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 .
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but they are not persuasive.
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Independent claims 1 and 2 have been amended to read:
Applicant argues that the amended claim language, seen underlined, adequately addresses the written description issues raised in the Non-Final Office action dated 9/30/2025. This language includes that a stimulation controller (claim 1) performs simulations using a three-dimensional model to identify electrode configurations that achieve a preset electric field threshold in the target area while minimizing off-target effects, wherein the simulation sequence applies stimulation sequentially from a distal electrode to a proximal electrode along the electrode array. This added language does not overcome the written description rejections because it fails to adequately explain how the stimulation controller and/or the method of claim 2 determines a number and arrangement of electrodes included in an electrode array according to a structure of a target area. Initially, the claim language gives no indication as to how applicant intends to determine “a/the structure of a/the target area”.
Paragraph 0023 of applicants disclosure states: “Specifically, a medical image of the target area where stimulation is to be applied is obtained. Here, the medical image includes at least one of CT, MRI, and an ultrasonic wave. Next, an image segmentation technique is applied to the acquired medical image to generate a three-dimensional tissue model, and a virtual electrode array is inserted into the generated three-dimensional tissue model.”
Paragraph 0023 gives a broad overview of how the structure of the target area could be determined. In this paragraph a medical image including CT, MRI or ultrasound is obtained. Once obtained an image segmentation technique is applied to the image to generate a three-dimensional tissue model. Image segmentation includes partitioning a digital image into multiple regions (pixels) for analysis. Segmentation is used to locate objects and boundaries and is often used in tumor detection and organ segmentation. There are a variety of techniques which include semantic image segmentation, instance segmentation and panoptic segmentation i. These techniques are not mathematically trivial and require extensive data analysis. In this case we have three types of images disclosed in the specification 1) MRI, 2) CT and 3) ultrasound as well as a potential for three segmentation techniques 1) semantic image segmentation, 2) instance segmentation and 3) panoptic segmentation. Therefore, as an example, the MRI, CT and/or ultrasound could be subjected to any of the three segmentation techniques. The written description fails to provide any discussion or disclosure as to which segmentation technique is used or if a separate segmentation technique is used. There is simply no disclosure as to how the images are processed and which technique is used to determine intensity, stimulation sequency and stimulation interval.
It is assumed that this is a computer-implemented function. The written description fails the written description requirement if the hardware and software is not adequately disclosed. In this case the only hardware discussed is a stimulation controller which is configured to perform these simulations. The simulation techniques are not disclosed and the development of the model is not disclosed.
The rejections of claims 1 and 2 is maintained. Any rejection not repeated below is withdrawn in favor of the below rejections.
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 1-19 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. The claim(s) contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a stimulation controller configured to determine stimulation parameters including intensity, a stimulation sequence, and a stimulation interval based on the structure of the target area and configured to control the stimulation generator according to the determined stimulation parameters.” Based on the specification this is assumed to be an algorithm and/or computer program which determines stimulation parameters. It is not disclosed or discussed how applicant intends to determine intensity, a stimulation sequence, and a stimulation interval which is based on the target structure (“based on the structure of the target area”). This language indicates that the intensity (assumed to be amplitude of stimulation), stimulation sequence and stimulation interval (assumed to be either pulse width or the frequency however this is unclear) are all based on the structure of the target area, however there is no discussion as to how applicant intends to perform this determination. This could be the application of stimulation, within the simulation, in the form of current or voltage amplitude and then observing or otherwise assessing a volume of activation based on the current or voltage applied in the model. However this is based on the target structure and it is not disclosed how these two things are interlinked. If this is voltage/current amplitude applied to create a volume of activation and/or electric field within the tissue of interest it is directly linked to how many neurons in that area are activated and or fire due to the voltage/current applied while all other stimulation parameters are held constant. The volume of activation itself can change (become larger or smaller) based on increases and decreases in voltage/current applied or the volume of activation can also have different intensities based on how many neurons are firing. This is to say that a lower amplitude stimulus will cause fewer neurons immediately adjacent to the electrode to fire while a higher amplitude stimulus will cause more neurons immediately adjacent to the electrode to fire resulting in changes to the size of the volume of activation as well as changes to the intensity of the volume of activation. It is not known based on the inventors, with respect to this claim language, intend to determine stimulation parameters based on the structure of the target area.
