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 .
Election/Restrictions
Applicant’s election of group I in the reply filed on 10 November 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 requires “audio signals internal to the user computing device generated by lateral movement of the user computing device along the user's kin.” This appears to be a typo, and for purposes of Examination, the Examiner will treat the claim as referring to the users’ “skin”. Appropriate correction is required.
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 1-5-6, 9-12 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1 and 13 and their dependent claims are directed to a user computing device (machine) and a computer-implemented method (process) for removing noise from a signal.
Step 2A, Prong One
Regarding claims 1 and 13, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “modify the first signal based on the noise signature signal to generate a modified first signal; and determine one or more characteristics associated with a user based on the modified first signal” and “modifying… the first signal based on the noise signature signal to generate a modified first signal; and determining… one or more characteristics associated with a user based on the modified first signal” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than glancing at a chart or display that shows processed signal and making a diagnosis based on medical expertise.
Regarding claim 5, the limitation of “subtracting, from the first signal, a signal portion corresponding to the noise signature signal to generate the modified first signal” is nothing more than performing a mathematical calculation. See MPEP 2106.04(a)(2)(I)(C).
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claims 1 and 13 also recite a physiological signal sensor, a transducer, one or more control circuits, a dry electrode, an electrode, one or more processors. The processors are recited at a high-level of generality and amount to nothing more than parts of a generic computer. See par. 0057 of the published application. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of a physiological signal sensor, a transducer, one or more control circuits, a dry electrode, an electrode, one or more processors amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of data collection and processing. The sensors, transducers, circuits and electrodes are well-understood, routine and conventional in the art. See, for example, Majumdar (“Wearable Sensors for Remote Health Monitoring”) for dry electrodes, and sensing motion temperature, and heart rate; and Guo (“A review of wearable and unobtrusive sensing technologies for chronic disease management”, Table 1) for a variety of sensing technologies including sound sensing. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of subtracting noise from a signal to produce a signal to be interpreted for medical diagnosis.
Regarding dependent claims 5-6, 9-12 and 14, the limitations of claims 1 and 13 further defines the limitations already indicated as being directed to the abstract idea.
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 13-19 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 13 requires “a dry electrode” and a “first electrode” in lines 2 and 3, respectively. It is unclear whether these electrodes are meant to refer to the same electrode or a different electrode within a set of electrodes. Furthermore, claim 13 requires “one or more processors” both lines 6 and 8. Again, it is unclear whether these steps are performed by a single set of processor(s) or two different sets of processor(s).
Furthermore, claim 18 requires “the first sensor” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luna et al (U.S. 2015/0264459). Luna discloses (Figure 2) a physiological signal sensor (sensor selector 222 and sensors 210c-e) configured to generate a first signal relating one or more characteristics associated with a user (raw sensor signal 225); a transducer (motion sensor 221) configured to generate a noise signature signal (motion artifact signal 223) based on detection of one or more noise sources; and one or more control circuits (motion artifact reduction unit 224) configured to: modify the first signal based on the noise signature signal to generate a modified first signal (par. 0055, especially “Motion artifact reduction unit 224 operates to subtract motion artifact signal 223 from sensor signal 225 to yield the physiological-related signal component (or an approximation thereof) as a raw physiological signal 227.”); and determine one or more characteristics associated with a user based on the modified first signal (“raw physiological signal 227 may include a respiration signal modulated on (or in association with) a heart rate ("HR") signal. Regardless, physiological characteristic determinator 226 is configured to perform digital signal processing to generate a heart rate ("HR") signal 229a and/or a respiration signal 229b. Portion 240 of respiration signal 229b represents an impedance signal due to cardiac activity, at least in some instances. Further, physiological characteristic determinator 226 is configured to use either HR signal 229a or a respiration signal 229b, or both, to derive other physiological characteristics, such as blood pressure data ("BP") 229c, a maximal oxygen consumption ("VO2 max") 229d, or any other physiological characteristic.”).
Regarding claim 2, Luna discloses (par. 0039) the physiological signal sensor is a dry electrode enabled to contact a user's skin. While Luna is silent on electrode being “dry” electrode, the electrode of Luna is being used to directly placed on the skin of a user [0039] without the use of electrolyte gel, which is consistent with applicant’s definition of dry electrode (see par. 0059 of USPGPub. version of instant specification).
Regarding claim 3, Luna discloses (par. 0042) the transducer includes an audio sensor situated to detect a noise source in the form of audio signals internal to the user computing device generated by lateral movement of the user computing device along the user's skin (“The motion-related component includes motion artifacts or noise induced into an electrode 110a. Motion artifact reduction unit 124 is configured to receive motion-related signals generated at one or more motion sensors 160, and is further configured to receive at least the motion-related signal component of the second signal. Motion artifact reduction unit 124 operates to eliminate the magnitude of the motion-related signal component, or to reduce the magnitude of the motion-related signal component relative to the magnitude of the physiological-related signal component, thereby yielding as an output the physiological-related signal component (or an approximation thereto). Thus, motion artifact reduction unit 124 can reduce the magnitude of the motion-related signal component (i.e., the motion artifact) by an amount associated with the motion-related signal generated by one or more accelerometers to yield the physiological-related signal component.”).
Regarding claim 4, Luna discloses (par. 0038) the transducer is a pressure sensor enabled to determine variations in pressure applied by a user (“Electrodes 110 can include any suitable structure for transferring signals and picking up signals, regardless of whether the signals are electrical, magnetic, optical, pressure-based, physical, acoustic, etc.”).
Regarding claim 5, Luna discloses (par. 0055) subtracting, from the first signal, a signal portion corresponding to the noise signature signal to generate the modified first signal (“Motion artifact reduction unit 224 operates to subtract motion artifact signal 223 from sensor signal 225 to yield the physiological-related signal component (or an approximation thereof) as a raw physiological signal 227.”).
Regarding claim 6, Luna discloses (par. 0043) the first signal and the noise signature signal are represented in at least a frequency domain (“physiological characteristic determinator 126 is configured to amplify and/or filter the physiological-related component signals (e.g., at different frequency ranges) to extract certain physiological signals.”).
Regarding claim 7, Luna discloses (par. 0042) the transducer includes a motion sensor and the noise signature signal represents movement of the user computing device (“The motion-related component includes motion artifacts or noise induced into an electrode 110a. Motion artifact reduction unit 124 is configured to receive motion-related signals generated at one or more motion sensors 160, and is further configured to receive at least the motion-related signal component of the second signal. Motion artifact reduction unit 124 operates to eliminate the magnitude of the motion-related signal component, or to reduce the magnitude of the motion-related signal component relative to the magnitude of the physiological-related signal component, thereby yielding as an output the physiological-related signal component (or an approximation thereto). Thus, motion artifact reduction unit 124 can reduce the magnitude of the motion-related signal component (i.e., the motion artifact) by an amount associated with the motion-related signal generated by one or more accelerometers to yield the physiological-related signal component.”).
Regarding claim 8, Luna discloses (par. 0038) the transducer includes a capacitance sensor and the noise signature signal represents changes in an area in which changes in differences in effective capacitance are detected (“The bioimpedance signal is a measured signal that includes real and complex components. Examples of real components include extra-cellular and intra-cellular spaces of tissue, among other things, and examples of complex components include cellular membrane capacitance, among other things.”).
Regarding claim 9, Luna discloses (par. 0105) the one or more characteristics associated with the user includes a presence of sweat on a surface of the user's skin (“physiological signs of pain may include, for example, an increase in respiration rate, an increase in the length of a respiration cycle (e.g., deeper inhalation and exhalation), changes and/or variations in blood pressure, changes and/or variations in heart rate, an increase in perspiration (e.g., increased skin conductance) , an increase in muscle tone (e.g., as determined by physiological characteristics indicating increased electrical impulses to or by musculature, and the like). Based on such physiological characteristics, pain/stress analyzer 2114 can be configured to detect that the user is experiencing pain, and in some cases, the level of pain.”).
