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 Group I, Species A, and Subspecies II in the reply filed on 08/07/2025 is acknowledged.
Claims 3-4, 14-17, 20-21, 33-37, and 62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-V, Species B, and Subspecies I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/07/2025.
Claim Objections
Claims 1, 8, 11-13, 18-19, and 30 are objected to because of the following informalities:
Claim 1 recites the limitation of “an ultrasound source such that the amplitude and phase” in lines 7-8; however, the limitation should read “the ultrasound source such that an amplitude and phase” since the ultrasound source limitation has been introduced before and the amplitude and phase limitation has not been introduced before.
Claim 8 recites the limitation of “to the acoustic impedance” in line 3; however, the limitation should read “to an acoustic impedance” since the acoustic impedance of the transmission medium limitation has not been introduced before.
Claim 11 recites the limitation of “have the same cross-sectional shape” in line 1; however, the limitation should read “have a same cross-sectional shape” since the same cross-sectional shape limitation has not been introduced before.
Claims 12-13 recite the limitation of “the wavelength” in lines 2-3; however, the limitation should read “a wavelength” since the wavelength limitation has not been introduced before.
Claims 18-19 recite the limitation of “the average pitch … the wavelength” in lines 1-3; however, the limitation should read “an average pitch … a wavelength” since the average pitch and the wavelength limitations have not been introduced before.
Claim 30 recites the limitation of “tumour… tumours” in lines 1-2, however, the limitation should read “tumor… tumors”.
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 25 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 25 recites the limitation “the other of amplitude or phase of ultrasound at the target” in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is the other, does the other refer to the unused one of “amplitude or phase” in the first selection, or based on another instance of “phase or amplitude”. The examiner is interpreting the limitation as selecting the lengths and cross-sections of the waveguides in the first layer and the second layer based on a desired one of amplitude or phase of ultrasound at the target.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 12-13, 18-19, 26-29, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez Gonzalez et al. (WO 2020/084181, however, the US 2021/0396712 is used for citation clarity purposes), hereinafter Gonzalez.
Regarding claim 1, Gonzalez teaches a method of designing a beam shaping device for shaping an ultrasound beam from an ultrasound source, the beam shaping device comprising an array of waveguides formed in a structure that is capable of reflecting ultrasound, the method comprising (paras. 0058 and 0066; the method according to the invention, intended for obtaining a lens which allows the modification of the ultrasound beam such that the resulting ultrasound field has a sufficient intensity in a volume which coincides with the treatment area. This lens 2 comprises a plurality of fragments 21 which are responsible for making the necessary corrections in the ultrasound beam to establish the desired pattern, centered on the previously defined treatment area.):
determining a desired shape of the ultrasound beam at a target (paras. 0009-0015, 0021-0022, and 0059-0062; providing a bone tissue model, a soft tissue model surrounded by the bone tissue, and a coupling medium model; choosing a source point situated inside the coupling medium model; choosing a predetermined wave frequency and wavelength, the predetermined frequency being comprised between 100 kHz and 20 MHz and the predetermined wavelength being determined by the predetermined frequency and a velocity of propagation of the wave in the coupling medium model; providing a treatment volume situated inside the bone tissue model; providing a plurality of nodes distributed inside the treatment volume; simulating the emission of a spherical wave from each of the nodes of the plurality of nodes, creating a simulated wave front resulting from the superposition of the spherical waves, each spherical wave requiring an amplitude and a phase, there being at least two nodes with different amplitudes and/or phases, each spherical wave having the predetermined frequency. The predetermined frequency is chosen before starting the method, primarily due to treatment criteria. Said predetermined frequency is set and will be used for simulating the waves starting from the nodes. On the basis of said frequency and the velocity of the wave in the soft tissue model, the wavelength can be calculated, resulting from dividing the velocity of propagation of the wave in the soft tissue model by the frequency. The examiner notes that the desired beam shape is determined based on the frequency, wavelength, and the treatment volume to simulate the desired beam shape.);
selecting lengths and cross-sections of the waveguides of the array based on the desired shape of the ultrasound beam and on an ultrasound field produced by an ultrasound source such that the amplitude and phase of the ultrasound emitted from the waveguides of the array provides the desired shape of the ultrasound beam at the target (paras. 0025-0026 and 0061-0066; This simulated wave front is received on the receiving surface 8 which contains the source point 6. The wave front received on this receiving surface 8 is analyzed and in this case, said receiving surface is divided into 1 mm×1 mm pixels. Once the data of the wave front received in each of the pixels of the receiving surface have been collected and processed, it is possible to design a lens surface, by means of methods such as the calculation of the Fabry-Perot resonator, equivalent heights for each fragment of the lens corresponding to each pixel into which the receiving surface has been divided being chosen. Each of these fragments 21 corresponds to a column of the previously described model, the base of each column has the size of one pixel and the height of each column corresponds with the previously indicated Fabry-Pérot resonator. The step of processing the results received comprises dividing the receiving surface into pixels and analyzing the amplitude and phase of the wave received in each pixel. In particular embodiments, the pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. Each pixel of the receiving surface is considered as a Fabry-Pérot type resonator which can resonate longitudinally, giving rise to a fragment of the lens, and in the step of designing the holographic lens surface equivalent heights are chosen for each fragment of the lens based on the amplitude and phase of the waves received in each pixel of the receiving surface. The examiner notes that the length (height) and the cross section (pixel size) are chosen based on the simulated wave front (desired beam shape) such that each fragment modulate the amplitude and phase of the desired beam.).
