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.
Claim 1-9 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, 2, 7, 11, 12, 17 (3-6, 8-9 by dependency) recites “reverse direction”. It is unclear which direction represents “reverse”.
Claim 6 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation 30-70ml/s, and the claim also recites 40-60ml/s which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 7 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation 40-/80ml/s, and the claim also recites 50-70ml/s which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 1-4, 6, 8, 10-14, 16, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehow Ltd (CN 110522450 A – cited by Applicant, translation with paragraphs provided by Examiner), hereinafter Mehow.
Regarding Claim 1, Mehow teaches: A device (figure 1) configured for monitoring a concentration of at least one volatile breathing compound in respiratory gases of patients (paragraph 1), the device comprising:
a patient respiratory gas interface (element 1) comprising a mouthpiece (paragraph 40, mouthend) for the patient to blow a respiratory gas into;
a connector adapted to couple the patient respiratory gas interface to a gas conduit (figure 1), the gas conduit leading the respiratory gas through a flow meter (flow sensor 5) and a valve (element 7), wherein the flow meter configured to measure a predefined first flux level of a patient respiratory gas flux (paragraph 19; flow rates, i.e. flux determined), wherein the gas conduit is configured to further lead the patient respiratory gas through an inlet into an intermediate gas storage having a winding inner volume (storage chamber 8), wherein the intermediate gas storage is open-ended via an exhaust outlet to let patient respiratory gas exhausts in excess of a volume of the intermediate gas storage out of the same in response to the flow meter sensing an expiration of the patient respiratory gas flux (paragraph 19-24); and
a pump configured to draw the patient respiratory gas with a predefined second flux level in a reverse direction out of a sampling gas outlet of the intermediate gas storage and into a gas sampling line (paragraph 46), wherein exhaled concentrations of the at least one volatile breathing compound are determined by corresponding at least one volatile breathing compound detector (title, abstract).
Regarding Claim 2, Mehow teaches: The device of claim 1, wherein the pump is arranged downstream of the at least one volatile breathing detector when the patient respiratory gas flows in the reverse direction (pump 12 can be considered downstream from sensor 13).
Regarding Claim 3, Mehow teaches: The device of claim 1, wherein the volatile breathing compound includes at least one of fractional exhaled nitric oxide (FeNO), exhaled carbon monoxide (eCO), hydrogen (H2), hydrogen sulfide, (H2S) and ammonia (NH3) (title – Exhaled NO; NO Sensor 13).
Regarding Claim 4, Mehow teaches: The device of claim 1, wherein the corresponding at least one breathing compound detector is at least one of an NO detector, a CO detector, an H2 detector, a H2S detector, and an NH3 detector (NO Sensor 13).
Regarding Claim 6, Mehow teaches: The device of claim 1, wherein the predefined first flux of respiratory gases is between 30-70 ml/s, between 40-60 ml/s, or at least 50 ml/s (paragraph 56).
Regarding Claim 8, Mehow teaches: The device of claim 1, wherein the intermediate gas storage has a patient respiratory gas intake volume of approximately 40-80 ml, approximately 55-65 ml, or approximately 60 ml (paragraph 51).
Regarding Claim 10, Mehow teaches: A system (figure 1) for monitoring a concentration of at least one volatile breathing compound in respiratory gases of patients, the system comprising:
a patient respiratory gas interface (element 1) comprising a mouthpiece (paragraph 40, mouthend) for the patient to blow a respiratory gas into;
an intermediate gas storage (storage chamber 8; figure 1) is in fluid communication with the patient respiratory gas interface and configured to receive the respiratory gas, wherein the intermediate gas storage is open-ended via an exhaust outlet (figure 1; sensor 13 is downstream implying open ended via outlet);
a flow meter (sensor 5) and a valve (valve 7) in fluid communication with the patient respiratory gas interface and the intermediate gas storage, wherein the flow meter is configured to measure a predefined first flux level of a patient respiratory gas flux (paragraph 19-24) and to let patient respiratory gas exhausts in excess of a volume of the intermediate gas storage out of the exhaust outlet in response to the flow meter sensing an expiration of the patient respiratory gas flux, the valve closing at the sensing of the expiration of the patient respiratory gas flux (paragraph 51 and 54); and
at least one volatile breathing compound detector connected to a sampling gas outlet of the intermediate gas storage and configured to determine exhaled concentrations of the at least one volatile breathing compound from a predefined second flux level of the patient respiratory gas (sensor 13).
Regarding Claim 11, Mehow teaches: The system of claim 10, further comprising a pump connected to the intermediate gas storage and configured to draw the patient respiratory gas with the predefined second flux level in a reverse direction out of the sampling gas outlet of the intermediate gas storage to the at least one volatile breathing compound detector (pump 12 can be considered downstream from sensor 13).
Regarding Claim 12, Mehow teaches: The system of claim 11, wherein the pump is arranged downstream of the at least one volatile breathing detector when the patient respiratory gas flows in the reverse direction (pump 12 can be considered downstream from sensor 13; figure 1).
Regarding Claim 13, Mehow teaches: The system of claim 10, wherein the at least one volatile breathing compound includes at least one of fractional exhaled nitric oxide (FeNO), exhaled carbon monoxide (eCO), hydrogen (H2), hydrogen sulfide, (H2S) and ammonia (NH3) (title – Exhaled NO; NO Sensor 13).
Regarding Claim 14, Mehow teaches: The system of claim 10, wherein the at least one breathing compound detector is at least one of an NO detector, a CO detector, an H2 detector, a H2S detector, and an NH3 detector (title – Exhaled NO; NO Sensor 13).
Regarding Claim 16, Mehow teaches: The system of claim 10, wherein the predefined first flux of respiratory gases is between 30-70 ml/s, between 40-60 ml/s, or at least 50 ml/s (paragraph 56).
Regarding Claim 18, Mehow teaches: The system of claim 10, wherein the intermediate gas storage has a patient respiratory gas intake volume of approximately 40-80 ml, approximately 55-65 ml, or approximately 60 ml (paragraph 51).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 5, 9, 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehow in view of Xian et al. (US 2021/0378546 A1 – cited by Applicant), hereinafter Xian.
Regarding Claim 5, Mehow teaches: The device of claim 1, but does not mention wherein the flow meter comprises a feedback display unit configured to display to the patient an actual exhaled patient respiratory gas flux in relation to the predefined first flux level while the patient is exhaling.
Xian teaches the use of a display integrated with a flow module (paragraph 0046). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device to include wherein the flow meter comprises a feedback display unit configured to display to the patient an actual exhaled patient respiratory gas flux in relation to the predefined first flux level while the patient is exhaling in order to provide real time feedback to a user.
Regarding Claim 9, Mehow teaches: The device of claim 1, but does not mention wherein the at least one volatile breathing compound detector is coupled to the gas sampling line via entrance and exit adapters, wherein the adapters are configured to allow a smooth and predominantly laminar flow through the entrance and the exit of a gas sensor of the at least one volatile breathing compound detector.
Xian teaches the use of adapters (support 306) to help avoid turbulent airflow (paragraph 0066-0067). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the device wherein the at least one volatile breathing compound detector is coupled to the gas sampling line via entrance and exit adapters, wherein the adapters are configured to allow a smooth and predominantly laminar flow through the entrance and the exit of a gas sensor of the at least one volatile breathing compound detector to avoid incorrect data introduced by turbulence.
Regarding Claim 15, Mehow teaches: The system of claim 10, but does not mention further comprising a feed-back display unit in electrical communication with the flow meter and configured to display to the patient an actual exhaled patient respiratory gas flux in relation to the predefined first flux level while the patient is exhaling.
Xian teaches the use of a display integrated with a flow module (paragraph 0046). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the flow meter comprises a feedback display unit configured to display to the patient an actual exhaled patient respiratory gas flux in relation to the predefined first flux level while the patient is exhaling in order to provide real time feedback to a user.
Regarding Claim 20, Mehow teaches: The system of claim 10, but does not mention wherein the at least one volatile breathing compound detector is coupled to a gas sampling line via entrance and exit adapters, wherein the adapters are configured to allow a smooth and predominantly laminar flow through the entrance and the exit of a gas sensor of the at least one volatile breathing compound detector.
Xian teaches the use of adapters (support 306) to help avoid turbulent airflow (paragraph 0066-0067). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the at least one volatile breathing compound detector is coupled to the gas sampling line via entrance and exit adapters, wherein the adapters are configured to allow a smooth and predominantly laminar flow through the entrance and the exit of a gas sensor of the at least one volatile breathing compound detector to avoid incorrect data introduced by turbulence.
Claim(s) 7, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehow.
Regarding Claim 7, Mehow teaches: The device of claim 1, wherein the patient respiratory gas is drawn in the reverse direction through the gas sampling line with a predefined second flux level (paragraph 59). Mehow does not mention a flux of 40-80 ml/min, of 50-70 ml/min, or of 60 ml/min. However, Examiner notes that it would have been obvious to one ordinary skill in the art, before the effective filing date to have modified the device to include a flux of 40-80 ml/min, of 50-70 ml/min, or of 60 ml/min as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 17, Mehow teaches: The system of claim 10, wherein the patient respiratory gas is drawn in a reverse direction through a gas sampling line with a predefined second flux (paragraph 59). Mehow does not mention a level of 40-80 ml/min, of 50-70 ml/min, or of 60 ml/min. However, Examiner notes that it would have been obvious to one ordinary skill in the art, before the effective filing date to have modified the system to include a flux of 40-80 ml/min, of 50-70 ml/min, or of 60 ml/min as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehow in view of Li et al. (Highly sensitive and selective nitric oxide sensor based on biomorphic ZnO microtubes with dual-defects assistance at low temperature; 2022), hereinafter Li.
Regarding Claim 19, Mehow teaches: The system of claim 10, but does not mention wherein the at least one volatile breathing compound detector comprises an electrochemical sensor having a response rate of up to 90% of a maximum response value in approximately 30 seconds.
Li teaches wherein the at least one volatile breathing compound detector comprises an electrochemical sensor having a response rate of up to 90% of a maximum response value in approximately 30 seconds (page 5; figure 3b). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system wherein the at least one volatile breathing compound detector comprises an electrochemical sensor having a response rate of up to 90% of a maximum response value in approximately 30 seconds accurately and quickly respond to NO presence.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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, Jennifer Robertson can be reached at 571-272-5001. 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.
JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791