DETAILED ACTION
This Office Action is in response to the interview, conducted on October 31, 2025, the amendment, filed on October 31, 2025, and the request by Primary Examiner for an examiner’s amendment to place the application into condition for allowance in which Claims 23 and 25 would be placed in independent form, requested on December 15, 2025 and denied by Applicant on December 18, 2025.
Primary Examiner acknowledges Claims 1-31 are pending in this application, with Claims 1, 6-9, 11, 14, and 19 having been currently amended, and Claims 23-31 having been newly added.
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 1-10, 13-19, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Fishman (2008/0264422) in view of Gibson (2013/0139822).
As to Claim 1, Fishman discloses a patient interface (Figures 1-5) for use in delivering breathable gas (via “CPAP machine”, “The prescription for the typical CPAP machine (not shown) coupled to the mask 16 may typically provide from zero (0) to twenty (20) CFM's (cubic feet per minute) positive pressure.” Para 0028) to a patient (best seen Figures 1-5), the patient interface (Figures 1-5) comprising: a cushion module (10, “FIG. 1 shows a frontal view of the system 10 adapted to a sleep apnea mask 16.” Para 0028) comprising: a chassis portion (16, “a sleep apnea mask 16” Para 0028) and a seal forming structure (12, “air-seal 12 application of the mask” Para 0028; also see: “mask seal 12” Para 0029 and 0030) together forming a plenum chamber (defined by the region encompasses the nose and mouth of the patient as seen in phantom in Figures 1-3) pressurizable to at least 4 cm of water above ambient pressure (“from zero (0) to twenty (20) CFM's (cubic feet per minute) positive pressure.” Para 0028), the chassis portion (16) having a width in a direction perpendicular to a sagittal plane of the patient when the patient interface (Figures 1-5) is worn in use, the chassis portion (16) including a plenum chamber inlet port (18, “swivel airway intake spout 18” Para 0028) configured to receive a flow of breathable gas (via “CPAP machine”) at the therapeutic pressure for breathing by the patient (“from zero (0) to twenty (20) CFM's (cubic feet per minute) positive pressure.” Para 0028), the seal forming structure (12) configured to form a seal with a region of the patient’s face (encompasses the nose and mouth of the patient as seen in phantom in Figures 1-3) surrounding an entrance to the patient’s airways, the seal forming structure (12) having an opening (defined by the region encompasses the nose and mouth of the patient as seen in phantom in Figures 1-3) therein such that the flow of breathable gas is delivered to the entrance of the patient’s airways, the seal forming structure (12) being configured to maintain said therapeutic pressure (“from zero (0) to twenty (20) CFM's (cubic feet per minute) positive pressure.” Para 0028) in the plenum chamber (defined by the region encompasses the nose and mouth of the patient as seen in phantom in Figures 1-3) throughout the patient’s respiratory cycle in use; a positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38, wherein 14 – “A horizontal band 14 is fixed on one side to the mask 16 which is positioned over the swivel airway intake spout 18.” Para 0028, wherein 20 – “It is adjusted on the side of the face with a Velcro.TM. adjustment band 20 which loops through the opposing side of the swivel airway intake spout restraint.” Para 0028; wherein 34 – “The horizontal band adjustments 34 are seen on both sides of the face with Velcro.TM. bands chosen to loop on either side of the mask (similar to the overhead Velcro.TM. loop (shown in FIG. 1) and are positioned below the wearer's ears.” Para 0029; and wherein 38 – “The other side of this vertical band is anchored to the junction of the horizontal bands 38 situated in the back of the head (see FIG. 4). The junction of the horizontal bands 38 is an anchor which is movable, and permits the horizontal band to glide through it, thus permitting compatibility with various size patients' heads.” Para 0029) to provide a force to hold the seal forming structure (12) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) comprising: a strap (defined as the combination of 14 and 38, wherein 14 - “A horizontal band 14 is fixed on one side to the mask 16 which is positioned over the swivel airway intake spout 18.” Para 0028; and wherein 38 – “The other side of this vertical band is anchored to the junction of the horizontal bands 38 situated in the back of the head (see FIG. 4). The junction of the horizontal bands 38 is an anchor which is movable, and permits the horizontal band to glide through it, thus permitting compatibility with various size patients' heads.” Para 0029) configured to be arranged, in use, so that an anterior portion of the strap (14) positioned anteriorly to and overlies an anterior surface of the chassis portion (16) across the width of the chassis portion (16) to position the anterior surface of the chassis portion (16) between the anterior portion of the strap (14) and the patient’s face (best seen Figures 1-3), the strap (14) passes around the sides of the patient’s head inferior to the patient’s ears (as shown in Figures 1-5) and a posterior portion of the strap (38) overlies a posterior portion of the patient’s neck (best seen Figures 3 and 4), wherein no part of the positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) is configured to be positioned superior to the patient’s ears in use.
Regarding the limitation “wherein no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use”, although Fishman includes additional positioning and stabilizing structure which extends over the head of the patient as shown in Figures 1-5, it should be noted the rejection of Primary Examiner is based on the characterization of the claimed positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) to include only the structure which extends anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient. Furthermore, it is noted Fishman expressly states “The horizontal band adjustments 34 are seen on both sides of the face with Velcro.TM. bands chosen to loop on either side of the mask (similar to the overhead Velcro.TM. loop (shown in FIG. 1) and are positioned below the wearer's ears. It is important the horizontal band is kept below the ears to ensure counter pressure for the mask seal 12 against the upper vertical band 32. The integrity of the mask seal 12 would be compromised by the strap riding up over the ears.” (Para 0029). Consequently, it is clear that Fishman is expressly concerned with the orientation of the claimed positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) to be oriented below the ears to provide sufficient sealing engagement of the cushion module (10) with associated chassis portion (16) and seal forming structure (12) to the face of the patient. In light of this consideration, the characterization of the claimed positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) to be limited to include only the structure which extends anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient does not yield an inoperable device, but rather meets the limitations of the claims in situations whereby the omission of the region of the positioning and stabilizing structure of Fishman which is “positioned superior to the patient’s ears in use” - nominally “top vertical band 32” (Para 0030) would be obvious if the function of the “top vertical band 32” is not desired.
Nevertheless, should Applicant respectfully disagree with Primary Examiner’s assertion that Fishman discloses and meets the limitations of the claims whereby “wherein no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use”, Primary Examiner presents Gibson which unequivocally shows the configuration of a patient interface with associated positioning and stabilizing structure in which “no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use” was a well-known, routine, and conventional configuration and further includes “a vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use”.
Gibson teaches a patient interface (Figures 1-9) for use in delivering breathable gas (“air” Para 0003 and “oxygen” Para 0030) to a patient (best seen Figure 1 in phantom), the patient interface (Figures 1-9) comprising: a cushion module (50, best seen Figures 6 and 7, “In the illustrated example, the full-face mask system 10 includes a headgear and cushion module 20 and a seal and frame module 50 provided to the headgear and cushion module.” Para 0031) comprising a chassis portion (54, “The seal and frame module 50 (shown in, for example, FIGS. 5 and 6) includes a seal portion 51 (also called the sealing membrane hereafter) and a frame portion 54.” Para 0072) and seal forming structure (51, “The seal and frame module 50 (shown in, for example, FIGS. 5 and 6) includes a seal portion 51 (also called the sealing membrane hereafter) and a frame portion 54.” Para 0072) together forming a plenum chamber (defined by the interior of 54 which embraces the face of the patient, “The frame portion 54 is shaped such as to create a breathing chamber or space between the mask and the patient's nose.” Para 0074) pressurizable to a therapeutic pressure of at least 4 cm of water above ambient air pressure (“Patient interfaces, such as a full-face or nasal mask systems, for use with positive airway pressure (PAP) devices in the treatment of Sleep Disordered Breathing (SDB), typically include a soft face-contacting portion, such as a cushion, and a rigid or semi-rigid shell or frame. In use, the interface is held in a sealing position by headgear so as to enable a supply of air at positive pressure (e.g., 2-30 cm H.sub.2O) to be delivered to the patient's airways.” Para 0003), the chassis portion (54) having a width in a direction perpendicular to a sagittal plane of the patient when the patient interface (Figures 1-9) is worn in use, and including a plenum chamber inlet port (via 95, “Preferably, the elbow connection ring 95 provided to the frame portion 54 (for connecting the elbow 90) may be harder than the frame portion 54.” Para 0073) configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient , the seal forming structure (51) being configured to form a seal with a region of the patient’s face (“The opposite side of the sealing membrane provides a sealing surface 53 adapted to engage the patient's face in use and provide seal. The cushion region provides a reactive force to maintain the sealing surface of the sealing membrane in sealing engagement with the face of the patient.” Para 0072), said seal forming structure (51) having an opening (via 53, “The opposite side of the sealing membrane provides a sealing surface 53 adapted to engage the patient's face in use and provide seal. The cushion region provides a reactive force to maintain the sealing surface of the sealing membrane in sealing engagement with the face of the patient.” Para 0072) therein such that the flow of breathable gas is delivered to the entrance to the patient’s airways, the seal forming structure (51) being configured to maintain said therapeutic pressure in the plenum chamber (defined by the interior of 54 which embraces the face of the patient) throughout the patient’s respiratory cycle in use; a vent structure (91 via 90, “In an example, the elbow 90 may include one or more vent holes 91 (e.g., see FIGS. 6 and 7) to permit the exhaust of gases from the mask system.” Para 0070) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber (defined by the interior of 54 which embraces the face of the patient) to ambient, said vent structure (91 via 90) being configured to maintain the therapeutic pressure in the plenum chamber (defined by the interior of 54 which embraces the face of the patient) in use; a positioning and stabilizing structure (best seen Figures 1-3, 8, and 9) to provide a force to hold the seal forming structure (51) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (best seen Figures 1-3, 8, and 9) comprising: a strap (20, “In the illustrated example, the full-face mask system 10 includes a headgear and cushion module 20 and a seal and frame module 50 provided to the headgear and cushion module.” Para 0031) configured to be arranged, in use, so that an anterior portion (30, “As described in greater detail below, the headgear and cushion module 20 includes a cushion region 30 and a headgear region 40.” Para 0034) of the strap (20) overlies an anterior surface of the chassis portion (54) across the width of the chassis portion (54), the strap (20) passes around the sides of the patient’s head (best seen Figure 1) inferior to the patient’s ears (“The headgear region 40 is used to support and stabilize the headgear and cushion module 30 on the face of the user. The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient's neck in use, e.g., see FIG. 1.” Para 0051), and a posterior portion (40, “headgear region 40” Para 0051) of the strap (20) overlies a posterior region of the patient’s neck (“back of the patient's neck in use, e.g., see FIG. 1.” Para 0051), wherein no part of the positioning and stabilizing structure (best seen Figures 1-3, 8, and 9) is configured to be positioned superior to the patient’s ears in use (“The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient's neck in use, e.g., see FIG. 1.” Para 0051).
Regarding the configuration in which “no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use”, as clearly shown in Figures 1-3, 8, and 9, the strap (20, “In the illustrated example, the full-face mask system 10 includes a headgear and cushion module 20 and a seal and frame module 50 provided to the headgear and cushion module.” Para 0031) configured to be arranged, in use, so that an anterior portion (30, “As described in greater detail below, the headgear and cushion module 20 includes a cushion region 30 and a headgear region 40.” Para 0034) of the strap (20) overlies an anterior surface of the chassis portion (54) across the width of the chassis portion (54), the strap (20) passes around the sides of the patient’s head (best seen Figure 1) inferior to the patient’s ears (“The headgear region 40 is used to support and stabilize the headgear and cushion module 30 on the face of the user. The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient's neck in use, e.g., see FIG. 1.” Para 0051), and a posterior portion (40, “headgear region 40” Para 0051) of the strap (20) overlies a posterior region of the patient’s neck (“back of the patient's neck in use, e.g., see FIG. 1.” Para 0051), wherein no part of the positioning and stabilizing structure (best seen Figures 1-3, 8, and 9) is configured to be positioned superior to the patient’s ears in use (“The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient's neck in use, e.g., see FIG. 1.” Para 0051).
Thus, the configuration whereby the orientation of the strap in which “no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use” is further affirmed by the teachings of Gibson to be a known alternative structure suitable for imparting securement of the cushion module on the face of the user. Hence, Primary Examiner’s characterization of the claimed positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) as shown in Fishman is affirmed as an alternative configuration that would be 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 properly secure the cushion module to seal against the user’s face wherein the positioning and stabilizing structure extends only anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient.
Regarding the configuration of the “vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use”, Gibson shows in Figures 6 and 7, a vent structure (91 via 90, “In an example, the elbow 90 may include one or more vent holes 91 (e.g., see FIGS. 6 and 7) to permit the exhaust of gases from the mask system.” Para 0070) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber (defined by the interior of 54 which embraces the face of the patient) to ambient, said vent structure (91 via 90) being configured to maintain the therapeutic pressure in the plenum chamber (defined by the interior of 54 which embraces the face of the patient) in use.
