DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because Figure 23 appears to be a duplicate of Figure 19. Both Figs. 19 and 23 show a chart in which an ornithine amount estimated from CH3SH concentration is plotted. Based on the wording in claim 9, it appears as though one of the charts should show a plot of an ornithine amount estimated from CO2 concentration instead. 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.
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 5-12 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 5-12, the claims are drawn towards apparatus claims, wherein a method step of information being estimated is performed. It is unclear as to how this is further limiting the apparatus of claim 1, from which claims 5-12 depend upon. The claims appear to be attempting to claim both an apparatus and method steps of using the apparatus, which is considered indefinite under 35 U.S.C. 112(b). See MPEP 2173.05(p).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 8, 13-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rui et al. (JP 2009-075091 A) (hereinafter Rui) (citations from attached English machine translation).
Regarding claim 1, Rui teaches an intestinal information estimation system [health condition measuring device] (see Abstract), comprising:
a detector configured to detect a predetermined component from a gas released from feces of a subject and output a detection signal depending on a concentration of the predetermined component [carbon dioxide sensor 5; measured carbon dioxide concentration] (Pg. 5); and
an estimator configured to input the detection signal or the concentration of the predetermined component corresponding to the detection signal to a prediction model [predetermined component conversion data stored in advance in the storage device] (Pgs. 3-4) and estimate information regarding an amount and/or an existence ratio of short-chain fatty acid producing bacteria and/or a metabolite contained in the feces of the subject [estimated value of septic component concentration in the stool is calculated from the component concentration and conversion data; septic component in stool contains at least one of ammonia, cresol, indole, skatole, or phenol as a component during defecation (protein metabolites)] (Pgs. 3-4 and 6),
wherein the predetermined component is at least one selected from the group consisting of methyl mercaptan, hydrogen sulfide, hydrogen, and carbon dioxide [carbon dioxide] (Pg. 5).
Regarding claim 3, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein the short chain fatty acid-producing bacteria are butyric acid producing bacteria and/or acetic acid-producing bacteria [carboxylic acid concentration contained in feces; carboxylic acids produced by the metabolism of enterobacteria, such as acetic acid, butyric acid, and the like] (Pg. 3).
Regarding claim 4, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein the metabolite is butyric acid and/or acetic acid [carboxylic acid concentration contained in feces; carboxylic acids produced by the metabolism of enterobacteria, such as acetic acid, butyric acid, and the like] (Pg. 3).
Regarding claim 8, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein information regarding an amount and/or an existence ratio of acetic acid is estimated from a concentration of hydrogen detected from the gas released from the feces of the subject [predetermined component may be hydrogen; convert hydrogen concentration into a septic component concentration; correlation between acetic acid concentration and the septic component concentration] (Pgs. 4, 6, see Fig. 1C).
Regarding claim 13, Rui as applied to claim 1 above teaches the claimed invention, in addition to further comprising a health information generator configured to generate health information based on an estimation result from the estimator [concentration of rot components in stool as health information] (Pg. 4).
Regarding claim 14, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein the detector is installed in a toilet of a bathroom (see Fig. 2).
Regarding claim 16, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein the detector can be carried by the subject [portable; sensors are capable of being carried] (Pg. 4).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rui as applied to claim 1 above, and further in view of Yooseph et al. (WO 2017/184899 A1) (hereinafter Yooseph).
Regarding claim 2, Rui as applied to claim 1 above teaches the claimed invention, in addition to wherein the prediction model includes a combination of a detection signal output from the detector when gases each released from a plurality of feces are supplied to the detector or a concentration of the predetermined component corresponding to the detection signal and measurement information obtained by analyzing in advance and including information regarding an amount and/or an existence ratio of short-chain fatty acid-producing bacteria and/or a metabolite contained in each of the plurality of feces [concentration conversion data stored in advance; correlation diagrams for various conversion data of concentrations] (Pgs. 9-13, see Figs. 8-18). Rui fails to teach wherein the prediction model is generated by machine learning using learning data. Yooseph teaches the usage of machine learning to generate prediction models for analyzing intestinal microbiome data (Para [0055, 0090], see Claim 38). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Yooseph such that the prediction model is generated by machine learning using learning data in order to improve prediction accuracy.
Claims 5-6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rui as applied to claim 1 above, and further in view of Hasegawa et al. (EP 3252468 A1) (hereinafter Hasegawa).
Regarding claim 5, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or existence ratio of Faecalibacteria is estimated from a concentration of methyl mercaptan detected from the gas released from the feces of the subject. Hasegawa teaches an intestinal information estimation system wherein concentrations of methyl mercaptan detected from the gas released from the feces of a subject is used to estimate an indication of patient health (Para [0067-0068], see Figs. 43A-43B). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Hasegawa such that a concentration of methyl mercaptan detected from the gas released from the feces of the subject is utilized to estimate an intestinal health indicator, such as an amount/or existence ratio of Faecalibacteria, in order to better determine the intestinal health of the subject.
Regarding claim 6, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or existence ratio of butyric acid is estimated from a concentration of hydrogen sulfide detected from the gas released from the feces of the subject. Hasegawa teaches an intestinal information estimation system wherein concentrations of hydrogen sulfide detected from the gas released from the feces of a subject is used to estimate an indication of patient health (Para [0067-0068], see Figs. 42A-42B). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Hasegawa such that a concentration of hydrogen sulfide detected from the gas released from the feces of the subject is utilized to estimate an intestinal health indicator, such as an amount/or existence ratio of butyric acid, in order to better determine the intestinal health of the subject.
Regarding claim 9, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or existence ratio of ornithine is estimated from a concentration of carbon dioxide and/or the methyl mercaptan detected from the gas released from the feces of the subject. Hasegawa teaches an intestinal information estimation system wherein concentrations of carbon dioxide and methyl mercaptan detected from the gas released from the feces of a subject is used to estimate an indication of patient health (Para [0067-0068], see Figs. 43A-43B, 45A-45B). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Hasegawa such that a concentration of carbon dioxide and/or methyl mercaptan detected from the gas released from the feces of the subject is utilized to estimate an intestinal health indicator, such as an amount/or existence ratio of ornithine, in order to better determine the intestinal health of the subject.
Regarding claim 10, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or existence ratio of Coprococcus bacteria is estimated from a concentration of carbon dioxide detected from the gas released from the feces of the subject. Hasegawa teaches an intestinal information estimation system wherein concentrations of carbon dioxide detected from the gas released from the feces of a subject is used to estimate an indication of patient health (Para [0067-0068], see Figs. 45A-45B). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Hasegawa such that a concentration of carbon dioxide detected from the gas released from the feces of the subject is utilized to estimate an intestinal health indicator, such as an amount/or existence ratio of Coprococcus bacteria, in order to better determine the intestinal health of the subject.
Regarding claim 11, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or existence ratio of at least one selected from the group consisting of Streptococcus bacteria, Ruminococcus bacteria, Lacnospira bacteria, and trimethylamine is estimated from a concentration of methyl mercaptan detected from the gas released from the feces of the subject. Hasegawa teaches an intestinal information estimation system wherein concentrations of methyl mercaptan detected from the gas released from the feces of a subject is used to estimate an indication of patient health (Para [0067-0068], see Figs. 43A-43B). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Hasegawa such that a concentration of methyl mercaptan detected from the gas released from the feces of the subject is utilized to estimate an intestinal health indicator, such as an amount/or existence ratio of at least one selected from the group consisting of Streptococcus bacteria, Ruminococcus bacteria, Lacnospira bacteria, and trimethylamine, in order to better determine the intestinal health of the subject.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rui as applied to claim 1 above, and further in view of Takeshita et al. (JP 2005-315836) (hereinafter Takeshita).
Regarding claim 7, Rui as applied to claim 1 above teaches the claimed invention, except for wherein information regarding an amount and/or an existence ratio of bifidobacteria is estimated from a concentration of carbon dioxide and/or hydrogen detected from the gas released from the feces of the subject. Takeshita, which is cited by Rui, teaches determining an amount and/or an existence of bifidobacteria estimated from a concentration of hydrogen detected from gas released by feces of a subject (see Fig. 7). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Takeshita such that information regarding an amount and/or an existence ratio of bifidobacteria is estimated from a concentration of carbon dioxide and/or hydrogen detected from the gas released from the feces of the subject, in order to further monitor the intestinal health of a subject.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rui as applied to claim 1 above.
Regarding claim 15, Rui as applied to claim 1 above teaches the claimed invention, except for wherein the detector is installed in a bed for a person requiring nursing care. Rui additionally teaches the detector can be made portable so that intestinal information can be easily measured regardless of where the toilet enters (Pg. 4). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui such that the detector is installed in a bed for a person requiring nursing care, in order to analyze the intestinal health information of a subject who is bedridden.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rui as applied to claim 1 above, and further in view of Bazemore (US 2019/0353639 A1) (hereinafter Bazemore).
Regarding claims 17-18, Rui as applied to claim 1 above teaches the claimed invention, except for wherein the estimator inputs the detection signal or a concentration of the predetermined component corresponding to the detection signal to a prediction model depending on a property of the subject and inputs information regarding a property of the subject to a prediction model. Bazemore teaches wherein subject metadata can be inputted into and utilized in a prediction model for predicting patterns associated (Para [0014]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Rui with Bazemore such that the estimator inputs the detection signal or a concentration of the predetermined component corresponding to the detection signal to a prediction model depending on a property of the subject and inputs information regarding a property of the subject to a prediction model, in order to improve prediction accuracy.
Allowable Subject Matter
Claim 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, the primary reason for the indication of allowable subject matter is the inclusion of the limitations regarding estimating bilophila bacteria from a concentration of 2-proponal detected from the feces gas, in combination with the rest of the limitations found in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID Z HUANG whose telephone number is (571)270-5360. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kristina Deherrera can be reached at 303-297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID Z HUANG/ Primary Examiner, Art Unit 2855
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