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 .
Election/Restrictions
Applicant’s election without traverse of Species B, sub-species IX (Claim 20) in the reply filed on 04/07/2026 is acknowledged.
Presently, Claims 16, 20 and 23 - 24 remain pending and are hereinafter examined on the merits. Claims 1 - 15, 17 - 19, 21 – 22 and 25 - 85 are withdrawn.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16, Line 6 recites “a normalized acoustic pressure profile”, which should be changed to “the normalized acoustic pressure profile”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16, 20 and 23-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16, Lines 13-15, recites “an average pressure across the volumetric free field that is in a range of 1% - 200% across each ultrasound array”. The recited limitation is not supported by Specification. Specification, Para 0024 specifies “… produce an average pressure across the volumetric free field that is in a range of 10-200%”, which is different from the claimed “1% - 200%”.
Claims 20 and 23-24 are also rejected under 35 U.S.C. 112(a) because they inherit the deficiencies of the claim(s) they respectively depend upon.
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 16, 20 and 23-24 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 16, Lines 13-15, recites “an average pressure across the volumetric free field that is in a range of 1% - 200% across each ultrasound array”. It is unclear which parameters or measurements the recited “1% - 200%” is relative to. For present purposes of examination, the underlined phrase is interpreted to refer to “a range of 1% - 200% of the peak pressure”.
Claims 20 and 23-24 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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 16 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Tosaya et al (US 20040049134 A1; hereafter Tosaya), in view of Song et al (IEEE Trans Biomed Eng 57(1); 124-133; 2010; hereafter Song), and further in view of Wilcox (US 20100022944 A1; hereafter Wilcox).
With regard to Claim 16, Tosaya discloses an ultrasound transducer system (Tosaya, Para 0206; “Turning now to FIG. 3, we see in schematic diagram a helmet 22 equipped with closely juxtaposed transducers 25, which is connected to a therapy system 21”. The disclosed helmet 22, transducers 25 and therapy system 21 combine to correspond to the claimed ultrasound transducer system) configured to produce a normalized acoustic pressure profile (Tosaya, Para 0197; “any acoustic emission cycle which avoids most or all of the following may provide benefit using the invention: …, and (3) avoid high peak acoustic pressures above 7 megapascals …”. The disclosed avoiding high peak acoustic pressures corresponds to the claimed producing of normalized acoustic pressure profile) for activating a sonosensitizer in conjunction with providing sonodynamic therapy (Tosaya, Abstract; “The system employs acoustic exposure therapy means for delivering therapeutic energy to at least one brain region … may be used in cooperation with a drug.”; Para 0205; “The microparticulate of microbubble may also release a drug payload via leakage or rupture, the drug being a drug(s) of the invention herein.” The disclosed microbubble can be activated by acoustic pressure, and is used in cooperation with the disclosed acoustic exposure therapy), the ultrasound transducer system comprising:
a plurality of ultrasound arrays (Tosaya, Page 25, Column 2, Line 24; “multiple emitters are employed”), each ultrasound array of the plurality of ultrasound arrays comprising a housing (Tosaya, Page 25, Column 2, Lines 35-36; “emitter housing or holder”) comprising a plurality of ultrasonic transducer elements (Tosaya, Page 25, Column 2, Lines 26-27; “at least one emitter comprises multiple acoustic subelements”) configured to generate a normalized acoustic pressure profile (Tosaya, Para 0197; “any acoustic emission cycle which avoids most or all of the following may provide benefit using the invention: …, and (3) avoid high peak acoustic pressures above 7 megapascals …”) for activating a sonosensitizer located within a target tissue of patient (Tosaya, Para 0205; “… one may introduce a contrast agent or microparticulate into the vascular system that molecularly targets AD neural plaques. After the agent has chemically attached to the plaque, ultrasound is introduced, which causes the contrast agent bubbles to resonate on the plaque, providing high-energy erosion of the plaque, possibly in addition to drug-related breakdown mechanisms.”),
wherein the normalized acoustic pressure profile comprises:
a peak pressure (Tosaya, Para 0197; “… avoid high peak acoustic pressures above 7 megapascals”);
wherein the plurality of ultrasonic transducer elements is driven by one or more of:
a modulated phase across the plurality of ultrasonic transducer elements (Tosaya, Para 0188; “The system may also be capable of applying time or phase delays between the firing of individual transducers or transducer elements.”), and
a modulated frequency across the plurality of ultrasonic transducer elements (Tosaya, Para 0188; “The attenuation of the beam versus depth for each transducer can be affected by varying the output frequency in a known manner. Doing this one could have a particular transducer treat only near-in tissues (at higher frequency) or treat tissues all the way to the opposite side of the skull (at lower frequency).”),
wherein the plurality of ultrasonic transducer elements in the plurality of ultrasound arrays comprises a planar emitting surface configured to emit an acoustic wave (Tosaya, Para 0186; “Emitters such as 15 and 18 could also be flat transducers …”), wherein the acoustic wave is a defocused acoustic wave or an unfocused acoustic wave (Tosaya, Page 20, Column 2, Lines 17-20; “… output from said at least one emitter is at least one of focused, collimated, weakly focused, unfocused, diffused, diffuse, defocused, beamformed, steered or wiggled in any manner”).
