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 .
Claim Objections
Claims 13 and 18-20 are objected to because of the following informalities:
In claim 13, the term “compare” in line 2 should be amended to --comparinig--.
In claims 18-20, the term –wherein-- should be inserted preceding the phrase “the implantable system” in line 1.
Appropriate correction is required.
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.
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation of “the control circuitry causes the therapy output circuit to generate the one or more electric fields at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue” in claim 1 and all its dependent claims implies that the implantable system would have to be implanted in a body of a patient (see Fig. 1). It is recommended that the limitation “causes” be amended to --configured to cause-- in order to obviate this rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hendrick et al. (US Publication No 20240399154).
Regarding Claim 1, Hendrick discloses an implantable system for cancer treatment (Hendrick ¶0068 “This disclosure describes various devices, systems, and techniques for planning and/or delivering modulated electrical field therapy (which may include the example of AEF therapy) to a patient via implanted electrodes. Alternating electric field application is a cancer treatment type with the potential to reduce treatment related toxicity.”) comprising: a therapy output circuit (Hendrick ¶0073 “IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry or other electrical circuitry configured to perform the functions attributed to IMD 106)”), wherein the therapy output circuit is configured to generate an electrical current for a plurality of electric field therapy electrodes (Hendrick ¶0073 “The group of electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes.”) to create one or more electric fields (Hendrick ¶0164 “processing circuitry 310 is configured to control stimulation circuitry 208 of IMD 106 to deliver AEF therapy to patient 112 “); and control circuitry (Hendrick Processing Circuitry 310); wherein the control circuitry causes the therapy output circuit to generate the one or more electric fields (Hendrick ¶0164 “processing circuitry 310 is configured to control stimulation circuitry 208 of IMD 106 to deliver AEF therapy to patient 112“) at frequencies selected from a range of between 10 kHz to 1 MHz within a bodily tissue (Hendrick ¶0181 “For example, an amplitude of 2.25V/cm or a frequency of 187.3 kHz may be used as an AEF configuration to cease cell division in target tissue. “); wherein the control circuitry is configured to select between operating in a first mode or a second mode of generating the electrical current for the electric field therapy electrodes (Hendrick ¶0301 “In some examples, processing circuitry 310 may implement any power saving techniques to reduce the amount of time the patient needs to recharge their therapy device (e.g., IMD 106). Processing circuitry 310 may generate different therapy modes, such as two or more different energy consumption modes that can be automatically selected by the system in response to one or more triggers, such as current battery charge state, therapy status, etc. “) based on a minimum electrical field strength threshold (Hendrick ¶0171 “The metric may include dosimetry and/or may be used by IMD 106 in a closed-loop manner to maintain a minimum electrical field strength and/or prevent exceeding a maximum electrical field strength.”); wherein the first mode comprises modulating amplitude of the electrical current; and wherein the second mode comprises duty cycling of the electrical current (Hendrick ¶301 “The different energy consumption modes might reduce signal amplitude or increase the “off” duration (or decrease the “on” duration) for therapy (e.g., duty cycles with on/off periods on the order of seconds or minutes).”).
Regarding claim 2, claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the control circuitry is configured to select between operating in the first mode or the second mode of generating the electrical current for the electric field therapy electrodes (Hendrick ¶0301 “In some examples, processing circuitry 310 may implement any power saving techniques to reduce the amount of time the patient needs to recharge their therapy device (e.g., IMD 106). Processing circuitry 310 may generate different therapy modes, such as two or more different energy consumption modes that can be automatically selected by the system in response to one or more triggers, such as current battery charge state, therapy status, etc. “) to maximize an amount of time that electric field strength is above the minimum electrical field strength threshold (Hendrick ¶0301 “In some examples, processing circuitry 310 may automatically reduce power or select a reduce power mode in response to patient activity (e.g., metabolic status, circadian rhythm, or patient availability schedule) or patient location from global positioning system (GPS) data or other location data indicative of the patient not being home to recharge the therapy device. Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”).
Regarding claim 3, claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the control circuitry is configured to estimate a field strength at a target therapy site and compare the same against the minimum electrical field strength threshold (Hendrick ¶0005 “The computing device may also predict electrical field strengths for AEF therapy using the model and recommend stimulation parameters (e.g., electrode combinations, amplitudes, frequencies, electrode implant locations, etc.) that define the AEF therapy based on the predictions. In some examples, the computing device may update the predictions based on sensed data obtained after delivery of the AEF therapy.”; ¶0170 “ In this manner, a user can define a desired target tissue and compare, or the system can automatically compare, predictions of electrical field to desired values for the anatomy.”).
