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 .
Information Disclosure Statement
The Information Disclosure statements filed 08/26/2025 and 04/13/2026 have been considered by the Examiner.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 are:
“a processor, configured to: … generate an electrophysiological (EP) map comprising one or more regions of interest (ROIs)” in claim 1.
“a processor, configured to: … deemphasize the EP map outside the ROIs responsively to the required level” in claim 1.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181 (II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations in the specification (References are made to Paragraph #’s in the corresponding U.S. PGPub (US 2025/0344986):
Par. [0003] – An electrophysiological (EP) map of a cardiac chamber of a patient is generated by positioning electrodes on a region of the chamber's tissue, acquiring an EP signal of the region, and then repeating the process for a different region. EP parameters are extracted from the EP signals in each region of measurement and then displayed over a graphical representation of the tissue, such as a three-dimensional (3D) rendering of the cardiac chamber; Par. [0010-0011]
Par. [0019] – The processor may deemphasize the EP map outside the ROIs by, for example, dimming the map outside the ROIs
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of generating an electrophysiological (EP) map comprising one or more regions of interest (ROIs) and deemphasizing the EP map outside the ROIs responsively to the required level) without significantly more.
Step 1
Independent claims 1 and 9 are directed to a system and a method, and thus meet the requirements for step 1.
Step 2A, Prong 1
Regarding claims 1 and 9, the following steps recite an abstract idea:
“generat[ing] an electrophysiological (EP) map comprising one or more regions of interest (ROIs)” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). Further, it is discussed that the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could use electrophysiological data to generate an EP map, either mentally or with the aid of pen and paper.
“deemphasiz[ing] the EP map outside the ROIs responsively to the required level” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). Further, it is discussed that the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could deemphasize (i.e., focus on the ROIs/block out area outside the ROIs), either mentally or with the aid of pen and paper.
Step 2A – Prong 2
Regarding claims 1 and 9, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
An input device – The input device is recited with a high level of generality. The Applicant’s specification (referring to printed publication) explains that the input device is for example a touch screen or a mouse (Par. [0018]). The involvement of the input device amounts to insignificant extra-solution activity (i.e., mere data gathering [MPEP 2106.05(g)]).
A processor – The processor is recited with a high level of generality. The Applicant’s specification explains that a processor typically comprises a general-purpose computer (Par. [0032]). The involvement of the processor is insignificant extra-solution activity in that it amounts to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
receive … an electrophysiological (EP) map comprising one or more regions of interest (ROIs) – insignificant pre-solution activity, i.e. mere data gathering [MPEP 2106.05(g)]
receive from a user, via the input device, a level of deemphasis the EP map required outside the ROIs – insignificant pre-solution activity, i.e. mere data gathering [MPEP 2106.05(g)]
display the deemphasized EP map to the user – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)].
Therefore, the claims are directed to an abstract idea without a practical application.
Step 2B
The additional elements of claims 1 and 9, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “processor”, along with its associated functions and components, is recited with a high level of generality and simply amounts to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
An input device – Heimbecher (US 2012/0173217) explains that a button may be used by a clinician--either directly as a touch screen input or indirectly by moving a cursor or other icon to actuate button 80 using a conventional input/output device such as a mouse or keyboard--to access a list (e.g., a menu) from which the clinician can identify the specific catheter to be used in the procedure (Par. [0035]).
receive … an electrophysiological (EP) map comprising one or more regions of interest (ROIs) – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data”).
receive from a user, via the input device, a level of deemphasis the EP map required outside the ROIs – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network, e.g., using the Internet to gather data”).
display the deemphasized EP map to the user – Cohen, et al. (US 2022/0087560) explains that displays of EP maps are conventional (Par. [0052]).
Therefore, the claims are directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claims 2, 5-7, 10, and 13-15, the limitations only further define the abstract idea.
Regarding dependent claims 3-8 and 11-15, the limitations only further define insignificant extra-solution activity.
Therefore, claims 1-15 are unpatentable under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stewart, et al. (US 2018/0325401 – cited on IDS).
Regarding claim 1, Stewart teaches (Figs. 1-2) a system (Abstract – A system for facilitating display of cardiac information), comprising:
(Fig. 1, input devices) an input device (Par. [0090] – The user input device used to make the selection may include a mouse, a touchscreen and/or the like, that is used to manipulate a selection tool that is provided on the GUI provided by the display device.); and
(Fig. 1, # 120) a processor (Par. [0063]), configured to:
(Fig. 3A-B, # 320) receive or generate an electrophysiological (EP) map comprising one or more regions of interest (ROIs) (Title; Par. [0056] – Embodiments of systems and methods described herein facilitate processing sensed cardiac electrical signals to present a representation of a region of interest (ROI) on an electroanatomical map; Par. [0070] – a region of interest may refer to a set of mapped data points such as, for example, a set of data points that are mapped, using a mesh, to an electroanatomical shell surface (e.g., a cardiac model); Par. [0080]; Par. [0091]);
receive from a user, via the input device, a level of deemphasis the EP map required outside the ROIs (Par. [0071] – display parameters may include brightness, contrast, color saturation, sharpness, and/or the like. Thus, in embodiments, the representation of the region of interest may include a first color saturation value that is different from a second color saturation value, where the second color saturation value is associated with at least one cardiac signal feature that is not included within the region of interest. Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like.; Par. [0086] – a representation of a region of interest is presented as a highlighted area of a map. Mesh pixels (pixels associated with a mesh that is used to generate the map) within the highlighted regions may appear to have a lighting effect that distinguishes them from the mesh pixels that are not within the highlighted regions);
(Figs. 3A-B) deemphasize the EP map outside the ROIs responsively to the required level (Par. [0071] – the representation of the region of interest may include a first color saturation value that is different from a second color saturation value, where the second color saturation value is associated with at least one cardiac signal feature that is not included within the region of interest. Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like; Par. [0086] – the saturation of highlighted areas and/or non-highlighted areas may be selected, controlled, and/or otherwise influenced (e.g., controlled within certain allowed parameters) by a user); and
(Figs. 3A-B) display the deemphasized EP map to the user (Pars. [0086] – An illustrative highlighting operation is depicted in FIGS. 3A & 3B; Par. [0089] – FIG. 3B an illustrative screenshot from an interactive GUI, showing another view of the cardiac map 300 depicted in FIG. 3A; Par. [0093]).
Therefore, claim 1 is unpatentable over Stewart, et al.
Regarding claim 2, Stewart teaches the system according to claim 1, wherein the processor is configured to deemphasize the EP map outside the ROIs by darkening the EP map outside the ROIs (Par. [0071]; Par. [0086]; The Examiner notes that changing the brightness or contrast may make the image darker).
Therefore, claim 2 is unpatentable over Stewart, et al.
Regarding claim 3, Stewart teaches the system according to claim 1, wherein (Fig. 2, # 200, 214) the processor is further configured to provide, using a display device and the input device, a graphical user interface (GUI) feature that lets the user adjust the level of deemphasis (Par. [0071] – Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like; Par. [0080] – a user (e.g., a clinician) interacts with a graphical user interface (GUI) via a user input device to select a set of interesting cardiac signal features; Pars. [0090-0091] – the GUI may include one or more selectable elements separate from the cardiac map 300 (e.g., selectable waveforms, histograms, EGMs, parameters, etc.) that may be selected using a user input device to cause the processing unit to highlight a corresponding portion 320 of the map 300; Par. [0116]).
Therefore, claim 3 is unpatentable over Stewart, et al.
Regarding claim 4, Stewart teaches the system according to claim 3, wherein the GUI feature comprises a sliding ruler that lets the user adjust the level of the deemphasis (Par. [0071]; Par. [0081] – the GUI may include interactive representations of sliders, buttons, knobs, and/or the like, that enable user selection of various electrical signal features, device parameters, physiological parameters, environmental parameters, and/or the like).
