DETAILED ACTION
Applicant’s arguments, filed on 11/03/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 11/03/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-3, 5-12, and 14-20 are the current claims hereby under examination.
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 § 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 10-12 and 14-18 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.
Regarding claim 10, the claim recites the limitation “a specified percept” in line 27. It is unclear if this is the same specified percept from line 20 or a different specified percept. If it is the same percept, it needs to refer back to it. If it is a different percept, it needs to be distinguished from the specified percept introduced earlier in the claim. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the specified percept from line 20. Claims 11-12 and 14-18 are also rejected due to their dependence from claim 10.
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 1, 6, 10, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over CN ‘113 (CN 113456110) in further view of Muse (US 20230081608), Patterson (US 20220095996), and Kopelman (WO 2018051220). Citations to CN 113456110 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, CN ‘113 teaches a system (Abstract: “The invention provides breast diagnosis and treatment equipment, and particularly relates to medical equipment for human breast examination and treatment”), comprising:
a padded platform (Abstract: “a diagnosis and treatment bed for enabling a subject to be in a prone position”), wherein the padded platform includes an aperture, and wherein the padded platform is shaped to permit a patient to lay prone on the platform with skin of the patient located within the aperture ([0013]: “the diagnosis and treatment bed is provided with a through hole for allowing the examinee's breast to pass through”);
a sensor configured to detect at least one of a pressure, a strain, a force, or a displacement at a sensor probe of the sensor (Abstract: “a palpation detection part for collecting breast pressure distribution data of the subject”; [0018]: “the adjustment member includes a pressure sensor, which maintains continuous contact with the subject's breast, feeds back pressure data collected by the pressure sensor at the contact position”);
an armature (Abstract: “an adjusting component, which is used for adjusting the pressure among the palpation detection part”), wherein the sensor is coupled to the armature, and wherein the armature is configured to bring the sensor probe into contact with the skin of the patient when the patient is laying prone on the platform such that the skin of the patient is located within the aperture ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
However, CN ‘113 does not teach a user interface.
Muse discloses an apparatus for observing neuropathy of a patient. Specifically, Muse teaches a user interface ([0049]: “The user computing entity 20 may also comprise a user interface device comprising one or more user input/output interfaces (e.g., a display 316 and/or speaker/speaker driver coupled to a processing element 308 and a touch interface, keyboard, mouse, and/or microphone coupled to a processing element 308)”). CN ‘113 and Muse are analogous arts as they are both systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from CN ‘113 as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
The CN ‘113/Muse combination teaches a controller, wherein the controller is operably coupled to the sensor and the user interface (CN ‘113, [0057]: “The mechanical carrier 43 controls the palpation detection unit 41 and the ultrasonic detection unit 42 to diagnose and treat the breast 11 of the examinee 1 at a certain angle to the horizontal plane. “; Claim 1: “the mechanical carrier (43) comprises a controller (433), for controlling the diagnosis and treatment main body”), and wherein the controller is configured to:
operate the sensor during a first period of time to detect the at least one of a pressure, a strain, a force, or a displacement at the sensor probe when the sensor probe is brought into contact with the skin of the patient at a first location of the skin (CN ‘113, [0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
However, the CN ‘113/Muse combination does not teach operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time.
Muse teaches operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time ([0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from the CN ‘113/Muse combination as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
However, the CN ‘113/Muse combination does not teach operating the sensor during a second period of time.
Patterson discloses a wearable medical device. Specifically, Patterson teaches operating the sensor during a second period of time ([0073]: “a sensor measurement for a first sensor during a first time period may be of 120 mmHg and the same sensor providing a second sensor measurement for a second time period may be 130 mmHg”). CN ‘113, Muse, and Patterson are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second period of time from Patterson into the system from the CN ‘113/Muse combination as it allows the system to take measurements over time, which can allow the system to track the health status of the user and monitor it over time.
However, the CN ‘113/Muse/Patterson combination does not teach the sensor probe being brought into contact with the skin of the patient at a second location that differs from the first location.