Regarding claim 4 claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the minimum electrical field strength threshold is 1 V/cm (Hendrick ¶0003 “Alternating electric field (AEF) therapy, is a type of electric field therapy which uses low-intensity electrical fields to treat brain tumors; glioblastoma in particular. Conventional cancer treatments include chemotherapy and radiation, which are associated with treatment-related toxicity and high rates of tumor recurrence. AEF uses an alternating electric field to disrupt cell division in cancer cells, thereby inhibiting cellular replication and initiating apoptosis (cell death). AEF therapy is typically delivered via electrodes located external to the patient.” Where 1V/cm is the minimum value required to achieve any therapeutic effect for cancer treatments [Hendrick ¶0181).
Regarding claim 5, claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the control circuitry switches to the second mode of generating the electrical current for the electric field therapy electrodes when the amount of time above the minimum electrical field strength threshold can be increased versus operating in the first mode (Hendrick ¶0301 “In some examples, processing circuitry 310 may automatically reduce power or select a reduce power mode in response to patient activity (e.g., metabolic status, circadian rhythm, or patient availability schedule) or patient location from global positioning system (GPS) data or other location data indicative of the patient not being home to recharge the therapy device. Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”.).
Regarding claim 6, claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the control circuitry switches to the second mode of generating the electrical current for the electric field therapy electrodes when the electrical field strength when operating in the first mode falls below the minimum electrical field strength threshold at a targeted therapy site. (Hendrick ¶0301 “Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”). .
Regarding claim 7, claim 1 is anticipated by Hendrick. Hendrick further discloses wherein the control circuitry switches to the first mode of generating the electrical current for the electric field therapy electrodes when the electrical field strength when operating in the first mode meets or exceeds the minimum electrical field strength threshold at a targeted therapy site. (Hendrick ¶0069 “The system may adjust the one or more stimulation parameters based on various feedback variables, such as impedance tomography, histological analysis, patient activity, sensed temperature, and the like. In this manner, the IMD may operate in a closed-loop manner based on one or more feedback variables obtained from the patient.”; ¶0171 “The metric may include dosimetry and/or may be used by IMD 106 in a closed-loop manner to maintain a minimum electrical field strength and/or prevent exceeding a maximum electrical field strength.”)
Regarding claim 8, claim 1 is anticipated by Hendrick. Hendrick further discloses a temperature sensor. (Hendrick ¶0123 “ For example, sensor 212 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other types of sensors.”)
Regarding claim 9, claim 1 is anticipated by Hendrick. Hendrick further discloses a plurality of implantable stimulation leads. (Hendrick ¶0150 “FIGS. 5C-5F are transverse cross-sections of example stimulation leads having one or more electrodes around the circumference of the lead. “).
Regarding claim 10, claims 1 & 9 are anticipated by Hendrick. Hendrick further discloses a plurality of electric field therapy electrodes; wherein at least some of the plurality of electric field therapy electrodes are disposed on the plurality of implantable stimulation leads and in electrical communication with the therapy output circuit (Hendrick ¶0150 “FIGS. 5C-5F are transverse cross-sections of example stimulation leads having one or more electrodes around the circumference of the lead. “).
Regarding Claim 11, Hendrick discloses a method of providing cancer treatment with an implantable system (Hendrick ¶0068 “This disclosure describes various devices, systems, and techniques for planning and/or delivering modulated electrical field therapy (which may include the example of AEF therapy) to a patient via implanted electrodes. Alternating electric field application is a cancer treatment type with the potential to reduce treatment related toxicity.”) comprising: generating an electrical current with a therapy output circuit (Hendrick ¶0073 “IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry or other electrical circuitry configured to perform the functions attributed to IMD 106)”)for a plurality of electric field therapy electrodes (Hendrick ¶0073 “The group of electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes.”)to create one or more electric fields (Hendrick ¶0164 “processing circuitry 310 is configured to control stimulation circuitry 208 of IMD 106 to deliver AEF therapy to patient 112 “); and selecting between operating in a first mode or a second mode of generating the electrical current for the electric field therapy electrodes with control circuitry (Hendrick ¶0301 “In some examples, processing circuitry 310 may implement any power saving techniques to reduce the amount of time the patient needs to recharge their therapy device (e.g., IMD 106). Processing circuitry 310 may generate different therapy modes, such as two or more different energy consumption modes that can be automatically selected by the system in response to one or more triggers, such as current battery charge state, therapy status, etc. “) based on a minimum electrical field strength threshold. (Hendrick ¶0171 “The metric may include dosimetry and/or may be used by IMD 106 in a closed-loop manner to maintain a minimum electrical field strength and/or prevent exceeding a maximum electrical field strength.”).
