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 .
Information Disclosure Statement
The information disclosure statements (IDS) dated April 28, 2025, October 3, 2025, November 05, 2025, and June 15, 2026 have been received and fully considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 154-160, 162, 167-173 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tham (US 20120174925 A1).
Regarding Claim 154, Tham discloses: A positive pressure breathing circuit for ventilating a patient (Paragraph 004, A system for providing mechanical ventilation support to a patient includes a mechanical ventilator configured to pneumatically provide mechanical ventilation support to the patient), (Paragraph 0015, The breathing circuit 14 is pneumatically connected to a bellows 24. The bellows 24 is operated by a mechanical ventilator 26 that provides a supply of drive gas 28 to the bellows 24 in order to create pressure waveforms of medical gas or breaths within the breathing circuit 14 that are delivered to the patient 12 as respiratory support), the positive pressure breathing circuit comprising:
an inspiratory member comprising a proximal portion and a distal portion (Annotated Figure 1)
the proximal portion being connectable to a patient interface configured to supply a breathing gas (Paragraph 0014, A Y connector 20 connects the inspiratory limb 16 and the expiratory limb 18 to a patient connection 22 that facilitates the pneumatic connection of the system 10 to the patient 12),
the distal portion being configured to connect to a first source of a pressurized first gas and a second source of a pressurized second gas (Paragraph 0023, The fresh gas conduit 50 splits into an upstream conduit 54 that is fluidly connected to the inspiratory limb 16 at a location upstream from the inspiratory check valve 30. The fresh gas conduit 50 also splits into a downstream conduit 56 that fluidly connects to the inspiratory limb 16 at a location downstream from the inspiratory check valve 30),
the pressurized second gas entering the inspiratory member (Annotated Figure 1, Paragraph 0024, In the system 10, an oxygen flush conduit 58 fluidly connects the oxygen source 40 to the fresh gas conduit 50. An oxygen flush valve 60 is disposed within the fresh gas conduit 58. The oxygen flush valve 60 is operated to deliver a high flow of mostly oxygen to the fresh gas line 50) downstream of where the pressurized first gas enters the inspiratory member (Paragraph 0025, In one arrangement, the fresh gas valve 52 is more than a three-way-valve or is in effect a plurality of valves such that the oxygen flush conduit 58 connects directly to the fresh gas valve 52 (not depicted) and the flow of oxygen gas during an oxygen flush procedure completely bypasses the fresh gas conduit 50. In this embodiment, the fresh gas valve is operated to not only select the destination of the gas flow (upstream conduit 54 or downstream conduit 56), but also the source of the gas flow (fresh gas conduit 50 or oxygen flush conduit 58));
and a pressure regulation device configured to regulate pressure in the positive pressure breathing circuit, including by venting exhaled gas (Paragraph 0017, During an expiratory phase, exhaled gases from the patient 12 are directed from the patient connection 22 into the expiratory limb 18 where the expired gases are further directed into the bellows 24. The mechanical ventilator 26 operates to lower the pressure of the drive gas 28 which allows the bellows 24 to expand to accept the expired breathing gases. Any excess gas volume of expired breathing gases is vented out of the bellows 24 through an exhaust valve 34).
PNG
media_image1.png
788
1132
media_image1.png
Greyscale
[Annotated Figure 1, Tham]
Regarding Claim 155, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the positive pressure breathing circuit comprises an expiratory member, the expiratory member receiving the exhaled gas from the patient interface (Annotated Figure 1, Paragraph 0014, The system 10 includes a breathing circuit 14. The breathing circuit 14 directs medical gas towards the patient 12 through an inspiratory limb 16 and directs expired gas away from the patient through an expiratory limb 18).
Regarding Claim 156, Tham discloses all of the limitations of Claim 155. Tham further discloses: wherein the expiratory member comprises an expiratory tube extending away from the patient interface (Paragraph 0014, A Y connector 20 connects the inspiratory limb 16 and the expiratory limb 18 to a patient connection 22 that facilitates the pneumatic connection of the system 10 to the patient 12. It is understood that there are a wide variety of patient connections 22 that can be used with embodiments of the system 10. These patient connections 22 includes, but are not limited to, an endotracheal tube, a ventilation mask, and a laryngeal mask).
Regarding Claim 157, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the inspiratory member comprises an inspiratory tube (Paragraph 0014, A Y connector 20 connects the inspiratory limb 16 and the expiratory limb 18 to a patient connection 22 that facilitates the pneumatic connection of the system 10 to the patient 12. It is understood that there are a wide variety of patient connections 22 that can be used with embodiments of the system 10. These patient connections 22 includes, but are not limited to, an endotracheal tube, a ventilation mask, and a laryngeal mask).
Regarding Claim 158, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the inspiratory member comprises a first non-return valve (Paragraph 0016, Inspiratory check valve 30 is disposed within the inspiratory limb 16 and expiratory check valve 32 is disposed within the expiratory limb 18. The inspiratory check valve 30 and the expiratory check valve 32 maintain a generally unidirectional flow within the breathing circuit 14), the pressurized first gas entering the inspiratory member upstream of the first non-return valve and the pressurized second gas entering the inspiratory member downstream of the first non-return valve (Paragraph 0025, In one arrangement, the fresh gas valve 52 is more than a three-way-valve or is in effect a plurality of valves such that the oxygen flush conduit 58 connects directly to the fresh gas valve 52 (not depicted) and the flow of oxygen gas during an oxygen flush procedure completely bypasses the fresh gas conduit 50. In this embodiment, the fresh gas valve is operated to not only select the destination of the gas flow (upstream conduit 54 or downstream conduit 56), but also the source of the gas flow (fresh gas conduit 50 or oxygen flush conduit 58)).
Regarding Claim 159, Tham discloses all of the limitations of Claim 158. Tham further discloses: wherein the first non-return valve is configured to inhibit the pressurized second gas from flowing upstream toward the pressurized first gas entering the inspiratory member (Paragraph 0025, In one arrangement, the fresh gas valve 52 is more than a three-way-valve or is in effect a plurality of valves such that the oxygen flush conduit 58 connects directly to the fresh gas valve 52 (not depicted) and the flow of oxygen gas during an oxygen flush procedure completely bypasses the fresh gas conduit 50. In this embodiment, the fresh gas valve is operated to not only select the destination of the gas flow (upstream conduit 54 or downstream conduit 56), but also the source of the gas flow (fresh gas conduit 50 or oxygen flush conduit 58)), (Paragraph 0023, The fresh gas conduit 50 splits into an upstream conduit 54 that is fluidly connected to the inspiratory limb 16 at a location upstream from the inspiratory check valve 30. The fresh gas conduit 50 also splits into a downstream conduit 56 that fluidly connects to the inspiratory limb 16 at a location downstream from the inspiratory check valve 30).
Regarding Claim 160, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the inspiratory member is configured so that a volume of the pressurized second gas can enter and flow toward the patient interface without being inhaled during patient exhalation (Paragraph 0036, In FIG. 3B, the expired gases 74 leave the patient 12 through the patient connection 22 and combine with the fresh gas flow 70 in the breathing circuit 14 from the inspiratory limb 16. A combined gas flow 78 of expired gas and fresh gas flows through the expiratory limb 18 and the expiratory check valve 32. The combined gas flow 78 is further directed through the breathing circuit 14 into the bellows 24 wherein the bellows 24 expands to receive the volume of the combined gas flow 78. Any excess gas flow received in the bellows 24 is exhausted as exhaust gas flow 76 through an exhaust valve 34).
Regarding Claim 162, Tham discloses all of the limitations of Claim 155. Tham further discloses: wherein the expiratory member comprises a second non-return valve to inhibit the exhaled gas from re- entering the patient interface (Paragraph 0016, Inspiratory check valve 30 is disposed within the inspiratory limb 16 and expiratory check valve 32 is disposed within the expiratory limb 18. The inspiratory check valve 30 and the expiratory check valve 32 maintain a generally unidirectional flow within the breathing circuit 14).
Regarding Claim 167, Tham discloses all of the limitations of Claim 155. Tham further discloses: wherein the inspiratory member is configured to connect to the expiratory member such that any excess of the pressurized first gas supplied to the inspiratory member passes from the inspiratory member to the expiratory member without passing through the patient interface (Paragraph 0036, In FIG. 3B, the expired gases 74 leave the patient 12 through the patient connection 22 and combine with the fresh gas flow 70 in the breathing circuit 14 from the inspiratory limb 16. A combined gas flow 78 of expired gas and fresh gas flows through the expiratory limb 18 and the expiratory check valve 32. The combined gas flow 78 is further directed through the breathing circuit 14 into the bellows 24 wherein the bellows 24 expands to receive the volume of the combined gas flow 78. Any excess gas flow received in the bellows 24 is exhausted as exhaust gas flow 76 through an exhaust valve 34)
Regarding Claim 168, Tham discloses all of the limitations of Claim 167. Tham further discloses: wherein the inspiratory member and the expiratory member are connected in a loop configuration and any excess of the pressurized first gas supplied to the inspiratory member is conveyed from the inspiratory member to the expiratory member in the loop configuration remote from the patient interface (Paragraph 0009, FIG. 2B is a schematic diagram that depicts fresh gas delivery upstream of the inspiratory check valve during expiration), (Paragraph 0011, FIG. 3B is a schematic diagram that depicts fresh gas delivery downstream of the inspiratory check valve during patient expiration), (Paragraph 0036, A combined gas flow 78 of expired gas and fresh gas flows through the expiratory limb 18 and the expiratory check valve 32. The combined gas flow 78 is further directed through the breathing circuit 14 into the bellows 24 wherein the bellows 24 expands to receive the volume of the combined gas flow 78. Any excess gas flow received in the bellows 24 is exhausted as exhaust gas flow 76 through an exhaust valve 34)
Regarding Claim 169, Tham discloses all of the limitations of Claim 167. Tham further discloses: wherein the distal portion of the expiratory member and the distal portion of the inspiratory member are connected to allow any excess of the pressurized first gas supplied to the inspiratory member to flow from the inspiratory member to the expiratory member (Paragraph 0031, During expiration by the patient 12, expired gases 74 flow back through the patient connection 22 into the breathing circuit 14. As can be seen in FIG. 2B, a portion of the expired gas flow 74 is directed into a portion of the inspiratory limb 16, but further flow is prevented by inspiratory check valve 30. The majority of the expired gas flow 74 is directed through the expiratory limb 18 and allowed to pass through the expiratory check valve 32. The expired gas flow 74 that passes through the expiratory check valve 32 is directed into the bellows)
Regarding Claim 170, Tham discloses all of the limitations of Claim 167. Tham further discloses: wherein the expiratory member includes a second non-return valve to inhibit any excess of the pressurized first gas supplied to the inspiratory member from entering the patient interface from the expiratory member (Paragraph 0031, The majority of the expired gas flow 74 is directed through the expiratory limb 18 and allowed to pass through the expiratory check valve 32. The expired gas flow 74 that passes through the expiratory check valve 32 is directed into the bellows 24), (Paragraph 0017, Any excess gas volume of expired breathing gases is vented out of the bellows 24 through an exhaust valve 34), (Paragraph 0036, In FIG. 3B, the expired gases 74 leave the patient 12 through the patient connection 22 and combine with the fresh gas flow 70 in the breathing circuit 14 from the inspiratory limb 16. A combined gas flow 78 of expired gas and fresh gas flows through the expiratory limb 18 and the expiratory check valve 32)
Regarding Claim 171, Tham discloses all of the limitations of Claim 170. Tham further discloses: wherein the expiratory member is configured so that any excess of the pressurized first gas supplied to the inspiratory member in the expiratory member downstream of the second non-return valve and the exhaled gas in the expiratory member downstream of the second non-return valve are vented from the positive pressure breathing circuit (Paragraph 0036, In FIG. 3B, the expired gases 74 leave the patient 12 through the patient connection 22 and combine with the fresh gas flow 70 in the breathing circuit 14 from the inspiratory limb 16. A combined gas flow 78 of expired gas and fresh gas flows through the expiratory limb 18 and the expiratory check valve 32. The combined gas flow 78 is further directed through the breathing circuit 14 into the bellows 24 wherein the bellows 24 expands to receive the volume of the combined gas flow 78. Any excess gas flow received in the bellows 24 is exhausted as exhaust gas flow 76 through an exhaust valve 34).
Regarding Claim 172, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the pressurized first gas is pressurized air (Paragraph 18, Since at least a portion of the expired gases are vented through the exhaust valve 34, a volume of fresh gas must be provided to the inspiratory limb 16 from a fresh gas manifold 38. The fresh gas manifold 38 is connected to sources of medical gas. The sources can include cylinders of pressurized medical gas or wall supply conduits found in a hospital or clinical setting. While an oxygen source 40 and an air source 42 are depicted, it is to be understood that a variety of other medical gases may be used instead of or in addition to oxygen and air. Non-limiting examples of alternative medical gases that can be used include Heliox, nitrous oxide, xenon, or nitrogen (which is used as a balance gas). Additionally, the fresh gas manifold 38 may include an anesthetic vaporizer to dispense vaporized anesthetic agent from an anesthetic liquid reservoir).
Regarding Claim 173, Tham discloses all of the limitations of Claim 154. Tham further discloses: wherein the pressurized second gas is pressurized oxygen gas (Paragraph 0018, Since at least a portion of the expired gases are vented through the exhaust valve 34, a volume of fresh gas must be provided to the inspiratory limb 16 from a fresh gas manifold 38. The fresh gas manifold 38 is connected to sources of medical gas. The sources can include cylinders of pressurized medical gas or wall supply conduits found in a hospital or clinical setting. While an oxygen source 40 and an air source 42 are depicted, it is to be understood that a variety of other medical gases may be used instead of or in addition to oxygen and air. Non-limiting examples of alternative medical gases that can be used include Heliox, nitrous oxide, xenon, or nitrogen (which is used as a balance gas). Additionally, the fresh gas manifold 38 may include an anesthetic vaporizer to dispense vaporized anesthetic agent from an anesthetic liquid reservoir).
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.
Claim 161 is rejected under 35 U.S.C. 103 as being unpatentable over Tham (US 20120174925 A1) in view of Fukunaga (US 20170095631 A1)
Regarding Claim 161, Tham discloses all of the limitations of Claim 160. Tham is silent regarding changing a length of the inspiratory member.
Fukunaga does disclose: wherein an internal volume of the inspiratory member for receiving the volume of the pressurized second gas can be changed by changing a length of the inspiratory member to accommodate a desired volume of the pressurized second gas during patient exhalation (Paragraph 0110, An alternative embodiment of the EcoFlex Dispo™ device includes an adjustable length distal breathing tube (e.g., flexitube), which places a patient airway device in fluid communication with the proximal portion of a circuit via a filter. Preferably, the filter and tube are bonded together to form an integral device. The proximal portion of a breathing circuit that incorporates an EcoFlex Reuse™ may optionally include an adjustable length proximal tube that permits further adjustment of the length in the circuit).
It is well-known in the art of respiratory devices and breathing circuits to adjust the dimensions of inhalation and exhalation interfaces as needed to accommodate different users. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Fukunaga’s adjustable breathing tube with the system of Tham.
Claim 163 is rejected under 35 U.S.C. 103 as being unpatentable over Tham (US 20120174925 A1) in view of Millar et al. (US 20180311461 A1, hereinafter Millar).
Regarding Claim 163, Tham discloses all of the limitations of Claim 154. Tham further discloses
a variety of possible patient interfaces that can be incorporated in the breathing circuit system (Paragraph 0014, It is understood that there are a wide variety of patient connections 22 that can be used with embodiments of the system 10. These patient connections 22 includes, but are not limited to, an endotracheal tube, a ventilation mask, and a laryngeal mask), but does not explicitly disclose wherein the pressure regulation device is directly connected to the patient interface.
Millar does disclose: wherein the pressure regulation device is directly connected to the patient interface (Paragraph 0035, Preferably, the occlusion valve 70 is located at or near the patient interface 14, such as within about 500 millimeters or less of the patient interface 14. However, in other arrangements, the occlusion valve 70 can be integrated with the patient interface 14 or expiratory pressure device 60. The occlusion valve 70 is configured to block the exit of gases from the system 10 to a sufficient extent such that the gas pressure within the system 10 rises above the PEEP.
It would have been obvious to one skilled in the art before the effective filing date to modify the patient interface disclosed by Tham to further include a valve, in order to better control pressure within the system. The occlusion valve serves as a pressure regulation device, helping maintain proper pressure levels for effective respiratory therapy and treatment.
Claims 164-165 are rejected under 35 U.S.C. 103 as being unpatentable over Tham (US 20120174925 A1) in view of Haggblom et al. (US 20160354568 A1, hereinafter “Haggblom”)
Regarding Claim 164, Tham discloses all of the limitations of Claim 155. Tham further discloses: wherein the pressure regulation device comprises a first pressure relief valve for venting exhaled gas, the first pressure relief valve comprising a positive end expiratory pressure valve or a restriction orifice (Paragraph 0031, The majority of the expired gas flow 74 is directed through the expiratory limb 18 and allowed to pass through the expiratory check valve 32. The expired gas flow 74 that passes through the expiratory check valve 32 is directed into the bellows 24. During the expiratory phase, the mechanical ventilator 26 is operated to reduce the pressure of the drive gas 28 to below that of the pressure of the expired gases 74 in the breathing circuit 14).
Though Tham does not explicitly disclose that the exhaust valve is a pressure relief valve¸ it is capable of functioning as such, as it directs excess gas flow out of the system.
However, if the Applicant is not convinced, Haggblom more explicitly discloses: wherein the pressure regulation device comprises a first pressure relief valve for venting exhaled gas, the first pressure relief valve comprising a positive end expiratory pressure valve or a restriction orifice (Paragraph 0037, During the inspiration the expiration valve 37 is maintained closed. However, for safety purposes the lungs must be protected for excessive pressure. Therefore the expiration circuit 22 may be programmed to open the expiration valve 37 in case the measured patient pressure increases beyond the given maximum pressure limit and thus limit the inspiratory pressure).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Haggblom’s pressure relief valve mechanism, as it is a common and art-recognized type of exhaust valve. Furthermore, the valve assists in reducing excess pressure on a user, and thus improves overall safety and efficacy of the respiratory treatment.
Regarding Claim 165, Tham in view of Haggblom discloses all of the limitations of Claim 164. Haggblom further discloses: wherein the pressure regulation device comprises a second pressure relief valve, the second pressure relief valve comprising a positive end expiratory pressure valve (0032, The pressure release is controlled for a desired expiration pressure such as a positive end expiration pressure (PEEP) target, which may be set using the user interface 25. For this control the ventilator control 21 uses the breathing circuit pressure measured by the pressure sensor 85 and the expiration valve 37. The expiration gas flow may be measured using the flow sensor 38 located in this embodiment at the expiration branch 39 or at the outlet the expiration valve 37 as shown in FIG. 1).
Claim 166 are rejected under 35 U.S.C. 103 as being unpatentable over Tham (US 20120174925 A1) in view of Haggblom (US 20160354568 A1), further in view of Eriksson (US 20200038605 A1)
Regarding Claim 166, Tham in view of Haggblom discloses all of the limitations of Claim 165. The combination does not disclose the different in pressure setting between the valves.
Eriksson does disclose: wherein the first pressure relief valve has a higher pressure setting than the second pressure relief valve (Paragraph 0087, According to embodiments of this disclosure, the lower pressure level setting may be a PEEP level setting of the expiratory pressure control valve 21. In this manner, a suitable lower pressure level for preventing atelectatic collapse of the lungs of the patient 8 may be provided. The PEEP level, Positive End-Expiratory Pressure level, is the positive pressure within the lungs at the end of the expiratory phase of a breath of the patient 8, which is a well-defined pressure level of the breathing apparatus 2), (Paragraph 0088, According to embodiments of this disclosure, the upper pressure level setting may be at a level below a threshold pressure level of a pressure relief valve 29 of the anaesthetic breathing apparatus 2. In this manner, pressure relief via the pressure relief valve 29 may be avoided during performing of the method 100 discussed herein. Thus, ventilation during an oxygen flush may be performed).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Eriksson’s adjustable pressure threshold settings, so as to better accommodate the different phases of breathing and provide an additional degree of safety in pressure building and releasing in the circuit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Callaghan et al. (US 20170246419 A1) discloses a system for combining breathable gases in a respiratory circuit
Adametz (US 20210275762 A1) discloses a gas control device for a ventilator
Carroll et al. (WO 2021248142 A2) discloses a respiratory system configured for delivery of nitric oxide
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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 S. 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.
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.
/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights