DETAILED ACTION
Primary Examiner acknowledges Claims 11-30 are pending in this application, with Claims 11-30 having been newly added, and Claims 1-10 having been cancelled by preliminary amendment on June 13, 2023.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, each of Claims 24-27 recite the limitation “the holes”; however, this limitation appears to be indefinite and lacks antecedent basis in the claims. It appears the concept of the “holes” refers back to the initial recitation of “a plurality of holes” as seen in Claim 23, Line 2. Thus, subsequent recitation should recite “the plurality of holes”. Appropriate correction and clarification is required.
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 11-26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Starr et al. (5,517,986) in view of Drew et al. (7,926,487) and Applegate (4,127,120).
As to Claim 11, Star discloses a patient interface (Figures 1, 3, 4, and 6), comprising: a plenum chamber (defined by the region of 40 exposed to the ambient atmosphere, “The mask 40 is a nasal/oral mask adapted to enclose the nose and mouth of a patient.” Column 3, Lines 1-15; “Once the mask 40 is connected to a gas source, the lower strap tabs 42, 44, (FIG. 3) of the lower strap means 30, 32 are unhooked and the lower strap means 30,32 are again gradually tightened until an adequate seal and a comfortable fit exists.” Column 4, Lines 15-35), the plenum chamber (defined by the region of 40 exposed to the ambient atmosphere) including a plenum chamber inlet port (via “the mask 40 is connected to a gas source” Column 4, Lines 15-35) sized and structure to receive a flow of air for breathing by a patient (“CPAP”, “Such a headgear is described and illustrated, for example, in a brochure entitled "RESPIRONICS SleepEasy.RTM. Nasal CPAP System" published by RESPIRONICS, INC., and dated Jan. 30, 1986.” Column 1, Lines 20-30); a seal forming structure (defined by the region of 40 in contact with the patient’s face, “The mask 40 is a nasal/oral mask adapted to enclose the nose and mouth of a patient.” Column 3, Lines 1-15) constructed and arranged to form a seal (“an adequate seal and a comfortable fit exists.” Column 4, Lines 15-35) with a region of the patient’s face surrounding an entrance of the patient’s airways for sealed delivery of a flow of air throughout the patient’s respiratory cycle in use, the seal forming structure (defined by the region of 40 in contact with the patient’s face) having a hole therein (best seen Figure 1, “to enclose the nose and mouth of a patient.” Column 3, Lines 1-15) such that the flow of air is delivered to at least an entrance of the patient’s nares (“The mask 40 is a nasal/oral mask adapted to enclose the nose and mouth of a patient.” Column 3, Lines 1-15), the seal forming structure (defined by the region of 40 in contact with the patient’s face) constructed and arranged to maintain pressure in the plenum chamber (defined by the region of 40 exposed to the ambient atmosphere) throughout the patient’s respiratory cycle in use; and a positioning and stabilizing structure (10, “Referring to FIGS. 1 and 3, there is illustrated an adjustable headgear 10 of this invention, comprising a head piece 12 having upper side edges 14, 15 positioned along the crown of a patient's head and lower side edges 16, 17 positionable along the back portion of the patient's head.” Column 2, Line 55 thru Column 3, Line 5) to provide a force (from the act of applying tension which yield a “tightened” configuration, “Each of the lower strap means 30, 32 is gradually tightened until a comfortable fit exists. Once the mask 40 is connected to a gas source, the lower strap tabs 42, 44, (FIG. 3) of the lower strap means 30, 32 are unhooked and the lower strap means 30,32 are again gradually tightened until an adequate seal and a comfortable fit exists.” Column 4, Lines 15-35) to hold the seal forming structure (defined by the region of 40 in contact with the patient’s face) in a therapeutically effective position on a patient’s head, the positioning and stabilizing structure (10) comprising: a superior strap (22/24, “Depending strap means 22, 24 depend downwardly from the said side portions 18, 20 and terminate in depending strap loops 26, 28, respectively.” Column 2, Line 55 thru Column 3, Line 5; also see: “The depending strap means 22 is disposed forwardly of the patient's ear and is connected to the lower strap means 30 by the depending strap loop 26 as explained above.” Column 4, Lines 15-35); an inferior strap portion (16/17, “Referring to FIGS. 1 and 3, there is illustrated an adjustable headgear 10 of this invention, comprising a head piece 12 having upper side edges 14, 15 positioned along the crown of a patient's head and lower side edges 16, 17 positionable along the back portion of the patient's head.” Column 2, Line 55 thru Column 3, Line 5); an anterior strap portion (30/32, “The adjustable headgear 10 also includes lower strap means 30, 32 positionable beneath the ears of the patient's head extending towardly from the lower side edges 16, 17 and through the depending strap loops 26, 28.” Column 3, Lines 1-15) connected to or formed intergrally with the superior strap portion (22/24) and the inferior strap portion (16/17); wherein the anterior strap portion (30/32) comprises: a strap receiving portion (34/36, “The lower strap means 30, 32 terminating in lower connection loops 34, 36 adapting the lower strap means 30, 32 for connection to side connector means 38 (only one visible in FIG. 1) provided on opposite sides of a mask 40.” Column 3, Lines 1-15); and a strap attachment portion (42/44, “The lower strap means, 30, 32 include lower strap tabs 42, 44 respectively at the ends thereof. Each of the strap means 30, 32 includes first adjustable securing means for securing the strap tabs 42, 44 at selective locations at the length of the associated one of the strap means 30, 32 to form the lower connecting loops 34, 36.” Column 3, Lines 15-30) which is releasbly connectable (via “In the preferred arrangement, the adhesive means 46 and the cooperating adhesive means 50 comprises the two components of a VELCRO.RTM. fastener.” Column 3, Lines 15-30) to the strap receiving portion (34/36) such that the anterior strap portion (30/32) forms a loop (defined as the fold along 34/36, best seen Figures 3 and 4), wherein in use, the loop (defined as the fold along 34/36, best seen Figures 3 and 4) engages a connection portion (38, “The lower strap means 30, 32 terminating in lower connection loops 34, 36 adapting the lower strap means 30, 32 for connection to side connector means 38 (only one visible in FIG. 1) provided on opposite sides of a mask 40.” Column 3, Lines 1-15; also see: “The lower strap means 30 extends forwardly from the lower head, beneath the patient's ear, and is connected to the side connector 38 of the gas delivery mask 40.” Column 4, Lines 15-35) which engages the plenum chamber (defined by the region of 40 exposed to the ambient atmosphere); wherein the strap receiving portion (34/36) is configured to engage the strap attachment portion (42/44) in a selected one of a plurality of possible positions to adjust the direction and magnitude of a headgear vector (a function of the act of applying tension which yield a “tightened” configuration to impart a comfortable fit and adequate seal based on the conformity to the anatomy of the patient, “Each of the lower strap means 30, 32 is gradually tightened until a comfortable fit exists. Once the mask 40 is connected to a gas source, the lower strap tabs 42, 44, (FIG. 3) of the lower strap means 30, 32 are unhooked and the lower strap means 30,32 are again gradually tightened until an adequate seal and a comfortable fit exists.” Column 4, Lines 15-35); wherein the connection portion (38) includes a slot (defined as the opening of 38) to permit the strap attachment portion (42/44) to pass through the slot (defined as the opening of 38) in a first direction prior to connecting to the strap receiving portion (34/36).
Yet Starr does not expressly disclose the plenum chamber “pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure”, nor “a tab coupled to the anterior strap portion and inclined with respect to the anterior strap portion … wherein the tab is configured to limit the strap attachment portion from passing through the slot in a second direction opposite to the first direction in order to retain the loop.”
Regarding the concept of therapeutic pressurization, Drew teaches an alternative construction of a patient interface (10, “FIG. 1 shows a nasal respiratory mask 10 according to a first embodiment of the invention. The mask 10 includes a rigid plastic mask shell 12, which has a peripheral flange 14 for mounting of a cushion (not shown) to the shell 12. The cushion abuts the wearer's face in use and is well known in the art. The flange 14 includes slots 15 for the connection of mask restraining straps (not shown) that extend around the head of the wearer to maintain the mask 10 adjacent to the wearer's face.” Column 4, Lines 20-35) comprising a plenum chamber (12, “a rigid plastic mask shell 12” Column 4, Lines 20-35), a plenum chambre inlet port (24, “The mask shell 12 includes a breathable gas inlet 20 which is rotatably mounted to the shell 12. The inlet 20 has a first end 22 which is adapted for connection with a breathable gas supply conduit (not shown) and a second end 24 which is adapted to connect to, and communicate the supplied gas to the interior of the shell 12 for subsequent communication with the wearer's airways.” Column 4, Lines 30-40), a seal forming structure (“a cushion (not shown) to the shell 12” Column 4, Lines 20-35) having a hole (via opening which receives the patient’s nose/mouth, “The cushion abuts the wearer's face in use and is well known in the art.” Column 4, Lines 20-35); and a positioning and stabilizing structure (“mask restraining straps (not shown)”, “The flange 14 includes slots 15 for the connection of mask restraining straps (not shown) that extend around the head of the wearer to maintain the mask 10 adjacent to the wearer's face.” Column 4, Lines 20-35) which engages a connection portion (14, “a peripheral flange 14” Column 4, Lines 20-35) of the plenum chamber (12) and includes slots (15, “slots 15” Column 4, Lines 20-35).
With respect to the limitations of “pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure”, although Starr hints at operational pressure of CPAP (“Such a headgear is described and illustrated, for example, in a brochure entitled "RESPIRONICS SleepEasy.RTM. Nasal CPAP System" published by RESPIRONICS, INC., and dated Jan. 30, 1986.” Column 1, Lines 20-30), takes a further step expressly reciting the operational pressures of a CPAP patient interface. Explicitly, Drew teaches the patient interface (10) is suitable “In CPAP treatment for OSA, air or other breathable gas is supplied to the entrance of a patient's airways at a pressure elevated above atmospheric pressure, typically in the range 3-20 cm H.sub.2O as measured in the patient interface.” (Column 1, Lines 20-35).
In light of the teachings of Drew as modifying Starr, the claimed pressurization range of at least 6 cm of water is a known consideration for CPAP treatment of patient whereby operational parameters at 6-20 cm of water was a known pressurization protocol to treat a patient with a breathing disorder.
Regarding the concept of the tab, Applegate teaches an alternative patient interface - in the form of a back board – (10, best seen Figures 1-4, “Restraining a patient to the torso board 10 requires in general the two sets of straps 34 and 35.” Column 4, Lines 40-50) having a positioning and stabilizing structure (34/35, “two sets of straps 34 and 35” Column 4, Lines 40-50) to hold the patient in a therapeutically effective position (Figures 1, 3, and 4), wherein the positioning and stabilizing structure (34/35) is releasably connectable (via interactive engagement of hooks 46 and loops 45, “Both ends of the strap 37 have the construction as shown in FIGS. 6 and 7 which, for convenience, shows only the section of hooks 46. The section of loops 45 connects to the section of hooks 46 in an area 50 intermediate the ends 51 and 52 of the hooks section 46. Both ends 51 and 52 of the section of hooks remain free to move away from and out of contact with the section of loops 45. Consequently, as shown in FIG. 8, any force tending to disengage the hooks 46 from the loops 45 is exerted upon the interior region 50 of the hooks 46.” Column 4, Line 55 thru Column 5, Line 10) to the connection portion (11, “The board's large area 11 includes the openings 20 and 21 at its bottom coinciding with the patient's pelvic or hip area.” Column 1, Lines 35-55) of the patient interface (10) via the slot (20/21, “openings 20 and 21” Column 1, Lines 35-55), whereby a portion of the positioning and stabilizing structure (34/35) is looped through (best seen Figure 2, “Specifically, the section of hooks 46 passes through the opening 21 and folds back and engages with the loops 45 at a point producing the desired effective length to the strap 37.” Column 5, Lines 5-15) the slot (20/21).
With respect to the limitations of “a tab coupled to the anterior strap portion and inclined with respect to the anterior strap portion … wherein the tab is configured to limit the strap attachment portion from passing through the slot in a second direction opposite to the first direction in order to retain the loop”, Applegate teaches the configuration of a strap (37, best seen Figures 2, and 6-8, “The lower strap 37 also includes a section of loops 45 which extends most of its length. At both ends of the lower straps 37, however, appear short sections of hooks, 46 at one end and 47 at the other. Both ends of the strap 37 have the construction as shown in FIGS. 6 and 7 which, for convenience, shows only the section of hooks 46. The section of loops 45 connects to the section of hooks 46 in an area 50 intermediate the ends 51 and 52 of the hooks section 46. Both ends 51 and 52 of the section of hooks remain free to move away from and out of contact with the section of loops 45. Consequently, as shown in FIG. 8, any force tending to disengage the hooks 46 from the loops 45 is exerted upon the interior region 50 of the hooks 46.” Column 4, Line 55 thru Column 5, Line 10) is constructed of a strap receiving portion (via 45 on 50, as shown in Figures 6-8, “The section of loops 45 connects to the section of hooks 46 in an area 50 intermediate the ends 51 and 52 of the hooks section 46.” Column 4, Line 55 thru Column 5, Line 10) and a strap attachment portion (via 46 on 51, “The section of loops 45 connects to the section of hooks 46 in an area 50 intermediate the ends 51 and 52 of the hooks section 46.” Column 4, Line 55 thru Column 5, Line 10), wherein a tab (52, best seen Figure 7, “end 52” Column 4, Line 55 thru Column 5, Line 10) is coupled to the strap receiving portion (via 45 on 50) of the strap (37) and inclined (at 52) with respect to the strap receiving portion (via 45 on 50) of the strap (37), wherein the connection portion (11) includes a slot (20/21) and the tab (52) is configured to permit the strap (37) to pass through the slot (20/21) in a first direction prior to connecting to the strap receiving portion (via 45 on 50); and wherein the tab (52) is configured to limit the strap (37) from passing through the slot (20/21) in a second direction opposite the first direction.
In operation, the tab (52) remains in an inclined state (best seen Figure 7) until it is looped back upon and the tab (52) is positioned in a planar state (best seen Figure 8). Consequently, when the tab (52) is in the inclined state (best seen Figure 7) the tab is free to be introduced into the slot (20/21) as the initial threading of the strap (37) through the slot (20/21) in a first direction; yet, once the tab (52) passes through the slot (20/21) the tab (52) prevents the disconnection of the strap (37) from the slot as the inclined feature of the tab (52) precludes free movement of the strap (37) within the slot (20/21), and further once the tab (52) is positioned to the planar state (best seen Figure 8), whereby the strap (37) is looped back upon its self, the tab (52) is secured to the strap (37) by the releasable connections (hooks and loop fasteners, 45/46) to preclude the disconnection of the strap (37) from the slot (20/21) in a second opposite direction.
The resultant effect of this configuration is the ability to introduce and then retain the placement of strap (37) about the patient interface (10) to restrain on the patient – “General use requires two sets of these straps to adequately restrain the patient.” (Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of Starr to operate at therapeutic pressures of at least 6 cm of water, as taught by Drew to be a known pressure valuation suitable for treatment of a patient in need of CPAP therapy for treatment of a breathing disorder, and further to modify the positioning and stabilizing structure of the patient interface of Starr to include the use of a tab, as taught by Applegate to retain/restrain the placement of the patient interface onto the patient.
As to Claim 12, the modified Starr, specifically Applegate teaches the configuration of the strap (37) with its associated tab (52) is constructed of the same material as strap attachment portion (46 on 51).
As to Claim 13, the modified Starr, specifically Applegate teaches the tab (52) forms an obtuse angle with respect to the strap attachment portion (46 on 51) in a relaxed position (best seen Figure 7).
As to Claim 14, the modified Starr, specifically Applegate teaches the tab (52) and the strap attachment portion (46 on 51) are disposed adjacent to the strap attachment portion (46 on 51).
As to Claim 15, the modified Starr, specifically Applegate teaches the tab (52) includes hook material (46) configured to engage with a loop material (45) on the strap receiving portion (via 45 on 50).
As to Claim 16, the modified Starr, specifically Applegate teaches the tab (52) is a one-way hinge and is limited in its movement toward the strap attachment portion (46 on 51) past the relaxed position (Figure 7).
As to Claim 17, the modified Starr, specifically Starr discloses when the patient interface (Figures 1, 3, 4, and 6) is worn by the patient, the strap attachment portion (42/44) is permitted to pass through the slot (defined as the opening of 38) in the second direction when the patient applies a force (disconnection of hook and loop fasteners) to the tab (52 of Applegate) toward the strap receiving portion (34/36).
As to Claim 18, the modified Starr, specifically Starr discloses the connection portion (38) is permanently coupled to the plenum chamber (defined by the region of 40 exposed to the ambient atmosphere).
As to Claim 19, the modified Starr, specifically Starr discloses the slot (defined as the opening of 38) is fully formed within the connection portion (38).