Tosaya does not clearly and explicitly disclose
a volumetric free field; and
an average pressure across the volumetric free field;
wherein the normalized acoustic pressure profile is configured to provide for a consistent average pressure across the volumetric free field, and
wherein the normalized acoustic pressure profile is configured to produce an average pressure across the volumetric free field that is in a range of 1% - 200% across each ultrasound array.
Song in the same field of endeavor discloses a volumetric free field (Song, Page 125, Column 2, Para 3; “A 45 x 50 x 120 cm3 water tank was lined with anechoic rubber to minimize any acoustic reflections from the tank walls.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tosaya, as suggested by Song, in order to use a volumetric free field in quantifying acoustic pressure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of obtaining a consistent measurement by minimizing any acoustic reflections.
Tosaya and Song do not clearly and explicitly disclose
an average pressure;
wherein the normalized acoustic pressure profile is configured to provide for a consistent average pressure across the volumetric free field, and
wherein the normalized acoustic pressure profile is configured to produce an average pressure across the volumetric free field that is in a range of 1% - 200% across each ultrasound array.
Wilcox in the same field of endeavor discloses
an average pressure (Wilcox, Para 0092; “the average acoustic pressure can be between … about 0.5 or 0.74 to 1.7 MPa”);
wherein the normalized acoustic pressure profile is configured to provide for a consistent average pressure across the volumetric free field (Specification, Para 0024 discloses “a consistent average pressure” to be “in a range of 10-200%”. As discussed in the next feature, Wilcox discloses a ratio of average over peak pressure of 10%-142%, which is in the claimed range of 10%-200%), and
wherein the normalized acoustic pressure profile is configured to produce an average pressure across the volumetric free field that is in a range of 1% - 200% across each ultrasound array (Wilcox, Para 0096; “The ultrasound radiating member 77 is capable of generating a peak acoustic pressures … that are more preferably between about 1.2 MPa and about 6 MPa.”. For the disclosed peak pressure of 1.2 - 6 MPa, the above disclosed average pressure of 0.5~0.74 – 1.7 MPa is about 10% - 142% of the peak pressure, which is within the claimed range of 1%-200%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tosaya and Song, as suggested by Wilcox, in order to quantify average acoustic pressure and limit the ratio of average over peak pressure in a range. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding burning or damage to tissue by limiting the peak acoustic pressure or intensity using an objective measure of peak over mean ratio (Wilcox, Para 0106; “because the ultrasound energy must pass through the sternum 206, ribs 210 and/or chest wall before reaching the heart 202, relatively high levels of ultrasound energy generally must be delivered for a sufficient amount of ultrasound energy to reach the exposed portions of the heart 202 and coronary vasculature 204. However, using high levels of ultrasound energy can cause burning or damage to tissue.”).
With regard to Claim 23, Tosaya, Song and Wilcox discloses the ultrasound transducer system of Claim 16. Tosaya further discloses wherein a control algorithm is configured to produce a unique phase drive pattern for each element in the ultrasound array (Tosaya, Para 0188; “The system may also be capable of applying time or phase delays between the firing of individual transducers or transducer elements.”; Para 0209; “… adjacent power supplies 26, may include any switching, amplification or phase-delay hardware/software utilized to fire the transducers singly …” The disclosed transducers or elements can be individually controlled with regard to their phase, so would have unique phase drive pattern as claimed).
With regard to Claim 24, Tosaya, Song and Wilcox discloses the ultrasound transducer system of Claim 16. Tosaya further discloses wherein the acoustic wave is amplitude modulated, frequency modulated, phase modulated, continuous, discontinuous, pulsed, randomized, or combinations thereof (Tosaya, Para 0196; “We include in the scope of the invention both pulsed and continuous wave operation (CW operation)”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tosaya, Song and Wilcox, further in view of Seppi (US 4875487 A; hereafter Seppi) and Hutchinson et al (US 6135971 A; hereafter Hutchinson).
With regard to Claim 20, Tosaya, Song and Wilcox discloses the ultrasound transducer system of Claim 16. Tosaya further discloses removing patterns that produce an unintended coherence between one or more elements (Tosaya, Para 0082; “… slight phase delays can be applied between adjacent transducers … we are preferably not forming a “focus” nor moving a beam-formed “focus” in the conventional sense of thermal-ablation ultrasound of ultrasound imaging wherein large focal gain is a primary goal”. Here the disclosed “slight phase delays” between adjacent transducers is equivalent to removing phase patterns that are same for adjacent transducers, and the aim is not to focus but to evenly fill a large region of tissue), thereby attenuating peak pressure locations to result in a more uniform field that can be driven to produce a larger therapeutic volume (Tosaya, Para 0082; “These transducers have broad coverage. Our therapy modes can preferably all be delivered without beam-steering in an effort to offer a simple inexpensive solution. Ideally, our transducers can deliver constant power density vs. tissue depth taking into account attenuation. Thus large brain volumes can receive a relatively uniform power density using only slight focusing. The aim is to treat uniformly with minimal or no scanning whatsoever.”).
Tosaya, Song and Wilcox do not clearly and explicitly disclose wherein a random phase drive pattern is configured to be filtered.
Seppi in the same field of endeavor discloses a random phase drive pattern (Seppi, Column 4, Line 67 – Column 5, Line 3 ; “… the electric energy applied to the transducers is randomly angle (i.e., frequency or phase) modulated, which randomly frequency or phase shifts the array compressional wave energy to cause the derivation of spatially incoherent beams.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tosaya, Song and Wilcox, as suggested by Seppi, in order to randomize phases of the different transducers. One of ordinary skill in the art would have been motivated to make the modification for the benefit of creating incoherent beams so as to distribute acoustic energy across a large region of tissue and at the same time reduce the risk of tissue injury (Seppi, Column 5, Lines 3-7; “The spatially incoherent beams from the different transducers spread the beam energy in the treated region, so that abrupt edges of spatially adjacent beams from the individual transducers are avoided.”).
Tosaya, Song, Wilcox and Seppi discussed above do not clearly and explicitly disclose further filtering or selecting randomized phases of transducers.
Hutchinson in the same field of endeavor discloses further filtering or selecting randomized phases of transducers (Hutchinson, Column 9, Line 65 – Column 10, Line 4; “The optimization technique used here involved the calculation of a cost function for different random distributions of two element widths. For each pair of element widths, a sufficient number of random distributions were simulated to evaluate the utility of the element pair, and the distribution with the lowest cost function was selected.” The disclosed “random distributions” of elements would lead to random phases, and optimization is further applied to select the optimal distributions). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tosaya, Song, Wilcox and Seppi, as suggested by Hutchinson, in order to further select optimal distributions of elements. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving desired distribution of acoustic pressure or energy across tissue region of interest.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Hynynen et al (Phys. Med. Biol. 61 (2016) R206 - R248) discloses using ultrasound phased array for therapy, particularly multiple approaches for optimizing acoustic field for different purposes such as aberration correction and multiple-foci generation.
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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