Regarding claim 12, Gonzalez teaches the method of claim 1, wherein a smallest cross-sectional dimension of each waveguide is in a range with a maximum value of λ, where λ is the wavelength of the ultrasound from the ultrasound source in the waveguide (para. 0025; the pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. The examiner notes that the cross section of the waveguide is the base of the column (size of one pixel) is 5λ/6 which is in range with a maximum value λ, which falls within the range defined in the claim).
Regarding claim 13, Gonzalez teaches the method of claim 1, wherein a smallest cross-sectional dimension of each waveguide is in a range with a minimum value of 0.6 λ, where λ is the wavelength of ultrasound from the ultrasound source in the waveguide (paras. 0025 and 0066; the pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. Each of these fragments 21 corresponds to a column of the previously described model, the base of each column has the size of one pixel and the height of each column corresponds with the previously indicated Fabry-Pérot resonator. The examiner notes that the cross section of the waveguide is the base of the column (size of one pixel) is 5λ/6 which is in a range with a minimum value 0.6λ, which falls within the range defined in the claim).
Regarding claim 18, Gonzalez teaches the wherein the average pitch is in a range with a maximum value of 2λ, or with a maximum value of 1.5λ, or with a maximum value of 1.2λ, where λ is the wavelength of ultrasound from the ultrasound source in the waveguide (paras. 0025 and 0066; Each of these fragments 21 corresponds to a column of the previously described model, the base of each column has the size of one pixel and the height of each column corresponds with the previously indicated Fabry-Pérot resonator. The pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. The examiner notes that each waveguide is a square column and pitch of the waveguide equals the waveguide cross section (pixel size) because the columns are arranged with no gaps. Thus, 5λ/6 average pitch is in range with a maximum value of 2λ, or a maximum value of 1.5λ, or a maximum value of 1.2λ.).
Regarding claim 19, Gonzalez teaches the wherein the average pitch is in a range with a minimum value of 0.7λ, or with a maximum value of λ, or with a maximum value of 1.1λ, where λ is the wavelength of ultrasound from the ultrasound source in the waveguide (paras. 0025 and 0066; Each of these fragments 21 corresponds to a column of the previously described model, the base of each column has the size of one pixel and the height of each column corresponds with the previously indicated Fabry-Pérot resonator. The pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. The examiner notes that each waveguide is a square column and pitch of the waveguide equals the waveguide cross section (pixel size) because the columns are arranged with no gaps. Thus, 5λ/6 average pitch is in range with a minimum value of 0.7λ, or a maximum value of λ, or a maximum value of 1.1λ.).
Regarding claim 26, Gonzalez teaches the method of claim 1, wherein the ultrasound source emits ultrasound with a frequency of 3MHz or less (paras. 0012 and 0021; choosing a predetermined wave frequency and wavelength, the predetermined frequency being comprised between 100 kHz and 20 MHz and the predetermined wavelength being determined by the predetermined frequency and a velocity of propagation of the wave in the coupling medium model. The examiner notes that the predetermined frequency of the ultrasound wave emitted from ultrasound source can be selected from 0.1 MHz to 20 MHz based on the treatment requirements. Thus, a frequency of 3 MHz or less falls within 0.1 MHz to 20 MHz range.).
