DETAILED ACTION
Response to Amendment
This Office Action is in response to the amendment filed 08/14/2026. Claims 1-4 and 6-21 are acknowledged as pending with claims 1-4, 6-11, 14-16, 18-19 being currently amended, claim 5 being cancelled, and claim 21 being new.
The claim objections, the rejection under 35 U.S.C. 112(b), and the rejections under 35 U.S.C. 102(a)(1) and 103 are withdrawn as having been overcome by the amendment. The amendment to claims 1, 14, and 18 introduces new claim limitations that change the scope of the claims. New rejections necessitated by the amendment are presented below.
Response to Arguments
Applicant's arguments filed 08/14/2026 have been fully considered but they are not persuasive.
On page 8, para. 2 of Applicant’s response, applicant argues that Tan et al. fails to teach the “prefrontal cortex region” as the treatment region. Examiner asserted in the previous Office Action that “Tan et al. fails to teach wherein the treatment region is the prefrontal cortex”; as a result, examiner relied on the secondary reference, Kozel et al., to teach the limitation. This argument is moot because Tan et al. was not originally relied upon to teach the limitation in question.
On page 8, para. 3 of applicant’s response, applicant argues that Tan et al. fails to teach adjusting “one or more treatment parameters, including a treatment location.” Examiner asserted in the previous Office Action that “Tan et al. fails to teach wherein the adjustment includes a location of the TMS treatment”; as a result, Examiner relied on the secondary reference, Kozel et al., to teach the limitation. This argument is moot because Tan et al. was not originally relied upon to teach the limitation in question.
On page 9, paras. 1-2 of Applicant’s response, applicant argues that Tan et al. fails to show certain features of the invention, it is noted that the limitations upon which applicant relies (i.e., the applied dosing determined from a comparison of the first set and the second set of measurements of and to calibrate the TMS treatment to the prefrontal cortex region) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). This argument is moot because the limitations upon which applicant relies (i.e., the applied dosing determined from a comparison of the first set and the second set of measurements of and to calibrate the TMS treatment to the prefrontal cortex region) are not recited in rejected claim 1.
On page 11, para 1 of the Applicant’s response, applicant argues that Kozel et al. fails to teach an “adjustment of treatment parameters including a treatment location”. MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. As stated in the previous Office Action, Kozel et al. discloses stimulating the motor cortex before subsequently stimulating the prefrontal cortex via a TMS figure eight coil (Refer to Figure 1 and page 4, sub-section labeled, “Visit 1”, wherein the coil’s location changes as distinct cortices are targeted). The BRI of “treatment location” does not preclude that the adjustment be limited to the prefrontal cortex. While the examiner appreciates that the disclosed invention may require discrete location adjustments, this is not commensurate with the scope of the claim. Therefore, the TMS coil location adjustment of Kozel et al. is considered to meet the claimed “adjustment of treatment parameters including a treatment location.” It is improper to import limitations from the specification into the claim. New rejections necessitated by the amendment are presented below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/14/2026 was filed after the mailing date of the Non-Final Office Action on 04/17/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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) 1, 3-4, 6, 8-10, 12-15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (CN 107497051), citing to attached translation, in view of Kozel et al. ("Using simultaneous repetitive Transcranial Magnetic Stimulation/functional Near Infrared Spectroscopy (rTMS/fNIRS) to measure brain activation and connectivity"), hereinafter "Kozel et al.”
Regarding claim 1, Tan et al. teaches a method (page 7, para. 7, “the working method of the system is as follows:”) comprising:
measuring, via a functional Near-Infrared Spectroscopy (fNIRS) device, a first set of measurements of a cerebral cortex region (Fig. 1, brain surface 4; page 6, para. 4, “cerebral cortex”; page 6, para. 6, “the different part of the brain surface is change of light intensity so as to reflect different brain part of oxygenated hemoglobin and deoxygenated hemoglobin content”) of a patient to be treated (page 8, para. 4, “starting the TMS and fNIRS device, after the subject quiet relaxation, near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal”);
performing, via a transcranial magnetic stimulation (TMS) device, TMS treatment to the cerebral cortex region for therapeutic effect (page 8, para. 4, “then starting TMS stimulation”; page 7, para. 7, “stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”; page 6, para. 4, “magnetic stimulation to the cerebral cortex”);
measuring, via the fNIRS device, a second set of measurements of the cerebral cortex region (page 8, para. 4, “after waiting for 15 s, and then measuring the time 15 s of near infrared signal, repeating until the stimulation is ended. hypothetical fNIRS measurement intensity of the stimulation is the period of time x, after calculating each 15 s period of hemoglobin oxygenation and percentage PerOxy and PerDeoxy the energy of the initial energy of deoxygenated hemoglobin, Per=max (PerOxy, PerDeoxy), Per PerOxy and PerDeoxy maximum value”; Fig. 1, brain surface 4; page 6, para. 4, “cerebral cortex”; page 6, para. 6, “the different part of the brain surface is change of light intensity so as to reflect different brain part of oxygenated hemoglobin and deoxygenated hemoglobin content”);
determining, by a processor (page 7, para. 8, “the analysis control device comprises…”), an applied dosing of the TMS treatment based on the first set of measurements and the second set of measurements (page 7, para. 7, “the fNIRS signal collecting module obtains the continuous time length of 30 s near infrared signal by the analyzing control device, analyzing the signal energy and the signal energy percentage after initial resting state of 15 s period, thereby giving a set of stimulation parameters, stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”), the applied dosing determined from a comparison of the first set and the second set of measurements of the cerebral cortex region (page 6, para. 7, “we firstly measuring resting state, duration of 15 s near infrared signal as the initial signal, and then measuring stimulating occur after time 15 s is 15 s near infrared signal, thus, taking 30 s as a period of time, measuring the back section 15 s length of near infrared signal, analyzing the signal and the relation between the initial signal, determine a new stimulation parameters. through each section 15 s the near infrared signal analysis, to achieve real-time control of approximation”; page 8, para. 4, “near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal, then the signal will be compared with the signal. then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal”); and
outputting control feedback to the TMS device or a visualization to a display to adjust one or more treatment parameters, based on the applied dosing (page 7, para. 7, “the display and control module can see the current stimulation parameters, such as manual/automatic mode selection, resting the motion threshold, current stimulation intensity, stimulation frequency and stimulation time, and can change parameter by LCD touch screen key module”) to calibrate the TMS treatment to the cerebral cortex region (page 7, para. 5, “a near infrared signal control transcranial stimulation method and system, using the near infrared signal subject to setting individual transcranial stimulation parameters and avoids the damage of excessive stimulation or stimulation”, wherein the stimulation parameters are adjusted to meet the needs of individual treatment; page 6, para. 4, “regulating the stimulation intensity and stimulation frequency, driving the stimulation coil, magnetic stimulation to the cerebral cortex”).
