DETAILED ACTION
This action is responsive to the preliminary amendment filed 1/3/23.
Claims 1-18 are rejected.
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.
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 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 4-8 and 10-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 4, the claim recites the limitations ‘normal biological function’ and ‘abnormal biological function’. The terms ‘normal’ and ‘abnormal’ are relative terms which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 5, it is not clear what is meant by the limitation ‘wherein the desired effect enables […]’.
Regarding claims 10 and 17 the term "abnormal signal" in claims 10 and 17 is a relative term which renders the claim indefinite. The term "abnormal" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 13, the claim recites the limitation, 'wherein the physical state of the brain tissue is a hibernation state'. It is unclear what is meant by the term ‘hibernation state’ in the context of the claim.
Regarding claim 17, the claim recites the limitation "the imaging system". There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8, 11-16 and 18 are rejected due to their dependence from claims 4-5, 10 and 17.
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) 1-4, 9-12, 14-15 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osorio et al. (US 20040082984).
Regarding claim 1, Osorio teaches a method for applying therapy using an interstitial probe (Abstract, “A multi-purpose electrode mechanism for detection and control of changes in brain state includes a shaft portion and extendible elements structured for insertion into target tissue of the brain of a subject patient, cooling means configured to operatively apply cooling therapy to the target tissue, stimulation means having at least one electrical contact structured to operatively apply electrical stimulation therapy to the target tissue”), comprising: positioning the interstitial probe proximate a target tissue (Par. 56, “The shaft portion 65 is first inserted into the target tissue […]”), the interstitial probe comprising a shaft region (Fig. 2a, shaft 37), a tip region (Fig. 2a, region along and around cooling surface 17), a temperature sensor (Par. 54, “Temperature sensing and monitoring may be achieved with small thermocouples, thermistors, surface acoustic wave technology or other suitable miniature or micro temperature sensors.”), at least one thermal therapy-generating element for thermal therapy emission via the tip region (Par. 54, ‘sensor 15 may also be used for injecting current into, or for applying electrical stimulation therapy to, brain tissue’; it is the examiner's contention that current flowing through tissue would inherently heat the tissue to at least some extent through resistive heating), and at least one cryotherapy-generating element for cryogenic therapy emission via the tip region (Par. 54 and fig. 2a, cooling surface 17); determining, by processing circuitry (Par. 55, ' Control units 25, see FIGS. 4a and 4b, may include a microprocessor') using the temperature sensor, an initial temperature of at least one of a) tissue proximate the tip region and b) the tip region (Par. 42, “monitoring and processing brain electrical and/or thermal signals in real-time for the prediction and detection of seizures or of undesirable brain state changes”; for instance, the ‘initial temperature’ can be mapped to the ‘thermal signal’ detected in the normal brain state prior to the detection of the ‘undesirable brain state’; fig. 2a, showing sensors 15 about cooling surface 17); identifying, by the processing circuitry, a therapeutic output for causing a temperature-induced effect to the target tissue, the therapeutic output comprising i) a thermal therapy emission of the thermal therapy-generating element (Par. 54, ‘sensor 15 may also be used for injecting current into, or for applying electrical stimulation therapy to, brain tissue’; it is the examiner's contention that current flowing through tissue would inherently heat the tissue to at least some extent through resistive heating), and ii) a cryogenic therapy emission of the cryogenic therapy element (Par. 51, ‘brain tissue which mediates or generates state changes is pre-cooled and continuously maintained in-between state-changes at a temperature that is lower than normal but is above that which blocks the state transition […] Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated so that the tissue or region temperature may be further cooled to a desired therapeutic level […] In another modified embodiment of the present invention, electrical stimulation therapy is applied in addition to cooling or cryogenic therapy, wherein the electrical stimulation therapy is delivered simultaneously with, before, or after cryogenic therapy. ’); activating, by the processing circuitry, the therapeutic output by the interstitial probe (Par. 51); during therapeutic output, monitoring, by the processing circuitry, temperatures collected by the temperature sensor relative to the initial temperature (Par. 45, “automated feedback to and from a cooling device for regulating and keeping the temperature of cooling being applied to target tissue within a safe and therapeutic range for the subject patient based on measurements of tissue temperature or electrical activity changes of the brain”); and based at least in part upon the monitoring, adjusting, by the processing circuitry, the therapeutic output (Par. 45).