Regarding claim 10, Luna discloses (par. 0105) the presence of sweat on the surface of the user's skin is used to estimate a stress level associated with the user (“physiological signs of pain may include, for example, an increase in respiration rate, an increase in the length of a respiration cycle (e.g., deeper inhalation and exhalation), changes and/or variations in blood pressure, changes and/or variations in heart rate, an increase in perspiration (e.g., increased skin conductance) , an increase in muscle tone (e.g., as determined by physiological characteristics indicating increased electrical impulses to or by musculature, and the like). Based on such physiological characteristics, pain/stress analyzer 2114 can be configured to detect that the user is experiencing pain, and in some cases, the level of pain.”).
Regarding claim 11, Luna discloses (par. 0038) the one or more characteristics associated with the user includes an impedance value as measured between two points on the user's skin (“physiological information generator 120 can determine the bioelectric impedance ("bioimpedance") of one or more types of tissues of a wearer to identify, measure, and monitor physiological characteristics.”).
Regarding claim 12, Luna discloses (par. 0109) the impedance value as measured between two points on the user's skin can be used to estimate a stress level associated with the user (“a physiological state analyzer 2222, a stressor analyzer 2224, and an emotion formation module 2223. According to some embodiments, physiological state analyzer 2222 is configured to receive and analyze the sensor data, such as bioimpedance-based sensor data 2211, to compute a sensor-derived value representative of an intensity of an affective state of user 2202”).
Regarding claim 13, Luna discloses (Figure 2) generating, by a first electrode (par. 0039) in a user computing device, in contact with user's skin, a first signal representing one or more characteristics associated with a user (raw sensor signal 225); detecting, by a transducer (motion sensor 225), a noise signature signal (motion artifact signal 223); modifying, by one or more processors, the first signal based on the noise signature signal to generate a modified first signal (par. 0055, especially “Motion artifact reduction unit 224 operates to subtract motion artifact signal 223 from sensor signal 225 to yield the physiological-related signal component (or an approximation thereof) as a raw physiological signal 227.”); and determining, by one or more processors, one or more characteristics associated with a user based on the modified first signal (“raw physiological signal 227 may include a respiration signal modulated on (or in association with) a heart rate ("HR") signal. Regardless, physiological characteristic determinator 226 is configured to perform digital signal processing to generate a heart rate ("HR") signal 229a and/or a respiration signal 229b. Portion 240 of respiration signal 229b represents an impedance signal due to cardiac activity, at least in some instances. Further, physiological characteristic determinator 226 is configured to use either HR signal 229a or a respiration signal 229b, or both, to derive other physiological characteristics, such as blood pressure data ("BP") 229c, a maximal oxygen consumption ("VO2 max") 229d, or any other physiological characteristic.”).
Regarding claim 14, Luna discloses (par. 0086) determining, by the one or more processors at a particular time, whether the noise signature signal exceeds a predetermined threshold value (“An example of a centering process includes subtracting the meaning of data from a sample to translate samples about a center.”); in accordance with a determination that the noise signature signal exceeds the predetermined threshold value, storing, by the one or more processors, a timestamp (O1(t) and O2(t)) of the particular time; and excluding, by the one or more processors, the first signal associated with the timestamp from consideration when determining one or more characteristics associated with a user based on the modified first signal.
Regarding claim 15, Luna discloses (par. 0103) wherein the user computing device includes a predetermined amount of time associated with gathering sufficient data to determine one or more characteristics associated with the user (“One or more motion sensors can be used to determine the orientation of a wearable device, and relative movement of the same (e.g., over a period of time or between events), to determine or predict a target location” in par. 0067), the method further comprising: before the predetermined amount of time has elapsed: determining, by the one or more processors, that the modified first signal includes data sufficient to determine one or more characteristics associated with the user; and presenting, by the one or more processors on a display associated with the user computing device, a notification that the user can disengage from contact with the dry electrode (“Upon detecting a sleep state condition (e.g., a sleep state transition), sleep manager 1912 can be configured to communicate the condition to physiological state determinator 2024, which, in turn, generates a notification signal as a vibratory activation signal, thereby causing vibratory energy source 2028 (e.g., mechanical motor as a vibrator) to impart vibration through housing 2003 unto a user, responsive to the vibratory activation signal, to indicate the presence of the sleep-related condition (e.g., transitioning from a wakefulness state to a sleep state). According to some embodiments, sleep manager 1912 can generate a wake enable/disable signal 2013 configured to enable or disable the ability of vibratory energy source 2028 to generate an alarm signal. For example, if sleep manager 1912 determines that the user is in a REM sleep state, sleep manager 1912 generates a wake disable signal 2013 to prevent vibratory energy source 2228 from waking the user. But if sleep manager 1912 determines that the user is in a non-REM sleep state that coincides with a wake alarm time, or is there shortly thereafter, sleep manager 1912 will generate enable signal 2013 to permit vibratory energy source 2028 to wake up the user.”).
Regarding claim 16, Luna discloses (par. 0103) the user computing device includes a predetermined amount of time associated with gathering sufficient data to determine one or more characteristics associated with the user (“One or more motion sensors can be used to determine the orientation of a wearable device, and relative movement of the same (e.g., over a period of time or between events), to determine or predict a target location” in par. 0067), the method further comprising: when the predetermined amount of time has elapsed: determining, by the one or more processors, that the modified first signal does not include data sufficient to determine one or more characteristics associated with the user; and presenting, by the one or more processors on a display associated with the user computing device, a request that the user continue to remain in contact with the dry electrode (“Upon detecting a sleep state condition (e.g., a sleep state transition), sleep manager 1912 can be configured to communicate the condition to physiological state determinator 2024, which, in turn, generates a notification signal as a vibratory activation signal, thereby causing vibratory energy source 2028 (e.g., mechanical motor as a vibrator) to impart vibration through housing 2003 unto a user, responsive to the vibratory activation signal, to indicate the presence of the sleep-related condition (e.g., transitioning from a wakefulness state to a sleep state). According to some embodiments, sleep manager 1912 can generate a wake enable/disable signal 2013 configured to enable or disable the ability of vibratory energy source 2028 to generate an alarm signal. For example, if sleep manager 1912 determines that the user is in a REM sleep state, sleep manager 1912 generates a wake disable signal 2013 to prevent vibratory energy source 2228 from waking the user. But if sleep manager 1912 determines that the user is in a non-REM sleep state that coincides with a wake alarm time, or is there shortly thereafter, sleep manager 1912 will generate enable signal 2013 to permit vibratory energy source 2028 to wake up the user.”).
Regarding claim 18, Luna discloses (par. 0039) the first sensor is a dry electrode enabled to contact a user's skin. While Luna is silent on electrode being “dry” electrode, the electrode of Luna is being used to directly placed on the skin of a user [0039] without the use of electrolyte gel, which is consistent with applicant’s definition of dry electrode (see par. 0059 of USPGPub. version of instant specification).
Regarding claim 19, Luna discloses (par. 0042) the transducer is an audio sensor situated to detect audio signals internal to the user computing device generated by lateral movement of the user computing device along the skin of the user (“The motion-related component includes motion artifacts or noise induced into an electrode 110a. Motion artifact reduction unit 124 is configured to receive motion-related signals generated at one or more motion sensors 160, and is further configured to receive at least the motion-related signal component of the second signal. Motion artifact reduction unit 124 operates to eliminate the magnitude of the motion-related signal component, or to reduce the magnitude of the motion-related signal component relative to the magnitude of the physiological-related signal component, thereby yielding as an output the physiological-related signal component (or an approximation thereto). Thus, motion artifact reduction unit 124 can reduce the magnitude of the motion-related signal component (i.e., the motion artifact) by an amount associated with the motion-related signal generated by one or more accelerometers to yield the physiological-related signal component.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792