Tan et al. fails to specifically teach a prefrontal cortex and wherein adjusting one or more treatment parameters includes a treatment location.
In the same field of endeavor, Kozel et al. teaches wherein the treatment region is the prefrontal cortex (Abstract) and wherein adjusting one or more treatment parameters includes a treatment location (Figure 1, where the TMS coil’s location was adjusted relative to the motor cortex and prefrontal cortex; page 5, para. 1, “The fNIRS probes were positioned over the prefrontal cortex (see Figure 1) – defined as 5 cm anterior to the motor cortex position in a para-sagittal line…the coil was moved 5 cm anteriorly in a para-sagittal line. The fNIRS recording and TMS stimulation were the same as for the motor cortex stimulation”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Tan et al. with the prefrontal cortex treatment region and the treatment location adjustment of Kozel et al. Adjusting the placement of the TMS treatment to stimulate the motor cortex and prefrontal cortex may be beneficial when treating patients with depression. While the effects of motor cortex stimulation are easy to observe and quantify, i.e., muscle response, the effects of TMS in areas of the brain, such as the prefrontal cortex, are difficult to observe. As a result, researchers rely on measured hemodynamic changes to evaluate brain responses in the prefrontal cortex. Therefore, by adjusting the location of the TMS coil to first stimulate the motor cortex and then the prefrontal cortex, the measured hemodynamic changes may provide a means to monitor the neuronal changes induced from TMS and provide an integrated approach for depression-related treatment (Kozel et al., page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”; page 5, fNIRS Statistical Analysis; page 2, para. 3, “The majority of rTMS (and TMS) studies of brain function and treatment effects have occurred with stimulation of the motor cortex…”; page 3, para. 3, “Functional NIRS offers the potential of measuring immediate brain effects…”).
Regarding claim 3, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al. fails to teach wherein the one or more treatment parameters include a gyrus orientation adjustment.
Kozel et al. further teaches wherein the one or more treatment parameters include a gyrus orientation adjustment (page 9, para. 3, “subjects were first stimulated over the motor cortex and then the prefrontal cortex”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the method of Tan et al., in view of Kozel et al., with the gyrus orientation adjustment of Kozel et al. Stimulating the prefrontal cortex via transcranial magnetic stimulation is a method frequency employed to treat depression; additionally, by successively stimulating the motor cortex as well as the ipsilateral and contralateral prefrontal cortices, where different gyri are located, bilateral changes in cortical activation and functional brain changes may be induced (Kozel et al., page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”; page 3, para. 5, “produce bilateral changes in cortical activation that would be measurable by fNIRS. Further, we hypothesized that functional brain changes induced by TMS over the motor cortex and the prefrontal cortex”).
Regarding claim 4, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al. fails to teach wherein the one or more treatment parameters include a cortical excitability output to a motor cortex and dorsolateral prefrontal cortex.
Kozel et al. further teaches wherein the one or more treatment parameters include a cortical excitability output to a motor cortex (page 13, Figure 1, “Motor Cortex”) and dorsolateral prefrontal cortex (see Annotated Figure 1; page 5, Visit-2, “simultaneous TMS/fNIRS over the motor cortex and the prefrontal cortex were performed as in Visit 1”; page 7, paragraphs with headings titled: Simultaneous rTMS/fNIRS of Motor Cortex, Simultaneous rTMS/fNIRS of Prefrontal Cortex, and Comparing Prefrontal and Motor Cortices of Simultaneous rTMS/fNIRS).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the method of Tan et al., in view of Kozel et al., with the treatment region and cortical excitability output to the motor cortex and dorsolateral prefrontal cortex of Kozel et al. Stimulating the prefrontal cortex via transcranial magnetic stimulation is a method frequency employed to treat depression; additionally, by successively stimulating the motor cortex as well as the ipsilateral and contralateral prefrontal cortices, bilateral changes in cortical activation and functional brain changes may be induced (Kozel et al., page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”; page 3, para. 5, “produce bilateral changes in cortical activation that would be measurable by fNIRS. Further, we hypothesized that functional brain changes induced by TMS over the motor cortex and the prefrontal cortex”).
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Annotated Figure 1
Regarding claim 6, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above wherein the one or more treatment parameters include a frequency of the TMS treatment (Tan et al., page 8, para. 1, TMS stimulation system comprising…a single chip control of the frequency modulation”; page 8, para. 2, “the stimulus intensity and the stimulus frequency can be adjusted”).
Regarding claim 8, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above wherein visualization to the display is used to monitor an effectiveness of treatment changes based on the TMS treatment
(Tan et al., page 6, para. 8, “the display and control module, which can be a small liquid crystal screen displays the oxygenated hemoglobin and deoxygenated hemoglobin in real time after change”, essentially, the obtained oxygenated and deoxygenated hemoglobin signals dictate whether the stimulation parameters need to be adjusted to ensure the treatment is effective; page 8, paras. 4-6, para. 4 begins with “step 1, making the subject wearing the good experimental device…”).
Regarding claim 9, Tan et al., in view of Kozel et al., teaches the method according to claim 8 as stated above wherein the effectiveness of treatment region changes includes monitoring a change in a hemodynamic response of the treatment region
(Tan et al., page 8, para. 4, “near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal, then the signal will be compared with the signal. then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal, repeating until the stimulation is ended. hypothetical fNIRS measurement intensity of the stimulation is the period of time x, after calculating each 15 s period of hemoglobin oxygenation and percentage PerOxy and PerDeoxy the energy of the initial energy of deoxygenated hemoglobin, Per=max (PerOxy, PerDeoxy), Per PerOxy and PerDeoxy maximum value”).
Regarding claim 10, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al. fails to teach wherein the control feedback to the TMS device or the visualization to the display is used to determine a stopping criteria for the TMS treatment.
Kozel et al. further teaches wherein the control feedback to the TMS device or the visualization to the display is used to determine a stopping criteria for the TMS treatment (page 4, para. 6, “one minute prior to stimulation, during the 15 stimulation/rest epochs (90 seconds per epoch), and during a one-minute poststimulation period resulting in a total recording time of 24 minutes and 30 seconds” wherein the treatment duration, i.e., twenty two and half minutes for the motor cortex stimulation interval, the end of the treatment duration is being construed as the “stopping criteria”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further combined the method of Tan et al., in view of Kozel et al., with the stopping criteria of Kozel et al. Implementing a specific treatment duration that is consistent across various patients ensures the comparability of obtained oxygenated and deoxygenated hemoglobin measurements within a target population (Kozel et al., page 6, para. 5, “a resting motor threshold (RMT) was obtained for nine…; the entirety of page 7).
Regarding claim 12, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al. further teaches wherein the fNIRS device includes a light source and a light detector, at least one of each forming a pair (Fig. 1, near infrared collecting probe 2; page 6, para. 6, “near infrared signal collecting system through the emitting end emits near infrared light, whose wavelength is 850 nm and 760 nm can detect oxygenated hemoglobin and deoxygenated hemoglobin, respectively, can have the same frequency characteristic of the photoelectric receiving diode or photocell as probe”), wherein each pair is configured to be placed a predetermined distance apart from one another (Fig. 4; page 5, para. 9, “the transmitting probe and receiving probe interval is not greater than 6 cm”).
Tan et al. fails to teach a plurality of lights sources and light detectors.
Kozel et al. further teaches wherein the fNIRS device includes a plurality of light sources and a plurality of light detectors, at least one of each forming a pair, wherein each pair is configured to be placed a predetermined distance apart from one another (page 13, Figure 1. Location of the rTMS coil and fNIRS Sources and Detectors, “The fNIRS probe comprised of 28 source-detector pairs”; as shown in Fig. 1, the source and detectors are spaced equal distance apart and 5 cm anterior to the motor cortex position).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Tan et al., in view of Kozel et al., with the plurality of light sources and light detectors of Kozel et al. A plurality of light sources and light detectors provides a variable number of channels (source-detector pairs) which may be manipulated to maximize the uniformity of the acquired fNIRS signals. Furthermore, the multitude of channels may provide an operating system with the ability to allocate responsive channels and exclude inconsistent and nonresponsive channels from a pooled analysis (Kozel et al., page 5, the entirety of paragraph 3 titled fNIRS Statistical Analysis).
Regarding claim 13, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al., in view of Kozel et al., further teaches wherein the treatment region is the prefrontal cortex (Kozel et al., Abstract), and wherein the control feedback to the TMS device or visualization to the display is to provide sufficient cortical excitability for neurological treatment (Tan et al., page 1, para. 6, “technical field of nerve disease treatment and brain function research”; page 6, para. 4, “analyzing control device automatically sends stimulation parameter to a transcranial magnetic stimulation system”; page 7, para. 7, “stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”).
Tan et al. fails to teach wherein the TMS treatment is for treatment of depression.
Kozel et al. further teaches wherein the TMS treatment is for treatment of depression (page 8, para. 1, “relieve the depressive symptoms”; page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”), the treatment region is the prefrontal cortex (page 5, para. 1, “The fNIRS probes were positioned over the prefrontal cortex (see Figure 1) – defined as 5 cm anterior to the motor cortex position in a para-sagittal line…the coil was moved 5 cm anteriorly in a para-sagittal line. The fNIRS recording and TMS stimulation were the same as for the motor cortex stimulation”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Tan et al., in view of Kozel et al., with the TMS depression treatment of Kozel et al. Transcranial magnetic stimulation is an non-invasive therapy proven effective in treating a multitude of neuropsychiatric disorders and diseases; therefore, it would be beneficial to include a treatment region to the prefrontal cortex, where TMS has demonstrated antidepressive properties (Kozel et al., page 2, para. 1, “Transcranial magnetic stimulation (TMS) is a technology that is being used to investigate normal brain function and various neuropsychiatric disorders…”; page 2, para. 2, “rTMS is being investigated as a possible treatment for various brain disorders. As an example, daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression…”).
Regarding claim 14, Tan et al. teaches a system (Abstract) comprising:
a functional Near-Infrared Spectroscopy (fNIRS) device (page 3, para. 8, “the fNIRS signal collecting system comprises a fNIRS signal collecting module, the storage module, and the communication module”; page 3, para. 10, “Furthermore, the fNIRS signal collecting module comprises an emitting probe and a receiving probe”);
a transcranial magnetic stimulation (TMS) device (Fig. 1, TMS coil 1; page 3, para. 9, “TMS stimulation system comprises a communication module, a power amplifying circuit, a storage module, the single chip control of the frequency modulation amplitude modulation of the magnetic stimulation system”); and
an integrated component having a processor and a memory having instructions stored thereon, wherein execution of the instructions by the processor cause the integrated component to (page 4, para. 1, “the analysis control device comprises a visible touch liquid crystal display screen, a single chip, a storage module, a power supply circuit”; page 8, para. 3, “the working method of the analyzing control device, comprising:”):
receive a second set of fNIRS measurements of the cerebral cortex region following the application of the TMS treatment (page 8, para. 4, “then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal, repeating until the stimulation is ended”; Fig. 1, brain surface 4; page 6, para. 4, “cerebral cortex”; page 6, para. 6, “the different part of the brain surface is change of light intensity so as to reflect different brain part of oxygenated hemoglobin and deoxygenated hemoglobin content”);
determine an applied dosing of the TMS treatment based on the first set of fNIRS measurements and the second set of fNIRS measurements (page 8, paras. 4, “hypothetical fNIRS measurement intensity of the stimulation is the period of time x, after calculating each 15 s period of hemoglobin oxygenation and percentage PerOxy and PerDeoxy the energy of the initial energy of deoxygenated hemoglobin, Per=max (PerOxy, PerDeoxy), Per PerOxy and PerDeoxy maximum value; page 8, para. 5, “step 2, according to stimulation mode of the Per value after determining, changing the stimulation intensity, the stimulation intensity reference value of the next time section”; page 7, para. 7, “the fNIRS signal collecting module obtains the continuous time length of 30 s near infrared signal by the analyzing control device, analyzing the signal energy and the signal energy percentage after initial resting state of 15 s period, thereby giving a set of stimulation parameters, stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”), the applied dosing determined from a comparison of the first set of fNIRS measurements and the second set of fNIRS measurements of the cerebral cortex region (page 6, para. 7, “we firstly measuring resting state, duration of 15 s near infrared signal as the initial signal, and then measuring stimulating occur after time 15 s is 15 s near infrared signal, thus, taking 30 s as a period of time, measuring the back section 15 s length of near infrared signal, analyzing the signal and the relation between the initial signal, determine a new stimulation parameters. through each section 15 s the near infrared signal analysis, to achieve real-time control of approximation”; page 8, para. 4, “near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal, then the signal will be compared with the signal. then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal”); and
provide control feedback to the TMS device or a visualization to a display to adjust one or more parameters, based on the applied dosing (page 7, para. 7, “the display and control module can see the current stimulation parameters, such as manual/automatic mode selection, resting the motion threshold, current stimulation intensity, stimulation frequency and stimulation time, and can change parameter by LCD touch screen key module, so as to fNIRS signal through real time control the TMS stimulation”) to calibrate the TMS treatment to the cerebral cortex region (page 7, para. 5, “a near infrared signal control transcranial stimulation method and system, using the near infrared signal subject to setting individual transcranial stimulation parameters and avoids the damage of excessive stimulation or stimulation”, wherein the stimulation parameters are adjusted to meet the needs of individual treatment; page 6, para. 4, “regulating the stimulation intensity and stimulation frequency, driving the stimulation coil, magnetic stimulation to the cerebral cortex”; furthermore, it is important to note that the limitation, “to calibrate the TMS treatment to the prefrontal cortex region” recited in lines 18-19 is an intended use, functional limitation. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus, if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114 II). The combination of Tan et al. and Kozel et al. teaches all the structure limitations recited in the claim; therefore, the modified system of Tan et al., in view of Kozel et al., meets the functional limitation).
Tan et al. fails to specifically teach a prefrontal cortex, wherein execution of the instructions by the integrated component causes the processor to: receive a first set of fNIRS measurements of a prefrontal cortex region responsive to application of a TMS treatment by the TMS device to the prefrontal cortex region of a patient, and wherein adjusting one or more treatment parameters includes a treatment location.
