DETAILED ACTION
This office action is in response to the amendment filed 10/8/2025. As directed by the amendment, claims 14-22 and 24 have been amended, claims 1-13 and 23 have been cancelled, and claim 27 has been newly added. Thus, claims 14-22 and 24-27 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/8/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 14-18 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaner et al (2011/0030694) in view of Goodyear (3,731,692).
Regarding claim 22, Schaner in figs 1-6 teaches a medico-surgical tube including a shaft (4) (shaft of endotracheal tube) and an expansible member (5) (airway occlusion cuff) on the outside of the shaft (4) adapted to make contact with the surface of a body cavity within which the tube is inserted (para [0025]), wherein the tube includes a plurality of sensor means (6) (sensor (6) can include a plurality (array) of sensing elements (10)) (para [0027]) on and disposed on the expansible (5) member such that the plurality of sensor means (6) are responsive to contact between the expansible member (5) and the wall of the body cavity (sensor (6) is disposed in surface of expandible member (5) to generate changes in voltage proportional to pressures applied to them) (para [0039]).
Schaner does not disclose the plurality of sensor means are on and disposed around the expansible member only at a part of the expandible member that has the largest circumference when inflated.
However, Goodyear teaches an endotracheal tube including a shaft (11) (tube) (col 3, ln 39-43) and an expandible member (20) (extending wall portion), wherein the expandible member (20) has the shape of a right cylinder terminating in flat end walls (19, 21) (col 4, ln 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the expandible member of Schaner by forming the expandible member in the shape of a right cylinder in order to provide a cuff that allows a desired sealing engagement at lower pressure and prevents inflation beyond its normal shape (Goodyear, col 2, ln 33-51). The now-modified Schaner’s device is considered so that the plurality of sensor means are on and disposed around the expansible member only at a part of the expandible member that has the largest circumference when inflated because the sensors (6 of Schaner) as shown in fig 4 are disposed on and around the expansible member, and the expandible member (20 of Goodyear) is in the shape of a right cylinder (col 4, ln 6-12), and therefore, because the expandible member is cylindrical, the entire cylindrical surface would have the largest circumference on the surface of the expandible member, and sensors disposed on and around the expandible member of the cuff would be disposed on a part of the expandible member that has the largest circumference.
Regarding claim 14, Schaner discloses that the plurality of sensor means (6) includes a plurality of pressure sensors responsive to pressure between the expansible member and the wall of the body cavity (as shown in fig 4, sensor means can comprise a plurality of electrodes (10) configured to detect a pressure between the expansible member and the wall of the body cavity) (para [0026]).
Regarding claim 15, Schaner discloses the plurality of sensor means includes electrical contacts (10) (plurality of electrodes) around the expansible member (5) (fig 4, para [0026])
Regarding claim 16, Schaner discloses the electrical contacts (10) are arranged to sense an electrical property at the contacts (10) caused by contact with the body tissue (converts pressure differences into electrical signals) (para [0027]).
Regarding claim 17, Schaner discloses the electrical contacts (10) are arranged to detect electrical properties between different contacts around the expansible member (5) caused by contact with body tissue (signal processing unit (8) can process signal from each electrical contact (10), and transfer each signal or a processed version of the signal to a display (8) where it can be converted into a visualization including color wavelength and/or intensity (para [0028]).
Regarding claim 18, Schaner discloses the plurality of sensor means (6) include temperature sensors to determine the temperature around the cuff (5) (sensor comprises a material that can change its electrical properties in response to a change in temperature (para [0007]), and as the sensor means (6) are disposed on the cuff, would be configured to determine a temperature around the cuff (5)).
Regarding claim 20, Schaner discloses the expansible member (5) is an inflatable cuff (airway occlusion cuff is a circumferential tube that surrounds the lumen of the endotracheal tube) (para [0025])
Regarding claim 21, Schaner discloses tube (4) is an endotracheal tube (para [0025]).
Regarding claim 27, the modified Schaner’s references discloses a largest circumference is an annular region of the expansible member adapted to contact the wall of the body cavity (the expandible member (20 of Goodyear) has the shape of a right cylinder terminating in flat end walls, and the outer surface of an annular region of the cylinder would be the portion of the cuff with the largest circumference) (Goodyear, col 4, ln 6-12); with the plurality of sensor means (6 of Schaner) along the annular region (as shown in fig 4 of Schaner, sensors (6 of Schaner) (shown as an array of electrodes (10 of Schaner) are disposed about an outer circumference of the cuff, and because the cuff is cylindrical, would be disposed on an annular region of the expansible member on the largest circumference and adapted to contact the wall of the body cavity) (Schaner, fig 4, para [0026]), wherein each sensor (6 of Schaner) are adapted to indicate a poor seal between the expansible member (5 of Schaner) and the wall of the body cavity to provide warning of potential leakage between the expansible member (5 of Schaner) and the wall of the of the body cavity (Schaner in figs 5-6 of Schaner a display, and when an external pressure is applied to the expandible element (5 of Schaner) and sensed by the at least one sensor means (6 of Schaner), pressure or mechanical change is communicated to a controller (signal processing unit), and the pressure or mechanical change is displayed on the display (para [0008]), and therefore each of Schaner’s sensor means (6) are adapted to indicate a poor seal between the expansible member and the wall of the body cavity to provide warning of potential leakage between the expansible member and the wall of the of the body cavity, as an indication of low or zero pressure of any of the pressure sensors (6) would provide an indication of a poor seal between the expansible member and the wall of the body cavity.
Claims 19 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaner et al and Goodyear as applied to claim 22 above, and further in view of Wood et al (2010/0312132).
Regarding claim 19, modified Schaner discloses that the plurality of sensors are disposed on the outer surface of the cuff (5) (Schaner, para [0027]), and in figs 5-6 of Schaner discloses a display, and when an external pressure is applied to the expandible element (5) and sensed by the at least one sensor means, pressure or mechanical change is communicated to a controller (signal processing unit), and the pressure or mechanical change is displayed on a display (para [0008]) and monitored pressure can be used to provide an indication to adjust the volume in the expandible member (5) to provide an optimal pressure to a patient) (para [0035]), or determine if the tube has been dislodged or changed position (para [0033]), and therefore modified Schaner’s display is operable as a leakage indicator unit to detect regions of incomplete contact between the expansible member and wall of the body cavity and thereby provide an indication of potential leakage as a low or zero pressure shown in Schaner’s display would indicate regions of incomplete contact between the expansible member and wall of the body cavity and thereby provide an indication of potential leakage.
Modified Schaner does not disclose the plurality of sensors are RFID tags adapted to be interrogated by a reader unit.
However, Wood in figs 1-3 teaches an arrangement including a pressure transducer (16) wherein the pressure transducer (16) is an RFID tag (pressure transducer (16) includes RFID circuit) adapted to be interrogated remotely by a reader unit (30) (monitor) (RFID circuit of pressure transducer (16) may be read wirelessly to convey pressure monitoring information to the monitor (30)) (para [0034])).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to substitute the pressure sensor means of modified Schaner to be an RFID pressure sensor tag adapted to be interrogated remotely by a reader unit as taught by Wood in order to allow the pressure sensor means to wireless convey the pressure monitoring information to a monitoring unit (Wood, para [0034]).
Regarding claim 25, modified Schaner discloses that the plurality of sensors are disposed on the outer surface of the cuff (5) (Schaner, para [0027]).
Modified Schaner does not disclose the plurality of sensors are RFID tags adapted to be interrogated remotely by a reader unit.
However, Wood in figs 1-3 teaches an arrangement including a pressure transducer (16) wherein the pressure transducer (16) is an RFID tag (pressure transducer (16) includes RFID circuit) adapted to be interrogated remotely by a reader unit (30) (monitor) (RFID circuit of pressure transducer (16) may be read wirelessly to convey pressure monitoring information to the monitor (30)) (para [0034])).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to substitute the pressure sensor means of modified Schaner to be an RFID pressure sensor tag adapted to be interrogated remotely by a reader unit as taught by Wood in order to allow the pressure sensor means to wireless convey the pressure monitoring information to a monitoring unit (Wood, para [0034]).
Claim 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaner et al and Goodyear as applied to claim 22 above, and further in view of Wood et al (2010/0312132) and Hayter (2007/0270672).
Regarding claim 24, modified Schaner discloses that the plurality of sensors (6 of Schaner) can be configured to send wireless signals by an RF wireless connection and the plurality of sensors (6 of Schaner) are disposed on the outer surface of the cuff (5) (Schaner, para [0027]).
Modified Schaner does not disclose the plurality of sensors are RFID tags.
However, Wood in figs 1-3 teaches an arrangement including a pressure transducer (16) wherein the pressure transducer (16) is an RFID tag (pressure transducer (16) includes RFID circuit that may be read wirelessly to convey pressure monitoring information to the monitor (30) (para [0034])).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the sensor means of modified Schaner to be an RFID tag as taught by Wood in order to allow the sensor means to wireless convey the pressure monitoring information to the leakage indicator unit (Wood, para [0034]).
