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 .
Response to Amendment
Examiner acknowledges the reply filed on 10/24/2025 in which claims 1-2, 6, 11-12, and 17-18 have been amended. Currently, claims 1-4, 6-18, and 20-22 are pending for examination in this application.
Response to Arguments
Applicant has resolved the objection to the claims.
Applicant's arguments, see Remarks pg. 11-15, filed 10/24/2025, regarding the rejections of claims 1, 6, and 11 have been fully considered but they are not persuasive.
Applicant argues none of Sharma, Spear, Bornholdt, and Guney teach the newly added limitations of the independent claims. However, Examiner disagrees as the modification of Sharma and Bornholdt establishes that the vent diffuser material is permanently integrated to form an inseparable whole with the inlet port of the vent body as supported by [0422] and Fig. 121 and 124 of Bornholdt. As such, the ventilation component only comprises two layers which are the vent diffuser material as part of the inlet port of the vent body and the vent cap on the opposite port of the vent body.
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(s) 1, 2, 4, 17-18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20230364373 A1) in view of Spear et al. (US 20210213227 A1), Bornholdt et al. (US 20190151592 A1), and Guney et al. (US 20090044808 A1).
Regarding claim 1, Sharma discloses a patient interface device to deliver continuous positive pressure gas to a nasal airway of a user in a sealed manner for treatment of sleep disordered breathing ([0196] Patient interface 3000; Fig. 43-47. [0026-0028] supports the patient interface of the present disclosure being used for sleep disordered breathing), the patient interface device comprising:
a front chamber section ([0196] plenum chamber 3200; Fig. 48 and all figures containing reference numeral 3200), which includes a main chamber formed by a continuous wall (Fig. 48 and 52-56 show the plenum chamber 3200 formed by a continuous wall) and includes two entrance ends located on both sides ([0233] The plenum chamber 3200 may also include tube connectors 3202 to connect to corresponding tubes, as shown in FIGS. 43-47, to receive pressurised air; Fig. 48-52), with the main chamber being curved towards a side nearer a face of the user to form a chamber structure with a certain curvature that does not make contact with the user (As seen by Fig. 43, plenum chamber 3200 curves outwardly to ensure that only the seal-forming structure 3100 contacts the user. Additionally, the cross sectional view in Fig. 56 shows the plenum chamber 3200 being curved);
a sealing structure ([0196] seal-forming structure 3100; Fig. 43-48 and all figures containing reference numeral 3100. [0223] nasal pillows 3165; Fig. 46-47), with a single-layer wall (Fig. 53-54, 56 and 85-87 depict seal-forming structure 3100 with a single layer wall), which is configured to be two frusto-cone shaped protrusions ([0223] In one form the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows 3165; Fig. 46-47; [0224] frusto-cone nasal pillows 3165) and to communicate with the main chamber of the front chamber section (All configurations of the seal-forming structure 3100/nasal pillows 3165 are directly connected to the plenum chamber 3200 as seen in Fig. 56), and at least a part of which, when in use, contacts a portion of a nose of the user and allows gas to be delivered through an exhaust end, to enter at least one nostril, thereby to complete a pressurized gas delivery and to seal the nasal airway of the user ([0223] each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient; Fig. 46-47);
wherein the front chamber section includes at least one opening ([0276] The plenum chamber 3200 may include a receiving hole 3204 that receives the vent assembly 3400; Fig. 57), and a ventilation component is provided on one of the openings of the front chamber section ([0276] vent assembly 3400; Fig. 57), the ventilation component comprising:
a noise reduction material ([0278] vent diffuser material 3404; Fig. 57) and a ventilation component body ([0277] vent body 3403; Fig. 57) with two ports (Inlet port: [0277] vent body holes 3405; Fig. 58 and 62. Outlet port: [0277] vent holes 3402; Fig. 59-61), wherein the noise reduction material first divides an airflow that exits from the front chamber section into smaller streams (0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400), before the airflow reaches an external environment through a mouth on one port of the ventilation component body away from the noise reduction material ([0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400); and
a positioning stabilizer ([0250] positioning and stabilising structure 3300; Fig. 43-47 and all figures containing reference numeral 3300), configured to be provided on both ends of the front chamber section to provide a connection between components to secure the patient interface device to the face of the user ([0250] the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the seal-forming structure 3100 from the air circuit 4170. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of patient interface 3000 to position and stabilise the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (for example, the nose and/or mouth); Fig. 43-47 and especially Fig. 43);
wherein the sealing structure communicates with the front chamber section through a neck ([0224] stalk positioned between 3160 and 3165; Fig. 46);
wherein, the neck has a first inner diameter (see Fig. 46), the end of the sealing structure near the neck has a second inner diameter (wide base of nasal pillows 3165; see Fig. 46-47), and an exhaust end opening has a third inner diameter (tip of nasal pillows 3165; see Fig. 46-47);
wherein the second inner diameter is a maximum outer circle of the sealing structure (wide base of nasal pillows 3165; see Fig. 46-47), the second inner diameter is greater than the first inner diameter (wide base of nasal pillows 3165 is greater in diameter than stalk positioned between 3160 and 3165; see Fig. 46), and the second inner diameter is greater than the third inner diameter (wide base of nasal pillows 3165 is greater diameter than tip of nasal pillows 3165; see Fig. 47),
wherein the noise reduction material is configured to include a noise reduction mesh ([0278] the vent diffuser material 3404 performs the function of reducing noise and may be a porous material such as a foam or a network of fibers. A network of fibers fits the definition of a mesh, such as: “the fabric of a net” or “a weblike pattern or construction” found on Merriam-Webster).
Sharma does not explicitly disclose the two frusto-cone shaped protrusions being symmetrical to each other, and wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user. However, Sharma illustrates the nasal pillows 3615 being symmetrical to each other (Fig. 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal pillows to be symmetrical to each other in order to comfortably fit both of the patient’s nostrils at the same time. Additionally, modified Sharma teaches wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user (par. [0224]. According to applicant’s specifications, pg. 11 line 10-15, the uniform pressure is enabled by the symmetry of the two shaped protrusions, see Fig. 45-46).
Sharma does not disclose wherein the exhaust end of each of the two shaped protrusions have a non-uniform wall thickness and the non-uniform thickness is greater than a wall thickness of an opening in the exhaust end, and wherein the non-uniform wall thickness is configured to be uniformly variable; and
wherein the noise reduction material forms an inseparable whole with one port of the ventilation component body, wherein a connection between the noise reduction material and the ventilation component body is seamless.
However, Spear teaches a nasal seal for a respiratory patient interface (title) comprising two shaped protrusions ([0190] each prong 11; Fig. 9 and 12-14), the two shaped protrusions being symmetrical to each other ([0042] the first and second nasal prongs may be symmetrical; see Fig. 9), wherein the exhaust end of each of the two shaped protrusions ([0190] terminal region 14 at a tip of the prong and nare sealing region 18; Fig. 14) have a non-uniform wall thickness and the non-uniform thickness is greater than a wall thickness of an opening in the exhaust end ([0190] The terminal region 14 of each nasal prong 11 has a wall thickness that tapers towards a tip of the nasal prong 11a. [0191] over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. In alternative embodiments, the extent of the taper may vary, but preferably the wall thickness at the tip of the nasal prongs 11a is less than about 20% of the wall thickness of the un-tapered lower nare sealing region 18; Fig. 14), and wherein the non-uniform wall thickness is configured to be uniformly variable ([0191] In the present example, over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. Examiner notes that a gradual decrease equates to a uniform varying as the thickness of the wall does not drastically change but instead gradually/slowly decreases to the desired thickness at the tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal pillows of Sharma to implement the shape and gradual taper toward the tip of the nasal prongs with the non-uniform thickness being greater than the wall thickness of the opening in the exhaust end in order to reduces pressure loading on the soft nose tissue in use, to reduce the likelihood of pressure sores as taught by Spear [0190].