Kozel et al. teaches an analogous fNIRS-TMS system and method wherein the treatment region is the prefrontal cortex (Abstract), wherein a first set of fNIRS measurements of a prefrontal cortex region responsive to application of a TMS treatment by the TMS device to the prefrontal cortex region of a patient (see Annotated Figure 2; page 4, para. 6, “fNIRS data was acquired one minute prior to stimulation, during the 15 stimulation/rest epochs (90 seconds per epoch), and during a one-minute poststimulation period resulting in a total recording time of 24 minutes and 30 seconds”), and wherein adjusting one or more treatment parameters includes a treatment location (Figure 1, where the TMS coil’s location was adjusted relative to the motor cortex and prefrontal cortex; page 5, para. 1, “The fNIRS probes were positioned over the prefrontal cortex (see Figure 1) – defined as 5 cm anterior to the motor cortex position in a para-sagittal line…the coil was moved 5 cm anteriorly in a para-sagittal line. The fNIRS recording and TMS stimulation were exactly the same as for the motor cortex stimulation”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Tan et al. with the prefrontal cortex treatment region, the first set of fNIRS measurements, and the treatment location adjustment of Kozel et al. Adjusting the placement of the TMS treatment to stimulate the motor cortex and prefrontal cortex may be beneficial when treating patients with depression. While the effects of motor cortex stimulation are easy to observe and quantify, i.e., muscle response, the effects of TMS in areas of the brain, such as the prefrontal cortex, are difficult to observe. As a result, researchers rely on measured hemodynamic changes to evaluate brain responses in the prefrontal cortex. Therefore, by adjusting the location of the TMS coil to first stimulate the motor cortex and then the prefrontal cortex, the measured hemodynamic changes may provide a means to monitor the neuronal changes induced from TMS and provide an integrated approach for depression-related treatments. Furthermore, fNIRS data acquired in response to a TMS treatment may be employed to conduct a comparative analysis between the brain’s hemodynamic changes associated with TMS of the motor cortex and the prefrontal cortex. Furthermore, fNIRS measurements collected during stimulation may provide insights into the effectiveness of the stimulation parameters and the localization of TMS stimulation (Kozel et al., page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”; page 5, fNIRS Statistical Analysis; page 2, para. 3, “The majority of rTMS (and TMS) studies of brain function and treatment effects have occurred with stimulation of the motor cortex…”; page 3, para. 3, “Functional NIRS offers the potential of measuring immediate brain effects…; page 4, para. 6, “After the fNIRS recording was complete, the location of the TMS stimulation relative to the fNIRS system was determined”; page 7, para. 3, “the conditions studied (healthy participants stimulated for 10 secs with 1 Hz rTMS), the brain changes associated with motor cortex stimulation and prefrontal cortex stimulation”; page 7, para. 6, “Gaining a better understanding of how different treatment parameters interact to produce clinical outcome is critical to optimizing the effectiveness of these new treatments”).
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Regarding claim 15, Tan et al., in view of Kozel et al., teaches the system according to claim 14 as stated above wherein the one or more treatment parameters adjusted based on the control feedback include to adjust one or more of: a coil to treatment region distance, a gyrus orientation, an excitability output, a location of the TMS treatment, a frequency of the TMS treatment (Tan et al., Fig. 3; page 8, para. 3, “the working method of the analyzing control device, comprising:” and paras. 5-6, “changing the stimulation intensity [via an adjusting formula] …the same treatment/[formula] [applies] for the stimulation frequency”; page 8, para. 1, TMS stimulation system comprising…a single chip control of the frequency modulation”; page 8, para. 2, “the stimulus intensity and the stimulus frequency can be adjusted”) a duration of the TMS treatment, an effectiveness of treatment region changes based on the TMS treatment, or a stopping criteria for the TMS treatment.
Regarding claim 17, Tan et al., in view of Kozel et al., teaches the system according to claim 14 as stated above. Tan et al. further teaches wherein the fNIRS device includes a light source and a light detector, at least one of each forming a pair (Fig. 1, near infrared collecting probe 2; page 6, para. 6, “near infrared signal collecting system through the emitting end emits near infrared light, whose wavelength is 850 nm and 760 nm can detect oxygenated hemoglobin and deoxygenated hemoglobin, respectively, can have the same frequency characteristic of the photoelectric receiving diode or photocell as probe”), wherein each pair is configured to be placed a predetermined distance apart from one another (Fig. 4; page 5, para. 9, “the transmitting probe and receiving probe interval is not greater than 6 cm”).
Tan et al. fails to teach a plurality of lights sources and light detectors.
Kozel et al. further teaches wherein the fNIRS device includes a plurality of light sources and a plurality of light detectors, at least one of each forming a pair, wherein each pair is configured to be placed a predetermined distance apart from one another (page 13, Figure 1. Location of the rTMS coil and fNIRS Sources and Detectors, “The fNIRS probe comprised of 28 source-detector pairs”; as shown in Fig. 1, the source and detectors are spaced equal distance apart and 5 cm anterior to the motor cortex position).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the system of Tan et al., in view of Kozel et al., with the plurality of light sources and light detectors of Kozel et al. A plurality of light sources and light detectors provides a variable number of channels (source-detector pairs) which may be manipulated to maximize the uniformity of the acquired fNIRS signals. Furthermore, the multitude of channels may provide an operating system with the ability to allocate responsive channels and exclude inconsistent and nonresponsive channels from a pooled analysis (Kozel et al., page 5, the entirety of paragraph 3 titled fNIRS Statistical Analysis).
