DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the previously applied 35 U.S.C. 112(b) have been fully considered and are persuasive and the rejections are withdrawn.
Applicant’s arguments with respect to the 35 U.S.C. 102 and 103 rejection(s) of claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gharibans et al. in view of Coleman et al. and Brown et al.
Applicant's arguments with respect to the 35 U.S.C. 101 rejections have been fully considered but they are not persuasive:
The applicant argues the claims require processing large volumes of spectral data which cannot be practically performed in the human mind. The examiner disagrees and submits that the claims recite no electrode count or data volume - measuring spectral data is data gathering that can be performed in the mind absent specific claim language that sets forth a specific, large volume, data gathering process. The identified abstract idea is correlating logged scores with an amplitude and judging a phenotype from the result, which is observation and evaluation a clinician performs. The applicant argues a quantitative correlation over a 2-hour period improves conventional diagnostics. The examiner disagrees and submits that the asserted statement is to the abstract analysis itself and not to any technology. The electrode array, symptom logging, and display are used in an ordinary capacity and the specification/claims identify no improvement to the sensor, signal processing, computer or the display. The 2-hour duration and display are standard post-solution activity and “correlating” and “a measure of correlation” are results and not a particular field improving way of achieving it. The 35 U.S.C. 101 rejections are maintained.
Election/Restrictions
Claims 52-60 and 75-83 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 (Maintained)
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, all over a continuous 2-hour period and based on a measure of correlation, determining a gastrointestinal phenotype.
Claim Rejections - 35 USC § 101 (Maintained)
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 over an entire continuous test period and correlating the symptom information to the amplitude to determine a gastrointestinal phenotype over the entire continuous test period (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, processor, display), 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, processor and display 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, processor and display.
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, processor and display 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, processor and display. 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 (Newly Presented)
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 48-51, 61-74 and 85-89 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.
Regarding claims 48 and 67, the claims set forth that the amplitude is determined “over at least a portion of the continuous test period” but the next step correlates the symptom information “with the gastric activity amplitude over the entire continuous test period”. It is unclear how a correlation is performed over the entire period using an amplitude that may exist for only a portion of it. For purposes of examination the indefinite limitation has been deemed to claim that the gastric the limitation “correlating the patient symptom information with the gastric activity amplitude over the entire continuous test period” has been interpreted to require that the gastric activity amplitude is determined over the entire continuous test period, and that the symptom information and amplitude are correlated across that period.
Regarding claim 61, the limitation “the predetermined test period” now lacks antecedent basis, due to the amendments set forth in claim 48.
Claim Rejections - 35 USC § 103 (Newly presented)
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 48-50, 61-73 and 85-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a novel non-invasive gastric mapping device to Gharibans et al. (hereinafter, Gharibans) in view of US 20180317800 A1 to Coleman et al. (hereinafter, Coleman).
Regarding claims 48, 67, and 69-71, Gharibans discloses a system and method for monitoring gastric activity with an electrode array patch disposed over a skin surface of a patient to determine a gastrointestinal phenotype (p. 8, “Array. The Gastric Alimetry Array™ includes 66 pre-gelled Ag/AgCl electrodes (8×8 grid +2 reference; inter-electrode spacing 20 mm)… was designed to overlie the majority of the stomach’s surface area”; see FIG. 1, p. 16), the method comprising inter alia:
measuring spectral gastric activity data of the patient with the electrode array over a continuous test period of at least 2 hours (pp. 1-2, “Continuous measurement encompassed a fasting baseline (30 min), 482 kCal meal, and 4-hr post-prandial recording, followed by spectral and spatial biomarker analyses.”);
concurrently receiving patient symptom information for a predetermined set of symptoms over the entire continuous test period with the measured spectral gastric activity data (p. 10, “Symptoms of nausea, bloating, upper gut pain, heartburn, stomach burn, and excessive fullness were also measured during testing via the validated Gastric Alimetry App at 15-minute intervals using 0–10 visual analog scales (0 indicating no symptoms; 10 indicating the worst imaginable extent of symptoms).”; p. 8, “Patients log symptoms every 15 minutes via a digital interface employing pictograms (Fig. 1A), which has been validated to enable reliable capture of patient symptom data in association with a standard meal with excellent compliance.(49) This system therefore enables precise temporal correlations between patient symptom profiles with electrophysiological data.”) and a patient logging device for patient symptom information input (p. 8, “The Gastric Alimetry App™ runs on an iPad mini (Apple, Cupertino, CA), and is used for device setup, data transfers, and to capture patient reported symptom data during testing.”)
determining a gastric activity amplitude over at least a portion of the continuous test period from the measured gastric activity data (p. 9, “These metrics encompass mean amplitude (microvolts; μV), dominant frequency (cycles per minute; cpm), standard deviation (SD) of the dominant frequency, and the power ratio (the ratio of the mean amplitude in the fed vs fasted phase).(52) In this study, these variables were visualized for the entire test period, but calculated in statistical analyses based on the first 2 hr postprandially, when gastric activity is typically most active and SNR is highest.”); and
correlating patient symptom information with gastric activity metrics including the gastric activity amplitude (p. 4, “In the NVS-Abn group, BSGM metrics correlated with the severity of symptoms (including nausea, pain, excessive fullness, early satiety, bloating, heartburn and GCSI score; all r>0.35, p<0.05),” where the BSGM metrics include “mean amplitude (microvolts; μV)” p. 9; p. 8, “This system therefore enables precise temporal correlations between patient symptom profiles with electrophysiological data,” the symptom profiles being the symptoms logged every 15 minutes over the entire test period);
determining a measure of correlation (p. 4, “r=-0.58; p. 11, “Pearsons correlations”);
determining a gastrointestinal phenotype ((p. 3, “Two dominant patient subgroups were identified based on normal vs abnormal BSGM tests”; p. 2, “distinct underlying phenotypes as revealed by a novel BSGM device”) and disclosing that the phenotypes correlate with symptoms (p. 2, “These phenotypes correlate with symptoms”; p. 5 “confirmed by group-wise statistics, PCA, and symptom correlations via linear regression analysis”));
generating a report (p. 8, “A proprietary algorithm automatically filters and analyzes raw myoelectrical signals to generate a report, including key metrics and data visualizations (detailed below), which are accessible via a secure online portal.”).
Gharibans discloses the claimed invention except for expressly disclosing correlating the concurrently received patient symptom information with the gastric activity amplitude over the entire continuous test period, determining the gastrointestinal phenotype based at least in part on the measure of correlation, and generating a report comprising at least the determined gastrointestinal phenotype, where the report is displayed on a device. Gharibans has concurrent symptom collection, and it has symptom EGG correlation, but the correlation it performs uses a questionnaire rather than the concurrently logged series.
However, Coleman teaches a method for the characterization of GI functions using EGG, and includes the capturing and processing of EGG signals to estimate a frequency and an amplitude across time (paragraphs 0011-0012). Coleman teaches “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… These event markers can then be combined with the data in the analysis” (paragraph 0050) for correlating the logged symptoms with EGG amplitude over the recording and “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” (paragraph 0083), plus “differentiate between these diseases and guide the clinical diagnosis and subsequent therapies” (paragraph 0102) for assigning the phenotype from that correlation. Thus, Coleman teaches the act of correlating the logged in-test symptom entries themselves against amplitude and assigning the classification from the result. Coleman further teaches generating a report comprising at least the determined gastrointestinal phenotype, where the report is displayed on a device (see paragraphs 0047, 0050, 0102).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the method of Gharibans to correlate the concurrently logged patient symptom information with the gastric activity amplitude over the test period, to determine the gastrointestinal phenotype based on that measure of correlation, and to include the determined phenotype in the report displayed on a device, as taught by Coleman. Gharibans expressly designated its 15-minute symptom logging so that the system “enables precise temporal correlations between patient symptom profiles with electrophysiological data” (p. 8), and Coleman teaches that combining the time-stamped symptom markers with the record “greatly increases the probability of detecting and quantifying abnormalities” (paragraph 0103) and that the relationship between the logged event and the electrical signal itself indicate the underlying mechanism, e.g., “a gastric electrical irregularity after a meal but not during fasting may indicate a central nervous system issues, while a dysrhythmia during fasting might indicate a problem with the nerve cells of the stomach” (paragraph 0083), thereby allowing the system to “differentiate between these diseases” (paragraph 0102). Gharibans acknowledges that their consensus-panel phenotype classification “introduces subjectivity” (p. 6), such that an objective classification derived from a symptom correlation, as in Coleman would have provided a reproducible phenotyping.
Regarding claims 49 and 72, Gharibans as modified teaches wherein the gastrointestinal phenotype comprises a sensorimotor phenotype (Gharibans p. 7, “gut-brain dysregulation or other aetiologies”).
Regarding claims 50 and 73, Gharibans as modified teaches wherein the sensorimotor phenotype is associated with postprandial distress syndrome therapies (Gharibans p. 5, “selection of targeted treatments”).
Regarding claim 61, Gharibans as modified teaches further comprising providing the patient with a standardized meal at a predetermined time during the predetermined test period (Gharibans p. 9, “fasting period of 30 minutes, followed by a 482 kCal meal consumed over 10 minutes.”).
Regarding claims 62 and 84, Gharibans as modified teaches wherein measuring gastric activity data with an electrode array further includes generating spatial information associated with gastric activity of the patient (Gharibans p. 9 “spatial frequency stability … average spatial covariance… between pairs of electrodes”).
Regarding claims 63 and 85, Gharibans as modified teaches wherein the patient symptom information is received predetermined intervals during the test period (Gharibans p. 8, “Patient logs symptoms every 15 minutes”).
Regarding claims 64 and 86, Gharibans as modified teaches wherein the patient symptom information includes a symptom severity metric (Gharibans p. 10, “0-10 visual analog scales”.
Regarding claims 65 and 87, Gharibans as modified teaches wherein the predetermined set of patient symptoms comprise: a) nausea b) bloating c) upper gut pain d) heartburn e) stomach burn, or f) excessive fullness (Gharibans p. 10, “nausea, bloating, upper gut pain, heartburn, stomach burn, and excessive fullness”).
Regarding claims 66, 88 and 89 Gharibans as modified teaches (claims 66 and 88) 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 (Gharibans p. 8, “precise temporal correlations between patient symptom profiles with electrophsiological data”) (Coleman paragraph 0050 “the data slightly between and after that event can be analyzied and correlated,” i.e. determining when the gastric change occurs relative to the logged symptom), 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 (Coleman paragraph 0083 “a gastic electrical irregularity after a meal but not during fasting may indicate a problem with the nerve cells of the stomach,” e.g., where the phenotype depends on both whether the amplitude change correlates with the event and its timing relative to it).
Claim(s) 51 and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gharibans in view of Coleman as applied to claims 48/67 above, and further in view of Coherence Between Subjective Experience and Physiology in Emotion: Individual Differences and Implications for Well-Being to Brown et al. (hereinafter, Brown).
Gharibans in view of Coleman does not teach a maximum temporal correlation coefficient or a value of 0.5. Brown teaches correlating a subject’s rated severity time series with a physiological amplitude time series by computer “cross-correlations for lags of -10 to +10” and selecting “the maximum absolute value correlation coefficients” (p. 6). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to compute the Gharibans/Coleman symptom-amplitude correlation in this manner to obtain a signel measure that accounts for the delay between the reported symptom and the gastic responds. While the references do not disclose exactly 0.5 as claimed, because the threshold is a result-effective variable defining how tightly symptoms much track amplitude, and Ghariban’s 0.58 (p. 4) and Browns range of .17-.60 (p. 6) shows 0.5 lies within the known range of values, a skilled artisan would have found a maximum temporal correlation coefficient greater than 0.5 obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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