Bornholdt teaches the respiratory mask system including a ventilation component wherein the noise reduction material ([0282] diffuser 152; Fig. 19-20. [0420-0424] Diffuser 782a; Fig. 121-124) forms an inseparable whole with one port of the ventilation component body ([0282] The diffuser may be located within the seal assembly, when the seal assembly comprises a vent aperture 150 within which the diffuser 152 may be located, as shown in FIGS. 19 and 20. [0422] the diffuser 782a is permanently bonded to the diffuser clip 780a by means such as over-moulding or welding. The diffuser clip 780a comprises an aperture that is filled by the diffuser 782a.; Fig. 124), wherein a connection between the noise reduction material and the ventilation component body is seamless (Fig. 19-20 and 121-124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vent assembly of Sharma by permanently integrating the vent diffuser material into the inlet port of the vent body as taught by Bornholdt, thereby replacing the vent body holes. This provides the benefit of maintaining the function of the diffuser by cleaning it as recognized by Bornholdt [0282] instead of having to completely replace the diffuser material and/or vent module whenever the diffuser is not functioning properly. Additionally, permanently integrating the vent diffuser material into the inlet port ensures that the diffuser material does not fall out of vent body when the vent cap is not being used.
As modified Sharma teaches wherein the ventilation component comprises only two layers ([0278-0279] vent diffuser material 3404 and vent cap 3401; Fig. 57), wherein a first layer includes the noise reduction material on a first port (as modified above, vent diffuser material 3404 is permanently integrated into the inlet port of the vent body 3403) and a second layer includes a port cover on a second port (see Sharma Fig. 59; vent cap 3401 is provided on the outlet port of the vent body 3403 to form the vent holes 3402).
Sharma is silent as to wherein the front chamber section and the sealing structure are integrally formed (Fig. 46-47, plenum chamber 3200 and nasal pillows 3165 appear to be integrally formed).
However, Guney teaches a patient interface (title) wherein the front chamber section ([0222] base 22; Fig. 2-1 to 2-2) and the sealing structure ([0222] nasal prong 24; Fig. 2-1 to 2-2) are integrally formed ([0223] The nasal prong assembly 20 may be integrally formed in one-piece, e.g., by silicone in an injection molding process (e.g., LSR (liquid silicone rubber) and CMSR (compression molded silicon rubber) molding technology)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plenum chamber and nasal pillows of Sharma to be integrally formed in one-piece as taught by Guney in order to reduce manufacturing complexity and have a seamless aesthetic appeal.
Regarding claim 2, the modified invention of Sharma discloses the patient interface device according to claim 1, wherein the port cover (S: [0277] vent cap 3401; Fig. 57) is connectable to the mouth on one port of the ventilation component body away from the noise reduction material (S: [0277] A vent cap 3401 may be connected to the vent body 3403, and the vent holes 3402 may be formed between the vent cap 3401 and the vent body 3403; Fig. 54 and 56. In the modified invention of Sharma the vent diffuser material 3404 is at the vent body holes 3405; Fig. 54 and 56), and a dispersed airflow from the ventilation component flows out to the external environment through a gap between a periphery of the port cover and the mouth of the ventilation component (S: The vent assembly 3400 may include vent holes 3402 that allow a continuous flow of gas to exit to atmosphere throughout the patient's respiratory cycle; Fig. 54. In the modified invention of Sharma, the vent diffuser material 3434 at the air inlet diffuses the air flowing out to the external environment as supported by Bornholdt [0283]. Additionally, by positioning the diffuser 152 in the seal assembly, exhausted air is diffused as the exhausted air exits the breathing chamber of the seal assembly, and before the exhausted air contacts any other mask components or has an opportunity to generate noise or entrain surrounding air).
Regarding claim 4, the modified invention of Sharma discloses the patient interface device according to claim 1, but does not explicitly disclose wherein the two frusto-cone protrusions are symmetrical themselves. However, Sharma illustrates the nasal pillows 3615 being symmetrical themselves (Fig. 46-47). Additionally, Spear discloses [0042] the first and second nasal prongs may be symmetrical; see Fig. 9. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal pillows to be symmetrical themselves in order to comfortably fit both of the patient’s nostrils at the same time.
Regarding claim 17, Sharma discloses a patient interface device to deliver continuous positive pressure gas to a nasal airway of a user in a sealed manner for treatment of sleep disordered breathing ([0196] Patient interface 3000; Fig. 43-47. [0026-0028] supports the patient interface of the present disclosure being used for sleep disordered breathing), the patient interface device comprising:
a front chamber section ([0196] plenum chamber 3200; Fig. 48 and all figures containing reference numeral 3200), which includes a main chamber formed by a continuous wall (Fig. 48 and 52-56 show the plenum chamber 3200 formed by a continuous wall) and includes two entrance ends located on both sides ([0233] The plenum chamber 3200 may also include tube connectors 3202 to connect to corresponding tubes, as shown in FIGS. 43-47, to receive pressurised air; Fig. 48-52), with the main chamber being curved towards a side nearer a face of the user to form a chamber structure with a certain curvature that does not make contact with the user (As seen by Fig. 43, plenum chamber 3200 curves outwardly to ensure that only the seal-forming structure 3100 contacts the user. Additionally, the cross sectional view in Fig. 56 shows the plenum chamber 3200 being curved);
a sealing structure ([0196] seal-forming structure 3100; Fig. 43-48 and all figures containing reference numeral 3100. [0223] nasal pillows 3165; Fig. 46-47), with a single-layer wall (Fig. 53-54, 56 and 85-87 depict seal-forming structure 3100 with a single layer wall), which is configured to be two frusto-cone shaped protrusions ([0223] In one form the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows 3165; Fig. 46-47; [0224] frusto-cone nasal pillows 3165) to communicate with the main chamber of the front chamber section (All configurations of the seal-forming structure 3100/nasal pillows 3165 are directly connected to the plenum chamber 3200 as seen in Fig. 56), and at least a part of which, when in use, contacts a portion of a nose of the user and allows gas to be delivered through an exhaust end, to enter at least one nostril, thereby to complete a pressurized gas delivery and to seal the nasal airway of the user ([0223] each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient; Fig. 46-47);
the front chamber section includes at least one opening ([0276] The plenum chamber 3200 may include a receiving hole 3204 that receives the vent assembly 3400; Fig. 57), and a ventilation component provided on one of the openings of the front chamber section ([0276] vent assembly 3400; Fig. 57), and wherein the ventilation component comprising:
a noise reduction material ([0278] vent diffuser material 3404; Fig. 57) and a ventilation component body ([0277] vent body 3403; Fig. 57) with two ports (Inlet port: [0277] vent body holes 3405; Fig. 58 and 62. Outlet port: [0277] vent holes 3402; Fig. 59-61), and wherein the noise reduction material first divides an airflow that exits from the front chamber section into smaller streams (0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400), before the airflow reaches an external environment through a mouth on one port of the ventilation component body away from the noise reduction material ([0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400);
a positioning stabilizer ([0250] positioning and stabilising structure 3300; Fig. 43-47 and all figures containing reference numeral 3300), which is configured to be provided on both ends of the front chamber section to provide a connection between components to secure the patient interface device to the face of the user ([0250] the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the seal-forming structure 3100 from the air circuit 4170. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of patient interface 3000 to position and stabilise the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (for example, the nose and/or mouth); Fig. 43-47 and especially Fig. 43);
wherein the sealing structure communicates with the front chamber section through a neck ([0224] stalk positioned between 3160 and 3165; Fig. 46);
wherein, the neck has a first inner diameter (see Fig. 46), the end of the sealing structure near the neck has a second inner diameter (wide base of nasal pillows 3165; see Fig. 46-47), and an exhaust end opening has a third inner diameter (tip of nasal pillows 3165; see Fig. 46-47);
wherein the second inner diameter is a maximum outer circle of the sealing structure (wide base of nasal pillows 3165; see Fig. 46-47), the second inner diameter is greater than the first inner diameter (wide base of nasal pillows 3165 is greater in diameter than stalk positioned between 3160 and 3165; see Fig. 46), and the second inner diameter is greater than the third inner diameter (wide base of nasal pillows 3165 is greater diameter than tip of nasal pillows 3165; see Fig. 47),
wherein the noise reduction material is configured to include a noise reduction mesh ([0278] the vent diffuser material 3404 performs the function of reducing noise and may be a porous material such as a foam or a network of fibers. A network of fibers fits the definition of a mesh, such as: “the fabric of a net” or “a weblike pattern or construction” found on Merriam-Webster); and
wherein the noise reduction material has at least one of the following features:
1) the noise reduction material being one of foam-type ([0278] The vent diffuser material 3404 may be a porous material, such as a foam or a network of fibers) or granular-type material.
