DETAILED ACTION
This Office Action is responsive to the Amendment filed 11 June 2026. Claims 1 -6 and 8 are now pending. The Examiner acknowledges the amendments to claims 1 – 6 and 8, as well as the cancellation of claim 7.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 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 8 is dependent on claim 7. Examiner suggests amending claim 8 to depend on claim 1.
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.
Claims 1 – 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth et al (US 20090112133 A1, hereinafter “Deisseroth”) in view of Tosaya et al (US 20050020945 A1, hereinafter “Tosaya”) in view of Li et al (US 20180001114 A1, hereinafter “Li”) in view of Vortman et al (US 20040122323 A1, hereinafter “Vortman”) in view of Menz et al (2017; NPL: U).
Regarding claim 1, Deisseroth teaches a method for transcranial focused ultrasound neuromodulation ([0012]) comprising:
generating an excitation waveform signal ([0033], [0035]) with a controller (“Ultrasound (or RF) source 104” [0033] Figure 1) configured to control operation of two ultrasound transducers (“Ultrasound transducers 251, 252” [0040] Figure 2B) ;
exciting the two ultrasound transducers (“Ultrasound transducers 251, 252” [0040] Figure 2B) using the excitation waveform signal ([0033], [0035]) to produce acoustic outputs ([0033], [0035]) comprising coincident focus regions ([0040] Figure 2B; [0035]) resulting in a focused radiation force between the two ultrasound transducers (251, 252) (“In one instance, each transducer can be individually calibrated so as to focus the ultrasound waves at the desired location.” [0035]; “Control 104 can then alter the phase of each transducer such that the ultrasound waves provide constructive interference rather than destructive interference so as to increase the effectiveness of the delivered ultrasound energy.” [0035]),
wherein exciting the two ultrasound transducers (251, 252) using the excitation waveform signal ([0033], [0035]) comprises exciting each of the two ultrasound transducers with the excitation waveform signal at different times from each other (“The delay from the time that the ultrasound wave is first transmitted to the time the ultrasound wave arrives at the target location may vary from transducer to transducer (e.g., due to differences in the location and orientation of the transducers).” [0046]), separated by a delay (“The delay from the time that the ultrasound wave is first transmitted to the time the ultrasound wave arrives at the target location may vary from transducer to transducer (e.g., due to differences in the location and orientation of the transducers).” [0046]; [0035]),
whereby a position of the focused radiation force between the two ultrasound transducers is selected (“arrives at the target location” [0046]; [0028], [0039]).
Deisseroth does not teach a focused pattern interference radiation force, the two ultrasound transducers are positioned to face each other in diametrically opposed configuration along a single axis, the excitation waveform signal has a time-varying frequency within range containing a resonance frequency of the two transducers, and a controlled delay.
However, Tosaya discloses “acoustically, ultrasonically or vibrationally-aided therapies for patients with, or with potential for developing, neurologically degenerative diseases.” (abstract) and teaches an excitation waveform signal has a time-varying frequency within range containing a resonance frequency (“chirped operation and multitone or broadband operation (known in the ultrasound arts) as well as customized operation for a given patients skull/brain anatomical system” [0074] [0101]; Examiner interprets “chirped operation” as a time-varying signal within a range.) of two transducers (“a pair of acoustic transducers 8” [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth such that the excitation waveform signal has a time-varying frequency within range containing a resonance frequency of the two transducers, as taught by Tosaya, for the benefit of “providing therapy to a patient having, or who may potentially develop, a neurodegenerative disease” (Tosaya: [0025]).
The modified invention of Deisseroth and Tosaya does not teach a focused pattern interference radiation force, the two ultrasound transducers are positioned to face each other in diametrically opposed configuration along a single axis and a controlled delay.
However, Li discloses an “apparatus and method for automatically lysing a clot to recanalize vessels using ultrasound” (abstract) and teaches the two ultrasound transducers (“one or more transducers 15”, [0069], [0073]) are positioned to face each other in diametrically opposed configuration along a single axis (Figure 1, [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth and Tosaya such that the two ultrasound transducers are positioned to face each other in diametrically opposed configuration along a single axis, as taught by Li, for the benefit of provide the desired therapeutic effect for the patient (Li: [0010], [0015]).
The modified invention of Deisseroth, Tosaya and Li does not teach a focused pattern interference radiation force and a controlled delay.
However, Vortman discloses “system for focusing ultrasonic energy through intervening tissue into a target site within a tissue region includes a transducer array including transducer element” (abstract) and teaches a controlled delay (“The corrected propagation times for each of the transducer elements 16 may be provided to a processor, such as the controller 20 coupled to the transducer 14 or the system image and display computer 40 (not shown, see FIG. 1), to determine corrective time delays for excitation signals delivered to each respective transducer element 16 such that the collective acoustic energy transmitted by the transducer 14 constructively interferes at the focal zone P1.” [0087]; [0071], [0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth, Tosaya and Li to incorporate a controlled delay, as taught by Vortman, for the benefit of providing “constructively interferes at the focal[/desired] zone” (Vortman: [0083]) for treatment of the patient.
The modified invention of Deisseroth, Tosaya, Li and Vortman does not teach a focused pattern interference radiation force.
However, Menz discloses ultrasonic neuromodulation includes stimulation that could reach deep in the brain with high spatial-temporal resolution (abstract) and teaches a focused pattern interference radiation force (abstract; page 5 paragraph 4; page 7 paragraph 3; page 14 paragraph 2; page 16 paragraphs 5 - 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth, Tosaya, Li and Vortman to incorporate a controlled delay, as taught by Menz, for the benefit of modulating effects (Menz: abstract) for patient treatment.
Regarding claim 2, Deisseroth, Tosaya, Li, Vortman and Menz teach all limitations of claim 1. The modified invention of Deisseroth, Tosaya, Li, Vortman and Menz teaches the excitation waveform comprises a chirp waveform (Tosaya: “chirped operation and multitone or broadband operation (known in the ultrasound arts) as well as customized operation for a given patients skull/brain anatomical system” [0074] [0101]).
Regarding claim 6, Deisseroth, Tosaya, Li, Vortman and Menz teach all limitations of claim 1. The modified invention of Deisseroth, Tosaya, Li, Vortman and Menz teaches exciting the two ultrasound transducers (Deisseroth: “Ultrasound transducers 251, 252” [0040] Figure 2B) using the excitation waveform signal comprises
exciting the two ultrasound transducers (Deisseroth: “Ultrasound transducers 251, 252” [0040] Figure 2B) with the excitation waveform signal simultaneously (Deisseroth: “Ultrasound transducers 251, 252, 253, 254 and 255 contribute to the total energy” [0040] Figure 2B; Examiner interprets the transducers contribute energy simultaneously.),
whereby the focused pattern interference radiation force (Deisseroth: [0040] Figure 2B) is centered between the two ultrasound transducers (Deisseroth: [0040] Figure 2B).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth, Tosaya, Li, Vortman and Menz, as applied in claim 2, in view of Konofagou et al (US 20130131495 A1, hereinafter “Konofagou”).
Regarding claim 3, Deisseroth, Tosaya, Li, Vortman and Menz teaches all limitations of claim 2. The modified invention of Deisseroth, Tosaya, Li, Vortman and Menz does not teach the chirp waveform comprises a linear chirp waveform.
However, Konofagou discloses “systems and methods for targeting tissue structures and applying ultrasound” (abstract) and teaches a chirp waveform comprises a linear chirp waveform (“linear chirps” [0048], [0054] Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth, Tosaya, Li, Vortman and Menz such that the chirp waveform comprises a linear chirp waveform, as taught by Konofagou, for the benefit of acquiring the necessary targeted tissue structure image data (Konofagou: [0038], [0051]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth, Tosaya, Li, Vortman and Menz, as applied in claim 1, in view of Mcmahon et al (US 20210275056 A1; filed 2017-09-19, hereinafter “Mcmahon”).