As to Claims 20 and 21, the modified Starr, specifically Starr discloses the positioning and stabilizing structure (10) is configured to be removable from the patient’s head without moving the strap attachment portion (42/44) through the slot (opening of 38) in the second direction. As the modified Starr includes a series of releasable connection points (via VELCRO fastener, Column 3, Lines 15-30), the positioning and stabilizing structure is configured to achieve various positions including but not limited to a loose placement on the patient’s face at initial threading and looping, to the “gradually tightened” (Column 4, Lines 15-35) placement on the user’s face. In that construction, the loose placement would permit the removal of the positioning and stabilizing structure (10) without complete disconnection and unthreading of the positioning and stabilizing structure (10) from the slot (opening of 38).
As to Claim 22, the modified Starr, specifically Starr discloses the positioning and stabilizing structure (10) further includes a posterior connection strap portion (12, “Referring to FIGS. 1 and 3, there is illustrated an adjustable headgear 10 of this invention, comprising a head piece 12 having upper side edges 14, 15 positioned along the crown of a patient's head and lower side edges 16, 17 positionable along the back portion of the patient's head. The head piece 12 preferably is formed from net-like material to allow for ventilation of the patient's head.” Column 2, Line 55 thru Column 3, Line 5) connected to or formed integrally with the superior strap portion (22/24) and the inferior strap portion (16/17).
As to Claim 23, the modified Starr, specifically Starr discloses the posterior connection strap portion (12) includes a plurality of holes (“net-like material” Column 2, Line 55 thru Column 3, Line 5) to provide increased stretchability to the posterior connection strap portion (12). By convention, “net” structures are formed by the weaving and/or knotting together of a fiber, wherein the fibers have a normal structural configuration without a loading force are able to be stretched as a function of tension forces which apply a loading force to the weave and/or knot.
As to Claim 24, the modified Starr, specifically Starr discloses the plurality of holes (“net-like material”) are arranged proximate to the inferior strap portion (16/17).
As to Claim 25, the modified Starr, specifically Starr discloses the plurality of holes (“net-like material”) are arranged in a pattern (“net”) on the posterior connection strap portion (12).
As to Claim 26, the modified Starr, specifically Starr discloses the posterior connection strap portion (12) includes a mesh material (“net-like material”) having the plurality of holes (“net-like material”).
As to Claim 28, the modified Starr, specifically Starr discloses the superior strap portion (22/24, “The depending strap means 22 is disposed forwardly of the patient's ear and is connected to the lower strap means 30 by the depending strap loop 26 as explained above.” Column 4, Lines 15-35) is configured to, in use, extend over a least a portion of the patient’s cheek between the patient’s eyes and ears (best seen Figure 6).
As to Claim 29, the modified Starr, specifically Starr discloses the inferior strap portion (16/17, “Referring to FIGS. 1 and 3, there is illustrated an adjustable headgear 10 of this invention, comprising a head piece 12 having upper side edges 14, 15 positioned along the crown of a patient's head and lower side edges 16, 17 positionable along the back portion of the patient's head.” Column 2, Line 55 thru Column 3, Line 5) is configured to, in use, extend over a region of the patient’s head below and/or behind the patient’s ears (best seen Figure 6).
Claims 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Starr et al. (5,517,986) in view of Drew et al. (7,926,487) and Applegate (4,127,120), as applied to Claims 26 and 29, and further in view of Chodkowski et al. (2014/0305439).
As to Claim 27, the modified Starr, specifically Starr discloses the posterior connection strap portion (12) includes a mesh material (“net-like material”) having the plurality of holes (“net-like material”).
Yet, does not expressly disclose “the mesh material is different than the material used to construct the superior strap portion and the inferior strap portion.”
Chodkowski teaches an alternative patient interface (as best seen in Figure 3) having a plenum chamber (defined by the portion of 36 exposed the ambient environment, “Curved member 35 serves to maintain the designed angle around the patient's ear as a patient interface, such as mask 36, is tightened on the patient's head.” Para 0048), a plenum chamber inlet port (defined via the hose anterior to the plenum chamber), a seal forming structure (defined by the portion of 36 which encompasses the nose and mouth of the patient), a positioning and stabilizing structure (30, “Headgear assembly 30 further includes a curved member 35 formed from a third material C.sub.1 (e.g., without limitation, dense foam having a less or non-elastic backing) having a low, if any, elasticity, less than the elasticity of second material B.sub.1.” Para 0048) including a superior strap portion (C1), an inferior strap portion (A1), an anterior strap portion (D1 proximate 35), and a posterior strap connection portion (D1 proximate 32).
With respect to the differences of materials in the posterior strap connection portion (D1 proximate 32) as compared to the superior strap portion (C1) and the inferior strap portion (A1), Chodkowski teaches the differences in material composition having different percent elongations, and elasticity and/or stiffness to prescribe the fitment of the headgear so the head of the user. In this configuration, the posterior strap connection portion (D1 proximate 32) and the anterior strap connection portion (D1 proximate 35) is constructed “from a generally elastic fourth material D.sub.1 (e.g., without limitation, a typical strapping material having an elongation in the range of about 125% to 150%) having an elasticity less than the second material B.sub.1 and first material A.sub.1.” (Para 0048), whilst the superior strap portion (C1) is constructed “from a third material C.sub.1 (e.g., without limitation, dense foam having a less or non-elastic backing) having a low, if any, elasticity, less than the elasticity of second material B.sub.1.” (Para 0048), and the inferior strap portion (A1) is constructed “from a highly elastic first material A.sub.1 (e.g., without limitation, a laminate material having a low density foam with a Lycra backing in highest spandex ratio) which allows for increased comfort and fit when the patient's head pivots back and forth.” (Para 0047). The resultant effect of these varying material compositions is the ability to prescribe the fitment of the headgear so the head of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the positioning and stabilizing structure of the modified Starr to include the construction of the mesh material of the posterior connection portion to be made of a different material than that of the superior strap portion and the inferior strap portion, as taught by Chodkowski to prescribe the fitment of the headgear so the head of the user, wherein the back of the head “allows for increased comfort and fit when the patient's head pivots back and forth”.
As to Claim 30, the modified Starr, specifically Starr discloses the inferior strap portion (16/17, “Referring to FIGS. 1 and 3, there is illustrated an adjustable headgear 10 of this invention, comprising a head piece 12 having upper side edges 14, 15 positioned along the crown of a patient's head and lower side edges 16, 17 positionable along the back portion of the patient's head.” Column 2, Line 55 thru Column 3, Line 5) is configured to, in use, extend over a region of the patient’s head below and/or behind the patient’s ears (best seen Figure 6).
Yet, does not expressly disclose “the inferior strap portion has increased strechability as compared to the superior strap portion”.
Chodkowski teaches an alternative patient interface (as best seen in Figure 3) having a plenum chamber (defined by the portion of 36 exposed the ambient environment, “Curved member 35 serves to maintain the designed angle around the patient's ear as a patient interface, such as mask 36, is tightened on the patient's head.” Para 0048), a plenum chamber inlet port (defined via the hose anterior to the plenum chamber), a seal forming structure (defined by the portion of 36 which encompasses the nose and mouth of the patient), a positioning and stabilizing structure (30, “Headgear assembly 30 further includes a curved member 35 formed from a third material C.sub.1 (e.g., without limitation, dense foam having a less or non-elastic backing) having a low, if any, elasticity, less than the elasticity of second material B.sub.1.” Para 0048) including a superior strap portion (C1), an inferior strap portion (A1), an anterior strap portion (D1 proximate 35), and a posterior strap connection portion (D1 proximate 32).
With respect to the differences of the material characteristics of the superior strap portion (C1) and the inferior strap portion (A1), Chodkowski teaches the differences in material composition having different percent elongations, and elasticity and/or stiffness to prescribe the fitment of the headgear so the head of the user. In this configuration, the inferior strap portion (A1) is constructed “from a highly elastic first material A.sub.1 (e.g., without limitation, a laminate material having a low density foam with a Lycra backing in highest spandex ratio) which allows for increased comfort and fit when the patient's head pivots back and forth.” (Para 0047); whilst, the superior strap portion (C1) is constructed “from a third material C.sub.1 (e.g., without limitation, dense foam having a less or non-elastic backing) having a low, if any, elasticity, less than the elasticity of second material B.sub.1.” (Para 0048). The resultant effect of these varying material compositions is the ability to prescribe the fitment of the headgear so the head of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the positioning and stabilizing structure of the modified Starr to include the construction of the inferior strap portion to have increased stretchability as compared to the superior strap portion, as taught by Chodkowski to prescribe the fitment of the headgear so the head of the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ho et al. (2011/0253143) discloses an additional patient interface having a positioning and stabilizing structure concerned with headgear force vectors (Paras 0018 and 0019).
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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785