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 Amendment
The amendment filed June 29, 2026 has been acknowledged. Claims 1-20 remain pending in the application and are under examination.
Response to Arguments
Applicant's arguments filed June 29, 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 rejection, Applicant argues that the additional elements integrate the concept of claim 1 into a practical application. Applicant amended the claim to specify that deep brain stimulation (DBS) is being performed and that there is a communication circuit for communicating a selected candidate therapy to the DBS system. Applicant argues that DBS systems are a specific type of system, rather than a generic computing system. Applicant argues that testing candidate therapies is a time-consuming process and that improvements to identifying candidate therapies are badly needed, thus not post-solution activity or system elements.
Examiner asserts in response to Applicant’s arguments that deep brain stimulation systems are well-known. Examiner asserts in response to Applicant’s arguments that using a communication circuit to communicate the selected therapy is merely a post-solution activity and does not integrate the abstract idea into a practical application as communication means moving information from one place to another. Examiner respectfully states that although the instant invention may provide improvements, the claimed invention does not overcome the 35 U.S.C. 101 rejections since claims 1 and 16 are still directed to abstract ideas and are therefore not patent eligible.
Regarding the 35 U.S.C. 103 rejection, Applicant argues that Paulk was used to say avoid grey matter and teach targeting white matter, which wouldn’t make a modification obvious; however, Paulk teaches targeting different areas depending on the desired result. Applicant argues that the generation of voxel and therapy scoring is independent of target or non-target tissue, and that they recommend against treating with different targets in mind.
In response to Applicant’s arguments, Examiner acknowledges that Paulk teaches targeting grey or white matter based on the desired result, however, Examiner respectfully disagrees that Paulk teaches that grey matter should be avoided completely. Paulk teaches that studies have been performed in direct electrical stimulation and deep brain stimulation that are trying to identify stimulation parameters by determining a brain region, grey or white matter, and amplitude, duration, and frequency that a stimulus should be given to in order to produce a specific output (pg. 38). Therefore, it would be obvious to try to create different therapy metrics based on the determined tissue type, linear or non-linear, being stimulated depending on the therapy program being applied to a region in the brain.
Applicant argues that Paulk uses direct electrical stimulation and not deep brain stimulation and that Paulk does not suggest that the definition of voxels as used in Mustakos would vary by the type of matter that the particular voxel represents. Applicant argues that Shamir does not teach differentiating white from grey matter for therapy response metrics. Applicant argues that Kaemmerer does not teach voxelization and/or therapy metrics.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Shamir teaches labeling voxels in the brain as grey or white matter. Paulk teaches that stimulating white or grey matter regions produce different outcomes. Kaemmerer does not teach voxelization or therapy metrics but does teach presenting candidate therapy programs to a user for a user to select. In combination with Mustakos, these modifications would yield labeling the voxels in Mustakos depending on their structure, determining different therapy metrics for the different structures based on the desired outcome for therapy, and presenting the candidate therapies to a user.
Claim Rejections - 35 USC § 112
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:
In re claim 1:
“a receiver module”
“a voxel definition module”
“a structure selection module”
“an optimizer”
“a therapy selection module”
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 § 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Independent claims 1 and 16 are directed to a system and method for configuring delivery of electrostimulation to specific tissue (what they’re doing). Thus, they are directed to statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claims 1 and 16 recite the following claim limitations which are directed to (abstract ideas, specifically mental processes) (see MPEP 2106.04(a)(2)):
In re claim 1:
“configured to define portions of the patient’s brain in voxel form as a voxel data structure,”
“configured to
identify a first non-linear response structure in the brain from the brain anatomy data and
identify voxels associated with the first non-linear response structure as a first set of non-linear voxels, and
to treat other voxels outside of the first non-linear response structure as linear voxels;” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts, i.e. evaluation).
“providing a graphical output allowing a user to identify and select structures in the patient’s brain as target structures and as avoid structures;” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts, i.e. judgement).
“configured to identify a plurality of candidate therapies by:
a) selecting a steering configuration for issuing output current in a fractional manner across a plurality of electrodes, the electrodes receiving a fraction of a total current;
b) determining, for each of a plurality of total current amplitudes, at least a first therapy metric for the non-linear voxels using a non-linear function, and a second therapy metric for the linear voxels for the selected steering configuration; and
c) selecting a different steering configuration and
repeating a) and b) to generate a plurality of therapy candidates each identifying a therapy metric associated with a particular total current amplitude and steering configuration; and” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts, i.e. mathematical concept).