Regarding claim 27, Gonzalez teaches the method of claim 1, wherein the ultrasound source emits ultrasound with a frequency of 0.3 MHz or more (paras. 0012 and 0021; choosing a predetermined wave frequency and wavelength, the predetermined frequency being comprised between 100 kHz and 20 MHz and the predetermined wavelength being determined by the predetermined frequency and a velocity of propagation of the wave in the coupling medium model. The examiner notes that the predetermined frequency of the ultrasound wave emitted from ultrasound source can be selected from 0.1 MHz to 20 MHz based on the treatment requirements. Thus, a frequency of 0.3 MHz or more falls within 0.1 MHz to 20 MHz range.).
Regarding claim 28, Gonzalez teaches the method of claim 1, wherein the ultrasound source comprise one or more ultrasound transducers (para. 0056; The ultrasound emitter 1 consists of a planar or focalized single-element emitter suitable for emitting an ultrasound beam targeting a treatment area 4 situated in a cerebral mass 9 inside the cranial cavity enclosed by the cranium 3).
Regarding claim 29, Gonzalez teaches the method of claim 1, wherein the target is a human body or is within a human body (para. 0056; The ultrasound emitter 1 consists of a planar or focalized single-element emitter suitable for emitting an ultrasound beam targeting a treatment area 4 situated in a cerebral mass 9 inside the cranial cavity enclosed by the cranium).
Regarding claim 31, Gonzalez teaches the method of claims 29, determining the desired shape of the ultrasound beam at the target comprises receiving measurements of the target in a patient (paras. 0009-0015; the method comprising the steps of providing a bone tissue model, a soft tissue model surrounded by the bone tissue, and a coupling medium model; choosing a source point situated inside the coupling medium model; choosing a predetermined wave frequency and wavelength, the predetermined frequency being comprised between 100 kHz and 20 MHz and the predetermined wavelength being determined by the predetermined frequency and a velocity of propagation of the wave in the coupling medium model; providing a treatment volume situated inside the bone tissue model; providing a plurality of nodes distributed inside the treatment volume).
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.
Claim(s) 2, 5-6, 10-11, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez Gonzalez et al. (WO 2020/084181, however, the US 2021/0396712 is used for citation clarity purposes), hereinafter Gonzalez, in the view of Amireddy et al. (NPL: “Porous metamaterials for deep sub-wavelength ultrasonic imaging”).
Regarding claim 2, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the waveguides are holes formed through the structure.
Amireddy, in the same field of endeavor, teaches the waveguides are holes formed through the structure (page 124102-1; We consider a metamaterial in the form of a 3D printed porous foam, wherein the hole size varies from 2 mm to 10 mm with an average value of about 4 mm).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify waveguide shape (fragment) of Gonzalez with the hole shaped wave guides of Amireddy to provide waveguides that are holes formed through the structure. This modification would result in a strong resonant transmission of sound due to coherent diffraction through such structures and the hole structure act as filters for the scattered wave field and can be thought to pass high frequency components from the input to the output surface, as disclosed within Amireddy in page 124102-1. Additionally, providing waveguides in the shape of holes will allow the ultrasound to transmit through the holes instead of transmitting through a material which will increase the sub-wavelength resolution.
Regarding claim 5, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the structure is a substrate.
Amireddy, in the same field of endeavor, teaches structure is a substrate (page 124102-1; a metamaterial in the form of a 3D printed porous foam).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure of Gonzalez with the metamaterial structure in the form of a 3D printed porous foam of Amireddy to provide substrate structure. This modification would result in improved control of acoustic waves propagation at multi-scale frequencies, as disclosed within Amireddy in page 124102-1.
Regarding claim 6, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the substrate is formed of a foam.
Amireddy, in the same field of endeavor, teaches the substrate is formed of a foam (page 124102-1; We consider a metamaterial in the form of a 3D printed porous foam, wherein the hole size varies from 2 mm to 10 mm with an average value of about 4 mm (dimensions deduced from X-ray) as shown in Fig. 1(a). The porous foam used in the experiments as a metamaterial lens was fabricated using selective laser sintering (SLS), an additive manufacturing process at ARCI, Hyderabad, India. SLS is a 3-D printing or additive manufacturing technique which uses a high power-density laser to sinter and fuse metallic powders together. Alumina powder was used in the process to make the layered foam structure.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure of Gonzalez with the metamaterial foam structure of Amireddy to provide substrate formed from foam. This modification would enable the higher order frequency (evanescent field) components to be more effectively transferred to the output surface, and hence, with this, the resolution is further improved as disclosed within Amireddy in page 124102-5.
Regarding claim 10, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the waveguides have varying lengths and/or cross-sections across the array.
