DETAILED ACTION
Primary Examiner acknowledges Claims 1-26 are pending in this application, as originally filed on March 1, 2024.
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 Objections
Claim 1 is objected to because of the following informalities:
Specifically, Claim 1, Line 13 should recite “the seal forming structure” since “a seal forming structure “ as already introduced in Claim 1, Line 6. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 14-16 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, Claim 14, Line 2 recites the limitation “a pad constructed from the second material”; while Claim 1, Line 23-26 recites “the rear strap constructed from a first material and a second material… the second material arranged to contact, in use, the occiput of the patient’s head”; yet, the breadth and scope of this limitation appears to be unclear. Primary Examiner is unsure if the pad is a feature that is separate and distinct from the “rear strap” having the “second material” or if the pad is a further limitation of the construction of the “second material”? How does the “pad” engage/contact/abut the “rear strap”? It appears by the claim limitations that both the “pad” and the “second material” of the “rear strap” both engage the “occiput” of the patient. How can two materials be oriented to engage the same location? Dependent claims, Claims 15 and 16, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Claim 16 contains the trademark/trade name VELCRO®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe hook and loop fastener and, accordingly, the identification/description is indefinite. 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 1-3, 5-9, 11-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chodkowski et al. (2014/0305439) in view of Sullivan (4,944,310) and Hanke et al. (5,724,965).
As to Claim 1, Chodkowski discloses a patient interface (Figure 4), comprising: a plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) pressurizable to a therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.” Para 0005) above ambient pressure, the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) including a plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (“continuous positive airway pressure (CPAP) or variable airway pressure”) for breathing by the patient; a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to a patient’s airways for sealed delivery of a flow of air at the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) through a patient’s respiratory cycle in use, said seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) having hole therein such that the flow of air at said therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) is delivered to at least an entrance to the patient’s nares, the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to maintain the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) in the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) through the patient’s respiratory cycle in use; a positioning and stabilizing structure (40, “FIG. 4 shows a side view of another example headgear assembly 40 formed in accordance with an embodiment of the present invention disposed on the head of a patient.” Para 0049) to provide a force to hold a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (40) comprising: a top strap (47, “a top strap 47” Para 0050) constructed and arranged to contact, in use, at least a region of the patient’s head superior to the otobasion superior of the patient’s head, a side strap (42, “a forward strap member 42” Para 0050) coupled to the top strap (47), the side strap (42) constructed and arranged, in use, to extend in an anterior and inferior direction towards the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4), and a rear strap (one of 41/43 AND one of 44/46, “Another portion 43 of second material B.sub.2 is disposed adjacent, and coupled to a rear edge (not numbered) of c-shaped portion 41 and is used to stabilize back straps 44 and 46.” Para 0050) coupled (at B2) to the top strap (47) and the side strap (42), the rear strap (one of 41/43 AND one of 44/46) being arranged to extend in a posterior and inferior direction on the patient’s head in order to contact, in use, an occiput of the patient’s head, the rear strap (one of 41/43 AND one of 44/46) is constructed from a first material (A2 or B2, wherein A2 – “A flexible, minimally elastic, preferably inelastic, first material A.sub.2 (e.g., without limitation, a foam core material with a non-elastic backing)” Para 0049; also see: “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” Para 0057; and wherein B2 – “A more stiff, preferably nearly rigid, second material B.sub.2 (e.g., a layered material including a rigid polymer sheet)” Para 0050; also see: “Mylar, polyethylene, Nylon, UBL, and various dense foams are non-limiting examples of suitable inelastic materials.” Para 0057) and a second material (C2, “A third, generally elastic and flexible material C.sub.2 (e.g., a material having an elongation in the range of about 125% to 150%)” Para 0050; also see: “Polyurethane, silicone, and certain foams are non-limiting examples of suitable semi-elastic materials.” Para 0057), the first material (A2/B2) arranged to contact, in use, a temporal region of the patient’s head, and the second material (C2) arranged to contact, in use, the occiput of the patient’s head, wherein the second material is silicone (“silicone” Para 0057), wherein the second material (C2) is configured to limit motion of the top strap (47) and/or the side strap (42) in an anterior and/or posterior direction while in the therapeutically effective position on the patient’s head; and wherein the patient interface (Figure 4) is configured to allow the patient to breath from ambient through their mouth (by the known embodiments of “a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs” Para 0006) in the absence of a flow of pressurized air through the plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions), or patient interface is configured to leave the patient’s mouth uncovered.
Yet, Chodkowski does not expressly disclose the configuration by which the therapeutic pressure is “at least 6 cm of H2O” with the explicit functionality of a “seal”, nor the configuration of the claimed “vent structure”.
Regarding the specific therapeutic pressure and functionality of a seal, Sullivan teaches a similar device to Chodkowski capable for operating at a therapeutic pressure (“CPAP” Column 3, Lines 5-30). In this configuration of providing a therapeutic pressure, Sullivan teaches “A typical relative pressure for a patient may be 6 cm H.sub.2 O although a range from 4 to 15 cms H.sub.2 O would cover most if not all individuals.” Column 2, Lines 45-55 as well as “ 9 cm H.sub.2 O CPAP” Column 3, Lines 5-30. To achieve this therapeutic pressure, Sullivan teaches the configuration of the patient interface in the form of a nasal mask (5, “Communicating with nose piece (3) is a face mask (5) adapted to be sealingly attached to a patient's nose and providing communication between the patient's nostrils and the interior of nose piece (3).” Abstract) to encompass the nose of the patient (via 7, “Nose mask 5 is shaped so as to fit over most noses and includes a cavity 7 for this purpose. Communicating between cavity 7 and the interior of nostril piece 3 are two openings 6 which are substantially aligned respectively with a patient's nostrils when nose mask 5 is in place.” Column 2, Lines 30-40), and further including a seal (“In use a seal is produced from surgical grade silicon, such as Dow Corning Silastic 382 (Registered Trade Mark), rubber by forming it around the inside of cavity 7 and placing the apparatus in its working position on the patient.” Column 2, Lines 55-65). The resultant effect of this configuration is the ability of Sullivan to provide therapeutic pressure to treat the patient’s disordered breathing.
Regarding the “vent structure”, Hanke teaches a patient interface (10, best seen Figure 1, “generally indicated at 10 in FIG. 1 a nasal mask and headgear apparatus comprised of a mask 12 and retaining headgear 14.” Column 3, Lines 5-15), similar to Chodkowski, including a plenum chamber (12, “a mask 12” Column 3, Lines 5-15), a seal forming structure (52, “a seal 52” Column 3, Lines 55-65), a positioning and stabilizing structure (14, “retaining headgear 14” Column 3, Lines 5-15, defined by the inclusion of 18, 16, 20, and 35, wherein “In use, the mask and headgear assembly is placed in position on a user's face and head as shown in FIG. 1 and straps 18 and 20 are adjusted for a suitable fit of ear pieces 16 on the user's head. Straps 35 are then adjusted to position and retain mask 12, with seal 52 inflated by gas pressure within cavity 56 to achieve sealing engagement with a portion of the user's face within the confines of the area between the lower part of the user's nose and the upper lip, as described hereinabove and as shown in FIG. 9, and with opening 60 confronting the nares of the user.” Column 5, Lines 30-55) including a top strap (18, “straps 18”), a side strap (35, “Straps 35”), a rear strap (the combination of 16 and 20, wherein 16 – “ear pieces 16” and wherein 20 – “straps 18 and 20”), wherein the patient interface (10) is suitable for operating a therapeutic pressure ( “positive pressure therapy for such conditions as obstructive sleep apnea (OSA).” Summary).
In this operation at a therapeutic pressure, Hanke teaches the configuration of the plenum chamber (12) including a vent structure (76, “Laterally outward to either side of port 54 there are formed openings 76 which project inwardly of body 72 to open inner ends 78, and which additionally open outwardly on the opposed side of the body 72 at outer open ends 80.” Column 4, Lines 25-45) to allow continuous flow of gases exhaled by the patient from an interior (56) of the plenum chamber (12) to the ambient (via 80), said vent structure (76) being sized and shaped to maintain therapeutic pressure in the plenum chamber in use. The resultant effect of the formation of the vent structure is the ability to entrain ambient air with provided gas during inhalation, and permit the passage of carbon dioxide from the patient to the ambient during exhalation – thus preventing a hypoxic environment within the patient interface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operation of the therapeutic pressure of Chodkowski to operate at “at least 6 cm of water” as taught by Sullivan to be a known therapeutic pressure suitable for treating sleep disordered breathing by with a sealed patient interface, and further to modify the patient interface of Chodkowski to include a vent structure as taught by Hanke to permit the exhaustion of carbon dioxide from the patient during exhalation.
As to Claim 2, the modified Chodkowski, specifically Chodkowski discloses the second material (C2) of the rear strap (at 44/46) does not extend across the parietal bone of the patient’s head. It is noted although Chodkowski disclose the top strap made of the second material (C2) the claims do not necessitate the material composition of the top strap. Thus, the term “second material” is limited only to the rear strap, regardless of the usage of the second material in other straps along the positioning and stabilizing structure.
