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 § 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 1-20, 22-24, and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “one of the plurality of electrodes” in line 12, but is indefinite and lacks proper antecedent basis. Is the one of the plurality of electrodes intended to be a single electrode or a single group of electrodes? Is the plurality of electrodes part of the arrangement of electrodes or separate therefrom? “[T]he plurality of electrodes” has not been previously disclosed and therefore should change “the” to --a-- for proper antecedent basis. For examination purposes, the limitation will be interpreted as a single electrode from the arrangement of electrodes. As such, the limitations that directly precede and include the same “between one of the plurality of electrodes” language, result in the same issue regarding the “plurality” and “arrangement” of electrodes. Claim 22 mirrors Claim 1, therefore, they both share the same issues.
Claim 5 recites “at least one electrode of the arrangement of the plurality of electrodes” in lines 7-8, but is indefinite. Claim 1 recites “arrangement of electrodes,” which indicates more than 1 electrodes, and “the plurality of electrodes.” That is, it is unclear if the arrangement of electrodes encompasses the plurality of electrodes or are the same. The limitation in claim 5 appears to support that the arrangement and plurality of electrodes are the same group of electrodes. Further clarification required. Moreover, the recited “said at least one electrode” in lines 7-9, fail to limit a previously recited limitation. Is “at least one electrode of the arrangement of electrodes” or “one of the plurality of electrodes” being further limited? Further clarification required.
Claims not listed are rejected by virtue of claim dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20, 22-24, and 27-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. An analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including determining by the processor a relative displacement of an internal object. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining a relative displacement between the internal object and the body part sets forth a judicial exception. This step describes a concept performed in the human mind or by using a human using a pen and paper (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The relative displacement determination does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the displacement, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of, using a processor, memory device and electrodes; and acquiring capacitance data and processing the capacitance data. Using computer components and obtaining data (capacitance) in order to compare it to reference data is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring and comparison steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 22, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited capacitance sensor is a generic sensor configured to perform pre-solutional data gathering activity and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Also, Main et al. (US 20130006151) teaches patient management system well known in the art and commercially available (¶[0064]), comprise well known capacitive sensors and computer systems comprising memory and processors (¶[0177]).
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data processing. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 22-24 and 27-28 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 22 recites the limitation “arrangement of electrodes being disposed adjacent to the body part of the patient” in lines 6-7, which incorporates a human organism and has been construed by the examiner that a human body surface is a component of the device. It is suggested that Applicant amend claim 22 to recite -- arrangement of electrodes configured to be disposed adjacent to the body part of the patient -- in order to remove the recitation of human tissue. Claims 23-24 and 27-28 are rejected by virtue of claim dependency.
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.
Claims 1-6, 9-10, 13, 20, 22-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa et al. (US 20150051468- Previously cited), hereinafter Srinivasa, in view of Doi et al. (US 20210310833- Previously cited), hereinafter Doi.
Regarding claim 1, Srinivasa teaches a method in a computer system including a processor, a memory device, and a capacitive sensor comprising an arrangement of electrodes for determining a displacement of an object (ABSTRACT, “ capacitive sensing system is adapted for noninvasive measurement of blood pulse . . . . includes a sensor electrode”), the method comprising:
generating, by the capacitive sensor with the arrangement of electrodes configured to be disposed adjacent to a body part of the patient, such that each electrode is spaced apart from the body part and wherein the body part at least part encloses the internal object of the patient (¶[00021] and figs. 2A-2B, “The sensor electrode is disposed over and spaced from the skin pulse point”),
a plurality of sensor signals, wherein each sensor is indicative of a capacitance in a vicinity of at least one electrode of the arrangement of electrodes; determining as set of capacitance values for at least a subset of the electrodes of the arrangement of electrodes based on processing the plurality of sensor signals (¶[0022], “ The capacitance acquisition/conversion circuitry is configured to acquire capacitance measurements for a proximal self-capacitance of the sensor electrode with the skin pulse point at proximal displacement, and a distal self-capacitance of the sensor electrode with the skin pulse point at distal displacement” (emphasis added). The provided excerpt teaches a set of two values);
wherein each capacitance value is indicative of at least between one of the plurality of electrodes and an outer surface (¶[0022] and figs. 2A-B, the same excerpt provided above discloses that the capacitance values are based on the electrode and displacement of the surface of the user); and
determining by the processor a displacement between the internal object and the body part based on a set of capacitance values (¶[0022] and figs. 2A-B, vessel displacement is determined based on displacement values of vascular pulsation 222A/B and 220A/B).
