DETAILED ACTION
This Office Action is response to the amendment filed on January 9, 2026. Primary Examiner acknowledges Claims 1-8, 10-14, 47-51, and 53-61 are pending in this application, with Claims 1-8, 10-14, 47-49, and 53-57 having been currently amended, Claims 58-61 having been newly added, and Claims 9, 15-46, and 52 having been cancelled.
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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 10-14, 47-51, and 53-61 are rejected under 35 U.S.C. 103 as being obvious over Formica (2013/0199537, which shares a common assignee with the instant application and has a disclosure date beyond of the grace period) in view of Ho et al. (2007/0125385) and Asvadi et al. (2014/0109911).
As to Claim 1, Formica discloses a patient interface (best seen Figures 1-2, 1-3, 1-5, 2, 3, and 4), comprising: a plenum chamber (49, “FIGS. 1-4 and 1-5, may include an aperture or opening 46 adapted to receive and seal with the connector 30 of the nares portion 20, to pneumatically connect the nares portion 20 to the chamber 49 of the mouth portion 40.” Para 0239) pressurizable to a therapeutic pressure of at least 6 cm of H2O above ambient pressure (CPAP, “by continuous positive airway pressure (CPAP) flow generator systems involves the continuous delivery of air (or other breathable gas) pressurized above atmospheric pressure to the airways of a human or other mammalian patient via a conduit and a mask. … Pressurized air is delivered to the mask by a conduit connected to the CPAP device and the mask.” Para 0003) throughout the patient’s respiratory cycle in use; a seal forming structure (defined by the combination of 20 and 40, wherein “FIGS. 1-4 and 1-5, may include an aperture or opening 46 adapted to receive and seal with the connector 30 of the nares portion 20, to pneumatically connect the nares portion 20 to the chamber 49 of the mouth portion 40.” Para 0239) joined to the plenum chamber (49) comprising a nasal portion (20, “nares portion 20” Para 0239) and an oral portion (40, “mouth portion 40” Para 0239), the nasal portion (20) having at least one nasal hole (one of 22, “The nares portion 20 may include nares sealing portion 22, a decoupling portion 25, headgear connectors 21, a swivel ring 4, and a plug 3.” Para 0219; also see: “As illustrated in FIGS. 1-1 to 4, embodiments of the present technology may include a nares sealing portion 22 in the form of a pillows or prongs type nares seal. The nares sealing portion 22 may alternatively be a membrane type nares seal or a nasal chamber. Nares sealing portion 22 is adapted to form a seal with the nares of a patient in use. Nares sealing portion 22 may be positioned to sit underneath the patient's nose, and be shaped to form an effective seal.” Para 0265) configured to deliver a flow of air at said therapeutic pressure to the patient’s nares in use, the oral portion (40) having an oral hole (42, “A mouth portion 40 as illustrated in FIGS. 1-2 to 4 may include mouth sealing portion 42, a decoupling portion 45 to decouple forces applied to the mouth portion 40 from the mouth sealing portion 42, lower headgear connectors 41, and a swivel connector 44. The mouth portion 42 forms a chamber 49 into which air may be delivered and directed to the patient's mouth.” Para 0237; also see: “As illustrated in FIGS. 1-1 to 4, embodiments of the present technology may include a mouth sealing portion 42. Mouth sealing portion 42 is adapted to form a seal with the mouth of a patient in use. Mouth sealing portion 42 may be positioned to sit around the patient's mouth, and be shaped to form an effective seal. The mouth sealing portion 42 may be in the form of a cushion, which forms a rear opening 50 for insertion of the patient's mouth.” Para 0279) configured to deliver the flow of air at therapeutic pressure to the patient’s mouth in use, the seal forming structure (defined by the combination of 20 and 40) constructed and arranged to maintain said therapeutic pressure in the plenum chamber (49) through the patient’s respiratory cycle in use; a vent (6, “The plug 3 may include a plurality of optional vent holes 6 that allow air exhaled by the patient's nose to be vented out of the nares portion 20. Preferably, vent holes 6 are arranged in a diffuse array to prevent jetting of air from the vent.” Para 0221) comprising a plurality of holes (best seen Figures 1-2, 1-3, 1-4, 1-5, and 2) configured to allow a continuous vent flow from an interior of the plenum chamber (49) to the ambient throughout the patient’s respiratory cycle while the therapeutic pressure within the plenum chamber (49) is positive with respect to ambient; and a positioning and stabilizing structure (60, “The positioning and stabilizing structure in the form of headgear 60 may be adapted to maintain the mask system in sealing engagement with the nares and mouth of a patient. The headgear 60 may include straps adapted to secure the position of the headgear 60 on the head of the patient. The straps may include a side strap headgear strap 61, a lower headgear strap 63, a rear headgear portion 65 and a crown headgear portion 66. The straps may also direct a tension force on the mask adapted to seal the mask with the face of the patient.” Para 0298) comprising at least one tie (one of 61/63, “The straps may include a side strap headgear strap 61, a lower headgear strap 63, a rear headgear portion 65 and a crown headgear portion 66.” Para 0298) being configured to hold the seal forming structure (defined by the combination of 20 and 40) in a therapeutically effective position on the patient’s head in use; wherein the nasal portion (20) of the seal forming structure (defined by the combination of 20 and 40) includes a nasal textile portion (“fabric” and “fabric” combinations, “Preferably the nares sealing portion may be constructed from a polymer such as silicone, thermoplastic elastomer, thermoplastic urethane. Alternatively, the nares seal portion may be constructed of foam, gel, fabric or other compliant material. Alternatively, the nares sealing portion may be constructed of a combination of materials such as a foam and fabric lamination, fabric and polymer combination or any other combination of the afore mentioned materials.” Para 0264) that forms at least one nasal hole (22) and is configured to contact the patient’s nose in use, the nasal textile portion (“fabric” and “fabric” combinations) being positively curved around a nasal axis (best seen Figures 3 and 4); wherein the oral portion (40) of the seal forming structure (defined by the combination of 20 and 40) includes an oral textile portion (“fabric” and “fabric” combinations, “Preferably the mouth sealing portion may be constructed from a polymer such as silicone, thermoplastic elastomer, or thermoplastic urethane. Alternatively the mouth seal portion may be constructed of a foam, gel, fabric or other compliant material. Alternatively, the mouth seal portion may be constructed of a combination of materials such as a foam and fabric lamination, fabric and polymer combination or any other combination of the afore mentioned materials.” Para 0278) that is separate (as shown in Figures 1-5, 2, 3, and 4) from the nasal textile portion (“fabric” and “fabric” combinations), forms the oral hole (42) and is configured to contact the patient’s face proximal to the patient’s mouth in use, the an oral textile portion (“fabric” and “fabric” combinations) being positively curved around an oral axis (best seen Figures 3 and 4) that is differently oriented form the nasal axis (best seen Figures 3 and 4); and wherein the patient interface (best seen Figures 1-2, 1-3, 1-5, 2, 3, and 4) is configured to allow the patient to breath from the ambient in the absence of the flow of air at the therapeutic pressure (as a function of the open vent 6).
Yet, Formica does not expressly disclose the construction of the nasal portion of the seal forming structure configured to contact the patient’s nose in a positively curved configuration “around only a single nasal axis”, nor the construction of the “nasal textile laminate comprising a first textile layer and a first elastomeric material layer” and the “oral textile laminate comprising a second textile layer and a second elastomeric material layer”.
Regarding the configuration of the nasal portion of the seal forming structure to be configured to positively curve “around only a single nasal axis”, although Formica discloses the configuration of the patient interface whereby the nasal portion (20) of the seal forming structure (defined by the combination of 20 and 40) is operatively separable from the oral portion (40) of the seal forming structure (defined by the combination of 20 and 40) to operate as nasal portion alone, an oral portion alone, or cooperatively as a combined oral portion and nasal portion, this construction does not preclude, prevent, or hinder the use of an alternative patient interface whereby the nasal portion (20) and the oral portion (40) are unable to be separated, formed in a unitary structure, and still perform the functionality of providing ventilation gas to the patient – when the separable feature is not needed or warranted.
Ho teaches the aforementioned patient interface whereby the nasal portion and the oral portion are not able to be separated, formed in a unitary structure, and able to provide ventilation gas to the patient.
As shown in Figures 23/24 and 25/26 of Ho, Ho teaches the nasal portion (x24, where 624 is associated with Figures 23/24 and 724 is associated with Figure 25/26, 624 - “A sixth exemplary embodiment is shown in FIGS. 23 and 24. In this embodiment, patient interface 610 includes a faceplate 612 and a seal member 614 having an oral cushion portion 622 and nasal interface portion 624.” Para 0088; and 724 - “FIGS. 25 and 26 illustrate a further embodiment for a seal member 714 suitable for use in the patient interface of the present invention. In this embodiment, seal member includes an oral cushion portion 722 and a nasal interface portion 724.” Para 0089) is integrally connected to and unable be separated from the oral portion (x22, where 622 is associated with Figures 23/24 and 722 is associated with Figures 25/26, 622 -“A sixth exemplary embodiment is shown in FIGS. 23 and 24. In this embodiment, patient interface 610 includes a faceplate 612 and a seal member 614 having an oral cushion portion 622 and nasal interface portion 624.” Para 0088; and 722 – “FIGS. 25 and 26 illustrate a further embodiment for a seal member 714 suitable for use in the patient interface of the present invention. In this embodiment, seal member includes an oral cushion portion 722 and a nasal interface portion 724.” Para 0089). In this configuration, the disclosure of Figures 23/24 appears to be more closely related to the construction of Formica’s seal forming structure as the nasal portion includes prongs; whilst, the disclosure of Figures 25/26 is an alternative structure of the nasal port having the claimed “only a single nasal axis”. Regardless of the decision to use prongs or the claimed “only a single nasal axis” the resultant effect remains a patient interface suitable for imparting ventilation support to patient to both the oral portion and the nasal portion. Thus the constructions as shown in Ho are functionally equivalent alternative structures suitable for imparting ventilation support to patient to both the oral portion and the nasal portion.
Still further, as shown in Figures 35/36 and 37/38 of Ho, Ho teaches the nasal portion (1062 of Figures 35/36 and 1108 of Figures 37/38 – “Seal member 1054 includes an oral cushion portion 1060 and a nasal interface portion 1062.” Para 102; “Seal member 1104 includes an oral cushion portion 1106 and a nasal interface portion 1108.” Para 0103) is integrally connected to and unable be separated from the oral portion (1060 of Figures 35/36 and 1106 of Figures 37/38 - “Seal member 1054 includes an oral cushion portion 1060 and a nasal interface portion 1062.” Para 102; “Seal member 1104 includes an oral cushion portion 1106 and a nasal interface portion 1108.” Para 0103). In this configuration, the disclosure of Figures 37/38 appears to be more closely related to the construction of Formica’s seal forming structure as the nasal portion includes prongs; whilst, the disclosure of Figures 35/36 is an alternative structure of the nasal port having the claimed “only a single nasal axis”. Regardless of the decision to use prongs or the claimed “only a single nasal axis” the resultant effect remains a patient interface suitable for imparting ventilation support to patient to both the oral portion and the nasal portion. Thus the constructions as shown in Ho are functionally equivalent alternative structures suitable for imparting ventilation support to patient to both the oral portion and the nasal portion.
Hence, the decision to modify the seal forming structure of Formica to be made in a unitary construction whereby the nasal portion is configured to have the claimed “only a single nasal axis” as taught by Ho was a known construction consideration of seal forming structures to permit ventilation of gases to be imparted to both the oral portion and the nasal portion when the patient interface is worn by the user.
Regarding the material composition of each of the “nasal textile laminate” and the “oral textile laminate” to each have a “textile layer” and an “elastomeric material layer”, although Formica clearly discloses the material composition of seal forming structure portions made of “fabric and polymer combination” (Paras 0264 and 0278) was known, the explicit features of lamination and layering was not addressed by Formica, but was known in prior art as taught by Asvadi.
As clearly shown in Figure 10 of Asvadi, Asvadi teaches the seal forming structure comprises a polymer layer (44, Para 0066) that is attached to a fabric layer (42, Para 0065) such that the “third layer 44 can be coated or laminated on [the] second layer 42” (Para 0066). In this teaching of Asvadi, Asvadi affirms the manner of manufacturing of a fabric and polymer combination in a seal forming structure to include the features of lamination of a fabric layer to a polymer layer was a known method of manufacturing to yield a seal forming structure for a patient interface.
Still further, as shown in Figure 14 of Asvadi, Asvadi teaches an additional alternative configuration of another seal forming structure of a patient interface having a polymer layer (66, Para 0074 – ref back to 44) is layered upon a textile layer (64, Para 0078) to form the claimed lamination of a fabric layer upon a polymer layer was a known method of manufacturing to yield a seal forming structure for a patient interface.
