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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 12/30/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 12/30/2025 has been entered. Claim 12 has been canceled. Claims 1-11 and 13-15 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 07/01/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1, 8, and claims dependent therefrom have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New reference Trahey (US20030171676) is now cited for teaching the amended feature argued upon.
Claim Objections
Claim 1 is objected to because of the following informalities:
“implementing a treatment plan, the treatment plan based on precise location of the tumor, using ultrasound” should be corrected to:
“implementing a treatment plan, wherein the treatment plan is based on the precise location of the tumor, using ultrasound”.
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 9 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 9 recites the limitation "the additional properties of the tumor". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) and Trahey (US20030171676).
Regarding claim 1, Hynynen teaches a method for detection and treatment of tumors using ultrasound comprising (Abstract, [0025-0026], [0037]):
imaging the location of the tumor using ultrasound pulses to mechanically disturb tissue ([0002-0003], [0011], “Accurate images for lesion localization can be obtained”, [0025-0026], [0036-0037]);
determining, from reflected waves that are reflections of the ultrasound pulses, mechanical properties of the tissue ([0025], [0029-0030], “The computer 32 is configured to process the received, amplified, and digitized reflected signals to determine the mechanical elasticity/stiffness of the target 44”, [0034-0036]);
determining a precise location of the tumor based on the determined mechanical properties of the tissue ([0003], [0011], wherein lesion localization is performed from the images which measure stiffness, [0037], “Relative elasticity/stiffness determinations may also be used to locate targets. By knowing the difference in elasticity/stiffness between two regions, surrounding tissue (e.g., healthy breast or brain tissue) can be differentiated from other tissue (e.g., a tumor) so that a target for treatment such as ablation may be located”); and
implementing a treatment plan, the treatment plan based on precise location of the tumor, using ultrasound ([0002], [0037], “Further, for therapy, the FUS transducers 18, 20 may have high intensities such that the ultrasound from the transducers 18,20 induces coagulation of tissue in the target region 44” and wherein treatment such as ablation or focused ultrasound (FUS) is implemented based on the identification/location of the target (e.g., a tumor)).
However, Hynynen fails to teach performing an early detection test on a patient; determining a location of a tumor based on the early detection test; wherein imaging the location of the tumor using ultrasound pulses to mechanically disturb tissue is in the location of the tumor determined based on the early detection test; and wherein determining mechanical properties of the tissue is in the location of the tumor determined based on the early detection test.
In an analogous tumor detection field of endeavor, Zhou teaches such a feature. Zhou teaches a method to detect early stage pre-symptom cancer/tumors (Abstract). Zhou teaches it is imperative to identify and locate cancer at the earliest stage possible ([0373]). Zhou teaches collecting blood and performing blood tests for early detection of tumors or cancer ([0373]). Zhou teaches by detecting cancer and knowing its location via early detection, medical intervention may provide most effectiveness in removal of cancer cells ([0373]). Zhou therefore teaches performing an early detection test on a patient to locate cancer/tumors. Because Zhou teaches wherein the early detection and location of cancer may assist medical intervention, Zhou therefore further teaches performing medical intervention (i.e. imaging and determining mechanical properties in view of Hynynen) based on the early detection test.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to perform an early detection on a patient to locate the origination of tumors and have medical intervention be performed in the location of the tumor determined based on the early detection as taught by Zhou ([0373]). By performing early detection, survival chances of a patient carrying cancer may be increased as recognized by Zhou ([0373]). Moreover, early stage cancer/tumor detection may allow for more effective medical intervention as further recognized by Zhou ([0373]). Because Hynynen teaches imaging, determining mechanical properties of tumors, and performing treatment, and Zhou teaches wherein the location of tumors provided by early detection may assist medical intervention, the combined teachings predictably result wherein the imaging of the location of the tumor and the determining of mechanical properties of tissue is in the location of the tumor determined based on the early detection test.
