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 Objections
Claims 15, 18-23, 25, & 28 are objected to because of the following informalities:
Claim 15 recites “and/or” should instead recite “and” or “or”.
Claim 18 recites “and/or” should instead recite “and” or “or”.
Claim 19 recites “and/or” should instead recite “and” or “or”.
Claim 20 recites “and/or” should instead recite “and” or “or”.
Claim 20 recites “ST”, should not be abbreviated at first instance
Claim 21 recites “and/or” should instead recite “and” or “or”.
Claim 22 recites “and/or” should instead recite “and” or “or”.
Claim 23 recites “and/or” should instead recite “and” or “or”.
Claim 25 recites “and/or” should instead recite “and” or “or”.
Claim 28 recites “and/or” should instead recite “and” or “or”.
. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “measuring device” (interpreted as being a Magnetocardiogram Measuring System Spec [Pg. 5]) in claims 15 & 28, and “analysis unit” (generic storage unit Spec [Pg. 3]) in claims 15, 20-23,26, & 28.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 & 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The steps of “derive longitudinal biomagnetic field data from the magnetic signals” and “evaluate a vital function of the human body based on the comparison” are not adequately defined in the Specification. The definition of the longitudinal data and the results can be found; however, the process by which these are derived or evaluated is insufficient.
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 15-28 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 15 recites the limitation “an analysis unit configured to store the detected magnetic signals, together with an associated measurement time, at regular time intervals and continuously” which renders the claim unclear. It is unclear how the system can record both at regular intervals and continuously.
Claim 15 also recites “derive longitudinal biomagnetic field data from the magnetic signals” and “evaluate a vital function of the human body based on the comparison” without providing sufficient corresponding structure in the claim or specification. It is unclear how the longitudinal biomagnetic data is derived or the evaluation is conducted. The Spec merely defines the data and results but not the process.
Claim 24 recites “further measures can be initiated depending on the evaluation of the vital function” which renders the claim. It is unclear what the metes and bounds of “further measures” includes.
Claim 28 recites “deriving longitudinal biomagnetic field data from the magnetic signals” and “evaluating a vital function of the human body based on the comparison” without providing sufficient corresponding structure in the claim or specification. It is unclear how the longitudinal biomagnetic data is derived or the evaluation is conducted. The Spec merely defines the data and results but not the process.
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 15-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims 15-28 recite a system comprising: at least one measuring device configured to detect magnetic signals; and an analysis unit configured to store the detected magnetic signals, together with an associated measurement time, at regular time intervals and continuously and/or over a specified period of time, and to derive longitudinal biomagnetic field data from the magnetic signals and to compare the detected magnetic signals and/or the longitudinal biomagnetic field data with one another on different time scales, wherein the analysis unit is configured to evaluate a vital function of the human body based on the comparison; as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but presumable recitation of generic computer components.
That is, other than presumably reciting “measuring device”, and “analysis unit”, nothing in the claim element precludes the step from practically being performed in the mind. For example “at least one measuring device configured to detect magnetic signals” in the context of this claim encompasses a generic data acquisition step achieved by a generic component. The user could manually also “store the detected magnetic signals, together with an associated measurement time, at regular time intervals and continuously and/or over a specified period of time, and to derive longitudinal biomagnetic field data from the magnetic signals and to compare the detected magnetic signals and/or the longitudinal biomagnetic field data with one another on different time scales” by conducting generic storing and comparing steps as well as “evaluate a vital function of the human body based on the comparison” by analyzing the data.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the imitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The judicial exception is not integrated into a practical application. In particular, the claim only recites two additional elements – using a measuring device, and an analysis unit to perform the above noted steps. The measuring device is recited at a high-level of generality (i.e., as a generic measuring device performing a generic data acquisition function of measuring parameters) such that it amounts no more than mere instructions to apply the exception using a measuring device. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the determining steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
As for the depending claim(s), they are also rejected under 35 USC 101 at least for the similar
reasons noted above as they are directed to abstract ideas and does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, & 20-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shusterman (US20060122525A1).
Regarding Claim 15, Shusterman discloses a system for analyzing magnetic signals generated by a human body (“This invention relates to the field of non-contact measurements of physiological and health data, including electrocardiographic, magnetocardiographic, mechanocardiographic, ballistocardiographic data, physical activity, body position, blood pressure, vasomotor activity, temperature, and respiration, and more specifically to a method and apparatus, which can be miniaturized and adapted to wear in a pocket or attached to the clothes of a subject or striped around the body, or implanted under the skin for non-contact or contact measurement,” [0002]), the system comprising:
at least one measuring device configured to detect magnetic signals (“The data acquisition system of this invention can also measure MCG signals by using any magnetometer, including fluxgate, optical, laser-optical, or SQUID-magnetometer.” [0016]);
and an analysis unit configured to store the detected magnetic signals, together with an associated measurement time, at regular time intervals and continuously and/or over a specified period of time (“non-contact MCG measurements do not require any skin preparation and can be used continuously or repeatedly for any period of time” [0008], “To perform the Scale II analysis, the primary elements from serial ECG or MCGs are stored into a database to construct the time series for each primary element” [0034], “ Storage unit 43 stores the compressed waveforms and the computed primary elements into memory. Comparative unit 44 compares the newly acquired waveforms and newly computed primary elements with the waveforms and primary elements previously stored in the storage unit 43. The analysis unit 40 has means for adjusting the thresholds for each indicator, whereas the default values correspond to normal ECG or MCG.“ [0062]),
and to derive longitudinal biomagnetic field data from the magnetic signals (“To increase robustness and accuracy of measurements of physiological data patterns, the method of this invention uses a series of data (collected over at least several seconds to several hours). The data are first, aligned by the fiducial points that represent the same phase of a physiological cycle.“ [0015], “The system may be used as a personal device for periodic self-examinations, collection of the serial data in a personal database, and analysis of serial changes.” [0024])
and to compare the detected magnetic signals and/or the longitudinal biomagnetic field data with one another on different time scales (“This invention achieves the desired increased sensitivity (signal-to-noise ratio) which permits miniaturization and reliable performance in a variety of real-life settings and environments by collecting the data over a period of at least several cardiac beats, extracting typical patterns from these data, and analyzing the trends in the data. The trends for analysis may use different time intervals, from several seconds to minutes to hours, days, weeks, months, or years.” [0012],
wherein the analysis unit is configured to evaluate a vital function of the human body based on the comparison (“the present invention uses only the most important characteristics of the MCG or ECG, such as heart rate, the amplitude, polarity, and duration of P, Q, R, S, T and U waves, ST-segment, and the intervals between the peaks (including PR, QRS, and QT intervals). Then the system of the present invention determines the trends in the data. The present system is suitable for one-time screening of individuals and populations or serial analysis of slow, gradual changes in the pattern of cardiac complexes, such as a wide QRS complex, abnormal ST-segment, QRS, P or T-wave. This invention can be used for examining the subjects at risk or with a history of cardiovascular disease, or the elderly. The system can be used also as a personal device for monitoring individual cardiovascular health and its changes due to disease development, treatment, behavioral or psychophysiological modifications, and can be worn during regular activities over any period of time (days-weeks-months).” [0022]).
Regarding Claim 20, Shusterman discloses that the analysis unit is configured to compare the magnetic signals and/or the longitudinal biomagnetic field data on a time scale of a few minutes, wherein a change in: (i) an electrical cardiac axis and/or (ii) ST elevations or ST depressions, can be detected (“This invention achieves the desired increased sensitivity (signal-to-noise ratio) which permits miniaturization and reliable performance in a variety of real-life settings and environments by collecting the data over a period of at least several cardiac beats, extracting typical patterns from these data, and analyzing the trends in the data. The trends for analysis may use different time intervals, from several seconds to minutes to hours, days, weeks, months, or years. For athletes and people monitoring their cardiovascular fitness response to exercises, the time interval might be minutes-to-hours. For patients with acute cardiovascular disease, the interval might be days-to-weeks. For patients with chronic diseases, the interval might be months-to-years.” [0012]).
Regarding Claim 21, Shusterman discloses that the analysis unit is configured compare the magnetic signals and/or the longitudinal biomagnetic field data on a time scale of hours to days, wherein right heart strain signs and/or increases in periods of tachycardic cardiac arrhythmias are recognizable (“This invention achieves the desired increased sensitivity (signal-to-noise ratio) which permits miniaturization and reliable performance in a variety of real-life settings and environments by collecting the data over a period of at least several cardiac beats, extracting typical patterns from these data, and analyzing the trends in the data. The trends for analysis may use different time intervals, from several seconds to minutes to hours, days, weeks, months, or years. For athletes and people monitoring their cardiovascular fitness response to exercises, the time interval might be minutes-to-hours. For patients with acute cardiovascular disease, the interval might be days-to-weeks. For patients with chronic diseases, the interval might be months-to-years.” [0012]).
Regarding Claim 22, Shusterman discloses that the analysis unit is configured to compare the magnetic signals and/or the longitudinal biomagnetic field data on a time scale of months to years, wherein long-term changes in a resting pulse rate and a heart rate variability can be detected (“This invention achieves the desired increased sensitivity (signal-to-noise ratio) which permits miniaturization and reliable performance in a variety of real-life settings and environments by collecting the data over a period of at least several cardiac beats, extracting typical patterns from these data, and analyzing the trends in the data. The trends for analysis may use different time intervals, from several seconds to minutes to hours, days, weeks, months, or years. For athletes and people monitoring their cardiovascular fitness response to exercises, the time interval might be minutes-to-hours. For patients with acute cardiovascular disease, the interval might be days-to-weeks. For patients with chronic diseases, the interval might be months-to-years.” [0012]).
Regarding Claim 23, Shusterman discloses that the system further comprisess one or more additional sensor devices, wherein the one or more additional sensor devices includes pressure sensors and/or temperature sensors and/or microphones, which detect additional biosignals of the human body, wherein the additional biosignals are included in the evaluation of the vital function by the analysis unit (“The data acquisition system of this invention can also use a microphone or several microphones or other acoustic sensors to register the sounds of the heart and breathing. The data acquisition system of this invention can also measure movements and vibrations caused by the heart, blood pressure wave (pulse wave), and respiratory movements of the chest using the pressure sensors also known as the piezoelectric sensors. “ [0018])
Regarding Claim 24, Shusterman discloses that further measures can be initiated depending on the evaluation of the vital function (“The output unit 60 may alternatively or additionally feed an output data to an action unit 80 for sounding an alarm, generating a vibration, or taking appropriate measures, such as applying the drugs or adjusting the therapy mode.“ [0062])
Regarding Claim 25, Shusterman discloses that the system further comprises a communication unit which is configured to send data and/or receive data (“ Communication unit 100 transmits the information between the device 10 and external higher-level processing device 150. The communication unit 100 may be a modem or a wireless transmitter/receiver. “ [0062]).
Regarding Claim 26, Shusterman discloses that data are received from at least one other system that is configured the same as the system, and the received data are included in the evaluation of the vital function by the analysis unit (“Whereas particular aspects of the method of the present invention and particular embodiments of the invention have been described for purposes of illustration, it will be appreciated by those skilled in the art that numerous variations of the details may be made without departing from the invention as described in the appended claims. For example, two or more ECG or MCG detector devices can be used simultaneously by a patient to detect multiple fiducial points in the patient's cardiac complex. The devices would be preferably located at least several inches apart so that each device would detect signals from a different angle to the heart. For example, one device can be located in the pre-cordial region and another device can be located at the back of the body. Alternatively, the number of the devices can be increased to three or more devices, located around the chest, so that more angles are covered. The devices can be placed on a strip or another type of a material that can be wearable. The devices would preferably be in communication with one another so the multiple ECG or MCG signals that are detected can be compiled into a cumulative result. The communication between these devices can be wireless and utilize, for example the Bluetooth or Wi-Fi or other wireless communication protocols.” [0097]).
Regarding Claim 27, Shusterman discloses that the communication unit is configured to transmit an evaluation of the vital function to an external device (“After that, the server that contained biochemical data initiates neural network analysis of the patient's enzyme level concentration for the period of time, in which ECG or MCG changes occurred. A small increasing trend is detected in the cardiac myoglobin levels, and this biochemical and ECG or MCG information are transmitted wirelessly to the personal digital assistant of an attending physician with a suggestion of a slowly developing ischemic process. The timely notification allows the physician to initiate early anti-ischemic treatment and prevent potentially life-threatening complications of the disease.” [0088]).
Regarding Claim 28, Shusterman discloses a method for analyzing magnetic signals generated by a human body (“This invention relates to the field of non-contact measurements of physiological and health data, including electrocardiographic, magnetocardiographic, mechanocardiographic, ballistocardiographic data, physical activity, body position, blood pressure, vasomotor activity, temperature, and respiration, and more specifically to a method and apparatus, which can be miniaturized and adapted to wear in a pocket or attached to the clothes of a subject or striped around the body, or implanted under the skin for non-contact or contact measurement,” [0002]), method comprising the following steps:
detecting magnetic signals from a human body using at least one measuring device (“The data acquisition system of this invention can also measure MCG signals by using any magnetometer, including fluxgate, optical, laser-optical, or SQUID-magnetometer.” [0016]);
storing the detected magnetic signals together with an associated measurement time (“non-contact MCG measurements do not require any skin preparation and can be used continuously or repeatedly for any period of time” [0008], “To perform the Scale II analysis, the primary elements from serial ECG or MCGs are stored into a database to construct the time series for each primary element” [0034], “ Storage unit 43 stores the compressed waveforms and the computed primary elements into memory. Comparative unit 44 compares the newly acquired waveforms and newly computed primary elements with the waveforms and primary elements previously stored in the storage unit 43. The analysis unit 40 has means for adjusting the thresholds for each indicator, whereas the default values correspond to normal ECG or MCG.“ [0062]);
deriving longitudinal biomagnetic field data from the magnetic signals (“To increase robustness and accuracy of measurements of physiological data patterns, the method of this invention uses a series of data (collected over at least several seconds to several hours). The data are first, aligned by the fiducial points that represent the same phase of a physiological cycle.“ [0015], “The system may be used as a personal device for periodic self-examinations, collection of the serial data in a personal database, and analysis of serial changes.” [0024]);
comparing the detected magnetic signals and/or the longitudinal biomagnetic field data with one another on different time scales (“This invention achieves the desired increased sensitivity (signal-to-noise ratio) which permits miniaturization and reliable performance in a variety of real-life settings and environments by collecting the data over a period of at least several cardiac beats, extracting typical patterns from these data, and analyzing the trends in the data. The trends for analysis may use different time intervals, from several seconds to minutes to hours, days, weeks, months, or years.” [0012]);
and evaluating a vital function of the human body based on the comparison (“the present invention uses only the most important characteristics of the MCG or ECG, such as heart rate, the amplitude, polarity, and duration of P, Q, R, S, T and U waves, ST-segment, and the intervals between the peaks (including PR, QRS, and QT intervals). Then the system of the present invention determines the trends in the data. The present system is suitable for one-time screening of individuals and populations or serial analysis of slow, gradual changes in the pattern of cardiac complexes, such as a wide QRS complex, abnormal ST-segment, QRS, P or T-wave. This invention can be used for examining the subjects at risk or with a history of cardiovascular disease, or the elderly. The system can be used also as a personal device for monitoring individual cardiovascular health and its changes due to disease development, treatment, behavioral or psychophysiological modifications, and can be worn during regular activities over any period of time (days-weeks-months).” [0022]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman in view of Ma et al (US20210378569A1; hereinafter referred to as Ma).
Regarding Claim 16, Shusterman discloses all limitations noted above except that the measuring device is configured to detect magnetic signals generated by a beating heart, and includes a base body, which has a support surface, and an arrangement of at least two nitrogen vacancy center (NV) magnetometer units, wherein the arrangement is embedded in the base body, and wherein the base body is configured to receive a human body sitting or lying on the support surface.
However, in a similar field of endeavor, Ma teaches a magnetometer used for cardiac magnetic field measurement and based on nitrogen-vacancy (NV) centers in diamond [0002].
Ma also teaches that the measuring device is configured to detect magnetic signals generated by a beating heart, and includes a base body, which has a support surface, and an arrangement of at least two nitrogen vacancy center (NV) magnetometer units, wherein the arrangement is embedded in the base body, and wherein the base body is configured to receive a human body sitting or lying on the support surface (“the special diamond 1-9 is an 8 mm*8 mm*1 mm cuboid block-shaped diamond, and is divided into 64 1 mm*1 mm*1 mm small unit blocks 1-9-1. In a process of preparing the NV centers in the special diamond, a mask injection process is used. That is, a layer of coating is covered on the front surface of the special diamond, and a circular hole (with a diameter of 0.2 mm) is formed in the center of each square small unit block, so that only the center of each small unit block is injected with nitrogen atoms to produce the NV centers 1-9-2 for fluorescence excitation of the array probe for cardiac magnetic field measurement.” [0041“A to-be-detected object is placed on the non-magnetic bed 3 in the magnetic shielding chamber 4. The array probe 1 for cardiac magnetic field measurement is moved to the upper left corner of a heart region of the to-be-detected object by using the three-axis displacement platform 2, and is in contact with the skin. The fiber laser source 6 and the microwave source 7 are turned on, and the probe 1 is initialized. Scanning is started, and operation time of the stepping motor 1-2 is set. A next through hole 1-4-1 is scanned every 30 breathing cycles till 64 through holes are all traversed. The three-axis displacement platform 2 is used to adjust a position of the probe to traverse the heart region in a one-stop way. Signals collected by the special PD set 1-6 are transmitted to the high-speed data collection card 5. The collected signals are observed on the computer 8 to determine whether the entire heart region is traversed. If the signals of the heart region are completely displayed on the computer, the traversal is completed and a strength diagram of a cardiac magnetic field is obtained.” [0042])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Shusterman as outlined above with the measuring device is configured to detect magnetic signals generated by a beating heart, and includes a base body, which has a support surface, and an arrangement of at least two nitrogen vacancy center (NV) magnetometer units, wherein the arrangement is embedded in the base body, and wherein the base body is configured to receive a human body sitting or lying on the support surface as taught by Ma, because it produces a new magnetocardiography system that has high sensitivity and low costs, and supports contact measurement [0004].
Regarding Claim 18, Shusterman discloses all limitations noted above except that the measuring device is configured to detect a magnetic field strength and field direction using each of the at least two NV magnetometer units, wherein each of the at least two NV magnetometer units has a diamond crystal or a portion of a diamond crystal having nitrogen vacancy centers as a sensor medium, wherein the device is configured to detect a magnetic field strength and/or field direction by reading out a spin resonance in a sensor medium that is dependent on the magnetic field strength, and wherein the measuring device further includes at least one excitation light source configured to for radiate light into the sensor medium, at least one microwave source configured to generate a resonant field in the sensor medium, and at least one photodetector configured to detect resonance-dependent fluorescent light from the sensor medium.
However, in a similar field of endeavor, Ma teaches that the measuring device is configured to detect a magnetic field strength and field direction using each of the at least two NV magnetometer units, wherein each of the at least two NV magnetometer units has a diamond crystal or a portion of a diamond crystal having nitrogen vacancy centers as a sensor medium (“In this way, a total of 64 small unit blocks of the special diamond 1-9 can excite measurement for magnetic fields at corresponding positions in turn, to finally achieve a scanning detection effect after the probe is secured.” [0038], “the special diamond 1-9 is an 8 mm*8 mm*1 mm cuboid block-shaped diamond, and is divided into 64 1 mm*1 mm*1 mm small unit blocks 1-9-1. In a process of preparing the NV centers in the special diamond, a mask injection process is used. That is, a layer of coating is covered on the front surface of the special diamond, and a circular hole (with a diameter of 0.2 mm) is formed in the center of each square small unit block, so that only the center of each small unit block is injected with nitrogen atoms to produce the NV centers 1-9-2 for fluorescence excitation of the array probe for cardiac magnetic field measurement.” [0041]),
wherein the device is configured to detect a magnetic field strength and/or field direction by reading out a spin resonance in a sensor medium that is dependent on the magnetic field strength (“the NV centers in the special diamond generate the 600-800 nm fluorescence under the 532 nm laser light. If there is a magnetic field (cardiac magnetic field) nearby, Zeeman splitting occurs. Under these conditions, the ODMR signal is generated on the condition that the NV centers received an electromagnetic wave by using the microwave antenna, and the sweeping frequency of microwave including to the Zeman splitting. Strength of the magnetic field (cardiac magnetic field) is determined based on splitting strength. The entire process may be performed under room temperature.“ [0014]),
and wherein the measuring device further includes at least one excitation light source configured to for radiate light into the sensor medium, at least one microwave source configured to generate a resonant field in the sensor medium, and at least one photodetector configured to detect resonance-dependent fluorescent light from the sensor medium (“The NV centers 1-9-2 in the special diamond are excited by 532 nm laser light to produce 600-800 nm fluorescence. The Zeeman splitting occurs under the function of magnetic field, and the ODMR signal is performed when the ring-shaped antenna 1-8 is connected to the microwave source 7 to evenly radiate electromagnetic waves with the sweeping frequency including to Zeeman splitting. A surface, close to the special diamond, of each of the six PDs is attached with a filter in the filter set 1-7 to pass light within a wavelength of 600-800 nm, so that the PD only accepts the 600-800 nm fluorescence excited by the NV centers.“ [0040]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Shusterman as outlined above with the measuring device is configured to detect a magnetic field strength and field direction using each of the at least two NV magnetometer units, wherein each of the at least two NV magnetometer units has a diamond crystal or a portion of a diamond crystal having nitrogen vacancy centers as a sensor medium, wherein the device is configured to detect a magnetic field strength and/or field direction by reading out a spin resonance in a sensor medium that is dependent on the magnetic field strength, and wherein the measuring device further includes at least one excitation light source configured to for radiate light into the sensor medium, at least one microwave source configured to generate a resonant field in the sensor medium, and at least one photodetector configured to detect resonance-dependent fluorescent light from the sensor medium as taught by Ma, because it produces a new magnetocardiography system that has high sensitivity and low costs, and supports contact measurement [0004].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Shusterman in view of Ma as applied to Claim 16 above, and further in view of Frangeskou et al (US20220146605A1; hereinafter referred to as Frangeskou).
Regarding Claim 17, Shusterman in view of Ma discloses all limitations noted above except that the base body includes elastic material between the arrangement and the support surface and is configured as a cushion, or a mattress, or a lounger, or a mat, or a bed, or a seat, or a chair.
However, in a similar field of endeavor, Frangeskou teaches a defect centre-based sensor, such as a magnetometer, electrometer or thermometer, in particular to a nitrogen-vacancy centre in diamond sensor which can be used as a magnetometer [0001].
Frangeskou also teaches that the base body includes elastic material between the arrangement and the support surface and is configured as a cushion, or a mattress, or a lounger, or a mat, or a bed, or a seat, or a chair (“The detection of magnetic fields produced by the cardiac cycle is known as magnetocardiography (MCG). It is the magnetic analogue of electrocardiography (ECG). The benefit of MCG is that the magnetic field from the heart is not distorted by the body. ECG signals are also affected by the positioning and contact quality of the electrodes, whereas an MCG sensor does not require contact. A fibre-coupled diamond sensor can have the benefit of having a light and mobile sensor head, or array of sensors, that can easily be placed on the patient in a variety of settings such as at the hospital bed side, or inside a magnetically shielded room, and the control unit can remain outside so as to not adversely affect the function of the shielding. Other possible uses of MCG systems are integration into seating and beds for preventative medical applications. Seats and beds are ideal locations for MCG systems as they are close to the patients back or chest, and by extension, the heart. A car seat containing an MCG system would be able to detect a unique cardiac signature of the car owner as an alternative to fingerprint or iris scans” [0078])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Shusterman in view of Ma as outlined above with the base body includes elastic material between the arrangement and the support surface and is configured as a cushion, or a mattress, or a lounger, or a mat, or a bed, or a seat, or a chair as taught by Frangeskou, because they are close to the patients back or chest, and by extension, the heart [0078].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shusterman in view of Ma as applied to Claim 16 above, and further in view of Masuyama et al ([Y. Masuyama et al., “Gradiometer using separated diamond quantum magnetometers,” Sensors, vol. 21, no. 3, p. 977, Feb. 2021; hereinafter referred to as Masuyama).
Regarding Claim 19, Shusterman in view of Ma discloses all limitations noted above except that the analysis unit or the measuring device includes a signal processing unit to which the at least two NV magnetometer units are connected, wherein the system is configured to determine, using the signal processing unit, an effective magnetic field strength and/or field direction as a difference between magnetic field strengths or field directions detected using the at least two NV magnetometer units as magnetic signals.
However, in a similar of endeavor, Masuyama teaches a gradiometer with variable sensor length that works at room temperature using a pair of diamond samples containing negatively charged NV centers [Abstract].
Masuyama also teaches the analysis unit or the measuring device includes a signal processing unit to which the at least two NV magnetometer units are connected (“Figure 1b shows a schematic setup of the gradiometer using two diamond quantum sensors that enabled us to change in a wide range of the base length. In each sensor, each diamond sample was attached to an optical fiber is mounted on a coplanar waveguide antenna that controls the NV centers homogeneously.” [Pg. 3]),
wherein the system is configured to determine, using the signal processing unit, an effective magnetic field strength and/or field direction as a difference between magnetic field strengths or field directions detected using the at least two NV magnetometer units as magnetic signals (“optical fiber illuminated both diamond samples containing the NV centers. Fluorescence from NV centers in a volume of 1.2 mm3 in each diamond was collected by a photodetector (Thorlabs FDS100A2) through the optical fiber, and photons detected by photodetectors were digitized using an oscilloscope.” [Pg. 3], “Our gradiometer obtained the difference between the magnetic field strength at each sensor. The magnetic field strength along the orientation axis was calculated from the fluorescent signal at the steepest point of each ODMR spectrum.” [Pg. 3]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Shusterman in view of Ma as outlined above with the analysis unit or the measuring device includes a signal processing unit to which the at least two NV magnetometer units are connected, wherein the system is configured to determine, using the signal processing unit, an effective magnetic field strength and/or field direction as a difference between magnetic field strengths or field directions detected using the at least two NV magnetometer units as magnetic signals as taught by Masuyama, because it allows for highly sensitive magnetic sensing in noisy environments such as outdoor and in vehicles [Abstract].
Conclusion
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