Kopelman teaches a device for detecting irregularities in soft tissue. Specifically, Kopelman teaches the sensor probe is brought into contact with the skin of the patient at a second location of the skin that differs from the first location ([239]: “a pressure distribution map of a screened breast is compared to a pressure distribution map of a heathy breast, for example compared to the second breast of the patient and/or to previous screening of the currently screened breast and/or to an expected pressure distribution calculated based on reference data”). CN ‘113, Muse, and Kopelman are analogous arts as they are all related to devices that provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensor probe contacting a different location from Kopelman into the CN ‘113/Muse/Patterson combination as it allows the device to measure different locations of the user’s skin, which can provide a more comprehensive analysis of the user’s health status.
The CN ‘113/Muse/Patterson/Kopelman combination teaches operate the user interface to receive a second input during or after the second period of time that is indicative of whether the patient experienced the specified percept during the second period of time (Muse, [0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Regarding claim 6, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach wherein the user interface comprises a display, and wherein the controller is additionally configured to: operate the display of the user interface during or after the second period of time to provide, to a patient laying prone on the platform such that the breast of the patient is located within the aperture, an indication that the patient should provide feedback related to whether the patient experienced the specified percept during the first period of time.
Muse teaches wherein the user interface comprises a display ([0049]: “The user computing entity 20 may also comprise a user interface device comprising one or more user input/output interfaces (e.g., a display 316 and/or speaker/speaker driver coupled to a processing element 308 and a touch interface, keyboard, mouse, and/or microphone coupled to a processing element 308). For example, the user interface may be configured to provide a mobile application, browser, interactive user interface, dashboard, webpage, and/or similar words used herein interchangeably executing on and/or accessible via the user computing entity 20 to cause display or audible presentation of information/data and for user interaction therewith via one or more user input interfaces.”), and wherein the controller is additionally configured to: operate the display of the user interface during or after the first period of time to provide, to the patient laying prone on the platform such that the skin of the patient is located within the aperture, an indication that the patient should provide feedback related to whether the patient experienced the specified percept during the first period of time ([0083]: “the system is configured to apply all pulse signals of a series of pulse signals before requesting user input”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the display and the request for user input from Muse into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide information to the user and prompt the user to provide input when it is necessary, therefore ensuring that the user provides the required information to the system so it can operate correctly.
Regarding independent claim 10, CN ‘113 teaches a system (Abstract: “The invention provides breast diagnosis and treatment equipment, and particularly relates to medical equipment for human breast examination and treatment”), comprising:
a padded platform (Abstract: “a diagnosis and treatment bed for enabling a subject to be in a prone position”), wherein the padded platform includes an aperture, and wherein the padded platform is shaped to permit a patient to lay prone on the platform with at least one of: a breast of the patient located within the aperture, a portion of a chest of the patient spanning the aperture, or a portion of an abdomen of the patient spanning the aperture ([0013]: “the diagnosis and treatment bed is provided with a through hole for allowing the examinee's breast to pass through”);
a sensor configured to detect at least one of a pressure, a strain, a force, or a displacement at a sensor probe of the sensor (Abstract: “a palpation detection part for collecting breast pressure distribution data of the subject”; [0018]: “the adjustment member includes a pressure sensor, which maintains continuous contact with the subject's breast, feeds back pressure data collected by the pressure sensor at the contact position”);
an armature (Abstract: “an adjusting component, which is used for adjusting the pressure among the palpation detection part”), wherein the sensor is coupled to the armature, and wherein the armature is configured to bring the sensor probe into contact with skin of the breast, chest, or abdomen of the patient when the patient is laying prone on the platform such that at least one of: the breast of the patient is located within the aperture, the portion of the chest of the patient is spanning the aperture, or the portion of the abdomen of the patient is spanning the aperture ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
However, CN ‘113 does not teach a user interface.
Muse discloses an apparatus for observing neuropathy of a patient. Specifically, Muse teaches a user interface ([0049]: “The user computing entity 20 may also comprise a user interface device comprising one or more user input/output interfaces (e.g., a display 316 and/or speaker/speaker driver coupled to a processing element 308 and a touch interface, keyboard, mouse, and/or microphone coupled to a processing element 308)”). CN ‘113 and Muse are analogous arts as they are both systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from CN ‘113 as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
The CN ‘113/Muse combination teaches a controller, wherein the controller is operably coupled to the sensor and the user interface (CN ‘113, [0057]: “The mechanical carrier 43 controls the palpation detection unit 41 and the ultrasonic detection unit 42 to diagnose and treat the breast 11 of the examinee 1 at a certain angle to the horizontal plane. “; Claim 1: “the mechanical carrier (43) comprises a controller (433), for controlling the diagnosis and treatment main body”), and wherein the controller is configured to:
operate the sensor during a first period of time to detect the at least one of a pressure, a strain, a force, or a displacement at the sensor probe when the sensor probe is brought into contact with the skin of the patient at a first location (CN ‘113, [0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
However, the CN ‘113/Muse combination does not teach operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time.
Muse teaches operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time ([0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from the CN ‘113/Muse combination as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
However, the CN ‘113/Muse combination does not teach operating the sensor during a second period of time.
Patterson discloses a wearable medical device. Specifically, Patterson teaches operating the sensor during a second period of time ([0073]: “a sensor measurement for a first sensor during a first time period may be of 120 mmHg and the same sensor providing a second sensor measurement for a second time period may be 130 mmHg”). CN ‘113, Muse, and Patterson are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second period of time from Patterson into the system from the CN ‘113/Muse combination as it allows the system to take measurements over time, which can allow the system to track the health status of the user and monitor it over time.
However, the CN ‘113/Muse/Patterson combination does not teach the sensor probe being brought into contact with the skin of the patient at a second location that differs from the first location.
Kopelman teaches a device for detecting irregularities in soft tissue. Specifically, Kopelman teaches the sensor probe is brought into contact with the skin of the patient at a second location of the skin that differs from the first location ([239]: “a pressure distribution map of a screened breast is compared to a pressure distribution map of a heathy breast, for example compared to the second breast of the patient and/or to previous screening of the currently screened breast and/or to an expected pressure distribution calculated based on reference data”). CN ‘113, Muse, and Kopelman are analogous arts as they are all related to devices that provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensor probe contacting a different location from Kopelman into the CN ‘113/Muse/Patterson combination as it allows the device to measure different locations of the user’s skin, which can provide a more comprehensive analysis of the user’s health status.
The CN ‘113/Muse/Patterson/Kopelman combination teaches operate the user interface to receive a second input during or after the second period of time that is indicative of whether the patient experienced the specified percept during the second period of time (Muse, [0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Regarding claim 15, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach wherein the user interface comprises a display, and wherein the controller is additionally configured to: operate the display of the user interface during or after the second period of time to provide, to a patient laying prone on the platform such that the breast of the patient is located within the aperture, an indication that the patient should provide feedback related to whether the patient experienced the specified percept during the first period of time.
Muse teaches wherein the user interface comprises a display ([0049]: “The user computing entity 20 may also comprise a user interface device comprising one or more user input/output interfaces (e.g., a display 316 and/or speaker/speaker driver coupled to a processing element 308 and a touch interface, keyboard, mouse, and/or microphone coupled to a processing element 308). For example, the user interface may be configured to provide a mobile application, browser, interactive user interface, dashboard, webpage, and/or similar words used herein interchangeably executing on and/or accessible via the user computing entity 20 to cause display or audible presentation of information/data and for user interaction therewith via one or more user input interfaces.”), and wherein the controller is additionally configured to: operate the display of the user interface during or after the first period of time to provide, to the patient laying prone on the platform, an indication that the patient should provide feedback related to whether the patient experienced the specified percept during the first period of time ([0083]: “the system is configured to apply all pulse signals of a series of pulse signals before requesting user input”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the display and the request for user input from Muse into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide information to the user and prompt the user to provide input when it is necessary, therefore ensuring that the user provides the required information to the system so it can operate correctly.
Regarding independent claim 19, CN ‘113 teaches a method for quantitatively assessing tactile acuity of a breast of a patient (Abstract: “The invention provides breast diagnosis and treatment equipment, and particularly relates to medical equipment for human breast examination and treatment”), the method comprising:
bringing a sensor probe of a sensor into contact with a breast of a patient (Abstract: “a palpation detection part for collecting breast pressure distribution data of the subject”; [0018]: “the adjustment member includes a pressure sensor, which maintains continuous contact with the subject's breast, feeds back pressure data collected by the pressure sensor at the contact position”) when the patient is laying prone on a padded platform (Abstract: “a diagnosis and treatment bed for enabling a subject to be in a prone position”) such that the breast of the patient is located within an aperture of the padded platform ([0013]: “the diagnosis and treatment bed is provided with a through hole for allowing the examinee's breast to pass through”);
operating the sensor during a first period of time to detect at least one of a pressure, a strain, a force, or a displacement at a sensor probe of the sensor when the sensor probe is in contact with the breast of the patient at a first location of the breast ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
However, CN ‘113 does not teach operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time.
Muse teaches operating a user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time ([0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from CN ‘113 as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
However, the CN ‘113/Muse combination does not teach operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time.
Muse teaches operate the user interface to receive a first input during or after the first period of time that is indicative of whether the patient experienced a specified percept during the first period of time ([0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user interface from Muse into the system from the CN ‘113/Muse combination as it allows the system to gather information from the user, which can assist in the analysis and provide a more accurate result.
However, the CN ‘113/Muse combination does not teach operating the sensor during a second period of time.
Patterson discloses a wearable medical device. Specifically, Patterson teaches operating the sensor during a second period of time ([0073]: “a sensor measurement for a first sensor during a first time period may be of 120 mmHg and the same sensor providing a second sensor measurement for a second time period may be 130 mmHg”). CN ‘113, Muse, and Patterson are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second period of time from Patterson into the system from the CN ‘113/Muse combination as it allows the system to take measurements over time, which can allow the system to track the health status of the user and monitor it over time.
However, the CN ‘113/Muse/Patterson combination does not teach the sensor probe being brought into contact with the skin of the patient at a second location that differs from the first location.
Kopelman teaches a device for detecting irregularities in soft tissue. Specifically, Kopelman teaches the sensor probe is brought into contact with the breast of the patient at a second location of the breast that differs from the first location ([239]: “a pressure distribution map of a screened breast is compared to a pressure distribution map of a heathy breast, for example compared to the second breast of the patient and/or to previous screening of the currently screened breast and/or to an expected pressure distribution calculated based on reference data”). CN ‘113, Muse, and Kopelman are analogous arts as they are all related to devices that provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensor probe contacting a different location from Kopelman into the CN ‘113/Muse/Patterson combination as it allows the device to measure different locations of the user’s skin, which can provide a more comprehensive analysis of the user’s health status.
The CN ‘113/Muse/Patterson/Kopelman combination teaches operate the user interface to receive a second input during or after the second period of time that is indicative of whether the patient experienced the specified percept during the second period of time (Muse, [0083]: “The user input may be provided directly into a user interface of the controller 501”; [0084]: “the user input indicates that the patient felt 3 pulses”).
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the CN ‘113/Muse/Patterson/Kopelman combination as applied to claims 1 and 10 above, and further in view of Campisi (WO 2021011757).
Regarding claim 2, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach wherein the user interface comprises a button that is configured to be pressed by the patient when the patient is laying prone on the platform such that the breast of the patient is located within the aperture.
Campisi discloses a system for measuring tissue parameters using a tactile sensor. Specifically, Campisi teaches wherein the user interface comprises a button that is configured to be pressed by the patient when the patient is laying prone on the platform such that the skin of the patient is located within the aperture ([0048]: “gripping surface 413 includes one or more buttons or other control elements allowing the operator to control the sensor assembly, for example to start or stop measurements or to zero out the sensor for calibration purposes”). CN ‘113, Muse, and Campisi are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the button from Campisi into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to let the user control the system and the operation process.
Regarding claim 11, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach wherein the user interface comprises a button that is configured to be pressed by the patient when the patient is laying prone on the platform such that at least one: of the breast of the patient is located within the aperture, the portion of the chest of the patient is spanning the aperture, or the portion of the abdomen of the patient is spanning the aperture.
Campisi teaches wherein the user interface comprises a button that is configured to be pressed by the patient when the patient is laying prone on the platform such that at least one: of the breast of the patient is located within the aperture, the portion of the chest of the patient is spanning the aperture, or the portion of the abdomen of the patient is spanning the aperture ([0048]: “gripping surface 413 includes one or more buttons or other control elements allowing the operator to control the sensor assembly, for example to start or stop measurements or to zero out the sensor for calibration purposes”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the button from Campisi into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to let the user control the system and the operation process.
Claims 3, 5, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the CN ‘113/Muse/Patterson/Kopelman combination as applied to claims 1 and 10 above, and further in view of Tahghighi (WO 2021151167).
Regarding claim 3, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a vibrator coupled to the sensor probe, wherein the controller is additionally configured to, during the first period of time, operate the vibrator to provide a vibratory stimulus.
