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 .
Response to Amendment
Examiner acknowledges the reply filed on 09/23/2025 in which claims 1, 2, 13, and 16-18 have been amended and claim 15 is cancelled. Currently, claims 1-14 and 16-20 are pending for examination in this application.
Response to Arguments
Applicant has resolved the rejection under 112(b).
Applicant’s arguments, see Remarks pg. 13-16, filed 09/23/2025, with respect to amended independent claims 2 and 18 have been fully considered and are persuasive. The rejection of 05/23/2025 has been withdrawn. However, amended independent claim does not include the entirety of the amendments to claim 2 and 18, notably that the anti-kink device is selectively attachable and detachable, and as such is rejected below.
Election/Restrictions
Applicant’s election without traverse of Sub-Species VII in the reply filed on 02/28/2025 is acknowledged.
Claims 6, 8, and 9 are withdrawn.
Claim Objections
Claims 2 and 18 are objected to because of the following informalities:
Claim 2, line 4, remove “or integral” as the anti-kink devices cannot be both integral and selectively attachable and detachable.
Claim 18, line 4, remove “or integral” as the anti-kink devices cannot be both integral and selectively attachable and detachable.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 10-14, and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 2, and 18 recite limitations regarding a plurality of sensors configured to sense a pressure along walls of the flexible tube at different sensor locations and a processing unit configured to detect a kink by processing sensor data of the pressure sensed at the different sensor locations along the walls of the flexible tube to determine a pressure change that indicates a presence of a kink or bend location along the walls of the flexible tube. In the specifications there is support for a plurality of sensor wires as part of the anti-kink device, for carrying a pressure or flow signal [0053-0054], and separately a singular pressure sensor located between the regulator and oxygen outlet that detects a kink [0068]. However, there is no support in the specifications for a plurality of pressure sensors positioned along the anti-kink device for sensing pressure at different locations. Examiner is interpreting the “plurality of pressure sensors” to be the sensor wires disclosed in [0054]. Even with this interpretation, the specification is silent as to detecting kinks at multiple locations and determining a pressure change that indicates a presence of a kink or bend location along the walls of flexible tube.
Claims 3-5, 7, 10-14 and 16-20 are rejected based on their dependency on a rejected claim.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Obenchain (US 20210046265 A1), Sampson (US 4949733 A), Peiris (US 20210077765 A1), and Harvie (US 20030189492 A1).
Regarding claim 1, Obenchain discloses a nasal cannula device, comprising:
a flexible tube ([0224] tubing 500 can be made of flexible polyvinyl chloride (PVC), crush resistant and flexible PVC, or any other suitable material; figure 32-34) having an inner surface (inner surface of tubing 500 (not shown)) and an outer surface (outer surface of tubing 500; figure 32-34);
one or more anti-kink devices attached to or integral with a distal end of the flexible tube ([0224] regular tubing designed with ribs 511 that prevent the tubing from being pinched together and preventing flow therethrough; figure 35. Examiner notes that in this configuration the ribs are designed integral with the entirety of the tubing 500) that connects to a connection adapter (see figure 32, regular tubing 500 connects to universal connector 504 at a distal end), so that the one or more anti-kink devices provide support to the flexible tube to prevent kinking of the flexible tube ([0224] regular tubing designed with ribs 511 that prevent the tubing from being pinched together and preventing flow therethrough; figure 35);
Obenchain does not disclose one or more ear protection devices attached to or integral with a portion of the flexible tube that contacts a user's ear, wherein the one or more ear protection devices comprise a material to mitigate skin irritation of the user's ear;
a plurality of pressure sensors positioned at different sensor locations along the one or more anti-kink devices, the plurality of pressure sensors configured to detect a kink in the flexible tube, wherein the one or more anti-kink devices are configured, using the plurality of pressure sensors, to continuously monitor the flexible tube and detect any kinks along the flexible tube from the connection adapter to the one or more ear protection devices during use of the nasal cannula device.
However, Sampson discloses a nasal cannula device (cannula tube 2 with tubing 5; figure 1) comprising:
one or more ear protection devices attached to or integral with a portion of the flexible tube that contacts a user's ear (pad 15; figure 1-6), wherein the one or more ear protection devices comprise a material to mitigate skin irritation of the user's ear (The tubing 5 in the area of the ear 6, and in absence of the pad of this invention, would be in relatively constant contact with the skin in the area of the trough 7. Over a period of time, this tends to cause discomfort due to irritation and inflammation. In order to reduce this tendency, a pad 15 embodying this invention is provided. The pad 15, in this example, is of cylindrical shape, as best illustrated in FIGS. 2, 5 and 6, and is constructed of a soft foam-like material; col. 5 line 46-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal cannula of Obenchain to implement a pad made of a soft-foam like material onto the tubing in the area of the ear in order to protect the skin and reduce the likeliness of discomfort caused by the cannula as taught by Sampson, col. 1 line 24-34.
Peiris teaches a medical tube for breathing circuits (title) comprising a plurality of pressure sensors positioned at different sensor locations ([0116] Sensor wire(s) embedded within the bead 16 can be configured to measure, for example, temperature, pressure, flow, or humidity. [0044] The bead can comprise at least one sensor wire for conveying power and/or data between at least one sensor and a controller. The at least one sensor wire can comprise one or two or more sensor wires disposed within the bead. The at least one sensor can comprise at least one of a temperature sensor, a humidity sensor, a flow sensor, and a pressure sensor) along one or more anti-kink devices (bead 16; figure 2-3B. [0102] the bead, which may be much thicker and/or made of a harder or more rigid material than the film may impart structural support, reinforcement, and/or resistance to crushing to the more flexible film portions of the tube. Such structural support, reinforcement, and/or resistance to crushing may be important in medical tubes, and in particular for breathing tubes).
Additionally, Harvie teaches a respiratory therapy device (figure 1) comprising a pressure sensor configured to detect a kink in the flexible tube ([0028] A pressure sensor can be used with an oxygen concentrator, compressed gas cylinder or liquid tank to alert the user that the oxygen supply tubing is kinked or blocked. With a compressed gas cylinder, the pressure and temperature sensor optimally would be located in the cannula near the point where it leaves the regulator, however, alternative mounting locations in the line between a tank and the user may be used. If there is a kink or blockage, a few p.s.i. of pressure will build up in the tubing, which can be detected by the sensor; see figure 1); a processing unit in communication with the pressure sensor ([0029] The pressure and temperature sensors are connected to a micro controller that reads the actual pressure level and temperature within the compressed cylinder and converts the signals received from the sensors to a displayable p.s.i. One component of the electronic control unit is a digital pressure gauge that utilizes a Micro Electro Mechanical Systems (MEMS) pressure sensor, a strain gauge diaphragm-type sensor or other type of electric signal pressure sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ribs of Obenchain to implement sensor wires disposed at different locations within the ribs in order to convey power and data between pressure sensors and a controller or to directly measure pressure as taught by Peiris [0044 and 0116] and implementing a microcontroller in communication with the pressure sensing devices in order to use the measured pressure to identify a kink in the tubing by detecting a build up of pressure, as taught by Harvie [0028].
As such, modified Obenchain teaches using the plurality of pressure sensors, to continuously monitor the flexible tube and detect any kinks along the flexible tube (modification of Peiris and Harvie) from the connection adapter to the one or more ear protection devices during use of the nasal cannula device (modification of Sampson implementing an ear protection device).
Modified Obenchain teaches a processing unit in communication with the plurality of pressure sensors (modification above: microcontroller of Harvie and pressure sensors of Peiris) and wherein each of the plurality of pressure sensors is configured to sense a pressure along walls of the flexible tube (Harvie: [0028] If there is a kink or blockage, a few p.s.i. of pressure will build up in the tubing, which can be detected by the sensor) at the different sensor locations of each of the plurality of sensors (modification of Peiris above); wherein the processing unit is configured to detect the kink by processing sensor data of the pressure sensed at the different sensor locations along the walls of the flexible tube to determine a pressure change that indicates a presence of a kink or bend location along the walls of the flexible tube (Harvie: [0028]); and wherein the processing unit is configured to provide information regarding the kink or bend location to the user (Harvie: [0028] A pressure sensor can be used with an oxygen concentrator, compressed gas cylinder or liquid tank to alert the user that the oxygen supply tubing is kinked or blocked. With a compressed gas cylinder, the pressure and temperature sensor optimally would be located in the cannula near the point where it leaves the regulator, however, alternative mounting locations in the line between a tank and the user may be used. If there is a kink or blockage, a few p.s.i. of pressure will build up in the tubing, which can be detected by the sensor. Examiner notes that the location of the kink is determined based on which of the pressure sensors along the ribs of modified Obenchain detects the build up of pressure).
Allowable Subject Matter
Claims 2-5, 7, and 10-14 and 16-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the claims in this application have been allowed because the closest prior art of recorded fails to teach among all the limitations or render obvious the combination of features recited in independent claims 2 and 18, as claimed in the instant application.
The closest prior art of record is Obenchain (US 20210046265 A1) and Concklin (US 20210290882 A1).
Obenchain teaches an integral anti-kink device in the form of ribs provided in the nasal cannula which does not read on the limitation requiring the anti-kink device being configured to be selectively attachable and detachable to the flexible tube of the cannula. Concklin teaches an attachable anti-kink devices along a flexible tube of a nasal cannula but fails to teach detecting kinks in the flexible tube. The means of detecting kinks in the prior art of record rely on the integral structure of ribs or beads along the tube to perform pressure readings an equate pressure readings to detection of kinking. The prior art of record is silent as to the combination of elements of a selectively attachable and detachable anti-kink device including means of detecting kinking via pressure sensors.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
THIS ACTION IS MADE FINAL. 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 Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785