However, the modified combination noted above fails to teach wherein the ultrasound pulses used for imaging the location of the tumor are generated with an output power with a spatial peak temporal average intensity (Ispta) equal to or greater than 720mW/cm^2.
In an analogous method for the detection of tumors field of endeavor, Trahey teaches such a feature. Trahey similarly teaches performing elastography and transmitting ultrasound pulses sufficient to mechanically disturb and displace tissue (Abstract, [0005], [0008], [0017], [0021], [0026]). Trahey teaches wherein the tissue is preferably breast tissue for the detection of breast cancer/tumors (Claim 7, [0004], [0017]). Trahey teaches wherein the pushing pulses delivered by the ultrasound transducer are used to generate a displacement image or palpation image ([0008], [0031], [0053]). Trahey teaches using a spatial peak temporal average intensity (Ispta) of between 100 to 400 W/cm2 as detectable displacements may be generated therefrom and better signal-to-noise ratio (SNR) may be had ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the ultrasound pulses use a spatial peak temporal average intensity (Ispta) of between 100 to 400 W/cm2 as taught by Trahey ([0051]). A higher Ispta may grant higher signal-to-noise ratio and generate detectable displacement for creating a displacement map/image as recognized by Trahey ([0031], [0051]), which may be used to detect breast tumors as further recognized by Trahey (Claims 6-8, [0004], [0017]).
Regarding claim 2, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 1.
However, Hynynen fails to teach wherein the early detection test is a blood test, a histology test, or elastography.
In an analogous tumor detection field of endeavor, Zhou teaches such a feature. Zhou teaches a method to detect early stage pre-symptom cancer/tumors (Abstract). Zhou teaches it is imperative to identify and locate cancer at the earliest stage possible ([0373]). Zhou teaches collecting blood and performing blood tests for early detection of tumors or cancer ([0373]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the early detection test be a blood test as taught by Zhou ([0373]). Blood tests for early detection are conventional and desirable as recognized by Zhou ([0373]).
Regarding claim 4, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 1.
Hynynen further teaches wherein implementing a treatment plan, the treatment plan based on the precise location of the tumor, using ultrasound further comprises generating ultrasound waves targeted to locations identified by the treatment plan using a transducer array of an ultrasound system ([0026], “with transducers 18, 20 being portions of the phased array”, [0037], “Further, for therapy, the FUS transducers 18, 20 may have high intensities such that the ultrasound from the transducers 18, 20 induces coagulation of tissue in the target region 44”).
Regarding claim 7, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 1.
Hynynen further teaches wherein imaging the location of the tumor using ultrasound pulses to mechanically disturb tissue in the location of the tumor determined based on the early detection test and implementing a treatment plan, the treatment plan based on precise location of the tumor, using ultrasound, use a same transducer array ([0026], wherein FUS transducers 18, 20 and diagnostic transducer 22 are portions of the same phased array of set 14), and further comprising:
not moving the transducer array during both of, and between, the imaging of the location of the tumor and the implementing of the treatment plan (Figs. 1-2, [0026], [0028], “Ultrasound beams from the transducers 18, 20 are directed to focus and intersect at the target 44 in the subject 42”, “The pulser/receiver 24 is configured such that it can cause the transducer 22 to send the ultrasound pulses/bursts toward the target region 44 while the transducers 18, 20 are transmitting energy beams to the target region 44”, “The diagnostic transducer 22 is also aimed at the target 44 of the subject 42”, [0029-0030], [0032-0036]; transducer array is stationary while ultrasound beams from the phased array are directed simultaneously towards the target for imaging and treatment, wherein transducers 18, 20 perform treatment and transducer 22 images).
Regarding claim 8, Hynynen teaches a method for detection and treatment of tumors using ultrasound comprising (Abstract, [0025-0026], [0037]):
imaging a location of a tumor using ultrasound pulses to mechanically disturb tissue ([0002-0003], [0011], “Accurate images for lesion localization can be obtained”, [0025-0026], [0037]);
determining, from reflected waves that are reflections of the ultrasound pulses, mechanical properties of the tissue ([0025], [0029-0030], “The computer 32 is configured to process the received, amplified, and digitized reflected signals to determine the mechanical elasticity/stiffness of the target 44”, [0034-0036]);
determining a precise location of the tumor based on the determined mechanical properties of the tissue ([0003], [0011], wherein lesion localization is performed from the images which measure stiffness, [0037], “Relative elasticity/stiffness determinations may also be used to locate targets. By knowing the difference in elasticity/stiffness between two regions, surrounding tissue (e.g., healthy breast or brain tissue) can be differentiated from other tissue (e.g., a tumor) so that a target for treatment such as ablation may be located”); and
applying therapy to the precise location of the tumor, the therapy comprising ultrasonic waves generated by an ultrasound system ([0002], [0037], “Further, for therapy, the FUS transducers 18, 20 may have high intensities such that the ultrasound from the transducers 18,20 induces coagulation of tissue in the target region 44” and wherein treatment such as ablation or focused ultrasound (FUS) is implemented based on the identification/location of the target (e.g., a tumor)).
However, Hynynen fails to teach wherein imaging the location of the tumor using ultrasound pulses to mechanically disturb tissue is in the location of the tumor determined based on an early detection test; and wherein determining mechanical properties of the tissue is in the location of the tumor determined based on the early detection test.
In an analogous tumor detection field of endeavor, Zhou teaches such a feature. Zhou teaches a method to detect early stage pre-symptom cancer/tumors (Abstract). Zhou teaches it is imperative to identify and locate cancer at the earliest stage possible ([0373]). Zhou teaches collecting blood and performing blood tests for early detection of tumors or cancer ([0373]). Zhou teaches by detecting cancer and knowing its location via early detection, medical intervention may provide most effectiveness in removal of cancer cells ([0373]). Zhou therefore teaches performing an early detection test on a patient to locate cancer/tumors. Because Zhou teaches wherein the early detection and location of cancer may assist medical intervention, Zhou therefore further teaches performing medical intervention (i.e. imaging and determining mechanical properties in view of Hynynen) based on the early detection test.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to perform an early detection on a patient to locate the origination of tumors and have medical intervention be performed in the location of the tumor determined based on the early detection as taught by Zhou ([0373]). By performing early detection, survival chances of a patient carrying cancer may be increased as recognized by Zhou ([0373]). Moreover, early stage cancer/tumor detection may allow for more effective medical intervention as further recognized by Zhou ([0373]). Because Hynynen teaches imaging, determining mechanical properties of tumors, and performing treatment, and Zhou teaches wherein the location of tumors provided by early detection may assist medical intervention, the combined teachings predictably result wherein the imaging of the location of the tumor and the determining of mechanical properties of tissue is in the location of the tumor determined based on the early detection test.
However, the modified combination noted above fails to teach wherein the ultrasound pulses used for imaging the location of the tumor are generated with an output power with a spatial peak temporal average intensity (Ispta) equal to or greater than 720mW/cm^2.
In an analogous method for the detection of tumors field of endeavor, Trahey teaches such a feature. Trahey similarly teaches performing elastography and transmitting ultrasound pulses sufficient to mechanically disturb and displace tissue (Abstract, [0005], [0008], [0017], [0021], [0026]). Trahey teaches wherein the tissue is preferably breast tissue for the detection of breast cancer/tumors (Claim 7, [0004], [0017]). Trahey teaches wherein the pushing pulses delivered by the ultrasound transducer are used to generate a displacement image or palpation image ([0008], [0031], [0053]). Trahey teaches using a spatial peak temporal average intensity (Ispta) of between 100 to 400 W/cm2 as detectable displacements may be generated therefrom and better signal-to-noise ratio (SNR) may be had ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the ultrasound pulses use a spatial peak temporal average intensity (Ispta) of between 100 to 400 W/cm2 as taught by Trahey ([0051]). A higher Ispta may grant higher signal-to-noise ratio and generate detectable displacement for creating a displacement map/image as recognized by Trahey ([0031], [0051]), which may be used to detect breast tumors as further recognized by Trahey (Claims 6-8, [0004], [0017]).
Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) and Trahey (US20030171676) as applied to claims 1 and 8 above, and further in view of Wodnicki (US20080315331). Wodnicki is cited in the IDS filed 09/19/2023.
Regarding claim 3, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 1.
However, Hynynen fails to teach wherein the ultrasound is generated by transducer array that has an active area with a surface area of greater than 15 square centimeters.
In an analogous ultrasound imaging field of endeavor, Wodnicki teaches such a feature. Wodnicki teaches ultrasound imaging and monitoring systems ([0003]). Wodnicki teaches transducer arrays typically span an area of about 20 square centimeters ([0007]). Moreover, Wodnicki teaches much larger arrays are required for screening for tumors, on the order of 300 square centimeters ([0007]). Wodnicki therefore teaches using an ultrasound array that has an active area with a surface area of greater than at least 15 square centimeters, the active area being the entire transducer array.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to use a transducer array that has an active area with a surface area of greater than 15 square centimeters as taught by Wodnicki ([0007]). Wodnicki teaches transducer arrays typically span an area of about 20 centimeters squared; therefore, it would be obvious to use such a transducer array as it is typical/conventional ([0007]). Moreover, Wodnicki teaches much larger sized areas may be required for screening tumors ([0007]).
Regarding claim 10, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
However, Hynynen fails to teach wherein the ultrasonic waves generated by the ultrasound system are generated by a transducer array of the ultrasound system that has an active area with a surface area greater than 15 cm2.
In an analogous ultrasound imaging field of endeavor, Wodnicki teaches such a feature. Wodnicki teaches ultrasound imaging and monitoring systems ([0003]). Wodnicki teaches transducer arrays typically span an area of about 20 square centimeters ([0007]). Moreover, Wodnicki teaches much larger arrays are required for screening for tumors, on the order of 300 square centimeters ([0007]). Wodnicki therefore teaches using an ultrasound array that has an active area with a surface area of greater than at least 15 square centimeters, the active area being the entire transducer array.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to use a transducer array that has an active area with a surface area of greater than 15 square centimeters as taught by Wodnicki ([0007]). Wodnicki teaches transducer arrays typically span an area of about 20 centimeters squared; therefore, it would be obvious to use such a transducer array as it is typical/conventional ([0007]). Moreover, Wodnicki teaches much larger sized areas may be required for screening tumors ([0007]). Hynynen teaches wherein the transducer array which performs therapy is the same transducer array which images/screens for tumors ([0026]). Therefore, Hynynen modified by the teachings of Wodnicki would predictably result wherein the transducer array of the ultrasound system which applies therapy would similarly have an active area with a surface area greater than 15 cm2.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) and Trahey (US20030171676) as applied to claim 1 above, and further in view of Tijore (US20220203138). Tijore is cited in the IDS filed 09/19/2023.
Regarding claim 5, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 1.
Hynynen further teaches wherein the treatment plan comprises indications of locations to which ultrasound should be applied ([0003], [0011], “Accurate images for lesion localization can be obtained. Localized treatment, e.g., of tissue, can be performed and/or verified following the localization”, [0037], wherein determining elasticity/stiffness identifies locations of tumors to treat).
However, Hynynen fails to teach wherein the treatment plan further comprises durations, frequencies, and power levels at which ultrasound should be applied to the indicated locations.
