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 .
Response to Amendment
This Office Action is in response to Amendments and Remarks filed 07/09/2026. As directed by Applicant’s amendments, claim 1 is amended and claim 3 is cancelled. Claims 1, 2, 4-7, 9, and 10 are pending in the application.
The rejections under 35 USC 112(b) applied to claims 1, 2, 4-7, 9, and 10 are withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments, see Remarks, filed 7/09/2026, with respect to the rejections of claims 1-7 under 35 USC 102 have been fully considered and are partially persuasive. Applicant argues that prior art Giron et al. (US 20050177056 A1 – Cited by Applicant) employs a pump in order to draw the breath sample through the system, therefore Giron concerns selective routing of exhaled breath after it has entered the system, rather than providing a bidirectional breathing path that permits substantially unrestricted inhalation between sampling events. However, Examiner notes that Giron discloses that the need for a pump is obviated when a breathing tube is used for collecting the sample [see in Giron ¶ 0070]. As such, Giron et al. is still pertinent as a prior art of the present application’s claimed subject matter. However, Applicant’s arguments pertaining to Giron failing to disclose the limitations of “wherein the inlet is connected to a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal” and “wherein the body further comprises a secondary outlet in communication with the inlet, the secondary outlet 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, whereby the animal can breathe in and out normally” are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Allsworth et al. (US 20170303823 A1 – Cited by Applicant). Examiner notes that the new grounds of rejection is made in light of Applicant’s amendments to claim 1, positively claiming the mask portion and moving details of the previously presented claim 3 and new additional related limitations into claim 1.
Applicant’s arguments, see Remarks, filed 7/09/2026, with respect to the rejections of claims 9 and 10 under 35 USC 103 have been fully considered but they are not persuasive. Applicant argues that prior art Cai et al. (US 20170227508 A1) does not remedy the deficiencies of Giron et al. regarding the previously listed limitations above and thus the combination of Giron et al. in view of Cai et al. fail to disclose all limitations of the claimed subject matter. However, Examiner would like to point out that prior art reference Cai et al. was only used as a teaching reference and was not utilized to reject the same limitations rejected using Giron et al. As a new grounds of rejection is made in light of Applicant’s amendments to claim 1, Examiner further notes that limitations Cai et al. is silent on are taught by Giron et al. in view of Allsworth et al. Cai et al. is still pertinent as a teaching reference for claim limitations disclosed in claims 9 and 10 and is utilized as such.
Updated rejections to claims 1, 2, 4-7, 9, and 10 are outlined in detail below.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Giron et al. (US 20050177056 A1 – Cited by Applicant), hereinafter Giron, in view of Allsworth et al. (US 20170303823 A1 – Cited by Applicant), hereinafter Allsworth.
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 connected to a chamber arranged to sealingly hold a biological sample [Schematic illustration of a breath collection system, see in ¶ 0069 and Figs. 1-2; Sample containers 24, see in Fig 1-2 and ¶ 0074],
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].
Giron fails to disclose where in the inlet is connected to a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal and wherein the body further comprises a secondary outlet in communication with the inlet, the secondary outlet 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, whereby the animal can breathe in and out normally.
However, Allsworth discloses a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal [see in Fig. 2A and 2B] and wherein the body further comprises a secondary outlet in communication with the inlet, the secondary outlet is openable by movement of the electrically operated valve [The selective sampling may involve, for example, opening or closing one or more valves, and/or operating or halting a pump or the like, so as to allow the exhaled breath representative of the desired portion to be captured, see in ¶ 0027], 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, whereby the animal can breathe in and out normally [The measured parameter(s), and/or values derived therefrom, may be compared with stored threshold values. When the measured parameter(s) and/or the values derived therefrom exceed or fall below the respective stored thresholds, as appropriate, this triggers the apparatus to start and stop collecting exhaled air, thereby selectively sampling a desired portion of the subject's breath, see in ¶ 0025; It is to be understood the outlet portion of the mask 30 includes a one-way valve 80 (FIG. 8) permitting the patient to breathe out to the room while inhaling (scrubbed) clean air, via its coupling to a clean air supply source 14 (via valve 26), see in ¶ 0149].
Giron and Allsworth are both analogous to the claimed invention because they are in the same field of breath analyzing devices. 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 Allsworth to include that there is a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal in order to comfortably and effectively fit over the animal’s nostrils for breath capture and wherein the body further comprises a secondary outlet in communication with the inlet, the secondary outlet 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, whereby the animal can breathe in and out normally in order to selectively allow breath samples into the targeted chamber.
Regarding claim 2, Giron, as modified, 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 4, Giron, as modified, 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, as modified, 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, as modified, 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, as modified, 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].
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 Allsworth (US 20170303823 A1 – Cited by Applicant), further in view of Cai et al. (US 20170227508 A1).
Regarding claim 10, and substantially similar limitations in claim 9, Giron, as modified, 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
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights