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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “device” in claim 1, “electrochemical sensor” in claim 1, “device”/“colorimetric sticker” in claim 17, “clip” in claim 8, “electrical wire” in claims 4 and 8, and the “probe” in claims 4 and 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 recites the limitation “a means of connecting the device to an apparatus”. The claim limitation will be interpreted as wired or wireless connection, consistent with para [0049]: “via wires, wireless, such as over a Wi-Fi connection, or Bluetooth” of applicant’s specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 17 recite the limitation “wherein the apparatus provides information on hydrogen gas level and the hydrogen gas level is used to assess gut health of the subject.”. While applicant’s specification discloses that gut health is tied to hydrogen gas emanated from the skin (paras [0046-0047]), the disclosure does not include a description as to how a measured hydrogen gas would be used to assess overall gut health. No metrics are provided to compare a hydrogen level to or to map a detected hydrogen level to a gut microbial profile. Further, the examples listed on pages 10-12 and corresponding figures 3-10 show a measure of hydrogen gas as it relates to chemotherapy, antibiotics, BMT, and blood pH. No direct correlation between these measured results and gut health is provided.
Per claim 17 and para [0052] of applicant’s specification, a colorimetric sensor may be used to detect hydrogen gas. No further methods of extracting quantitative data from a colorimetric sensor is provided. Additionally, no method of interpreting such qualitative data in view of gut health is provided.
Claims 2-16 and 18 are rejected due to dependency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-11, and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hall et al. (US 20240268749 A1), hereinafter Hall.
Regarding claim 1, Hall discloses a method of assessing gut health in a subject (abstract: “detecting a gastrointestinal disorder”) comprising placing a device on or near the subject’s skin ([0063]: “may be attached to the undergarment 110 adjacent to the perineum”) and measuring a level of hydrogen gas emanating through the subject’s skin ([0064]: “for the measurement of various biomarkers, (e.g., H2S).”), wherein the device comprises an electrochemical sensor capable of detecting hydrogen gas ([0064]: “electrochemical sensor and/or a metal oxide sensor”) and a means of connecting the device to an apparatus comprising a central processing unit (CPU) ([0068]: “the controller 200 is configured to wirelessly transmit (e.g., by Bluetooth™ or other wireless protocol) the data to a smartphone application.”); and further, wherein the apparatus provides information on hydrogen gas level and the hydrogen gas level is used to assess gut health of the subject ([0106]: “diagnoses the presence or absence of intestinal inflammation and/or an Inflammatory Bowel Disease based on the indication of the concentration of the biomarker”).
Regarding claim 2, Hall discloses wherein the apparatus is selected from the group consisting of computers, smartphones, and tablets ([0099]: “, the operations of FIG. 20 may be performed all or in part by another device, for example, a mobile device, such as a smartphone, and/or a computer system”).
Regarding claim 3, Hall discloses wherein the apparatus is capable of displaying graphical readings based on information from the sensor ([0083]: “a custom-designed smartphone application, the system 300 can connect to a user's mobile device to upload or otherwise provide data that can be further shared with clinicians in real-time or near real-time”).
Regarding claim 4, Hall discloses probe connected to the electrochemical sensor by an electrical wire ([0082]: “through communication cables such as serial ATA cables or other types of cables”).
Regarding claim 5, Hall discloses wherein the electrochemical sensor is capable of providing quantitative hydrogen gas level data (Fig 9).
Regarding claim 6, Hall discloses wherein the electrochemical sensor is capable of providing continuous data regarding the hydrogen gas level ([0060]: “measured passively in real-time or near real-time using sensors.”).
Regarding claim 7, Hall discloses wherein the device is reusable ([0083]: “The battery life of the system 300 is more than ten days, which is longer than the proposed wearing duration for diagnosing whether the patient has a gastrointestinal disorder”, wherein the device may be reused over several days).
Regarding claim 9, Hall discloses herein the device is located near an area of the subject’s skin selected from the group consisting of sternal notch, belly button, right iliac crest, left iliac crest, finger, and earlobe (Fig 1 element 300).
Regarding claim 10, Hall discloses wherein the device further comprises a probe in wireless communication with the electrochemical sensor ([0068]: “In aspects, the controller 200 is configured to wirelessly transmit (e.g., by Bluetooth™ or other wireless protocol) the data to a smartphone application. In aspects, the data may be wirelessly transmitted (securely) to other types of authorized systems/devices, including but not limited to local health monitoring devices, remote health monitoring systems (e.g.,”).
Regarding claim 11, Hall discloses wherein the wireless communication is enabled via a wi-fi or bluetooth connection ([0068]).
Regarding claim 16, Hall discloses wherein the electrochemical sensor comprises an adhesive portion. ([0102]: “ that is adhered to a user's undergarment (FIG. 1 )… via double-sided tape”).
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.
Claim(s) 8 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Shulz et al. (US 20050085704 A1)
Regarding claim 8, Hall discloses the method of claim 1, but fails to disclose the device further comprises a clip connected to the electrochemical sensor by an electrical wire.
Shulz discloses a sensor device comprises a clip connected to the electrochemical sensor by an electrical wire ([0005]: “The sensor cable 120 electrically communicates monitor originated LED drive signals from the connector 110 to the sensor clip 200 and monitor destined detector signals from the sensor clip 200 to the connector 110.”).
As Hall discloses the sensor may be adhered by any suitable means ([0063]: “be attached to the undergarment 110 using any suitable means”), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known adhesive disclosed by Hall with the clip disclosed by Shulz for the predictable result of attaching a sensor to a user.
Regarding claim 14, Hall as modified by Shulz discloses the method of claim 8, and Shulz further discloses wherein the clip comprises a flexible device or a device worked by a spring mechanism that grips or clasps connected to an electrochemical sensor ([0004]: “. A spring 280 (FIG. 2) applies force to the back end 202 that determines the pressure on an inserted finger in the closed position”).
Regarding claim 15, Hall as modified by Shulz discloses the method of claim 8, and Shulz further discloses further discloses wherein the device is located near an area of the subject’s skin selected from the group consisting of one or more fingers and one or more earlobes ([0004]: “typically the index finger, and a close position (shown) for securing the sensor clip 200 to opposite sides of the finger.”).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of McNeil et al (US 20070032748 A1), hereinafter McNeil.
Regarding claim 12, Hall discloses the method of claim 1 but fails to disclose wherein the device further comprises a clip in wireless communication with the electrochemical sensor.
McNeil discloses a sensor device (abstract) comprising a clip in wireless communication with a sensor ([0029]: “All of the sensor units 10 are connected to the belt-clip unit either wirelessly”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Hall to include the clip disclosed by McNeil in order to allow for more secure attachment to the user.
Regarding claim 13, Hall as modified by McNeil discloses the method of claim 12, and McNeil further discloses wherein the wireless communication is enabled via a wi-fi or bluetooth connection ([0035]: “the system is wireless and the individual sensor units 10 are connected to the Belt Clip 20 by 900 MHz or 2.4 GHz transceivers.”).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Hsu et al. (US 2020/0300827 A1), hereinafter Hsu.
Regarding claim 17, Hall discloses a method of assessing gut health in a subject (abstract: “detecting a gastrointestinal disorder”) comprising placing a device on or near the subject’s skin ([0063]: “may be attached to the undergarment 110 adjacent to the perineum”) and measuring a level of hydrogen gas emanating through the subject’s skin ([0064]: “for the measurement of various biomarkers, (e.g., H2S).”), wherein the device comprises an electrochemical sensor capable of detecting hydrogen gas ([0064]: “electrochemical sensor and/or a metal oxide sensor”); and further, wherein the apparatus provides information on hydrogen gas level and the hydrogen gas level is used to assess gut health of the subject ([0106]: “diagnoses the presence or absence of intestinal inflammation and/or an Inflammatory Bowel Disease based on the indication of the concentration of the biomarker”).
Hall fails to disclose that the electrochemical sensor is a colorimetric sticker capable of detecting hydrogen gas. However, Hall discloses a colorimetric sensor capable of detecting nitric oxide ([0069]: “may be used for nitric oxide (NO) and NO2 detection to detect the color change in a Griess reaction”).
Hsu discloses a colorimetric sticker ([0007]: “a gas-sensing tattoo sticker including an adhesive layer, a coloring reaction layer, and a chemical reaction layer”) capable of detecting hydrogen gas ([0028]: “it can be black lead sulfide precipitate produced when lead acetate meets hydrogen sulfide”).
As Hall discloses using a colorimetric sensor for a different substrate, it would have been obvious to substitute the known electrochemical sensor disclosed by Hall with the colorimetric sensor disclosed by Hsu for the predictable result of detecting hydrogen gas.
Regarding claim 18, Hall further discloses wherein the device is located near an area of the subject’s skin selected from the group consisting of sternal notch, belly button, right iliac crest, left iliac crest, finger, and earlobe (Fig 1 element 300).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hyde et al. (US 20190076081 A1) – discloses assessment of gut health based on detection of hydrogen gas.
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791