In re claim 16, see above and the following limitations:
“b) calculating, for the selected steering configuration, and for each of a plurality of total current amplitudes, at least a first therapy metric for the non-linear voxels using a non-linear function, and a second therapy metric for the linear voxels, and summing the first therapy metric with the second therapy metric; and” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts, i.e. mathematical concept)
These limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, allowing users to identify target and avoid structures, selecting a steering configuration for issuing current in a fractional manner across a plurality of electrodes, determining or calculating a first and second therapy metric, and repeating the steps with different steering configurations are a matter of observation, evaluation, judgement, and opinion recognized by the courts as mental processes. Additionally, these limitations are drawn to an abstract idea because they are evaluation, judgement, opinion, and mathematical concepts, i.e. judgement and mathematical concept.
Step 2A, Prong 2:
Claims 1 and 16 recite the following additional elements:
In re claim 1,
“a receiver module” (mere data gathering)
“configured to receive
brain anatomy data for a patient and
lead position data for a lead forming part of a DBS system,
the lead position data indicating a location of the lead in the brain of the patient;” (pre-solution activity)
“a voxel definition module” (generically recited computer elements)
“a structure selection module coupled to a user interface” (generically recited computer elements)
“an optimizer” (generically recited computer elements)
“a therapy selection module adapted to present the candidate therapies to a user for selection of one or more candidate therapies for testing on a patient and to receive a selection from the user of a selected candidate therapy.” (insignificant extra-solution activity)
“a communications circuit configured to communicate the selected candidate therapy to an implantable pulse generator of the DBS system” (generically recited computer elements).
In re claim 16, see above.
The above limitations do not integrate the exception into a practical application of the exception because the elements are directed to mere data gathering, pre-solution activity, generically recited computer elements, and insignificant extra-solution activity.
The limitations “a receiver module”, “a voxel definition module”, “a structure selection module”, “an optimizer”, “a therapy selection module”, and “a communications circuit” are merely directed towards generically recited computer elements which do not improve the function of a computer, or any other technology or technical field. In other words, the computer components are being used as a tool to carry out the system’s functions (see MPEP 2106.05(a)).
The limitations “configured to receive brain anatomy data and lead position data” are directed towards pre-solution activity (see MPEP 2106.05(g)) since they’re used to obtain information about the user (i.e. mere data gathering).
The limitation “to present the candidate therapies… and to receive a selection from the user” is directed to insignificant extra-solution activity (see MPEP 2106.05(g)), as it is just outputting different therapies to a user found from determining the different therapy configurations.
The judicial exception does not integrate the claims as a whole into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements in the claim amount to no more than mere instructions to implement an abstract idea on a generic computer and mere data gathering.
Regarding the limitations directed to
Deep brain stimulation system,
See Patil et al. (US 2021/0085257) which teaches a method for predicting a volume of brain tissue for stimulation or activation which can be used to determine a more effective therapeutic treatment [0004]. The method can be used for deep brain stimulation [0003, 0020].
Thus, the limitations directed to DBS systems are well-understood, routine, and conventional, as evidenced by the reference above.
Claims 2-15 depend on claim 1 and recite the same abstract ideas as claim 1 for which they depend. Furthermore, these claims only contain recitations that further limit the abstract idea.
Claims 17-20 depend on claim 16 and recite the same abstract ideas as claim 1 and 16 for which they depend. Furthermore, these claims only contain recitations that further limit the abstract idea.
Thus, none of the claims 1-20 amount to significantly more than the abstract idea itself. Accordingly, claims 1-20 are not patent eligible and are rejected under 35 U.S.C. 101 as being directed to abstract ideas in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), MPEP 2106.04(d)(2), and MPEP 2106.05(g).
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, 2, 5-7, 11-13, 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mustakos et al. (US 2019/0184171) in view of Paulk et al. (Paulk, Angelique C., et al. "Impact of stimulation location relative to grey and white matter on single pulse electrical stimulation responses in the human brain." BioRxiv (2021): 2021-10) in view of Shamir et al. (US 2021/0196943) in view of Kaemmerer et al. (US 2016/0250476).
In re claim 1, A system for configuring delivery of Deep Brain Stimulation (DBS) to the brain of a patient [0047], the system comprising:
a receiver module (fig 7; [0075]; the implant storage device stores the position of leads and electrodes based on the patient’s anatomy) configured to receive
brain anatomy data for the patient [0075] and
lead position data for a lead forming part of a (DBS) system [0075],
the lead position data indicating a location of the lead in the brain of the patient [0075];
a voxel definition module (fig 8: 820; [0081]; the programmer circuit is able to create a 3D voxelized model) configured to define portions of the patient's brain in voxel form as a voxel data structure [0081],
the voxel definition module configured to
identify a first region ([0079]: “target region”) in the brain from the brain anatomy data [0079] and
identify voxels associated with the first region as a first set of first voxels [0079], and
to treat other voxels outside of the first region ([0079]: “avoidance region”) as second voxels;
a structure selection module ([0079]: “user selected regions”) coupled to a user interface (fig 8: 810) providing a graphical output allowing a user to identify and select structures in the patient's brain as target structures [0079] and as avoid structures [0079];
an optimizer configured to identify a plurality of candidate therapies ([0089]: the storage device can store multiple stimulation fields which can use different electrodes and parameters to deliver stimulation) by:
a) selecting a steering configuration [0049] for issuing output current in a fractional manner across a plurality of electrodes [0063], the electrodes receiving a fraction of a total current (fig 4B);
b) determining, for each of a plurality of total current amplitudes, at least
a first therapy metric (fig 10A-10B; [0084]) for the first voxels using a non-linear function [0085], and
a second therapy metric (fig 10A-10B) for the second voxels ([0084, 0085]; the therapy metric is determined for every region)
for the selected steering configuration [0038]; and
c) selecting a different steering configuration [0063] and repeating a) and b) ([0063]; fig 10A-10B) to generate a plurality of therapy candidates each identifying a therapy metric [0085] associated with a particular total current amplitude and steering configuration [0086];
a therapy selection module [0089, 0110] adapted to *present the candidate therapies to a user for selection of one or more candidate therapies for testing on a patient fig 11; [0089, 0110]; the user may select different steering parameters or receive them from the receiver circuit) and to receive a selection from the user of a selected candidate therapy ([0052]; fig 7; fig 8: external programming device with the user interface can communicate with implantable stimulator via wireless or wired link, 640);
a communications circuit configured to communicate the selected candidate therapy to an implantable pulse generator of the DBS system [0052].
Mustakos lacks:
the voxel definition module configured to
identify a first non-linear response structure in the brain from the brain anatomy data and
identify voxels associated with the first non-linear response structure as a first set of non-linear voxels, and
to treat other voxels outside of the first non-linear response structure as linear voxels;
a first therapy metric for the non-linear voxels using a non-linear function, and
a second therapy metric for the linear voxels
Paulk teaches electrical stimulation of brain tissue and its potential use in alleviating symptoms of neuropsychiatric diseases (pg 3, introduction). Paulk analyzes how different factors affect results of electrical stimulation including location of stimulation to grey or white matter (pg 3, introduction; Note: Applicant’s instant specification recites that gray matter responds linearly, while white matter responds non-linearly [0004]). Paulk teaches how stimulation therapies should be modified based on their targeted outcome (pg 38: “main results of grey and white matter stimulation and local and distant effects in our study suggest that therapies using stimulation should be modified per targeted neurophysiological outcome”). Paulk teaches that white matter stimulation results in larger responses (pg 35) and may be ideal when targeting widespread changes (pg 38).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Mustakos with determining a first metric for stimulating a region of white matter (the more targeted region due to having larger responses to stimulation) while also determining a metric for stimulating a region of grey matter (the more avoided region due to being typically less effective except when aiming for a highly localized response) as taught by Paulk, as it is known that treating both regions of the brain can be useful depending on the desired outcome of the therapy, such as focusing on white matter regions which may be more beneficial for treating neuropsychiatric conditions and focusing on the grey matter regions for highly localized responses.
Additionally, Shamir teaches a method to analyze a set of images using voxels and determines a tissue type for each voxel [0082]. The voxels can be labeled as gray matter or white matter [0084].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by labeling the voxels with different tissue types, such as white or grey matter, and further calculating the metrics based on the identified voxels, as taught by Shamir, as identifying the tissue structures in each voxel is a known way to map brain anatomy and would allow the user to determine which region of the brain they wanted to target.
*Regarding the limitation, Mustakos teaches wherein the user can select from different stimulation configurations, stimulation waveforms, pulse waveforms, and stimulation fields [0089]. However, insofar as it is not explicitly stated that the different parameters are presented to the user for selecting different candidate therapies, this limitation is additionally addressed as follows:
Kaemmerer teaches a system for determining therapy programs based on the expected volume of tissue activated by electrical stimulation [0005]. The therapy programs can include different parameters such as frequency, current or voltage amplitude, and electrode combinations [0027]. The user is able to select from different therapy programs based on their clinical scores (fig. 8).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of proposed combination with a display interface with different programs ranked by their overall therapeutic effects as taught by Kaemmerer, as showing the therapy programs ranked by efficacy would make it easier for a user to select the one that would be most beneficial for their specific needs.
Accordingly, such a modification would yield a proposed combination voxel definition module that identifies grey or white matter as linear or non-linear response structures in the brain and determines different therapy metrics based on whether the structures are grey or white matter as stimulating white matter usually results in larger responses and is more effective while stimulating grey matter is less effective unless a highly localized response is needed. The proposed combination would also be able to take the different stimulation parameters and sort them into programs with clinical ratings for easier selection by the user.
In re claim 2, the proposed combination discloses wherein the structure selection module is configured to associate each target structure and each avoid structure with a weight to be used in calculating the therapy metrics (Mustakos: [0079]).
In re claim 5, the proposed combination (all mapping directed to Mustakos) discloses
wherein the optimization module is configured to identify a combination of total current amplitude and highest metric [0094]: “voxel ranking or current amplitude ranking”) for each steering configuration that is tested [0098], and
selects the combinations of steering configuration and total current amplitude having highest metrics as the candidate therapies [0090].
In re claim 6, the proposed combination (all mapping directed to Mustakos) discloses wherein
wherein each of the therapy metrics are calculated using a cost function analysis by:
determining a first partial therapy metric associated with the non-linear response structure using a non-linear function ([0084: “each 3D voxel I in a region j (either a target or an avoidance region), a corresponding voxel effect (X(i,j)) representing voxel i’s contribution to the MV for the region j, may be computed”; each voxel in the target region’s contribution is calculated);
determining a second partial therapy metric associated with the set of linear response voxels using a linear function ([0084: “each 3D voxel I in a region j (either a target or an avoidance region), a corresponding voxel effect (X(i,j)) representing voxel i’s contribution to the MV for the region j, may be computed”; each voxel in the avoidance region’s contribution is calculated); and
summing the first partial therapy metric and the second partial therapy metric to determine the first therapy metric ([0084]; “the MV for the region j may be determined using a combination of voxel effects across all N voxels within the region j”; the individual contributions are summed for each voxel to determine the overall metric).
In re claim 7, the proposed combination discloses (all mapping directed to Mustakos) wherein the optimizer is configured to determine, for each of a plurality of total current amplitudes [0063],
at least a first therapy metric (fig 10A-10B; [0084]) for the non-linear voxels using a non-linear function [0085] by determining a quantity of voxels in the non-linear response structure are activated ([0079]; voxels in a targeted region can be selected in the 3D model)
in a given steering configuration [0063] and
at a given total current amplitude [0063], and
applying a non-linear function to the quantity [0085].
In re claim 11, the proposed combination (all mapping directed to Mustakos) discloses
wherein the optimizer is configured to estimate voltage fields (fig 11: 1106) within the first non-linear structure ([0114]; a minimum current is required to activate a neural target like an axon or cell body which are part of nerves”) to determine whether the non-linear structure would be activated at a given steering configuration ([0115]: “a voltage field of the plurality of electrodes”) and total current amplitude ([0114]: “threshold current represents a minimum current required for modulating a physiologic target”).
In re claim 12, the proposed combination lacks wherein the therapy selection module is configured to generate and display an image to the user to aid in selecting among the candidate therapies, the image indicating a volume of activation of the neural tissue for at least one candidate therapy.
Kaemmerer teaches a system for determining therapy programs based on the expected volume of tissue activated by electrical stimulation [0005]. Kaemmerer also teaches that a volume of tissue activation as a result of electrical stimulation can be visually illustrated on the user interface to show the region of tissue being activated [0091].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination with allowing the user interface to show the volume of tissue activation for the selected therapy programs as taught by Kaemmerer because it would allow the user a visual way to understand where the different therapy programs are stimulating which would help the user select the most beneficial programs.
In re claim 13, the proposed combination (all mapping directed to Mustakos) discloses further comprising
a communications circuit configured to communicate a selected therapy candidate to be tested to a pulse generator ([0059]; the programming device generates stimulation configurations) of the neurostimulation system (fig 4A: 404),
the pulse generator being connected to the lead (408A-408B) to allow delivery electrical outputs defined by the selected therapy candidate to the patient [0060].
In re claim 16, see above (In re claim 1) and the following limitation:
summing the first therapy metric with the second therapy metric (Mustakos [0025, 0104]; the voxel metrics can be summed); and
In re claim 17, see above (In re claim 2).
In re claim 20, see above (In re claim 5).
Claims 3, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mustakos et al. (US 2019/0184171) in view of Paulk et al. (Paulk, Angelique C., et al. "Impact of stimulation location relative to grey and white matter on single pulse electrical stimulation responses in the human brain." BioRxiv (2021): 2021-10) in view of Shamir et al. (US 2021/0196943) in view of Kaemmerer et al. (US 2016/0250476) in view of Sughrue et al. (US 11,354,803).
In re claim 3, the proposed combination lacks wherein the first non-linear response structure is a nerve fiber, and a weight associated with the non-linear structure is calculated by determining neural structures to which the nerve fiber connects.
Sughrue teaches a system for parceling the brain into different voxels based on the tissue (col 1, ln 46-49) and using the data to plan stimulation (col 3, ln 42-45). Tracts can be 3D modeled in the brain by using voxels (col 22, ln 20-22). The tracts can be white matter which contains nerve fibers (col 2, ln 1-3) or bundles of nerve fibers (col 2, ln 10-12). Then, the individual voxel’s connectivity with other voxels, based on the probability that they are in related structures can be determined (col 22, ln 23-26).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by determining the weights of the individual voxels based on the other voxels surrounding it and whether they are part of the same nerve tract as taught by Sughrue, as weighing the voxels based on the nerve fiber and whether the nerve fiber next to it is part of the same tract or a different tract would allow for more accurate identification as a target or avoid structures which would help identify more beneficial areas of stimulation.
In re claim 14, the proposed combination discloses wherein the non-linear response structure is white matter.
The proposed combination lacks wherein the first non-linear response structure is a nerve fiber or a bundle of nerve fibers.
Sughrue teaches a system for parceling the brain into different voxels based on the tissue (col 1, ln 46-49). Tracts can be 3D modeled in the brain by using voxels (col 22, ln 20-22). The tracts can be white matter which contains nerve fibers (col 2, ln 1-3) or bundles of nerve fibers (col 2, ln 10-12).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by having nerve fibers or bundles of nerve fibers be what is making up the white matter as taught by Sughrue, as it is known white matter is made of nerve fibers.
In re claim 18, see above (In re claim 3).
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mustakos et al. (US 2019/0184171) in view of Paulk et al. (Paulk, Angelique C., et al. "Impact of stimulation location relative to grey and white matter on single pulse electrical stimulation responses in the human brain." BioRxiv (2021): 2021-10) in view of Shamir et al. (US 2021/0196943) in view of Kaemmerer et al. (US 2016/0250476) in view of Chaturvedi et al. (US 10,583,293).
In re claim 4, the proposed combination lacks wherein the structure selection module is configured to associate a background weight with any volume in the patient neural tissue that would be activated by a therapy.
