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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Shamir et al. (hereinafter ‘Shamir’, U.S. PGPub No. 2021/0299439).
In regards to claim 1, Shamir discloses a computer-implemented method to determine locations of transducers to apply tumor treating fields to a target tissue of a subject's body, the method comprising: obtaining a three-dimensional model of at least a portion of the subject's body (see Abstract, [0005]: "Another aspect of the invention is directed to another method of assisting transducer placements on a subject's body for applying tumor treating fields. The method comprises: generating, based on a first image data, a three-dimensional (3D) model of a portion of the subject's body, wherein the 3D model comprising a presentation of one or more recommended transducer placement positions..."), and identifying a first location on the three-dimensional model to place a first transducer, simulating administering TTFields in a frequency range of 50 kHz to 1 MHz to the subject's body using the first transducer at the first location ([0052]: "The signal generator 108 may be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (e.g., the TTFields)."), wherein the first transducer has a first surface to be located facing the subject's body, wherein the first transducer has at least one electrode element adapted to provide tumor treating fields, wherein when viewed from a direction perpendicular to the first surface of the first transducer, an area of the at least one electrode element of the first transducer ranges from approximately 150 cm2 to approximately 265 cm2 (see Figs. 12A-12D).
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In regards to claim 2, Shamir discloses obtaining a second transducer and identifying a second location on the three-dimensional model to place a second transducer, wherein the second transducer has a second surface to be located facing the subject's body, wherein the second transducer has at least one electrode element adapted to provide tumor treating fields, wherein when viewed from a direction perpendicular to the second surface of the second transducer, an area of the at least one electrode element of the second transducer ranges from approximately 150 cm2 to approximately 265 cm2 ([0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions.").
In regards to claim 3, Shamir discloses that the target tissue is located in an organ of the subject's body, wherein an area of the organ is determined when viewed from a direction perpendicular to the first location for the first transducer, wherein the area of the first transducer is less than or equal to approximately 70% of the area of the organ ([0077]: "The patient model may be a digital representation in three-dimensional space of the portion of the patient's body, including internal structures, such as tissues, organs, tumors, etc.").
In regards to claim 4, Shamir discloses that the area of the first transducer is less than or equal to approximately 50% of the area of the organ ([0080]: "A pair of transducer arrays may be systematically rotated around the z-axis of the head model, i.e. in the xy-plane, from 0 to 180 degrees, thereby covering the entire circumference of the head (by symmetry).").
In regards to claim 5, Shamir discloses that the at least one electrode element of the first transducer comprises at least one ceramic disk that is adapted to generate an alternating electric field ([0055]: "The one or more electrodes 116 may comprise, for example, one or more insulated ceramic discs. ").
In regards to claim 6, Shamir discloses that the first transducer is adapted to be located on a torso of the subject ([0085]: "In another embodiment, an augmented reality assistance tool may use the three-dimensional array layout map to assist the patient and/or a patient caregiver to affix one or more transducer arrays to an associated portion of the patient's body (e.g., head, torso, etc.).").
In regards to claim 7, Shamir discloses a computer-implemented method to determine locations of transducers to apply tumor treating fields to a target tissue of a subject's body, the method comprising: obtaining a three-dimensional model of at least a portion of the subject's body (see Abstract, [0005]: "Another aspect of the invention is directed to another method of assisting transducer placements on a subject's body for applying tumor treating fields. The method comprises: generating, based on a first image data, a three-dimensional (3D) model of a portion of the subject's body, wherein the 3D model comprising a presentation of one or more recommended transducer placement positions..."), identifying a first location on the three-dimensional model to place a first transducer of the first transducer ([0052]: "The signal generator 108 may be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (e.g., the TTFields)."), 'identifying a second location on the three-dimensional model to place a second transducer ([0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions."), and simulating administering TTFields in a frequency range of 50 kHz to 1 MHz to the subject's body using the first transducer at the first location; and simulating administering TTFields in the frequency range of 50 kHz to 1 MHz to the subject's body using the second transducer at the second location (see [0052]), determining the first location with the first transducer provides more tumor treating fields to the target tissue than the second location with the second transducer, wherein the first and second transducers each have a first surface to be located facing the subject's body, wherein the first and second transducers each have at least one electrode element adapted to provide tumor treating fields, wherein when viewed from a direction perpendicular to the first surface of the first transducer, an area of the at least one electrode element of the first transducer is less than or equal to approximately 50% of an area of the at least one electrode element of the second transducer ([0080]: "A pair of transducer arrays may be systematically rotated around the z-axis of the head model, i.e. in the xy-plane, from 0 to 180 degrees, thereby covering the entire circumference of the head (by symmetry).").
