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 § 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.
Claims 2-5, 8-9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over of Allum et al (US 2015/0250973), hereinafter Allum in view of Edwards et al (US 2010/0116270), hereinafter Edwards.
Regarding claim 2, Allum teaches a system for providing oxygen and mechanical ventilation therapy to an ambulatory patient (paragraph 10, an ambulatory assist ventilation apparatus), the system comprising:
a nasal interface apparatus (Fig. 1) comprising:
a pair of nasal pillows (Fig. 7: 101a, 101b), each of the pair of nasal pillows configured to be secured at least partially within a nostril of the patient (Fig. 10A, paragraph 21) and having a first end and a second end opposite the first end (Fig. 10A, first end at bottom of nostril), the second end configured to be positioned farther inside the nostril when the nasal interface apparatus is in use (Fig. 10A, top end of nasal pillow);
and a pair of hub components (Fig. 10b: 104a, 104b, paragraph 56), each of the pair of hub components arranged at the first end of one of the pair of nasal pillows (Fig. 7 104 at one end of pillows 101) and configured to receive oxygen-enriched gas from one of a pair of tubes of the system (Fig. 8: tubes 12a, 128b), each of the pair of hub components comprising one or more delivery openings configured to direct the oxygen-enriched gas toward the second end of the one of the pair of nasal pillows; (Fig. 7: 112a, 112b, paragraph 48, delivery openings)
an oxygen source (paragraph 10, a compressed oxygen delivery source) and an outlet configured to output the generated oxygen-enriched gas wherein the outlet is connected to the pair of tubes (Fig 19, compressed gas cylinder outlets to tubing 1928 and 1928’) and the pair of tubes are configured to guide the oxygen enriched gas directly to the pair of hub components of the nasal interface apparatus; (Fig. 19, tubes 1928 lead to nasal interface, see Fig.8 tubing connects to hub components of nasal interface 100)
wherein the oxygen source has a flow rate (paragraph 10, provides a gas flow) and the nasal interface apparatus is configured to entrain ambient air in conjunction with the oxygen enriched gas received from the oxygen source such that a total flow rate of the oxygen enriched gas and the entrained ambient air to the patient’s nostrils is at least 3 to 5 times the oxygen flow rate (paragraph 57, air apertures provide 300 to 400% of ambient air entrainment), thereby providing simultaneous oxygen and mechanical ventilation therapy to the patient when ambulating. (paragraph 57, providing a therapeutic volume of entrained ambient air and respiratory gas mixture to the patient.)
Allum teaches an oxygen source but does not teach a portable oxygen concentrator (POC), the POC weighing less than 9 pounds and comprising: a compressor, a gas separation member or providing 20 LPM flow rate.
However, Edwards teaches a system for providing oxygen and mechanical ventilation therapy to an ambulatory patient(Abstract, Fig. 2) a portable oxygen concentrator (POC), (Paragraph 8, the oxygen source is an oxygen concentrator, portable oxygen concentrator, Fig. 2: 20, paragraph 45) the POC weighing less than 9 pounds (Paragraph 45, when the oxygen concentrator is a portable oxygen concentration system it weighs 4 to 20 lbs.), and comprising:
a compressor configured to receive and compress ambient air, (Paragraph 70, compressor 112)the compressor further configured to output the compressed ambient air at a compressor flow rate; (Paragraph 72)
a gas separation member configured to receive the compressed ambient air outputted by the compressor at the compressor flow rate and generate the oxygen- enriched gas (Paragraph 71, the compressor delivers air to the concentrator, paragraph 74 concentrator separates oxygen gas from air for delivery to the user); wherein the oxygen source flow rate is 20LPM. (paragraph 63, flow rates of 10-60 LPM) and an outlet (Fig. 8, paragraph 74, the concentrator outputs oxygen to the user), wherein the outlet is connected to the tube flowing to the user mask. (Fig. 8, paragraph 74);
Therefore the combination of Allum with Edwards teaches an outlet of a POC configured to output the generated oxygen-enriched gas, wherein the outlet is connected to the pair of tubes of connecting to the nasal interface and the pair of tubes are configured to guide the oxygen-enriched gas directly to the pair of hub components of the nasal interface apparatus;
and the nasal interface apparatus is configured to entrain ambient air in conjunction with the oxygen- enriched gas received from the POC such that a total flow rate of the oxygen-enriched gas and the entrained ambient air to the patient's nostrils is at least 100 LPM (Edwards teaches a flow rate of 10-60 LPM (Edwards paragraph 63) and Allum teaches 3 to 5 times more entrained ambient air (paragraph 57), thereby providing simultaneous oxygen and mechanical ventilation therapy to the patient when ambulating. (Allum, paragraph 73)
It would have been obvious to a person of ordinary skill in the art to have substituted the oxygen source of Allum with the oxygen concentrator of Edwards since Edwards teaches that the oxygen source may be portable oxygen generators, compressed oxygen tanks and the portable oxygen generator of Edwards would provide the predictable result of supplying oxygen to the user at the desired flow rate.