Regarding claim 2, Osorio further teaches wherein identifying the therapeutic output comprises identifying a modulation pattern, comprising at least one higher thermal output corresponding to activation of a first thermal therapy element of the at least the thermal therapy-generating element for a first time interval, and at least one lower thermal output corresponding to activation of a first cryogenic therapy element of the at least one cryogenic therapy element for a second time interval different than the first time interval (Par. 51, “In another modified embodiment of the present invention, electrical stimulation therapy is applied in addition to cooling or cryogenic therapy, wherein the electrical stimulation therapy is delivered simultaneously with, before, or after cryogenic therapy. ”).
Regarding claim 3, Osorio further teaches receiving a thermal dose for effecting thermal therapy treatment, wherein identifying the therapeutic output comprises identifying the therapeutic output based at least in part on the thermal dose (Par. 51, “Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated so that the tissue or region temperature may be further cooled to a desired therapeutic level”; for instance, the ‘thermal dose’ can be considered the ‘desired therapeutic level’ ).
Regarding claim 4, Osorio further teaches wherein identifying the therapeutic output comprises identifying the therapeutic output based at least in part on a desired effect upon the tissue, wherein the desired effect comprises at least one of altering normal biological function, altering abnormal biological function, and disrupting a blood-brain barrier (Par. 51, “Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated so that the tissue or region temperature may be further cooled to a desired therapeutic level;” par. 3, “The present invention is related to […] closed-loop prevention/control or blockage of brain state changes using electrical or thermal signals either individually or simultaneously for detection or prediction of seizures or other changes in brain states” ).
Regarding claim 9, Osorio further teaches wherein the interstitial probe comprises at least a portion of the processing circuitry (Fig. 2a, control unit 25; par. 59, “The control units 25 generally comprise a processor or a microprocessor or a digital signal processor, memory for storing instructions, and a battery.”).
Regarding claim 10, Osorio teaches an interstitial probe (Fig. 2a, invention 10), comprising: a shaft region (Fig. 2a, shaft 37), a tip region (Fig. 2a, region near cooling surface 17), a recording element disposed proximate the tip region (Fig. 2a, sensors 15), at least one thermal therapy-generating element for thermal therapy emission via the tip region (Par. 54, ‘sensor 15 may also be used for injecting current into, or for applying electrical stimulation therapy to, brain tissue’; it is the examiner's contention that current flowing through tissue would inherently heat the tissue to at least some extent through resistive heating), and at least one cryotherapy-generating element for cryogenic therapy emission via the tip region (Par. 54 and fig. 2a, cooling surface 17); processing circuitry (Par. 55, ' Control units 25, see FIGS. 4a and 4b, may include a microprocessor'); and a memory having instructions stored thereon (Par. 54, microprocessors inherently have memory), wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to identify a therapeutic output for causing a temperature-induced effect to a target tissue, the therapeutic output comprising at least one of i) a thermal therapy emission of the thermal therapy-generating element, and ii) a cryogenic therapy emission of the cryogenic therapy element; activate the therapeutic output by the interstitial probe (Par. 51, ‘brain tissue which mediates or generates state changes is pre-cooled and continuously maintained in-between state-changes at a temperature that is lower than normal but is above that which blocks the state transition’); during therapeutic output, monitor data collected by the recording element (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state’); and based upon the monitoring, identify, by the processing circuitry, at least one location responding to the therapeutic output with an abnormal signal pattern indicative of at least one of a physical state of the brain tissue and a medical condition (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state’; the location is the location being monitored).
Regarding claim 11, Osorio further teaches wherein the instructions, when executed by the processing circuitry, further cause the processing circuitry to, responsive to identifying the at least one location: select a second therapeutic output; and apply the second therapeutic output at the at least one location (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated so that the tissue or region temperature may be further cooled to a desired therapeutic level’).
