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 .
Amendment
This office action is responsive to the amendment filed on 5/27/26. As directed by the amendment: claims 1, 8 and 14 have been amended, claim 2 has been canceled, and no new claims have been added. Thus, claims 1 and 3-20 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 1, 4-5, 7-9, 12-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan et al. (2017/0340216) in view of Fu et al. (2017/0361045) and Grashow (2016/0184538).
Regarding claim 1, in fig. 11 Morgan discloses an endotracheal tube cuff 1100 comprising: a first layer 1103; a second layer 1105 surrounding the first layer (Fig. 11 [0080-0081]), one or more sensors are in a space between the first and second layers (Fig. 11 [0027][0080-0081] paragraph 80 describes that a pressure sensor and additionally an optical sensor for measuring blood flow may be positioned between the first and second cuffs), wherein the one or more sensors are operable to measure pressure between the endotracheal tube cuff and a tracheal wall of a patient [0027][0070][0080], and the one or more sensors are operable to measure changes in blood flow in the tracheal wall (optical blood flow sensor 22 [0058][0080] and fig. 9 shows multiple sensors), but is silent regarding that the one or more sensors detect, based on the measured pressure between the endotracheal tube cuff and the tracheal wall, a leak of air around the endotracheal tube cuff. However, Fu teaches one or more pressure sensors that detects a leak of air around a seal of a face mask [0165-0168], which alerts a user to tighten the mask seal [0220]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morgan’s pressure sensor with a pressure sensor that detects a leak of air, as taught by Fu, for the purpose of detecting a leak. The modified Morgan is silent regarding the inflation of the cuff may be adjusted in real time to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow in the tracheal wall. However, in fig. 13 Grashow teaches inflation of a cuff may be adjusted in real time (automatic adjustments made based on sensor data indicating a leak or over-tightness [0064]) to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow (the automatic adjustments are made to reduce a detected leak, while at the same time preventing over-tightness, which corresponds to occlusion of blood flow based on sensor readings [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s leak detecting with the addition of automatic inflation adjustment due to a detected leak while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow, as taught by Grashow, for the purpose of preventing leakage and occlusion of blood flow.
Regarding claim 4, the modified Morgan discloses that the one or more sensors are not fixed to the first or second layer (when the sensor is on the surface of the first layer then it is not fixed to the other layer, Fig. 11 [0080-0081] Morgan).
Regarding claim 5, the modified Morgan discloses that the one or more sensors is a piezoelectric sensor ([0061] Fu), a force sensitive resistor, or a force sensitive capacitor.
Regarding claim 7, the modified Morgan discloses that the patient is a neonate ([0089] neonatologists are able to protect their patients, neonates, and thus the patient in this invention may be a neonate, Morgan).
Regarding claim 8, in fig. 11 Morgan discloses placing an endotracheal tube cuff (1103, 1105) inside the patient's trachea (abstract), wherein the endotracheal tube cuff comprises a first layer 1103, a second layer 1105, and one or more sensors 1101 in a space between the first and second layers; inflating the endotracheal tube cuff [0055]; detecting, via the one or more sensors (Fig. 11 [0027][0080-0081] paragraph 80 describes that a pressure sensor and additionally an optical sensor for measuring blood flow may be positioned between the first and second cuffs), changes in blood flow in a tracheal wall of the patient’s trachea (optical blood flow sensor 22 [0058][0080] and fig. 9 shows multiple sensors); but does not explicitly recite detecting, via the one or more sensors, based on a measured pressure between the endotracheal tube cuff and a tracheal wall of the patient a leak of air around the endotracheal tube cuff. However, Fu teaches one or more sensors that detects a leak of air around a seal of a face mask [0165-0168], which alerts a user to tighten the mask seal [0220]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morgan’s pressure sensor with a pressure sensor that detects a leak of air, as taught by Fu, for the purpose of detecting a leak. The modified Morgan is silent regarding adjusting the inflation of the endotracheal tube cuff in real time to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow in the tracheal wall. However, in fig. 13 Grashow teaches adjusting the inflation of the cuff in real time (automatic adjustments made based on sensor data indicating a leak or over-tightness [0064]) to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow (the automatic adjustments are made to reduce a detected leak, while at the same time preventing over-tightness, which corresponds to occlusion of blood flow based on sensor readings [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s leak detecting with the addition of automatic inflation adjustment due to a detected leak while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow, as taught by Grashow, for the purpose of preventing leakage and occlusion of blood flow.
