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 .
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 1 – 7, 9, and 10 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.
Claim 1 recites the limitation "the relative concentration" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, the claim 1 limitation reciting “wherein the microcontroller is arranged, upon determining the relative concentration…” fails to distinctly and clearly claim the subject matter. As written, the limitation can be interpreted as the microcontroller moves the valve to an open condition once the relative concentration is determined, rather than moving the valve only when the relative concentration is at a desired concentration. Examiner suggests slight rewording and potentially omitting the current use of the term “upon” to more clearly define the limitations pertaining to the microcontroller.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giron et al. (US 20050177056 A1 – Cited by Applicant), hereinafter Giron.
Regarding claim 1, Giron discloses a biological sample analysis device [related to the field of breath tests and methods of collecting the breath samples for remote analysis, see in ¶ 0001] comprising
a body including an outlet connectable to a chamber arranged to sealingly hold a biological sample and an inlet connectable to a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal [Schematic illustration of a breath collection system, see in ¶ 0069 and Figs. 1-2; According to one embodiment of the present invention, the breath subject's breath is collected at the breath collection port preferably by means of an oral, a nasal or an oral/nasal cannula, as is known in the art, or by means of a breath tube into which the subject blows a breath, see in ¶ 0069; Sample containers 24, see in Fig 1-2 and ¶ 0074; Examiner notes that the mask is not a positively claimed element, therefore the oral/nasal cannula of the present invention, which can be configured/adapted to be attached to any mask, is considered to meet the claim details],
an electrically operated valve located within the body and positioned between the inlet and outlet [The breath sample is preferably directed to a three way solenoid valve, see in ¶ 0071], and
a sensor located in the body and disposed at or near the inlet [After entering the system, the breath sample passes into the breath sensor, which can be any one of a number of different types, ¶ 0069] in a manner such that the sensor is capable of measuring the presence of at least one compound contained in the breath sample [the breath sensor incorporates a capnographic probe, operative to determine the carbon dioxide concentration in the breath, see in ¶ 0069] to provide an electrical signal indicative of the presence of the at least one compound to a microcontroller [an electronic signal proportional to the temporal carbon dioxide concentration of the breath is input to the system controller, see in ¶ 0069],
wherein the microcontroller is arranged, upon determining the relative concentration of the at least one compound in the breath sample, and if the relative concentration is a desired concentration, the microcontroller moves the valve to an open condition, to allow the breath sample to flow into the chamber [the solenoid valve is additionally or alternatively controlled so that only those parts of the breath samples are collected, where the carbon dioxide concentration is above a predefined level, see in ¶ 0072; when the solenoid valve and the sample distributor valve to a particular sample container bag are open, the container bag will fill up with a breath sample, see in ¶ 0082].
Regarding claim 2, Giron discloses the device according to claim 1, further comprising a temperature sensor arranged to provide an electric signal indicative of the temperature to the microcontroller, wherein the temperature signal is utilised by the microcontroller as an input value in the calculation of the relative concentration of the at least one compound [the controller may preferably cause the sample distributor to direct the samples at predetermined times, which may preferably be at fixed time intervals, or may preferably be determined by a characteristic of the breaths of the subject. This characteristic of the breaths may preferably be at least one of the carbon dioxide concentration, the oxygen concentration, the excess pressure, the temperature…, see in ¶ 0034; sensors of pressure, flow, acoustic noise, temperature and humidity may also preferably be used to detect breaths, see in ¶ 0072].
Regarding claim 3, Giron discloses the device according to claim 1, further comprising a secondary outlet, wherein the secondary outlet is in communication with the inlet and is openable by movement of the electrically operated valve, where if the relative concentration of the at least one compound is not a desired concentration, the microcontroller causes the valve to a closed condition, to prevent the breath sample from entering the chamber and consequently causes the breath sample to be ventilated through the secondary outlet [the controller 14 which provides the solenoid control signal, is programmed to determine when the subject's breaths are to be collected and when they are to be rejected, according to the predetermined test procedure, see in ¶ 0071; sample distributor unit 20, see in Fig. 1].
Regarding claim 4, Giron discloses the device according to claim 1, further comprising a one-way valve positioned intermediate the electrically operated valve and the outlet, wherein breath which flow into the chamber is prevented from exiting the chamber via the outlet [one way check valve 40 and sample distributor 20, see in ¶ 0081].
Regarding claim 5, Giron discloses the device according to claim 1, wherein the desired concentration of the at least one compound is a predetermined range [the controller can be adjusted to select or reject any predefined part of the breath waveform, according to the carbon dioxide level instantaneously detected, see in ¶ 0072].
Regarding claim 6, Giron discloses the device according to claim 1, wherein the compound is carbon dioxide [the carbon dioxide concentration is above a predefined level. Those parts where the carbon dioxide concentration is below that predefined level are rejected, see in ¶ 0072].
Regarding claim 7, Giron discloses the device according to claim 1, further including a flexible bag arranged to locate within the chamber, the bag being arranged sealingly over the outlet to capture the biological sample [sample collection bags, see in ¶ 0065, ¶ 0082, and Fig. 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.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Giron (US 20050177056 A1 – Cited by Applicant) in view of Cai et al. (US 20170227508 A1).
Regarding claim 10, and substantially similar limitations in claim 9, Giron discloses the device according to claim 1.
Giron fails to disclose wherein the chamber is arranged to receive a total volume in the range of approximately 800 ml to 1000 ml.
However, Cai discloses a chamber arranged to receive a total volume in the range of approximately 800 ml to 1000 ml [For breath analysis, the chamber may be intended to hold a gas sample such as an exhaled animal breath, or a portion thereof. In some embodiments, the volume of the chamber may be equal to or less than the lung capacity of an animal such as a human being. In some embodiments, the chamber's volume may be about … 1,000 mL, or any other volume in a range bounded by any of these values, see in ¶ 0026].
Giron and Cai are both analogous to the claimed invention because they are in the same field of breath sampling. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Giron to incorporate the teachings of Cai and include that the chamber is arranged to receive a total volume in the range of approximately 800 ml to 1000 ml, as such volume is on the higher end of a human’s lung capacity [see in Cai, ¶ 0026]. Examiner notes that claim 9 directly pertains to the volume of the flexible bag and further notes that the flexible bag is arranged to be located within the chamber of the presented invention. As such, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Giron to incorporate the teachings of Cai and include that the flexible bag, intended to capture the biological sample, is arranged to receive a total volume in the range of approximately 800 ml to 1000 ml of breath, since the flexible bag volume would not exceed the total volume of the chamber and would intentionally be designed to be able to hold an appropriate volume of breath sample fit for a human [see Cai in ¶ 0026].
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/HY KHANH DOAN/Examiner, Art Unit 3791