DETAILED ACTION
Election/Restrictions
Claims 52-60 and 75-83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/24/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 48-51, 61-74 and 84-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12336824. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-25 of U.S. Patent No. 12336824 also disclose using electrodes to measure gastric activity, receive patient symptom information, determine gastric amplitude, correlate symptom information with gastric amplitude and based on a measure of correlation, determining a gastrointestinal phenotype.
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 48-51, 61-74 and 84-89 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 48-51, 61-74 and 84-89 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 48-51, 61-74 and 84-89 recites at least one step or instruction for determining a gastrointestinal phenotype based at least on a measure of a correlation, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 48-51, 61-74 and 84-89 recites an abstract idea.
Specifically, Claims 48-51, 61-74 and 84-89 recite using electrodes, measuring an amplitude spectral gastric activity and receiving patient symptom information and correlating the symptom information to the amplitude to determine a gastrointestinal phenotype (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG). Further, Claims 48-51, 61-74 and 84-89 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in Claims 48-51, 61-74 and 84-89 is not integrated into a practical application under 2019 PEG because the additional elements (e.g., electrodes and processor), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of electrodes and processor are generically recited computer elements in Claims 48-51, 61-74 and 84-89 do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in Claims 48-51, 61-74 and 84-89 are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Claims 48-51, 61-74 and 84-89 is not integrated into a practical application under the 2019 PEG.
Accordingly, Claims 48-51, 61-74 and 84-89 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 48-51, 61-74 and 84-89 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: electrodes and a processor.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. [
Accordingly, in light of Applicant’s specification, the claimed terms of electrodes and a processor are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the electrode and processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 48-51, 61-74 and 84-89 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and methods of Claims 48-51, 61-74 and 84-89 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 48-51, 61-74 and 84-89 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in Claims 48-51, 61-74 and 84-89 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 48-51, 61-74 and 84-89 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 48-51, 61-74 and 84-89amounts to significantly more than the abstract idea itself. Accordingly, Claims 48-51, 61-74 and 84-89are not patent eligible and rejected under 35 U.S.C. 101.
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 51 and 73 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.
The term “substantial synchronization” in claim 51 is a relative term which renders the claim indefinite. The term “substantial synchronization” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As currently claimed, it also appears that where the measure of correlation is functionally/inherently “indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude”, because the claim fails to define how or what makes the measure of correlation indicative of “a severity of patient symptom information” and “the gastric activity amplitude”. For purposes of examination the indefinite limitation has been deemed to claim where any measure of correlation is indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude.
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.
Claim(s) 48-51, 61-74 and 84-89 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180317800 A1 to Coleman et al. (hereinafter, Coleman).
Regarding Claims 48 and 67, Coleman discloses a method and system for monitoring gastric activity with an electrode array patch disposed over a skin surface of a patient to determine a gastrointestinal phenotype ([0014] “…an electrode sensing module 110 that has different measurement electrodes 101 and reference and ground electrodes 102 placed at different locations on a subject to obtain electrical signals representing GI activities of the subject under monitoring…”) ([0015] discloses the electrodes attached to a patient’s skin via a substrate), the method comprising inter alia:
measuring spectral gastric activity data of the patient with the electrode array over a predetermined test period ([0013] “The processor can… yields maximum a posteriori (MAP) spectral estimates. The electrodes can record the gut electrophysiology using Electrogastrography (EGG)… The electrodes can include an array of electrodes.”) ([0065]-[0074] describe spectral estimation);
concurrently receiving patient symptom information for a predetermined set of symptoms over the predetermined test period ([0050] “… if someone is experiencing nausea and logs that symptom on the mobile device, the data slightly before and after that event can be analyzed and correlated with any abnormalities…”) ([0083] “For example, a gastric electrical irregularity after a meal but not during fasting may indicate a central nervous system issue, while an dysrhythmia during fasting might indicate a problem with the nerve cells of the stomach controlling the gastric slow wave that leads to peristalsis. For this specific case, the power or magnitude of the 3 cpm (0.05 Hz) component of the EGG can be evaluated shortly before and after the marked event. A drop in the EGG power could indicate an abnormality.”);
determining a gastric activity amplitude over at least a portion of the test period from the measured gastric activity data ([0012] “The system includes electrodes to capture a gut electrophysiology recording and a processor to estimate a frequency and an amplitude of the recording across time.”); and
correlating the patient symptom information with the gastric activity amplitude ([0050] “… if someone is experiencing nausea and logs that symptom on the mobile device, the data slightly before and after that event can be analyzed and correlated with any abnormalities. Another example is when an abnormality in the gut is detected with the noninvasive recording, the events slightly before and after that time can be analyzed to determine the causality of the abnormality.”) ([0067] “The disclosed technology can be used to accurately characterize the dynamics of GI function that correlate with disease, with dietary intakes, effects of various drugs, etc.”);
determining a measure of correlation ([0050] and [0083] disclose EGG irregularities after a meal but not during fasting, and a measured drop in EGG power correlated to irregularities after a logged meal; [0123] discloses EGG irregularities during bad sleep but not during good sleep, and a measured increase in EGG power correlated to a bad sleep);
determining a gastrointestinal phenotype based at least in part on the measure of correlation ([0067] “…characterize the dynamics of GI function that correlate with disease, with dietary intakes, effects of various drugs, etc.”) ([0102] “The quantitative physiological monitoring method disclosed herein can differentiate between these diseases and guide the clinical diagnosis and subsequent therapies.”) ([0103] “Common GI disorders including, but not limited to, functional dyspepsia, gastroparesis, slow-transit constipation, irritable bowel syndrome, irritable bowel disease, gastritis, and eating disorders can be quantified and diagnosed using the system and methods described in this document. Moreover, since symptoms (e.g. nausea, vomiting, pain, etc.) resulting from various GI disorders are usually transient, the ability to record in an ambulatory setting outside of the clinic setting with relevant event markers (e.g. meals, sleep, bowel movements) greatly increases the probability of detecting and quantifying abnormalities.”).