Srinivasa fails to explicitly teach determining by the processor a relative displacement between the internal object and the body part based on comparing by the processor the determined set of capacitance values with a set of predetermined reference capacitance values stored in the memory device.
Doi teaches a proximity sensor unit comprising an electrode for detecting a capacitance value and calculating the distance of the sensed object with distance calculation unit (see ABSTRACT and para. [0033]). The processor is configured to determine a reference capacitance value C0, a first capacitance value C1, and movement of the object (see para. [0012,0041,0046,0052], “a movement amount detection unit that detects an amount of movement when . . . the object to be detected is moved from a reference position to a movement position along the detection direction.” That is “distance calculation unit 130 determines whether the distance D between the proximity sensor section 20 and the object to be detected 200 can be calculated based on the capacitance value C detected at each of the reference position P0 and the movement position”). In summary, Doi teaches determining the displacement of an object relative to the proximity sensor/electrode based on a predetermined reference capacitance value C0.
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa, such that the processor determines a relative displacement between the object and sensor location based on comparing by the processor the determined set of capacitance values with a set of predetermined reference capacitance values stored in the memory device, as taught by Doi, to aid in determining relative displacement and/or to determine whether it is capable to correctly calculate the displacement (¶[0035] of Doi). Also, it would be using a known technique (determining object displacement) to improve similar methods (using capacitance and electrodes for the determination) in the same way.
Therefore the combination leads to determining by the processor a relative displacement between the internal object and the body part (fig. 2A-B of Lars, the blood vessel (internal object) and the body part (position of the electrodes) in view of the teachings of Doi (determining displacement between an object and the sensor)).
Regarding claim 2, Srinivasa-Doi teaches wherein determining displacement of the internal object comprises, determining an occurrence of the displacement of the internal object with respect to the body part (see fig. 2A and ¶[0022] of Srinivasa, “convert the proximal and distal self-capacitance measurements into sensor data representative of vascular pulsation”),
determining at least one of a size and direction of the displacement of the internal object with respect to the body part (¶[0028] of Srinivasa, “exhibits pulse displacement of skin tissue caused by vascular pulsation, cycling between respectively a proximal and a distal sensing distance” the amount of the distance in the direction of the sensors is calculated; see para. [0012] of Doi, “a movement amount detection unit that detects an amount of movement when the proximity sensor section or the object to be detected is moved”).
Regarding claim 3, Doi teaches wherein the set of reference capacitance values is indicative of the capacitance values of the at least subset of electrodes when the arrangement of electrodes is at least one of positioned at a reference position (see para. [0012,0041,0046,0052], “a movement amount detection unit that detects an amount of movement when . . . the object to be detected is moved from a reference position to a movement position along the detection direction.” (emphasis added)).
Regarding claim 4, Srinivasa teaches wherein at least one of the set of capacitance values is determined at a measurement time (¶[0021], the measurements are taken during an expansion/contraction cycle of the vessel).
Regarding claim 5, Srinivasa teaches the capacitance in the vicinity of the at least one electrode of the arrangement of the plurality of electrodes is at least one of a capacitance between said at least one electrode of the plurality of electrodes and an outer surface of the patient (¶[0022] and figs. 2A-B, the capacitance values are based on the electrode and displacement of the surface of the user).
Regarding claim 6, Srinivasa-Doi teaches determining the set of reference capacitance values based on positioning the arrangement of electrodes at a reference position and in a reference orientation with respect to the body part of the patient and based on measuring the reference capacitance values using the capacitive sensor (see para. [0013] of Doi, “a first capacitance value which is the capacitance value detected at the reference position”).
Regarding claim 9, Srinivasa fails to teach wherein determining the displacement of the internal object comprises comprising: computing a deviation between each capacitance value of the determined set of capacitance values and at least one reference capacitance value of the set of reference capacitance values;
and comparing the computed deviation for each capacitance value of the determined set of capacitance values with a threshold value, thereby determining whether the capacitance in the vicinity of one or more electrodes has changed.
Doi teaches a method including an electrode for detecting capacitance values to detect to an object (see abstract). Doi further teaches measuring capacitance values, a reference and capacitance value, which are compared to determine a distance when the noise is satisfies a threshold criteria (see para. [0033-34], that is a deviation is computed to determine noise and then further compared to a threshold to determine distance between the electrodes and object).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa, such that a deviation of the capacitance values is computed and compared to a threshold to determine a change in capacitance, as taught by Doi, to aid in determining a distance associated with the target object (see para. [0034] of Doi).
Regarding claim 10, Srinivasa-Doi teach identifying one or more electrodes in the vicinity of which the capacitance has changed, and comprising one or more of: determining an occurrence of the displacement of the internal object with respect to the body part based on determining that the capacitance in the vicinity of one or more individual electrodes has changed (¶[0022] and figs. 2A-B of Srinivasa, the electrode identifies when the capacitance values change based on the displacement of the surface of the user).
Regarding claim 13, Doi teaches wherein the threshold value for the deviations between the capacitance values and the reference capacitance values are determined based on at least a calibration (see para. [0054], the calibration process happens before comparing step, therefore the calculated deviations would be based on a pre-calibration measurement/process).
Regarding claim 20, Srinivasa teaches wherein the internal object is at least part of an internal organ/vessel (see abstract).
Regarding claim 23, Srinivasa teaches wherein the arrangement of electrodes includes at least one of an array of electrodes (see fig. 2A-B and ¶[0026,0041-42], the electrode has a driving shield electrode, referred as a sensor shield by one of ordinary skill in the art, stacked thereon. Therefore, an electrode array is described).
Regarding claim 24, Srinivasa teaches wherein the electrodes of the arrangement of electrodes are arranged in a three dimensional stacked configuration (see figs. 2A-B).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 1, further in view of Marashdeh et al. (US 20140365152- Previously cited).
Regarding claim 7, Srinivasa-Doi fail to teach determining a set of reference capacitance values based on a simulation calculation with the arrangement of electrodes being positioned at a reference position and in a reference orientation with respect to the body part.
Marashdeh teaches an electrical capacitance tomography sensor and method for analyzing biological processes and tissue(see abstract and para. [003]). Marashdeh further teaches “[s]elf calibration of a capacitance sensor can be achieved by simulating the capacitance signal of an empty sensor and adjusting parameters of data acquisition using the reference capacitor” and “the present invention measures parameters of a reference capacitor through an FPGA and uses those parameters as a reference for parameters of other measured capacitances” thereby indicating that reference capacitance values are simulated based on reference values to aid in performing calibration to compensate for long term drift and temperature variation, and provide data of virtual flows (see para. [0048-54]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that a set of reference capacitance values are determined based on a simulation using reference values, as taught by Marashdeh, to aid in performing calibration to compensate for long term drift and temperature variation, and provide data of virtual flows.
Regarding claim 8, Srinivasa-Doi teaches determining the set of reference capacitance values based on positioning the arrangement of electrodes at a reference and in a reference orientation with respect to the body part of the patient and based on measuring the reference orientation with respect to the body part of the patient and based on measuring the capacitance values using the capacitive sensor, and storing the determine set of reference values in data storage (see para. [0013] of Doi, “a first capacitance value which is the capacitance value detected at the reference position”; see pg. 10, para. [0005] of Srinivasa, “The sensor may comprise additional electrodes, e.g. used for reference measurements, positioned such that main field lines do not extend through large arteries, veins or parts disturbing measurements”);
and storing the determined set of reference capacitance values in a data storage (see pg. 10, para. [0007], “The first sensor signal and/or the second sensor signal may be stored in the data acquisition device 26”).