Tahghighi discloses a wearable apparatus for treating mastitis. Specifically, Tahghighi teaches further comprising a vibrator coupled to the sensor probe, wherein the controller is additionally configured to, during the first period of time, operate the vibrator to provide a vibratory stimulus ([0012]: “The wearable may further comprise micro stimulation vibrators which induce micro vibrations under the epidermis of the breast thereby enhancing micro circulation and therefore healing”). CN ‘113, Muse, and Tahghighi are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the vibration from Tahghighi into the system from CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide a stimulus that can assist in healing, which can allow the system not only to measure physiological parameters, but also promote circulation and healing.
Regarding claim 5, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a stimulator coupled to the armature, wherein the controller is additionally configured to: operate the stimulator during and/or prior to the first period of time to provide a first stimulus via the sensor probe; and operate the stimulator during and/or prior to the second period of time to provide a second stimulus via the sensor probe, wherein the first stimulus and second stimulus differ with respect to at least one of pressure, force, displacement, or location at which the first and second stimuli are applied to the breast of the patient.
Tahghighi teaches further comprising a stimulator coupled to the armature, wherein the controller is additionally configured to: operate the stimulator during and/or prior to the first period of time to provide a first stimulus via the sensor probe; and operate the stimulator during and/or prior to the second period of time to provide a second stimulus via the sensor probe ([0012]: “The wearable may further comprise micro stimulation vibrators which induce micro vibrations under the epidermis of the breast thereby enhancing micro circulation and therefore healing”), wherein the first stimulus and second stimulus differ with respect to at least one of pressure, force, displacement, or location at which the first and second stimuli are applied to the skin of the patient ([0118]: “The user may control the touch sensitive backing to apply different wavelengths and/or micro stimulation vibrations including of different frequencies.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the vibration from Tahghighi into the system from CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide a stimulus that can assist in healing, which can allow the system not only to measure physiological parameters, but also promote circulation and healing.
Regarding claim 12, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a vibrator coupled to the sensor probe, wherein the controller is additionally configured to, during the first period of time, operate the vibrator to provide a vibratory stimulus.
Tahghighi teaches further comprising a vibrator coupled to the sensor probe, wherein the controller is additionally configured to, during the first period of time, operate the vibrator to provide a vibratory stimulus ([0012]: “The wearable may further comprise micro stimulation vibrators which induce micro vibrations under the epidermis of the breast thereby enhancing micro circulation and therefore healing”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the vibration from Tahghighi into the system from CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide a stimulus that can assist in healing, which can allow the system not only to measure physiological parameters, but also promote circulation and healing.
Regarding claim 14, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a stimulator coupled to the armature, wherein the controller is additionally configured to: operate the stimulator during and/or prior to the first period of time to provide a first stimulus via the sensor probe; and operate the stimulator during and/or prior to the second period of time to provide a second stimulus via the sensor probe, wherein the first stimulus and second stimulus differ with respect to at least one of pressure, force, displacement, or location at which the first and second stimuli are applied to the breast of the patient.
Tahghighi teaches further comprising a stimulator coupled to the armature, wherein the controller is additionally configured to: operate the stimulator during and/or prior to the first period of time to provide a first stimulus via the sensor probe; and operate the stimulator during and/or prior to the second period of time to provide a second stimulus via the sensor probe ([0012]: “The wearable may further comprise micro stimulation vibrators which induce micro vibrations under the epidermis of the breast thereby enhancing micro circulation and therefore healing”), wherein the first stimulus and second stimulus differ with respect to at least one of pressure, force, displacement, or location at which the first and second stimuli are applied to the breast of the patient ([0118]: “The user may control the touch sensitive backing to apply different wavelengths and/or micro stimulation vibrations including of different frequencies.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the vibration from Tahghighi into the system from CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to provide a stimulus that can assist in healing, which can allow the system not only to measure physiological parameters, but also promote circulation and healing.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over the CN ‘113/Muse/Patterson/Kopelman combination as applied to claims 1 and 10 above, and further in view of Kandlikar (US 20190385308).
Regarding claim 7, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a second sensor operably coupled to the controller and the user interface, wherein the second sensor is configured to detect visual changes in the breast when the sensor probe is brought into contact with the breast of the patient.