Regarding claim 12, Osorio further teaches wherein the second therapeutic output is selected to suppress a symptom pattern or pre-symptom pattern (Par. 3, ‘prevention/control or blockage of brain state changes using electrical or thermal signals either individually or simultaneously’).
Regarding claim 14, Osorio further teaches wherein the abnormal signal pattern comprises one of a seizure activity pattern, a pre-seizure activity pattern, a neurological symptom pattern, and a neurological pre-symptom pattern (Par. 3, ‘for detection or prediction of seizures or other changes in brain states’).
Regarding claim 15, Osorio further teaches wherein the recording element comprises at least one of an 25 electroencephalography (EEG) and a stereo EEG (SEEG) recording element (Par. 29, ‘a multi-purpose electrode that can be used to detect relevant one-, two-, or three-dimensional changes in electrical or thermal or other types of signals reflective of brain state’).
Regarding claim 17, Osorio teaches a non-transitory computer readable medium having instructions stored thereon (Par. 55, ' Control units 25, see FIGS. 4a and 4b, may include a microprocessor'; a microprocessor inherently comprises a non-transitory computer readable medium which comprises instructions), wherein the instructions, when executed by processing circuitry, cause the processing circuitry to: identify a therapeutic output for causing a temperature-induced effect to a target tissue, the therapeutic output comprising at least one of a thermal therapy emission of at least one of a thermal therapy-generating element, and a cryogenic therapy emission of a cryogenic therapy element (Par. 51, ‘brain tissue which mediates or generates state changes is pre-cooled and continuously maintained in-between state-changes at a temperature that is lower than normal but is above that which blocks the state transition’); activate the therapeutic output by an interstitial probe comprising at least one of the thermal therapy-generating element and the cryogenic therapy element (Par. 51 ‘brain tissue which mediates or generates state changes is pre-cooled’), and a recording element (Fig. 2a, sensors 15); during therapeutic output, monitor data collected by the recording element (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state’); based upon the monitoring, identify, by the processing circuitry, at least one location responding to the therapeutic output with an abnormal signal pattern indicative of at least one of a physical state of the brain tissue and a medical condition (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state’; the location is the location being monitored); responsive to identifying the at least one location, select a second therapeutic output comprising at least one of a second thermal therapy emission different than the thermal therapy emission, and a second cryogenic therapy emission different than the cryogenic therapy emission (Par. 51, ‘Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated so that the tissue or region temperature may be further cooled to a desired therapeutic level’); and apply the second therapeutic output at the at least one location (Par. 51, “Upon detection of signal changes indicative of an impending change of state, the electrode of the present invention is activated”) while monitoring image data collected by the imaging system to identify suppression of the abnormal signal pattern (Par. 50, “As relevant signals at those sites reach a critical level indicative of state change, the target tissue or region receives cooling therapy in a controlled manner until the detected abnormality is eliminated”).
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) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osorio in view of Imran et al. (US 20100191305, “Imran”).
Regarding claim 5, Osorio fails to teach wherein the desired effect enables at least one of delivery, speed, and efficacy of a secondary treatment to be applied at the region of interest, wherein the type of secondary treatment comprises at least one of a drug treatment, a chemical treatment, a biochemical treatment, and a radiation treatment.
Imran teaches an analogous interstitial probe (Fig. 2a, apparatus 10) for preventing epileptic seizures (Par. 13, “Additionally, upon detection of such events, the patient can be given electrical stimulation (using the same or a different set of electrode members) that is configured to prevent or lessen the seizure duration.”) which can be used in conjunction with the delivery of an anti-seizure drug treatment as a secondary treatment applied to the region of interest (Par. 13, “Concurrent or separate to such stimulation, the patient can also be automatically given anti-seizure medication which is delivered intra-cranially (through a burr hole in the scalp such as that used for the detection apparatus) or intravenously or both.”).
Therefore, in view of Imran, it would have been obvious to POSITA at the time that the invention was filed to modify Osorio by providing a secondary anti-seizure drug treatment in conjunction with the interstitial probe treatment in order to further prevent or lessen the duration of epileptic seizures, as taught by Imran.