As to Claim 3, the modified Chodkowski, specifically Chodkowski discloses the rear strap (one of 41/43 AND one of 44/46) does not extend across the parietal bone from a left side of the patient’s head to a right side of the patient’s head.
As to Claim 5, the modified Chodkowski, specifically Chodkowski discloses the second material (C2) is constructed of silicone and the first material (A2/B2). In the construction of A2 of the first material, A2 is constructed of “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” (Para 0057). Silicone is a naturally tacky material with a static coefficient of friction around 1.0 μₛ; while, e.g. velstretch has a static coefficient of friction between 0.4-0.6 μₛ and e.g. spandex 0.1 – 0.2 μₛ. In the configuration of B2 of the first material, B2 is constructed of “Mylar, polyethylene, Nylon, UBL, and various dense foams are non-limiting examples of suitable inelastic materials.” (Para 0057). Silicone is a naturally tacky material with a static coefficient of friction around 1.0 μₛ; while, e.g. Mylar is a smooth, non-stick polyester film that is typically has a static coefficient of friction between 0.2 and 3 μₛ - e.g polyethylene 0.2 μₛ, and e.g. nylon 0.15-0.25 μₛ. In each case of the first material either A2 or B2, the coefficient of friction of the second material (C2) silicone is greater than either first material of A2 or B2.
As to Claim 6, the modified Chodkowski, specifically Chodkowski discloses the first material (A2/B2) is connected at a transition (best seen Figure 4), the first material (B2) does not cross the transition and overlap the second material (C2), and the second material (C2) does not cross the transition and overlap the first material (A2/B2).
As to Claim 7, the modified Chodkowski, specifically Chodkowski discloses the first material (A2/B2) and the second material (C2) are connected along the transition using sewing, adhesive, sonic welding (“Coupling the sub-portions may comprise coupling the edge faces of the sub-portions, without overlap, by at least one of: stitching, adhering, heat bonding and sonic welding.” Para 0011, also see: Para 0014 and 0040).
As to Claim 8, the modified Chodkowski, specifically Chodkowski discloses the top strap (47) and the side strap (42) are formed as a continuous structure and are not connected using a fastener.
As to Claim 9, the modified Chodkowski, specifically Chodkowski discloses the second material (C2) of the rear strap (at 44/46) is silicone and is included only on the occiput and nowhere else along the patient’s head. It should be noted C2 has additional material compositions to include “Polyurethane, silicone, and certain foams are non-limiting examples of suitable semi-elastic materials.” (Para 0057). Although Applicant has designated the second material (C2) of the rear strap (at 44/46) to be silicone, there is no structure that would preclude, prevent, or hinder, the application of the remaining areas of C2 to be made from a material which is not silicone, such as: “Polyurethane … and certain foams”.
As to Claim 11, the modified Chodkowski, specifically Chodkowski discloses the first material (A2/B2) is a textile: with respect to A2 – “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” (Para 0057) and with respect to B2 – “Mylar, polyethylene, Nylon, UBL, and various dense foams are non-limiting examples of suitable inelastic materials.” (Para 0057).
As to Claim 12, the modified Chodkowski, specifically Chodkowski discloses the first material (A2/B2) is an elastic (specifically A2 - “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” (Para 0057)), and is configured, in use, to increase in length as a result of tensile force.
As to Claim 13, the modified Chodkowski, specifically Chodkowski discloses the second material (C2) of the rear strap (at 44/46) does not contact the temporal region below an otobasion inferior of the patient’s head. The term “second material” is limited only to the rear strap, regardless of the usage of the second material in other straps along the positioning and stabilizing structure.
As to Claim 17, the modified Chodkowski, specifically Chodkowski discloses the first material (A2/B2) and the second material (C2) are permanently affixed to one another (“Coupling the sub-portions may comprise coupling the edge faces of the sub-portions, without overlap, by at least one of: stitching, adhering, heat bonding and sonic welding.” Para 0011, also see: Para 0014 and 0040).
Claims 1-5, 11-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Walls et al. (2016/02878830) in view of Sullivan (4,944,310) in view of Chodkowski et al. (2014/0305439).
As to Claim 1, Walls discloses a patient interface (Figures 1 and 16), comprising: a plenum chamber (106, “The illustrated interface 102 is a nasal pillows mask that includes a mask frame 106.” Para 0083) pressurizable to a therapeutic pressure above ambient air pressure, said plenum chamber (106) including a plenum chamber inlet port (via conduit as shown in Figure 1) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal forming structure (102, “The illustrated interface 102 is a nasal pillows mask that includes a mask frame 106.” Para 0083) constructed and arranged to form a seal with a region of a patient’s face surrounding an entrance to a patient’s airways for sealed delivery of a flow of air at therapeutic pressure throughout a patient’s respiratory cycle in use, said seal forming structure (102) having a hole therein such that the flow of air at the therapeutic pressure is delivered to at least the entrance of the patient’s nares, the seal forming structure (102) constructed and arranged to maintain said therapeutic pressure in the plenum chamber (106) through the patient’s respiratory cycle in use; a positioning and stabilizing structure (104, “The assembly 100 features an interface 102 that is removably connectable with a headgear assembly 104.” Para 0082) to provide a force to hold the seal forming structure (102) in a therapeutically effective position on a patient’s head, the positioning and stabilizing structure (104) comprising: a top strap (130, “With reference again to FIG. 1, the headgear assembly 104 also can comprise a crown strap assembly 130.” Para 0097) constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head, a side strap (114 anterior to 158, “The headgear assembly 104 generally comprises a main strap 114. The main strap 114 can be configured to extend around the back of the head or neck of the wearer. The main strap 114 can have any suitable configuration and can be formed of any suitable material. In some configurations, the main strap 114 can be formed of a stretchable material. In some configurations, the main strap 114 comprises a tubular-knitted elastic strap.” Para 0085) coupled (at 158, “In some configurations, the passage 156 can be defined by three supporting components 158. The supporting components 158 are spaced apart along a length of the second bridge region 146. In some configurations, two of the three supporting components 158 are configured to secure the main strap 114 against significant upward movement relative to the second bridge region 146 while the third of the three supporting components 158 is configured to secure the main strap 114 against significant downward movement relative to the second bridge region 146. In some configurations, all three of the supporting components 158 are configured to secure the main strap against significant downward movement relative to the second bridge region 146.” Para 0110) to the top strap (130), the side strap (114 anterior to 158) constructed and arranged to extend in an anterior and inferior direction toward the seal forming structure (102), and a rear strap (the combination of 114 posterior to 158 AND 122, wherein 114 - “The headgear assembly 104 generally comprises a main strap 114. The main strap 114 can be configured to extend around the back of the head or neck of the wearer. The main strap 114 can have any suitable configuration and can be formed of any suitable material. In some configurations, the main strap 114 can be formed of a stretchable material. In some configurations, the main strap 114 comprises a tubular-knitted elastic strap.” Para 0085; and wherein 122 – “With reference to FIG. 14, to enhance comfort, a sleeve 122 can be positioned along the main strap 114 between the ends 116. The sleeve 122 can be configured in any suitable manner and the sleeve can be formed of any suitable material. In some configurations, the sleeve 122 is repositionable along the main strap 114 in any location between the ends 116. In some configurations, the sleeve 122 is secured to the main strap 114 and cannot be removed and/or cannot be moved along the length of the main strap 114. The sleeve 122 can be formed of polyester, nylon, micro fibre, fleece, or any other suitable materials, including those that are quick drying and/or moisture wicking. Paras 0095-0095) coupled (at 158) to the top strap (130) and the side strap (114 anterior to 158), the rear strap (the combination of 114 posterior to 158 AND 122) being arranged to extend in a posterior and inferior direction on the patient’s head in order to contact, in use, an occiput of the patient’s head, the rear strap (the combination of 114 posterior to 158 AND 122) constructed from a first material (“stretchable material … tubular-knitted elastic strap” Para 0085) and a second material (“polyester, nylon, micro fibre, fleece, or any other suitable materials, including those that are quick drying and/or moisture wicking” Para 0095), the first material (“stretchable material … tubular-knitted elastic strap” Para 0085) arranged to contact, in use, a temporal region of the patient’s head, and the second material (“polyester, nylon, micro fibre, fleece, or any other suitable materials, including those that are quick drying and/or moisture wicking” Para 0095) arranged to contact, in use, the occiput of the patient’s head, wherein the second material (“polyester, nylon, micro fibre, fleece, or any other suitable materials, including those that are quick drying and/or moisture wicking” Para 0095) is configured to limit motion of the top strap (130) and/or side strap (114 anterior to 158) in an anterior and/or posterior direction while in the therapeutically effective position on the patient’s head; a vent structure (best seen Figure 1 on elbow) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber (106) to the ambient, said vent structure (best seen Figure 1 on elbow) being sized and shaped to maintain the therapeutic pressure in the plenum chamber (106) in use, wherein the patient interface is configured to allow the patient to breath from ambient though their mouth in the absence of a flow of pressurized air through the plenum chamber inlet port (via conduit as shown in Figure 1) or the patient interface is configured to leave the patient’s mouth uncovered.
Yet, Walls does not expressly disclose the configuration by which the therapeutic pressure is “at least 6 cm of H2O” nor the second material is “silicone”.
Regarding the specific therapeutic pressure, Sullivan teaches a similar device to Walls capable for operating at a therapeutic pressure. In this configuration of providing a therapeutic pressure, Sullivan teaches “A typical relative pressure for a patient may be 6 cm H.sub.2 O although a range from 4 to 15 cms H.sub.2 O would cover most if not all individuals.” Column 2, Lines 45-55 as well as “ 9 cm H.sub.2 O CPAP” Column 3, Lines 5-30. To achieve this therapeutic pressure, Sullivan teaches the configuration of the patient interface in the form of a nasal mask (5, “Communicating with nose piece (3) is a face mask (5) adapted to be sealingly attached to a patient's nose and providing communication between the patient's nostrils and the interior of nose piece (3).” Abstract) to encompass the nose of the patient (via 7, “Nose mask 5 is shaped so as to fit over most noses and includes a cavity 7 for this purpose. Communicating between cavity 7 and the interior of nostril piece 3 are two openings 6 which are substantially aligned respectively with a patient's nostrils when nose mask 5 is in place.” Column 2, Lines 30-40), and further including a seal (“In use a seal is produced from surgical grade silicon, such as Dow Corning Silastic 382 (Registered Trade Mark), rubber by forming it around the inside of cavity 7 and placing the apparatus in its working position on the patient.” Column 2, Lines 55-65). The resultant effect of this configuration is the ability of Sullivan to provide therapeutic pressure to treat the patient’s disordered breathing.
Regarding the second material being silicone, Chodkowski teaches a patient interface (Figure 4), comprising: a plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) pressurizable to a therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.” Para 0005) above ambient pressure, the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) including a plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (“continuous positive airway pressure (CPAP) or variable airway pressure”) for breathing by the patient; a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to a patient’s airways for sealed delivery of a flow of air at the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) through a patient’s respiratory cycle in use, said seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) having hole therein such that the flow of air at said therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) is delivered to at least an entrance to the patient’s nares, the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to maintain the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) in the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) through the patient’s respiratory cycle in use; a positioning and stabilizing structure (40, “FIG. 4 shows a side view of another example headgear assembly 40 formed in accordance with an embodiment of the present invention disposed on the head of a patient.” Para 0049) to provide a force to hold a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (40) comprising: a top strap (47, “a top strap 47” Para 0050) constructed and arranged to contact, in use, at least a region of the patient’s head superior to the otobasion superior of the patient’s head, a side strap (42, “a forward strap member 42” Para 0050) coupled to the top strap (47), the side strap (42) constructed and arranged, in use, to extend in an anterior and inferior direction towards the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4), and a rear strap (one of 41/43 AND one of 44/46, “Another portion 43 of second material B.sub.2 is disposed adjacent, and coupled to a rear edge (not numbered) of c-shaped portion 41 and is used to stabilize back straps 44 and 46.” Para 0050) coupled (at B2) to the top strap (47) and the side strap (42), the rear strap (one of 41/43 AND one of 44/46) being arranged to extend in a posterior and inferior direction on the patient’s head in order to contact, in use, an occiput of the patient’s head, the rear strap (one of 41/43 AND one of 44/46) is constructed from a first material (A2 or B2, wherein A2 – “A flexible, minimally elastic, preferably inelastic, first material A.sub.2 (e.g., without limitation, a foam core material with a non-elastic backing)” Para 0049; also see: “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” Para 0057; and wherein B2 – “A more stiff, preferably nearly rigid, second material B.sub.2 (e.g., a layered material including a rigid polymer sheet)” Para 0050; also see: “Mylar, polyethylene, Nylon, UBL, and various dense foams are non-limiting examples of suitable inelastic materials.” Para 0057) and a second material (C2, “A third, generally elastic and flexible material C.sub.2 (e.g., a material having an elongation in the range of about 125% to 150%)” Para 0050; also see: “Polyurethane, silicone, and certain foams are non-limiting examples of suitable semi-elastic materials.” Para 0057), the first material (A2/B2) arranged to contact, in use, a temporal region of the patient’s head, and the second material (C2) arranged to contact, in use, the occiput of the patient’s head, wherein the second material is silicone (“silicone” Para 0057), wherein the second material (C2) is configured to limit motion of the top strap (47) and/or the side strap (42) in an anterior and/or posterior direction while in the therapeutically effective position on the patient’s head; and wherein the patient interface (Figure 4) is configured to allow the patient to breath from ambient through their mouth (by the known embodiments of “a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs” Para 0006) in the absence of a flow of pressurized air through the plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions), or patient interface is configured to leave the patient’s mouth uncovered. Silicone is a known material composition suitable for the formation of a positioning and stabilizing structure in order to maintain the patient interface on the head of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operation of the therapeutic pressure of Walls to operate at “at least 6 cm of water” as taught by Sullivan to be a known therapeutic pressure suitable for treating sleep disordered breathing by with a sealed patient interface, and to modify the material composition of the second material of the rear strap to be silicone, as taught by Chodkowski to formulate a positioning and stabilizing structure suitable for retaining the patient interface on the head of the patient.
As to Claim 2, the modified Walls, specifically Walls discloses the second material (122) does not extend across the parietal bone of the patient’s head.
As to Claim 3, the modified Walls, specifically Walls discloses the rear strap (the combination of 114 posterior to 158 AND 122) does not extend across the parietal bone from a left side of the patient’s head to a right side of the patient’s head.
As to Claim 4, the modified Walls, specifically Walls discloses the positioning and stabilizing structure (104) does not extend across a STE muscle of the patient (best seen Figure 16).
As to Claim 5, the modified Walls, specifically Walls discloses the first material (“stretchable material … tubular-knitted elastic strap” Para 0085), and the modified Walls, specifically Chodkowski teaches the second material to be silicone. Silicone is a naturally tacky material with a static coefficient of friction around 1.0 μₛ; while, e.g. velstretch has a static coefficient of friction between 0.4-0.6 μₛ and e.g. spandex 0.1 – 0.2 μₛ. Thus, the coefficient of friction of the second material is greater than that of the first material.
As to Claim 11, the modified Walls, specifically Walls discloses the first material (“stretchable material … tubular-knitted elastic strap” Para 0085) is a textile.
As to Clam 12, the modified Walls, specifically Walls discloses the first material (“stretchable material … tubular-knitted elastic strap” Para 0085) is an elastic, and is configured in use to increase in length as a result of a tensile force.
As to Claim 13, the modified Walls, specifically Walls discloses the second material does not contact the temporal region below the otobasion inferior of the patient’s head.
As to Claim 14, the modified Walls, specifically Walls discloses a pad (126, “The illustrated sleeve 122 also has a contact surface 126. The contact surface 126 is the surface that will be directly in contact with the wearer. In the illustrated configuration, the contact surface 126 is enlarged relative to the corresponding surface of the main strap 114. In the illustrated configuration, the contact surface 126 and the opposite surface both can provide an elongate flattened surface. By providing an elongate flattened surface, labeling can be positioned on the sleeve 122, which can be used to provide guidance for the proper orientation of the main strap 114 when donning the interface and headgear assembly 100. In some configurations, the contact surface 126 can be provided with surface texturing or the like to enhance gripping on short haired or bald headed patients.” Para 0096) constructed form the second material, the pad (126) configured to grip the occiput in order to provide an anchor point for a gas delivery tube.
As to Claim 15, the modified Walls, specifically Walls discloses the pad (126) includes an adjustment mechanism (via sliding along 114 via 124 – “the sleeve 122 is repositionable along the main strap 114 in any location between the ends 116” Para 0094).
As to Claim 17, the modified Walls, specifically Walls discloses the first material (via 114 posterior to 158) and the second material (via 122) are permanently affixed to one another (“In some configurations, the sleeve 122 is secured to the main strap 114 and cannot be removed and/or cannot be moved along the length of the main strap 114.” Para 0094).
As to Claim 18, the modified Walls, specifically Walls discloses a tab (158, “In some configurations, the passage 156 can be defined by three supporting components 158. The supporting components 158 are spaced apart along a length of the second bridge region 146. In some configurations, two of the three supporting components 158 are configured to secure the main strap 114 against significant upward movement relative to the second bridge region 146 while the third of the three supporting components 158 is configured to secure the main strap 114 against significant downward movement relative to the second bridge region 146. In some configurations, all three of the supporting components 158 are configured to secure the main strap against significant downward movement relative to the second bridge region 146.” Para 0110) coupled between the top strap (130) and the side strap (via 114 anterior to 158), the rear strap (122 – “In configurations in which the sleeve 122 is removable, the openings 124 can be sufficiently large or flexible to accommodate the hook members 118A, 118B.” Para 0095) being removably coupled to the tab (158).
As to Claim 19, the modified Walls, specifically Walls discloses the first material (via 114 posterior to 158) of the rear strap extends from the tab (158) to the second material (122).
Claims 1-4, 8, 18, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Veliss et al. (2010/0018534) in view of Sullivan (4,944,310) in view of Chodkowski et al. (2014/0305439).
As to Claim 1, Veliss discloses patient interface (Figures 1-1 thru 1-6, 6-3, and 6-4) comprising: a plenum chamber (20) pressurisable to a therapeutic pressure above ambient air pressure, said plenum chamber (20) including a plenum chamber inlet port (22) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure (80) constructed and arranged to form a seal with a region of a patient’s face surrounding an entrance to a patient’s airways for sealed delivery of a flow of air at the therapeutic pressure throughout a patient’s respiratory cycle in use, said seal-forming structure (80) having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to a patient’s nares, the seal-forming structure (80) constructed and arranged to maintain said therapeutic pressure in the plenum chamber (20) throughout the patient’s respiratory cycle in use; a positioning and stabilizing structure (30) to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient’s head, the positioning and stabilizing structure comprising: a top strap (42 above the ears toward 70) constructed and arranged to contact, in use, at least a region of the patient’s head superior to an otobasion superior of the patient’s head, a side strap (42 below the ears toward 22) coupled to the top strap (42 above the ears toward 70), the side strap (42 below the ears toward 22) constructed and arranged, in use, to extend in an anterior and inferior direction toward the seal-forming structure (80), and a rear strap (60) coupled to the top strap (42 above the ears toward 70) and the side strap (42 below the ears toward 22), the rear strap (60) being arranged to extend in a posterior and inferior direction on the patient’s head in order to contact, in use, an occiput of the patient’s head; and a vent structure (81) to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber (20) to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber (20) in use, wherein the patient interface is configured to allow the patient to breath from ambient through their mouth in the absence of a flow of pressurised air through the plenum chamber inlet port, or the patient interface is configured to leave the patient’s mouth uncovered.
Yet, Veliss does not expressly disclose the configuration by which the therapeutic pressure is “at least 6 cm of H2O” nor the rear strap having a first material and a second material, wherein the second material is “silicone”.
Regarding the specific therapeutic pressure, Sullivan teaches a similar device to Veliss capable for operating at a therapeutic pressure. In this configuration of providing a therapeutic pressure, Sullivan teaches “A typical relative pressure for a patient may be 6 cm H.sub.2 O although a range from 4 to 15 cms H.sub.2 O would cover most if not all individuals.” Column 2, Lines 45-55 as well as “ 9 cm H.sub.2 O CPAP” Column 3, Lines 5-30. To achieve this therapeutic pressure, Sullivan teaches the configuration of the patient interface in the form of a nasal mask (5, “Communicating with nose piece (3) is a face mask (5) adapted to be sealingly attached to a patient's nose and providing communication between the patient's nostrils and the interior of nose piece (3).” Abstract) to encompass the nose of the patient (via 7, “Nose mask 5 is shaped so as to fit over most noses and includes a cavity 7 for this purpose. Communicating between cavity 7 and the interior of nostril piece 3 are two openings 6 which are substantially aligned respectively with a patient's nostrils when nose mask 5 is in place.” Column 2, Lines 30-40), and further including a seal (“In use a seal is produced from surgical grade silicon, such as Dow Corning Silastic 382 (Registered Trade Mark), rubber by forming it around the inside of cavity 7 and placing the apparatus in its working position on the patient.” Column 2, Lines 55-65). The resultant effect of this configuration is the ability of Sullivan to provide therapeutic pressure to treat the patient’s disordered breathing.
Regarding the rear strap having a first material and the second material, wherein the second material being silicone, Chodkowski teaches a patient interface (Figure 4), comprising: a plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) pressurizable to a therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.” Para 0005) above ambient pressure, the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) including a plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (“continuous positive airway pressure (CPAP) or variable airway pressure”) for breathing by the patient; a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to a patient’s airways for sealed delivery of a flow of air at the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) through a patient’s respiratory cycle in use, said seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) having hole therein such that the flow of air at said therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) is delivered to at least an entrance to the patient’s nares, the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) constructed and arranged to maintain the therapeutic pressure (“continuous positive airway pressure (CPAP) or variable airway pressure”) in the plenum chamber (“a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth” Para 0006) through the patient’s respiratory cycle in use; a positioning and stabilizing structure (40, “FIG. 4 shows a side view of another example headgear assembly 40 formed in accordance with an embodiment of the present invention disposed on the head of a patient.” Para 0049) to provide a force to hold a seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4) in a therapeutically effective position on the patient’s head, the positioning and stabilizing structure (40) comprising: a top strap (47, “a top strap 47” Para 0050) constructed and arranged to contact, in use, at least a region of the patient’s head superior to the otobasion superior of the patient’s head, a side strap (42, “a forward strap member 42” Para 0050) coupled to the top strap (47), the side strap (42) constructed and arranged, in use, to extend in an anterior and inferior direction towards the seal forming structure (defined by the exterior perimeter that abuts the skin of the patient in Figure 4), and a rear strap (one of 41/43 AND one of 44/46, “Another portion 43 of second material B.sub.2 is disposed adjacent, and coupled to a rear edge (not numbered) of c-shaped portion 41 and is used to stabilize back straps 44 and 46.” Para 0050) coupled (at B2) to the top strap (47) and the side strap (42), the rear strap (one of 41/43 AND one of 44/46) being arranged to extend in a posterior and inferior direction on the patient’s head in order to contact, in use, an occiput of the patient’s head, the rear strap (one of 41/43 AND one of 44/46) is constructed from a first material (A2 or B2, wherein A2 – “A flexible, minimally elastic, preferably inelastic, first material A.sub.2 (e.g., without limitation, a foam core material with a non-elastic backing)” Para 0049; also see: “Velstretch and spandex are two non-limiting examples of suitable elastic materials.” Para 0057; and wherein B2 – “A more stiff, preferably nearly rigid, second material B.sub.2 (e.g., a layered material including a rigid polymer sheet)” Para 0050; also see: “Mylar, polyethylene, Nylon, UBL, and various dense foams are non-limiting examples of suitable inelastic materials.” Para 0057) and a second material (C2, “A third, generally elastic and flexible material C.sub.2 (e.g., a material having an elongation in the range of about 125% to 150%)” Para 0050; also see: “Polyurethane, silicone, and certain foams are non-limiting examples of suitable semi-elastic materials.” Para 0057), the first material (A2/B2) arranged to contact, in use, a temporal region of the patient’s head, and the second material (C2) arranged to contact, in use, the occiput of the patient’s head, wherein the second material is silicone (“silicone” Para 0057), wherein the second material (C2) is configured to limit motion of the top strap (47) and/or the side strap (42) in an anterior and/or posterior direction while in the therapeutically effective position on the patient’s head; and wherein the patient interface (Figure 4) is configured to allow the patient to breath from ambient through their mouth (by the known embodiments of “a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs” Para 0006) in the absence of a flow of pressurized air through the plenum chamber inlet port (defined by the conduit, tube in Figure 4 leading to the nasal/oral regions), or patient interface is configured to leave the patient’s mouth uncovered. Silicone is a known material composition suitable for the formation of a positioning and stabilizing structure in order to maintain the patient interface on the head of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the operation of the therapeutic pressure of Veliss to operate at “at least 6 cm of water” as taught by Sullivan to be a known therapeutic pressure suitable for treating sleep disordered breathing by with a sealed patient interface, and to modify the material composition of the rear strap to include a first material and a second material wherein the second material of the rear strap to be silicone, as taught by Chodkowski to formulate a positioning and stabilizing structure suitable for retaining the patient interface on the head of the patient.
As to Claim 2, the modified Vellis, specifically Vellis discloses the second material does not extend across a parietal bone of the patient’s head (Figures 1-1 thru 1-6, 6-3, and 6-4).
As to Claim 3, the modified Vellis, specifically Vellis discloses the rear strap does not extend across the parietal bone from a left side of the patient’s head to a right side of the patient’s head (Figures 1-1 thru 1-6, 6-3, and 6-4).
As to Claim 4, the modified Vellis, specifically Vellis discloses the positioning and stabilizing structure does not extend across a Sternocleidomastoid muscle of the patient (Figures 1-1 thru 1-6, 6-3, and 6-4).
As to Claim 8, the modified Vellis, specifically Vellis discloses the top strap (42 above the ears toward 70) and the side strap (42 below the ears toward 22) are formed as a continuous structure and are not connected using a fastener.
As to Claim 18, the modified Vellis, specifically Vellis discloses the positioning and stabilizing structure includes a tab (46) coupled between the top strap (42 above the ears toward 70) and the side strap (42 below the ears toward 22), the rear strap (60) being removably coupled to the tab (46).
As to Claim 26, the modified Vellis, specifically Vellis discloses the top strap (42 above the ears toward 70) and the side strap (42 below the ears toward 22) together define a gas delivery tube (40) formed as a continuous structure to receive the flow of air from a connection port (70) on top of the patient’s head and to deliver the flow of air to the entrance of the patient’s airways via the seal-forming structure (80).
Allowable Subject Matter
Claims 10, 16, and 20-25 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Formica et al. (8,950,404) discloses an additional positioning and stabilizing structure for a patient interface.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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