Regarding claim 12, claim 11 is anticipated by Hendrick. Hendrick further discloses selecting with the control circuitry between operating in the first mode or the second mode of generating the electrical current for the electric field therapy electrodes (Hendrick ¶0301 “In some examples, processing circuitry 310 may implement any power saving techniques to reduce the amount of time the patient needs to recharge their therapy device (e.g., IMD 106). Processing circuitry 310 may generate different therapy modes, such as two or more different energy consumption modes that can be automatically selected by the system in response to one or more triggers, such as current battery charge state, therapy status, etc. “) to maximize an amount of time that electric field strength is above the minimum electrical field strength threshold (Hendrick ¶0301 “In some examples, processing circuitry 310 may automatically reduce power or select a reduce power mode in response to patient activity (e.g., metabolic status, circadian rhythm, or patient availability schedule) or patient location from global positioning system (GPS) data or other location data indicative of the patient not being home to recharge the therapy device. Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”).
Regarding claim 13, claim 11 is anticipated by Hendrick. Hendrick further discloses estimating a field strength at a target therapy site and compare the same against the minimum electrical field strength threshold (Hendrick ¶0005 “The computing device may also predict electrical field strengths for AEF therapy using the model and recommend stimulation parameters (e.g., electrode combinations, amplitudes, frequencies, electrode implant locations, etc.) that define the AEF therapy based on the predictions. In some examples, the computing device may update the predictions based on sensed data obtained after delivery of the AEF therapy.”; ¶0170 “ In this manner, a user can define a desired target tissue and compare, or the system can automatically compare, predictions of electrical field to desired values for the anatomy.”).
Regarding claim 14, claim 11 is anticipated by Hendrick. Hendrick further discloses wherein the minimum electrical field strength threshold is 1 V/cm (Hendrick ¶0003 “Alternating electric field (AEF) therapy, is a type of electric field therapy which uses low-intensity electrical fields to treat brain tumors; glioblastoma in particular. Conventional cancer treatments include chemotherapy and radiation, which are associated with treatment-related toxicity and high rates of tumor recurrence. AEF uses an alternating electric field to disrupt cell division in cancer cells, thereby inhibiting cellular replication and initiating apoptosis (cell death). AEF therapy is typically delivered via electrodes located external to the patient.” Where 1V/cm is the minimum value required to achieve any therapeutic effect for cancer treatments [Miller Introduction Paragraph 3 Referencing the research of Palti [See Attached Reference]]).
Regarding claim 15, claim 11 is anticipated by Hendrick. Hendrick further discloses switching to the second mode of generating the electrical current for the electric field therapy electrodes when the amount of time above the minimum electrical field strength threshold can be increased versus operating in the first mode. (Hendrick ¶0301 “In some examples, processing circuitry 310 may automatically reduce power or select a reduce power mode in response to patient activity (e.g., metabolic status, circadian rhythm, or patient availability schedule) or patient location from global positioning system (GPS) data or other location data indicative of the patient not being home to recharge the therapy device. Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”)
Regarding claim 16, claim 11 is anticipated by Hendrick. Hendrick further discloses switching to the second mode of generating the electrical current for the electric field therapy electrodes when the electrical field strength when operating in the first mode falls below the minimum electrical field strength threshold at a targeted therapy site. (Hendrick ¶0301 “Processing circuitry 310 may select a reduced power mode in response to battery power below a threshold in order to maintain some electric field therapy until recharging can occur to reduce lengthy amounts of time with no therapy at all.”).
Regarding claim 17, claim 11 is anticipated by Hendrick. Hendrick further discloses switching to the first mode of generating the electrical current for the electric field therapy electrodes when the electrical field strength when operating in the first mode meets or exceeds the minimum electrical field strength threshold at a targeted therapy site. (Hendrick ¶0069 “The system may adjust the one or more stimulation parameters based on various feedback variables, such as impedance tomography, histological analysis, patient activity, sensed temperature, and the like. In this manner, the IMD may operate in a closed-loop manner based on one or more feedback variables obtained from the patient.”; ¶0171 “The metric may include dosimetry and/or may be used by IMD 106 in a closed-loop manner to maintain a minimum electrical field strength and/or prevent exceeding a maximum electrical field strength.”).
Regarding claim 18, claim 11 is anticipated by Hendrick. Hendrick further discloses a temperature sensor. (Hendrick ¶0123 “ For example, sensor 212 may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other types of sensors.”).
Regarding claim 19, claim 11 is anticipated by Hendrick. Hendrick further discloses a plurality of implantable stimulation leads. (Hendrick ¶0150 “FIGS. 5C-5F are transverse cross-sections of example stimulation leads having one or more electrodes around the circumference of the lead. “).
Regarding claim 20, claims 11 & 19 are anticipated by Hendrick. Hendrick further discloses a plurality of electric field therapy electrodes. (Hendrick Abstract “deliver the first electric field from a first electrode combination of implanted electrodes “).
Conclusion
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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