Thus by the teachings of Gibson, the modification of the plenum chamber inlet port (18), in the form of an elbow, of Fishman to be substituted for the elbow (90) of Gibson is a known result effective variable in order to yield an exhaust port for exhalation gases to be cleared from the plenum chamber.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the positioning and stabilizing structure of Fishman to include the region which is only anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient, as taught by Gibson to be a known result effective variable to properly secure the cushion module to seal against the user’s face wherein the positioning and stabilizing structure, and further to modify the plenum chamber inlet port of Fishman to include a vent structure, as taught by Gibson to permit the exhausting of exhaled gases from the plenum chamber.
As to Claim 2, the modified Fishman, specifically Gibson teaches the strap (20) comprises a first end (one of 44, “The headgear region includes headgear straps 44 that extend from either side of the cushion region 30 so as to wrap the headgear and cushion module around the head of the wearer.” Para 0052) and a second end (other of 44, “The headgear region includes headgear straps 44 that extend from either side of the cushion region 30 so as to wrap the headgear and cushion module around the head of the wearer.” Para 0052) and the strap (20) is configured so that the first end (one of 44) is able to be secured (via 45, “The headgear straps preferably connect to one another by hook and loop material 45 (e.g., see FIGS. 2, 8, and 9). Alternatively, the headgear straps may connect to each other by any other reasonable means, for example clips or buckles.” Para 0052) to the second end (other of 44) so that the strap (20) forms a loop (“so as to wrap the headgear and cushion module around the head of the wearer.” Para 0052).
As to Claim 3, the modified Fishman, specifically Gibson teaches the strap (20) comprises a cushion engaging portion (defined by the interior of 30 which engages the exterior of the chassis portion 54, “The cushion region 30 includes a cushioning component 31 within the fabric layer 25 (see FIG. 4). The cushioning component may be a conformable, flexible region that provides comfort for the patient. The cushioning component may also support and shape the sealing membrane 52 of the seal and frame module 50 (described below) when positioned on the patient's face in use.” Para 0038) between the first end (one of 44) and the second end (other of 44), wherein the strap (20) is arranged, in use, so that the anterior portion of the strap (30) overlying the anterior surface of the chassis portion (54) comprises the cushion engaging portion (defined by the interior of 30 which engages the exterior of the chassis portion 54), and the posterior portion of the strap (40) overlying the posterior region of the patient’s neck use (“The headgear region preferably is positioned along the cheeks and under the ears of the patient extending to the back of the patient's neck in use, e.g., see FIG. 1.” Para 0051) comprises the first end (one of 44) and the second end (other of 44).
As to Claims 4 and 16, the modified Fishman, specifically Gibson teaches the chassis portion (54) has a height in a direction perpendicular to the Frankfort horizontal plane of the patient when the patient interface is worn in use (best seen Figures 1 and 7), and a height of the strap (20) in the cushion engaging portion (defined by the interior of 30 which engages the exterior of the chassis portion 54) being such that, in use (best seen Figure 1), the strap (20) covers a majority of the height of the chassis portion (54).
As to Claim 5, the modified Fishman, specifically Gibson teaches the anterior portion of the strap (30) has an opening (best seen Figures 1, 2, 8, and 9, upon which 90 is inserted therethrough to 95 of 54) therein, the opening (best seen Figures 1, 2, 8, and 9, upon which 90 is inserted therethrough to 95 of 54) being configured to accommodate a conduit (“The frame portion 54 is shaped such as to create a breathing chamber or space between the mask and the patient's nose. The frame portion is also shaped so as to receive the elbow or other connection to an air delivery tube.” Para 0074) for conveying the flow of breathable gas to the plenum chamber inlet portion (95).
As to Claims 6 and 17, the modified Fishman, specifically Gibson teaches the anterior portion of the strap (30) has a curvature (best seen Figures 1-3, 8, and 9 as bounded with 42) so that, in use, the anterior portion of the strap (30) cups around the chassis portion (54).
As to Claims 7, 18, and 19, the modified Fishman, specifically Gibson teaches the positioning and stabilizing structure (best seen Figures 1-3, 8, and 9) comprises one or more support members (35, “In an example, the structural component may be thermoformed within the fabric layer to assist in shaping the seal portion of the seal and frame module 50. The structural component may be an additional component, e.g. malleable wire or plastic strip, or may be a region of the foam having a stiffer or more rigid property than surrounding regions of the foam, i.e., the foam may be selectively stiffened in one more regions.” Para 0048; also see: “As shown in FIG. 4, the cushion region 30 may also include a structural component 35 that provides support to the cushioning component 31 so that the cushion can be positioned so as to engage with the patient's face. The structural component (also referred to as a stiff element, rigid element, or rigidizer) may provide structural support to help prevent the cushion from flexing or bending out of contact with the patient's face. The structural component may be made from a silicone (preferably low durometer silicone so that the mask is flexible, for example 10-30 Shore A), TPE, polypropylene, polycarbonate, polyurethane.” Para 0042) provided to the anterior portion of the strap (30), the support members (35) being rigid or semi-rigid (“having a stiffer or more rigid property” Para 0048; also see: “The structural component (also referred to as a stiff element, rigid element, or rigidizer)” Para 0042) and being configured to provide or substantially maintain the curvature of the anterior portion of the strap (30) when the anterior portion of the strap (30) is put under tension.