Therefore, claim 4 is unpatentable over Stewart, et al.
Regarding claim 5, Stewart teaches the system according to claim 1, wherein the EP map is a local activation time (LAT) map (Par. [0005] – activation map; Par. [0058] – examples of cardiac electrical signal features include… activation times; Par. [0078] – An activation waveform is a set of activation waveform values and may include, for example, a set of discrete activation waveform values (e.g., a set of activation waveform values, a set of activation time annotations, etc.), a function defining an activation waveform curve, and/or the like.; Par. [0108]).
Therefore, claim 5 is unpatentable over Stewart, et al.
Regarding claim 6, Stewart teaches the system according to claim 1, wherein the EP map is bipolar potential map (Par. [0100] – The data stream 402 may include signals such as unipolar and/or bipolar intracardiac electrograms (EGMs)).
Therefore, claim 6 is unpatentable over Stewart, et al.
Regarding claim 7, Stewart teaches the system according to claim 1, wherein (Fig. 2, # 214) the ROIs are tissue regions suspected of arrhythmogenic activity (Par. [0003] – Such procedures involve the mapping of electrical activity in the heart (e.g., based on cardiac signals), such as at various locations on the endocardium surface (“cardiac mapping”), to identify the site of origin of the arrhythmia followed by a targeted ablation of the site.; Par. [0083] – the ROI component 214 may determine the radius of influence of an electrical signal feature by determining a likelihood (e.g., probability) that the electrical signal feature (and/or other electrical signal features associated with the corresponding electrical signal) would have an influence (e.g., by contributing to a portion of operation of the heart, by contributing to an arrhythmia, by contributing to a signal measured within a certain distance, and/or the like)).
Therefore, claim 7 is unpatentable over Stewart, et al.
Regarding claim 8, Stewart teaches the system according to claim 1, wherein the input device comprises one of a touchscreen and a computer mouse (Par. [0090] – The user input device used to make the selection may include a mouse, a touchscreen and/or the like, that is used to manipulate a selection tool that is provided on the GUI provided by the display device.).
Therefore, claim 8 is unpatentable over Stewart, et al.
Regarding claim 9, Stewart teaches (Figs. 4-5) a method (Par. [0002] – The present disclosure relates to … methods for mapping an anatomical space of the body), comprising:
(Fig. 3A-B, # 320) receiving or generating an electrophysiological (EP) map comprising one or more regions of interest (ROIs) (Title; Par. [0056] – Embodiments of systems and methods described herein facilitate processing sensed cardiac electrical signals to present a representation of a region of interest (ROI) on an electroanatomical map; Par. [0070] – a region of interest may refer to a set of mapped data points such as, for example, a set of data points that are mapped, using a mesh, to an electroanatomical shell surface (e.g., a cardiac model); Par. [0080]; Par. [0091]);
receiving from a user a level of deemphasis the EP map required outside the ROIs (Par. [0071] – display parameters may include brightness, contrast, color saturation, sharpness, and/or the like. Thus, in embodiments, the representation of the region of interest may include a first color saturation value that is different from a second color saturation value, where the second color saturation value is associated with at least one cardiac signal feature that is not included within the region of interest. Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like.; Par. [0086] – a representation of a region of interest is presented as a highlighted area of a map. Mesh pixels (pixels associated with a mesh that is used to generate the map) within the highlighted regions may appear to have a lighting effect that distinguishes them from the mesh pixels that are not within the highlighted regions);
(Figs. 3A-B) deemphasizing the EP map outside the ROIs responsively to the required level (Par. [0071] – the representation of the region of interest may include a first color saturation value that is different from a second color saturation value, where the second color saturation value is associated with at least one cardiac signal feature that is not included within the region of interest. Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like; Par. [0086] – the saturation of highlighted areas and/or non-highlighted areas may be selected, controlled, and/or otherwise influenced (e.g., controlled within certain allowed parameters) by a user); and
(Figs. 3A-B) displaying the deemphasized EP map to the user (Pars. [0086] – An illustrative highlighting operation is depicted in FIGS. 3A & 3B; Par. [0089] – FIG. 3B an illustrative screenshot from an interactive GUI, showing another view of the cardiac map 300 depicted in FIG. 3A; Par. [0093]).