The now-modified Schaner’s device discloses the plurality of sensors are RFID tags (Wood, para [0034]) and are disposed on the outside of the cuff (Schaner, para [0027]). The limitation “printed on the outside of the cuff” is considered to be a product be process limitation. Product by process limitations are not limited to the manipulations of the recited steps, only the structure implied by the steps. In this case, Schaner discloses the plurality of sensors (6) are disposed on the outside of the cuff (5) (Schaner, para [0027]) and Wood discloses that the sensors are RFID tags (Wood, para [0034]), and therefore, the teaching of a plurality of RFID tags disposed on the outside of the cuff is considered to be a product that has the structure implied by the process step of printing the RFID tag on the outside of the cuff.
In the alternative, although modified Schaner is silent as to the process to form the RFID tags onto the surface of the cuff, Hayter teaches a sensor system, and in fig 1 teaches an RFID tag (10), wherein the RFID tag is formed from a screen printing process (para [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Schaner so that the RFID tags are printed onto the surface of the cuff (for example, by a screen process) as taught by Hayter, as the use of a screen printing process to form an RFID tag onto a substrate is known in the art, and it appears that the RFID tag of modified Schaner would perform equally well if the RFID tag were formed onto the cuff by a printing process. See MPEP 2143(I)(A).
Claim 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaner et al and Goodyear as applied to claim 22 above, and further in view of Mickle et al.
Regarding claim 26, modified Schaner a plurality of sensors.
Modified Schaner does not disclose the plurality of sensor means are electrically connected to a common RFID tag attached to the shaft, the RFID tag adapted to be interrogated remotely by a reader unit.
However, Mickle in fig 1 teaches a device for monitoring an object of interest (12) on a patient, wherein the device includes a plurality of sensors (16, 18, 20), wherein the sensors (16, 18, 20 are connected to a common remote station (4) via wires (16, 18, 20) (para [0052]), and as shown in fig 3, wherein the remote station (4) is operable as a common RFID tag, as it includes an antenna (100) to receive RF transmissions and includes a converter (102) to convert RF energy into DC power (para [0061]), wherein the common remote station (4) is adapted to be interrogated by a reader unit (2) (base station) to derive the output from the sensors (16, 18, 20) in arrow (30) (para [0052]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the plurality of sensor means of modified Schaner by providing a common RFID tag connected to the sensors, wherein the leakage indicator unit is arranged to interrogate the RFID tag and derive the output from the plurality of sensor means as taught by Mickle, in order to provide a remote station operable as an RFID tag to allow the remote station to energize the plurality of sensor means and wirelessly transmit the sensor data (Mickle, para [0052]). The now-modified Schaner’s RFID tag is considered to be attached to the shaft, as the shaft (4 of Schaner) is connected to the expandible member (5 of Schaner) with the sensor means (6 of Schaner) connected to the expandible member (5 of Schaner) (Schaner, fig 4, para [0026]), and the sensor means (16, 18, 20 of Mickle) are connected to the RFID tag (4 of Mickle) via wires (24, 26, 28) (Mickle, para [0052]), and therefore, the RFID tag is attached to the shaft at least indirectly via the intervening structures discussed above.
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argues on page 5, fifth full paragraph- page 7, second full paragraph of applicant’s remarks, that Morgan does not disclose that the plurality of sensor means on and around the expansible member only at a part of the expandible member that has the largest circumference when inflated, as Morgan’s sensors are only formed longitudinally along the expansible member, with sensors offset from the largest circumference of the expansible, and Goodyear merely shows a tracheal tube having a cuff that is cylindrical when inflated. However, applicant’s argument is moot in view of the new grounds of rejection in view of Schaner, which in fig 4 shows a plurality of sensor means (6) (sensor (6) can include a plurality (array) of sensing elements (10)) (para [0027]) on and disposed on the expansible member (5), and although fig 4 of Schaner shows the sensor means (6) disposed on a curved cuff with some sensors not disposed at the expandible member that has the largest circumference; Goodyear teaches an endotracheal tube including an expandible member (20) (extending wall portion), wherein the expandible member (20) has the shape of a right cylinder terminating in flat end walls (19, 21) (col 4, ln 6-12). Therefore, because the expandible member of the modified Schaner’s device is cylindrical, the entire cylindrical surface would have the largest circumference on the surface of the expandible member, and sensors disposed on and around the expandible member of the cuff would be disposed on a part of the expandible member that has the largest circumference. Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS YOUNG SUL whose telephone number is (571)270-5260. The examiner can normally be reached on Monday-Friday 8:30 am-5 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-48354835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785