DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
This office action is responsive to the amendment filed 8/5/2025. As directed, claim 1 has been amended. Thus claims 1-15 are currently pending.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-3, 6, 7, 9, 10, 13-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Singh (2010/0163023) in view of Denton (5,885,248).
Regarding claim 1, Singh discloses a method for ventilating an individual, the method comprising: inserting a ventilation device (300) within a natural respiratory opening (mouth) of the individual by advancing a working end (distal) of the ventilation device within a body passageway ([0041] lines 1-5), where the working end includes a distal opening (304b) fluidly coupled to a first lumen (305b) and a medial opening (304a) fluidly coupled to a second lumen (305a).
Singh discloses determining which lumen is the ventilation lumen from the first or second lumen by taking into account the difference in structures of the trachea and the esophagus ([0057] lines 6-14, [0059] lines 1-15) and discloses detecting strain measurements with a pressure sensor to determine forces ([0061] last 6 lines) but does not specifically disclose drawing suction through the distal opening using a suction mechanism and maintaining the suction for a period of time; assessing whether the distal opening is sealed by measuring strain on the suction mechanism after a pre-determined time to determine a ventilation lumen; determining a ventilation lumen from one of the first lumen or second lumen by ceasing suction and selecting the first lumen as the ventilation lumen when the tissue of the body passageway does not seal the first/distal opening within the period of time; and maintaining suction and selecting the second lumen as the ventilation lumen when the tissue of the body passageway seals the first/distal opening within the period of time; and ventilating the patient through the ventilation lumen. However, Denton discloses a method (col. 2 lines 8-25) including drawing suction through the distal opening (col. 10 lines 20-30, col. 11 lines 35-50) using a suction mechanism (volume changing device 14 with antechamber 128 and sensor 130 as suction mechanism) and maintaining the suction for a period of time (col. 8 lines 5-20, col. 12 lines 20-30); assessing whether the distal opening is sealed by measuring strain (i.e. col. 7 lines 22-35 discloses the pressure transducer includes a Whetstone bridge which thereby measures strain) on the suction mechanism after a pre-determined time (fig. 7 and col. 7 lines 65-67 through col. 8 lines 1-30 disclose after a predetermined time determined by the flow restrictor, it is determined whether the distal end is sealed is based on negative pressure measurements and the corresponding pressure curve); determining a ventilation lumen from whether the working end is located in the trachea or esophagus by determining whether tissue of the body passageway seals or doesn’t seal the first opening (col. 2 lines 9-25, col. 8 lines 5-20) and selecting the first lumen as the ventilation lumen when tissue does not seal and ceasing suction (i.e. suction is ceased after the determination so as to begin ventilation; col. 2 lines 9-25, col. 8 lines 5-20); and maintaining suction and selecting the second lumen (i.e. tracheal lumen) as the ventilation lumen when the tissue of the body passageway seals the distal opening within the period of time (col. 18 lines 14-25 discloses maintaining suction until the esophagus is occluded and after determination the esophagus is included, moving the ventilate through the proper tracheal lumen) and ventilating the patient through the ventilation lumen (col. 18 lines 1-25). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify or supplement the method of airway identification and cuff pressure checking as taught by Singh with the negative pressure method of airway identification as taught by Denton to provide more efficient airway identification and simultaneous ventilation in emergency situations as disclosed by Denton in col. 18 lines 1-30.
Regarding claim 2, Singh teaches monitoring a fluid parameter (i.e. pressure) to indicate movement of the wall against the working end (col. 2 lines 9-25, col. 8 lines 5-20).
Regarding claim 3, Singh discloses adjusting a ventilation parameter to improve ventilation of the individual where the ventilation parameter comprises a ventilation volume or pressure ((0088] lines 15-25 disclose adjusting the pressure or volume by turning the ventilator on or off in accordance with the ventilation needs of a patient to improve ventilation).
Regarding claims 6 and 7 Singh teaches deploying a balloon anchor (310) coupled to the distal end to temporarily secure the ventilation device in the body passageway ((0047] lines 1-10) and the modified Singh discloses upon detecting collapse of the body passageway maintaining sufficient suction for a period of time which is able to anchor the ventilation device (col. 18 lines 20-30 of Denton disclose that after occlusion is determined, the bulb continues to attempt to expand for a period of time until a user removes it. In addition, the modified Singh include the suction device such that the device of the modified Singh would be able to perform the claimed method).
Regarding claims 9 and 10, Singh teaches that the body passageway comprises either a trachea (315) or an esophagus (320) of the individual and where selecting the first lumen (305b) comprises selecting the first lumen (305b) if the working portion of the ventilation device is positioned within the trachea ([0041] lines 1-15, [0047] lines 1-10) and selecting the second lumen (305a) if the working portion of the ventilation device is positioned within the esophagus ([0041] lines 1-15, [0047] lines 1-10).