Srinivasa-Doi fail to teach determining the set of reference capacitance values based on a simulation calculation with the arrangement of electrodes being positioned at a reference position and in a reference orientation with respect to the body part, and storing the determined set of reference capacitance values in a data storage.
Marashdeh teaches an electrical capacitance tomography sensor and method for analyzing biological processes and tissue(see abstract and para. [003]). Marashdeh further teaches “Self calibration of a capacitance sensor can be achieved by simulating the capacitance signal of an empty sensor and adjusting parameters of data acquisition using the reference capacitor” and “the present invention measures parameters of a reference capacitor through an FPGA and uses those parameters as a reference for parameters of other measured capacitances” thereby indicating that reference capacitance values are simulated based on reference values to aid in performing calibration to compensate for long term drift and temperature variation, and provide data of virtual flows (see para. [0048-54]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that a set of reference capacitance values are determined based on a simulation using reference values, as taught by Marashdeh, to aid in performing calibration to compensate for long term drift and temperature variation, and provide data of virtual flows.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 10, further in view of Luna et al. (US 20150282768- Previously cited), hereinafter Luna.
Regarding claim 11, Srinivasa-Doi fail to teach wherein the occurrence of the patient motion is determined based on: determining a first number of electrodes arranged at the first boundary of the arrangement of electrodes, in the vicinity of which the capacitance has changed; determining a second number of electrodes arranged at the second boundary of the arrangement of electrodes, in the vicinity of which the capacitance has changed; and comparing the first number of electrodes arranged at the first boundary with the second number of electrodes arranged at the second boundary of the arrangement of electrodes.
Luna teaches a wearable device and method for measuring physiological parameters (see abstract). The method comprises identifying and determining when a first and second electrode are arranged at specific locations to detect sensor signals, and compare the number of electrodes arranged at each boundary to determine which matches a profile (see para. [0067] and figs. 3A-3B).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that a determination that a first and second electrodes are arranged at respective boundaries and comparing the first and second of electrodes, as taught by Luna, to aid in determining that the electrodes are positioned in the target location and/or provides more robust/accurate data (see para. [0067] of Luna).
Regarding claim 12, Luna teaches wherein the occurrence of the patient motion relative to the arrangement of electrodes is checked and/or determined based on determining that the first number of electrodes at the first boundary matches the second number of electrodes arranged at the second boundary of the arrangement of electrodes (see para. [0067], the device is configured to identify electrode pairs and based on the values established between the two pairs, select the most optimal pair). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that the occurrence of a patient parameter, e.g., the patient motion, relative to the electrode is based the number of electrodes pairs, as taught by Luna, to aid in providing more robust/accurate data.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 1, further in view of Ten Kate et al. (US 20160203692- Previously cited), hereinafter Ten.
Regarding claim 14, Srinivasa-Doi fail to teach wherein the displacement of the internal object with respect to the body part is determined using at least a classificator, artificial intelligence module, or neural network.
Ten teaches a system for determining displacement of an object (see abstract) that is based on a classifier (see para. [0022], “the processing unit is configured to use the result of the processing to determine whether the distance measured by the object is to the ground, the floor or another object in the processing of the measurements from the proximity sensor and the measurements from the movement sensor to determine if the user has fallen” indicating that that an objects displacement can be tracked; “The derived features are then tested in a classifier to determine if a fall has taken place” indicating that a classificator is used to determine the displacement of an object).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that displacement of an object is determined using at least a classificator, as taught Ten, as it would merely be using a known technique (using a calssificator for displacement detection) to improve similar methods (displacement determination) in the same way.
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 1, further in view of Gregerson et al. (US 20180185113- Previously cited), hereinafter Gregerson.
