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 .
Response to Amendment
Applicant’s amendment, filed 20 March 2026, is acknowledged. Claims 53-56, 58 and 60 are amended. Claims 1-52 are cancelled. Claims 61-82 are new.
Claims 53-82 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 20 March 2026, with respect to the claim objection to claim 36 and the 35 USC 112(b) rejections of claims 31-37 have been fully considered and are persuasive in light of the claims being cancelled. The claim objection to claim 36 and the 35 USC 112(b) rejections of claims 31-37 have been withdrawn.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 53-60 under 35 USC 103 have been fully considered and are persuasive in light of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schwarz (US20230277862A1) in view of Kim (US20200000428A1) and further in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1) and Ning (US20230211168A1).
Claim Objections
Claims 68 and 73 are objected to because of the following informalities:
Claim 68, line 14 recites “shifting the applicator toward in a direction to the patient's nose” but should read --shifting the applicator in a direction to the patient's nose— or --shifting the applicator toward the patient's nose--.
Claim 73, line 2 recites “the treatment session are” but should read --the treatment sessions are--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 74 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 74 recites the limitation "a second repetition rate lower than a repetition rate of the first time-varying magnetic field," but claim 68 recites three repetition rates for the first time-varying magnetic field, so it is unclear which repetition rate is being referenced, rending the claim indefinite.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 53-56, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Kim (US20200000428A1) and further in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1) and Ning (US20230211168A1).
Regarding claim 53, Schwarz discloses a method for applying a time-varying magnetic field to a patient’s head by a device (Paragraphs [0007], [0475]) comprising a main body (Paragraph [0160]) comprising an energy source (Paragraph [0125]), an energy storage device (Paragraph [0125]), and a switching device (Paragraph [0125]); and an applicator comprising a magnetic field generating device (Paragraph [0027]), the method comprising: charging an energy storage device by an energy source (Paragraph [0125]); switching a switching device to discharge the energy storage device to the magnetic field generating device to generate impulse of the time-varying magnetic field (Paragraph [0125]); positioning the applicator proximate to patient (Paragraph [0196]); aligning a first visual element with a first anatomical structure of the patient (Paragraph [0102]); setting an initial value of the magnetic flux density (Paragraph [0539]); assembling a plurality of impulses into a trapezoidal envelope (Figure 13); wherein the trapezoidal envelope comprises: first plurality of impulses into a first envelope over a first time period, wherein a magnetic flux density of the first plurality of impulses increases over the first time period (Paragraphs [0185], [0276], [0296]-[0302], Figure 13); a second plurality of impulses into a second envelope over a second time period, wherein a magnetic flux density of the second plurality of impulses is constant over the second time period, and wherein the magnetic flux density of the second plurality of impulses is equal to the maximal value of the magnetic flux density to be applied to the patient (Paragraphs [0185], [0276], [0296]-[0302], Figure 13); a third plurality of impulses into a third envelope over a third time period, wherein a magnetic flux density of the third plurality of impulses decreases over the third time period (Paragraphs [0185], [0276], [0296]-[0302], Figure 13).
Schwarz does not explicitly disclose changing the magnetic flux density of the second envelope to change an increase rate of the magnetic flux density of the first plurality of impulses. Schwarz discloses the trapezoid envelope (Paragraphs [0185], [0276], and Figure 13) and further discloses changing magnetic flux density as needed (Paragraph [0272]). Using the trapezoid envelope and assuming fixed time periods (first, second, third time periods), if the constant value of the second magnetic flux density is increased, it would require changing the increasing rate of the magnetic flux density of impulses in the first plurality of impulses in order for the method to maintain the trapezoid envelope (See annotated Figure 13 below). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art that the method as disclosed by Schwarz, would require the increasing rate of the magnetic flux density of impulses in the first plurality of impulses to change if the value of the magnetic flux density of the second envelope changed in order to maintain the trapezoid envelope taught by Schwarz. The same would apply if the time periods are static and the second flux value is changed to decrease, the first increasing rate of flux density would have a lower rate of change.
Modified Schwarz does not disclose aligning a second visual element with a second anatomical structure of the patient, wherein the second visual element is less proximate to the handle than to the first visual element. Kim discloses a device for applying energy to a patient’s brain via transcranial stimulation (Abstract). Kim further discloses the applicator (Figure 2, applicator “32”) includes a marker (second marker “33”) on top of the applicator for determining the location of the applicator with respect to the patient’s brain. The marker includes a first visual element, a second visual element on the left side, and a third visual element on the right side, wherein the first visual element is positioned proximate to the front side and is positioned proximate to a first anatomical structure of the patient, wherein the second visual element or the third visual element are configured to be positioned proximate to a second anatomical structure, wherein the second anatomical structure is different from the first anatomical. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with aligning a second visual element with a second anatomical structure of the patient, wherein the first and second visual elements are identified so that the second visual element is less proximate to the handle than to the first visual element as taught by Kim, since such a modification would provide the predictable results of allowing a user to track the focal direction of the directed energy (Paragraph [0065]).
Modified Schwarz does not disclose applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density. Lee discloses a transcranial magnetic stimulation method (Abstract) wherein a motor threshold value of a magnetic flux density is established (Paragraph [0009]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density as taught by Lee, since such a modification would provide the predictable results for accurate and safe treatment (Paragraph [0070]).
Modified Schwarz fails to disclose determining a maximal value of magnetic flux density based on a scaling factor. Stokes discloses for accurate, safe, and effective application of brain stimulation, it is essential that an appropriate level of electric current be induced within a target region (Page 4520). Stokes further discloses a scaling factor for determining a maximal value of a magnetic flux density to be applied to a patient based on the distance of the coil from the scalp (Page 4525). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with determining a maximal value of magnetic flux density based on a scaling factor as taught by Stokes, since such a modification would provide more accurate stimulation protocols and more effective treatment regimens (Page 4526).
Modified Schwarz fails to disclose positioning the patient's head on a positioning pillow such that a crown of the patient's head is in contact with the pillow. Pemberton discloses a method for applying magnetic stimulation to a patient (Abstract), wherein the method includes positioning a crown of patient’s head in contact with a positioning pillow (Paragraph [0059] Figures 3a and 3b pillow “226”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with positioning the patient's head on a positioning pillow such that a crown of the patient's head is in contact with the pillow as taught by Pemberton, since such a modification would provide the predictable results of reducing unexpected movement of the patient during treatment.
Modified Schwarz fails to disclose the method is for treating of obsessive compulsive disorder (OCD) comprising applying the time-varying magnetic field to the patient's head to treat OCD. Ning teaches it is known in the art to use time-varying transcranial magnetic stimulation (Paragraph [0021]) for the treatment of OCD (Paragraph [0003]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with using the method to treat OCD by applying a time-varying magnetic stimulation as taught by Ning, since such a modification is a known treatment for OCD (Paragraph [0003]).
Regarding claim 54, Schwarz, as modified in claim 53, further discloses the time-varying magnetic field is applied to the patient's head with a repetition rate of 20 Hz and with an inter-train pause of 20 seconds (Paragraphs [0182]).
Regarding claim 55, Schwarz, as modified in claim 54, discloses aligning the first visual element on the applicator with a first anatomical structure of the patient to find the motor threshold
value of the magnetic flux density (Paragraph [0102], See the rejection of claim 53 further in view of Lee supra. ), wherein the device further comprises a connecting tube connected to the applicator (Figure 3c, connecting tube ”9”), and wherein the first visual element (Paragraph [0102]) is positioned less proximate to the connecting tube than to the second visual element. The shape of the marker as disclosed by Kim in claim 53 in combination with the limitation of claim 53, “the second visual element is less proximate to the handle than to the first visual element” would require that if the second visual element was less proximate to the handle than the first visual element, the first visual element would have to be less proximate to the connecting tube than the second visual element.
Regarding claim 56, Schwarz, as modified in claim 54, further discloses the handle forms an opening (Figure 3a). Modified Schwarz discloses the method further comprises inserting a belt through an opening of the applicator to maintain the applicator proximate to the patient in different handle embodiment (Figure 3b, Paragraph [0101]), but does not disclose inserting a belt through the closed loop opening of the applicator. As the devices of figure 3a and 3b function in the same manner, a POSITA would recognize inserting a belt through the closed loop opening would have the same operational effects if the opening was not closed as disclosed in Paragraph [0101]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with inserting a belt through the closed loop opening of the applicator, since such a modification would provide the predictable results of reducing unexpected movement of the patient during treatment (Paragraph [0115]).
Regarding claim 58, Schwarz, as modified in claim 56, previously disclosed aligning a first visual element with a first anatomical structure of the patient and aligning a second visual element with a second anatomical structure of the patient (Supra in claim 53). Schwarz further discloses the first anatomical structure can be a patient’s head or nose (Paragraph [0475], Modified Schwarz disclosed placing the applicator to the patient’s head in claims 53, 54 and 56 supra and as the handle is on the top of the applicator, the handle would have to be to the left or right of the patient’s head.) but does not disclose aligning the second or a third visual element with the patient's nose. Lee discloses using the nose as a reference coordinate for positioning the coil to repeatedly locate the target position of the treatment (Lee, Paragraph [0119]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with aligning a second or third marker with patient’s nose in some manner because it can be used as a reference point for brain mapping as taught by Lee, since such a modification would provide the predictable results of possibly detecting a more accurate position to thus increase the treatment efficiency (Lee, Paragraph [0120]).
Regarding claim 59, Schwarz, as modified in claim 53, further discloses directing air into the applicator; directing the air out of the applicator in a direction away from the patient; and cooling the magnetic field generating device by the air (Figures 2 and 3a, wherein the blower “4” intakes air through the inlet on the rear of the applicator and directs air around the magnetic field generating device and out the outlet “8” at the front of the applicator).
Regarding claim 60, Schwarz as modified in claim 53, further discloses positioning the applicator to the patient by a positioning arm (Paragraph [0115]).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1), Kim (US20200000428A1), Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005) and Pemberton (US20220362570A1), as applied to claim 56, in view of Juliana (US20060161039A1).
Regarding claim 57, Schwarz, as modified in claim 56, fails to disclose the applicator comprises an operating member opposite to the handle, wherein the method further comprises using the operating member to generate a single impulse. Juliana discloses a device, method and system for positioning a magnetic stimulation device with respect to a patient. (Abstract). Juliana further discloses an operating member opposite to the handle (Figure 4, controls “403”) comprising using the operating member to generate a single impulse (Paragraphs [0050], [0051]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Schwarz, Lee and Stokes, with the applicator comprising an operating member opposite to the handle, wherein the method further comprises using the operating member to generate a single impulse as taught by Juliana, since such a modification would provide the predictable results of easy access to the device controls for the practitioner.
Claims 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1) and further in view of Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1) and Ning (US20230211168A1).
Regarding claim 61, Schwarz discloses a method for applying a time-varying magnetic field to a patient by a device (Paragraphs [0007], [0475]) comprising a main body (Paragraph [0160]) comprising an energy source (Paragraph [0125]), an energy storage device (Paragraph [0125]), a switching device (Paragraph [0125]); and an applicator comprising a magnetic field generating device (Paragraph [0027]), the method comprising: charging an energy storage device by an energy source (Paragraph [0125]); switching a switching device to discharge the energy storage device to the magnetic field generating device to generate impulse of the time-varying magnetic field (Paragraph [0125]); positioning the applicator proximate to patient’s head (Paragraph [0475]); aligning a first visual element with a first anatomical structure of the patient (Paragraph [0102]); setting an initial value of the magnetic flux density (Paragraph [0539]); assembling a plurality of impulses into a train having a trapezoidal envelope (Figure 13), wherein the trapezoidal envelope comprises a first plurality of impulses, a second plurality of impulses and a third plurality of impulses (Figure 13), wherein the first plurality of impulses is generated for a first time period, and wherein an amplitude of the magnetic flux density of sequential impulses within the first plurality of impulses increases over the first time period (Figure 13); wherein the second plurality of impulses is generated for a second time period, and wherein an amplitude of the magnetic flux density of sequential impulses within the second plurality of impulses is equal (Figure 13); wherein the third plurality of impulses is generated for a third time period, and wherein an amplitude magnetic flux density of sequential impulses within the third plurality of impulses decreases over the third time period (Figure 13); wherein the plurality of impulses is generated with a constant repetition rate in a range of 10 Hz (Paragraph [0182]) and applying a plurality of trains to the patient's head with an inter-train pause of 11 seconds
Schwarz does not explicitly disclose changing the amplitude of the magnetic flux density of the second plurality of impulses to change an increase rate of the magnetic flux density of the first plurality of impulses. Schwarz discloses the trapezoid envelope (Paragraphs [0185], [0276], and Figure 13) and further discloses changing magnetic flux density as needed (Paragraph [0272]). Using the trapezoid envelope and assuming fixed time periods (first, second, third time periods), if the constant value of the second magnetic flux density is increased, it would require changing the increasing rate of the magnetic flux density of impulses in the first plurality of impulses in order for the method to maintain the trapezoid envelope (See annotated Figure 13 below). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art that the method as disclosed by Schwarz, that the method would require the increasing rate of the magnetic flux density of impulses in the first plurality of impulses to change if the value of the magnetic flux density of the second envelope changed in order to maintain the trapezoid envelope taught by Schwarz. The same would apply if the time periods are static and the second flux value is changed to decrease, the first increasing rate of flux density would have a lower rate of change.
Schwarz discloses the passive period between trains is variable (Paragraph [0182]), using a passive period of 20 seconds as an example (Paragraph [0182]) and further discloses the passive periods may be modulated depending on the treatment effect and target location desired (Paragraph [0747]), but Schwarz does not explicitly disclose applying a plurality of trains to the patient's head with an inter-train pause of 11 seconds. As Schwarz discloses, that the inter-train pause can be modulated for the desired effect, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, through routine experimentation to arrive at an inter-train pause of 11 seconds for the most effective therapeutic effect at a desired location.
Modified Schwarz does not disclose applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density. Lee discloses a transcranial magnetic stimulation method (Abstract) wherein a motor threshold value of a magnetic flux density is established (Paragraph [0009]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density as taught by Lee, since such a modification would provide the predictable results for accurate and safe treatment (Paragraph [0070]).
Modified Schwarz fails to disclose determining a maximal value of magnetic flux density based on a scaling factor. Stokes discloses for accurate, safe, and effective application of brain stimulation, it is essential that an appropriate level of electric current be induced within a target region (Page 4520). Stokes further discloses a scaling factor for determining a maximal value of a magnetic flux density to be applied to a patient based on the distance of the coil from the scalp (Page 4525). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with determining a maximal value of magnetic flux density based on a scaling factor as taught by Stokes, since such a modification would provide more accurate stimulation protocols and more effective treatment regimens (Page 4526).
Modified Schwarz fails to disclose positioning the patient's head on a positioning pillow such that the positioning pillow maintains the patient's head in a stable position. Pemberton discloses a method for applying magnetic stimulation to a patient (Abstract), wherein the method includes positioning a patient’s head in contact with a positioning pillow (Paragraph [0059] Figures 3a and 3b pillow “226”). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with positioning the patient's head on a positioning pillow such the positioning pillow maintains the patient's head in a stable position as taught by Pemberton, since such a modification would provide the predictable results of reducing unexpected movement of the patient during treatment.
Modified Schwarz fails to disclose the method is for treating of major depressive disorder (MDD) comprising applying the time-varying magnetic field to the patient's head to treat MDD. Ning teaches it is known in the art to use time-varying transcranial magnetic stimulation (Paragraph [0021]) for the treatment of MDD (Paragraph [0003]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with using the method to treat MDD by applying a time-varying magnetic stimulation as taught by Ning, since such a modification is a known treatment for MDD (Paragraph [0003]).
Regarding claim 62, Schwarz, as modified in claim 61, further discloses connecting the applicator to a positioning arm (Figures 4a-4c) to enable positioning of the applicator to the patient (Paragraph [0115]).
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1) and Ning (US20230211168A1), as applied to claim 62, and further in view of Fitzgerald (US20150174423A1).
Regarding claim 63, Schwarz as disclosed in claim 62, does not disclose shifting the applicator in a same parasagittal plane where the motor threshold value of the magnetic flux density was determined. Fitzgerald discloses a method of optimizing transcranial magnetic stimulation (Abstract), wherein the applicator is shifted in the same parasagittal plane where the motor threshold magnetic flux density was established (Paragraph [0078]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with shifting the applicator in the same parasagittal plane where the motor threshold magnetic flux density was established as taught by Fitzgerald, since such a modification would provide the predictable results to of an effective method for increasing blood oxygenation (Paragraph [0034]).
