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
Claim 24 is objected to because of the following informalities: “a impedance” should be corrected to “an impedance”. Appropriate correction is required.
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 17-36 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17, 30, 31, and 32 recite the limitation “determine a level of gastro-intestinal disorder based on the determined set of pairs of values.”. Applicant’s specification pages 13 paras 6-7 and page 14 discloses how to normalize the first and second value and weight the values to obtain a third score value. However, per claims 20-24 and claim 26, a variety of different parameters may be used for the first and second values. The disclosure does not state how different parameters for the first value, such as heart rate or pH, are used in different combinations with the second value, such as acceleration or position, to obtain the third score. Additionally, the PRS may include “type of symptom (for example, heartburn, chest pain, pyrosis, belching, dysphagia, regurgitation or cough and a level of intensity of this symptom.” (page 11 para 8), but no description is included as to how different symptoms are used in combination with different parameters. While page 14 para 4 states that the third value may be obtained by multiplying the first and second value, no further explanation is provided as to how those values are normalized to be multiplied with one another. Page 13 para 4 merely states that the second value is obtained “by multiplying the value of the GECM measured at step S2 by a weight coefficient, the weight coefficient being based on the patient activity information and/or the movement and posture information. For example, a mapping can be pre-established assigning to each possible triplet of activities, postures and movements a weight coefficient. Therefore, based on the activities, postures and movements indicated by the patient activity information and the movement and posture information, the processing module 12 can retrieve and apply the relevant weight coefficient”, but not further normalization of differing parameters.
Claims 17, 30, 31, and 32 recite the limitation “determine a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value”. As the limitation states that the pairs of values correspond to “a set of different time intervals”, it is unclear if the pair of values comprised of a first value and a second value is taken from different time intervals or the same time interval. Per page 3 para 3 of applicant’s specification “By a set of different time intervals it is understood all-time division of a time period during which the gastro-esophageal content is measured.”, suggesting that the set of time intervals refers to segments of one continuous measurement period. Applicant’s specification page 3 para 4 further states “By parameter corresponding to a given time interval it is understood that the measurement of the parameter has been carried out in the given time interval.”, suggesting that the “given” interval refers to a single interval in the series from which the parameters are extracted. For the purposes of examination, the first and second value will be interpreted to be taken from the same time interval, consistent with page 10 para “configured to determine a set of time intervals, and for each time interval, to determine a first value and a second value.”
Claims 18-29 and 34-35 are rejected due to dependency.
Claim Rejections - 35 USC § 101
Claim(s) 17-36 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 17 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 17 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “determine a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value, wherein, if an input from the patient corresponds to the given time interval, said first value is determined based on a measurement of the parameter corresponding to the given time interval and on the input from the patient corresponding to the given time interval, and wherein said second value is determined based on a measurement of gastro- esophageal content corresponding to the given time interval;”, and “determine a level of gastro-intestinal disorder based on the determined set of pairs of values.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “gastro-intestinal probe”, “patient interface”, “sensor” and “processor”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0014]: “Accordingly, most conventional techniques tend to involve invasive methods, such as rectal probes, gastro-intestinal sensors… Some such conventional technique uses an ingestible sensors” of Popovic et al. (US 20170340208 A1). Regarding the processor and patient interface, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 17 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 18-29 fail to cure the deficiencies of independent claim 17 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 17-29 is/are rejected under 35 U.S.C. 101.
Claim 30 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 30 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving data representing gastro-esophageal content measurements of a patient;”, “receiving data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient;”, “receiving data representing inputs from the patient, said inputs corresponding to patient reported symptoms,”, “determining a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value, wherein, if data representing inputs from the patient represents an input corresponds to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval, and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time interval;”, and “determining a level of gastro-intestinal disorder based on the determined set of pairs of values.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 30 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Thus, claim(s) 30 is/are rejected under 35 U.S.C. 101.
Claim 31 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 31 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving data representing gastro-esophageal content measurements of a patient;”, “receiving data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient;”, “receiving data representing inputs from the patient, said inputs corresponding to patient reported symptoms,”, “determining a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value, wherein, if data representing inputs from the patient represents an input corresponding to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval, and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time interval;”, and “determining a level of gastro-intestinal disorder based on the determined set of pairs of values.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a non-transitory computer-readable medium” and “a processor”. However, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 31 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 33 and 34 fail to cure the deficiencies of independent claim 31 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 31, 33, and 34 is/are rejected under 35 U.S.C. 101.
