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 Amendments
This office action is responsive to the amendment filed on 12/22/2025. As directed by the amendment: claims 35, 40, 49, 51-53, 56-57, 59, and 66-67 have been amended, no new claims have been canceled, and no new claims have been added. Thus, claims 35-36, 40, 42, 45, 49-54, 56-57, 59, 64, 66-68, and 79-81 are presently pending in the application.
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.
Claims 35-36, 40, 42, 45, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1).
Regarding claim 35, Jaffe discloses a nasal cannula interface (FIG. 41 Patient Interface 440, as illustrated, the patient interface 440 includes the features and attributes of the patient interface 10 illustrated in FIG. 1-3 as set forth in [231]) for supplying a gases flow to a patient (As set forth in the “Technical Field” section) comprising: a gases inlet conduit for receiving the gases flow from a flow source (FIG. 41 A first fluid path 14 provided by tubing 11 as set forth in [95] configured to supply a fluid that includes oxygen to the patient from a suitable fluid supply as set forth in [101]), the gases inlet conduit defining at least a portion of a gases flow path (FIG. 41 First fluid path 14) and comprising a patient end and a distal end (As shown in the annotated figure below), a first set of wires (FIG. 41 Sensor 442 may be hardwired with wiring being harnessed with or integrally formed with the tubing forming the fluid paths as set forth in [237]), one or more sensors configured to be placed on skin of the patient's skin (FIG. 41 Sensor 442 includes an emitter 452 and a detector 454 that may both engage the outside surface of the patient’s nose as set forth in [234]) and configured to measure at least one parameter (FIG. 41 Sensor 442 is a photoplethysmography sensor as set forth in [231]; Photoplethysmography sensors may be used to measure blood oxygen levels, SpO2, and effort as set forth in [229]), and a nasal cannula (Shown in detail by FIG. 2) defining at least a portion of a gases flow path (FIG. 2 Internal conduit 23 as set forth in [101]) and comprising a body (FIG. 2 Body portion 12 as set forth in [101]) having a base portion (FIG. 2 Surface of body portion 12 comprising the nostril interfaces 18, 21 as shown in the annotated figure below) and at least one prong extending from the base portion (FIG. 2 Nostril Interface 18 as set forth in [100]), the at least one prong being configured to direct the gases flow to an orifice of the patient (FIG. 2 Nostril interface 18 configured to be inserted into an associated nostril of a patient and have a respective internal orifice in communication with associated fluid path 14 configured to supply oxygen to the patient as set forth in [100]-[101]), and an interface connector for receiving the gases flow from the gases inlet conduit and directing the gases flow towards the at least one prong (FIG. 2 Tubing connecting portion 17 as set forth in [97]; Communication between nostril interface 18 and the orifice of connecting portion 17 is provided by an internal conduit 23, allowing fluid path 14 to be in fluid communication with the nostril as set forth in [101]), and wherein the patient end is configured to be connected to the interface connector (FIG. 41 The patient end in connected to connecting portion 17 as shown in the annotated figure below), the distal end comprises an interface inlet (As shown in the annotated figure below), and the first set of wires of the nasal cannula interface provides electrical communication between the one or more sensors and a control device (FIG. 341 Signal may be provided via a wireless interface or a hardwired interface with the processor as set forth in [237]).
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Jaffe fails to explicitly disclose the interface inlet comprising a set of electrical contacts, and the first set of wires of the nasal cannula interface provides electrical communication between the one or more sensors and the set of electrical contacts of the interface inlet.
However, Bahr teaches an interface inlet (Bahr: FIG. 2 and 3 Interface 34 of the endotracheal tube 42 as set forth in [0020]-[0021]) comprising a set of electrical contacts (Bahr: FIG. 2 and 3 Electrical contacts 30a and 30b as set forth in [0020]), and the first set of wires (Bahr: FIG. 2 Cable 26 as set forth in [0020]) of the interface provides electrical communication between the one or more sensors (Bahr: FIG. 2 Sensor 28 as set forth in [0020]) and the set of electrical contacts of the interface inlet (Bahr: FIG. 2 and 3 A cable 36 is provided to establish an electrical signal transmission path between the sensor 28 and the contacts 30a and 30b).
