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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 10/28/2025 (“Amendment”). Claims 1, 4-9, 11, and 14-26 are currently under consideration. The Office acknowledges the amendments to claims 1, 4-6, 8, 11, 14-16, 18, 19, 22, and 23, as well as the cancellation of claims 3 and the addition of new claims 24-26.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Claim Objections
Claims 1, 25, and 26 are objected to because of the following informalities:
Regarding claim 1, the recitation of “said brain model shows” should instead read –wherein said brain model shows-- or –said brain model showing--.
Regarding claims 25 and 26, the recitations of “The method” should instead read –The system--.
Appropriate correction is required.
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(s) is/are: “storage devices” in claim 1, “EEG device” in claims 1, 7, 11, and 17, and “computer modeling system” in claims 11 and 23.
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.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-9, 11, and 14-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Regarding claims 1, 7, 11, 17, and 23, they contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim element “EEG device” invokes 35 USC 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for the claimed functions. Specifically, it is unclear what the structure that generates the EEG data is (if not the electrodes). See the 35 USC 112(b) and 35 USC 112(f) analysis herein.
Regarding claims 1, 11, and 23, the recitations of “on or in the head” or “in or on the head” are not supported. For example, if the electrodes are only on the head, then they cannot show electrical activity at specific regions in the internal anatomy of the head.
Regarding claims 4-9 and 14-26, they are rejected because they depend on rejected claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-9, 11, and 14-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 1, 7, 11, 17, and 23, claim limitation “EEG device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for the claimed functions. Specifically, it is unclear what the structure that generates the EEG data is (if not the electrodes). See the 35 USC 112(a) and 35 USC 112(f) analysis herein. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claims 1, 8, 11, 18, and 23, there is insufficient antecedent basis for the recitations of “the brain,” or “said seizure activity in the brain.”
Regarding claims 4-9 and 14-26, they are rejected because they depend on rejected claims.
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, 4-9, 11, and 14-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1, 4-9, 22, 25, and 26 are directed to a “system,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claims 11, 14-21, 23, and 24 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 11, and 23 recite (“sets forth” or “describes”) the abstract idea of a mental process, substantially as follows:
generate a 3D brain model from the anatomy of the head of the patient based on one or more images of the head showing the internal anatomy of the head of the patient with said electrodes shown in place on or in the head of the patient, said brain model shows model images of electrode locations in relation to said internal anatomy as provided by said images of the head
graphical brain model representative of the brain; convert the EEG data into a graphical seizure model representative of seizure activity in the brain, said seizure model indicating different regions of the seizure activity; integrate the seizure model with the 3D brain model, thereby enabling visualization of and interaction with the seizure model within the context of the 3D brain model while showing electrode locations.
The generating, converting, and integrating steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of the image data and the EEG data, they would be able to convert (generate) each to a model, and localize the seizure model onto the brain model. There is nothing to suggest an undue level of complexity in either of the models or in the integration. Therefore, a person would be able to perform the steps mentally or with pen and paper.
Prong Two: Claims 1, 11, and 23 do not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a computer having a processor, a storage device, a program, an artificial intelligence algorithm, a computer modeling system), and
add insignificant extra-solution activity (the pre-solution activity of: receiving EEG data using generic data-gathering components (e.g. an EEG device and electrodes), scanning the head of a patient, etc.; and the post-solution activity of: communicating the integrated model to a generic data-outputting component (e.g. a display)).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the integrated model need not be displayed, seen, or acted on (indeed, the communicated data need not even reach the display). The use of an artificial intelligence algorithm is merely a “black box” processing function since no detail is provided about the algorithm, and the computer is merely used as a tool to perform this kind of processing. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 11, and 23 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. generating a heat map (claims 4 and 14), analyzing images, detecting positions, correlating the positions, and detecting anomalies (claims 5, 6, 15, and 16), mapping a surface of the brain (claims 9 and 19), learning from historical data and providing suggestions (claims 20-22), identifying locations and regions (claims 24-26), etc.),
further describe the pre-solution activity (or the structure used for such activity) (e.g. receiving data in real time (claims 7 and 17), etc.), and
further describe the post-solution activity (e.g. providing a recommendation (claims 8 and 18), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
Claims 1, 4-9, 11, 14-19, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2017/0065349 (“Ourselin”) in view of US Patent 10,588,561 (“Vale”).
Regarding claim 1, Ourselin teaches [a] system for modeling neurological activity, the system comprising: a display (Fig. 1, display 140); a plurality of electrodes configured to be placed in or on the head of a patient (¶ 0028); and a computer comprising one or more processors, one or more computer-readable tangible storage devices, and program instructions stored on at least one of the one or more storage devices for execution by at least one of the one or more processors (Fig. 1, operating system 130, computer 120, ¶ 0039 - also see ¶ 0025), the program instructions being configured to: generate a 3D brain model from the anatomy of the head of the patient based on one or more images of the head showing the internal anatomy of the head of the patient with said electrodes shown in place on or in the head of the patient, said brain model shows model images of electrode locations in relation to said internal anatomy as provided by said images of the head (¶¶s 0088-0091, images from a CT scan displaying the implanted electrodes in a 3D view – also see ¶ 0050); receive electroencephalogram (“EEG”) data generated by an EEG device coupled to the plurality of electrodes disposed on or in the head (¶¶s 0088-0091, acquiring SEEG data), the EEG data comprising a plurality of waveforms representative of electrical activity detected by the plurality of electrodes over a period of time (¶ 0089, amplitudes displayed as a time-sequence for each electrode); convert the EEG data into a graphical [EEG] model representative of [electrical] activity in the brain, said [EEG] model indicating different regions of [electrical] activity (¶ 0089, displaying the EEG readings as a time-sequence for different electrodes, with a 2D/3D visualization synchronized to the EEG display); integrate the [EEG] model with the 3D brain model, thereby enabling visualization of and interaction with the [EEG] model within the context of the 3D brain model while showing electrode locations (¶ 0089, synchronized display); and communicate the integrated [EEG] and brain model to the display for display to a user in an interactive manner (Figs. 2 and 7, ¶ 0046 – also see ¶ 0089, describing scanning forward/backward, etc.).
Ourselin does not appear to explicitly teach converting the EEG data into a graphical seizure model representative of seizure activity in the brain, said seizure model indicating different regions of the seizure activity, integrating the seizure model with the 3D brain model, and communicating the integrated model to a display.
Vale teaches converting EEG data into a graphical seizure model that is integrated with a 3D brain/head model (Fig. 2, col. 4, lines 16-23, dots for interictal events and crosses for ictal events).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to integrate a graphical seizure model into the integrated model of Ourselin, as in Vale, for the purpose of being able to map epilepsy networks, visualize interictal and ictal events, and more precisely identify neurosurgery targets (Vale: Abstract, col. 2, lines 8-15, col. 4, lines 16-23, etc.).
Regarding claim 11, Ourselin teaches [a] method for modeling neurological activity, comprising the steps of: scanning the head of a patient having a plurality of electrodes placed in or on said head (¶ 0028), said scanning providing one or more images of the internal anatomy of the head of the patient with electrode locations associated therewith (¶¶s 0088-0091, CT scanning); using a computer modeling system for generating a 3D brain model from the anatomy of the head of the patient, wherein said brain model shows model images of said electrodes at said electrode locations as determined by said scanning of the head (¶¶s 0088-0091, images from the CT scan display the implanted electrodes in a 3D view – also see ¶ 0050); receiving electroencephalogram (“EEG”) data generated by an EEG device coupled to the plurality of electrodes (¶¶s 0088-0091, acquiring SEEG data), the EEG data comprising a plurality of waveforms representative of electrical activity detected by the plurality of electrodes over a period of time (¶ 0089, amplitudes displayed as a time-sequence for each electrode); converting the EEG data into a graphical [EEG] model representative of said [electrical] activity in the brain, said [EEG] model visually identifying different regions of the [electrical] activity (¶ 0089, displaying the EEG readings as a time-sequence for different electrodes, with a 2D/3D visualization synchronized to the EEG display); integrating the [EEG] model with the brain model, thereby enabling visualization of and interaction with the [EEG] model within the context of the brain model (¶ 0089, synchronized display); and communicating the integrated [EEG] and brain model to a display for display to a user in an interactive manner (Figs. 2 and 7, ¶ 0046 – also see Fig. 1, display 140 – also see ¶ 0089, describing scanning forward/backward, etc.).
Ourselin does not appear to explicitly teach converting the EEG data into a graphical seizure model representative of seizure activity in the brain, said seizure model visually identifying different regions of the seizure activity, integrating the seizure model with the brain model, and communicating the integrated model to a display.
Vale teaches converting EEG data into a graphical seizure model that is integrated with a 3D brain/head model (Fig. 2, col. 4, lines 16-23, dots for interictal events and crosses for ictal events).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to integrate a graphical seizure model into the integrated model of Ourselin, as in Vale, for the purpose of being able to map epilepsy networks, visualize interictal and ictal events, and more precisely identify neurosurgery targets (Vale: Abstract, col. 2, lines 8-15, col. 4, lines 16-23, etc.).
Regarding claims 4 and 14, Ourselin-Vale teaches all the features with respect to the corresponding claims 1 and 11, as outlined above. Regarding claim 4, Ourselin-Vale further teaches wherein the computer is configured to generate a heat map representative of the strength of the neurological activity at different positions within the brain (Ourselin: ¶ 0091, a heat map identifying some areas as having increased/stronger neurological activity).
Claim 14 is rejected in like manner.
Regarding claims 5, 6, 15, and 16, Ourselin-Vales teaches all the features with respect to the corresponding claims 1 and 11, as outlined above. Regarding claims 5 and 6, Ourselin-Vale further teaches analyzing images of an anatomy including the EEG electrodes disposed on the anatomy (Ourselin: Figs. 2, 6, 7, and 9); automatically detecting positions of the EEG electrodes (Ourselin: ¶¶s 0088-0090, via CT scan and EpiNav); and correlating positions of the EEG electrodes with a plurality of EEG waveforms (Ourselin: ¶ 0091, the system knows which electrode produced which waveform to create the heatmap), and also teaches detecting anomalies in the waveforms and correlating the anomalies to positions of the EEG electrodes (Ourselin: ¶ 0089, detecting seizure spreading).
Claims 15 and 16 are rejected in like manner.
Regarding claims 7 and 17, Ourselin-Vale teaches all the features with respect to the corresponding claims 1 and 11, as outlined above. Regarding claim 7, Ourselin-Vale further teaches wherein the computer is configured to receive EEG data in real time directly from the EEG device (Ourselin: ¶¶s 0008, 0026, 0027, etc., a real-time system providing real-time visualizations).
Claim 17 is rejected in like manner.
Regarding claims 8, 9, 18, and 19, Ourselin-Vale teaches all the features with respect to the corresponding claims 1 and 11, as outlined above. Regarding claims 8 and 9, Ourselin-Vale further teaches wherein the computer is further configured to provide a recommendation for safely placing an electrode on a skull or the brain (Ourselin: ¶¶s 0022, 0040, etc.) by analyzing the brain model to determine locations of vessels and determining at least one location on the skull for placing the electrode such that the proximity between the vessels and a trajectory stemming from the location of the electrode is minimized (Ourselin: ¶ 0040), wherein the computer is further configured to map a surface of the brain such that the map is indicative of the proximity between the vessels and a trajectory stemming from a location on the map (Ourselin: Figs. 2, 3, 5-7, and 9, including distance graphs).
