DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 38-57 are pending.
This action is Non-Final.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 41, 44, 51, 53 are objected to because of the following informalities: claim terminology should be clear and consistent: Claims 44 and 51 “the capsule” should read “the ingestible capsule device”. Abbreviations should be defined prior to use: Claim 41 “VOCs” is never defined; Claim 45 TCD is never defined. Claim 53 preamble should be reworded as it appears to intend to reference more than 1 claim, and there is a semicolon right before the period. Appropriate correction is required.
Drawings
The drawings are objected to because:
-Figures 1A-18 use the incorrect labels (should be FIG. not Figure)
-Figure 1A incorrectly use underlining when a lead line should be used for “10”
-Figures 1B-C, 2A-2B, 4A-4H, 18 have reference characters that are neither underlined nor contain lead leads, which is improper
-Figures 5-12B, 14A-17 each use unnecessary shading which detracts from the information graphed and contains text directly on the shaded sections which is improper
37 CFR 1.84
(p) Numbers, letters, and reference characters.
(1) Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted.
(2) The English alphabet must be used for letters, except where another alphabet is customarily used, such as the Greek alphabet to indicate angles, wavelengths, and mathematical formulas.
(3) Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. They should not be placed in the drawing so as to interfere with its comprehension. Therefore, they should not cross or mingle with the lines. They should not be placed upon hatched or shaded surfaces. When necessary, such as indicating a surface or cross section, a reference character may be underlined and a blank space may be left in the hatching or shading where the character occurs so that it appears distinct.
(4) The same part of an invention appearing in more than one view of the drawing must always be designated by the same reference character, and the same reference character must never be used to designate different parts.
(5) Reference characters not mentioned in the description shall not appear in the drawings. Reference characters mentioned in the description must appear in the drawings.
(q) Lead lines. Lead lines are those lines between the reference characters and the details referred to. Such lines may be straight or curved and should be as short as possible. They must originate in the immediate proximity of the reference character and extend to the feature indicated. Lead lines must not cross each other. Lead lines are required for each reference character except for those which indicate the surface or cross section on which they are placed. Such a reference character must be underlined to make it clear that a lead line has not been left out by mistake. Lead lines must be executed in the same way as lines in the drawing. See paragraph (l) of this section.
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
(2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: abbreviations should be defined prior to usage: TCD has never been defined, it also appears VOC is never properly set forth and defined either.
Appropriate correction is required.
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 38-57 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 claim 38, the limitations “an ingestible capsule device… an ingestible capsule device… the ingestible capsule device” renders the claim indefinite. It is unclear if these instances refer to the same device or difference device and which is further limited. This makes the metes and bounds of the claim unclear, which renders the claim indefinite.
Claim 38 recites the limitation "the location" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 39, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 39, the limitations “wherein the determining comprises, as a first comparison, comparing the metric representing fluctuation with a predefined threshold, and using a result of the first comparison to determine presence or absence of SIBO, and wherein the metric representing fluctuation is an aggregate fluctuation such as a cumulative aggregate fluctuation, or wherein the metric representing fluctuation is a standard deviation or variance from a trend line.
Claim 42 “an output signal” is indefinite. It is unclear if this is the same or different from claim 41 instance, which the claim depends from.
Regarding claim 44, the limitations “combining a result of the first comparison the gradient with the result of the second comparison to detect presence or absence of small-intestinal bacterial overgrowth in the subject” is not clear what is meant, and “the first comparison” and “the result” lack proper antecedent basis. Further the limitations “wherein the determining comprises calculating a weighted average or weighted sum of characteristics including at least the metric representing fluctuation and the trend line gradient, comparing the weighted average with a predefined threshold” is not clear what the function is when a weighted sum is calculated. Furthermore, “the result of the comparison” is not clear which comparison is being referenced. Lastly, it is not clear if “the characteristics further comprise” is further limiting “weighted average or weighted sum of characteristics”. For these reasons, the metes and bounds of the claim are unclear, which renders the claim indefinite.