As to Claim 8, the modified Fishman, specifically Gibson teaches the one or more support members (35) are provided to a side of the anterior portion of the strap (30) configured to face towards the patient in use (“The structural component may influence the position of the cushion component. For example, the structural component may be curved, for example to the contours of a person's face, so that when in contact with the cushion component, the cushion is also curved. Furthermore, the structural component may be adjustable so that the patient can influence the position of the cushion component by altering the shape of the structural component. For example, the structural component may be a malleable wire. … the structural component may be adjustable at the nasal bridge region so the patient can compress the cushion into position around their nose.” Para 0043 and 0044).
As to Claim 9, the modified Fishman, specifically Gibson teaches at least one of the one or more support members (35) is arranged to span across a length of the anterior portion of the strap (30). In the configuration at the nasal bridge, the orientation of the structural component will span across the length of the anterior portion of the strap (30) as the construction laterally embraces each side of the patient’s nose (Para 0043 and 0044 – “the structural component may be curved, for example to the contours of a person's face … so the patient can compress the cushion into position around their nose.”).
As to Claim 10, the modified Fishman, specifically Gibson teaches the one or more support members (35) comprises a first support member portion (located at one of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047) and a second support member (located at the other of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047), each of the first support member portion (located at one of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047) and the second support member (located at the other of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047) is positioned so that, in use, the first support member portion (located at one of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047) contacts a first lateral side of the chassis portion (54) and the second support member (located at the other of “the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face” Para 0047) contacts a second lateral side of the chassis portion (54), the first lateral side of the chassis portion (54) being opposite a second lateral side of the chassis portion (54).
As to Claim 13, the modified Fishman, specifically Gibson teaches the chassis portion (54) is flexible (“The seal and frame module is made from silicone. Preferably, the silicone may have a polished surface so that it is sticky and may therefore maintain its position on the user's face.” Para 0073), whereby silicone is a known “conformable polymer” (0079) that is “flexible” (Para 0042).
As to Claim 14, please see the rejection of Claim 1. The difference between Claim 1 and Claim 14 is the construction of the strap of the positioning and stabilizing structure. Explicitly, Claim 14 requires “wherein the strap is structured and arranged to maintain the seal- forming structure in the therapeutically effective position when the plenum chamber is pressurised to a therapeutic pressure in the absence of other straps.”
The modified Fishman, specifically Gibson teaches the strap (20) is structured and arranged to maintain the seal forming structure (51) in the therapeutically effective position when the plenum chamber (defined by the interior of 54 which embraces the face of the patient) is pressurized to a therapeutic pressure in the absence of other straps.
As to Claim 15, please see the rejections of Claims 2 and 3. Regarding the term “midway”, as best seen in Figures 1-3, 8, and 9, clearly the cushion engaging portion (defined by the interior of 30 which engages the exterior of the chassis portion 54) is located between the first end (one of 44) and the second end (other of 44).
As to Claim 27, the modified Fishman, specifically Gibson teaches a chassis portion (54) comprises a flex region (as a function of the varying thickness as shown in Figure 6, wherein the thicker region proximate the elbow 90 is more rigid than the region proximate the seal 51 which is less thick and thus more flexible) having greater flexibility than other regions of the chassis portion (e.g. the thicker region proximate the elbow 90 is more rigid), the flex region (as a function of the varying thickness as shown in Figure 6, wherein the thicker region proximate the elbow 90 is more rigid than the region proximate the seal 51 which is less thick and thus more flexible) being configured to enable a superior portion of the chassis portion to move relative to an inferior portion of the cushion module (50).
In light of the teachings of Gibson, it would have been obvious to modify the construction of the chassis portion of the modified Fishman to include the variation in thickness and thus the claimed flex region as taught by Gibson to impart varying degrees of flexibility so that the region proximate the elbow is sufficiently rigid to retain the placement of the plenum chamber inlet port in a fixed orientation to decoupling forces from movement and the region proximate the seal is less rigid and thus flexible in order to facilitate the conformability of the seal to the face of the patient.
As to Claims 28 and 30, please see the rejection of Claims 27 and 29. The modified Fishman, specifically Gibson teaches the flex region (as a function of the varying thickness as shown in Figure 6, wherein the thicker region proximate the elbow 90 is more rigid than the region proximate the seal 51 which is less thick and thus more flexible) extends across substantially the width of the chassis portion (54) as best seen in Figures 6 and 7.
As to Claim 29, the modified Fishman, specifically Gibson teaches a cushion module (50, best seen Figures 6 and 7, “In the illustrated example, the full-face mask system 10 includes a headgear and cushion module 20 and a seal and frame module 50 provided to the headgear and cushion module.” Para 0031) comprising a chassis portion (54, “The seal and frame module 50 (shown in, for example, FIGS. 5 and 6), the chassis portion (54) and the seal forming structure (51, “The seal and frame module 50 (shown in, for example, FIGS. 5 and 6) includes a seal portion 51 (also called the sealing membrane hereafter) at least partially forming the plenum chamber to encompass the nose and mouth of the patient.
Additionally, the modified Fishman, specifically Gibson teaches a chassis portion (54) comprises a flex region (as a function of the varying thickness as shown in Figure 6, wherein the thicker region proximate the elbow 90 is more rigid than the region proximate the seal 51 which is less thick and thus more flexible) having greater flexibility than other regions of the chassis portion (e.g. the thicker region proximate the elbow 90 is more rigid), the flex region (as a function of the varying thickness as shown in Figure 6, wherein the thicker region proximate the elbow 90 is more rigid than the region proximate the seal 51 which is less thick and thus more flexible) being configured to enable a superior portion of the chassis portion to move relative to an inferior portion of the cushion module (50).
In light of the teachings of Gibson, it would have been obvious to modify the construction of the chassis portion of the modified Fishman to include the variation in thickness and thus the claimed flex region as taught by Gibson to impart varying degrees of flexibility so that the region proximate the elbow is sufficiently rigid to retain the placement of the plenum chamber inlet port in a fixed orientation to decoupling forces from movement and the region proximate the seal is less rigid and thus flexible in order to facilitate the conformability of the seal to the face of the patient.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Fishman (2008/0264422) in view of Gibson (2013/0139822), as applied to Claim 1, and further in view of Drew et al. (6,581,594).
As to Claim 31, the modified Fishman, specifically Gibson teaches the orientation of the vent structure (91) on the plenum inlet chamber port, whereby the strap (20) comprises a gas permeable portion (“the textile may allow the skin to breathe and/or may allow for moisture and heat to travel from the skin.” Para 0058).
Yet, does not expressly disclose the orientation of “the vent structure is in the anterior surface of the chassis portion … , the strap being configured so that, in use, the gas permeable portion overlies the vent structure so that the continuous flow of gases exhaled by the patient passes through the gas permeable portion.”
Drew teaches an alternative patient interface wherein the vent structure (28) may be located on the elbow (20) as shown in Figure 2 – and similar to the modified Fishman, or alternatively positioned on the chassis portion (12) of the cushion module (10). Regardless of the orientation of the vent structure (28) the intended purpose remains to provide for “a gas washout vent” for the purpose of directing “exhaust gas from the inner cavity to atmosphere.” (Column 2, Lines 10-25).
Therefore, it would have been obvious to modify the vent structure of the modified Fishman to be located on the chassis portion as taught by Drew to be a known alternative location suitable for imparting the direction of exhaust gas from the interior of the plenum chamber to the ambient environment.
Claims 11, 12, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fishman (2008/0264422) in view of Gibson (2013/0139822), as applied to Claims 11 and 14, and further in view of Tebbutt et al. (2023/0211106, which has provisional date before the effective filing date of this instant application).
As to Claims 11 and 20, the modified Fishman, specifically Gibson teaches the strap (20) comprises a first elastic region of the strap (20) that, in use, is positioned between the anterior portion of the strap (30) and the posterior portion of the strap (40) on a first lateral side of the patient’s head (one of left/right side), and a second elastic region of the strap (20) that, in use, is positioned between the anterior portion of the strap (30) and the posterior portion of the strap (40) on a second lateral side of the patient’s head (other of left/right side), the first lateral side of the patient’s head (one of left/right side) being opposite a second lateral side of the patient’s head (other of left/right side).
Regarding the concept of “elastic”, Gibson teaches the Primary Examiner defined strap (20) – “The headgear and cushion module 20 includes a composite including an outer fabric or textile layer that provides an exterior surface of the module and an inner conformable, cushioning, and flexible layer or filler encapsulated or contained within the fabric layer.” (Para 0034) – is constructed of a fabric or textile layer, whereby “The fabric may be a soft, flexible textile and may be elastic or non-elastic. Preferably, the textile may not irritate the skin. Preferably, the textile may allow the skin to breathe and/or may allow for moisture and heat to travel from the skin.” (Para 0058). Consequently, the construction of the Primary Examiner defined strap (20) includes considerations to elastic material compositions.
Yet, the modified Fishman does not expressly disclose the “wherein the strap comprises a first substantially inextensible portion positioned between the anterior portion of the strap and the posterior portion of the strap on the first lateral side of the patient's head in use, and a second substantially inextensible portion positioned between the anterior portion of the strap and the posterior portion of the strap on the second lateral side of the patient's head in use”
Tebbutt teaches an alternative positioning and stabilizing structure, in the form of a headgear, whereby “the headgear 10 may comprise zones with variable rigidity. For example, the headgear zone forward of a user's ear may be non-rigid (without strap cores), while the headgear zone behind the patient's ear may be semi-rigid (comprising one or more semi-rigid strap cores). The transition between semi-rigid and non-rigid zone may be flush or seamless to avoid causing irritation or discomfort to a user.” (Para 0357). The resultant effect of the construction of varying rigidity and thus stiffness is the ability to modulate the amount of pressure applied to the by the headgear structure to the head and face of the patient to enhance conformability (“The reduction in thickness (and stiffness) of the lower side strap portion may allow the strap to more easily conform to the cheek region. This may reduce the pressure applied to the sensitive cheek region, particularly when the user is sleeping or lying on their side.” Para 0356). In this fact, the aforementioned configuration of the claimed “inextensible portion” or Tebbutt’s “semi-rigid” region behind the ears of the patient applies a greater level of force through its stiffness than that of the remaining regions of the positioning and stabilizing structure which are the claimed “elastic region” or Tebbutt’s “non-rigid” region forward of the ears of the patient to provide less force and more conformability.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the strap of the modified Fishman to include regions which are both elastic and inextensible, as taught by Tebbutt to modulate the desired force and conformability of the strap about the head of the patient.
As to Claim 12, please see the rejection of Claim 11, whereby the modified Fishman, specifically Gibson teaches the formation of the first elastic region of the strap (20) and the second elastic region of the strap (20) such that the configuration does not “irritate the skin” of the patient (Para 0058).
Regarding the limitation of the “edge of the strap”, Gibson discloses the construction method of “Ultrasonic die cutting allows the edges of the fabric to be substantially rounded so there is less chance of facial marking and provides a more appealing look and feel.” (Para 0066). In this configuration, the rounded and elastic construction is based on a desire to not “irritate the skin” of the patient (Para 0058) so that “there is less chance of facial marking” (Para 0066). Consequently, Gibson teaches the elasticity at the edges of the strap (20).
As to Claim 21, please see the rejection of Claim 20, whereby the strap (20) is defined to be either “elastic or non-elastic” (Para 0058).
Regarding the remaining features to “a first substantially inextensible portion” and “a second substantially inextensible portion”, Gibson discloses the configuration of the strap (20) having various regions of rigidity – “The structural component may have varying hardness or stiffness zones that may create regions having more support of the cushion component, and other regions having less support for the cushion component. For example, the structural component may have a lower stiffness at the nose bridge to accommodate varying nose bridge sizes, and may have a higher stiffness at the corners of the nose or chin region to ensure stability and anchoring of the cushion component at the boney regions of the face.” (Para 0047). Consequently, the decision to make one portion of the first lateral side of the patient’s head (one of left/right side) or the second lateral side of the patient’s head (other of left/right side) to have varied stiffness is a known consideration in order to facilitate the conformability of the strap to the patient.
As to Claim 22, please see the rejection of Claim 21, whereby the varied rigidity of the strap (20) was known.
Regarding the “superior edge” and the “inferior edge” limitations, Gibson discloses concerns to the edges of straps to not “irritate the skin” of the patient (Para 0058) so that “there is less chance of facial marking” (Para 0066), whereby edges which are not rounded are “positioned away from the patient's face, e.g., to avoid facial marking.” (Para 0067). In this consideration, the “superior edge” and the “inferior edge” are positioned such that they are remote from the patient’s face as a function of the construction of the chassis portion (54), thus the concerns of “facial marking” and “irritat[ion] the skin” are negated.
Consequently, the placement of the first elastic region and the second elastic region are a function of the proximity to the patient’s skin, whilst the “superior edge” and the “inferior edge” and the “a first substantially inextensible portion” and “a second substantially inextensible portion” are positioned in locations remote of the patient’s skin such that the entirety of the strap (20) as looped about the chassis portion (54) at the anterior portion of the strap (30) is remote from the patient’s skin by the intervening structure – characteristic of the “inextensible portion” – adjoined by the “superior edge” and the “inferior edge” – to the location of the strap at the first and second ends (44/44) at the posterior portion of the strap (40) is proximate the neck of the patient’s skin – characteristic of the “elastic regions”.
Allowable Subject Matter
Claims 23-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art made of record does not disclose, teach, or fairly suggest the construction of a strap having “a pair of low extensibility portions located on respective lateral sides of the strap, the low extensibility portions being more extendable than the first substantially inextensible portion and the second substantially inextensible portion but less extendable than the first elastic region and the second elastic region.”
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot.
Although Primary Examiner appreciates Applicant’s clarifying amendments and further Applicant’s consideration of the request for the examiner’s amendment, the current claim listing does not overcome the application of the newly located prior art reference of Fishman (2008/0264422), as applied in combination of Fishman (2008/0264422) in view of Gibson (2013/0139822).
As clearly shown in Figure 3 of Fishman (2008/0264422), Fishman discloses a strap (defined as the combination of 14 and 38, wherein 14 - “A horizontal band 14 is fixed on one side to the mask 16 which is positioned over the swivel airway intake spout 18.” Para 0028; and wherein 38 – “The other side of this vertical band is anchored to the junction of the horizontal bands 38 situated in the back of the head (see FIG. 4). The junction of the horizontal bands 38 is an anchor which is movable, and permits the horizontal band to glide through it, thus permitting compatibility with various size patients' heads.” Para 0029) configured to be arranged, in use, so that an anterior portion of the strap (14) positioned anteriorly to and overlies an anterior surface of the chassis portion (16) across the width of the chassis portion (16) to position the anterior surface of the chassis portion (16) between the anterior portion of the strap (14) and the patient’s face (best seen Figures 1-3), the strap (14) passes around the sides of the patient’s head inferior to the patient’s ears (as shown in Figures 1-5) and a posterior portion of the strap (38) overlies a posterior portion of the patient’s neck (best seen Figures 3 and 4), wherein no part of the positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) is configured to be positioned superior to the patient’s ears in use.
Regarding the modification of Fishman with Gibson, Gibson is reintroduced into the new grounds of rejection to affirm the construction of the position and stabilizing structure was well-known, routine, and conventional practice and to further modify the plenum chamber inlet port of Fishman to include the feature of the vent structure.
Regarding the configuration whereby the orientation of the strap in which “no part of the positioning and stabilizing structure is configured to be positioned superior to the patient’s ears in use” is further affirmed by the teachings of Gibson to be a known alternative structure suitable for imparting securement of the cushion module on the face of the user. Hence, Primary Examiner’s characterization of the claimed positioning and stabilizing structure (defined as the combination of 14, 20, 34, and 38) as shown in Fishman is affirmed as an alternative configuration that would be 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 properly secure the cushion module to seal against the user’s face wherein the positioning and stabilizing structure extends only anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient.
Regarding the configuration of the “vent structure to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use”, Gibson shows in Figures 6 and 7, a vent structure (91 via 90, “In an example, the elbow 90 may include one or more vent holes 91 (e.g., see FIGS. 6 and 7) to permit the exhaust of gases from the mask system.” Para 0070) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber (defined by the interior of 54 which embraces the face of the patient) to ambient, said vent structure (91 via 90) being configured to maintain the therapeutic pressure in the plenum chamber (defined by the interior of 54 which embraces the face of the patient) in use.
Thus by the teachings of Gibson, the modification of the plenum chamber inlet port (18), in the form of an elbow, of Fishman to be substituted for the elbow (90) of Gibson is a known result effective variable in order to yield an exhaust port for exhalation gases to be cleared from the plenum chamber.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the positioning and stabilizing structure of Fishman to include the region which is only anterior to the cushion module and posterior to the patient’s neck and below the ears of the patient, as taught by Gibson to be a known result effective variable to properly secure the cushion module to seal against the user’s face wherein the positioning and stabilizing structure, and further to modify the plenum chamber inlet port of Fishman to include a vent structure, as taught by Gibson to permit the exhausting of exhaled gases from the plenum chamber.
In light of the aforementioned reasoning, the non-final rejection of the claims is maintained and made FINAL.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785