Claim 32 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 32 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive data representing gastro-esophageal content measurements of a patient;”, “receive data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient;”, “receive data representing inputs from the patient, said inputs corresponding to patient reported symptoms,”, “determine a set of pairs of values respectively corresponding to a set of different time intervals, each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value, wherein, if data representing inputs from the patient represents an input corresponding to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval, and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time interval;”, and “determine a level of gastro-intestinal disorder based on the determined set of pairs of values.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a computer apparatus”,a communication interface,” and “a processor”. However, a generic computer structure is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 32 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 35 and 36 fail to cure the deficiencies of independent claim 32 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 32, 35, and 36 is/are rejected under 35 U.S.C. 101.
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)(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.
Claim(s) 17, 19-32, 34, and 36 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Devanaboyina (US 20170035318 A1).
Regarding claim 17, Devanaboyina discloses a system for monitoring gastro-intestinal disorders (title), comprising: a gastro-intestinal probe configured to perform gastro-esophageal content measurements of a patient ([0046]: “a swallowable device containing a sensor or electrode.”, [0105]: “a sensor 102 . . . N of the present invention may be an internal sensor 2101… The sensor 2101 can be administered orally, and contains various means to be secured to or detach from the internal lining of gastrointestinal tract, such as for example suction cups, clamps, hooks and an expandable scaffold.” Wherein the probe consists of the sensor and attachment means); at least one sensor configured to measure a parameter of the patient ([0046]: “sensor”), said parameter being dependent to pain and/or stress of the patient ([0057]: "positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements "); a patient interface configured to receive inputs from the patient ([0055]: “input control buttons 106”), said inputs corresponding to patient reported symptoms, PRS ([0055]: " Patient symptom and event recording can allow for input of symptoms such as pain, bloating, cramping, psychological status indicative any stress, physical activities such as eating, drinking and bowel movements through observation device 104 and the input control buttons 106.”); a processor configured to ([0045]: “a processor 222 to process various software modules”): determine a set of pairs of values respectively corresponding to a set of different time intervals ([0031-0034]: “recording, collecting, disseminating and storing various physiological parameters… display parameters such as Signal 1, signal from organs 164, user activity 160 and other physiological parameters 166”, parameter 1 being signal 1 and parameter 2 being signal 166), each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value (Fig 1 elements 162 and 166, consistent with applicant’s specification page 3 para 3: “By parameter corresponding to a given time interval it is understood that the measurement of the parameter has been carried out in the given time interval”, wherein the parameters are determined within the same time interval, as in the given time interval among other different time intervals), wherein, if an input from the patient corresponds to the given time interval, said first value is determined based on a measurement of the parameter corresponding to the given time interval and on the input from the patient corresponding to the given time interval ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced.”, [0057]: “positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain,”), and wherein said second value is determined based on a measurement of gastro- esophageal content corresponding to the given time interval ([0034]: “other physiological parameters 166”, Fig 1 element 166, [0042]: "additional sensors that can record the gastrointestinal tract pH, motility, pressure, chemical composition of the gastrointestinal tract contents"); and determine a level of gastro-intestinal disorder based on the determined set of pairs of values ([0057]: “The parameter of interest 605, for example electrical signals, can be acquired and conditioned 607. The acquired signal can be recorded, processed, displayed and saved through appropriate sequence of steps 609. Using this information the clinician may diagnose the disease condition 611… may integrate the various parameters such as gastrointestinal tract electrical activity, autonomic function, various events and symptoms recorded by the user, and display a comprehensive score for easy understanding”, wherein the first parameter of interest and the additional parameters are combined and the score is representative of a disease condition).
Regarding claim 18, Devanaboyina discloses wherein the first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient, or weighting a value corresponding to the input from the patient according to the measurement of the parameter ([0057]: “gastrointestinal tract electrical activity, autonomic function, various events and symptoms recorded by the user, and display a comprehensive score for easy understanding”).
Regarding claim 19, Devanaboyina discloses wherein, if no input from the patient corresponds to the given time interval, the processor is further configured to determine said first value based on the measurement of the parameter corresponding to the given time interval ([0057]: “in conjunction with lack of or presence of other symptoms and changes in autonomic activity recorded by the device for arriving at the diagnosis of irritable bowel syndrome.”, wherein autonomic activity may be taken with lack of symptoms).