Jaffe and Bahr are both considered to be analogous to the claimed invention because they are in the same field of gas delivery interfaces forming a flow path to the patient’s airway. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Bahr and include an interface inlet (Bahr: FIG. 2 and 3 Interface 34 of the endotracheal tube 42 as set forth in [0020]-[0021]) comprising a set of electrical contacts (Bahr: FIG. 2 and 3 Electrical contacts 30a and 30b as set forth in [0020]), and the first set of wires (Bahr: FIG. 2 Cable 26 as set forth in [0020]) of the interface provides electrical communication between the one or more sensors (Bahr: FIG. 2 Sensor 28 as set forth in [0020]) and the set of electrical contacts of the interface inlet (Bahr: FIG. 2 and 3 A cable 36 is provided to establish an electrical signal transmission path between the sensor 28 and the contacts 30a and 30b). Doing so would enable a signal path between the sensor and a processing or control device of a ventilator/gas supply device to control its operation based on sensor data (Bahr: As set forth in [0023]-[0024]).
Jaffe as modified fails to explicitly disclose, wherein the one or more sensors are removably mounted.
However, Bowditch teaches, wherein a sensor is removably mounted (The sensors, that can communicate to the controller via a wired connection, may be removed and replaced on a new set of headgear, mask, straps, scaffold, etc. as set forth in [0026]-[0037] and[0129]).
Jaffe and Bowditch are both considered to be analogous to the claimed invention because they are in the same field of patient interfaces forming a flow path to the patient’s airway and utilize sensors for patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Jaffe to incorporate the teaching of Bowditch and include an wherein a sensor is removably mounted (The sensors, that can communicate to the controller via a wired connection, may be removed and replaced on a new set of headgear, mask, straps, scaffold, etc. as set forth in [0026]-[0037] and[0129]). Doing so would allow for the sensors to be attached to an alternate part of the device that is already intended to be reused and would also allow for the patient interface to be cleaned and/or replaced periodically (Bowditch: As set forth in [0026] and [0129]).
Regarding claim 36, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe further discloses the nasal cannula interface, wherein the at least one prong is configured to be received in one or more nares of the patient (FIG. 41 Nostril interface 18 is configured to be inserted into an associated nostril of a patient as set forth in [100]) in an unsealed manner (FIG. 41 Stabilizers 22 are sized to work in tandem with fluid paths 14, 15 to hold the nostril interfaces 18, 21 in a substantially stable position as set forth in [109], indicating the absence of a seal to hold the nostril interface in a stable position).
Regarding claim 40, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe further discloses the nasal cannula interface, wherein at least one of the one or more sensors is a patient sensor, and the at least one parameter is a physiological parameter of the patient (FIG. 41 sensor 442 is a photoplethysmographic sensor as set forth in [231]).
Regarding claim 42, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe further discloses the nasal cannula interface, wherein at least one of the one or more sensors is a reflectance-type pulse oximeter (FIG. 41 Sensor 442 is a photoplethysmographic sensors which is used to measure blood oxygen levels SpO2 and effort and is a reflectance-type sensor as set forth in [229]).
Regarding claim 45, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe further discloses the nasal cannula interface, wherein the body of the nasal cannula further comprises a pair of side arms (FIG. 41 Flexible stabilizers 22 as set forth in [109]).
Jaffe fails to explicitly disclose the nasal cannula interface, further comprising a head securement assembly comprising one or more straps, wherein the body of the nasal cannula further comprises a pair of side arms configured to be connected to the head securement assembly in reference to the embodiment of FIG. 41.
However, Jaffe does teach the nasal cannula interface, further comprising a head securement assembly comprising one or more straps (FIG. 7 A first strap 52 connected to first stabilizer 50 at the distal end of first stabilizer, and a second strap connected to second stabilizer 51 at the distal end thereof as set forth in [124]), wherein the pair of side arms are configured to be connected to the head securement assembly (FIG. 7 Strap 52 is configured to extend from first stabilizer 50 and at least partially around the ear of the patient to hold body portion 32 in a stable or fixed position relative to the patient's nose as set forth in [124]-[125]), in reference to FIG. 7.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of FIG. 41 of Jaffe to incorporate the teaching of FIG. 7 and include a head securement assembly comprising one or more straps (FIG. 7 A first strap 52 connected to first stabilizer 50 at the distal end of first stabilizer, and a second strap connected to second stabilizer 51 at the distal end thereof as set forth in [124]), wherein the pair of side arms are configured to be connected to the head securement assembly (FIG. 7 Strap 52 is configured to extend from first stabilizer 50 and at least partially around the ear of the patient to hold body portion 32 in a stable or fixed position relative to the patient's nose as set forth in [124]-[125]). Doing so would provide a securement method to hold the cannula in a stable or fixed position relative to the patient's nose (As set forth in [125]).
Regarding claim 50, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe further discloses the nasal cannula interface, further comprising a sensor arm (FIG. 41 Arm portion of sensor 442 as shown in the annotated figure below), wherein the one or more sensors are located on the sensor arm (FIG. 41 Sensing portion of sensor 442 containing the emitter 452 and detector 454 as shown in the annotated figure below and set forth in [234]).
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Claims 49 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claims 35 and 50, in further view of Parshionikar (US 20190324551 A1).
Regarding claim 49, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the one or more sensors are moveable relative to the body of the nasal cannula interface.
However, Parshionikar teaches wherein a sensor is moveable relative to the body of the device (Parshionikar: FIG. 3 Sensor 204 adjustable to sensor arm 204’ as set forth in [0055]).
Jaffe and Parshionikar are both considered to be analogous to the claimed invention because they are in the same field of sensors to contact the skin of a user in order to obtain data relative to the state of the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Parshionikar and include wherein the sensor is moveable relative to the body of the device (Parshionikar: FIG. 3 Sensor 204 adjustable to sensor arm 204’ as set forth in [0055]). Doing so would enable the user to adjust the arm to any area so that the skin stays against or stays within optimal distance range from the sensor arm (Parshionikar: As set forth in [0055]).
Regarding claim 52, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is resiliently deformable.
However, Parshionikar teaches wherein a sensor arm is resiliently deformable (Parshionikar: Shown by 204 adjustably bent to be positioned as 204’ as set forth in [0055] and is shown to be deformable by the dotted line indicating arm 204’, where the end of the sensor arm 204 is moveable to engage correctly with the user, and the base of the arm is fixed in a position on the housing 202).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Parshionikar and include wherein the sensor arm is resiliently deformable such that it can be easily bent by a user (Parshionikar: Shown by 204 adjustably bent to be positioned as 204’ as set forth in [0055] and is shown to be deformable by the dotted line indicating arm 204’, where the end of the sensor arm 204 is moveable to engage correctly with the user, and the base of the arm is fixed in a position on the housing 202). Doing so would enable the user to adjust the arm to any area so that the skin stays against or stays within optimal distance range from the sensor arm (Parshionikar: As set forth in [0055]).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claim 50, in further view of Abreu (WO 2015054681 A1).
Regarding claim 51, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is rigid.
However, Abreu teaches wherein a sensor arm is rigid (Abreu: FIG. 86B Arm 2004 can be rigid, made of a sheet of metal such as stainless steel or aluminum as set forth in [0777]).
Jaffe and Abreu are both considered to be analogous to the claimed invention because they are in the same field of sensors to contact the skin of a user in order to obtain data relative to the state of the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Abreu and include wherein the sensor arm is rigid such that it cannot be easily bent by a user (Abreu: FIG. 86B Arm 2004 can be rigid, made of a sheet of metal such as stainless steel or aluminum as set forth in [0777]). Doing so would ensure the sensor is held in a stable position , unable to be deformed by the user (Abreu: As set forth in [0777]), an unwanted deformation of the sensor arm would result in unstable sensor readings.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claim 50, in further view of Goff (US 20190142625 A1).