Claims 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1), Ning (US20230211168A1) and Fitzgerald (US20150174423A1), as applied to claim 63, and further in view of Sajda (US20230143233A1).
Regarding claim 64, Schwarz as modified in claim 63, does not disclose applying a plurality of trapezoidal envelopes to a dorsolateral prefrontal cortex. Sajda discloses a method of treating MDD with TMS (Abstract), wherein pulses applied over the left dorsolateral prefrontal cortex can be used to treat MDD (Paragraph [0006]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying a plurality of trapezoidal envelopes to a dorsolateral prefrontal cortex as taught by Sajda, since such a modification would provide the predictable results to of an effective method for treating MDD (Paragraph [0006]).
Regarding claim 65, Schwarz, as modified in claim 64, further discloses number of impulses applied to the patient's brain is 2,000 to 12,500 applied in 50 to 100 trains (Paragraphs [0248]-[0249]).
Regarding claim 66, Schwarz, as disclosed in claim 65, further discloses the amplitude of the magnetic flux density of sequential impulses within the second plurality of impulses is equal to at least the motor threshold value of the magnetic flux density, or higher (Paragraph [0754], as the second plurality of impulses are considered the highest amplitude, reaching the motor threshold would have to occur during the second plurality of impulses).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Pemberton (US20220362570A1) and Ning (US20230211168A1), as applied to claim 61 and further in view of Kim (US20200000428A1).
Regarding claim 67, Schwarz as modified in claim 61, discloses aligning a first visual element on the applicator with a first anatomical marker on the patient's head (Paragraph [0102]). Modified Schwarz does not disclose aligning a second visual element with a second anatomical marker on the patient's head to find a position where the motor threshold value of the magnetic flux density is established, wherein the first anatomical marker is different and distant from the second anatomical marker. Kim discloses a device for applying energy to a patient’s brain via transcranial stimulation (Abstract). Kim further discloses the applicator (Figure 2, applicator “32”) includes a marker (second marker “33”) on top of the applicator for determining the focus location of the energy with respect to the patient’s brain (Paragraph [0065]). The marker includes a first visual element, a second visual element on the left side, and a third visual element on the right side, wherein the first visual element is positioned proximate to the front side and is positioned proximate to a first anatomical structure of the patient, wherein the second visual element or the third visual element are configured to be positioned proximate to a second anatomical structure, wherein the second anatomical structure is different from the first anatomical. As the purpose of Kim is to determine the focus location of the energy with respect to the patient’s anatomy, the markers of Kim would be able to is to find a position where the motor threshold value of the magnetic flux density is established (Paragraph [0065]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with aligning a second visual element with a second anatomical marker on the patient's head to find a position where the motor threshold value of the magnetic flux density is established, wherein the first anatomical marker is different and distant from the second anatomical marker as taught by Kim, since such a modification would provide the predictable results of allowing a user to track the focal direction of the directed energy (Paragraph [0065]).
Claims 68-74 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1) and further in view of Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), Riehl (US20050261542A1) and Fitzgerald (US20150174423A1).
Regarding claim 68, Schwarz discloses a method for applying a first time-varying magnetic field to a patient by a device (Paragraphs [0007], [0475]) comprising a main body (Paragraph [0160]) comprising an energy source (Paragraph [0125]), an energy storage device (Paragraph [0125]), a switching device (Paragraph [0125]); and an applicator comprising a magnetic field generating device (Paragraph [0027]), the method comprising: charging an energy storage device by an energy source (Paragraph [0125]); switching a switching device to discharge the energy storage device to the magnetic field generating device to generate impulse of the first time-varying magnetic field (Paragraph [0125]); positioning the applicator proximate to patient’s head (Paragraph [0475]); setting an initial value of the magnetic flux density (Paragraph [0539]); assembling a plurality of bursts (Paragraph [0181]), wherein each burst comprises a train comprising a plurality of impulses (Paragraph [0182]) modulated to a trapezoidal envelope (Figure 13), wherein each trapezoidal envelope comprises: a first plurality of impulses having increasing magnetic flux density of sequential impulses up to the maximal value of the magnetic flux density (Figure 13), a second plurality of impulse having magnetic flux density equal to the maximal value of the magnetic flux density (Figure 13), and a third plurality of impulses having decreasing magnetic flux density of sequential impulses from the maximal value of the magnetic flux density (Figure 13), wherein the first plurality of impulses lasts 0.7 second (Paragraph [0182]), the second plurality of impulses lasts 0.2 second (Paragraph [0182]), and the third plurality of impulses lasts 1.1 second (Paragraph [0182]), and wherein the first plurality of impulses is generated with a first repetition rate, the second plurality of impulses is generated with a second repetition rate higher than the first repetition rate, and the third plurality of impulses is generated with a third repetition rate higher than each of the first repetition rate and the second repetition rate (Figure 29a); applying a plurality of trains in a treatment session to the patient's head (Paragraph [0475]), wherein sequential trains are separated by an inter-train period (Paragraph [0182]).
Schwarz does not disclose applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density. Lee discloses a transcranial magnetic stimulation method (Abstract) wherein a motor threshold value of a magnetic flux density is established (Paragraph [0009]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density as taught by Lee, since such a modification would provide the predictable results for accurate and safe treatment (Paragraph [0070]).
Modified Schwarz fails to disclose determining a maximal value of magnetic flux density based on a scaling factor. Stokes discloses for accurate, safe, and effective application of brain stimulation, it is essential that an appropriate level of electric current be induced within a target region (Page 4520). Stokes further discloses a scaling factor for determining a maximal value of a magnetic flux density to be applied to a patient based on the distance of the coil from the scalp (Page 4525). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with determining a maximal value of magnetic flux density based on a scaling factor as taught by Stokes, since such a modification would provide more accurate stimulation protocols and more effective treatment regimens (Page 4526).
Schwarz, as modified by Lee supra, disclosed applying at least one impulse of the time-varying magnetic field to the patient to determine a motor threshold value of a magnetic flux density, but modified Schwarz does not disclose positioning the applicator to the patient's motor cortex. Riehl discloses a method for treating a patient for mental illnesses by applying a magnetic field to the patient (Abstract), wherein the motor threshold value of a magnetic flux density is found by placing the coil near the corresponding area of the motor cortex (Paragraph [0039]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with positioning the applicator to the patient's motor cortex as taught by Riehl, since such a modification would provide the predictable results of an effective location to determine the motor threshold (Paragraph [0039]).
Modified Schwarz does not disclose treating binge eating by applying the first time-varying magnetic field to patient's head. Riehl discloses a method for treating a patient for mental illnesses by applying a magnetic field to the patient (Abstract), wherein the application of a magnetic field is used to treat binge eating (Paragraph [0015]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with treating binge eating by applying the first time-varying magnetic field to patient's head as taught by Riehl, since such a modification would provide an effective method for treatment.
Modified Schwarz does not disclose shifting the applicator toward in a direction to the patient's nose. Fitzgerald discloses a method of optimizing transcranial magnetic stimulation (Abstract), wherein the applicator is in a direction to the patient's nose (Figures 2a-2e). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with shifting the applicator toward in a direction to the patient's nose as taught by Fitzgerald, since such a modification would provide the predictable results to of an effective method for increasing blood oxygenation (Paragraph [0034]).
Regarding claim 69, modified Schwarz further discloses the positioning comprises following instruction on a human machine interface to set the applicator to the position to find the motor threshold value of the magnetic flux density (Paragraph [0711]).
Regarding claim 70, modified Schwarz further discloses the first repetition rate is 12 Hz, wherein the second repetition rate is 15 Hz, and wherein the third repetition rate is 18 Hz (Paragraph [0023]).
Regarding claim 71, modified Schwarz further discloses the magnetic flux density is below the motor threshold value of the magnetic flux density (Paragraph [0540]).
Regarding claim 72, modified Schwarz further discloses the treatment session lasts in a range of 10 min to 60 min (Paragraph [0222]) in a treatment lasting 1 week to 3 weeks (Paragraph [0786]).
Regarding claim 73, modified Schwarz further discloses applying the treatment session to the patient repetitively 4 times to 6 times (Paragraph [0248]), wherein the treatment session are 2 days to 3 day apart (Paragraph [0786]).
Regarding claim 74, modified Schwarz further discloses generating a second time-varying magnetic field with a second repetition rate lower than a repetition rate of the first time-varying magnetic field, (Paragraph [0355]), wherein the plurality of trains in the treatment session is the first time-varying magnetic field (Figure 13).
Claims 75-77 and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1) and further in view of Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), and Zhang (CN218356631U).
Regarding claim 75, Schwarz discloses a method for applying a time-varying magnetic field to a patient by a device (Paragraphs [0007], [0475]) comprising a main body (Paragraph [0160]) comprising an energy source (Paragraph [0125]), an energy storage device (Paragraph [0125]), a switching device (Paragraph [0125]); and an applicator comprising a magnetic field generating device (Paragraph [0027]), the method comprising: charging an energy storage device by an energy source (Paragraph [0125]); switching a switching device to discharge the energy storage device to the magnetic field generating device to generate impulse of the time-varying magnetic field (Paragraph [0125]); positioning the applicator proximate to a motor cortex (Paragraph [0475]); setting an initial value of the magnetic flux density (Paragraph [0539]); assembling a first plurality of impulses into a first envelope over a first time period, wherein a magnetic flux density of the first plurality of impulses increases over the first time period (Paragraphs [0185], [0276], [0296]-[0302], Figure 13); assembling a second plurality of impulses into a second envelope over a second time period, wherein a magnetic flux density of the second plurality of impulses is constant over the second time period, and wherein the magnetic flux density of the second plurality of impulses is equal to the maximal value of the magnetic flux density to be applied to the patient’ head (Paragraphs [0185], [0276], [0296]-[0302], Figure 13); assembling a third plurality of impulses into a third envelope over a third time period, wherein a magnetic flux density of the third plurality of impulses decreases over the third time period (Paragraphs [0185], [0276], [0296]-[0302], Figure 13), applying the first plurality of impulses, the second plurality of impulses, and the third plurality of impulses to patient's head (Paragraph [0475]).
Schwarz does not explicitly disclose changing the magnetic flux density of the second envelope to change an increase rate of the magnetic flux density of the first plurality of impulses. Schwarz discloses the trapezoid envelope (Paragraphs [0185], [0276], and Figure 13) and further discloses changing magnetic flux density as needed (Paragraph [0272]). Using the trapezoid envelope and assuming fixed time periods (first, second, third time periods), if the constant value of the second magnetic flux density is increased, it would require changing the increasing rate of the magnetic flux density of impulses in the first plurality of impulses in order for the method to maintain the trapezoid envelope (See annotated Figure 13 below). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art that the method as disclosed by Schwarz, that the method would require the increasing rate of the magnetic flux density of impulses in the first plurality of impulses to change if the value of the magnetic flux density of the second envelope changed in order to maintain the trapezoid envelope taught by Schwarz. The same would apply if the time periods are static and the second flux value is changed to decrease, the first increasing rate of flux density would have a lower rate of change.
Modified Schwarz does not disclose applying at least one impulse of the time-varying magnetic field to the patient’s head to determine a motor threshold value of a magnetic flux density. Lee discloses a transcranial magnetic stimulation method (Abstract) wherein a motor threshold value of a magnetic flux density is established (Paragraph [0009]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying at least one impulse of the time-varying magnetic field to the patient’s head to determine a motor threshold value of a magnetic flux density as taught by Lee, since such a modification would provide the predictable results for accurate and safe treatment (Paragraph [0070]).
Modified Schwarz fails to disclose determining a maximal value of magnetic flux density based on a scaling factor. Stokes discloses for accurate, safe, and effective application of brain stimulation, it is essential that an appropriate level of electric current be induced within a target region (Page 4520). Stokes further discloses a scaling factor for determining a maximal value of a magnetic flux density to be applied to a patient based on the distance of the coil from the scalp (Page 4525). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with determining a maximal value of magnetic flux density based on a scaling factor as taught by Stokes, since such a modification would provide more accurate stimulation protocols and more effective treatment regimens (Page 4526).
Modified Schwarz discloses coupling the applicator to the patient by a belt (Paragraph [0108]) but Schwarz fails to disclose positioning the patient's head onto a positioning pillow such that the patient's head in maintained in a stable position by the positioning pillow and coupling the applicator by a belt to the positioning pillow to maintain the applicator proximate to the patient's head. Zhang discloses a method for TMS comprising a multifunctional treatment bed (Abstract) wherein the patient's head is positioned onto a positioning pillow (Figures 3 and 4) such that the patient's head in maintained in a stable position by the positioning pillow (Figures 3 and 4, the headrest has a concave shape to support the head) and a belt coupled to the headrest for supporting the patient’s head (Figure 4 “215”). As modified Schwarz teaches attaching the applicator to the patient via a belt, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with positioning the patient's head onto a positioning pillow such that the patient's head in maintained in a stable position by the positioning pillow and coupling the applicator by a belt to the positioning pillow to maintain the applicator proximate to the patient's head as taught by Zhang, since such a modification would provide the predictable results of providing support and immobilizing the head and applicator during treatment for comfort (Page 2).
Regarding claim 76, modified Schwarz further discloses generating a plurality of clusters (Paragraph [0271]), wherein each cluster comprises a plurality of trains, wherein each train lasts 60 ms (Paragraph [0270]) and wherein each train comprises impulses having a repetition rate of 50 Hz (Paragraph [0182]), and wherein each train is followed by an inter-train period of 160 ms (Paragraph [0271]); and wherein each cluster lasts 2 seconds and wherein each cluster is followed by an inter-cluster period lasting 8 seconds (Paragraph [0296]).
Regarding claim 77, modified Schwarz further discloses applying 600 impulses to the patient's head (Paragraph [0729]) with at least the motor threshold value of the magnetic flux density (Paragraph [0754]).
Regarding claim 79, modified Schwarz discloses selecting a treatment protocol via a
human machine interface (Paragraph [0046]); and following instruction visualized by the human machine interface to find a position to determine the motor threshold value of the magnetic flux density (Paragraph [0711]).
Regarding claim 80, modified Schwarz discloses applying the time-varying magnetic field
in trains, wherein each train has a first repetition rate of 18 Hz or a second repetition rate of 20 Hz (Paragraph [0023]), and wherein each train lasts 2 seconds (Paragraph [0306]).
Regarding claim 81, modified Schwarz discloses applying the trains to the patient's head (Paragraph [0475]) with an inter-train period (Paragraph [0182]). Modified Schwarz does not explicitly dislose an inter-train period of 6 seconds. Modified Schwarz does disclose the passive period between trains is variable (Paragraph [0182]), using a passive period of 20 seconds as an example (Paragraph [0182]) and further discloses the passive periods may be modulated depending on the treatment effect and target location desired (Paragraph [0747]). As Schwarz discloses, that the inter-train pause can be modulated for the desired effect, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, through routine experimentation to arrive at an inter-train pause of 6 seconds for the most effective therapeutic effect at a desired location.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), and Zhang (CN218356631U), as applied to claim 75 above, and further in view of Wölfel (US20180250521A1).
Regarding claim 78, modified Schwarz discloses aligning a visual element with the head of the patient (Paragraphs [0102], [0475]); wherein the device further comprising a connecting tube configured to couple the applicator to the main body (Figures 4a-4c), and wherein the applicator further comprising a handle and the visual element (Figures 3c and 4c), wherein the visual element is positioned proximate to the handle and less proximate to the connecting tube (Figures 3c and 4c). Modified Schwarz does not disclose aligning a visual element with the ear of the patient. Wölfel a method for positioning a magnetic coil in relation to the head of a patient (Paragraph [0002]), wherein the marker can be aligned with the ear features of the patients head (Paragraph [0068]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with aligning a visual element with the ear of the patient as taught by Wölfel, since such a modification would provide the predictable results of allowing for consistent placement of the coil with respect to the patient for repeated sessions.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz (US20230277862A1) in view of Lee (US20240042227A1), Stokes (“Simple Metric For Scaling Motor Threshold Based on Scalp-Cortex Distance: Application to Studies Using Transcranial Magnetic Stimulation” 2005), and Zhang (CN218356631U), as applied to claim 75 above, and further in view of Sajda (US20230143233A1).
Regarding claim 82, Schwarz as modified in claim 75, does not disclose applying the time-varying magnetic field to frontal or prefrontal cortex of the patient. Sajda discloses a method of treating MDD with TMS (Abstract), wherein pulses applied over the left dorsolateral prefrontal cortex can be used to treat MDD (Paragraph [0006]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by modified Schwarz, with applying the time-varying magnetic field to a prefrontal cortex of the patient as taught by Sajda, since such a modification would provide the predictable results to of an effective method for treating MDD (Paragraph [0006]).
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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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