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 .
Specification
The disclosure is objected to because the description of figure 3, reference numbers 1 and 2 do not have a clear description. Page 27, lines 20-21 describe 1 and 2 as the “toe modes of air supply to the device”. It appears that this is a typographical error referring to the two modes of operation described at the end of page 26.
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 is 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.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph since it is not clear when infringement occurs, whether it is when one creates a system that allows the user to do the process, or when the user actually uses the system. In contrast, when a claim recites a product and additional limitations which focus on the capabilities of the system, not the specific actions of the user, the claim may be definite. (See MPEP 2173.05(p)(II)). It is suggested to amend the claims to recite the method or process rather than “a system” comprising modules, since it appears that the applicant intends to claim the process rather than a device.
Claim 1 limitation “mixing the oxygen with the carbon dioxide based on a pressure balance regulation result to obtain a baseline gas mixture” (page 2, line 7) is rejected for being unclear whether this refers to the previous limitation “regulating a pressure balance of the oxygen and the carbon dioxide based on the gas pressure”, or some other result. It has been interpreted that this claim limitation “a pressure balance result” is from the previously recited step of “regulating a pressure balance”. For example, amending the limitation to “mixing the oxygen with the carbon dioxide based on the regulated pressure balance” is a suggestion to clarify this limitation.
Appropriate correction is required.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman (US 2007/0169779 A1), hereafter Freeman, in view of Raemer (US 5320093), hereafter Raemer.
Regarding Claim 1, Freeman discloses a system for addressing hyperventilation (abstract) based on a ventilator device (fig. 1, ventilator 15 [0025]), comprising:
a monitoring module (fig. 1, 2 [0032]) for obtaining a carbon dioxide partial pressure of a subject (fig. 3B, partial pressure CO₂ is measure [0035]), and determining whether the subject is experiencing respiratory alkalosis based on the carbon dioxide partial pressure (fig. 5, pH is measured at 59 as part of the closed loop feedback method [0040]);
an analyzing module for obtaining vital sign data of the subject when the respiratory alkalosis occurs (fig. 2, the microprocessor receives capnometric measurement data from sensors to determine an increase in end tidal CO₂ [0032]) and determining a degree of the respiratory alkalosis of the subject based on the vital sign data ([0032] the processor is triggered by an increase of more than 30% of baseline EtCO₂, indicating excess carbon dioxide, i.e. alkalosis);
and an adjusting module for adjusting a mixing ratio of oxygen and carbon dioxide based on the degree of the respiratory alkalosis (fig. 2, compressed CO₂ 26, compressed O₂ 25 [0033]), then re-supplying the subject, and monitoring a respiratory status of the subject in real time (subsequent exhalations are monitored [0033]);
wherein adjusting the mixing ratio of the oxygen and the carbon dioxide based on the degree of the respiratory alkalosis, then re-supplying the subject, and monitoring the respiratory status of the subject in real time comprise steps of:
obtaining the degree of the respiratory alkalosis of the subject ([0032] the processing unit detects an increase of more than 30% in the baseline EtCO₂ value),
extracting a target characteristic of the degree of the respiratory alkalosis in the subject ([0033] the target characteristic of the degree of respiratory alkalosis is the EtCO₂) and determining a target carbon dioxide ratio adjustment range for mitigating the degree of the respiratory alkalosis in the subject based on the target characteristic ([0033] the target CO₂ level is selected based on the end tidal CO₂ relative to the initial levels);
determining an initial adjustment parameter for a carbon dioxide mixing ratio in the initial mixing ratio of the oxygen and the carbon dioxide based on the target carbon dioxide ratio adjustment range ([0033] the target adjustment CO₂ level is +/-10% of the EtCO₂, and it is determined whether the CO₂ should be adjusted up or down), and adjusting the initial mixing ratio of the oxygen and the carbon dioxide based on the initial adjustment parameter to obtain a baseline mixing ratio ([0033]);
mixing the oxygen with the carbon dioxide to obtain a baseline gas mixture, and delivering the baseline gas mixture to the subject based on the ventilator device ([0033]);
monitoring respiration data of the subject in real time based on a delivery result, and adjusting a carbon dioxide ratio in the baseline gas mixture in a gradient form based on the respiration data ([0033] the EtCO₂ is compared to the initial partial pressure CO₂, and the delivered CO₂ depends on the comparison; the gradient is a 10% decrease);
and determining a delivering period of the gas mixture of each gradient based on gradient adjustment results, and delivering the gas mixture of each gradient to the subject based on the delivering period until the respiratory data of the subject returns to normal, thus completing mixture adjustment of the oxygen and the carbon dioxide ([0033] the delivering period looks for at least 3 cycles of EtCO₂ to not be found higher than initial CO₂ levels in order to reduce the delivered CO₂).
Freeman is silent on wherein the target carbon dioxide ratio adjustment range is 1 %-6% (the target adjustment ratio is 10%), as well as silent on meanwhile sampling a gas mixture currently received by the subject and analyzing the gas mixture based on a sampling result, so as to obtain an initial mixing ratio of the oxygen and the carbon dioxide in the gas mixture (Freeman’s initial ventilation is set such that the flow ratios of oxygen, room air, and CO₂ is set such that the partial pressure of CO₂ is 90% of the EtCO₂, but does not disclose if the delivered gas is sampled); and determining a gas pressure of the oxygen and the carbon dioxide through the ventilator device based on the baseline mixing ratio, and regulating a pressure balance of the oxygen and the carbon dioxide based on the gas pressure (Freeman does not disclose whether the pressure of the delivered gas is determined and regulated; flow is discussed in [0035]).
Raemer teaches a system for restoring ventilatory drive to a patient after anesthesia by delivering carbon dioxide to the breathing air mixture (abstract). This system has a maximum target carbon dioxide adjustment range of 7% (col. 9 lines 59-64; i.e. a range of 0-7%) as a safety measure to prevent excess inhalation of carbon dioxide by the patient. Additionally, Raemer teaches sampling the gas mixture received by the subject (col. 8 lines 4-5, both inspired and expired gases are sampled in order to determine the source of the CO₂, whether exhaled or delivered by the system, to ensure a reliably calculated arterial partial pressure of CO₂, col. 8 lines 5-8). Raemer also teaches, as an alternative to regulating gas delivery by flow rate, using a pressure regulator to control the flow of CO₂ (col. 7 lines 27-30 and col. 9 lines 31-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Freeman’s invention to change the target carbon dioxide ratio adjustment range from 0-7% as taught by Raemer to 1-6% for the safety of the patient, as the applicant appears to have placed no criticality on the claimed range (see page 24) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It additionally would have been obvious to modify Freeman’s invention to sample a gas mixture currently received by the subject and analyzing the gas mixture based on a sampling result, so as to obtain an initial mixing ratio of the oxygen and the carbon dioxide in the gas mixture as taught by Raemer in order to more accurately identify the patient’s arterial partial pressure CO₂ levels versus what the system is delivering in order to more accurately dose the patient with carbon dioxide (Raemer col. 8 lines 5-8). It also would have been obvious to modify Freeman to determine a gas pressure of the oxygen and the carbon dioxide through the ventilator device based on the baseline mixing ratio, and regulating a pressure balance of the oxygen and the carbon dioxide based on the gas pressure, resulting in mixing the oxygen with the carbon dioxide based on a pressure balance regulation result to obtain a baseline gas mixture, since Raemer teaches that regulating and measuring gas pressure as opposed to flow rate is a known alternative in the art (Raemer col. 7 lines 27-30 and col. 9 lines 31-35).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thomas et al. (US 2004/0144383 A1) discloses a method of providing a user with carbon dioxide supplementation to correct sleep apnea events using an oxygen concentrator, a CO₂ canister, control valve, a gas mixing module, and patient monitoring to control the delivery of carbon dioxide ([0041]).
Daly (US 2007/0240718 A1) discloses a method of managing obstructive sleep apnea using carbon dioxide measurement (fig. 8).
L’her et al. (US 2014/015124 A1) disclose a method of delivering carbon dioxide to a patient for sleep disordered breathing (abstract, [0046]).
Studer et al. (US 2021/0330996 A1) disclose delivering a gas mixture of oxygen and carbon dioxide to a person to treat hyperventilation ([0001]).
Kuzelka et al. (US 2021/0369995 A1) disclose a monitoring system for the delivery of mixed medical gases ([0018]).
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785