DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 22, 2026 has been considered by the examiner.
Response to Amendment
The following section is in reference to the Applicant’s Amendments, filed February 06, 2026.
The Applicant’s amendments to Claims 1-8 and 10-20 have been acknowledged. See updated 103 claim rejections below.
The Applicant’s cancellation of Claim 9 has been acknowledged.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1-2 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflung et al. (US 20170028162 A1, hereinafter "Leeflung") in view of Sather et al. (US 20090241965A1, hereinafter “Sather”).
Regarding Claim 1, Leeflung discloses: A mouth closure mask assembly (Paragraph 0002, The present invention relates generally to devices and methods for improving breathing and/or sleep, e.g., to adhesive devices for application over a user's mouth to hold the lips, jaw, and/or mouth closed to facilitate nasal breathing, e.g., during use of a positive airway pressure (PAP) or oral pressure therapy (OPT) device and/or to reduce snoring or other breathing problems while sleeping, and/or to improve sleep-related dry mouth and dry-mouth-related oral and dental disease) comprising:
a flexible sheet (Figure 2C, flexible membrane 12) configured to overlie a mouth of a wearer and having an adhesive disposed on a back-facing surface thereof, the adhesive configured for adhering the flexible sheet to a face of the wearer (Paragraph 0044, FIGS. 1A and 1B show an exemplary embodiment of an adhesive device 10 that generally includes a flexible membrane 12 sized for application over a user's mouth 92 and an adhesive layer 14. Optionally, the adhesive device 10 may also include a removable cover sheet 20, e.g., as shown in FIG. 1B, which may be provided over the adhesive layer 14 to prevent exposure before use);
a port defined through a portion of the flexible sheet (Figure 2C, opening 22), the port being configured, when uncovered, to permit access between an inside and outside of the mouth of the wearer while the flexible sheet remains adhered to the face of the wearer (Paragraph 0058, Turning to FIG. 2C, another embodiment of an adhesive device 10″′ is shown that includes a membrane 12″′ and an adhesive layer (not shown) similar to other embodiments, except that the membrane 12″′ includes one or more openings (one opening 22″′ shown) therethrough, and a detachable patch 24″′ over the opening 22″′ (or over each opening if multiple openings are provided);
a seal (Figure 2C, patch 24) configured to cover and occlude the port, wherein the seal is configured to be repeatedly disengaged from and re-engaged while the flexible sheet overlies the mouth of the wearer and remains adhered to the face of the wearer (Paragraph 0059, The patch 24″′ and/or the membrane 12″′ may include adhesive to detachably attach the patch 24″′ to the outer surface of the membrane 12″′ over the opening 22.″′ For example, a continuous layer of adhesive (not shown) may be provided around the perimeter of the patch 24″′ and/or around the opening 22″′ such that the patch 24″′ may be attached to the membrane 12″′ to substantially seal the opening 22″ from airflow);
and wherein the assembly is configured to substantially prevent oral breathing by the wearer when the seal is covering and occluding the port (Paragraph 0007, The present invention is directed generally to devices and methods for sealing the lips and/or mouth, maintaining jaw position, encouraging natural nasal breathing and/or otherwise improving breathing and/or sleep. More particularly, the present invention is directed to adhesive devices for application over a user's mouth to hold the mouth closed to facilitate normal nasal breathing, e.g., during use of a PAP device, to encourage normal nasal breathing, reduce snoring or other breathing problems while sleeping, and/or to reduce sleep-related dry mouth, and to methods for using such devices).
Leeflung discloses a variety of embodiments in which different openings and sealing methods are applied to the mouth closure assembly. However, Leeflung does not explicitly disclose a retaining flange.