Amireddy, in the same field of endeavor, teaches the waveguides have varying lengths and/or cross-sections across the array (page 124102-1; We consider a metamaterial in the form of a 3D printed porous foam, wherein the hole size varies from 2 mm to 10 mm with an average value of about 4 mm ).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify periodicity of the waveguide’s cross sections of Gonzalez with the varying waveguide cross sections of Amireddy to provide waveguides have varying cross-sections across the array. This modification would enable the higher order frequency (evanescent field) components to be more effectively transferred to the output surface, and hence, with this, the resolution is further improved. Additionally, the phenomenon of Wood anomaly can be avoided, and hence, all high frequency (evanescent) components can reach the image plane through the porous meta-lens, as disclosed within Amireddy in page 124102-5.
Regarding claim 11, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the waveguides have the same cross-sectional shape and have varying cross-sectional sizes across the array to provide varying cross-sections.
Amireddy, in the same field of endeavor, teaches the waveguides have the same cross-sectional shape and have varying cross-sectional sizes across the array to provide varying cross-sections (page 124102-1; We consider a metamaterial in the form of a 3D printed porous foam, wherein the hole size varies from 2 mm to 10 mm with an average value of about 4 mm. The examiner notes that the waveguides has a hole shape with varying sizes.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify periodicity of the waveguide’s cross sections of Gonzalez with the varying waveguide cross sections of Amireddy to provide waveguides have varying cross-sections across the array. This modification would enable the higher order frequency (evanescent field) components to be more effectively transferred to the output surface, and hence, with this, the resolution is further improved. Additionally, the phenomenon of Wood anomaly can be avoided, and hence, all high frequency (evanescent) components can reach the image plane through the porous meta-lens, as disclosed within Amireddy in page 124102-5.
Regarding claim 22, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein one or more waveguides have cross-sections varying along their length.
Amireddy, in the same field of endeavor, teaches one or more waveguides have cross-sections varying along their length (page 124102-3; The kind of porous metamaterial lens used in the study may be thought to consist of layers with varying periods and hole sizes. The examiner notes that the structure is composed of different layers each having varying hole sizes. Which means that the waveguide (holes) extending through the layers have different sizes along the thickness of the layers.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify cross sections of the waveguides of Gonzalez with the varying waveguide cross sections along the length of the layers (length of the waveguide) of Amireddy to provide waveguides have varying cross-sections along their length. This modification would enable the Wood anomaly in one layer is overcome by the other layer and the overall TR is the cumulative response of individual layers, as disclosed within Amireddy in page 124102-4.
Regarding claim 23, Gonzalez teaches the method of claim 22, however, fails to explicitly teach wherein the structure comprises a first layer and a second layer, wherein the waveguides are formed through each of the first layer and the second layer, and wherein the cross-section of at least one of the waveguides varies between the first layer and the second layer.
Amireddy, in the same field of endeavor, teaches the structure comprises a first layer and a second layer, wherein the waveguides are formed through each of the first layer and the second layer, and wherein the cross-section of at least one of the waveguides varies between the first layer and the second layer (page 124102-3; The kind of porous metamaterial lens used in the study may be thought to consist of layers with varying periods and hole sizes. The model renders the porous metamaterial in the form of layers each of which has holes (as shown in Fig. 6) with randomly assigned sizes (in the range of 2–10 mm, the same range as used in the experiments). m layers of thickness n were considered (where m varies from 1 to 9). The examiner notes that the structure is composed of different layers each having varying hole sizes. Which means that the waveguide (holes) extending through the layers have different sizes along the thickness of the layers.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure and cross sections of the waveguides of Gonzalez with the varying waveguide cross sections along the length of the layers of Amireddy to provide waveguides have varying cross-sections along the layers. This modification would enable the Wood anomaly in one layer is overcome by the other layer and the overall TR is the cumulative response of individual layers, as disclosed within Amireddy in page 124102-4.
Regarding claim 24, Gonzalez teaches the method of claim 23, however, fails to explicitly teach wherein each waveguide has a first length in the first layer and a second length in the second layer, and wherein for at least one waveguide the first length is different to the second length.
Amireddy, in the same field of endeavor, teaches each waveguide has a first length in the first layer and a second length in the second layer, and wherein for at least one waveguide the first length is different to the second length (page 124102-3; The kind of porous metamaterial lens used in the study may be thought to consist of layers with varying periods and hole sizes. The model renders the porous metamaterial in the form of layers each of which has holes (as shown in Fig. 6) with randomly assigned sizes (in the range of 2–10 mm, the same range as used in the experiments). m layers of thickness n were considered (where m varies from 1 to 9). The examiner notes that the structure is composed of different layers each having varying hole sizes and different thicknesses. Which means that the waveguide (holes) extending through the layers have different lengths based on the thickness of the layers.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure and length of the waveguides of Gonzalez with the varying waveguide lengths along the layers of Amireddy to provide waveguides have a first length in the first layer and a second length in the second layer. This modification would enable the Wood anomaly in one layer is overcome by the other layer and the overall TR is the cumulative response of individual layers, as disclosed within Amireddy in page 124102-4.
Regarding claim 25, Gonzalez teaches the method of claim 23, wherein the lengths and cross-sections of the waveguides are selected based on a desired one of amplitude or phase of ultrasound at the target (paras. 0025-0026 and 0061-0066; This simulated wave front is received on the receiving surface 8 which contains the source point 6. The wave front received on this receiving surface 8 is analyzed and in this case, said receiving surface is divided into 1 mm×1 mm pixels. Once the data of the wave front received in each of the pixels of the receiving surface have been collected and processed, it is possible to design a lens surface, by means of methods such as the calculation of the Fabry-Perot resonator, equivalent heights for each fragment of the lens corresponding to each pixel into which the receiving surface has been divided being chosen. Each of these fragments 21 corresponds to a column of the previously described model, the base of each column has the size of one pixel and the height of each column corresponds with the previously indicated Fabry-Pérot resonator. The step of processing the results received comprises dividing the receiving surface into pixels and analyzing the amplitude and phase of the wave received in each pixel. In particular embodiments, the pixel size depends on the predetermined wavelength, and in particular the size of each pixel is a square of 5λ/6 of side, λ being the predetermined wavelength. Each pixel of the receiving surface is considered as a Fabry-Pérot type resonator which can resonate longitudinally, giving rise to a fragment of the lens, and in the step of designing the holographic lens surface equivalent heights are chosen for each fragment of the lens based on the amplitude and phase of the waves received in each pixel of the receiving surface. The examiner notes that the length (height) and the cross section (pixel size) are chosen based on the simulated wave front (desired beam shape) such that each fragment modulate the amplitude and phase of the desired beam.).
However, Gonzalez fails to explicitly teach the structure comprises a first layer and a second layer, wherein the waveguides are formed through each of the first layer and the second layer, and wherein the cross-section and lengths of the waveguides varies between the first layer and the second layer.
Amireddy, in the same field of endeavor, teaches the structure comprises a first layer and a second layer, wherein the waveguides are formed through each of the first layer and the second layer, and wherein the cross-section of at least one of the waveguides varies between the first layer and the second layer (page 124102-3; The kind of porous metamaterial lens used in the study may be thought to consist of layers with varying periods and hole sizes. The model renders the porous metamaterial in the form of layers each of which has holes (as shown in Fig. 6) with randomly assigned sizes (in the range of 2–10 mm, the same range as used in the experiments). m layers of thickness n were considered (where m varies from 1 to 9). The examiner notes that the structure is composed of different layers (two or more) each having varying hole sizes and layer thickness. Which means that the waveguide (holes) extending through the layers have different sizes along the thickness of the layers.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure and cross sections of the waveguides of Gonzalez with the varying waveguide cross sections along the length of the layers of Amireddy to provide waveguides have varying cross-sections and lengths along the layers. This modification would enable the Wood anomaly in one layer is overcome by the other layer and the overall TR is the cumulative response of individual layers, as disclosed within Amireddy in page 124102-4.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez Gonzalez et al. (WO 2020/084181, however, the US 2021/0396712 is used for citation clarity purposes), hereinafter Gonzalez, in the view of Laureti et al. (NPL: “Trapped air metamaterial concept for ultrasonic sub-wavelength imaging in water”).
Regarding claim 7, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the structure comprises gas held in a container.
Laureti, in the same field of endeavor, teach structure comprises gas held in a container (page 2; This uses a new “trapped air metamaterial” (TAM) concept, where the acoustic impedance mismatch between a polymer and water is strongly enhanced if air is trapped within the bulk material in a particular way.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure of Gonzalez with the structure comprising trapped air material of Laureti to provide structure comprises gas held in a container. This modification would greatly reduce acoustic cross-coupling from the water-filled channels into the substrate which will improve the performance of the device. Additionally, the acoustic impedance mismatch between the structure and the ultrasound transmission medium will be strongly enhanced if air is trapped within the bulk material of the structure, as disclosed within Laureti in pages 2 and 6.
Regarding claim 8, Gonzalez teaches the method of claim 1, wherein the waveguide array is designed for use in an ultrasound transmission medium (paras. 0031 and 0066; This lens 2 comprises a plurality of fragments 21 which are responsible for making the necessary corrections in the ultrasound beam to establish the desired pattern, centered on the previously defined treatment area. The examiner notes that the treatment area consists of ultrasound transmission medium).
However, fails to explicitly teach wherein the ratio of acoustic impedance of the structure to the acoustic impedance of the transmission medium is 1/100 or less, or 1/500 or less.
Laureti, in the same field of endeavor, teach the ratio of acoustic impedance of the structure to the acoustic impedance of the transmission medium is 1/100 or less, or 1/500 or less (page 2; This uses a new “trapped air metamaterial” (TAM) concept, where the acoustic impedance mismatch between a polymer and water is strongly enhanced if air is trapped within the bulk material in a particular way. This uses the fact that the acoustic impedance of air (Zair) is very low (so that Zair << Zb, Zwater), enhancing acoustic isolation. Zwater/ Zair = 3.6 × 103. The examiner notes that the acoustic impedance of the trapped air material to water is 1/3600)).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure of Gonzalez with the structure comprising trapped air material of Laureti to provide ratio of acoustic impedance of the structure to the acoustic impedance of the transmission medium is 1/100 or less, or 1/500 or less. This modification would greatly reduce acoustic cross-coupling from the water-filled channels into the substrate which will improve the performance of the device. Additionally, the acoustic impedance mismatch between the structure and the ultrasound transmission medium will be strongly enhanced if air is trapped within the bulk material of the structure, as disclosed within Laureti in pages 2 and 6.
Regarding claim 9, Gonzalez teaches the method of claim 1, however, fails to explicitly teach wherein the structure has an acoustic impedance of 20000 Rayl or less, or 15000 Rayl or less, and/or wherein the structure has an acoustic impedance of 400 Rayl or more, or 1000 Rayl or more, or 1800 Rayl or more.
Laureti, in the same field of endeavor, teach the structure has an acoustic impedance of 20000 Rayl or less, or 15000 Rayl or less, and/or wherein the structure has an acoustic impedance of 400 Rayl or more, or 1000 Rayl or more, or 1800 Rayl or more (page 2, This uses a new “trapped air metamaterial” (TAM) concept, where the acoustic impedance mismatch between a polymer and water is strongly enhanced if air is trapped within the bulk material in a particular way. This uses the fact that the acoustic impedance of air (Zair) is very low (so that Zair << Zb, Zwater), enhancing acoustic isolation. Zwater/ Zair = 3.6 × 103. When used in air at room temperature (𝜌𝑎𝑖𝑟=1.2kgm−3, 𝑐𝑎𝑖𝑟=343ms−1). The examiner notes that the acoustic impedance of the trapped air material is 413 Rayl).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify structure of Gonzalez with the structure comprising trapped air material of Laureti to provide structure that has an acoustic impedance of 400 Rayl or more. This modification would greatly reduce acoustic cross-coupling from the water-filled channels into the substrate which will improve the performance of the device. Additionally, the acoustic impedance mismatch between the structure and the ultrasound transmission medium will be strongly enhanced if air is trapped within the bulk material of the structure, as disclosed within Laureti in pages 2 and 6.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Jimenez Gonzalez et al. (WO 2020/084181, however, the US 2021/0396712 is used for citation clarity purposes), hereinafter Gonzalez, in the view of Bailley et al. (US 2021/0187330).
Regarding claim 30, Gonzalez teaches the method of claim 29, wherein the target is a treatment volume (para. 0056; The ultrasound emitter 1 consists of a planar or focalized single-element emitter suitable for emitting an ultrasound beam targeting a treatment area 4 situated in a cerebral mass 9 inside the cranial cavity enclosed by the cranium).
However, fails to explicitly teach that the treatment volume is a tumour, or wherein the target is a region of the body comprising one or more tumours.
Bailley, in the same field of endeavor, teaches the treatment volume is a tumour (para. 0082; The sample targets in FIGS. 8A, 9A and 10A may correspond to stones, calcifications, concretions, blood vessels, tumors, etc., that are treated by the ultrasound.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify treatment target of Gonzalez with the tumor target of Bailley to provide a target that is tumor. This modification would facilitate removal of soft tissues such as tumors. The examiner notes that tumors are well known treatment targets for ultrasound therapy and choosing a tumor as the target volume is merely selecting a known target for a known treatment modality.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797