DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 11 and 20 are objected to because of the following informalities: Claims 11 and 20 is to an apparatus, i.e. a product, and claim 1 also requires specific method steps of “the programmer having a processor, a user interface, and machine readable instructions for the programmer to perform the following […]”. Examiner suggest amending to recite the following product by process limitation “the programmer having a processor, a user interface, and machine readable instructions, the programmer configured to […]”. Appropriate correction is required.
Claims 19 is objected to because of the following informalities: the phrase “by each receiving an indication of which electrodes” is an awkward limitation as the “user selection” appears to be a single user selection, may contain multiple selections due to the term “each”. Appropriate correction is required.
Claims 11 and 18 are objected to because of the following informalities: the enumeration “a)” and “b)” are unnecessary as they are placed in the middle of the functional steps. Examiner suggests removing the enumerations. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the lead" in line 2, 5, and 6. There is insufficient antecedent basis for this limitation in the claim. Claim 1 line 2 recites “an implantable neuromodulation lead”.
Regarding claim 1, it is unclear if the “one or more neural structures” of line 5-6 is the same or different than the “neural structure” of line 2.
Regarding claim 1, it is unclear if the “borders” of line 10 and 18 is the same or different than the “borders of regions” of line 8. Examiner notes that a border can be a line and borders of regions must have a range and is enclosed.
Regarding claim 1, it is unclear if the “location” of line 11 and 14 is the same or different than the “location near neural structures” of line 2.
Regarding claim 1, it is unclear if the “a therapy benefit” of line 17 is the same or different than the “therapy benefit” of line 16 and/or the “likely therapy benefit” of line 8.
Regarding claim 1, it is unclear if the “a side effect” of line 18 is the same or different than the “side effect” of line 16 and/or the “likely side effects” of line 8.
Regarding claim 2, it is unclear if the “a likely therapy benefit” of line 1 is the same or different than the “therapy benefit” of line 16 and/or the “likely therapy benefit” of line 8 of claim 1.
Regarding claim 2, it is unclear if the “a therapy benefit” of line 3 and 4 is the same or different than the “therapy benefit” of line 16 and/or the “likely therapy benefit” of line 8 of claim 1.
Regarding claim 2, it is unclear if the “therapy pulses” of line 5 is the same or different than the “therapy pulses” of line 3 of claim 2 and/or the “test neuromodulation therapy” of line 11 of claim 1.
Regarding claim 3, it is unclear if the “a likely side effects” of line 1 is the same or different than the “side effects” of line 16 and/or the “likely side effects” of line 8 of claim 1.
Regarding claim 3, it is unclear if the “ side effects” of line 2 is the same or different than the “side effects” of line 16 and/or the “likely therapy benefit” of line 8 of claim 1.
Regarding claim 3, it is unclear if the “neural side effects” of line 4 is the same or different than the “side effects” of line 16 and/or the “likely therapy benefit” of line 8 of claim 1.
Regarding claim 3, it is unclear if the “therapy pulses” of line 5 is the same or different than the “therapy pulses” of line 3 of claim 3 and/or the “test neuromodulation therapy” of line 11 of claim 1.
Regarding claim 4, it is unclear if the “electrode position” of line 1 is the same or different than the “electrode positions” of claim 1 line 7.
Regarding claim 5, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 8 of claim 1.
Regarding claim 6, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 8 of claim 1.
Regarding claim 7, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 8 of claim 1.
Regarding claim 8, it is unclear if the “user selection” of line 1 is the same or different than the “user selection” of line 11 of claim 1.
Regarding claim 8, it is unclear if the “location” of line 2 is the same or different than the “location near neural structures” of line 2 and/or the “location” of line 11 of claim 1.
Regarding claim 8, it is unclear if the “test modulation therapy” of line 2 is the same or different than the “test modulation therapy” of line 11 of claim 1.
Regarding claim 8, it is unclear if the “indication” of line 2 is the same or different than the “indication” of line 15 of claim 1.
Regarding claim 8, it is unclear if the “electrodes” of line 3 is the same or different than the “plurality of electrodes” of line 3 of claim 1.
Claim 8 recites the limitation "the lead" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 line 2 recites “an implantable neuromodulation lead”.
Claim 9 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 8 of claim 1.
Claim 10 recites the limitation "the lead" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 line 2 recites “an implantable neuromodulation lead”.
Claim 11 recites the limitation "the lead" in line 3, 7, and 8. There is insufficient antecedent basis for this limitation in the claim. Claim 11 line 2 recites “an implantable neuromodulation lead”.
Regarding claim 11, it is unclear if the “one or more neural structures” of line 8 is the same or different than the “neural structure” of line 3.
Regarding claim 11, it is unclear if the “borders” of line 13 and 20 is the same or different than the “borders of regions” of line 10.
Regarding claim 11, it is unclear if the “a therapy benefit” of line 20 is the same or different than the “therapy benefit” of line 18 and/or the “likely therapy benefit” of line 10.
Regarding claim 11, it is unclear if the “a side effect” of line 20 is the same or different than the “side effect” of line 18 and/or the “likely side effects” of line 10.
Regarding claim 12, it is unclear if the “a likely therapy benefit” of line 1 is the same or different than the “therapy benefit” of line 18 and/or the “likely therapy benefit” of line 10 of claim 11.
Regarding claim 12, it is unclear if the “a therapy benefit” of line 3 and 4 is the same or different than the “therapy benefit” of line 18 and/or the “likely therapy benefit” of line 10 of claim 11.
Regarding claim 12, it is unclear if the “therapy pulses” of line 5 is the same or different than the “therapy pulses” of line 3 of claim 12 and/or the “test neuromodulation therapy” of line 14 of claim 11.
Regarding claim 13, it is unclear if the “a likely side effects” of line 1 is the same or different than the “side effects” of line 18 and/or the “likely side effects” of line 10 of claim 11.
Regarding claim 13, it is unclear if the “ side effects” of line 2 is the same or different than the “side effects” of line 18 and/or the “likely therapy benefit” of line 10 of claim 11.
Regarding claim 13, it is unclear if the “neural side effects” of line 4 is the same or different than the “side effects” of line 18 and/or the “likely therapy benefit” of line 10 of claim 11.
Regarding claim 13, it is unclear if the “therapy pulses” of line 5 is the same or different than the “therapy pulses” of line 3 of claim 13 and/or the “test neuromodulation therapy” of line 14 of claim 11.
Regarding claim 14, it is unclear if the “electrode position” of line 1 is the same or different than the “electrode positions” of claim 11 line 9.
Regarding claim 15, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 10 of claim 11.
Regarding claim 16, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 10 of claim 11.
Regarding claim 18, it is unclear if the “borders” of line 1 is the same or different than the “borders of regions” of line 10 of claim 11.
Regarding claim 18, it is unclear if the “ side effects” of line 2, 3, 4, and 6 is the same or different than the “side effects” of line 18 and/or the “likely therapy benefit” of line 10 of claim 11.
Regarding claim 19, it is unclear if the “location” of line 3 is the same or different than the “location near neural structures” of line 3 of claim 11 and/or the “location” of line 7 of claim 11 and/or “test location” of line 13 of claim 11.
Regarding claim 19, it is unclear if the “electrodes” of line 4 is the same or different than the “plurality of electrodes” of line 3 of claim 11.
Claim 19 recites the limitation "the lead" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 11 line 2 recites “an implantable neuromodulation lead”.
Regarding claim 19, it is unclear of the “user selection” of line 2 is the same or different than the “user selection” of line 13 of claim 11.
Claim 20 recites the limitation "the lead" in line 4, 8, and 9. There is insufficient antecedent basis for this limitation in the claim. Claim 20 line 2 recites “an implantable lead”.
Regarding claim 20, it is unclear if the “borders” of line 13 and 20 is the same or different than the “borders of regions” of line 11.
Regarding claim 20, it is unclear if the “a therapy benefit” of line 21 is the same or different than the “therapy benefit” of line 19 and/or the “likely therapy benefit” of line 11.
Regarding claim 20, it is unclear if the “a side effect” of line 21 is the same or different than the “side effect” of line 19 and/or the “likely side effects” of line 11.
Claim 20 recites the limitation "the test location" in line 17. There is insufficient antecedent basis for this limitation in the claim. Claim 20 line 8 recites “a location”.
