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 12/19/25. 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 § 112
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.
Claims 1 and 3-20 are 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.
Claim 1 recites “wherein inflation of the cuff may be adjusted based on detecting the leak of air to maintain blood flow in the tracheal wall” however the phrasing is confusing. If the cuff is adjusted based on a detected leak, then an increase in pressure would not be what maintains the blood flow. The one or more sensors detecting pressure and changes in blood flow could be relied upon to maintain blood flow such that the pressure is not too great on the tracheal walls, as applicant describes in paragraph 4. Claims 8 and 14 recite “adjusting the inflation of the endotracheal tube cuff based on detecting the leak of air to maintain blood flow in the tracheal wall,” which is similar language and introduces the same questions.
Any remaining claims are rejected as being dependent on a rejected claim.
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 14 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]), 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], and the one or more sensors are operable to measure changes in blood flow in the tracheal wall ([0058] and fig. 9 shows multiple sensors), but is silent regarding that the one or more sensors detect 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 sealing cuff with the addition of one or more sensors that detect 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 based on detecting the leak of air. However, in fig. 13 Grashow teaches inflation of a cuff may be adjusted based on detecting the leak of air [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 inflation adjustment due to a detected leak, as taught by Grashow, for the purpose of preventing leakage. The modified Morgan discloses that inflation of the cuff may be adjusted based on detecting the leak of air ([0064] Grashow) to maintain blood flow in the tracheal wall ([0020] Morgan).
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, changes in blood flow in a tracheal wall of the patient’s trachea ([0058] and fig. 9 shows multiple sensors); but does not explicitly recite detecting, via the one or more sensors, 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 sealing cuff with the addition of one or more sensors that detect 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 based on detecting the leak of air. However, in fig. 13 Grashow teaches inflation of a cuff may be adjusted based on detecting the leak of air [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 inflation adjustment due to a detected leak, as taught by Grashow, for the purpose of preventing leakage. The modified Morgan discloses adjusting the inflation of the endotracheal tube cuff based on detecting the leak of air ([0064] Grashow) to maintain blood flow in the tracheal wall ([0020] Morgan).
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 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 ([0058] and fig. 9 shows multiple sensors); but is silent regarding that the one or more sensors detect 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 sealing cuff with the addition of one or more pressure sensors that detect 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 based on detecting the leak of air. However, in fig. 13 Grashow teaches inflation of a cuff may be adjusted based on detecting the leak of air [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 inflation adjustment due to a detected leak, as taught by Grashow, for the purpose of preventing leakage. The modified Morgan discloses adjusting the inflation of the endotracheal tube cuff based on detecting the leak of air ([0064] Grashow) to maintain blood flow in the tracheal wall ([0020] Morgan).
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 12/19/25 have been fully considered but they are not persuasive.
Applicant argues on page 2 that none of Morgan, Fu and Grashow teach sensors that can detect both cuff pressure and changes in blood flow.
Examiner disagrees since Morgan discloses one or more sensors operable to measure pressure between the endotracheal tube cuff and a tracheal wall of a patient [0027][0070], and that the one or more sensors are operable to measure changes in blood flow in the tracheal wall ([0058] and fig. 9 shows multiple sensors).
Applicant argues on page 2 that Morgan does not teach sensors that both detect leaks and measure cuff pressure to maintain blood flow in the tracheal wall, as recited in amended claim 1.
Examiner disagrees since 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] and in fig. 13 Grashow teaches inflation of a cuff may be adjusted based on detecting the leak of air [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 Morgan’s sealing cuff with the addition of one or more sensors that detect a leak of air and inflation adjustment due to a detected leak, as taught by Fu and Grashow, for the purpose of preventing leakage. The modified Morgan discloses that the one or more sensors both detect leaks ([0165-0168] Fu) and measure cuff pressure ([0027][0070] Morgan) to maintain blood flow in the tracheal wall ([0020] Morgan).
Conclusion
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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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785