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 .
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.
(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 25 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sasaki et al (US 2019/0388644), hereinafter Sasaki.
Regarding claim 25, Sasaki teaches a method of generating a trigger signal for controlling release of a bolus of oxygen enriched gas from an oxygen concentrator(paragraph 26, supplying oxygen for a certain period of time, paragraph 40, Fig. 1), the method comprising:
calculating a trigger threshold from an initial pressure signal representing an airway pressure of a user and a movement signal (paragraph 10, a pressure sensor measures the pressure, the control system determines the trigger point from the pressure gradient, and switches the one pressure gradient threshold to any of the multiple pressure gradient thresholds based on a frequency of the inspiratory sensing point, paragraph 8 this is representative of the respiratory rate which is related to the activity state of the user, paragraph 18, paragraph41, judges the inspiration sensing point as a start of the inspiratory phase);
comparing a subsequent pressure signal representing the airway pressure of the user with the trigger threshold (paragraph 11, paragraph 42, judges whether switching of threshold is necessary based on a frequency of inspiration sensing point detected); and
generating, based on the comparison, the trigger signal for controlling release of the bolus. (paragraph 26, pulsatively supplying the respiratory gas for ac certain period of time after detecting an inspiration sensing point, paragraph 41, opens the control valve and supplies gas to the cannula)
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.
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.
Claims 1-3, 8-10, 14, 19-23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki in view of Zapol et al (US 2018/0243528), hereinafter Zapol.
Regarding claim 1, Sasaki teaches an oxygen concentration system (paragraph 40, Fig. 1) comprising:
a pressure sensor configured to generate pressure signals (Fig. 1, pressure sensor 4, detects inspiration), wherein the pressure sensor is pneumatically coupled to a delivery conduit for providing a user with oxygen enriched air (Fig. 1, paragraph 41, pressure sensor 4 constantly measures pressure in gas supply path 3);
a movement signal; (paragraph 39, judges based on a frequency of inspiration whether a user is awake or asleep)and
one or more processors communicatively coupled to the pressure sensor and the movement sensor, (paragraph 42, control unit 5)wherein the one or more processors are configured to:
adjust a trigger threshold based on an initial pressure signal obtained from the pressure sensor and the movement signal obtained from the movement sensor; (paragraph 42, control unit judges whether switching of threshold is necessary based on the frequency of inspiration)and
compare the adjusted trigger threshold with a subsequent pressure signal obtained from the pressure sensor to determine when to provide the user with a bolus of oxygen enriched air through the conduit. (paragraph 48, paragraph 49, pulsatively supplies the respiratory gas, paragraph 52)
Sasaki does not teach a separate movement sensor to generate the movement signal.
However, Zapol teaches a device ambulatory generation of nitric oxide which teaches a movement sensor to detect increased activity (Paragraph 208, an accelerometer can detect increased activity, paragraph 209, an accelerometer on the patient’s chest may detect respiration)
It would have been obvious to a person of ordinary skill in the art to have used the movement sensor of Zapol in the device of Sasaki to increase accuracy of the respiration detection.
Regarding claim 2, Sasaki in view of Zapol teaches the system of claim 1, Sasaki further teaches wherein the one or more processors are further configured to maintain the trigger threshold when a magnitude or a frequency of the movement signal is greater than a predetermined threshold. (Paragraph 50, Fig. 2, if the frequency is greater than 4 in 5 seconds the pressure threshold remains the same)
Regarding claim 3, Sasaki in view of Zapol teaches the system of claim 1, and Sasaki further teaches wherein adjusting the trigger threshold based on the initial pressure signal and the movement signal comprises:
generating an activity signal (paragraph 50, Fig. 2, frequency of respiration; increasing a magnitude of the trigger threshold when a window of the activity signal indicates an increase in the user's activity (paragraph 50, Fig. 2, looks at activity in 30 second period, looks at activity in 5 second period); and decreasing a magnitude of the trigger threshold when the window of the activity signal indicates a decrease in the user's activity. (Fig. 2, Paragraph 50, reduces threshold if the frequency sensed is less than a certain amount)
Regarding claim 8, Sasaki teaches the system of claim 3, wherein a length of the window is fixed. (paragraph 51, a predetermined time for counting the number of inspiration points is preferably 60 seconds are shorter, the window is fixed for the particular threshold)
Regarding claim 9, Sasaki in view of Zapol teaches system of claim 3, and Sasaki teaches wherein adjusting the trigger threshold based on the initial pressure signal and the movement signal further comprises adjusting a length of the window based on the movement signal. (paragraphs 47, 49, 51, 53, depending on the rate of respiration the length of the window changes.
Regarding claim 10, Sasaki in view of Zapol teaches the system of claim 9, and Sasaki further teaches wherein adjusting the length of the window based on the movement signal comprises shortening the length of the window when a magnitude or a frequency of the movement signal is greater than a predetermined threshold. (Fig. 2, the greater the frequency the shorter the window length. Paragraph
Regarding claim 14, Sasaki teaches an oxygen concentration system (paragraph 40, Fig. 1):
a pressure sensor configured to generate pressure signals, wherein the pressure sensor is pneumatically coupled to a delivery conduit for providing a user with oxygen enriched air; (Fig. 1, paragraph 41, pressure sensor 4 constantly measures pressure in gas supply path 3)
a movement signal; (paragraph 39, judges based on a frequency of inspiration whether a user is awake or asleep); and
one or more processors communicatively coupled to the pressure sensor and the movement sensor, (paragraph 42, control unit 5)wherein the one or more processors are configured to:
adjust a trigger threshold based on an initial pressure signal obtained from the pressure sensor and the movement signal obtained from the movement sensor; (paragraph 42, control unit judges whether switching of threshold is necessary based on the frequency of inspiration); and
compare a trigger threshold with the adjusted pressure signal to determine when to provide the user with a bolus of oxygen enriched air through the conduit. (paragraph 48, paragraph 49, pulsatively supplies the respiratory gas, paragraph 52)
Sasaki does not teach a separate movement sensor to generate the movement signal.
However, Zapol teaches a device ambulatory generation of nitric oxide which teaches a movement sensor to detect increased activity (Paragraph 208, an accelerometer can detect increased activity, paragraph 209, an accelerometer on the patient’s chest may detect respiration)
It would have been obvious to a person of ordinary skill in the art to have used the movement sensor of Zapol in the device of Sasaki to increase accuracy of the respiration detection.
Regarding claim 19, Sasaki teaches an oxygen concentration system (paragraph 40, Fig. 1) comprising:
a pressure sensor configured to generate pressure signals, wherein the pressure sensor is pneumatically coupled to a delivery conduit for providing a user with oxygen enriched air; (Fig. 1, paragraph 41, pressure sensor 4 constantly measures pressure in gas supply path 3)
a movement signal; (paragraph 39, judges based on a frequency of inspiration whether a user is awake or asleep); and
one or more processors communicatively coupled to the pressure sensor and the movement sensor, (paragraph 42, control unit 5)wherein the one or more processors are configured to:
detect a potential onset of inhalation by comparing a trigger threshold with a pressure signal obtained from the pressure sensor; (paragraph 42, control unit judges whether switching of threshold is necessary based on the frequency of inspiration);
determine whether to verify the potential onset of inhalation based on the movement signal obtained from the movement sensor; (paragraph 39, determines whether the start of the inspiratory phase can be sensed appropriately) and
provide the user with a bolus of oxygen enriched air through the conduit if the potential onset of inhalation is verified. (paragraph 48, paragraph 49, pulsatively supplies the respiratory gas, paragraph 52)
Sasaki does not teach a separate movement sensor to generate the movement signal.
However, Zapol teaches a device ambulatory generation of nitric oxide which teaches a movement sensor to detect increased activity (Paragraph 208, an accelerometer can detect increased activity, paragraph 209, an accelerometer on the patient’s chest may detect respiration)
It would have been obvious to a person of ordinary skill in the art to have used the movement sensor of Zapol in the device of Sasaki to increase accuracy of the respiration detection.
Regarding claim 20, Sasaki in view of Zapol teaches a system of claim 19, wherein determining whether to verify the potential onset of inhalation based on the movement signal comprises comparing a magnitude of the movement signal to a predetermined threshold. (paragraph 39, judges based on a frequency of inspiration during predetermined time)
Regarding claim 21, Sasaki in view of Zapol teaches the system of claim 20, and Sasaki further teaches wherein the potential onset of inhalation is verified if the magnitude of the movement signal is less than the predetermined threshold. (Fig. 2, (paragraph 39, judges based on a frequency of inspiration during predetermined time)
Regarding claim 22, Sasaki in view of Zapol teaches the system of claim 19, and Sasaki further teaches wherein determining whether to verify the potential onset of inhalation based on the movement signal comprises comparing a frequency of the movement signal to a predetermined threshold. (paragraph 39, judges based on a frequency of inspiration, Fig. 2)
Regarding claim 23, Sasaki in view of Zapol teaches the system of claim 22, and Sasaki further teaches wherein the potential onset of inhalation is verified if the frequency of the movement signal is less than the predetermined threshold. (Fig. 4, Step S10, if the frequency is less than 4, the threshold setting remains the same)
Regarding claim 26, Sasaki teaches a method of generating a trigger signal for controlling release of a bolus of oxygen enriched gas from an oxygen concentrator(paragraph 26, supplying oxygen for a certain period of time, paragraph 40, Fig. 1), the method comprising, the method comprising:
adjusting a pressure signal representing an airway pressure of a user based on a movement signal; (paragraph 10, a pressure sensor measures the pressure, the control system determines the trigger point from the pressure gradient, and switches the one pressure gradient threshold to any of the multiple pressure gradient thresholds based on a frequency of the inspiratory sensing point, paragraph 8 this is representative of the respiratory rate which is related to the activity state of the user, paragraph 18, paragraph41, judges the inspiration sensing point as a start of the inspiratory phase);
comparing the adjusted pressure signal with a trigger threshold; (paragraph 41, judges the inspiration point from the respiratory pattern) and
generating, based on the comparison, the trigger signal for controlling release of the bolus. (paragraph 41, signals the oxygen valve to open)
Regarding claim 27, Sasaki teaches a method of generating a trigger signal for controlling release of a bolus of oxygen enriched gas from an oxygen concentrator(paragraph 26, supplying oxygen for a certain period of time, paragraph 40, Fig. 1), the method comprising, the method comprising:
comparing a pressure signal with a trigger threshold to detect a potential onset of inhalation; (paragraph 10, 18, 41)
determining whether to verify the potential onset of inhalation based on a movement signal; (paragraph 39, determines whether the start of the inspiratory phase can be sensed appropriately) and
and
generating, based on the verifying, the trigger signal for controlling release of the bolus. (paragraph 48, paragraph 49, pulsatively supplies the respiratory gas, paragraph 52)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sasaki in view of Zapol and further in view of Edwards et al (US 2010/0116270), hereinafter Edwards.
Regarding claim 13, Sasaki in view of Zapol teaches system of claim 1 and Sasaki teaches an oxygen concentrator but does not disclose further comprising:
However, Edwards teaches an oxygen concentrator with a compression system (paragraph 97, compressor 112), configured to generate a pressurized stream of ambient air (paragraph 97); and
a canister system comprising a canister containing a gas separation adsorbent, wherein the gas separation adsorbent is configured to separate at least some nitrogen from the pressurized stream of ambient air to produce oxygen enriched air. (paragraph 97, ad adsorbent such as Zeolite may be used to absorb nitrogen. Oxygen is produced as the nonadsorbed gas).
It would have been obvious to a person of ordinary skill in the art to have modified Sasaki in view of Zapol to include a compression system and a canister system as this a well-known operation of an oxygen concentrator.
Allowable Subject Matter
Claims 4-7, 11-12, 15-18 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, the prior art does not teach generating the activity signal comprises:
deriving at least one breathing parameter from the initial pressure signal;
deriving at least one movement parameter from the movement signal; and
combining the at least one breathing parameter and the at least one movement parameter to generate the activity signal.
Regarding claim 5, the prior art does not teach wherein the at least one breathing parameter is a breathing rate of the user, and wherein the at least one movement parameter is a number of steps taken per unit of time by the user.
Regarding claims 6 and 7, the prior art does not teach wherein generating the activity signal comprises: generating a non-respiratory signal from the initial pressure signal; and scaling the non-respiratory signal based on the movement signal to generate the activity signal.
Regarding claims 11, 15, and 24 the prior art does not teach wherein the movement sensor comprises an accelerometer coupled to the delivery conduit.
Regarding claim 12, the prior art does not teach wherein the movement sensor comprises a strain gauge coupled to the delivery conduit.
Regarding claim 16, the prior art does not teach wherein adjusting the pressure signal based on the movement signal comprises analyzing a direction of acceleration derived from the movement signal in relation to an orientation of the pressure sensor.
Regarding claim 17, the prior art does not teach wherein the movement sensor comprises a strain gauge coupled to the delivery conduit, and wherein adjusting the pressure signal based on the movement signal comprises analyzing a measured bending of one or more portions of the delivery conduit.
Regarding claim 18, the prior art does not teach, wherein the one or more processors are further configured to adjust the trigger threshold based on the movement signal before the trigger threshold is compared with the adjusted pressure signal.
Conclusion
The following are suggested formats for either a Certificate of Mailing or Certificate of Transmission under 37 CFR 1.8(a). The certification may be included with all correspondence concerning this application or proceeding to establish a date of mailing or transmission under 37 CFR 1.8(a). Proper use of this procedure will result in such communication being considered as timely if the established date is within the required period for reply. The Certificate should be signed by the individual actually depositing or transmitting the correspondence or by an individual who, upon information and belief, expects the correspondence to be mailed or transmitted in the normal course of business by another no later than the date indicated.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Arp, US Pat. No. 5,165397 teaches an oxygen monitoring system wherein the control system determines if a signal was produced by inhalation or is a signal was produced by an artifact source such as motion of the patient.
Starr (US 2005/0121033) teaches that movement in the lumen may appear as noise in the output of the pressure or flow sensor. The noise may be subtracted from pressure signal. (paragraphs 73, 76)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785