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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7 of copending Application No. 19/324,780 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because broader in scope than in ‘485.
19/369,485
1. A method of improving a medical condition in a patient in need thereof comprising: delivering a focused ultrasound neuromodulation signal to a neural target site of the patient’s brain, the ultrasound signal having a mechanical index of between about 1.0 and 8.0 and/or an acoustic pressure of between about 1.0 MPa to about 3.0 MPa, the medical condition comprising addiction, binge eating, tinnitus, anxiety disorders and anxiety associated disorders, neurodegenerative disorders, neuropsychiatric disorders, cognitive disorders, neurodevelopmental disorders, post-traumatic stress disorder, stroke recovery, and combinations thereof; and improving the patient’s medical condition.
2. The method of claim 1, further comprising: screening a patient to determine if the focused ultrasound neuromodulation signal is appropriate for the patient to treat the medical condition; monitoring the patient to measure a plurality of parameters for the patient and detect or predict an onset of symptoms associated with the disorder from the plurality of parameters if the focused ultrasound neuromodulation signal has been determined to be appropriate for the patient; selecting a location within the neural target site according to at least one of the parameters when an onset of symptoms has been detected or predicted; selecting a dosage parameter associated with the focused ultrasound neuromodulation signal according to at least one of the plurality of parameters, the focused ultrasound neuromodulation signal being delivered with the selected dosage parameter; and measuring the plurality of parameters after the focused ultrasound neuromodulation signal is delivered to determine an effectiveness of the focused ultrasound neuromodulation signal.
3. The method of claim 2, wherein the location is a first location and the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; selecting a second location within the neural target site; and delivering the focused ultrasound neuromodulation signal to the second location.
4. The method of claim 2, wherein the dosage parameter is a first dosage parameter and the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; selecting a second dosage parameter according to at least one of the plurality of parameters; and delivering the focused ultrasound neuromodulation signal using the second dosage parameter.
5. The method of claim 2, wherein the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is effective in treating the medical condition; predicting an onset of symptoms for the patient from the plurality of parameters; and delivering the focused ultrasound neuromodulation signal to the location within the neural target site in response to predicting the onset of symptoms.
6. The method of claim 2, wherein the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; and selecting an alternative therapy for the medical condition.
7. A non-transitory computer accessible medium having stored thereon computer executable instructions which when executed by a processor causes the steps of: controlling an ultrasound pulse generator to deliver a focused ultrasound neuromodulation signal to a neural site of the brain, the ultrasound signal having a mechanical index of between about 0.1 to about 8.0 and/or an acoustic pressure of between about 0.1 MPa to about 3.0 MPa and being sufficient to improve chronic or refractory rhinitis, chronic rhinosinusitis, autonomic instability/autonomic dysfunction, functional gastrointestinal disorders, inflammatory disorders, immune disorders, complex regional pain syndrome, post-traumatic stress disorder (PTSD), anxiety and anxiety-associated disorders, autism, fibromyalgia, uterine function, metabolic disorder, urinary incontinence, or binge eating.
19/324,780
1. A method of improving a medical condition in a patient in need thereof comprising:delivering a focused ultrasound neuromodulation signal to a neural target site of the patient's autonomic nervous system, the ultrasound signal having a mechanical index of between about 0.1 to about 5.0 and/or an acoustic pressure of between about 0.1 MPa to about 2.5 MPa, the medical condition comprising chronic or refractory rhinitis, chronic rhinosinusitis, autonomic instability/autonomic dysfunction, functional gastrointestinal disorders, inflammatory disorders, immune disorders (including improving cancer and infections by neuromodulation of immune function), complex regional pain syndrome, post-traumatic stress disorder (PTSD), anxiety and anxiety-associated disorders, autism, fibromyalgia, uterine function, metabolic disorder, urinary incontinence or binge eating; andimproving the patient's medical condition.