Regarding claims 6-7, Osorio, as modified fails to teach wherein the secondary treatment comprises a delayed secondary treatment applied during a time period at least three hours after concluding therapeutic output; and wherein the secondary treatment comprises a series of at least two treatments, a second treatment of the at least two treatments delivered during a second time period at least three days after concluding therapeutic output.
The examiner notes however, that epilepsy is a chronic medical condition which requires chronic care. Therefore, it would have been obvious to POSITA at the time that the invention was filed to further modify Osorio, as modified, by providing the secondary drug treatment as needed or desired at any time period after the use of the interstitial device, in order to continue to treat epileptic seizures in a chronic fashion.
Regarding claim 8, Osorio, as modified, further teaches wherein the secondary treatment comprises an intravenous drug treatment (Osorio has previously been modified in view of Imran to comprise a secondary anti-seizure drug treatment; see Imran, par. 13, “Concurrent or separate to such stimulation, the patient can also be automatically given anti-seizure medication which is delivered intra-cranially (through a burr hole in the scalp such as that used for the detection apparatus) or intravenously or both.”).
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osorio in view of John et al. (US 20060265022, “John”).
Regarding claim 16, Osorio fails to teach wherein the instructions, when executed by the processing circuitry, further cause the processing circuitry to, responsive to identifying the at least one location, present, for review by an operator of the system at a display device, information regarding the at least one of the physical state of the brain tissue and the medical condition.
John teaches an analogous implantable device for suppressing epileptic seizures (Abstract, ‘A system including an implantable neurostimulator device capable of modulating cerebral blood flow to treat epilepsy and other neurological disorders’) which comprises instructions, which when executed by processing circuitry are configured to present, for review by an operator of the system at a display device, information regarding the at least one of the physical state of the brain tissue and the medical condition (Par. 71, ‘When running a computer workstation software operating program, the programmer 312 can process, store, play back and display the patient's EEG signals, which were previously stored by the implantable neurostimulator 110 of the implantable neurostimulator system’). John further teaches that providing this capability assists the physician in developing optimized seizure detection parameters for each specific patient (Par. 69).
Therefore, in view of John, it would have been obvious to POSITA at the time that the invention was filed to configure the Osorio to transmit information regarding the pre-seizure state of the lesion and the seizure state of the lesion to a display device, in order to assist a physician in optimizing operating parameters of the implantable device, as taught by John.
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osorio in view of John (US 20080058773, “John 2”).
Regarding claim 18, Osorio fails to teach wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to, prior to applying the second therapeutic output, receive, via an input device in communication with the processing circuitry, input submitted by an operator authorizing application of the second therapeutic output.
John 2 teaches an analogous implantable device (Abstract, “Systems and methods are described for adjusting the operation of implantable stimulation devices used to provide medical monitoring and treatment.”) for suppressing epileptic seizures (Par. 152, “For example, treatment can be provided for psychiatric, mood, movement, cognitive and neurological disorders; seizure and epileptiform disorders”) which comprises processing circuitry (Par. 83, “The control subsystem can also include various components such as programmable memory, a microprocessor, additional timers/clocks, multiplexors, switches/relays and other components which are found in the control subsystems of most implantable neural or cardiac stimulators as is known well to those skilled in the art. ”), wherein instructions, when executed by the processing circuitry, cause the processing circuitry to, prior to applying therapeutic output (Par. 100, “An alert can also be sent prior to adjusting the stimulation (e.g., increasing voltage by 1 volt) or responsively providing stimulation.”; fig. 6b, step 86, “send alert signal”), receive, via an input device in communication with the processing circuitry (Claim 11, “wherein the external patient programmer permits the patient to provide a response using a patient interface”), input submitted by an operator authorizing application of the therapeutic output (Fig. 6b, step 89a: “Yes” and par. 102, “As shown in FIG. 6B, the response condition is set to false until the patient inputs a response 89a”).
Therefore, in view of John 2, it would have been obvious to POSITA at the time that the invention was filed to modify Osorio by configuring the device to provide for user authorization prior to the commencement of the second therapeutic output, in order to improve the therapy by allowing the patient to guide the therapy by responding to automatically generated alert messages (See John 2, par. 94), as taught by John 2.
Conclusion
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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