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 an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 11 and 20 are directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1, 11, and 20, the following step is an abstract idea:
“creating a map of electrode positions;
placing borders of regions of likely therapy benefit and likely side effects on the map of electrode positions;
updating the borders on the map responsive to the indication having a therapy benefit or a side effect and displaying the map with updated borders to the user”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a medical professional draws on paper electrode positions after receiving a print out of image data, further placing borders on the paper to categorize therapy benefit and side effects, and showing the map draw on paper to another person.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1, 11, and 20, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a programmer (processor and UI)”, and “pulse generator” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “plurality of electrodes” and “neuromodulation lead” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “clinical effects map”, “imaging information”, “location”, “map”, “electrode positions”, “borders of regions/borders”, “(likely) therapy benefit”, “(likely) side effects”, “user selection”, “test neuromodulation therapy”, “indication, “no effect”, and “updated borders” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “instruction to the pulse generator to generate the test neuromodulation therapy” - mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a programmer (processor and UI)”, and “pulse generator” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “plurality of electrodes” and “neuromodulation lead” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “clinical effects map”, “imaging information”, “location”, “map”, “electrode positions”, “borders of regions/borders”, “(likely) therapy benefit”, “(likely) side effects”, “user selection”, “test neuromodulation therapy”, “indication, “no effect”, and “updated borders” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “instruction to the pulse generator to generate the test neuromodulation therapy” - mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).
The additional elements of claims 1, 11, and 20, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the programmer (processor and UI), along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer.
Dependent claims 2-10 and 12-19 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1 and 11. The dependent claim limitations are directed to data gathering (claims 2-9, and 12-18) and to gathering structure (claims 10, and 19), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-20 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 8-11, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carcieri et al. (US 20200129768)(Hereinafter Carcieri).
Regarding claims 1, 11, and 20, Carcieri teaches A method of creating a clinical effects map for a patient ([0082] “the minimum and maximum pulse amplitudes may be displayed on display screen 856 as markers on a button or controller for the pulse amplitude, markers on a clinical effects map, or boundaries on a 3-dimensional representation of the stimulation field.” [0043] “the minimum and maximum pulse amplitudes may be displayed on display screen 856 as markers on a button or controller for the pulse amplitude, markers on a clinical effects map, or boundaries on a 3-dimensional representation of the stimulation field.”) having an implantable neuromodulation lead implanted at a location near neural structures ([0047] “Stimulation device 104 is configured to be electrically connected to electrodes 106 and deliver neurostimulation energy, such as in the form of electrical pulses, to the one or more neural targets though electrodes 106.”), the lead having a plurality of electrodes thereon and being coupled to a pulse generator, the pulse generator in communication with a programmer ([0047] “programming device 102 is configured to be communicatively coupled to stimulation device via a wired or wireless link.”), a programmer having a processor, a user interface, and machine-readable instructions for the programmer to perform the following ([0049] “programming device 102 includes a user interface 110 that allows the user to control the operation of system 100 and monitor the performance of system 100” [0056] “the circuit of user interface 110… may be implemented using an application-specific circuit constructed to perform one or more particular functions or a general-purpose circuit programmed to perform such function(s). Such a general-purpose circuit includes, but is not limited to, a microprocessor or a portion”): the method comprising:
obtaining imaging information including the location of the lead and one or more neural structures near the lead ([0069] “positions of lead(s) 708 and electrodes 706 relative to the patient's anatomy (transformation for fusing computerized tomogram (CT) of post-operative lead placement to magnetic resonance imaging (MRI) of the brain)”);
creating a map of electrode positions (Fig. 12 shows each electrode position 1208 of the lead.);
placing borders of regions of likely therapy benefit and likely side effects on the map of electrode positions (Fig. 12 shows the borders for the therapeutic effects and the side effects.);
displaying the map with borders to a user via the programmer (Fig. 12 shows the borders for the therapeutic effects and the side effects.);
receiving, at the programmer, a user selection of a location to test neuromodulation therapy ([0092] “Clinical effects map configuration module 965 receives a selection of a target for the neurostimulation (such as DBS) and/or an indication for the neurostimulation (such as a disease known as being treatable by DBS), and automatically configures a clinical effects map based on the selection.” See selected location of Fig. 12.);
issuing from the programmer an instruction to the pulse generator to generate the test neuromodulation therapy at the location ([0122] “automatically configuring a clinic effects map indicative of therapeutic effects and side effects estimated for the one or more stimulation waveforms based on a selection of a target for neurostimulation or a selection of an indication for the neurostimulation.”);
receiving, at the programmer, an indication of whether the test neuromodulation therapy caused a therapy benefit, a side effect, or no effect ([0122] “automatically configuring a clinic effects map indicative of therapeutic effects and side effects estimated for the one or more stimulation waveforms based on a selection of a target for neurostimulation or a selection of an indication for the neurostimulation.”); and
updating the borders on the map responsive to the indication having a therapy benefit or a side effect and displaying the map with updated borders to the user ([0122] “automatically configuring a clinic effects map indicative of therapeutic effects and side effects estimated for the one or more stimulation waveforms based on a selection of a target for neurostimulation or a selection of an indication for the neurostimulation.” [0115] “automatically update the side effects based on the selected target or the selected indication.” [0114] “automatically update the therapeutic effects based on the selected indication.” Examiner notes that the effect map of Fig. 12 will automatically update with the update borders shown.).
“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” “The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Note the phrase, “whether the test neuromodulation therapy caused a therapy benefit, a side effect, or no effect” in claim 1 is conditional language, that is, if a condition precedent in a method claim is not met, the conditional steps recited in the claim are not required to be performed. The conditions of the therapy benefit or a side effect may or may not be required. As such, the broadest reasonable interpretation of such a method claim does not include the conditional step along with the steps proceeding the conditional step. See MPEP 2111.04(II).
For claim 1, if no effect occurs, the step of updating is not required.
Regarding claims 8 and 19, Carcieri teaches wherein receiving, at the programmer, a user selection of a location to test neuromodulation therapy includes each of receiving an indication of which electrodes on the lead to use, and an amplitude to test ([0047] “The delivery of the neurostimulation is controlled by using a plurality of stimulation parameters, such as stimulation parameters specifying a pattern of the electrical pulses and a selection of electrodes through which each of the electrical pulses is delivered.” [0060] “Examples of pulse parameters include, among other things, the amplitude of a pulse (specified in current or voltage)”).
Regarding claim 9, Carcieri teaches wherein the step of updating the borders on the map occurs automatically in response to the indication ([0115] “automatically update the side effects based on the selected target or the selected indication.” [0114] “automatically update the therapeutic effects based on the selected indication.”).
Regarding claims 10, Carcieri teaches wherein the lead is implanted in the brain of the patient, and the neural structures are in the brain of the patient ([0047] “Stimulation device 104 is configured to be electrically connected to electrodes 106 and deliver neurostimulation energy, such as in the form of electrical pulses, to the one or more neural targets though electrodes 106.” [0046] “the neurostimulation system can include an implantable device configured to deliver neurostimulation (also referred to as neuromodulation) therapies (such as deep brain stimulation (DBS), spinal cord stimulation (SCS), peripheral nerve stimulation (PNS), and vagus nerve stimulation (VNS))”).
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.
Claim(s) 2-3 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri et al. (US 20200129768)(Hereinafter Carcieri) in view of Carcieri et al. (US 20140066999)(Hereinafter Carcieri2).
Regarding claims 2 and 12, Carcieri teaches the invention of claim 1. Although, Carcieri teaches multiple borders for the therapy benefit, Carcieri does not teach the borders of regions of likely therapy benefit include a first border and a second border, the first border indicating a first likelihood of therapy benefit occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of therapy benefit occurring in response to therapy pulses within the second border. Carcieri, in the same field of endeavor, teaches the displaying of historical stimulation information via DBS stimulation (Abstract and [0003]), and further teaches wherein the borders of regions of likely therapy benefit include a first border and a second border, the first border indicating a first likelihood of therapy benefit occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of therapy benefit occurring in response to therapy pulses within the second border ([0023] “the system calculates a blended score. According to alternative example embodiments of the present invention, the graphical representation of the effects of stimulation on the anatomy of a particular group of patients includes a maximum or minimum value of an overall value (therapeutic effect+side-effect) of therapeutic and/or side-effect values obtained for each anatomical location based on historical stimulations of a patient population, e.g., of all recorded patient stimulations or of those of a selected sub-group of the patient population, e.g., selected based on medical indications and/or patient demographics.” [0059] “an equation can be used by which a therapeutic value positively impacts the voxel's overall score and a side effect value negatively impacts the voxel's overall score. Side effect and therapeutic effect values can be equally weighted or differently weighted. Similarly, while the figures have been described as reflecting minimum or maximum values, in an example embodiment of the present invention, all of a voxel's scores” See Fig. 6c with the first likelihood being a minimum score value with its own first border (see the score of 1 on the therapeutic effects scale) and the second likelihood being the maximum score value with its own second border (see the score of 4 on the therapeutic effects scale). The border is between the colors for the best and worst ranges.) to inform the user of the optimal positioning ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the borders of regions of likely therapy benefit include a first border and a second border, the first border indicating a first likelihood of therapy benefit occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of therapy benefit occurring in response to therapy pulses within the second border of Carcieri2, because such a modification would allow to inform the user of the optimal positioning.
Regarding claims 3 and 13, Carcieri teaches the invention of claim 1. Although, Carcieri teaches multiple borders for the therapy benefit, Carcieri does not teach borders of regions of likely side effects include a first border and a second border, the first border indicating a first likelihood of side effects occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of neural side effects occurring in response to therapy pulses within the second border. Carcieri, in the same field of endeavor, teaches the displaying of historical stimulation information via DBS stimulation (Abstract and [0003]), and further teaches wherein the borders of regions of likely side effects include a first border and a second border, the first border indicating a first likelihood of side effects occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of neural side effects occurring in response to therapy pulses within the second border ([0023] “the system calculates a blended score. According to alternative example embodiments of the present invention, the graphical representation of the effects of stimulation on the anatomy of a particular group of patients includes a maximum or minimum value of an overall value (therapeutic effect+side-effect) of therapeutic and/or side-effect values obtained for each anatomical location based on historical stimulations of a patient population, e.g., of all recorded patient stimulations or of those of a selected sub-group of the patient population, e.g., selected based on medical indications and/or patient demographics.” [0059] “an equation can be used by which a therapeutic value positively impacts the voxel's overall score and a side effect value negatively impacts the voxel's overall score. Side effect and therapeutic effect values can be equally weighted or differently weighted. Similarly, while the figures have been described as reflecting minimum or maximum values, in an example embodiment of the present invention, all of a voxel's scores” See Fig. 6c with the first likelihood being a minimum score value with its own first border (see the score of 1 on the side effects scale) and the second likelihood being the maximum score value with its own second border (see the score of 2 on the side effects scale). The border is between the colors for the best and worst ranges.) to inform the user of the optimal positioning ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the borders of regions of likely side effects include a first border and a second border, the first border indicating a first likelihood of side effects occurring in response to therapy pulses within the first border, and the second border indicating a second likelihood higher than the first likelihood of neural side effects occurring in response to therapy pulses within the second border of Carcieri2, because such a modification would allow to inform the user of the optimal positioning.
Claim(s) 4-7, 14-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri et al. (US 20200129768)(Hereinafter Carcieri) in view of Blum et al. (US 20200155859)(Hereinafter Blum).
Regarding claims 4 and 14, Carcieri teaches the invention of claim 1. However, Carcieri does not teach the map displays electrode position along the lead on a first axis, and pulse amplitude on a second axis. Blum, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the map displays electrode position along the lead on a first axis, and pulse amplitude on a second axis ([0154] “FIGS. 6A-6J are example display screens for a user interface for visualizing stimulation parameter determinations using the feedback loop stimulation parameter control system according to described techniques...Contact location may be specified as a single value of a contact along the axis of a lead for ring electrodes, and may have a x, y, z (around circumference) component to specify which segment is specified in a segmented or directional lead.” See Fig. 6C-G showing the electrode contact on the y axis and the amplitude on the x axis.) to find the optimal parameter for the best clinical outcome ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the map displays electrode position along the lead on a first axis, and pulse amplitude on a second axis of Blum, because such a modification would allow to find the optimal parameter for the best clinical outcome.
Regarding claims 5 and 12, Carcieri teaches the invention of claim 1. However, Carcieri does not teach the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude. Blum, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the borders include:
a first side effect border determined from the imaging information ([0113] “The clinical effects map 620 shows all eight prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far.” See grey region created from the border in Fig. 6I with the different colored regions.); and
the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude (See Fig. 6I where every value above the border at the point of contact electrode 6 is an open region outside the border is the side effect, as seen in the inputting of step 8 onto the graph, based on the border produced, creating the grey area. The border is between the colors for the best and worst ranges.) to find the optimal parameter for the best clinical outcome ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude of Blum, because such a modification would allow to find the optimal parameter for the best clinical outcome.
Regarding claims 6 and 16, Carcieri teaches the invention of claim 1. However, Carcieri does not teach the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits. Blum, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the borders include:
a first benefit border determined from the imaging information ([0113] “The clinical effects map 620 shows all eight prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far.” See purple region created from the border in Fig. 6J.); and
the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits (See Fig. 6J where the purple region is shown at arrow 628 with the lower amplitude limit a little over 3 mA and the upper limit a little over 5 mA. The border is between the colors for the best and worst ranges.) to find the optimal parameter for the best clinical outcome ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits of Blum, because such a modification would allow to find the optimal parameter for the best clinical outcome.
Regarding claim 7, Carcieri teaches the invention of claim 1. However, Carcieri does not teach the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits and the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude. Blum, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the borders include:
a first benefit border determined from the imaging information ([0113] “The clinical effects map 620 shows all eight prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far.” See purple region created from the border in Fig. 6J. The border is between the colors for the best and worst ranges.);
a first side effect border determined from the imaging information ([0113] “The clinical effects map 620 shows all eight prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far.” See grey region created from the border in Fig. 6I with the different colored regions. The border is between the colors for the best and worst ranges.);
the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits (See Fig. 6J where the purple region is shown at arrow 628 with the lower amplitude limit a little over 3 mA and the upper limit a little over 5 mA. The border is between the colors for the best and worst ranges.); and
the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude (See Fig. 6I where every value above the border at the point of contact electrode 6 is an open region outside the border is the side effect, as seen in the inputting of step 8 onto the graph, based on the border produced, creating the grey area. The border is between the colors for the best and worst ranges.) to find the optimal parameter for the best clinical outcome ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits and the first side effect border forms an open region having a lowest amplitude and encompassing all amplitudes higher than the lowest amplitude of Blum, because such a modification would allow to find the optimal parameter for the best clinical outcome.
Regarding claims 18, Carcieri teaches the invention of claim 1. However, Carcieri does not teach a first side effect border indicating a first likelihood of a side effect, a second side effect border indicating a second likelihood of a side effect higher than the first likelihood of a side effect, and the updated borders at b) replace the first side effect border and the second side effect border with a third side effect border indicating a side effect occurred during testing. Blum, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the borders at a) include:
a first side effect border indicating a first likelihood of a side effect (See border in Fig. 6H before input of first side effect. The border is between the colors for the best and worst ranges. [0163] “In this step, the values 610 are for contact=5.8 and amplitude=6. The observed therapeutic response 611 is 1.4 for tremor (benefit 612) but there is a side effect indicated (613). Pressing the update button enters the step 8 data into the system. The clinical effects map 620 shows all seven prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far.”);
a second side effect border indicating a second likelihood of a side effect higher than the first likelihood of a side effect (See new border in Fig. 6I after input of first side effect. The border is between the colors for the best and worst ranges. [0164] “The clinical effects map 620 shows all eight prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far. Of note, any prior response (e.g., step 8) which produced a side effect (undesired) are coded differently.”); and
the updated borders at b) replace the first side effect border and the second side effect border with a third side effect border indicating a side effect occurred during testing (See Fig. 6J with the updated border with additional side effects. The border is between the colors for the best and worst ranges. [0165] “The clinical effects map 620 shows all fourteen prior steps of programming and where they fall into the predicted best and worst response ranges (for example, purples and greys) based upon the data processed thus far. Of note, the prior responses that produced side effect 627 are coded differently. It also indicates where this step 628 (recommended values for the next step) falls on the map (the triangle). The best response tracked so far is now the step 15 results.”) to find the optimal parameter for the best clinical outcome ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the first side effect border indicating a first likelihood of a side effect, a second side effect border indicating a second likelihood of a side effect higher than the first likelihood of a side effect, and the updated borders at b) replace the first side effect border and the second side effect border with a third side effect border indicating a side effect occurred during testing of Blum, because such a modification would allow to find the optimal parameter for the best clinical outcome.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri et al. (US 20200129768)(Hereinafter Carcieri) in view of Carcieri et al. (US 20220176135)(Hereinafter Carcieri3).
Regarding claims 17, Carcieri teaches the invention of claim 1. However, Carcieri does not teach user interface allows rotation of the map view. Carcieri3, in the same field of endeavor, teaches the displaying of clinical responses via DBS stimulation (Abstract), and further teaches wherein the user interface allows rotation of the map view ([0069] Fig. 4(440)) to provide a user with perspective display techniques ([0154]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method and system of Carcieri, with the first benefit border forms an enclosed region within a range of amplitudes having upper and lower limits of Carcieri3, because such a modification would allow to provide a user with perspective display techniques.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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