Regarding claim 49, the limitations “the value of the metric representing fluctuation”, “the gradient of the trend line” , and “the concentration of the specific gas or gases” all lack proper antecedent basis.
Regarding claim 51, “the gradient of a trend line” lacks proper antecedent basis.
Regarding claim 52, the limitation “a metric representing fluctuation” is unclear if this is the same or different from that feature of claim 38. This makes the metes and bounds of the claim unclear, which renders the claim indefinite.
Claim 52 “the measured level of fermentation activity” lacks proper antecedent basis.
Claims 55-56 recite the limitation "the location". There is insufficient antecedent basis for this limitation in the claims.
Claim 56 recites the limitation "the method". There is insufficient antecedent basis for this limitation in the claim.
The dependent claims are rejected for depending on a rejected claim.
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 38-57 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 38
using the gas sensor data to calculate a metric representing fluctuation of the gas sensor data during a passage of the ingestible capsule device through the small intestine of the gastrointestinal tract (mathematical concepts and/or mental processes)
determining presence or absence of SIBO in the subject at least partially in dependence upon the metric representing fluctuation (mathematical concepts and/or mental processes)
Claim 55
using the gas sensor data to calculate a gradient of a first order polynomial best fit line fitted to the gas sensor data from passage of the ingestible capsule device through the small intestine of the gastrointestinal tract (mathematical concepts);
determining presence or absence of SIBO in the subject at least partially in dependence upon the gradient of the best fit line (mathematical concepts and/or mental processes)
Claim 56
determining presence or absence of SIBO in the subject at least partially in dependence upon the concentration of the specific gas or gases exceeding a predefined threshold concentration at one or a predefined threshold minimum number of locations during passage of the ingestible capsule device through the small intestine (mathematical concepts and/or mental processes)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 38
An ingestible capsule device comprising (field of use)
an ingestible indigestible bio-compatible housing; and, within the housing: a power source; sensor hardware including gas sensor hardware; processor hardware; memory hardware; and a wireless data transmitter (further limitations of field of use, limitations related to data gathering, and computer structures used as tools)
the memory hardware storing processing instructions which, when executed by the processor hardware, cause the processor hardware to perform a process for detecting presence or absence of small-intestinal bacterial overgrowth, SIBO, in a subject, the process (computer structures used as tools)
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject (data gathering, insignificant extra solution activities)
Claim 55
a non-transitory computer-readable medium storing processing instructions which, when executed by processor hardware, causes the processor hardware to perform a process (computer structures used as tools)
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of a composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject (limitations of field of use, limitations related to data gathering, and computer structures used as tools)
Claim 56
a non-transitory computer-readable medium storing processing instructions which, when executed by processor hardware, causes the processor hardware to perform a process (computer structures used as tools)
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of a composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject; wherein the gas sensor data represents a concentration of a specific gas or gases (limitations of field of use, limitations related to data gathering, and computer structures used as tools)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitations that are not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental processes, and thus, do not add a meaningful limitation to the claims as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process. In addition, these sensor structures are known from US 2019/0183380 and US 2013/0289368, and in general are sensors in generic locations producing the expected related data signals. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further details of the sensors which are known in the cited art above, further post solution data of transmitting information, and to further details of the claimed exceptions (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 38-57 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Covington et al. (Covington, US 2013/0289368).
Regarding claim 38, Covington teaches an ingestible capsule device (see Figures 1-3) comprising:
an ingestible indigestible bio-compatible housing (see at least Figures 1-3, [0057], [0033]); and,
within the housing:
a power source (see at least [0026], Figures 1-3 element 10);
sensor hardware including gas sensor hardware (see at least [0015], [0023], [0034]);
processor hardware (see at least Figures 1-3 element 9);
memory hardware (see at least Figures 1-3 element 11); and
a wireless data transmitter (see at least [0027]);
the memory hardware storing processing instructions which, when executed by the processor hardware, cause the processor hardware to perform a process for detecting presence or absence of small-intestinal bacterial overgrowth, SIBO, in a subject (see at least [0055]), the process comprising:
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject (see at least [0028], [0034], [0059], [0012]-[0015]);
using the gas sensor data to calculate a metric representing fluctuation of the gas sensor data during a passage of the ingestible capsule device through the small intestine of the gastrointestinal tract (see at least [0012]-[0015], [0027]);
determining presence or absence of SIBO in the subject at least partially in dependence upon the metric representing fluctuation (see at least [0011], [0013]-[0014], [0032] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present.).
Regarding claim 39, Covington teaches wherein the determining comprises, as a first comparison, comparing the metric representing fluctuation with a predefined threshold, and using a result of the first comparison to determine presence or absence of SIBO, and wherein the metric representing fluctuation is an aggregate fluctuation such as a cumulative aggregate fluctuation, or wherein the metric representing fluctuation is a standard deviation or variance from a trend line (see at least [0011], [0013]-[0014], [0032] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present.).
Regarding claim 40, Covington teaches wherein the gas sensor data is obtained by obtaining readings from an environmental temperature sensor housed within the ingestible capsule device representing environmental temperature at the ingestible capsule device, and compensating sampled values of an output signal generated by the gas sensor hardware to account for variations in environmental temperature, the gas sensor data being the compensated values (intended use, see at least [0015] structures capable).
Regarding claim 41, Covington teaches wherein the gas sensor data represents a concentration of a specific gas or gases; wherein the gas sensor data is obtained by processing sampled values of an output signal generated by the gas sensor hardware to extract the concentration of the specific gas or gases; and wherein the specific gas or gases is one or more from among: carbon dioxide CO2, hydrogen H2, methane, and one or more VOCs (see at least [0012]).
Regarding claim 42, Covington teaches wherein determining presence or absence of SIBO in the subject at least partially in dependence upon the concentration of the specific gas or gases exceeding a predefined threshold concentration at one or a predefined threshold number of locations during passage of the ingestible capsule device through the small intestine; and wherein the gas sensor data is, or is in direct proportion to, sampled values of an output signal generated by the gas sensor hardware (see at least [0011], [0013]-[0014], [0032] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present.).
Regarding claim 43, the limitations are met by Covington, except the limitations of wherein the process further comprises: fitting a trend line to the gas sensor data; wherein the determining presence or absence of SIBO in the subject is at least partially in dependence upon the metric representing fluctuation and at least partially in dependence upon a gradient of the trend line or an average gradient of the trend line is not directly taught. However, Covington does teach that known diseases are identified by known patterns (see at least [0011]-[0014], [0032]) and teaches that statistical analysis can be completed on the data (see at least [0064]). With such teachings it would lead to one of ordinary skill in the art to use trends or changes over time to identify such known patterns in order to diagnose or conclude no diagnosis as ordinary scientific practice in statistical analysis of gathered data.
Regarding claim 44, the limitations are met by Covington, except the limitations of wherein the determining comprises, as a second comparison, comparing a gradient of the trend line with a second predefined threshold; combining a result of the first comparison the gradient with the result of the second comparison to detect presence or absence of small-intestinal bacterial overgrowth in the subject; and wherein the determining comprises calculating a weighted average or weighted sum of characteristics including at least the metric representing fluctuation and the trend line gradient, comparing the weighted average with a predefined threshold, and determining presence or absence of SIBO in dependence upon the result of the comparison; and wherein the gas sensor data represents a concentration of a specific gas or gases, and the characteristics further comprise a number of times, or a duration for which, during passage of the capsule through the small intestine that the concentration of the specific gas or gases exceeds a predefined threshold concentration are not directly taught. However, Covington does teach that known diseases are identified by known patterns (see at least [0011]-[0014], [0032]) and teaches that statistical analysis can be completed on the data (see at least [0064]). With such teachings it would lead to one of ordinary skill in the art to use trends or changes over time to identify such known patterns in order to diagnose or conclude no diagnosis as ordinary scientific practice in statistical analysis of gathered data.
Regarding claim 45, Covington teaches wherein the gas sensor hardware comprises a TCD gas sensor and the gas sensor data represents a time series of readings from the TCD gas sensor (see at least [0034]).
Regarding claim 46, Covington teaches wherein the process further comprises at least one of: (i) detecting a gas sensor data gastric-duodenal transition indicator among the gas sensor data and/or detecting a gas sensor data ileocecal junction transition indicator among the gas sensor data, and based on a timing of the detected gas sensor data gastric-duodenal transition indicator and/or the detected gas sensor data ileocecal junction transition indicator, determining timing of the passage of the ingestible capsule device through the small intestine of the subject; (ii) obtaining accelerometer data representing a time series of readings from an accelerometer housed within the ingestible capsule device, the time series of readings being taken during the passage of the ingestible capsule device through the gastrointestinal tract of the subject; and detecting an accelerometer data gastric-duodenal indicator and/or an accelerometer data ileocecal junction indicator in the accelerometer data, and determining the timing of the passage of the ingestible capsule device through the small intestine of the gastrointestinal tract based on the accelerometer data gastric-duodenal indicator and/or the accelerometer data ileocecal junction indicator; and (iii) obtaining reflectometer data representing a time series of readings from a reflectometer housed within the ingestible capsule device, the reflectometer comprising a transmission antenna connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna, the time series of readings being taken during the passage of the ingestible capsule device through the gastrointestinal tract of the subject; and detecting a reflectometer data gastric-duodenal indicator and/or a reflectometer data ileocecal junction indicator in the reflectometer data, and determining the timing of the passage of the ingestible capsule device through the small intestine of the gastrointestinal tract based on the reflectometer data gastric-duodenal indicator and/or the reflectometer ileocecal junction indicator (inferenced elements, see at least [0053] iii) reasonably reads on the usage of doppler effect for determining position; Dopler technology is well known to include antennas for transmit and receiving waves OFFICIAL NOTICE).
Regarding claim 47, Covington teaches wherein: determining the timing of the passage of the ingestible capsule device through the small intestine of the subject comprises: determining a timing of a passage of the ingestible capsule device across the gastric-duodenal junction based on one or more from among: the gas sensor data gastric-duodenal indicator; the accelerometer data gastric-duodenal indicator; and the reflectometer data gastric-duodenal indicator (see at least [0053] iii) reasonably reads on the usage of doppler effect for determining position; Dopler technology is well known to include antennas for transmit and receiving waves OFFICIAL NOTICE).
Regarding claim 48, Covington teaches wherein determining the timing of the passage of the ingestible capsule device through the small intestine of the subject comprises: determining a timing of a passage of the ingestible capsule device across the ileocecal junction based on one or more from among: the gas sensor data ileocecal junction indicator; the accelerometer data ileocecal junction indicator; and the reflectometer data ileocecal junction indicator (see at least [0053] iii) reasonably reads on the usage of doppler effect for determining position; Dopler technology is well known to include antennas for transmit and receiving waves OFFICIAL NOTICE).
Regarding claim 49, Covington teaches the process further comprising: quantifying an amount of small-intestinal bacterial overgrowth in the subject according to the value of the metric representing fluctuation, quantifying an amount of small-intestinal bacterial overgrowth in the subject according to the gradient of the trend line, or quantifying an amount of small-intestinal bacterial overgrowth in the subject according to a number of times, or a duration for which, during passage of the capsule through the small intestine that the concentration of the specific gas or gases exceeds a predefined threshold concentration (see at least [0011], [0013]-[0014], [0032]-[0033] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present including a quantification of the bacteria being present).
Regarding claim 50, Covington teaches generating a report including the detected presence or absence of small-intestinal bacterial overgrowth in the subject (see at least [0027]-[0028], [0059]).
Regarding claim 51, Covington teaches further comprising: based on one or more from among :a detected fermentation indicator, the metric representing fluctuation, a number of events, or a duration for which, during passage of the capsule through the small intestine that a concentration of the specific gas or gases represented by the gas sensor data exceeds a predefined threshold concentration, and the gradient of a trend line fitted to the gas sensor data, measuring a level of fermentation activity detected in the small intestine of the subject, and including the measured level in the generated report (see at least [0011], [0013]-[0014], [0032]-[0033] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present including a quantification of the bacteria being present).
Regarding claim 52, Covington teaches the process further comprising determining, based on a timing of: deviations from a trend line contributing to a metric representing fluctuation, and/or a timing of events at which concentration of a specific gas or gases represented by the gas sensor data exceeds a predefined threshold concentration; an estimated location or locations within the small intestine of fermentation activity; wherein the report further comprises the measured level of fermentation activity and/or the estimated location or locations within the small intestine of fermentation activity (see at least [0018], [0064] location, [0011], [0013]-[0014], [0032]-[0033] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present including a quantification of the bacteria being present).
Regarding claim 53, Covington teaches wherein the process further comprises wirelessly transmitting the report to a receiver device outside of the body of the subject (see at least [0027]).
Regarding claim 54, Covington teaches wherein the wirelessly transmitting is via a Bluetooth transceiver housed by the ingestible capsule device (see at least [0027]).
Regarding claim 55, Covington teaches a non-transitory computer-readable medium storing processing instructions which, when executed by processor hardware, causes the processor hardware to perform a process (see at least Figures 1-3 elements 9 and 11) comprising:
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of a composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject (see at least [0028], [0034], [0059], [0012]-[0015]);
using the gas sensor data to calculate a metric representing fluctuation of the gas sensor data during a passage of the ingestible capsule device through the small intestine of the gastrointestinal tract (see at least [0012]-[0015], [0027]);
determining presence or absence of SIBO in the subject at least partially in dependence upon the metric representing fluctuation (see at least [0011], [0013]-[0014], [0032] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present.), but does not directly teach using the gas sensor data to calculate a gradient of a first order polynomial best fit line fitted to the gas sensor data from passage of the ingestible capsule device through the small intestine of the gastrointestinal tract; and determining presence or absence of SIBO in the subject at least partially in dependence upon the gradient of the best fit line. However, Covington does teach that known diseases are identified by known patterns (see at least [0011]-[0014], [0032]) and teaches that statistical analysis can be completed on the data (see at least [0064]). With such teachings it would lead to one of ordinary skill in the art to use trends or changes over time to identify such known patterns in order to diagnose or conclude no diagnosis as ordinary scientific practice in statistical analysis of gathered data.
Regarding claim 56, Covington teaches a non-transitory computer-readable medium storing processing instructions which, when executed by processor hardware, causes the processor hardware to perform a process (see at least Figures 1-3 elements 9 and 11) comprising:
obtaining gas sensor data representing a time series of readings from gas sensor hardware housed within an ingestible capsule device orally ingested by the subject, the time series of readings being taken during exposure of the gas sensor hardware to a gas mixture at the ingestible capsule device during passage of the ingestible capsule device through a gastrointestinal tract of the subject, the gas sensor hardware being sensitive to changes of a composition of the gas mixture at the location of the ingestible capsule device in the gastrointestinal tract of the subject (see at least [0028], [0034], [0059], [0012]-[0015]);
wherein the gas sensor data represents a concentration of a specific gas or gases (see at least [0012]);
the method further comprising determining presence or absence of SIBO in the subject at least partially in dependence upon the concentration of the specific gas or gases exceeding a predefined threshold concentration at one or a predefined threshold minimum number of locations during passage of the ingestible capsule device through the small intestine (see at least [0018], [0064] location [0011], [0013]-[0014], [0032] teaches known bacterial have known profiles such that the presence is inherent to the detection or in the alternative, obvious that the known gases are present at the known levels to indicate positive or negative conditions being present.).
Regarding claim 57, Covington teaches wherein the specific gas or gases is one or more from among hydrogen, carbon dioxide, and methane (see at least [0012]).
Conclusion
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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