Regarding Claim 49, Coleman discloses the method of claim 48, wherein the gastrointestinal phenotype comprises a sensorimotor phenotype ([0083] “…a gastric electrical irregularity after a meal but not during fasting may indicate a central nervous system issue…” where a central nervous system issue is a sensorimotor phenotype).
Regarding Claim 50, Coleman discloses the method of claim 49, wherein the sensorimotor phenotype is associated with postprandial distress syndrome therapies ([0089]-[0091] describe system guiding medication therapy based on GI function characterization, i.e., central nervous system issue in [0083] treated by the procedure in [0089]-[0091]).
Regarding Claim 51, Coleman discloses the method of claim 49, wherein the measure of correlation is indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude ([0050] and [0083] disclose EGG irregularities after a meal but not during fasting, and a measured drop in EGG power correlated to irregularities after a logged meal; [0123] discloses EGG irregularities during bad sleep but not during good sleep, and a measured increase in EGG power correlated to a bad sleep).
Regarding Claim 61, Coleman discloses the method of claim 48, further comprising providing the patient with a standardized meal at a predetermined time during the predetermined test period ([0108] “After an overnight fast, the EGG was recorded 30/60 minutes pre/post-prandial. A test meal including an energy bar and 8 ounces of water was provided to the subject.” where a meal after a fast is at known time during a test period of EGG recordings).
Regarding Claim 62, Coleman discloses the method of claim 48, wherein measuring gastric activity data with an electrode array further includes generating spatial information associated with gastric activity of the patient ([0113] “Multi-channel EGG was recorded with a 5 by 5 array of skin-mounted electrodes positioned over the stomach during an ADM study.”) ([0040] “There are advantages to using multiple measurement electrodes. For example, additional measurement electrodes can provide more spatial sensing coverage at different locations in connection with the monitored organ.”).
Regarding Claim 63, Coleman discloses the method of claim 48, wherein the patient symptom information is received predetermined intervals during the test period ([0050] “An application on the mobile device can be used to time-stamp events, such as meals, bowel movements, sleep, exercise, activity, symptoms, etc. In some embodiments, events can also be marked using buttons on the system or by user's input. These event markers can then be combined with the data in the analysis.” where the predetermined intervals are intervals that are the interval/times between time-stamps/markings).
Regarding Claim 64, Coleman discloses the method of claim 48, wherein the patient symptom information includes a symptom severity metric ([0050] and [0083] disclose EGG irregularities after a meal but not during fasting, and a measured drop in EGG power correlated to irregularities after a logged meal, a drop being a severity; [0123] discloses EGG irregularities during bad sleep but not during good sleep, and a measured increase in EGG power correlated to a bad sleep, an increase being a severity).
Regarding Claim 65, Coleman discloses the method as claimed in claim 48, wherein the predetermined set of patient symptoms comprise: a) nausea ([0050] “…if someone is experiencing nausea and logs that symptom on the mobile device…”).
Regarding Claim 66, Coleman discloses the method as claimed in claim 48, further comprising determining a measure of temporal association and determining the gastrointestinal phenotype of the patient based on the measure of correlation and the measure of temporal association ([0050] “…if someone is experiencing nausea and logs that symptom on the mobile device, the data slightly before and after that event can be analyzed and correlated with any abnormalities. Another example is when an abnormality in the gut is detected with the noninvasive recording, the events slightly before and after that time can be analyzed to determine the causality of the abnormality. For example, sometimes a meal can cause abnormalities. The mobile device can also provide real-time feedback to a user, for example, how the subject reacts to a certain type of food, treatment, etc.” where data slightly before and after an event is the determination of a measure of temporal association, where the phenotype is determined based on the temporal association and the correlation, i.e., phenotype is determined based on data before and after event, e.g. temporal association, and correlation, e.g. measure of EGG data to type of gastric issue).
Regarding Claim 68, Coleman discloses the system of claim 67, further comprising a connector device coupled to the electrode array patch ([0049] “The components of the systems disclosed herein, including the sensors or electrodes, data processing unit, displays, data storage, mobile device, etc., can be connected via one or more communication conduits or other suitable linking devices.”).
Regarding Claim 69, Coleman discloses the system of claim 67, further comprising a patient logging device for patient symptom information input ([0050] “An application on the mobile device can be used to time-stamp events, such as meals, bowel movements, sleep, exercise, activity, symptoms, etc.”).
Regarding Claim 70, Coleman discloses the system of claim 67, further comprising a display for displaying the generated report in a digital medium ([0047] “…the data processing unit can communicate the processed signals to the display.”).
Regarding Claim 71, Coleman discloses the system of claim 67, wherein the report comprises a physical medium ([0047] “…the data processing unit can communicate the processed signals to the display.” where the physical medium is the display).
Regarding Claim 72, Coleman discloses the system of claim 67, wherein the gastrointestinal phenotype comprises a sensorimotor phenotype ([0083] “…a gastric electrical irregularity after a meal but not during fasting may indicate a central nervous system issue…”).
Regarding Claim 73, Coleman discloses the system of claim 72, wherein the sensorimotor phenotype is associated with postprandial distress syndrome therapies ([0089]-[0091] describe system guiding medication therapy based on GI function characterization, i.e., central nervous system issue in [0083] treated by the procedure in [0089]-[0091]). Coleman discloses the system of claim 72, wherein the measure of correlation is indicative of substantial synchronization between a severity of patient symptom information and the gastric activity amplitude ([0050] and [0083] disclose EGG irregularities after a meal but not during fasting, and a measured drop in EGG power correlated to irregularities after a logged meal; [0123] discloses EGG irregularities during bad sleep but not during good sleep, and a measured increase in EGG power correlated to a bad sleep).
Regarding Claim 84, Coleman discloses the system of claim 67, wherein the spectral gastric activity data further includes spatial information associated with gastric activity of the patient ([0113] “Multi-channel EGG was recorded with a 5 by 5 array of skin-mounted electrodes positioned over the stomach during an ADM study.”) ([0040] “There are advantages to using multiple measurement electrodes. For example, additional measurement electrodes can provide more spatial sensing coverage at different locations in connection with the monitored organ.”).
Regarding Claim 85, Coleman discloses the system of claim 67, wherein the patient symptom information is received at predetermined intervals during the test period ([0050] “An application on the mobile device can be used to time-stamp events, such as meals, bowel movements, sleep, exercise, activity, symptoms, etc. In some embodiments, events can also be marked using buttons on the system or by user's input. These event markers can then be combined with the data in the analysis.” where the predetermined intervals are intervals that are the interval/times between time-stamps/markings).
Regarding Claim 86, Coleman discloses the system of claim 67, wherein the patient symptom information includes a symptom severity metric ([0050] and [0083] disclose EGG irregularities after a meal but not during fasting, and a measured drop in EGG power correlated to irregularities after a logged meal, a drop being a severity; [0123] discloses EGG irregularities during bad sleep but not during good sleep, and a measured increase in EGG power correlated to a bad sleep, an increase being a severity).
Regarding Claim 87, Coleman discloses the system of claim 67, wherein the predetermined set of patient symptoms comprise: a) nausea ([0050] “…if someone is experiencing nausea and logs that symptom on the mobile device…”).
Regarding Claim 88, Coleman discloses the system of claim 67, wherein the processor is further configured to determine a measure of temporal association ([0050] “…if someone is experiencing nausea and logs that symptom on the mobile device, the data slightly before and after that event can be analyzed and correlated with any abnormalities. Another example is when an abnormality in the gut is detected with the noninvasive recording, the events slightly before and after that time can be analyzed to determine the causality of the abnormality. For example, sometimes a meal can cause abnormalities. The mobile device can also provide real-time feedback to a user, for example, how the subject reacts to a certain type of food, treatment, etc.” where data slightly before and after an event is the determination of a measure of temporal association, where the phenotype is determined based on the temporal association and the correlation, i.e., phenotype is determined based on data before and after event, e.g. temporal association, and correlation, e.g. measure of EGG data to type of gastric issue).
Regarding Claim 89, Coleman discloses the system of claim 88, wherein the processor is further configured to determine the gastrointestinal phenotype of the patient based on the measure of correlation and the measure of temporal association ([0050] “…if someone is experiencing nausea and logs that symptom on the mobile device, the data slightly before and after that event can be analyzed and correlated with any abnormalities. Another example is when an abnormality in the gut is detected with the noninvasive recording, the events slightly before and after that time can be analyzed to determine the causality of the abnormality. For example, sometimes a meal can cause abnormalities. The mobile device can also provide real-time feedback to a user, for example, how the subject reacts to a certain type of food, treatment, etc.” where data slightly before and after an event is the determination of a measure of temporal association, where the phenotype is determined based on the temporal association and the correlation, i.e., phenotype is determined based on data before and after event, e.g. temporal association, and correlation, e.g. measure of EGG data to type of gastric issue).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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