Regarding claims 15-17, Srinivasa-Doi fail to teach determining, with at least one surface scanner, a first position of at least a part of a skin of the patient at a first time;
determining, with the at least one surface scanner, a second position of the at least part of the skin at a second time different than the first time; and determining an occurrence of the displacement of the internal object with respect to the body part based on comparing the determined first position and the determined second position of the at least part of the skin; and
determining, with at least one distance sensor, a first distance between at least a part of the patient and at least one fixed point in an environment of the patient at a first time;
determining, with the at least one distance sensor, a second distance between the at least part of the patient and the at least one fixed point in the environment of the patient at a second time different than the first time: and determining an occurrence of the displacement of the internal object with respect to the body part based on comparing the determined first distance and the determined second distance between the at least part of the patient and the at least one fixed point;
wherein at least one of the at least one surface scanner or the at least one distance sensor is at least one of a camera, a surface camera, a thermo-camera, a 3D camera, a stereo camera, a range camera, a laser sensor, a LIDAR sensor, a radar sensor, a time-of-flight sensor, or an ultrasound sensor.
Gregerson teaches a method for performing image guided surgery using a two fixed reference markers at separate locations to detect displacement of organs (see para. [0012,00042-50], “performing image-guided surgery using multiple reference marker devices fixed to a patient, the methods including obtaining patient images using an imaging device, registering patient images to a patient coordinate system” indicating that a position of the users skin/organ/legs/arms at respective times and positions are determined based on a change in distance between the fixed markers, e.g., requires comparing, computing a difference; “he second image dataset may indicate the current position and/or orientation of the patient. The second image dataset may include at least one image of a marker device that may be obtained using an optical sensing device 111 (e.g., cameras 207). The marker device (e.g., reference arc 115) detected by the optical sensing device 111 may be in a known fixed relationship with the surgically-relevant portion of the patient's anatomy. The motion tracking system 105 may determine the transformation between the marker device 115 and the optical sensing device 111 (e.g., using well-known triangulation techniques), and may thereby determine the transformation between the sensing device 111 (e.g., camera 207 position) and the surgically-relevant portion of the patient's anatomy. The motion tracking system 105 may similarly determine transformations between each of the other marker devices (e.g., marker devices 119 and 202 in FIG. 1) and the optical sensing device 111. Each of the markers 115, 119 and 202 being tracked may then be placed within a common coordinate system. In embodiments, the common coordinate system may have an origin or zero point that is fixed relative to the surgically-relevant portion of the patient's anatomy, and may also be referred to the patient coordinate system”(emphasis added)). The surface scanner or distance sensor is at least a camera (see para. [0036]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that the following steps are performed: determining, with at least one surface scanner, a first position of at least a part of a skin of the patient at a first time;
determining, with the at least one surface scanner, a second position of the at least part of the skin at a second time different than the first time; and determining an occurrence of the displacement of the internal object with respect to the body part based on comparing the determined first position and the determined second position of the at least part of the skin; and
determining, with at least one distance sensor, a first distance between at least a part of the patient and at least one fixed point in an environment of the patient at a first time;
determining, with the at least one distance sensor, a second distance between the at least part of the patient and the at least one fixed point in the environment of the patient at a second time different than the first time: and determining an occurrence of the displacement of the internal object with respect to the body part based on comparing the determined first distance and the determined second distance between the at least part of the patient and the at least one fixed point;
wherein at least one of the at least one surface scanner or the at least one distance sensor is at least one of a camera, as taught by Gregerson, as it would merely be applying a known technique (camera based displacement measurements) to a known method (object displacement tracking based on measured capacitance) ready for improvement to yield predictable results.
Regarding claim 18, Srinivasa-Doi fails to teach generating an alert signal in response to determining the displacement of the internal object with respect to a body part.
Gregerson teaches that a user may be notified based on detection of object satisfying an alert criteria (see para. [0125]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that an alert signal in response to determining the displacement of an object, as taught by Gregerson, as it would merely be combining prior art elements (displacement of an object) according known methods (displacement satisfying an alert criteria) to yield predictable results.