2. The method of claim 1, further comprising:screening a patient to determine if the focused ultrasound neuromodulation signal is appropriate for the patient to treat the medical condition;monitoring the patient to measure a plurality of parameters for the patient and detect or predict an onset of symptoms associated with the disorder from the plurality of parameters if the focused ultrasound neuromodulation signal has been determined to be appropriate for the patient;selecting a location within the neural target site according to at least one of the parameters when an onset of symptoms has been detected or predicted;selecting a dosage parameter associated with the focused ultrasound neuromodulation signal according to at least one of the plurality of parameters, the focused ultrasound neuromodulation signal being delivered with the selected dosage parameter; andmeasuring the plurality of parameters after the focused ultrasound neuromodulation signal is delivered to determine an effectiveness of the focused ultrasound neuromodulation signal.
3. The method of claim 2, wherein the location is a first location and the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition;selecting a second location within the neural target site; anddelivering the focused ultrasound neuromodulation signal to the second location.
4. The method of claim 2, wherein the dosage parameter is a first dosage parameter and the method further comprises:determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition;selecting a second dosage parameter according to at least one of the plurality of parameters; anddelivering the focused ultrasound neuromodulation signal using the second dosage parameter.
5. The method of claim 2, wherein the method further comprises:determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is effective in treating the medical condition;predicting an onset of symptoms for the patient from the plurality of parameters; anddelivering the focused ultrasound neuromodulation signal to the location within the neural target site in response to predicting the onset of symptoms.
6. The method of claim 2, wherein the method further comprises:determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; andselecting an alternative therapy for the medical condition.
7. A computer program comprising instructions, which, when the program is executed by a processor causes the step of:controlling an ultrasound device to deliver a focused ultrasound neuromodulation signal to a neural site of the autonomic nervous system, the ultrasound signal having a mechanical index of between about 0.1 to about 5.0 and/or an acoustic pressure of between about 0.1 MPa to about 2.5 MPa and to a site of the ANS sufficient to improve chronic or refractory rhinitis, chronic rhinosinusitis, autonomic instability/autonomic dysfunction, functional gastrointestinal disorders, inflammatory disorders, immune disorders (including improving cancer and infections by neuromodulation of immune function), complex regional pain syndrome, post-traumatic stress disorder (PTSD), anxiety and anxiety-associated disorders, autism, fibromyalgia, uterine function, metabolic disorder, urinary incontinence, or binge eating.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-7 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.
In claims 1,7 is unclear as to how is determined there is an improvement in a medical condition, when the claims only provides for an ultrasound emission, and the claims do not set forth a step for performing an assessment of the emission in order to determined an improvement; claiming just a result (i.e. claim 1, “improving the patient’s medical condition”) is just a result of the emission. The claim is indefinite.
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) 1-5, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by General Electric (US 2020/0406065, hereinafter GE).
With respect to claims 1, 7, GE '065 discloses the steps of (abstract; processor 30 of controller 16 of neuromodulation system 10, Figs. 1 and 2): controlling an ultrasound pulse generator to deliver a focused ultrasound neuromodulation signal to a neural site of the brain ("FIG. 1 is a schematic representation of a system 10 for neuromodulation to achieve neurotransmitter release and/or activate components (e.g., the presynaptic cell, the postsynaptic cell) of a synapse in response to an application of energy. The depicted system includes a pulse generator 14 coupled to an energy application device 12 (e.g., an ultrasound transducer)", Para. [0099]. "the energy application device 12 and/ or the pulse generator 14 may communicate wirclessly, for example with a controller 16 that may in turn provide instructions to the pulse generator 14", Para. [0100]. "different ultrasound parameters (frequency, aperture, or energy) are applied for selecting (e.g., spatially selecting) a region of interest and for focusing energy to the selected region of interest for targeting and subsequently neuromodulation", Para. [0109]. "ultrasound modulation of the central nervous system (CNS) involves stimulation of cortical regions of the brain, which are rich in synaptic structures while attempts at ultrasound stimulation of peripheral nerves have targeted nerve trunks that are less rich in or devoid of synaptic structures", Para. [0092], Fig. 1), the ultrasound signal having a mechanical index of between about 0.1 to about 8.0 and/or an acoustic pressure of between about 0.1 MPa to about 3.0 MPa ("the memory 32 stores operating modes for different types of treatment. For example, activation may be associated with a different stimulating pressure or frequency range relative to those associated with depressing or blocking tissue function. In a specific example, when the energy application device is an ultrasound transducer, the time-averaged power. and 0.1 MPa to 7 MPa (peak pressure)", Para. [0107]) and being sufficient to improve chronic or refractory rhinitis, chronic rhinosinusitis, autonomic instability/autonomic dysfunction, functional gastrointestinal disorders, inflammatory disorders, immune disorders, complex regional pain syndrome, post-traumatic stress disorder (PTSD), anxiety and anxiety-associated disorders, autism, fibromyalgia, uterine function, metabolic disorder ("In one example, the present techniques may be used to treat a subject with a metabolic disorder", Para. [0112]), urinary incontinence, or binge eating.
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Regarding Claim 2 GE '065 discloses the method of claim 1, further comprising: screening the patient to determine if the focused ultrasound neuromodulation signal is appropriate for the patient to treat the medical condition ("the system 10 may include an assessment device 20 that is coupled to the controller 16 and assesses characteristics that are indicative of whether the targeted physiological outcome of the modulation have been achieved", Para. [0101], Fig. 1); monitoring the patient to measure a plurality of parameters for the patient and detect or predict an onset of symptoms associated with the disorder from the plurality of parameters if the focused ultrasound neuromodulation signal has been determined to be appropriate for the patient; selecting a location within the neural target site according to at least one of the parameters when an onset of symptoms has been detected or predicted; selecting a dosage parameter associated with the focused ultrasound neuromodulation signal according to at least one of the plurality of parameters, the focused ultrasound neuromodulation signal being delivered with the selected dosage parameter; and measuring the plurality of parameters after the focused ultrasound neuromodulation signal is delivered to determine an effectiveness of the focused ultrasound neuromodulation signal ("Based on the assessment, the modulation parameters of the controller 16 may be altered. a change of the modulation parameters such as pulse frequency or other parameters may be desired, which in turn may be provided to the controller 16", Para. [0103]. "The system 10 as provided herein may provide energy pulses according to various modulation parameters. For example, the modulation parameters may include various stimulation time patterns, ranging from continuous to intermittent. With intermittent stimulation, energy is delivered for a period of time at a certain frequency during a signal-on time", Para. [0104]. "if a circulating glucose concentration, as measured by the assessment device 20, is above a predetermined threshold or range, the controller 16 may initiate energy application to a region of interest (e.g., liver) and with modulation parameters that are associated with a reduction in circulating glucose. The initiation of energy application may be triggered by the glucose concentration drifting above a predetermined (e.g., desired) threshold or outside a predefined range. In another embodiment, the adjustable control may be in the form of altering modulation parameters when an initial application of energy does not result in an expected change in a targeted physiological outcome", Para. [0106]. "the memory 32 stores different operating modes that are selectable by the operator. For example, the stored operating modes may include instructions for executing a set of modulation parameters associated with a particular treatment site, such as regions of interest in the liver, pancreas, gastrointestinal tract, spleen. Different sites may have different associated modulation parameters. Rather than having the operator manually input the modes, the controller 16 may bc configured to execute the appropriate instruction based on the selection", Para. [0107]. "The system may also include an imaging device that facilitates focusing the energy application device 12. In one embodiment, the imaging device may be integrated with or the same device as the energy application device 12 such that different ultrasound parameters (frequency, aperture, or energy) are applied for selecting (e.g., spatially selecting) a region of interest and for focusing energy to the selected region of interest for targeting and subsequently neuromodulation", Para. [0109]. "a desired modulation parameter set may also be stored by the controller 16. In this manner, subject-specific parameters may be determined. Further, the effectiveness of such parameters may be assessed over time. If a particular set of parameters is less effective over time, the subject may be developing insensitivity to activated pathways. If the system 10 includes an assessment device 20, the assessment device 20 may provide feedback to the controller 16... based on the feedback, the processor 16 may automatically alter the modulation parameters (e.g., the frequency, amplitude, or pulse width of an ultrasound beam or mechanical vibration) in real time and responsive to feedback from the assessment device 20", Para. [0111], Figs. 1 and 2).