Sharma does not explicitly disclose the two frusto-cone shaped protrusions being symmetrical to each other, and wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user. However, Sharma illustrates the nasal pillows 3615 being symmetrical to each other (Fig. 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal pillows to be symmetrical to each other in order to comfortably fit both of the patient’s nostrils at the same time. Additionally, modified Sharma teaches wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user (par. [0224]. According to applicant’s specifications, pg. 11 line 10-15, the uniform pressure is enabled by the symmetry of the two shaped protrusions, see Fig. 45-46).
Sharma does not disclose wherein the exhaust end of each of the two frusto-cone shaped protrusions have a non-uniform wall thickness and the non-uniform wall thickness is greater than a wall thickness of an opening in the exhaust end; and
the noise reduction material forms an inseparable whole with one port of the ventilation component body, wherein a connection between the noise reduction material and the ventilation component body is seamless.
However, Spear teaches a nasal seal for a respiratory patient interface (title) comprising two shaped protrusions ([0190] each prong 11; Fig. 9 and 12-14), the two shaped protrusions being symmetrical to each other ([0042] the first and second nasal prongs may be symmetrical; see Fig. 9), wherein the exhaust end of each of the two shaped protrusions ([0190] terminal region 14 at a tip of the prong and nare sealing region 18; Fig. 14) have a non-uniform wall thickness and the non-uniform thickness is greater than a wall thickness of an opening in the exhaust end([0190] The terminal region 14 of each nasal prong 11 has a wall thickness that tapers towards a tip of the nasal prong 11a. [0191] over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. In alternative embodiments, the extent of the taper may vary, but preferably the wall thickness at the tip of the nasal prongs 11a is less than about 20% of the wall thickness of the un-tapered lower nare sealing region 18; Fig. 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal pillows of Sharma to implement the shape and taper toward the tip of the nasal prongs with the non-uniform thickness being greater than the wall thickness of the opening in the exhaust end in order to reduces pressure loading on the soft nose tissue in use, to reduce the likelihood of pressure sores as taught by Sharma [0190].
However, Bornholdt teaches the respiratory mask system including a ventilation component wherein the noise reduction material ([0282] diffuser 152; Fig. 19-20. [0420-0424] Diffuser 782a; Fig. 121-124) forms an inseparable whole with one port of the ventilation component body ([0282] The diffuser may be located within the seal assembly, when the seal assembly comprises a vent aperture 150 within which the diffuser 152 may be located, as shown in FIGS. 19 and 20. [0422] the diffuser 782a is permanently bonded to the diffuser clip 780a by means such as over-moulding or welding. The diffuser clip 780a comprises an aperture that is filled by the diffuser 782a.; Fig. 124), wherein a connection between the noise reduction material and the ventilation component body is seamless (Fig. 19-20 and 121-124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vent assembly of Sharma by permanently integrating the vent diffuser material into the inlet port of the vent body as taught by Bornholdt, thereby replacing the vent body holes. This provides the benefit of maintaining the function of the diffuser by cleaning it as recognized by Bornholdt [0282] instead of having to completely replace the diffuser material and/or vent module whenever the diffuser is not functioning properly. Additionally, permanently integrating the vent diffuser material into the inlet port ensures that the diffuser material does not fall out of vent body when the vent cap is not being used.
As modified Sharma teaches wherein the ventilation component comprises only two layers ([0278-0279] vent diffuser material 3404 and vent cap 3401; Fig. 57), wherein a first layer includes the noise reduction material on a first port (as modified above, vent diffuser material 3404 is permanently integrated into the inlet port of the vent body 3403) and a second layer includes a port cover on a second port (see Sharma Fig. 59; vent cap 3401 is provided on the outlet port of the vent body 3403 to form the vent holes 3402).Sharma is silent as to wherein the front chamber section and the sealing structure are integrally formed (Fig. 46-47, plenum chamber 3200 and nasal pillows 3165 appear to be integrally formed).
However, Guney teaches a patient interface (title) wherein the front chamber section ([0222] base 22; Fig. 2-1 to 2-2) and the sealing structure ([0222] nasal prong 24; Fig. 2-1 to 2-2) are integrally formed ([0223] The nasal prong assembly 20 may be integrally formed in one-piece, e.g., by silicone in an injection molding process (e.g., LSR (liquid silicone rubber) and CMSR (compression molded silicon rubber) molding technology)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plenum chamber and nasal pillows of Sharma to be integrally formed in one-piece as taught by Guney in order to reduce manufacturing complexity and have a seamless aesthetic appeal.
Further regarding claim 17, the modified invention of Sharma does not explicitly disclose wherein an area of the opening of the front chamber section, at which the ventilation component is installed, has a ratio of at least 1:9 to an outer wall area of the front chamber section, and the area of the opening of the front chamber section has a ratio of at least 5:1 to an area of the noise reduction material.
Sharma discloses a vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Sharma to have an area of the receiving hole, at which the vent body is installed, to have a ratio of at least 1:9 to an outer wall area of the plenum chamber, and the area of the receiving hole has a ratio of at least 5:1 to an area of the vent diffuser material since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sharma would not operate differently with the claimed area ratios and since plenum chamber is designed to fit the vent body via the receiving hole and the vent body houses the vent diffuser material, the device would function appropriately having the claimed area ratios. Further, it appears that applicant places no criticality on the area ratios claimed, indicating simply that the area ratios should “at least” be the claimed ratios (specification page 23 line 4-9).