Regarding claim 3, Allum in view of Edwards teaches the system of Claim 2, and Allum teaches wherein a flow amplification rate due to air entrained by the nasal interface apparatus is 5 times. (Paragraph 57, 3 to 5 times)
Regarding claim 4, Allum in view of Edwards teaches the system of Claim 2, and Allum further teaches wherein the POC has a peak concentrated oxygen flowrate output of between 10 and 20 LPM when delivered synchronously with an onset of inspiration of the patient. (Paragraph 63, Edwards teaches flow rates between 10 to 60 LPM, paragraph 67 delivers with inspiration, Allum paragraph 8, oxygen source is triggered with inspiration, paragraph 10)
Regarding claim 5, Allum in view of Edwards teaches the system of Claim 2, and Allum further teaches wherein the POC has a peak concentrated oxygen flowrate output of greater than 20 LPM when delivered synchronously with an onset of inspiration of the patient. (Paragraph 63, may deliver between 10-60 LPM, paragraph 67 delivers with inspiration, Allum paragraph 8, oxygen source is triggered with inspiration, paragraph 10)
Regarding claim 8, Allum in view of Edwards teaches the system of Claim 2, and Allum further teaches wherein the one or more delivery openings comprises a plurality of delivery openings. (Fig. 7, multiples openings 112a and 112b)
Regarding claim 9, Allum in view of Edwards teaches the system of Claim 2, and Edwards teaches wherein the POC weighs between 5 and 7 pounds. (Paragraph 45, weights between 4 to 20lbs)
Regarding claim 11, Allum in view of Edwards teaches the system of Claim 2, and Allum further teaches the nasal interface apparatus further comprising a connector strip that extends between the pair of nasal pillows. (Fig. 7: 106)
Regarding claim 12, Allum in view of Edwards teaches the system of Claim 2, wherein a length of each nasal pillow is greater than a length of its respective hub component. (Figs. 10A-10C, paragraph 55)
Regarding claim 13, Allum in view of Edwards teaches the system of Claim 2, and Allum further teaches wherein each of the pair of nasal pillows comprises a tubular structure (Fig. 10A, tubular body portion 125a, paragraph 55) and wherein a respective hub component is concentrically disposed with the first end of each nasal pillow such that the one or more delivery openings of the hub component are positioned to deliver the compressed gas within the nasal pillow. (Paragraph 56, disposed coaxial to the nasal pillow, Fig. 10B, paragraph 61, hubs are disposed concentrically or axially with respect to distal ports of nasal pillow)
Regarding claim 14, Allum in view of Edwards teaches the system of Claim 2, the nasal interface apparatus, ambient air aperture formed at the first end of each nasal pillow near or proximate to the one or more delivery openings of the respective hub component disposed therein, wherein the one or more delivery openings are configured to entrain ambient air via the at least one ambient air aperture when delivering the compressed gas. (Figs. 6-7, ambient air apertures 116a, 116b, paragraph 52, in conjunction with ambient air that is entrained by the respiratory gas frow from ambient air apertures paragraph 64, ambient air apertures 216a, 216b, paragraph 65 the flow of pressurized respiratory gas from the delivery openings in conjunction with the entrained ambient air drawn from ambient air apertures)
Regarding claim 15, Allum in view of Edwards teaches the system of Claim 2, wherein each of the hub components includes an inlet for receiving the compressed gas (paragraph 49, inlet 115a, 115b, Fig. 7)and a plenum (Fig. 4: plenum 115a, 115b) for distributing the compressed gas through the one or more delivery openings.(paragraph 49)
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Edwards, and further in view Occhialini et al (US 2005/0257686), hereinafter Occhialini.
Regarding claim 6, Allum in view of Edwards teaches the system of Claim 2, and Edwards teaches flow rates from the oxygen concentrator of 10-60 LPM, paragraph 63) but does not teach wherein a total gas flow output of the POC is 20 LPM or less per liter of oxygen produced, and wherein the POC weighs 6.75 pounds or less per liter of oxygen produced.
However, Occhialini teaches that the design of the portable oxygen concentrators need to achieve a balance among product gas flow rate, weight and power supply life which requires the proper choice of operating and design parameters. (paragraph 2) As such, the weight and flow rates are results effective variables in that changing the weight of different components or size of the compressor affects the resulting oxygen production. Therefore, it would have been obvious to one having ordinary skill of the art at the time of the invention to modify the system of Allum in view of Edwards by having the portable oxygen concentrator total gas flow output to be 16LPM or less per liter of concentrated oxygen produced and wherein the POC weighs 6.75 lbs. or less as a matter of routine optimization since it has been held that wherein the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In Re Aller.
Regarding claim 7, Allum in view of Edwards teaches the system of Claim 2, and Edwards teaches flow rates from the oxygen concentrator of 10-60 LPM, paragraph 63) but does not teach but does not teach wherein a total gas flow output of the POC is 16 LPM or less per liter of oxygen produced, and wherein the POC weighs 5.4 pounds or less.
However, Occhialini teaches that the design of the portable oxygen concentrators need to achieve a balance among product gas flow rate, weight and power supply life which requires the proper choice of operating and design parameters. (paragraph 2) As such, the weight and flow rates are results effective variables in that changing the weight of different components or size of the compressor affects the resulting oxygen production. Therefore, it would have been obvious to one having ordinary skill of the art at the time of the invention to modify the system of Allum in view of Edwards by having the portable oxygen concentrator total gas flow output to be 16LPM or less per liter of concentrated oxygen produced and wherein the POC weighs 5.4 lbs. or less as a matter of routine optimization since it has been held that wherein the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In Re Aller.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Edwards and further in view of Kato et al (US Pat. no. 4,822,384), hereinafter Kato.
Regarding claim 10, Allum in view of Edwards teaches the system of Claim 2, but does not teach wherein the POC is further configured to provide varying levels of ventilation support and oxygen enrichment to the patient when ambulating by varying an amount of the compressed ambient air bypassing the gas separation member.
However, Kato teaches an apparatus for producing oxygen enriched air (Abstract, Fig. 4A) which is configured to provide varying levels of ventilation support and oxygen enrichment to the patient when ambulating by varying an amount of the compressed ambient air bypassing the gas separation member. (Col 7: lines 63 – Col. 8 line 20, a gas conduit 35 is provided as a bypass conduit for supplying the upstream portion of the storage tank 3 with a portion of the air A under pressure fed by the compressor 4. A flow control valve is disposed to non-continuously control the amount of flow of the air A in relation to a required oxygen concentration level of the oxygen enriched gas D delivered from the outlet. The flow control valve can be operated to control the amount of flow of the air through the bypass conduit to obtain different oxygen concentrations, 40%, 90%)
Therefore, it would have been obvious to a person of ordinary skill in the art to have modified the apparatus of Allum in view of Edwards to include varying an amount of the compressed ambient air bypassing the gas separation member as taught by Kato in order to produce different concentration of oxygen needed by the user. (Col. 8: lines 15-20)
Conclusion
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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