Therefore, claim 9 is unpatentable over Stewart, et al.
Regarding claim 10, Stewart teaches the method according to claim 9, wherein deemphasizing the EP map outside the ROIs comprises darkening the EP map outside the ROIs (Par. [0071]; Par. [0086]; The Examiner notes that changing the brightness or contrast may make the image darker).
Therefore, claim 10 is unpatentable over Stewart, et al.
Regarding claim 11, Stewart teaches the method according to claim 9, and (Fig. 2, # 200, 214) comprising providing a graphical user interface (GUI) feature that lets the user adjust the level of deemphasis (Par. [0071] – Color saturation values, relative color saturation values, and/or the like, may be adjustable via user input, an algorithm, and/or the like; Par. [0080] – a user (e.g., a clinician) interacts with a graphical user interface (GUI) via a user input device to select a set of interesting cardiac signal features; Pars. [0090-0091] – the GUI may include one or more selectable elements separate from the cardiac map 300 (e.g., selectable waveforms, histograms, EGMs, parameters, etc.) that may be selected using a user input device to cause the processing unit to highlight a corresponding portion 320 of the map 300; Par. [0116]).
Therefore, claim 11 is unpatentable over Stewart, et al.
Regarding claim 12, Stewart teaches the method according to claim 11,wherein the GUI feature comprises a sliding ruler that lets the user adjust the level of the deemphasis (Par. [0071]; Par. [0081] – the GUI may include interactive representations of sliders, buttons, knobs, and/or the like, that enable user selection of various electrical signal features, device parameters, physiological parameters, environmental parameters, and/or the like).
Therefore, claim 12 is unpatentable over Stewart, et al.
Regarding claim 13, Stewart teaches the method according to claim 9,wherein the EP map is a local activation time (LAT) map (Par. [0005] – activation map; Par. [0058] – examples of cardiac electrical signal features include… activation times; Par. [0078] – An activation waveform is a set of activation waveform values and may include, for example, a set of discrete activation waveform values (e.g., a set of activation waveform values, a set of activation time annotations, etc.), a function defining an activation waveform curve, and/or the like.; Par. [0108]).
Therefore, claim 13 is unpatentable over Stewart, et al.
Regarding claim 14, Stewart teaches the method according to claim 9,wherein the EP map is bipolar potential map (Par. [0100] – The data stream 402 may include signals such as unipolar and/or bipolar intracardiac electrograms (EGMs)).
Therefore, claim 14 is unpatentable over Stewart, et al.
Regarding claim 15, Stewart teaches the method according to claim 9, wherein the ROIs are tissue regions suspected of arrhythmogenic activity (Par. [0003] – Such procedures involve the mapping of electrical activity in the heart (e.g., based on cardiac signals), such as at various locations on the endocardium surface (“cardiac mapping”), to identify the site of origin of the arrhythmia followed by a targeted ablation of the site.; Par. [0083] – the ROI component 214 may determine the radius of influence of an electrical signal feature by determining a likelihood (e.g., probability) that the electrical signal feature (and/or other electrical signal features associated with the corresponding electrical signal) would have an influence (e.g., by contributing to a portion of operation of the heart, by contributing to an arrhythmia, by contributing to a signal measured within a certain distance, and/or the like)).
Therefore, claim 15 is unpatentable over Stewart, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ramos (US 2011/0225546) – Par. [0018]: In at least some embodiments, spotlighting can include leaving spotlighted regions visually untouched, while visually dimming region(s) that are not spotlighted.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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