Regarding claim 18, Tan et al. teaches a non-transitory computer-readable medium for a transcranial magnetic stimulation (TMS) functional Near-Infrared Spectroscopy (fNIRS) (TMS-fNIRS) system, the non-transitory computer-readable medium having instructions stored thereon, wherein execution of the instructions by one or more processors causes the one or more processors to (page 4, para. 1, “the analysis control device comprises a visible touch liquid crystal display screen, a single chip, a storage module, a power supply circuit”; page 5, para. 12, “analyzing control device connected with the TMS stimulation system and fNIRS signal acquisition system”):
receive a first set of fNIRS measurements from a fNIRS device of the TMS-fNIRS system (Fig. 1, brain surface 4; page 6, para. 4, “cerebral cortex”; page 6, para. 6, “the different part of the brain surface is change of light intensity so as to reflect different brain part of oxygenated hemoglobin and deoxygenated hemoglobin content”; page 8, para. 4, “starting the TMS and fNIRS device, after the subject quiet relaxation, near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal”),
receive a second set of fNIRS measurements from the fNIRS device of the cerebral cortex region (page 8, para. 4, “then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal, repeating until the stimulation is ended”; Fig. 1, brain surface 4; page 6, para. 4, “cerebral cortex”; page 6, para. 6, “the different part of the brain surface is change of light intensity so as to reflect different brain part of oxygenated hemoglobin and deoxygenated hemoglobin content”);
determine an applied dosing of the TMS treatment based on the first set of fNIRS measurements and the second set of fNIRS measurements (page 8, paras. 4, “hypothetical fNIRS measurement intensity of the stimulation is the period of time x, after calculating each 15 s period of hemoglobin oxygenation and percentage PerOxy and PerDeoxy the energy of the initial energy of deoxygenated hemoglobin, Per=max (PerOxy, PerDeoxy), Per PerOxy and PerDeoxy maximum value; page 8, para. 5, “step 2, according to stimulation mode of the Per value after determining, changing the stimulation intensity, the stimulation intensity reference value of the next time section”; page 7, para. 7, “the fNIRS signal collecting module obtains the continuous time length of 30 s near infrared signal by the analyzing control device, analyzing the signal energy and the signal energy percentage after initial resting state of 15 s period, thereby giving a set of stimulation parameters, stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”), the applied dosing determined from a comparison of the first set of fNIRS measurements and the second set of fNIRS measurements of the cerebral cortex region (page 6, para. 7, “we firstly measuring resting state, duration of 15 s near infrared signal as the initial signal, and then measuring stimulating occur after time 15 s is 15 s near infrared signal, thus, taking 30 s as a period of time, measuring the back section 15 s length of near infrared signal, analyzing the signal and the relation between the initial signal, determine a new stimulation parameters. through each section 15 s the near infrared signal analysis, to achieve real-time control of approximation”; page 8, para. 4, “near infrared signal measured before the stimulation, and the measuring time is 15 s to obtain the oxygenated hemoglobin and deoxygenated hemoglobin signal for its amplitude squaring and summation, as the initial energy of the fNIRS signal, then the signal will be compared with the signal. then starting TMS stimulation, after waiting for 15 s, and then measuring the time 15 s of near infrared signal”); and
provide control feedback to the TMS device or a visualization to a display to adjust one or more treatment parameters based on the applied dosing (page 7, para. 7, “the display and control module can see the current stimulation parameters, such as manual/automatic mode selection, resting the motion threshold, current stimulation intensity, stimulation frequency and stimulation time, and can change parameter by LCD touch screen key module, so as to fNIRS signal through real time control the TMS stimulation”) to calibrate the TMS treatment to the cerebral cortex region (page 7, para. 5, “a near infrared signal control transcranial stimulation method and system, using the near infrared signal subject to setting individual transcranial stimulation parameters and avoids the damage of excessive stimulation or stimulation”, wherein the stimulation parameters are adjusted to meet the needs of individual treatment; page 6, para. 4, “regulating the stimulation intensity and stimulation frequency, driving the stimulation coil, magnetic stimulation to the cerebral cortex”; furthermore, it is important to note that the limitation, “to calibrate the TMS treatment to the prefrontal cortex region” recited in lines 18-19 is an intended use, functional limitation. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus, if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114 II). The combination of Tan et al. and Kozel et al. teaches all the structure limitations recited in the claim; therefore, the modified system of Tan et al., in view of Kozel et al., meets the functional limitation).
Tan et al. fails to specifically teach a prefrontal cortex, wherein the first set of fNIRS measurements taken from a prefrontal cortex region of a patient in response to a TMS treatment applied by a TMS device of the TMS-fNIRS system to the prefrontal cortex region; and wherein adjusting one or more treatment parameters includes a treatment location.
Kozel et al. teaches an analogous fNIRS-TMS system and method wherein the treatment region is the prefrontal cortex (Abstract), wherein the first set of fNIRS measurements taken from a prefrontal cortex region of a patient in response to a TMS treatment applied by a TMS device of the TMS-fNIRS system to the prefrontal cortex region (see Annotated Figure 2; page 4, para. 6, “fNIRS data was acquired one minute prior to stimulation, during the 15 stimulation/rest epochs (90 seconds per epoch), and during a one-minute poststimulation period resulting in a total recording time of 24 minutes and 30 seconds”), and wherein adjusting one or more treatment parameters includes a treatment location (Figure 1, where the TMS coil’s location was adjusted relative to the motor cortex and prefrontal cortex; page 5, para. 1, “The fNIRS probes were positioned over the prefrontal cortex (see Figure 1) – defined as 5 cm anterior to the motor cortex position in a para-sagittal line…the coil was moved 5 cm anteriorly in a para-sagittal line. The fNIRS recording and TMS stimulation were the same as for the motor cortex stimulation”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the non-transitory computer-readable medium of Tan et al. with the prefrontal cortex treatment region, the first set of fNIRS measurements, and the treatment location adjustment of Kozel et al. Adjusting the placement of the TMS treatment to stimulate the motor cortex and prefrontal cortex may be beneficial when treating patients with depression. While the effects of motor cortex stimulation are easy to observe and quantify, i.e., muscle response, the effects of TMS in areas of the brain, such as the prefrontal cortex, are difficult to observe. As a result, researchers rely on measured hemodynamic changes to evaluate brain responses in the prefrontal cortex. Therefore, by adjusting the location of the TMS coil to first stimulate the motor cortex and then the prefrontal cortex, the measured hemodynamic changes may provide a means to monitor the neuronal changes induced from TMS and provide an integrated approach for depression-related treatments. Furthermore, fNIRS data acquired in response to a TMS treatment may be employed to conduct a comparative analysis between the brain’s hemodynamic changes associated with TMS of the motor cortex and the prefrontal cortex. Furthermore, fNIRS measurements collected during stimulation may provide insights into the effectiveness of the stimulation parameters and the localization of TMS stimulation (Kozel et al., page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”; page 5, fNIRS Statistical Analysis; page 2, para. 3, “The majority of rTMS (and TMS) studies of brain function and treatment effects have occurred with stimulation of the motor cortex…”; page 3, para. 3, “Functional NIRS offers the potential of measuring immediate brain effects…; page 4, para. 6, “After the fNIRS recording was complete, the location of the TMS stimulation relative to the fNIRS system was determined”; page 7, para. 3, “the conditions studied (healthy participants stimulated for 10 secs with 1 Hz rTMS), the brain changes associated with motor cortex stimulation and prefrontal cortex stimulation”; page 7, para. 6, “Gaining a better understanding of how different treatment parameters interact to produce clinical outcome is critical to optimizing the effectiveness of these new treatments”).
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Annotated Figure 2
Regarding claim 19, Tan et al., in view of Kozel et al., teaches the non-transitory computer-readable medium according to claim 18 as stated above wherein the one or more treatment parameters adjusted based on the control feedback include to adjust one or more of: a coil to treatment region distance, a gyrus orientation, an excitability output, a location of the TMS treatment, a frequency of the TMS treatment (Tan et al., Fig. 3; page 8, para. 3, “the working method of the analyzing control device, comprising:” and paras. 5-6, “changing the stimulation intensity [via an adjusting formula] …the same treatment/[formula] [applies] for the stimulation frequency”; page 8, para. 1, TMS stimulation system comprising…a single chip control of the frequency modulation”; page 8, para. 2, “the stimulus intensity and the stimulus frequency can be adjusted”) a duration of the TMS treatment, an effectiveness of treatment region changes based on the TMS treatment, or a stopping criteria for the TMS treatment.
Regarding claim 20, Tan et al., in view of Kozel et al., teaches the non-transitory computer-readable medium according to claim 18 as stated above. Tan et al., in view of Kozel et al., further teaches wherein the treatment region is the prefrontal cortex (Kozel et al., Abstract), and wherein the control feedback to the TMS device or visualization to the display is to provide sufficient cortical excitability for neurological treatment (Tan et al., page 1, para. 6, “technical field of nerve disease treatment and brain function research”; page 6, para. 4, “analyzing control device automatically sends stimulation parameter to a transcranial magnetic stimulation system”; page 7, para. 7, “stimulation coil driven by TMS stimulation system, for magnetic stimulation to the cortex of the brain”).
Tan et al. fails to teach wherein the TMS treatment is for treatment of depression.
Kozel et al. further teaches wherein the TMS treatment is for treatment of depression (page 8, para. 1, “relieve the depressive symptoms”; page 2, para. 2, “daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression”), the treatment region is the prefrontal cortex (page 5, para. 1, “The fNIRS probes were positioned over the prefrontal cortex (see Figure 1) – defined as 5 cm anterior to the motor cortex position in a para-sagittal line…the coil was moved 5 cm anteriorly in a para-sagittal line. The fNIRS recording and TMS stimulation were the same as for the motor cortex stimulation”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the non-transitory computer-readable medium of Tan et al., in view of Kozel et al., with the TMS depression treatment of Kozel et al. Transcranial magnetic stimulation is an non-invasive therapy proven effective in treating a multitude of neuropsychiatric disorders and diseases; therefore, it would be beneficial to include a treatment region to the prefrontal cortex, where TMS has demonstrated antidepressive properties (Kozel et al., page 2, para. 1, “Transcranial magnetic stimulation (TMS) is a technology that is being used to investigate normal brain function and various neuropsychiatric disorders…”; page 2, para. 2, “rTMS is being investigated as a possible treatment for various brain disorders. As an example, daily prefrontal rTMS has been found to have antidepressant properties when treating patients with depression…”).
