DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of claims 1-23 in the reply filed on 18 August 2025 is acknowledged. Accordingly, claims 24-30 are withdrawn from consideration.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 7, 17 and 20 are objected to because of the following informalities: at line 1 of claims 7 and 20, “of each” should apparently read --for each--; at line 2, of claim 17 --be-- should be inserted before “positioned”; and at line 6 of claim 17, “the memory” should apparently read --the at least one memory--. 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.
Claims 4, 15 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites wherein “the at least one application area of the head corresponds to an area of the subject’s brain affected by a tumor or blood vessel abnormality in a different area of the subject's brain”. Clarification is requested on what “a different area” is relative to as it is not clear from this recitation.
At line 3 of claim 15, it is unclear if “a first rotatable magnetic source” is part of (or different than) “a plurality of rotatable magnetic sources” recited at line 2 of claim 1, from which claim 15 depends. A suggested amendment to line 3 of claim 15 is --a first rotatable magnetic source of the plurality of rotatable magnetic sources--.
At line 4 of claim 15, it is unclear if “a second rotatable magnetic source” is part of (or different than) “a plurality of rotatable magnetic sources” recited at line 2 of claim 1, from which claim 15 depends. A suggested amendment to line 4 of claim 15 is --a second rotatable magnetic source of the plurality of rotatable magnetic sources--.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 5-8, 13, 14, 17, 10 and 21 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Schneider et al. (U.S. Pub. No. 2005/0228209). Regarding claim 1, Schneider et al. (hereinafter Schneider) discloses a method of treating a subject, comprising:
positioning a plurality of rotatable magnetic sources in proximity to a head of the subject (Figs. 2 and 6; [0042], [0046] and [0048]), each rotatable magnetic source being configured to provide a pulsed magnetic field ([0043], [0045], [0053] and [0074]);
selecting a rotation frequency for each rotatable magnetic source of the plurality of rotatable magnetic sources (determined by variables calculated for stepper motor control (as described at [0080]-[0081]; and “selecting a speed of movement of the coil” in claim 9);
selecting a timing pattern for the pulsed magnetic field provided by each rotatable magnetic source of the plurality of rotatable magnetic sources (as described at [0083]-[0084] and with respect to “selecting an inter-pulse interval” of claim 7 and “selecting a duration for applying the current” of claim 6);
operating the plurality of rotatable magnetic sources with the selected rotation frequencies and timing patterns; and applying the pulsed magnetic fields provided by the plurality of rotatable magnetic sources to the head of the subject ([0059], [0076]-[0078] and [0083], and Figs. 6-7) to influence cellular behavior in at least one application area of the head ([0017] and [0009]).
Regarding claim 5, positioning the plurality of rotatable magnetic sources in proximity to the head of the subject includes positioning the plurality of rotatable magnetic sources around the head of the subject (as shown in Fig. 2 and described at [0054]).
Regarding claim 6, positioning the plurality of rotatable magnetic sources in proximity to the head of the subject includes positioning the plurality of rotatable magnetic sources adjacent to the at least one application area (as shown in Figs. 2, 3C and 4 and described at [0054] and [0067]-[0071]).
Regarding claim 7, the rotation frequency for each rotatable magnetic source corresponds to a rate of change of the pulsed magnetic field provided by the rotatable magnetic source [0045].
Regarding claim 8, the timing pattern of each rotatable magnetic source corresponds to a time series arrangement of pulses (“inter-pulse interval” of claim 7) in the pulsed magnetic field provided by the rotatable magnetic source (as described above with respect to claim 1; also see [0074]).
Regarding claims 13 and 14, selecting the timing pattern for the pulsed magnetic field provided by each rotatable magnetic source of the plurality of rotatable magnetic sources includes selecting a rotation pattern for each rotatable magnetic source, wherein the selected rotation pattern is one of a full-waveform pattern or a half-waveform pattern (selection of one or more continuous, orbital paths is considered to be a full-waveform pattern as disclosed at [0013]-[0015]).
Regarding claim 17, Schneider discloses a system for providing treatment to a subject, comprising:
a plurality of rotatable magnetic sources configured to positioned in proximity to a head of the subject (Figs. 2 and 6; [0042], [0046] and [0048]), each rotatable magnetic source being configured to provide a pulsed magnetic field ([0043], [0045], [0053] and [0074]);
at least one memory storing computer-executable instructions; and at least one processor for executing the instructions stored on the memory (Fig. 1, [0048]-[0053]),
wherein execution of the instructions programs the at least one processor to perform operations comprising:
selecting a rotation frequency for each rotatable magnetic source of the plurality of rotatable magnetic sources (determined by variables calculated for stepper motor control (as described at [0080]-[0081]; and “selecting a speed of movement of the coil” in claim 9);
selecting a timing pattern for the pulsed magnetic field provided by each rotatable magnetic source of the plurality of rotatable magnetic sources (as described at [0083]-[0084] and with respect to “selecting an inter-pulse interval” of claim 7 and “selecting a duration for applying the current” of claim 6);
operating the plurality of rotatable magnetic sources with the selected rotation frequencies and timing patterns and applying the pulsed magnetic fields provided by the plurality of rotatable magnetic sources to the head of the subject ([0059], [0076]-[0078] and [0083], and Figs. 6-7) to influence an energy level in at least one application area of the head ([0017], [0018] and [0009]).
Regarding claim 20, the rotation frequency for each rotatable magnetic source corresponds to a rate of change of the pulsed magnetic field provided by the rotatable magnetic source [0045].
Regarding claim 21, the timing pattern of each rotatable magnetic source corresponds to a time series arrangement of pulses (“inter-pulse interval” of claim 7) in the pulsed magnetic field provided by the rotatable magnetic source (as described above with respect to claim 17; also see [0074]).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4, 10-12, 15, 16, 18 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schneider et al. (U.S. Pub. No. 2005/0228209). Regarding claims 2, 4 and 18, while Schneider does not disclose explicitly wherein the at least one application area of the head corresponds to a location of a tumor in the subject's brain, Schneider makes such obvious as Schneider teaches that the at least one application area of the head corresponds to a location of a lesion in the brain ([0067]-[0068]), and one of ordinary skill in the art would readily recognize that a tumor is a type of lesion. Further regarding claim 4 (and in view of its indefinite nature), the application area is exterior to the brain and the target 308 is inside the brain (Fig. 3C and ([0067]-[0068]).
Regarding claim 10, while Schneider does not disclose explicitly wherein each rotatable magnetic source of the plurality of rotatable magnetic sources is configured to provide a pulsed magnetic field having a maximum field strength of at least 1 Tesla, Schneider makes such obvious as Schneider teaches that the method includes determining magnetic field intensities for planning purposes ([0100]-[0101]), wherein the field intensities can be measured up to 2 Teslas [0109], obviating magnetic fields having a maximum field strength of at least 1 Tesla.
Regarding claims 11 and 12, Schneider discloses collecting, via at least one biological sensor, feedback data in response to the application of the pulsed magnetic fields provided by the plurality of rotatable magnetic sources (“monitored data from an EKG can warrant a modification of operational variables” [0084]; the configuration should allow for EEG recording to monitor status or participate in control of the stimulation process” [0062]). While Schneider does not explicitly disclose adjusting the rotation frequency and/or the timing pattern of at least one rotatable magnetic source of the plurality of rotatable magnetic sources based on the feedback data, Schneider makes such obvious as Schneider discloses modifying the operational variables/parameters of the system/method ([0084]-[0086]), wherein such variables are rotation rate and positioning of the sources, for example [0084]-[0087]).
Regarding claim 15, Schneider discloses selecting the timing pattern for the pulsed magnetic field provided by each rotatable magnetic source of the plurality of rotatable magnetic sources (as indicated above with respect to claim 1), however Schneider fails to disclose explicitly that selecting the timing pattern includes selecting a first timing pattern for a first source (of the plurality of sources) and a second timing pattern for a second source (of the plurality of sources) such that the pulsed magnetic field provided by the first rotatable magnetic source is active while the pulsed magnetic field provided by the second rotatable magnetic source is inactive. Schneider makes obvious the limitation of selecting the first timing pattern for the first source and the second timing pattern for the second source, such that the pulsed magnetic field provided by the first source is active while the pulsed magnetic field provided by the second source is inactive, as Schneider teaches that when multiple magnetic sources are present, it is possible to displace the stimulation both in terms of location and in time to permit selective activation of the target(s) [0099], and that when a critical structure should not be targeted, no pulse is emitted [0088]-[0089] to spare critical areas at certain points in the orbital positions of the electromagnets [0068]).