Regarding claim 18, the modified invention of Sharma discloses the patient interface device according to claim 11, wherein the a port cover (S: [0277] vent cap 3401; Fig. 57) is connectable to the mouth on one port of the ventilation component body away from the noise reduction material (S: [0277] A vent cap 3401 may be connected to the vent body 3403, and the vent holes 3402 may be formed between the vent cap 3401 and the vent body 3403; Fig. 54 and 56. In the modified invention of Sharma the vent diffuser material 3404 is at the vent body holes 3405; Fig. 54 and 56), and a dispersed airflow from the ventilation component flows out to the external environment through a gap between a periphery of the port cover and the mouth of the ventilation component (S: The vent assembly 3400 may include vent holes 3402 that allow a continuous flow of gas to exit to atmosphere throughout the patient's respiratory cycle; Fig. 54. In the modified invention of Sharma, the vent diffuser material 3434 at the air inlet diffuses the air flowing out to the external environment as supported by Bornholdt [0283]. Additionally, by positioning the diffuser 152 in the seal assembly, exhausted air is diffused as the exhausted air exits the breathing chamber of the seal assembly, and before the exhausted air contacts any other mask components or has an opportunity to generate noise or entrain surrounding air).
Regarding claim 20, the modified invention of Sharma discloses the patient interface device according to claim 17, but does not explicitly disclose wherein the protrusions of the sealing structure are formed by extending in a normal direction from a specific location of the front chamber section. However, Sharma discloses the nasal pillows structure ([0224]) illustrates the nasal pillows 3165 extending from the plenum chamber 3200 while being angled in a position to connect to a patient’s nose (Fig. 47). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125.) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal pillows to be formed by extending in a normal direction from the plenum chamber in order to comfortably fit both nostrils at the same time.
Regarding claim 21, the modified invention of Sharma discloses the patient interface device according to claim 17, but does not explicitly disclose wherein each center of two exhaust ends on the sealing structure that contact the face of the user, is equidistant from a center of the noise reduction material. However, Sharma illustrates the vent diffuser material 3404 being a flat structure and the nasal pillows 3165 being symmetrical to each other (Fig. 47 and 57). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125.) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the exhaust ends of the nasal pillows to be equidistant from a center of the vent diffuser material 3404 in order to form a comfortable fit for both nostrils of a patient.
Regarding claim 22, the modified invention of Sharma discloses the patient interface device according to claim 17, wherein the sealing structure has a tendency to converge towards a point of its center (S: As seen in Fig. 47, the pair of nasal pillows are angled toward each other and a center of the seal forming-structure meaning their axes intersect each other at a point).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20230364373 A1) in view of Spear (US 20210213227 A1), Bornholdt et al. (US 20190151592 A1), and Guney et al. (US 20090044808 A1) as applied to claim 1 above, and further in view of Law et al. (US 20220296837 A1) and Ferdinand et al. (US 20090308398 A1).
Regarding claim 3, the modified invention of Sharma discloses the patient interface device according to claim 1, but does not disclose wherein the noise reduction material and the ventilation component body are made of a same material.
Law teaches a patient interface (3300) comprising a ventilation component body (vent module 3410; Fig. 14A-14D), wherein the ventilation component body is made of polycarbonate ([0834] The vent module may be formed from a substantially rigid material such as polycarbonate, polypropylene, nylon or the like).
Ferdinand teaches nasal device comprising a noise reduction material ([0067] One variation of an adjustable-resistance nasal device may include a noise-reduction feature (e.g., a noise-reduction flap or noise-reduction element)), wherein the noise reduction material is made of polycarbonate (The various components of the device may be made of any appropriate materials, as described in greater detail below. For example, some device components (e.g., an alignment guide, a body region, noise-reduction element, control, resistance modifying member) may be made of medical grade plastic, such as Acrylonitrile Butadiene Styrene (ABS), polypropylene, polyethylene, polycarbonate, polyurethane or polyetheretherketone.)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify both the vent diffuser material and the vent body of Sharma to be made from polycarbonate as taught by Ferdinand and Law. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) and In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 6-8 and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20230364373 A1) in view of Spear et al. (US 20210213227 A1), Bornholdt et al. (US 20190151592 A1), Guney et al. (US 20090044808 A1), and Baecke et al. (WO 2017044392 A1).
Regarding claim 6, Sharma discloses a patient interface device to deliver continuous positive pressure gas to a nasal airway of a user in a sealed manner for treatment of sleep disordered breathing ([0196] Patient interface 3000; Fig. 43-47. [0026-0028] supports the patient interface of the present disclosure being used for sleep disordered breathing), the patient interface device comprising:
a front chamber section ([0196] plenum chamber 3200; Fig. 48 and all figures containing reference numeral 3200), which includes a main chamber formed by a continuous wall (Fig. 48 and 52-56 show the plenum chamber 3200 formed by a continuous wall) and includes two entrance ends located on both sides ([0233] The plenum chamber 3200 may also include tube connectors 3202 to connect to corresponding tubes, as shown in FIGS. 43-47, to receive pressurised air; Fig. 48-52), with the main chamber being curved towards a side nearer a face of the user to form a chamber structure with a certain curvature that does not make contact with the user (As seen by Fig. 43, plenum chamber 3200 curves outwardly to ensure that only the seal-forming structure 3100 contacts the user. Additionally, the cross sectional view in Fig. 56 shows the plenum chamber 3200 being curved);
a sealing structure ([0196] seal-forming structure 3100; Fig. 43-48 and all figures containing reference numeral 3100. [0223] nasal pillows 3165; Fig. 46-47), which is configured to be two frusto-cone shaped protrusions ([0223] In one form the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows 3165; Fig. 46-47; [0224] frusto-cone nasal pillows 3165) and to communicate with the main chamber of the front chamber section (All configurations of the seal-forming structure 3100/nasal pillows 3165 are directly connected to the plenum chamber 3200 as seen in Fig. 56), and at least a part of which, when in use, contacts a portion of a nose of the user and allows gas to be delivered through an exhaust end, to enter at least one nostril, thereby to complete a pressurized gas delivery and to seal the nasal airway of the user ([0225] the seal-forming structure 3100 is configured to form a seal in use with the underside of the nose around the nares and optionally with the lip superior of the patient 1000; Fig. 43-45. [0223] each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient; Fig. 46-47);
wherein the front chamber section includes at least one opening ([0276] The plenum chamber 3200 may include a receiving hole 3204 that receives the vent assembly 3400; Fig. 57), and a ventilation component is provided on one of the openings of the front chamber section ([0276] vent assembly 3400; Fig. 57), the ventilation component comprising:
a noise reduction material ([0278] vent diffuser material 3404; Fig. 57) and a ventilation component body ([0277] vent body 3403; Fig. 57) with two ports (Inlet port: [0277] vent body holes 3405; Fig. 58 and 62. Outlet port: [0277] vent holes 3402; Fig. 59-61), and a port cover ([0277] vent cap 3401; Fig. 57);
wherein the sealing structure communicates with the front chamber section through a neck ([0224] stalk positioned between 3160 and 3165; Fig. 46);
wherein, the neck has a first inner diameter (see Fig. 46), the end of the sealing structure near the neck has a second inner diameter (wide base of nasal pillows 3165; see Fig. 46-47), and an exhaust end opening has a third inner diameter (tip of nasal pillows 3165; see Fig. 46-47);
wherein the second inner diameter is a maximum outer circle of the sealing structure (wide base of nasal pillows 3165; see Fig. 46-47), the second inner diameter is greater than the first inner diameter (wide base of nasal pillows 3165 is greater in diameter than stalk positioned between 3160 and 3165; see Fig. 46), and the second inner diameter is greater than the third inner diameter (wide base of nasal pillows 3165 is greater diameter than tip of nasal pillows 3165; see Fig. 47),
wherein the noise reduction material is configured to include a noise reduction mesh ([0278] the vent diffuser material 3404 performs the function of reducing noise and may be a porous material such as a foam or a network of fibers. A network of fibers fits the definition of a mesh, such as: “the fabric of a net” or “a weblike pattern or construction” found on Merriam-Webster).