Regarding claim 21, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above wherein the applied dosing is determined to match a degree of activation of the treatment region to a degree of activation of the motor cortex (Tan et al., page 6, para. 2, “When the stimulation state and the initial resting state energy percentage between 110 and 90% %, the stimulation intensity and stimulation frequency remains unchanged, when the energy percentage less than 90%, increasing the stimulation intensity and stimulation frequency; when the energy percentage exceeds 110 %, reduces the stimulation intensity and stimulation frequency”; page 8, para. 2, “the stimulus intensity and the stimulus frequency can be adjusted, wherein the minimum value of the stimulus intensity is 60% resting motion threshold value, and the maximum is 120 % resting motion threshold, stimulating the minimum value of frequency is 1 Hz, the maximum value is 20 Hz”, wherein the intensity of stimulation is applied according to the user’s resting motor threshold).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al., in view of Kozel et al., further in view of Riehl et al. (US 2017/0232267).
Regarding claim 2, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al., in view of Kozel et al., fails to teach wherein the one or more treatment parameters include a coil to treatment region distance adjustment.
Riehl et al. teaches an analogous method for controlling TMS devices wherein the one or more treatment parameters include a coil to treatment region distance adjustment (Fig. 1A, articulating arm 12 and TMS coil assembly 20; para. 0050, where the articulating arm 12 allows the TMS coil assembly 20 to be adjusted relative to the patient’s head; para. 0052, where the display 40 may guide an operator to reposition the TMS coil assembly 20 to improve scalp contact).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Tan et al., in view of Kozel et al., with the TMS device adjustment assembly of Riehl et al. The ability to adjust the TMS device relative to a subject’s head ensures a proper magnetic field intensity is applied to the patient (Riehl et al., para. 0004).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al., in view of Etkin et al. (WO 2017189757).
Regarding claim 7, Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al., in view of Kozel et al., fails to teach wherein the one or more treatment parameters include a duration of the TMS treatment.
Etkin et al. teaches an analogous method for diagnosing and treating depression with TMS wherein the one or more treatment parameters include a duration of the TMS treatment (paras. 0046 and 0051).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Tan et al., in view of Kozel et al., with the TMS treatment duration adjustment of Etkin et al. The treatment duration may need to be increased or decreased relative to the original planned treatment protocol in response to a patient’s evoked brain changes. Correspondingly, the ability to adjust the treatment duration and/or parameters establishes a tolerable and effective stimulation for the patient (Etkin et al., paras. 0070, 0073, and 0083).
Claim(s) 11 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al., in view of Kozel et al., further in view of Jiang et al. ("Neuroimaging of depression with diffuse optical tomography during repetitive transcranial magnetic stimulation"), hereinafter "Jiang et al."
Regarding claim 11 Tan et al., in view of Kozel et al., teaches the method according to claim 1 as stated above. Tan et al., in view of Kozel et al., fails to teach wherein the TMS device is configured to generate at least one of: a 12-block sequence of 1 Hz stimulation with 4 sec on and off 26 sec, a 12-block sequence of 10 Hz stimulation with 4 sec on and off 26 sec, or a 48-jittered single pulses stimulation sequence.
Jiang et al. teaches an analogous method for TMS treatment wherein the TMS device is configured to generate at least one of: a 12-block sequence of 1 Hz stimulation with 4 sec on and off 26 sec, a 12-block sequence of 10 Hz stimulation with 4 sec on and off 26 sec (page 5, Figure 2, “Ten hertz stimulation was performed for 4 s followed by 26 s of rest for a total of 12 epochs”), or a 48-jittered single pulses stimulation sequence.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the method of Tan et al., in view of Kozel et al., with the TMS device configured to generate a 12-block sequence of 10 Hz stimulation with 4 seconds on and off 26 seconds of Jiang et al. Implementing a ten hertz stimulation with four second duration per session, constitutes a standard treatment protocol for transcranial magnetic stimulation (TMS) (Jiang et al., page 2, para. 6, “All rTMS treatments were performed with a Neurostar TMS Therapy System (Neuronet ics, Inc., Malvern, PA, USA). Stimulation protocol was followed per the product documentation…”; page 7, para. 2, “10 Hz stimulation has been shown to increase [HbO], which was associated with continued therapeutic effects of TMS”).
Regarding claim 16, Tan et al., in view of Kozel et al., teaches the system according to claim 14 as stated above. Tan et al., in view of Kozel et al., fails to teach wherein the TMS device is configured to generate at least one of: a 12-block sequence of 1 Hz stimulation with 4 sec on and off 26 sec, a 12-block sequence of 10 Hz stimulation with 4 sec on and off 26 sec, or a 48-jittered single pulses stimulation sequence.
Jiang et al. teaches an analogous system and method for TMS treatment wherein the TMS device is configured to generate at least one of: a 12-block sequence of 1 Hz stimulation with 4 sec on and off 26 sec, a 12-block sequence of 10 Hz stimulation with 4 sec on and off 26 sec (page 5, Figure 2, “Ten hertz stimulation was performed for 4 s followed by 26 s of rest for a total of 12 epochs”), or a 48-jittered single pulses stimulation sequence.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the system of Tan et al., in view of Kozel et al., with the TMS device configured to generate a 12-block sequence of 10 Hz stimulation with 4 seconds on and off 26 seconds of Jiang et al. Implementing a ten hertz stimulation with four second duration per session, constitutes a standard treatment protocol for transcranial magnetic stimulation (TMS) (Jiang et al., page 2, para. 6, “All rTMS treatments were performed with a Neurostar TMS Therapy System (Neuronet ics, Inc., Malvern, PA, USA). Stimulation protocol was followed per the product documentation…”; page 7, para. 2, “10 Hz stimulation has been shown to increase [HbO], which was associated with continued therapeutic effects of TMS”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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