Regarding claim 4, Deisseroth, Tosaya, Li, Vortman and Menz teach all limitations of claim 1. The modified invention of Deisseroth, Tosaya, Li, Vortman and Menz does not teach the excitation waveform comprises a chirp-up waveform and a chirp-down waveform.
However, Mcmahon discloses “Methods and devices provide physiological movement detection with active sound generation” (abstract) and teaches a excitation waveform comprises a chirp-up waveform and a chirp-down waveform (“sawtooth chirps, triangular chirps” [0069]; Examiner interprets “sawtooth chirps, triangular chirps” include “a chirp-up waveform and a chirp-down waveform”.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth, Tosaya, Li, Vortman and Menz such that the excitation waveform comprises a chirp-up waveform and a chirp-down waveform, as taught by Mcmahon, for the benefit of using acoustic sensing to detect physiological movement (Mcmahon: [0002]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth, Tosaya, Li, Vortman and Menz, as applied in claim 1, in view of Tyler (US 20120289869 A1).
Regarding claim 5, Deisseroth, Tosaya, Li, Vortman and Menz teach all limitations of claim 1. The modified invention of Deisseroth, Tosaya, Li, Vortman and Menz does not teach the time-varying frequency varies within the range 300-700 kHz.
However, Tyler discloses “devices and methods for modulating brain activity using ultrasound, particularly devices and methods that provide ultrasound wavelengths to neural tissues” (abstract) and teaches a time-varying frequency varies within the range 200 - 700 kHz (“0.2 and 0.7 MHz” [0043]; Examiner interprets frequencies of the transducer may be expected to be between .2 MHz and .7 MHz which equates to 200 - 700 kHz.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify frequency of the method of Deisseroth, Tosaya, Li, Vortman and Menz such as a range of 200 - 700 kHz, as taught by Tyler, for the benefit of providing effective ultrasound therapy to neural tissue for continuous or short term applications (Tyler: [0005]). It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” See MPEP 2144.05(I). Furthermore, applicant appears to have placed no criticality on the claimed range.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth, Tosaya, Li, Vortman, Menz and Tyler, as applied in claim 7, in view of Brisken et al (US 6575956 B1, hereinafter “Brisken”).
Regarding claim 8, Deisseroth, Tosaya, Li, Vortman, Menz and Tyler teach all limitations of claim 7. The modified invention of Deisseroth, Tosaya, Li, Vortman, Menz and Tyler teaches the controlled delay is varied to scan a position of the focused pattern interference radiation force.
However, Brisken discloses a “wide beam ultrasound delivery system providing a uniform exposure field” and teaches a controlled delay is varied to scan a position of a focused pattern interference radiation force (“each of ultrasound elements 281, 282, 283, etc. are preferably individually controlled with a dedicated time delay and power amplifier such that the phases of the signals of each of elements 281, 282, 283, etc., could be adjusted to direct a shaped composite ultrasound beam to a specific location within the patient's body” column 16 lines 19 - 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Deisseroth, Tosaya, Li, Vortman, Menz and Tyler such that the controlled delay is varied to scan a position of the focused radiation force, as taught by Brisken, for the benefit of directing to a specific location within the patient’s body (Brisken: column 16 lines 19 - 26).
Response to Arguments
Applicant’s arguments, see page 4, filed 11 June 2026, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections of 12 January 2026 have been withdrawn.
Applicant’s arguments, see page 4, filed 11 June 2026, with respect to 35 U.S.C. 112 rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C. 112 rejections of 12 January 2026 have been withdrawn.
Applicant’s arguments with respect to claim(s) 1 – 6 and 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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