Claims 18 and 19 are rejected in like manner.
Regarding claims 25 and 26, Ourselin-Vale teaches all the features with respect to claim 1, as outlined above. Ourselin-Vale further teaches wherein the program instructions are further configured to identify the most likely location of occurrence of the seizure based on the EEG data as the focus region of the seizure (Vale: Figs. 2, 3, 5, etc., showing dots and crosses, where the crosses represent ictal activity, and concentrations of crosses identify the focus region of the seizure – also see Figs. 9A and 9B and their related description (e.g. col. 12, lines 41-51), which describes tracking of seizure localization/focus, etc. together with correlated cortical activity), and wherein said different regions of the seizure activity in the seizure model includes visual identification of the focus region (Vale: the concentrations of crosses as noted above), wherein said different regions of the seizure activity in the seizure model also includes visual identification of a middle region different than the focus region, and also includes visual identification of an outer region separate from the focus region and separate from the middle region (Vale: as above, different crosses corresponding to focus, middle, outer, and other regions – also see col. 4, lines 16-23, 40-52, etc., describing color-coding based on degree of connectivity or correlation, identification of centroids and edges, etc., such that e.g. the focus region is identified by crosses, the middle region is identified by dots and crosses, and the outer region is identified by dots and lines).
Claims 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2017/0065349 (“Ourselin”) in view of US Patent 10,588,561 (“Vale”) and US Patent Application Publication 2019/0223779 (“Mersmann”).
Regarding claim 20, Ourselin-Vale teaches all the features with respect to claim 11, as outlined above. Ourselin-Vale does not appear to explicitly teach using artificial intelligence techniques to learn from historical epilepsy data and to provide suggestions for future epilepsy treatment, including at least one of electrode placement and anomaly detection (although see Ourselin: ¶¶s 0010, 0022, 0069, 0093, 0097, etc. about automated risk analysis, cost functions, and the use of historical data).
Mersmann teaches applying machine learning methods to automatically analyze EEG data (¶¶s 0059-0061)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate the suggestion/recommendation process of the combination using machine learning, as described in Mersmann, as the simple substitution of one known automated suggestion/recommendation process (that of Ourselin: ¶ 0022) for another (that of Mersmann: ¶ 0060, doing the same thing but with an artificial intelligence algorithm), with predictable results (automatic selection of an entry point and trajectory as described in Ourselin: ¶ 0022).
Regarding claims 21 and 22, Ourselin-Vale teaches all the features with respect to the corresponding claims 11 and 1, as outlined above. Regarding claim 21, Ourselin-Vale does not appear to explicitly teach utilizing an artificial intelligence algorithm which has been trained from historical data of previous electrode placements to provide a suggestion for electrode placement on a skull of a current patient (although see Ourselin: ¶¶s 0010, 0022, 0069, 0093, 0097, etc. about automated risk analysis, cost functions, and the use of historical data).
Mersmann teaches applying machine learning methods to automatically analyze EEG data (¶¶s 0059-0061)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate the suggestion/recommendation process of the combination using machine learning, as described in Mersmann, as the simple substitution of one known automated suggestion/recommendation process (that of Ourselin: ¶ 0022) for another (that of Mersmann: ¶ 0060, doing the same thing but with an artificial intelligence algorithm), with predictable results (automatic selection of an entry point and trajectory as described in Ourselin: ¶ 0022).
Claim 22 is rejected in like manner (with the suggestion being an updated location for placement).
Regarding claim 23, Ourselin teaches [a] method for modeling neurological activity, comprising the steps of: … scanning the head of a patient having [the] plurality of electrodes placed in or on said head at [a] suggested location (¶ 0028), said scanning providing one or more images of the internal anatomy of the head of the patient with electrode locations associated therewith (¶¶s 0088-0091, CT scanning); using a computer modeling system for generating a 3D brain model from the anatomy of the head of the patient, said 3D brain model showing model images of said electrodes at said electrode locations as determined by said scanning of the head (¶¶s 0088-0091, images from the CT scan display the implanted electrodes in a 3D view – also see ¶ 0050); receiving EEG data generated by an EEG device coupled to a plurality of electrodes disposed on a head or a brain of the current patient based on the provided suggestion (¶¶s 0088-0091, acquiring SEEG data), the EEG data comprising a plurality of waveforms representative of electrical activity detected by the plurality of electrodes over a period of time (¶ 0089, amplitudes displayed as a time-sequence for each electrode); converting the EEG data into a graphical [EEG] model representative of said [electrical] activity in the brain (¶ 0089, displaying the EEG readings as a time-sequence for different electrodes, with a 2D/3D visualization synchronized to the EEG display); integrating the [EEG] model with the 3D brain model, thereby enabling visualization of, and interaction with, the [EEG] model within the context of the 3D brain model while showing the electrode locations in relation to said internal anatomy of the head (¶ 0089, synchronized display); and communicating the integrated [EEG] and brain model to a display for display to a user in an interactive manner (Figs. 2 and 7, ¶ 0046 – also see Fig. 1, display 140 – also see ¶ 0089, describing scanning forward/backward, etc.).
Ourselin does not appear to explicitly teach converting the EEG data into a graphical seizure model representative of said seizure activity in the brain, integrating the seizure model with the 3D brain model, and communicating the integrated model to a display.
Vale teaches converting EEG data into a graphical seizure model that is integrated with a 3D brain/head model (Fig. 2, col. 4, lines 16-23, dots for interictal events and crosses for ictal events).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to integrate a graphical seizure model into the integrated model of Ourselin, as in Vale, for the purpose of being able to map epilepsy networks, visualize interictal and ictal events, and more precisely identify neurosurgery targets (Vale: Abstract, col. 2, lines 8-15, col. 4, lines 16-23, etc.).
Ourselin-Vale does not appear to explicitly teach utilizing an artificial intelligence algorithm which has been trained from historical data of previous electroencephalogram (“EEG”) electrode placements to provide a suggested location for electrode placement in or on the head of a current patient (although see Ourselin: ¶¶s 0010, 0022, 0069, 0093, 0097, etc. about automated risk analysis, cost functions, and the use of historical data).
Mersmann teaches applying machine learning methods to automatically analyze EEG data (¶¶s 0059-0061)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate the suggestion/recommendation process of the combination using machine learning, as described in Mersmann, as the simple substitution of one known automated suggestion/recommendation process (that of Ourselin: ¶ 0022) for another (that of Mersmann: ¶ 0060, doing the same thing but with an artificial intelligence algorithm), with predictable results (automatic selection of an entry point and trajectory as described in Ourselin: ¶ 0022).
Regarding claim 24, Ourselin-Vale-Mersmann teaches all the features with respect to claim 23, as outlined above. Ourselin-Vale-Mersmann further teaches the step of identifying the most likely location of occurrence of the seizure based on the EEG data as the focus region of the seizure (Vale: Figs. 2, 3, 5, etc., showing dots and crosses, where the crosses represent ictal activity, and concentrations of crosses identify the focus region of the seizure – also see Figs. 9A and 9B and their related description (e.g. col. 12, lines 41-51), which describes tracking of seizure localization/focus, etc. together with correlated cortical activity), wherein said seizure model is configured to visually identify the focus region in the seizure model (Vale: the concentrations of crosses as noted above).
Response to Arguments
Applicant’s arguments filed 10/28/2025 have been fully considered.
As an initial matter, it is noted that Applicant has not addressed all claim objections or all rejections under 35 USC 112(a).
In response to the arguments regarding interpretations under 35 USC 112(f), they are not persuasive. Interpretation under 35 USC 112(f) is invoked because the claims use a generic placeholder (e.g. “device”), which is modified by functional language, and not modified by sufficient structure to perform the function. E.g. there is no structure described for performing the functions of generating EEG data or storing a program. The claimed electrodes are distinct from the EEG device, so the electrodes are not the structure. Then, the question is not whether an EEG device or a storage device is an actual device, but whether these are understood as the names for structure. In this case, they are not. “EEG” and “storage” are not structure. Associated rejections under 35 USC 112(a) and 112(b) are maintained because Applicant has not pointed to support in the disclosure for the structure of the EEG device. It is true that there is an EEG device 108, but the structure of this device is not described. Again, the question is not whether there is such a thing as an EEG device, but what the structure of the EEG device is. The specification does not describe it.
In response to the arguments regarding the rejections under 35 USC 112(a) and 112(b), they are not persuasive. The EEG device is distinct from the electrodes. Thus, the electrodes do not provide the structure for the EEG device. The Office agrees that the term “device” is not a function. Instead, it is a generic placeholder. Applicant has provided no evidence to support that “EEG device” is the name of structure. Their argument that “any device that generates EEG signals from electrodes installed on a patient can be used” supports the idea that it is not the name for structure, but merely refers to a generic placeholder. The Office’s position is not “ludicrous” since the only evidence provided by Applicant is the bare allegation that EEG devices are well known in the art.
The Office is not demanding detail. The Office is simply saying that the detail is not present. Regarding Applicant’s example of a “light emitting device,” this would also be interpreted under 35 USC 112(f) (absent other context). But all that would be needed to overcome any related rejections under 35 USC 112(a) or 112(b) would be disclosure of an example of what the light emitting device might be, such as a lightbulb or an LED. There is no requirement to list every possible type of light source. The Office simply needs to be able to know how to interpret the claim. When 112(f) is invoked and no exemplary structure is disclosed in the specification, it is unclear how to interpret the claim. So in the case of “light emitting device,” a rejection would similarly be maintained, as here, if the specification did not disclose at least one structure for performing the function. In the present case, it remains unclear how to interpret “EEG device” since it invokes 112(f), but the specification does not provide an exemplary structure.
The rejections under 35 USC 101 are maintained, at least because Applicant is arguing an improvement to the technology but has not pointed to where in the specification the improvement is discussed, and how this improvement is reflected in the claims. The claims say nothing about real-time interaction or visualization. The integrated model is not necessarily displayed on a display, and nothing in the claims suggests that a user needs to see the display and make a decision based on what is displayed. If a processor is configured to communicate a model to a display, that does not mean that the user needs to see, hear, or interact with the model or the display.
The Office disagrees that one cannot integrate models mentally. It is simply overlaying one type of data over another. Applicant argues that the claims require the generation of computer interactive 3D models, but this is not true. Where is this found in the claims? The claims do not even require changes over time to the models. The models are simply created based on received data, and integrated with each other. No user interaction is required, even if it is possible.
Applicant argues that there is no requirement to identify in the specification the improvements to the technology. The Office notes that this requirement is with respect to arguing a practical application for 101 purposes, and has nothing to do with novelty or non-obviousness. Applicant has failed to establish a practical application for 101 purposes. See MPEP 2106.04(d)(1).
In response to the amendments and arguments regarding the rejections under 35 USC 102, they are persuasive to the extent that Ourselin is not explicit regarding a graphical seizure model. Thus, a new grounds of rejection is made in further view of Vale and all claims remain rejected in light of the prior art.
The Office is not able to find where it “admits that nowhere does [Mersmann] teach training an algorithm based on previous placement of electrodes.” The evidence for the use of AI in claim 23 is e.g. in Ourselin and Mersmann, as outlined above. The Office has shown teachings of the prior art, has proposed a modification, and has explained why it would have been obvious in view of the teachings of the art itself. The primary reference already teachings making suggestions and recommendations. It is not explicit whether or not AI is used, so a reference was introduced to show that AI can be used to perform the already-contemplated automation. Applicant has not rebutted this rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791