Regarding claim 9, the modified Morgan discloses that the one or more sensors is a piezoelectric sensor ([0061] Fu), a force sensitive resistor, a force sensitive capacitor, or a strain gauge sensor.
Regarding claim 12, the modified Morgan discloses that the one or more sensors are not fixed to the first or second layer (when the sensor is on the surface of the first layer then it is not fixed to the other layer, Fig. 11 [0080-0081] Morgan).
Regarding claim 13, the modified Morgan discloses that the patient is a neonate ([0089] neonatologists are able to protect their patients, neonates, and thus the patient in this invention may be a neonate, Morgan).
Regarding claim 14, in fig. 11 Morgan discloses a method of preventing ischemia in a patient [0069][0028], the method comprising: placing an endotracheal tube cuff (1103, 1005) inside the patient's trachea (abstract), wherein the endotracheal tube cuff comprises a first layer 1103, a second layer 1005, and one or more sensors (1101, Fig. 11 [0027][0080-0081] paragraph 80 describes that a pressure sensor and additionally an optical sensor for measuring blood flow may be positioned between the first and second cuffs) in a space between the first and second layers (Fig. 11); inflating the endotracheal tube cuff [0028]; measuring, via the one or more sensors, a pressure that the endotracheal tube cuff is exerting on a tracheal wall of the patient’s trachea [0027-0028]; and measuring, via the one or more sensors, changes in blood flow in the tracheal wall (optical blood flow sensor 22 [0058][0080] and fig. 9 shows multiple sensors); but is silent regarding detecting, based on the measured pressure between the endotracheal tube cuff and the tracheal wall, a leak of air around the endotracheal tube cuff. However, Fu teaches one or more pressure sensors that detects a leak of air around a seal of a face mask [0165-0168], which alerts a user to tighten the mask seal [0220]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morgan’s pressure sensor with a pressure sensor that detects a leak of air, as taught by Fu, for the purpose of detecting a leak. The modified Morgan is silent regarding adjusting the inflation of the endotracheal tube cuff in real time to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow in the tracheal wall. However, in fig. 13 Grashow teaches adjusting the inflation of the cuff in real time (automatic adjustments made based on sensor data indicating a leak or over-tightness [0064]) to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow (the automatic adjustments are made to reduce a detected leak, while at the same time preventing over-tightness, which corresponds to occlusion of blood flow based on sensor readings [0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s leak detecting with the addition of automatic inflation adjustment due to a detected leak while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow, as taught by Grashow, for the purpose of preventing leakage and occlusion of blood flow.
Regarding claim 15, the modified Morgan discloses measuring and/or calculating one or more additional physiologic parameters selected from blood flow (abstract Morgan), blood pressure, cardiac output, and/or heart rate.
Regarding claim 16, the modified Morgan discloses that the one or more sensors is a piezoelectric sensor ([0061] Fu), a force sensitive resistor, a force sensitive capacitor, or a strain gauge sensor.
Regarding claim 19, the modified Morgan discloses that the one or more sensors are not fixed to the first or second layer (when the sensor is on the surface of the first layer then it is not fixed to the other layer, Fig. 11 [0080-0081] Morgan).
Regarding claim 20, the modified Morgan discloses that the patient is a neonate ([0089] neonatologists are able to protect their patients, neonates, and thus the patient in this invention may be a neonate, Morgan).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 1 above, in further view of Tupper et al. (2021/0402120).
Regarding claim 3, the modified Morgan discloses that the space between the first and second layers is filled with a gas or liquid ([0055] Morgan), but is silent regarding that the gas or liquid is air or a saline solution. However, Tupper teaches inflating a balloon cuff with air or saline [0018]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s gas or liquid with air or saline, as taught by Tupper, for the purpose of providing an alternate liquid or gas having the predictable results of inflating an endotracheal tube balloon cuff.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 5 above, in further view of Tyler et al. (2008/0009772).
Regarding claim 6, the modified Morgan is silent regarding that the piezoelectric sensor comprises a force sensitive resistor polymer. However, Tyler teaches a force sensitive resistor polymer [0252]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s piezoelectric sensor with a force sensitive resistor polymer, as taught by Tyler, for the purpose of providing an alternate force sensitive resistor having the predictable results of determining contact between the cuff and the user’s body.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 9 above, in further view of Tyler et al. (2008/0009772).
