DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the amendment filed on December 11, 2025. As directed by the amendment: claims 1-6, 9-14, and 16-18 have been amended, claims 7-8 and 15 have been cancelled, and claims 19-21 have been added. Thus, claims 1-6, 9-14, and 16-21 are presently pending in this application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 13-14 and 16-18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the limitation “the flexible ear cuff is configured to simultaneously facilitate monitoring of blood oxygen levels of the patient and delivery of oxygen to the patient” in lines 4-6 is unclear if the flexible ear cuff is able to monitor blood oxygen levels and delivery of oxygen to the patient or if a pulse oximeter earlobe clamp is used to monitor blood oxygen as suggested in the specification (see specification paragraph [0019]). In the case the flexible ear cuff is intended to be used, it is unclear what structure is being used to monitor blood oxygen levels and delivery of oxygen to the patient.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claim(s) 1-4, 6, 9-11, and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh (US 2011/0203595) in view of Narkiss et al. (US 2019/0076100), Raulerson (US 2005/0038453), Leonard et al. (US 2021/0283357) and Jaffe et al. (US 2008/0190436).
Regarding claim 1, Hashemieh discloses a device (fig. 1, nasal cannula 11) comprising: a flexible ear cuff with a first and a second end (fig. 2, annular sleeve 15 has a first end near the earlobe and a second end near the top of the ear) configured to receive an oxygen tube (fig. 1, annular ear sleeves 14 and 15 surround cannula tubing 12), wherein the flexible ear cuff is configured to nestle between a pinna of an ear and a head of the patient ([0017] states that sleeves 14 and 15 surround the cannula tubing 12 behind the patient’s ears which increase the cross section of the tubing for more secure fitment).
Hashemieh is silent on a pulse oximeter at a first end of the flexible ear cuff, the flexible ear cuff is configured to simultaneously facilitate monitoring of blood oxygen levels of a patient and delivery of oxygen to the patient, a proximity sensor configured to surround the oxygen tube at or near the second end, detect a displacement of the oxygen tube, and issue an alert upon the detection of the displacement of the oxygen tube.
However, Narkiss teaches of a system that senses a displacement of a medical device from an operational point on a subject that uses a position sensing unit (fig. 8B, 830) which has a position sensor ([0027]) that can be a proximity sensor ([0028]) which can be attached to a medical device via a clip ([0032]). This issues an alert (fig. 1, via a signal from the proximity sensor sent to signal processing circuit 150 and subsequently alert system 142) when the device moves ([0007]) and turn off these alerts when the movement is intended indicated by a displacement from a desired point is above a threshold value ([0008]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the nasal cannula device of Hashemieh with the position sensing unit, signal processing circuit, and alert system as taught by Narkiss (Narkiss fig. 8B, position sensor unit 830, fig. 1, signal processing circuit 150 and alert system 142) for the purpose of indicating when the medical device is removed or moved from its intended location (Narkiss fig. 8B, 830 is mounted on a side section or a face section of the cannula, [0074]) to ensure the accuracy of the measured physiological parameters that can identify medical problems (Narkiss [0005]).
The modified device of Hashemieh further discloses the proximity sensor (Narkiss fig. 8B, position sensor unit 830) is releasably attached to the cannula (Narkiss [0008]; [0074] discloses the releasable attachment of sensor unit 830 to cannula 810) near a second end of the flexible ear cuff (Narkiss fig. 8B, position sensing unit 830 is located near a face section 840 of the cannula, which is close to the top of the ear, and Hashemieh fig. 2, annular sleeve 15 ends near the top of the ear which is defined as a second end), but does not expressly disclose the proximity sensor surrounds the oxygen tube.
However, Raulerson teaches of a conduit retaining clip (fig. 3, clip 100) which can attach to a tube via a first and second connector portions (fig. 3, 110 and 120) which are connected via a hinge (fig. 3, 106, [0018] states the type of hinge provided is not critical to the operation of the clip).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the clip attached to the proximity sensor of the modified device of Hashemieh with the conduit retaining clip as taught by Raulerson as a simple substitution of known elements to obtain a predictable result of allowing the proximity sensor (Narkiss fig. 8B, 830) to be securable onto a tube.
Regarding pulse oximeter at a first end of the flexible ear cuff and the flexible ear cuff is configured to simultaneously facilitate monitoring of blood oxygen levels of a patient and delivery of oxygen to the patient, Leonard teaches of a respiratory therapy unit that further includes a pulse oximeter (fig. 12, 1287) that can clip onto a fingertip or earlobe ([0167]) to allow pulse measurement and generate various alarm condition signals regarding blood oxygen ([0167]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Hashemieh with the pulse oximeter as taught by Leonard so that a pulse can be measured and an alert can be provided to a caregiver if an alarm condition regarding blood oxygen concentration is detected ([0167]).
The modified device of Hashemieh would appear to have the pulse oximeter at a first end of the flexible ear cuff because this is where the user’s ear lobe would be located relative to the first end of the ear cuff (see annotated Hashemieh fig. 2 below), but does not expressly disclose the pulse oximeter being at the first end of the flexible ear cuff.
However, Jaffe teaches of a patient interface with a tubing (fig. 23, 220) with a spring clip (fig. 23, 234) that clamps to the ear of the patient so that the patient’s ear may support tubing (fig. 23, 222) more directly ([0188]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to connect the pulse oximeter of the modified device of Hashemieh to the tubing so that it may be used as a clip as taught by Jaffe for the purpose of providing increased support for the oxygen tubing thereby limiting movement ([0188]).
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Regarding claim 2, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on the pulse oximeter (Leonard fig. 12, pulse oximeter 1287 can clip onto a fingertip or earlobe, see [0167]) with an earlobe clamp (Jaffe fig. 23, spring clip 234 is clipped onto the earlobe of the patient) at the first end of the flexible ear cuff (see annotated Hashemieh fig. 2 above, the earlobe is located at a first end of annular sleeve 15 thereby the earlobe clamp is also located at the first end).
Regarding claim 3, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on the proximity sensor has two pieces (Raulerson fig. 3, first connector portion 110 and second connector portion 120) connected by a hinge (Raulerson fig. 3, hinge 106), and
Wherein the two pieces are configured to close surrounding the oxygen tube (Raulerson fig. 3, clip 100 retains conduit 140) and secure the proximity sensor to the oxygen tube (Narkiss [0074] states that the positions sensor unit can be mounted onto the cannula).
Regarding claim 4, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on the flexible ear cuff is configured to slide over an oxygen tube (Hashemieh [0018] states that the sleeves can include a backside cut line so that they can be easily mounted onto the tubing).
Regarding claim 6, Hashemieh discloses a system for attaching an oxygen tube to a patient, the system comprising: a flexible ear cuff (fig. 1, annular sleeves 14 and 15) wherein the flexible ear cuff is configured to nestle between a pinna of an ear of the patient and a head of the patient ([0017] states that sleeves 14 and 15 surround the cannula tubing 12 behind the patient’s ears which increase the cross section of the tubing for more secure fitment). Hashemieh is silent on the flexible ear cuff configured to facilitate monitoring of blood oxygen levels of the patient and delivery of oxygen to the patient, a pulse oximeter with an earlobe clamp at a first end of the flexible ear cuff, the oxygen tube at a second end of the flexible ear cuff, and a proximity sensor configured to surround the oxygen tube at or near the second end, detect a displacement of the oxygen tube, and issue an alert upon the detection of the displacement of the oxygen tube based on a change in distance between the proximity sensor and the patient.
However, Narkiss teaches of a system that senses a displacement of a medical device from an operational point on a subject that uses a position sensing unit (fig. 8B, 830) which has a position sensor ([0027]) that can be a proximity sensor ([0028]) which can be attached to a medical device via a clip ([0032]). This allows the medical device to trigger an alert (fig. 1, via a signal sent to signal processing circuit 150 and subsequently alert system 142) when the device moves ([0007]) and turn off these alerts when the movement is intended indicated by a displacement from a desired point is above a threshold value ([0008]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the nasal cannula device of Hashemieh with the position sensing unit, signal processing circuit, and alert system as taught by Narkiss (Narkiss fig. 8B, position sensor unit 830, fig. 1, signal processing circuit 150 and alert system 142) for the purpose of indicating when the medical device is removed or moved from its intended location (Narkiss fig. 8B, 830 is mounted on a side section or a face section of the cannula, [0074]) to ensure the accuracy of the measured physiological parameters that can identify medical problems (Narkiss [0005]).
The modified device of Hashemieh further discloses the proximity sensor (Narkiss fig. 8B, position sensor unit 830) is releasably attached to the cannula (Narkiss [0008]) near a second end of the flexible ear cuff (Narkiss fig. 8B, position sensing unit 830 is located near a face section 840 of the cannula, which is close to the top of the ear, and Hashemieh fig. 2, annular sleeve 15 ends near the top of the ear which is defined as a second end), but does not expressly disclose the proximity sensor surrounds the oxygen tube.
However, Raulerson teaches of a conduit retaining clip (fig. 3, clip 100) which can attach to a tube via a first and second connector portions (fig. 3, 110 and 120) which are connected via a hinge (fig. 3, 106, [0018] states the type of hinge provided is not critical to the operation of the clip).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the clip attached to the proximity sensor of the modified device of Hashemieh with the conduit retaining clip as taught by Raulerson as a simple substitution of known elements to obtain a predictable result of allowing the proximity sensor (Narkiss fig. 8B, 830) to be securable onto a tube.
Regarding pulse oximeter at a first end of the flexible ear cuff and the flexible ear cuff is configured to simultaneously facilitate monitoring of blood oxygen levels of a patient and delivery of oxygen to the patient, Leonard teaches of a respiratory therapy unit that further includes a pulse oximeter (fig. 12, 1287) that can clip onto a fingertip or earlobe ([0167]) to allow pulse measurement and generate various alarm condition signals regarding blood oxygen ([0167]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Hashemieh with the pulse oximeter as taught by Leonard so that a pulse can be measured and an alert can be provided to a caregiver if an alarm condition regarding blood oxygen concentration is detected ([0167]).
The modified device of Hashemieh appears to have the pulse oximeter at a first end of the flexible ear cuff (see annotated Hashemieh fig. 2 below), but does not expressly disclose the pulse oximeter being at the first end of the flexible ear cuff.
However, Jaffe teaches of a patient interface with a tubing (fig. 23, 220) with a spring clip (fig. 23, 234) that clamps to the ear of the patient so that the patient’s ear may support tubing (fig. 23, 222) more directly ([0188]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to connect the pulse oximeter of the modified device of Hashemieh to the tubing so that it may be used as a clip as taught by Jaffe for the purpose of providing increased support for the oxygen tubing thereby limiting movement ([0188]).
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Regarding claim 9, the modified system of Hashemieh reads on the limitations of claim 6 and further reads on the proximity sensor is configured to issue an alert when the distance between the patient’s skin (Narkiss [0009] defined as the medically operational point on a subject) and the proximity sensor breaches a threshold (Narkiss [0008] states that an alert is delivered when the position sensing unit is displaced from a medically operational point, meaning that an alert is not delivered when the position sensing unit is in the medically operational point which is proximal to the skin of the patient, see Narkiss fig. 8B, position sensing unit 830 is on a face section 840 of the cannula).
Regarding claim 10, the modified system of Hashemieh reads on the limitations of claim 6 and further reads on the proximity sensor has two pieces (Raulerson fig. 3, first connector portion 110 and second connector portion 120) connected by a hinge (Raulerson fig. 3, hinge 106), and
Wherein the two pieces are configured to close surrounding the oxygen tube (Raulerson fig. 3, clip 100 retains conduit 140) and secure the proximity sensor to the oxygen tube (Narkiss [0074] states that the positions sensor unit can be mounted onto the cannula).
Regarding claim 11, the modified system of Hashemieh reads on the limitations of claim 6 and further reads on the flexible ear cuff is configured to slide over an oxygen tube (Hashemieh [0018] states that the sleeves can include a backside cut line so that they can be easily mounted onto the tubing).
Regarding claim 19, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on the displacement of the oxygen tube is determined based on a change in distance between the proximity sensor (Narkiss fig. 8B, position sensor unit 830 is shown on a face section 840 of cannula 810) and the patient (Narkiss [0008] states that the position sensing unit senses a displacement of a device from a medically operational point on a subject, meaning that the position sensor unit 830 can detect if a distance increases between the sensor and the patient due to the medically operational point being on a face section).
Regarding claim 20, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on a wireless communication interface (Narkiss fig. 1, alert system 142) configured to transmit the alert to a user (Narkiss [0005] states that alerts are delivered to medical staff to ensure operation is accurate) when the displacement exceeds a threshold (Narkiss [0008] states that an alert is delivered within a threshold of displacement, the lower value can be interpreted as a threshold above which an alert is delivered).
Regarding claim 21, the modified device of Hashemieh reads on the limitations of claim 1 and further reads on the oxygen tube is secured to the patient (Hashemieh fig. 2, nostril sleeve 13, annular sleeve 15, and retaining strap 19 all help secure tubing 12 to the patient) such that the proximity sensor (Narkiss fig. 8B, position sensor unit 830) is within a threshold proximity to skin of the patient (Narkiss [0008] states that an alert is delivered when the position sensing unit is displaced from a medically operational point, meaning that an alert is not delivered when the position sensing unit is in the medically operational point which is proximal to the skin of the patient, see Narkiss fig. 8B, position sensing unit 830 is on a face section 840 of the cannula).
8. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh in view of Narkiss, Raulerson, Leonard, and Jaffe as applied to claim 1 above, and further in view of Cortez, JR. et al. (US 2018/0001045).
Regarding claim 5, the modified device of Hashemieh reads on the limitations of claim 2 and further reads on the sleeves are comprised of a soft, elastic material (Hashemieh [0018]), but is silent on the elastic material being silicone.
However, Cortez JR teaches of a cannula device fastening mechanism (fig. 13, 1303) with over-ear connectors (fig. 13, 1397 and 1398) that can be made of silicone ([0083]) so as to reduce movement of the over ear connectors on the skin ([0083]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the material of the sleeves of the modified device of Hashemieh with silicone as taught by Cortez JR to reduce the movement of the portion contacting the ears (Cortez JR [0083]).
9. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh in view of Narkiss, Raulerson, Leonard, and Jaffe as applied to claim 6 above, and further in view of Cortez, JR.
Regarding claim 12, the modified device of Hashemieh reads on the limitations of claim 6 and further reads on the sleeves are comprised of a soft, elastic material (Hashemieh [0018]), but is silent on the elastic material being silicone.
However, Cortez JR teaches of a cannula device fastening mechanism (fig. 13, 1303) with over-ear connectors (fig. 13, 1397 and 1398) that can be made of silicone ([0083]) so as to reduce movement of the over ear connectors on the skin ([0083]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the material of the sleeves of the modified device of Hashemieh with silicone as taught by Cortez JR to reduce the movement of the portion contacting the ears (Cortez JR [0083]).
10. Claim(s) 13, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh in view of Narkiss and Leonard.
Regarding claim 13, Hashemieh discloses a method comprising: attaching a flexible ear cuff over an oxygen tube ([0018] states that the sleeves can include a backside cut line so that they can be easily mounted onto the tubing), wherein the flexible ear cuff is configured to nestle between a pinna of an ear of a patient and a head of the patient ([0017] states that sleeves 14 and 15 surround the cannula tubing 12 behind the patient’s ears which increase the cross section of the tubing for more secure fitment). Hashemieh is silent on the flexible ear cuff being configured to simultaneously facilitate monitoring of blood oxygen levels of the patient and delivery of oxygen to the patient, and attaching a proximity sensor to the oxygen tube, to detect a displacement of the oxygen tube and issue an alert upon the detection of the displacement of the oxygen tube.
However, Narkiss teaches of a method that senses a displacement of a medical device from an operational point on a subject that uses a position sensing unit (fig. 8B, 830) which has a position sensor ([0027]) that can be a proximity sensor ([0028]) which can be attached to a medical device via a clip ([0032]). This allows the medical device to trigger an alert (fig. 1, via a signal sent to signal processing circuit 150 and subsequently alert system 142) when the device moves ([0007]) and turn off these alerts when the movement is intended indicated by a displacement from a desired point is above a threshold value ([0008]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Hashemieh with the position sensing and alerting steps as taught by Narkiss (Narkiss fig. 8B, position sensor unit 830, fig. 1, signal processing circuit 150 and alert system 142) for the purpose of indicating when the medical device is removed or moved from its intended location (Narkiss fig. 8B, 830 is mounted on a side section or a face section of the cannula, [0074]) to ensure the accuracy of the measured physiological parameters that can identify medical problems (Narkiss [0005]).
Regarding the monitoring of blood oxygen levels of the patient and delivery of oxygen to the patient, Leonard teaches of a method for detecting respiratory therapy issues using a pulse oximeter (fig. 12, 1287) that can clip onto a fingertip or earlobe ([0167]) to allow pulse measurement and generate various alarm condition signals regarding blood oxygen ([0167]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified method of Hashemieh with the monitoring and alerting steps using a pulse oximeter as taught by Leonard so that a pulse can be measured and an alert can be provided to a caregiver if an alarm condition regarding blood oxygen concentration is detected ([0167]).
Regarding claim 16, the modified method of Hashemieh reads on the limitations of claim 13 and further reads on the proximity sensor is configured to issue an alert when the distance between the patient’s skin (Narkiss [0009] defined as the medically operational point on a subject) and the proximity sensor breaches a threshold (Narkiss [0008] states that an alert is delivered when the position sensing unit is displaced from a medically operational point, meaning that an alert is not delivered when the position sensing unit is in the medically operational point which is proximal to the skin of the patient, see Narkiss fig. 8B, position sensing unit 830 is on a face section 840 of the cannula).
Regarding claim 18, the modified method of Hashemieh reads on the limitations of claim 13 and further reads on the flexible ear cuff is configured to slide over the oxygen tube (Hashemieh [0018] states that the sleeves can include a backside cut line so that they can be easily mounted onto the tubing).
11. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh in view of Narkiss and Leonard as applied to claim 13 above, and further in view of Jaffe.
Regarding claim 14, the modified method of Hashemieh reads on the limitations of claim 13 and further reads on the use of a pulse oximeter (Leonard [0167] states a pulse oximeter can measure blood oxygen to detect issues a generate alarm conditions) and further states that the pulse oximeter can clip onto an earlobe (Leonard [0167]), but does not expressly disclose that the pulse oximeter is located at a first end of the flexible ear cuff using an earlobe clamp.
However, Jaffe teaches of a patient interface with a tubing (fig. 23, 220) with a spring clip (fig. 23, 234) that clamps to the ear of the patient so that the patient’s ear may support tubing (fig. 23, 222) more directly ([0188]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to connect the pulse oximeter of the modified device of Hashemieh to the tubing so that it may be used as a clip as taught by Jaffe for the purpose of providing increased support for the oxygen tubing thereby limiting movement ([0188]).
12. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hashemieh in view of Narkiss and Leonard as applied to claim 13 above, and further in view of Raulerson.
Regarding claim 17, the modified method of Hashemieh reads on the limitations of claim 13 and further reads on the proximity sensor being attachable to the cannula using various connectors (Narkiss [0074]), but does not expressly disclose that the proximity sensor has two pieces connected by a hinge that are configured to close surrounding the oxygen tube.
However, Raulerson teaches of a conduit retaining clip (fig. 3, clip 100) which can attach to a tube via a first and second connector portions (fig. 3, 110 and 120) which are connected via a hinge (fig. 3, 106, [0018] states the type of hinge provided is not critical to the operation of the clip).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the clip attached to the proximity sensor of the modified method of Hashemieh with the conduit retaining clip as taught by Raulerson as a simple substitution of known elements to obtain a predictable result of allowing the proximity sensor (Narkiss fig. 8B, 830) to be securable onto a tube.
Response to Arguments
13. Applicant’s arguments with respect to claim(s) 1-6, 9-14, and 16-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
14. Applicant’s arguments, see Remarks pages 9-11, filed December 11, 2025, with respect to the rejection of independent claims 1, 6, and 13 and dependent claims under 103 have been fully considered but they are not persuasive.
In response to applicant’s arguments that none of the references define the structural and functional relationship between the first and second ends of the flexible ear cuff where the first end is configured to receive a pulse oximeter and the proximity sensor is at or near a second end: Narkiss teaches of a position sensing unit (Narkiss fig. 8B, 830) that is positioned on a face section of the cannula (Narkiss fig. 8B, 840) which can be considered near a second end of the flexible ear cuff (see annotated Hashemieh fig. 2 below, annular sleeve 15 where the second end is defined as the section of the annular sleeve on top of the ear) similar to the embodiments shown in the drawings of the application (application drawings fig. 3B and 3C). Further, Leonard teaches of a pulse oximeter that can be an ear clamp (Leonard [0167]), which can be considered as being near a first end of the flexible ear cuff (see annotated Hashemieh fig. 2 below, annular sleeve 15 where the first end is defined as the section of the annular sleeve near the earlobe of the patient), especially when in view of Jaffe which uses an earlobe clamp to support the tubing (Jaffe [0188]).
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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., “Narkiss’s position sensor cooperates with a separate ‘sensing facilitating means’ and outputs a signal to a medical system’s processor to enable or disable alerts, rather than directly issuing the alerts upon detecting displacement of the oxygen tube” is interpreted to mean that the proximity sensor of Narkiss is able to directly issue alerts) 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). Further, the present invention appears to also issue alerts through paired devices (see specification paragraph [0025]).
Conclusion
15. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nutter (US 5,025,805)discloses a nasal cannula cuff that slides onto the nasal cannula axially.
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785