Sharma does not explicitly disclose wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user. However, Sharma illustrates the nasal pillows 3615 being symmetrical to each other (Fig. 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal pillows to be symmetrical to each other in order to comfortably fit both of the patient’s nostrils at the same time. Additionally, modified Sharma teaches wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user (par. [0224]. According to applicant’s specifications, pg. 11 line 10-15, the uniform pressure is enabled by the symmetry of the two shaped protrusions, see Fig. 45-46).
Sharma does not disclose wherein the exhaust end of each of the two frusto-cone shaped protrusions have a non-uniform wall thickness and the non-uniform wall thickness is greater than a wall thickness of an opening in the exhaust end, and wherein the non-uniform wall thickness is configured to be uniformly variable.
However, Spear teaches a nasal seal for a respiratory patient interface (title) comprising two shaped protrusions ([0190] each prong 11; Fig. 9 and 12-14) wherein the exhaust end of each of the two shaped protrusions ([0190] terminal region 14 at a tip of the prong and nare sealing region 18; Fig. 14) have a non-uniform wall thickness and the non-uniform thickness is greater than a wall thickness of an opening in the exhaust end ([0190] The terminal region 14 of each nasal prong 11 has a wall thickness that tapers towards a tip of the nasal prong 11a. [0191] over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. In alternative embodiments, the extent of the taper may vary, but preferably the wall thickness at the tip of the nasal prongs 11a is less than about 20% of the wall thickness of the un-tapered lower nare sealing region 18; Fig. 14), and wherein the non-uniform wall thickness is configured to be uniformly variable ([0191] In the present example, over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. Examiner notes that a gradual decrease equates to a uniform varying as the thickness of the wall does not drastically change but instead gradually/slowly decreases to the desired thickness at the tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal pillows of Sharma to implement the shape and gradual taper toward the tip of the nasal prongs with the non-uniform thickness being greater than the wall thickness of the opening in the exhaust end in order to reduces pressure loading on the soft nose tissue in use, to reduce the likelihood of pressure sores as taught by Spear [0190].
Sharma does not disclose wherein the noise reduction material is integrally formed with one port of the ventilation component body to make an inseparable whole.
Bornholdt teaches the respiratory mask system including a ventilation component wherein the noise reduction material ([0282] diffuser 152; Fig. 19-20. [0420-0424] Diffuser 782a; Fig. 121-124) forms an inseparable whole with one port of the ventilation component body ([0282] The diffuser may be located within the seal assembly, when the seal assembly comprises a vent aperture 150 within which the diffuser 152 may be located, as shown in FIGS. 19 and 20. [0422] the diffuser 782a is permanently bonded to the diffuser clip 780a by means such as over-moulding or welding. The diffuser clip 780a comprises an aperture that is filled by the diffuser 782a.; Fig. 124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vent assembly of Sharma by permanently integrating the vent diffuser material into the inlet port of the vent body as taught by Bornholdt, thereby replacing the vent body holes. This provides the benefit of maintaining the function of the diffuser by cleaning it as recognized by Bornholdt [0282] instead of having to completely replace the diffuser material and/or vent module whenever the diffuser is not functioning properly. Additionally, permanently integrating the vent diffuser material into the inlet port ensures that the diffuser material does not fall out of vent body when the vent cap is not being used.
As modified Sharma teaches wherein the ventilation component comprises only two layers ([0278-0279] vent diffuser material 3404 and vent cap 3401; Fig. 57), wherein a first layer includes the noise reduction material on a first port (as modified above, vent diffuser material 3404 is permanently integrated into the inlet port of the vent body 3403) and a second layer includes a port cover on a second port (see Sharma Fig. 59; vent cap 3401 is provided on the outlet port of the vent body 3403 to form the vent holes 3402).Sharma is silent as to wherein the front chamber section and the sealing structure are integrally formed (Fig. 46-47, plenum chamber 3200 and nasal pillows 3165 appear to be integrally formed).
However, Guney teaches a patient interface (title) wherein the front chamber section ([0222] base 22; Fig. 2-1 to 2-2) and the sealing structure ([0222] nasal prong 24; Fig. 2-1 to 2-2) are integrally formed ([0223] The nasal prong assembly 20 may be integrally formed in one-piece, e.g., by silicone in an injection molding process (e.g., LSR (liquid silicone rubber) and CMSR (compression molded silicon rubber) molding technology)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plenum chamber and nasal pillows of Sharma to be integrally formed in one-piece as taught by Guney in order to reduce manufacturing complexity and have a seamless aesthetic appeal. Sharma does not disclose wherein the port cover is positionable on the other port of the two ports of the ventilation component body away from the noise reduction material, wherein the noise reduction material, through which an airflow that exits from the front chamber section is dispersed via pores in the noise reduction material, is situated at a specific distance from the port cover such that the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production.
According to the Applicant’s specifications, pg. 22 line 15-20, the distance between the port cover and the noise reduction material (more than 3.5 mm) enables the airflow dispersing from the noise reduction material to release gently into the external environment at a gas flow rate ranging between 0.1 to 6 liters per second.
Sharma teaches [0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400. The vent diffuser material 3404 may be a porous material, such as a foam or a network of fibers.
Additionally, Baecke teaches a nasal interface (title) comprising a noise reduction material ([00131] sound-deadening and/or humidification elements/material 400; Fig. 17B and 18) and a port cover (Fig. 18; See Examiner Annotations 1 below) wherein the noise reduction material, through which an airflow that exits from the front chamber section is dispersed via pores in the noise reduction material ([00131] The HME can be made out of foam, a pleated filter, paper, or any substance which acts as a condensation absorption media. The integrated HME muffler can be made out of any material that acts as a condensation absorption media, as well as any material that can absorb acoustic vibrations. The HME or integrated HME muffler may be placed anywhere that would allow the user to obtain the humidification or acoustic absorption benefits of the material; Fig. 17B and 18), is situated at a specific distance from the port cover (Fig. 18; See Examiner Annotations 1 below), such that the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production (as noted above the gas flow rate of between 0.1 to 6 liters per second is a product of the distance between the port cover and noise reduction material).
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Examiner Annotations 1
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Sharma to incorporate the teachings of the noise reduction material and port cover being spaced from each other as taught by Baecke in order to allow the user to obtain the acoustic absorption benefits of the material [00131] of Baecke and additionally to have a distance between the noise reduction material and the port cover be more than 3.5 mm, such that the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sharma would not operate differently with the claimed distance and since the noise reduction material is designed to reduce jetting and noise produced by diffusing the air flow before it reaches the environment, the device would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the distance claimed, indicating simply that the “certain distance” is “more than 3.5 mm” creating a glow rate “ranging between 0.1 to 6 liters per second” (specification page 22 line 15-20).
Further regarding claim 6, the modified invention of Sharma discloses
wherein there is a gap with a certain distance between a periphery of the port cover and a mouth of the ventilation component (S: [0277] vent holes 3402; Fig. 54 and 59-60), configured to guide a direction of the airflow through the noise reduction material to facilitate disassembly ([0277] The vent assembly 3400 may include vent holes 3402 that allow a continuous flow of gas to exit to atmosphere throughout the patient's respiratory cycle. A vent cap 3401 may be connected to the vent body 3403, and the vent holes 3402 may be formed between the vent cap 3401 and the vent body 3403. The vent cap 3401 may be permanently joined to the vent body 3403 or the vent cap 3401 may removable. Examiner notes that in a configuration where the vent cap 3401 is removable the vent holes 3402 facilitate disassembly since it provides a space for a user to pull the vent cap 3401), and wherein a positioning of the port cover results in different structures for an air inlet and an air outlet of the ventilation component (S: Fig. 57, 71 and 72: The air inlet is an oval structure as per Fig. 72 while the vent cap 3401 covers partially covers the air outlet as seen in Fig. 71 and manipulates the air outlet to be a plurality of vent holes 3402 with the structure of rectangular vents); and
a positioning stabilizer (S: [0250] positioning and stabilising structure 3300; Fig. 43-47 and all figures containing reference numeral 3300), which is configured to be provided on both ends of the front chamber section to provide a connection between components to secure the patient interface device to the face of the user (S: [0250] the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the seal-forming structure 3100 from the air circuit 4170. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of patient interface 3000 to position and stabilise the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (for example, the nose and/or mouth); Fig. 43-47 and especially Fig. 43).
Regarding claim 7, the modified invention of Sharma discloses the patient interface device according to claim 6, wherein the noise reduction material (3404) and the ventilation component body (3403) are made of different materials (S: [0278] The vent diffuser material 3404 may be a porous material, such as a foam or a network of fibers. [0279] The vent body 3403 may be constructed from a material that is more rigid than the plenum chamber 3200. [0233] The plenum chamber 3200 in examples of the present technology may be constructed from a relatively flexible material such as silicone rubber. Examiner notes that a material more rigid than a relatively flexible material such as silicone rubber is different from a porous material such as a foam or a network of fibers).
Regarding claim 8, the modified invention of Sharma discloses the patient interface device according to claim 6, wherein the positioning stabilizer (S: [0250] the positioning and stabilising structure 3300 comprises one or more tubes 3350; Fig. 43-47. [0271] In one form, the tubes 3350 are formed from silicone and the lower end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like) is harder than the front chamber section (S: [0233] The plenum chamber 3200 in examples of the present technology may be constructed from a relatively flexible material such as silicone rubber).
Regarding claim 10, the modified invention of Sharma discloses the patient interface device according to claim 6, wherein the ventilation component is detachably connectable to the opening of the front chamber section (S: [0276] the plenum chamber 3200 includes a connection lip 3201 and the vent body 3403 includes a connection channel 3408 that receives the connection lip 3201 to connect the vent body 3403 to the plenum chamber 3200. The connection may be permanent, e.g., via an adhesive or overmoulding the plenum chamber 3200 onto the vent body 3403, or the vent body 3403 may be removably connected to the plenum chamber 3200 such that the connection lip 3201 and the connection channel 3408 are separable; Fig. 57).
Regarding claim 11, Sharma discloses a patient interface device to deliver continuous positive pressure gas to a nasal airway of a user in a sealed manner for treatment of sleep disordered breathing ([0196] Patient interface 3000; Fig. 43-47. [0026-0028] supports the patient interface of the present disclosure being used for sleep disordered breathing), the patient interface device comprising:
a front chamber section ([0196] plenum chamber 3200; Fig. 48 and all figures containing reference numeral 3200), which includes a main chamber formed by a continuous wall (Fig. 48 and 52-56 show the plenum chamber 3200 formed by a continuous wall) and includes two entrance ends located on both sides ([0233] The plenum chamber 3200 may also include tube connectors 3202 to connect to corresponding tubes, as shown in FIGS. 43-47, to receive pressurised air; Fig. 48-52), with the main chamber being curved towards a side nearer a face of the user to form a chamber structure with a certain curvature that does not make contact with the user (As seen by Fig. 43, plenum chamber 3200 curves outwardly to ensure that only the seal-forming structure 3100 contacts the user. Additionally, the cross sectional view in Fig. 56 shows the plenum chamber 3200 being curved);
a sealing structure ([0196] seal-forming structure 3100; Fig. 43-48 and all figures containing reference numeral 3100. [0223] nasal pillows 3165; Fig. 46-47), which is configured to be two frusto-cone shaped protrusions ([0223] In one form the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or nasal pillows 3165; Fig. 46-47; [0224] frusto-cone nasal pillows 3165) and to communicate with the main chamber of the front chamber section (All configurations of the seal-forming structure 3100/nasal pillows 3165 are directly connected to the plenum chamber 3200 as seen in Fig. 56), and at least a part of which, when in use, contacts a portion of a nose of the user and allows gas to be delivered through an exhaust end to enter at least one nostril, thereby to complete a pressurized gas delivery and to seal the nasal airway of the user ([0225] the seal-forming structure 3100 is configured to form a seal in use with the underside of the nose around the nares and optionally with the lip superior of the patient 1000; Fig. 43-45. [0223] each nasal puff or nasal pillow being constructed and arranged to form a seal with a respective naris of the nose of a patient; Fig. 46-47);
wherein the front chamber section includes at least one opening ([0276] The plenum chamber 3200 may include a receiving hole 3204 that receives the vent assembly 3400; Fig. 57), and a ventilation component is provided on one of the openings of the front chamber section ([0276] vent assembly 3400; Fig. 57), and wherein the ventilation component comprising:
a noise reduction material ([0278] vent diffuser material 3404; Fig. 57) and a ventilation component body ([0277] vent body 3403; Fig. 57) with two ports (Inlet port: [0277] vent body holes 3405; Fig. 58 and 62. Outlet port: [0277] vent holes 3402; Fig. 59-61), and wherein the noise reduction material is configured to first divide an airflow that exits from the front chamber section into smaller streams (0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400), before the airflow reaches an external environment through a mouth on the other port of the two ports of the ventilation component body away from the noise reduction material ([0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400);
a positioning stabilizer ([0250] positioning and stabilising structure 3300; Fig. 43-47 and all figures containing reference numeral 3300), which is configured to be provided on both ends of the front chamber section to provide a connection between components to secure the patient interface device to the face of the user ([0250] the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the seal-forming structure 3100 from the air circuit 4170. The tubes 3350 are an integral part of the positioning and stabilising structure 3300 of patient interface 3000 to position and stabilise the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (for example, the nose and/or mouth); Fig. 43-47 and especially Fig. 43);
wherein the sealing structure communicates with the front chamber section through a neck ([0224] stalk positioned between 3160 and 3165; Fig. 46);
wherein, the neck has a first inner diameter (see Fig. 46), the end of the sealing structure near the neck has a second inner diameter (wide base of nasal pillows 3165; see Fig. 46-47), and an exhaust end opening has a third inner diameter (tip of nasal pillows 3165; see Fig. 46-47);
wherein the second inner diameter is a maximum outer circle of the sealing structure (wide base of nasal pillows 3165; see Fig. 46-47), the second inner diameter is greater than the first inner diameter (wide base of nasal pillows 3165 is greater in diameter than stalk positioned between 3160 and 3165; see Fig. 46), and the second inner diameter is greater than the third inner diameter (wide base of nasal pillows 3165 is greater diameter than tip of nasal pillows 3165; see Fig. 47),
wherein the noise reduction material is configured to include a noise reduction mesh ([0278] the vent diffuser material 3404 performs the function of reducing noise and may be a porous material such as a foam or a network of fibers. A network of fibers fits the definition of a mesh, such as: “the fabric of a net” or “a weblike pattern or construction” found on Merriam-Webster);wherein the noise reduction material has at least one of the following features:
1) the noise reduction material being made of fibrous material ([0278] The vent diffuser material 3404 may be a porous material, such as a foam or a network of fibers).
Sharma does not explicitly disclose wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user. However, Sharma illustrates the nasal pillows 3615 being symmetrical to each other (Fig. 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the nasal pillows to be symmetrical to each other in order to comfortably fit both of the patient’s nostrils at the same time. Additionally, modified Sharma teaches wherein when the patient interface is worn, the frusto-cone shaped protrusion is at least partially deformed to provide uniform pressure around a periphery of the at least one nostril to seal the nasal airway of the user (par. [0224]. According to applicant’s specifications, pg. 11 line 10-15, the uniform pressure is enabled by the symmetry of the two shaped protrusions, see Fig. 45-46).
Sharma does not disclose wherein the exhaust end of each of the two frusto-cone shaped protrusions have a non-uniform wall thickness and the non-uniform wall thickness is greater than a wall thickness of an opening in the exhaust end, and wherein the non-uniform wall thickness is configured to be uniformly variable.
However, Spear teaches a nasal seal for a respiratory patient interface (title) comprising two shaped protrusions ([0190] each prong 11; Fig. 9 and 12-14) wherein the exhaust end of each of the two shaped protrusions ([0190] terminal region 14 at a tip of the prong and nare sealing region 18; Fig. 14) have a non-uniform wall thickness and the non-uniform thickness is greater than a wall thickness of an opening in the exhaust end([0190] The terminal region 14 of each nasal prong 11 has a wall thickness that tapers towards a tip of the nasal prong 11a. [0191] over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. In alternative embodiments, the extent of the taper may vary, but preferably the wall thickness at the tip of the nasal prongs 11a is less than about 20% of the wall thickness of the un-tapered lower nare sealing region 18; Fig. 14), and wherein the non-uniform wall thickness is configured to be uniformly variable ([0191] In the present example, over the length of the terminal region 14, the wall thickness of the nasal prongs 11 gradually decreases from a thickness t.sub.1 of about 0.8 mm to a thickness t.sub.3 at the tip of about 0.1 mm. Examiner notes that a gradual decrease equates to a uniform varying as the thickness of the wall does not drastically change but instead gradually/slowly decreases to the desired thickness at the tip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nasal pillows of Sharma to implement the shape and gradual taper toward the tip of the nasal prongs with the non-uniform thickness being greater than the wall thickness of the opening in the exhaust end in order to reduces pressure loading on the soft nose tissue in use, to reduce the likelihood of pressure sores as taught by Spear [0190].
Sharma does not disclose wherein the noise reduction material forms an inseparable whole with one port of the ventilation component body, wherein a connection between the noise reduction material and the ventilation component body is seamless.
However, Bornholdt teaches the respiratory mask system including a ventilation component wherein the noise reduction material ([0282] diffuser 152; Fig. 19-20. [0420-0424] Diffuser 782a; Fig. 121-124) forms an inseparable whole with one port of the ventilation component body ([0282] The diffuser may be located within the seal assembly, when the seal assembly comprises a vent aperture 150 within which the diffuser 152 may be located, as shown in FIGS. 19 and 20. [0422] the diffuser 782a is permanently bonded to the diffuser clip 780a by means such as over-moulding or welding. The diffuser clip 780a comprises an aperture that is filled by the diffuser 782a.; Fig. 124), wherein a connection between the noise reduction material and the ventilation component body is seamless (Fig. 19-20 and 121-124).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vent assembly of Sharma by permanently integrating the vent diffuser material into the inlet port of the vent body as taught by Bornholdt, thereby replacing the vent body holes. This provides the benefit of maintaining the function of the diffuser by cleaning it as recognized by Bornholdt [0282] instead of having to completely replace the diffuser material and/or vent module whenever the diffuser is not functioning properly. Additionally, permanently integrating the vent diffuser material into the inlet port ensures that the diffuser material does not fall out of vent body when the vent cap is not being used.
As modified Sharma teaches wherein the ventilation component comprises only two layers ([0278-0279] vent diffuser material 3404 and vent cap 3401; Fig. 57), wherein a first layer includes the noise reduction material on a first port (as modified above, vent diffuser material 3404 is permanently integrated into the inlet port of the vent body 3403) and a second layer includes a port cover on a second port (see Sharma Fig. 59; vent cap 3401 is provided on the outlet port of the vent body 3403 to form the vent holes 3402).Sharma is silent as to wherein the front chamber section and the sealing structure are integrally formed (Fig. 46-47, plenum chamber 3200 and nasal pillows 3165 appear to be integrally formed).
However, Guney teaches a patient interface (title) wherein the front chamber section ([0222] base 22; Fig. 2-1 to 2-2) and the sealing structure ([0222] nasal prong 24; Fig. 2-1 to 2-2) are integrally formed ([0223] The nasal prong assembly 20 may be integrally formed in one-piece, e.g., by silicone in an injection molding process (e.g., LSR (liquid silicone rubber) and CMSR (compression molded silicon rubber) molding technology)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plenum chamber and nasal pillows of Sharma to be integrally formed in one-piece as taught by Guney in order to reduce manufacturing complexity and have a seamless aesthetic appeal.
Sharma does not disclose the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production.
According to the Applicant’s specifications, pg. 22 line 15-20, the distance between the port cover and the noise reduction material (more than 3.5 mm) enables the airflow dispersing from the noise reduction material to release gently into the external environment at a gas flow rate ranging between 0.1 to 6 liters per second.
Sharma teaches [0278] A vent diffuser material 3404 may be positioned between the vent cap 3401 and the vent body 3403 to diffuse the flow of gas exiting through the vent body holes 3405 before it reaches atmosphere via the vent holes 3402 to reduce jetting and noise produced by the flow as it travels through the vent assembly 3400. The vent diffuser material 3404 may be a porous material, such as a foam or a network of fibers.
Additionally, Baecke teaches a nasal interface (title) comprising a noise reduction material ([00131] sound-deadening and/or humidification elements/material 400; Fig. 17B and 18) and a port cover (Fig. 18; See Examiner Annotations 1 above) wherein the noise reduction material, through which an airflow that exits from the front chamber section is dispersed via pores in the noise reduction material ([00131] The HME can be made out of foam, a pleated filter, paper, or any substance which acts as a condensation absorption media. The integrated HME muffler can be made out of any material that acts as a condensation absorption media, as well as any material that can absorb acoustic vibrations. The HME or integrated HME muffler may be placed anywhere that would allow the user to obtain the humidification or acoustic absorption benefits of the material; Fig. 17B and 18), is situated at a specific distance from the port cover (Fig. 18; See Examiner Annotations 1 above), such that the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production (as noted above the gas flow rate of between 0.1 to 6 liters per second is a product of the distance between the port cover and noise reduction material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Sharma to incorporate the teachings of the noise reduction material and port cover being spaced from each other as taught by Baecke in order to allow the user to obtain the acoustic absorption benefits of the material [00131] and additionally to have a distance between the noise reduction material and the port cover be more than 3.5 mm, such that the ventilation component body is configured such that the airflow, once dispersed by the noise reduction material, is able to gather more gently before being discharged into an external environment at a gas flow rate between 0.1 to 6 liters per second, to reduce noise production since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sharma would not operate differently with the claimed distance and since the noise reduction material is designed to reduce jetting and noise produced by diffusing the air flow before it reaches the environment, the device would function appropriately having the claimed distance. Further, it appears that applicant places no criticality on the distance claimed, indicating simply that the “certain distance” is “more than 3.5 mm” creating a glow rate “ranging between 0.1 to 6 liters per second” (specification page 22 line 15-20).
Further regarding claim 11, the modified invention of Sharma does not explicitly disclose wherein an area of the opening of the front chamber section, at which the ventilation component is installed, has a ratio of at least 1:9 to an outer wall area of the front chamber section, and the area of the opening of the front chamber section has a ratio of at least 5:1 to an area of the noise reduction material.
Sharma discloses a vent structure configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use [0072].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Sharma to have an area of the receiving hole, at which the vent body is installed, to have a ratio of at least 1:9 to an outer wall area of the plenum chamber, and the area of the receiving hole has a ratio of at least 5:1 to an area of the vent diffuser material since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sharma would not operate differently with the claimed area ratios and since plenum chamber is designed to fit the vent body via the receiving hole and the vent body houses the vent diffuser material, the device would function appropriately having the claimed area ratios. Further, it appears that applicant places no criticality on the area ratios claimed, indicating simply that the area ratios should “at least” be the claimed ratios (specification page 23 line 4-9).
Regarding claim 12, the modified invention of Sharma discloses the patient interface device according to claim 11, wherein the a port cover (S: [0277] vent cap 3401; Fig. 57) is connectable to the mouth on one port of the ventilation component body away from the noise reduction material (S: [0277] A vent cap 3401 may be connected to the vent body 3403, and the vent holes 3402 may be formed between the vent cap 3401 and the vent body 3403; Fig. 54 and 56. In the modified invention of Sharma the vent diffuser material 3404 is at the vent body holes 3405; Fig. 54 and 56), and a dispersed airflow from the ventilation component flows out to the external environment through a gap between a periphery of the port cover and the mouth of the ventilation component (S: The vent assembly 3400 may include vent holes 3402 that allow a continuous flow of gas to exit to atmosphere throughout the patient's respiratory cycle; Fig. 54. In the modified invention of Sharma, the vent diffuser material 3434 at the air inlet diffuses the air flowing out to the external environment as supported by Bornholdt [0283]. Additionally, by positioning the diffuser 152 in the seal assembly, exhausted air is diffused as the exhausted air exits the breathing chamber of the seal assembly, and before the exhausted air contacts any other mask components or has an opportunity to generate noise or entrain surrounding air).
Regarding claim 13, the modified invention of Sharma discloses the patient interface device according to claim 11, wherein a periphery of the ventilation component includes a clamping structure that connects to the front chamber section (S: [0276] the plenum chamber 3200 includes a connection lip 3201 and the vent body 3403 includes a connection channel 3408 that receives the connection lip 3201 to connect the vent body 3403 to the plenum chamber 3200. The connection may be permanent, e.g., via an adhesive or overmoulding the plenum chamber 3200 onto the vent body 3403, or the vent body 3403 may be removably connected to the plenum chamber 3200 such that the connection lip 3201 and the connection channel 3408 are separable. Also, in another example, the vent body 3403 may have a connection lip that is received in a connection channel of the plenum chamber 3200; Fig. 43-57, specifically 53-57 depicts the connection channel lip 3201 being clamped by the lip 3201).
Regarding claim 14, the modified invention of Sharma discloses the patient interface device according to claim 11, wherein a shape of the noise reduction material is similar to a shape of the mouth connectable to the noise reduction material (S: Port at vent body holes 3405; Fig. 54 and 57, see Examiner Annotations 2) of the ventilation component body (S: vent diffuser material 3404 perfectly fits into the shape of the vent body 3403 as seen in Fig. 57. In the modified invention of Sharma, the vent diffuser material 3404 fits perfectly into mouth at the vent body holes 3405 in a similar fashion taught by the vent diffuser 152 having a similar shape as and fitting into the vent aperture 150 as seen in Bornholdt Fig. 20).
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Examiner Annotations 2
Regarding claim 15, the modified invention of Sharma discloses the patient interface device according to claim 12, wherein the mouth connectable to the noise reduction material of the ventilation component body (S: Port at vent body holes 3405; Fig. 54 and 57, see Examiner Annotations 2) is smaller than or equal to the mouth of the ventilation component body connectable to the port cover (S: Port at vent holes 3405; Fig. 54 and 57, see Examiner Annotations 2) (S: the shape of the vent body opens outwardly as seen in Fig. 54 and 57(also see Examiner Annotations 2) makes the inlet port/mouth at vent body holes 3405 smaller than the outlet port/mouth at vent holes 3402 which is easier to see when the vent cap 3401 is removed).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20230364373 A1) in view of Spear et al. (US 20210213227 A1), Bornholdt et al. (US 20190151592 A1), Guney et al. (US 20090044808 A1), and Baecke et al. (WO 2017044392 A1) as applied to claim 6 above, and further in view of Dantanarayana et al. (US 20040094157 A1), hereinafter Dan.
Regarding claim 9, the modified invention of Sharma discloses the patient interface device according to claim 6, but does not disclose wherein the port cover is connectable to the ventilation component body via a snap-fitting.
Sharma teaches the vent cap 3401 may be permanently joined to the vent body 3403 or the vent cap 3401 may removable but does not teach the vent cap 3404 is connectable to the vent body 3403 via a snap-fitting.
However, Dan teaches a flow regulation vent wherein a cover (40) is attached to a base portion (30) via a snap fitting ([0071] The cover can be attached to the base portion in any known manner, including snap-fit, screw-on or glued. The snap-fit or screw-on connection is preferred since this provides for ease of cleaning or replacing the vent 10; Fig. 4-6)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vent cap of Sharma to be attached to the vent body via a snap-fit as taught by Dan to provide for easy cleaning of the vent diffuser material.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 20230364373 A1) in view of Spear et al. (US 20210213227 A1), Bornholdt et al. (US 20190151592 A1), Guney et al. (US 20090044808 A1), and Baecke (WO 2017044392 A1) as applied to claim 11 above, and further in view of Edwards (US 20220347417 A1).
Regarding claim 16, the modified invention of Sharma discloses the patient interface device according to claim 11, but does not disclose wherein the positioning stabilizer extends in a direction of the openings at both ends of the front chamber section without bending itself.
However, Edwards teaches a patient interface wherein the positioning stabilizer ([0211] One or more positioning and stabilising structure connectors (or headgear connectors) 3290 may be provided to the plenum base 3105.The positioning and stabilising structure connectors 3290 are configured to, in use, connect to the positioning and stabilising structure 3300. The positioning and stabilising connectors 3290 may be located on opposing lateral sides of the plenum base 3105. It is contemplated that the positioning and stabilising structure connectors 3290 may comprise clips, buckles or any other connector able to connect to, or be connected to, a positioning and stabilising structure 3300, for example headgear straps and headgear conduits; Fig. 3Y-3CC) extends in a direction of the openings at both ends of the front chamber section (plenum base 3105; Fig. 3Y-3CC) without bending itself (As seen in Fig. 3Y-3CC, positioning and stabilising structure connectors 3290 extend out from the openings on both sides of the plenum base 3150 without bending).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the positioning and stabilizing structure of Sharma to include positioning and stabilising structure connectors extending from both openings of the plenum chamber without bending as taught by Edwards in order to provide a more versatile and secure connection to headgear conduits or straps.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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