Kandlikar discloses a system to identify regions in the breast tissue of a user. Specifically, Kandlikar teaches further comprising a second sensor operably coupled to the controller and the user interface, wherein the second sensor is configured to detect visual changes in the skin when the sensor probe is brought into contact with the skin of the patient ([0068]: “Mastectomies, lumpectomies and other forms of scar tissue may create variations in thermal images or create confusing distortion. Combining IR imaging with visual data could help in determining if various thermal distortions should be examined more closely. However, obtaining visual images can be a sensitive issue from privacy considerations. Instead of digital photography, the tissue surface may be digitally reproduced using MRI images. Digital reproduction of a body part can be accomplished through other imaging modalities, including but not limited to, infrared imaging, outline capture techniques, shadow techniques, etc.”). CN ‘113, Muse, and Kandlikar are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the visual sensor from Kandlikar into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows another method of measuring the health of the user, which can improve the analysis by providing another type of measurement to the device.
Regarding claim 16, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising a second sensor operably coupled to the controller and the user interface, wherein the second sensor is configured to detect visual changes in the breast when the sensor probe is brought into contact with the breast of the patient.
Kandlikar teaches further comprising a second sensor operably coupled to the controller and the user interface, wherein the second sensor is configured to detect visual changes in the breast when the sensor probe is brought into contact with the skin of the patient ([0068]: “Mastectomies, lumpectomies and other forms of scar tissue may create variations in thermal images or create confusing distortion. Combining IR imaging with visual data could help in determining if various thermal distortions should be examined more closely. However, obtaining visual images can be a sensitive issue from privacy considerations. Instead of digital photography, the tissue surface may be digitally reproduced using MRI images. Digital reproduction of a body part can be accomplished through other imaging modalities, including but not limited to, infrared imaging, outline capture techniques, shadow techniques, etc.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the visual sensor from Kandlikar into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows another method of measuring the health of the user, which can improve the analysis by providing another type of measurement to the device.
Claims 8-9, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the CN ‘113/Muse/Patterson/Kopelman combination as applied to claims 1 and 10 above, and further in view of Li (CN 110420027). Citations to CN 110420027 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 8, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 1.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising: a plate, wherein the plate includes a first hole formed therethrough, wherein the plate is coupled to the armature.
Li discloses a system for analyzing a human breast. Specifically, Li teaches further comprising: a plate, wherein the plate includes a first hole formed therethrough, wherein the plate is coupled to the armature ([0013]: “the puncture bracket includes a positioning grid, a sliding portion and a stop limit portion. The positioning grid is used to guide the puncture of the puncture needle, is arranged at one end of the sliding portion close to the positioning plate, and is fixedly connected to the sliding portion. The positioning grid is arranged opposite to the positioning plate, and clamps and fixes the breast from both sides respectively. The positioning grid is provided with a plurality of grid holes for the puncture needle to pass through.”). CN ‘113, Muse, and Li are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plate from Li into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to have a uniform plate to rest the breast on so the measurements can be as accurate and uniform as possible.
The CN ‘113/Muse/Patterson/Kopelman/Li combination teaches wherein the armature is configured to bring the plate into contact with the skin of the patient when the patient is laying prone on the platform such that the skin of the patient is located within the aperture, and wherein the armature is configured to bring the sensor probe into contact with the skin of the patient through the first hole of the plate (CN ‘113, ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”)).
Regarding claim 9, the CN ‘113/Muse/Patterson/Kopelman/Li combination teaches the system of claim 8, wherein the plate includes a second hole formed therethrough (Li, [0013]: “the puncture bracket includes a positioning grid, a sliding portion and a stop limit portion. The positioning grid is used to guide the puncture of the puncture needle, is arranged at one end of the sliding portion close to the positioning plate, and is fixedly connected to the sliding portion. The positioning grid is arranged opposite to the positioning plate, and clamps and fixes the breast from both sides respectively. The positioning grid is provided with a plurality of grid holes for the puncture needle to pass through.”), and wherein the armature is also configured to bring the sensor probe into contact with the skin of the patient through the second hole of the plate (CN ‘113, ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
Regarding claim 17, the CN ‘113/Muse/Patterson/Kopelman combination teaches the system of claim 10.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach further comprising: a plate, wherein the plate includes a first hole formed therethrough, wherein the plate is coupled to the armature.
Li discloses a system for analyzing a human breast. Specifically, Li teaches further comprising: a plate, wherein the plate includes a first hole formed therethrough, wherein the plate is coupled to the armature ([0013]: “the puncture bracket includes a positioning grid, a sliding portion and a stop limit portion. The positioning grid is used to guide the puncture of the puncture needle, is arranged at one end of the sliding portion close to the positioning plate, and is fixedly connected to the sliding portion. The positioning grid is arranged opposite to the positioning plate, and clamps and fixes the breast from both sides respectively. The positioning grid is provided with a plurality of grid holes for the puncture needle to pass through.”). CN ‘113, Muse, and Li are analogous arts as they are all systems used to provide stimulus to a user and measure the response to determine health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plate from Li into the system from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to have a uniform plate to rest the breast on so the measurements can be as accurate and uniform as possible.
The CN ‘113/Muse/Patterson/Kopelman/Li combination teaches wherein the armature is configured to bring the plate into contact with the skin of the patient when the patient is laying prone on the platform such that at least one of: the breast of the patient is located within the aperture, the portion of the chest of the patient is spanning the aperture, or the portion of the abdomen of the patient is spanning the aperture, and wherein the armature is configured to bring the sensor probe into contact with the skin of the patient through the first hole of the plate (CN ‘113, ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
Regarding claim 18, the CN ‘113/Muse/Patterson/Kopelman/Li combination teaches the system of claim 17, wherein the plate includes a second hole formed therethrough (Li, [0013]: “the puncture bracket includes a positioning grid, a sliding portion and a stop limit portion. The positioning grid is used to guide the puncture of the puncture needle, is arranged at one end of the sliding portion close to the positioning plate, and is fixedly connected to the sliding portion. The positioning grid is arranged opposite to the positioning plate, and clamps and fixes the breast from both sides respectively. The positioning grid is provided with a plurality of grid holes for the puncture needle to pass through.”), and wherein the armature is also configured to bring the sensor probe into contact with the skin of the patient through the second hole of the plate (CN ‘113, ([0029]: “The adjustment component provided by the present invention includes a pressure sensor, which is in continuous contact with the subject's breast, collects the pressure applied by the palpation detection part on the subject's breast, and uses a mechanical carrier to maintain the palpation detection part during the pressure palpation examination, so that the palpation detection part applies pressure on the subject's breast with a relatively consistent pressure, thereby ensuring the accuracy of the palpation examination data. The adjustment component includes a displacement sensor, which collects distance data between the ultrasonic treatment unit and the subject's breast, and uses a mechanical carrier to adjust the distance so that the ultrasound emitted by the ultrasonic treatment unit is focused”).
Regarding claim 20, the CN ‘113/Muse/Patterson/Kopelman combination teaches the method of claim 19.
However, the CN ‘113/Muse/Patterson/Kopelman combination does not teach wherein bringing the sensor probe of the sensor into contact with the breast of a patient when the patient is laying prone on the padded platform such that the breast of the patient is located within the aperture of the padded platform comprises bringing the sensor probe of the sensor into contact with the breast of a patient through a hole formed through a plate that is in contact with the breast of the patient when the patient is laying prone on the padded platform.
Li teaches wherein bringing the sensor probe of the sensor into contact with the breast of a patient when the patient is laying prone on the padded platform such that the breast of the patient is located within the aperture of the padded platform comprises bringing the sensor probe of the sensor into contact with the breast of a patient through a hole formed through a plate that is in contact with the breast of the patient when the patient is laying prone on the padded platform ([0013]: “the puncture bracket includes a positioning grid, a sliding portion and a stop limit portion. The positioning grid is used to guide the puncture of the puncture needle, is arranged at one end of the sliding portion close to the positioning plate, and is fixedly connected to the sliding portion. The positioning grid is arranged opposite to the positioning plate, and clamps and fixes the breast from both sides respectively. The positioning grid is provided with a plurality of grid holes for the puncture needle to pass through.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plate from Li into the method from the CN ‘113/Muse/Patterson/Kopelman combination as it allows the system to have a uniform plate to rest the breast on so the measurements can be as accurate and uniform as possible.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant amended the claims to overcome the 112(b) rejections, however the amendments to claim 10 raised another 112(b) rejection.
Applicant’s arguments with respect to the 103 rejections of claims 1-20 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.
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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791