Chaturvedi teaches a system for determining the therapeutic efficacy of therapy programs based on their expected target of tissue activation (col 1, ln 45-48). The score is indicated by an efficacy map which is a 3D grid made of voxels that are assigned values (col 1, ln 52-62). The voxels can be assigned with a positive score, a negative score, or neither a positive or negative score based on the target volume of tissue activation for an efficacy map (col 31, ln 30-36). The voxels outside of the efficacy map that have no value assigned may be assigned negative values when calculating the overall target of volume activation for the therapy program (col 31, ln 19-21).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by assigning a score to voxels outside of the target area if they are still part of the region that stimulation will affect as taught by Chaturvedi, as knowing the overall area affected by stimulation, instead of just the target area, would allow the user to see which programs stimulate larg1er volumes of tissue activation and whether the amount of tissue being activated is associated with a positive, negative, or background effect. Additionally, the voxels with no assigned value could be assigned a negative (penalty) value when determining the target volume of tissue activation and efficacy of the therapy, as any voxels affected by stimulation outside of the targeted voxels could have unnecessary effects so selecting a therapy that minimizes the amount of background voxels would be more beneficial to the user.
In re claim 19, see above (In re claim 4).
Claims 8, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mustakos et al. (US 2019/0184171) in view of Paulk et al. (Paulk, Angelique C., et al. "Impact of stimulation location relative to grey and white matter on single pulse electrical stimulation responses in the human brain." BioRxiv (2021): 2021-10) in view of Shamir et al. (US 2021/0196943) in view of Kaemmerer et al. (US 2016/0250476) in view of Lin et al. (US 2019/0304145) in view of Andersson et al. (US 2020/0269066) in view of Dempsey et al. (US 2005/0207531).
In re claim 8, the proposed combination lacks wherein the non-linear function is a polynomial function.
However, Mustakos suggests using a non-linear function for calculating the therapy metrics but is silent as to what type of non-linear function is used. It would be obvious to one of ordinary skill in the art to look for known non-linear functions such as polynomial functions (claim 8), step functions (claim 9), or segmented functions (claim 10) and to try using those to determine the therapy metrics.
Alternatively, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Mustakos et al. with the non-linear function being a polynomial, step, or segmented function, because Applicant has not disclosed that a polynomial, step, or segmented function provides an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant' s invention to perform equally well with a non-linear function as taught by Mustakos et al., because it can be used to determine the therapy metrics and since it appears to be an arbitrary design consideration which fails to be patentably distinguish over Mustakos et al.
Therefore, it would have been an obvious matter of design choice to modify Mustakos et al. to obtain the invention as specified in the claims. Additionally, it would be obvious to look for types of non-linear functions used in medical applications as evidenced by Lin (abstract), Andersson [0067], Dempsey [0026].
In re claim 9, regarding the limitation: wherein the non-linear function is a step function (see above in re claim 8).
In re claim 10, regarding the limitation: wherein the non-linear function comprises two or more segments, each segment corresponding to a range of the quantity, and each segment applying a different linear or non-linear function (see above in re claim 8).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mustakos et al. (US 2019/0184171) in view of Paulk et al. (Paulk, Angelique C., et al. "Impact of stimulation location relative to grey and white matter on single pulse electrical stimulation responses in the human brain." BioRxiv (2021): 2021-10) in view of Shamir et al. (US 2021/0196943) in view of Kaemmerer et al. (US 2016/0250476) in view of Dou (US 2016/0089532) in view of Tsukashima (US 2022/0273943).
In re claim 15, the proposed combination lacks wherein the first non-linear response structure is a nerve fiber located in the internal capsule, and the lead is positioned to deliver therapy to a target in the thalamus.
Dou teaches a deep brain stimulation lead for directing electrical stimulation to nerve nucleuses or nervous tracts, such as the anterior limb of the internal capsule, to treat a variety of psychological disorders [0021].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by specifically targeting a nerve fiber or tract in the internal capsule, as it is known that deep brain stimulation of the nerves in the internal capsule can be used to treat a variety of disorders.
Tsukashima teaches a method for deep brain stimulation treatment using an electrode assembly [0005] between the internal capsule and the thalamus [0006]. The electrode assembly can be positioned to face towards or away from either the internal capsule or thalamus to direct stimulation [0014].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination with the with the lead positioned between the thalamus and internal capsule to deliver therapy to a target in the thalamus as taught by Tsukashima, as it is known that the position of the lead can be changed depending on which structure is targeted, and it is known that both the internal capsule and the thalamus have structures that benefit from stimulation.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights