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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The abstract of the disclosure is objected to because it contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 2-4, and 8-18 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 10, and all dependent claims thereof, recite “[a]n ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 1.” That is, a method of the system of claim 1. Applicant is reminded that it is improper to claim two statutory categories in the same claim (e.g. method and system in the same claim). See MPEP 2173.05(p)(II).
Claim 10, and all dependent claims thereof, recites the limitations “the data acquisition module”, “the analog-to-digital conversion”, “the storage”, “the digital signal”, and “the image reconstruction module.” None of these limitations have proper antecedent basis in the claims.
Claims 2 and 11 recite the limitations “wherein a maximum angular difference in an ultrasound propagation direction at any point within an imaging region of each of different ultrasound transducer elements on the large-aperture ultrasound transducer array (2) is at least 60 degrees.” It is not possible to reasonably ascertain the meaning of these limitations. First, it is not clear what the “maximum angular difference” is relative to. It is set forth as “a maximum angular difference in an ultrasound propagation direction at any point within an imaging region of each of different ultrasound transducer elements” and it is unclear if the difference is meant to be a difference in the propagation direction of one transducer element in the array relative to another transducer element in the array, or if some other difference is being contemplated. Second, it is unclear what it means for a maximum to be “at least 60 degrees.” That is, a maximum value, the highest possible value, is being defined as the lowest value in an open-ended range. It is not possible to reasonably determine how to define “maximum” in this context. The disclosure contains this language essentially verbatim, but provides no further clarifying explanation.
Because it is not possible to determine a reasonable interpretation for the meaning of these claims, the claims will not be further examined on the merits. See MPEP 2173.06(II): “…where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art” and “a rejection…should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
Claims 3 and 12 recite the limitations “wherein the large-aperture ultrasound transducer array (2) comprises the following forms: at least one arc-shaped ultrasound transducer array constitutes an arc-shaped large-aperture ultrasound transducer array; multiple linear ultrasound transducer arrays constitute a linear large-aperture ultrasound transducer array; and the multiple ultrasound transducer elements are spatially arranged as a spherical large-aperture ultrasound transducer array or a polyhedral large-aperture ultrasound transducer array.” It appears that each of the arc-shaped transducer array, the multiple linear ultrasound transducer arrays, and the multiple transducer elements spatially arranged as a spherical transducer array or a polyhedral transducer array represent separate embodiments (see figs. 2, 3-4, and 7-8), however they are not being claimed in the alternative and the claims therefore requires a single embodiment having all of these features. For the purposes of further examination, these claims will be interpreted to require only a single embodiment as disclosed in figs. 2-4 and 7-8.
Claims 4 and 13 recite the limitation “…an excitation angle of the focused wave, the plane wave or the divergent wave varies between -90° and 90°.” However, the claim does not provide any reference from which the excitation angle is to be measured from. It is unclear if this range might represent an angle between -90° and 90° relative to, for example, the surface of the transducer or a normal of the surface of the transducer. It is further unclear how this angular range might be embodied in some of the transducer shapes provided in the disclosure, e.g. what would constitute an angle between -90° and 90° relative to a spherical transducer array? For the purposes of further examination this limitation will be interpreted to mean that the excitation angle is an angle between -90° and 90° relative to a normal to the transducer face.
Claims 8 and 17, and all dependent claims thereof, recite the limitations “and a grayscale value at a point on the sub-image is as follows: I(x,z)= RF(i,(i,a,x,z),a)wherein, x, z are coordinates of the point on the sub-image, a is the excitation angle of the ultrasound pulse wave, RF is the ultrasound echo signal, T is ultrasound propagation time, sub-images obtained by exciting different ultrasound pulse waves being coherently compounded to obtain a final reconstructed image, and i is an index of each of the ultrasound transducer elements.” The meaning of this limitation is unclear for multiple reasons. First, it is not tied to any structure or manipulative step in the system of claim 8 or the method of claim 17. That is to say, there is no indication that this is a particular calculation that is performed to generate a value, as opposed to merely being a way that the value of I(x,z) might be characterized. The phrase “a grayscale value…is as follows” does not convey any link to the configuration of the system or a step in the method. Second, the limitations following the equation mostly comprise definitions of the variables (x, z are coordinates of the point on the sub-image, a is the excitation angle of the ultrasound pulse wave, RF is the ultrasound echo signal, T is ultrasound propagation time, and i is an index of each of the ultrasound transducer elements) but the inclusion of the phrase “sub-images obtained by exciting different ultrasound pulse waves being coherently compounded to obtain a final reconstructed image” in the middle of the variable definitions is extremely confusing. It is not clear if there is meant to be an additional variable associated with this, whether it is meant to convey some kind of step to be performed, or if it was merely inserted by mistake. The disclosure contains this language essentially verbatim, but provides no further clarifying explanation.
Because it is not possible to determine a reasonable interpretation for the meaning of these claims, the claims will not be further examined on the merits. See MPEP 2173.06(II): “…where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art” and “a rejection…should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
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 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al. (US 2023/0210490 A1, Jul. 6, 2023) (hereinafter “He”).
Regarding claim 1: He discloses A large-aperture ultrafast ultrasound imaging system, comprising: an ultrasound transmitting module (1) and a large-aperture ultrasound transducer array (2), wherein the ultrasound transmitting module (1) is configured to generate a transmitting pulse sequence (fig. 2, [0045] – the function of generating a transmitting pulse sequence is considered to be an implicit disclosure of the hardware required to do so; it is noted that “large-aperture” is not defined and there is no evidence that the aperture(s) of He would not be considered “large”); through pulses of different waveforms in the transmitting pulse sequence, transmit elements on the large-aperture ultrasound transducer array (2) are excited simultaneously or with a transmission delay to generate an ultrasound pulse wave (fig. 3, [0046]); and multiple ultrasound pulse waves generated by excitation of multiple transmitting pulse sequences constitute a group of ultrafast ultrasound sequences ([0042]); and the large-aperture ultrasound transducer array (2) comprises multiple ultrasound transducer elements ([0046]-[0047] - N elements, where N is greater than 1); the multiple ultrasound transducer elements are configured to receive the transmitting pulse sequence generated by the ultrasound transmitting module, convert the transmitting pulse sequence into the ultrasound pulse wave, and transmit the ultrasound pulse wave to a to-be-tested subject ([0045]-[0048], fig. 2); the ultrasound pulse wave is reflected and scattered during propagation in the to-be-tested subject ([0049], [0051]-[0052]; this is simply a description of how ultrasound interacts with tissue); and a resulting ultrasound pulse wave is propagated to the large-aperture ultrasound transducer array (2), received by the large-aperture ultrasound transducer array (2) and converted into an ultrasound echo signal ([0051]-[0053]).
Regarding claim 4, as best understood based on limitations which are indefinite: He discloses the large-aperture ultrafast ultrasound imaging system according to claim 1, wherein the ultrafast ultrasound sequences each comprise at least one ultrasound pulse wave ([0045]-[0048]); the ultrasound pulse wave completely covers and excites an imaging region in propagation (fig. 3); under the control of the transmitting pulse sequence, the ultrasound pulse wave is any combination of a divergent wave, a plane wave, and a focused wave at a single excitation angle or multiple different excitation angles ([0045]); an excitation angle of the ultrasound pulse wave is changed by changing the transmission delay or exciting transmit elements at different positions ([0046]); and an excitation angle of the focused wave, the plane wave or the divergent wave varies between -90° and 90° (fig. 3).
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) 5-7, 10, and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (US 2023/0210490 A1, Jul. 6, 2023) (hereinafter “He”) in view of Magee (US 2009/0326375 A1, Dec. 31, 2009) (hereinafter “Magee”).
Regarding claim 5: He discloses the system of claim 1. While the system of He is considered to perform conventional ultrasound processing functions, He does not explicitly describe the hardware that would perform such functions.
Magee, in the same field of endeavor, discloses a Doppler ultrasound system comprising a data acquisition module configured to receive the ultrasound echo signal, perform analog amplification, analog-to-digital conversion, storage and transmission on the ultrasound echo signal, and output a digital signal to an image reconstruction module (figs. 3A-3B and 5, VCA 116, ADC 117, DSP 300). Magee further discloses that this data acquisition scheme improves system performance ([0020]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the data acquisition functions of He using hardware as disclosed by Magee in order to improve system performance.
Regarding claim 6: He and Magee disclose the large-aperture ultrafast ultrasound imaging system according to claim 5, further comprising a system control module (3), wherein the system control module (3) is configured to control parameters comprising a quantity and a distribution of the transmit elements, a property of the transmitting pulse sequence, the transmission delay, an analog amplification gain of the data acquisition module (4), and a sampling rate (He – [0045]-[0046]; Magee – fig. 5, [0053]).
Regarding claim 7: He and Magee The large-aperture ultrafast ultrasound imaging system according to claim 6, further comprising the image reconstruction module (5), wherein the image reconstruction module (5) is configured to perform image reconstruction through a delay-and-sum beamforming algorithm (He - [0053]).
Regarding claim 10: He discloses an ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 1, comprising the following steps: step 1: generating, by the ultrasound transmitting module (1), the transmitting pulse sequence to excite the large-aperture ultrasound transducer array (2), wherein through the transmitting pulse sequence, the transmit elements on the large-aperture ultrasound transducer array are excited simultaneously or with the transmission delay to generate the ultrasound pulse wave (fig. 1, [0045]-[0046]; it is noted that “large-aperture” is not defined and there is no evidence that the aperture(s) of He would not be considered “large”); and the multiple ultrasound pulse waves generated by the excitation of the multiple transmitting pulse sequences constitute the group of ultrafast ultrasound sequences (fig. 3, [0042]); step 2: receiving, by the large-aperture ultrasound transducer array (2), the transmitting pulse sequence generated by the ultrasound transmitting module (1), and transmitting the ultrasound pulse wave to the to-be-tested subject at a large-aperture ultrasound excitation angle to cover a target imaging range (figs. 1 and 2, [0045]-[0048]); and step 3: detecting, by the large-aperture ultrasound transducer array (2), the ultrasound echo signal from the to-be-tested subject at a large-aperture ultrasound detection angle, transmitting the ultrasound echo signal to the data acquisition module ([0049], [0051]-[0053]). While the method of He is considered to include conventional ultrasound processing functions, He does not explicitly describe these functions.
Magee, in the same field of endeavor, discloses a Doppler ultrasound beamforming method comprising performing the analog-to- digital conversion, the storage and the transmission on the ultrasound echo signal, and outputting the digital signal to the image reconstruction module (5) for ultrasound image reconstruction (figs. figs. 3A-3B and 5-6, VCA 116, ADC 117, DSP 300; [0053]-[0054]). Magee further discloses that this data acquisition scheme improves system performance ([0020]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the data acquisition functions of He using hardware as disclosed by Magee in order to improve system performance.
Regarding claim 13, as best understood based on limitations which are indefinite: He and Magee disclose The ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 10, wherein the ultrafast ultrasound sequences each comprise at least one ultrasound pulse wave ([0045]-[0048]); the ultrasound pulse wave completely covers and excites an imaging region in propagation; under the control of the transmitting pulse sequence, the ultrasound pulse wave is any combination of a divergent wave, a plane wave, and a focused wave at a single excitation angle or multiple different excitation angles (fig. 3, [0045]); an excitation angle of the ultrasound pulse wave is changed by changing the transmission delay or exciting transmit elements at different positions (fig. 3, [0046]); and an excitation angle of the focused wave, the plane wave or the divergent wave varies between -90° and 90° (figs. 3-4).
Regarding claim 14: He and Magee disclose the ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 10, further comprising a data acquisition module(4), wherein the data acquisition module (4) is configured to receive the ultrasound echo signal, perform analog amplification, analog-to-digital conversion, storage and transmission on the ultrasound echo signal, and output a digital signal to an image reconstruction module (Magee - figs. 3A-3B and 5, VCA 116, ADC 117, DSP 300).
Regarding claim 15: He and Magee disclose the ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 14, further comprising a system control module (3), wherein the system control module (3) is configured to control parameters comprising a quantity and a distribution of the transmit elements, a property of the transmitting pulse sequence, the transmission delay, an analog amplification gain of the data acquisition module (4), and a sampling rate (He – fig. 1 and all associated description; Magee – fig. 5, [0053]).
Regarding claim 16: He and Magee disclose the ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 15, further comprising the image reconstruction module (5), wherein the image reconstruction module (5) is configured to perform image reconstruction through a delay-and-sum beamforming algorithm (He – [0053]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over He in view of Gong et al. (US 2020/0183004 A1, Jun. 11, 2020) (hereinafter “Gong”).
Regarding claim 3, as best understood based on limitations which are indefinite: He discloses the large-aperture ultrafast ultrasound imaging system according to claim 1, but is silent on the features of the ultrasound transducer array.
Gong, in the same field of endeavor, discloses an imaging system which may be used for wide-beam or Doppler imaging ([0037]) comprising multiplane wave transmission and compounding ([0023]) using an ultrasound transducer having one of the following forms: at least one arc-shaped ultrasound transducer array constitutes an arc-shaped large-aperture ultrasound transducer array; multiple linear ultrasound transducer arrays constitute a linear large-aperture ultrasound transducer array; and the multiple ultrasound transducer elements are spatially arranged as a spherical large-aperture ultrasound transducer array or a polyhedral large-aperture ultrasound transducer array ([0055] – “The transducer array 602 can include any suitable ultrasound transducer array, including linear arrays, curved arrays, phased arrays, and so on.”).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the transducer array of He having one of the conventional shapes disclosed by Gong because the claimed transducer array shapes and imaging method were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over He and Magee as applied to claim 10 above, and further in view of Gong et al. (US 2020/0183004 A1, Jun. 11, 2020) (hereinafter “Gong”).
Regarding claim 12, as best understood based on limitations which are indefinite: He and Magee disclose the ultrafast ultrasound imaging method of the large-aperture ultrafast ultrasound imaging system according to claim 10, but are silent on the features of the ultrasound transducer array.
Gong, in the same field of endeavor, discloses an imaging system which may be used for wide-beam or Doppler imaging ([0037]) comprising multiplane wave transmission and compounding ([0023]) using an ultrasound transducer having one of the following forms: at least one arc-shaped ultrasound transducer array constitutes an arc-shaped large-aperture ultrasound transducer array; multiple linear ultrasound transducer arrays constitute a linear large-aperture ultrasound transducer array; and the multiple ultrasound transducer elements are spatially arranged as a spherical large-aperture ultrasound transducer array or a polyhedral large-aperture ultrasound transducer array ([0055] – “The transducer array 602 can include any suitable ultrasound transducer array, including linear arrays, curved arrays, phased arrays, and so on.”).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the transducer array of He and Magee having one of the conventional shapes disclosed by Gong because the claimed transducer array shapes and imaging method were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