Regarding claim 20, Devanaboyina further discloses wherein said second value is determined based on the measurement of gastro-esophageal content corresponding to the given time interval and on a patient activity information and/or a movement and posture information, said patient activity information and said movement and posture information corresponding to the given time interval ([0055]: ". Any provided accelerometer is provided is configured to detect movement related artifacts of the patient. When movement is detected that interferes with the gastrointestinal tract or other signals, the system may choose to pause acquiring such data until the movement has subsided. Alternatively, the system may flag the segment of the signals as artifacts and may not be considered for analysis").
Regarding claim 21, Devanaboyina further discloses wherein the second value determined based on the measurement of gastro-esophageal content and based on the patient activity information and/or the movement and posture information is determined by weighting the measurement of gastro-esophageal content according to the patient activity information and/or the movement and posture information ([0055], [0042]).
Regarding claim 22, Devanaboyina further discloses comprising at least one electronic sensor among an accelerometer sensor, a gyroscope sensor and a flexible angular sensor, and wherein said movement and posture information is determined based on the output of the at least one electronic sensor ([0055]: ". Any provided accelerometer is provided is configured to detect movement related artifacts of the patient.”).
Regarding claim 23, Devanaboyina further discloses wherein the patient activity information being determined based on at least one among an output of a heart rate sensor, an output of a blood pressure sensor, an output of a temperature sensor, an output of a breathing rate sensor, an output of an oxygen saturation sensor, an output of an accelerometer sensor, an output of a gyroscope sensor, an output of a flexible angular sensor, an output of a clock, a geolocation information and an activity input given by the patient ([0055]: ". Any provided accelerometer is provided is configured to detect movement related artifacts of the patient.”).
Regarding claim 24, Devanaboyina further discloses wherein the gastro-intestinal probe comprises at least one probe sensor among a pH sensor and an impedance sensor ([0042]: " additional sensors that can record the gastrointestinal tract pH").; and wherein said gastro-esophageal content measurements are obtained based on the output of the at least one probe sensor ([0052]: " acquire signals related to contractility, pressure, electrical activity of gastrointestinal tract, or pH or chemical composition of the contents of the gastrointestinal tract).
Regarding claim 25, Devanaboyina further discloses wherein the gastro-intestinal probe comprises a plurality of probe sensors arranged in array, wherein said gastro-esophageal content measurements are obtained based on the outputs of the plurality of probe sensors ([0090]: “Arrays of sensors 102”).
Regarding claim 26, Devanaboyina further discloses wherein the sensor configured to measure the parameter is a sensor among a heart rate sensor, a blood pressure sensor, a temperature sensor ([0048]: “, a temperature monitor,”), a breathing rate sensor, an oxygen saturation sensor, a lactate level sensor, a sodium level sensor, a uric acid level sensor, a potassium level sensor, a stress- related hormones sensor; and wherein parameter measurements are obtained based on the output of the sensor configured to measure the parameter ([0048]: “An electrode or sensor may have the capability to record electromyography, electrocardiography, electroencephalography, skin conductance, electrical signals from gastrointestinal tract or urinary bladder, or any combination of the foregoing.”).
Regarding claim 28, Devanaboyina further discloses further comprising a receiving wireless communication unit configured to receive gastro-esophageal content measurements from the gastro-intestinal probe, and wherein the gastro-intestinal probe comprises a transmitting wireless communication unit configured to transmit gastro-esophageal content measurements ([0042]: "internally placed device may be able to communicate wirelessly through another device placed externally to record and store the data for further transmission, storage or analysis.").
Regarding claim 28, Devanaboyina further discloses a device, said device comprising the receiving wireless communication unit and/or the patient interface and said device being a user equipment or a patient worn device (Fig 4 elements 104 and 130).
Regarding claim 29, Devanaboyina further discloses associating the level of gastro-intestinal disorder to a first gastro-intestinal disorder and determining another level of gastro-intestinal disorder associated to a second gastro-intestinal disorder, said another level being determined based on the determined set of pairs of values ([0057-0058]: "and display a comprehensive score for easy understanding… the progression of ulcerative colitis and Crohn's disease in a non-invasive fashion. For example, in Crohn's disease patients the slow wave frequency is less frequent and may be absent sometimes, depending on the intensity of the disease condition due to severe scarring of gut segments. This can be differentiated from ulcerative colitis, which is likely presents with increase slow wave frequency, but lower amplitude, compared to the healthy individuals.").
Regarding claim 30, Devanaboyina discloses a method to monitor Gastro-intestinal disorders (title), comprising: receiving data representing gastro-esophageal content measurements of a patient ([0046]: “internal sensors or electrodes are used, such sensors may be suitably implanted or anchored to the respective portion of the gastrointestinal tract”); receiving data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient ([0057]: "positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device"); receiving data representing inputs from the patient, said inputs corresponding to patient reported symptoms, PRS ([0055]: " Patient symptom and event recording can allow for input of symptoms such as pain, bloating, cramping, psychological status indicative any stress, physical activities such as eating, drinking and bowel movements through observation device 104 and the input control buttons 106.”); determining a set of pairs of values respectively corresponding to a set of different time intervals ([0031-0034]: “recording, collecting, disseminating and storing various physiological parameters… display parameters such as Signal 1, signal from organs 164, user activity 160 and other physiological parameters 166”, parameter 1 being signal 1 and parameter 2 being signal 166), each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value ([0056]: “parameter 1 and 2”, see Fig 1 and Fig 5, consistent with applicant’s specification page 3 para 3: “By parameter corresponding to a given time interval it is understood that the measurement of the parameter has been carried out in the given time interval”, wherein the parameters are determined within the same time interval, as in the given time interval among other different time intervals), wherein, if data representing inputs from the patient represents an input corresponding to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point.", [0057]: “positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device,”, [0107]; “recording by the patient in real time one or more symptoms…. pain from chest, abdomen or pelvic regions”, wherein the patient reported events are correlated with the recorded activity and wherein the parameter dependent on pain is any parameter that varies with stress, consistent with applicant’s specification page 3 para 1: “By parameter being dependent to pain and/or stress of the patient it is understood any parameter of the patient that varies when the patient experiences pain or stress, for example, increase of the heart rate, the temperature, the sweating, stress-related hormone levels, et” and per para [0057], the parameter is correlation with pain), and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time ([0042]: "additional sensors that can record the gastrointestinal tract pH, motility, pressure, chemical composition of the gastrointestinal tract contents", consistent with applicant’s specification page 8: “a parameter of the gastro-esophageal content, for example, the pH of the gastro-esophageal content, Fig 1 element 166); and determining a level of gastro-intestinal disorder based on the determined set of pairs of values ([0057]: “The parameter of interest 605, for example electrical signals, can be acquired and conditioned 607. The acquired signal can be recorded, processed, displayed and saved through appropriate sequence of steps 609… may integrate the various parameters such as gastrointestinal tract electrical activity, autonomic function, various events and symptoms recorded by the user, and display a comprehensive score for easy understanding”, wherein the first parameter of interest and the additional parameters are combined ).
Regarding claim 31, Devanaboyina discloses a non-transitory computer-readable medium encoded with executable instructions which, when executed, causes an apparatus comprising a processor operatively coupled with a memory ([0008]: “with various modules including a processor and memory to run the software.”), to perform a method to monitor gastro-intestinal disorders (title), comprising: receiving data representing gastro-esophageal content measurements of a patient ([0046]: “internal sensors or electrodes are used, such sensors may be suitably implanted or anchored to the respective portion of the gastrointestinal tract”); receiving data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient ([0057]: "positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device"); receiving data representing inputs from the patient, said inputs corresponding to patient reported symptoms, PRS ([0055]: " Patient symptom and event recording can allow for input of symptoms such as pain, bloating, cramping, psychological status indicative any stress, physical activities such as eating, drinking and bowel movements through observation device 104 and the input control buttons 106 . “); determining a set of pairs of values respectively corresponding to a set of different time intervals ([0031]: “recording, collecting, disseminating and storing various physiological parameters… display parameters such as Signal 1, signal from organs 164, user activity 160 and other physiological parameters 166.”, parameter 1 being signal 1 and parameter 2 being signal 166), each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value ([0056]: “parameter 1 and 2”, see Fig 1 and Fig 5, consistent with applicant’s specification page 3 para 3: “By parameter corresponding to a given time interval it is understood that the measurement of the parameter has been carried out in the given time interval”, wherein the parameters are determined within the same time interval, as in the given time interval among other different time intervals), wherein, if data representing inputs from the patient represents an input corresponding to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point.", [0057]: “positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device,”, [0107]; “recording by the patient in real time one or more symptoms…. pain from chest, abdomen or pelvic regions”, wherein the patient reported events are correlated with the recorded activity and wherein the parameter dependent on pain is any parameter that varies with stress, consistent with applicant’s specification page 3 para 1: “By parameter being dependent to pain and/or stress of the patient it is understood any parameter of the patient that varies when the patient experiences pain or stress, for example, increase of the heart rate, the temperature, the sweating, stress-related hormone levels, et” and per para [0057], the parameter is correlation with pain), and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time interval ( [0042]: "additional sensors that can record the gastrointestinal tract pH, motility, pressure, chemical composition of the gastrointestinal tract contents", consistent with applicant’s specification page 8: “a parameter of the gastro-esophageal content, for example, the pH of the gastro-esophageal content); and determining a level of gastro-intestinal disorder based on the determined set of pairs of values ([0057]: “The parameter of interest 605, for example electrical signals, can be acquired and conditioned 607. The acquired signal can be recorded, processed, displayed and saved through appropriate sequence of steps 609… may integrate the various parameters such as gastrointestinal tract electrical activity, autonomic function, various events and symptoms recorded by the user, and display a comprehensive score for easy understanding”, wherein the first parameter of interest and the additional parameters are combined ).
Regarding claim 32, Devanaboyina discloses a computer apparatus comprising (Fig 4 element 130): a communication interface configured to: receive data representing gastro-esophageal content measurements of a patient ([0046]: “internal sensors or electrodes are used, such sensors may be suitably implanted or anchored to the respective portion of the gastrointestinal tract”); receive data representing parameter measurements, said parameter being dependent to pain and/or stress of the patient ([0057]: "positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device"); receive data representing inputs from the patient, said inputs corresponding to patient reported symptoms, PRS ([0055]: " Patient symptom and event recording can allow for input of symptoms such as pain, bloating, cramping, psychological status indicative any stress, physical activities such as eating, drinking and bowel movements through observation device 104 and the input control buttons 106 . “); the computer apparatus further comprising a processor configured to ([0008]: “with various modules including a processor and memory to run the software.”): determine a set of pairs of values respectively corresponding to a set of different time intervals ([0031]: “recording, collecting, disseminating and storing various physiological parameters… display parameters such as Signal 1, signal from organs 164, user activity 160 and other physiological parameters 166.”, parameter 1 being signal 1 and parameter 2 being signal 166), each pair of values corresponding to a given time interval among the set of different time intervals comprises a first value and a second value ([0056]: “parameter 1 and 2”, see Fig 1 and Fig 5, consistent with applicant’s specification page 3 para 3: “By parameter corresponding to a given time interval it is understood that the measurement of the parameter has been carried out in the given time interval”, wherein the parameters are determined within the same time interval, as in the given time interval among other different time intervals), wherein, if data representing inputs from the patient represents an input corresponding to the given time interval, said first value is determined based on a data representing a measurement of the parameter corresponding to the given time interval and on data representing the input from the patient corresponding to the given time interval ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point.", [0057]: “positive correlation is obtained with electrical activity/contractility and symptoms of the patients such as abdominal pain accompanying bowel movements, along with increased autonomic activity recorded from the said device,”, [0107]; “recording by the patient in real time one or more symptoms…. pain from chest, abdomen or pelvic regions”, wherein the patient reported events are correlated with the recorded activity and wherein the parameter dependent on pain is any parameter that varies with stress, consistent with applicant’s specification page 3 para 1: “By parameter being dependent to pain and/or stress of the patient it is understood any parameter of the patient that varies when the patient experiences pain or stress, for example, increase of the heart rate, the temperature, the sweating, stress-related hormone levels, et” and per para [0057], the parameter is correlation with pain)and wherein said second value is determined based on data representing a measurement of gastro-esophageal content corresponding to the given time interval ( [0042]: "additional sensors that can record the gastrointestinal tract pH, motility, pressure, chemical composition of the gastrointestinal tract contents", consistent with applicant’s specification page 8: “a parameter of the gastro-esophageal content, for example, the pH of the gastro-esophageal content); and determine a level of gastro-intestinal disorder based on the determined set of pairs of values ([0057]: “The parameter of interest 605, for example electrical signals, can be acquired and conditioned 607. The acquired signal can be recorded, processed, displayed and saved through appropriate sequence of steps 609… may integrate the various parameters such as gastrointestinal tract electrical activity, autonomic function, various events and symptoms recorded by the user, and display a comprehensive score for easy understanding”, wherein the first parameter of interest and the additional parameters are combined).
Regarding claim 34, Devanaboyina further discloses wherein said second value is determined based on the measurement of gastro-esophageal content corresponding to the given time interval and on a patient activity information and/or a movement and posture information, said patient activity information and said movement and posture information corresponding to the given time interval [0055]: ". Any provided accelerometer is provided is configured to detect movement related artifacts of the patient. When movement is detected that interferes with the gastrointestinal tract or other signals, the system may choose to pause acquiring such data until the movement has subsided. Alternatively, the system may flag the segment of the signals as artifacts and may not be considered for analysis").
Regarding claim 36, Devanaboyina further discloses wherein said second value is determined based on the measurement of gastro-esophageal content corresponding to the given time interval and on a patient activity information and/or a movement and posture information, said patient activity information and said movement and posture information corresponding to the given time interval [0055]: ". Any provided accelerometer is provided is configured to detect movement related artifacts of the patient. When movement is detected that interferes with the gastrointestinal tract or other signals, the system may choose to pause acquiring such data until the movement has subsided. Alternatively, the system may flag the segment of the signals as artifacts and may not be considered for analysis").
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 18, 33, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devanaboyina in view of Pikov (US 20210393954 A1).
Regarding claim 18, Devanaboyina discloses the system of claim 17 but fails to disclose wherein the first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient, or weighting a value corresponding to the input from the patient according to the measurement of the parameter.
Pikov discloses a system for monitoring gastro-intestinal disorders (abstract) wherein a first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”), or weighting a value corresponding to the input from the patient according to the measurement of the parameter ([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”, [0088]: “may correlate various patient-provided physiological states (601) with various physiological parameters,”, wherein the physiological state is patient input).
As Devanaboyina discloses correlating patient input with the measurement parameter ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point."), it would have been obvious to a person of ordinary skill in the art before the effective filing date to further weight the measurement of the parameter according to the input from the patient as disclosed by Pikov in order to customize the system to a patient (Pikov [0004])
Regarding claim 33, Devanaboyina discloses the system of claim 31 but fails to disclose wherein the first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient, or weighting a value corresponding to the input from the patient according to the measurement of the parameter.
Pikov discloses a system for monitoring gastro-intestinal disorders (abstract) wherein a first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”), or weighting a value corresponding to the input from the patient according to the measurement of the parameter ([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”, [0088]: “may correlate various patient-provided physiological states (601) with various physiological parameters,”, wherein the physiological state is patient input).
As Devanaboyina discloses correlating patient input with the measurement parameter ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point."), it would have been obvious to a person of ordinary skill in the art before the effective filing date to further weight the measurement of the parameter according to the input from the patient as disclosed by Pikov in order to customize the system to a patient (Pikov [0004]).
Regarding claim 35, Devanaboyina discloses the system of claim 32 but fails to disclose wherein the first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient, or weighting a value corresponding to the input from the patient according to the measurement of the parameter.
Pikov discloses a system for monitoring gastro-intestinal disorders (abstract) wherein a first value determined based on the measurement of the parameter and the input from the patient is determined by: weighting the measurement of the parameter according to the input from the patient([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”), or weighting a value corresponding to the input from the patient according to the measurement of the parameter ([0034-0036]: “to calculate and adjust correlation weights between physiological parameters and physiological states 132… the physiological states form an output layer node, and the correlation weight values between the physiological parameters and the physiological states form the hidden layer nodes. The algorithm may calculate the correlation weights”, [0088]: “may correlate various patient-provided physiological states (601) with various physiological parameters,”, wherein the physiological state is patient input).
As Devanaboyina discloses correlating patient input with the measurement parameter ([0055]: "patient can press the appropriate one of the control buttons 106 . . . N, when abdominal pain is experienced. The event can be recorded with a time stamp and allow for comparison with changes in the motility pattern of the small or large bowels in relation to that time point."), it would have been obvious to a person of ordinary skill in the art before the effective filing date to further weight the measurement of the parameter according to the input from the patient as disclosed by Pikov in order to customize the system to a patient (Pikov [0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jensen et al. (US 20220346664 A1) – discloses an ingestible device
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791