Regarding claim 19, Srinivasa fails to teach wherein providing a pre-operative scan of at least a part of the body part, the pre-operative scan including at least a part of the internal object; and adjusting at least one of a shape, a geometry, a position, an orientation of the at least part of the internal object in the pre-operative scan based on the determined displacement of the internal object with respect to the body part.
Gregerson teaches the imaging data can comprise per-operative data (see para. [0052], “The imaging data 407 may be imaging data that is obtained prior to a surgical procedure (e.g., pre-operative image data) and/or imaging data that is obtained during a surgical procedure (e.g., intra-operative image data).” and adjusting position and/or orientation of the object, i.e., implantable marker, based on the displacement (see para. [0128], “the user may perform a registration correction when one of the reference marker devices 1001, 1003 has moved with respect to the patient”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that a pre-operative scan is provided of at least a part of the body part, the pre-operative scan including at least a part of the internal object and adjusting at a position and an orientation of the at least part of the internal object in the pre-operative scan based on the determined displacement of the internal object, as taught by Gregerson, as it would merely be applying a known technique (preoperative imaging and adjustment of the object) to a known method (determining displacement) ready for improvement to yield predictable results.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 22 and further in view of Lang (WO 2010057495- Previously cited).
Regarding claim 27, Srinivasa-Doi fail to teach wherein the arrangement of electrodes includes an arc shaped array of electrodes of electrodes at least one further arc-shaped array of electrodes; and wherein the arc-shaped array and the at least one further shaped array arc-shaped array at least extend in different directions.
Lang teaches wherein the arrangement of electrodes includes an arc shaped array of electrodes of electrodes at least one further arc-shaped array of electrodes (see figs. 6,9, and 10, sensors 18,18’ are arranged in an arc shape);
and wherein the arc-shaped array and the at least one further shaped array arc-shaped array at least extend in different directions (see fig. 9, electrodes 50 and 68 extend in a different directions compared to those arrange in sensor 18) to aid in determining a displacement between the internal object and the body part based on a set of reference capacitance values (see pgs. 2 and 7, ln. [0010-21;0010-11], vessel displacement is determined based on comparison with values obtained from reference electrode).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that the arrangement of electrodes is in an arc shaped with one further arc-shaped array of electrodes that extend in different directions, as taught by Lang, to aid in positioning the sensor onto the user thereby improving data gathering (pg. 12, ln. [0005-16]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasa in view of Doi, as applied to claim 1, further in view of Robar (US 20230226376- Previously cited).
Regarding claim 28, Srinivasa-Doi fail to teach wherein the electrodes of the arrangement of electrodes are arranged on at least one of a head clamp for immobilizing a head of the patient, an immobilization mask for immobilizing at least a part of the patient, and a patient support for supporting at least a part of the patient.
Robar teach monitoring patient motion via detection of changes in capacitance (see abstract). The patient monitoring system comprising a head clamp, immobilization mask, and patient support through which electrodes will obtain measurements (see figs. 1 and 12 and para. [0121,0128]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Srinivasa-Doi, such that the electrodes of the arrangement of electrodes are arranged on at least one of a head clamp for immobilizing a head of the patient, an immobilization mask for immobilizing at least a part of the patient, and a patient support for supporting at least a part of the patient, as taught by Robar, to aid in providing accurate therapeutic procedures based on patient motion (¶[0002-5,0009]).
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not fully persuasive.
Applicant contends that the Examiner and Supervisor indicated that the claim amendments would overcome all the Section 101 rejections, on page 11 of the Remarks. The Examiner disagrees. Examiner indicated what amendments overcome the Section 101 rejection directed to or encompassing a human organism. The parties agreed that the Applicant’s arguments regarding Section 101 rejection directed toward an abstract idea would be detailed in the next response. As such, the Section 101 abstract idea rejection remains. In this case, there was no amendment to claim 22 to overcome the rejection.
Applicant’s arguments with respect to 35 U.S.C. 103 rejection of claims have been considered but are moot because the amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sleeman teaches a self-capacitance measurement system, an optional shield electrode may be connected to a drive circuit to use the established technique of guarding. US 20180274952
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791