Regarding Claim 3, GE '065 discloses the method of claim 2, wherein the location is a first location and the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; selecting a second location within the neural target site; and delivering the focused ultrasound neuromodulation signal to the second location ("The controller 16 permits adjustably controlling the energy by changing the modulation parameters and/or initiating energy application at certain times or cancelling/suppressing energy application at certain times. In one embodiment, the adjustable control of the energy application device is based on information about a concentration of one or more molecules in the subject (e.g., a circulating molecule). If the information is from the assessment device 20, a feedback loop may drive the adjustable control. For example, if a circulating glucose concentration, as measured by the assessment device 20, is above a predetermined threshold or range, the controller 16 may initiate energy application to a region of interest (e.g., liver) and with modulation parameters that are associated with a reduction in circulating glucose. The initiation of energy application may be triggered by the glucose concentration drifting above a predetermined (e.g., desired) threshold or outside a predefined range. In another embodiment, the adjustable control may be in the form of altering modulation parameters when an initial application of energy does not result in an expected change in a targeted physiological outcome", Para. [0106]. "the memory 32 stores different operating modes that are selectable by the operator. For example, the stored operating modes may include instructions for executing a set of modulation parameters associated with a particular treatment site, such as regions of interest in the liver, pancreas, gastrointestinal tract, spleen. Different sites may have different associated modulation parameters", Para. [0107]. "the energy applied during neuromodulation may be stepped back to a minimum level that supports the desired outcome. If the change in the characteristic relative to the threshold is associated with insufficient change in glucose concentration, certain modulation parameters, including, but not limited to, the modulation amplitude or frequency, the pulse shape, the stimulation pattern, and/or the stimulation location may be changed", Para. [0124]).
Regarding Claim 4, GE '065 discloses the method of claim 2, wherein the dosage parameter is a first dosage parameter and the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition; selecting a second dosage parameter according to at least one of the plurality of parameters; and delivering the focused ultrasound neuromodulation signal using the second dosage parameter ("applying an ultrasound dose regimen to an internal organ of the subject having the metabolic disorder to treat the metabolic disorder, wherein the ultrasound dose regimen comprises a plurality of ultrasound energy doses applied at separate time points", Claim 8, Pg. 20. "Based on the assessment, the modulation parameters of the controller 16 may be altered, a change of the modulation parameters such as pulse frequency or other parameters may be desired, which in turn may be provided to the controller 16", Para. [0103]. "The controller 16 permits adjustably controlling the energy by changing the modulation parameters and/or initiating energy application at certain times or cancelling/suppressing energy application at certain times. In one embodiment, the adjustable control of the energy application device is based on information about a concentration of one or more molecules in the subject (e.g., a circulating molecule). If the information is from the assessment device 20, a feedback loop may drive the adjustable control. For example, if a circulating glucose concentration, as measured by the assessment device 20, is above a predetermined threshold or range, the controller 16 may initiate energy application to a region of interest (e.g., liver) and with modulation parameters that are associated with a reduction in circulating glucose. The initiation of energy application may be triggered by the glucose concentration drifting above a predetermined (c.g., desired) threshold or outside a predefined range. In another embodiment, the adjustable control may be in the form of altering modulation parameters when an initial application of energy does not result in an expected change in a targeted physiological outcome", Para. [0106]. "the memory 32 stores different operating modes that are selectable by the operator. For example, the stored operating modes may include instructions for executing a set of modulation parameters associated with a particular treatment site, such as regions of interest in the liver, pancreas, gastrointestinal tract, spleen. Different sites may have different associated modulation parameters", Para. [0107]. "assessments may be performed before and after applying energy pulses to assess a change in glucose concentration as a result of the modulation. If the glucose concentration is above or below a threshold, appropriate modification in the modulation parameters may be made. For example, if the glucose concentration with desired physiological outcome, the energy applied during neuromodulation may be stepped back to a minimum level that supports the desired outcome. If the change in the characteristic relative to the threshold is associated with insufficient change in glucose concentration, certain modulation parameters, including, but not limited to, the modulation amplitude or frequency, the pulse shape, the stimulation pattern, and/or the stimulation location may be changed", Para. [0124]).