In regards to claim 8, Shamir discloses that when viewed from a direction perpendicular to the first surface of the second transducer, an area of the at least one electrode element of the second transducer ranges from approximately 300 cm2 to approximately 525 cm2 ([0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions.").
In regards to claim 9, Shamir discloses that the target tissue is located in an organ of the subject's body, wherein an area of the organ is determined when viewed from a direction perpendicular to the first location for the first transducer, wherein the area of the first transducer is less than or equal to approximately 70% of the area of the organ ([0077]: "The patient model may be a digital representation in three-dimensional space of the portion of the patient's body, including internal structures, such as tissues, organs, tumors, etc.").
In regards to claim 10, Shamir discloses that the area of the first transducer is less than or equal to approximately 50% of the area of the organ ([0080]: "A pair of transducer arrays may be systematically rotated around the z-axis of the head model, i.e. in the xy-plane, from 0 to 180 degrees, thereby covering the entire circumference of the head (by symmetry).").
In regards to claim 11, Shamir discloses that the first transducer and the second transducer are adapted to be located on a torso of the subject ([0085]: "In another embodiment, an augmented reality assistance tool may use the three-dimensional array layout map to assist the patient and/or a patient caregiver to affix one or more transducer arrays to an associated portion of the patient's body (e.g., head, torso, etc.).").
In regards to claim 12, Shamir discloses a system to apply tumor treating fields to a target tissue of a subject's body, the system comprising: a first transducer adapted to be located at a first location of the subject's body (see Abstract, [0005]: "Another aspect of the invention is directed to another method of assisting transducer placements on a subject's body for applying tumor treating fields. The method comprises: generating, based on a first image data, a three-dimensional (3D) model of a portion of the subject's body, wherein the 3D model comprising a presentation of one or more recommended transducer placement positions..."), a second transducer adapted to be located at a second location of the subject's body, wherein the target tissue is to be located between the first transducer and the second transducer ([0082]: "One or more sets of pairs of positions of the plurality of pairs of positions that satisfy an angular restriction between pairs of transducer arrays may be determined. For example, the angular restriction may be and/or indicate an orthogonal angle between the plurality of pairs of transducer arrays."), a voltage generator adapted to provide a first voltage to the first transducer and a second voltage to the second transducer ([0052]: "The signal generator 108 may generate one or more electric signals in the shape of waveforms or trains of pulses. The signal generator 108 may be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (e.g., the TTFields)."), and a controller coupled to the voltage generator, wherein the controller is adapted to instruct the voltage generator to induce a first alternating electric field between at least part of the first transducer and at least part of the second transducer, wherein the first alternating electric field has a frequency range of 50 kHz to 1 MHz, wherein the first transducer has a first surface to be located facing the subject's body, wherein the first transducer has at least one electrode element adapted to be coupled to the voltage generator, wherein when viewed from a direction perpendicular to the first surface of the first transducer, an area of the at least one electrode element of the first transducer ranges from approximately 150 cm2 to approximately 265 cm2 ([0051]: "The electrical field generator 102 may comprise control software 110 configured for controlling the performance of the processor 106 and the signal generator 108.", [0052]: "The signal generator 108 may be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (e.g., the TTFields).", [0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions.").
In regards to claim 13, Shamir discloses that the second transducer has a second surface to be located facing the subject's body, wherein the second transducer has at least one electrode element adapted to be coupled to the voltage generator, wherein when viewed from a direction perpendicular to the second surface of the second transducer, an area of the at least one electrode element of the second transducer ranges from approximately 150 cm2 to approximately 265 cm2 ([0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions.").
