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 .
Election/Restrictions
This action is responsive to the election filed 09/10/2026. Applicant has elected group 1 and species I with traverse, reading on claims 1-5 and 10-17.
Applicant asserts that there would not be a serious burden on the examiner to examine all claims/species (see pg 1-2 of election filed 09/10/2026). However, as the groups/species and claims would require a variety of differing text terms in the search it is seen that examination/search of all groups and species does present a burden.
Applicant additionally asserts that as the International Searching Authority did not raise a unity of invention concern, and the ISA has substantial experience with unity of invention determinations the restriction here is improper (see pg 2 of election filed 09/10/2026). However, the USPTO is a different governing body and so long as the requirements are met, the USPTO need not follow the same restrictions or rejection basis as the ISA.
Applicant next asserts that all of the claims share the special technical feature of a monitoring tube having “an open end positioned within the central cavity” (see pg 2 of election filed 09/10/2026). Applicant specifically asserts that the art relied upon in the restriction, Wisniewski (US 2017/0021122 A1), fails to disclose this feature and instead discloses the open end of the monitoring tube being positioned in the interior of the tracheostomy port rather than the central cavity (see pg 2-3 of election filed 09/10/2026). However, it is seen that Wisniewski discloses the monitoring tube being in the central cavity as Wisniewski can be reasonable interpreted to delineate between the central cavity and the tracheostomy port at a point where the monitoring tube is no longer present (see Wisniewski annotated fig 5 below).
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Wisniewski annotated fig 5
Therefore, the examiner maintains the restrictions. Further, the examiner notes that applicant has asserted that all of claims 1-5 and 10-20 are generic to all species (see pg 1 of election filed 09/10/2026). However, it is seen that claims 2-5 and 10-11 fail to read on at least one of species ii and iii and therefore are not generic.
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, 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 1-3, 10-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura (WO 2015107320 A1) in view of Wisniewski (US 2017/0021122 A1).
Regarding claim 1, Nakamura discloses a heat moisture exchanger (HME) system (abstract), for use during a sleep study of a patient (it is seen that the structure of Nakamura is capable of being used during a sleep study of a patient) with a tracheostomy (abstract disclosing tracheal tube and pg 1 par 3 disclosing tracheostomy), the system comprising: a housing assembly (#11 fig 2) defining a central cavity (see Nakamura annotated fig 2 below) and at least one opening (#13/14 fig 2, pg 4 last par “ The housing 11 is open at both ends 13 and 14”), and comprising a tracheostomy port (#17 fig 2, pg 4 last par “The housing 11 includes a female tracheal coupling 17”) configured to couple to a hub of a tracheostomy tube of the patient (hub #5 fig 1, 3 of tracheostomy tube #1 fig 1, see pg 5 par 2 “ into the tracheal coupling 17 and the tracheostomy fitting 5”), wherein the tracheostomy port is in direct fluidic communication with the central cavity (see fig 2); at least one HME filter (#15/16 fig 2, pg 4 last par “both of the HME elements 15 and 16”) positioned within the housing assembly between the at least one opening and the central cavity (see fig 2), wherein the at least one HME filter is configured to absorb heat and moisture of exhalations from the patient in order to warm and humidify inhalations of the patient flowing from the at least one opening through the HME filter to the tracheostomy port (pg 1 par 3 disclosing HME function, pg 4 last par disclosing gas flow through the HME and tracheostomy port when a patient is spontaneously breathing).
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Nakamura annotated fig 2
Nakamura is silent to a monitoring tube extending from outside of the housing assembly into the housing assembly, wherein the monitoring tube comprises an open end positioned within the central cavity, and wherein the monitoring tube is configured to be connected to a respiration monitoring device in order to detect respiration parameters of the patient during the sleep study.
Wisniewski teaches a heat moisture exchanger (HME) system, for use during a sleep study of a patient with a tracheostomy (abstract, it is seen that the structure of Wisniewski is capable of being used during a sleep study of a patient with a tracheostomy), the system comprising: a housing assembly (#10 fig 2-5) defining a central cavity (interior of #46 fig 2-5) and at least one opening (#42 fig 2-5), and comprising a tracheostomy port configured to couple to a hub of a tracheostomy tube of the patient (#46 fig 2-5, par 0025-0026), wherein the tracheostomy port is in direct fluidic communication with the central cavity (see fig 4-5); at least one HME filter (#54 fig 3-5, par 0029) positioned within the housing assembly between the at least one opening and the central cavity (see fig 4-5), wherein the at least one HME filter is configured to absorb heat and moisture of exhalations from the patient in order to warm and humidify inhalations of the patient flowing from the at least one opening through the HME filter to the tracheostomy port (as par 0029 discloses the material as an HME it is seen that the claimed function is performed); and a monitoring tube (#64 fig 3, 5) extending from outside of the housing assembly into the housing assembly, wherein the monitoring tube comprises an open end positioned within the central cavity (end of #64 at point B in fig 5, par 0031), and wherein the monitoring tube is configured to be connected to a respiration monitoring device in order to detect respiration parameters of the patient during the sleep study (par 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a monitoring tube that extends through the HME filters into the central cavity as taught by Wisniewski on the HME system of Nakamura as doing so allows for the gas inhaled/exhaled by the patient to be monitored (Wisniewski par 0031).
Regarding claim 2, modified Nakamura discloses the system of claim 1. Nakamura further discloses the at least one HME filter comprises a first HME filter (#15 fig 2) and a second HME filter (#16 fig 2), wherein the at least one opening comprises a first opening (#13 fig 2) and a second opening (#14 fig 2), wherein the first HME filter is positioned adjacent to the first opening (see fig 2) and the second HME filter is positioned adjacent to the second opening (see fig 2), and wherein the first HME filter and second HME filter are positioned on opposite sides of the central cavity (see fig 2) so that the open end of the monitoring tube is positioned between the first HME filter and the second HME filter (as taught by Wisniewski such that the tube passes through one of the filters to have the open end in the central cavity which is located between the first and second filters).
Regarding claim 3, modified Nakamura discloses the system of claim 2. Modified Nakamura further discloses the housing assembly further comprises a main body (Nakamura: #11 fig 2) defining the central cavity, and an end cap coupled to the main body adjacent to the first HME filter (Wisniewski cap #44 fig 3-5), and wherein the end cap defines a sleeve (Wisniewski: #56 fig 3-5) through which the monitoring tube extends.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an end cap as taught by Wisniewski on the system of Nakamura as doing so allows for the monitoring tube to be secured to the system such that the open end remains in place in the central cavity.
Regarding claim 10, modified Nakamura discloses the system of claim 1. Modified Nakamura further discloses the tracheostomy port defines an axis (Nakamura horizontal axis of fig 2), and wherein the monitoring tube extends away from the housing assembly in a direction approximately perpendicular to the axis of the tracheostomy port (modified Nakamura has the monitoring tube extending through an HME filter into the central cavity thus the monitoring tube extends in a direction generally vertical on the system of Nakamura as shown in fig 2, thus perpendicular to the tracheostomy port axis).
Regarding claim 11, modified Nakamura discloses the system of claim 3. Nakamura further discloses the main body defines a suction port (#20 fig 2, pg 5 par 1 “suction port coupling 20”) and a cap (pg 5 par 1 “Instead of a flap valve a cap or other closure could be used”) removably coupled to the suction port configured to allow for removal of secretions from the central cavity.
Regarding claim 12, modified Nakamura discloses the system of claim 1. Wisniewski further discloses the monitoring tube further comprises at least one connector at an end opposite to the open end within the central cavity, and wherein the connector is configured to connect the monitoring tube to the respiration monitoring device (#26 fig 1, par 0022 discloses gas sampling line 24 connected to gas sampling apparatus 26).
Regarding claim 14, Nakamura discloses a sleep study system (it is seen that the system of Nakamura can be utilized for a sleep study) comprising: a heat moisture exchange (HME) system (abstract) comprising: a housing assembly (#11 fig 2) defining a central cavity (see Nakamura annotated fig 2 below) and at least one opening (#13/14 fig 2, pg 4 last par “ The housing 11 is open at both ends 13 and 14”), and comprising a tracheostomy port (#17 fig 2, pg 4 last par “The housing 11 includes a female tracheal coupling 17”) configured to couple to a hub of a tracheostomy tube of the patient (hub #5 fig 1, 3 of tracheostomy tube #1 fig 1, see pg 5 par 2 “ into the tracheal coupling 17 and the tracheostomy fitting 5”), wherein the tracheostomy port is in direct fluidic communication with the central cavity (see fig 2); at least one HME filter (#15/16 fig 2, pg 4 last par “both of the HME elements 15 and 16”) positioned within the housing assembly between the at least one opening and the central cavity (see fig 2), wherein the at least one HME filter is configured to absorb heat and moisture of exhalations from the patient in order to warm and humidify inhalations of the patient flowing from the at least one opening through the HME filter to the tracheostomy port (pg 1 par 3 disclosing HME function, pg 4 last par disclosing gas flow through the HME and tracheostomy port when a patient is spontaneously breathing).
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Nakamura annotated fig 2
Nakamura is silent to a monitoring tube extending from outside of the housing assembly into the housing assembly, wherein the monitoring tube comprises an open end positioned within the central cavity, and wherein the monitoring tube is configured to be connected to a respiration monitoring device in order to detect respiration parameters of the patient during the sleep study: and at least one respiration monitoring device fluidically coupled to the monitoring tube and configured to monitor respiration of the patient.
Wisniewski teaches a system comprising: a housing assembly (#10 fig 2-5) defining a central cavity (interior of #46 fig 2-5) and at least one opening (#42 fig 2-5), and comprising a tracheostomy port configured to couple to a hub of a tracheostomy tube of the patient (#46 fig 2-5, par 0025-0026), wherein the tracheostomy port is in direct fluidic communication with the central cavity (see fig 4-5); at least one HME filter (#54 fig 3-5, par 0029) positioned within the housing assembly between the at least one opening and the central cavity (see fig 4-5), wherein the at least one HME filter is configured to absorb heat and moisture of exhalations from the patient in order to warm and humidify inhalations of the patient flowing from the at least one opening through the HME filter to the tracheostomy port (as par 0029 discloses the material as an HME it is seen that the claimed function is performed); and a monitoring tube (#64 fig 3, 5) extending from outside of the housing assembly into the housing assembly, wherein the monitoring tube comprises an open end positioned within the central cavity (end of #64 at point B in fig 5, par 0031), and wherein the monitoring tube is configured to be connected to a respiration monitoring device in order to detect respiration parameters of the patient during the sleep study (par 0031): and at least one respiration monitoring device fluidically coupled to the monitoring tube and configured to monitor respiration of the patient (#26 fig 1, par 0022 discloses gas sampling apparatus 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a monitoring tube that extends through the HME filters into the central cavity as taught by Wisniewski on the system of Nakamura as doing so allows for the gas inhaled/exhaled by the patient to be monitored (Wisniewski par 0031).
Regarding claim 15, modified Nakamura discloses the system of claim 14. Wisniewski further discloses the at least one respiration monitoring device comprises an end tidal carbon dioxide (ETCO2) detector (par 0022 discloses measuring carbon dioxide levels of exhaled air thus disclosing measuring end tidal carbon dioxide) and/or a pressure transducer configured to measure inhalation and exhalation airflow of the patient.
Regarding claim 16, modified Nakamura discloses the system of claim 14. Wisniewski further discloses a processor unit, wherein the at least one respiration monitoring device is connected to the processor unit (par 0022 disclosing 26 as a gas sampling apparatus thus disclosing a processor for monitoring the gas samples).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over modified Nakamura as applied to claim 3 above, and further in view of Neubauer (DE 202017003898 U1).
Regarding claim 4, modified Nakamura discloses the system of claim 3. Wisniewski further discloses the monitoring tube extends from the sleeve to the central cavity (see fig 5).
Modified Nakamura does not disclose the monitoring tube being between the first HME filter and an inner sidewall of the main body.
Neubauer teaches a similar T-shaped HME system (abstract, fig 3) wherein an outside line communicates with the central cavity (line #5/6 fig 3) such that the line is between the first HME filter (#1 on the right-side fig 3) and an inner sidewall of the main body (lower sidewall #2 fig 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to move the monitoring line of modified Nakamura to be along the sidewall as taught by Neubauer in order to protect the monitoring line by having it adjacent to a stable/rigid component.
Regarding claim 5, modified Nakamura discloses the system of claim 4. Modified Nakamura further discloses the first HME filter is cylindrical (Nakamura: pg 4 last par “outer housing 11 of a generally cylindrical shape” thus disclosing the HME filters within being cylindrical as well) and defines a channel (Wisniewski: see central channel in #54 fig 3), and wherein the monitoring tube is positioned within the channel (Wisniewski: see fig 5 showing monitoring tube positioned through central channel of HME filter).
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over modified Nakamura as applied to claims 12 and 16 above, and further in view of Lynn (US 2006/0155206 A1).
Regarding claim 13, modified Nakamura discloses the system of claim 12. Wisniewski discloses the monitoring line having a connector configured to connect to an end tidal carbon dioxide (ETCO2) detector (par 0022 discloses measuring carbon dioxide levels of exhaled air thus disclosing measuring end tidal carbon dioxide).
Modified Nakamura is silent to the monitoring tube further comprises a bifurcation, wherein the at least one connector comprises a first connector and a second connector, and wherein the first connector is configured to connect to an end tidal carbon dioxide (ETCO2) detector and the second connector is configured to connect to a pressure transducer to measure inhalation and exhalation airflow.
Lynn teaches a monitoring tube further comprises a bifurcation (par 0343 “providing an accessory tubing bifurcation”), wherein the at least one connector comprises a first connector and a second connector, and wherein the first connector is configured to connect to an end tidal carbon dioxide (ETCO2) detector (par 0343 disclosing connecting to a capnometer, #1824 fig 18) and the second connector is configured to connect to a pressure transducer to measure inhalation and exhalation airflow (par 0343 disclosing pressure transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a bifurcation as taught by Lynn on the system of modified Nakamura as doing so allows for the carbon dioxide levels and the pressure levels to be monitored concurrently.
Regarding claim 17, modified Nakamura discloses the system of claim 16. Nakamura is silent to at least one of an electroencephalogram (EEG) monitor, an electrooculogram (EOG) monitor, a pulse oximeter, and an electrocardiogram (ECG) monitor connected to the processor unit.
Lynn teaches a system with a processor (#1820 fig 18) for communicating with a monitoring line (#1810/1824 fig 18) and further discloses at least one of an electroencephalogram (EEG) monitor, an electrooculogram (EOG) monitor, a pulse oximeter (#1818 fig 18), and an electrocardiogram (ECG) monitor connected to the processor unit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a pulse oximeter as taught by Lynn on the system of modified Nakamura as doing so allows for the patient’s oxygen saturation to be monitored through the same processor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Komar US 2021/0023317 A1 discloses a heat and moisture exchanger with a monitoring line
Mehta US 2020/0001028 A1 discloses a tracheostomy tube and monitoring device with HME filters
DE-202004004633-U1 discloses an HME system with a line running perpendicular to the axis of the tracheostomy port
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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