Regarding claim 13, Singh discloses a control unit (880, 890) ([0088]) and the modified Singh discloses (see figs. 2 and 5 of Denton) the ventilation device (90) is in fluid communication with a control unit (10) that is configured for determining the ventilation lumen from one of the first lumen or the second lumen (col. 6 lines 12-30, col. 8 lines 5-30 of Denton).
Regarding claim 14, the modified Singh discloses the control unit (10) includes the suction mechanism (14, 46).
Regarding claim 15, Singh discloses the control unit (880, 890) includes a ventilation mechanism ([0088] last 20 lines disclose the control unit includes a mechanism for controlling a ventilator).
Claim 4 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Singh in view Denton, as applied to claim 1 above, and further in view of Freeman (7,747,319).
Regarding claim 4, Singh discloses use of the device in emergency field settings ([0046 line 5) but does not specifically disclose an indicator signal to identify desired times of chest compression. However, Freeman teaches in figs. 6A and 7B timing ventilating the individual with chest compression using an indicator signal to identify desired times of chest compression (col. 12 lines 5-10) which is able to increase the effectiveness of both compression and ventilation. It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the endotracheal tube of Singh with an AED as taught by Freeman to provide enhanced therapy in emergency situations.
Claim 8 is rejected under 35 U.S.C. 103(a) as being unpatentable over Singh in view of Denton, as applied to claim 1 above, and further in view of Kolobow et al. (7,503,328).
Regarding claim 8, the modified Singh substantially teaches the claimed invention except for coupling a collection member to the first lumen and collecting bodily fluids in the collection member during suctioning. However, Kolobow teaches coupling a collection member (96) to the first lumen and collecting bodily fluids in the collection member during suctioning (col. 5 lines 52-65). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the endotracheal tube of the modified Singh with a secretion collector as taught by Kolobow to provide enhanced ventilation and airway clearance.
Claim 11 is rejected under 35 U.S.C. 103(a) as being unpatentable over Singh in view of Denton, as applied to claim 1 above, and further in view of Don Michael (5,339,808).
Regarding claim 11, Singh teaches esophageal intubation ([0041] lines 1-10) wherein the distance but does not specifically disclose a face mask. However, Don Michael teaches a face mask (170) wherein the distance between the facemask and the distal opening is adjustable (i.e. by bending the tube). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the endotracheal tube of Singh with a mask as taught by Don Michael to provide enhanced ventilation.
Claim 12 is rejected under 35 U.S.C. 103(a) as being unpatentable over Singh in view of Denton, as applied to claim 1 above, and further in view of Fortuna (2004/0020491).
Regarding claim 12, Singh teaches in fig. 3 placement of the tube (300) into a user’s mouth but does not specifically disclose that a proximal portion of the ventilation device further comprises a reinforced section to prevent collapse of the ventilation device in a mouth of the individual. However, Fortuna teaches that a proximal portion of the ventilation device comprises a reinforced section (30) to prevent collapse of the ventilation device in a mouth of the individual ({0060] lines 1-7). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the endotracheal tube of Singh with a reinforcement ring as taught by Fortuna to enhance patency.
Claims 1 and 5 are also rejected under 35 U.S.C. 103(a) as being unpatentable over Voss in view of Denton.
Regarding claim 1, Voss teaches a method for ventilating an individual, the method comprising: inserting a ventilation device (20, 70) within a natural respiratory opening (mouth) of the individual by advancing a working end (214, 708) of the ventilation device within a body passageway of the individual, where the working end (214, 708) includes a distal opening ([0073] last 3 lines) fluidly coupled to a first lumen (702) and a medial opening (713) fluidly coupled to a second lumen (707). Additionally, or alternatively, Voss discloses in [0065] lines 1-10 providing combitubes which inherently include dual lumens having distal and medial openings. However, Voss does not specifically disclose a confirming the locating of the distal end by drawing suction through the distal opening and maintaining the suction for a period of time, determining a ventilation lumen from the second lumen by selecting the second lumen as the ventilation lumen if the tissue of the body passageway seals the first opening; andventilating the patient through the ventilation lumen. However, Denton discloses a method (col. 2 lines 8-25) including drawing suction through the distal opening (col. 10 lines 20-30, col. 11 lines 35-50) using a suction mechanism (volume changing device 14 with antechamber 128 and sensor 130 as suction mechanism) and maintaining the suction for a period of time (col. 8 lines 5-20, col. 12 lines 20-30); assessing whether the distal opening is sealed by measuring strain (i.e. col. 7 lines 22-35 discloses the pressure transducer includes a Whetstone bridge which thereby measures strain) on the suction mechanism after a pre-determined time (fig. 7 and col. 7 lines 65-67 through col. 8 lines 1-30 disclose after a predetermined time determined by the flow restrictor, it is determined whether the distal end is sealed is based on negative pressure measurements and the corresponding pressure curve); determining a ventilation lumen from whether the working end is located in the trachea or esophagus by determining whether tissue of the body passageway seals or doesn’t seal the first opening (col. 2 lines 9-25, col. 8 lines 5-20) and selecting the first lumen as the ventilation lumen when tissue does not seal and ceasing suction (i.e. suction is ceased to after the determination so as to begin ventilation; col. 2 lines 9-25, col. 8 lines 5-20); and maintaining suction and selecting the second lumen (i.e. tracheal lumen) as the ventilation lumen when the tissue of the body passageway seals the distal opening within the period of time (col. 18 lines 14-25 discloses maintaining suction until the esophagus is occluded and after determination the esophagus is included, moving the ventilate through the proper tracheal lumen) and ventilating the patient through the ventilation lumen (col. 18 lines 1-25). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the CPR device and method of Voss with a negative pressure method of airway identification as taught by Denton to provide more efficient airway identification and simultaneous ventilation in emergency situations as disclosed by Denton in col. 18 lines 1-30.
Regarding claim 5, Voss discloses initially ventilating through the second lumen during application of suction through the first lumen ([0014] lines 1-20).
Response to Arguments
Applicant's arguments filed 8/5/2025 have been fully considered but they are not persuasive.
Applicant argues on page 5 last paragraph through page 6 1st paragraph that Denton does not disclose the method of claim 1. Examiner respectfully disagrees as Singh discloses the method including inserting a ventilation device (300) within a natural respiratory opening (mouth) of the individual where the working end includes a distal opening (304b) fluidly coupled to a first lumen (305b) and a medial opening (304a) fluidly coupled to a second lumen (305a). Further, Singh discloses determining which lumen is the ventilation lumen from the first or second lumen by taking into account the difference in structures of the trachea and the esophagus ([0057] lines 6-14, [0059] lines 1-15). Denton is relied on for teaching in fig. 7 that when the tube is in the esophagus (curve 164) negative pressure stays relatively high after the period of time due to the distal end becoming occluded and when the distal end is in the trachea (curve 166) negative pressure decreases after a period of time due to an open airway. Thus during the predetermined time of intubation (i.e. predetermined by the physician), Denton discloses determining a ventilation lumen from whether the working end is located in the trachea or esophagus by determining whether tissue of the body passageway seals or doesn’t seal the first opening (col. 2 lines 9-25, col. 8 lines 5-20) and selecting the first lumen as the ventilation lumen when tissue does not seal and ceasing suction (i.e. suction is ceased to after the determination so as to begin ventilation; col. 2 lines 9-25, col. 8 lines 5-20); and maintaining suction and selecting the second lumen (i.e. tracheal lumen) as the ventilation lumen when the tissue of the body passageway seals the distal opening within the period of time (col. 18 lines 14-25 discloses maintaining suction until the esophagus is occluded and after determination the esophagus is included, moving the ventilate through the proper tracheal lumen). Thus the combination of Singh and Denton teach these limitations as claimed.
Applicant also argues on page 8 2nd paragraph that Denton does not disclose the method of claim 1. Examiner respectfully disagrees as Voss teaches a method for ventilating an individual comprising: inserting a ventilation device (20, 70) within a natural respiratory opening (mouth) of the individual where the working end (214, 708) includes a distal opening ([0073] last 3 lines) fluidly coupled to a first lumen (702) and a medial opening (713) fluidly coupled to a second lumen (707). Additionally, or alternatively, Voss discloses in [0065] lines 1-10 providing combitubes which inherently include dual lumens having distal and medial openings. Denton is relied on for teaching in fig. 7 that when the tube is in the esophagus (curve 164) negative pressure stays relatively high after the period of time due to the distal end becoming occluded and when the distal end is in the trachea (curve 166) negative pressure decreases after a period of time due to an open airway. Thus during the predetermined time of intubation (i.e. predetermined by the physician), Denton discloses determining a ventilation lumen from whether the working end is located in the trachea or esophagus by determining whether tissue of the body passageway seals or doesn’t seal the first opening (col. 2 lines 9-25, col. 8 lines 5-20) and selecting the first lumen as the ventilation lumen when tissue does not seal and ceasing suction (i.e. suction is ceased to after the determination so as to begin ventilation; col. 2 lines 9-25, col. 8 lines 5-20); and maintaining suction and selecting the second lumen (i.e. tracheal lumen) as the ventilation lumen when the tissue of the body passageway seals the distal opening within the period of time (col. 18 lines 14-25 discloses maintaining suction until the esophagus is occluded and after determination the esophagus is included, moving the ventilate through the proper tracheal lumen). Thus the combination of Singh and Denton teach these limitations as claimed.
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 LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LaToya M Louis/ Primary Examiner, Art Unit 3785