In an analogous field of cancer treatment planning, Tijore teaches such a feature. Tijore teaches systems and methods for cancer treatment (Title). Tijore teaches internal tissues may be imaged for generating a treatment plan using an imaging modality such as ultrasound imaging ([0062], [0064]). Tijore further teaches one or more characteristics may be determined and specified by the treatment plan, one of which includes information about the treatment region such as its location ([0066], [0090]). Moreover, Tijore teaches the treatment plan may include information regarding duration, magnitude, frequency, and/or cyclic force to be delivered ([0031], [0063] [0066], [0090], wherein magnitude and cyclic force comprises power levels).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to further include the amount of power, duration, and frequency to be delivered in the treatment plan as taught by Tijore ([0031], [0063], [0066], [0090]). By having the treatment plan include the location and correct/appropriate amount of power to be applied, cancer cells may be treated while normal cells may be spared as recognized by Tijore ([0005], [0008], [0030-0032], wherein the duration, magnitude, and frequency of the waves are controlled to sufficiently distort/kill cancer cells while keeping normal/healthy cells and tissues undamaged).
Regarding claim 6, Hynynen in view of Zhou, Trahey, and Tijore teaches the invention as claimed above in claim 5.
Hynynen further teaches wherein the indications of locations to which ultrasound should be applied are based on mechanical properties of the tissue ([0003], [0037], wherein locations to treat are based on elasticity/stiffness).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) Trahey (US20030171676) as applied to claim 8 above, and further in view of Wang (US20200209244).
Regarding claim 9, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
However, Hynynen fails to teach wherein the additional properties of the tumor are determined based on one or more of a blood test, a histology test, and elastography.
In an analogous detection of tumors field of endeavor, Wang teaches such a feature. Wang teaches by performing a blood test from a patient, the stage of tumor progression may be determined from the blood test ([0026-0029]). Wang therefore teaches determining a property (i.e. stage of progression) of a tumor based on a blood test, which is additional to Hynynen’s determination of mechanical properties (i.e. elasticity/stiffness of the tumor).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to determine the stage of progression of the tumor via blood test as taught by Wang ([0026-0029]). By determining the progression of the tumor via the blood test, a medical professional may determine whether a patient’s tumor is shrinking or growing and decide to either continue a selected treatment or change the treatment/therapy.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) Trahey (US20030171676) as applied to claim 8 above, and further in view of Weng (US20010031922).
Regarding claim 11, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
However, Hynynen fails to teach wherein the ultrasonic waves generated by the ultrasound system are generated by a transducer array of the ultrasound system that has elements with a pitch that is less than or equal to a wavelength of the ultrasonic waves.
In an analogous ultrasound transducer for imaging and therapy field of endeavor, Weng teaches such a feature. Weng teaches to provide imaging and therapy functions while having a sharp focus, conventional therapeutic phased array design configurations typically will have an element pitch size about 0.5 to 0.7 times the wavelength of the ultrasound beam it produces ([0011]). Weng therefore teaches a transducer array having a pitch that is less than a wavelength of the ultrasound wave it produces (wherein 0.5 to 0.7 times the wavelength of the ultrasound wave/beam is less than the wavelength of the ultrasound waves).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the transducer array have elements with a pitch less than the wavelength of the ultrasound waves it produces as taught by Weng ([0011]). Phased transducer arrays of this configuration are typical/conventional and are able to treat lesions and have a sharp focus as recognized by Weng ([0011]).
Regarding claim 15, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
Hynynen further teaches performing high intensity focused ultrasound (HIFU) for treating tumorous tissue ([0037], “Further, for therapy, the FUS transducers 18, 20 may have high intensities such that the ultrasound from the transducers 18, 20 induces coagulation of tissue in the target region 44”).
However, Hynynen fails to explicitly teach wherein the ultrasonic waves generated by the ultrasound system are generated with a maximum temperature in air greater than 50C or greater than 27C over ambient temperature.
In an analogous ultrasound transducer for imaging and therapy field of endeavor, Weng helps teach such a feature. Weng teaches wherein high intensity focused ultrasound (HIFU) can raise tissue temperature to above 60 degrees Celsius ([0004]).
While Hynynen in view of Weng fails to teach wherein ultrasonic waves are generated with a maximum temperature in air is greater than 50C or greater than 27C over ambient temperature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of Hynynen to do so. Hynynen teaches performing high intensity focused ultrasound (HIFU) which generates heat ([0037]). Weng teaches wherein this heat may cause tissue to rise up to 60C ([0004]). Thus, Hynynen in view of Weng teaches at least generating or raising the temperature of the surrounding air as a result of raising the temperature of the tissue via ultrasound. Thus, Hynynen in view of Weng teaches the claimed feature except for the specific maximum temperature of the ultrasonic waves in air being greater than 50C or greater than 27C over ambient temperature. This “greater than 50C or greater than 27C over ambient temperature” parameter comprise an optimized parameter and a result-effective variable. The higher the temperature, the faster the tissue (i.e. tumors) can be necrosed and destroyed. Thus, an ordinarily skilled artisan through routine experimentation may arrive at this claimed value of greater than 50C or greater than 27C over ambient by optimizing for treatment of tissue using high intensity focused ultrasound which relies on heat. In addition, Applicant’s specification fails to disclose the criticality of such a maximum temperature. See MPEP §2144.05 (II), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation’”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) and Trahey (US20030171676) as applied to claim 8 above, and further in view of Cain (US20130102932).
Regarding claim 13, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
However, Hynynen fails to teach wherein the ultrasonic waves generated by the ultrasound system are generated by a transducer array of the ultrasound system that has an output power with a spatial peak pulse average intensity (Isppa) equal to or greater than 190mW/cm2.
In an analogous ultrasound imaging and treatment of lesions field of endeavor, Cain teaches such a feature. Cain teaches performing ultrasound shear wave elastography for monitoring and guiding histotripsy treatment (Title, Abstract, [0023], [0037], [0063-0064]). Cain teaches wherein the therapeutic transducer array fires or pushes multiple ultrasound beams with a 2.3, 2.5, and 2.8 kW/cm2 spatial peak pulse average intensity (Isppa) on tissue ([0077], Table 1, wherein 2.3, 2.5, and 2.8 kW/cm2 are greater than 190mW/cm2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the transducer array be configured to output power with a spatial peak pulse average intensity greater than 190mW/cm2 as taught by Cain ([0077], Table 1). Shear waves generated using these parameters (Table 1) taught by Cain may be used to determine elasticity of the tissue and thus used to monitor/detect treatment progress as recognized by Cain (Abstract, [0013], [0078-0080], [0105]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hynynen (US20050004466) in view of Zhou (US20190271025) and Trahey (US20030171676) as applied to claim 8 above, and further in view of Xie (US20170188997).
Regarding claim 14, Hynynen in view of Zhou and Trahey teaches the invention as claimed above in claim 8.
However, Hynynen fails to teach wherein the ultrasonic waves generated by the ultrasound system are generated with a Mechanical Index (MI) of greater than 1.9.
In an analogous method for treating tumors using ultrasound field of endeavor, Xie teaches such a feature. Xie teaches targeted tumor ablation and using ultrasound shear wave elastography to monitor the ablation ([0003], [0015]). Xie teaches using ultrasound pulses exceeding the mechanical index (MI) regulatory limit of 1.9 (Abstract, [0012], [0015], [0018], [0029], [0044]). Xie teaches by exceeding the limit, greater signal-to-noise ratio (SNR) may be achieved ([0010], [0028]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hynynen to have the ultrasound waves generated by the transducer array exceed a mechanical index (MI) of 1.9 as taught by Xie (Abstract, [0018], [0029], [0044]). By exceeding the limit of 1.9, greater SNR may be achieved as recognized by Xie ([0010], [0028]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797