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 .
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 1 - 8 are objected to because of the following informalities:
Claim 1, line 8, “within range” should read –within a range--.
Claims 2 - 4, line 1, "the excitation waveform comprises" should read --the excitation waveform signal comprises--.
Claim 6, lines 2 and 3, "excitation waveform comprises" should read --excitation waveform signal comprises--.
Claims 2 - 8, line 1, "The method of claim [#] wherein" should read --The method of claim [#], wherein--.
Claim 7, line 2, "excitation waveform comprises" should read --excitation waveform signal comprises--.
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 1 – 8 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 1 recites the limitation "the acoustic transducers" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1, line 8, “within range” is unclear as it raises the question whether “range” refers to distance or a numerical range.
Claim 1, line 9, “of the two transducers” is unclear as it raises the question which transducers are being referred to.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “substantially” in claim 1 is unclear as it raises the question what does that entail.
Claim 6 recites the limitation "the focused radiation force" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6, line 4, "between the transducers" is unclear as it raises the question which "transducers".
Claim 7, lines 2- 3, “exciting the two ultrasound transducers with the excitation waveform at different times” is unclear as it raises the question if “different times” refer to the two transducers each being excited separately or together at different times.
Claim 7 recites the limitation "the focused radiation force" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7, line 4, "between the transducers" is unclear as it raises the question which "transducers".
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 – 7 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”).
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 the acoustic transducers (“Ultrasound (or RF) source 104 focuses the ultrasound (or RF) 106, 108 at locations 110 and 114.” [0033], [0035]);
exciting two ultrasound transducers (“Ultrasound transducers 251, 252” [0040] Figure 2B) using the excitation waveform signal ([0033], [0035]) to produce acoustic outputs ([0033], [0035]) comprising substantially coincident focus regions ([0040] Figure 2B) resulting in a pattern interference 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]).
Deisseroth does not teach the excitation waveform signal has a time-varying frequency within range containing a resonance frequency of the two transducers.
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]).
Regarding claim 2, Deisseroth and Tosaya teach all limitations of claim 1. The modified invention of Deisseroth and Tosaya 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 and Tosaya teach all limitations of claim 1. The modified invention of Deisseroth and Tosaya teaches exciting the two ultrasound transducers (Deisseroth: “Ultrasound transducers 251, 252” [0040] Figure 2B) using the excitation waveform comprises
exciting the two ultrasound transducers (Deisseroth: “Ultrasound transducers 251, 252” [0040] Figure 2B) with the excitation waveform 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 radiation force (Deisseroth: [0040] Figure 2B) is centered between the transducers (Deisseroth: [0040] Figure 2B).
Regarding claim 7, Deisseroth and Tosaya teach all limitations of claim 1. The modified invention of Deisseroth and Tosaya teaches exciting the two ultrasound transducers (Deisseroth: “Ultrasound transducers 251, 252” [0040] Figure 2B) using the excitation waveform comprises
exciting the two ultrasound transducers with the excitation waveform at different times (Deisseroth: “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 controlled delay (Deisseroth: “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]),
whereby a position of the focused radiation force between the transducers is selected (Deisseroth: “arrives at the target location” [0046]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth and Tosaya, as applied in claim 2, in view of Konofagou et al (US 20130131495 A1, hereinafter “Konofagou”).
Regarding claim 3, Deisseroth and Tosaya teaches all limitations of claim 2. The modified invention of Deisseroth and Tosaya 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 and Tosaya 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 and Tosaya, as applied in claim 1, in view of Mcmahon et al (US 20210275056 A1; filed 2017-09-19, hereinafter “Mcmahon”).
Regarding claim 4, Deisseroth and Tosaya teach all limitations of claim 1. The modified invention of Deisseroth and Tosaya 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 and Tosaya 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 and Tosaya, as applied in claim 1, in view of Tyler (US 20120289869 A1).
Regarding claim 5, Deisseroth and Tosaya teach all limitations of claim 1. The modified invention of Deisseroth and Tosaya 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 and Tosaya 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 and Tosaya, as applied in claim 7, in view of Brisken et al (US 6575956 B1, hereinafter “Brisken”).
Regarding claim 8, Deisseroth and Tosaya teach all limitations of claim 7. The modified invention of Deisseroth and Tosaya teaches the controlled delay is varied to scan a position of the focused 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 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 and Tosaya 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weng et al (US 20010031922 A1, hereinafter “Weng”) discloses “devices and methods for modulating brain activity using ultrasound, particularly devices and methods that provide ultrasound wavelengths to neural tissues” (abstract).
Mishelevich (US 20110112394 A1) discloses “methods and systems for non-invasive deep brain or superficial neuromodulation for up-regulation or down-regulation using ultrasound” (abstract).
Emery et al (US 20110112400 A1) discloses “catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access” (abstract).
Alford et al (US 20160243381 A1) discloses “devices, systems, and techniques for reducing neural degeneration within a brain of a patient” (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791