Regarding Claim 5, GE '065 discloses the method of claim 2, wherein the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is effective in treating the medical condition; predicting an onset of symptoms for the patient from the plurality of parameters; and delivering the focused ultrasound neuromodulation signal to the location within the neural target site in response to predicting the onset of symptoms ("The controller 16 may also be configured to receive inputs related to the targeted physiological outcomes as an input to the selection of the modulation parameters. For example, when an imaging modality is used to assess a tissue characteristic, the controller 16 may be configured to receive a calculated index or parameter of the characteristic the energy application device 12 (e.g., an ultrasound transducer) may operate under control of the controller 16 to a) acquire image data of a tissue that may be used to spatially select a region of interest within the target tissue b) apply the modulating energy to the region of interest and c) acquire image to determine that the targeted physiological outcome has occurred", Para. [0110]. "the energy may be substantially applied only to the region or regions of interest 44 to preferentially activate the synapse in a targeted manner to achieve targeted physiological outcomes and is not substantially applied in a general or a nonspecific manner across the entire tissue 43 the system 10 may apply energy to individual axon terminals until the desired targeted physiological effect is achieved. It should be understood that the spleen image is by way of example only. The disclosed selection of axon terminals for preferential activation via a direct energy application to the region of interest using spatial information of visualized nerves may be used in conjunction with other organs or structures (e.g., liver, pancreas, gastrointestinal tissue)", Para. [0118], Figs. 1-3).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over General Electric (US 2020/0406065, hereinafter GE) in view of West Virginia (WO 2023/215717).
Regarding Claim 6, GE '065 discloses the method of claim 2, wherein the method further comprises: determining, from the plurality of parameters, that the focused ultrasound neuromodulation signal is not effective in treating the medical condition ("Based on the assessment, the modulation parameters of the controller 16 may be altered. a change of the modulation parameters such as pulse frequency or other parameters may be desired, which in turn may be provided to the controller 16", Para. [0103]. "The controller 16 permits adjustably controlling the energy by changing the modulation parameters and/or initiating energy application at certain times or cancelling/suppressing energy application at certain times. In one embodiment, the adjustable control of the energy application device is based on information about a concentration of one or more molecules in the subject (e.g., a circulating molecule). If the information is from the assessment device 20, a feedback loop may drive the adjustable control. For example, if a circulating glucose concentration, as measured by the assessment device 20, is above a predetermined threshold or range, the controller 16 may initiate energy application to a region of interest (e.g., liver) and with modulation parameters that are associated with a reduction in circulating glucose. The initiation of energy application may be triggered by the glucose concentration drifting above a predetermined (e.g., desired) threshold or outside a predefined range. In another embodiment, the adjustable control may be in the form of altering modulation parameters when an initial application of energy does not result in an expected change in a targeted physiological outcome", Para. [0106]).
GE '065 fails to explicitly disclose selecting an alternative therapy for the medical condition.
However, West Virginia is in the field of focused ultrasound treatment (abstract) and teaches selecting an alternative therapy for the medical condition ("Returning to FIG. 1, if it is determined that focused ultrasound treatment is not appropriate for the patient (N), the method advances to 104, where the patient is assigned to an alternative treatment. Alternative treatments can include any of medications, transcranial magnetic stimulation, deep brain stimulation", Para. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filling date to modify the method of GE '065 to include selecting an alternative therapy for the medical condition as taught by West Virginia. The motivation would be to ensure the patient receives the appropriate treatment for the medical condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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