential by inverse operation is as follows:
E
1
=
(
A
T
*
A
+
λ
*
I
)
-
1
*
A
T
*
E
2
;
wherein
E
1
∈
R
M
is endocardial potential data, M represents the number of triangles in the triangular mesh model of the three-dimensional endocardium model,
E
2
∈
R
N
is the electrode potential data collected by the plurality of mapping electrodes, N represents the number of mapping electrodes,
A
∈
R
N
*
M
is the transformation matrix which is used to transform the endocardial potential to the multichannel electrode potential, T represents transposition, λ is a regularization coefficient,
I
∈
R
M
*
M
is an unit matrix, wherein the transformation matrix is used to transform the endocardial potential to the multichannel electrode potential.
wherein the charge density algorithm is as follows:
E
1
x
⃑
=
∫
S
d
(
y
⃑
)
cos
φ
x
y
x
⃑
-
y
⃑
2
d
s
y
⃑
wherein
x
⃑
and
y
⃑
are spatial positions of any point on the boundary of the endocardium,
d
(
y
⃑
)
is an endocardial charge density at
y
⃑
,
φ
x
y
is an included angle between
x
⃑
-
y
⃑
and a normal vector
n
⃑
, S is a triangle mesh network,
E
1
x
⃑
is an endocardial potential at the spatial position
x
⃑
on the boundary of the endocardium.
While the art cited does derive charge density, the operations performed differ in the specific mathematical functions performed, and therefore these are not taught or suggested.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2017/0068796 to Passerini et al. teaches a patient specific cardiac model and mapping performed using electrical diffusivity using a boundary element method.
U.S. Patent Application Publication No. 2021/0169394 to Chou et al. teaches a mapping catheter system that is deployable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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