In light of the teachings of Asvadi, it is clear the use of the methodology of lamination through the layering of one material composition upon another was a known method of manufacturing a seal forming structure to support the ventilation of gases to be administered to a patient wearing the patient interface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the nasal portion of the seal forming structure of Formica to be made of the claimed “only a single nasal axis” as taught by Ho, a known functionally equivalent structure, suitable for imparting ventilation support to the patient wearing the patient interface, and further to modify the material composition of both the nasal portion and the oral portions to include a fabric layer laminated upon a polymer layer, as taught by Asvadi, to be known manufacturing technique to yield a seal forming structure suitable for imparting ventilation support to the patient wearing the patient interface.
As to Claims 2 and 48, the modified Formica, specifically Formica discloses the seal forming structure (defined by the combination of 20 and 40) is constructed from silicone (“a polymer such as silicone …. may be constructed of a combination of materials such as a foam and fabric lamination, fabric and polymer combination” Para 0264 and 0278) overmolded (“lamination” or “combination” Para 0264 and 0278, the act of lamination is a known process by which one material is molded over the other – and thus overmolded; similarly, the act of a combination requires the process of intermeshing one material with another whether by layering or interlacing which effectively results in an interlinked material) to the nasal textile portion (“fabric” and “fabric” combinations) and the oral textile portion (“fabric” and “fabric” combinations).
As to Claims 3 and 50, the modified Formica, specifically Formica discloses the silicone (“a polymer such as silicone …. may be constructed of a combination of materials such as a foam and fabric lamination, fabric and polymer combination” Para 0264 and 0278) is exposed between the nasal textile portion (“fabric” and “fabric” combinations) and the oral textile portion (“fabric” and “fabric” combinations).
As to Claims 4 and 51, the modified Formica, specifically Formica discloses the silicone (“a polymer such as silicone …. may be constructed of a combination of materials such as a foam and fabric lamination, fabric and polymer combination” Para 0264 and 0278) exposed between the nasal textile portion (“fabric” and “fabric” combinations) and the oral textile portion (“fabric” and “fabric” combinations) is configured to be positioned adjacent to the patient’s lip superior in use (“The mouth sealing portion may include a membrane that can stretch over the upper lip and chin regions of the patient, i.e. be more flexible than the side regions of the membrane that interface with the cheeks of the patient. … . Further, the flexibility of the upper lip and chin regions means that the mouth sealing portion is able to flex from a generally planar position to fit flat/pancake faces, and can also fit pointy/angular faces by flexing into a concave position.” Para 0277; also see: “The sealing portion 42 of the mouth portion 40 may include a bottom portion 79, side portions 81, a top portion 85 and a neck portion 87. The bottom portion 79 may be adapted to form a seal with a patient's lower lip or chin area. The top portion 85 may be adapted to form a seal with the patient's upper lip area.” Para 0245; “The nares sealing portion and the mouth sealing portion may both need to form a seal with the upper lip of the patient. However, due to the limited amount of surface area in which to position the flares sealing portion and the mouth sealing portion in the upper lip region, the various embodiments utilize structural elements to accomplish sealing of both the nares sealing portion and the mouth sealing portion in the upper lip region of the patient.” Para 0256; “The nares sealing portion 222 may include a nose tip engagement portion 254, an upper lip engagement portion 256, and thickened corner regions 258.” Para 0267; “The sealing portion 222 includes an upper lip engagement portion 256 that engages with a patient's upper lip in use. The upper lip engagement portion 256 is formed as a hanging, flexible membrane, with a rear gap between the upper lip engagement portion 256 of the sealing portion 222 and the supporting portion 253. The rear gap is positioned between rear anchor points 259 that anchor the sealing portion 222 to the supporting portion 253. The flexible, hanging membrane provides a flexible surface that remains in tensile contact with the upper lip of the patient during patient interface movement, and can stretch to accommodate varying facial geometries by allowing movement of the upper lip engagement portion 256.” Para 0269).
As to Claim 5, the modified Formica, specifically Ho teaches the nasal axis (best seen Figures 25/26 and 35/36) and the oral axis (best seen Figures 25/26 and 35/36) are located in the patient’s sagittal plane in use.
As to Claim 6, the modified Formica, specifically Ho teaches the nasal axis (best seen Figures 25/26 and 35/36) and the oral axis (best seen Figures 25/26 and 35/36) are oriented relative to one another at an angle. As best seen in Figures 25/26 and 35/36, the nasal axis is oriented in a vertical direction upwards towards the eyes of the patient, whilst the oral axis is oriented in a horizontal direction into the mouth of the user. The resultant effect of this configuration is effectively at least 90 degrees.
Yet, the modified Formica does not expressly disclose the explicit angle to be “greater than 90 degrees”.
Nevertheless, the configuration of “greater than 90 degrees” is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide sealed engagement of the seal forming structure to the anatomy of the patient. From an anatomical standpoint, the general anatomy of a face includes a nose which extends anterior to the mouth of the user. In this anterior extension, the nose of the patient additionally requires the encompassing of the nose point and at least a portion of the slope of the nose towards the nasal bridge. Consequently, the anatomy of the patient is not 90 degrees but rather greater than 90 degrees to embrace the nose of the patient in a vertical direction whilst also encompassing the mouth of the patient in a horizontal direction.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the angular relationship of the nasal axis to the oral axis of the modified Formica to be greater than 90 degrees, a known result effective variable, to meet the anatomy of the patient’s nose and mouth.
As to Claim 7, the modified Formica, specifically Formica discloses the radius of curvature of the nasal textile portion (“fabric” and “fabric” combinations) is less than the radius of curvature of the oral textile portion (“fabric” and “fabric” combinations). As best seen in Figures 3 and 4, the radius of curvature at the central opening of the nasal portion (20) is significantly smaller than the radius of curvature at the central opening of the oral portion (40), as the construction of the nasal portion (20) for engagement with the nasal passageways of the patient is smaller than the construction of the oral portion for engagement with the oral passageway of the patient.
As to Claims 8 and 55, the modified Formica, specifically Formica discloses the nasal textile portion (“fabric” and “fabric” combinations) and the oral textile portion (“fabric” and “fabric” combinations) are constructed from an air impermeable material (as a function of the “silicone” polymer added to the “fabric” resulting in the “fabric” combination).
As to Claims 10 and 53, the modified Formica, specifically Formica discloses the first textile (any of “fabric” and “fabric” combinations) and the second textile (any of “fabric” and “fabric” combinations) have the same properties. There is no structure which would preclude or prevent the selection of the same “fabric” or “fabric” combination for each of the nasal portion (20) and the oral portion (40), thus meeting the limitations of the claims.
As to Claims 11 and 54, the modified Formica, specifically Formica discloses the first textile (any of “fabric” and “fabric” combinations) and the second textile (any of “fabric” and “fabric” combinations) have at least one property that is different. There is no structure which would preclude or prevent the selection of one “fabric” and another “fabric” combination for each of the nasal portion (20) and the oral portion (40), thus meeting the limitations of the claims.
As to Claims 12 and 56, the modified Formica, specifically Formica discloses the nasal textile portion (“fabric” and “fabric” combinations) consists of one nasal hole (in the form of “ a membrane seal such as a nasal cradle, and/or a nasal chamber” Para 0261) configured to direct the flow of air into both nares during use.
As to Claims 13 and 57, the modified Formica, specifically Formica discloses the nasal textile portion (“fabric” and “fabric” combinations) consists of two nasal holes (22, as best seen in Figures 3 and 4) configured to direct the flow of air into a corresponding one of the nares during use.
As to Claim 14, the modified Formica, specifically Formica discloses the nasal textile portion (“fabric” and “fabric” combinations) is configured to be positioned adjacent to the patient’s columella in use. (“Nares sealing portion 22 is adapted to form a seal with the nares of a patient in use. Nares sealing portion 22 may be positioned to sit underneath the patient's nose, and be shaped to form an effective seal.” Para 0265; by convention columella of the nose is the central external part of the septum that sits between the two nostrils – thus the aforementioned engagement meets the limitations of the claims).
As to Claim 47, please see the rejection of Claim 1, the difference between Claim 1 and Claim 47 is the removal of the conceptual orientation of “the nasal textile portion being positively curved around a nasal axis; … an oral textile portion that is separate from the nasal textile portion … the oral textile portion being positively curved around an oral axis that is oriented differently from the nasal axis” for the addition of conceptual orientation of “a gap in the textile portion between the at least one nasal hole and the oral hole”.
In this functional orientation, as the nasal portion (20) and the oral portion (40) are separable there is a gap between the nasal portion (20) and the oral portion (40), such that the nasal hole (22) of the nasal portion (20) is separated between the oral hole (42) of the oral portion (40). As each of the nasal portion (20) and the oral portion (40) are each formed of their respective nasal textile portion (“fabric” and “fabric” combinations) and oral textile portion (“fabric” and “fabric” combinations), the claimed “gap in the textile portion between the at least one nasal hole (22) and the oral hole (42)” as claimed is met.
As to Claim 49, the modified Formica, specifically Formica discloses the textile portion (“fabric” and “fabric” combinations) of each of the nasal portion (20) and the oral portion (40) can be constructed of the same material whereby the one common material is used to manufacture the construction of each of the nasal portion (20) - nasal textile portion (“fabric” and “fabric” combinations) – and the oral portion (40) - oral textile portion (“fabric” and “fabric” combinations). Thus, resulting in a unitary construction of the textile portion (“fabric” and “fabric” combinations). Alternatively, It should be noted, Formica considers the construction of the patient interface having “the nares portion 20 and the mouth portion 40 … formed as a unitary element” (Para 0367). In light of this alternative construction, as the entirety of the nasal portion (20) and the oral portion (40) are formed as a single piece, the textile portion (“fabric” and “fabric” combinations) therein would be formed of a common material , thus resulting in the unitary construction of the textile portion (“fabric” and “fabric” combinations).
As to Claims 58 and 60, the modified Formica, specifically Asvadi teaches the elastomeric material layer (44) can be made of silicone (“In the exemplary embodiment, third layer 44 is a polymer layer (based on, e.g., without limitation, silicone or TPU).” Para 0066).
As to Claims 59 and 61, the modified Formica, specifically Ho teaches the curvature of the nasal axis (best seen Figures 25/26 and 35/36) and the oral axis (best seen Figures 25/26 and 35/36), wherein the curvature of the single nasal axis is distinct from the oral axis. As best seen in Figures 25/26 and 35/36, the nasal axis is oriented in a vertical direction upwards towards the eyes of the patient, whilst the oral axis is oriented in a horizontal direction into the mouth of the user.
Regarding the concept of curvature, the curvature is a function of the anatomy of the patient. From an anatomical standpoint, the general anatomy of a face includes a nose which extends anterior to the mouth of the user. In this anterior extension, the nose of the patient additionally requires the encompassing of the nose point and at least a portion of the slope of the nose towards the nasal bridge in the single nasal axis; whilst, the anatomy of the mouth requires a lateral extension about the mouth to encompass the lateral ends of the lips/cheek of the patient.
Thus, the curvature of the single nasal axis is distinct from the curvature of the oral axis as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot.
Although Primary Examiner appreciates Applicant’s amendments to overcome Formica alone, as indicated in the interview, conducted on January 6, 2026, the reliance on the lamination of the first textile layer upon the elastomeric material layer, is met by the teachings of Asvadi et al. (2014/0109911) which shows to constructions of seal forming structures in Figures 10 and 14 constructed with an elastomeric material layer – in the form of a polymer (44)– that is laminated onto a fabric layer (42). (Paras 0065, 0066, 0074, and 0078 of Asvadi).
Additionally with respect to Applicant’s further amendment to now address “the single nasal axis” in the interview, conducted on January 6, 2026, Primary Examiner advised Applicant that the construction of a unitary oral portion and nasal portion was known by Ho et al. (2007/0125385)
As explicitly addressed in the aforementioned rejections Figures 25/26 and 35/36 of Ho, each appear to show the construction of a unitary seal forming structure made of a single nasal axis and an oral axis, whereby the nasal axis is oriented in a vertical direction upwards towards the eyes of the patient, whilst the oral axis is oriented in a horizontal direction into the mouth of the user in order to impart a unitary patient interface suitable for imparting ventilation support to the patient wearing the patient interface.
Regarding the concept of curvature, the curvature is a function of the anatomy of the patient. From an anatomical standpoint, the general anatomy of a face includes a nose which extends anterior to the mouth of the user. In this anterior extension, the nose of the patient additionally requires the encompassing of the nose point and at least a portion of the slope of the nose towards the nasal bridge in the single nasal axis; whilst, the anatomy of the mouth requires a lateral extension about the mouth to encompass the lateral ends of the lips/cheek of the patient. In this construction, the resultant effect of the curvature yields a sealed formation to the anatomy of the patient to support ventilation of the patient wearing the patient interface.
Consequently, although Applicant has overcome a rejection of the claims under anticipation, Applicant has not established a chasm between the claimed invention and the prior art made of record to overcome the now pending obviousness rejection of Formica in view of Ho and Asvadi.
Thus, in light of the aforementioned reasoning, the rejection of the claims is maintained and made FINAL.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785