Claims 1 and 2 further recite that the stimulation parameters which are based on the structure of the target area are determined “by performing simulations using a three-dimensional tissue model to identify electrode configurations that achieve a preset electric field threshold in the target area while minimizing off-target effects”. The only mention of a 3-D model is found in paragraphs 0014, 0023-24, 0052 and 0056 of applicant’s disclosure. Paragraphs 0023-24 provide the most detail and read:
[0023] Specifically, a medical image of the target area where stimulation is to be applied is obtained. Here, the medical image includes at least one of CT, MRI, and an ultrasonic wave. Next, an image segmentation technique is applied to the acquired medical image to generate a three-dimensional tissue model, and a virtual electrode array is inserted into the generated three-dimensional tissue model.
[0024] Next, a simulation is performed such that the strength of an induced electric field in the target area reaches a preset threshold during electrical stimulation by applying stimulation to the three-dimensional tissue model through the inserted virtual electrode array.
In these paragraphs a CT, MRI or ultrasonic wave is obtained and an imaging segmentation technique is applied to generate a 3-D tissue model. There is no disclosure as to the specific imaging segmentation technique the inventors intend to used in order to generate a 3-D model. There are no steps, no procedures and there are no algorithms disclosed. Therefore any of the images CT, MRI or ultrasound wave can have any imaging technique applied to create any 3-D tissue model, this is an expansive breadth. Further, with respect to written description, the algorithm or steps/procedures needed to preform the segmentation and eventual 3-D model construction are not discussed nor are they disclosed thus resulting in one of ordinary skill in the art being unable to understand how the inventor intended to perform segmentation and/or 3-D model construction.
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 1-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 3 each recite “determine stimulation parameters including stimulation intensity, a stimulation sequence, and a stimulation interval based on the structure of the target area by performing simulations using a three-dimensional tissue model to identify electrode configurations that achieve a preset electric field threshold in the target area while minimizing off-target effects”.
In this language stimulation parameters are determined based on the structure of the target area by performing simulations using a three-dimensional tissue model. As discussed with the written description rejection, this is best described in the specification in paragraphs 0023-24 which state that a CT, MRI or ultrasonic wave is obtained and an imaging segmentation technique is applied to generate a 3-D tissue model. When discussing enablement the Wands Factors are analyzed this analysis is below.
Breadth
In the language a CT, MRI or ultrasonic wave is obtained and an imaging segmentation technique is applied to generate a 3-D tissue model. Therefore any imaging segmentation technique can be applied to one of a CT, MRI or ultrasonic wave to create any 3-D tissue model, this is an expansive breadth.
Nature of the invention
The nature of the invention is considered to be complex in that these are data processing techniques.
State of the prior art
The state of the prior art is developing.
Level of skill of one or ordinary skill in the art
The level of skill of one of ordinary skill in the art is considered to be high, PhD level.
Level of predictability in the art
The level of predictability in the art is low.
Amount of direction provided by the inventors
In this case, with respect to the claim language identified above there is no direction provide by the inventors as to which imaging segmentation technique is used, how the imaging segmentation technique is performed or how this leads to a 3D model.
Existence of working examples
There are no working examples.
Therefore there is undue experimentation needed. Because any and all segmentation techniques can be used and any and all models can be used there is a failure to enable the full scope of the protection sought by the claim language in light of the specification.
With respect to the language “performing simulations”. A simulation represents the dynamic responses of one system by the behavior of anotherii. Therefore the use of simulations is also not enabled by the specification.
Breadth
The breadth of the language “performing simulations” is expansive in that this could be any simulation related to any system and the responses and behaviors of any other system. In this case it is likely a simulation as to how the brain tissue responds to stimulation using specific stimulation parameters however this is not discussed and only an assumption.
Nature of the invention
The nature of the invention is considered to be complex in that these are data processing techniques.
State of the prior art
The state of the prior art is developing.
Level of skill of one or ordinary skill in the art
The level of skill of one of ordinary skill in the art is considered to be high, PhD level.
Level of predictability in the art
The level of predictability in the art is low.
Amount of direction provided by the inventors
In this case, with respect to the claim language identified above there is no direction provide by the inventors as to which imaging segmentation technique is used, how the imaging segmentation technique is performed or how this leads to a 3D model.
Existence of working examples
There are no working examples.
Therefore this language also fails to meet the enablement requirement in that undue experimentation is required to determine how to perform these simulations.
All claims are rejected under 35 U.S.C § 112 and it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i https://medium.com/@fraidoonomarzai99/image-segmentation-in-depth-8ec11fb56371
ii https://www.britannica.com/technology/computer-simulation