Regarding claim 53, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein a surface of the sensor arm comprises an adhesive such that the surface is capable of adhering to the patient's skin.
However, Goff teaches wherein a surface of the sensor comprises an adhesive such that the surface is capable of adhering to a patient's skin (Goff: FIG. 1-2 Sensor assembly 100 is adhesively attached to a skin surface of the subject as set forth in [0105] and claim 15).
Jaffe and Goff are both considered to be analogous to the claimed invention because they are in the same field of sensors to contact the skin of a user in order to obtain data relative to the state of the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor arm of Jaffe to incorporate the teaching of Goff and include wherein a surface of the sensor comprises an adhesive such that the surface is capable of adhering to the patient's skin (Goff: FIG. 1-2 Sensor assembly 100 is adhesively attached to a skin surface of the subject as set forth in [0105] and claim 15). Doing so would ensure the sensor is well secured to the skin of the user (Goff: As set forth in [0066]).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claim 50, in further view of Abreu (WO 2015054681 A1) and Freestone (WO 2017158476 A2).
Regarding claim 54, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Jaffe as modified fails to explicitly disclose the nasal cannula interface, wherein a length of the sensor arm is adjustable.
However, Abreu teaches wherein a length of the sensor arm is adjustable through an accordion motion (Abreu: FIG. 90B Sensing device 2000 has an adjustably extendable neck portion 2011 such as an accordion portion as set forth in [0920]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Abreu and include wherein a length of the sensor arm is adjustable through an accordion motion (Abreu: FIG. 90B Sensing device 2000 has an adjustably extendable neck portion 2011 such as an accordion portion as set forth in [0920]). Doing so would allow for extending of the arm for positioning a sensor at a designated area (Abreu: As set forth in [0920]).
Jaffe as modified by Abreu discloses the nasal cannula interface, wherein a length of the sensor arm is adjustable through an accordion motion, but fails to explicitly disclose the arm is adjustable through telescopic motion.
However, Freestone teaches using telescopic motion to extend the length of an arm (Freestone: FIG. 112B Mask connector member 9112 can be pulled outward, away from the mask assembly 9104 in a telescopic motion as set forth in [0591]).
Jaffe and Freestone are both considered to be analogous to the claimed invention because they are in the same field of oxygen delivery devices for use in combination with a breathing apparatus. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor arm of Jaffe as modified to incorporate the length adjustment method of Freestone wherein telescopic motion is used to extend the length of an arm (Freestone: FIG. 112B Mask connector member 9112 can be pulled outward, away from the mask assembly 9104 in a telescopic motion as set forth in [0591]). Doing so would provide a known method of extending an element adjustment to a desired position (Freestone: As set forth in [0591]). Additionally, the method of extension of modified Jaffe and the method of extension of Freestone perform an identical function, which is specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. The method of extension of modified Jaffe, method of extension of Freestone and method of sensor arm extension claimed by Applicant are configured to position an element at a desired location. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the elements shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, positioning an arm at a desired location. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Jaffe as modified to obtain the invention as specified in claim 54 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Jaffe as modified.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claim 45, in further view of Burton (WO 0143804 A1) and Abreu (WO 2015054681 A1).
Regarding claim 56, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 45 above.
Jaffe further discloses the nasal cannula interface, further comprising a sensor arm (FIG. 41 Arm portion of sensor 442 as shown in the annotated figure below), wherein the one or more sensors are located on the sensor arm (FIG. 41 Sensing portion of sensor 442 containing the emitter 452 and detector 454 as shown in the annotated figure below and set forth in [234]).
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Jaffe as modified fails to explicitly disclose the nasal cannula interface, wherein the head securement assembly further comprises a sensor connected to one of the straps.
However, Burton teaches wherein the head securement assembly further comprises a sensor connected to one of the straps (Burton: FIG. 4 The straps 35 have sensors 25 as set forth on page 7 paragraph 2).