In regards to claim 14, Shamir discloses a third transducer adapted to be located at a third location of the subject's body and a fourth transducer adapted to be located at a fourth location of the subject's body, wherein the target tissue is to be located between the third transducer and the fourth transducer, wherein the voltage generator is adapted to provide a third voltage to the third transducer and a fourth voltage to the fourth transducer, wherein the controller is adapted to instruct the voltage generator to induce a second alternating electric field between at least part of the third transducer and at least part of the fourth transducer ([0082]: "One or more sets of pairs of positions of the plurality of pairs of positions that satisfy an angular restriction between pairs of transducer arrays may be determined.").
In regards to claim 15, Shamir discloses that the at least one electrode element of the first transducer or the second transducer comprises at least one ceramic disk that is adapted to generate an alternating electric field ([0055]: "The one or more electrodes 116 may comprise, for example, one or more insulated ceramic discs.").
In regards to claim 16, Shamir discloses that at least one electrode element of the first or the second transducer comprises a polymer film that is adapted to generate an alternating field ([0081]: "However, as TTFields employ alternating fields, this choice is arbitrary and does not influence the results.").
In regards to claim 17, Shamir discloses that the first transducer or the second transducer is triangular, rectangular, circular, oval, ovaloid, ovoid, or elliptical in shape or substantially triangular, substantially rectangular, substantially circular, substantially oval, substantially ovaloid, substantially ovoid, or substantially elliptical in shape ([0054]: "The one or more transducer arrays 104 may be configured in a variety of shapes and positions so as to generate an electrical field of the desired configuration, direction and intensity at a target volume so as to focus treatment.").
In regards to claim 18, Shamir discloses a method of applying tumor treating fields to a target tissue of a subject's body, the method comprising: locating a first transducer at a first location of the subject's body (see Abstract, [0005]: "Another aspect of the invention is directed to another method of assisting transducer placements on a subject's body for applying tumor treating fields. The method comprises: generating, based on a first image data, a three-dimensional (3D) model of a portion of the subject's body, wherein the 3D model comprising a presentation of one or more recommended transducer placement positions..."), locating a second transducer at a second location of the subject's body, wherein the target tissue is located between the first transducer and the second transducer ([0082]: "For example, a first electrical field generated by a first transducer array may be simulated at a first position, a second electrical field generated by a second transducer array may be simulated at a second position opposite the first position, and, based on the first electrical field and the second electrical field, the simulated electrical field distribution may be determined. In some instances, a third electrical field generated by the first transducer array may be simulated at a third position, and a fourth electrical field generated by the second transducer array may be simulated at a fourth position opposite the third position, and, based on the third electrical field and the fourth electrical field, the simulated electrical field distribution may be determined. The method may include determining, for each pair of positions of the plurality of pairs positions on the modified plane, a simulated electrical field distribution, and determining, based on the simulated electrical field distributions, a dose metric for each pair of positions of the plurality of pairs positions."), and inducing a first electric field between at least part of the first transducer and at least part of the second transducer, wherein the first electric field has a frequency range of 50 kHz to 1 MHz, wherein the first transducer has a first surface located facing the subject's body, wherein the first transducer has at least one electrode element adapted to be coupled to the voltage generator, wherein when viewed from a direction perpendicular to the first surface of the first transducer, an area of the at least one electrode element of the first transducer ranges from approximately 150 cm2 to approximately 265 cm2 ([0052]: "The signal generator 108 may be configured to generate an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (e.g., the TTFields).", see Figs. 12A-12D).
In regards to claim 19, Shamir discloses that the second transducer has a second surface to be located facing the subject's body, wherein the second transducer has at least one electrode element adapted to be coupled to the voltage generator, wherein when viewed from a direction perpendicular to the second surface of the second transducer, an area of the at least one electrode element of the second transducer ranges from approximately 150 cm2 to approximately 265 cm2 (see Figs. 12A-12D).
In regards to claim 20, Shamir discloses that the target tissue is located in an organ of the subject's body, wherein an area of the organ is determined when viewed from a direction perpendicular to the first location for the first transducer, wherein the area of the first transducer is less than or equal to approximately 70% of the area of the organ ([0077]: "The patient model may be a digital representation in three-dimensional space of the portion of the patient's body, including internal structures, such as tissues, organs, tumors, etc.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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