Sather, however, does disclose:
a retaining flange (Figure 1A, outer rim bodies 101) disposed on the flexible sheet adjacent to the port (Paragraph 0075, The holdfast 104 (which adhesively secures the device to the subject) is shown as a layered structure including a backing or adhesive substrate 105. This backing may act as a substrate for an adhesive material, or it may itself be adhesive. The holdfast 104 may have different regions, including two peri-nasal regions surrounding the rim bodies 101);
a seal (Figure 1B, inner rim bodies 103) configured to selectively engage the retaining flange to cover and occlude the port (Figure 1B, passageway 108) when the seal and retaining flange are engaged (Paragraph 0076, These first (e.g., outer) rim body regions may mate with second (e.g., inner) rim body regions to form the rim body region(s) of the device that each include a passageway 108. This passageway is interrupted by crossing support members 114 (e.g., cross-beams or cross-struts) that may partly support or restrict movement of the airflow restrictor), (Paragraph 0079, All of the nasal devices described herein also include an airflow resistor, which is located in one or more passageways formed through the device)
wherein the seal is configured to be repeatedly disengaged from and re-engaged with the retaining flange while the flexible sheet overlies the nose of the wearer and remains adhered to the face of the wearer (Paragraph 0076, These first (e.g., outer) rim body regions may mate with second (e.g., inner) rim body regions to form the rim body region(s) of the device that each include a passageway 108), (Paragraph 0115, The noise-reduction element 1801 may be attached by any appropriate method. For example, the noise-reduction element 1801 may be attached with an adhesive to a portion of the adhesive holdfast 1803, 1811 which includes an opening or passageway in which the airflow resistor is attached. The airflow resistor in this example is formed from a flap valve 1805 and a flap valve limiter 1807. An annular attachment ring or substrate 1811 is also used to attach to (and/or partially form) the adhesive holdfast which may secure the airflow resistor in place. The airflow resistor may include a noise-reduction flap valve as the flap valve 1805);
Both Leeflung and Sather teach respiratory devices composed of adhesive facials seals that reduce airflow and aid in the treatment of disordered breathing conditions (Sather, Paragraph 0002, Nasal respiratory devices may be worn to treat many medical conditions, such as sleep disordered breathing (including snoring, sleep apnea, etc.), Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD, heart failure, and other respiratory and sleep conditions. Devices that provide a greater resistance to exhalation than to inhalation may be particularly useful, and may be worn by a subject when the subject is either awake or asleep), (Leeflung, Paragraph 0032, Embodiments of the disclosure relates to mouth shield devices for passive treatment of nocturnal dry mouth, snoring, or sleep apnea). It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Sather’s various attachable rimmed elements and covers with the mouth closure mask assembly taught by Leeflung to provide adjustable sealing structures, air flow restrictors, and/or valves that can accommodate different users and their needs.
Regarding Claim 2, Leeflung in view of Sather discloses all of the limitations of Claim 1. Sather further discloses: wherein the retaining flange is disposed on a portion of a front-facing surface of the flexible sheet and configured to support engagement of the seal to cover and occlude the port (Paragraph 0075, The holdfast 104 (which adhesively secures the device to the subject) is shown as a layered structure including a backing or adhesive substrate 105. This backing may act as a substrate for an adhesive material, or it may itself be adhesive. The holdfast 104 may have different regions, including two peri-nasal regions surrounding the rim bodies 101).
Regarding Claim 11, Leeflung in view of Sather discloses all of the limitations of Claim 1. Leeflung further discloses: wherein the seal comprises an enclosure defining a passageway in fluid communication with the port and wherein the passageway is configured to permit intentional access to the mouth of the wearer when the seal is disengaged while the flexible sheet remains adhered to the face of the wearer (Paragraph 0058, Turning to FIG. 2C, another embodiment of an adhesive device 10″′ is shown that includes a membrane 12″′ and an adhesive layer (not shown) similar to other embodiments, except that the membrane 12″′ includes one or more openings (one opening 22″′ shown) therethrough, and a detachable patch 24″′ over the opening 22″′ (or over each opening if multiple openings are provided).
Regarding Claim 12, Leeflung in view of Sather discloses all of the limitations of Claim 11. Leeflung further discloses: wherein the seal further comprises a valve disposed in the passageway and configured to restrict flow through the passageway when the seal covers and occludes the port, while permitting flow through the passageway when the seal is disengaged to allow intentional access to the mouth of the wearer (Paragraph 0010, Optionally, the device may include one or more valves, e.g., a one-way valve attached to the mouth cover, for selectively sealing the one or more openings. For example, when a positive pressure within a user's mouth is generated between the first and second surfaces, the one or more valves may seal the one or more openings, while, when a user inhales to generate a negative pressure between the first and second surfaces, the one or more valves may open the one or more openings).
Regarding Claim 13, Leeflung in view of Sather discloses all of the limitations of Claim 11. Sather further discloses: wherein the seal further comprises a removable insert configured to be received within the passageway to restrict access through the passageway and the port (Paragraph 0062, Nasal devices composed of layers, which may also be referred to as layered nasal devices, may be completely or partially flexible, as previously mentioned. For example, a layered nasal device may include an airflow resistor configured to resist airflow in a first direction more than airflow in a second direction and an adhesive holdfast layer. In some variations, the airflow resistor may be a flap valve layer adjacent to a flap valve limiting layer, and may include an adhesive holdfast layer comprising an opening across which the airflow resistor is operably secured. The airflow resistor may be disposed substantially in the plane of the adhesive holdfast layer) and wherein the insert is configured for interference fitting within the passageway and to be removable and replaceable while the flexible sheet remains adhered to the face of the wearer (Paragraph 0106, FIG. 11 illustrates examples of a number of flap valves, some of which are noise-reduction flap valves. Although these flaps are formed from a circular layer, any appropriate flap design may be used. For example, a flap (including a noise-reduced flap) may be oval or may be pinned or otherwise attached to the nasal device, rather than being partially cut out of a substrate), (Paragraph 0116, This figure is very similar to FIG. 2B except that the flap layer 207 of FIG. 2B has been replaced with the noise-reduction flap valve 2007. As mentioned above with reference to FIG., 17, additional noise-reduction elements may also be included. The devices may be assembled in any appropriate order, using appropriate manufacture techniques, to form the nasal devices. For example, the devices may be manually or automatically assembled).
Regarding Claim 14, Leeflung in view of Sather discloses all of the limitations of Claim 13. Sather further discloses: wherein the insert carries a mesh or filter material configured to permit user access through the passageway when the seal is disengaged while the flexible sheet remains adhered to the face of the wearer (Paragraph 0072, A nasal device may include a filter. This filter may be a movable filter, such as a filter that filters air flowing through the passageway in one direction more than another direction (e.g., the device may filter during inhalation but not exhalation).
Leeflung also discloses the above limitation: (Paragraph 0085, a third layer 328′ is provided that allows the flaps 326′ to substantially open in only one direction. For example, the third layer 328′ may be a nonporous layer of material, a mesh, a series of separate bands (not shown), and the like, similar to other embodiments herein.
Claims 3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflung (US 20170028162 A1) in view of Sather (US 20090241965A1), in further view of Heatherington (US 20210008318 A1).
Regarding Claim 3, Leeflung in view of Sather discloses all of the limitations of Claim 1. Leeflung discloses allow[ing] repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0059, The patch 24″′ and/or the membrane 12″′ may include adhesive to detachably attach the patch 24″′ to the outer surface of the membrane 12″′ over the opening 22.″′ For example, a continuous layer of adhesive (not shown) may be provided around the perimeter of the patch 24″′ and/or around the opening 22″′ such that the patch 24″′ may be attached to the membrane 12″′ to substantially seal the opening 22″ from airflow). Sather discloses the use of outer and inner rims, adhesives, and annular rings to attach different elements of the nasal device together. However, Leeflung in view of Sather does not disclose wherein the retaining flange and the seal are magnetically attracted.
Heatherington does disclose: wherein the retaining flange (Figure 1, ring 62) and the seal (Figure 1, post 20) are magnetically attracted to allow repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0060, The nasal respiratory assembly also includes socket magnet posts such as posts 20. One end of each post 20 is configured to removably attach to a ferromagnetic dome-shaped ring 62 on sheet 25 through the presence of a magnetic field; the other end of each post 20 is configured to engage an opening of nasal connector 90. In various embodiments, each post 20 can represent a socket magnet post. In one embodiment, ferromagnetic dome-shaped ring 62 can be a permanent magnet), (Paragraph 0061, each sheet defining an opening 17 sized and shaped to fit over the nostril of a patient, with a ferromagnetic dome-shaped ring 62 positioned at an underside of the sheet and circumferentially aligned with the opening, with an upper side of the sheet configured for sealable engagement with the nostril).
Similar to Leeflung and Sather, Heatherington also teaches a respiratory treatment device that incorporates adhesive facial elements. It would have been obvious to one skilled in the art before the effective filing date to incorporate an art-recognized magnetic attachment taught by Heatherington with the flange and seal disclosed by Leeflung in view of Sather to provide an alternative means of selective engagement for the respiratory devices.
Regarding Claim 5, Leeflung in view of Sather and Heatherington discloses all of the limitations of Claim 3. Heatherington further discloses: wherein the retaining flange includes a magnet assembly having a portion configured to magnetically engage the seal to support repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0062, each post 20 including a magnet 50 (e.g. in the form of a magnetic ring as shown in FIG. 1) positioned at a first end and a receptacle 35 positioned at a second end with a passageway extending from the first to the second ends. Each magnet 50 defines an opening. The magnet 50 removably attaches to the ferromagnetic dome-shaped ring 62 at exit end 16).
Regarding Claim 6, Leeflung in view of Sather and Heatherington discloses all of the limitations of Claim 3. Heatherington further discloses: the seal includes a magnet assembly and the retaining flange includes a ferrous material and wherein the magnet assembly and ferrous material are configured to support repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0060, One end of each post 20 is configured to removably attach to a ferromagnetic dome-shaped ring 62 on sheet 25 through the presence of a magnetic field; the other end of each post 20 is configured to engage an opening of nasal connector 90. In various embodiments, each post 20 can represent a socket magnet post. In one embodiment, ferromagnetic dome-shaped ring 62 can be a permanent magnet).
Regarding Claim 7, Leeflung in view of Sather and Heatherington discloses all of the limitations of Claim 3. Heatherington does not explicitly disclose wherein the seal includes a ferrous material and the retaining flange includes a magnet assembly and wherein the magnet assembly and ferrous material are configured to support repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to alternate the magnetic arrangement of the assembly, as it provides the same coupling mechanism without impeding the functionality of the overall device
Regarding Claim 8, Leeflung in view of Sather and Heatherington discloses all of the limitations of Claim 3. Heatherington further discloses: wherein the seal and the retaining flange include attractive magnet assemblies and wherein the magnet assemblies are configured to support repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0060, One end of each post 20 is configured to removably attach to a ferromagnetic dome-shaped ring 62 on sheet 25 through the presence of a magnetic field; the other end of each post 20 is configured to engage an opening of nasal connector 90. In various embodiments, each post 20 can represent a socket magnet post. In one embodiment, ferromagnetic dome-shaped ring 62 can be a permanent magnet).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflung (US 20170028162 A1) in view of Sather (US 20090241965A1), in view of Heatherington (US 20210008318 A1)), further in view of Busch et al. (US 7793987 B1, hereinafter “Busch”).
Regarding Claim 4, Leeflung in view of Sather and Heatherington discloses all of the limitations of Claim 3. Heatherington further discloses: wherein the seal includes a magnet assembly (Paragraph 0060, One end of each post 20 is configured to removably attach to a ferromagnetic dome-shaped ring 62 on sheet 25 through the presence of a magnetic field; the other end of each post 20 is configured to engage an opening of nasal connector 90. In various embodiments, each post 20 can represent a socket magnet post. In one embodiment, ferromagnetic dome-shaped ring 62 can be a permanent magnet) and also teaches a variety of magnetic embodiments (Paragraph 0071, Magnet socket 52, magnet 50 and opening 17 too can take various cross-sectional shapes. According to one or more embodiments, an upper surface of the magnetic ring is angled. In such embodiments, the magnetic ring can have different thicknesses in different regions of the magnetic ring), but does not explicitly disclose a plurality of magnets.
Busch does disclose: wherein the seal includes a magnet assembly comprising a plurality of magnets mounted within the seal and arranged around the port (Column 5, lines 52-57, In the embodiment illustrated in FIGS. 1-4, first plurality of magnetic elements 62 includes a number of individual magnetic elements 64, each of which is disposed on the first member such that a first pole, labeled North (N) or South (S), is disposed proximate to an exposed portion or surface 66 of first member 60), (Column 6, lines 5-9, the first plurality of magnetic elements and the second plurality of magnetic elements are also arrayed on the first and second members, respectively, such that the magnetic element are disposed around openings 45 and 49), each of the magnets having a portion configured to magnetically engage the retaining flange (Column 5, lines 57-61, Similarly, second plurality of magnetic elements 82 includes a number of individual magnetic elements 84, each of which is disposed on the second member such that a first pole, labeled North (N) or South (S), is proximate to an exposed portion or surface 86 of second member 80),
and wherein adjacently disposed magnets have opposed polarities to maintain alignment of the seal over the port during repeated engagement and disengagement (To connect first member 60 to second member 80, these two components need only be moved toward each other. The magnetic field generated between the two magnetic arrays (i.e., first and second plurality of magnetic elements 62 and 82) will pull them together. As the first member and the second member approach each other, the individual magnetic elements in the first member will align with the individual magnetic elements in the second member having an opposite pole), (To detach first member 60 from second member 80 the user need only twist or rotate the first member relative to the second member in either direction, as indicated by arrow 90 in FIG. 2. This will cause the poles of the magnetic elements to become unaligned, thereby reducing the magnetic attraction between first group 62 and second group 82 of magnetic elements)
It is known in the art of mechanical couplings to incorporate magnetic arrangements, similar to those disclosed by both Heatherington and Busch. It would have been obvious to one skilled in the art before the effective filing date to modify Heatherington to include an alternative magnetic assembly that incorporates a plurality of magnets with different embodiments and arrangements, as taught by Busch (Column 6, lines 5-9, In the illustrated embodiment, magnetic elements 64 and 84 are embedded in a symmetrical pattern about central openings 45, 49, with each magnetic element being approximately the same size and shape. It is to be understood that the present invention contemplates providing the groups of magnetic elements, and the individual magnet elements in each group, in a variety of shapes, sizes, patterns, and configurations)
Claims 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflung (US 20170028162 A1) in view of Sather (US 20090241965A1), in further view of Heatherington (US 20180296785 A1, hereinafter “Heather”).
Regarding Claim 10, Leeflung in view of Sather discloses all of the limitations of Claim 1. Leeflung discloses repeated selective engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0059, The patch 24″′ and/or the membrane 12″′ may include adhesive to detachably attach the patch 24″′ to the outer surface of the membrane 12″′ over the opening 22.″′ For example, a continuous layer of adhesive (not shown) may be provided around the perimeter of the patch 24″′ and/or around the opening 22″′ such that the patch 24″′ may be attached to the membrane 12″′ to substantially seal the opening 22″ from airflow). Sather discloses the use of a seal and retaining flange (Figures 1A-1B, outer rim bodies 101, inner rim bodies 103), adhesives, and annular rings to attach different elements of the nasal device together. However, Leeflung in view of Sather does not disclose wherein the seal and retaining flange are selectively coupled by a hook and loop fastener assembly configured to permit repeated engagement and disengagement of the seal to cover and occlude the port while the flexible sheet remains adhered to the face of the wearer.
Heather does disclose wherein the seal and retaining flange are selectively coupled by a hook and loop fastener assembly configured to permit repeated engagement and disengagement of the seal (Paragraph 0098, Turning to FIGS. 16A-17B, the use of hook and loop fasteners for selectively coupling and decoupling components of the assembly 10 is depicted according to several embodiments of the invention; other embodiments coupling other components of the system 10 may be envisioned. For example, in FIGS. 16A and 16B, a connector 91 may include a hook fastener and a post 14 may include a loop fastener each shaped to nestingly engaged the other for selective coupling. In other embodiments, the connector 92 may include the loop fastener and the post 14 may include a hook fastener. In FIGS. 17A and 17B, a socket 94 is coupled with the connector 92 using hook and loop fasteners 53. The hook and loop fasteners 53 may also be used to couple the socket 94 with the post 14).
Heather teaches a variety of connection means between the elements of the mask assembly. It would have been obvious to one skilled in the art before the effective filing date to incorporate these teachings with the assembly disclosed by Leeflung in view of Sather, so as to provide an alternative and art-recognized means of coupling in a respiratory interface.
Regarding Claim 15, Leeflung in view of Sather discloses all of the limitations of Claim 1. Leeflung further discloses: wherein the seal includes a tab for a wearer to selectively disengage the seal from the retaining flange and wherein the tab is configured to allow a user to repeatedly uncover the port while the flexible sheet remains adhered to the face of the wearer (Paragraph 0076, Optionally, the adhesive device 210 may also include one or more flaps or other valve(s) 226 attached to the mouth cover 220 and/or lip closing element 212. For example, as best seen in FIG. 4B, a flap 226 may be positioned between the mouth cover 220 and lip closing element 212 and secured therebetween, e.g., by tabs 227. With the tabs 227 secured to the mouth cover 220 and/or lip closing element 212, the flap 226 may move towards the lip closing element 212, e.g., to close and/or seal the openings 222, and/or away from the lip closing element 212, e.g., into the opening through the mouth cover 220 to allow airflow through the openings 222)
If the Applicant is not convinced, Heather more explicitly discloses the above limitation (Paragraphs 0097-98, The handle portion 140 may define a handle tab 142 extending externally therefrom for sliding the socket 94 into engagement with the pinchers 94. By using the handle portion and/or the handle tab 142 instead of the pinchers 117, the audible click of the pinchers 117 is much more likely to occur and be heard, confirming coupling engagement of the socket 94 and post 14. A handle bridge 150 may be defined between the handle tab 142 and the handle body 143 for supporting the handle tab and lessening the flexibility of the handle tab 142 when pressure is applied. […] Notably, the pincher 117 and handle portion 140 embodiments described herein with relation to the socket 94 and post 14 interaction could be applied to other components of the respiratory assembly 10 where selective engagement and/or coupling is desired. Other selective engagement and/or coupling mechanisms are also described herein and may be used with other components of the respiratory assembly 10 as well)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Heather to provide an alternative structural configuration for the receptacle so as to allow for ease in coupling and decoupling of the various elements of the respiratory assembly.
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflung (US 20170028162 A1) in view of Chen et al. (US 20110180075 A1, hereinafter “Chen”).
Regarding Claim 16, Leeflung discloses: A mouth closure mask assembly (Paragraph 0002, The present invention relates generally to devices and methods for improving breathing and/or sleep, e.g., to adhesive devices for application over a user's mouth to hold the lips, jaw, and/or mouth closed to facilitate nasal breathing, e.g., during use of a positive airway pressure (PAP) or oral pressure therapy (OPT) device and/or to reduce snoring or other breathing problems while sleeping, and/or to improve sleep-related dry mouth and dry-mouth-related oral and dental disease) comprising:
a flexible sheet (Figure 2C, flexible membrane 12) configured to overlie a mouth of a wearer and having a front-facing surface and an opposed back-facing surface (Paragraphs 0021-0022, FIG. 1A is a front view of an exemplary embodiment of an adhesive device applied over a user's mouth. FIG. 1B is a cross-sectional side view of the adhesive device of FIG. 1A taken along line 1B-1B);
an adhesive disposed on the back-facing surface of the flexible sheet and configured for adhering the flexible sheet to a face of the wearer (Paragraph 0044, FIGS. 1A and 1B show an exemplary embodiment of an adhesive device 10 that generally includes a flexible membrane 12 sized for application over a user's mouth 92 and an adhesive layer 14. Optionally, the adhesive device 10 may also include a removable cover sheet 20, e.g., as shown in FIG. 1B, which may be provided over the adhesive layer 14 to prevent exposure before use);
a port defined through a portion of the flexible sheet (Figure 2C, opening 22), the port being configured, when uncovered, to permit access between an inside and outside of a wearer's mouth while the flexible sheet remains adhered to the face of the wearer (Paragraph 0058, Turning to FIG. 2C, another embodiment of an adhesive device 10″′ is shown that includes a membrane 12″′ and an adhesive layer (not shown) similar to other embodiments, except that the membrane 12″′ includes one or more openings (one opening 22″′ shown) therethrough, and a detachable patch 24″′ over the opening 22″′ (or over each opening if multiple openings are provided);
a seal configured to cover and occlude the port (Figure 2C, patch 24), wherein the seal is configured to be repeatedly disengaged from and re-engaged while the flexible sheet overlies the wearer's mouth and remains adhered to the face of the wearer (Paragraph 0059, The patch 24″′ and/or the membrane 12″′ may include adhesive to detachably attach the patch 24″′ to the outer surface of the membrane 12″′ over the opening 22.″′ For example, a continuous layer of adhesive (not shown) may be provided around the perimeter of the patch 24″′ and/or around the opening 22″′ such that the patch 24″′ may be attached to the membrane 12″′ to substantially seal the opening 22″ from airflow);
and wherein the assembly is configured to substantially prevent oral breathing by the wearer when the seal is covering and occluding the port (Paragraph 0007, The present invention is directed generally to devices and methods for sealing the lips and/or mouth, maintaining jaw position, encouraging natural nasal breathing and/or otherwise improving breathing and/or sleep. More particularly, the present invention is directed to adhesive devices for application over a user's mouth to hold the mouth closed to facilitate normal nasal breathing, e.g., during use of a PAP device, to encourage normal nasal breathing, reduce snoring or other breathing problems while sleeping, and/or to reduce sleep-related dry mouth, and to methods for using such devices).
Leeflung does not disclose a hook and loop fastener assembly. However, Chen does disclose:
a loop-type fabric portion of a hook and loop fastener assembly (Paragraph 0043, The oral apparatus also has a hook-and-loop connector 1430 to control the distance between the upper attaching component 1410 and the lower attaching component 1420 in order to close the mouth. The upper and lower attaching components 1410, 1420 may only be applied to lip region away from the opening of the mouth to allow for the mouth to open) disposed on the front- facing surface of the flexible sheet (Paragraph 0043, Please refer to FIG. 14A to FIG. 14E. FIG. 14A demonstrates the front view of an oral apparatus according to the fourteenth embodiment of the present invention. The oral apparatus comprises of an upper attaching component 1410 and a lower attaching component 1420. The attaching components can be of various thickness and flexibility, and is capable of adhering firmly to the skin. );
a seal comprising a hook-type fabric portion of the hook and loop fastener assembly configured to selectively engage the loop-type fabric portion to cover the port (Paragraph 0043, The hook-and-loop connector 1430 is used to close and release the mouth by engaging and disengaging the loop 1431 around one of the hooks 1432 respectively. The existence of several hooks 1432 at different locations results in an adjustable apparatus for users with thicker or thinner lips to achieve an effective tighter or looser mouth closing as desired and more comfortable for the user as shown in FIG. 14C),
wherein the seal is configured to be repeatedly disengaged from and re-engaged with the loop-type fabric portion while the flexible sheet overlies the wearer's mouth and remains adhered to the face of the wearer (Paragraph 0043, The user can also temporarily manually disengage the connector assembly to allow the user to drink water, speak or perform other activities. FIG. 14D and FIG. 14E demonstrate the side view of the engaged and disengaged apparatus respectively. The present invention can be used in combination with constant positive airway pressure devices, oral appliances, or other sleep apnea therapies to prevent mouth breathing)
Both Leeflung and Chen teach respiratory devices composed of adhesive facials seals that reduce airflow and aid in the treatment of disordered breathing conditions (Paragraph 0002, The present invention is related to methods and systems capable of reducing obstruction of the upper airway in obstructive sleep apnea (OSA) and snore patients. More particularly, the present invention relates to an oral apparatus that prevents mouth breathing and also provides negative pressure in the oral cavity). Furthermore, Chen teaches a variety of connection means between the different closure elements of the oral apparatus. It would have been obvious to one skilled in the art before the effective filing date to incorporate the hook-and-loop attachment taught by Chen with the detachable seal assembly disclosed by Leeflung, so as to provide an alternative and art-recognized means of coupling in a respiratory interface.
Regarding Claim 17, Leeflung in view of Chen discloses all of the limitations of Claim 16. Leeflung further discloses: wherein the seal comprises an enclosure defining a passageway in fluid communication with the port and wherein the passageway is configured to permit intentional access to the wearer's mouth when the seal is disengaged while the flexible sheet remains adhered to the face of the wearer (Paragraph 0058, Turning to FIG. 2C, another embodiment of an adhesive device 10″′ is shown that includes a membrane 12″′ and an adhesive layer (not shown) similar to other embodiments, except that the membrane 12″′ includes one or more openings (one opening 22″′ shown) therethrough, and a detachable patch 24″′ over the opening 22″′ (or over each opening if multiple openings are provided).
Regarding Claim 18, Leeflung in view of Chen discloses all of the limitations of Claim 17. Leeflung further discloses: wherein the seal further comprises a valve disposed in the passageway and configured to restrict flow through the passageway when the seal covers and occludes the port, while permitting flow through the passageway when the seal is disengaged to allow intentional access to the wearer's mouth (Paragraph 0010, Optionally, the device may include one or more valves, e.g., a one-way valve attached to the mouth cover, for selectively sealing the one or more openings. For example, when a positive pressure within a user's mouth is generated between the first and second surfaces, the one or more valves may seal the one or more openings, while, when a user inhales to generate a negative pressure between the first and second surfaces, the one or more valves may open the one or more openings).
Regarding Claim 20, Leeflung in view of Chen discloses all of the limitations of Claim 16. Leeflung further discloses: wherein the hook-type fabric portion of the seal is configured to directly overlie and fully cover the port to prevent access therethrough while the flexible sheet remains adhered to the face of the wearer (Paragraph 0043, The hook-and-loop connector 1430 is used to close and release the mouth by engaging and disengaging the loop 1431 around one of the hooks 1432 respectively. The existence of several hooks 1432 at different locations results in an adjustable apparatus for users with thicker or thinner lips to achieve an effective tighter or looser mouth closing as desired and more comfortable for the user as shown in FIG. 14C).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Leeflung (US 20170028162 A1) in view of Chen (US 20110180075 A1), further in view of Sather (US 20090241965A1).
Regarding Claim 19, Leeflung in view of Chen discloses all of the limitations of Claim 17. Leeflung in view of Chen, however, does not disclose a removable insert.
Sather does disclose: wherein the seal further comprises a removable insert configured to be received within the passageway to restrict access through the passageway and the port (Paragraph 0062, Nasal devices composed of layers, which may also be referred to as layered nasal devices, may be completely or partially flexible, as previously mentioned. For example, a layered nasal device may include an airflow resistor configured to resist airflow in a first direction more than airflow in a second direction and an adhesive holdfast layer. In some variations, the airflow resistor may be a flap valve layer adjacent to a flap valve limiting layer, and may include an adhesive holdfast layer comprising an opening across which the airflow resistor is operably secured. The airflow resistor may be disposed substantially in the plane of the adhesive holdfast layer), (Paragraph 0072, A nasal device may include a filter. This filter may be a movable filter, such as a filter that filters air flowing through the passageway in one direction more than another direction), the insert being removable and replaceable while the flexible sheet remains adhered to the face of the wearer (Paragraph 0106, FIG. 11 illustrates examples of a number of flap valves, some of which are noise-reduction flap valves. Although these flaps are formed from a circular layer, any appropriate flap design may be used. For example, a flap (including a noise-reduced flap) may be oval or may be pinned or otherwise attached to the nasal device, rather than being partially cut out of a substrate), (Paragraph 0116, This figure is very similar to FIG. 2B except that the flap layer 207 of FIG. 2B has been replaced with the noise-reduction flap valve 2007. As mentioned above with reference to FIG. 17, additional noise-reduction elements may also be included. The devices may be assembled in any appropriate order, using appropriate manufacture techniques, to form the nasal devices. For example, the devices may be manually or automatically assembled)
Both Leeflung and Sather teach respiratory devices composed of adhesive facials seals that reduce airflow and aid in the treatment of disordered breathing conditions (Sather, Paragraph 0002, Nasal respiratory devices may be worn to treat many medical conditions, such as sleep disordered breathing (including snoring, sleep apnea, etc.), Cheyne Stokes breathing, UARS, COPD, hypertension, asthma, GERD, heart failure, and other respiratory and sleep conditions. Devices that provide a greater resistance to exhalation than to inhalation may be particularly useful, and may be worn by a subject when the subject is either awake or asleep), (Leeflung, Paragraph 0032, Embodiments of the disclosure relates to mouth shield devices for passive treatment of nocturnal dry mouth, snoring, or sleep apnea). It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Sather’s various valve elements with the mouth closure mask assembly taught by Leeflung to provide adjustable sealing structures and airflow resistors that can accommodate different users and their needs.
Response to Arguments
Applicant’s arguments, with respect to the previous rejections of independent Claims 1 and 16 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection has been made using Leeflung as a primary reference in view of the Applicant’s amended claim language.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Fernandez DeCastro (US 7044127 B1) discloses a protective mask with a detachable elastic mouth covering that can be attached using hook-and-loop closures
Black et al. (US 20140251335 A1) discloses an adhesive device for inhibiting mouth breathing and/or improving nasal breathing
Germinario (WO 2019195579 A1) discloses a mouth shield device for the restriction of mouth breathing
Moulton (US 0774446 A) discloses a flexible mouthpiece for controlling air expelled through the mouth
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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