Regarding claim 16, the second timing pattern is interpreted to be out of phase relative to the first timing pattern as when the critical structure is within the target area, no pulse is emitted (as indicated above) and therefore the second timing pattern would be out of phrase with the first timing pattern if no pulse is being emitted ([0088]-[0089]).
Regarding claim 23, while Schneider does not disclose explicitly wherein each rotatable magnetic source of the plurality of rotatable magnetic sources is configured to provide a pulsed magnetic field having a maximum field strength of at least 1 Tesla, Schneider makes such obvious as Schneider teaches that the system is configured to determine magnetic field intensities for planning purposes ([0100]-[0101]), wherein the field intensities can be measured up to 2 Teslas [0109], obviating magnetic fields having a maximum field strength of at least 1 Tesla.
17. Claims 3 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schneider et al. (U.S. Pub. No. 2005/0228209) in view of Zangen et al. (U.S. Pub. No. 2004/0078056). Regarding claims 3 and 19, Schneider teaches stimulation of the at least one application area of the head corresponding to a location of an abnormality (“target lesion 308”) of the subject's brain ([0067]-[0068]), however Schneider fails to disclose explicitly that the lesion is in a blood vessel. Zangen et al. (hereinafter Zangen) teaches a magnetic stimulator for providing TMS to the brain of a subject, useful in treating and studying neurophysiological conditions associated with the brain of a subject (see Abstract), as likewise disclosed by Schneider, wherein the application area corresponds to an area of blood flow (such as a blood vessel) through the brain of the subject [0088]. At the time the invention was made, it would have been obvious to one of ordinary skill in the art to have targeted a blood vessel for stimulation, as taught by Zangen, in a method for treating a lesion in a brain as suggested by Schneider, as Schneider recognizes that magnetically stimulating certain lesions/target areas in the brain alleviate neurological disorders ([0002], [0011] and [0043]-[0045]) and Zangen teaches that such lesions or targets areas may be associated with conditions related to blood flow or blockages in a blood vessel [0088].
18. Claims 9 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schneider et al. (U.S. Pub. No. 2005/0228209) in view of Souder (U.S. Patent No. 6,001,055). Regarding claims 9 and 22, Schneider teaches the invention as claimed, see rejection supra; however Schneider fails to disclose that selecting the rotation frequency for each rotatable magnetic source of the plurality of rotatable magnetic sources includes selecting a rotation frequency over 50 Hz. Souder teaches a magnetic therapy device for providing magnetic stimulation to various areas of the body, wherein the magnetic source may be rotated, oscillated or moved through a particular pattern relative to the treatment area and the specific region of interest to influence therapeutic benefit (see Abstract; col. 1, lines 16-50). Souder further teaches that the rate of change of the magnetic field may be varied by varying the speed of the motor which rotates the magnetic source (col. 1, lines 48-50), and further that a range of rotation frequencies may be selected, up to 8000 revolutions per minute (the equivalent of 133 Hz) (col. 8, lines 18-33). At the time the invention was made, it would have been obvious to one of ordinary skill in the art to select a rotation frequency over 50 Hz as taught by Souder, in a method/system for treating a subject with magnetic stimulation to influence cellular behavior as suggested by Schneider, as Schneider recognizes that certain parameters related to the application of energy may be varied to effect appropriate pulses based on positioning of the magnetic sources, such as rate of rotation/speed of the source ([0079]-[0084]), wherein the magnetic sources can be moved at fairly high speeds [0081], and Souder teaches that such high speeds may be selected, up to 8000 revolutions per minute (the equivalent of 133 Hz) (col. 8, lines 18-33).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791