Regarding claim 10, the modified Morgan is silent regarding that the piezoelectric sensor comprises a force sensitive resistor polymer. However, Tyler teaches a force sensitive resistor polymer [0252]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s piezoelectric sensor with a force sensitive resistor polymer, as taught by Tyler, for the purpose of providing an alternate force sensitive resistor having the predictable results of determining contact between the cuff and the user’s body.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 8 above, in further view of Tupper et al. (2021/0402120).
Regarding claim 11, the modified Morgan discloses that the space between the first and second layers is filled with a gas or liquid ([0055] Morgan), but is silent regarding that the gas or liquid is air or a saline solution. However, Tupper teaches inflating a balloon cuff with air or saline [0018]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s gas or liquid with air or saline, as taught by Tupper, for the purpose of providing an alternate liquid or gas having the predictable results of inflating an endotracheal tube balloon cuff.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 16 above, in further view of Tyler et al. (2008/0009772).
Regarding claim 17, the modified Morgan is silent regarding that the piezoelectric sensor comprises a force sensitive resistor polymer. However, Tyler teaches a force sensitive resistor polymer [0252]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Morgan’s piezoelectric sensor with a force sensitive resistor polymer, as taught by Tyler, for the purpose of providing an alternate force sensitive resistor having the predictable results of determining contact between the cuff and the user’s body.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, Fu and Grashow, as applied to claim 14 above, in further view of Tupper et al. (2021/0402120).
Regarding claim 18, the modified Morgan discloses that the space between the first and second layers is filled with a gas or liquid [0055], but is silent regarding that the gas or liquid is air or a saline solution. However, Tupper teaches inflating a balloon cuff with air or saline [0018]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morgan’s gas or liquid with air or saline, as taught by Tupper, for the purpose of providing an alternate liquid or gas having the predictable results of inflating an endotracheal tube balloon cuff.
Response to Arguments
Applicant's arguments filed 5/27/26 have been fully considered but they are not persuasive. Applicant argues on page 3 that Grashow is silent as to monitoring blood flow.
This argument is not taken well since Morgan already discloses monitoring blood flow and Grashow teaches inflation of a cuff may be adjusted in real time (automatic adjustments made based on sensor data indicating a leak or over-tightness [0064]) to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow (the automatic adjustments are made to reduce a detected leak, while at the same time preventing over-tightness, which corresponds to occlusion of blood flow based on sensor readings [0064]).
Applicant argues on page 3 that Fu only discusses predicting blood flow in the context of a skin oximeter, not sensors that can detect both cuff pressure and changes in blood flow, as recited in amended claim 1.
This argument is not taken well since Morgan discloses one or more sensors operable to measure pressure between the endotracheal tube cuff and a tracheal wall of a patient (Fig. 11 [0027][0080-0081] paragraph 80 describes that a pressure sensor and additionally an optical sensor for measuring blood flow may be positioned between the first and second cuffs), and that the one or more sensors are operable to measure changes in blood flow in the tracheal wall (optical blood flow sensor 22 [0058][0080] and fig. 9 shows multiple sensors).
Applicant argues on page 3 that Morgan does not teach sensors that both detect leaks and measure cuff pressure concurrently in real time to maintain blood flow in the tracheal wall, as recited in amended claim 1.
This argument is not taken well since Morgan discloses one or more sensors operable to measure pressure between the endotracheal tube cuff and a tracheal wall of a patient (Fig. 11 [0027][0080-0081] paragraph 80 describes that a pressure sensor and additionally an optical sensor for measuring blood flow may be positioned between the first and second cuffs), and that the one or more sensors are operable to measure changes in blood flow in the tracheal wall (optical blood flow sensor 22 [0058][0080] and fig. 9 shows multiple sensors). Morgan also discusses adjusting the inflation for patients based on the blood flow and pressure measurements during use [0013] to maintain blood flow in the tracheal wall [0013][0068]. Fu is applied to teach one or more pressure sensors that detect a leak of air around a seal of a face mask [0165-0168] and Grashow teaches inflation of a cuff may be adjusted in real time (automatic adjustments made based on sensor data indicating a leak or over-tightness [0064]) to reduce a detected leak of air while maintaining pressure of the cuff below a threshold corresponding to occlusion of blood flow (the automatic adjustments are made to reduce a detected leak, while at the same time preventing over-tightness, which corresponds to occlusion of blood flow based on sensor readings [0064]). Although examiner disagrees that the applied reference do not teach concurrently real time monitoring of pressure and blood flow, it is noted that the claimed language only requires adjustment in real time, rather than monitoring in real time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 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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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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