Jaffe and Burton are both considered to be analogous to the claimed invention because they are in the same field of oxygen delivery devices for use in combination with a breathing apparatus comprising sensors for obtaining patient related parameters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Burton wherein the head securement assembly further comprises a sensor mount connected to one of the straps (Burton: FIG. 4 The straps 35 have sensors 25 as set forth on page 7 paragraph 2). Doing so provides a known location for a sensor in the art of the claimed invention, enabling the sensor to obtain measurements regarding a patient parameter from the skin proximate to the strap (Burton: As set forth on page 7 paragraph 2).
Jaffe as modified by Burton fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is connected to the securement assembly via a sensor mount connected to one of the straps, wherein the sensor arm projects from the sensor mount.
However, Abreu teaches wherein the sensor arm (Abreu: FIG. 90J Arm 2454 as set forth in [0928]) is connected to the securement assembly via a sensor mount (Abreu: FIG. 90J Body 2452 as set forth in [0928]) connected to one of the straps (Abreu: FIG. 90J Headband 2456 as set forth in [0928]), wherein the sensor arm projects from the sensor mount (Abreu: FIG. 90J Shows Arm 2454 extending from Body 2452 as set forth in [0928]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Abreu wherein the sensor arm (Abreu: FIG. 90J Arm 2454 as set forth in [0928]) is connected to the securement assembly via a sensor mount (Abreu: FIG. 90J Body 2452 as set forth in [0928]) connected to one of the straps (Abreu: FIG. 90J Headband 2456 as set forth in [0928]), wherein the sensor arm projects from the sensor mount (Abreu: FIG. 90J Shows Arm 2454 extending from Body 2452 as set forth in [0928]). Doing so would allow the sensor to attach and extend from the strap in order to position the sensor to contact a desired area of the user’s skin (Abreu: As set forth in [0928]).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1), Burton (WO 0143804 A1), and Abreu (WO 2015054681 A1) as applied to claim 56, in further view of Nuovo (US 9592007 B2).
Regarding claim 57, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 56 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor mount is moveably and/or slidably connected to one of the one or more straps.
However, Nuovo teaches wherein the sensor mount (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) is moveably and/or slidably connected to one of the straps (Nuovo: FIG. 17 Band 1712 as set forth in column 17 line 7-25).
Jaffe and Nuovo are both considered to be analogous to the claimed invention because they are in the same field of sensors to contact the skin of a user in order to obtain data relative to the state of the user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor mount of Jaffe as modified to incorporate the teaching of Nuovo and include wherein the sensor mount (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) is moveably and/or slidably connected to one of the straps (Nuovo: FIG. 17 Band 1712 as set forth in column 17 line 7-25). Doing so would aid in accommodating the positioning of the sensor for a given user as desired (Nuovo: As set forth in column 17 line 7-25).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1), Burton (WO 0143804 A1), and Abreu (WO 2015054681 A1) as applied to claim 56, in further view of Szasz (US 20190358473 A1).
Regarding claim 59, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 56 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor mount is removably connected to one of the one or more straps.
However, Szasz teaches wherein a mount is removably connected to one of the straps (Szasz: FIG. 13B The electronic circuit 180 includes a clip 186 that is removably attachable to the inelastic component 156 of the head strap 171 as set forth in [0082]).
Jaffe and Szasz are both considered to be analogous to the claimed invention because they are in the same field of patient interfaces for use in combination with a sensor for obtaining a parameter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor mount of Jaffe to incorporate the teaching of Szasz wherein a mount is removably connected to one of the straps (Szasz: FIG. 13B The electronic circuit 180 includes a clip 186 that is removably attachable to the inelastic component 156 of the head strap 171 as set forth in [0082]). Doing so would enable the device to be used for the desired level of functionality determined by the user. If the user desires not to monitor a specific parameter, the mount may be removed and the user may reattach the mount to the head strap when necessary. Further, the mount could be attached somewhere else on the user, as desired by the user to improve comfort (Szasz: As set forth in [0082]).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1), Burton (WO 0143804 A1), and Abreu (WO 2015054681 A1) as applied to claim 56, in further view of Parshionikar (US 20190324551 A1).
Regarding claim 64, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 56 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is moveable relative to the sensor mount.
However, Parshionikar teaches wherein a sensor arm is moveable relative to a sensor mount (Parshionikar: Shown by 204 adjustably bent to be positioned as 204’ as set forth in [0055] and is shown to be deformable by the dotted line indicating arm 204’, where the end of the sensor arm 204 is moveable to engage correctly with the user, and the base of the arm is fixed in a position on the housing 202, the housing 202 being the sensor arm mount).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Parshionikar and include wherein the sensor arm is moveable relative to the sensor mount (Parshionikar: Shown by 204 adjustably bent to be positioned as 204’ as set forth in [0055] and is shown to be deformable by the dotted line indicating arm 204’, where the end of the sensor arm 204 is moveable to engage correctly with the user, and the base of the arm is fixed in a position on the housing 202, the housing 202 being the sensor arm mount). Doing so would enable the user to adjust the arm to any area so that the skin stays against or stays within optimal distance range from the sensor arm (Parshionikar: As set forth in [0055]).
Claims 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1), Burton (WO 0143804 A1), Abreu (WO 2015054681 A1), and Parshionikar (US 20190324551 A1) as applied to claim 64, in further view of Nuovo (US 9592007 B2).
Regarding claim 66, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 64 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is slidably mounted to the sensor mount so as to be able to slide in a direction parallel to a length of the strap to which the sensor mount is connected.
However, Nuovo teaches wherein a sensor is slidably mounted (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) to the sensor mount (Nuovo: FIG. 17 Track of band 1712 as set forth in column 17 line 7-25) so as to be able to slide in a direction parallel to a length of the strap to which the sensor mount is connected (Nuovo: As shown in the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor arm of Jaffe as modified to incorporate the teaching of Nuovo wherein the sensor is slidably mounted (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) to the sensor mount (Nuovo: FIG. 17 Track of band 1712 as set forth in column 17 line 7-25) so as to be able to slide in a direction parallel to a length of the strap to which the sensor mount is connected (Nuovo: As shown in the annotated figure). Doing so would aid in accommodating the positioning of the sensor for a given user as desired (Nuovo: As set forth in column 17 line 7-25).
Regarding claim 67, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 64 above.
Jaffe fails to explicitly disclose the nasal cannula interface, wherein the sensor arm is slidably mounted to the sensor mount so as to be able to slide in a direction relative of the strap which the sensor mount is connected to.
However, Nuovo teaches wherein a sensor arm is slidably mounted (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) to the sensor mount (Nuovo: FIG. 17 Track of band 1712 as set forth in column 17 line 7-25) so as to be able to slide in a direction relative of the strap which the sensor mount is connected to (Nuovo: As set forth in column 17 line 7-25).
Jaffe as modified by Nuovo fails to explicitly disclose wherein the direction relative of the strap is a transverse direction relative to a length of the strap.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor arm of Jaffe as modified to incorporate the slidable nature of the sensor of Nuovo wherein the sensor arm is slidably mounted (Nuovo: FIG. 17 Sensor slide 1796 accommodating sensor module 16 of FIG. 1 as set forth in column 17 line 7-25) to the sensor mount (Nuovo: FIG. 17 Track of band 1712 as set forth in column 17 line 7-25) so as to be able to slide in a direction relative of the strap which the sensor mount is connected to (Nuovo: As set forth in column 17 line 7-25) in a transverse direction as well. Doing so would aid in accommodating the positioning of the sensor for a given user as desired (Nuovo: As set forth in column 17 line 7-25), the track/mount of the sensor functioning in the same way, just being oriented in a configuration that allows for adjustment in the transverse direction relative of the strap.
Regarding claim 68, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 64 above.
Jaffe as modified by Parshionikar further teaches the nasal cannula interface, wherein the sensor arm is configured to rotate about an axis at which it connects to the sensor mount (Parshionikar: Shown by 204 adjustably bent to be positioned as 204’ as set forth in [0055] and is shown to be deformable by the dotted line indicating arm 204’, where the end of the sensor arm 204 is moveable to engage correctly with the user, and the base of the arm is fixed in a position on the housing 202; The sensor arm capable of rotating about an axis as shown in the annotated figure below).
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Claims 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (WO 2008019294 A2) in view of Bahr (US 20010017134 A1) and Bowditch (US 20150367092 A1) as applied to claim 35, in further view of Klenner (US 20160030696 A1).
Regarding claim 79, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe is silent as to the details regarding how the set of wires are hardwired into the gases inlet conduit and fails to explicitly disclose wherein at least a portion of the first set of wires of the nasal cannula interface are embedded into at least a portion of the gases inlet conduit.
However, Klenner teaches wherein at least a portion of the first set of wires of the nasal cannula interface are embedded into at least a portion of the body of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 can be embedded into the wall of the supply tube 3102 external of a supply passage of the supply tube 3012 as set forth in [0567]).
Jaffe and Klenner are both considered to be analogous to the claimed invention because they are in the same field of patient interfaces for use in combination with a sensor for obtaining a parameter, comprising wires for communication from the sensor. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Klenner wherein at least a portion of the first set of wires of the nasal cannula interface are embedded into at least a portion of the body of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 can be embedded into the wall of the supply tube 3102 external of a supply passage of the supply tube 3012 as set forth in [0567]). Doing so provides a known method for incorporating a wire into a conduit for allowing signal transfer between device elements (Klenner: As set forth in [0567]).
Regarding claim 80, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe is silent as to the details regarding how the set of wires are hardwired into the gases inlet conduit and fails to explicitly disclose wherein at least a portion of the first set of wires of the nasal cannula interface are located on an outer surface of at least a portion of the gases inlet conduit.
However, Klenner teaches wherein at least a portion of the first set of wires of the nasal cannula interface are located on an outer surface of at least a portion of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 may be a malleable spiral wound wire or strip wound around the circumference of the supply tube 3102 as set forth in [0567]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Klenner wherein at least a portion of the first set of wires of the nasal cannula interface are located on an outer surface of at least a portion of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 may be a malleable spiral wound wire or strip wound around the circumference of the supply tube 3102 as set forth in [0567]). Doing so provides a known method for incorporating a wire into a conduit for allowing signal transfer between device elements as well as provide the tube with additional structure (Klenner: As set forth in [0567]).
Regarding claim 81, Jaffe as modified discloses the claimed invention substantially as claimed as set forth for claim 35 above.
Jaffe is silent as to the details regarding how the set of wires are hardwired into the gases inlet conduit and fails to explicitly disclose wherein at least a portion of the first set of wires of the nasal cannula interface are located on an inner surface of at least a portion of the gases inlet conduit.
However, Klenner teaches wherein at least a portion of the first set of wires of the nasal cannula interface are located on an inner surface of at least a portion of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 can be provided within the supply passage or bore of the supply tube 3102 as set forth in [0567]; the wire contacting the inner surface of tube as shown in the figure).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jaffe to incorporate the teaching of Klenner wherein at least a portion of the first set of wires of the nasal cannula interface are located on an inner surface of at least a portion of the gases inlet conduit (Klenner: FIG. 31A The wire or strip 3150 can be provided within the supply passage or bore of the supply tube 3102 as set forth in [0567]; the wire contacting the inner surface of tube as shown in the figure). Doing so provides a known method for incorporating a wire into a conduit for allowing signal transfer between device elements (Klenner: As set forth in [0567]).
Response to Arguments
The rejections under 35 U.S.C. 112(b) regarding claims 49 and 51-52 have been withdrawn
based on Applicant’s amendments.
New grounds of rejection have been made above to address the amendments to claims 35, 40, 49, 51-53, 56-57, 59, and 66-67.
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., wherein the one or more sensors are removably mounted) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection have been made above to address the amendment to claim 35.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785